Plasma homovanillic acid differences in clinical subgroups of first episode schizophrenic patients.

PubMed

Baeza, Immaculada; Castro-Fornieles, Josefina; Deulofeu, Ramon; de la Serna, Elena; Goti, Javier; Salvà, Joan; Bernardo, Miquel

2009-07-30

This study evaluates the relationship between plasma homovanillic acid (pHVA) levels, which have been used to study the role of central dopamine in schizophrenia, and the positive/negative syndrome in first episode schizophrenic patients before and after antipsychotic treatment. Forty neuroleptic-naive first episode schizophrenic patients were monitored at baseline and on days 7, 14 and 28. Clinical status was evaluated with the Scale for the Assessment of Positive Symptoms (SAPS), the Scale for the Assessment of Negative Symptoms (SANS), and the Brief Psychotic Rating Scale. Plasma HVA levels were also measured. Patients were divided into predominantly positive or negative syndrome groups by subtracting SAPS from SANS scores, at baseline. A healthy control group was also enrolled. Schizophrenic patients as a group had significantly higher pHVA levels than controls at baseline (20.50+/-11.85 vs. 13.04+/-7.22 ng/ml). Moreover, 12 predominantly negative syndrome patients had similar mean baseline pHVA levels (21.30+/-12.36 ng/ml) to those of 28 predominantly positive syndrome patients (19.40+/-11.33 ng/ml). During follow-up, there was a different evolution of pHVA levels in the predominantly positive syndrome group than in the predominantly negative syndrome group, with a significantly greater global reduction of pHVA levels in the former. Although both groups showed clinical improvement following 4 weeks of treatment with risperidone, pHVA levels at endpoint were lower (13.29+/-5.91 ng/ml) than at baseline in patients in the predominantly positive syndrome group, while among those in the predominantly negative syndrome group there was no difference in pHVA levels before and after treatment (21.02+/-13.06 ng/ml). The different pHVA level profiles observed in predominantly positive and negative syndrome first episode patients after 4 weeks of treatment with risperidone suggest that each syndrome may have a different underlying neurobiology.

Effect of Health Education Based on Integrative Therapy of Chinese and Western Medicine for Adult Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Study.

PubMed

Shi, Mai; Liu, Zhao-Lan; Zhu, Yan-Bo; Xu, Mei-Yan; Duan, Xue-Ying; Shi, Hui-Mei; Jiang, Bo; Zhang, Xiao-Mei; Yu, Xiao-Han

2018-02-01

To investigate the effects of health education based on integrative therapy of Chinese and Western medicine for type 2 diabetes mellitus (T2DM) from the aspects of knowledge, attitude and practice (KAP), health-related quality of life (HRQoL), body mass index (BMI) and glucose control. Patients were individually randomized into intervention group (receiving integrative education, n=120) and control group (receiving usual education, n=120). The primary outcome was the changes in glycosylated hemoglobin A1c (HbA1c) levels after 3, 6, 9 and 12 months from baseline. Hierarchical linear models (HLMs) were used to assess within-group changes in outcomes over time and between-group differences in patterns of change. Secondary outcomes were KAP scores, HRQoL scores and BMI after 6 and 12 months, paired-sample t test was used to assess within-group changes in outcomes in 6 and 12 months, independent-sample t test was used to assess between-group differences in patterns of change. HbA1c decreased statistically from baseline to 3 months, from 3 to 6 months, from 6 to 9 months and from 9 to 12 months in the intervention group (all P<0.01); and decreased significantly from baseline to 3 months, and from 3 to 6 months in the control group P<0.01). There was a significant between-group difference from baseline to 3 months (P=0.044), from 6 to 9 months (P<0.01) and from 9 to 12 months (P<0.01). Significant improvements in the intervention group along with significant between-group differences were found in KAP and HRQoL scores respectively (all P<0.05). The number in the intervention group of normal weight increased from 56 at baseline to 81 (6 months), 94 (12 months), the number in the control group were 63 (baseline), 69 (6 months), 70 (12 months), the χ 2 of hierarchical analysis of BMI were 6.93 (P=0.075), 10.31 (P=0.016), 15.53 (P<0.01), respectively. Health education based on integrative therapy of Chinese and Western medicine is beneficial to the control of T2DM and should be recommended for T2DM.

A Randomized, Double-Blind, Placebo-Controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients.

PubMed

Christie, Jennifer; Shroff, Sagar; Shahnavaz, Nikrad; Carter, Latoya A; Harrison, Melanie S; Dietz-Lindo, Karan A; Hanfelt, John; Srinivasan, Shanthi

2017-02-01

Constipation is the most common GI symptom in patients with diabetes mellitus (DM). Importantly, patients with constipation have lower health-related quality of life than those without constipation. Effective therapies for constipation are limited and there is a paucity of data evaluating the treatment of constipation in diabetics. Diabetic patients with chronic idiopathic constipation (CIC) as defined by Rome III criteria were recruited from outpatient clinics at a tertiary-care center and a Veterans Administration Hospital. Demographic data, baseline stool patterns, and a constipation-specific quality of life survey (Patient Assessment of Constipation Quality of Life (PAC-QOL)) were obtained. Baseline colonic transit time (CTT) was evaluated utilizing the wireless motility capsule. Patients were randomized in a double-blind fashion to 48 mcg per day lubiprostone or placebo for 8 weeks. The primary end point measured was the difference in number of spontaneous bowel movements (SBMs) per week vs. baseline for each group at each week after initiation of therapy. Secondary end points included changes in CTT after 4 weeks of therapy, PAC-QOL after 8 weeks of therapy, and changes from baseline in associated gastrointestinal (GI) symptoms as well as need for rescue medication at 2, 4, and 8 weeks. Seventy-six patients (mean age, 56.9±9.1 years, 62% females) were randomized. There were no significant differences between the two groups' baseline data or demographics. During the 8-week treatment period, patients in the lubiprostone group experienced an average of 1.83±0.80 (P=0.02) more SBMs per week than those in the placebo group as compared with baseline. The duration of CTT at Week 4 was shorter by an average of 13 h compared with baseline in the lubiprostone group, and was prolonged by an average of 7 h compared with baseline in the placebo group, leading to a treatment effect of 20.3±7.3 h (P=0.006). PAC-QOL improved in both the groups; however, there was no significant difference between the groups. There was no difference in associated GI symptoms and need for rescue medication between the two groups after 8 weeks. There were no serious adverse events reported during the study. This study suggests that lubiprostone is a safe and effective treatment for increasing weekly SBMs and decreasing CTT in patients with DM and CIC.

The impact of insight in a first-episode mania with psychosis population on outcome at 18 months.

PubMed

Smith, Leo T; Shelton, Clare L; Berk, Michael; Hasty, Melissa K; Cotton, Sue M; Henry, Lisa; Daglas, Rothanthi; Gentle, Ellen; McGorry, Patrick D; Macneil, Craig A; Conus, Philippe

2014-01-01

To explore whether poor initial insight during a first episode of mania with psychotic features was predictive of poor psychosocial and clinical outcomes at 18 months. Secondary analysis was performed on data collected during an 8-week RCT comparing the efficacy of olanzapine versus chlorpromazine as an adjunct to lithium, and at 18-month follow-up. 74 participants were divided into three groups (no insight, partial insight, and full insight) according to the insight item from the Young Mania Rating Scale (YMRS). Differences between these three groups were examined at baseline and at 18 months on measures of symptoms (YMRS, HAMD-21, and CGI-S), and social and occupational functioning (SOFAS). Baseline differences between the three groups were determined using general linear models and chi-squared analyses. Group differences from baseline to 18-month follow-up were determined using repeated measures general linear models. At baseline there were significant differences between the three insight groups in terms of mania and functioning, but at 18 months all groups had improved significantly in terms of psychopathology, mania, depression and social and occupational functioning. There were no significant differences between the three groups at study completion with respect to these domains. The study was limited by the lack of availability of a more detailed rating scale for insight, and it did not account for the duration of untreated psychosis (DUI). Poor initial insight during a first episode of mania with psychotic features does not predict poor clinical and psychosocial outcome at 18 months. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

Effect of lidocaine patches on upper trapezius EMG activity and pain intensity in patients with myofascial trigger points: A randomized clinical study.

PubMed

Firmani, Mónica; Miralles, Rodolfo; Casassus, Rodrigo

2015-04-01

To compare the effects of 5% lidocaine patches and placebo patches on pain intensity and electromyographic (EMG) activity of an active myofascial trigger point (MTrP) of the upper trapezius muscle. Thirty-six patients with a MTrP in the upper trapezius muscle were randomly divided into two groups: 20 patients received lidocaine patches (lidocaine group) and 16 patients received placebo patches (placebo group). They used the patches for 12 h each day, for 2 weeks. The patch was applied to the skin over the upper trapezius MTrP. Spontaneous pain, pressure pain thresholds, pain provoked by a 4-kg pressure applied to the MTrP and trapezius EMG activity were measured before and after treatment. Baseline spontaneous pain values were similar in both groups and significantly lower in the lidocaine group than the placebo group after treatment. The baseline pressure pain threshold was significantly lower in the lidocaine group, but after treatment it was significantly higher in this group. Baseline and final values of the pain provoked by a 4-kg pressure showed no significant difference between the groups. Baseline EMG activity at rest and during swallowing of saliva was significantly higher in the lidocaine group, but no significant difference was observed after treatment. Baseline EMG activity during maximum voluntary clenching was similar in both groups, but significantly higher in the lidocaine group after treatment. These clinical and EMG results support the use of 5% lidocaine patches for treating patients with MTrP of the upper trapezius muscle.

Clinical and Radiographic Comparative Evaluation of Buccal and Palatal Corticotomy with Buccal Corticotomy in Periodontally Accelerated Osteogenic Orthodontics with Surgical Bur

PubMed Central

Addanki, Pavankumar; Gooty, Jagadish Reddy; Palaparthy, Rajababu

2017-01-01

Background: Periodontally accelerated osteogenic orthodontics is a clinical procedure that combines selective corticotomy, particulate grafting, and application of orthodontics. It reduces treatment time, increases stability of teeth, and prevents relapse of orthodontic tooth moment. The present study was aimed to explore the clinical and radiographic comparison of bone density changes, retraction time differences in buccal and palatal corticotomy with buccal corticotomy which was done by surgical bur. Materials and Methods: A split-mouth was designed in 16 patients and divided into right (buccal and palatal corticotomy) (Group I), left (buccal corticotomy) (Group II) sides. In both groups, decortication was done with surgical bur. Clinical parameters such as gingival bleeding index and probing pocket depth were recorded at baseline, 1 month, 3 months, and 6 months. Bone density changes were measured by computed tomography at baseline and after 6 months after surgery and also used for evaluating differences in bone density changes between two groups. Retraction time differences were also measured in both groups. Results: In both groups, there was significant difference between bone density changes at baseline and 6 months after surgery. However, the difference between two groups was not significant. The difference in clinical parameters between two groups was not significant. The difference in retraction time differences was not significant. Conclusion: Within limits of the study, it may be concluded that there was difference between bone density changes before and 6 months after surgery. Difference in total treatment time found to be no significant between two groups. PMID:28839422

Methylphenidate during early consolidation affects long-term associative memory retrieval depending on baseline catecholamines.

PubMed

Wagner, Isabella C; van Buuren, Mariët; Bovy, Leonore; Morris, Richard G; Fernández, Guillén

2017-02-01

Synaptic memory consolidation is thought to rely on catecholaminergic signaling. Eventually, it is followed by systems consolidation, which embeds memories in a neocortical network. Although this sequence was demonstrated in rodents, it is unclear how catecholamines affect memory consolidation in humans. Here, we tested the effects of catecholaminergic modulation on synaptic and subsequent systems consolidation. We expected enhanced memory performance and increased neocortical engagement during delayed retrieval. Additionally, we tested if this effect was modulated by individual differences in a cognitive proxy measure of baseline catecholamine synthesis capacity. Fifty-three healthy males underwent a between-subjects, double-blind, placebo-controlled procedure across 2 days. On day 1, subjects studied and retrieved object-location associations and received 20 mg of methylphenidate or placebo. Drug intake was timed so that methylphenidate was expected to affect early consolidation but not encoding or retrieval. Memory was tested again while subjects were scanned three days later. Methylphenidate did not facilitate memory performance, and there was no significant group difference in activation during delayed retrieval. However, memory representations differed between groups depending on baseline catecholamines. The placebo group showed increased activation in occipito-temporal regions but decreased connectivity with the hippocampus, associated with lower baseline catecholamine synthesis capacity. The methylphenidate group showed stronger activation in the postcentral gyrus, associated with higher baseline catecholamine synthesis capacity. Altogether, methylphenidate during early consolidation did not foster long-term memory performance, but it affected retrieval-related neural processes depending on individual levels of baseline catecholamines.

Do compensation processes impair mental health? A meta-analysis.

PubMed

Elbers, Nieke A; Hulst, Liesbeth; Cuijpers, Pim; Akkermans, Arno J; Bruinvels, David J

2013-05-01

Victims who are involved in a compensation processes generally have more health complaints compared to victims who are not involved in a compensation process. Previous research regarding the effect of compensation processes has concentrated on the effect on physical health. This meta-analysis focuses on the effect of compensation processes on mental health. Prospective cohort studies addressing compensation and mental health after traffic accidents, occupational accidents or medical errors were identified using PubMed, EMBASE, PsycInfo, CINAHL, and the Cochrane Library. Relevant studies published between January 1966 and 10 June 2011 were selected for inclusion. Ten studies were included. The first finding was that the compensation group already had higher mental health complaints at baseline compared to the non-compensation group (standardised mean difference (SMD)=-0.38; 95% confidence interval (CI) -0.66 to -0.10; p=.01). The second finding was that mental health between baseline and post measurement improved less in the compensation group compared to the non-compensation group (SMD=-0.35; 95% CI -0.70 to -0.01; p=.05). However, the quality of evidence was limited, mainly because of low quality study design and heterogeneity. Being involved in a compensation process is associated with higher mental health complaints but three-quarters of the difference appeared to be already present at baseline. The findings of this study should be interpreted with caution because of the limited quality of evidence. The difference at baseline may be explained by a selection bias or more anger and blame about the accident in the compensation group. The difference between baseline and follow-up may be explained by secondary gain and secondary victimisation. Future research should involve assessment of exposure to compensation processes, should analyse and correct for baseline differences, and could examine the effect of time, compensation scheme design, and claim settlement on (mental) health. Copyright © 2011 Elsevier Ltd. All rights reserved.

Effect of estrogen therapy for 1 year on thyroid volume and thyroid nodules in postmenopausal women.

PubMed

Ceresini, Graziano; Milli, Bruna; Morganti, Simonetta; Maggio, Marcello; Bacchi-Modena, Alberto; Sgarabotto, Maria Paola; Chirico, Carla; Di Donato, Pietro; Campanati, Paolo; Valcavi, Roberto; Ceda, Gian Paolo; Braverman, Lewis E; Valenti, Giorgio

2008-01-01

Estrogen receptors are present in thyroid follicular cells in normal and neoplastic tissue. We evaluated changes in total thyroid volume and volume of thyroid nodules in postmenopausal women given either hormone therapy (HT) or no treatment in a 1-year observational follow-up. We studied 33 women receiving HT and 76 women receiving no treatment, comparing total thyroid volume, thyroid nodule volume, and serum concentrations of thyroid-stimulating hormone and estradiol at baseline and 1 year of follow-up. Serum thyroid-stimulating hormone concentrations were not different between groups either at baseline or at 1 year. Estradiol rose significantly in the HT group. The final percent changes in total thyroid volume were comparable between groups (HT, 1.59 +/- 2.56%; no treatment, 1.20 +/- 2.28%). At baseline, nodules were detected in 17 (51.5%) and 33 (43.4%) of women in the HT and no treatment groups, respectively, with no statistically significant difference between groups. The final number of nodules was unchanged or reduced in 88.2% and 81.1% and increased in 11.8% and 18.9% of women in the HT and no treatment groups, respectively, with no differences between groups. Baseline volumes of thyroid nodules were 0.8 +/- 0.4 and 1.4 +/- 0.4 mL in women in the HT and no treatment groups, respectively (P = 0.4). After 1 year the volume of thyroid nodules was unchanged or reduced in 47.1% and 52.8% and increased in 52.9% and 47.2% of women in the HT and no treatment groups, respectively, with no differences between groups. Estrogen administration for 1 year did not affect thyroid volume or the number and volume of thyroid nodules in postmenopausal women.

Performance Differences in Year 1 of Pioneer Accountable Care Organizations

PubMed Central

McWilliams, J. Michael; Chernew, Michael E.; Landon, Bruce E.; Schwartz, Aaron L.

2015-01-01

BACKGROUND In 2012, a total of 32 organizations entered the Pioneer accountable care organization (ACO) program, in which providers can share savings with Medicare if spending falls below a financial benchmark. Performance differences associated with characteristics of Pioneer ACOs have not been well described. METHODS In a difference-in-differences analysis of Medicare fee-for-service claims, we compared Medicare spending for beneficiaries attributed to Pioneer ACOs (ACO group) with other beneficiaries (control group) before (2009 through 2011) and after (2012) the start of Pioneer ACO contracts, with adjustment for geographic area and beneficiaries’ sociodemographic and clinical characteristics. We estimated differential changes in spending for several subgroups of ACOs: those with and those without clear financial integration between hospitals and physician groups, those with higher and those with lower baseline spending, and the 13 ACOs that withdrew from the Pioneer program after 2012 and the 19 that did not. RESULTS Adjusted Medicare spending and spending trends were similar in the ACO group and the control group during the precontract period. In 2012, the total adjusted per-beneficiary spending differentially changed in the ACO group as compared with the control group (−$29.2 per quarter, P = 0.007), consistent with a 1.2% savings. Savings were significantly greater for ACOs with baseline spending above the local average, as compared with those with baseline spending below the local average (P = 0.05 for interaction), and for those serving high-spending areas, as compared with those serving low-spending areas (P = 0.04). Savings were similar in ACOs with financial integration between hospitals and physician groups and those without, as well as in ACOs that withdrew from the program and those that did not. CONCLUSIONS Year 1 of the Pioneer ACO program was associated with modest reductions in Medicare spending. Savings were greater for ACOs with higher baseline spending than for those with lower baseline spending and were unrelated to withdrawal from the program. (Funded by the National Institute on Aging and others.) PMID:25875195

Effect of simvastatin on CSF Alzheimer disease biomarkers in cognitively normal adults.

PubMed

Li, Ge; Mayer, Cynthia L; Morelli, Daniel; Millard, Steven P; Raskind, Wendy H; Petrie, Eric C; Cherrier, Monique; Fagan, Anne M; Raskind, Murray A; Peskind, Elaine R

2017-09-19

To examine potential disease-modifying effects of statin drugs, we conducted a 12-month randomized, placebo-controlled clinical trial of simvastatin in cognitively normal adults using change in CSF Alzheimer disease biomarkers as primary outcome measure. Participants were 45-64 years old and statin-naive with normal cognition and normal or mildly elevated cholesterol. Forty-six participants completed the 1-year study per protocol (25 in the simvastatin and 21 in the placebo group). Simvastatin was titrated to 40 mg/d. CSF Aβ 42 , total tau, and p-tau 181 were measured at baseline and after 12 months of treatment using the INNO-BIA AlzBio3 assay. We used analysis of covariance to assess differences in biomarker change from baseline between treatment groups, adjusting for age, sex, and APOE ε4 status. Changes from baseline did not differ significantly between treatment groups for any CSF biomarker, with p values of 0.53, 0.36, and 0.25 for CSF Aβ 42 , total tau, and p-tau 181 , respectively. There was no significant modifying effect of sex, APOE ε4, or baseline high-density lipoprotein or triglycerides on treatment group for any of the biomarkers (all p > 0.18). However, a significant interaction between treatment group and baseline low-density lipoprotein (LDL) was observed for p-tau 181 ( p = 0.003), where greater decreases from baseline in CSF p-tau 181 concentrations were associated with higher baseline LDL level for the simvastatin group. Simvastatin-related reductions in CSF p-tau 181 concentrations may be modulated by LDL cholesterol. The potential disease-modifying effects of simvastatin on CSF phospho-tau should be further investigated in persons with hypercholesterolemia. © 2017 American Academy of Neurology.

No short-term effects of calorie-controlled Mediterranean or fast food dietary interventions on established biomarkers of vascular or metabolic risk in healthy individuals.

PubMed

Parcina, Marijo; Brune, Maik; Kaese, Vareska; Zorn, Markus; Spiegel, Rainer; Vojvoda, Valerija; Fleming, Thomas; Rudofsky, Gottfried; Paul Nawroth, Peter

2015-04-01

This study addressed the question whether the composition of supposedly 'healthy' or 'unhealthy' dietary regimes has a calorie-independent short-term effect on biomarkers of metabolic stress and vascular risk in healthy individuals. Healthy male volunteers (age 29.5 ± 5.9 years, n = 39) were given a standardized baseline diet for two weeks before randomization into three groups of different dietary regimes: fast food, Mediterranean and German cooking style. Importantly, the amount of calories consumed per day was identical in all three groups. Blood samples were analyzed for biomarkers of cardiovascular risk and metabolic stress after two weeks of the baseline diet and after two weeks of the assigned dietary regime. No dietary intervention affected the metabolic or cardiovascular risk profile when compared in-between groups or compared to baseline. Subjects applied to the Mediterranean diet showed a statistically significant increase of uric acid compared to baseline and compared to the German diet group. Plasma concentrations of urea were significantly higher in both the fast food group and the Mediterranean group, when compared to baseline and compared to the German diet group. No significant differences were detected for the levels of vitamins, trace elements or metabolic stress markers (8-hydroxy-2-deoxyguanosine, malondialdehyde and methylglyoxal, a potent glycating agent). Established parameters of vascular risk (e.g. LDL-cholesterol, lipoprotein(a), homocysteine) were not significantly changed in-between groups or compared to baseline during the intervention period. The calorie-controlled dietary intervention caused neither protective nor harmful short-term effects regarding established biomarkers of vascular or metabolic risk. When avoiding the noxious effects of overfeeding, healthy individuals can possess the metabolic capacity to compensate for a potentially disadvantageous composition of a certain diet.

Transient and residual stresses in a pressable glass-ceramic before and after resin-cement coating determined using profilometry.

PubMed

Isgró, G; Addison, O; Fleming, G J P

2011-05-01

The effect of heat-pressing and subsequent pre-cementation (acid-etching) and resin-cementation operative techniques on the development of transient and residual stresses in different thicknesses of a lithium disilicate glass-ceramic were characterised using profilometry prior to biaxial flexure strength (BFS) determination. 60 IPS e.max Press discs were pressed and divested under controlled conditions. The discs were polished on one surface to thicknesses of 0.61±0.05, 0.84±0.08, and 1.06±0.07 mm (Groups A-C, respectively). The mean of the maximum deflection (acid-etching and resin-coating was determined using high resolution profilometery prior to BFS testing. Paired sample t-tests were performed (p<0.05) on the 20 individual samples in each group (Groups A-C) for each comparison. Differences between the baseline quantification and resin-cement coating deflection values and BFS values for Groups A-C were determined using a one-way ANOVA with post hoc Tukey tests (p<0.05). Baseline quantification for Groups A-C identified no significant differences between the group means of the maximum deflection values (p=0.341). Following HF acid-etching, a significant increase in deflection for all groups (p<0.001) was identified compared with the baseline quantification. Additionally, resin-cement coating significantly increased deflection for Group A (p<0.001), Group B (p<0.001) and Group C (p=0.001) specimens for the individual groups. The increased deflection from baseline quantification to resin-cement coating was significantly different (p<0.001) for the three specimen thicknesses, although the BFS values were not. The lower reported baseline quantification range of the mean of the maximum deflection for the IPS e.max(®) Press specimens was predominantly the result of specimen polishing regime inducing a tensile stress state across the surface defect integral which accounted for the observed surface convexity. Acid-etching and resin-cementation had a significant impact on the development and magnitude of the transient and residual stresses in the lithium disilicate glass-ceramic investigated. Copyright © 2011 Elsevier Ltd. All rights reserved.

Premorbid determinants of left ventricular dysfunction in a novel model of gradually induced pressure overload in the adult canine

NASA Technical Reports Server (NTRS)

Koide, M.; Nagatsu, M.; Zile, M. R.; Hamawaki, M.; Swindle, M. M.; Keech, G.; DeFreyte, G.; Tagawa, H.; Cooper, G. 4th; Carabello, B. A.

1997-01-01

BACKGROUND: When a pressure overload is placed on the left ventricle, some patients develop relatively modest hypertrophy whereas others develop extensive hypertrophy. Likewise, the occurrence of contractile dysfunction also is variable. The cause of this heterogeneity is not well understood. METHODS AND RESULTS: We recently developed a model of gradual proximal aortic constriction in the adult canine that mimicked the heterogeneity of the hypertrophic response seen in humans. We hypothesized that differences in outcome were related to differences present before banding. Fifteen animals were studied initially. Ten developed left ventricular dysfunction (dys group). Five dogs maintained normal function (nl group). At baseline, the nl group had a lower mean systolic wall stress (96 +/- 9 kdyne/cm2; dys group, 156 +/- 7 kdyne/cm2; P < .0002) and greater relative left ventricular mass (left ventricular weight [g]/body wt [kg], 5.1 +/- 0.36; dys group, 3.9 +/- 0.26; P < .02). On the basis of differences in mean systolic wall stress at baseline, we predicted outcome in the next 28 dogs by using a cutoff of 115 kdyne/cm2. Eighteen of 20 dogs with baseline mean systolic stress > 115 kdyne/cm2 developed dysfunction whereas 6 of 8 dogs with resting stress < or = 115 kdyne/cm2 maintained normal function. CONCLUSIONS: We conclude that this canine model mimicked the heterogeneous hypertrophic response seen in humans. In the group that eventually developed dysfunction there was less cardiac mass despite 60% higher wall stress at baseline, suggesting a different set point for regulating myocardial growth in the two groups.

Effects of baseline risk information on social and individual choices.

PubMed

Gyrd-Hansen, Dorte; Kristiansen, Ivar Sønbø; Nexøe, Jørgen; Nielsen, Jesper Bo

2002-01-01

This article analyzes preferences for risk reductions in the context of individual and societal decision making. The effect of information on baseline risk is analyzed in both contexts. The results indicate that if individuals are to imagine that they suffer from 1 low-risk and 1 high-risk ailment, and are offered a specified identical absolute risk reduction, a majority will ceteris paribus opt for treatment of the low-risk ailment. A different preference structure is elicited when priority questions are framed as social choices. Here, a majority will prefer to treat the high-risk group of patients. The preference reversal demonstrates the extent to which baseline risk information can influence preferences in different choice settings. It is argued that presentation of baseline risk information may induce framing effects that lead to nonoptimal resource allocations. A solution to this problem may be to not present group-specific baseline risk information when eliciting preferences.

Efficacy of sublingual specific immunotherapy on allergic asthma and rhinitis in children's real life.

PubMed

De Castro, G; Zicari, A M; Indinnimeo, L; Tancredi, G; di Coste, A; Occasi, F; Castagna, G; Giancane, G; Duse, M

2013-08-01

Sublingual-specific immunotherapy (SLIT) is considered as a valid treatment of respiratory allergies. We performed a case-control study to evaluate the effect of SLIT in children with allergic asthma and rhinitis. The study plan included 140 patients (age 6-14 yr, 43% girls and 57% boys) presenting allergic rhinitis and/or asthma, 70 treated with SLIT actively for three years and 70 controls never treated with specific immunotherapy (only symptomatic drugs). Rhinitis Symptom Score (RSS), Asthma Symptom Score (ASS) and Medication Score (MS) were evaluated at beginning and during the 3 years of immunotherapy. results: There was a significant improvement of RSS (mean ± SD) in the SLIT group: baseline 5.31 ± 2.01, third year 1.38 ± 1.06 (p < 0.0001 vs baseline). baseline 5.00 ± 1.08, third year 4.68 ± 1.152 (P ¼ NS). ASS (mean ± SD) in the SLIT group: baseline 4.09 ± 2.21, third year 1.23 ± 1.4 (p < 0.0001 vs baseline). baseline 4.04 ± 2.46, third year 3.62 ± 2.26 (p ¼ NS). MS (mean ± SD) in the SLIT group: baseline 3.30 ± 1.4, third year 0.88 ± 1.26 (p < 0.0001 vs baseline). baseline 3.19 ± 1.23, third year 3.39 ± 1.12 (p ¼ NS). There are no statistically significant differences among monosensitized/polysensitized patients and at different age ranges. None of the patients included reported severe systemic reactions or anaphylaxis. During the treatment, the active group showed sustained reductions in mean asthma and rhinitis symptom scores when compared with controls to confirm the efficacy and safety of sublingual immunotherapy.

Differences in physical characteristics and response to rehabilitation for patients with hand dystonia: musicians' cramp compared to writers' cramp.

PubMed

McKenzie, Alison L; Goldman, Sarah; Barrango, Cindy; Shrime, Maria; Wong, Tricia; Byl, Nancy

2009-01-01

Pre-Post, Mixed Factorial Trial. Focal hand dystonia is a challenging movement disorder to rehabilitate in musicians and writers. To compare the neuromusculoskeletal characteristics of those with writers' cramp (WC) and musicians' cramp (MC), and evaluate responsiveness to learning-based sensorimotor training. Twenty-seven individuals (14 musicians, 13 writers) participated in 8 weeks of supervised therapy supplemented with a home program. Between-group differences on measures of musculoskeletal (physical), sensory, and motor performance were evaluated at baseline and post-intervention. Subjects with MC had a higher level of functional independence and better range of motion, but less strength in the affected upper limb than those of subjects with WC. Subjects with MC demonstrated greater accuracy on graphesthesia, kinesthesia, and localization at baseline. No between-group differences in motor performance were noted at baseline or post-intervention. Following individually adapted learning-based sensorimotor training, both groups improved in musculoskeletal (physical) parameters, sensory processing, and motor control; however, improvements on certain subtests differed by group. At follow-up, differences in posture, ROM, strength, graphesthesia, and kinesthesia persisted between the groups. Subjects with WC have different physical and performance risk factors compared with those of subjects with MC. Intervention paradigms are efficacious, but variable responses to rehabilitation occur.

Effect of Sedation with Xylazine and Ketamine on Intraocular Pressure in New Zealand White Rabbits

PubMed Central

Holve, Dana L; Gum, Glenwood G; Pritt, Stacy L

2013-01-01

To determine the effects of intravenous and intramuscular xylazine–ketamine on intraocular pressure (IOP) in laboratory rabbits, 10 New Zealand white rabbits received xylazine (0.46 mg/kg) and ketamine (1.5 mg/kg) intravenously whereas another 10 rabbits received intramuscular xylazine (10 mg/kg) and ketamine (50 mg/kg). IOP was measured at baseline and 5, 10, 20, and 25 min after administration in rabbits that were injected intravenously and at baseline and 10, 20, 30, and 45 min in rabbits injected intramuscularly. Baseline IOP (mean ± 1 SD; intravenous group, 20.15 ± 2.24 mm Hg; intramuscular group, 19.03 ± 1.77 mm Hg) did not differ between groups. Compared with baseline values, IOP decreased significantly after intravenous administration at 10, 20, and 25 min (decreases of 2.73, 4.10, and 4.55 mm Hg, respectively) but not at 5 min (decrease of 1.40 mm Hg). IOP in intramuscularly dosed rabbits showed significant differences from baseline at 10, 20, 30, and 45 min (decreases of 2.88, 3.30, 3.95, and 4.60 mm Hg, respectively). In the intravenous group, IOP differed at 10 min compared with 25 min (1.83 mm Hg, P = 0.0143) but not at 20 min compared with 25 min (0.450 mm Hg). In the intramuscular group, differences in IOP at 10 min compared with 20 min, 20 min compared with 30 min, and 30 min compared with 45 min were nonsignificant. Intravenous and intramuscular xylazine–ketamine decreased IOP in laboratory rabbits and may be used safely during ocular procedures for which increased IOP is a concern. PMID:23849448

Acute alcohol effects on set-shifting and its moderation by baseline individual differences: a latent variable analysis.

PubMed

Korucuoglu, Ozlem; Sher, Kenneth J; Wood, Phillip K; Saults, John Scott; Altamirano, Lee; Miyake, Akira; Bartholow, Bruce D

2017-03-01

To compare the acute effects of alcohol on set-shifting task performance (relative to sober baseline performance) during ascending and descending limb breath alcohol concentration (BrAC), as well as possible moderation of these effects by baseline individual differences. Shifting performance was tested during an initial baseline and a subsequent drinking session, during which participants were assigned randomly to one of three beverage conditions (alcohol, placebo or control) and one of two BrAC limb conditions [ascending and descending (A/D) or descending-only (D-only)]. A human experimental laboratory on the University of Missouri campus in Columbia, MO, USA. A total of 222 moderate-drinking adults (ages 21-30 years) recruited from Columbia, MO and tested between 2010 and 2013. The outcome measure was performance on set-shifting tasks under the different beverage and limb conditions. Shifting performance assessed at baseline was a key moderator. Although performance improved across sessions, this improvement was reduced in the alcohol compared with no-alcohol groups (post-drink latent mean comparison across groups, all Ps ≤ 0.05), and this effect was more pronounced in individuals with lower pre-drink performance (comparison of pre- to post-drink path coefficients across groups, all Ps ≤ 0.05). In the alcohol group, performance was better on descending compared with ascending limb (P ≤ 0.001), but descending limb performance did not differ across the A/D and D-only groups. Practising tasks before drinking moderates the acute effects of alcohol on the ability to switch between tasks. Greater impairment in shifting ability on descending compared with ascending breath alcohol concentration is not related to task practice. © 2016 Society for the Study of Addiction.

The impact of motivation on neuropsychological performance in sports-related mild traumatic brain injury.

PubMed

Bailey, Christopher M; Echemendia, Ruben J; Arnett, Peter A

2006-07-01

The current project examined the impact of differential motivation on baseline versus post-mild traumatic brain injury (MTBI) neuropsychological measures in athletes. Collegiate athletes were administered a neuropsychological battery prior to and post-MTBI. High Motivation at Baseline (HMB) and Suspect Motivation at Baseline (SMB) groups were established for each measure based on whether baseline performance fell +/- one or more standard deviations from the mean of the given measure. Greater improvement was expected in the SMB group than the HMB group given hypothesized differences in baseline motivation. In repeated measures analysis of covariance (ANCOVA) that removed achievement performance, the SMB groups demonstrated greater improvement than the HMB groups for the Trail Making Test A & B (TMT-A & B), Digit Span, and Stroop-Color Word (Stroop-CW) tests. Also, the percentage of participants who improved according to reliable change indices was greater for the SMB groups on the TMT-A & B, Stroop-CW, and the Vigil. These findings are likely due to lower motivation in the SMB group for each test. However, results also suggest that some tests may be relatively unaffected by motivation. These data may have clinical implications and point to the need for better methods of identifying athletes with suspect motivation at baseline.

Prognostic Value of Hypoalbuminemia After Transcatheter Aortic Valve Implantation (from the Japanese Multicenter OCEAN-TAVI Registry).

PubMed

Yamamoto, Masanori; Shimura, Tetsuro; Kano, Seiji; Kagase, Ai; Kodama, Atsuko; Sago, Mitsuru; Tsunaki, Tatsuya; Koyama, Yutaka; Tada, Norio; Yamanaka, Futoshi; Naganuma, Toru; Araki, Motoharu; Shirai, Shinichi; Watanabe, Yusuke; Hayashida, Kentaro

2017-03-01

Hypoalbuminemia, a frailty criterion, belongs to a group of co-morbidities not captured as a traditional risk factor. We assessed its prognostic value in patients who underwent transcatheter aortic valve implantation (TAVI). The study included 1,215 consecutive patients from the Optimized Catheter Valvular Intervention -TAVI Japanese multicenter registry. Hypoalbuminemia was defined as serum albumin level <3.5 g/dl. Baseline characteristics, procedural outcomes, and all-cause, cardiovascular and noncardiovascular mortality rates after TAVI were compared between patients with albumin level <3.5 g/dl (hypo[h]-ALB group, n = 284) and those with albumin level >3.5 g/dl (nonhypo[nh]-ALB group, n = 931). Several baseline characteristics differed significantly between both groups, including age (85.1 ± 5.1 vs 84.2 ± 4.9 years, p = 0.012), ejection fraction (58.5 ± 14.3% vs 62.9 ± 12.4%, p <0.001), baseline kidney function, or liver disease. The 30-day mortality rate in all patients showed significant differences between the 2 groups (3.9% vs 1.3%, p = 0.005). During a mean follow-up of 330 days, cumulative all-cause, cardiovascular, and noncardiovascular mortality rates were significantly higher in the hALB group than in the nhALB group (log-rank test, p <0.001, p = 0.0021, and p <0.001, respectively). The groups were also analyzed using a propensity matching model for adjusting the baseline differences. The analysis revealed that the poorer prognosis of the hALB group in terms of cumulative all-cause and noncardiovascular mortality was retained (p = 0.038, and p = 0.0068, respectively); however, differences in cardiovascular mortality rates in the 2 groups were attenuated (p = 0.93). In conclusion, hypoalbuminemia was associated with poor prognosis, highlighted by the increase in noncardiovascular mortality. Baseline albumin level could be a useful marker for risk stratification before TAVI. Copyright © 2016 Elsevier Inc. All rights reserved.

Assessing the learning curve for the acquisition of laparoscopic skills on a virtual reality simulator.

PubMed

Sherman, V; Feldman, L S; Stanbridge, D; Kazmi, R; Fried, G M

2005-05-01

The aim of this study was to develop summary metrics and assess the construct validity for a virtual reality laparoscopic simulator (LapSim) by comparing the learning curves of three groups with different levels of laparoscopic expertise. Three groups of subjects ('expert', 'junior', and 'naïve') underwent repeated trials on three LapSim tasks. Formulas were developed to calculate scores for efficiency ('time-error') and economy of 'motion' ('motion') using metrics generated by the software after each drill. Data (mean +/- SD) were evaluated by analysis of variance (ANOVA). Significance was set at p < 0.05. All three groups improved significantly from baseline to final for both 'time-error' and 'motion' scores. There were significant differences between groups in time error performances at baseline and final, due to higher scores in the 'expert' group. A significant difference in 'motion' scores was seen only at baseline. We have developed summary metrics for the LapSim that differentiate among levels of laparoscopic experience. This study also provides evidence of construct validity for the LapSim.

Effect of angiotensin converting enzyme inhibitor on glomerular hyperfiltration in patients with type 1 diabetes

PubMed Central

Naqvi, S. A. Jaffar; Ahsan, Shahid; Fawwad, Asher; Basit, Abdul; Shera, A Samad

2016-01-01

Objective: To assess the effect of angiotensin converting enzyme inhibition on glomerular filtration rate (GFR) in normotensive patient with type 1 diabetes. Methods: A two year non-placebo control prospective study was conducted after ethical approval at Diabetes Centre of Diabetic Association of Pakistan, a WHO collaborating centre in Karachi, Pakistan. All patients with type 1 diabetes visited the out-patients department from August 2009 till July 2011 and those who fulfilled the inclusion criteria were invited to participate. A total of 121 people aged ≥18 years and ≥ 5 years of diabetes were included. Pregnant and lactating woman and those aged <18 years were excluded. GFR was calculated by using CKD-EPI formula (eGFR) at baseline and after two year. On the basis of estimated GFR, patients at baseline were divided according to KDIGO classification of chronic kidney diseases into, hyperfiltration (eGFR ≥ 100 ml/min) and normal filtration group (eGFR < 100 ml/min). All subjects in hyperfiltration group received ACE inhibitor (treatment group) while patients with normal filtration did not receive ACE inhibitor (control group). Results: Fifty two patients (43%) were in the treatment and sixty nine (57%) were in the control group. At baseline eGFR, systolic and diastolic blood pressures between groups were non-significantly different. After two years, compared to baseline, eGFR of the treatment group declined and the control group increased significantly. No significant difference in systolic while diastolic blood pressure of the treatment group increased significantly after two years compared to baseline. In contrast both systolic and diastolic blood pressure of control group increased significantly after two years compared to their baseline values. Conclusion: Present study demonstrated that initiation of ACEI in hyperfiltration stage declined GFR and keep blood pressure within normal range. PMID:27375689

Effect of a Home-Based Exercise Program on Functional Recovery Following Rehabilitation After Hip Fracture A Randomized Clinical Trial

PubMed Central

Latham, Nancy K.; Harris, Bette Ann; Bean, Jonathan F.; Heeren, Timothy; Goodyear, Christine; Zawacki, Stacey; Heislein, Diane M.; Mustafa, Jabed; Pardasaney, Poonam; Giorgetti, Marie; Holt, Nicole; Goehring, Lori; Jette, Alan M.

2015-01-01

IMPORTANCE For many older people, long-term functional limitations persist after a hip fracture. The efficacy of a home exercise program with minimal supervision after formal hip fracture rehabilitation ends has not been established. OBJECTIVE To determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted from September 2008 to October 2012 in the homes of 232 functionally limited older adults who had completed traditional rehabilitation after a hip fracture. INTERVENTIONS The intervention group (n = 120) received functionally oriented exercises (such as standing from a chair, climbing a step) taught by a physical therapist and performed independently by the participants in their homes for 6 months. The attention control group (n = 112) received in-home and telephone-based cardiovascular nutrition education. MAIN OUTCOMES AND MEASURES Physical function assessed at baseline, 6 months (ie, at completion of the intervention), and 9 months by blinded assessors. The primary outcome was change in function at 6 months measured by the Short Physical Performance Battery (SPPB; range 0-12, higher score indicates better function) and the Activity Measure for Post-Acute Care (AM-PAC) mobility and daily activity (range, 23-85 and 9-101, higher score indicates better function). RESULTS Among the 232 randomized patients, 195 were followed up at 6 months and included in the primary analysis. The intervention group (n=100) showed significant improvement relative to the control group (n=95) in functional mobility (mean SPPB scores for intervention group: 6.2 [SD, 2.7] at baseline, 7.2 [SD, 3] at 6 months; control group: 6.0 [SD, 2.8] at baseline, 6.2 [SD, 3] at 6 months; and between-group differences: 0.8 [95% CI, 0.4 to 1.2], P < .001; mean AM-PAC mobility scores for intervention group: 56.2 [SD, 7.3] at baseline, 58.1 [SD, 7.9] at 6 months; control group: 56 [SD, 7.1] at baseline, 56.6 [SD, 8.1] at 6 months; and between-group difference, 1.3 [95% CI, 0.2 to 2.4], P = .03; and mean AM-PAC daily activity scores for intervention group: 57.4 [SD, 13.7] at baseline, 61.3 [SD, 15.7] at 6 months; control group: 58.2 [SD, 15.2] at baseline, 58.6 [SD, 15.3] at 6 months; and between-group difference, 3.5 [95% CI, 0.9 to 6.0], P = .03). In multiple imputation analyses, between-group differences remained significant for SPPB and AM-PAC daily activity, but not for mobility. Significant between-group differences persisted at 9 months for all functional measures with and without imputation. CONCLUSIONS AND RELEVANCE Among patients who had completed standard rehabilitation after hip fracture, the use of a home-based functionally oriented exercise program resulted in modest improvement in physical function at 6 months after randomization. The clinical importance of these findings remains to be determined. PMID:24549550

Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial.

PubMed

Latham, Nancy K; Harris, Bette Ann; Bean, Jonathan F; Heeren, Timothy; Goodyear, Christine; Zawacki, Stacey; Heislein, Diane M; Mustafa, Jabed; Pardasaney, Poonam; Giorgetti, Marie; Holt, Nicole; Goehring, Lori; Jette, Alan M

2014-02-19

For many older people, long-term functional limitations persist after a hip fracture. The efficacy of a home exercise program with minimal supervision after formal hip fracture rehabilitation ends has not been established. To determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended. Randomized clinical trial conducted from September 2008 to October 2012 in the homes of 232 functionally limited older adults who had completed traditional rehabilitation after a hip fracture. The intervention group (n = 120) received functionally oriented exercises (such as standing from a chair, climbing a step) taught by a physical therapist and performed independently by the participants in their homes for 6 months. The attention control group (n = 112) received in-home and telephone-based cardiovascular nutrition education. Physical function assessed at baseline, 6 months (ie, at completion of the intervention), and 9 months by blinded assessors. The primary outcome was change in function at 6 months measured by the Short Physical Performance Battery (SPPB; range 0-12, higher score indicates better function) and the Activity Measure for Post-Acute Care (AM-PAC) mobility and daily activity (range, 23-85 and 9-101, higher score indicates better function). Among the 232 randomized patients, 195 were followed up at 6 months and included in the primary analysis. The intervention group (n=100) showed significant improvement relative to the control group (n=95) in functional mobility (mean SPPB scores for intervention group: 6.2 [SD, 2.7] at baseline, 7.2 [SD, 3] at 6 months; control group: 6.0 [SD, 2.8] at baseline, 6.2 [SD, 3] at 6 months; and between-group differences: 0.8 [95% CI, 0.4 to 1.2], P < .001; mean AM-PAC mobility scores for intervention group: 56.2 [SD, 7.3] at baseline, 58.1 [SD, 7.9] at 6 months; control group: 56 [SD, 7.1] at baseline, 56.6 [SD, 8.1] at 6 months; and between-group difference, 1.3 [95% CI, 0.2 to 2.4], P = .03; and mean AM-PAC daily activity scores for intervention group: 57.4 [SD, 13.7] at baseline, 61.3 [SD, 15.7] at 6 months; control group: 58.2 [SD, 15.2] at baseline, 58.6 [SD, 15.3] at 6 months; and between-group difference, 3.5 [95% CI, 0.9 to 6.0], P = .03). In multiple imputation analyses, between-group differences remained significant for SPPB and AM-PAC daily activity, but not for mobility. Significant between-group differences persisted at 9 months for all functional measures with and without imputation. Among patients who had completed standard rehabilitation after hip fracture, the use of a home-based functionally oriented exercise program resulted in modest improvement in physical function at 6 months after randomization. The clinical importance of these findings remains to be determined. clinicaltrials.gov Identifier: NCT00592813.

Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy.

PubMed

Rompe, Jan D; Cacchio, Angelo; Weil, Lowell; Furia, John P; Haist, Joachim; Reiners, Volker; Schmitz, Christoph; Maffulli, Nicola

2010-11-03

Whether plantar fascia-specific stretching or shock-wave therapy is effective as an initial treatment for proximal plantar fasciopathy remains unclear. The aim of this study was to test the null hypothesis of no difference in the effectiveness of these two forms of treatment for patients who had unilateral plantar fasciopathy for a maximum duration of six weeks and which had not been treated previously. One hundred and two patients with acute plantar fasciopathy were randomly assigned to perform an eight-week plantar fascia-specific stretching program (Group I, n = 54) or to receive repetitive low-energy radial shock-wave therapy without local anesthesia, administered weekly for three weeks (Group II, n = 48). All patients completed the seven-item pain subscale of the validated Foot Function Index and a patient-relevant outcome questionnaire. Patients were evaluated at baseline and at two, four, and fifteen months after baseline. The primary outcome measures were a mean change in the Foot Function Index sum score at two months after baseline, a mean change in item 2 (pain during the first few steps of walking in the morning) on this index, and satisfaction with treatment. No difference in mean age, sex, weight, or duration of symptoms was found between the groups at baseline. At two months after baseline, the Foot Function Index sum score showed significantly greater changes for the patients managed with plantar fascia-specific stretching than for those managed with shock-wave therapy (p < 0.001), as well as individually for item 2 (p = 0.002). Thirty-five patients (65%) in Group I versus fourteen patients (29%) in Group II were satisfied with the treatment (p < 0.001). These findings persisted at four months. At fifteen months after baseline, no significant between-group difference was measured. A program of manual stretching exercises specific to the plantar fascia is superior to repetitive low-energy radial shock-wave therapy for the treatment of acute symptoms of proximal plantar fasciopathy.

Effect of health education on knowledge, attitude and practices of personal hygiene among secondary school students in rural Sokoto, North West, Nigeria.

PubMed

Abiola, A O; Nwogu, E E; Ibrahim, M T O; Hassan, R

2012-01-01

Personal hygiene related diseases are serious public health problems in developing countries. To assess the effect of health education on knowledge, attitude, and practices of personal hygiene among rural secondary school students in Sokoto state, north western Nigeria. A quasi-experimental controlled study with pretest and post-test design was carried out. A total 120 subjects per group were selected by multistage sampling technique. Two pre-tested instruments, structured interviewer-administered questionnaire and observer's checklist for personal hygiene practices were used for data collection. Health education intervention was carried out one week after baseline data collection and repeated after four weeks for the intervention group only. Postintervention data collection was carried out in both intervention and control groups three months after the 2nd intervention. However, for ethical consideration, the control group was also provided with the health education intervention similar to that provided to the intervention group. A total of 120 and 116 subjects in the intervention and control groups respectively participated in all phases of the study. The mean knowledge score (%) of the study subjects was high and similar (73.18 +/- 25.82; 77.06 +/- 21.79; p = 0.21) in both the intervention and control groups at baseline, but differed very significantly (91.16 +/- 11.03; 81.74 +/- 21.78; p < 0.0001) at post-intervention. The mean attitude score (%) was high but differ significantly (82.6 +/- 12.73; 86.38 +/- 10.74; p = 0.01) between the intervention and control groups at baseline, and further differed very significantly (95.5 +/- 3.66; 86.90 +/- 10.44; p < 0.0001) at post intervention. The mean reported practice score (%) was high but differ significantly (94.86 +/- 3.00; 93.25 +/- 6.31; p = 0.01) between the intervention and control groups at baseline, and further differed very significantly (96.68 +/- 4.08; 93.7 +/- 6.28; p < 0.0001) at post-intervention. The mean observed practice score (%) was high and similar (57.50 +/- 29.65; 61.35 +/- 28.49; p = 0.31) in both the intervention and control groups at baseline, but differed very significantly (88.20 +/- 9.99; 62.10 +/- 26.94; p < 0.0001) at post-intervention. Health education intervention had impact on knowledge base, attitude and practice of study subjects in intervention group compared to control group. Personal hygiene health education is therefore recommended to be taught in secondary schools.

Intravenous lipid emulsion alters the hemodynamic response to epinephrine in a rat model.

PubMed

Carreiro, Stephanie; Blum, Jared; Jay, Gregory; Hack, Jason B

2013-09-01

Intravenous lipid emulsion (ILE) is an adjunctive antidote used in selected critically ill poisoned patients. These patients may also require administration of advanced cardiac life support (ACLS) drugs. Limited data is available to describe interactions of ILE with standard ACLS drugs, specifically epinephrine. Twenty rats with intra-arterial and intravenous access were sedated with isoflurane and split into ILE or normal saline (NS) pretreatment groups. All received epinephrine 15 μm/kg intravenously (IV). Continuous mean arterial pressure (MAP) and heart rate (HR) were monitored until both indices returned to baseline. Standardized t tests were used to compare peak MAP, time to peak MAP, maximum change in HR, time to maximum change in HR, and time to return to baseline MAP/HR. There was a significant difference (p = 0.023) in time to peak MAP in the ILE group (54 s, 95 % CI 44-64) versus the NS group (40 s, 95 % CI 32-48) and a significant difference (p = 0.004) in time to return to baseline MAP in ILE group (171 s, 95 % CI 148-194) versus NS group (130 s, 95 % CI 113-147). There were no significant differences in the peak change in MAP, peak change in HR, time to minimum HR, or time to return to baseline HR between groups. ILE-pretreated rats had a significant difference in MAP response to epinephrine; ILE delayed the peak effect and prolonged the duration of effect of epinephrine on MAP, but did not alter the peak increase in MAP or the HR response.

Early antihypertensive treatment and clinical outcomes in acute ischemic stroke: subgroup analysis by baseline blood pressure.

PubMed

He, William J; Zhong, Chongke; Xu, Tan; Wang, Dali; Sun, Yingxian; Bu, Xiaoqing; Chen, Chung-Shiuan; Wang, Jinchao; Ju, Zhong; Li, Qunwei; Zhang, Jintao; Geng, Deqin; Zhang, Jianhui; Li, Dong; Li, Yongqiu; Yuan, Xiaodong; Zhang, Yonghong; Kelly, Tanika N

2018-06-01

We studied the effect of early antihypertensive treatment on death, major disability, and vascular events among patients with acute ischemic stroke according to their baseline SBP. We randomly assigned 4071 acute ischemic stroke patients with SBP between 140 and less than 220 mmHg to receive antihypertensive treatment or to discontinue all antihypertensive medications during hospitalization. A composite primary outcome of death and major disability and secondary outcomes were compared between treatment and control stratified by baseline SBP levels of less than 160, 160-179, and at least 180 mmHg. At 24 h after randomization, differences in SBP reductions were 8.8, 8.6 and 7.8 mmHg between the antihypertensive treatment and control groups among patients with baseline SBP less than 160, 160-179, and at least 180 mmHg, respectively (P < 0.001 among subgroups). At day 14 or hospital discharge, the primary and secondary outcomes were not significantly different between the treatment and control groups among subgroups. However, there was a significant interaction between antihypertensive treatment and baseline SBP subgroups on death (P = 0.02): odds ratio (95% CI) of 2.42 (0.74-7.89) in patients with baseline SBP less than 60 mmHg and 0.34 (0.11-1.09) in those with baseline SBP at least 180 mmHg. At the 3-month follow-up, the primary and secondary clinical outcomes were not significantly different between the treatment and control groups by baseline SBP levels. Early antihypertensive treatment had a neutral effect on clinical outcomes among acute ischemic stroke patients with various baseline SBP levels. Future clinical trials are warranted to test BP-lowering effects in acute ischemic stroke patients by baseline SBP levels. ClinicalTrials.gov Identifier: NCT01840072.

Changes in Eating Behaviors of Children with Obesity in Response to Carbohydrate-Modified and Portion-Controlled Diets.

PubMed

Kirk, Shelley; Woo, Jessica G; Brehm, Bonnie; Daniels, Stephen R; Saelens, Brian E

2017-10-01

This study's objective was to determine whether two distinct carbohydrate (CHO)-modified diets and a standard portion-controlled (PC) diet differentially impacted children's eating behaviors and whether eating behavior scores predicted lower BMI among children with obesity. Children (n = 102) aged 7-12 years with obesity were randomly assigned to a 12-month intervention of a low-carbohydrate (LC), reduced glycemic load (RGL), or standard PC diet. The Three-Factor Eating Questionnaire (TFEQ) was completed at baseline, 3, 6, and 12 months by parents to characterize their child's hunger (H), disinhibition (D), and cognitive restraint (CR). Baseline and follow-up TFEQ scores by diet were evaluated relative to BMI status over time. All diet groups showed increased CR and decreased H and D from baseline to 3 months, with differences from baseline remaining at 12 months for CR and H. Lower BMI status during study follow-up was associated with different TFEQ scores by diet group (LC and RGL: higher CR; PC: lower H), adjusting for sex, age, and race. Higher CR at follow-up was predicted by race and higher baseline CR; only lower H at baseline predicted lower H at follow-up. Eating behaviors improved significantly with all diets during the initial 3 months; higher CR and lower H were sustained at treatment's end. BMI outcomes were associated with different eating behaviors in CHO-modified diet groups compared with PC diets. Targeting diets of children with obesity with specific baseline characteristics may lead to improved outcomes.

The Seated Inactivity Trial (SIT): Physical Activity and Dietary Outcomes Associated With 8 Weeks of Imposed Sedentary Time.

PubMed

Cull, Brooke J; Haub, Mark D; Rosenkranz, Richard R; Lawler, Thomas; Rosenkranz, Sara K

2016-03-01

Sedentary time is an independent risk factor for chronic diseases and mortality. It is unknown whether active adults alter their dietary and/or physical activity behaviors in response to imposed sedentary time, possibly modifying risk. The aim of this study was to determine whether imposed sedentary time would alter typical behaviors of active adults. Sixteen physically active, young adults were randomized to the no-intervention control (CON, n = 8) group or the sedentary-intervention (SIT, n = 8) group. SIT participants attended monitored sedentary sessions (8 wk, 10 h/wk). Assessments including diet and physical activity occurred at baseline, week 4, and week 9. There were no differences (P > .05) between CON and SIT groups for step counts or time spent in sedentary, light, moderate, or vigorous physical activity when comparing a week during imposed sedentary time (week 4) to baseline and week 9. At week 4, caloric intake was not different from baseline (P > .05) in either group. Caloric intake decreased significantly (P > .05) in SIT from baseline to week 9. Active adults did not alter physical activity or dietary behaviors during the imposed sedentary intervention. However, SIT reduced caloric intake from baseline to week 9, indicating a possible compensatory response to imposed sitting in active adults.

Effect of Consuming Tea with Stevia on Salivary pH - An In Vivo Randomised Controlled Trial.

PubMed

Pallepati, Akhil; Yavagal, Puja; Veeresh, D J

To assess the effect of consuming tea with stevia on salivary pH. This randomised controlled trial employed a Latin square design. Twenty-four male students aged 20-23 years were randomly allocated to 4 different groups, 3 experimental with tea sweetened by sucrose, jaggery or stevia, and one unsweetened control. Salivary pH assessments were performed at baseline and 1 min, 20 and 60 min after consumption of the respective tea. One-way ANOVA and repeated measures ANOVA followed by Tukey's post-hoc tests were employed to analyse the data. One minute after tea consumption, the salivary pH of the sucrose group significantly decreased compared to the stevia group (p = 0.01). There was a significant difference between baseline mean salivary pH and post-interventional mean salivary pH values at all time intervals in the tea + sucrose, tea + jaggery, and plain tea groups (p < 0.01). One hour after consumption of tea, the salivary pH values reached the baseline pH in stevia and plain tea groups, but it remained lower in the sucrose and jaggery groups. The results of the present study, in which the salivary pH values returned to baseline pH 1 h after drinking stevia-sweetened tea, suggest stevia's potential as a non-cariogenic sweetener.

Effects of lifestyle intervention using patient-centered cognitive behavioral therapy among patients with cardio-metabolic syndrome: a randomized, controlled trial.

PubMed

Zhang, Ying; Mei, Songli; Yang, Rui; Chen, Ling; Gao, Hang; Li, Li

2016-11-18

Cardio-metabolic syndrome (CMS) is a highly prevalent condition. There is an urgent need to identify effective and integrated multi-disciplinary approaches that can reduce risk factors for CMS. Sixty-two patients with a history of CMS were randomized 1:1 into two groups: a standard information -only group (control), or a self-regulated lifestyle waist circumference (patient-centered cognitive behavioral therapy) intervention group. A pretest and posttest, controlled, experimental design was used. Outcomes were measured at the baseline (week 0) and at the end of intervention (week 12). Comparisons were drawn between groups and over time. The mean (standard deviation) age of the subjects was 48.6 (5.8) years ranging from 32 to 63, and 56.9% of the participants were female. Both groups showed no significant differences in Demographic variables and the metabolic syndrome indicators at baseline. While the control group only showed modest improvement after 12 weeks, compared to baseline, the intervention group demonstrated significant improvement from baseline. This study controlled for patients' demographics and baseline characteristics when assessing the effects of intervention. After adjusting for age, education and baseline level, the experimental group and the control group were statistically significant different in the following post-treatment outcomes: WC (F = 35.96, P < 0.001), TG (F = 18.93, P < 0.001), RSBP (F = 33.89, P < 0.001) and SF-36(F = 157.93, P < 0.001). The results showed patients' age and education were not strong predictors of patients' outcome (including WC, TG, RSBP and SF-36). Lifestyle intervention on patient-centered cognitive behavioral therapy can improve the physical and mental health conditions among individuals reporting a history of cardio-metabolic syndrome, and possibly provided preliminary benefits for the treatment of CMS. Chinese Clinical Trial Register #, ChiCTR15006148 .

Sex differences in response to targeted kyphosis specific exercise and posture training in community-dwelling older adults: a randomized controlled trial.

PubMed

Katzman, Wendy B; Parimi, Neeta; Gladin, Amy; Poltavskiy, Eduard A; Schafer, Anne L; Long, Roger K; Fan, Bo; Wong, Shirley S; Lane, Nancy E

2017-12-04

Hyperkyphosis, an excessive anterior curvature in the thoracic spine, is associated with reduced health status in older adults. Hyperkyphosis is highly prevalent, more common in older women than men. There is no standard intervention to reduce age-related hyperkyphosis. Sex differences in response to a kyphosis-specific exercise intervention are not known. We conducted a randomized controlled trial of a targeted kyphosis-specific exercise and postural training program on the primary outcome Cobb angle of kyphosis, and investigated whether the magnitude of change differed between men and women. One hundred twelve participants aged ≥60 years with kyphosis ≥40° were enrolled and randomized to exercise or waitlist control, and 101 participants had analyzable baseline and follow-up radiographs for Cobb angle measurements. A group intervention including 10 participants per group was delivered by a physical therapist, 1-h, twice a week for 3-months. Controls were placed on a waitlist for 3 months before receiving a delayed intervention. Primary outcome was change from baseline to 3-months in Cobb angle measured from standing lateral spine radiographs. Secondary outcomes included change over 3-months in kyphometer-measured kyphosis, physical function and quality of life. Groups were combined for analysis after both received the intervention, and sex differences in response to the intervention were tested with ANOVA. Participants (60 women, 41 men) were 70.0 (SD = 5.7) years old with mean Cobb angle 55.9 (SD = 12.2) degrees at baseline. The active group had higher baseline modified Physical Performance Test scores than control, p = 0.03. Men had greater baseline kyphometer-measured kyphosis, p = 0.09, and higher bone mineral density (BMD), spine strength, more vertebral fractures and diffuse idiopathic skeletal hyperostosis (DISH) than women, p ≤ 0.01. There was no statistically significant difference between groups in change in Cobb at 3-months, p = 0.09, however change in kyphometer-measured kyphosis differed by 4.8 (95% CI:-6.8,-2.7) degrees, p < 0.001, favoring the active group. There were no differences between men and women in change in either kyphosis measurement after intervention, p > 0.1. A 3-month targeted spine strengthening exercise and posture training program reduced kyphometer-measured, but not radiographic-measured kyphosis. Despite sex differences in baseline kyphosis, BMD, spine strength, fractures and DISH, sex did not affect treatment response. ClinicalTrials.gov Identifier: NCT01766674.

Longitudinal Evaluation of Cognitive Functioning in Young Children with Type 1 Diabetes over 18 Months.

PubMed

Cato, M Allison; Mauras, Nelly; Mazaika, Paul; Kollman, Craig; Cheng, Peiyao; Aye, Tandy; Ambrosino, Jodie; Beck, Roy W; Ruedy, Katrina J; Reiss, Allan L; Tansey, Michael; White, Neil H; Hershey, Tamara

2016-03-01

Decrements in cognitive function may already be evident in young children with type 1 diabetes (T1D). Here we report prospectively acquired cognitive results over 18 months in a large cohort of young children with and without T1D. A total of 144 children with T1D (mean HbA1c: 7.9%) and 70 age-matched healthy controls (mean age both groups 8.5 years; median diabetes duration 3.9 years; mean age of onset 4.1 years) underwent neuropsychological testing at baseline and after 18-months of follow-up. We hypothesized that group differences observed at baseline would be more pronounced after 18 months, particularly in those T1D patients with greatest exposure to glycemic extremes. Cognitive domain scores did not differ between groups at the 18 month testing session and did not change differently between groups over the follow-up period. However, within the T1D group, a history of diabetic ketoacidosis (DKA) was correlated with lower Verbal IQ and greater hyperglycemia exposure (HbA1c area under the curve) was inversely correlated to executive functions test performance. In addition, those with a history of both types of exposure performed most poorly on measures of executive function. The subtle cognitive differences between T1D children and nondiabetic controls observed at baseline were not observed 18 months later. Within the T1D group, as at baseline, relationships between cognition (Verbal IQ and executive functions) and glycemic variables (chronic hyperglycemia and DKA history) were evident. Continued longitudinal study of this T1D cohort and their carefully matched healthy comparison group is planned.

Longitudinal Evaluation of Cognitive Functioning in Young Children with Type 1 Diabetes over 18 Months

PubMed Central

Cato, M. Allison; Mauras, Nelly; Mazaika, Paul; Kollman, Craig; Cheng, Peiyao; Aye, Tandy; Ambrosino, Jodie; Beck, Roy W.; Ruedy, Katrina J.; Reiss, Allan L.; Tansey, Michael; White, Neil H.; Hershey, Tamara

2016-01-01

Objective Decrements in cognitive function may already be evident in young children with type 1 diabetes (T1D). Here we report prospectively acquired cognitive results over 18 months in a large cohort of young children with and without T1D. Methods 144 children with T1D (mean HbA1c: 7.9%) and 70 age-matched healthy controls (mean age both groups 8.5 years; median diabetes duration 3.9 yrs; mean age of onset 4.1 yrs) underwent neuropsychological testing at baseline and after 18-months of follow-up. We hypothesized that group differences observed at baseline would be more pronounced after 18 months, particularly in those T1D patients with greatest exposure to glycemic extremes. Results Cognitive domain scores did not differ between groups at the 18 month testing session and did not change differently between groups over the follow-up period. However, within the T1D group, a history of diabetic ketoacidosis (DKA) was correlated with lower Verbal IQ and greater hyperglycemia exposure (HbA1c area under the curve) was inversely correlated to executive functions test performance. In addition, those with a history of both types of exposure performed most poorly on measures of executive function. Conclusions The subtle cognitive differences between T1D children and nondiabetic controls observed at baseline were not observed 18 months later. Within the T1D group, as at baseline, relationships between cognition (VIQ and executive functions) and glycemic variables (chronic hyperglycemia and DKA history) were evident. Continued longitudinal study of this T1D cohort and their carefully matched healthy comparison group is planned. PMID:26786245

The effect of antacid on salivary pH in patients with and without dental erosion after multiple acid challenges.

PubMed

Dhuhair, Sarah; Dennison, Joseph B; Yaman, Peter; Neiva, Gisele F

2015-04-01

To evaluate the effect of antacid swish in the salivary pH values and to monitor the pH changes in subjects with and without dental erosion after multiple acid challenge tests. 20 subjects with tooth erosion were matched in age and gender with 20 healthy controls according to specific inclusion/exclusion criteria. Baseline measures were taken of salivary pH, buffering capacity and salivary flow rate using the Saliva Check System. Subjects swished with Diet Pepsi three times at 10-minute intervals. Changes in pH were monitored using a digital pH meter at 0-, 5-, and 10- minute intervals and at every 5 minutes after the third swish until pH resumed baseline value or 45 minutes relapse. Swishing regimen was repeated on a second visit, followed by swishing with sugar-free liquid antacid (Mylanta Supreme). Recovery times were also recorded. Data was analyzed using independent t-tests, repeated measures ANOVA, and Fisher's exact test (α= 0.05). Baseline buffering capacity and flow rate were not significantly different between groups (P= 0.542; P= 0.2831, respectively). Baseline salivary pH values were similar between groups (P= 0.721). No significant differences in salivary pH values were found between erosion and non-erosion groups in response to multiple acid challenges (P= 0.695) or antacid neutralization (P= 0.861). Analysis of salivary pH recovery time revealed no significant differences between groups after acid challenges (P= 0.091) or after the use of antacid (P= 0.118). There was a highly significant difference in the survival curves of the two groups on Day 2, with the non-erosion group resolving significantly faster than the erosion group (P= 0.0086).

Change in KOOS and WOMAC Scores in a Young Athletic Population With and Without Anterior Cruciate Ligament Injury.

PubMed

Antosh, Ivan J; Svoboda, Steven J; Peck, Karen Y; Garcia, E'Stephan J; Cameron, Kenneth L

2018-06-01

Several studies have examined changes in patient-reported outcome measures (PROMs) after anterior cruciate ligament (ACL) injury, but no studies to date have prospectively evaluated changes from preinjury baseline through injury and follow-up among ACL-injured patients compared to the baseline and follow-up changes of uninjured patients. To examine changes in PROMs over time from preinjury baseline to at least 2 years after ACL reconstruction and to compare these changes with those of an uninjured control group having similar physical activity requirements. Cohort study; Level of evidence, 2. The authors conducted a prospective cohort study with a nested case-control analysis at a US service academy. All incoming first year students were recruited to participate in this study. Consenting participants completed a baseline questionnaire that included the KOOS (Knee injury and Osteoarthritis Outcome Score), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), and MARS (Marx Activity Rating Scale). Participants who sustained a subsequent ACL injury completed assessments at the time of surgery and at 6, 12, and 24 months after surgery. Healthy participants were recruited to repeat the baseline assessments within 1 year of graduation. Inter- and intragroup differences at these time points were evaluated with dependent and independent t tests, respectively. We also compared these results with established minimum clinically important difference (MCID) values. Of 1268 first year students entering the academy, 1005 with no previous injuries consented to participate in this study (82% male, mean ± SD age 19 ± 1 years). Of those enrolled, 30 suffered an ACL injury and met the inclusion criteria for this study. Ninety uninjured control students who met the inclusion criteria completed follow-up assessments. There were statistically significant differences across all KOOS and WOMAC subscales between ACL-injured group and uninjured group at the time of the final follow-up assessment. Four KOOS subscales (Pain, Symptoms, Sports and Recreation Function, and Knee-Related Quality of Life) and the WOMAC Stiffness subscale demonstrated >8-point differences between groups, which exceeded the established MCID for these instruments. There were no significant differences between the ACL-injured group and uninjured groups noted for the MARS ( P = .635). At the time of final follow-up, the ACL-injured group also reported significant deficits on the WOMAC Stiffness subscale ( P = .032), the MARS ( P = .030), and all KOOS subscales, with the exception of Functional Activities of Daily Living, as compared with their preinjury baseline scores. These deficits exceeded the established MCID values for 3 KOOS subscales and the MARS. Patients with ACL injuries reported significant deficits on PROMs at least 2 years after surgical reconstruction in relation to preinjury baseline scores and an uninjured control group. Many of these deficits exceeded established MCID values.

Intravenous flurbiprofen axetil can stabilize the hemodynamic instability due to mesenteric traction syndrome--evaluation with continuous measurement of the systemic vascular resistance index using a FloTrac® sensor.

PubMed

Takada, Motoshi; Taruishi, Chieko; Sudani, Tomoko; Suzuki, Akira; Iida, Hiroki

2013-08-01

Evaluation of the stabilizing effect of intravenous flurbiprofen axetil against hemodynamic instability due to mesenteric traction syndrome (MTS) by continuous measurement of systemic vascular resistance index (SVRI) using a FloTrac(®) sensor was evaluated. Prospective randomized trial. A single-center study performed in an educational hospital. Two prospective studies were carried out, each with 40 patients scheduled for elective open abdominal surgery. Twenty patients received 50 mg of flurbiprofen axetil after the recognition of MTS by the anesthesiologist (group FT). The remaining patients served as controls (groups CP and CT). SVRI data was collected every 20 seconds for 1 hour after starting the laparotomy. The average SVRI prior to skin incision was taken as the baseline. Following 3 values were devised to evaluate MTS: the S-value (sum total of changes in SVRI from baseline), the T-value (period during which SVRI remained 20% or more below baseline), and the M-value (maximum change in SVRI from baseline). In group FP, decrease in SVRI was smaller than in group CP, and statistical differences in the 3 values were found. In group FT, SVRI recovered earlier than in group CT, and statistical differences were found in S-value and T-value. However, the M-value had no statistical differences. Intravenous flurbiprofen axetil can stabilize the hemodynamic instability due to MTS. Copyright © 2013 Elsevier Inc. All rights reserved.

DIF Detection Using Multiple-Group Categorical CFA with Minimum Free Baseline Approach

ERIC Educational Resources Information Center

Chang, Yu-Wei; Huang, Wei-Kang; Tsai, Rung-Ching

2015-01-01

The aim of this study is to assess the efficiency of using the multiple-group categorical confirmatory factor analysis (MCCFA) and the robust chi-square difference test in differential item functioning (DIF) detection for polytomous items under the minimum free baseline strategy. While testing for DIF items, despite the strong assumption that all…

The Effect of Pretest Exercise on Baseline Computerized Neurocognitive Test Scores.

PubMed

Pawlukiewicz, Alec; Yengo-Kahn, Aaron M; Solomon, Gary

2017-10-01

Baseline neurocognitive assessment plays a critical role in return-to-play decision making following sport-related concussions. Prior studies have assessed the effect of a variety of modifying factors on neurocognitive baseline test scores. However, relatively little investigation has been conducted regarding the effect of pretest exercise on baseline testing. The aim of our investigation was to determine the effect of pretest exercise on baseline Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) scores in adolescent and young adult athletes. We hypothesized that athletes undergoing self-reported strenuous exercise within 3 hours of baseline testing would perform more poorly on neurocognitive metrics and would report a greater number of symptoms than those who had not completed such exercise. Cross-sectional study; Level of evidence, 3. The ImPACT records of 18,245 adolescent and young adult athletes were retrospectively analyzed. After application of inclusion and exclusion criteria, participants were dichotomized into groups based on a positive (n = 664) or negative (n = 6609) self-reported history of strenuous exercise within 3 hours of the baseline test. Participants with a positive history of exercise were then randomly matched, based on age, sex, education level, concussion history, and hours of sleep prior to testing, on a 1:2 basis with individuals who had reported no pretest exercise. The baseline ImPACT composite scores of the 2 groups were then compared. Significant differences were observed for the ImPACT composite scores of verbal memory, visual memory, reaction time, and impulse control as well as for the total symptom score. No significant between-group difference was detected for the visual motor composite score. Furthermore, pretest exercise was associated with a significant increase in the overall frequency of invalid test results. Our results suggest a statistically significant difference in ImPACT composite scores between individuals who report strenuous exercise prior to baseline testing compared with those who do not. Since return-to-play decision making often involves documentation of return to neurocognitive baseline, the baseline test scores must be valid and accurate. As a result, we recommend standardization of baseline testing such that no strenuous exercise takes place 3 hours prior to test administration.

Therapeutic effects of an alpha-casozepine and L-tryptophan supplemented diet on fear and anxiety in the cat.

PubMed

Landsberg, Gary; Milgram, Bill; Mougeot, Isabelle; Kelly, Stephanie; de Rivera, Christina

2017-06-01

Objectives This study assessed the anxiolytic effectiveness of a test diet (Royal Canin Feline Calm diet) supplemented with L-tryptophan and alpha-casozepine. Methods Subjects were 24 cats that were classified as mildly or markedly fearful based on the presence of a person in their home room. Three different protocols were used to assess anxiety: (1) evaluation of the response to a human in the cat's home room (home room test); (2) analysis of the response to placement in an empty test room (open-field test); and (3) analysis of the response to an unfamiliar human (human interaction test). All three protocols were first run at baseline, and the results were used to assign the animals to control and test diet groups that showed equivalent fear and anxiety. Both groups were retested on the three protocols after 2 weeks (test 1) and again after 4 weeks (test 2). Results The diet groups differed for two behavioral measures in the open-field test: inactivity duration and inactivity frequency. The control group showed statistically significant increases in inactivity duration between baseline and test 1 and baseline and test 2, while the group fed the test diet showed a marginally not significant decrease in inactivity duration between baseline and test 1 and a not significant decrease for test 2. There was also a significant increase in inactivity frequency between baseline and test 1 in the test diet group and marginally not significant decrease in the control group. There were no differences between groups in the approach of the cats toward people for the home room test and the human interaction test. Conclusions and relevance These results suggest that the test diet reduced the anxiety response to placement in an unfamiliar location, but that fear in the presence of an unfamiliar person was not counteracted by the diet.

Applying team-based learning of diagnostics for undergraduate students: assessing teaching effectiveness by a randomized controlled trial study

PubMed Central

Zeng, Rui; Xiang, Lian-rui; Zeng, Jing; Zuo, Chuan

2017-01-01

Background We aimed to introduce team-based learning (TBL) as one of the teaching methods for diagnostics and to compare its teaching effectiveness with that of the traditional teaching methods. Methods We conducted a randomized controlled trial on diagnostics teaching involving 111 third-year medical undergraduates, using TBL as the experimental intervention, compared with lecture-based learning as the control, for teaching the two topics of symptomatology. Individual Readiness Assurance Test (IRAT)-baseline and Group Readiness Assurance Test (GRAT) were performed in members of each TBL subgroup. The scores in Individual Terminal Test 1 (ITT1) immediately after class and Individual Terminal Test 2 (ITT2) 1 week later were compared between the two groups. The questionnaire and interview were also implemented to survey the attitude of students and teachers toward TBL. Results There was no significant difference between the two groups in ITT1 (19.85±4.20 vs 19.70±4.61), while the score of the TBL group was significantly higher than that of the control group in ITT2 (19.15±3.93 vs 17.46±4.65). In the TBL group, the scores of the two terminal tests after the teaching intervention were significantly higher than the baseline test score of individuals. IRAT-baseline, ITT1, and ITT2 scores of students at different academic levels in the TBL teaching exhibited significant differences, but the ITT1-IRAT-baseline and ITT2-IRAT-baseline indicated no significant differences among the three subgroups. Conclusion Our TBL in symptomatology approach was highly accepted by students in the improvement of interest and self-directed learning and resulted in an increase in knowledge acquirements, which significantly improved short-term test scores compared with lecture-based learning. TBL is regarded as an effective teaching method worthy of promoting. PMID:28331383

Applying team-based learning of diagnostics for undergraduate students: assessing teaching effectiveness by a randomized controlled trial study.

PubMed

Zeng, Rui; Xiang, Lian-Rui; Zeng, Jing; Zuo, Chuan

2017-01-01

We aimed to introduce team-based learning (TBL) as one of the teaching methods for diagnostics and to compare its teaching effectiveness with that of the traditional teaching methods. We conducted a randomized controlled trial on diagnostics teaching involving 111 third-year medical undergraduates, using TBL as the experimental intervention, compared with lecture-based learning as the control, for teaching the two topics of symptomatology. Individual Readiness Assurance Test (IRAT)-baseline and Group Readiness Assurance Test (GRAT) were performed in members of each TBL subgroup. The scores in Individual Terminal Test 1 (ITT1) immediately after class and Individual Terminal Test 2 (ITT2) 1 week later were compared between the two groups. The questionnaire and interview were also implemented to survey the attitude of students and teachers toward TBL. There was no significant difference between the two groups in ITT1 (19.85±4.20 vs 19.70±4.61), while the score of the TBL group was significantly higher than that of the control group in ITT2 (19.15±3.93 vs 17.46±4.65). In the TBL group, the scores of the two terminal tests after the teaching intervention were significantly higher than the baseline test score of individuals. IRAT-baseline, ITT1, and ITT2 scores of students at different academic levels in the TBL teaching exhibited significant differences, but the ITT1-IRAT-baseline and ITT2-IRAT-baseline indicated no significant differences among the three subgroups. Our TBL in symptomatology approach was highly accepted by students in the improvement of interest and self-directed learning and resulted in an increase in knowledge acquirements, which significantly improved short-term test scores compared with lecture-based learning. TBL is regarded as an effective teaching method worthy of promoting.

Perioperative Alanyl-Glutamine-Supplemented Parenteral Nutrition in Chronic Radiation Enteritis Patients With Surgical Intestinal Obstruction: A Prospective, Randomized, Controlled Study.

PubMed

Yao, Danhua; Zheng, Lei; Wang, Jian; Guo, Mingxiao; Yin, Jianyi; Li, Yousheng

2016-04-01

A prospective, randomized, controlled study was performed to evaluate the effects of perioperative alanyl-glutamine-supplemented parenteral nutrition (PN) support on the immunologic function, intestinal permeability, and nutrition status of surgical patients with chronic radiation enteritis (CRE)-induced intestinal obstruction. Patients who received 0.4 g/kg/d alanyl-glutamine and isonitrogenous PN were assigned to an alanyl-glutamine-supplemented PN (Gln-PN) group and a control group, respectively. Serum levels of alanine aminotransferase and glutamine, body fat mass (FM), immunologic function, and intestinal permeability were measured before and after surgery. Serum glutamine levels of the Gln-PN group significantly exceeded that of the control group (P < .001; Gln-PN, baseline 460.7 ± 42.5 vs 523.3 ± 48.6 µmol/L on postoperative day 14 [POD14], P < .001; control, baseline 451.9 ± 44.0 vs 453.8 ± 42.3 µmol/L on POD14, P = .708). Lactulose/mannitol ratios of both groups decreased over time (Gln-PN, baseline 0.129 ± 0.0403 vs 0.024 ± 0.0107 on POD1 4; control, baseline 0.125 ± 0.0378 vs 0.044 ± 0.0126 on POD14, P < .001 in both groups). CD4/CD8-positive T-lymphocyte ratios significantly rose in both groups, with significant intergroup difference (P < .001; Gln-PN, baseline 1.36 ± 0.32 vs 1.82 ± 0.30 on POD14, P < .001; control, baseline 1.37 ± 0.25 vs 1.63 ± 0.31 on POD14, P < .001). In the Gln-PN group, FM increased from 3.68 ± 1.68 kg at baseline to 5.22 ± 1.42 kg on POD14 (P < .001). FM of control group increased from 3.84 ± 1.57 kg at baseline to 5.40 ± 1.54 kg on POD14 (P < .001). However, there were no significant intergroup differences (P = .614). Gln-PN significantly boosted the immune state and decreased the intestinal permeability of CRE patients. However, Gln-PN was not superior to standard PN in improving the nutrition state and intestinal motility of surgical patients with CRE-induced intestinal obstruction. © 2015 American Society for Parenteral and Enteral Nutrition.

Baseline neurocognitive testing in sports-related concussions: the importance of a prior night's sleep.

PubMed

McClure, D Jake; Zuckerman, Scott L; Kutscher, Scott J; Gregory, Andrew J; Solomon, Gary S

2014-02-01

The management of sports-related concussions (SRCs) utilizes serial neurocognitive assessments and self-reported symptom inventories to assess recovery and safety for return to play (RTP). Because postconcussive RTP goals include symptom resolution and a return to neurocognitive baseline levels, clinical decisions rest in part on understanding modifiers of this baseline. Several studies have reported age and sex to influence baseline neurocognitive performance, but few have assessed the potential effect of sleep. We chose to investigate the effect of reported sleep duration on baseline Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) performance and the number of patient-reported symptoms. We hypothesized that athletes receiving less sleep before baseline testing would perform worse on neurocognitive metrics and report more symptoms. Cross-sectional study; Level of evidence, 3. We retrospectively reviewed 3686 nonconcussed athletes (2371 male, 1315 female; 3305 high school, 381 college) with baseline symptom and ImPACT neurocognitive scores. Patients were stratified into 3 groups based on self-reported sleep duration the night before testing: (1) short, <7 hours; (2) intermediate, 7-9 hours; and (3) long, ≥9 hours. A multivariate analysis of covariance (MANCOVA) with an α level of .05 was used to assess the influence of sleep duration on baseline ImPACT performance. A univariate ANCOVA was performed to investigate the influence of sleep on total self-reported symptoms. When controlling for age and sex as covariates, the MANCOVA revealed significant group differences on ImPACT reaction time, verbal memory, and visual memory scores but not visual-motor (processing) speed scores. An ANCOVA also revealed significant group differences in total reported symptoms. For baseline symptoms and ImPACT scores, subsequent pairwise comparisons revealed these associations to be most significant when comparing the short and intermediate sleep groups. Our results indicate that athletes sleeping fewer than 7 hours before baseline testing perform worse on 3 of 4 ImPACT scores and report more symptoms. Because SRC management and RTP decisions hinge on the comparison with a reliable baseline evaluation, clinicians should consider sleep duration before baseline neurocognitive testing as a potential factor in the assessment of athletes' recovery.

Baseline Obesity Status Modifies Effectiveness of Adapted Diabetes Prevention Program Lifestyle Interventions for Weight Management in Primary Care

PubMed Central

Azar, Kristen M. J.; Xiao, Lan; Ma, Jun

2013-01-01

Objective. To examine whether baseline obesity severity modifies the effects of two different, primary care-based, technology-enhanced lifestyle interventions among overweight or obese adults with prediabetes and/or metabolic syndrome. Patients and Methods. We compared mean differences in changes from baseline to 15 months in clinical measures of general and central obesity among participants randomized to usual care alone (n = 81) or usual care plus a coach-led group (n = 79) or self-directed individual (n = 81) intervention, stratified by baseline body mass index (BMI) category. Results. Participants with baseline BMI 35+ had greater reductions in mean BMI, body weight (as percentage change), and waist circumference in the coach-led group intervention, compared to usual care and the self-directed individual intervention (P < 0.05 for all). In contrast, the self-directed intervention was more effective than usual care only among participants with baseline BMIs between 25 ≤ 35. Mean weight loss exceeded 5% in the coach-led intervention regardless of baseline BMI category, but this was achieved only among self-directed intervention participants with baseline BMIs <35. Conclusions. Baseline BMI may influence behavioral weight-loss treatment effectiveness. Researchers and clinicians should take an individual's baseline BMI into account when developing or recommending lifestyle focused treatment strategy. This trial is registered with ClinicalTrials.gov NCT00842426. PMID:24369008

The Role of Neuroticism in the Maintenance of Chronic Baseline Stress Perception and Negative Affect.

PubMed

Abbasi, Irum Saeed

2016-03-04

The influence of neuroticism on stress perception and its associated negative affect is explored in a quasi-experimental repeated measure study. The study involves manipulating the stress perception and affect of high N group (n = 24) and low N group (n = 28) three times; first, through exposure to neutral stimuli; second, through exposure to a laboratory stressor; third, through exposure to positive stimuli. The results reveal that after exposure to neutral stimuli, there is a significant difference in the baseline Perceived Stress Scores (PSS) (p = .005) and Negative Affect (NA) scores (p = .001) of the two groups. During the stress task, however, both groups show a non-significant difference in the PSS (p = .200) and NA scores (p = .367). After exposure to positive stimuli, there is a significant difference in the PSS scores (p = .001), but a non-significant difference in the NA scores (p = .661) of the two groups. When compared across three conditions, the high N group report significantly higher perceived stress (p = .002), but not significantly higher negative affect (p = .123) than the low N group. Finally for both PSS and NA scores, there is no interaction between neuroticism and any of the three treatment conditions (p = .176; p = .338, respectively). This study shows that the high N group may be at risk for health disparities due to maintaining a chronic higher baseline stress perception and negative affect state under neutral conditions, than the low N group. Implications of the study are discussed.

Preoperative carbohydrate-rich beverage reduces hypothermia during general anesthesia in rats.

PubMed

Yatabe, Tomoaki; Kawano, Takashi; Yamashita, Koichi; Yokoyama, Masataka

2011-08-01

Intraoperative hypothermia is associated with several unfavorable events; therefore, it is important to prevent the development of hypothermia. Amino acid consumption and/or infusion have been reported to prevent hypothermia. We hypothesized that preoperative carbohydrate-rich beverage (Arginaid Water™) loading can reduce intraoperative hypothermia in rats under general anesthesia. We divided 18 rats into 3 groups (group A, 8 mL/kg of saline; group B, 8 mL/kg of a carbohydrate-rich beverage; and group C, 21 mL/kg of the carbohydrate-rich beverage). The rats were administered each beverage at the above mentioned doses via an oral gastric tube 30 min before the induction of anesthesia. During the 2-h general anesthesia, rectal temperature was measured at 20-min intervals. Serum ketone body concentration was measured at 0 and 120 min. The baseline temperature was not significantly different among the groups. At the end of the experiment, group A showed a significantly greater decrease in temperature from the baseline (5.4 ± 0.8°C) than group B (3.9 ± 0.7°C, P = 0.01) and group C (3.8 ± 0.8°C, P = 0.01). The temperatures in groups B and C were not significantly different. There was no significant change in the serum ketone body concentration from the baseline at the end of the experiment in group A. However, the serum ketone body concentrations in group B and group C were significantly decreased from the baseline. Preoperative carbohydrate loading reduces hypothermia in rats under general anesthesia.

Association of HIV transmission categories with sociodemographic, viroimmunological and clinical parameters of HIV-infected patients.

PubMed

Collazos, J; Asensi, V; Carton, J A

2010-07-01

To analyse sociodemographic, viroimmunological and clinical parameters in different HIV-transmission categories at baseline and during treatment, 3039 patients were followed up for 12 months after the initiation of a nelfinavir-based regimen. Multiple baseline parameters were significantly different in the diverse categories, including CD4 counts (P<0.0001) and viral load (P=0.02). There were differences in the groups regarding the CD4 response (P=0.01), but not the virological response (P=0.4), to therapy over time. Multivariate analyses revealed that transmission categories were significantly related to baseline CD4 counts (P=0.01), viral load at 12 months (P=0.0006), poorer adherence to therapy of injecting drug users (IDUs) vs. each of the other groups (P<0.001) and failure to complete the 12-month evaluation of IDU vs. heterosexual (P=0.003) and men who have sex with men (MSM) groups (P=0.02). We conclude that transmission categories had a significant influence on several baseline parameters and viroimmunological outcomes following highly active antiretroviral therapy (HAART), as well as on adherence to therapy and to medical appointments.

Ethnoracial differences in brain structure change and cognitive change.

PubMed

Gavett, Brandon E; Fletcher, Evan; Harvey, Danielle; Farias, Sarah Tomaszewski; Olichney, John; Beckett, Laurel; DeCarli, Charles; Mungas, Dan

2018-04-12

The purpose of this study was to examine longitudinal associations between structural MRI and cognition in a diverse sample. Older adults (n = 444; Mage = 74.5)-121 African Americans, 212 Whites, and 111 Hispanics-underwent an average of 5.3 annual study visits. Approximately half were cognitively normal at baseline (global Clinical Dementia Rating M = 0.5). Of the patients with dementia, most (79%) were diagnosed with Alzheimer's disease (AD). MRI measures of gray matter volume (baseline and change), and hippocampal and white matter hyperintensity (WMH) volumes (baseline), were used to predict change in global cognition. Multilevel latent variable modeling was used to test the hypothesis that brain effects on cognitive change differed across ethnoracial groups. In a multivariable model, global gray matter change was the strongest predictor of cognitive decline in Whites and African Americans and specific temporal lobe change added incremental explanatory power in Whites. Baseline WMH volume was the strongest predictor of cognitive decline in Hispanics and made an incremental contribution in Whites. We found ethnoracial group differences in associations of brain variables with cognitive decline. The unique patterns in Whites appeared to suggest a greater influence of AD in this group. In contrast, cognitive decline in African Americans and Hispanics was most uniquely attributable to global gray matter change and baseline WMH, respectively. Brain changes underlying cognitive decline in older adults are heterogeneous and depend on fixed and modifiable risk factors that differ based on ethnicity and race. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Effect of sedation with detomidine on intraocular pressure with and without topical anesthesia in clinically normal horses.

PubMed

Holve, Dana L

2012-02-01

To determine the effect of sedation with detomidine on intraocular pressure (IOP) in standing horses and whether topical ocular application of anesthetic alters this effect. Clinical trial. 15 clinically normal horses. Horses were assigned to group 1 (n = 7) or 2 (8). Intraocular pressure measurements were obtained at baseline (before sedation) and 10 minutes after IV administration of detomidine (0.02 mg/kg [0.009 mg/lb]). Group 1 horses had an additional IOP measurement at 20 minutes after sedation. For group 2 horses, topical ocular anesthetic was administered 10 minutes prior to baseline IOP measurements. Mean ± SD baseline IOP for horses without topical anesthesia (group 1 horses; IOP, 24.30 ± 3.09 mm Hg) was significantly lower, compared with that of horses with topical anesthesia (group 2 horses; IOP, 30.40 ± 3.25 mm Hg). Compared with baseline values, IOP at 10 minutes after sedation decreased significantly in all horses (by 3.61 ± 1.48 mm Hg and 5.78 ± 4.32 mm Hg in groups 1 and 2, respectively). In group 1 horses, IOP at 10 (20.69 ± 3.45 mm Hg) and 20 (19.96 ± 2.13 mm Hg) minutes after sedation was significantly decreased, compared with baseline values; however, the difference between IOP at 10 versus 20 minutes was not significant. The difference in IOP between group 1 and 2 horses at 10 minutes after sedation was not significant. IV administration of detomidine caused a decrease in IOP in clinically normal horses and may be a safe sedative when performing ocular procedures.

The serotonin transporter gene polymorphism and the effect of baseline on amygdala response to emotional faces.

PubMed

von dem Hagen, Elisabeth A H; Passamonti, Luca; Nutland, Sarah; Sambrook, Jennifer; Calder, Andrew J

2011-03-01

Previous research has found that a common polymorphism in the serotonin transporter gene (5-HTTLPR) is an important mediator of individual differences in brain responses associated with emotional behaviour. In particular, relative to individuals homozygous for the l-allele, carriers of the s-allele display heightened amygdala activation to emotional compared to non-emotional stimuli. However, there is some debate as to whether this difference is driven by increased activation to emotional stimuli, resting baseline differences between the groups, or decreased activation to neutral stimuli. We performed functional imaging during an implicit facial expression processing task in which participants viewed angry, sad and neutral faces. In addition to neutral faces, we included two further baseline conditions, houses and fixation. We found increased amygdala activation in s-allele carriers relative to l-homozygotes in response to angry faces compared to neutral faces, houses and fixation. When comparing neutral faces to houses or fixation, we found no significant difference in amygdala response between the two groups. In addition, there was no significant difference between the groups in response to fixation when compared with a houses baseline. Overall, these results suggest that the increased amygdala response observed in s-allele carriers to emotional faces is primarily driven by an increased response to emotional faces rather than a decreased response to neutral faces or an increased resting baseline. The results are discussed in relation to the tonic and phasic hypotheses of 5-HTTLPR-mediated modulation of amygdala activity. Copyright © 2010 Elsevier Ltd. All rights reserved.

Clinical and functional outcomes of patients who experience partial response to citalopram: secondary analysis of STAR*D.

PubMed

Dennehy, Ellen B; Marangell, Lauren B; Martinez, James; Balasubramani, G K; Wisniewski, Stephen R

2014-05-01

We analyzed the public STAR*D database to better characterize the baseline clinical characteristics and functional outcomes of patients with major depressive disorder (MDD) who experienced partial response in order to better understand the burden associated with this outcome. Patients (n=2,876) received treatment with citalopram. The last available Quick Inventory of Depressive Symptoms (QIDS-SR) from the 12-week treatment period was used to assign subjects to one of three groups: remitters QIDS-SR≤5; non-responders QIDS-SR >5 and <25% reduction from baseline; and partial responders QIDS-SR >5 and ≥25% reduction from baseline. Baseline sociodemographic and clinical characteristics were compared across groups, as well as functional outcomes at Level 1 exit. RESULTS. Of the 2,876 patients, 943 patients (33%) were classified as remitters, 1069 (37%) as partial responders, and 854 (30%) as non-responders. The groups differed on a number of pre-treatment course of illness variables and comorbidities. In addition, remitters, partial responders, and non-responders all separated on posttreatment quality of life and functional outcomes at Level 1 exit. Partial responders demonstrated significant functional impairment at Level 1 exit, differing significantly from the patients who remitted on quality of life, mental and physical functioning, and social and work-related impairment. Adjusted outcomes showed similar differences. Differences in baseline rates of suicidality, comorbidity, and atypical presentations of depression were also observed between outcome groups. Given the substantial clinical and economic burden associated with functional impairment in depression, the need to fully treat partially responding patients to achieve depression remission and restoration of functioning is highlighted by this work.

Carotid intima-media thickness is associated with the progression of cognitive impairment in older adults.

PubMed

Moon, Jae Hoon; Lim, Soo; Han, Ji Won; Kim, Kyoung Min; Choi, Sung Hee; Park, Kyong Soo; Kim, Ki Woong; Jang, Hak Chul

2015-04-01

We investigated the association between cardiovascular risk factors, including carotid intima-media thickness (CIMT), and future risk of mild cognitive impairment (MCI) and dementia in elderly subjects. We conducted a population-based prospective study as a part of the Korean Longitudinal Study on Health and Aging. Our study included 348 participants who were nondemented at the baseline (mean age, 71.7±6.3 years) and underwent cognitive evaluation at the 5-year follow-up. Baseline cardiovascular risk factors were compared according to the development of MCI or dementia during the study period. At the baseline evaluation, 278 subjects were cognitively normal and 70 subjects had MCI. Diagnoses of cognitive function either remained unchanged or improved during the study period in 292 subjects (nonprogression group), whereas 56 subjects showed progression of cognitive impairment to MCI or dementia (progression group). The progression group exhibited a higher prevalence of hypertension and greater CIMT compared with the nonprogression group. Other baseline cardiovascular risk factors, including sex, body mass index, diabetes mellitus, insulin resistance, total cholesterol, waist-to-hip ratio, visceral fat, pulse wave velocity, and ankle-brachial index, were not significantly different between 2 groups. The association between greater baseline CIMT and the progression of cognitive impairment was maintained after adjustment for conventional baseline risk factors of cognitive impairment. Greater baseline CIMT was also independently associated with the development of MCI in the subjects whose baseline cognitive function was normal. Greater baseline CIMT was independently associated with the risk of cognitive impairment, such as MCI and dementia in elderly subjects. © 2015 American Heart Association, Inc.

[The prognostic value of cerebral oxygen saturation measurement for assessing prognosis after cardiopulmonary resuscitation].

PubMed

Inal, Mehmet Turan; Memiş, Dilek; Yıldırım, Ilker; Uğur, Hüseyin; Erkaymaz, Aysegul; Turan, F Nesrin

Despite new improvements on cardiopulmonary resuscitation (CPR), brain damage is very often after resuscitation. To assess the prognostic value of cerebral oxygen saturation measurement (rSO 2 ) for assessing prognosis on patients after cardiopulmonary resuscitation. Retrospective analysis. We analyzed 25 post-CPR patients (12 female and 13 male). All the patients were cooled to a target temperature of 33-34°C. The Glascow Coma Scale (GCS), Corneal Reflexes (CR), Pupillary Reflexes (PR), arterial Base Excess (BE) and rSO 2 measurements were taken on admission. The rewarming GCS, CR, PR, BE and rSO 2 measurements were made after the patient's temperature reached 36°C. In survivors, the baseline rSO 2 value was 67.5 (46-70) and the percent difference between baseline and rewarming rSO 2 value was 0.03 (0.014-0.435). In non-survivors, the baseline rSO 2 value was 30 (25-65) and the percent difference between baseline and rewarming rSO 2 value was 0.031 (-0.08 to -20). No statistical difference was detected on percent changes between baseline and rewarming values of rSO 2. Statistically significant difference was detected between baseline and rewarming GCS groups (p=0.004). No statistical difference was detected between GCS, CR, PR, BE and rSO 2 to determine the prognosis. Despite higher values of rSO 2 on survivors than non-survivors, we found no statistically considerable difference between groups on baseline and the rewarming rSO 2 values. Since the measurement is simple, and not affected by hypotension and hypothermia, the rSO 2 may be a useful predictor for determining the prognosis after CPR. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

Missing continuous outcomes under covariate dependent missingness in cluster randomised trials

PubMed Central

Diaz-Ordaz, Karla; Bartlett, Jonathan W

2016-01-01

Attrition is a common occurrence in cluster randomised trials which leads to missing outcome data. Two approaches for analysing such trials are cluster-level analysis and individual-level analysis. This paper compares the performance of unadjusted cluster-level analysis, baseline covariate adjusted cluster-level analysis and linear mixed model analysis, under baseline covariate dependent missingness in continuous outcomes, in terms of bias, average estimated standard error and coverage probability. The methods of complete records analysis and multiple imputation are used to handle the missing outcome data. We considered four scenarios, with the missingness mechanism and baseline covariate effect on outcome either the same or different between intervention groups. We show that both unadjusted cluster-level analysis and baseline covariate adjusted cluster-level analysis give unbiased estimates of the intervention effect only if both intervention groups have the same missingness mechanisms and there is no interaction between baseline covariate and intervention group. Linear mixed model and multiple imputation give unbiased estimates under all four considered scenarios, provided that an interaction of intervention and baseline covariate is included in the model when appropriate. Cluster mean imputation has been proposed as a valid approach for handling missing outcomes in cluster randomised trials. We show that cluster mean imputation only gives unbiased estimates when missingness mechanism is the same between the intervention groups and there is no interaction between baseline covariate and intervention group. Multiple imputation shows overcoverage for small number of clusters in each intervention group. PMID:27177885

Missing continuous outcomes under covariate dependent missingness in cluster randomised trials.

PubMed

Hossain, Anower; Diaz-Ordaz, Karla; Bartlett, Jonathan W

2017-06-01

Attrition is a common occurrence in cluster randomised trials which leads to missing outcome data. Two approaches for analysing such trials are cluster-level analysis and individual-level analysis. This paper compares the performance of unadjusted cluster-level analysis, baseline covariate adjusted cluster-level analysis and linear mixed model analysis, under baseline covariate dependent missingness in continuous outcomes, in terms of bias, average estimated standard error and coverage probability. The methods of complete records analysis and multiple imputation are used to handle the missing outcome data. We considered four scenarios, with the missingness mechanism and baseline covariate effect on outcome either the same or different between intervention groups. We show that both unadjusted cluster-level analysis and baseline covariate adjusted cluster-level analysis give unbiased estimates of the intervention effect only if both intervention groups have the same missingness mechanisms and there is no interaction between baseline covariate and intervention group. Linear mixed model and multiple imputation give unbiased estimates under all four considered scenarios, provided that an interaction of intervention and baseline covariate is included in the model when appropriate. Cluster mean imputation has been proposed as a valid approach for handling missing outcomes in cluster randomised trials. We show that cluster mean imputation only gives unbiased estimates when missingness mechanism is the same between the intervention groups and there is no interaction between baseline covariate and intervention group. Multiple imputation shows overcoverage for small number of clusters in each intervention group.

Longitudinal performance of plasma neurofilament light and tau in professional fighters: The Professional Fighters Brain Health Study.

PubMed

Bernick, Charles; Zetterberg, Henrik; Shan, Guogen; Banks, Sarah; Blennow, Kaj

2018-04-02

The objective of this study is to evaluate longitudinal change in plasma neurofilament light (NF-L) and tau levels in relationship to clinical and radiological measures in professional fighters. Participants (active and retired professional fighters and control group) underwent annual blood sampling, 3 Tesla MRI brain imaging, computerized cognitive testing, and assessment of exposure to head trauma. Plasma tau and NF-L concentrations were measured using Simoa assays. Multiple linear regression models were used to compare the difference across groups in regard to baseline measurements, while mixed linear models was used for the longitudinal data with multiple measurements for each participant. Plasma samples were available on 471 participants. Baseline NF-L measures differed across groups (F_3,393=6.99, p=0.0001), with the active boxers having the highest levels. Higher NF-L levels at baseline were correlated with lower baseline MRI regional volumes and lower cognitive scores. The number of sparring rounds completed by the active fighters was correlated with NF-L (95% CI 0.0116-0.4053, p=0.0381), but not tau, levels. Among 126 subjects having multiple yearly samples, there was a significant difference in average yearly percentage change in tau across groups (F_3,83=3.87, p=0.0121).). We conclude that plasma NF-L and tau behave differently in a group of active and retired fighters; NF-L better reflects acute exposure whereas the role of plasma tau levels in signifying chronic change in brain structure over time requires further study.

Upper trapezius relaxation induced by TENS and interferential current in computer users with chronic nonspecific neck discomfort: An electromyographic analysis.

PubMed

Acedo, Adriano Alexandre; Luduvice Antunes, Ana Carolina; Barros dos Santos, André; Barbosa de Olveira, Cintia; Tavares dos Santos, Claudia; Colonezi, Gustavo Lacreta Toledo; Fontana, Felipe Antonio Medeiros; Fukuda, Thiago Yukio

2015-01-01

Recent studies have shown that a transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC) application reduces pain in subjects with musculoskeletal disorders. However there are no clinical trials evaluating or comparing the muscle relaxation generated for these devices. To compare the muscle relaxation of the upper trapezius induced by the application of TENS and IFC in females with chronic nonspecific neck discomfort. Sixty-four females between 18 and 40 years of age and a history of nonspecific neck discomfort were randomly assigned to a TENS or an IFC group. The women in the TENS (N = 32; mean age 22 years) and IFC (N = 32, mean age 23 years) group were submitted to current application during 3 consecutive days and were assessed by electromyography (EMG) in different times aiming to quantify the muscular tension of the upper trapezius. A visual analogue scale (VAS) was used as pain measure at baseline (before TENS or IFC application) and at the end of the study. At baseline, demographic, pain, and EMG assessment data were similar between groups. Those in the IFC group had a significant trapezius relaxation after 3 IFC applications when compared to baseline and intermediate evaluations (P < 0.05). In contrast, the same analysis showed no significant difference between all assessments in the TENS group (P >0.05). In relation to pain relief, both groups showed an improvement at the end of the study when compared to baseline (both,P <0.05). The between-group analysis showed no difference for the subjects who received such IFC as TENS application (P <0.05). IFC induced the upper trapezius relaxation after 3 sessions in females with neck discomfort, but the TENS application did not change the muscular tension. However, these results should be carefully interpreted due to the lack of differences between groups. A significant pain decrease was found in the subjects of both groups, however, only the IFC application presented a clinically important improvement.

Iron Status and the Acute Post-Exercise Hepcidin Response in Athletes

PubMed Central

Peeling, Peter; Sim, Marc; Badenhorst, Claire E.; Dawson, Brian; Govus, Andrew D.; Abbiss, Chris R.; Swinkels, Dorine W.; Trinder, Debbie

2014-01-01

This study explored the relationship between serum ferritin and hepcidin in athletes. Baseline serum ferritin levels of 54 athletes from the control trial of five investigations conducted in our laboratory were considered; athletes were grouped according to values <30 μg/L (SF<30), 30–50 μg/L (SF30–50), 50–100 μg/L (SF50–100), or >100 μg/L (SF>100). Data pooling resulted in each athlete completing one of five running sessions: (1) 8×3 min at 85% vVO2peak; (2) 5×4 min at 90% vVO2peak; (3) 90 min continuous at 75% vVO2peak; (4) 40 min continuous at 75% vVO2peak; (5) 40 min continuous at 65% vVO2peak. Athletes from each running session were represented amongst all four groups; hence, the mean exercise duration and intensity were not different (p>0.05). Venous blood samples were collected pre-, post- and 3 h post-exercise, and were analysed for serum ferritin, iron, interleukin-6 (IL-6) and hepcidin-25. Baseline and post-exercise serum ferritin levels were different between groups (p<0.05). There were no group differences for pre- or post-exercise serum iron or IL-6 (p>0.05). Post-exercise IL-6 was significantly elevated compared to baseline within each group (p<0.05). Pre- and 3 h post-exercise hepcidin-25 was sequentially greater as the groups baseline serum ferritin levels increased (p<0.05). However, post-exercise hepcidin levels were only significantly elevated in three groups (SF30–50, SF50–100, and SF>100; p<0.05). An athlete's iron stores may dictate the baseline hepcidin levels and the magnitude of post-exercise hepcidin response. Low iron stores suppressed post-exercise hepcidin, seemingly overriding any inflammatory-driven increases. PMID:24667393

Dietary change and reduced breast cancer events among women without hot flashes after treatment of early-stage breast cancer: subgroup analysis of the Women's Healthy Eating and Living Study1234

PubMed Central

Pierce, John P; Natarajan, Loki; Caan, Bette J; Flatt, Shirley W; Kealey, Sheila; Gold, Ellen B; Hajek, Richard A; Newman, Vicky A; Rock, Cheryl L; Pu, Minya; Saquib, Nazmus; Stefanick, Marcia L; Thomson, Cynthia A; Parker, Barbara

2009-01-01

Background: A diet high in vegetables, fruit, and fiber and low in fat decreased additional risk of secondary breast cancer events in women without hot flashes (HF−) compared with that in women with hot flashes (HF+), possibly through lowered concentrations of circulating estrogens. Objective: The objective was to investigate the intervention effect by baseline quartiles of dietary pattern among breast cancer survivors in the HF− subgroup of the Women's Healthy Eating and Living Study. Design: A randomized controlled trial compared a putative cancer prevention diet with a diet of 5 servings of vegetables and fruit daily in early-stage breast cancer survivors. Participants did not experience hot flashes at baseline (n = 896). We confirmed cancer status for 96% of participants ≈7.3 y after enrollment. Results: The study intervention achieved a large between-group difference in dietary pattern that, at 4 y, was not significantly different across baseline quartiles of dietary pattern. The intervention group experienced fewer breast cancer events than did the comparison group for all of the baseline quartiles. This difference was significant only in upper baseline quartiles of intake of vegetables, fruit, and fiber and in the lowest quartile of fat. A significant trend for fewer breast cancer events was observed across quartiles of vegetable-fruit and fiber consumption. Conclusions: The secondary analysis showing the decreased risk in the HF− subgroup was not explained by amount of change in dietary pattern achieved. The difference was strongest in the quartile with the most putatively cancer-preventive dietary pattern at baseline. PMID:19339393

Do older adults with chronic low back pain differ from younger adults in regards to baseline characteristics and prognosis?

PubMed

Manogharan, S; Kongsted, A; Ferreira, M L; Hancock, M J

2017-05-01

Low back pain (LBP) in older adults is poorly understood because the vast majority of the LBP research has focused on the working aged population. The aim of this study was to compare older adults consulting with chronic LBP to middle aged and young adults consulting with chronic LBP, in terms of their baseline characteristics, and pain and disability outcomes over 1 year. Data were systematically collected as part of routine care in a secondary care spine clinic. At initial presentation patients answered a self-report questionnaire and underwent a physical examination. Patients older than 65 were classified as older adults and compared to middle aged (45-65 years old) and younger adults (17-44 years old) for 10 baseline characteristics. Pain intensity and disability were collected at 6 and 12 month follow-ups and compared between age groups. A total of 14,479 participants were included in the study. Of these 3087 (21%) patients were older adults, 6071 (42%) were middle aged and 5321 (37%) were young adults. At presentation older adults were statistically different to the middle aged and younger adults for most characteristics measured (e.g. less intense back pain, more leg pain and more depression); however, the differences were small. The change in pain and disability over 12 months did not differ between age groups. This study found small baseline differences in older people with chronic LBP compared to middle aged and younger adults. There were no associations between age groups and the clinical course. Small baseline differences exist in older people with chronic low back pain compared to middle aged and younger adults referred to secondary care for chronic low back pain. Older adults present with slightly less intense low back pain but slightly more intense leg pain. Changes in pain intensity and disability over a 12 month period were similar across all age groups. © 2017 European Pain Federation - EFIC®.

60 seconds to survival: A pilot study of a disaster triage video game for prehospital providers.

PubMed

Cicero, Mark X; Whitfill, Travis; Munjal, Kevin; Madhok, Manu; Diaz, Maria Carmen G; Scherzer, Daniel J; Walsh, Barbara M; Bowen, Angela; Redlener, Michael; Goldberg, Scott A; Symons, Nadine; Burkett, James; Santos, Joseph C; Kessler, David; Barnicle, Ryan N; Paesano, Geno; Auerbach, Marc A

2017-01-01

Disaster triage training for emergency medical service (EMS) providers is not standardized. Simulation training is costly and time-consuming. In contrast, educational video games enable low-cost and more time-efficient standardized training. We hypothesized that players of the video game "60 Seconds to Survival" (60S) would have greater improvements in disaster triage accuracy compared to control subjects who did not play 60S. Participants recorded their demographics and highest EMS training level and were randomized to play 60S (intervention) or serve as controls. At baseline, all participants completed a live school-shooting simulation in which manikins and standardized patients depicted 10 adult and pediatric victims. The intervention group then played 60S at least three times over the course of 13 weeks (time 2). Players triaged 12 patients in three scenarios (school shooting, house fire, tornado), and received in-game performance feedback. At time 2, the same live simulation was conducted for all participants. Controls had no disaster training during the study. The main outcome was improvement in triage accuracy in live simulations from baseline to time 2. Physicians and EMS providers predetermined expected triage level (RED/YELLOW/GREEN/BLACK) via modified Delphi method. There were 26 participants in the intervention group and 21 in the control group. There was no difference in gender, level of training, or years of EMS experience (median 5.5 years intervention, 3.5 years control, p = 0.49) between the groups. At baseline, both groups demonstrated median triage accuracy of 80 percent (IQR 70-90 percent, p = 0.457). At time 2, the intervention group had a significant improvement from baseline (median accuracy = 90 percent [IQR: 80-90 percent], p = 0.005), while the control group did not (median accuracy = 80 percent [IQR:80-95], p = 0.174). However, the mean improvement from baseline was not significant between the two groups (difference = 6.5, p = 0.335). The intervention demonstrated a significant improvement in accuracy from baseline to time 2 while the control did not. However, there was no significant difference in the improvement between the intervention and control groups. These results may be due to small sample size. Future directions include assessment of the game's effect on triage accuracy with a larger, multisite site cohort and iterative development to improve 60S.

Self-Perceived Quality of Life Among Patients with Alzheimer's Disease: Two Longitudinal Models of Analysis.

PubMed

Conde-Sala, Josep L; Turró-Garriga, Oriol; Portellano-Ortiz, Cristina; Viñas-Diez, Vanesa; Gascón-Bayarri, Jordi; Reñé-Ramírez, Ramón

2016-04-12

The objective was to analyze the factors that influence self-perceived quality of life (QoL) in patients with Alzheimer's disease (AD), contrasting two different longitudinal models. A total of 127 patients were followed up over 24 months. The instruments applied were: Quality of Life in Alzheimer's Disease scale (QoL-AD), Geriatric Depression Scale-15, Anosognosia Questionnaire-Dementia, Disability Assessment in Dementia, Neuropsychiatric Inventory, and the Mini-Mental State Examination. Two models for grouping patients were tested: 1) Baseline score on the QoL-AD (QoL-Baseline), and 2) Difference in QoL-AD score between baseline and follow-up (QoL-Change). Generalized estimating equations were used to analyze longitudinal data, and multinomial regression analyses were performed. Over the follow-up period the QoL-Baseline model showed greater variability between groups (Wald χ2 = 172.3, p < 0.001) than did the QoL-Change model (Wald χ2  = 1.7, p = 0.427). In the QoL-Baseline model the predictive factors were greater depression (odds ratio [OR] = 1.20; 95% CI: 1.00- 1.45) and lower functional ability (OR = 0.92; 95% CI: 0.85- 0.99) for the Low QoL group (< 33 QoL-AD), and less depression (OR = 0.68; 95% CI: 0.52- 0.88), more anosognosia (OR = 1.07; 95% CI: 1.01- 1.13), and fewer neuropsychiatric symptoms (OR = 0.95; 95% CI: 0.91- 0.99) for the High-QoL group (>37 QoL-AD). The model based on baseline scores (QoL-Baseline) was better than the QoL-Change model in terms of identifying trajectories and predictors of QoL in AD.

Demographic, health-related, and work-related factors associated with body mass index and body fat percentage among workers at six Connecticut manufacturing companies across different age groups: a cohort study.

PubMed

Garza, Jennifer L; Dugan, Alicia G; Faghri, Pouran D; Gorin, Amy A; Huedo-Medina, Tania B; Kenny, Anne M; Cherniack, Martin G; Cavallari, Jennifer M

2015-01-01

Effective workplace interventions that consider the multifactorial nature of obesity are needed to reduce and prevent obesity among adults. Furthermore, the factors associated with obesity may differ for workers across age groups. Therefore, the objective of this study was to identify demographic, health-related, and work-related factors associated with baseline and changes in body mass index (BMI) and body fat percentage (BFP) and among Connecticut manufacturing workers acrossage groups. BMI and BFPof 758 workers from six Connecticut manufacturing companies were objectively measuredat two time points approximately 36 months apart. Demographic, health-related, and work-related factors wereassessed via questionnaire. All variables were included in linear regression models to identify factors associated with baseline and changes in BMI and BFP for workers in 3 age groups: <45 years (35 %), 45-55 years (37 %), >55 years (28 %). There were differences in baseline and changes in BMI and BFP among manufacturing workers across age groups. Being interested in changing weight was significantly (p < 0.01) associated with higher baseline BMI and BFP across all age categories. Other factors associated with higher baseline BMI and BFP differed by age group and included: male gender (BMI p = 0.04), female gender (BFP p < 0.01), not having a college education (BMI p = 0.01, BFP p = 0.04), having childcare responsibilities (BMI p = 0.04), and working less overtime (p = 0.02) among workers in the <45 year age category, male gender (BMI p = 0.02), female gender (BFP p < 0.01) and reporting higher stress in general (BMI p = 0.04) among workers in the 45-55 year age category, and female gender (BFP p < 0.01) and job tenure (BFP p = 0.03) among workers in the >55 year age category. Few factors were associated with change in BMI or BFP across any age category. Among manufacturing workers, we identified associations between individual, health-related, and work-related factors and baseline BMIand BFP that differed by age. Such results support the use of strategies tailored to the challenges faced by workers in specific age groups rather than adopting a one size fits all approach. Effective interventions should consider a full range of individual, health-related, and work-related factors. More work must be done to identify factors or strategies associated with changes in obesity over time.

Comparison of a dietary intervention promoting high intakes of fruits and vegetables with a low-fat approach: long-term effects on dietary intakes, eating behaviours and body weight in postmenopausal women.

PubMed

Lapointe, Annie; Weisnagel, S John; Provencher, Véronique; Bégin, Catherine; Dufour-Bouchard, Andrée-Ann; Trudeau, Caroline; Lemieux, Simone

2010-10-01

The aim of the present study was to compare the long-term effects of two dietary approaches on changes in dietary intakes, eating behaviours and body weight: (1) approach using restrictive messages to limit high-fat foods (low-fat intake; LOFAT); (2) approach emphasising non-restrictive messages directed towards the inclusion of fruits and vegetables (high intake of fruits and vegetables; HIFV). A total of sixty-eight overweight or obese postmenopausal women were randomly assigned to one of the two dietary approaches. The 6-month dietary intervention included three group sessions and ten individual sessions with a dietitian. Dietary intakes, eating behaviours and anthropometrics were measured at baseline, at the end of the dietary intervention (T = 6) and 6 months and 12 months after the end of the intervention (T = 12 and T = 18). In the LOFAT group, energy and fat intakes were lower at T = 6 when compared with baseline and remained lower at T = 12 and T = 18. In the HIFV group, fruit and vegetable intakes increased significantly at T = 6 but were no longer significantly different from baseline at T = 12 and T = 18. Dietary restraint increased at T = 6 and remained higher than baseline at T = 18 in the LOFAT group while no significant change was observed in the HIFV group. At T = 6, body weight was significantly lower than baseline in both groups (LOFAT: - 3.7 (SD 2.8) kg; HIFV: - 1.8 (SD 3.0) kg) and no significant difference in body-weight change from baseline was found between groups at T = 18. We concluded that weight loss was similar at 1-year follow-up in both dietary approaches. Despite relatively good improvements in the short term, the adherence to a 6-month dietary intervention promoting high intakes of fruits and vegetables was difficult to maintain.

An Investigation of Stimulant Effects on the EEG of Children With Attention-Deficit/Hyperactivity Disorder.

PubMed

Clarke, Adam R; Barry, Robert J; Baker, Iris E; McCarthy, Rory; Selikowitz, Mark

2017-07-01

Stimulant medications are the most commonly prescribed treatment for Attention-Deficit/Hyperactivity Disorder (AD/HD). These medications result in a normalization of the EEG. However, past research has found that complete normalization of the EEG is not always achieved. One reason for this may be that studies have used different medications interchangeably, or groups of subjects on different stimulants. This study investigated whether methylphenidate and dexamphetamine produce different levels of normalization of the EEG in children with AD/HD. Three groups of 20 boys participated in this study. There were 2 groups with a diagnosis of AD/HD; one group, good responders to methylphenidate, and the second, good responders to dexamphetamine. The third group was a normal control group. Baseline EEGs were recorded using an eyes-closed resting condition, and analyzed for total power and relative delta, theta, alpha, and beta. Subjects were placed on a 6-month trial of methylphenidate or dexamphetamine, after which a second EEG was recorded. At baseline, the children with AD/HD had elevated relative theta, less relative alpha and beta compared with controls. Baseline differences were found between the two medication groups, with the dexamphetamine group having greater EEG abnormalities than the methylphenidate group. The results indicate that good responders to methylphenidate and dexamphetamine have different EEG profiles when assessed before medication, and these differences may represent different underlying central nervous system deficits. The 2 medications were found to result in substantial normalization of the EEG, with no significant differences in EEG changes occurring between the 2 medications. This indicates that the degree of pretreatment EEG abnormality was the major factor contributing to the degree of normalization of the EEG. As good responders to the 2 medications appear to have different central nervous system abnormalities, it is recommended that stimulant medications be treated independently and not used interchangeably in research and treatment of AD/HD.

Critical thinking of registered nurses in a fellowship program.

PubMed

Zori, Susan; Kohn, Nina; Gallo, Kathleen; Friedman, M Isabel

2013-08-01

Critical thinking is essential to nursing practice. This study examined differences in the critical thinking dispositions of registered nurses (RNs) in a nursing fellowship program. Control and experimental groups were used to compare differences in scores on the California Critical Thinking Disposition Inventory (CCTDI) of RNs at three points during a fellowship program: baseline, week 7, and month 5. The control group consisted of RNs who received no education in critical thinking. The experimental group received education in critical thinking using simulated scenarios and reflective journaling. CCTDI scores examined with analysis of variance showed no significant difference within groups over time or between groups. The baseline scores of the experimental group were slightly higher than those of the control group. Chi-square analysis of demographic variables between the two groups showed no significant differences. Critical thinking dispositions are a combination of attitudes, values, and beliefs that make up one's personality based on life experience. Lack of statistical significance using a quantitative approach did not capture the development of the critical thinking dispositions of participants. A secondary qualitative analysis of journal entries is being conducted. Copyright 2013, SLACK Incorporated.

Statistical testing of baseline differences in sports medicine RCTs: a systematic evaluation.

PubMed

Peterson, Ross L; Tran, Matthew; Koffel, Jonathan; Stovitz, Steven D

2017-01-01

The CONSORT (Consolidated Standards of Reporting Trials) statement discourages reporting statistical tests of baseline differences between groups in randomised controlled trials (RCTs). However, this practice is still common in many medical fields. Our aim was to determine the prevalence of this practice in leading sports medicine journals. We conducted a comprehensive search in Medline through PubMed to identify RCTs published in the years 2005 and 2015 from 10 high-impact sports medicine journals. Two reviewers independently confirmed the trial design and reached consensus on which articles contained statistical tests of baseline differences. Our search strategy identified a total of 324 RCTs, with 85 from the year 2005 and 239 from the year 2015. Overall, 64.8% of studies (95% CI (59.6, 70.0)) reported statistical tests of baseline differences; broken down by year, this percentage was 67.1% in 2005 (95% CI (57.1, 77.1)) and 64.0% in 2015 (95% CI (57.9, 70.1)). Although discouraged by the CONSORT statement, statistical testing of baseline differences remains highly prevalent in sports medicine RCTs. Statistical testing of baseline differences can mislead authors; for example, by failing to identify meaningful baseline differences in small studies. Journals that ask authors to follow the CONSORT statement guidelines should recognise that many manuscripts are ignoring the recommendation against statistical testing of baseline differences.

N-acetylcysteine attenuates endotoxin-induced leukocyte-endothelial cell adhesion and macromolecular leakage in vivo.

PubMed

Schmidt, H; Schmidt, W; Müller, T; Böhrer, H; Gebhard, M M; Martin, E

1997-05-01

To determine the influence of N-acetylcysteine on endotoxin-induced leukocyte-endothelial cell adhesion, vascular leakage, and venular microhemodynamics. Randomized, blinded, controlled trial. Experimental laboratory. Thirty male Wistar rats. After pretreatment with N-acetylcysteine (150 mg/kg; n = 40; group A) or 0.9% saline solution (n = 10; group B) animals were given an intravenous infusion of endotoxin (Escherichia coli lipopolysaccharide 026:B6; 2 mg/kg/hr) over 120 mins. Animals in the control group (n = 10; group C) received a volume-equivalent infusion of 0.9% saline solution. Leukocyte adherence, red cell velocity (VRBC), vessel diameters, venular wall shear rate, and macromolecular leakage were determined in mesenteric postcapillary venules using in vivo videomicroscopy at baseline and at 30, 50, 90, and 120 mins after the start of the endotoxin challenge. Endotoxin exposure induced a marked increase in adherent leukocytes (group B: baseline, 391 +/- 24 cells/mm2; 120 mins, 1268 +/- 131 cells/mm2; p < .01). N-acetylcysteine pretreatment attenuated the adherence of leukocytes during endotoxemia (baseline, 366 +/- 28 cells/mm2; 120 mins, 636 +/- 49 cells/mm2; p < .01 vs. baseline; p < .01 vs. group B). Leukocyte adherence in control animals (group C) did not increase significantly. Administration of N-acetylcysteine did not influence the decrease in VRBC observed during endotoxemia. In group B1 VRBC decreased during the infusion of endotoxin from 2.0 +/- 0.2 mm/sec at baseline to 1.1 +/- 0.2 mm/ sec after 120 mins (p < .01 vs. baseline; p < .05 vs. group C), and in group A from 2.2 +/- 0.2 mm/sec to 1.1 +/- 0.1 mm/sec after 120 mins (p < .01 vs. baseline; p < .05 vs. group C). In group C, VRBC remained unchanged (baseline, 1.7 +/- 0.2 mm/sec; at 120 mins, 1.5 +/- 0.2 mm/sec). The venular diameters remained unchanged in all groups during the entire study period. After 120 mins, the venular wall shear rate decreased from 502 +/- 62 secs-1 at baseline to 272 +/- 46 sec-1 in group B (p < .01), and from 563 +/- 45 secs-1 at baseline to 283 +/- 31 secs-1 in group A (p < .01). No differences in venular wall shear rate were observed between these groups. In group C, the venular wall shear rate remained unchanged (baseline, 457 +/- 54 secs-1; at 120 mins, 409 +/- 51 secs-1). Macromolecular leakage, expressed as perivenular/intravenular fluorescence intensity after injection of fluorescence-labeled albumin, increased from 0.29 +/- 0.03 to 0.58 +/- 0.03 (p < .01) during the infusion of endotoxin in group B. In contrast, pretreatment with N-acetylcysteine diminished the extravasation of albumin (baseline, 0.27 +/- 0.01; at 120 mins, 0.37 +/- 0.02; p < .01 vs. baseline; p < .01 vs. group B). These results demonstrate that N-acetylcysteine attenuates endotoxin-induced alterations in leukocyte-endothelial cell adhesion and macromolecular leakage, suggesting N-acetylcysteine might be therapeutic in the prevention of endothelial damage in sepsis.

Impact of a Work-Focused Intervention on the Productivity and Symptoms of Employees with Depression

PubMed Central

Lerner, Debra; Adler, David; Hermann, Richard C.; Chang, Hong; Ludman, Evette J.; Greenhill, Annabel; Perch, Katherine; McPeck, William C.; Rogers, William H.

2012-01-01

Objective To test a new program’s effectiveness in reducing depression’s work burden. Methods A brief telephonic program to improve work functioning was tested in an early-stage randomized controlled trial (RCT) involving 79 Maine State Government employees who screened-in for depression and at-work limitations (treatment group=59; usual care group=27). Group differences in baseline to follow-up change scores on The Work Limitations Questionnaire (WLQ), WLQ Absence Module and PHQ-9 depression severity scale were tested with analysis of covariance. Results While there were no baseline group differences (p≥.05), by follow-up the treatment group had significantly better scores on every outcome and differences in the longitudinal changes were all statistically significant (p=.0.27 to .0001). Conclusions The new program was superior to usual care. The estimated productivity cost savings are $6041.70 per participant annually. PMID:22252528

Duration of IOP reduction with travoprost BAK-free solution.

PubMed

Gross, Ronald L; Peace, James H; Smith, Stephen E; Walters, Thomas R; Dubiner, Harvey B; Weiss, Mark J; Ochsner, Katherine I

2008-01-01

To compare the duration of action of travoprost ophthalmic solution 0.004% (Travatan Z) formulated without benzalkonium chloride (BAK) to travoprost ophthalmic solution 0.004% formulated with BAK (Travatan). This was a prospective, randomized, double-masked study. Patients with open-angle glaucoma or ocular hypertension were randomized to receive 2 weeks of once-daily therapy with travoprost BAK-free or travoprost with BAK. Patients received the last dose of medication on day 13 and then intraocular pressure (IOP) was assessed every 12 hours for 60 hours. Statistical analysis included change in IOP from baseline for each group and comparison of mean IOP between groups. Of the 109 patients enrolled, 106 patients completed the study. Untreated mean baseline IOP at 8 AM was 26.9 mm Hg in the travoprost BAK-free group and 27.1 mm Hg in the travoprost with BAK group. At 12, 24, 36, 48, and 60 hours after the last dose, mean IOP in the travoprost BAK-free group was 18.7, 17.2, 19.5, 18.7, and 20.8 mm Hg, respectively; whereas mean IOP in the travoprost with BAK group was 18.5, 16.8, 19.7, 18.0, and 20.8 mm Hg, respectively. Mean IOP at all time points after the last dose of medication was >6 mm Hg lower than the 8 AM baseline in both groups. Between-group differences were within +/-0.6 mm Hg at all postdose time points. There were no statistically significant differences between the 2 treatment groups at baseline or at any postdose time point. Drug-related side effects were uncommon, mild in intensity, and comparable between groups. Travoprost without BAK has similar IOP-lowering efficacy and safety compared with travoprost preserved with BAK. Both formulations of travoprost have a prolonged duration of action, with statistically and clinically significant reductions from baseline persisting up to 60 hours after the last dose.

Bone mineral density and markers of bone turnover and inflammation in diabetes patients with or without a Charcot foot: An 8.5-year prospective case-control study.

PubMed

Jansen, Rasmus Bo; Christensen, Tomas Møller; Bülow, Jens; Rørdam, Lene; Holstein, Per E; Jørgensen, Niklas Rye; Svendsen, Ole Lander

2018-02-01

Charcot foot is a rare but severe complication to diabetes and peripheral neuropathy. It is still unclear if an acute Charcot foot has long-term effects on the bone metabolism. To investigate this, we conducted a follow-up study to examine if a previously acute Charcot foot has any long-term effects on bone mineral density (BMD) or local or systemic bone metabolism. An 8.5-year follow-up case-control study of 44 individuals with diabetes mellitus, 24 of whom also had acute or chronic Charcot foot at the baseline visit in 2005-2007, who were followed up in 2015 with DXA scans and blood samples. 21 of the 44 baseline participants participated in the follow-up. There were no difference in the change in total hip BMD from baseline to follow-up in either the Charcot or the control group (p = 0.402 and 0.517), and no increased risk of osteoporosis in the previous Charcot feet either. From baseline to follow-up, there was a significant difference in the change in levels of fsRANK-L in the Charcot group, but not in the control group (p = 0.002 and 0.232, respectively). At follow-up, there were no differences in fsRANK-L between the groups. The fsRANK-L/OPG ratio also significantly decreased from baseline to follow-up in the Charcot group (3.4 versus 0.5) (p = 0.009), but not in the control group (1.3 versus 1.1) (p = 0.302). We found that diabetes patients with an acute Charcot foot have an elevated fsRANK-L/OPG ratio, and that the level decreased from baseline to follow-up to be comparable to the level in diabetes patients without previous or current Charcot foot. We found no permanent effect of an acute Charcot foot on hip or foot BMD. Copyright © 2017 Elsevier Inc. All rights reserved.

Geotaxis baseline data for Drosophila

NASA Technical Reports Server (NTRS)

Schnebel, E. M.; Bhargava, R.; Grossfield, J.

1987-01-01

Geotaxis profiles for 20 Drosophila species and semispecies at different ages have been examined using a calibrated, adjustable slant board device. Measurements were taken at 5 deg intervals ranging from 0 deg to 85 deg. Clear strain and species differences are observed, with some groups tending to move upward (- geotaxis) with increasing angles, while others move downward (+ geotaxis). Geotactic responses change with age in some, but not all experimental groups. Sample geotaxis profiles are presented and their application to ecological and aging studies are discussed. Data provide a baseline for future evaluations of the biological effects of microgravity.

Effects of high-dose parenteral vitamin D therapy on lipid profile and blood pressure in patients with diabetic nephropathy: A randomized double-blind clinical trial.

PubMed

Liyanage, Gayani C; Lekamwasam, Sarath; Weerarathna, Thilak P; Liyanage, Chandrani E

2017-12-01

Aim of this study was to determine the effect of high dose vitamin D given to patients with early diabetic renal disease on systolic and diastolic blood pressure, total cholesterol (TC), low-density lipoproteins (LDL), triglycerides (TG) and high density lipoproteins (HDL) in a randomized controlled trial MATERIALS AND METHOD: Patients with early diabetic nephropathy were recruited. Selected patients were allocated to two groups by Block randomization method. Treatment group received 50,000 IU of vitamin D3 intramuscularly and the control group was given an equal volume of distilled water (0.25mL) monthly for six months. Blood and urine were collected at the baseline for biochemical analyses and blood pressure was measured. After six months all the measurements done at the baseline were repeated. Of 155 patients invited, 85 were randomly assigned to two groups. No significant differences were found between treatment and control groups at the baseline. Vitamin D therapy significantly reduced DBP, total cholesterol and LDL but the between group differences were not significant. There was an increase in HDL cholesterol level in the treatment group while there was no change in the control group Between groups difference was significant (P=<0.001). There was a significant improvement of serum HDL level with six months therapy of high dose vitamin D in patients with early diabetic nephropathy. Copyright © 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved.

[The effects of simvastatin combined with different antioxidant vitamin regimens on serum lipid profile in patients with low HDL cholesterol levels].

PubMed

Pirat, Bahar; Korkmaz, Mehmet Emin; Eroğlu, Serpil; Tayfun, Egemen; Yildirir, Aylin; Uluçam, Melek; Ozin, Bülent; Müderrisoğlu, Haldun

2004-12-01

This study was designed to compare the effects of simvastatin versus a combination of simvastatin with vitamin C or E on serum lipid profile, particularly, high-density lipoprotein (HDL)-cholesterol (C) level, in patients with a low HDL-C level. Fifty-nine women and 49 men, who had a baseline HDL-C level equal to or lower than 40 mg/dl were randomized to one of the following study treatment groups: Group S (n=39) simvastatin 20 mg/day, Group S+C (n=33) simvastatin 20 mg/day + vitamin C 500 mg/day, and Group S+E (n=36) simvastatin 20 mg/day + vitamin E 400 IU/day. The groups' lipid profiles were obtained at baseline, 3rd and 6th months. Comparing with baseline values, total-C and low-density cholesterol (LDL-C) values significantly reduced (p<0.001) and HDL-C values significantly increased (Group S--33.9+/-3.9 mg/dl vs. 39.8+/-6.9 mg/dl, Group S+C--34.2+/-3.5 mg/dl vs. 38.1+/-6.1 mg/dl, Group S+E--33.1+/-3.6 mg/dl vs. 34.8+/-5.9 mg/dl, p<0.001) on therapy within the groups; however, there were no significant differences among the groups with regards to these parameters. The HDL-C levels increased from baseline by 14.0%, 11.7% and 10.2% in Group S, S+C, and S+E, respectively (p>0.05). A combination of simvastatin with antioxidant vitamins does not offer any beneficial effect over simvastatin alone. Particularly vitamin E seems to blunt the simvastatin induced HDL-C increase.

The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes.

PubMed

Haluzík, Martin; Fulcher, Greg; Pieber, Thomas R; Bardtrum, Lars; Tutkunkardas, Deniz; Rodbard, Helena W

2018-02-16

To investigate whether the proven benefits of insulin degludec (IDeg) combined with insulin aspart (IAsp), known as IDegAsp, given twice daily, extend across a wide spectrum of patients with diabetes. This was a post hoc pooled analysis of 5 phase III randomized, 26-week, open-label, treat-to-target trials comparing IDegAsp twice daily (n = 1111) with one of two comparators: premixed insulin (biphasic insulin aspart 30 [BIAsp 30]) twice daily (n = 561) or IDeg once daily + IAsp (n = 136). Patient data were stratified according to baseline glycated haemoglobin (HbA1c) or fasting plasma glucose (FPG) categories, as well as by baseline duration of diabetes or body mass index (BMI) categories. We conducted a meta-analysis of 5 clinical trials: NCT01513590, NCT01009580, NCT01059812, NCT01680341 and NCT01713530. End-of-trial results were broadly consistent, with differences between IDegAsp and comparators observed in phase III trials. HbA1c results were similar for IDegAsp and the comparators in all baseline characteristic (HbA1c, duration of diabetes or BMI) and category groups (number ranges). Significantly lower FPG level was observed with IDegAsp vs comparators in all baseline characteristic and most category groups (excluding FPG <5.5 mmol/L). Significantly lower insulin doses were observed with IDegAsp vs comparators in all baseline characteristic and half of the category groups, and significantly lower rates of confirmed and nocturnal confirmed hypoglycaemia were observed with IDegAsp vs comparators in all baseline variable and category groups. IDegAsp retains a consistent safety and efficacy profile in patients with different baseline characteristics. © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Cognitive Performance as Predictor and Outcome of Adolescent Bariatric Surgery: A Nonrandomized Pilot Study.

PubMed

Mackey, Eleanor R; Jacobs, Marni; Nadler, Evan P; Olson, Alexandra; Pearce, Alaina; Cherry, J Bradley C; Magge, Sheela N; Mietus-Snyer, Michele; Vaidya, Chandan

2018-05-16

Evidence in adults suggests that improvements in cognitive performance may follow weight loss resulting from bariatric surgery, and baseline cognitive performance may be associated with weight loss following surgery. This has not been evaluated in adolescents. Participants were 38 adolescents of age 14-21 years composed of three groups: (1) 12 adolescents with severe obesity who received vertical sleeve gastrectomy during the study (VSG); (2) 14 adolescents with severe obesity who were wait-listed for VSG (WL); and (3) 12 healthy weight controls (HC). Participants completed testing of visual memory, verbal memory, and executive functioning at baseline (T1), which occurred presurgery for the VSG group, and approximately 4 months after baseline (T2). Body mass index (BMI) was assessed at T1, T2, and additionally at 6 months following VSG for the adolescents who received surgery. Although there was evidence of greater improvement for the VSG as compared with WL and HC groups in visual and verbal memory, group differences did not reach significance and effect sizes were small (η2 < 0.01). There was a significant positive association between indices of baseline executive functioning and excess BMI loss at 6 months postsurgery. This small pilot study showed no significant differences by group in cognitive performance post-VSG. There was a significant association of baseline cognitive performance with weight loss outcomes. Given the very preliminary nature of these results in a small sample, future research should examine these relationships in a larger sample and evaluate mechanisms of these associations (e.g., insulin resistance, sleep, physical activity).

Effectiveness of active-online, an individually tailored physical activity intervention, in a real-life setting: randomized controlled trial.

PubMed

Wanner, Miriam; Martin-Diener, Eva; Braun-Fahrländer, Charlotte; Bauer, Georg; Martin, Brian W

2009-07-28

Effective interventions are needed to reduce the chronic disease epidemic. The Internet has the potential to provide large populations with individual advice at relatively low cost. The focus of the study was the Web-based tailored physical activity intervention Active-online. The main research questions were (1) How effective is Active-online, compared to a nontailored website, in increasing self-reported and objectively measured physical activity levels in the general population when delivered in a real-life setting? (2) Do respondents recruited for the randomized study differ from spontaneous users of Active-online, and how does effectiveness differ between these groups? (3) What is the impact of frequency and duration of use of Active-online on changes in physical activity behavior? Volunteers recruited via different media channels completed a Web-based baseline survey and were randomized to Active-online (intervention group) or a nontailored website (control group). In addition, spontaneous users were recruited directly from the Active-online website. In a subgroup of participants, physical activity was measured objectively using accelerometers. Follow-up assessments took place 6 weeks (FU1), 6 months (FU2), and 13 months (FU3) after baseline. A total of 1531 respondents completed the baseline questionnaire (intervention group n = 681, control group n = 688, spontaneous users n = 162); 133 individuals had valid accelerometer data at baseline. Mean age of the total sample was 43.7 years, and 1146 (74.9%) were women. Mixed linear models (adjusted for sex, age, BMI category, and stage of change) showed a significant increase in self-reported mean minutes spent in moderate- and vigorous-intensity activity from baseline to FU1 (coefficient = 0.14, P = .001) and to FU3 (coefficient = 0.19, P < .001) in all participants with no significant differences between groups. A significant increase in the proportion of individuals meeting the HEPA recommendations (self-reported) was observed in all participants between baseline and FU3 (OR = 1.47, P = .03), with a higher increase in spontaneous users compared to the randomized groups (interaction between FU3 and spontaneous users, OR = 2.95, P = .02). There were no increases in physical activity over time in any group for objectively measured physical activity. A significant relation was found between time spent on the tailored intervention and changes in self-reported physical activity between baseline and FU3 (coefficient = 1.13, P = .03, intervention group and spontaneous users combined). However, this association was no longer significant when adjusting for stage of change. In a real-life setting, Active-online was not more effective than a nontailored website in increasing physical activity levels in volunteers from the general population. Further research may investigate ways of integrating Web-based physical activity interventions in a wider context, for example, primary care or workplace health promotion.

The effects of transport by car on coagulation tests.

PubMed

Ergin, Merve; Erdogan, Serpil; Akturk, Onur; Erel, Ozcan

2017-10-26

This research investigated the effects of the transport of blood samples between centers/laboratories by car on coagulation tests. Five tubes of blood samples were taken from 20 healthy volunteers. The samples consisted of a baseline (control) group, centrifuged and noncentrifuged transported samples; centrifuged and noncentrifuged untransported samples. The groups of centrifuged and noncentrifuged samples were transported by car for 2 h. The centrifuged and noncentrifuged untransported samples were incubated in the laboratory until the transported samples arrived. Prothrombin time (PT) and activated partial thromboplastin time (APTT) tests were conducted for all samples. Significant differences between the baseline group and the centrifuged and noncentrifuged transported samples and the noncentrifuged untransported samples were found for APTT levels (p<0.05, for all). In addition, significant mean percentage differences in PT values were found between the baseline group and the noncentrifuged transported samples (p<0.001) and the noncentrifuged untransported samples (p=0.005). The mean level of PT in the noncentrifuged transported samples was outside the upper limit of the clinical decision level. Noncentrifuged transported samples showed clinically significant differences in PT test results that may have stemmed from mechanical agitation during transportation. Therefore, we recommend not transporting noncentrifuged specimens for PT testing by car.

T-Tau is Associated with Objective Memory Decline Over Two Years in Persons Seeking Help for Subjective Cognitive Decline: A Report from the Gothenburg-Oslo MCI Study.

PubMed

Hessen, Erik; Nordlund, Arto; Stålhammar, Jacob; Eckerström, Marie; Bjerke, Maria; Eckerström, Carl; Göthlin, Mattias; Fladby, Tormod; Reinvang, Ivar; Wallin, Anders

2015-01-01

There is a need to find very early markers for pre-clinical Alzheimer's disease as interventions early in the disease process are thought to be most effective. The present study aimed to address the potential relation between cerebrospinal fluid (CSF) biomarkers and reduced cognitive function in a relatively young cohort of memory clinic patients with subjective cognitive decline. 122 patients (mean age 63 years) with subjective cognitive decline were recruited from two university memory clinics and followed for two years. The main finding was that the subgroup with objective memory decline during the study period had significantly higher T-tau at baseline than the group with improved memory. Baseline CSF variables showed a trend toward more pathological values in the patients with memory decline compared to those who improved or remained stable. The baseline memory score of those who declined was significantly better than the baseline score of those who improved over two years. The general trend for the whole group was improved memory and executive test scores. There were no differences in cognitive scores based on CSF quartiles at baseline, nor were there differences in cognitive outcome for patients with early amnestic mild cognitive impairment versus average cognitive function at baseline. The main finding that T-tau rather than amyloid-β was associated with memory decline do not support the prevailing opinion about the chain of events assumed to take place in Alzheimer's disease. In addition, memory decline was not associated with poor baseline memory score. Thus, a memory cut-off indicating low baseline memory would not would have identified the declining group.

Placental baseline conditions modulate the hyperoxic BOLD-MRI response.

PubMed

Sinding, Marianne; Peters, David A; Poulsen, Sofie S; Frøkjær, Jens B; Christiansen, Ole B; Petersen, Astrid; Uldbjerg, Niels; Sørensen, Anne

2018-01-01

Human pregnancies complicated by placental dysfunction may be characterized by a high hyperoxic Blood oxygen level-dependent (BOLD) MRI response. The pathophysiology behind this phenomenon remains to be established. The aim of this study was to evaluate whether it is associated with altered placental baseline conditions, including a lower oxygenation and altered tissue morphology, as estimated by the placental transverse relaxation time (T2*). We included 49 normal pregnancies (controls) and 13 pregnancies complicated by placental dysfunction (cases), defined by a birth weight < 10th percentile in combination with placental pathological signs of vascular malperfusion. During maternal oxygen inhalation, we measured the relative ΔBOLD response ((hyperoxic BOLD - baseline BOLD)/baseline BOLD) from a dynamic single-echo gradient-recalled echo (GRE) MRI sequence and the absolute ΔT2* (hyperoxic T2*- baseline T2*) from breath-hold multi-echo GRE sequences. In the control group, the relative ΔBOLD response increased during gestation from 5% in gestational week 20 to 20% in week 40. In the case group, the relative ΔBOLD response was significantly higher (mean Z-score 4.94; 95% CI 2.41, 7.47). The absolute ΔT2*, however, did not differ between controls and cases (p = 0.37), whereas the baseline T2* was lower among cases (mean Z-score -3.13; 95% CI -3.94, -2.32). Furthermore, we demonstrated a strong negative linear correlation between the Log 10 ΔBOLD response and the baseline T2* (r = -0.88, p < 0.0001). The high hyperoxic ΔBOLD response demonstrated in pregnancies complicated by placental dysfunction may simply reflect altered baseline conditions, as the absolute increase in placental oxygenation (ΔT2*) does not differ between groups. Copyright © 2017 Elsevier Ltd. All rights reserved.

Onset and duration of intravenous and intraosseous rocuronium in hypovolemic swine.

PubMed

Nemeth, Miguel; Williams, George N; Prichard, Debbie; McConnico, Angie; Johnson, Don; Loughren, Michael

2016-01-01

Compare the onset and duration of rocuronium administered via the intravenous (IV), and intraosseous (IO) routes in a hypovolemic swine model. Prospective, between subjects, experimental study. Vivarium. Yorkshire-cross swine (N = 8). Electromyography (EMG) amplitudes were recorded at baseline and for every 15 seconds after administering 1.2 mg/kg of rocuronium via IV or IO routes to hypovolemic swine. EMG amplitudes were measured until termination of EMG activity and then measured every 5 minutes until there was a return to baseline values. Individual data were transformed to percent baseline. The time from the end of injection to 90 percent reduction of baseline EMG activity (Onset 90 ), the time to maximum reduction (Onset peak ), and the maximum reduction of the neuromuscular response (peak effect), as well as, time from the end of injection to the return of 25, 50, 75, and 95 percent of baseline EMG activity was used to characterize onset and recovery of neuromuscular function. Maximum reduction, Onset 90 and Onset peak times were not statistically different between groups. The IV group's mean time to recovery of all benchmarks was faster than the IO group. The IO group took statistically longer than the IV group to return to 25, 50, 75, and 95 percent of baseline activity. The IO route is an effective method of administering rocuronium and is comparable to the IV route even under conditions of significant hemorrhage.

[Withdrawal of a specialised diabetes education program in primary care: long term impact on the metabolic control outcomes].

PubMed

Jurado Campos, Jerónimo; Caula Ros, Jacint A; Hernández Anguera, Josep M; Juvinyà Canal, Dolors; Pou Torelló, José M

2009-12-01

To evaluate the possible relationships between a health policy decision, in relation to the diabetes education strategies and the metabolic control outcomes. Longitudinal prospective cohort study. A random cohort sample of 276 type II diabetes mellitus subjects. All primary care centres in three regions of Catalonia. Patients were classified as specialised (n=59) or non-specialised (n=217) groups, as regards whether having received previous diabetes education before the start of the study. HbA1c values were evaluated in all subjects at baseline and after 5 years after receiving only conventional education. Baseline evaluation showed a better metabolic control in the specialised group (P=0.009). The final evaluation showed no significant differences in outcomes between the two groups (P=0.679). When baseline and outcomes values were compared, significant differences were observed in all subjects (P=0.001), the specialised group showed significantly poorer metabolic control (P<0.001), but in the group with previous conventional education no significant differences were observed (P=0.058). Our results suggest that the withdrawal of higher levels of diabetes education may play a major role in poor metabolic control, and that conventional diabetes education does not improve outcomes. Health policy in Primary Care should consider improving the level of diabetes education.

The Effects of Intravenous Hydration on Amniotic Fluid Index in Pregnant Women with Preterm premature Rupture of Membranes: A Randomized Clinical Trial

PubMed Central

Shahnazi, Mahnaz; Tagavi, Simin; Hajizadeh, Khadije; Farshbaf Khalili, Azize

2013-01-01

Introduction: Preterm premature rupture of membranes (PPROM) can result in fetal complications such as oligohydramnios. This study aimed to determine the effects of intravenous (IV) fluid bolus on amniotic fluid index (AFI) in pregnant women with PPROM. Methods: 24 women with PPROM during singleton live pregnancy of 28 to 34 weeks whose baseline AFI was ≤ 5cm were randomized into two groups. The study group received one liter intravenous fluid bolus of isotonic Ringer serum during 30-minute period. Reevaluations of amniotic fluid index in both groups were made 90 minutes and 48 hours after baseline measurement. Independent t-test and paired t-test were used to compare the two groups and mean amniotic fluid index before and after treatment, respectively. Results: The results of this study demonstrate that AFI decreased statistically significant in both the control and study groups. AFI decreased in both groups at 48 hours later. This decrease was not statistically significant in any group. The mean change in AFI (90 minutes and baseline) and (48 hours and baseline) between the two groups were not significant. The time between mean baseline measurements and delivery were 196.41 and 140.58 hours in the study and control groups, respectively. This difference was not statistically significant. Conclusion: This study did not find significant impact of hydration On AFI as a prophylactic method on oligohydramnios in pregnant women with PPROM. PMID:25276709

Once Versus Thrice Daily Colistin in Critically Ill Ptients with Multi-Drug Resistant Infections

PubMed Central

Ghazaeian, Monireh; Mokhtari, Majid; Kouchek, Mehran; Miri, MirMohammad; Goharani, Reza; Ghodssi-Ghassemabadi, Robabeh; Sistanizad, Mohammad

2017-01-01

The aim of this study was to evaluate the procalcitonin (PCT) changes in two different high-dose colistin regimens in the treatment of multi-drug resistant MDR gram negative infections in ICU patients. This is a prospective study of adult ICU patients with bacteremia and ventilator associated pneumonia (VAP) caused by MDR gram negative pathogens. Patients were assigned to two colistin administration groups. Group A received 9 and group B received 3 million international units every 24 and 8 h respectively. Baseline characteristics and measurements of PCT concentrations at the start, the 3rd and the 5th day of the antibiotic therapy and their trends between the two groups were recorded and compared. of 40 patients enrolled, 34 completed the study protocol, of whom 30 (88.2%) had (VAP) and 4 (11.8%) had bacteremia. There were no statistically significant differences in the baseline characteristics between the two groups. The mean PCT levels in two study groups were; 2.34, 1.24, and 0.95 in group A and 5.89, 1.24 and 0.8 in group B at the baseline, 3rd and 5th day of colistin administration respectively (P=0.47). The ICU length of stay (LOS) in days and ICU mortality were; 31.31, 35.3% and 32.06, 22.2% in groups A and B (P=0.39, 0.87), respectively. Conclusion: We did not find any statistically significant differences in the serum PCT levels, ICU LOS or ICU mortality, between the two groups, who received maximum recommended dose of CMS with 2 different intervals of every 8 or 24 h. PMID:29201114

Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer's dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial.

PubMed

Park, Kyung Won; Kim, Eun-Joo; Han, Hyun Jeong; Shim, Yong S; Kwon, Jae C; Ku, Bon D; Park, Kee Hyung; Yi, Hyon-Ah; Kim, Kwang K; Yang, Dong Won; Lee, Ho-Won; Kang, Heeyoung; Kwon, Oh Dae; Kim, SangYun; Lee, Jae-Hyeok; Chung, Eun Joo; Park, Sang-Won; Park, Mee Young; Yoon, Bora; Kim, Byeong C; Seo, Sang Won; Choi, Seong Hye

2017-01-01

Studies investigating the impact of white matter hyperintensities (WMHs) on the response of acetylcholinesterase inhibitors in patients with Alzheimer's disease (AD) have presented inconsistent results. We aimed to compare the effects of the rivastigmine patch between patients with AD with minimal WMHs and those with moderate WMHs. Three hundred patients with mild to moderate AD were enrolled in this multicenter prospective open-label study and divided into two groups. Group 1 comprised patients with AD with minimal WMHs and group 2 comprised those with moderate WMHs. The patients were treated with a rivastigmine patch for 24 weeks. Efficacy measures were obtained at baseline and after 24 weeks. The primary endpoint was the change in the AD Assessment Scale-Cognitive subscale (ADAS-Cog) from the baseline to the end of the study. Of the 300 patients, there were 206 patients in group 1 and 94 patients in group 2. The intention-to-treat group comprised 198 patients (group 1, n = 136; group 2, n = 46) during the 24-week study period. Demographic factors did not differ between group 1 and group 2. There were no significant differences in change in ADAS-cog between group 1 (-0.62±5.70) and group 2 (-0.23±5.98) after the 24-week rivastigmine patch therapy (p = 0.378). The patients in group 1 had a 0.63-point improvement from baseline on the Frontal Assessment Battery, while group 2 had a 0.16-point decline compared to baseline at the end of the study (p = 0.037). The rates of adverse events (AEs) (42.6 vs. 40.3%) and discontinuation due to AEs (10.3% vs. 4.3%) did not differ between the groups. Although the efficacy and tolerability of rivastigmine patch therapy were not associated with WMH severity in patients with AD, some improvement in frontal function was observed in those with minimal WMHs. ClinicalTrials.gov NCT01380288.

Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer’s dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial

PubMed Central

Kim, Eun-Joo; Han, Hyun Jeong; Shim, Yong S.; Kwon, Jae C.; Ku, Bon D.; Park, Kee Hyung; Yi, Hyon-Ah; Kim, Kwang K.; Yang, Dong Won; Lee, Ho-Won; Kang, Heeyoung; Kwon, Oh Dae; Kim, SangYun; Lee, Jae-Hyeok; Chung, Eun Joo; Park, Sang-Won; Park, Mee Young; Yoon, Bora; Kim, Byeong C.; Seo, Sang Won; Choi, Seong Hye

2017-01-01

Background and objective Studies investigating the impact of white matter hyperintensities (WMHs) on the response of acetylcholinesterase inhibitors in patients with Alzheimer’s disease (AD) have presented inconsistent results. We aimed to compare the effects of the rivastigmine patch between patients with AD with minimal WMHs and those with moderate WMHs. Methods Three hundred patients with mild to moderate AD were enrolled in this multicenter prospective open-label study and divided into two groups. Group 1 comprised patients with AD with minimal WMHs and group 2 comprised those with moderate WMHs. The patients were treated with a rivastigmine patch for 24 weeks. Efficacy measures were obtained at baseline and after 24 weeks. The primary endpoint was the change in the AD Assessment Scale-Cognitive subscale (ADAS-Cog) from the baseline to the end of the study. Results Of the 300 patients, there were 206 patients in group 1 and 94 patients in group 2. The intention-to-treat group comprised 198 patients (group 1, n = 136; group 2, n = 46) during the 24-week study period. Demographic factors did not differ between group 1 and group 2. There were no significant differences in change in ADAS-cog between group 1 (-0.62±5.70) and group 2 (-0.23±5.98) after the 24-week rivastigmine patch therapy (p = 0.378). The patients in group 1 had a 0.63-point improvement from baseline on the Frontal Assessment Battery, while group 2 had a 0.16-point decline compared to baseline at the end of the study (p = 0.037). The rates of adverse events (AEs) (42.6 vs. 40.3%) and discontinuation due to AEs (10.3% vs. 4.3%) did not differ between the groups. Conclusions Although the efficacy and tolerability of rivastigmine patch therapy were not associated with WMH severity in patients with AD, some improvement in frontal function was observed in those with minimal WMHs. Trial registration ClinicalTrials.gov NCT01380288 PMID:28786987

Robot-assisted gait training in multiple sclerosis patients: a randomized trial.

PubMed

Schwartz, Isabella; Sajin, Anna; Moreh, Elior; Fisher, Iris; Neeb, Martin; Forest, Adina; Vaknin-Dembinsky, Adi; Karusis, Dimitrios; Meiner, Zeev

2012-06-01

Preservation of locomotor activity in multiple sclerosis (MS) patients is of utmost importance. Robotic-assisted body weight-supported treadmill training is a promising method to improve gait functions in neurologically impaired patients, although its effectiveness in MS patients is still unknown. To compare the effectiveness of robot-assisted gait training (RAGT) with that of conventional walking treatment (CWT) on gait and generalized functions in a group of stable MS patients. A prospective randomized controlled trial of 12 sessions of RAGT or CWT in MS patients of EDSS score 5-7. Primary outcome measures were gait parameters and the secondary outcomes were functional and quality of life parameters. All tests were performed at baseline, 3 and 6 months post-treatment by a blinded rater. Fifteen and 17 patients were randomly allocated to RAGT and CWT, respectively. Both groups were comparable at baseline in all parameters. As compared with baseline, although some gait parameters improved significantly following the treatment at each time point there was no difference between the groups. Both FIM and EDSS scores improved significantly post-treatment with no difference between the groups. At 6 months, most gait and functional parameters had returned to baseline. Robot-assisted gait training is feasible and safe and may be an effective additional therapeutic option in MS patients with severe walking disabilities.

Prevalence and predictors of healthcare utilization among older people (60+): focusing on ADL dependency and risk of depression.

PubMed

Sandberg, Magnus; Kristensson, Jimmie; Midlöv, Patrik; Fagerström, Cecilia; Jakobsson, Ulf

2012-01-01

The aim of this study was to investigate healthcare utilization patterns over a six-year period among older people (60+), classified as dependent/independent in Activities of Daily Living (ADL) and/or at/not at risk of depression and to identify healthcare utilization predictors. A sample (n=1402) comprising ten age cohorts aged between 60 and 96 years was drawn from the Swedish National study on Aging and Care (SNAC). Baseline data were collected between 2001 and 2003. Number and length of hospital stays were collected for six years after baseline year. Group differences and mean changes over time were investigated. Healthcare utilization predictors were explored using multiple linear regression analysis. The results revealed that 21-24% had at least one hospital stay in the six years after baseline, 29-37% among ADL dependent subjects and 24-33% among those at risk of depression. There was a significant increase of hospital stays in all groups over time. ADL-dependent subjects and those at risk of depression had significant more hospital stays, except for those at/not at risk of depression in years 2, 4 and 5. The healthcare utilization predictors 5-6 years after baseline were mainly age, previous healthcare utilization and various symptoms and, in 1-2 and 3-4 years after baseline, age, various diagnostic groups and various physical variables. Thus healthcare utilization patterns seem to be similar for the different groups, but it is difficult to find universal predictors. This suggests that different variables should be considered, including both ADL and psychosocial variables, when trying to identify future healthcare users. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Clinical evaluation of an Er:YAG laser for nonsurgical treatment of peri-implantitis: a pilot study.

PubMed

Schwarz, Frank; Sculean, Anton; Rothamel, Daniel; Schwenzer, Katja; Georg, Thomas; Becker, Jürgen

2005-02-01

The aim of this controlled, parallel design clinical study was to compare the effectiveness of an Er:YAG laser (ERL) to that of mechanical debridement using plastic curettes and antiseptic therapy for nonsurgical treatment of peri-implantitis. Twenty patients with moderate to advanced peri-implantitis lesions were randomly treated with either (1) an ERL using a cone-shaped glass fiber tip at an energy setting of 100 mJ/pulse and 10 pps (ERL), or (2) mechanical debridement using plastic curettes and antiseptic therapy with chlorhexidine digluconate (0.2%) (C). The following clinical parameters were measured at baseline, 3 and 6 months after treatment by one blinded and calibrated examiner: Plaque index (PI), bleeding on probing (BOP), probing depth (PD), gingival recession (GR) and clinical attachment level (CAL). At the baseline examination, there were no statistically significant differences in any of the investigated parameters. Mean value of BOP decreased in the ERL group from 83% at baseline to 31% after 6 months (P < 0.001) and in the C group from 80% at baseline to 58% after 6 months (P < 0.001). The difference between the two groups was statistically significant (P < 0.001, respectively). The sites treated with ERL demonstrated a mean CAL change from 5.8 +/- 1 mm at baseline to 5.1 +/- 1.1 mm (P < 0.01) after 6 months. The C sites demonstrated a mean CAL change from 6.2 +/- 1.5 mm at baseline to 5.6 +/- 1.6 mm (P < 0.001) after 6 months. After 6 months, the difference between the two groups was statistically not significant (P > 0.05). Within the limits of the present study, it was concluded that (i) at 6 months following treatment both therapies led to significant improvements of the investigated clinical parameters, and (ii) ERL resulted in a statistically significant higher reduction of BOP than C.

Effects of a tailored lifestyle self-management intervention (TALENT) study on weight reduction: a randomized controlled trial.

PubMed

Melchart, Dieter; Löw, Peter; Wühr, Erich; Kehl, Victoria; Weidenhammer, Wolfgang

2017-01-01

Overweight and obesity are globally increasing risk factors for diseases in the context of metabolic syndrome. A randomized controlled trial was conducted to investigate whether there are any existing differences between two lifestyle intervention strategies with respect to weight reduction after 1 year. A total of 166 subjects with a body mass index of 28-35 kg/m 2 were enrolled in this trial at seven study centers; 109 were randomly allocated to the intervention group (comprehensive lifestyle modification program: web-based Individual Health Management [IHM]) with 3-month reduction phase plus 9-month maintenance phase, and 57 were allocated to the control group (written information with advice for healthy food habits: usual care [UC]). Body weight, waist circumference, blood pressure, laboratory findings, and bioimpedance analysis used to determine body composition were measured at baseline and after 3, 6, 9, and 12 months. The primary outcome parameter was body weight at month 12 compared to baseline. With respect to baseline status there were no statistically significant differences between the groups. Based on the intent-to-treat population, body weight showed a mean decrease of 8.7 kg (SD 6.1) in the intervention group (IHM) and 4.2 kg (SD 5) in the control group (UC) at month 12. This statistically significant difference ( P <0.001) was confirmed by various sensitivity analyses. Body mass index, waist circumference, high-density lipid cholesterol, body fat, and the ratio of fat and body cell mass improved to a significantly higher degree in the IHM group. IHM proved to be superior to UC in weight reduction after 1 year. With a mean loss of about 10% of the baseline weight, a clinically high relevant risk reduction for cardio-metabolic diseases is achievable.

Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years.

PubMed

Lemieux, Julie; Brundage, Michael D; Parulekar, Wendy R; Goss, Paul E; Ingle, James N; Pritchard, Kathleen I; Celano, Paul; Muss, Hyman; Gralow, Julie; Strasser-Weippl, Kathrin; Whelan, Kate; Tu, Dongsheng; Whelan, Timothy J

2018-02-20

Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.

The influence of text messaging on oral hygiene effectiveness.

PubMed

Bowen, T Brent; Rinchuse, Daniel J; Zullo, Thomas; DeMaria, Mark E

2015-07-01

To investigate whether text message reminders regarding oral hygiene have an effect on plaque removal in orthodontic patients. In this randomized, controlled clinical trial, 50 orthodontic patients were assigned to either a text message or control group. Patients in the text message group received 12 text messages over the course of 4 weeks and one text message for 8 weeks thereafter. Photos were taken at baseline (T0), at 4 weeks after baseline (T1), and at 12 weeks after baseline (T2). For each subject, photos of eight teeth were taken and then the area of the tooth and amount of plaque were measured using planimetry. There was a statistically significant difference in plaque coverage between baseline and both T1 and T2 in the text message group as measured using planimetry. This was demonstrated by comparing the average measurements of the control group and the treatment group. This study demonstrated that the use of automated text message reminders sent from an orthodontic office was effective in improving oral hygiene compliance in orthodontic patients.

Effects of Preoperative Serotonin-Receptor-Antagonist Administration in Spinal Anesthesia-Induced Hypotension: A Randomized, Double-blind Comparison Study of Ramosetron and Ondansetron.

PubMed

Shin, Hyun-Jung; Choi, Eun-Su; Lee, Gwan-Woo; Do, Sang-Hwan

2015-01-01

The adverse effects of spinal anesthesia (SA) include arterial hypotension and bradycardia. The aim of this study was to compare the effects of 2 type 3 serotonin receptor antagonists in SA-induced adverse effects. Specifically, we assessed whether ramosetron was more effective than ondansetron in reducing SA-induced decreases in blood pressure (BP) and heart rate (HR). A total of 117 patients undergoing orthopedic surgery and receiving SA were intravenously administered 0.3 mg of ramosetron (n = 39, group R), 4 mg of ondansetron (n = 39, group O4), or 8 mg of ondansetron (n = 39, group O8). Systolic BP (SBP), diastolic BP (DBP), mean BP (MBP), HR, and the lowest SBP, DBP, MBP, and HR values were measured preoperatively (baseline) and intraoperatively. The incidence of postoperative nausea and vomiting, the need for rescue antiemetics, the amount of patient-controlled analgesia consumption, and pain score in the first 48 hours after surgery were determined. Baseline values did not significantly differ among the 3 groups. After SA, SBP, DBP, MBP, and HR were lower than their baseline values in all 3 groups. The differences between the baseline and the lowest values were significantly less in group R than in groups O4 and O8 with respect to SBP (P < 0.001), DBP (P = 0.001), and MBP (P < 0.001) less in group R than in group O4 with respect to HR (P = 0.032). Intergroup differences were not significant for postoperative nausea and vomiting, the need for rescue antiemetics, patient-controlled analgesia consumption, or pain score. The administration of ramosetron (0.3 mg) significantly attenuated the SA-induced decrease in BP compared with 4 or 8 mg of ondansetron and HR compared with 4 mg of ondansetron.

Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry.

PubMed

Attizzani, Guilherme F; Ohno, Yohei; Capodanno, Davide; Cannata, Stefano; Dipasqua, Fabio; Immé, Sebastiano; Mangiafico, Sarah; Barbanti, Marco; Ministeri, Margherita; Cageggi, Anna; Pistritto, Anna Maria; Giaquinta, Sandra; Farruggio, Silvia; Chiarandà, Marta; Ronsivalle, Giuseppe; Schnell, Audrey; Scandura, Salvatore; Tamburino, Corrado; Capranzano, Piera; Grasso, Carmelo

2015-01-01

This study sought to compare, in high-risk patients with 3+ to 4+ mitral regurgitation (MR) dichotomized by baseline echocardiographic features, acute, 30-day, and 12-month outcomes following percutaneous mitral valve repair using the MitraClip. The feasibility and mid-term outcomes after MitraClip implantation in patients with echocardiographic features different from the EVEREST (Endovascular Valve Edge-to-Edge Repair) I and II trials have been scarcely studied. Clinical and echocardiographic outcomes through 12-month follow-up of consecutive patients who underwent MitraClip implantation were obtained from an ongoing prospective registry. Two different groups, divided according to baseline echocardiographic criteria (investigational group [EVERESTOFF] and control group [EVERESTON]), were compared. Seventy-eight patients were included in EVERESTOFF and 93 patients in EVERESTON groups. Important and comparable acute reductions in MR and no clip-related complications were revealed. The primary safety endpoint at 30 days was comparable between groups (2.6% vs. 6.5%, respectively, p = 0.204); in addition, MR reduction was mostly sustained, whereas equivalent improvement in New York Heart Association functional class were demonstrated. Kaplan-Meier freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 12 months was demonstrated in 71.4% and 76.2%, respectively, in the EVERESTOFF and EVERESTON groups (log rank p = 0.378). Significant improvements in ejection fraction and reduction in left ventricle volumes were demonstrated in both groups over time, but the baseline between-group differences were sustained. MitraClip implantation in patients with expanded baseline echocardiographic features, compared with the control group, was associated with similar rates of safety and efficacy through 12-month follow-up. Further validation of our findings is warranted. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Randomised placebo-controlled trial of lisinopril in normotensive patients with insulin-dependent diabetes and normoalbuminuria or microalbuminuria. The EUCLID Study Group.

PubMed

1997-06-21

Renal disease in people with insulin-dependent diabetes (IDDM) continues to pose a major health threat. Inhibitors of angiotensin-converting enzyme (ACE) slow the decline of renal function in advanced renal disease, but their effects at earlier stages are unclear, and the degree of albuminuria at which treatment should start is not known. We carried out a randomised, double-blind, placebo-controlled trial of the ACE inhibitor lisinopril in 530 men and women with IDDM aged 20-59 years with normoalbuminuria or microalbuminuria. Patients were recruited from 18 European centres, and were not on medication for hypertension. Resting blood pressure at entry was at least 75 and no more than 90 mm Hg diastolic, and no more than 155 mm Hg systolic. Urinary albumin excretion rate (AER) was centrally assessed by means of two overnight urine collections at baseline, 6, 12, 18, and 24 months. There were no difference in baseline characteristics by treatment group; mean AER was 8.0 micrograms/min in both groups; and prevalence of microalbuminuria was 13% and 17% in the placebo and lisinopril groups, respectively. On intention-to-treat analysis at 2 years, AER was 2.2 micrograms/min lower in the lisinopril than in the placebo group, a percentage difference of 18.8% (95% CI 2.0-32.7, p = 0.03), adjusted for baseline AER and centre, absolute difference 2.2 micrograms/min. In people with normoalbuminuria, the treatment difference was 1.0 microgram/min (12.7% [-2.9 to 26.0], p = 0.1). In those with microalbuminuria, however, the treatment difference was 34.2 micrograms/min (49.7% [-14.5 to 77.9], p = 0.1; for interaction, p = 0.04). For patients who completed 24 months on the trial, the final treatment difference in AER was 38.5 micrograms/min in those with microalbuminuria at baseline (p = 0.001), and 0.23 microgram/min in those with normoalbuminuria at baseline (p = 0.6). There was no treatment difference in hypoglycaemic events or in metabolic control as assessed by glycated haemoglobin. Lisinopril slows the progression of renal disease in normotensive IDDM patients with little or no albuminuria, though greatest effect was in those with microalbuminuria (AER > or = 20 micrograms/min). Our results show that lisinopril does not increase the risk of hypoglycaemic events in IDDM.

A 5-year randomized trial to compare 1 or 2 implants for implant overdentures.

PubMed

Bryant, S R; Walton, J N; MacEntee, M I

2015-01-01

The hypothesis of this 5-y randomized clinical trial was that there would be no significant difference in the satisfaction of edentulous participants with removable complete overdentures attached to 1 or 2 mandibular implants. Secondary aims were to test changes in satisfaction between and within the groups from baseline to 5 y and differences between the groups in implant survival and prosthodontic maintenance over 5 y. Each of the 86 participants (mean age, 67 y) was randomly allocated to receive either 1 implant in the midline (group 1) or 2 implants in the canine areas (group 2) attached to a mandibular overdenture opposing a maxillary complete denture. Satisfaction was self-assessed by participants on a visual analog scale at baseline prior to implants, as well as at 2 mo and 1, 3, and 5 y with implant overdentures, whereas implant survival and prosthodontic maintenance were assessed by clinical examination. After 5 y, 29 participants in group 1 and 33 in group 2 were available, with most dropouts due to death. Satisfaction with the implant denture after 5 y was significantly (P < 0.001) higher than at baseline in both groups and remained with no significant difference (P = 0.32) between the groups. No implants failed in group 1 but 5 failed before loading in 4 participants in group 2. Most participants required maintenance or occasionally denture replacement, and although differences between the groups were not statistically significant, group 1 experienced almost twice as many fractured dentures usually adjacent to the implant attachment. We conclude that there were no significant differences after 5 y in satisfaction or survival of implants with mandibular overdentures retained by 1 implant or 2 implants. Additional research is required to confirm long-term treatment effectiveness of single-implant dentures and the implications of prosthetic maintenance with implant overdentures (ClinicalTrials.gov: NCT02117856). © International & American Associations for Dental Research 2014.

Long-term multiple risk factor interventions in Japanese elderly diabetic patients: the Japanese Elderly Diabetes Intervention Trial--study design, baseline characteristics and effects of intervention.

PubMed

Araki, Atsushi; Iimuro, Satoshi; Sakurai, Takashi; Umegaki, Hiroyuki; Iijima, Katsuya; Nakano, Hiroshi; Oba, Kenzo; Yokono, Koichi; Sone, Hirohito; Yamada, Nobuhiro; Ako, Junya; Kozaki, Koichi; Miura, Hisayuki; Kashiwagi, Atsunori; Kikkawa, Ryuichi; Yoshimura, Yukio; Nakano, Tadasumi; Ohashi, Yasuo; Ito, Hideki

2012-04-01

To evaluate long-term, multiple risk factor intervention on physical, psychological and mental prognosis, and development of complications and cardiovascular disease in elderly type 2 diabetes patients. Our randomized, controlled, multicenter, prospective intervention trial included 1173 elderly type 2 diabetes patients who were enrolled from 39 Japanese institutions and randomized to an intensive or conservative treatment group. Glycemic control, dyslipidemia, hypertension, obesity, diabetic complications and atherosclerotic disease were measured annually. Instrumental activity of daily living, cognitive impairment, depressive symptoms and diabetes burden were assessed at baseline and 3 years. There was no significant difference in clinical or cognitive parameters at baseline between the two groups. The prevalence of low activities of daily living, depressive symptoms and cognitive impairment was 13%, 28% and 4%, respectively, and was similar in the two groups. A small, but significant difference in HbA1c between the two groups was observed at 1 year after the start of intervention (7.9% vs 8.1%, P < 0.05), although this significant difference was not observed after the second year. With the exception of coronary revascularization, there was no significant difference in fatal or non-fatal events between the two groups. Composite events were also similar in the two groups. This study showed no significant differences in fatal or non-fatal events between intensive and conventional treatment. The present study might clarify whether treatment of risk factors influences function and quality of life in elderly diabetic patients. © 2012 Japan Geriatrics Society.

Comparison of baseline and post-concussion ImPACT test scores in young athletes with stimulant-treated and untreated ADHD.

PubMed

Gardner, Ryan M; Yengo-Kahn, Aaron; Bonfield, Christopher M; Solomon, Gary S

2017-02-01

Baseline and post-concussion neurocognitive testing is useful in managing concussed athletes. Attention deficit hyperactivity disorder (ADHD) and stimulant medications are recognized as potential modifiers of performance on neurocognitive testing by the Concussion in Sport Group. Our goal was to assess whether individuals with ADHD perform differently on post-concussion testing and if this difference is related to the use of stimulants. Retrospective case-control study in which 4373 athletes underwent baseline and post-concussion testing using the ImPACT battery. 277 athletes self-reported a history of ADHD, of which, 206 reported no stimulant treatment and 69 reported stimulant treatment. Each group was matched with participants reporting no history of ADHD or stimulant use on several biopsychosocial characteristics. Non-parametric tests were used to assess ImPACT composite score differences between groups. Participants with ADHD had worse verbal memory, visual memory, visual motor speed, and reaction time scores than matched controls at baseline and post-concussion, all with p ≤ .001 and |r|≥ 0.100. Athletes without stimulant treatment had lower verbal memory, visual memory, visual motor speed, and reaction time scores than controls at baseline (p ≤ 0.01, |r|≥ 0.100 [except verbal memory, r = -0.088]) and post-concussion (p = 0.000, |r|> 0.100). Athletes with stimulant treatment had lower verbal memory (Baseline: p = 0.047, r = -0.108; Post-concussion: p = 0.023, r = -0.124) and visual memory scores (Baseline: p = 0.013, r = -0.134; Post-concussion: p = 0.003, r = -0.162) but equivalent visual motor speed and reaction time scores versus controls at baseline and post-concussion. ADHD-specific baseline and post-concussion neuropsychological profiles, as well as stimulant medication status, may need to be considered when interpreting ImPACT test results. Further investigation into the effects of ADHD and stimulant use on recovery from sport-related concussion (SRC) is warranted.

Efficacy of individualized Chinese herbal medication in osteoarthrosis of hip and knee: a double-blind, randomized-controlled clinical study.

PubMed

Lechner, Matthias; Steirer, Iva; Brinkhaus, Benno; Chen, Yun; Krist-Dungl, Claudia; Koschier, Alexandra; Gantschacher, Martina; Neumann, Kurt; Zauner-Dungl, Andrea

2011-06-01

The objective of this study was to determine the efficacy of individually designed herbal formulas according to the rules of Traditional Chinese Medicine (TCM) in patients with osteoarthritis of the hip and knee. This was a randomized, controlled, double-blind study with two parallel groups. This study was conducted at the University-centre in Gars am Kamp/Austria and was organized by the Institute of TCM and Complementary Medicine of the Danube University Krems /Austria. The study comprised female and male patients with osteoarthritis of hip or knee aged between 45 and 75 years. Patients were randomized into a treatment with individualized, water-based herbal decoctions prepared in a standardized cooking process (Verum group) or to a treatment with nonspecific presumably ineffective, water-based herbal decoctions (Control group). The primary outcome was the comparison of change between the intervention groups in the Western Ontario and McMaster Universities lower limb global index questionnaire (WOMAC global index) between baseline and week 20. Secondary outcomes included subscales of WOMAC for pain (A), stiffness (B), and functional impairment (C) and general quality of life in the form of the SF-36 questionnaire. Altogether, 102 patients were randomized in this trial. The demographic and medical baseline characteristics were comparable in the 2 groups. The change of the WOMAC global index and all three subscales was significant in both groups between week 20 and baseline (verum group, global WOMAC: at baseline 47 [SD ± 11.8] and at week 20: 24 (SD ± 18.3); change of mean 23; p > 0.001; control group; global WOMAC: at baseline: 48 (SD ± 14.7) and at week 20: 25 (SD ± 18.3); change of mean 23; p > 0.001). However, there was no significant difference (p = 0.783) between the treatment groups. There were significant changes in the subscales "physical functioning," "bodily pain," "vitality," "social-functioning," and "role-physical" of the SF-36 in both study groups between 20 weeks and baseline, but again no significant difference between the groups. There were no drug-related serious adverse events. While the individual prescription consisting of medicinal herbs according to TCM diagnosis investigated in this trial tend to improve the osteoarthritis, the same effect was also achieved with the nonspecific prescription.

Predicting the Trajectories of Perceived Pain Intensity in Southern Community-Dwelling Older Adults: The Role of Religiousness.

PubMed

Sun, Fei; Park, Nan Sook; Wardian, Jana; Lee, Beom S; Roff, Lucinda L; Klemmack, David L; Parker, Michael W; Koenig, Harold G; Sawyer, Patricia L; Allman, Richard M

2013-11-01

This study focuses on the identification of multiple latent trajectories of pain intensity, and it examines how religiousness is related to different classes of pain trajectory. Participants were 720 community-dwelling older adults who were interviewed at four time points over a 3-year period. Overall, intensity of pain decreased over 3 years. Analysis using latent growth mixture modeling (GMM) identified three classes of pain: (1) increasing ( n = 47); (2) consistently unchanging ( n = 292); and (3) decreasing ( n = 381). Higher levels of intrinsic religiousness (IR) at baseline were associated with higher levels of pain at baseline, although it attenuated the slope of pain trajectories in the increasing pain group. Higher service attendance at baseline was associated with a higher probability of being in the decreasing pain group. The increasing pain group and the consistently unchanging group reported more negative physical and mental health outcomes than the decreasing pain group.

Peripheral blood mononuclear cell gene expression profile in obese boys who followed a moderate energy-restricted diet: differences between high and low responders at baseline and after the intervention.

PubMed

Rendo-Urteaga, Tara; García-Calzón, Sonia; González-Muniesa, Pedro; Milagro, Fermín I; Chueca, María; Oyarzabal, Mirentxu; Azcona-Sanjulián, M Cristina; Martínez, J Alfredo; Marti, Amelia

2015-01-28

The present study analyses the gene expression profile of peripheral blood mononuclear cells (PBMC) from obese boys. The aims of the present study were to identify baseline differences between low responders (LR) and high responders (HR) after 10 weeks of a moderate energy-restricted dietary intervention, and to compare the gene expression profile between the baseline and the endpoint of the nutritional intervention. Spanish obese boys (age 10-14 years) were advised to follow a 10-week moderate energy-restricted diet. Participants were classified into two groups based on the association between the response to the nutritional intervention and the changes in BMI standard deviation score (BMI-SDS): HR group (n 6), who had a more decreased BMI-SDS; LR group (n 6), who either maintained or had an even increased BMI-SDS. The expression of 28,869 genes was analysed in PBMC from both groups at baseline and after the nutritional intervention, using the Affymetrix Human Gene 1.1 ST 24-Array plate microarray. At baseline, the HR group showed a lower expression of inflammation and immune response-related pathways, which suggests that the LR group could have a more developed pro-inflammatory phenotype. Concomitantly, LEPR and SIRPB1 genes were highly expressed in the LR group, indicating a tendency towards an impaired immune response and leptin resistance. Moreover, the moderate energy-restricted diet was able to down-regulate the inflammatory 'mitogen-activated protein kinase signalling pathway' in the HR group, as well as some inflammatory genes (AREG and TNFAIP3). The present study confirms that changes in the gene expression profile of PBMC in obese boys may help to understand the weight-loss response. However, further research is required to confirm these findings.

Effects of nicergoline on the retinal and cortical electrophysiological responses in glaucoma patients: a preliminary open study.

PubMed

Parisi, V; Colacino, G; Milazzo, G; Scuderi, A C; Manni, G

1999-09-01

The retinal dysfunction and the delayed visual cortex responses shown by patients affected by glaucoma can be objectively assessed by Pattern Electroretinogram (PERG) and Visual Evoked Potentials (VEP) recordings. The present study aims to evaluate the effects of nicergoline on the retinal function and on the visual cortical responses in glaucoma patients. Sixty patients (mean age 44.6+/-3.7) with open angle glaucoma were enrolled. The patients were divided into two groups: NG Group, where 30 patients were treated with nicergoline (Cebran((R)), 2 cps day) for 30 days; and CG Group, where 30 patients were not treated. Simultaneous recordings of PERG and VEP were performed in NG patients at the baseline, at 30 days after treatment with nicergoline (day 30), and at 45 days from the end of the treatment (day 75). PERG and VEP were recorded in CG patients at the baseline and after 30 and 75 days. The visual stimulus for recording PERGs and VEPs was a checkerboard whose elements subtended a visual arc of 60' and 15' with a 70% contrast, and alternated at a frequency of 2 Hz. At the baseline none of the electrophysiological parameters observed in NG Group patients differed (P>0.05) from those of CG Group patients. At days 30 and 75, in CG Group patients the values of the PERG and VEP parameters were unmodified (P>0.05) with respect to the baseline. In NG Group patients, the 30-day treatment period with nicergoline induced a significant (P<0.01) improvement of the PERG and VEP parameters. At day 75 all the electrophysiological parameters of NG Group did not differ significantly (P>0.05) from those at the baseline. Treatment with nicergoline induces an improvement of the retinal function and of the visual cortical responses in patients affected by glaucoma. This effect disappears within 45 days after the suspension of the treatment. Copyright 1999 Academic Press.

The prevalence of periodontopathogenic bacteria in saliva is linked to periodontal health status and oral malodour.

PubMed

Kurata, Hiroshi; Awano, Shuji; Yoshida, Akihiro; Ansai, Toshihiro; Takehara, Tadamichi

2008-05-01

This study investigated whether an improvement in periodontal health resulted in changes in the prevalence of periodontopathogenic bacteria in saliva and tongue coatings and a reduction in volatile sulfur compounds (VSCs: H(2)S and CH(3)SH) linked to oral malodour. The subjects were 35 patients who visited the breath odour clinic of Kyushu Dental College, Japan. Their mean age was 51.2+/-18.3 years (mean+/-sd). A clinical examination performed at baseline and 2 months after periodontal treatment assessed VSCs in mouth air using gas chromatography, periodontal probing depth and bleeding on probing (BOP) in all subjects; saliva and tongue coatings were also collected. Genomic DNA was isolated from the samples, and the proportions of five periodontopathogenic bacteria (Porphyromonas gingivalis, Tannerella forsythensis, Treponema denticola, Prevotella intermedia and Prevotella nigrescens) were investigated using quantitative real-time PCR. The subjects were classified into four groups based on the presence of a periodontal pocket of more than 4 mm (PD) and VSCs above the organoleptic threshold level (VSCT) as follows: -PD/-VSCT group, subjects without PD or VSCT; -PD/+VSCT group, those without PD but with VSCT; +PD/-VSCT group, those with PD but without VSCT; and +PD/+VSCT group, those with PD and VSCT. Although the mean PD values in the +PD/-VSCT and +PD/+VSCT groups, BOP in the +PD/+VSCT group, and H(2)S and CH(3)SH concentrations in the -PD/+VSCT and +PD/+VSCT groups were greater than in the other groups at baseline, we found no significant difference among the four groups after periodontal treatment. The proportion of periodontopathogenic bacteria in saliva was higher in the +PD/-VSCT and +PD/+VSCT groups than in the -PD/-VSCT and -PD/+VSCT groups at baseline and after treatment, but the proportions of bacteria in saliva after treatment were reduced compared to the baseline. Furthermore, the differences in the proportions of the five target bacteria in the tongue coating were not as apparent as those in saliva at baseline or after treatment. The prevalence of periodontopathogenic bacteria in saliva may reflect periodontal health status and influence VSC levels in mouth air.

Effects of Kivia powder on gut health in patients with occasional constipation: a randomized, double-blind, placebo-controlled study.

PubMed

Udani, Jay K; Bloom, David W

2013-06-08

To evaluate the efficacy of Kivia powder on supporting overall gut health through the relief of the discomfort of occasional constipation. Randomized, double-blind, placebo-controlled, parallel-group trial. The investigational product for this study was Kivia powder (Vital Food Processors Ltd., Auckland, New Zealand), containing the active ingredient Zyactinase™, 5.5 g taken daily for four weeks. One hundred thirty-eight subjects reporting occasional constipation were screened and 87 were randomized to placebo (n = 44) and product (n = 43). Bowel movement frequency, as measured by both average daily spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM), were the same in both groups at baseline. There were significant increases in spontaneous bowel movements at week 1 (p = 0.001), week 2 (p = 0.001), week 3 (p = 0.000), and week 4 (p = 0.000) compared to baseline. SBM demonstrated significant differences between the treatment group and the placebo group at week 3 (p = 0.000), and week 4 (p = 0.020). The treatment group demonstrated a significantly higher rate of SBM at week 3 (p = 000) and from baseline to week 4 (p = 0.019). Significant increases in complete spontaneous bowel movements were observed at week 1 (p = 0.000), week 2 (p = 0.000), week 3 (p = 0.000), and week 4 (p = 0.000) compared to baseline. Moreover, CSBM was significantly higher for the treatment group compared to placebo at week 2 (p = 0.001). The change in average daily CSBM from baseline to week 2 was significantly higher in the treatment group than in the placebo group (p = 0.004).Abdominal discomfort or pain demonstrated significant differences between groups at week 1 (p = 0.044) and week 3 (p = 0.026). Flatulence was significantly lower for active group compared to placebo at week 2 (p = 0.047) and week 3 (p = 0.023). The number of bowel movements associated with urgency was significantly lower in the treatment group compared to the placebo group at week 3 (p = 0.048). In addition, it was decreased from baseline to week 1 (p = 0.040) and from baseline to week 3 (p = 0.024) in the treatment group, while the placebo group did not report any reductions in bowel urgency. Bowel movements in the treatment arm were significantly smoother and softer by week 2 (p = 0.020) and week 3 (p = 0.041). Treatment with Kivia powder, an extract of kiwifruit containing Zyactinase™, for four weeks was well tolerated and more effective than placebo in gently enhancing bowel movement frequency and reducing abdominal pain and flatulence in subjects with occasional constipation. ISRCTN: ISRCTN49036618.

Ibudilast may improve attention during early abstinence from methamphetamine.

PubMed

Birath, J Brandon; Briones, Marisa; Amaya, Stephanie; Shoptaw, Steven; Swanson, Aimee-Noelle; Tsuang, John; Furst, Benjamin; Heinzerling, Keith; Obermeit, Lisa; Maes, Lauryn; McKay, Charles; Wright, Matthew J

2017-09-01

Inattention is a deficit related to instilling abstinence from methamphetamine (MA) dependence. This study aimed to determine whether ibudilast (IB; 50mg bid) improves attentional abilities compared to placebo during early abstinence from MA dependence. Attention was assessed in 11 MA-dependent non-treatment seeking participants in a phase IB safety-interaction trial. The Conners' Continuous Performance Test-II (CPT-II), a measure of sustained attention and response inhibition, was administered at baseline and on day 22, 48h post a MA challenge under placebo (P; n=6) or IB 50mg bid (n=5). Group differences were compared using Mann-Whitney U Tests. Groups were similar at baseline in premorbid intellectual functioning, attention deficit hyperactivity symptom scores, impulsivity ratings, and education level, but differed in age. Demographically corrected T-scores for CPT-II performances were utilized. Although no group differences in sustained attention existed at baseline, at follow-up, the IB group (Mdn=44.4) showed reduced variability in response times compared with the P group (Mdn=69.9), U=0.00, z=-2.74, p=.006, r=.83. The IB group (Mdn=45.8) also gave fewer perseverative responses than the P group (Mdn=67.0), U=2.00, z=-2.50, p=.01, r=.75. No other significant differences were observed. Findings suggest that IB may have a protective effect on sustained attention during early abstinence from MA dependence. This may guide thinking about mechanism of action should IB demonstrate efficacy as a treatment for MA dependence. Copyright © 2017 Elsevier B.V. All rights reserved.

Effect of music care on depression and behavioral problems in elderly people with dementia in Taiwan: a quasi-experimental, longitudinal study.

PubMed

Wang, Su-Chin; Yu, Ching-Len; Chang, Su-Hsien

2017-02-01

The purpose was to examine the effectiveness of music care on cognitive function, depression, and behavioral problems among elderly people with dementia in long-term care facilities in Taiwan. The study had a quasi-experimental, longitudinal research design and used two groups of subjects. Subjects were not randomly assigned to experimental group (n = 90) or comparison group (n = 56). Based on Bandura's social cognition theory, subjects in the experimental group received Kagayashiki music care (KMC) twice per week for 24 weeks. Subjects in the comparison group were provided with activities as usual. Results found, using the control score of the Clifton Assessment Procedures for the Elderly Behavior Rating Scale (baseline) and time of attending KMC activities as a covariate, the two groups of subjects had statistically significant differences in the mini-mental state examination (MMSE). Results also showed that, using the control score of the Cornell Scale for Depression in Dementia (baseline) and MMSE (baseline) as a covariate, the two groups of subjects had statistically significant differences in the Clifton Assessment Procedures for the Elderly Behavior Rating Scale. These findings provide information for staff caregivers in long-term care facilities to develop a non-invasive care model for elderly people with dementia to deal with depression, anxiety, and behavioral problems.

Comparison of exercise capacity in COPD and other etiologies of chronic respiratory failure requiring non-invasive mechanical ventilation at home: retrospective analysis of 1-year follow-up.

PubMed

Salturk, Cuneyt; Karakurt, Zuhal; Takir, Huriye Berk; Balci, Merih; Kargin, Feyza; Mocin, Ozlem Yazıcıoglu; Gungor, Gokay; Ozmen, Ipek; Oztas, Selahattin; Yalcinsoy, Murat; Evin, Ruya; Ozturk, Murat; Adiguzel, Nalan

2015-01-01

The objective of this study was to compare the change in 6-minute walking distance (6MWD) in 1 year as an indicator of exercise capacity among patients undergoing home non-invasive mechanical ventilation (NIMV) due to chronic hypercapnic respiratory failure (CHRF) caused by different etiologies. This retrospective cohort study was conducted in a tertiary pulmonary disease hospital in patients who had completed 1-year follow-up under home NIMV because of CHRF with different etiologies (ie, chronic obstructive pulmonary disease [COPD], obesity hypoventilation syndrome [OHS], kyphoscoliosis [KS], and diffuse parenchymal lung disease [DPLD]), between January 2011 and January 2012. The results of arterial blood gas (ABG) analyses and spirometry, and 6MWD measurements with 12-month interval were recorded from the patient files, in addition to demographics, comorbidities, and body mass indices. The groups were compared in terms of 6MWD via analysis of variance (ANOVA) and multiple linear regression (MLR) analysis (independent variables: analysis age, sex, baseline 6MWD, baseline forced expiratory volume in 1 second, and baseline partial carbon dioxide pressure, in reference to COPD group). A total of 105 patients with a mean age (± standard deviation) of 61±12 years of whom 37 had COPD, 34 had OHS, 20 had KS, and 14 had DPLD were included in statistical analysis. There were no significant differences between groups in the baseline and delta values of ABG and spirometry findings. Both univariate ANOVA and MLR showed that the OHS group had the lowest baseline 6MWD and the highest decrease in 1 year (linear regression coefficient -24.48; 95% CI -48.74 to -0.21, P=0.048); while the KS group had the best baseline values and the biggest improvement under home NIMV (linear regression coefficient 26.94; 95% CI -3.79 to 57.66, P=0.085). The 6MWD measurements revealed improvement in exercise capacity test in CHRF patients receiving home NIMV treatment on long-term depends on etiological diagnoses.

Visual Field Outcomes for the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT).

PubMed

Wall, Michael; Johnson, Chris A; Cello, Kimberly E; Zamba, K D; McDermott, Michael P; Keltner, John L

2016-03-01

The Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) showed that acetazolamide provided a modest, significant improvement in mean deviation (MD). Here, we further analyze visual field changes over the 6-month study period. Of 165 subjects with mild visual loss in the IIHTT, 125 had perimetry at baseline and 6 months. We evaluated pointwise linear regression of visual sensitivity versus time to classify test locations in the worst MD (study) eye as improving or not; pointwise changes from baseline to month 6 in decibels; and clinical consensus of change from baseline to 6 months. The average study eye had 36 of 52 test locations with improving sensitivity over 6 months using pointwise linear regression, but differences between the acetazolamide and placebo groups were not significant. Pointwise results mostly improved in both treatment groups with the magnitude of the mean change within groups greatest and statistically significant around the blind spot and the nasal area, especially in the acetazolamide group. The consensus classification of visual field change from baseline to 6 months in the study eye yielded percentages (acetazolamide, placebo) of 7.2% and 17.5% worse, 35.1% and 31.7% with no change, and 56.1% and 50.8% improved; group differences were not statistically significant. In the IIHTT, compared to the placebo group, the acetazolamide group had a significant pointwise improvement in visual field function, particularly in the nasal and pericecal areas; the latter is likely due to reduction in blind spot size related to improvement in papilledema. (ClinicalTrials.gov number, NCT01003639.).

Effects of Diabetic Ketoacidosis on Visual and Verbal Neurocognitive Function in Young Patients Presenting with New-Onset Type 1 Diabetes.

PubMed

Jessup, Ashley B; Grimley, Mary Beth; Meyer, Echo; Passmore, Gregory P; Belger, Ayşenil; Hoffman, William H; Çalıkoğlu, Ali S

2015-09-01

To evaluate the effects of diabetic ketoacidosis (DKA) on neurocognitive functions in children and adolescents presenting with new-onset type 1 diabetes. Newly diagnosed patients were divided into two groups: those with DKA and those without DKA (non-DKA). Following metabolic stabilization, the patients took a mini-mental status exam prior to undergoing a baseline battery of cognitive tests that evaluated visual and verbal cognitive tasks. Follow-up testing was performed 8-12 weeks after diagnosis. Patients completed an IQ test at follow-up. There was no statistical difference between the DKA and non-DKA groups neither in alertness at baseline testing nor in an IQ test at follow-up. The DKA group had significantly lower baseline scores than the non-DKA group for the visual cognitive tasks of design recognition, design memory and the composite visual memory index (VMI). At follow-up, Design Recognition remained statistically lower in the DKA group, but the design memory and the VMI tasks returned to statistical parity between the two groups. No significant differences were found in verbal cognitive tasks at baseline or follow-up between the two groups. Direct correlations were present for the admission CO2 and the visual cognitive tasks of VMI, design memory and design recognition. Direct correlations were also present for admission pH and VMI, design memory and picture memory. Pediatric patients presenting with newly diagnosed type 1 diabetes and severe but uncomplicated DKA showed a definite trend for lower cognitive functioning when compared to the age-matched patients without DKA.

A randomized, placebo-controlled trial of an amino acid preparation on timing and quality of sleep.

PubMed

Shell, William; Bullias, Debbie; Charuvastra, Elizabeth; May, Lawrence A; Silver, David S

2010-01-01

This study was an outpatient, randomized, double-blind, placebo-controlled trial of a combination amino acid formula (Gabadone) in patients with sleep disorders. Eighteen patients with sleep disorders were randomized to either placebo or active treatment group. Sleep latency and duration of sleep were measured by daily questionnaires. Sleep quality was measured using a visual analog scale. Autonomic nervous system function was measured by heart rate variability analysis using 24-hour electrocardiographic recordings. In the active group, the baseline time to fall asleep was 32.3 minutes, which was reduced to 19.1 after Gabadone administration (P = 0.01, n = 9). In the placebo group, the baseline latency time was 34.8 minutes compared with 33.1 minutes after placebo (P = nonsignificant, n = 9). The difference was statistically significant (P = 0.02). In the active group, the baseline duration of sleep was 5.0 hours (mean), whereas after Gabadone, the duration of sleep increased to 6.83 (P = 0.01, n = 9). In the placebo group, the baseline sleep duration was 7.17 +/- 7.6 compared with 7.11 +/- 3.67 after placebo (P = nonsignificant, n = 9). The difference between the active and placebo groups was significant (P = 0.01). Ease of falling asleep, awakenings, and am grogginess improved. Objective measurement of parasympathetic function as measured by 24-hour heart rate variability improved in the active group compared with placebo. An amino acid preparation containing both GABA and 5-hydroxytryptophan reduced time to fall asleep, decreased sleep latency, increased the duration of sleep, and improved quality of sleep.

Heat production and body temperature during cooling and rewarming in overweight and lean men.

PubMed

Claessens-van Ooijen, Anne M J; Westerterp, Klaas R; Wouters, Loek; Schoffelen, Paul F M; van Steenhoven, Anton A; van Marken Lichtenbelt, Wouter D

2006-11-01

To compare overweight and lean subjects with respect to thermogenesis and physiological insulation in response to mild cold and rewarming. Ten overweight men (mean BMI, 29.2 +/- 2.8 kg/m(2)) and 10 lean men (mean BMI, 21.1 +/- 2.0 kg/m(2)) were exposed to cold air for 1 hour, followed by 1 hour of rewarming. Body composition was determined by hydrodensitometry and deuterium dilution. Heat production and body temperatures were measured continuously by indirect calorimetry and thermistors, respectively. Muscle activity was recorded using electromyography. In both groups, heat production increased significantly during cooling (lean, p = 0.004; overweight, p = 0.006). The increase was larger in the lean group compared with the overweight group (p = 0.04). During rewarming, heat production returned to baseline in the overweight group and stayed higher compared with baseline in the lean group (p = 0.003). The difference in heat production between rewarming and baseline was larger in the lean (p = 0.01) than in the overweight subjects. Weighted body temperature of both groups decreased during cold exposure (lean, p = 0.002; overweight, p < 0.001) and did not return to baseline during rewarming. Overweight subjects showed a blunted mild cold-induced thermogenesis. The insulative cold response was not different among the groups. The energy-efficient response of the overweight subjects can have consequences for energy balance in the long term. The results support the concept of a dynamic heat regulation model instead of temperature regulation around a fixed set point.

Ringers lactate vs Normal saline for children with acute diarrhea and severe dehydration- a double blind randomized controlled trial.

PubMed

Mahajan, Vidushi; Sajan, Shiv Saini; Sharma, Amit; Kaur, Jasbinder

2012-12-01

WHO recommends Ringers lactate (RL) and Normal Saline (NS) for rapid intravenous rehydration in childhood diarrhea and severe dehydration. We compared these two fluids for improvement in pH over baseline during rapid intravenous rehydration in children with acute diarrhea. Double-blind randomized controlled trial Pediatric emergency facilities at a tertiary-care referral hospital. Children with acute diarrhea and severe dehydration received either RL (RL-group) or NS (NS-group), 100 mL/kg over three or six hours. Children were reassessed after three or six hours. Rapid rehydration was repeated if severe dehydration persisted. Blood gas was done at baseline and repeated after signs of severe dehydration disappeared. Primary outcome was change in pH from baseline. Secondary outcomes included changes in serum electrolytes, bicarbonate levels, and base-deficit from baseline; mortality, duration of hospital stay, and fluids requirement. Twenty two children, 11 each were randomized to the two study groups. At primary end point (disappearance of signs of severe dehydration), the improvement in pH from baseline was not significant in RL-group [from 7.17 (0.11) to 7.28 (0.09)] as compared to NS-group [7.09 (0.11) to 7.21 (0.09)], P=0.17 (after adjusting for baseline serum Na/ Cl). Among this limited sample size, children in RL group required less fluids [median 310 vs 530 mL/kg, P=0.01] and had shorter median hospital stay [38 vs 51 hours, P=0.03]. There was no difference in improvement in pH over baseline between RL and NS among children with acute diarrhea and severe dehydration.

Role of Text Message Reminder on Oral Hygiene Maintenance of Orthodontic Patients.

PubMed

Kumar, G Sujay; Kashyap, Arpita; Raghav, Shweta; Bhardwaj, Rishibha; Singh, Arunesh; Guram, Guneet

2018-01-01

Fixed orthodontic treatment is frequently associated with increased plaque accumulation leading to gingivitis and white spot lesions (WSLs). This study evaluated the role of text message reminder on oral hygiene of orthodontic patients. A total of 60 patients under fixed orthodontic treatment were randomly divided into two equal groups as control group and study (text message) group. Text message group received reminders about oral hygiene, while the control group did not receive any messages. Oral hygiene of both the groups was evaluated at baseline, 2, and 3 months using plaque indices (PIs) along with WSL status. Data were statistically analyzed using Statistical Package for the Social Sciences (SPSS) statistical software, version 19, with chi-square test and t-test. At the baseline, plaque score was higher in the study group over control group (p > 0.038), whereas it was decreased after 3 months in the test group (p > 0.001). For WSL, there was no significant difference at baseline, but it was significantly lower in study group (p > 0.003). Oral hygiene status improved with text message reminder.

The effect of symptoms of carpal tunnel syndrome on ultrasonographic median nerve measures before and after wheelchair propulsion.

PubMed

Impink, Bradley G; Collinger, Jennifer L; Boninger, Michael L

2011-09-01

To quantify median nerve characteristics before and after strenuous wheelchair propulsion and relate them to symptoms of carpal tunnel syndrome (CTS). We hypothesized that persons with and without symptoms of CTS would have significantly different nerve characteristics at baseline and after propulsion. A repeated-measures design was used to obtain ultrasound images of the median nerve at 3 levels of the wrist (radius, pisiform, and hamate) before and after wheelchair propulsion. Investigators were blinded to subject history related to CTS. The 2007 and 2008 National Veterans Wheelchair Games and the Human Engineering Research Laboratories. Fifty-four participants between the ages of 18 and 65 years with a nonprogressive disability who used a manual wheelchair as their primary means of mobility completed this study. Participants completed questionnaires regarding demographics and the presence and severity of symptoms of CTS. Ultrasound images of the median nerve were obtained before and after a 15-minute strenuous wheelchair-propulsion task. Baseline values and post-propulsion changes were determined for median nerve cross-sectional area, flattening ratio, and swelling ratio. Differences in median nerve variables between symptomatic and asymptomatic groups were assessed. No significant differences between symptom groups were identified at baseline; however, persons with symptoms of CTS showed a significantly different percent change from baseline compared with the asymptomatic participants for cross-sectional area at pisiform (P = .014) and flattening ratio at hamate (P = .022), and they showed a strong trend toward a difference in swelling ratio (P = .0502). For each of these variables, the change in the symptomatic group was in the opposite direction of the change in the asymptomatic group. We found several median nerve responses to wheelchair propulsion associated with symptoms of CTS. These responses occurred even though no baseline ultrasound difference was found based on symptoms. Future research is necessary to determine how propulsion characteristics (ie, force, repetition, and posture) affect the median nerve response. Copyright © 2011 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

A new universal simplified adhesive: 36-Month randomized double-blind clinical trial.

PubMed

Loguercio, Alessandro D; de Paula, Eloisa Andrade; Hass, Viviane; Luque-Martinez, Issis; Reis, Alessandra; Perdigão, Jorge

2015-09-01

It is still debatable which technique should be used with universal adhesives, either etch-and-rinse (wet or dry) or self-etch strategy (with or without selective enamel etching). To evaluate the 36-month clinical performance of Scotchbond Universal Adhesive (SU, 3M ESPE) in non-carious cervical lesions (NCCLs) using two evaluation criteria. Thirty-nine patients participated in this study. Two-hundred restorations were assigned to four groups: ERm: etch-and-rinse+moist dentin; ERd: etch-and-rinse+dry dentin; Set: selective enamel etching; and SE: self-etch. The same composite resin was inserted for all restorations in up to 3 increments. The restorations were evaluated at baseline and at 6-, 18-, and 36-months using both the FDI and the USPHS criteria. Statistical analyses were performed with Friedman repeated measures ANOVA by rank and McNemar test for significance in each pair (α=0.05). Eight restorations (ERm: 1; ERd: 1; Set: 1 and SE: 5) were lost after 36 months, but only significant for SE when compared with baseline (p=0.02 for either criteria). Marginal staining occurred in 6.8% of the restorations (groups ERm, ERd, and Set) and 17.5% of the restorations (group SE), with significant difference for each group when compared with baseline using the FDI criteria (p<0.04), while statistical significance was reached only for SE when compared with baseline using the USPHS criteria (p<0.03). Twenty-eight and 49 restorations were scored as bravo for marginal adaptation using the USPHS and FDI criteria, respectively, with significant difference for each group when compared with baseline (p<0.05). While there was no statistical difference among bonding strategies when a universal adhesive was used, there were signs of degradation when the universal adhesive was applied in SE mode. The FDI criteria remain more sensitive than the USPHS criteria, especially for the criteria marginal staining and marginal adaptation. Copyright © 2015 Elsevier Ltd. All rights reserved.

Impact of different aspects of social participation and social capital on smoking cessation among daily smokers: a longitudinal study

PubMed Central

Lindstrom, M; Isacsson, S; Elmstahl, S

2003-01-01

Objective: To investigate differences in different aspects of social participation and social capital among baseline daily smokers that had remained daily smokers, become intermittent smokers, or stopped smoking at one year follow up. Design/setting/participants/measurements: 12 507 individuals, aged 45–69 years, interviewed at baseline between 1992 and 1994 and at a one year follow up were investigated in this longitudinal study. The three groups of baseline daily smokers were compared to the reference population (baseline intermittent smokers and non-smokers) according to different aspects of social participation and social capital. A multivariate logistic regression model was used to assess differences in different aspects of social participation and social capital. Results: The baseline daily smokers that remained daily smokers at the one year follow up had significantly increased odds ratios of non-participation in study circles in other places than at work, meeting of organisations other than unions, theatre/cinema, arts exhibition, church, sports events, large gatherings of relatives, and private parties compared to the reference population. The baseline daily smokers that had become intermittent smokers at the one year follow up had significantly increased odds ratios of non-participation in church services. The baseline daily smokers that had stopped smoking had increased odds ratios of non-participation in having attended a meeting of organisations other than labour unions during the past year, having been to a theatre or cinema, and of having visited an arts exhibition during the past year. All three categories of baseline daily smokers had significantly decreased odds ratios of non-participation in night club/entertainment. Conclusions: The baseline daily smokers that had remained daily smokers at the one year follow up had particularly high rates of non-participation compared to the reference population in both activities specifically related to social capital, such as other study circles, meetings of organisations other than labour unions, and church attendance and cultural activities such as theatre/cinema and arts exhibition, although significantly lower participation in cultural activities and meetings of other organisations was also observed among daily smokers that had stopped smoking. All three baseline daily smoker groups had higher rates of having visited a night club during the past year. PMID:12958387

Effect of modulated-frequency and modulated-intensity transcutaneous electrical nerve stimulation after abdominal surgery: a randomized controlled trial.

PubMed

Tokuda, Mitsunori; Tabira, Kazuyuki; Masuda, Takashi; Nishiwada, Takashi; Shomoto, Koji

2014-07-01

This study aimed to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) for treatment of postoperative pain and pulmonary functions (vital capacity [VC]; cough peak flow, [CPF]) in patients who underwent abdominal surgery. Forty-eight patients were randomly allocated to receive TENS, placebo TENS, or no TENS (control) 1 hour a day for 3 days postoperatively. A 0-100 visual analog scale was used to assess pain at preintervention, mid-intervention, and postintervention on the third postoperative day. Pulmonary functions (VC, CPF) were evaluated by spirometer at preoperation (baseline) and at preintervention, mid-intervention, and postintervention on the third postoperative day. One-way analysis of variance was used to assess differences between groups at baseline. Mann-Whitney test was used to compare the control group with the placebo-TENS and TENS group, at each assessment timepoint. Two-way analysis of variance and Bonferroni post hoc test assessed the difference between the 2 (placebo-TENS×TENS) groups. A value of P<0.01 was considered statistically significant. The baselines were not significantly different between any groups. The TENS group had significant reductions in postoperative pain compared with the placebo group (P<0.01) and control group (P<0.01). There was also improvement in pulmonary functions (VC, CPF) at mid-TENS and post-TENS, but not in the placebo-TENS (P<0.01) or control groups (P<0.01). TENS is a valuable treatment to alleviate postoperative pain and improve pulmonary functions (ie, VC, CPF) in patients following abdominal surgery.

Effect of heliox- and air-driven nebulized bronchodilator therapy on lung function in patients with asthma.

PubMed

El-Khatib, Mohamad F; Jamaleddine, Ghassan; Kanj, Nadim; Zeineddine, Salah; Chami, Hassan; Bou-Akl, Imad; Husari, Ahmad; Alawieh, Marwan; Bou-Khalil, Pierre

2014-06-01

This study compares the effect of heliox-driven to that of air-driven bronchodilator therapy on the pulmonary function test (PFT) in patients with different levels of asthma severity. One-hundred thirty-two participants were included in the study. Participants underwent spirometry twice with bronchodilator testing on two consecutive days. Air-driven nebulization was used one day and heliox-driven nebulization the other day in random order crossover design. After a baseline PFT, each participant received 2.5 mg of albuterol sulfate nebulized with the randomized driving gas. Post bronchodilator PFT was repeated after 30 min. The next day, the exact same protocol was repeated, except that the other driving gas was used to nebulize the drug. Participants were subgrouped and analyzed according to their baseline FEV(1) on day 1: Group I, FEV(1) ≥80 %; Group II, 80 % > FEV(1) > 50 %; Group III, FEV(1) ≤50 %. The proportion of participants with greater than 12 % and 200-mL increases from their baseline FEV(1) and the changes from baseline in PFT variables were compared between heliox-driven versus air-driven bronchodilation therapy. The proportion of participants with >12 % and 200-mL increases from their baseline FEV(1) with air- or heliox-driven bronchodilation was not different with respect to the proportion of participants with baseline FEV(1) ≥80 % (20 vs. 18 %, respectively) and 80 % > FEV(1) > 50 % (36 vs. 43 %, respectively), but it was significantly greater with heliox-driven bronchodilation in participants with FEV(1) ≤50 % (43 vs. 73 %, respectively; p = 0.01). Changes from baseline FVC, FEV(1), FEV(1)/FVC, FEF(25-75) %, FEF(max), FEF(25) %, FEF(50) %, and FEF(75) % were significantly larger with heliox-driven versus air-driven bronchodilation in participants with baseline FEV(1) ≤50 %. Improvements in PFT variables are more frequent and profound with heliox-driven compared to air-driven bronchodilator therapy only in asthmatic patients with baseline FEV(1) ≤50 %.

Log (TG)/HDL-C ratio as a predictor of decreased islet beta cell function in patients with type 2 diabetes: 6-year cohort study.

PubMed

Zhou, Meicen; Li, Zengyi; Min, Rui; Dong, Yaxiu; Sun, Qi; Li, Yuxiu

2015-09-01

The aim of the present study was to explore whether the triglyceride to high density lipoprotein cholesterol ratio [log (TG)/HDL-C] and peripheral blood leukocytes DNA telomere length could predict future islet beta cell function decreased in Chinese type 2 diabetes mellitus (T2DM) during a 6-year cohort. Sixty T2DM patients (without insulin treatment at baseline) were included in the 6-year cohort study. Peripheral blood leukocytes DNA telomere length, HbA1c, blood lipid profile, fatty fat acid, glucose, insulin and C peptide (3 h after a mixed meal) were determined. Delta C peptide area under curve (Delta CP AUC) was used to reflect change in beta cell secretion function (Delta CP AUC = baseline CP AUC - CP AUC after 6 years). Subjects were divided into slow decrease of beta cell function group (Delta CP AUCslow group) and fast decrease group (Delta CP AUCfast group) according to median of Delta CP AUC. Baseline demographic characteristics, clinical variables between two groups were compared. Correlations between baseline data and Delta CP AUC were analyzed. Baseline log (TG)/HDL-C was positively correlated with Delta CP AUC (r = 0.306, P = 0.027); log (TG)/HDL-C in Delta CP AUCfast group was higher than that in Delta CP AUCslow group (0.103 ± 0.033 vs 0.083 ± 0.030, P = 0.027). There was no significant difference in DNA telomere length between the two groups. Change in DNA telomere length over 6 years was not significantly correlated with baseline blood lipid. In Chinese T2DM patients, high baseline log (TG)/HDL-C ratio predicts fast progression of islet beta cell dysfunction. It may be a simple index to predict progression speed of islet beta cell dysfunction. © 2014 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

PubMed

Hendren, Samantha; Griggs, Jennifer J; Epstein, Ronald; Humiston, Sharon; Jean-Pierre, Pascal; Winters, Paul; Sanders, Mechelle; Loader, Starlene; Fiscella, Kevin

2012-10-01

Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer. A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measured at baseline and four subsequent time points, using the validated Functional Assessment of Cancer Therapy (FACT-B, FACT-C) instruments. Among 319 randomized patients (165 patient navigation, 154 control), median age was 57 years and 32.5% were from minority race/ethnicity groups. Patient navigation and control groups were comparable on baseline factors, except home ownership versus renting (more home ownership among controls, P = 0.05) and race (more whites among controls, P = 0.05). Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months, or at various time points. The emotional well-being subscale change from baseline approached significance (better change among patient navigation group, P = 0.05). Time trends of QOL measures did not differ significantly between groups. Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL. In this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL. These results suggest that patient navigation may not affect QOL during cancer treatment, that social/medical support are adequate in this study's setting, or that the trial failed to target patients likely to experience QOL benefit from patient navigation. 2012 AACR

Identifying a system of predominant negative symptoms: Network analysis of three randomized clinical trials.

PubMed

Levine, Stephen Z; Leucht, Stefan

2016-12-01

Reasons for the recent mixed success of research into negative symptoms may be informed by conceptualizing negative symptoms as a system that is identifiable from network analysis. We aimed to identify: (I) negative symptom systems; (I) central negative symptoms within each system; and (III) differences between the systems, based on network analysis of negative symptoms for baseline, endpoint and change. Patients with chronic schizophrenia and predominant negative symptoms participated in three clinical trials that compared placebo and amisulpride to 60days (n=487). Networks analyses were computed from the Scale for the Assessment of Negative Symptoms (SANS) scores for baseline and endpoint for severity, and estimated change based on mixed models. Central symptoms to each network were identified. The networks were contrasted for connectivity with permutation tests. Network analysis showed that the baseline and endpoint symptom severity systems formed symptom groups of Affect, Poor responsiveness, Lack of interest, and Apathy-inattentiveness. The baseline and endpoint networks did not significantly differ in terms of connectivity, but both significantly (P<0.05) differed to the change network. In the change network the apathy-inattentiveness symptom group split into three other groups. The most central symptoms were Decreased Spontaneous Movements at baseline and endpoint, and Poverty of Speech for estimated change. Results provide preliminary evidence for: (I) a replicable negative symptom severity system; and (II) symptoms with high centrality (e.g., Decreased Spontaneous Movement), that may be future treatment targets following replication to ensure the curent results generalize to other samples. Copyright © 2016 Elsevier B.V. All rights reserved.

Evaluation of the siRNA PF-04523655 versus ranibizumab for the treatment of neovascular age-related macular degeneration (MONET Study).

PubMed

Nguyen, Quan Dong; Schachar, Ronald A; Nduaka, Chudy I; Sperling, Marvin; Klamerus, Karen J; Chi-Burris, Katherine; Yan, Eric; Paggiarino, Dario A; Rosenblatt, Irit; Aitchison, Roger; Erlich, Shai S

2012-09-01

To evaluate the efficacy of different dosing paradigms of PF-04523655 (PF) versus ranibizumab (comparator) in subjects with neovascular age-related macular degeneration (AMD). Multicenter, open-label, prospective, randomized, comparator-controlled exploratory study. A total of 151 patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular AMD who were naive to AMD therapy. In this phase 2 study, patients were randomized to 1 of 5 treatment groups with equal ratio. All groups received ranibizumab 0.5 mg at baseline and (a) PF 1 mg every 4 weeks (Q4W) from week 4 to week 12; (b) PF 3 mg Q4W from week 4 to week 12; (c) PF 3 mg every 2 weeks (Q2W) from week 4 to week 12; (d) PF 1 mg + ranibizumab (combination) Q4W from baseline to week 12; and (e) ranibizumab Q4W to week 12. All study treatments were given as intravitreal injections. The primary end point was the mean change in best-corrected visual acuity (BCVA) from baseline at week 16; secondary end points included the percentage of patients gaining ≥ 10 and ≥ 15 letters in BCVA and mean change in retinal central subfield thickness, lesion thickness, and CNV area. At week 16, the PF 1 mg + ranibizumab combination group achieved numerically greater improvement in mean BCVA from baseline (9.5 letters) than the ranibizumab group (6.8 letters). The difference was not statistically significant. The BCVA improvement in the PF monotherapy groups was less than in the ranibizumab group. Similar trends were observed in the percentage of patients who gained ≥ 10 and ≥ 15 letters. From baseline to week 16 (last observed carried forward), the combination and ranibizumab groups had similar mean reductions in central subfield retinal thickness and total CNV area, which were greater than in all PF monotherapy groups. There were no clinically meaningful differences in reduction of lesion thickness among treatment groups. In this early, underpowered study evaluating treatments for neovascular AMD, the combination of PF with ranibizumab led to an average gain in BCVA that was more than with ranibizumab monotherapy. No safety concerns were identified. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Effects of Advice to Drink 8 Cups of Water per Day in Adolescents With Overweight or Obesity: A Randomized Clinical Trial.

PubMed

Wong, Julia M W; Ebbeling, Cara B; Robinson, Lisa; Feldman, Henry A; Ludwig, David S

2017-05-01

Health care professionals commonly recommend increased water consumption, typically to 8 cups per day, as part of a weight-reducing diet. However, this recommendation is based on limited evidence and virtually no experimental data from the pediatric population. To compare 2 standardized weight-loss diets among adolescents with overweight or obesity, either with or without additional advice and behavioral support to increase habitual water intake to 8 cups per day. A randomized clinical, parallel-group trial was conducted between February 2, 2011, and June 26, 2014, at Boston Children's Hospital, Boston, Massachusetts, among 38 adolescents with overweight or obesity who reported drinking 4 cups or less of water per day. All participants in both groups received similar weight-reducing interventions, differentiated by advice about water intake (the water group received advice to increase water intake to 8 cups per day; the control group did not receive such advice) but controlled for other dietary recommendations and treatment intensity. The interventions included dietary counseling, daily text messages, and a cookbook with health guides. To support adherence to 8 cups of water per day, the water group received well-defined messages about water through counseling and daily text messages, a water bottle, and a water pitcher with filters. The primary outcome was 6-month change in body mass index z score. Data analyses followed the intention-to-treat principle. All 38 participants (27 girls and 11 boys; mean [SD] age, 14.9 [1.7] years) completed the study. Both groups reported drinking approximately 2 cups of water per day at baseline. Self-reported change in water intake at 6 months was greater in the water group (difference from baseline, 2.8 cups per day [95% CI, 1.8 to 3.8]; P < .001) compared with that in the control group (difference from baseline, 1.2 cups per day [95% CI, 0.2 to 2.2]; P = .02) (difference between groups, 1.6 cups per day [95% CI, 0.2 to 3.0 cups per day]; P = .03). The 6-month change in body mass index z score did not differ between the water group (difference from baseline, -0.1 [95% CI, -0.2 to -0.0]; P = .005) and the control group (difference from baseline, -0.1 [95% CI, -0.2 to -0.0]; P = .008) (difference between groups, -0.0 [95% CI, -0.1 to 0.1]; P = .88). Advice and behavioral supports to consume 8 cups of water per day in the context of a weight-reducing diet did not affect body weight among adolescents with overweight or obesity. Despite intensive behavior supports, few adolescents achieved the target of 8 cups of water per day. Environmental interventions to reduce barriers to water consumption at school may be necessary in future research of the feasibility and effectiveness to achieve the target of an intake of 8 cups of water per day in adolescents. clinicaltrials.gov Identifier: NCT01044134.

Effects of exposure in single and multiple contexts on fear renewal: The moderating role of threat-specific and nonspecific emotionality.

PubMed

Olatunji, Bunmi O; Tomarken, Andrew; Wentworth, Brian; Fritzsche, Laura

2017-03-01

The current study examines effects of exposure in multiple contexts on fear reduction and renewal and the moderating effect of baseline threat-specific and nonspecific emotionality. Snake-fearful participants received a negative or neutral emotion induction and were randomized to video exposure to a snake in a single context, multiple context, or a no exposure control group. Anxiety in response to video presentations of a snake was significantly reduced in the two exposure groups compared to the control group, especially among those with heightened baseline threat-specific emotionality as indicated by snake anxiety ratings at baseline. Although the two exposure groups did not differ in responding when confronted with a novel snake, both exposure groups reported significantly lower snake anxiety and arousal than the control group. Subsequent analysis did show that compared to controls, the single context group demonstrated greater increase in anxiety and arousal from post-exposure to exposure to the novel snake among those with heightened snake anxiety at baseline. Furthermore, the multiple context group was less avoidant and less fearful than the single context group on a post-exposure behavioral test. The study used an analogue exposure paradigm with an analogue sample and findings may not be generalizable to a clinical population. These findings suggest that baseline threat-specific emotionality influences fear reduction and renewal. The benefits of exposure in multiple contexts are discussed in relation to a distinct pattern of symptom change that is in line with an inhibitory learning approach. Copyright © 2016 Elsevier Ltd. All rights reserved.

The influence of the utilization time of brush heads from different types of power toothbrushes on oral hygiene assessed over a 6-month observation period: A randomized clinical trial.

PubMed

Schmickler, Jan; Wurbs, Sabine; Wurbs, Susanne; Kramer, Katharina; Rinke, Sven; Hornecker, Else; Mausberg, Rainer F; Ziebolz, Dirk

2016-12-01

This randomized clinical trial investigated the influence of the utilization time of brush heads from different types of power toothbrushes [oscillating rotating (OR) and sonic action (SA)93; on oral hygiene (plaque accumulation and gingival inflammation) over a 6-month observation period. 49 participants were randomly allocated into two groups: use of the same brush head over 6 months (NR: non-replacement) or replacement of brush head every 4 weeks over 6 months (R: replacement). Each group was subdivided into two subgroups according to kind of toothbrush (TB) used (OR and SA). Modified Quigley-Hein plaque index (QHI), papilla bleeding index (PBI), and gingival index (GI) were recorded at baseline and 2, 8, 12, 16, and 24 weeks after baseline. After 24 weeks, participants of both groups (R and NR) received a new brush head. At week 26, final QHI, PBI, and GI were recorded. QHI decreased between baseline and follow-up visits in R groups (P< 0.05), with the exception of week 12 (P= 0.26). In NR groups, no significant decrease was detected (P> 0.05). There was no significant effect of time on PBI or GI in any of R subgroups (P> 0.05). In NR oscillating/rotating TB: significant increase in PBI and GI was detected 24 weeks after baseline (PBI: P= 0.02, GI: P= 0.03); sonic action TBs showed significant decrease in PBI at every follow-up visit (P< 0.05), except at 24 weeks after baseline (P= 0.73). GI was significantly decreased at 2 weeks after baseline only (P< 0.01). Six-month use of the same brush head reduced effectiveness in removing plaque, and gingival inflammation appeared to increase after a utilization time of over 4 months. Replacing brush heads is advised after 4 months.

Glycolic Acid Peels/Azelaic Acid 20% Cream Combination and Low Potency Triple Combination Lead to Similar Reduction in Melasma Severity in Ethnic Skin: Results of a Randomized Controlled Study

PubMed Central

Mahajan, Rahul; Kanwar, Amrinder Jit; Parsad, Davinder; Kumaran, Muthu Sendhil; Sharma, Reena

2015-01-01

Background: Numerous therapeutic options have been tried in the management of melasma. Aims and Objectives: This prospective randomized study was planned to assess the efficacy of low potency triple combination (TC) cream (TC-hydroquinone 2%/tretinoin 0.05%/fluocinolone 0.01%) versus glycolic acid (GA) peels/azelaic acid (AA) 20% cream (GA/AA) combination in melasma. Materials and Methods: Forty patients with melasma were recruited into this study and randomized into two groups. Group A consisting 20 patients received TC cream once a day for night time application for 3 months. Group B comprising of 20 patients received GA/AA 20% cream combination for 3 months. The disease severity was monitored with digital photography, melasma area and severity index (MASI) score, which was calculated at baseline, 6 weeks and 12 weeks, and visual analog scale (VAS) score, which was calculated at baseline and 12 weeks. Results: Of 40 patients, 38 were completed the study. A significant reduction in MASI and VAS was recorded after 6 weeks and 12 weeks of treatment in both groups A and B (P = 0.001). However, there was no significant difference in the mean MASI scores between the two groups at baseline, 6 weeks and 12 weeks. Similarly, there was no difference in the mean VAS scores between the two groups at baseline and 12 weeks. Four patients in group A and 3 in group B experienced adverse effects such as irritation, dryness, and photosensitivity. Conclusion: Both low potency TC cream and GA/AA 20% cream combination are effective in treating melasma among Indian patients. PMID:25814702

Glycolic Acid peels/azelaic Acid 20% cream combination and low potency triple combination lead to similar reduction in melasma severity in ethnic skin: results of a randomized controlled study.

PubMed

Mahajan, Rahul; Kanwar, Amrinder Jit; Parsad, Davinder; Kumaran, Muthu Sendhil; Sharma, Reena

2015-01-01

Numerous therapeutic options have been tried in the management of melasma. This prospective randomized study was planned to assess the efficacy of low potency triple combination (TC) cream (TC-hydroquinone 2%/tretinoin 0.05%/fluocinolone 0.01%) versus glycolic acid (GA) peels/azelaic acid (AA) 20% cream (GA/AA) combination in melasma. Forty patients with melasma were recruited into this study and randomized into two groups. Group A consisting 20 patients received TC cream once a day for night time application for 3 months. Group B comprising of 20 patients received GA/AA 20% cream combination for 3 months. The disease severity was monitored with digital photography, melasma area and severity index (MASI) score, which was calculated at baseline, 6 weeks and 12 weeks, and visual analog scale (VAS) score, which was calculated at baseline and 12 weeks. Of 40 patients, 38 were completed the study. A significant reduction in MASI and VAS was recorded after 6 weeks and 12 weeks of treatment in both groups A and B (P = 0.001). However, there was no significant difference in the mean MASI scores between the two groups at baseline, 6 weeks and 12 weeks. Similarly, there was no difference in the mean VAS scores between the two groups at baseline and 12 weeks. Four patients in group A and 3 in group B experienced adverse effects such as irritation, dryness, and photosensitivity. Both low potency TC cream and GA/AA 20% cream combination are effective in treating melasma among Indian patients.

Stronger back muscles reduce the incidence of vertebral fractures: a prospective 10 year follow-up of postmenopausal women.

PubMed

Sinaki, M; Itoi, E; Wahner, H W; Wollan, P; Gelzcer, R; Mullan, B P; Collins, D A; Hodgson, S F

2002-06-01

The long-term protective effect of stronger back muscles on the spine was determined in 50 healthy white postmenopausal women, aged 58-75 years, 8 years after they had completed a 2 year randomized, controlled trial. Twenty-seven subjects had performed progressive, resistive back-strengthening exercises for 2 years and 23 had served as controls. Bone mineral density, spine radiographs, back extensor strength, biochemical marker values, and level of physical activity were obtained for all subjects at baseline, 2 years, and 10 years. Mean back extensor strength (BES) in the back-exercise (BE) group was 39.4 kg at baseline, 66.8 kg at 2 years (after 2 years of prescribed exercises), and 32.9 kg at 10 years (8 years after cessation of the prescribed exercises). Mean BES in the control (C) group was 36.9 kg at baseline, 49.0 kg at 2 years, and 26.9 kg at 10 years. The difference between the two groups was still statistically significant at 10 year follow-up (p = 0.001). The difference in bone mineral density, which was not significant between the two groups at baseline and 2 year follow-up, was significant at 10 year follow-up (p = 0.0004). The incidence of vertebral compression fracture was 14 fractures in 322 vertebral bodies examined (4.3%) in the C group and 6 fractures in 378 vertebral bodies examined (1.6%) in the BE group (chi-square test, p = 0.0290). The relative risk for compression fracture was 2.7 times greater in the C group than in the BE group. To our knowledge, this is the first study reported in the literature demonstrating the long-term effect of strong back muscles on the reduction of vertebral fractures in estrogen-deficient women.

The role of a personalized dietary intervention in managing gestational weight gain: a prospective, controlled study in a low-risk antenatal population.

PubMed

Di Carlo, Costantino; Iannotti, Giuseppina; Sparice, Stefania; Chiacchio, Maria Pia; Greco, Elena; Tommaselli, Giovanni Antonio; Nappi, Carmine

2014-04-01

To compare the efficacy of a personal dietary intervention on gestational weight gain control with a general intervention promoting healthy eating. Prospective, controlled study including 154 low-risk pregnant women randomly allocated to two groups: 77 receiving a personalized diet plan and a close follow-up by a dietician (intervention group), 77 receiving standard dietary care by means of a brochure on healthy eating during pregnancy (control group). Pre-pregnancy weight, gestational age, height, weight and BMI at baseline, weight at term, gestational age at delivery and newborn weight were recorded for all participants. The primary end-point was the difference in body weight between baseline and term. Secondary end-points were the difference in body weight between pre-pregnancy and term and in newborn weights. Maternal weight gain at term was significantly lower both as compared to pre-pregnancy weight (8.2 ± 4.0 vs. 13.4 ± 4.2 kg; p < 0.001) and to weight at baseline (7.7 ± 3.8 vs. 13.7 ± 4.3 kg; p < 0.001) in the intervention group as compared to controls. A positive, significant correlation between the delta weight between baseline and term and newborn weight was observed in both groups, but stronger in patients from the intervention group (intervention group R = 0.76, p < 0.001; control group R = 0.35, p = 0.01). This study suggests that a personalized nutritional intervention, in which the dietician plays an active role within the obstetric team, may represent a successful approach in limiting weight gain in pregnant women.

Effect of different ventilatory strategies on local and systemic cytokine production in intact swine lungs in vivo.

PubMed

Myrianthefs, P; Boutzouka, E; Venetsanou, K; Papalois, A; Kouloukousa, M; Kittas, C; Baltopoulos, G

2006-05-01

The purpose of the study was to investigate the effect of different ventilatory strategies on local and systemic cytokine production in swine with intact lungs in vivo after 4 h of mechanical ventilation. Twenty-five swine were anesthetized and then randomized into five groups (n = 5): (1) low tidal volume zero PEEP (LVZP); (2) medium tidal volume zero PEEP (MVZP); (3) high tidal volume zero PEEP (HVZP); (4) low tidal volume PEEP (LVP); (4) high tidal volume PEEP (HVP). Respiratory rate was adjusted to maintain normocapnia and fraction of inspired oxygen (FiO2) was 1.0. TNF-alpha and IL-10 were measured in BALF and serum at baseline, 2 h, and 4 h of MV. One animal in LVZP (2 h) and two in HVP (3 h) group died before the end of the experiment. TNF-alpha level in BALF was significantly higher in LVZP and LVP at 4 h compared to baseline and the other groups. IL-10 level in BALF was significantly higher in LVP at 4h compared to baseline and the other groups. There was a statistically significant increase in serum TNF-alpha levels at 4 h in LVP group compared to baseline and the other groups at 4 h. There was statistically significant increase in serum IL-10 levels in HVZP and LVP groups at 2 and 4 h which was significantly higher compared to the other groups at 4 h. Our results show that a) low volume MV may induce local and systemic pro- and anti-inflammatory cytokine increase b) in the presence of pro-inflammatory cytokine response there is also an anti-inflammatory response in the same compartment (lungs, circulation). c) There maybe loss of alveolar-to-systemic cytokine compartmentalization.

Effect of Baseline Spastic Hemiparesis on Recovery of Upper-Limb Function Following Botulinum Toxin Type A Injections and Postinjection Therapy

PubMed Central

Chang, Chia-Lin; Munin, Michael C.; Skidmore, Elizabeth R.; Niyonkuru, Christian; Huber, Lynne M.; Weber, Douglas J.

2015-01-01

Objective To determine whether baseline hand spastic hemiparesis assessed by the Chedoke-McMaster Assessment influences functional improvement after botulinum toxin type A (BTX-A) injections and postinjection therapy. Design Prospective cohort study. Setting Outpatient spasticity clinic. Participants Participants (N = 14) with spastic hemiparesis divided into 2 groups: Chedoke-McMaster Assessment Hand-Higher Function (stage≥4, n = 5) and Chedoke-McMaster Assessment Hand-Lower Function (stage = 2 or 3, n = 9). Interventions Upper-limb BTX-A injections followed by 6 weeks of postinjection therapy. Main Outcome Measures Primary outcomes were Motor Activity Log-28 and Motor Activity Log items. Secondary outcomes were Action Research Arm Test (ARAT), Motor Activity Log-Self-Report, and Modified Ashworth Scale (MAS). Measures were assessed at baseline (preinjection), 6 weeks, 9 weeks, and 12 weeks postinjection. Results Primary and secondary outcomes improved significantly over time in both groups. Although no significant differences in ARAT or MAS change scores were noted between groups, Chedoke-McMaster Assessment Hand-Higher Function group demonstrated greater change on Motor Activity Log-28 (P = .013) from baseline to 6 weeks and Motor Activity Log items (P = .006) from baseline to 12 weeks compared to Chedoke-McMaster Assessment Hand-Lower Function group. Conclusions BTX-A injections and postinjection therapy improved hand function and reduced spasticity for both Chedoke-McMaster Assessment Hand-Higher Function and Chedoke-McMaster Assessment Hand-Lower Function groups. Clinicians should expect to see larger gains for persons with less baseline impairment. PMID:19735772

Psychosocial effects of workplace physical exercise among workers with chronic pain

PubMed Central

Andersen, Lars L.; Persson, Roger; Jakobsen, Markus D.; Sundstrup, Emil

2017-01-01

Abstract While workplace physical exercise can help manage musculoskeletal disorders, less is known about psychosocial effects of such interventions. This aim of this study was to investigate the effect of workplace physical exercise on psychosocial factors among workers with chronic musculoskeletal pain. The trial design was a 2-armed parallel-group randomized controlled trial with allocation concealment. A total of 66 slaughterhouse workers (51 men and 15 women, mean age 45 years [standard deviation (SD) 10]) with upper limb chronic musculoskeletal pain were randomly allocated to group-based strength training (physical exercise group) or individual ergonomic training and education (reference group) for 10 weeks. Social climate was assessed with the General Nordic Questionnaire for Psychological and Social Factors at Work, and vitality and mental health were assessed with the 36-item Short Form Health Survey. All scales were converted to 0 to 100 (higher scores are better). Between-group differences from baseline to follow-up were determined using linear mixed models adjusted for workplace, age, gender, and baseline values of the outcome. Mean baseline scores of social climate, mental health, and vitality were 52.2 (SD 14.9), 79.5 (SD 13.7), and 53.9 (SD 19.7), respectively. Complete baseline and follow-up data were obtained from 30 and 31 from the physical exercise and reference groups, respectively. The between-group differences from baseline to follow-up between physical exercise and reference were 7.6 (95% CI 0.3 to 14.9), −2.3 (95% CI -10.3 to 5.8), and 10.1 (95% CI 0.6 to 19.5) for social climate, mental health, and vitality, respectively. For social climate and vitality, this corresponded to moderate effect sizes (Cohen d = 0.51 for both) in favor of physical exercise. There were no reported adverse events. In conclusion, workplace physical exercise performed together with colleagues improves social climate and vitality among workers with chronic musculoskeletal pain. Mental health remained unchanged. PMID:28072707

Psychosocial effects of workplace physical exercise among workers with chronic pain: Randomized controlled trial.

PubMed

Andersen, Lars L; Persson, Roger; Jakobsen, Markus D; Sundstrup, Emil

2017-01-01

While workplace physical exercise can help manage musculoskeletal disorders, less is known about psychosocial effects of such interventions. This aim of this study was to investigate the effect of workplace physical exercise on psychosocial factors among workers with chronic musculoskeletal pain.The trial design was a 2-armed parallel-group randomized controlled trial with allocation concealment. A total of 66 slaughterhouse workers (51 men and 15 women, mean age 45 years [standard deviation (SD) 10]) with upper limb chronic musculoskeletal pain were randomly allocated to group-based strength training (physical exercise group) or individual ergonomic training and education (reference group) for 10 weeks. Social climate was assessed with the General Nordic Questionnaire for Psychological and Social Factors at Work, and vitality and mental health were assessed with the 36-item Short Form Health Survey. All scales were converted to 0 to 100 (higher scores are better). Between-group differences from baseline to follow-up were determined using linear mixed models adjusted for workplace, age, gender, and baseline values of the outcome.Mean baseline scores of social climate, mental health, and vitality were 52.2 (SD 14.9), 79.5 (SD 13.7), and 53.9 (SD 19.7), respectively. Complete baseline and follow-up data were obtained from 30 and 31 from the physical exercise and reference groups, respectively. The between-group differences from baseline to follow-up between physical exercise and reference were 7.6 (95% CI 0.3 to 14.9), -2.3 (95% CI -10.3 to 5.8), and 10.1 (95% CI 0.6 to 19.5) for social climate, mental health, and vitality, respectively. For social climate and vitality, this corresponded to moderate effect sizes (Cohen d = 0.51 for both) in favor of physical exercise. There were no reported adverse events.In conclusion, workplace physical exercise performed together with colleagues improves social climate and vitality among workers with chronic musculoskeletal pain. Mental health remained unchanged.

Introducing reproductive life plan-based information in contraceptive counselling: an RCT.

PubMed

Stern, J; Larsson, M; Kristiansson, P; Tydén, T

2013-09-01

Can reproductive life plan (RLP)-based information in contraceptive counselling before pregnancy increase women's knowledge of reproduction, and of the importance of folic acid intake in particular? The RLP-based information increased women's knowledge of reproduction including knowledge of folic acid intake. Many women have insufficient knowledge of reproduction, including a health-promoting lifestyle prior to conception, and highly educated women in particular postpone childbearing until an age when their fertile capacity has started to decrease. The study was an randomized controlled trial with one intervention group (IG) and two control groups (CG1, CG2). A sample size calculation indicated that 82 women per group would be adequate. Recruitment took place during 3 months in 2012 and 299 women were included. The women were randomized in blocks of three. All groups received standard care (contraceptive counselling, Chlamydia testing, cervical screening). In addition, women in the IG were given oral and written RLP-based information about reproduction. A total of 299 out of 338 (88%) Swedish-speaking women visiting a Student Health Centre were included (mean age 23 years); response rate was 88%. Before the counselling, women in the IG and the CG1 completed a baseline questionnaire, including questions about lifestyle changes in connection to pregnancy planning, family planning intentions and knowledge of reproduction (e.g. the fecundity of an ovum). At follow-up 2 months after inclusion, a structured telephone interview was performed in all groups (n = 262, 88% participation rate). There was no difference between the groups regarding the mean knowledge score at baseline. The IG scored higher at follow-up than at baseline (P < 0.001); the mean increased from 6.4 to 9.0 out of a maximum 20 points. The women in the CG1 scored no differently at follow-up than at baseline. The difference in the knowledge score between the IG and the two CGs was significant (P < 0.001), whereas no difference was shown between the two CGs. There was no difference between the groups at baseline regarding how many women could mention folic acid intake among the things to do when planning to get pregnant. At follow-up, 22% in the IG, 3% in CG1 and 1% in CG2 mentioned folic acid intake (P < 0.001). At follow-up, more women in the IG also wished to have their last child earlier in life (P < 0.001) than at baseline, while there was no difference in the CG1. As the study sample consisted of university students, it is possible that the effect of the intervention was connected to a high level of education and conclusions for all women of reproductive age should be drawn with caution. The provision of RLP-based information seems to be a feasible tool for promoting reproductive health. Study funding was received from the Faculty of Medicine, Uppsala University, Sweden. There are no conflicts of interest. ClinicalTrial.gov Identifier NCT01739101.

5HTTLPR genotype moderates the longitudinal impact of early caregiving on externalizing behavior

PubMed Central

Smyke, Anna T.; Gleason, Mary Margaret; Nelson, Charles A.; Zeanah, Charles H.; Fox, Nathan A; Drury, Stacy S.

2014-01-01

We examined caregiver report of externalizing behavior from 12 to 54 months of age in 102 children randomized to care as usual in institutions or to newly-created high quality foster care. At baseline no differences by group or genotype in externalizing were found. However, changes in externalizing from baseline to 42 months of age were moderated by 5HTTLPR genotype and intervention group, where the slope for s/s individuals differed as a function of intervention group. The slope for individuals carrying the l allele did not significantly differ between groups. At 54 months of age, s/s children in the foster care group had the lowest levels of externalizing behavior, while children with the s/s genotype in the care as usual group demonstrated the highest rates of externalizing behavior. No intervention group differences were found in externalizing behavior among children who carried the l allele. These findings, within a randomized control trial of foster care compared to continued care as usual, indicate that 5HTTLPR genotype moderates the relation between early caregiving environments to predict externalizing behavior in children exposed to early institutional care in a manner most consistent with differential susceptibility. PMID:25640827

Matched Comparison Group Design Standards in Systematic Reviews of Early Childhood Interventions.

PubMed

Thomas, Jaime; Avellar, Sarah A; Deke, John; Gleason, Philip

2017-06-01

Systematic reviews assess the quality of research on program effectiveness to help decision makers faced with many intervention options. Study quality standards specify criteria that studies must meet, including accounting for baseline differences between intervention and comparison groups. We explore two issues related to systematic review standards: covariate choice and choice of estimation method. To help systematic reviews develop/refine quality standards and support researchers in using nonexperimental designs to estimate program effects, we address two questions: (1) How well do variables that systematic reviews typically require studies to account for explain variation in key child and family outcomes? (2) What methods should studies use to account for preexisting differences between intervention and comparison groups? We examined correlations between baseline characteristics and key outcomes using Early Childhood Longitudinal Study-Birth Cohort data to address Question 1. For Question 2, we used simulations to compare two methods-matching and regression adjustment-to account for preexisting differences between intervention and comparison groups. A broad range of potential baseline variables explained relatively little of the variation in child and family outcomes. This suggests the potential for bias even after accounting for these variables, highlighting the need for systematic reviews to provide appropriate cautions about interpreting the results of moderately rated, nonexperimental studies. Our simulations showed that regression adjustment can yield unbiased estimates if all relevant covariates are used, even when the model is misspecified, and preexisting differences between the intervention and the comparison groups exist.

Essential fatty acids for premenstrual syndrome and their effect on prolactin and total cholesterol levels: a randomized, double blind, placebo-controlled study

PubMed Central

2011-01-01

Objective To evaluate the effectiveness and safety of polyunsaturated fatty acids for the treatment of the premenstrual syndrome (PMS) using a graded symptom scale and to assess the effect of this treatment on basal plasma levels of prolactin and total cholesterol. Methods A randomized, double-blind, placebo-controlled study was conducted with 120 women with PMS divided into three groups and treated with 1 or 2 grams of the medication or placebo. Symptoms were recorded over a 6-month period using the Prospective Record of the Impact and Severity of Menstruation (PRISM) calendar. Total cholesterol and prolactin levels were measured. Analysis of variance (ANOVA), Pearson's chi-square test, Wilcoxon's nonparametric signed-rank test for paired samples and the Mann-Whitney nonparametric test for independent samples were used in the statistical analysis. Results There were no differences in age, marital status, schooling or ethnicity between the groups. In the group treated with 1 gram of the medication, a significant reduction was found when the median PRISM score recorded in the luteal phase at baseline (99) was compared with the median score recorded in the 3rd month (58) and in the 6th month of evaluation (35). In the 2-gram group, these differences were even more significant (baseline score: 98; 3rd month: 48; 6th month: 28). In the placebo group, there was a significant reduction at the 3rd but not at the 6th month (baseline: 96.5; 3rd month: 63.5; 6th month: 62). The difference between the phases of the menstrual cycle was greater in the 2-gram group compared to the group treated with 1 gram of the medication. There were no statistically significant differences in prolactin or total cholesterol levels between baseline values and those recorded after six months of treatment. Conclusion The difference between the groups using the medication and the placebo group with respect to the improvement in symptomatology appears to indicate the effectiveness of the drug. Improvement in symptoms was higher when the 2-gram dose was used. This medication was not associated with any changes in prolactin or total cholesterol levels in these women. PMID:21241460

Analysis of surface EMG baseline for detection of hidden muscle activity

NASA Astrophysics Data System (ADS)

Zhang, Xu; Zhou, Ping

2014-02-01

Objective. This study explored the feasibility of detecting hidden muscle activity in surface electromyogram (EMG) baseline. Approach. Power spectral density (PSD) analysis and multi-scale entropy (MSE) analysis were used. Both analyses were applied to computer simulations of surface EMG baseline with the presence (representing activity data) or absence (representing reference data) of hidden muscle activity, as well as surface electrode array EMG baseline recordings of healthy control and amyotrophic lateral sclerosis (ALS) subjects. Main results. Although the simulated reference data and the activity data yielded no distinguishable difference in the time domain, they demonstrated a significant difference in the frequency and signal complexity domains with the PSD and MSE analyses. For a comparison using pooled data, such a difference was also observed when the PSD and MSE analyses were applied to surface electrode array EMG baseline recordings of healthy control and ALS subjects, which demonstrated no distinguishable difference in the time domain. Compared with the PSD analysis, the MSE analysis appeared to be more sensitive for detecting the difference in surface EMG baselines between the two groups. Significance. The findings implied the presence of a hidden muscle activity in surface EMG baseline recordings from the ALS subjects. To promote the presented analysis as a useful diagnostic or investigatory tool, future studies are necessary to assess the pathophysiological nature or origins of the hidden muscle activity, as well as the baseline difference at the individual subject level.

Analysis of Surface EMG Baseline for Detection of Hidden Muscle Activity

PubMed Central

Zhang, Xu; Zhou, Ping

2014-01-01

Objective This study explored the feasibility of detecting hidden muscle activity in surface electromyogram (EMG) baseline. Approach Power spectral density (PSD) analysis and multi-scale entropy (MSE) analysis were used respectively. Both analyses were applied to computer simulations of surface EMG baseline with presence (representing activity data) or absence (representing reference data) of hidden muscle activity, as well as surface electrode array EMG baseline recordings of healthy control and amyotrophic lateral sclerosis (ALS) subjects. Main results Although the simulated reference data and the activity data yielded no distinguishable difference in the time domain, they demonstrated a significant difference in the frequency and signal complexity domains with the PSD and MSE analyses. For a comparison using pooled data, such a difference was also observed when the PSD and MSE analyses were applied to surface electrode array EMG baseline recordings of healthy control and ALS subjects, which demonstrated no distinguishable difference in the time domain. Compared with the PSD analysis, the MSE analysis appeared to be more sensitive for detecting the difference in surface EMG baselines between the two groups. Significance The findings implied presence of hidden muscle activity in surface EMG baseline recordings from the ALS subjects. To promote the presented analysis as a useful diagnostic or investigatory tool, future studies are necessary to assess the pathophysiological nature or origins of the hidden muscle activity, as well as the baseline difference at the individual subject level. PMID:24445526

The efficacy of problem solving therapy to reduce post stroke emotional distress in younger (18-65) stroke survivors.

PubMed

Chalmers, Charlotte; Leathem, Janet; Bennett, Simon; McNaughton, Harry; Mahawish, Karim

2017-11-26

To investigate the efficacy of problem solving therapy for reducing the emotional distress experienced by younger stroke survivors. A non-randomized waitlist controlled design was used to compare outcome measures for the treatment group and a waitlist control group at baseline and post-waitlist/post-therapy. After the waitlist group received problem solving therapy an analysis was completed on the pooled outcome measures at baseline, post-treatment, and three-month follow-up. Changes on outcome measures between baseline and post-treatment (n = 13) were not significantly different between the two groups, treatment (n = 13), and the waitlist control group (n = 16) (between-subject design). The pooled data (n = 28) indicated that receiving problem solving therapy significantly reduced participants levels of depression and anxiety and increased quality of life levels from baseline to follow up (within-subject design), however, methodological limitations, such as the lack of a control group reduce the validity of this finding. The between-subject results suggest that there was no significant difference between those that received problem solving therapy and a waitlist control group between baseline and post-waitlist/post-therapy. The within-subject design suggests that problem solving therapy may be beneficial for younger stroke survivors when they are given some time to learn and implement the skills into their day to day life. However, additional research with a control group is required to investigate this further. This study provides limited evidence for the provision of support groups for younger stroke survivors post stroke, however, it remains unclear about what type of support this should be. Implications for Rehabilitation Problem solving therapy is no more effective for reducing post stroke distress than a wait-list control group. Problem solving therapy may be perceived as helpful and enjoyable by younger stroke survivors. Younger stroke survivors may use the skills learnt from problem solving therapy to solve problems in their day to day lives. Younger stroke survivors may benefit from age appropriate psychological support; however, future research is needed to determine what type of support this should be.

Phenotypic factors influencing the variation in response of circulating cholesterol level to personalised dietary advice in the Food4Me study.

PubMed

Kirwan, Laura; Walsh, Marianne C; Celis-Morales, Carlos; Marsaux, Cyril F M; Livingstone, Katherine M; Navas-Carretero, Santiago; Fallaize, Rosalind; O'Donovan, Clare B; Woolhead, Clara; Forster, Hannah; Kolossa, Silvia; Daniel, Hannelore; Moschonis, George; Manios, Yannis; Surwillo, Agnieszka; Godlewska, Magdalena; Traczyk, Iwona; Drevon, Christian A; Gibney, Mike J; Lovegrove, Julie A; Martinez, J Alfredo; Saris, Wim H M; Mathers, John C; Gibney, Eileen R; Brennan, Lorraine

2016-12-01

Individual response to dietary interventions can be highly variable. The phenotypic characteristics of those who will respond positively to personalised dietary advice are largely unknown. The objective of this study was to compare the phenotypic profiles of differential responders to personalised dietary intervention, with a focus on total circulating cholesterol. Subjects from the Food4Me multi-centre study were classified as responders or non-responders to dietary advice on the basis of the change in cholesterol level from baseline to month 6, with lower and upper quartiles defined as responder and non-responder groups, respectively. There were no significant differences between demographic and anthropometric profiles of the groups. Furthermore, with the exception of alcohol, there was no significant difference in reported dietary intake, at baseline. However, there were marked differences in baseline fatty acid profiles. The responder group had significantly higher levels of stearic acid (18 : 0, P=0·034) and lower levels of palmitic acid (16 : 0, P=0·009). Total MUFA (P=0·016) and total PUFA (P=0·008) also differed between the groups. In a step-wise logistic regression model, age, baseline total cholesterol, glucose, five fatty acids and alcohol intakes were selected as factors that successfully discriminated responders from non-responders, with sensitivity of 82 % and specificity of 83 %. The successful delivery of personalised dietary advice may depend on our ability to identify phenotypes that are responsive. The results demonstrate the potential use of metabolic profiles in identifying response to an intervention and could play an important role in the development of precision nutrition.

Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial.

PubMed

Libman, Ingrid M; Miller, Kellee M; DiMeglio, Linda A; Bethin, Kathleen E; Katz, Michelle L; Shah, Avni; Simmons, Jill H; Haller, Michael J; Raman, Sripriya; Tamborlane, William V; Coffey, Julie K; Saenz, Ashleigh M; Beck, Roy W; Nadeau, Kristen J

2015-12-01

Previous studies assessing the effect of metformin on glycemic control in adolescents with type 1 diabetes have produced inconclusive results. To assess the efficacy and safety of metformin as an adjunct to insulin in treating overweight adolescents with type 1 diabetes. Multicenter (26 pediatric endocrinology clinics), double-blind, placebo-controlled randomized clinical trial involving 140 adolescents aged 12.1 to 19.6 years (mean [SD] 15.3 [1.7] years) with mean type 1 diabetes duration 7.0 (3.3) years, mean body mass index (BMI) 94th (4) percentile, mean total daily insulin 1.1 (0.2) U/kg, and mean HbA1c 8.8% (0.7%). Randomization to receive metformin (n = 71) (≤2000 mg/d) or placebo (n = 69). Primary outcome was change in HbA1c from baseline to 26 weeks adjusted for baseline HbA1c. Secondary outcomes included change in blinded continuous glucose monitor indices, total daily insulin, BMI, waist circumference, body composition, blood pressure, and lipids. Between October 2013 and February 2014, 140 participants were enrolled. Baseline HbA1c was 8.8% in each group. At 13-week follow-up, reduction in HbA1c was greater with metformin (-0.2%) than placebo (0.1%; mean difference, -0.3% [95% CI, -0.6% to 0.0%]; P = .02). However, this differential effect was not sustained at 26-week follow up when mean change in HbA1c from baseline was 0.2% in each group (mean difference, 0% [95% CI, -0.3% to 0.3%]; P = .92). At 26-week follow-up, total daily insulin per kg of body weight was reduced by at least 25% from baseline among 23% (16) of participants in the metformin group vs 1% (1) of participants in the placebo group (mean difference, 21% [95% CI, 11% to 32%]; P = .003), and 24% (17) of participants in the metformin group and 7% (5) of participants in the placebo group had a reduction in BMI z score of 10% or greater from baseline to 26 weeks (mean difference, 17% [95% CI, 5% to 29%]; P = .01). Gastrointestinal adverse events were reported by more participants in the metformin group than in the placebo group (mean difference, 36% [95% CI, 19% to 51%]; P < .001). Among overweight adolescents with type 1 diabetes, the addition of metformin to insulin did not improve glycemic control after 6 months. Of multiple secondary end points, findings favored metformin only for insulin dose and measures of adiposity; conversely, use of metformin resulted in an increased risk for gastrointestinal adverse events. These results do not support prescribing metformin to overweight adolescents with type 1 diabetes to improve glycemic control. clinicaltrials.org Identifier: NCT01881828.

Association Between Coronary Artery Calcification and the Hemoglobin Glycation Index: The Kangbuk Samsung Health Study.

PubMed

Rhee, Eun-Jung; Cho, Jung-Hwan; Kwon, Hyemi; Park, Se Eun; Park, Cheol-Young; Oh, Ki-Won; Park, Sung-Woo; Lee, Won-Young

2017-12-01

The hemoglobin glycation index (HGI) is known to be correlated with the risk for cardiovascular disease. To analyze the association between incident coronary artery calcification (CAC) and the changes in HGI among participants without diabetes, over 4 years. A retrospective study of 2052 nondiabetic participants in whom the coronary artery calcium score was measured repeatedly over 4 years, as part of a health checkup program in Kangbuk Samsung Hospital in Korea, and who had no CAC at baseline. The HGI was defined as the difference between the measured and predicted hemoglobin A1c (HbA1c) levels. A total of 201 participants developed CAC after 4 years, and the mean baseline HGI was significantly higher in those patients. The incidence of CAC gradually increased from the first to the fourth quartile groups of baseline HGI. The odds ratio (OR) for incident CAC was the highest among the four groups divided by the quartiles of the baseline HGI and was significant after adjustment for confounding variables (vs first quartile group: OR, 1.632; 95% confidence interval, 1.024 to 2.601). The incidence of and risk for CAC development were significantly higher than in other groups compared with the low-to-low group after adjustment for confounding factors; however, when baseline HbA1c level was included in the model, only participants with a low-to-high HGI over 4 years showed a significantly increased OR for CAC development compared with the low-to-low group (OR, 1.722; 95% confidence interval, 1.046 to 2.833). The participants with a high baseline HGI and consistently high HGI showed a higher risk for incident CAC than those with a low baseline HGI. An increased HGI over 4 years significantly increased the risk for CAC regardless of the baseline HbA1c levels. Copyright © 2017 Endocrine Society

Management of sleep-time masticatory muscle activity using stabilisation splints affects psychological stress.

PubMed

Takahashi, H; Masaki, C; Makino, M; Yoshida, M; Mukaibo, T; Kondo, Y; Nakamoto, T; Hosokawa, R

2013-12-01

To treat sleep bruxism (SB), symptomatic therapy using stabilisation splints (SS) is frequently used. However, their effects on psychological stress and sleep quality have not yet been examined fully. The objective of this study was to clarify the effects of SS use on psychological stress and sleep quality. The subjects (11 men, 12 women) were healthy volunteers. A crossover design was used. Sleep measurements were performed for three consecutive days or longer without (baseline) or with an SS or palatal splint (PS), and data for the final day were evaluated. We measured masseter muscle activity during sleep using portable electromyography to evaluate SB. Furthermore, to compare psychological stress before and after sleep, assessments were made based on STAI-JYZ and the measurement of salivary chromogranin A. To compare each parameter among the three groups (baseline, SS and PS), Friedman's and Dunn's tests were used. From the results of the baseline measurements, eight subjects were identified as high group and 15 as low group. Among the high group, a marked decrease in the number of bruxism events per hour and an increase in the difference in the total STAI Y-1 scores were observed in the SS group compared with those at baseline (P < 0·05). No significant difference was observed in sleep stages. SS use may be effective in reducing the number of SB events, while it may increase psychological stress levels, and SS use did not apparently influence sleep stages. © 2013 John Wiley & Sons Ltd.

Long-term effects on the progress of neuropathy after diabetic Charcot foot: an 8.5-year prospective case-control study.

PubMed

Jansen, Rasmus Bo; Møller Christensen, Tomas; Bülow, Jens; Rørdam, Lene; Holstein, Per E; Lander Svendsen, Ole

2018-02-20

Charcot foot is a severe complication to diabetes mellitus, associated with diabetic neuropathy. Any long-term effects of a Charcot foot on the progress of neuropathy are still largely unexplored. The objective was to investigate whether a previous Charcot foot had any long-term effects on the progress of neuropathy. An 8.5-year follow-up case-control study of 49 individuals with diabetes mellitus, 24 of whom also had Charcot foot at baseline visit in 2005-2007. Neuropathy was assessed with a questionnaire, biothesiometry, heart rate variability and venous occlusion plethysmography. Of the 49 baseline participants, 22 were able to participate in the follow-up. Twelve had passed away in the meantime. Heart rate variability was unchanged in both groups; from 9.7 to 7.2 beats/min (p = 0.053) in the Charcot group, and 14.3 to 12.6 beats/min (p = 0.762) in the control group. Somato-sensoric neuropathy showed no difference between baseline and follow-up in the Charcot group (from 39.1 to 38.5 V) (p = 0.946), but a significantly worsened sensitivity in the control group (from 25.1 to 38.9 V) (p = 0.002). In conclusion, we found that any differences in somatic or cardial autonomic neuropathy present at baseline had disappeared at follow-up after 8.5 years.

Feasibility of a skills-based substance abuse prevention program following traumatic brain injury.

PubMed

Vungkhanching, Martha; Heinemann, Allen W; Langley, Mervin J; Ridgely, Mary; Kramer, Karen M

2007-01-01

To demonstrate the feasibility of a skills-based substance abuse prevention counseling program in a community setting for adults who sustained traumatic brain injury. Convenience sample of 117 participants (mean age=35 years) with preinjury history of alcohol or other drug use. Intervention group participants (n=36) from 3 vocational rehabilitation programs; a no-intervention comparison group (n=81) from an outpatient rehabilitation service. 12 individual counseling sessions featuring skills-based intervention. Changes in self-reported alcohol and other drug use, coping skillfulness, affect, and employment status from baseline to 9 months postintervention. Significant differences were noted at baseline for the intervention and comparison groups on ethnicity, time postinjury, marital status, and employment (P<.05). At the 9-month follow-up, the intervention group participants achieved a statistically significant decrease in alcohol and drug use (P<.05), increase in coping skillfulness (P<.01), and increased likelihood of maintaining employment (P<.01) relative to the comparison group. Controlling for baseline-adjusted means for the intervention and comparison groups, a statistically significant group difference in adjusted change was noted; the intervention group participants reported lower negative affect at the 9-month follow-up assessment (P<.05). A skills-based intervention provides a promising approach to promoting abstinence from all substances and increasing readiness for employment for adults with traumatic brain injuries in outpatient settings.

Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years

PubMed Central

Brundage, Michael D.; Parulekar, Wendy R.; Goss, Paul E.; Ingle, James N.; Pritchard, Kathleen I.; Celano, Paul; Muss, Hyman; Gralow, Julie; Strasser-Weippl, Kathrin; Whelan, Kate; Tu, Dongsheng; Whelan, Timothy J.

2018-01-01

Purpose MA.17R was a Canadian Cancer Trials Group–led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor–positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL. PMID:29328860

Effects of aqueous extracts of dried calyx of sour tea (Hibiscus sabdariffa L.) on polygenic dyslipidemia: A randomized clinical trial.

PubMed

Hajifaraji, Majid; Matlabi, Mohammad; Ahmadzadeh-Sani, Farihe; Mehrabi, Yadollah; Rezaee, Mohammad Salem; Hajimehdipour, Homa; Hasanzadeh, Abbas; Roghani, Katayoun

2018-01-01

Dyslipidemia has been considered as a major risk factor for coronary heart disease. Alternative medicine has a significant role in treatment of dyslipidemia. There are controversial findings regarding the effects of sour tea on dyslipidemia. The aim of this study was to evaluate the impact of aqueous extract of dried calyx of sour tea on polygenic dyslipidemia. This clinical trial was done on 43 adults (30-60 years old) with polygenic dyslipidemia that were randomly assigned to the intervention and control groups. The control group was trained in lifestyle modifications at baseline. The intervention group was trained for lifestyle modifications at baseline and received two cups of sour tea daily, and both groups were followed up for 12 weeks. Lipid profile was evaluated at baseline, and six and 12 weeks following the intervention. In addition, dietary and physical activity assessed at baseline for twelve weeks. Mean concentration of total cholesterol, HDL-C and LDL-C significantly decreased by up to 9.46%, 8.33%, and 9.80%, respectively, after 12 weeks in the intervention group in comparison to their baseline values. However, LDL-C/HDL-C ratio significantly increased by up to 3.15%, following 12 weeks in the control group in comparison to their baseline values. This study showed no difference in lipid profiles between the two groups, except for HDL-C concentrations. sour tea may have significant positive effects on lipid profile of polygenic dyslipidemia subjects and these effect might be attributed to its anthocyanins and inflation factor content. Therefore, sour tea intake with recommended dietary patterns and physical activity can be useful in regulation of lipid profile in patients with polygenic dyslipidemia.

Comparative efficacy of two battery-powered toothbrushes on dental plaque removal.

PubMed

Ruhlman, C Douglas; Bartizek, Robert D; Biesbrock, Aaron R

2002-01-01

A number of clinical studies have consistently demonstrated that power toothbrushes deliver superior plaque removal compared to manual toothbrushes. Recently, a new power toothbrush (Crest SpinBrush) has been marketed with a design that fundamentally differs from other marketed power toothbrushes. Other power toothbrushes feature a small, round head designed to oscillate for enhanced cleaning between the teeth and below the gumline. The new power toothbrush incorporates a similar round oscillating head in conjunction with fixed bristles, which allows the user to brush with optimal manual brushing technique. The objective of this randomized, examiner-blind, parallel design study was to compare the plaque removal efficacy of a positive control power toothbrush (Colgate Actibrush) to an experimental toothbrush (Crest SpinBrush) following a single use among 59 subjects. Baseline plaque scores were 1.64 and 1.40 for the experimental toothbrush and control toothbrush treatment groups, respectively. With regard to all surfaces examined, the experimental toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.47, while the control toothbrush delivered an adjusted mean difference of 0.33. On average, the difference between toothbrushes was statistically significant (p = 0.013). Because the covariate slope for the experimental group was statistically significantly greater (p = 0.001) than the slope for the control group, a separate slope model was used. Further analysis demonstrated that the experimental group had statistically significantly greater plaque removal than the control group for baseline plaque scores above 1.43. With respect to buccal surfaces, using a separate slope analysis of covariance, the experimental toothbrush delivered an adjusted mean difference between baseline and post-brushing plaque scores of 0.61, while the control toothbrush delivered an adjusted mean difference of 0.39. This difference between toothbrushes was also statistically significant (p = 0.002). On average, the results on lingual surfaces demonstrated similar directional scores favoring the experimental toothbrush; however these results did not achieve statistical significance. In conclusion, the experimental Crest SpinBrush, with its novel fixed and oscillating bristle design, was found to be more effective than the positive control Colgate Actibrush, which is designed with a small round oscillating cluster of bristles.

Comparison of efficacy of an arginine-calcium carbonate-MFP toothpaste to a calcium carbonate-MFP toothpaste in controlling supragingival calculus formation and gingivitis: a 6-month clinical study.

PubMed

Li, Yiming; Lee, Sean; Stephens, Joni; Mateo, Luis R; Zhang, Yun Po; DeVizio, William

2012-02-01

To investigate whether the long-term use (6 months) of an arginine-calcium carbonate-MFP toothpaste would affect calculus formation and/or gingivitis when compared to a calcium carbonate-MFP toothpaste. This was a double-blind clinical study. Eligible adult subjects (120) entered a 2-month pre-test phase of the study. After receiving an evaluation of oral tissue and a dental prophylaxis, the subjects were provided with a regular fluoride toothpaste, a soft-bristled adult toothbrush with instructions to brush their teeth for 1-minute twice daily (morning and evening) for 2 months. The subjects were then examined for baseline calculus using the Volpe-Manhold Calculus Index (VMI) and gingivitis using the Löe-Silness Gingival Index (GI), along with an oral tissue examination. Qualifying subjects were randomized to two treatment groups: (1) Colgate Sensitive Pro-Relief toothpaste containing 8.0% arginine, 1450 ppm MFP and calcium carbonate (Test group), or (2) Colgate Cavity Protection toothpaste containing 1450 ppm MFP and calcium carbonate (Control group). Subjects were stratified by the VMI score and gender. After a dental prophylaxis (VMI=0), the subjects entered a 6-month test phase. Each received the assigned toothpaste and a soft-bristled adult toothbrush for home use with instructions of brushing teeth for 1 minute twice daily (morning and evening). The examinations of VMI, Löe-Silness GI and oral tissues were conducted after 3 and 6 months. Prior to each study visit, subjects refrained from brushing their teeth as well as eating and drinking for 4 hours. 99 subjects complied with the study protocol and completed the 6-month test phase. No within-treatment comparison was performed for the VMI because it was brought down to zero after the prophylaxis at the baseline of the test phase. For the Löe-Silness GI, subjects of the Test group exhibited a significant difference from baseline at the 3- and 6-month examinations. The 3-month Löe-Silness GI of the Control group was significantly different from that of the baseline; however, its 6-month Löe-Silness GI was not statistically significantly different from the baseline values. After 3 and 6 months, there were no significant differences between the Test and Control groups with respect to the mean VMI scores; there were no statistically significant differences between the two groups with respect to the Löe-Silness GI results after 3 and 6 months of product use.

Effect of training on corticomotor excitability in clinical neck pain.

PubMed

Rittig-Rasmussen, B; Kasch, H; Fuglsang-Frederiksen, A; Svensson, P; Jensen, T S

2014-09-01

Corticomotor excitability has been shown to correlate with motor learning and functional recovery. The aim of the present study was to monitor changes in excitability of the corticomotor pathways induced by neck training and to compare the effects in patients with neck or knee pain and pain-free participants. Corticomotor excitability was assessed using transcranial magnetic stimulation and electromyography at baseline, after 30 min and 1 h, and at a 1-week follow-up visit. The primary outcome measures were changes in amplitudes and latencies of motor evoked potentials (MEPs) at 1-week follow-up. MEP responses induced by neck training yielded significantly different outcomes in the three groups. In the group with neck pain and training, MEP amplitudes were significantly reduced between baseline and 30 min (p ≤ 0.05), but with no significant difference between baseline, 1 h (p = 0.178) and 1 week (p = 0.067). In the group with knee pain and training, MEP amplitudes significantly increased between baseline and 30 min (p ≤ 0.01) and 1 h (p < 0.001), but not after 1 week (p = 0.524) compared with baseline. In the pain-free group, there were no changes over time. Neck training reduced neuroplastic responsiveness of corticomotor pathways in neck pain patients in contrast to knee pain patients and pain-free participants. Increased attention to adaptive and maladaptive neuroplastic responses induced by training may prove valuable in the process of optimizing clinical outcomes. © 2014 European Pain Federation - EFIC®

Comparison of the Effects of Two Auditory Methods by Mother and Fetus on the Results of Non-Stress Test (Baseline Fetal Heart Rate and Number of Accelerations) in Pregnant Women: A Randomized Controlled Trial

PubMed Central

Khoshkholgh, Roghaie; Keshavarz, Tahereh; Moshfeghy, Zeinab; Akbarzadeh, Marzieh; Asadi, Nasrin; Zare, Najaf

2016-01-01

Objective: To compare the effects of two auditory methods by mother and fetus on the results of NST in 2011-2012. Materials and methods: In this single-blind clinical trial, 213 pregnant women with gestational age of 37-41 weeks who had no pregnancy complications were randomly divided into 3 groups (auditory intervention for mother, auditory intervention for fetus, and control) each containing 71 subjects. In the intervention groups, music was played through the second 10 minutes of NST. The three groups were compared regarding baseline fetal heart rate and number of accelerations in the first and second 10 minutes of NST. The data were analyzed using one-way ANOVA, Kruskal-Wallis, and paired T-test. Results: The results showed no significant difference among the three groups regarding baseline fetal heart rate in the first (p = 0.945) and second (p = 0.763) 10 minutes. However, a significant difference was found among the three groups concerning the number of accelerations in the second 10 minutes. Also, a significant difference was observed in the number of accelerations in the auditory intervention for mother (p = 0.013) and auditory intervention for fetus groups (p < 0.001). The difference between the number of accelerations in the first and second 10 minutes was also statistically significant (p = 0.002). Conclusion: Music intervention was effective in the number of accelerations which is the indicator of fetal health. Yet, further studies are required to be conducted on the issue. PMID:27385971

Comparison of the Effects of Two Auditory Methods by Mother and Fetus on the Results of Non-Stress Test (Baseline Fetal Heart Rate and Number of Accelerations) in Pregnant Women: A Randomized Controlled Trial.

PubMed

Khoshkholgh, Roghaie; Keshavarz, Tahereh; Moshfeghy, Zeinab; Akbarzadeh, Marzieh; Asadi, Nasrin; Zare, Najaf

2016-03-01

To compare the effects of two auditory methods by mother and fetus on the results of NST in 2011-2012. In this single-blind clinical trial, 213 pregnant women with gestational age of 37-41 weeks who had no pregnancy complications were randomly divided into 3 groups (auditory intervention for mother, auditory intervention for fetus, and control) each containing 71 subjects. In the intervention groups, music was played through the second 10 minutes of NST. The three groups were compared regarding baseline fetal heart rate and number of accelerations in the first and second 10 minutes of NST. The data were analyzed using one-way ANOVA, Kruskal-Wallis, and paired T-test. The results showed no significant difference among the three groups regarding baseline fetal heart rate in the first (p = 0.945) and second (p = 0.763) 10 minutes. However, a significant difference was found among the three groups concerning the number of accelerations in the second 10 minutes. Also, a significant difference was observed in the number of accelerations in the auditory intervention for mother (p = 0.013) and auditory intervention for fetus groups (p < 0.001). The difference between the number of accelerations in the first and second 10 minutes was also statistically significant (p = 0.002). Music intervention was effective in the number of accelerations which is the indicator of fetal health. Yet, further studies are required to be conducted on the issue.

Physical activity and associated medical cost savings among at-risk older adults participating a community-based health & wellness program

PubMed Central

Li, Yajuan; Lee, Shinduk; Smith, Matthew Lee; Han, Gang; Quinn, Cindy; Du, Yuxian; Benden, Mark; Ory, Marcia G.

2018-01-01

Introduction Physical activity declines are seen with increasing age; however, the US CDC recommends most older adults (age 65 and older) engage in the same levels of physical activity as those 18–64 to lessen risks of injuries (e.g., falls) and slow deteriorating health. We aimed to identify whether older adults participating in a short (approx. 90-minute sessions) 20 session (approximately 10-weeks) health and wellness program delivered in a community setting saw improvements in physical activity and whether these were sustained over time. Methods Employing a non-equivalent group design, community-dwelling older adults were purposely recruited into either an intervention or comparison group. The intervention was a multicomponent lifestyle enhancement intervention focused on healthy eating and physical activity, including structured physical activity exercises within the class sessions. Two groups were included: intervention (survey group: n = 65; accelerometer subgroup: n = 38) and the comparison group (survey group: n = 102; accelerometer subgroup: n = 55). Measurements were made at baseline and approximately three months later to reflect immediate post-treatment period (survey, accelerometer) with long-term follow-up 6 months after baseline (survey). Adults not meeting the physical activity guidelines (i.e., 150/75 minutes of moderate-to-vigorous physical activity or MVPA) were targeted for subgroup analyses. Paired t-tests were used for bivariate comparisons, while repeated measures random coefficient models (adjusting for propensity scores using inverse probability of treatment weighted (IPTW) estimation) were used for multivariate models. Estimated medical costs associated with gains in physical activity were also measured among survey respondents in the intervention group. Results The accelerometer group contained 38 participants in the intervention group with 71% insufficiently active at baseline and 55 participants in the comparison group with 76% insufficiently active at baseline (<150 weekly MVPA minutes). The survey group contained 65 participants in the intervention group with 73.85% insufficiently active at baseline and 102 participants in the comparison group with 76.47% insufficiently active at baseline. In paired t-tests with the accelerometer group, a moderate effect size (-0.4727, p = 0.0210) indicating higher MVPA was found for intervention participants with <150 weekly MVPA at baseline. In fully adjusted analyses using propensity score matching, among the subjectively measured physical activity (survey) group, there was a differential impact from baseline to 6-month post among the intervention group with an improvement of 160 minutes among all study participants (p < .0001) versus no difference among the comparison group. For those insufficiently active at baseline, there was an improvement of 103 minutes among intervention (p < .0001) and 55 minutes among the comparison (p < .0001) with the improvement of the intervention significantly greater than that among the comparison (p = 0.0224). Further, among those insufficiently active at baseline there was a relative cost savings from baseline to 6-months over and above the estimated cost of the intervention estimated between $143 and $164 per participant. Discussion This intervention was able to reach and retain older adults and showed significant MVPA gains and estimated medical cost savings among more at-risk individuals (baseline <150 MVPA). This intervention can be used in practice as a strategy to improve MVPA among the growing population of older community-dwelling adults. PMID:29894478

Physical activity and associated medical cost savings among at-risk older adults participating a community-based health & wellness program.

PubMed

Towne, Samuel D; Li, Yajuan; Lee, Shinduk; Smith, Matthew Lee; Han, Gang; Quinn, Cindy; Du, Yuxian; Benden, Mark; Ory, Marcia G

2018-01-01

Physical activity declines are seen with increasing age; however, the US CDC recommends most older adults (age 65 and older) engage in the same levels of physical activity as those 18-64 to lessen risks of injuries (e.g., falls) and slow deteriorating health. We aimed to identify whether older adults participating in a short (approx. 90-minute sessions) 20 session (approximately 10-weeks) health and wellness program delivered in a community setting saw improvements in physical activity and whether these were sustained over time. Employing a non-equivalent group design, community-dwelling older adults were purposely recruited into either an intervention or comparison group. The intervention was a multicomponent lifestyle enhancement intervention focused on healthy eating and physical activity, including structured physical activity exercises within the class sessions. Two groups were included: intervention (survey group: n = 65; accelerometer subgroup: n = 38) and the comparison group (survey group: n = 102; accelerometer subgroup: n = 55). Measurements were made at baseline and approximately three months later to reflect immediate post-treatment period (survey, accelerometer) with long-term follow-up 6 months after baseline (survey). Adults not meeting the physical activity guidelines (i.e., 150/75 minutes of moderate-to-vigorous physical activity or MVPA) were targeted for subgroup analyses. Paired t-tests were used for bivariate comparisons, while repeated measures random coefficient models (adjusting for propensity scores using inverse probability of treatment weighted (IPTW) estimation) were used for multivariate models. Estimated medical costs associated with gains in physical activity were also measured among survey respondents in the intervention group. The accelerometer group contained 38 participants in the intervention group with 71% insufficiently active at baseline and 55 participants in the comparison group with 76% insufficiently active at baseline (<150 weekly MVPA minutes). The survey group contained 65 participants in the intervention group with 73.85% insufficiently active at baseline and 102 participants in the comparison group with 76.47% insufficiently active at baseline. In paired t-tests with the accelerometer group, a moderate effect size (-0.4727, p = 0.0210) indicating higher MVPA was found for intervention participants with <150 weekly MVPA at baseline. In fully adjusted analyses using propensity score matching, among the subjectively measured physical activity (survey) group, there was a differential impact from baseline to 6-month post among the intervention group with an improvement of 160 minutes among all study participants (p < .0001) versus no difference among the comparison group. For those insufficiently active at baseline, there was an improvement of 103 minutes among intervention (p < .0001) and 55 minutes among the comparison (p < .0001) with the improvement of the intervention significantly greater than that among the comparison (p = 0.0224). Further, among those insufficiently active at baseline there was a relative cost savings from baseline to 6-months over and above the estimated cost of the intervention estimated between $143 and $164 per participant. This intervention was able to reach and retain older adults and showed significant MVPA gains and estimated medical cost savings among more at-risk individuals (baseline <150 MVPA). This intervention can be used in practice as a strategy to improve MVPA among the growing population of older community-dwelling adults.

Recovery from sports-related concussion: Days to return to neurocognitive baseline in adolescents versus young adults.

PubMed

Zuckerman, Scott L; Lee, Young M; Odom, Mitchell J; Solomon, Gary S; Forbes, Jonathan A; Sills, Allen K

2012-01-01

Sports-related concussions (SRC) among high school and collegiate athletes represent a significant public health concern. The Concussion in Sport Group (CIS) recommended greater caution regarding return to play with children and adolescents. We hypothesized that younger athletes would take longer to return to neurocognitive baseline than older athletes after a SRC. Two hundred adolescent and young adult athletes who suffered a SRC were included in our clinical research cohort. Of the total participants, 100 were assigned to the 13-16 year age group and 100 to the 18-22 year age group and were matched on the number of prior concussions. Each participant completed baseline and postconcussion neurocognitive testing using the Immediate Post-Concussion assessment and Cognitive Testing (ImPACT) test battery. Return to baseline was defined operationally as post-concussion neurocognitive and symptom scores being equivalent to baseline using reliable change index (RCI) criteria. For each group, the average number of days to return to cognitive and symptom baseline were calculated. Independent sample t-tests were used to compare the mean number of days to return to baseline. Significant differences were found for days to return to baseline between 13-16 year olds and 18-22 year olds in three out of four neurocognitive measures and on the total symptom score. The average number of days to return to baseline was greater for 13-16 year olds than for 18-22 year olds on the following variables: Verbal memory (7.2 vs. 4.7, P = 0.001), visual memory (7.1 vs. 4.7, P = 0.002), reaction time (7.2 vs. 5.1 P = 0.01), and postconcussion symptom scale (8.1 vs. 6.1, P = 0.026). In both groups, greater than 90% of athletes returned to neurocognitive and symptom baseline within 1 month. Our results in this clinical research study show that in SRC, athletes 13-16 years old take longer to return to their neurocognitive and symptom baselines than athletes 18-22 years old.

Substance use outcomes 5½ years past baseline for partnership-based, family-school preventive interventions

PubMed Central

Spoth, Richard L.; Randall, G. Kevin; Trudeau, Linda; Shin, Chungyeol; Redmond, Cleve

2008-01-01

This article reports adolescent substance use outcomes of universal family and school preventive interventions 5½ years past baseline. Participants were 1677 7th grade students from schools (N = 36) randomly assigned to the school-based Life Skills Training plus the Strengthening Families Program: For Parents and Youth 10–14 (LST + SFP 10–14), LST-alone, or a control condition. Self-reports were collected at baseline, 6 months later following the interventions, then yearly through the 12th grade. Measures included initiation—alcohol, cigarette, marijuana, and drunkenness, along with a Substance Initiation Index (SII)—and measures of more serious use—frequency of alcohol, cigarette, and marijuana use, drunkenness frequency, monthly poly-substance use, and advanced poly-substance use. Analyses ruled out differential attrition. For all substance initiation outcomes, one or both intervention groups showed significant, positive point-in-time differences at 12th grade and/or significant growth trajectory outcomes when compared with the control group. Although no main effects for the more serious substance use outcomes were observed, a higher-risk subsample demonstrated significant, positive 12th grade point-in-time and/or growth trajectory outcomes for one or both intervention groups on all measures. The observed pattern of results likely reflects a combination of predispositions of the higher-risk subsample, the timing of the interventions, and baseline differences between experimental conditions favoring the control group. PMID:18434045

Vitamin D status and physical function in older Finnish people: A one-year follow-up study.

PubMed

Salminen, Marika; Saaristo, Pilvi; Salonoja, Maritta; Vaapio, Sari; Vahlberg, Tero; Lamberg-Allardt, Christel; Aarnio, Pertti; Kivelä, Sirkka-Liisa

2015-01-01

The aim was to describe vitamin D status and its association with changes in PF during 12 months in Finnish community-dwelling elderly (≥65 years). Baseline serum 25-hydroxyvitamin D (25OHD) concentration was measured by enzymeimmunoassay, and participants (n=518) were divided according to 25OHD to three groups (I <50 nmol/l, II 50-74.9 nmol/l, and III ≥75 nmol/l). PF (maximal isometric extension strength of right and left knee, and time in five-repetition sit-to-stand test (5STS) and 10-m walking test) was measured at baseline and after 12 months. 25OHD deficiency (<50 nmol/l) was found in 20.5% of the participants. During a 12-month follow-up, differences in changes in knee extensor strength of right (p=0.044) and left (p=0.010) lower extremity and in 10-m walking test (p=.040) between the groups were significant. According to further pairwise comparisons these differences were between groups I and III (right knee, p=0.036; left knee, p=0.009; 10-m walk, p=0.044), with the exception of left knee extensor strength in which there were also significant difference between groups I and II (p=0.039). All significant differences in changes were in favour of group II or III. Significant differences in changes in knee extensor strengths maintained after adjustments for group (intervention/control), parathyroid hormone, and baseline level of knee extensor strength. Prospective analyses showed low 25OHD concentrations (<50 nmol/l) to be associated with deterioration in PF during 12 months compared with high 25OHD concentrations (≥75 nmol/l). Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial.

PubMed

Hoffmann, Kristine; Sobol, Nanna A; Frederiksen, Kristian S; Beyer, Nina; Vogel, Asmus; Vestergaard, Karsten; Brændgaard, Hans; Gottrup, Hanne; Lolk, Annette; Wermuth, Lene; Jacobsen, Søren; Laugesen, Lars P; Gergelyffy, Robert G; Høgh, Peter; Bjerregaard, Eva; Andersen, Birgitte B; Siersma, Volkert; Johannsen, Peter; Cotman, Carl W; Waldemar, Gunhild; Hasselbalch, Steen G

2016-01-01

Studies of physical exercise in patients with Alzheimer's disease (AD) are few and results have been inconsistent. To assess the effects of a moderate-to-high intensity aerobic exercise program in patients with mild AD. In a randomized controlled trial, we recruited 200 patients with mild AD to a supervised exercise group (60-min sessions three times a week for 16 weeks) or to a control group. Primary outcome was changed from baseline in cognitive performance estimated by Symbol Digit Modalities Test (SDMT) in the intention-to-treat (ITT) group. Secondary outcomes included changes in quality of life, ability to perform activities of daily living, and in neuropsychiatric and depressive symptoms. The ITT analysis showed no significant differences between intervention and control groups in change from baseline of SDMT, other cognitive tests, quality of life, or activities of daily living. The change from baseline in Neuropsychiatric Inventory differed significantly in favor of the intervention group (mean: -3.5, 95% confidence interval (CI) -5.8 to -1.3, p = 0.002). In subjects who adhered to the protocol, we found a significant effect on change from baseline in SDMT as compared with the control group (mean: 4.2, 95% CI 0.5 to 7.9, p = 0.028), suggesting a dose-response relationship between exercise and cognition. This is the first randomized controlled trial with supervised moderate-to-high intensity exercise in patients with mild AD. Exercise reduced neuropsychiatric symptoms in patients with mild AD, with possible additional benefits of preserved cognition in a subgroup of patients exercising with high attendance and intensity.

Effect of 3D animation videos over 2D video projections in periodontal health education among dental students.

PubMed

Dhulipalla, Ravindranath; Marella, Yamuna; Katuri, Kishore Kumar; Nagamani, Penupothu; Talada, Kishore; Kakarlapudi, Anusha

2015-01-01

There is limited evidence about the distinguished effect of 3D oral health education videos over conventional 2 dimensional projections in improving oral health knowledge. This randomized controlled trial was done to test the effect of 3 dimensional oral health educational videos among first year dental students. 80 first year dental students were enrolled and divided into two groups (test and control). In the test group, 3D animation and in the control group, regular 2D video projections pertaining to periodontal anatomy, etiology, presenting conditions, preventive measures and treatment of periodontal problems were shown. Effect of 3D animation was evaluated by using a questionnaire consisting of 10 multiple choice questions given to all participants at baseline, immediately after and 1month after the intervention. Clinical parameters like Plaque Index (PI), Gingival Bleeding Index (GBI), and Oral Hygiene Index Simplified (OHI-S) were measured at baseline and 1 month follow up. A significant difference in the post intervention knowledge scores was found between the groups as assessed by unpaired t-test (p<0.001) at baseline, immediate and after 1 month. At baseline, all the clinical parameters in the both the groups were similar and showed a significant reduction (p<0.001)p after 1 month, whereas no significant difference was noticed post intervention between the groups. 3D animation videos are more effective over 2D videos in periodontal disease education and knowledge recall. The application of 3D animation results also demonstrate a better visual comprehension for students and greater health care outcomes.

Serum VEGF-D concentration as a biomarker of lymphangioleiomyomatosis severity and treatment response: a prospective analysis of the Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus (MILES) trial

PubMed Central

Young, Lisa R; Lee, Hye-Seung; Inoue, Yoshikazu; Moss, Joel; Singer, Lianne G; Strange, Charlie; Nakata, Koh; Barker, Alan F; Chapman, Jeffrey T; Brantly, Mark L; Stocks, James M; Brown, Kevin K; Lynch, Joseph P; Goldberg, Hilary J; Downey, Gregory P; Swigris, Jeffrey J; Taveira-DaSilva, Angelo M; Krischer, Jeffrey P; Trapnell, Bruce C; McCormack, Francis X

2013-01-01

Summary Background VEGF-D is a lymphangiogenic growth factor that has a key role in tumour metastasis. Serum VEGF-D concentrations are increased in most patients with lymphangioleiomyomatosis, a rare neoplasm associated with mTOR-activating tuberous sclerosis gene mutations, lymphadenopathy, metastatic spread, and pulmonary cyst formation. We used data from the Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus (MILES) trial to assess the usefulness of serum VEGF-D concentration as a marker of severity and therapeutic response to sirolimus in patients with lymphangioleiomyomatosis. Methods In the MILES trial, patients with lymphangioleiomyomatosis who had forced expiratory volume in 1 second (FEV1) of 70% or less of predicted were randomly assigned (1:1) to 12 months masked treatment with sirolimus or placebo. Serum VEGF-D concentrations were measured at baseline, 6 months, and 12 months. We used a linear regression model to assess associations of baseline VEGF-D concentrations with markers of disease severity, and a linear mixed effects model to assess the associations of VEGF-D concentrations with between-group differences in clinical, physiological, and patient-reported outcomes. Findings We included 42 patients from the placebo group and 45 from the sirolimus group in our analysis. Baseline VEGF-D concentrations in individual patients varied from 0·34 ng/mL to 16·7 ng/mL. Baseline VEGF-D concentrations were higher in patients who needed supplemental oxygen than in those who did not need supplemental oxygen (1·7 ng/mL [IQR 0·99–3·36] vs 0·84 ng/mL [0·52–1·39]; p<0·0001) and in those who had a bronchodilator response than in those who did not (2·01 ng/mL [0·99–2·86] vs 1·00 ng/mL [0·61–2·15]; 0·0273). Median serum VEGF-D concentrations were similar at baseline in the sirolimus and placebo groups, and fell from baseline at 6 and 12 months in the sirolimus group but remained roughly stable in the placebo group. Each one-unit increase in baseline log(VEGF-D) was associated with a between-group difference in baseline-to-12-month FEV1 change of 134 mL (p=0·0007). In the sirolimus group, improvement in baseline-to-12-month FEV1 occurred in 15 of 23 (65%) VEGF-D responders (ie, those in whom baseline-to-12-month VEGF-D concentrations decreased by more than they did in any patients in the placebo group) and four of 15 (27%) VEGF-D non-responders (p=0·0448). Interpretation Serum VEGF-D is a biologically plausible and useful biomarker in lymphangioleiomyomatosis that correlates with disease severity and treatment response. Measurement of serum VEGF-D concentrations could inform the risk–benefit analysis of sirolimus therapy in patients with lymphangioleiomyomatosis and reduce the numbers of patients needed for clinical trials. PMID:24159565

Randomized Controlled Trial of Icodextrin versus Glucose Containing Peritoneal Dialysis Fluid

PubMed Central

Lin, Aiwu; Li, Xiaomei; Yu, Xueqing; Liu, Wenhu; Sun, Yang; Chen, Nan; Mei, Changlin

2009-01-01

Background and objectives: While peritoneal dialysis with icodextrin is commonly used in patients with poor peritoneal membrane characteristics, the data on the usefulness of this solution in patients with lower transport characteristics are limited. The study was designed to compare icodextrin to glucose in Chinese prevalent peritoneal dialysis patients of different peritoneal transport characteristics (PET) categories. Design, setting, participants, & measurements: This was a randomized, double-blind, perspective control study. Stable prevalent continuous ambulatory peritoneal dialysis (CAPD) patients were randomized to either 7.5% icodextrin (ICO) or 2.5% glucose (GLU) solution for 4 wk. Peritoneal membrane function was measured to define PET category in baseline. Creatinine clearance (Ccr), urea nitrogen clearance (CBUN), ultrafiltration (UF) during the long night dwell, dialysate, and metabolic biomarkers were measured at baseline, 2, and 4 wk. UF, Ccr, and CBUN were compared among different PET categories. Results: A total of 201 CAPD patients were enrolled in the study. There were no baseline differences between the groups. Following 2 and 4 wk of therapy, Ccr, CBUN, and UF were all significantly higher in the ICO versus the GLU group. Additionally, switching to ICO resulted in a significant increase in UF in high, high-average, and low-average transporters as compared with baseline. The extent of increased UF was more obvious in higher transporters. Blood cholesterol level in the ICO group decreased significantly than that in the GLU group. Conclusion: Compared with glucose-based solution, 7.5% icodextrin significantly improved UF and small solute clearance, even in patients with low-average peritoneal transport. PMID:19808224

The effect of adjunctive chlorhexidine mouthrinse on GCF MMP-8 and TIMP-1 levels in gingivitis: a randomized placebo-controlled study.

PubMed

Türkoğlu, Oya; Becerik, Sema; Tervahartiala, Taina; Sorsa, Timo; Atilla, Gül; Emingil, Gülnur

2014-05-20

The aim of the present study was to evaluate the effect of adjunctive chlorhexidine (CHX) mouthrinse on gingival crevicular fluid (GCF) MMP-8 and TIMP-1 levels in plaque-associated gingivitis. A total of 50 gingivitis patients were included in the present study. In addition to daily plaque control, CHX group rinsed with CHX, while placebo group rinsed with placebo mouthrinse for 4 weeks. GCF samples were collected, and clinical parameters including plaque index, papillary bleeding index, calculus index and pocket depth were recorded at baseline and 4 weeks. GCF MMP-8 and TIMP-1 levels were determined by immunofluorometric assay (IFMA) and enzyme-linked immunosorbent assay (ELISA), respectively. In both groups, GCF MMP-8 levels of anterior and posterior sites at four weeks were not different from baseline (p > 0.05). There were no significant differences in GCF MMP-8 levels between the study groups at four weeks (p > 0.05). GCF TIMP-1 levels of anterior and posterior sites at four weeks were higher compared to baseline in both groups (p < 0.05). There was no significant difference in GCF TIMP level between the study groups at four weeks (p > 0.05). CHX usage had no significant effects on the GCF MMP-8 and TIMP-1 levels in plaque-associate gingivitis. However, daily plaque control resulted in the increase of GCF TIMP-1 levels regardless of CHX usage.

The effect of adjunctive chlorhexidine mouthrinse on GCF MMP-8 and TIMP-1 levels in gingivitis: a randomized placebo-controlled study

PubMed Central

2014-01-01

Background The aim of the present study was to evaluate the effect of adjunctive chlorhexidine (CHX) mouthrinse on gingival crevicular fluid (GCF) MMP-8 and TIMP-1 levels in plaque-associated gingivitis. Methods A total of 50 gingivitis patients were included in the present study. In addition to daily plaque control, CHX group rinsed with CHX, while placebo group rinsed with placebo mouthrinse for 4 weeks. GCF samples were collected, and clinical parameters including plaque index, papillary bleeding index, calculus index and pocket depth were recorded at baseline and 4 weeks. GCF MMP-8 and TIMP-1 levels were determined by immunofluorometric assay (IFMA) and enzyme-linked immunosorbent assay (ELISA), respectively. Results In both groups, GCF MMP-8 levels of anterior and posterior sites at four weeks were not different from baseline (p > 0.05). There were no significant differences in GCF MMP-8 levels between the study groups at four weeks (p > 0.05). GCF TIMP-1 levels of anterior and posterior sites at four weeks were higher compared to baseline in both groups (p < 0.05). There was no significant difference in GCF TIMP level between the study groups at four weeks (p > 0.05). Conclusions CHX usage had no significant effects on the GCF MMP-8 and TIMP-1 levels in plaque-associate gingivitis. However, daily plaque control resulted in the increase of GCF TIMP-1 levels regardless of CHX usage. PMID:24886536

The Effects of an Amino Acid Supplement on Glucose Homeostasis, Inflammatory Markers, and Incretins after Laparoscopic Gastric Bypass

PubMed Central

Breitman, Igal; Saraf, Neha; Kakade, Manasi; Yellumahanthi, Kishore; White, Merritt; Hackett, Jo Ann; Clements, Ronald H.

2011-01-01

Background Protein supplements are routinely used after a laparoscopic gastric bypass (LGB). The aim of this study is to evaluate the impact of an amino acid supplement on glucose homeostasis, hormonal and inflammatory markers after LGB. Methods 30 patients undergoing LGB were randomized to receive or not to receive 24g of an oral supplement containing a leucine metabolite, glutamine and arginine twice daily for 8 weeks. Changes in weight, BMI, ghrelin, GLP-1, GIP, glucose, insulin, C-peptide, insulin sensitivity, IL-6, CRP, leptin and IGF-1 were assessed preoperatively, 2 weeks and 8-weeks postoperatively. Results 30 patients (96.7% females, 46.9 ± 8.4 years, 113.4 ± 11.6 kg and BMI 43.3 ± 4.1 kg/m2) were randomized. The experimental (N=14) and control groups (N=16) were not significantly different at baseline. Weight and BMI were decreased significantly at two weeks and at eight weeks (p<0.0001 for each variable), but no statistical significance was observed between the two groups. Fasting glucose decreased significantly at 2 & 8 weeks as compared to base line (p<0.0001) with no difference between experimental and control groups (p=0.8), but insulin and calculated insulin sensitivity, that were similar at baseline, become significantly worse in the experimental group 8 weeks after surgery ( p=0.02 for insulin, p=0.04 for the homeostasis model assessment (HOMA) index). CRP, which was similar at baseline, was found to be significantly lower at 8 weeks in control vs. experimental group, (P=0.018). IL-6 decreased significantly from baseline at 2 weeks and rebounded at 8 weeks in both groups, there was a trend of higher IL-6 in the experimental group that becomes significant at 8 weeks (p=0.05). Leptin and IGF-1 levels decreased significantly from baseline at 2 & 8 weeks (p<0.0001) but there was no difference between the two groups. No significant change in GLP-1, ghrelin or GIP were noticed after 8 weeks. Conclusion An amino acid supplement had no effect on the early postoperative incretins following LGB. It may have a negative influence on glycemic control and degree of inflammation. Future studies are needed to clarify these effects. PMID:21463799

Impact of surgical ventricular reconstruction on sphericity index in patients with ischaemic cardiomyopathy: follow-up from the STICH trial.

PubMed

Choi, Jin-Oh; Daly, Richard C; Lin, Grace; Lahr, Brian D; Wiste, Heather J; Beaver, Thomas M; Iacovoni, Attilio; Malinowski, Marcin; Friedrich, Ivar; Rouleau, Jean L; Favaloro, Roberto R; Sopko, George; Lang, Irene M; White, Harvey D; Milano, Carmelo A; Jones, Robert H; Lee, Kerry L; Velazquez, Eric J; Oh, Jae K

2015-04-01

We sought to evaluate associations between baseline sphericity index (SI) and clinical outcome, and changes in SI after coronary artery bypass graft (CABG) surgery with or without surgical ventricular reconstruction (SVR) in ischaemic cardiomyopathy patients enrolled in the SVR study (Hypothesis 2) of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. Among 1000 patients in the STICH SVR study, we evaluated 546 patients (255 randomized to CABG alone and 291 to CABG + SVR) whose baseline SI values were available. SI was not significantly different between treatment groups at baseline. After 4 months, SI had increased in the CABG + SVR group, but was unchanged in the CABG alone group (0.69 ± 0.10 to 0.77 ± 0.12 vs. 0.67 ± 0.07 to 0.66 ± 0.09, respectively; P < 0.001). SI did not significantly change from 4 months to 2 years in either group. Although LV end-systolic volume and EF improved significantly more in the CABG + SVR group compared with CABG alone, the severity of mitral regurgitation significantly improved only in the CABG alone group, and the estimated LV filling pressure (E/A ratio) increased only in the CABG + SVR group. Higher baseline SI was associated with worse survival after surgery (hazard ratio 1.21, 95% confidence interval 1.02 - 1.43; P = 0.026). Survival was not significantly different by treatment strategy. Although SVR was designed to improve LV geometry, SI worsened after SVR despite improved LVEF and smaller LV volume. Survival was significantly better in patients with lower SI regardless of treatment strategy. © 2015 The Authors. European Journal of Heart Failure © 2015 European Society of Cardiology.

Effectiveness of a decision-training aid on referral prioritization capacity: a randomized controlled trial.

PubMed

Harries, Priscilla; Tomlinson, Christopher; Notley, Elizabeth; Davies, Miranda; Gilhooly, Kenneth

2012-01-01

In the community mental health field, occupational therapy students lack the capacity to prioritize referrals effectively. The purpose of this study was to test the effectiveness of a clinical decision-training aid on referral prioritization capacity. A double-blind, parallel-group, randomized controlled trial was conducted using a judgment analysis approach. Each participant used the World Wide Web to prioritize referral sets at baseline, immediate posttest, and 2-wk follow-up. The intervention group was provided with training after baseline testing; control group was purely given instructions to continue with the task. One hundred sixty-five students were randomly allocated to intervention (n = 87) or control (n = 81). Intervention. Written and graphical descriptions were given of an expert consensus standard explaining how referral information should be used to prioritize referrals. Participants' prioritization ratings were correlated with the experts' ratings of the same referrals at each stage of testing, as well as to examine the effect on mean group scores, regression weights, and the lens model indices. At baseline, no differences were found between control and intervention on rating capacity or demographic characteristics. Comparison of the difference in mean correlation baseline scores of the control and intervention group compared with immediate posttest showed a statistically significant result that was maintained at 2-wk follow-up. The effect size was classified as large. At immediate posttest and follow-up, the intervention group improved rating capacity, whereas the control group's capacity remained poor. The results of this study indicate that the decision-training aid has a positive effect on referral prioritization capacity. This freely available, Web-based decision-training aid will be a valuable adjunct to the education of these novice health professionals internationally.

Greater Trochanteric Pain Syndrome: Percutaneous Tendon Fenestration Versus Platelet-Rich Plasma Injection for Treatment of Gluteal Tendinosis.

PubMed

Jacobson, Jon A; Yablon, Corrie M; Henning, P Troy; Kazmers, Irene S; Urquhart, Andrew; Hallstrom, Brian; Bedi, Asheesh; Parameswaran, Aishwarya

2016-11-01

The purpose of this study was to compare ultrasound-guided percutaneous tendon fenestration to platelet-rich plasma (PRP) injection for treatment of greater trochanteric pain syndrome. After Institutional Review Board approval was obtained, patients with symptoms of greater trochanteric pain syndrome and ultrasound findings of gluteal tendinosis or a partial tear (<50% depth) were blinded and treated with ultrasound-guided fenestration or autologous PRP injection of the abnormal tendon. Pain scores were recorded at baseline, week 1, and week 2 after treatment. Retrospective clinic record review assessed patient symptoms. The study group consisted of 30 patients (24 female), of whom 50% were treated with fenestration and 50% were treated with PRP. The gluteus medius was treated in 73% and 67% in the fenestration and PRP groups, respectively. Tendinosis was present in all patients. In the fenestration group, mean pain scores were 32.4 at baseline, 16.8 at time point 1, and 15.2 at time point 2. In the PRP group, mean pain scores were 31.4 at baseline, 25.5 at time point 1, and 19.4 at time point 2. Retrospective follow-up showed significant pain score improvement from baseline to time points 1 and 2 (P< .0001) but no difference between treatment groups (P= .1623). There was 71% and 79% improvement at 92 days (mean) in the fenestration and PRP groups, respectively, with no significant difference between the treatments (P >.99). Our study shows that both ultrasound-guided tendon fenestration and PRP injection are effective for treatment of gluteal tendinosis, showing symptom improvement in both treatment groups. © 2016 by the American Institute of Ultrasound in Medicine.

The optimal frequency of aquatic physiotherapy for individuals with chronic musculoskeletal pain: a randomised controlled trial.

PubMed

Cuesta-Vargas, Antonio I; White, Melanie; González-Sánchez, Manuel; Kuisma, Raija

2015-01-01

To establish whether there was a difference in health-related quality of life (HRQoL) in people with chronic musculoskeletal disorders (PwCMSKD) after participating in a multimodal physiotherapy program (MPP) either two or three sessions a week. Total of 114 PwCMSKD participated in this prospective randomised controlled trial. An individualised MPP, consisting of exercises for mobility, motor-control, muscle strengthening, cardiovascular training, and health education, was implemented either twice a week (G2: n = 58) or three times a week) (G3: n = 56) for 1 year. HRQoL physical and mental health state (PHS/MHS), Roland Morris disability Questionnaire (RMQ), Neck-Disability-Index (NDI) and Western Ontario and McMaster Universities' Arthritis Index (WOMAC) were used to measure outcomes of MPP for people with chronic low back pain, chronic neck pain and osteoarthritis, respectively. Measures were taken at baseline, 8 weeks (8 w), 6 months (6 m), and 1 year (1 y) after starting the programme. No statistically significant differences were found between the two groups (G2 and G3), except in NDI at 8 w (-3.34, (CI 95%: -6.94/0.84, p = 0.025 (scale 0-50)). All variables showed improvement reaching the following values (from baseline to 1 y) G2: PHS: 57.72 (baseline: 41.17; (improvement: 16.55%), MHS: 74.51 (baseline: 47.46, 27.05%), HRQoL 0.90 (baseline: 0.72, 18%)), HRQoL-VAS 84.29 (baseline: 58.04, 26.25%), RMQ 4.15 (baseline: 7.85, 15.42%), NDI 3.96 (baseline: 21.87, 35.82%), WOMAC 7.17 (baseline: 25.51, 19.10%). G3: PHS: 58.64 (baseline: 39.75, 18.89%), MHS: 75.50 (baseline: 45.45, (30.05%), HRQoL 0.67 (baseline: 0.88, 21%), HRQoL-VAS 86.91 (baseline: 52.64, 34.27%), RMQ 4.83 (baseline: 8.93, 17.08%), NDI 4.91 (baseline: 23.82, 37.82%), WOMAC 6.35 (baseline: 15.30, 9.32%). No significant differences between the two groups were found in the outcomes of a MPP except in the NDI at 8 weeks, but both groups improved in all variables during the course of 1 year under study. Implications for Rehabilitation A multimodal physiotherapy program (MPP) improves quality of life, overall health, and function in people with chronic musculoskeletal disease after an intervention of short, medium and long term. This implies that twice a week MPP for people with chronic musculoskeletal pain has comparable results to three times a week provision and therefore may have implications in saving resources and cost for patients and service providers without compromising the outcomes of treatment. These results can be considered not only for therapists, but also for managers who offer the services to optimise the balance cost-effectiveness of the proposed interventions.

Habitat quality affects stress responses and survival in a bird wintering under extremely low ambient temperatures

NASA Astrophysics Data System (ADS)

Cīrule, Dina; Krama, Tatjana; Krams, Ronalds; Elferts, Didzis; Kaasik, Ants; Rantala, Markus J.; Mierauskas, Pranas; Luoto, Severi; Krams, Indrikis A.

2017-12-01

Animals normally respond to stressful environmental stimuli by releasing glucocorticoid hormones. We investigated whether baseline corticosterone (CORT), handling-induced corticosterone concentration(s), and body condition indices of members of willow tit ( Poecile montanus) groups differed while wintering in old growth forests and managed young forests in mild weather conditions and during cold spells. Willow tits spend the winter season in non-kin groups in which dominant individuals typically claim their priority to access resources, while subordinate individuals may experience greater levels of stress and higher mortality, especially during cold spells. We captured birds to measure baseline CORT and levels of handling-induced CORT secretion after 20 min of capture. Willow tits in the young forests had higher baseline CORT and a smaller increase in CORT in response to capture than individuals in the old forests. Baseline CORT was higher in females and juvenile birds compared to adult males, whereas handling-induced CORT secretion did not differ between birds of different ages. During cold spells, baseline CORT of willow tits increased and handling-induced CORT secretion decreased, especially in birds in young forests. Willow tits' survival was higher in the old forests, with dominant individuals surviving better than subordinates. Our results show that changes in CORT secretion reflect responses to habitat quality and climate harshness, indicating young managed coniferous forests as a suboptimal habitat for the willow tit.

Racial and Ethnic Differences in Longitudinal Patterns of Family Mealtimes: Link to Adolescent Fruit and Vegetable Consumption.

PubMed

Surjadi, Florensia F; Takeuchi, David T; Umoren, Josephine

2017-03-01

To examine the longitudinal patterns of family mealtimes across racial/ethnic groups and to investigate whether the associations between longitudinal patterns of family mealtimes, baseline family and demographic characteristics, and healthy food consumption in adolescence differ by race/ethnicity. Data from the Early Childhood Longitudinal Study spanning from kindergarten to eighth grade were used for this study. Longitudinal patterns of family mealtimes and their link to baseline characteristics and healthy food consumption in adolescence, as defined by fruit and vegetable intakes, were determined using latent growth curves. From childhood to adolescence, family mealtimes were stable among Asian families. Although Hispanic families displayed a downward pattern, mealtimes declined more steeply in non-Hispanic white and black families. The links among family mealtimes, baseline characteristics, and healthy food consumption were not observed equally across racial/ethnic groups. Differences in longitudinal patterns of family mealtimes and in the association between family mealtimes and adolescent healthy food consumption across racial/ethnic groups call for targeted intervention in this nutritionally vulnerable period. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Twelve years evolution of skin as seen by electrical impedance

NASA Astrophysics Data System (ADS)

Nicander, Ingrid; Emtestam, Lennart; Åberg, Peter; Ollmar, Stig

2010-04-01

Twelve years ago we reported an electrical impedance baseline study related to age, sex and body locations. The results showed significant differences between different anatomical locations and ages. In this study, the same participants were recalled to explore how the skin had evolved at the individual level over time. A total of 50 subjects, divided into an older and a younger group, were recalled for measurements of electrical impedance at eight anatomical locations. Readings were taken with an electrical impedance spectrometer. Information was extracted from the impedance spectra using indices based on magnitude and phase at two frequencies as in the earlier study. All included body sites had undergone alterations over time, and the size of the changes varied at different locations. The results also showed that changes in the younger group were different over time compared with the older group. In conclusion: Electrical impedance can be used to monitor skin evolution over time and baseline characteristics differ between various locations.

Effects of kivia powder on Gut health in patients with occasional constipation: a randomized, double-blind, placebo-controlled study

PubMed Central

2013-01-01

Objective To evaluate the efficacy of Kivia powder on supporting overall gut health through the relief of the discomfort of occasional constipation. Design Randomized, double-blind, placebo-controlled, parallel-group trial. Interventions The investigational product for this study was Kivia powder (Vital Food Processors Ltd., Auckland, New Zealand), containing the active ingredient Zyactinase™, 5.5 g taken daily for four weeks. Results One hundred thirty-eight subjects reporting occasional constipation were screened and 87 were randomized to placebo (n = 44) and product (n = 43). Bowel movement frequency, as measured by both average daily spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM), were the same in both groups at baseline. There were significant increases in spontaneous bowel movements at week 1 (p = 0.001), week 2 (p = 0.001), week 3 (p = 0.000), and week 4 (p = 0.000) compared to baseline. SBM demonstrated significant differences between the treatment group and the placebo group at week 3 (p = 0.000), and week 4 (p = 0.020). The treatment group demonstrated a significantly higher rate of SBM at week 3 (p = 000) and from baseline to week 4 (p = 0.019). Significant increases in complete spontaneous bowel movements were observed at week 1 (p = 0.000), week 2 (p = 0.000), week 3 (p = 0.000), and week 4 (p = 0.000) compared to baseline. Moreover, CSBM was significantly higher for the treatment group compared to placebo at week 2 (p = 0.001). The change in average daily CSBM from baseline to week 2 was significantly higher in the treatment group than in the placebo group (p = 0.004). Abdominal discomfort or pain demonstrated significant differences between groups at week 1 (p = 0.044) and week 3 (p = 0.026). Flatulence was significantly lower for active group compared to placebo at week 2 (p = 0.047) and week 3 (p = 0.023). The number of bowel movements associated with urgency was significantly lower in the treatment group compared to the placebo group at week 3 (p = 0.048). In addition, it was decreased from baseline to week 1 (p = 0.040) and from baseline to week 3 (p = 0.024) in the treatment group, while the placebo group did not report any reductions in bowel urgency. Bowel movements in the treatment arm were significantly smoother and softer by week 2 (p = 0.020) and week 3 (p = 0.041). Conclusions Treatment with Kivia powder, an extract of kiwifruit containing Zyactinase™, for four weeks was well tolerated and more effective than placebo in gently enhancing bowel movement frequency and reducing abdominal pain and flatulence in subjects with occasional constipation. Trial registration ISRCTN: ISRCTN49036618 PMID:23758673

Preoperative carbohydrate loading in patients undergoing coronary artery bypass or spinal surgery.

PubMed

Tran, Susan; Wolever, Thomas M S; Errett, Lee E; Ahn, Henry; Mazer, C David; Keith, Mary

2013-08-01

Surgical stress creates a state of insulin resistance which may contribute to the development of hyperglycemia and, subsequently, postoperative complications. Consumption of an oral carbohydrate supplement before surgery may improve insulin sensitivity and reduce hyperglycemia. In this trial, we investigated the effects of carbohydrate supplementation on insulin resistance in coronary artery bypass graft and spinal decompression and fusion surgical patients. Twenty-six patients undergoing coronary artery bypass graft and 12 undergoing spine surgery were randomized to receive 800 mL of an oral carbohydrate supplement the evening before and 400 mL 2 hours before surgery (CHO) or to fasting per standard hospital protocol (FAST). Baseline and postoperative measurements of insulin sensitivity were assessed using the short insulin tolerance test and homeostasis model assessment (HOMA). Interleukin-6, C-reactive protein, and free fatty acid levels were determined at baseline, postoperatively, and 24, 48, and 72 hours after surgery. Adiponectin was measured at baseline. Subjective feelings of well-being were measured immediately before surgery, and intra- and postoperative outcomes were documented. Postoperative insulin sensitivity did not differ significantly between the FAST and CHO groups whether measured by the short insulin tolerance test (rate of disappearance of blood glucose: 0.29%/min vs 0.38%/min; 99% confidence interval [CI] for difference, -0.17 to 0.32, P = 0.41) or HOMA (insulin resistance at values >1: 2.3 vs 3.3; 99% CI for difference, -0.8 to 2.8, P = 0.14). Circulating blood glucose levels after surgery in the CHO group, 6.2 mmol/L, tended to be lower than the FAST group, 6.9 mmol/L (99% CI for difference, -1.7 to 0.25, P = 0.05) and postoperative β-cell function, measured by HOMA-β (impaired β-cell function at values <100%), tended to be higher in the CHO group, 87%, vs 47.5% in the FAST group (99% CI for difference, -9.4 to 88.4), but these differences were not significant. Adiponectin levels were not different between groups at baseline, and levels of free fatty acid, interleukin-6 and C-reactive protein were not affected by treatment. Preoperative carbohydrate loading did not improve postoperative insulin sensitivity. However, the observed postoperative blood glucose levels and β-cell function as well as secondary outcomes warrant further study to reevaluate traditional fasting practices in surgical patients.

Safety of intracameral injection of gatifloxacin, levofloxacin on corneal endothelial structure and viability.

PubMed

Choi, Jin A; Chung, Sung Kun

2009-10-01

To investigate the safety of intracameral injection of gatifloxacin, levofloxacin in a rabbit model as prophylaxis against endophthalmitis. Twenty-four eyes of New Zealand white rabbits were randomly divided into 3 treatment groups: levofloxacin, gatifloxacin, and balanced salt solution (BSS) control groups. After 100 microL of each was injected into the anterior chamber, endothelial toxicity was evaluated by measuring the central corneal thicknesses and the clinical toxicity scores using a slit-lamp at post-procedure days 3 and 7. The percent of dead cells was determined by vital staining with alizarin red and trypan blue at 7 days after injection. Finally, in each group, scanning electron microscopy (SEM) and transmission electron microscopy (TEM) were performed for the evaluation of structural integrity. The toxicity scores were increased at post-procedure days 3 and 7, but the difference among the groups was not statistically significant (P = 0.661, 0.216, respectively). With regard to baseline corneal thickness, only the levofloxacin group exhibited a significant increase from baseline (P = 0.028), whereas the other treatment groups showed no difference from baseline (P = 0.128 in gatifloxacin, 0.161 in BSS group). The mean corneal endothelial damage was 0.81 +/- 0.31% in the levofloxacin group, 0.56 +/- 0.47% in the gatifloxacin group, and 0.53 +/- 0.52% in the BSS group, with no statistically significant difference noted among the groups (P = 0.582). SEM revealed a well-preserved hexagonal endothelial cell mosaic and normal microvilli on the endothelial cell surface in the gatifloxacin and control groups. However, the levofloxacin group showed slightly disintegrated cellular borders. TEM revealed that each group maintained normal intracellular organization, whereas the levofloxacin group exhibited slightly flat cell configuration with irregular folds on the apical cell surface. Intracameral injection of gatifloxacin and levofloxacin was nontoxic in terms of clinical toxicity score, corneal thickness, and viability. However, there were changes on electron microscopy in the levofloxacin group, which may indicate microstructural damage to corneal endothelial cells.

Predicting the Trajectories of Perceived Pain Intensity in Southern Community-Dwelling Older Adults: The Role of Religiousness

PubMed Central

Sun, Fei; Park, Nan Sook; Wardian, Jana; Lee, Beom S.; Roff, Lucinda L.; Klemmack, David L.; Parker, Michael W.; Koenig, Harold G.; Sawyer, Patricia L.; Allman, Richard M.

2013-01-01

This study focuses on the identification of multiple latent trajectories of pain intensity, and it examines how religiousness is related to different classes of pain trajectory. Participants were 720 community-dwelling older adults who were interviewed at four time points over a 3-year period. Overall, intensity of pain decreased over 3 years. Analysis using latent growth mixture modeling (GMM) identified three classes of pain: (1) increasing (n = 47); (2) consistently unchanging (n = 292); and (3) decreasing (n = 381). Higher levels of intrinsic religiousness (IR) at baseline were associated with higher levels of pain at baseline, although it attenuated the slope of pain trajectories in the increasing pain group. Higher service attendance at baseline was associated with a higher probability of being in the decreasing pain group. The increasing pain group and the consistently unchanging group reported more negative physical and mental health outcomes than the decreasing pain group. PMID:24187410

Electroconvulsive therapy and age: Age-related clinical features and effectiveness in treatment resistant major depressive episode.

PubMed

Socci, Chiara; Medda, Pierpaolo; Toni, Cristina; Lattanzi, Lorenzo; Tripodi, Beniamino; Vannucchi, Giulia; Perugi, Giulio

2018-02-01

This study was aimed to compare clinical features, treatments outcomes and tolerability between young (18-45 years), middle age (46-64 years) and old (≥ 65 years) patients treated with bilateral ECT for treatment resistant major depressive episode. 402 patients were evaluated 1 day prior to ECT and a week after the treatment termination using the Clinical Global Impression Scale (CGI), the Hamilton Rating Scale for Depression-17 items (HAM-D-17), the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMRS) and the Mini Mental State Examination (MMSE). Response was defined as a reduction of at least 50% from baseline on the HAM-D-17 score. Remission was defined as a score ≤ 7 on the HAM-D-17 at the final evaluation. Rates of response were not statistically different in the three groups (69.6% in old versus 63.5% in young and 55.5% in middle age groups). No significant differences were also observed in the proportions of remitters between the age groups (31.4% in young group, 27.7% in middle age group and 29.3% in old group). One week after the end of the ECT course the middle and old age groups showed a statistically significant increase in the MMSE score compared to baseline. We did not find significant differences between the three age groups in rates of premature drops-out due to ECT-related side effects. Our data support the use of ECT in elderly patients with treatment-resistant major depressive episode, with rates of response around 70% and effectiveness being independent from age. In the old age group the baseline cognitive impairment improved after ECT and no life-threatening adverse event was detected. Copyright © 2017 Elsevier B.V. All rights reserved.

Hypotensive effects of hawthorn for patients with diabetes taking prescription drugs: a randomised controlled trial

PubMed Central

Walker, Ann F; Marakis, Georgios; Simpson, Eleanor; Hope, Jessica L; Robinson, Paul A; Hassanein, Mohamed; Simpson, Hugh CR

2006-01-01

Background Hawthorn (Crataegus laevigata) leaves, flowers and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs. Small-scale human studies support this approach. Aim To investigate the effects of hawthorn for hypertension in patients with type 2 diabetes taking prescribed drugs. Design of study Randomised controlled trial. Setting General practices in Reading, UK. Method Patients with type 2 diabetes (n = 79) were randomised to daily 1200 mg hawthorn extract (n = 39) or placebo (n = 40) for 16 weeks. At baseline and outcome a wellbeing questionnaire was completed and blood pressure and fasting blood samples taken. A food frequency questionnaire estimated nutrient intake. Results Hypotensive drugs were used by 71% of the study population with a mean intake of 4.4 hypoglycaemic and/or hypotensive drugs. Fat intake was lower and sugar intake higher than recommendations, and low micronutrient intake was prevalent. There was a significant group difference in mean diastolic blood pressure reductions (P = 0.035): the hawthorn group showed greater reductions (baseline: 85.6 mmHg, 95% confidence interval [CI] = 83.3 to 87.8; outcome: 83.0 mmHg, 95% CI = 80.5 to 85.7) than the placebo group (baseline: 84.5 mmHg, 95% CI = 82 to 87; outcome: 85.0 mmHg, 95% CI = 82.2 to 87.8). There was no group difference in systolic blood pressure reduction from baseline (3.6 and 0.8 mmHg for hawthorn and placebo groups, respectively; P = 0.329). Although mean fat intake met current recommendations, mean sugar intake was higher and there were indications of potential multiple micronutrient deficiencies. No herb–drug interaction was found and minor health complaints were reduced from baseline in both groups. Conclusions This is the first randomised controlled trial to demonstrate a hypotensive effect of hawthorn in patients with diabetes taking medication. PMID:16762125

Hypotensive effects of hawthorn for patients with diabetes taking prescription drugs: a randomised controlled trial.

PubMed

Walker, Ann F; Marakis, Georgios; Simpson, Eleanor; Hope, Jessica L; Robinson, Paul A; Hassanein, Mohamed; Simpson, Hugh C R

2006-06-01

Hawthorn (Crataegus laevigata) leaves, flowers and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs. Small-scale human studies support this approach. To investigate the effects of hawthorn for hypertension in patients with type 2 diabetes taking prescribed drugs. Randomised controlled trial. General practices in Reading, UK. Patients with type 2 diabetes (n = 79) were randomised to daily 1200 mg hawthorn extract (n = 39) or placebo (n = 40) for 16 weeks. At baseline and outcome a wellbeing questionnaire was completed and blood pressure and fasting blood samples taken. A food frequency questionnaire estimated nutrient intake. Hypotensive drugs were used by 71% of the study population with a mean intake of 4.4 hypoglycaemic and/or hypotensive drugs. Fat intake was lower and sugar intake higher than recommendations, and low micronutrient intake was prevalent. There was a significant group difference in mean diastolic blood pressure reductions (P = 0.035): the hawthorn group showed greater reductions (baseline: 85.6 mmHg, 95% confidence interval [CI] = 83.3 to 87.8; outcome: 83.0 mmHg, 95% CI = 80.5 to 85.7) than the placebo group (baseline: 84.5 mmHg, 95% CI = 82 to 87; outcome: 85.0 mmHg, 95% CI = 82.2 to 87.8). There was no group difference in systolic blood pressure reduction from baseline (3.6 and 0.8 mmHg for hawthorn and placebo groups, respectively; P = 0.329). Although mean fat intake met current recommendations, mean sugar intake was higher and there were indications of potential multiple micronutrient deficiencies. No herb-drug interaction was found and minor health complaints were reduced from baseline in both groups. This is the first randomised controlled trial to demonstrate a hypotensive effect of hawthorn in patients with diabetes taking medication.

The Effect of New Shower Facilities on Physical Activity Behaviors of Employees: A Quasi-experiment.

PubMed

Nehme, Eileen K; Pérez, Adriana; Ranjit, Nalini; Amick, Benjamin C; Kohl, Harold W

2017-02-01

This quasi-experimental study assessed the effects of new workplace showers on physical activity behaviors in a sample of downtown employees in Austin, TX. The study design was quasi-experimental with 2 comparison groups. Data were collected via internet-based surveys before and 4 months after shower installation at 1 worksite. Differences across study groups in the ranks of change in past-week minutes of physical activity from baseline to follow-up were assessed. Adjusted odds ratios and 95% confidence intervals for reporting an increase of ≥10 min past-week physical activity and workday physical activity among those with new showers and existing showers relative to those with no showers were also assessed. No significant differences in changes in physical activity from baseline to follow-up across study groups were found. One-quarter of participants with new workplace showers and 46.9% of those with existing workplace showers at baseline reported ever using the showers. This prospective study did not find significant changes in employee physical activity 4 months after installation of worksite showers. Worksite shower users were highly active at baseline, suggesting a possible early adopter effect, with potential for diffusion. Future studies may benefit from longer exposure times and larger samples.

Baseline Telomere Length and Effects of a Multidomain Lifestyle Intervention on Cognition: The FINGER Randomized Controlled Trial

PubMed Central

Sindi, Shireen; Ngandu, Tiia; Hovatta, Iiris; Kåreholt, Ingemar; Antikainen, Riitta; Hänninen, Tuomo; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Paajanen, Teemu; Peltonen, Markku; Khalsa, Dharma Singh; Wolozin, Benjamin; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia; Solomon, Alina

2017-01-01

Leukocyte telomere length (LTL) is a biomarker of aging, and it is associated with lifestyle. It is currently unknown whether LTL is associated with the response to lifestyle interventions. The goal is to assess whether baseline LTL modified the cognitive benefits of a 2-year multidomain lifestyle intervention (exploratory analyses). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was a 2-year randomized controlled trial including 1,260 people at risk of cognitive decline, aged 60–77 years identified from the general population. Participants were randomly assigned to the lifestyle intervention (diet, exercise, cognitive training, and vascular risk management) and control (general health advice) groups. Primary outcome was change in cognition (comprehensive neuropsychological test battery). Secondary outcomes were changes in cognitive domains: memory, executive functioning, and processing speed. 775 participants (392 control, 383 intervention) had baseline LTL (peripheral blood DNA). Mixed effects regression models with maximum likelihood estimation were used to analyze change in cognition as a function of randomization group, time, baseline LTL, and their interaction. Intervention and control groups did not significantly differ at baseline. Shorter LTL was related to less healthy baseline lifestyle. Intervention benefits on executive functioning were more pronounced among those with shorter baseline LTL (p-value for interaction was 0.010 adjusted for age and sex, and 0.007 additionally adjusted for baseline lifestyle factors). The FINGER intervention cognitive benefits were more pronounced with shorter baseline LTL, particularly for executive functioning, indicating that the multidomain lifestyle intervention was especially beneficial among higher-risk individuals. PMID:28777749

Baseline Telomere Length and Effects of a Multidomain Lifestyle Intervention on Cognition: The FINGER Randomized Controlled Trial.

PubMed

Sindi, Shireen; Ngandu, Tiia; Hovatta, Iiris; Kåreholt, Ingemar; Antikainen, Riitta; Hänninen, Tuomo; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Paajanen, Teemu; Peltonen, Markku; Khalsa, Dharma Singh; Wolozin, Benjamin; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia; Solomon, Alina

2017-01-01

Leukocyte telomere length (LTL) is a biomarker of aging, and it is associated with lifestyle. It is currently unknown whether LTL is associated with the response to lifestyle interventions. The goal is to assess whether baseline LTL modified the cognitive benefits of a 2-year multidomain lifestyle intervention (exploratory analyses). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was a 2-year randomized controlled trial including 1,260 people at risk of cognitive decline, aged 60-77 years identified from the general population. Participants were randomly assigned to the lifestyle intervention (diet, exercise, cognitive training, and vascular risk management) and control (general health advice) groups. Primary outcome was change in cognition (comprehensive neuropsychological test battery). Secondary outcomes were changes in cognitive domains: memory, executive functioning, and processing speed. 775 participants (392 control, 383 intervention) had baseline LTL (peripheral blood DNA). Mixed effects regression models with maximum likelihood estimation were used to analyze change in cognition as a function of randomization group, time, baseline LTL, and their interaction. Intervention and control groups did not significantly differ at baseline. Shorter LTL was related to less healthy baseline lifestyle. Intervention benefits on executive functioning were more pronounced among those with shorter baseline LTL (p-value for interaction was 0.010 adjusted for age and sex, and 0.007 additionally adjusted for baseline lifestyle factors). The FINGER intervention cognitive benefits were more pronounced with shorter baseline LTL, particularly for executive functioning, indicating that the multidomain lifestyle intervention was especially beneficial among higher-risk individuals.

Does disease activity at start of biologic therapy influence work-loss in RA patients?

PubMed

Olofsson, Tor; Johansson, Kari; Eriksson, Jonas K; van Vollenhoven, Ronald; Miller, Heather; Petersson, Ingemar F; Askling, Johan; Neovius, Martin

2016-04-01

To compare work-loss in RA patients starting their first biologic with high vs moderate disease activity. We identified all RA patients aged 20-63 years in the Swedish Biologics Register who started their first biologic 2007-09 with high disease activity (DAS28 >5.1; n = 868) or moderate disease activity (DAS28 3.2-5.1; n = 854). Work days lost, defined as sick leave and disability pension days from the Swedish Social Insurance Agency, were assessed over 5 years after first bio-start. We estimated between-group mean differences adjusted for age, sex, calendar year, education level, disease duration, comorbidities and work-loss the month before bio-start. During 5 years after anti-TNF start, mean monthly work days lost declined from 16.0 to 9.2 (42%; P < 0.001) in patients with high disease activity at baseline and from 12.0 to 7.2 (40%; P < 0.001) in patients with moderate disease activity, with no between-group difference (adjusted mean difference 0.81; 95% CI - 0.44, 2.05). Accumulated 5-year work-loss was, however, higher in the high activity group (724 vs 548 days; adjusted mean difference 70; 95% CI 20, 120), but after stratification on baseline disability pension status, no differences in accumulated work-loss were detected. Substantial work-loss was seen in both patients with high and patients with moderate disease activity at anti-TNF start, with a 5-year decline in mean monthly work days lost by ∼40% in both groups and no between-group difference. Accumulated work-loss over 5 years was higher in the high-activity group, which may be explained by differences in baseline disability pension status. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Metabolic Syndrome Components and Their Response to Lifestyle and Metformin Interventions are Associated with Differences in Diabetes Risk in Persons with Impaired Glucose Tolerance

PubMed Central

Florez, Hermes; Temprosa, Marinella G; Orchard, Trevor J; Mather, Kieren J; Marcovina, Santica M; Barrett-Connor, Elizabeth; Horton, Edward; Saudek, Christopher; Pi-Sunyer, Xavier F; Ratner, Robert E; Goldberg, Ronald B

2013-01-01

Aims To determine the association of metabolic syndrome (MetS) and its components with diabetes risk in participants with impaired glucose tolerance (IGT), and whether intervention-related changes in MetS lead to differences in diabetes incidence. Methods We used the NCEP/ATP III revised MetS definition at baseline and intervention-related changes of its components to predict incident diabetes using Cox models in 3234 Diabetes Prevention Program (DPP) participants with IGT over an average follow-up of 3.2 years. Results In an intention-to-treat analysis, the demographic-adjusted hazard ratios (95%CI) for diabetes in those with MetS (versus no MetS) at baseline were 1.7(1.3-2.3), 1.7(1.2-2.3), and 2.0(1.3-3.0) for placebo, metformin, and lifestyle groups, respectively. Higher levels of fasting plasma glucose and triglycerides at baseline were independently associated with increased risk of diabetes. Greater waist circumference (WC) was associated with higher risk in placebo and lifestyle groups, but not in the metformin group. In a multivariate model, favorable changes in WC (placebo and lifestyle) and HDLc (placebo and metformin) contributed to reduced diabetes risk. Conclusions MetS and some of its components are associated with increased diabetes incidence in persons with IGT in a manner that differed according to DPP intervention. After hyperglycemia, the most predictive factors for diabetes were baseline hypertriglyceridemia and both baseline and lifestyle-associated changes in waist circumference. Targeting these cardio-metabolic risk factors may help to assess the benefits of interventions that reduce diabetes incidence. PMID:24118860

Randomised clinical trial: the efficacy of gut-directed hypnotherapy is similar to that of the low FODMAP diet for the treatment of irritable bowel syndrome.

PubMed

Peters, S L; Yao, C K; Philpott, H; Yelland, G W; Muir, J G; Gibson, P R

2016-09-01

A low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet is effective in treating irritable bowel syndrome (IBS). To compare the effects of gut-directed hypnotherapy to the low FODMAP diet on gastrointestinal symptoms and psychological indices, and assess additive effects. Irritable bowel syndrome patients were randomised (computer-generated list), to receive hypnotherapy, diet or a combination. Primary end-point: change in overall gastrointestinal symptoms across the three groups from baseline to week 6. Secondary end-points: changes in psychological indices, and the durability of effects over 6 months. Of 74 participants, 25 received hypnotherapy, 24 diet and 25 combination. There were no demographic differences at baseline across groups. Improvements in overall symptoms were observed from baseline to week 6 for hypnotherapy [mean difference (95% CI): -33 (-41 to -25)], diet [-30 (-42 to -19)] and combination [-36 (-45 to -27)] with no difference across groups (P = 0.67). This represented ≥20 mm improvement on visual analogue scale in 72%, 71% and 72%, respectively. This improvement relative to baseline symptoms was maintained 6 months post-treatment in 74%, 82% and 54%. Individual gastrointestinal symptoms similarly improved. Hypnotherapy resulted in superior improvements on psychological indices with mean change from baseline to 6 months in State Trait Personality Inventory trait anxiety of -4(95% CI -6 to -2) P < 0.0001; -1(-3 to 0.3) P = ns; and 0.3(-2 to 2) P = ns, and in trait depression of -3(-5 to -0.7) P = 0.011; -0.8(-2 to 0.2) P = ns; and 0.6(-2 to 3) P = ns, respectively. Groups improved similarly for QOL (all p ≤ 0.001). Durable effects of gut-directed hypnotherapy are similar to those of the low FODMAP diet for relief of gastrointestinal symptoms. Hypnotherapy has superior efficacy to the diet on psychological indices. No additive effects were observed. © 2016 John Wiley & Sons Ltd.

Adipokines, insulin resistance and hyperandrogenemia in obese patients with polycystic ovary syndrome: cross-sectional correlations and the effects of weight loss.

PubMed

Spanos, Nikolaos; Tziomalos, Konstantinos; Macut, Djuro; Koiou, Ekaterini; Kandaraki, Eleni A; Delkos, Dimitrios; Tsourdi, Elena; Panidis, Dimitrios

2012-01-01

To assess the effects of weight loss on serum adipokine levels in polycystic ovary syndrome (PCOS). We determined serum leptin, adiponectin, resistin, and visfatin levels in 60 overweight/obese women with PCOS and 48 BMI-matched female volunteers. Measurements were repeated after 24 weeks of treatment with orlistat 120 mg 3 times per day along with an energy-restricted diet. At baseline, serum visfatin concentration was higher in patients with PCOS than in controls (p = 0.036); serum levels of leptin, adiponectin, and resistin did not differ between the two groups. After 24 weeks, a significant reduction in BMI and waist circumference was observed in both patients with PCOS and controls (p < 0.001 vs. baseline in both groups). Also serum leptin levels decreased in both patients with PCOS and controls (p < 0.001 vs. baseline in both groups). The reduction in serum leptin levels did not differ between groups. Serum adiponectin, resistin, and visfatin levels did not change in either group. Leptin, adiponectin, and resistin do not appear to play major pathogenetic roles in overweight/obese patients with PCOS. In contrast, visfatin emerges as a potentially important mediator of the endocrine abnormalities of these patients. However, serum visfatin levels are not substantially affected by weight loss.

Nutritional Recovery after Open and Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Prospective Multicenter Comparative Trial (CCOG1204).

PubMed

Matsushita, Hidenobu; Tanaka, Chie; Murotani, Kenta; Misawa, Kazunari; Ito, Seiji; Ito, Yuichi; Kanda, Mitsuro; Mochizuki, Yoshinari; Ishigure, Kiyoshi; Yaguchi, Toyohisa; Teramoto, Jin; Nakayama, Hiroshi; Kawase, Yoshihisa; Fujiwara, Michitaka; Kodera, Yasuhiro

2018-01-01

Little information from prospective clinical trials is available on the influences of surgical approaches on postoperative body compositions and nutritional status. We designed a prospective non-randomized trial to compare postoperative chronological changes in body composition and nutritional status between laparoscopic and open distal gastrectomy for stage I gastric cancer (GC). Body compositions and nutritional indicators in blood tests were measured at the baseline and at the 1st, 3rd, 6th, and 12th postoperative months (POM). The primary end point was the decrease relative to the baseline in the body muscle mass at POM 6. Ninety-six patients for the laparoscopic group and 52 for the open group were eligible for data analysis. No significant differences were found in any baseline demographics, body compositions, and nutritional indicators between the groups. The changes of body muscle mass at POM 6 were similar in both groups. Overall, no significant differences between the groups were observed in any of the body composition and nutritional indicators during the first year after surgery. Postoperative body compositions and nutritional status were not affected by surgical approaches during the first 12 months after surgery in patients who underwent distal gastrectomy for stage I GC. © 2017 S. Karger AG, Basel.

Effect of home exercise of quadriceps on knee osteoarthritis compared with nonsteroidal antiinflammatory drugs: a randomized controlled trial.

PubMed

Doi, Tokuhide; Akai, Masami; Fujino, Keiji; Iwaya, Tsutomu; Kurosawa, Hisashi; Hayashi, Kunihiko; Marui, Eiji

2008-04-01

To examine the effect of home-based exercise on knee osteoarthritis among Japanese in comparison with that of nonsteroidal antiinflammatory drugs (NSAIDs). An open-labeled, randomized, controlled, multiclinic trial compared home-based quadriceps exercise with NSAIDs. Treatments were basically evaluated after 8 wks and compared with the baseline scores. Outcomes were evaluated with a set of psychometric measurements including the Western Ontario and McMaster Universities Arthritis Index (WOMAC), 36-Item Short-Form Health Survey (SF-36), Japanese Knee Osteoarthritis Measure (JKOM), and pain with the visual analog scale. A total of 142 patients entered this trial to provide the baseline data. After 21 cases withdrew, the final number analyzed was 121 cases: 63 for the exercise group and 58 for the NSAIDs group. Between these two groups, there was no significant difference in gender, age, body height and weight, body mass index, or each score at baseline. The subjects in both groups showed improvements in all scores at the end of intervention. The difference in improvement rate of each score between the two groups was not statistically significant, though the mean rank score measured with JKOM in the exercise was slightly better than that of the NSAIDs. Home-based exercise using quadriceps strengthening improves knee osteoarthritis no less than NSAIDs.

[A preliminary study on the color effect of IPS Empress all-ceramic veneers].

PubMed

Li, Zhi-yong; Cheng, Xiang-rong; Wang, Yi-ning

2004-09-01

To evaluate the opaquing capacity, color compatibility and stability of IPS Empress all-ceramic veneers. A total of 86 IPS Empress all-ceramic veneers were made for 18 patients. The patients were divided into three groups: Group A was tetracycline teeth, 64 veneers for 5 patients; Group B was non-tetracycline teeth, 22 veneers for 13 patients; Group C was 22 natural vital teeth with normal color as control group. Before and after veneers were inserted, ShadeEye NCC was employed to obtain L * a * b * values of each tooth. The values of cemented veneers used as the baseline, the L * a * b * values of each veneer were measured half a year, 1 year, and 2 years after restoration respectively. All L * a * b * values at different evaluation times were analyzed by SPSS 10.0. Before and after veneers were restored, the L * a * b * values of both Group A and Group B were significantly different, the color difference being 5.01 and 4.15 respectively. The color difference between Group A and selected shade guides was 2.45. Compared with the baseline value, the L * value of Group A significantly decreased 2 years after restoration, but the DeltaE of different evaluation times was not significantly different. The color difference between Group B and Group C was 0.22 and there was no significant color difference after restoration. IPS Empress all-ceramic veneers have excellent opaquing capacity, color compatibility and stability to non-tetracycline teeth. To tetracycline teeth IPS Empress all-ceramic veneers have a certain opaquing capacity, but they cannot completely match with shade guides; the L * value is significantly different after restoration and further studies are needed to evaluate its color effect.

Combined Racial and Gender Differences in the Long-Term Predictive Role of Education on Depressive Symptoms and Chronic Medical Conditions.

PubMed

Assari, Shervin

2017-06-01

Despite a well-established literature on the protective effect of education on health, less is known about group differences in the mechanisms underlying this association. Using a life course approach and cumulative advantage theory, this study compared Black men, Black women, White men, and White women to assess the long-term gradient (education as a continuous measure) and threshold (>12 years) effects of baseline education on change in chronic medical conditions (CMC) and depressive symptoms (DS) from baseline to 25 years later. Data came from the Americans' Changing Lives Study, 1986-2011. The study followed Black and White respondents for up to 25 years, among whom 1271 individuals who had survived and were under follow-up were interviewed in 2011 and reported their number of chronic medical conditions and depressive symptoms (Center for Epidemiological Studies-Depression; CES-D 11). Multi-group structural equation modeling was used to compare gradient and threshold effects of education on change in chronic medical conditions and depressive symptoms from baseline (1986) to 25 years later (2011) among Black men, Black women, White men, and White women. There were group differences in the long-term association between education measured as a gradient and the change in depressive symptoms and chronic medical conditions during the follow-up, and in the association between education measured at the threshold of 12 years on change in depressive symptoms from baseline to follow-up. However, the association between education measured at this threshold and change in chronic medical conditions did not differ across race-gender groups. With the exception of Black men, who showed a gradient protective effect for baseline education against increase in the number of chronic medical associations (threshold or gradient) with change in chronic medical conditions. Among White men and White women, education had a threshold protective effect against increase in depressive symptoms from baseline to 25 years later. Black men and women showed a gradient protective effect of baseline education against an increase in depressive symptoms over the 25-year follow-up period, but unexpectedly, a threshold effect of education was also found to be associated with an increase in depressive symptoms over the follow-up period among Black men. This finding suggests that although Black men benefit from each incremental increase in education, those who graduated from high school were at an additional risk of depressive symptoms over a 25-year period. Findings suggest that the intersection of race and gender influences how education is associated with long-term changes in physical and mental health of individuals from baseline to 25 years later. As the shape of the association between education and health depends on the intersection of race and gender, these groups may vary for operant mechanisms by which education operates as a main social determinant of health.

Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle Glaucoma and Ocular Hypertension.

PubMed

Suzuki, Katsuyoshi; Otsuka, Naomi; Hizaki, Hiroko; Hashimoto, Masayo; Kuwayama, Yasuaki

2018-06-05

This was the first exploratory randomized controlled study to compare the efficacy and safety of a preserved tafluprost/timolol fixed combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination (LAT/TIM). This prospective, randomized, open-label study was conducted in Japanese patients with primary open-angle glaucoma, including normal-tension glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, eligible patients entered a 12-week treatment period, during which they received either LAT/TIM or TAF/TIM. The efficacy endpoint was the change in intraocular pressure (IOP) from baseline to week 12 and the safety endpoints included the changes from baseline to week 12 in superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), and hyperemia score, as well as adverse events (AEs). At week 6, ocular symptoms were evaluated using a questionnaire. In total, 131 patients provided informed consent. Of these, 115 completed the run-in period and were assigned to receive TAF/TIM (n = 60) or LAT/TIM (n = 55). At week 12, there were no significant differences between the TAF/TIM and LAT/TIM groups in the change from baseline in trough IOP and IOP at 4-6 h after instillation. There were no significant differences between the two groups in the change from baseline to week 12 in SPK score, TBUT, and hyperemia score. However, only in the TAF/TIM group, the total SPK score and the inferior cornea SPK score were significantly lower at week 12 compared with baseline. Eye irritation and eye pain were significantly decreased in the TAF/TIM group compared with the LAT/TIM group. Two treatment-related AEs were reported in the TAF/TIM group (3.3%) and none in the LAT/TIM group, while no serious AEs were reported in either group. TAF/TIM is as effective as LAT/TIM in terms of IOP-reducing effect, with fewer ocular symptoms. TAF/TIM was associated with a significant improvement in SPK scores. UMIN Clinical Trials Registry Identifier, UMIN000023862. Santen Pharmaceutical Co., Ltd., Osaka, Japan.

Effects of ezetimibe added to statin therapy on markers of cholesterol absorption and synthesis and LDL-C lowering in hyperlipidemic patients

PubMed Central

Thongtang, Nuntakorn; Lin, Jianxin; Schaefer, Ernst J.; Lowe, Robert S.; Tomassini, Joanne E.; Shah, Arvind K.; Tershakovec, Andrew M.

2013-01-01

Objective Statins inhibit cholesterol synthesis but can upregulate cholesterol absorption, with higher doses producing larger effects. Ezetimibe inhibits cholesterol absorption but also upregulates synthesis. We tested whether ezetimibe added to ongoing statin therapy would be most effective in lowering LDL-cholesterol (LDL-C) in subjects on high-potency statins and whether these effects would be related to alterations in cholesterol absorption (β-sitosterol) and synthesis (lathosterol) markers. Methods Hypercholesterolemic subjects (n=874) on statins received ezetimibe 10 mg/day. Plasma lipids, lathosterol, and β-sitosterol were measured at baseline and on treatment. Subjects were divided into low- (n=133), medium- (n=582), and high- (n=159) statin potency groups defined by predicted LDL-C–lowering effects of each ongoing statin type and dose (reductions of ~20-30%, ~31-45%, or ~46-55%, respectively). Results The high-potency group had significantly lower baseline lathosterol (1.93 vs. 2.58 vs. 3.17 μmol/l; p <0.001) and higher baseline β-sitosterol values (6.21 vs. 4.58 vs. 4.51 μmol/l, p <0.001) than medium-/low-potency groups. Ezetimibe treatment in the high-potency group produced significantly greater reductions from baseline in LDL-C than medium-/low-potency groups (−29.1% vs. −25.0% vs. −22.7%; p <0.001) when evaluating unadjusted data. These effects and group differences were significantly (p <0.05) related to greater β-sitosterol reductions and smaller lathosterol increases. However, LDL-C reduction differences between groups were no longer significant after controlling for placebo effects, due mainly to modest LDL-C lowering by placebo in the high-potency group. Conclusion Patients on high-potency statins have the lowest levels of cholesterol synthesis markers and the highest levels of cholesterol absorption markers at baseline, and the greatest reduction in absorption markers and the smallest increases in synthesis markers with ezetimibe addition. Therefore, such patients may be good candidates for ezetimibe therapy if additional LDL-C lowering is needed. PMID:23040830

Relative peripheral refraction in children: twelve-month changes in eyes with different ametropias.

PubMed

Lee, Tsui-Tsui; Cho, Pauline

2013-05-01

To determine the peripheral refraction of children with different types of ametropias and to evaluate the relationship between central refractive changes, baseline relative peripheral refraction (RPR) and changes in RPR over a 12-month monitoring period. Cycloplegic central and peripheral refraction were performed biannually on the right eyes of children aged 6-9 for 12 months, using an open-view autorefractor. Peripheral refraction were measured along 10°, 20° and 30° from central fixation in both nasal and temporal fields. Refractive data were transposed into M, J0 and J45 vectors for analyses. RPR was determined by subtracting the central measurement from each peripheral measurement. Hyperopic eyes showed relative peripheral myopia while myopic eyes had relative hyperopia across the central 60° horizontal field at baseline. Emmetropic eyes had relative myopia within but showed relative hyperopia beyond the central 30° field. However, there was no significant correlation between central refractive changes and baseline RPR or between changes in central refraction and RPR over twelve months in any refractive groups. Correlations between changes in PR and central myopic shift were found mainly in the nasal field in different groups. In the subgroup analysis on the initially emmetropic and the initially myopic groups, the subgroups with faster myopic progression did not have significantly different RPR from the subgroups with slower progression. The RPR pattern of the initially emmetropic and the initially myopic groups became more asymmetric at the end of the study period with a larger increase in relative hyperopia in the temporal field. RPR patterns were different among hyperopic, emmetropic and myopic eyes. However, baseline RPR and changes in RPR cannot predict changes in central refraction over time. Our results did not provide evidence to support the hypothesis of RPR as a causative factor for myopic central refractive changes in children. Ophthalmic & Physiological Optics © 2013 The College of Optometrists.

Effects of uric acid on kidney function decline differ depending on baseline kidney function in type 2 diabetic patients.

PubMed

Hanai, Ko; Tauchi, Eriko; Nishiwaki, Yui; Mori, Tomomi; Yokoyama, Yoichi; Uchigata, Yasuko; Babazono, Tetsuya

2018-05-30

Most existing data regarding effects of uric acid (UA) on diabetic kidney disease have considered patients with preserved kidney function. We examined a hypothesis that there are differences in the effects of serum UA levels on the decline in kidney function depending on baseline kidney function in diabetic patients. In this historical cohort study, 7033 type 2 diabetic patients were analyzed and classified into two groups as follows: nonchronic kidney disease (non-CKD), with an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 (n = 4994), and CKD, with an eGFR <60 mL/min/1.73 m2 (n = 2039). The composite endpoint was a ≥30% decrease in eGFR from baseline or the initiation of renal replacement therapy. The hazard ratio (HR) of serum UA levels at baseline was estimated using multivariate Cox proportional hazards models. There was a significant interaction between UA levels and baseline eGFR with respect to the endpoint (P < 0.001). The HRs of 1 mg/dL increase in UA levels were 1.13 [95% confidence interval (CI) 1.05-1.22, P = 0.002] and 0.93 (95% CI 0.88-0.99, P = 0.02) in the non-CKD and CKD groups, respectively. When patients were classified by quintile of UA levels, the HRs of those in the 5th quintile (versus 1st quintile) were 1.64 (95% CI 1.23-2.18, P < 0.001) and 0.76 (95% CI 0.58-0.99, P = 0.05) in the non-CKD and CKD groups, respectively. The effects of UA on kidney function decline might differ depending on baseline kidney function in type 2 diabetic patients. High UA levels are the prognostic factor only in patients with preserved kidney function.

Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial

PubMed Central

Edinger, Jack D.; Kuchibhatla, Maragatha; Lachowski, Angela M.; Bogouslavsky, Olya; Krystal, Andrew D.; Shapiro, Colin M.

2017-01-01

Abstract Study Objective: To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. Design: A blinded, randomized split-plot experimental study. Setting: Two urban academic clinical centers. Participants: 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Interventions: Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Measurements and Results: Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Conclusions: Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH’s sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of CBT-I. PMID:28199710

The role of anxiety in cortisol stress response and cortisol recovery in boys with oppositional defiant disorder/conduct disorder.

PubMed

Schoorl, Jantiene; Rijn, Sophie van; Wied, Minet de; van Goozen, Stephanie; Swaab, Hanna

2016-11-01

Children with antisocial and aggressive behaviors have been found to show abnormal neurobiological responses to stress, specifically impaired cortisol stress reactivity. The role of individual characteristics, such as comorbid anxiety, in the stress response is far less studied. Furthermore, this study extended previous studies in that not only baseline and reactivity to a psychosocial stressor were examined, but also recovery from a stressor. These three phases of cortisol could be impacted differentially in boys with oppositional defiant disorder/conduct disorder (ODD/CD) with (+ANX) and without anxiety (-ANX). The results revealed that cortisol patterns in response to psychosocial stress were different for boys with ODD/CD+ANX (n=32), ODD/CD-ANX (n=22) and non-clinical controls (NC) (n=34), with age range of 7.8-12.9 years. The ODD/CD-ANX group showed lower overall cortisol levels than the NC group. When considering the three phases of cortisol separately, the ODD/CD-ANX group had lower baseline cortisol levels relative to the other groups, whereas the ODD/CD+ANX showed an impaired cortisol recovery response. Within those with ODD/CD, callous-unemotional traits were predictive of high baseline cortisol levels. Also, anxiety predicted high baseline and recovery cortisol levels, whereas a high number of CD symptoms predicted reduced cortisol stress reactivity. These results clearly indicate that comorbid anxiety is an important factor in explaining differences in stress response profiles in boys with ODD/CD; although boys with CD/ODD are generally characterized by an impaired cortisol stress response, we found that those with comorbid anxiety showed impaired cortisol recovery, whereas those without anxiety showed reduced baseline cortisol levels. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes

PubMed Central

Kaval, Başak; Renaud, Diane E.; Scott, David A.; Buduneli, Nurcan

2015-01-01

Background This study evaluates possible effects of smoking on the following: 1) biochemical content in gingival crevicular fluid (GCF) samples from sites of gingival recession and saliva; and 2) clinical outcomes of coronally advanced flap (CAF) for root coverage. Methods Eighteen defects in 15 patients were included in each of the smoker and non-smoker groups. Baseline cotinine, basic fibroblast growth factor, vascular endothelial growth factor, platelet-derived growth factor, interleukin (IL)-8, IL-10, IL-12, tumor necrosis factor-α, matrix metalloproteinase (MMP)-8, MMP-9, and plasminogen activator inhibitor-1 levels were determined in GCF and saliva samples. CAF with microsurgery technique was applied. Plaque index, papilla bleeding index, recession depth (RD), recession width (RW), and root surface area were evaluated at baseline and postoperative months 1, 3, and 6. Probing depth, clinical attachment level (CAL), and keratinized gingival width (KGW) was recorded at baseline and month 6. Percentage of root coverage and complete root coverage were calculated at postoperative months 1, 3, and 6. Results All biochemical parameters were similar in the two groups apart from the definite difference in salivary cotinine concentrations (P = 0.000). Compared with the baseline values, RD, RW, CAL, and root surface area decreased, and KGW increased, with no significant difference between the study groups. CAL gain, percentage of root coverage, and complete root-coverage rates were similar in the study groups. Conclusion Similar baseline biochemical data and comparably high success rates of root coverage with CAF in systemically and periodontally healthy smokers versus non-smokers suggest lack of adverse effects of smoking on clinical outcomes. PMID:23725027

Physiotherapy program through home visits for community-dwelling elderly Japanese women with mild knee pain.

PubMed

Konishi, Isamu; Tanabe, Naohito; Seki, Nao; Suzuki, Hiroshi; Okamura, Taro; Shinoda, Kunihiko; Hoshino, Emiko

2009-10-01

Knee pain is extremely common among the elderly, particularly women. Hence, there is an urgent need for applicable community-based intervention models for halting the progression of knee pain and related disabilities in elderly women. We aimed to assess the efficacy of home-visit physiotherapy as a new intervention model. This non-randomized 5-month-long controlled trial enrolled elderly community-dwelling women (aged 60-83 years) with mild knee pain. The intervention consisted of two home visits by a physiotherapist, with instructions on routinely performing muscle-strengthening exercises at home and implementing simple environmental modifications when necessary. Outcome measures were assessed at baseline and 5 months later. The primary outcomes were measured as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a newly devised seiza-style sitting score. People in Japan, especially elderly women, are accustomed to seiza-style sitting that involves kneeling on one's lower legs while resting the buttocks on the heels. The secondary outcomes included quadriceps isometric strength, knee alignment in the frontal and sagittal planes, and passive knee extension range. Forty-two subjects (20 in the intervention group and 22 in the control group) completed the study. At baseline, characteristics and the primary outcomes did not significantly differ between the 2 groups. At 5 months, the primary outcomes improved significantly in the intervention group. Estimated differences in the change from baseline for each outcome between the 2 groups were computed, adjusting for outcome variables imbalanced at baseline. Even after the adjustment, the home-visit physiotherapy regimen provides favorable improvement in the seiza-style sitting score.

The relationship among psychological and psychophysiological characteristics of fibromyalgia patients.

PubMed

Thieme, Kati; Turk, Dennis C; Gracely, Richard H; Maixner, William; Flor, Herta

2015-02-01

This study examined the relationship of psychophysiological response patterns in fibromyalgia with psychological characteristics and comorbid mental disorders. Surface electromyographic data, systolic and diastolic blood pressure, heart rate (HR), and skin conductance levels were recorded continuously during baseline, stress, and relaxation tasks. Cluster analysis revealed 4 subgroups of patients who differed on pain characteristics and cognitive, affective, and behavioral responses to pain and stress. The largest group (46.7%) was characterized by elevated blood pressure levels and stress reactivity (a disposition assumed to be a vulnerability factor for the development of diseases) associated with pain, anxiety, physical interference, low activity, and pain behaviors. A second group (41.6%) showed low baseline blood pressure and reactivity, and high activity and stress. A third group (9.2%) displayed high baseline skin conductance level, reactivity, and depression, and a fourth small group (2.5%) displayed elevated baseline electromyographic response and reactivity with high levels of anxiety and depression. These data suggest that unique psychophysiological response patterns are associated with psychological coping and mental disorders in fibromyalgia patients. The identification of the mechanisms that contribute to these group differences will further our understanding of the mechanisms involved in the development and maintenance of fibromyalgia and suggest differential treatment strategies. This article presents psychological characteristics and comorbidity with mental disorders of psychophysiological subgroups of fibromyalgia patients. This mechanistic analysis will assist scientific identification of systems-based pathways that contribute to autonomic and stress mechanisms that mediate chronic pain. Demonstration of distinct, homogeneous subgroups is an important step towards personalized, mechanism-oriented treatments. Copyright © 2015 American Pain Society. All rights reserved.

Comparative-Effectiveness of Simulation-Based Deliberate Practice Versus Self-Guided Practice on Resident Anesthesiologists' Acquisition of Ultrasound-Guided Regional Anesthesia Skills.

PubMed

Udani, Ankeet Deepak; Harrison, T Kyle; Mariano, Edward R; Derby, Ryan; Kan, Jack; Ganaway, Toni; Shum, Cynthia; Gaba, David M; Tanaka, Pedro; Kou, Alex; Howard, Steven K

2016-01-01

Simulation-based education strategies to teach regional anesthesia have been described, but their efficacy largely has been assumed. We designed this study to determine whether residents trained using the simulation-based strategy of deliberate practice show greater improvement of ultrasound-guided regional anesthesia (UGRA) skills than residents trained using self-guided practice in simulation. Anesthesiology residents new to UGRA were randomized to participate in either simulation-based deliberate practice (intervention) or self-guided practice (control). Participants were recorded and assessed while performing simulated peripheral nerve blocks at baseline, immediately after the experimental condition, and 3 months after enrollment. Subject performance was scored from video by 2 blinded reviewers using a composite tool. The amount of time each participant spent in deliberate or self-guided practice was recorded. Twenty-eight participants completed the study. Both groups showed within-group improvement from baseline scores immediately after the curriculum and 3 months following study enrollment. There was no difference between groups in changed composite scores immediately after the curriculum (P = 0.461) and 3 months following study enrollment (P = 0.927) from baseline. The average time in minutes that subjects spent in simulation practice was 6.8 minutes for the control group compared with 48.5 minutes for the intervention group (P < 0.001). In this comparative effectiveness study, there was no difference in acquisition and retention of skills in UGRA for novice residents taught by either simulation-based deliberate practice or self-guided practice. Both methods increased skill from baseline; however, self-guided practice required less time and faculty resources.

Improving residents' oral health through staff education in nursing homes.

PubMed

Le, Phu; Dempster, Laura; Limeback, Hardy; Locker, David

2012-01-01

This study assessed the efficacy of oral care education among nursing home staff members to improve the oral health of residents. Nursing home support staff members (NHSSMs) in the study group received oral care education at baseline between a pretest and posttest. NHSSMs' oral care knowledge was measured using a 20-item knowledge test at baseline, posteducation, and at a 6-month follow-up. Residents' oral health was assessed at baseline and again at a 6-month follow-up using the Modified Plaque Index (PI) and Modified Gingival Index (GI). Among staff members who received the oral care education (n = 32), posttest knowledge statistically significantly increased from the pretest level (p < .05). Thirty-nine control residents of the nursing homes and 41 study residents participated. Among residents in the study group, PI decreased at 6 months compared to baseline (p < .05), but there was no statistically significant difference in their GI measurements between baseline and 6-month follow-up (p= .07). © 2012 Special Care Dentistry Association and Wiley Periodicals, Inc.

Fracture toughness of bleached enamel: Effect of applying three different nanobiomaterials by nanoindentation test.

PubMed

Khoroushi, Maryam; Mazaheri, Hamid; Saneie, Tahere; Samimi, Pouran

2016-01-01

Despite the absence of dispute about the efficacy of bleaching agents, a prime concern is about their compromising effect on the enamel structure. This in vitro study investigated whether the addition of three different biomaterials, including nano-bioactive glass (n-BG)/nano-hydroxy apetite (n-HA)/nano-amorphous calcium phosphate (n-ACP), to bleaching agents can affect the fracture toughness (FT) and vickers hardness number (VHN) of bovine enamel. The crowns of the newly extracted permanent bovine incisors teeth were separated from the root and sectioned along their central line; one half serving as the control specimen and the other half as the test specimen. After mounting and polishing procedure, all the control specimens (C) were subjected to nano-indentation test to obtain the baseline values of FT. Then, the control specimens were exposed to a 38% hydrogen peroxide for four times, each time for 10 min. The test specimens were divided into three groups and treated as follows, with the same protocol used for the control specimens: Group 1; ACP + hydrogen peroxide (HP) mixed gel; Group 2 BG + HP mixed gel; and Group 3 HA + HP mixed gel. FT measurements with nano-indentation were carried out subsequent to bleaching experiments. Data were analyzed using SPSS and Kruskal-Wallis test (α = 0.05). A significant difference in young's modulus (YM), VHN, and FT at baseline and subsequent to bleaching in control group was observed. However, no significant differences were found in YM, VHN, and FT between the test groups, compared to the respective baseline values. Under the limitations of the current study, it can be concluded that the n-HA, n-ACP, and n-BG could be potential biomaterials used to reduce the adverse effects of tooth bleaching.

Fracture toughness of bleached enamel: Effect of applying three different nanobiomaterials by nanoindentation test

PubMed Central

Khoroushi, Maryam; Mazaheri, Hamid; Saneie, Tahere; Samimi, Pouran

2016-01-01

Background: Despite the absence of dispute about the efficacy of bleaching agents, a prime concern is about their compromising effect on the enamel structure. This in vitro study investigated whether the addition of three different biomaterials, including nano-bioactive glass (n-BG)/nano-hydroxy apetite (n-HA)/nano-amorphous calcium phosphate (n-ACP), to bleaching agents can affect the fracture toughness (FT) and vickers hardness number (VHN) of bovine enamel. Materials and Methods: The crowns of the newly extracted permanent bovine incisors teeth were separated from the root and sectioned along their central line; one half serving as the control specimen and the other half as the test specimen. After mounting and polishing procedure, all the control specimens (C) were subjected to nano-indentation test to obtain the baseline values of FT. Then, the control specimens were exposed to a 38% hydrogen peroxide for four times, each time for 10 min. The test specimens were divided into three groups and treated as follows, with the same protocol used for the control specimens: Group 1; ACP + hydrogen peroxide (HP) mixed gel; Group 2 BG + HP mixed gel; and Group 3 HA + HP mixed gel. FT measurements with nano-indentation were carried out subsequent to bleaching experiments. Data were analyzed using SPSS and Kruskal–Wallis test (α = 0.05). Results: A significant difference in young's modulus (YM), VHN, and FT at baseline and subsequent to bleaching in control group was observed. However, no significant differences were found in YM, VHN, and FT between the test groups, compared to the respective baseline values. Conclusion: Under the limitations of the current study, it can be concluded that the n-HA, n-ACP, and n-BG could be potential biomaterials used to reduce the adverse effects of tooth bleaching. PMID:27307669

Selective impairment of attention networks during propofol anesthesia after gynecological surgery in middle-aged women.

PubMed

Chen, Chen; Xu, Guang-hong; Li, Yuan-hai; Tang, Wei-xiang; Wang, Kai

2016-04-15

Postoperative cognitive dysfunction is a common complication of anesthesia and surgery. Attention networks are essential components of cognitive function and are subject to impairment after anesthesia and surgery. It is not known whether such impairment represents a global attention deficit or relates to a specific attention network. We used an Attention Network Task (ANT) to examine the efficiency of the alerting, orienting, and executive control attention networks in middle-aged women (40-60 years) undergoing gynecologic surgery. A matched group of medical inpatients were recruited as a control. Fifty female patients undergoing gynecologic surgery (observation group) and 50 female medical inpatients (control group) participated in this study. Preoperatively patients were administered a mini-mental state examination as a screening method. The preoperative efficiencies of three attention networks in an attention network test were compared to the 1st and 5th post-operative days. The control group did not have any significant attention network impairments. On the 1st postoperative day, significant impairment was shown in the alerting (p=0.003 vs. control group, p=0.015 vs. baseline), orienting (p<0.001 vs. both baseline level and control group), and executive control networks (p=0.007 vs. control group, p=0.002 vs. baseline) of the observation group. By the 5th postoperative day, the alerting network efficiency had recovered to preoperative levels (p=0.464 vs. baseline) and the orienting network efficiency had recovered partially (p=0.031 vs. 1st post-operative day), but not to preoperative levels (p=0.01 vs. baseline). The executive control network did not recover by the 5th postoperative day (p=0.001 vs. baseline, p=0.680 vs. 1st post-operative day). Attention networks of middle-aged women show a varying degree of significant impairment and differing levels of recovery after surgery and propofol anesthetic. Copyright © 2016 Elsevier B.V. All rights reserved.

The Hispanic Americans Baseline Alcohol Survey (HABLAS):Predictive invariance of Demographic Characteristics on Attitudes towards Alcohol across Hispanic National Groups#

PubMed Central

Mills, Britain A.; Caetano, Raul; Bernstein, Ira H.

2011-01-01

This study compares the demographic predictors of items assessing attitudes towards drinking across Hispanic national groups. Data were from the 2006 Hispanic Americans Baseline Alcohol Survey (HABLAS), which used a multistage cluster sample design to interview 5,224 individuals randomly selected from the household population in Miami, New York, Philadelphia, Houston, and Los Angeles. Predictive invariance of demographic predictors of alcohol attitudes over four Hispanic national groups (Puerto Rican, Cuban, Mexican, and South/Central Americans) was examined using multiple-group seemingly unrelated probit regression. The analyses examined whether the influence of various demographic predictors varied across the Hispanic national groups in their regression coefficients, item intercepts, and error correlations. The hypothesis of predictive invariance was supported. Hispanic groups did not differ in how demographic predictors related to individual attitudinal items (regression slopes were invariant). In addition, the groups did not differ in attitudinal endorsement rates once demographic covariates were taken into account (item intercepts were invariant). Although Hispanic groups have different attitudes about alcohol, the influence of multiple demographic characteristics on alcohol attitudes operates similarly across Hispanic groups. Future models of drinking behavior in adult Hispanics need not posit moderating effects of group on the relation between these background characteristics and attitudes. PMID:25379120

Cellulose Dressing Versus Rayon Dressing in Skin Graft Donor Sites: Aspects of Patients' Health-related Quality of Life and Self-esteem .

PubMed

Ferreira, Lydia M; Blanes, Leila; Gragnani, Alfredo; Veiga, Daniela F; Veiga, Frederico; Nery, Gilka B; Rocha, Gustavo H; Gomes, Heitor C; Rocha, Mario G; Okamoto, Regina

2009-06-01

 Objective. The aim of this study was to compare the health-related quality of life (HRQoL) and self-esteem of patients who underwent split-thickness skin grafting, when either cellulose dressings or rayon dressings were applied to the donor sites. A total of 25 patients, who were enrolled at five participant hospitals and required split-thickness skin grafting for various clinical reasons, were randomized into two treatment groups, the rayon dressing group (n = 13), or the cellulose dressing group (n = 12). All patients were assessed preoperatively and 60 days postoperatively. The HRQoL was assessed with the Short Form-36 (SF-36) health survey questionnaire, and self-esteem was evaluated using the Rosenberg Self-Esteem Scale (RSE)/UNIFESP-EPM (Brazilian versions). There were no surgery-related complications during the study period. In both treatment groups, SF-36 scores for emotional role, mental health, vitality, and general health decreased from baseline. RSE scores increased from baseline in both treatment groups, showing a reduction in self-esteem after treatment. There was a statistical difference (P = 0.024) in the SF-36 bodily pain domain for the rayon group. There were no significant differences in HRQoL and self-esteem between treatment groups. In the rayon-dressing group, there was a significant decrease in bodily pain from baseline .

The Effect of Right Ventricular Apical and Nonapical Pacing on the Short- and Long-Term Changes in Left Ventricular Ejection Fraction: A Systematic Review and Meta-Analysis of Randomized-Controlled Trials.

PubMed

Hussain, Mohammad Akhtar; Furuya-Kanamori, Luis; Kaye, Gerald; Clark, Justin; Doi, Suhail A R

2015-09-01

The right ventricular apex (RVA) is the traditional lead site for chronic pacing but in some patients may cause impaired left ventricular (LV) systolic function over time. Comparisons with right ventricular nonapical (RVNA) pacing sites have generated inconsistent results and recent meta-analyses have demonstrated unclear benefit due to heterogeneity across studies. A systematic search for randomized controlled trials that compared LV ejection fraction (LVEF) outcomes between RVNA and RVA pacing was performed up to October 2014. Twenty-four studies (n = 1,628 patients) met the inclusion criteria. To avoid between study heterogeneity two homogenous groups were created; group 1 where studies reported a difference (in favor of RVNA pacing) and group 2 where studies reported no difference between pacing sites. For group 1, weighted mean difference between RVNA and RVA pacing in terms of LVEF at follow-up was 5.40% (95% confidence interval [CI]: 3.94-6.87), related in part to group one's RVA arm demonstrating a significant reduction (mean loss -3.31%; 95% CI: -6.19 to -0.43) in LVEF between study baseline and end of follow-up. Neither of these finding were seen in group 2. Weighted regression modeling demonstrated that inclusion of poor baseline LVEF (<40%) in combination with greater than 12 months follow-up was three times more common in group 1 compared to group 2 (weighted relative risk 2.82; 95% CI: 1.03-7.72; P = 0.043). In patients requiring chronic right ventricular pacing where there is inclusion of impaired baseline LVEF (<40%), RVA pacing is associated with deterioration in LV function relative to RVNA pacing. © 2015 Wiley Periodicals, Inc.

Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study.

PubMed

Tanglertsampan, Chuchai

2012-10-01

Topical minoxidil and oral finasteride have been used to treat men with androgenetic alopecia (AGA). There are concerns about side effects of oral finasteride especially erectile dysfunction. To compare the efficacy and safety of the 24 weeks application of 3% minoxidil lotion (MNX) versus combined 3% minoxidil and 0.1% finasteride lotion (MFX) in men with AGA. Forty men with AGA were randomized treated with MNX or MFX. Efficacy was evaluated by hair counts and global photographic assessment. Safety assessment was performed by history and physical examination. At week 24, hair counts were increased from baseline in both groups. However paired t-test revealed statistical difference only in MFX group (p = 0.044). Unpaired t-test revealed no statistical difference between two groups with respect to change of hair counts at 24 weeks from baseline (p = 0.503). MFX showed significantly higher efficacy than MNX by global photographic assessment (p = 0.003). There was no significant difference in side effects between both groups. Although change of hair counts was not statistically different between two groups, global photographic assessment showed significantly greater improvement in the MFX group than the MNX group. There was no sexual side effect. MFX may be a safe and effective treatment option.

Serotonin transporter linked polymorphic region (5-HTTLPR) genotype moderates the longitudinal impact of early caregiving on externalizing behavior.

PubMed

Brett, Zoë H; Humphreys, Kathryn L; Smyke, Anna T; Gleason, Mary Margaret; Nelson, Charles A; Zeanah, Charles H; Fox, Nathan A; Drury, Stacy S

2015-02-01

We examined caregiver report of externalizing behavior from 12 to 54 months of age in 102 children randomized to care as usual in institutions or to newly created high-quality foster care. At baseline no differences by group or genotype in externalizing were found. However, changes in externalizing from baseline to 42 months of age were moderated by the serotonin transporter linked polymorphic region genotype and intervention group, where the slope for short-short (S/S) individuals differed as a function of intervention group. The slope for individuals carrying the long allele did not significantly differ between groups. At 54 months of age, S/S children in the foster care group had the lowest levels of externalizing behavior, while children with the S/S genotype in the care as usual group demonstrated the highest rates of externalizing behavior. No intervention group differences were found in externalizing behavior among children who carried the long allele. These findings, within a randomized controlled trial of foster care compared to continued care as usual, indicate that the serotonin transporter linked polymorphic region genotype moderates the relation between early caregiving environments to predict externalizing behavior in children exposed to early institutional care in a manner most consistent with differential susceptibility.

Frequent cellular phone use modifies hypothalamic-pituitary-adrenal axis response to a cellular phone call after mental stress in healthy children and adolescents: A pilot study.

PubMed

Geronikolou, Styliani A; Chamakou, Aikaterini; Mantzou, Aimilia; Chrousos, George; KanakaGantenbein, Christina

2015-12-01

The hypothalamic-pituitary-adrenal (HPA) axis is the main "gate-keeper" of the organism's response to every somatic or mental stress. This prospective study aims to investigate the HPA-axis response to a cellular phone call exposure after mental stress in healthy children and adolescents and to assess the possible predictive role of baseline endocrine markers to this response. Two groups of healthy school-age children aged 11-14 (12.5±1.5) years were included in the study, the one comprising those who are occasional users of a cellular phone (Group A) while the second those who do regularly use one (Group B). Blood samples were obtained from all participants at 8.00 am after a 12-hour overnight fasting for thyroid hormone, glucose, insulin, and cortisol levels determination. The participants performed the Trier Social Stress Test for Children (TSST-C) (5 minoral task followed by 5 min arithmetic task). Salivary cortisol samples were obtained at baseline, 10' and 20' min after the TSST-C and 10' and 20' after a 5 minute cellular phone call. Significant changes in the salivary cortisol levels were noted between 10' and 20' mins after the cellular phone call with different responses between the two groups. Baseline thyroid hormone levels seem to predict the cortisol response to mental stress mainly in group A, while HOMA had no impact on salivary cortisol response at any phase of the test, in either group. HPA axis response to cellular phone after mental stress in children and adolescents follow a different pattern in frequent users than in occasional users that seems to be influenced by the baseline thyroid hormone levels. Copyright © 2015 Elsevier B.V. All rights reserved.

Rosemary oil vs minoxidil 2% for the treatment of androgenetic alopecia: a randomized comparative trial.

PubMed

Panahi, Yunes; Taghizadeh, Mohsen; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

2015-01-01

Rosmarinus officinalis L. is a medicinal plant with diverse activities including enhancement microcapillary perfusion. The present study aimed to investigate the clinical efficacy of rosemary oil in the treatment of androgenetic alopecia (AGA) and compare its effects with minoxidil 2%. Patients with AGA were randomly assigned to rosemary oil (n = 50) or minoxidil 2% (n = 50) for a period of 6 months. After a baseline visit, patients returned to the clinic for efficacy and safety evaluations every 3 months. A standardized professional microphotographic assessment of each volunteer was taken at the initial interview and after 3 and 6 months of the trial. No significant change was observed in the mean hair count at the 3-month endpoint, neither in the rosemary nor in the minoxidil group (P > .05). In contrast, both groups experienced a significant increase in hair count at the 6-month endpoint compared with the baseline and 3-month endpoint (P < .05). No significant difference was found between the study groups regarding hair count either at month 3 or month 6 (> .05). The frequencies of dry hair, greasy hair, and dandruff were not found to be significantly different from baseline at either month 3 or month 6 trial in the groups (P > .05). The frequency of scalp itching at the 3- and 6-month trial points was significantly higher compared with baseline in both groups (P < .05). Scalp itching, however, was more frequent in the minoxidil group at both assessed endpoints (P < .05). The findings of the present trial provided evidence with respect to the efficacy of rosemary oil in the treatment of AGA.

Effect of 3D animation videos over 2D video projections in periodontal health education among dental students

PubMed Central

Dhulipalla, Ravindranath; Marella, Yamuna; Katuri, Kishore Kumar; Nagamani, Penupothu; Talada, Kishore; Kakarlapudi, Anusha

2015-01-01

Background: There is limited evidence about the distinguished effect of 3D oral health education videos over conventional 2 dimensional projections in improving oral health knowledge. This randomized controlled trial was done to test the effect of 3 dimensional oral health educational videos among first year dental students. Materials and Methods: 80 first year dental students were enrolled and divided into two groups (test and control). In the test group, 3D animation and in the control group, regular 2D video projections pertaining to periodontal anatomy, etiology, presenting conditions, preventive measures and treatment of periodontal problems were shown. Effect of 3D animation was evaluated by using a questionnaire consisting of 10 multiple choice questions given to all participants at baseline, immediately after and 1month after the intervention. Clinical parameters like Plaque Index (PI), Gingival Bleeding Index (GBI), and Oral Hygiene Index Simplified (OHI-S) were measured at baseline and 1 month follow up. Results: A significant difference in the post intervention knowledge scores was found between the groups as assessed by unpaired t-test (p<0.001) at baseline, immediate and after 1 month. At baseline, all the clinical parameters in the both the groups were similar and showed a significant reduction (p<0.001)p after 1 month, whereas no significant difference was noticed post intervention between the groups. Conclusion: 3D animation videos are more effective over 2D videos in periodontal disease education and knowledge recall. The application of 3D animation results also demonstrate a better visual comprehension for students and greater health care outcomes. PMID:26759805

Esophageal baseline impedance levels in patients with pathophysiological characteristics of functional heartburn.

PubMed

Martinucci, I; de Bortoli, N; Savarino, E; Piaggi, P; Bellini, M; Antonelli, A; Savarino, V; Frazzoni, M; Marchi, S

2014-04-01

Recently, it has been suggested that low esophageal basal impedance may reflect impaired mucosal integrity and increased acid sensitivity. We aimed to compare baseline impedance levels in patients with heartburn and pathophysiological characteristics related to functional heartburn (FH) divided into two groups on the basis of symptom relief after proton pump inhibitors (PPIs). Patients with heartburn and negative endoscopy were treated with esomeprazole or pantoprazole 40 mg daily for 8 weeks. According to MII-pH (off therapy) analysis, patients with normal acid exposure time (AET), normal reflux number, and lack of association between symptoms and refluxes were selected; of whom 30 patients with a symptom relief higher than 50% after PPIs composed Group A, and 30 patients, matched for sex and age, without symptom relief composed Group B. A group of 20 healthy volunteers (HVs) was enrolled. For each patient and HV, we evaluated the baseline impedance levels at channel 3, during the overnight rest, at three different times. Group A (vs Group B) showed an increase in the following parameters: mean AET (1.4 ± 0.8% vs 0.5 ± 0.6%), mean reflux number (30.4 ± 8.7 vs 24 ± 6.9), proximal reflux number (11.1 ± 5.2 vs 8.2 ± 3.6), acid reflux number (17.9 ± 6.1 vs 10.7 ± 6.9). Baseline impedance levels were lower in Group A than in Group B and in HVs (p < 0.001). Evaluating baseline impedance levels in patients with heartburn and normal AET could achieve a better understanding of pathophysiology in reflux disease patients, and could improve the distinction between FH and hypersensitive esophagus. © 2014 John Wiley & Sons Ltd.

A randomized, controlled study of a single intra-articular injection of etanercept or glucocorticosteroids in patients with rheumatoid arthritis.

PubMed

Bliddal, H; Terslev, L; Qvistgaard, E; Konig, M; Holm, C C; Rogind, H; Boesen, M; Danneskiold-Samsøe, B; Torp-Pedersen, S

2006-01-01

Glucocorticosteroids are used successfully for both systemic and intra-articular treatment of arthritis. Inhibitors of tumour necrosis factor alpha (TNF-alpha) are effective when administered systemically and this study was performed to compare the effect of intra-articular injection of these two substances. A randomized, parallel-group, double-blind study with an independent observer. Thirty-eight patients with flare of arthritis in a single joint (wrist, elbow, or knee) were given intra-articular 25 mg etanercept or 40 mg methylprednisolone guided by ultrasound. The primary end-point was the 4-week change in pain in the target joint. The study complied with Good Clinical Practice (GCP) and the Consolidated Standards for Reporting of Trials (CONSORT) statement. At 4 weeks no difference in pain outcome between treatment groups was demonstrated by analysis of covariance (ANCOVA). Pain on the Visual Analogue Scale (VAS) for etanercept was baseline mean 40.9 (SD 19.6) mm, follow-up 32.7 (29.1) mm (p = 0.29), methylprednisolone baseline mean 47.1 (29.6) mm, follow-up 25.3 (24.7) mm (p<0.001). The investigator's evaluation was for etanercept baseline 30.6 (21.2) mm, follow-up 17.1 (15.5) mm (p = 0.054) and for methylprednisolone baseline 35.4 (26.4) mm, follow-up 11.9 (14.6) mm (p = 0.012). Joint swelling was for etanercept baseline 1.78 (0.73), follow-up 1.25 (0.77) (p = 0.015) and for methylprednisolone baseline 1.74 (0.73), follow-up 0.71 (0.77) (p<0.001). One serious adverse event was seen in a patient treated with methylprednisolone injection. Although no difference between groups was demonstrated, the within-group effect of methylprednisolone was more marked than that of etanercept. Injections with 25 mg etanercept were well tolerated. However, the cost of etanercept will presumably limit its use to patients with adverse reactions to steroid.

Maternal Warm Responsiveness and Negativity Following Traumatic Brain Injury in Young Children

PubMed Central

Fairbanks, Joy M.; Brown, Tanya M.; Cassedy, Amy; Taylor, H. Gerry; Yeates, Keith O.; Wade, Shari L.

2014-01-01

Purpose/Objective To understand how traumatic brain injury (TBI) affects maternal warm responsiveness and negativity over the first 12 months following injury. Method/Design We used a concurrent cohort research design to examine dyadic interactions in young children with a TBI (n = 78) and a comparison group of young children with orthopedic injuries (OI; n = 112) and their families during the initial weeks following injury (i.e., baseline) and at two follow-up periods (approximately 6 and 12 months later). Trained raters coded videotaped interactions during a free play and structured teaching task for maternal warm responsiveness and negativity. Results Mothers in the complicated mild/moderate TBI group, but not those in the severe TBI group, exhibited significantly lower levels of maternal warm responsiveness than mothers in the OI group. However, these differences were observed only at baseline during free play and only at baseline and 6 months postinjury during the structured teaching task, suggesting diminishing adverse effects of complicated mild/moderate TBI on parenting over time postinjury. Analysis failed to reveal group differences in maternal negativity at any of the assessments. Across groups, lower socioeconomic status (SES) was associated with lower levels of warm responsiveness and higher levels of negativity. Conclusions/Implications These findings, though preliminary, indicate possible alterations in mother–child interactions in the months following a TBI. PMID:23978080

Gadolinium prevents high airway pressure-induced permeability increases in isolated rat lungs.

PubMed

Parker, J C; Ivey, C L; Tucker, J A

1998-04-01

To determine the initial signaling event in the vascular permeability increase after high airway pressure injury, we compared groups of lungs ventilated at different peak inflation pressures (PIPs) with (gadolinium group) and without (control group) infusion of 20 microM gadolinium chloride, an inhibitor of endothelial stretch-activated cation channels. Microvascular permeability was assessed by using the capillary filtration coefficient (Kfc), a measure of capillary hydraulic conductivity. Kfc was measured after ventilation for 30-min periods with 7, 20, and 30 cmH2O PIP with 3 cmH2O positive end-expiratory pressure and with 35 cmH2O PIP with 8 cmH2O positive end-expiratory pressure. In control lungs, Kfc increased significantly to 1.8 and 3.7 times baseline after 30 and 35 cmH2O PIP, respectively. In the gadolinium group, Kfc was unchanged from baseline (0.060 +/- 0.010 ml . min-1 . cmH2O-1 . 100 g-1) after any PIP ventilation period. Pulmonary vascular resistance increased significantly from baseline in both groups before the last Kfc measurement but was not different between groups. These results suggest that microvascular permeability is actively modulated by a cellular response to mechanical injury and that stretch-activated cation channels may initiate this response through increases in intracellular calcium concentration.

Effects of Oral L-Carnitine on Liver Functions after Transarterial Chemoembolization in Intermediate-Stage HCC Patients.

PubMed

Hassan, Abeer; Tsuda, Yasuhiro; Asai, Akira; Yokohama, Keisuke; Nakamura, Ken; Sujishi, Tetsuya; Ohama, Hideko; Tsuchimoto, Yusuke; Fukunishi, Shinya; Abdelaal, Usama M; Arafa, Usama A; Hassan, Ali T; Kassem, Ali M; Higuchi, Kazuhide

2015-01-01

Transarterial chemoembolization (TACE) is usually followed by hepatic dysfunction. We evaluated the effects of L-carnitine on post-TACE impaired liver functions. Methods. 53 cirrhotic hepatocellular carcinoma patients at Osaka Medical College were enrolled in this study and assigned into either L-carnitine group receiving 600 mg oral L-carnitine daily or control group. Liver functions were evaluated at pre-TACE and 1, 4, and 12 weeks after TACE. Results. The L-carnitine group maintained Child-Pugh (CP) score at 1 week after TACE and exhibited significant improvement at 4 weeks after TACE (P < 0.01). Conversely, the control group reported a significant CP score deterioration at 1 week (P < 0.05) and 12 weeks after TACE (P < 0.05). L-carnitine suppressed serum albumin deterioration at 1 week after TACE. There were significant differences between L-carnitine and control groups regarding mean serum albumin changes from baseline to 1 week (P < 0.05) and 4 weeks after TACE (P < 0.05). L-carnitine caused prothrombin time improvement from baseline to 1, 4 (P < 0.05), and 12 weeks after TACE. Total bilirubin mean changes from baseline to 1 week after TACE exhibited significant differences between L-carnitine and control groups (P < 0.05). The hepatoprotective effects of L-carnitine were enhanced by branched chain amino acids combination. Conclusion. L-carnitine maintained and improved liver functions after TACE.

[Telerehabilitation to treat stress urinary incontinence. Pilot study].

PubMed

Carrión Pérez, Francisca; Rodríguez Moreno, María Sofía; Carnerero Córdoba, Lidia; Romero Garrido, Marina C; Quintana Tirado, Laura; García Montes, Inmaculada

2015-05-21

We aimed to test a new telerehabilitation device for stress urinary incontinence (SUI) in order to make an initial assessment of its effectiveness. Randomized, controlled pilot study. experimental group (10 patients): pelvic floor muscle training, device training and home treatment with it; control group (9 patients): conventional rehabilitation treatment. Outcome measures (baseline and 3 months) overall and specific quality of life: International Consultation Incontinence Questionnaire and King's Health Questionnaire, bladder diary, perineometry, satisfaction with the program and degree of compliance. Baseline characteristics were similar in both groups. There was no statistically significant difference for any outcome measures between groups at the end of the follow-up. The change in perineometry values at baseline and after the intervention was significant in the experimental group (23.06 to 32.00, P=.011). No group in this study had any serious adverse effects. The tested device is safe and well accepted. Although there is some evidence of its efficacy in the rehabilitation treatment of SUI, larger trials are needed to appropriately evaluate the potential advantages. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema.

PubMed

Wells, John A; Glassman, Adam R; Jampol, Lee M; Aiello, Lloyd Paul; Antoszyk, Andrew N; Baker, Carl W; Bressler, Neil M; Browning, David J; Connor, Crystal G; Elman, Michael J; Ferris, Frederick L; Friedman, Scott M; Melia, Michele; Pieramici, Dante J; Sun, Jennifer K; Beck, Roy W

2016-02-01

Comparisons of the relative effect of 3 anti-vascular endothelial growth factor agents to treat diabetic macular edema warrant further assessment. To provide additional outcomes from a randomized trial evaluating 3 anti-vascular endothelial growth factor agents for diabetic macular edema within subgroups based on baseline visual acuity (VA) and central subfield thickness (CST) as evaluated on optical coherence tomography. Post hoc exploratory analyses were conducted of randomized trial data on 660 adults with diabetic macular edema and decreased VA (Snellen equivalent, approximately 20/32 to 20/320). The original study was conducted between August 22, 2012, and August 28, 2013. Analysis was conducted from January 7 to June 2, 2015. Repeated 0.05-mL intravitreous injections of 2.0 mg of aflibercept (224 eyes), 1.25 mg of bevacizumab (218 eyes), or 0.3 mg of ranibizumab (218 eyes) as needed per protocol. One-year VA and CST outcomes within prespecified subgroups based on both baseline VA and CST thresholds, defined as worse (20/50 or worse) or better (20/32 to 20/40) VA and thicker (≥400 µm) or thinner (250 to 399 µm) CST. In the subgroup with worse baseline VA (n = 305), irrespective of baseline CST, aflibercept showed greater improvement than bevacizumab or ranibizumab for several VA outcomes. In the subgroup with better VA and thinner CST at baseline (61-73 eyes across 3 treatment groups), VA outcomes showed little difference between groups; mean change was +7.2, +8.4, and +7.6 letters in the aflibercept, bevacizumab, and ranibizumab groups, respectively. However, in the subgroup with better VA and thicker CST at baseline (31-43 eyes), there was a suggestion of worse VA outcomes in the bevacizumab group; mean change from baseline to 1 year was +9.5, +5.4, and +9.5 letters in the aflibercept, bevacizumab, and ranibizumab groups, respectively, and VA letter score was greater than 84 (approximately 20/20) in 21 of 33 (64%), 7 of 31 (23%), and 21 of 43 (49%) eyes, respectively. The adjusted differences and 95% CIs were 39% (17% to 60%) for aflibercept vs bevacizumab, 25% (5% to 46%) for ranibizumab vs bevacizumab, and 13% (-8% to 35%) for aflibercept vs ranibizumab. These post hoc secondary findings suggest that for eyes with better initial VA and thicker CST, some VA outcomes may be worse in the bevacizumab group than in the aflibercept and ranibizumab groups. Given the exploratory nature of these analyses and the small sample size within subgroups, caution is suggested when using the data to guide treatment considerations for patients. clinicaltrials.gov Identifier: NCT01627249.

Local delivery of hyaluronan as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

PubMed

Johannsen, Annsofi; Tellefsen, Monica; Wikesjö, Ulf; Johannsen, Gunnar

2009-09-01

The aim of the present study was to evaluate the adjunctive effect of the local application of a hyaluronan gel to scaling and root planing in the treatment of chronic periodontitis. Twelve patients with chronic periodontitis were recruited to participate in a study with a split-mouth design and provided informed consent. Plaque formation and bleeding on probing were evaluated pretreatment (baseline) and at 1, 4, and 12 weeks post-treatment. Probing depths and attachment levels were evaluated at baseline and at 12 weeks. The patients received full-mouth scaling and root planing. A hyaluronan gel was administered subgingivally in the test sites at baseline and after 1 week. Significant differences between test and control were evaluated using the paired t test, repeated-measures analysis of variance (Wilks lambda), and a non-parametric Wilcoxon signed-rank test. A significant reduction in bleeding on probing scores and probing depths was observed in both groups at 12 weeks (P <0.05). Significantly lower bleeding on probing scores were observed in the hyaluronan group compared to control at 12 weeks (P <0.05). Mean probing depth reductions between baseline and 12 weeks were 1.0 +/- 0.3 mm and 0.8 +/- 0.2 mm for the hyaluronan and control groups, respectively. The difference between the groups was statistically significant (P <0.05). The local application of hyaluronan gel in conjunction with scaling and root planing may have a beneficial effect on periodontal health in patients with chronic periodontitis.

Effects of Cinnamon Consumption on Glycemic Status, Lipid Profile and Body Composition in Type 2 Diabetic Patients

PubMed Central

Vafa, Mohammadreza; Mohammadi, Farhad; Shidfar, Farzad; Sormaghi, Mohammadhossein Salehi; Heidari, Iraj; Golestan, Banafshe; Amiri, Fatemehsadat

2012-01-01

Objective: Type 2 diabetes is the most common metabolic disorder worldwide. Traditional herbs and spices can be used to control blood glucose concentrations. The objective of this study was to evaluate the effects of the daily intake of three grams cinnamon over eight weeks on glycemic status, lipid profiles and body composition in type 2 diabetic patients. Methods: A double blind, randomized, placebo controlled clinical trial was conducted on 44 patients with type 2 diabetes. Participants were randomly assigned to take either a three g/day cinnamon supplement (n=22) or a placebo (n=22) for eight weeks. Weight, height, body fat mass and systolic and diastolic blood pressure were measured at baseline and after intervention. The fasting blood glucose, insulin, HbA1c, total cholesterol, LDL C, HDL C, Apo lipoprotein A I and B were measured at baseline and endpoint. Results: From 44 subjects participated in this study 37 completed the study. There were no significant differences in baseline characteristics, dietary intake and physical activity between groups. In the treatment group, the levels of fasting blood glucose, HbA1c, triglyceride, weight, BMI and body fat mass decreased significantly compared to baseline, but not in placebo group. No significant differences were observed in glycemic status indicators, lipid profile and anthropometric indicators between the groups at the end of intervention. Conclusion: These data suggest that cinnamon may have a moderate effect in improving glycemic status indicators. PMID:22973482

Effect of oral calcium disodium EDTA on iron absorption in a human model of iron overdose.

PubMed

Matteucci, Michael J; Habibe, Michael; Robson, Kristie; Baldassano, Accursia A; Riffenburgh, Robert H; Tanen, David A

2006-01-01

Anecdotal case reports and animal models have suggested that the administration of CaNa2EDTA (EDTA) may be effective in reducing the absorption of iron after an oral iron overdose. We designed this study to determine the effect of orally administrated EDTA with or without activated charcoal (AC) on iron absorption after a mild iron ingestion in healthy human volunteers. A randomized, crossover study was conducted in eight healthy human volunteers. All subjects ingested 5 mg/kg of elemental iron in the form of ferrous sulfate. One hour post ingestion, subjects were randomized to receive 35 mg/kg EDTA, EDTA plus 50 grams of AC, or water. Serial iron levels were obtained at baseline and every hour for the first 6 hours, then at 8, 12, and 24 hours. A 2-week washout was used between study arms. The Kruskal-Wallis test was used for the following comparisons between treatment groups: baseline serum iron levels, area under time-concentration curves (AUCs) from baseline to 12 hours and baseline to 24 hours, and peak iron levels. Baseline serum iron levels did not differ among the three treatment groups (p = 0.844). AUCs were not different among groups (p = 0.746 for 12 hr, p = 0.925 for 24 hr). AUC medians (with 95% binomial confidence bounds) for control, EDTA, EDTA + AC groups, respectively, for 12 hr were: 2813 (2298, 3561), 2570 (1669, 3476), and 2654 (2125, 3600); and for 24 hr were: 4083 (3488,5314), 4139 (2666, 5547), and 4274 (3336, 5577). Peak serum iron levels did not differ among treatment groups (p = 0.481). Peak iron level medians in microg/dL (with 95% binomial confidence bounds) were for control: 329 (253, 382), for EDTA: 271 (184, 375), and for EDTA + AC: 285 (229, 352). Orally administered EDTA did not significantly reduce iron absorption when administered 1 hour post iron ingestion during the 12 or 24-hour period following the ingestion of 5 mg/kg of elemental iron in healthy human volunteers.

Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China.

PubMed

He, Zhong; Chen, Rong; Zhou, Yingfang; Geng, Li; Zhang, Zhenyu; Chen, Shuling; Yao, Yanjun; Lu, Junli; Lin, Shouqing

2009-05-20

To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (p<0.0001). The difference in the mean scores from the baseline to the 3rd cycle in the treatment group (22.71+/-10.33) was significantly lower than the difference in the placebo group (15.50+/-12.94, p<0.0001). Results of PMTS were similar, the total scores for PMTS were significantly lower between the two groups (p<0.01) and within each group (p<0.01). The score was decreased from 26.17+/-4.79 to 9.92+/-9.01 for the treatment group, and from 27.10+/-4.76 to 14.59+/-10.69 for the placebo group. A placebo effect of 50% was found in the present study. No serious adverse event (SAE) occurred in both groups. Vitex agnus castus (VAC BNO 1095 corresponding to 40mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS.

Long-term soy isoflavone supplementation and cognition in women: a randomized, controlled trial.

PubMed

Henderson, V W; St John, J A; Hodis, H N; Kono, N; McCleary, C A; Franke, A A; Mack, W J

2012-06-05

To determine the cognitive effects of long-term dietary soy isoflavones in a daily dose comparable to that of traditional Asian diets. In the double-blind Women's Isoflavone Soy Health trial, healthy postmenopausal women were randomly allocated to receive daily 25 g of isoflavone-rich soy protein (91 mg of aglycone weight of isoflavones: 52 mg of genistein, 36 mg of daidzein, and 3 mg glycitein) or milk protein-matched placebo. The primary cognitive endpoint compared between groups at 2.5 years was change from baseline on global cognition, a composite of the weighted sum of 14 neuropsychological test score changes. Secondary outcomes compared changes in cognitive factors and individual tests. A total of 350 healthy postmenopausal women aged 45-92 years enrolled in this trial; 313 women with baseline and endpoint cognitive test data were included in intention-to-treat analyses. Adherence in both groups was nearly 90%. There was no significant between-group difference on change from baseline in global cognition (mean standardized improvement of 0.42 in the isoflavone group and 0.31 in the placebo group; mean standardized difference 0.11, 95% confidence interval [CI] -0.13 to 0.35). Secondary analyses indicated greater improvement on a visual memory factor in the isoflavone group (mean standardized difference 0.33, 95% CI 0.06-0.60) but no significant between-group differences on 3 other cognitive factors or individual test scores, and no significant difference within a subgroup of younger postmenopausal women. For healthy postmenopausal women, long-term dietary soy isoflavone supplementation in a dose comparable to that of traditional Asian diets has no effect on global cognition but may improve visual memory. This study provides Class I evidence that long-term dietary supplementation with isoflavone-rich soy protein does not improve global cognition of healthy postmenopausal women.

Heavy Drinking in College Students Is Associated with Accelerated Gray Matter Volumetric Decline over a 2 Year Period

PubMed Central

Meda, Shashwath A.; Dager, Alecia D.; Hawkins, Keith A.; Tennen, Howard; Raskin, Sarah; Wood, Rebecca M.; Austad, Carol S.; Fallahi, Carolyn R.; Pearlson, Godfrey D.

2017-01-01

Background: Heavy and/or harmful alcohol use while in college is a perennial and significant public health issue. Despite the plethora of cross-sectional research suggesting deleterious effects of alcohol on the brain, there is a lack of literature investigating the longitudinal effects of alcohol consumption on the adolescent brain. We aim to probe the longitudinal effects of college drinking on gray matter change in students during this crucial neurodevelopmental period. Methods: Data were derived from the longitudinal Brain and Alcohol Research in College Students (BARCS) study of whom a subset underwent brain MRI scans at two time points 24 months apart. Students were young adults with a mean age at baseline of about 18.5 years. Based on drinking metrics assessed at both baseline and followup, subjects were classified as sustained abstainers/light drinkers (N = 45) or sustained heavy drinkers (N = 84) based on criteria established in prior literature. Gray matter volumetric change (GMV-c) maps were derived using the longitudinal DARTEL pipeline as implemented in SPM12. GMV-c maps were then subjected to a 1-sample and 2-sample t-test in SPM12 to determine within- and between-group GMV-c differences in drinking groups. Supplementary between-group differences were also computed at baseline only. Results: Within-group analysis revealed significant decline in GMV in both groups across the 2 year followup period. However, tissue loss in the sustained heavy drinking group was more significant, larger per region, and more widespread across regions compared to abstainers/light drinkers. Between-group analysis confirmed the above and showed a greater rate of GMV-c in the heavy drinking group in several brain regions encompassing inferior/medial frontal gyrus, parahippocampus, and anterior cingulate. Supplementary analyses suggest that some of the frontal differences existed at baseline and progressively worsened. Conclusion: Sustained heavy drinking while in college was associated with accelerated GMV decline in brain regions involved with executive functioning, emotional regulation, and memory, which are critical to everyday life functioning. Areas of significant GMV decreases also overlapped largely with brain reward and stress systems implicated in addictive behavior. PMID:29033801

Effect of Store and Forward Teledermatology on Quality of Life

PubMed Central

Whited, John D.; Warshaw, Erin M.; Edison, Karen E.; Kapur, Kush; Thottapurathu, Lizy; Raju, Srihari; Cook, Bethany; Engasser, Holly; Pullen, Samantha; Parks, Patricia; Sindowski, Tom; Motyka, Danuta; Brown, Rodney; Moritz, Thomas E.; Datta, Santanu K.; Chren, Mary-Margaret; Marty, Lucinda; Reda, Domenic J.

2013-01-01

Importance Although research on quality of life and dermatologic conditions is well represented in the literature, information on teledermatology’s effect on quality of life is virtually absent. Objective To determine the effect of store and forward teledermatology on quality of life. Design Two-site, parallel-group, superiority randomized controlled trial. Setting Dermatology clinics and affiliated sites of primary care at 2 US Department of Veterans Affairs medical facilities. Participants Patients being referred to a dermatology clinic were randomly assigned, stratified by site, to teledermatology or the conventional consultation process. Among the 392 patients who met the inclusion criteria and were randomized, 326 completed the allocated intervention and were included in the analysis. Interventions Store and forward teledermatology (digital images and a standardized history) or conventional text-based consultation processes were used to manage the dermatology consultations. Patients were followed up for 9 months. Main Outcome Measures The primary end point was change in Skindex-16 scores, a skin-specific quality-of-life instrument, between baseline and 9 months. A secondary end point was change in Skindex-16 scores between baseline and 3 months. Results Patients in both randomization groups demonstrated a clinically significant improvement in Skindex-16 scores between baseline and 9 months with no significant difference by randomization group (P=.66, composite score). No significant difference in Skindex-16 scores by randomization group between baseline and 3 months was found (P=.39, composite score). Conclusions Compared with the conventional consultation process, store and forward teledermatology did not result in a statistically significant difference in skin-related quality of life at 3 or 9 months after referral. Trial Registration clinicaltrials.gov Identifier: NCT00488293 PMID:23426111

Ethnic Differences in HIV Risk Behaviors Among Methadone-Maintained Women Receiving Contingency Management for Cocaine Use Disorders

PubMed Central

Barry, Danielle; Weinstock, Jeremiah; Petry, Nancy M.

2008-01-01

Objective To identify ethnic differences in HIV risk behaviors among cocaine using women receiving methadone maintenance for opioid dependence, and to evaluate the efficacy of contingency management (CM) for cocaine use disorders in reducing HIV risk behaviors. Methods African American (N=47), Hispanic (N=47), and White women (N = 29) were randomized to standard methadone treatment or standard methadone treatment plus a CM intervention. They completed the HIV Risk Behavior Scale (HRBS) indicating frequency of drug use and sexual behaviors across the lifetime, in the month before baseline, and in the 3 months following clinical trial participation. Ethnic group differences and the effect of CM on change in HIV risk behaviors between baseline and follow-up were evaluated. Results White women reported significantly higher lifetime rates of risky drug use and sexual behaviors on the HRBS than African American women; neither group differed significantly from Hispanic women. No ethnic group differences in HIV risk behaviors were identified in the month prior to baseline. At follow-up, African American women reported fewer high-risk drug use behaviors than White or Hispanic women, and Hispanic women reported more high-risk sexual behaviors than White or African American women. CM was associated with reduction in high-risk drug use behaviors regardless of ethnicity, but did not affect high-risk sexual behaviors. Conclusions White women receiving methadone maintenance engage in more lifetime HIV risk behaviors than African American women. CM for cocaine use reduces risky drug use behaviors, but certain ethnic groups may benefit from additional targeted HIV prevention efforts. PMID:18684571

Health-related quality of life using SF-8 and EPIC questionnaires after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy.

PubMed

Hashine, Katsuyoshi; Kusuhara, Yoshito; Miura, Noriyoshi; Shirato, Akitomi; Sumiyoshi, Yoshiteru; Kataoka, Masaaki

2009-08-01

The health-related quality of life (HRQOL) after treatment of prostate cancer is examined using a new HRQOL tool. HRQOL, based on the expanded prostate cancer index composite (EPIC) and SF-8 questionnaires, was prospectively compared after either a radical retropubic prostatectomy (RRP) or a permanent prostate brachytherapy (PPB) at a single institute. Between October 2005 and June 2007, 96 patients were treated by an RRP and 88 patients were treated by a PPB. A HRQOL survey was completed at baseline, and at 1, 3, 6 and 12 months after treatment, prospectively. The general HRQOL in the RRP and PPB groups was not different after 3 months. However, at baseline and 1 month after treatment, the mental component summary was significantly better in the PPB group than in the RRP group. Moreover, the disease-specific HRQOL was worse regarding urinary and sexual functions in the RRP group. Urinary irritative/obstructive was worse in the PPB group, but urinary incontinence was worse in the RRP group and had not recovered to baseline after 12 months. The bowel function and bother were worse in the PPB group than in the RRP group after 3 months. In the RRP group, the patients with nerve sparing demonstrated the same scores in sexual function as the PPB group. This prospective study revealed the differences in the HRQOL after an RRP and PPB. Disease-specific HRQOL is clarified by using EPIC survey. These results will be helpful for making treatment decisions.

Health-related Quality of Life using SF-8 and EPIC Questionnaires after Treatment with Radical Retropubic Prostatectomy and Permanent Prostate Brachytherapy

PubMed Central

Hashine, Katsuyoshi; Kusuhara, Yoshito; Miura, Noriyoshi; Shirato, Akitomi; Sumiyoshi, Yoshiteru; Kataoka, Masaaki

2009-01-01

Objective The health-related quality of life (HRQOL) after treatment of prostate cancer is examined using a new HRQOL tool. HRQOL, based on the expanded prostate cancer index composite (EPIC) and SF-8 questionnaires, was prospectively compared after either a radical retropubic prostatectomy (RRP) or a permanent prostate brachytherapy (PPB) at a single institute. Methods Between October 2005 and June 2007, 96 patients were treated by an RRP and 88 patients were treated by a PPB. A HRQOL survey was completed at baseline, and at 1, 3, 6 and 12 months after treatment, prospectively. Results The general HRQOL in the RRP and PPB groups was not different after 3 months. However, at baseline and 1 month after treatment, the mental component summary was significantly better in the PPB group than in the RRP group. Moreover, the disease-specific HRQOL was worse regarding urinary and sexual functions in the RRP group. Urinary irritative/obstructive was worse in the PPB group, but urinary incontinence was worse in the RRP group and had not recovered to baseline after 12 months. The bowel function and bother were worse in the PPB group than in the RRP group after 3 months. In the RRP group, the patients with nerve sparing demonstrated the same scores in sexual function as the PPB group. Conclusions This prospective study revealed the differences in the HRQOL after an RRP and PPB. Disease-specific HRQOL is clarified by using EPIC survey. These results will be helpful for making treatment decisions. PMID:19477898

The effect of periodontal therapy on glycaemic control in a Hispanic population with type 2 diabetes: a randomized controlled trial.

PubMed

Gay, Isabel C; Tran, Duong T; Cavender, Adriana C; Weltman, Robin; Chang, Jennifer; Luckenbach, Estelle; Tribble, Gena D

2014-07-01

In the Mexican-American population, the prevalence of Type 2 diabetes mellitus (T2DM) is as high as 50% of the population. This randomized controlled clinical trial was designed to elucidate how treatment of periodontal disease affects HbA1c values in this population. One hundred and fifty-four T2DM patients with periodontal disease were enrolled in the study. The test group was treated with scaling and root planing (SRP); the control group received oral hygiene instructions. At baseline and 4-6 weeks after therapy, a complete periodontal examination was performed. Blood was collected at baseline and 4 months later for HbA1c levels. One hundred and twenty-six individuals completed the study. Baseline mean ± SD HbA1c for the test and control groups were 9.0 ± 2.3% and 8.4 ± 2.0% respectively. Non-significant difference in HbA1c reductions (0.6 ± 2.1% and 0.3 ± 1.7%) was found between test and control groups at 4 months. Comparisons of the periodontal clinical parameters between the test and control groups found significant differences with improved results in the test subjects. No statistically significant differences were found in the changes of HbA1c levels between test and control groups. Non-surgical periodontal therapy improved the magnitude of change in periodontal parameters as compared to the control subjects. ClinicalTrials.gov Identifier: NCT01128374. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effect of SSRI antidepressants on ejaculation: a double-blind, randomized, placebo-controlled study with fluoxetine, fluvoxamine, paroxetine, and sertraline.

PubMed

Waldinger, M D; Hengeveld, M W; Zwinderman, A H; Olivier, B

1998-08-01

Depression is a common cause of sexual dysfunction, but also antidepressant medication is often associated with sexual side effects. This article includes two related studies. The first double-blind, placebo-controlled study was conducted in men with lifelong rapid ejaculation and aimed to assess putative differences between the major selective serotonin reuptake inhibitors (SSRIs) (fluoxetine, fluvoxamine, paroxetine, and sertraline) with regard to their ejaculation-delaying effect. Sixty men with an intravaginal ejaculation latency time (IELT) of 1 minute or less were randomly assigned to receive fluoxetine 20 mg/day, fluvoxamine 100 mg/day, paroxetine 20 mg/day, sertraline 50 mg/day, or placebo for 6 weeks. During the 1-month baseline and 6-week treatment periods, the men measured their IELT at home using a stopwatch. The trial was completed by 51 men. During the 6-week treatment period, the geometric mean IELT in the placebo group was constant at approximately 20 seconds. Analysis of variance revealed a between-groups difference in the evolution of IELT delay (p = 0.0004); in the paroxetine, fluoxetine, and sertraline groups there was a gradual increase to about 110 seconds, whereas in the fluvoxamine group, IELT was increased to only approximately 40 seconds. The paroxetine, fluoxetine, and sertraline groups differed significantly (p < 0.001, p < 0.001, p = 0.017, respectively) from placebo but the fluvoxamine group did not (p = 0.38). Compared with baseline, paroxetine exerted the strongest delay in ejaculation, followed by fluoxetine and sertraline. There was no clinically relevant delay in ejaculation with fluvoxamine. In men with lifelong rapid ejaculation, paroxetine delayed ejaculation most strongly, whereas fluvoxamine delayed ejaculation the least. The second double-blind, placebo-controlled study was carried out in men with lifelong rapid ejaculation (IELT < or = 1 minute) and in men with lifelong less-rapid ejaculation (IELT > 1 minute) to investigate whether data about SSRI-induced delayed ejaculation in men with rapid ejaculation may be extrapolated to men with less-rapid ejaculation. After measurement of IELT at home (using a stopwatch) during a 1-month baseline assessment, 32 men with an IELT of 1 minute or less (group 1) or more than 1 minute (group 2) were randomly assigned to receive paroxetine 20 mg/day or placebo for 6 weeks in a double-blind manner. Patients continued to measure their IELTs at home during the 6 weeks of the study. At baseline, 24 patients consistently had IELTs of one minute or less (group 1), and eight patients had IELTs of more than 1 minute (group 2). The geometric mean IELT was 14 seconds in group 1 and 83 seconds in group 2. Twelve patients in group 1 and five in group 2 were randomized to the paroxetine 20 mg/day. The percentage increase in the geometric mean IELT compared with baseline in patients treated with paroxetine was 420% (95% confidence interval [CI], 216-758%) in group 1 and 480% (95% CI, 177-1,118%) in group 2 (p = 0.81). After 6 weeks of treatment with paroxetine, the geometric mean IELT was 92 seconds in group 1 and 602 seconds in group 2 (p < 0.001). Therefore, the paroxetine-induced percentage increase in IELT seems to be independent of the baseline IELT. This suggests that ejaculation-delaying side effects of some SSRIs investigated in men with lifelong rapid ejaculation may be generalized to men with less-rapid ejaculation.

Skin Conductance at Baseline and Post-Heel Lance Reflects Sympathetic Activation in Neonatal Opiate Withdrawal

PubMed Central

Oji-Mmuo, Christiana N.; Michael, Eric J.; McLatchy, Jacqueline; Lewis, Mary M.; Becker, Julie E.; Doheny, Kim Kopenhaver

2015-01-01

Aim Skin conductance (SC) provides an objective measure of autonomic system regulation through sympathetic-mediated filling of sweat glands. This study aimed to test the utility of SC to detect sympathetic activation in neonatal abstinence syndrome (NAS). Methods 14 term (mean, SE: 38.8 ± 0.35 weeks gestational age) neonates with chronic prenatal opiate exposure were enrolled. SC (peaks/sec and mean of peaks) were measured at baseline, during heel lance/squeeze (HLS) and recovery from HLS at 24-48 (mean 38) hours of life prior to treatment for NAS. Blinded coders with established reliability assessed neonates using the Modified Finnegan Neonatal Scoring System (MFNSS). Non-parametric tests were used to determine group differences, phase differences from baseline to HLS and HLS to recovery, and associations between MFNSS and SC measures. Results Neonates that would later require morphine treatment for NAS (n = 6) had higher baseline SC mean of peaks than those that did not require treatment (n = 8) (P<0.05). Moreover, there were unique phase differences between groups and SC positively correlated with MFNSS (P< 0.05). Conclusion SC provides early identification of NAS severity. However, a larger sample is needed to determine sensitivity and specificity of SC for early identification of NAS and treatment effectiveness. PMID:26613197

The effects of lesion baseline characteristics and different Sr:Ca ratios in plaque fluid-like solutions on caries lesion de- and remineralization.

PubMed

Lippert, Frank

2012-10-01

This study investigated the effects of lesion baseline characteristics and different strontium (Sr) to calcium (Ca) ratios in plaque fluid-like solutions (PF) on lesion de- and remineralization. Caries lesions were formed in enamel using three protocols: methylcellulose acid gel (MeC) and partially saturated lactic acid solutions containing carboxymethylcellulose (CMC) or not (SOLN). Lesions were exposed to PF with four distinct Sr:Ca molar ratios (0:1/3:1:3), but otherwise identical composition and total Sr+Ca molarity, for seven days. Lesions were characterized using transverse microradiography (TMR) at baseline and post-treatment. At baseline, MeC and CMC had similar integrated mineral loss values, whereas SOLN lesions were more demineralized. All lesions showed significant differences in their mineral distributions, with CMC and SOLN having lower R values (integrated mineral loss to lesion depth ratio) than MeC. Post-PF exposure, no interaction was found between lesion type and Sr:Ca ratio. Within lesion type, MeC demineralized, whereas CMC and SOLN exhibited some remineralization, with the differences between MeC and the other lesion types being of statistical significance. Within Sr:Ca ratio, the 1:3 ratio exhibited some remineralization whereas other groups tended to demineralize. Only the difference between groups SrCa1/3 and SrCa0 was of statistical significance. In summary, both lesion baseline characteristics and Sr:Ca ratio were shown to effect lesion de- and remineralization. Under the conditions of the study, high-R lesions are more prone to demineralize under PF-like conditions than low-R lesions. In addition, partial Sr substitution for Ca in PF was shown to enhance lesion remineralization. Copyright © 2012 Elsevier Ltd. All rights reserved.

Sex-Based Differences as a Predictor of Recovery Trajectories in Young Athletes After a Sports-Related Concussion.

PubMed

Ono, Kim E; Burns, Thomas G; Bearden, Donald J; McManus, Susan M; King, Harold; Reisner, Andrew

2016-03-01

To date, few studies have delineated clear sex-based differences in symptom resolution after a sports-related concussion (SRC), and equivocal results have been identified in sex-based differences on baseline assessments. To assess whether female athletes displayed prolonged recovery and more symptoms at baseline and after an SRC compared with male athletes. Cohort study; Level of evidence, 3. The current study assessed 135 male and 41 female athletes (10-18 years old) who participated in high-impact sports in metropolitan Atlanta middle and high schools. All athletes completed a baseline assessment and at least 1 postconcussion assessment from the Immediate Post-Concussion Assessment and Cognitive Testing battery. Longitudinal hierarchical linear modeling was employed to examine individual-level variables and their associations with adolescents' rates of recovery in concussive symptoms after controlling for age and number of prior concussions. Aggregate symptoms were rated as higher in female athletes compared with male athletes at baseline (mean ± SD: females, 13.49 ± 11.20; males, 4.88 ± 8.74; F(1,175) = 10.59, P < .001) and immediately after a concussion (females: 16.75 ± 18.08; males: 10.58 ± 14.21; F(1,175) = 3.99, P = .05). There were no group differences in the slope of recovery between male and female athletes, indicating generally similar trajectories of change for both groups. Post hoc analyses revealed higher baseline levels of migraine and neuropsychological symptoms in female athletes. Although female athletes in the current study reported increased symptoms, identical recovery patterns were observed in both sexes, suggesting that sex-based differences in concussion recovery are better explained by increased symptom frequency among female athletes when compared with their male counterparts. © 2015 The Author(s).

Thrombin activatable fibrinolysis inhibitor and clot lysis time in pregnant patients with antiphospholipid syndrome: relationship with pregnancy outcome and thrombosis.

PubMed

Martinez-Zamora, Maria Angeles; Tassies, Dolors; Carmona, Francisco; Espinosa, Gerard; Cervera, Ricard; Reverter, Juan Carlos; Balasch, Juan

2009-12-01

Antiphospholipid syndrome (APS) pregnancies are associated with thrombotic obstetric complications, despite treatment. This study evaluated Thrombin Activatable Fibrinolysis Inhibitor (TAFI) levels, TAFI gene polymorphisms and Clot Lysis Time (CLT) in pregnant patients with APS in relation to pregnancy outcome and thrombosis. Group 1 consisted of 67 pregnant patients with APS. Group 2 included 66 pregnant patients with uneventful term pregnancies and delivery. Patients were sampled during each trimester and at baseline. TAFI antigen and CLT and two polymorphisms of the TAFI gene, Ala147Thr and +1542C/G, were determined. Significantly prolonged CLT was found at baseline in Group 1. Allele distribution of the TAFI gene polymorphisms was similar in both groups. Basal TAFI and CLT in patients with APS having an adverse or a good obstetrical outcome were similar. Comparison of TAFI and CLT baseline levels in patients with APS with or without previous thrombosis showed no statistical differences. Patients with APS have impairment in fibrinolysis evidenced by prolonged CLT at baseline. TAFI and CLT do not seem to be useful as markers of obstetric outcome or risk of thrombosis in patients with APS.

On reducing hand impact force in forward falls: results of a brief intervention in young males.

PubMed

Lo, J; McCabe, G N; DeGoede, K M; Okuizumi, H; Ashton-Miller, J A

2003-10-01

To test the working hypotheses that after a brief (10 min) intervention, (a) young adults can volitionally reduce fall-related wrist impact forces, and (b) no difference in impact force would exist between intervention and control groups at 3-weeks or 3-months follow-up. The wrist is the most commonly fractured site in the body at any age, most often as a result of impact with the ground while arresting a forward fall.Methods. Twenty-nine healthy young male volunteers participated. A 3-month intervention group (n=10) performed five standardized forward falls before and after a 10-min instructional intervention aimed at reducing wrist impact forces during the baseline visit. They, along with a 3-month control group (n=11) who did not receive the intervention, were remeasured in five trials at 3-weeks and 3-months follow-up, without intervening practice. A baseline control group (n=8) performed the five trials, then repeated them at the baseline visit without receiving the intervention. Unilateral body segment kinematics and bilateral hand-ground impact forces were measured and the hypotheses were tested using repeated measures analysis of variance. At the baseline visit, a significant group-by-trial-block interaction was found (P=0.02): the 3-month intervention group reduced their average maximum impact forces by 18% from initial values (P=0.002); the baseline control group did not do so (0.5% increase, P=0.91). The 3-month intervention (20 falls) and control (15 falls) groups did not differ at the 3-month follow-up (P=0.62); however, when the groups were combined their maximum impact force had decreased significantly (8.9%, P=0.04) over that time. Healthy young males learned in 10 min to significantly reduce wrist impact forces in forward falls, but retention was poor at 3-weeks follow-up. Irrespective of group, however, after the 5 falls at 3-weeks subjects had taught themselves to reduce their impact forces at the 3-months follow-up. A brief educational intervention can significantly reduce forward fall-related impact forces in the short term. However, with or without the brief intervention, the experience of performing between 5-10 forward falls 3 weeks apart apparently resulted in decreased impact forces over the next 2 months, thereby reducing the risk of injury in these forward falls.

Understanding the Impact of Treatment on the Dimensions of Childhood Depression.

PubMed

Isa, Ameena; Bernstein, Ira; Trivedi, Madhukar; Mayes, Taryn; Kennard, Betsy; Emslie, Graham

2017-03-01

Childhood depression is often chronic and recurrent, with only modest improvements after optimal treatments. Novel approaches are needed for accurate diagnosis, timely selection of the best treatment for childhood depression, and improvement of remission rates. An important part of diagnosis is to determine how many consistent dimensions underlie childhood depression and what impact treatment may have on these dimensions. The goal of the current study is evaluate the consistency of the number of depressive symptom dimensions and examine the effect of depression treatment on the change in dimensions by seeing if this dimensional structure is the same for groups that were given a placebo and groups that were given an active drug, fluoxetine. We examined a combined sample of three clinical trials data sets with a total of 269 placebo patients and 261 fluoxetine patients at baseline, and 253 placebo patients and 249 fluoxetine patients at exit. Principal components analysis with associated parallel analysis followed by a ProMax oblique rotation was conducted on each week's scores. The similarity of the rotated structures between treatments and between weeks was then assessed using Wrigley and Neuhaus' (1955) degree of factorial similarity measure, which is a correlation-like statistic that takes two solutions based upon the same measures and assesses how similar they are. Preliminary analysis indicated that mean scores of both treatment groups declined from baseline to exit, but the decline was greater for the fluoxetine group. There were four dimensions at baseline and two dimensions at exit in each treatment group. Hence the numbers of dimensions were the same in the two groups, whereas the content of the components was the same at baseline for the two groups, but was different at exit. Basically, the factorial similarities of the rotated factors were very high at baseline between the two groups for both factors (Ψ = 0.97 for factor I and 0.94 for factor II) before they were treated differently. However, at exit, the respective similarities dropped to 0.58 and -0.04 for factors I and II. Therefore, time had a large effect in changing both groups' factor structure, but it was especially large when there was an active treatment. In comparing the baseline and exit dimensions in a forced two factor solution of two treatment groups, it was revealed that treatment did have an impact on the change in dimensions. These results further the generality of the simplification of the factor structure of the Childhood Depression Rating Scale- Revised (CDRS-R) over time. In addition, these results show the effect of time and therapy on the factor structures. The fluoxetine group followed the trend of the content of the dimensions revealed in a previous study, whereas the placebo group had a less distinct change over time.

The whitening effect of bleaching agents on tetracycline-stained rat teeth.

PubMed

Shin, D H; Summitt, J B

2002-01-01

This study compared the whitening effect of three bleaching agents on the teeth of rats and demonstrated differences in bleaching where dentin was exposed or enamel was thin. Thirty Albino rats were peritoneally injected with tetracycline solution daily for two weeks. Thirty-two disc-shaped specimens were cut from the crowns of incisors removed from sacrificed rats and were irradiated with UV light for 16 hours. Sections were stored in saline. Eight sections served as controls and were not bleached. Three bleaching agents (Opalescence, Rembrandt and Nite White) were applied to eight specimens each, five times a day for two weeks, and images of the sections were recorded at the following times: before bleaching (baseline), day 1, day 3, day 5, day 7, day 9, day 11 and day 14. Mean colors to demonstrate any change (deltaE) from baseline for each time period were as follows: control-9.78 (baseline), 9.17, 9.36, 9.65, 9.40, 9.99, 10.57, 11.36; Opalescence-10.08, (baseline) 7.63, 6.72, 6.04, 5.10, 4.87, 4.89, 4.27; Rembrandt-9.83 (baseline), 11.27, 9.55, 8.36, 7.75, 6.94, 7.11, 7.04; Nite White-10.44 (baseline), 9.92, 7.58, 6.80, 5.45, 5.05, 4.73, 4.01. All bleached teeth were lightened (p<.01). Another 56 tetracycline-stained rat incisors were UV irradiated for three days. Three different penetration depths were tested: penetration through lingual dentin and labial enamel (DN group), penetration through labial enamel only (RE group) and penetration through labial enamel covered with 1.0 mm human enamel (HE group). Specimens were bleached with Opalescence for one hour five times a day for one week or four weeks. A control group of unbleached teeth was also examined. Results (deltaE) were as follows: control--11.67; 1-week DN--13.55; 1-week RE--12.80; 1-week HE--12.07; 4-week DN--7.48; 4-week RE--7.50; 4-week HE--11.69. The color change in the 4-week DN and the 4-week RE groups showed the greatest reduction (p<.01).

Impact of fixed orthodontic appliance or clear-aligner on daily performance, in adult patients with moderate need for treatment

PubMed Central

Lin, Feiou; Yao, Linjie; Bhikoo, Chandradev; Guo, Jing

2016-01-01

Objective To assess the impact of wearing fixed orthodontic appliance (FOA) or clear-aligner, on daily performance in adult patients. Methods The Oral Impacts on Daily Performance (OIDP) index was assessed in 152 adults aged 25–35 years at baseline (T0), 6 months after bonding (T1), and 12 months after bonding (T2). Participants were randomly divided into two groups: CA group (participants treated with clear-aligner) and a control group (FOA group; participants treated with FOA). Baseline malocclusion severity was assessed using the Index of Orthodontic Treatment Need. Results There were no significant differences in sociodemographic variables and OIDP scores at baseline between the two groups. Significant changes in OIDP total and subscale scores were observed while wearing FOA: OIDP total score and subscale scores of eating, cleaning teeth, smiling, and social relation at T1 and T2 were significantly higher than at baseline (P<0.05 or P<0.01). However, only OIDP total score was significantly increased at T1 compared to the baseline in the CA group. OIDP total score and subscale scores of eating, cleaning teeth, smiling, and social relation were significantly higher in patients wearing FOA than in patients wearing clear-aligner at T1 and T2 (P<0.05 or P<0.01). Conclusion Patients wearing clear-aligner have fewer impacts on daily life than those wearing FOA during treatment, and have no significant changes in OIPD subscale scores at 12 months. FOA therapy significantly impacts daily performance in adult patients during treatment. PMID:27616881

Significant reduction in risk of falls and back pain in osteoporotic-kyphotic women through a Spinal Proprioceptive Extension Exercise Dynamic (SPEED) program.

PubMed

Sinaki, Mehrsheed; Brey, Robert H; Hughes, Christine A; Larson, Dirk R; Kaufman, Kenton R

2005-07-01

To determine the outcome of intervention with a spinal weighted kypho-orthosis (WKO) and a spinal proprioceptive extension exercise dynamic (SPEED) program on the risk of falls in ambulatory community-dwelling persons older than 60 years with osteoporosis-kyphosis at risk for falls. The study had 3 stages. At stage 1 (baseline), the 12 women in the kyphotic group were compared with 13 healthy controls to assess the risk of falls and balance disorder in the kyphotic group. At stage 2, the 12 kyphotic women began the SPEED program with a WKO (2 supervised sessions in an outpatient clinic and a 4-week, daily home-based training program). At stage 3, baseline and follow-up data of the kyphotic group were compared to determine the effect of intervention. At baseline, there were significant differences between the osteoporotic-kyphotic group and the control group in balance (P=.002), gait (P<.05), and strength (P<.05). After a 4-week intervention, comparison of the kyphotic group's baseline and follow-up results showed a significant change in balance (P=.003) and several gait parameters (P<.05). Mean back extensor strength improved significantly from baseline (144.0-46.5 N) to follow-up (198.6+/-55.2 N; P<.001). Lower extremity muscle strength was not changed significantly, except for improved left ankle plantar flexors (P=.02). Back pain decreased significantly (P=.001). Balance, gait, and risk of falls improved significantly with the 4-week SPEED program.

A Randomized Controlled Trial of Team-Based Learning Versus Lectures with Break-Out Groups on Knowledge Retention.

PubMed

Thrall, Grace C; Coverdale, John H; Benjamin, Sophiya; Wiggins, Anna; Lane, Christianne Joy; Pato, Michele T

2016-10-01

This goal of this study was to evaluate the efficacy of team-based learning (TBL) on knowledge retention compared to traditional lectures with small break-out group discussion (teaching as usual (TAU)) using a randomized controlled trial. This randomized controlled trial was conducted during a daylong conference for psychiatric educators on attention-deficit hyperactivity disorder and the research literacy topic of efficacy versus effectiveness trials. Learners (n = 115) were randomized with concealed allocation to either TBL or TAU. Knowledge was measured prior to the intervention, immediately afterward, and 2 months later via multiple-choice tests. Participants were necessarily unblinded. Data enterers, data analysts, and investigators were blinded to group assignment in data analysis. Per-protocol analyses of test scores were performed using change in knowledge from baseline. The primary endpoint was test scores at 2 months. At baseline, there were no statistically significant differences between groups in pre-test knowledge. At immediate post-test, both TBL and TAU groups showed improved knowledge scores compared with their baseline scores. The TBL group performed better statistically on the immediate post-test than the TAU group (Cohen's d = 0.73; p < 0.001), although the differences in knowledge scores were not educationally meaningful, averaging just one additional test question correct (out of 15). On the 2-month remote post-test, there were no group differences in knowledge retention among the 42 % of participants who returned the 2-month test. Both TBL and TAU learners acquired new knowledge at the end of the intervention and retained knowledge over 2 months. At the end of the intervention day and after 2 months, knowledge test scores were not meaningfully different between TBL and TAU completers. In conclusion, this study failed to demonstrate the superiority of TBL over TAU on the primary outcome of knowledge retention at 2 months post-intervention.

Leukocyte telomere length and depression, anxiety and stress and adjustment disorders in primary health care patients.

PubMed

Wang, Xiao; Sundquist, Kristina; Hedelius, Anna; Palmér, Karolina; Memon, Ashfaque A; Sundquist, Jan

2017-04-24

The primary aim was to examine possible differences in telomere length between primary health care patients, with depression, anxiety or stress and adjustment disorders, and healthy controls. The second aim was to examine the association between telomere length and baseline characteristics in the patients. The third aim was to examine the potential effects of the 8-week treatments (mindfulness-based group therapy or treatment as usual, i.e. mostly cognitive-based therapy) on telomere length, and to examine whether there was a difference in the potential effect on telomere length between the two groups. A total of 501 individuals including 181 patients (aged 20-64 years), with depression, anxiety and stress and adjustment disorders, and 320 healthy controls (aged 19-70 years) were recruited in the study. Patient data were collected from a randomized controlled trial comparing mindfulness-based group therapy with treatment as usual. We isolated genomic DNA from blood samples, collected at baseline and after the 8-week follow-up. Telomere length was measured by quantitative real-time (qRT)-PCR. Telomere length was significantly shorter in the patients (mean = 0.77 ± 0.12,), compared to the controls (mean = 0.81 ± 0.14) (p = 0.006). The difference in telomere length remained significant after controlling for age and sex. Old age, male sex and being overweight were associated with shorter telomere length. There was no significant difference in telomere length between baseline and at the 8-week follow-up in any of the treatment groups and no difference between the two groups. Our findings confirm that telomere length, as compared with healthy controls, is shortened in patients with depression, anxiety and stress and adjustment disorders. In both groups (mindfulness-based group therapy or treatment as usual), the telomere length remained unchanged after the 8-week treatment/follow-up and there was no difference between the two groups. (ClinicalTrials.gov ID: NCT01476371 ) Registered November 11, 2011.

Effects of adjunctive N-acetylcysteine on depressive symptoms: Modulation by baseline high-sensitivity C-reactive protein.

PubMed

Porcu, Mauro; Urbano, Mariana Ragassi; Verri, Waldiceu A; Barbosa, Decio Sabbatini; Baracat, Marcela; Vargas, Heber Odebrecht; Machado, Regina Célia Bueno Rezende; Pescim, Rodrigo Rossetto; Nunes, Sandra Odebrecht Vargas

2018-05-01

Outcomes in a RCTs of 12 weeks of theclinical efficacy of N-acetylcysteine (NAC) as an adjunctive treatment on depression and anxiety symptoms and its effects on high-sensitivity C-reactive protein (hs-CRP) levels. A wide array of measures were made. The 17-item version of the Hamilton Depression Rating Scale (HDRS17); the Hamilton Anxiety Rating Scale (HAM-A); Sheehan Disability Scale; Quality of Life; Clinical Global Impression (CGI); anthropometrics measures; and vital signs and biochemical laboratory. There were no significant differences among the groups regarding demographic, clinical features, use of medication, metabolic syndrome and comorbidities. From baseline to week 12, individuals receiving NAC, versus placebo, had a statistically significant reduction in depressive symptoms on HDRS 17 (p < 0.01) and anxiety symptoms on HAM-A (p = 0.04), but only for individuals with levels of hs-CRP > 3 mg/L at baseline. Individuals receiving NAC with baseline levels of hs-CRP > 3 mg/L, had more significant reduction in uric acid levels compared to individuals with baseline levels of hs-CRP ≤ 3 mg/L on week 12. Participants receiving placebogained significantly more weight during the 12 weeks for baseline levels of hs-CRP ≤ 3 mg/L and hs-CRP > 3 mg/L, and individuals receiving NAC in both groups did not have significant weight change during the 12 weeks. No individuals were withdrawn from the study because of adverse event. NAC group exhibited significantly greater reduction on hs-CRP levels than placebo group from baseline to week 12. clinicaltrials.gov Identifier; NCT02252341. Copyright © 2018 Elsevier B.V. All rights reserved.

Serum anti-Müllerian hormone and ovarian morphology assessed by magnetic resonance imaging in response to acupuncture and exercise in women with polycystic ovary syndrome: secondary analyses of a randomized controlled trial.

PubMed

Leonhardt, Henrik; Hellström, Mikael; Gull, Berit; Lind, Anna-Karin; Nilsson, Lars; Janson, Per Olof; Stener-Victorin, Elisabet

2015-03-01

To investigate whether electro-acupuncture or physical exercise influence serum anti-Müllerian hormone (AMH), antral follicle count (AFC) or ovarian volume in women with polycystic ovary syndrome (PCOS). Secondary analyses of a prospective, randomized controlled clinical trial. University Hospital, Sweden. Seventy-four women with PCOS recruited from the general population. Women with PCOS were randomized to 16 weeks of electro-acupuncture (14 treatments), exercise (at least three times/week), or no intervention. Serum AMH recorded at baseline, after 16 weeks of intervention, and at follow up at 32 weeks. AFC, and ovarian volume assessed by magnetic resonance imaging at baseline and at follow up at 32 weeks. After 16 weeks of intervention, serum levels of AMH were significantly decreased in the electro-acupuncture group by 17.5% (p < 0.001), and differed from the change in the exercise group. AMH remained decreased by 15% (p = 0.004) also at follow up at 32 weeks, but did not differ from the exercise or the no intervention groups. There was a decrease by 8.5% (p = 0.015) in ovarian volume between baseline and follow up in the electro-acupuncture group, and by 11.7% (p = 0.01) in AFC in the physical exercise group. No other variables were affected. This study is the first to demonstrate that acupuncture reduces serum AMH levels and ovarian volume. Physical exercise did not influence circulating AMH or ovarian volume. Despite a within-group decrease in AFC, exercise did not lead to a between-group difference. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

Effect of overnight orthokeratology on conjunctival goblet cells.

PubMed

Carracedo, Gonzalo; Martin-Gil, Alba; Fonseca, Begoña; Pintor, Jesús

2016-08-01

To evaluate the differences between goblet cell density (GCD) and symptomatology after one month of orthokeratology lens wear. A pilot, short-term study was conducted. Twenty-two subjects (29.7±7.0 years old) participated voluntarily in the study. Subjects were divided into two groups: habitual silicone hydrogel contact lens wearers (SiHCLW) and new contact lens wearers (NCLW). Schirmer test, tear break up time (TBUT), Ocular Surface Disease Index (OSDI) questionnaire and conjunctival impression cytology. GCD, mucin cloud height (MCH) and cell layer thickness (CLT) were measured. All measurements were performed before orthokeratology fitting and one month after fitting to assess the evolution of the changes throughout this time. No differences in tear volume and TBUT between groups were found (p>0.05). However, the OSDI score was statistically better after one month of orthokeratology lens wear than the baseline for the SiHCLW group (p=0.03). Regarding the goblet cell analysis, no differences were found in CLT and MCH from the baseline visit to the one month visit for the SiHCLW compared with NCLW groups (p>0.05). At baseline, the GCD in the SiHCLW group were statistically lower than NCLW group (p<0.001). There was a significant increase in GCD after orthokeratology fitting from 121±140cell/mm(2) to 254±130cell/mm(2) (p<0.001) in the SiHCLW group. Orthokeratology improves the dry eye subject symptoms and GCD after one month of wearing in SiHCLW. These results suggest that orthokeratology could be considered a good alternative for silicone hydrogel contact lens discomfort and dryness. Copyright © 2016 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

Green tea extract as a local drug therapy on periodontitis patients with diabetes mellitus: A randomized case-control study.

PubMed

Gadagi, Jayaprakash S; Chava, Vijay K; Reddy, Venkata Ramesh

2013-03-01

The green tea extract is a naturally occurring product having beneficial effects that counteract with the pathobiological features of periodontitis and diabetes mellitus. Hence, the present study was aimed at incorporation of green tea extract into hydroxylpropyl methylcellulose and investigates its efficacy in chronic periodontitis patients associated with and without diabetes mellitus. For the in vitro study, formulation of green tea strips and placebo strips, and analysis of drug release pattern from the green tea strips at different time intervals were performed. For the in vivo study, 50 patients (20-65 years), including 25 systemically healthy patients with chronic periodontitis (group 1) and 25 diabetic patients with chronic periodontitis (group 2) were enrolled. In each patient, test and control sites were identified for the placement of green tea and placebo strips, respectively. Gingival Index (GI), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL) were examined at baseline, first, second, third, and fourth weeks. Microbiological analysis for Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans was performed at baseline and fourth week. The in vitro study showed 10.67% green tea release at 30 min; thereafter, a slow release was noted till 120 min. Both groups showed significant reduction in GI scores at the test sites. Group 1 showed significant (P < 0.001) PPD reduction at different time intervals at the test sites. However, group 2 showed significant reduction from baseline (5.30 ± 0.70) to fourth week (3.5 ± 0.97). Statistically significant gain in CAL at the test sites was observed both in group 1 (1.33 mm) and group 2 (1.43 mm). The prevalence of P. gingivalis in group 1 test sites was significantly reduced from baseline (75%) to fourth week (25%). Local drug delivery using green tea extract could be used as an adjunct in the treatment of chronic periodontitis in diabetic and non-diabetic individuals.

Hypoglycemia Reduction and Changes in Hemoglobin A1c in the ASPIRE In-Home Study.

PubMed

Weiss, Ram; Garg, Satish K; Bode, Bruce W; Bailey, Timothy S; Ahmann, Andrew J; Schultz, Kenneth A; Welsh, John B; Shin, John J

2015-08-01

ASPIRE In-Home randomized 247 subjects with type 1 diabetes to sensor-augmented pump therapy with or without the Threshold Suspend (TS) feature, which interrupts insulin delivery at a preset sensor glucose value. We studied the effects of TS on nocturnal hypoglycemia (NH) in relation to baseline hemoglobin A1c (A1C) and change in A1C during the study. NH event rates and mean area under curve (AUC) of NH events were evaluated at different levels of baseline A1C (<7%, 7-8%, and >8%) and at different levels of changes in A1C (less than -0.3% [decreased], -0.3% to 0.3% [stable], and >0.3% [increased]), in the TS Group compared with the Control Group (sensor-augmented pump only). In the TS Group, 27.9% of the NH events were accompanied by a confirmatory blood glucose value, compared with 39.3% in the Control Group. Among subjects with baseline A1C levels of <7% or 7-8%, those in the TS Group had significantly lower NH event rates than those in the Control Group (P=0.001 and P=0.004, respectively). Among subjects with decreased or stable A1C levels, those in the TS Group had significantly lower NH event rates, and the events had lower AUCs (P≤0.001 for each). Among subjects with increased A1C levels, those in the TS Group had NH events with significantly lower AUCs (P<0.001). Use of the TS feature was associated with decreases in the rate and severity (as measured by AUC) of NH events in many subjects, including those with low baseline A1C levels and those whose A1C values decreased during the study period. Use of the TS feature can help protect against hypoglycemia in those wishing to intensify diabetes management to achieve target glucose levels.

Hypoglycemia Reduction and Changes in Hemoglobin A1c in the ASPIRE In-Home Study

PubMed Central

Weiss, Ram; Garg, Satish K.; Bode, Bruce W.; Bailey, Timothy S.; Ahmann, Andrew J.; Schultz, Kenneth A.; Welsh, John B.

2015-01-01

Abstract Background: ASPIRE In-Home randomized 247 subjects with type 1 diabetes to sensor-augmented pump therapy with or without the Threshold Suspend (TS) feature, which interrupts insulin delivery at a preset sensor glucose value. We studied the effects of TS on nocturnal hypoglycemia (NH) in relation to baseline hemoglobin A1c (A1C) and change in A1C during the study. Materials and Methods: NH event rates and mean area under curve (AUC) of NH events were evaluated at different levels of baseline A1C (<7%, 7–8%, and >8%) and at different levels of changes in A1C (less than −0.3% [decreased], −0.3% to 0.3% [stable], and >0.3% [increased]), in the TS Group compared with the Control Group (sensor-augmented pump only). Results: In the TS Group, 27.9% of the NH events were accompanied by a confirmatory blood glucose value, compared with 39.3% in the Control Group. Among subjects with baseline A1C levels of <7% or 7–8%, those in the TS Group had significantly lower NH event rates than those in the Control Group (P=0.001 and P=0.004, respectively). Among subjects with decreased or stable A1C levels, those in the TS Group had significantly lower NH event rates, and the events had lower AUCs (P≤0.001 for each). Among subjects with increased A1C levels, those in the TS Group had NH events with significantly lower AUCs (P<0.001). Conclusions: Use of the TS feature was associated with decreases in the rate and severity (as measured by AUC) of NH events in many subjects, including those with low baseline A1C levels and those whose A1C values decreased during the study period. Use of the TS feature can help protect against hypoglycemia in those wishing to intensify diabetes management to achieve target glucose levels. PMID:26237308

The utility of serum tryptase in the diagnosis of food-induced anaphylaxis.

PubMed

Wongkaewpothong, Patcharaporn; Pacharn, Punchama; Sripramong, Chaweewan; Boonchoo, Siribangon; Piboonpocanun, Surapon; Visitsunthorn, Nualanong; Vichyanond, Pakit; Jirapongsananuruk, Orathai

2014-07-01

This study investigates the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis. Patients with a history of shrimp allergy and positive skin prick tests (SPT) to commercial shrimp extract were recruited for shrimp challenges. Serum total tryptase was obtained at baseline and 60 min (peak) after the onset of symptoms. Thirty-nine patients were challenged. There were 12 patients with anaphylaxis, 20 with mild reactions and 7 without symptoms (control group). Characteristic features and baseline tryptase were not different among the 3 groups. The peak tryptase levels were higher than the baseline in anaphylaxis and mild reaction groups (P<0.05). The delta-tryptase (peak minus baseline) and the tryptase ratio (peak divided by baseline) in the anaphylaxis group were higher than the mild reaction and control groups (P<0.01). The optimum cut-off for peak tryptase to confirm anaphylaxis was 2.99 µg/L with 50% sensitivity, 85% specificity, 3.33 positive likelihood ratio (LR) and 0.59 negative LR. The manufacturer's cut-off for peak tryptase was >11.4 µg/L with 17% sensitivity, 100% specificity, infinity positive LR and 0.83 negative LR. The best cut-off for delta-tryptase was ≥0.8 µg/L with 83% sensitivity, 93% specificity, 11.86 positive LR and 0.18 negative LR. The best cut-off for tryptase ratio was ≥1.5 with 92% sensitivity, 96% specificity, 23 positive LR and 0.08 negative LR. The peak tryptase level should be compared with the baseline value to confirm anaphylaxis. The tryptase ratio provide the best sensitivity, specificity, positive and negative LR than a single peak serum tryptase for the confirmation of shrimp-induced anaphylaxis.

LIFECOURSE SOCIOECONOMIC POSITION AND 16 YEAR BODY MASS INDEX TRAJECTORIES : DIFFERENCES BY RACE AND SEX

PubMed Central

Insaf, Tabassum Z; Shaw, Benjamin A; Yucel, Recai M; Chasan-Taber, Lisa; Strogatz, David S

2014-01-01

Objective To evaluate the association between lifecourse socioeconomic position (SEP) and changes in body mass index (BMI), and assess disparities in these associations across racial/ethnic groups. Methods With longitudinal data from 4 waves of the Americans Changing Lives Study (1986–2002), we employed mixed-effects modeling to estimate BMI trajectories for 1,174 Blacks and 2,323 White adults. We also estimated associations between these trajectories and lifecourse SEP variables, including father’s education, perceived childhood SEP, own education, income, wealth, and financial security. Results Blacks had higher baseline BMI’s, and steeper increases in BMI, compared to Whites. Childhood SEP, as measured by high father’s education, was associated with lower baseline BMI among Whites. High education was associated with a lower baseline BMI within both race and sex categories. Income had contrasting effects among men and women. Higher income, was associated with higher BMI only among males Associations between indicators of SEP and BMI trajectories were only found for Whites. Conclusions Our study demonstrates that lifecourse SEP may influence adult BMI differently within different racial and sex groups. PMID:24967954

Characteristics and Behavioral Outcomes for Youth in Group Care and Family-Based Care: A Propensity Score Matching Approach Using National Data

ERIC Educational Resources Information Center

James, Sigrid; Roesch, Scott; Zhang, Jin Jin

2012-01-01

This study aimed to answer two questions: (a) Given expected differences in children who are placed in group care compared to those in family-based settings, is it possible to match children on baseline characteristics? (b) Are there differences in behavioral outcomes for youth with episodes in group care versus those in family-based care? Using…

Gender differences in psychotic disorders with concurrent substance use.

PubMed

Caton, Carol L M; Xie, Haiyi; Drake, Robert E; McHugo, Gregory

2014-01-01

We conducted a comparative analysis of gender differences in patients with primary psychotic disorders with concurrent substance use and in those with substance-induced psychoses. A total of 385 individuals admitted to psychiatric emergency departments with early-onset psychosis and recent substance use were interviewed at baseline and at six-month intervals for two years. Using a standardized research diagnostic assessment instrument, we classified patients at baseline into primary and substance-induced psychosis groups and analyzed the effects of gender on demographic, family, and clinical characteristics at baseline, the interaction of gender and diagnosis, and gender main effects on illness course, adjustment, and service use over the two-year follow-up period. Women had better premorbid adjustment, less misattribution of symptoms, and a later age at onset of regular drug use compared to men. Women, however, showed greater depression and histories of abuse compared to men. Men had greater arrest histories. No interactions between gender and diagnosis were significant. Both genders in the primary and substance-induced psychosis groups showed clinical and functional improvement over the follow-up period despite the overall minimal use of mental health and substance abuse treatment services. Women and men with psychosis and substance use differ on several dimensions. Our findings suggest the need for gender-specific treatment programming across both diagnostic groups.

Thalamofrontal neurodevelopment in new-onset pediatric idiopathic generalized epilepsy

PubMed Central

Dabbs, K.; Tuchsherer, V.; Sheth, R.D.; Koehn, M.A.; Hermann, B.P.; Seidenberg, M.

2011-01-01

Background: Quantitative MRI techniques have demonstrated thalamocortical abnormalities in idiopathic generalized epilepsy (IGE). However, there are few studies examining IGE early in its course and the neurodevelopmental course of this region is not adequately defined. Objective: We examined the 2-year developmental course of the thalamus and frontal lobes in pediatric new-onset IGE (i.e., within 12 months of diagnosis). Methods: We performed whole-brain MRI in 22 patients with new-onset IGE and 36 age-matched healthy controls. MRI was repeated 24 months after baseline MRI. Quantitative volumetrics were used to examine thalamic and frontal lobe volumes. Results: The IGE group showed significant differences in thalamic volume within 1 year of seizure onset (baseline) and went on to show thalamic volume loss at a significantly faster rate than healthy control children over the 2-year interval. The control group also showed a significantly greater increase in frontal white matter expansion than the IGE group. In contrast, frontal lobe gray matter volume differences were moderate at baseline and persisted over time, indicating similar developmental trajectories with differences early in the disease process that are maintained. Conclusions: Brain tissue abnormalities in thalamic and frontal regions can be identified very early in the course of IGE and an abnormal trajectory of growth continues over a 2-year interval. PMID:21205692

Thalamofrontal neurodevelopment in new-onset pediatric idiopathic generalized epilepsy.

PubMed

Pulsipher, D T; Dabbs, K; Tuchsherer, V; Sheth, R D; Koehn, M A; Hermann, B P; Seidenberg, M

2011-01-04

Quantitative MRI techniques have demonstrated thalamocortical abnormalities in idiopathic generalized epilepsy (IGE). However, there are few studies examining IGE early in its course and the neurodevelopmental course of this region is not adequately defined. We examined the 2-year developmental course of the thalamus and frontal lobes in pediatric new-onset IGE (i.e., within 12 months of diagnosis). We performed whole-brain MRI in 22 patients with new-onset IGE and 36 age-matched healthy controls. MRI was repeated 24 months after baseline MRI. Quantitative volumetrics were used to examine thalamic and frontal lobe volumes. The IGE group showed significant differences in thalamic volume within 1 year of seizure onset (baseline) and went on to show thalamic volume loss at a significantly faster rate than healthy control children over the 2-year interval. The control group also showed a significantly greater increase in frontal white matter expansion than the IGE group. In contrast, frontal lobe gray matter volume differences were moderate at baseline and persisted over time, indicating similar developmental trajectories with differences early in the disease process that are maintained. Brain tissue abnormalities in thalamic and frontal regions can be identified very early in the course of IGE and an abnormal trajectory of growth continues over a 2-year interval.

The effects of earphones and music on the temperature measured by infrared tympanic thermmeter: preliminary results.

PubMed

Palese, Alvisa; Pasqualini, Davide

2014-01-01

The main aim of the study was to evaluate the effect on subjects' temperature measurement readings when using the infrared tympanic thermometer after correct earphone placement and use, with or without music transmission through the earphone. A comparative study design was adopted. A sample of 39 healthy people was randomly divided into three groups. Subjects in all groups used an earphone that had been correctly placed in the right ear only: Group 1: listened to heavy metal music through the earphone (13 participants); Group 2: listened to classical music through the earphone (13 participants); Group 3: no music or sound was transmitted through the earphone (13 participants). Average differences (CI 95%) and Pearson correlations for the temperature measured in the right ear, which was exposed to the different independent variables, and the left ear which was not exposed, were calculated at different times: (1) after 10 minutes compared to the baseline measurement; (2) after 30 minutes compared to the 10 minutes measurement; and (3) after 30 minutes compared to the baseline measurement. The inter-ear temperature correlation at the baseline was Pearson r .801 (p = .01). There was a significant decrease in the correlations between right and left ear temperatures in Group 1 and in Group 3 which was demonstrated after 10 minutes of earphone use, and reached critical values after 30 minutes of use in all groups. The average warmth in the right ear, as perceived by participants after 20 minutes, was reported. Using the Numerical Rating Score the average was 3.3 +/- 1.3 for Group 1, for Group 2 was 1.9 +/- 1.3 and for Group 3 was 3.3 +/- 1.2 (p = .05). Within the limitations of the study, which involved a limited number of healthy people the results show that it is best to not measure tympanic temperature in an ear that has very recently had an earphone in place.

Comparison of early dexamethasone retreatment versus standard dexamethasone regimen combined with PRN ranibizumab in diabetic macular edema.

PubMed

Arıkan Yorgun, Mücella; Toklu, Yasin; Mutlu, Melek

2017-02-01

The purpose of the study is to evaluate the efficacy and safety of as-needed dexamethasone (DEX) retreatment compared with standard DEX retreatment combined with PRN ranibizumab injections among patients with persistent diabetic macular edema (DME). Twenty-eight patients with persistent macular edema having recurrence earlier than 6 months after initial DEX implantation were included in this retrospective study. Group I consisted of 13 patients retreated using monthly PRN ranibizumab injections combined with standard 6-monthly DEX implantation; Group II consisted of 15 patients retreated with DEX implantation earlier than 6 months on an "as-needed" basis. There was no significant difference between the groups with regarding to age, gender, HbA1C levels, duration of diabetes, duration of macular edema, baseline central macular thickness (CMT), best-corrected visual acuity (BCVA), and intraocular pressure (IOP) values (p > 0.05). The mean follow-up time of the whole study population was 10.13 ± 1.75 months (range 9-15). The mean CMT values were significantly decreased in both groups compared to baseline values except for the 6th-month CMT in Group I (p < 0.05). The mean logMAR BCVA values were not statistically different between groups during the follow-up compared to baseline BCVA values (p > 0.05). However, a significant change in mean BCVA from baseline was seen at 4th, 6th, and 9th months in Group II (p ≤ 0.05). The mean number of total intravitreal treatments was 3.50 ± 0.77 in Group I and 2.53 ± 0.51 in Group II (p = 0.001). During the follow-up period, one patient in Group I and five patients in Group II had increased IOP (≥25 mmHg). Early DEX retreatment improved vision with superior anatomical improvement at 6th month and with fewer intravitreal treatments in eyes with DME. However, improvement in visual acuity is similar with standard DEX retreatment combined with PRN ranibizumab group.

Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain.

PubMed

Rompe, Jan D; Furia, John; Cacchio, Angelo; Schmitz, Christoph; Maffulli, Nicola

2015-12-01

Whether shock wave therapy or shock wave therapy combined with plantar fascia-specific stretching is more efficient in treating chronic plantar heel pain remains unclear. The aim of the study was to test the null hypothesis of no difference of these two forms of management for patients who had unilateral plantar fasciopathy for a minimum duration of twelve months and which had failed at least three other forms of treatment. One hundred and fifty-two patients with chronic plantar fasciopathy were assigned to receive repetitive low-energy radial shock-wave therapy without local anesthesia, administered weekly for three weeks (Group 1, n = 73) or to receive the identical shock wave treatment and to perform an eight-week plantar fascia-specific stretching program (Group 2, n = 79). All patients completed the nine-item pain subscale of the validated Foot Function Index and a subject-relevant outcome questionnaire. Patients were evaluated at baseline, and at two, four, and twenty-four months after baseline. The primary outcome measures were a mean change in the Foot Function Index sum score at two months after baseline, a mean change in item 2 (pain during the first steps of walking in the morning) on this Index, and satisfaction with treatment. No difference in mean age, sex, weight or duration of symptoms was found between the groups at baseline. At two months after baseline, the Foot Function Index sum score showed significantly greater changes for the patients managed with shock-wave therapy plus plantar fascia-specific stretching than those managed with shock-wave therapy alone (p < 0.001), as well as individually for item 2 (p < 0.001). Twenty-four patients in Group 1 (32%) versus forty-seven patients in Group 2 (59%) were satisfied with the treatment (p < 0.001). Significant differences persisted at four months, but not at twenty-four months. A program of manual stretching exercises specific to the plantar fascia in combination with repetitive low-energy radial shock-wave therapy is more efficient than repetitive low-energy radial shock-wave therapy alone for the treatment of chronic symptoms of proximal plantar fasciopathy. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans.

PubMed

Raskind, Murray A; Peskind, Elaine R; Chow, Bruce; Harris, Crystal; Davis-Karim, Anne; Holmes, Hollie A; Hart, Kimberly L; McFall, Miles; Mellman, Thomas A; Reist, Christopher; Romesser, Jennifer; Rosenheck, Robert; Shih, Mei-Chiung; Stein, Murray B; Swift, Robert; Gleason, Theresa; Lu, Ying; Huang, Grant D

2018-02-08

In randomized trials, prazosin, an α 1 -adrenoreceptor antagonist, has been effective in alleviating nightmares associated with post-traumatic stress disorder (PTSD) in military veterans. We recruited veterans from 13 Department of Veterans Affairs medical centers who had chronic PTSD and reported frequent nightmares. Participants were randomly assigned to receive prazosin or placebo for 26 weeks; the drug or placebo was administered in escalating divided doses over the course of 5 weeks to a daily maximum of 20 mg in men and 12 mg in women. After week 10, participants continued to receive prazosin or placebo in a double-blind fashion for an additional 16 weeks. The three primary outcome measures were the change in score from baseline to 10 weeks on the Clinician-Administered PTSD Scale (CAPS) item B2 ("recurrent distressing dreams"; scores range from 0 to 8, with higher scores indicating more frequent and more distressing dreams); the change in score from baseline to 10 weeks on the Pittsburgh Sleep Quality Index (PSQI; scores range from 0 to 21, with higher scores indicating worse sleep quality); and the Clinical Global Impression of Change (CGIC) score at 10 weeks (scores range from 1 to 7, with lower scores indicating greater improvement and a score of 4 indicating no change). A total of 304 participants underwent randomization; 152 were assigned to prazosin, and 152 to placebo. At 10 weeks, there were no significant differences between the prazosin group and the placebo group in the mean change from baseline in the CAPS item B2 score (between-group difference, 0.2; 95% confidence interval [CI], -0.3 to 0.8; P=0.38), in the mean change in PSQI score (between-group difference, 0.1; 95% CI, -0.9 to 1.1; P=0.80), or in the CGIC score (between-group difference, 0; 95% CI, -0.3 to 0.3; P=0.96). There were no significant differences in these measures at 26 weeks (a secondary outcome) or in other secondary outcomes. At 10 weeks, the mean difference between the prazosin group and the placebo group in the change from baseline in supine systolic blood pressure was a decrease of 6.7 mm Hg. The adverse event of new or worsening suicidal ideation occurred in 8% of the participants assigned to prazosin versus 15% of those assigned to placebo. In this trial involving military veterans who had chronic PTSD, prazosin did not alleviate distressing dreams or improve sleep quality. (Funded by the Department of Veterans Affairs Cooperative Studies Program; PACT ClinicalTrials.gov number, NCT00532493 .).

Substance Use and Abuse Trajectories across Adolescence: A Latent Trajectory Analysis of a Community-Recruited Sample of Girls

ERIC Educational Resources Information Center

Marti, C. Nathan; Stice, Eric; Springer, David W.

2010-01-01

We used data from a school-based study of 496 adolescent girls to identify qualitatively distinct substance use and substance abuse developmental trajectory groups and tested whether the problematic groups differed from the non-problematic groups on baseline and outcome validation variables. Results identified four substance use groups (late…

Microstructure of β-zone parapapillary atrophy and rate of retinal nerve fiber layer thinning in primary open-angle glaucoma.

PubMed

Kim, Yong Woo; Lee, Eun Ji; Kim, Tae-Woo; Kim, Mijin; Kim, Hyunjoong

2014-07-01

To investigate whether the rate of retinal nerve fiber layer (RNFL) thinning differs according to the microstructure of β-zone parapapillary atrophy (PPA) as evaluated by spectral-domain (SD) optical coherence tomography (OCT) in primary open-angle glaucoma (POAG). Prospective, observational, comparative study. A total of 195 eyes with POAG that had been evaluated by serial SD-OCT RNFL thickness measurements for ≥ 2 years. On the basis of the extent of Bruch's membrane (BM) within the β-zone PPA (area without retinal pigment epithelium [RPE]), as shown in the infrared fundus images, PPA was divided into PPA+BM (PPA with intact BM) and PPA-BM (PPA devoid of BM). Eyes were categorized into group A (having PPA+BM only, n=64), group B (having both PPA+BM and PPA-BM, n=58), group C (having PPA-BM only, n=32), and group D (without β-zone PPA, n=41). The rate of progressive OCT RNFL thinning was determined by linear regression and compared between groups. Factors influencing the rate of RNFL thinning were evaluated, including age, sex, follow-up duration, history of filtering surgery, baseline RNFL thickness, baseline intraocular pressure (IOP), mean IOP and IOP fluctuation during follow-up, PPA types, baseline PPA width, PPA width increase, axial length (AXL), central corneal thickness, and visual field mean deviation (MD). Rate of thinning of OCT RNFL thicknesses over time. Patients in groups B and C were significantly younger and more myopic, and had a greater AXL, than those in groups A and D (all P<0.001). The rate of global RNFL thinning was significantly faster in group A (-1.66 ± 2.94 μm/year) than in the other groups (group B, -0.87 ± 1.28 μm/year; group C, 0.20 ± 1.86 μm/year; group D, -0.28 ± 1.74 μm/year; P = 0.001). Multivariate regression showed a significant association of shorter follow-up period (P = 0.016), greater baseline global RNFL thickness (P = 0.035), type of β-zone PPA (group A, P = 0.023), and greater baseline PPA+BM width (P = 0.034) with a faster rate of RNFL thinning. The rate of RNFL thinning differed according to the microstructure of β-zone PPA. It was faster for eyes with β-zone PPA with intact BM than for eyes without β-zone PPA or with β-zone PPA devoid of BM. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome.

PubMed

Roy, Ambuj; Roe, Matthew T; Neely, Megan L; Cyr, Derek D; Zamoryakhin, Dmitry; Fox, Keith A A; White, Harvey D; Armstrong, Paul W; Ohman, E Magnus; Prabhakaran, Dorairaj

2015-02-01

To study the impact of national economic and human development status on patient profiles and outcomes in the setting of acute coronary syndrome (ACS). We conducted a retrospective analysis of the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial (TRILOGY ACS) population (51 countries; 9301 patients). Outcome measures compared baseline characteristics and clinical outcomes through 30 months by 2010 country-level United Nations Human Development Indices (HDIs) and per-capita gross national income. TRILOGY ACS enrolled 3659 patients from 27 very-high HDI countries, 3744 from 18 high-HDI countries and 1898 from 6 medium-HDI countries. Baseline characteristics of groups varied significantly, with the medium-HDI group having a lower mean age (63.0 years, vs 65.0 and 68.0 years for high-HDI and very-high HDI, respectively; p<0.001), lower baseline Global Registry of Acute Coronary Events risk score and lower rate of non-ST-segment elevation myocardial infarction (58.0%, vs 62.2% and 83.9% among high-HDI and very-high HDI, respectively). Medium-HDI and high-HDI patients had lower unadjusted 30-month rates for the composite of cardiovascular death/myocardial infarction/stroke (17.6%, 16.9% and 23.1% for medium-HDI, high-HDI and very-high HDI, respectively); this difference disappeared after adjusting for baseline characteristics. Adjusted HRs for the composite endpoint were lower in lower-income/middle-income countries vs upper-income/middle-income (0.791(95% CI 0.632 to 0.990)) and high-income countries (0.756 (95% CI 0.616 to 0.928)), with differences largely attributable to myocardial infarction rates. Clinical patient profiles differed substantially by country HDI groupings. Lower unadjusted event rates in medium-HDI countries may be explained by younger age and lower comorbidity burden among these countries' patients. This heterogeneity in patient recruitment across country HDI groupings may have important implications for future global ACS trial design. NCT00699998. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Effects of Baseline Levels of Flexibility and Vertical Jump Ability on Performance Following Different Volumes of Static Stretching and Potentiating Exercises in Elite Gymnasts

PubMed Central

Donti, Olyvia; Tsolakis, Charilaos; Bogdanis, Gregory C.

2014-01-01

This study examined the effects of baseline flexibility and vertical jump ability on straight leg raise range of motion (ROM) and counter-movement jump performance (CMJ) following different volumes of stretching and potentiating exercises. ROM and CMJ were measured after two different warm-up protocols involving static stretching and potentiating exercises. Three groups of elite athletes (10 male, 14 female artistic gymnasts and 10 female rhythmic gymnasts) varying greatly in ROM and CMJ, performed two warm-up routines. One warm-up included short (15 s) static stretching followed by 5 tuck jumps, while the other included long static stretching (30 s) followed by 3x5 tuck jumps. ROM and CMJ were measured before, during and for 12 min after the two warm-up routines. Three-way ANOVA showed large differences between the three groups in baseline ROM and CMJ performance. A type of warm-up x time interaction was found for both ROM (p = 0.031) and CMJ (p = 0.016). However, all athletes, irrespective of group, responded in a similar fashion to the different warm-up protocols for both ROM and CMJ, as indicated from the lack of significant interactions for group (condition x group, time x group or condition x time x group). In the short warm-up protocol, ROM was not affected by stretching, while in the long warm-up protocol ROM increased by 5.9% ± 0.7% (p = 0.001) after stretching. Similarly, CMJ remained unchanged after the short warm-up protocol, but increased by 4.6 ± 0.9% (p = 0.012) 4 min after the long warm- up protocol, despite the increased ROM. It is concluded that the initial levels of flexibility and CMJ performance do not alter the responses of elite gymnasts to warm-up protocols differing in stretching and potentiating exercise volumes. Furthermore, 3 sets of 5 tuck jumps result in a relatively large increase in CMJ performance despite an increase in flexibility in these highly-trained athletes. Key Points The initial levels of flexibility and vertical jump ability have no effect on straight leg raise range of motion (ROM) and counter-movement jump performance (CMJ) of elite gymnasts following warm-up protocols differing in stretching and potentiating exercise volumes Stretching of the main leg muscle groups for only 15 s has no effect on ROM of elite gymnasts In these highly-trained athletes, one set of 5 tuck jumps during warm-up is not adequate to increase CMJ performance, while 3 sets of 5 tuck jumps result in a relatively large increase in CMJ performance (by 4.6% above baseline), despite a 5.9% increase in flexibility due to the 30 s stretching exercises PMID:24570613

Comparative assessment of the efficacy and safety of acarbose and metformin combined with premixed insulin in patients with type 2 diabetes mellitus

PubMed Central

Wu, Honghua; Liu, Jie; Lou, Qingqing; Liu, Jing; Shen, Li; Zhang, Mingxia; Lv, Xiaofeng; Gu, Mingjun; Guo, Xiaohui

2017-01-01

Abstract This study, a subgroup analysis of the data from the Organization Program of DiabEtes INsulIN ManaGement study, aimed to compare the efficacy and safety profiles of acarbose and metformin used in combination with premixed insulin. This analysis included 80 and 192 patients taking only 1 oral antidiabetic drug, classified into acarbose (treated with acarbose + insulin) and metformin groups (treated with metformin + insulin), respectively. The efficacy and safety data were analyzed for within- and between-group differences. The clinical trial registry number was NCT01338376. The percentage of patients who achieved target hemoglobin A1c (HbA1c) <7% in the acarbose and metformin groups were 38.75% and 30.73%, respectively, after a 16-week treatment. The average HbA1c levels in the acarbose and metformin groups were comparable at baseline and decreased significantly in both groups at the end of the study. All 7 blood glucose decreased significantly in both groups at endpoint compared with that at baseline. Insulin consumption was higher in the metformin group in terms of total daily amount and units/kg body weight. Incidences of hypoglycemia were similar in both groups. Body weight changed significantly in both groups from baseline to endpoint, but with no significant difference between the groups. Mean scores of Morisky Medication Adherence Scale improved in both groups at endpoint. Combination of insulin with acarbose or metformin could improve glycemic control in patients with type 2 diabetes mellitus. Acarbose and metformin were found to be comparable in terms of efficacy, weight gain, and incidence of hypoglycemia. PMID:28858080

Comparative assessment of the efficacy and safety of acarbose and metformin combined with premixed insulin in patients with type 2 diabetes mellitus.

PubMed

Wu, Honghua; Liu, Jie; Lou, Qingqing; Liu, Jing; Shen, Li; Zhang, Mingxia; Lv, Xiaofeng; Gu, Mingjun; Guo, Xiaohui

2017-09-01

This study, a subgroup analysis of the data from the Organization Program of DiabEtes INsulIN ManaGement study, aimed to compare the efficacy and safety profiles of acarbose and metformin used in combination with premixed insulin.This analysis included 80 and 192 patients taking only 1 oral antidiabetic drug, classified into acarbose (treated with acarbose + insulin) and metformin groups (treated with metformin + insulin), respectively. The efficacy and safety data were analyzed for within- and between-group differences. The clinical trial registry number was NCT01338376.The percentage of patients who achieved target hemoglobin A1c (HbA1c) <7% in the acarbose and metformin groups were 38.75% and 30.73%, respectively, after a 16-week treatment. The average HbA1c levels in the acarbose and metformin groups were comparable at baseline and decreased significantly in both groups at the end of the study. All 7 blood glucose decreased significantly in both groups at endpoint compared with that at baseline. Insulin consumption was higher in the metformin group in terms of total daily amount and units/kg body weight. Incidences of hypoglycemia were similar in both groups. Body weight changed significantly in both groups from baseline to endpoint, but with no significant difference between the groups. Mean scores of Morisky Medication Adherence Scale improved in both groups at endpoint.Combination of insulin with acarbose or metformin could improve glycemic control in patients with type 2 diabetes mellitus. Acarbose and metformin were found to be comparable in terms of efficacy, weight gain, and incidence of hypoglycemia.

Primary Prevention of Lead Exposure: The Philadelphia Lead Safe Homes Study

PubMed Central

Campbell, Carla; Tran, Mary; Gracely, Edward; Starkey, Naomi; Kersten, Hans; Palermo, Peter; Rothman, Nancy; Line, Laura; Hansen-Turton, Tine

2011-01-01

Objective Lead exposure in children can lead to neuropsychological impairment. This study tested whether primary prevention interventions in the newborn period prevent elevated blood lead levels (BLLs). Methods The Philadelphia Lead Safe Homes (LSH) Study offered parental education, home evaluation, and lead remediation to the families of urban newborns. Households were randomized to a standard lead education group or maintenance education group. We conducted home visits at baseline, six months, and 12 months. To compare BLLs, we identified a matched comparison group. Results We enrolled and randomized 314 newborns in the intervention component; 110 completed the study. There were few significant differences between the randomized groups. In the combined intervention groups, positive results on visual inspection declined from baseline to 12 months (97.0% to 90.6%, p=0.007). At baseline, 36.9% of homes were above the U.S. Environmental Protection Agency's lead dust standard, compared with 26.9% at 12 months (p=0.032), mainly due to a drop in windowsill dust levels. Both groups showed a significant increase in parental scores on a lead education test. Children in the intervention and matched control groups had similar geometric mean initial BLLs (2.6 vs. 2.7, p=0.477), but a significantly higher percentage of children in the intervention group had an initial blood lead screening compared with those in the matched group (88.9% vs. 84.4%, p=0.032). Conclusions A study of primary prevention of lead exposure showed a higher blood lead screening rate for the combined intervention groups and mean BLLs at one year of age not statistically different from the comparison group. Most homes had lead hazards. Lead education significantly increased knowledge. PMID:21563715

Primary prevention of lead exposure: the Philadelphia lead safe homes study.

PubMed

Campbell, Carla; Tran, Mary; Gracely, Edward; Starkey, Naomi; Kersten, Hans; Palermo, Peter; Rothman, Nancy; Line, Laura; Hansen-Turton, Tine

2011-01-01

Lead exposure in children can lead to neuropsychological impairment. This study tested whether primary prevention interventions in the newborn period prevent elevated blood lead levels (BLLs). The Philadelphia Lead Safe Homes (LSH) Study offered parental education, home evaluation, and lead remediation to the families of urban newborns. Households were randomized to a standard lead education group or maintenance education group. We conducted home visits at baseline, six months, and 12 months. To compare BLLs, we identified a matched comparison group. We enrolled and randomized 314 newborns in the intervention component; 110 completed the study. There were few significant differences between the randomized groups. In the combined intervention groups, positive results on visual inspection declined from baseline to 12 months (97.0% to 90.6%, p = 0.007). At baseline, 36.9% of homes were above the U.S. Environmental Protection Agency's lead dust standard, compared with 26.9% at 12 months (p = 0.032), mainly due to a drop in windowsill dust levels. Both groups showed a significant increase in parental scores on a lead education test. Children in the intervention and matched control groups had similar geometric mean initial BLLs (2.6 vs. 2.7, p = 0.477), but a significantly higher percentage of children in the intervention group had an initial blood lead screening compared with those in the matched group (88.9% vs. 84.4%, p = 0.032). A study of primary prevention of lead exposure showed a higher blood lead screening rate for the combined intervention groups and mean BLLs at one year of age not statistically different from the comparison group. Most homes had lead hazards. Lead education significantly increased knowledge.

Validity and Reliability of Baseline Testing in a Standardized Environment.

PubMed

Higgins, Kathryn L; Caze, Todd; Maerlender, Arthur

2017-08-11

The Immediate Postconcussion Assessment and Cognitive Testing (ImPACT) is a computerized neuropsychological test battery commonly used to determine cognitive recovery from concussion based on comparing post-injury scores to baseline scores. This model is based on the premise that ImPACT baseline test scores are a valid and reliable measure of optimal cognitive function at baseline. Growing evidence suggests that this premise may not be accurate and a large contributor to invalid and unreliable baseline test scores may be the protocol and environment in which baseline tests are administered. This study examined the effects of a standardized environment and administration protocol on the reliability and performance validity of athletes' baseline test scores on ImPACT by comparing scores obtained in two different group-testing settings. Three hundred-sixty one Division 1 cohort-matched collegiate athletes' baseline data were assessed using a variety of indicators of potential performance invalidity; internal reliability was also examined. Thirty-one to thirty-nine percent of the baseline cases had at least one indicator of low performance validity, but there were no significant differences in validity indicators based on environment in which the testing was conducted. Internal consistency reliability scores were in the acceptable to good range, with no significant differences between administration conditions. These results suggest that athletes may be reliably performing at levels lower than their best effort would produce. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Intravenous injection of gadobutrol in an epidemiological study group did not lead to a difference in relative signal intensities of certain brain structures after 5 years.

PubMed

Kromrey, Marie-Luise; Liedtke, Kim Rouven; Ittermann, Till; Langner, Sönke; Kirsch, Michael; Weitschies, Werner; Kühn, Jens-Peter

2017-02-01

To investigate if application of macrocyclic gadolinium-based contrast agents in volunteers is associated with neuronal deposition detected by magnetic resonance imaging in a 5-year longitudinal survey. Three hundred eighty-seven volunteers who participated in a population-based study were enrolled. Subjects underwent plain T1-weighted brain MRI at baseline and 5 years later with identical sequence parameters. At baseline, 271 participants additionally received intravenous injection of the macrocyclic contrast agent gadobutrol (0.15 mmol/kg). A control group including 116 subjects received no contrast agent. Relative signal intensities of thalamus, pallidum, pons and dentate nucleus were compared at baseline and follow-up. No difference in relative signal intensities was observed between contrast group (thalamus, p = 0.865; pallidum, p = 0.263; pons, p = 0.533; dentate nucleus, p = 0.396) and control group (thalamus, p = 0.683; pallidum; p = 0.970; pons, p = 0.773; dentate nucleus, p = 0.232) at both times. Comparison between both groups revealed no significant differences in relative signal intensities (thalamus, p = 0.413; pallidum, p = 0.653; pons, p = 0.460; dentate nucleus, p = 0.751). The study showed no significant change in globus pallidus-to-thalamus or dentate nucleus-to-pons ratios. Five years after administration of a 1.5-fold dose gadobutrol to normal subjects, signal intensity of thalamus, pallidum, pons and dentate nucleus did not differ from participants who had not received gadobutrol. • Gadobutrol does not lead to neuronal signal alterations after 5 years. • Neuronal deposition of macrocyclic contrast agent could not be confirmed. • Macrocyclic contrast agents in a proven dosage are safe.

Distress levels in patients with oropharyngeal vs. non-oropharyngeal squamous cell carcinomas of the head and neck over 1 year after diagnosis: a retrospective cohort study.

PubMed

Schorr, Melissa; Carlson, Linda E; Lau, Harold Y; Zhong, Lihong; Bultz, Barry D; Waller, Amy; Groff, Shannon L; Hao, Desiree

2017-10-01

Human papillomavirus (HPV)-related cancers have been associated with different demographic profiles and disease characteristics than HPV-unrelated cancers in head and neck patients, but distress and other symptoms have not been compared. The aim of this study was to assess whether distress levels, fatigue, pain, anxiety, depression, and common psychological and practical problems differ between head and neck cancer patients with HPV-related vs. HPV-unrelated carcinomas (using oropharyngeal carcinoma (OPC) and non-OPC cancers as surrogates for HPV status). Distress, depression, anxiety, fatigue, pain, and common problems were examined in 56 OPC and 90 non-OPC patients at 4 timepoints during the first year following diagnosis. Two-level hierarchical linear modeling was used to examine effects. The HPV-related OPC group was more likely to be younger (p = 0.05), Caucasian (p = 0.001), non-smokers (p = 0.01), earn more (p = 0.04), and present with more advanced stage (p < 0.0001). At baseline, OPC patients reported only higher pain scores (p = 0.01) than non-OPC patients. Total problems decreased more in the OPC group (p = 0.08) than the non-OPC group from baseline to 12-month follow-up. In both groups, scores on distress, depression, psychosocial problems, and practical problems decreased similarly over time. Despite a difference in the clinico-demographic characteristics of HPV-related vs. HPV-unrelated patients, only baseline pain levels and total problems over time differed between the two groups.

Biofilm removal from implants supported restoration using different instruments: a 6-month comparative multicenter clinical study.

PubMed

Blasi, Andrea; Iorio-Siciliano, Vincenzo; Pacenza, Carina; Pomingi, Francesca; Matarasso, Sergio; Rasperini, Giulio

2016-02-01

The aim of this study was to compare the efficacy of different instruments on biofilm removal from implant supported restorations. The study was designed as comparative multicenter clinical study including patients proceeding from the Milan, Naples, and Buenos Aires, with a peri-implant mucositis. Implants enrolled for the study were allocated in 4 groups and treated with ultrasonic scalers with plastic tips, with titanium curettes, with airflow with glycine powder, and with rubber cup and polishing paste, respectively. mPI was assessed at baseline, immediately after therapy, at 1, 3, and 6 months. mBI, PD, and REC were assessed at baseline, 1, 3, and 6 months. All parameters were recorded on six sites per implant. Kruskal-Wallis and Mann-Whitney tests were used to compare groups and centers. A generalized linear model for repeated measures was chosen for inter-group comparison. An intra-group comparison was performed with repeated measure ANOVA test to assess differences between baseline and recalls. A total of 89 patients (39 males, 50 females) were enrolled in the study, and 141 implants were available for the analysis. 55 implants were enrolled in University of Buenos Aires, 32 in University of Milan, and 54 in University of Naples. There were no significant differences between the four groups in inflammatory status reduction of peri-implant mucosa. Non-surgical therapy is effective in reducing peri-implant mucositis. Sonic scaler with plastic tip and rubber cup with polishing paste showed higher efficacy when compared with titanium curettes or airflow with glycine powder. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinical Characteristics of Proper Robot-Assisted Gait Training Group in Non-ambulatory Subacute Stroke Patients

PubMed Central

Kim, Soo Jeong; Lee, Hye Jin; Hwang, Seung Won; Pyo, Hannah; Yang, Sung Phil; Lim, Mun-Hee; Park, Gyu Lee

2016-01-01

Objective To identify the clinical characteristics of proper robot-assisted gait training group using exoskeletal locomotor devices in non-ambulatory subacute stroke patients. Methods A total of 38 stroke patients were enrolled in a 4-week robotic training protocol (2 sessions/day, 5 times/week). All subjects were evaluated for their general characteristics, Functional Ambulatory Classification (FAC), Fugl-Meyer Scale (FMS), Berg Balance Scale (BBS), Modified Rankin Scale (MRS), Modified Barthel Index (MBI), and Mini-Mental Status Examination (MMSE) at 0, 2, and 4 weeks. Statistical analysis were performed to determine significant clinical characteristics for improvement of gait function after robot-assisted gait training. Results Paired t-test showed that all functional parameters except MMSE were improved significantly (p<0.05). The duration of disease and baseline BBS score were significantly (p<0.05) correlated with FAC score in multiple regression models. Receiver operating characteristic (ROC) curve showed that a baseline BBS score of '9' was a cutoff value (AUC, 0.966; sensitivity, 91%–100%; specificity, 85%). By repeated-measures ANOVA, the differences in improved walking ability according to time were significant between group of patients who had baseline BBS score of '9' and those who did not have baseline BBS score of '9' Conclusion Our results showed that a baseline BBS score above '9' and a short duration of disease were highly correlated with improved walking ability after robot-assisted gait training. Therefore, baseline BBS and duration of disease should be considered clinically for gaining walking ability in robot-assisted training group. PMID:27152266

Efficacy of acetylcholinesterase inhibitors versus nootropics in Alzheimer's disease: a retrospective, longitudinal study.

PubMed

Tsolaki, M; Pantazi, T; Kazis, A

2001-01-01

The aim of this study was to investigate the efficacy of nootropics (piracetam, aniracetam, nimodopine and dihydroergicristine) versus acetylcholinesterase inhibitors (AChE-Is) (tacrine and donepezil) in the treatment of Alzheimer's disease. This is a retrospective study of 510 patients with Alzheimer's disease. To determine clinical efficacy of treatment, we used the mean change over time in scores for the following tests: the Mini-Mental State Examination (MMSE); the Cambridge Cognitive Examination for the Elderly; and the Functional Rating Scale for Symptoms of Dementia. In all patients and in patients with severe Alzheimer's disease (baseline MMSE < 11), no significant differences were seen in the neuropsychological test scores between the two treatment groups. In patients with moderate dementia (baseline MMSE between 11 and 20), however, there was a significantly greater deterioration, as shown on the CAMCOG scale, after 12 months' treatment for patients receiving AChE-Is compared with those receiving nootropics (-4.38 for AChE-Is group versus 1.48 for nootropics group). For patients with mild dementia (baseline MMSE score between 21 and 26), there was a significantly greater deterioration on the MMSE scale for each time-point in the nootropics group compared with the AChE-Is group. In conclusion, we did not find any strong evidence that a difference in efficacy exists between AChE-Is and nootropics in the treatment of Alzheimer's disease.

Effect of gatifloxacin ophthalmic solution 0.3% on human corneal endothelial cell density and aqueous humor gatifloxacin concentration.

PubMed

Price, Marianne O; Quillin, Clorissa; Price, Francis W

2005-07-01

To evaluate the effect of gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan, Inc., Irvine, CA, USA) on corneal endothelial cell density and morphology and to measure gatifloxacin penetration into aqueous humor. This was a single-center, open-label clinical study. Ten patients undergoing standard cataract surgery and 20 nonsurgical subjects instilled gatifloxacin 0.3% four times per day for 2 days, then every 10 min for 1 hr on the third day (the surgery day for the cataract patients). Corneal endothelial cells were counted using noncontact specular microscopy. Anterior chamber fluid was withdrawn from the surgical patients, and the gatifloxacin concentration was quantified by high-pressure liquid chromatography. Baseline endothelial cell counts (mean +/- SD) were 2400 +/- 442 in the surgical group and 2520 +/- 212 in the nonsurgical group. The mean differences from baseline 1 hr after the last dose of gatifloxacin 0.3% were -51 +/- 213 (p = 0.23) in the surgical group and -7 +/- 150 (p = 0.42) in the nonsurgical group. In the nonsurgical group, the mean difference from baseline 3 weeks after the last dose was 18 +/- 147 (p = 0.71). The mean concentration (+/- SD) of gatifloxacin in aqueous humor was 1.26 +/- 0.55 microg/ml. A preoperative, prophylactic course of gatifloxacin 0.3% ophthalmic solution did not significantly affect endothelial cell density or morphology, while meaningful drug concentration was achieved in the aqueous humor.

Efficacy of a self-help manual in increasing resilience in carers of adults with depression in Thailand.

PubMed

McCann, Terence V; Songprakun, Wallapa; Stephenson, John

2016-02-01

Caring for a person with a mental illness can have adverse effects on caregivers; however, little is known about how best to help such caregivers. The aim of the present study was to examine the efficacy of a cognitive behaviour therapy-guided self-help manual in increasing resilience in caregivers of individuals with depression, in comparison to caregivers who receive routine support only. A randomized, controlled trial was conducted, following CONSORT guidelines, with 54 caregivers allocated to parallel intervention (self-help manual) (n = 27) or control (standard support) (n = 27) groups. Resilience was assessed at baseline, post-test (week 8), and follow up (week 12). Intention-to-treat analyses were undertaken. Repeated-measures ANOVA indicated a significant difference in resilience scores between the three time points, showing a large effect. Pairwise comparisons between intervention and control groups indicated resilience to be significantly different between baseline and post-test, and between baseline and follow up, but not between post-test and follow up. Overall, the intervention group showed a slightly greater increase in resilience over time than the control group; however, the time-group interaction was not significant. Guided self-help is helpful in improving caregivers' resilience and could be used as an adjunct to the limited support provided to carers by mental health nurses and other clinicians. © 2016 Australian College of Mental Health Nurses Inc.

Risedronate therapy for the prevention of steroid-induced osteoporosis in patients with minimal-change nephrotic syndrome.

PubMed

Takei, Takashi; Itabashi, Mitsuyo; Tsukada, Misao; Sugiura, Hidekazu; Moriyama, Takahito; Kojima, Chiari; Shiohira, Shunji; Shimizu, Ari; Karasawa, Kazunori; Amemiya, Nobuyuki; Kawanishi, Kunio; Ogawa, Tetsuya; Uchida, Keiko; Tsuchiya, Ken; Nitta, Kosaku

2010-01-01

Minimal-change nephrotic syndrome (MCNS) is treated by the administration of prednisolone (PSL) at high doses. Steroid-induced osteoporosis is a serious adverse effect of this drug. Patients with MCNS were randomly assigned to two groups, the risedronate (2.5 mg/day) + alfacalcidol (0.25 µg/day) group (n=20) and the alfacalcidol (0.25 µg/day)-alone group (n=20). All the patients had received PSL and the clinical characteristics were compared between the two groups at baseline and at 12 months. A significant decrease of the mean bone mineral density (BMD) of the lumbar spine from 0.710±0.162 (g/cm(2)) to 0.588±0.125 was observed in the alfacalcidol-alone group (p=0.02), while no such decrease of the bone mineral density was found in the risedronate + alfacalcidol group (0.663±0.169 at baseline and 0.626±0.129 at 12 months). No significant differences in the results of other biochemical tests performed at the baseline and at 12 months were observed between the two groups. The likelihood of development of steroid-induced osteoporosis was influenced by the cumulative dose of PSL, the mean BMD at the baseline, occurrence of disease relapse, and risedronate therapy. Risedronate appears to be effective in preventing steroid-induced osteoporosis. It is necessary to use bisphosphonates to maintain the BMD in patients with MCNS receiving prolonged steroid therapy.

A feasibility study of educational tools for osteomalacia.

PubMed

Waxman, R; Adebajo, A; Robinson, S; Walker, D; Johnson, M; Rahman, A; Samanta, A; Kumar, K; Raza, K; Helliwell, P

2017-03-01

Many people in the UK, particularly people of South Asian origin, are advised to supplement their vitamin D intake, yet most do not. This suggests an unmet educational need. The osteomalacia mind map was developed to meet this need. The mind map contains culturally sensitive images, translated into Urdu and made interactive on a DVD. This study explores the feasibility of a randomised controlled study to measure the effect of education on improving vitamin D knowledge and adherence. This was a pilot and feasibility study. Cluster randomisation was used to avoid inter person contamination. Two South Asian women's groups were recruited to receive information about osteomalacia either by interactive DVD or an Arthritis Research UK leaflet. Knowledge and compliance were tested before and after the educational interventions via a knowledge questionnaire and the measurement of vitamin D and parathormone levels. The groups were found to be mismatched for knowledge, educational attainment and language at baseline. There were also organisational difficulties and possible confounding due to different tutors and translators. The DVD group had high knowledge at baseline which did not improve. The leaflet group had low knowledge at baseline that did improve. The DVD group had lower parathormone which did not change. The leaflet group had an increase in vitamin D but parathormone remained high. Performing a randomised study with this population utilising an educational intervention was difficult to execute. If cluster randomisation is used, extreme care must be taken to match the groups at baseline.

Effect of physical training on urinary incontinence: a randomized parallel group trial in nursing homes.

PubMed

Vinsnes, Anne G; Helbostad, Jorunn L; Nyrønning, Signe; Harkless, Gene E; Granbo, Randi; Seim, Arnfinn

2012-01-01

Residents in nursing homes (NHs) are often frail older persons who have impaired physical activity. Urinary incontinence (UI) is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI. To investigate if an individualized training program designed to improve activity of daily living (ADL) and physical capacity among residents in nursing homes has any impact on UI. This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48) or a control group (n = 50) after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15). Changes were calculated from baseline to 3 months after the end of the intervention. Altogether, 68 participants were included in the analysis, 35 in the intervention group and 33 in the control group. The average age was 84.3 years. The 3 months' postintervention adjusted mean difference between groups according to amount of leakage was 191 g (P = 0.03). This result was statistically significant after adjusting for baseline level, age, sex, and functional status. The leakage increased in residents not receiving the experimental intervention, while UI in the training group showed improvement. The intervention group had significant better results compared with the control group after an individualized training program designed to improve ADL and physical capacity. Further studies are needed to evaluate the effect of a goal-oriented physical training program toward NH residents UI complaints.

Effectiveness of a 'Global Postural Reeducation' program for persistent Low Back Pain: a non-randomized controlled trial

PubMed Central

2010-01-01

Background The aim of this non-randomized controlled trial was to evaluate the effectiveness of a Global Postural Reeducation (GPR) program as compared to a Stabilization Exercise (SE) program in subjects with persistent low back pain (LBP) at short- and mid-term follow-up (ie. 3 and 6 months). Methods According to inclusion and exclusion criteria, 100 patients with a primary complaint of persistent LBP were enrolled in the study: 50 were allocated to the GPR group and 50 to the SE group. Primary outcome measures were Roland and Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index (ODI). Secondary outcome measures were lumbar Visual Analogue Scale (VAS) and Fingertip-to-floor test (FFT). Data were collected at baseline and at 3/6 months by health care professionals unaware of the study. An intention to treat approach was used to analyze participants according to the group to which they were originally assigned. Results Of the 100 patients initially included in the study, 78 patients completed the study: 42 in the GPR group and 36 in the SE group. At baseline, the two groups did not differ significantly with respect to gender, age, BMI and outcome measures. Comparing the differences between groups at short- and mid-term follow-up, the GPR group revealed a significant reduction (from baseline) in all outcome measures with respect to the SE group. The ordered logistic regression model showed an increased likelihood of definitive improvement (reduction from baseline of at least 30% in RMDQ and VAS scores) for the GPR group compared to the SE group (OR 3.9, 95% CI 2.7 to 5.7). Conclusions Our findings suggest that a GPR intervention in subjects with persistent LBP induces a greater improvement on pain and disability as compared to a SE program. These results must be confirmed by further studies with higher methodological standards, including randomization, larger sample size, longer follow-up and subgrouping of the LBP subjects. Trial registration NCT00789204 PMID:21162726

Supplementation with a highly concentrated docosahexaenoic acid plus xanthophyll carotenoid multivitamin in nonproliferative diabetic retinopathy: prospective controlled study of macular function by fundus microperimetry.

PubMed

Rodríguez González-Herrero, María Elena; Ruiz, Marcos; López Román, Francisco Javier; Marín Sánchez, José María; Domingo, Joan Carles

2018-01-01

There is little evidence of real-life outcomes of dietary supplementation with high-dose docosahexaenoic acid (DHA) and carotenoids in patients with diabetic retinopathy (DR). We assessed the effect of supplementation with DHA triglyceride (1,050 mg/d) + xanthophyll carotenoid multivitamin on macular function in nonproliferative DR. Asymptomatic patients with nonproliferative DR were included in a prospective controlled study and assigned (1:1) to the DHA supplementation group or the control group. Macular sensitivity and macular integrity area were the main outcome measures. Functional vision measures (macular function [MAIA™ CenterVue], best-corrected visual acuity), structural retinal measures (central subfield macular thickness), and biochemical parameters (plasma total antioxidant capacity, DHA content of the erythrocyte membrane, and plasma IL-6) were evaluated at baseline and after 45 and 90 days of DHA supplementation. The study included 24 patients (48 eyes) (12 patients, 24 eyes in each group). Baseline clinical characteristics of patients in both groups were similar. Macular sensitivity increased from a mean (SD) of 25.9 (2.4) dB at baseline to 27.3 (2.3) dB at 90 days ( P =0.030) in the DHA group only (between-group differences P <0.19). The macular integrity index decreased from 71.2 (33.2) at baseline to 63.5 (36.4) at 45 days and to 51.6 (35.9) at 90 days ( P =0.002) in the DHA group only (between-group differences P <0.05). Best-corrected visual acuity and central subfield macular thickness did not vary significantly in any of the comparisons and in none of the groups. DHA content of erythrocyte membrane and total antioxidant capacity levels increased significantly only in the DHA group. Plasma IL-6 levels decreased significantly only in the DHA group. In an early stage of DR, supplementation with high-dose DHA plus xanthophyll carotenoid multivitamin during 90 days was associated with a progressive and significant improvement of macular function measured by microperimetry. Biochemical changes supported the effect of DHA.

Effect of oral cleaning using mouthwash and a mouth moisturizing gel on bacterial number and moisture level of the tongue surface of older adults requiring nursing care.

PubMed

Kobayashi, Kenichiro; Ryu, Masahiro; Izumi, Sachi; Ueda, Takayuki; Sakurai, Kaoru

2017-01-01

To evaluate the effect of oral cleaning using a mouthwash and a mouth moisturizing gel on the number of bacteria and moisture level of the tongue surface of older adults requiring nursing care. The 60 participants were randomly divided into groups according to their use of oral cleaning procedures as follows: group 1, mouthwash and a moisturizing gel (M + m); group 2, mouthwash (M); group 3, water and a moisturizing gel (W + m); and group 4, water (W). The number of anaerobic bacteria, tongue coating index and moisture level of the tongue surface were measured at baseline, and after 1 and 2 weeks after cleaning commenced to compare the effectiveness of oral cleaning among the groups. There was no significant difference in baseline measurements among the groups. The numbers of anaerobic bacteria decreased for all groups, and there were significant differences in the rates of decrease after 2 weeks between the M + m and W + m groups, M + m and W groups, and M and W groups. The tongue coating index decreased for all groups. There was no significant difference in the rate of decrease among the groups after 1 week, and there was a significant difference after 2 weeks between the M + m and W groups. The moisture levels of all groups increased, and there were significant differences after 2 weeks between the M + m and M groups, the M + m and W groups, and the W + m and W groups. The most effective cleaning technique was the combination of a mouthwash and a moisturizing gel. Geriatr Gerontol Int 2017; 17: 116-121. © 2015 Japan Geriatrics Society.

Chronic Psychological Stress Was Not Ameliorated by Omega-3 Eicosapentaenoic Acid (EPA).

PubMed

Bradbury, Joanne; Myers, Stephen P; Meyer, Barbara; Brooks, Lyndon; Peake, Jonathan; Sinclair, Andrew J; Stough, Con

2017-01-01

Background: Chronic psychological stress and mental health disorders are endemic in Western culture where population dietary insufficiencies of omega-3 fatty acids (n-3FA) from seafood have been observed. Objective: This study was designed to test for a causal relationship between one of the most active components of fish oil, eicosapentaenoic acid (EPA), and chronic psychological stress. Method: A randomized double-blind, placebo-controlled clinical trial with parallel-assignment to two groups was designed (Trial Id: ACTRN12610000404022). The interventions were four EPA-rich fish oil capsules per day, delivering 2.2 g/d EPA (and 0.44 g/d DHA), or identical placebo (low-phenolic olive oil capsules with 5% fish oil to aid blinding). The primary outcome was the between-group difference on the Perceived Stress Scale (PSS-10) after 12 weeks supplementation. An a priori power analysis determined that group sizes of 43 would provide 80% power to detect a significant between-group difference of 12.5%, at α = 0.05. Ninety community members (64 females, 26 males) reporting chronic work stress were recruited via public advertising in northern NSW, Australia. Results: At baseline the omega-3 index (EPA + DHA as % to total fatty acids in red blood cell membranes) was 5.2% in both groups ( SD = 1.6% control group; 1.8% active group). After supplementation this remained stable at 5.3% ( SD = 1.6%) for the control group but increased to 8.9% ( SD = 1.5%) for the active group, demonstrating successful incorporation of EPA into cells. Intention-to-treat (ITT) analysis found no significant between-group differences in PSS outcome scores post-intervention ( b = 1.21, p = 0.30) after adjusting for sex ( b = 2.36, p = 0.079), baseline PSS ( b = 0.42, p = 0.001) and baseline logEPA [ b = 1.41, p = 0.185; F (3, 86) = 8.47, p < 0.01, n = 89, R-square = 0.243]. Discussion: Treatment increased cell membrane EPA but, contrary to the hypothesis, there was no effect on perceived stress. Limitations included an imbalance of gender in groups after randomization (68% of the males were in the placebo group). While we found no significant interaction between sex and group on the outcome after adjusting for baseline PSS, larger studies with groups stratified for gender may be required to further confirm these findings. Conclusion: This study demonstrated that 2. 2 g/day of EPA for 12 weeks did not reduce chronic psychological stress.

Chronic Psychological Stress Was Not Ameliorated by Omega-3 Eicosapentaenoic Acid (EPA)

PubMed Central

Bradbury, Joanne; Myers, Stephen P.; Meyer, Barbara; Brooks, Lyndon; Peake, Jonathan; Sinclair, Andrew J.; Stough, Con

2017-01-01

Background: Chronic psychological stress and mental health disorders are endemic in Western culture where population dietary insufficiencies of omega-3 fatty acids (n-3FA) from seafood have been observed. Objective: This study was designed to test for a causal relationship between one of the most active components of fish oil, eicosapentaenoic acid (EPA), and chronic psychological stress. Method: A randomized double-blind, placebo-controlled clinical trial with parallel-assignment to two groups was designed (Trial Id: ACTRN12610000404022). The interventions were four EPA-rich fish oil capsules per day, delivering 2.2 g/d EPA (and 0.44 g/d DHA), or identical placebo (low-phenolic olive oil capsules with 5% fish oil to aid blinding). The primary outcome was the between-group difference on the Perceived Stress Scale (PSS-10) after 12 weeks supplementation. An a priori power analysis determined that group sizes of 43 would provide 80% power to detect a significant between-group difference of 12.5%, at α = 0.05. Ninety community members (64 females, 26 males) reporting chronic work stress were recruited via public advertising in northern NSW, Australia. Results: At baseline the omega-3 index (EPA + DHA as % to total fatty acids in red blood cell membranes) was 5.2% in both groups (SD = 1.6% control group; 1.8% active group). After supplementation this remained stable at 5.3% (SD = 1.6%) for the control group but increased to 8.9% (SD = 1.5%) for the active group, demonstrating successful incorporation of EPA into cells. Intention-to-treat (ITT) analysis found no significant between-group differences in PSS outcome scores post-intervention (b = 1.21, p = 0.30) after adjusting for sex (b = 2.36, p = 0.079), baseline PSS (b = 0.42, p = 0.001) and baseline logEPA [b = 1.41, p = 0.185; F(3, 86) = 8.47, p < 0.01, n = 89, R-square = 0.243]. Discussion: Treatment increased cell membrane EPA but, contrary to the hypothesis, there was no effect on perceived stress. Limitations included an imbalance of gender in groups after randomization (68% of the males were in the placebo group). While we found no significant interaction between sex and group on the outcome after adjusting for baseline PSS, larger studies with groups stratified for gender may be required to further confirm these findings. Conclusion: This study demonstrated that 2. 2 g/day of EPA for 12 weeks did not reduce chronic psychological stress. PMID:29163147

Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus

PubMed Central

Chen, Yao

2016-01-01

Aims. To evaluate the efficacy and safety of mulberry twig alkaloid (SZ-A) tablet compared with acarbose in patients with type 2 diabetes. Methods. This clinical trial enrolled 38 patients who were randomized into two groups (SZ-A: 23; acarbose: 15) and were treated for 24 weeks. Patients and clinical trial staffs were masked to treatment assignment throughout the study. The primary outcome measures were glycated hemoglobin (HbA1c) and 1-hour and 2-hour postprandial and fasting plasma glucose levels from baseline to the end of treatment. Analysis included all patients who completed this study. Results. By the end of this study, HbA1c level in SZ-A group was decreased from baseline significantly (P < 0.001). No significant difference was found when compared with acarbose group (P = 0.652). Similarly, 1-hour and 2-hour postprandial plasma glucose levels in SZ-A group were decreased from baseline statistically (P < 0.05), without any significant differences compared with acarbose group (P = 0.748 and 0.558, resp.). The fasting plasma glucose levels were not significantly changed in both groups. One of 23 patients in SZ-A group (4.76%) and 5 of 15 patients in acarbose group (33.33%) suffered from gastrointestinal adverse events. Conclusions. Compared with acarbose, SZ-A tablet was effective and safe in glycemic control in patients with type 2 diabetes. PMID:27547230

Pre-treatment red blood cell distribution width provides prognostic information in multiple myeloma.

PubMed

Zhou, Di; Xu, Peipei; Peng, Miaoxin; Shao, Xiaoyan; Wang, Miao; Ouyang, Jian; Chen, Bing

2018-06-01

The red blood cell distribution width (RDW), a credible marker for abnormal erythropoiesis, has recently been studied as a prognostic factor in oncology, but its role in multiple myeloma (MM) hasn't been thoroughly investigated. We performed a retrospective study in 162 patients with multiple myeloma. Categorical parameters were analyzed using Pearson chi-squared test. The Mann-Whitney and Wilcoxon tests were used for group comparisons. Comparisons of repeated samples data were analyzed with the general linear model repeated-measures procedure. The Kaplan-Meier product-limit method was used to determine OS and PFS, and the differences were assessed by the log-rank test. High RDW baseline was significantly associated with indexes including haemoglobin, bone marrow plasma cell infiltration, and cytogenetics risk stratification. After chemotherapy, the overall response rate (ORR) decreased as RDW baseline increased. In 24 patients with high RDW baseline, it was revealed RDW value decreased when patients achieved complete remission (CR), but increased when the disease progressed. The normal-RDW baseline group showed both longer overall survival (OS) and progression-free survival (PFS) than the high-RDW baseline group. Our study suggests pre-treatment RDW level is a prognostic factor in MM and should be regarded as an important parameter for assessment of therapeutic efficiency. Copyright © 2018. Published by Elsevier B.V.

The Impact of ART on the Economic Outcomes of People Living with HIV/AIDS.

PubMed

Nannungi, Annet; Wagner, Glenn; Ghosh-Dastidar, Bonnie

2013-01-01

Background. Clinical benefits of ART are well documented, but less is known about its effects on economic outcomes such as work status and income in sub-Saharan Africa. Methods. Data were examined from 482 adult clients entering HIV care (257 starting ART; 225 not yet eligible for ART) in Kampala, Uganda. Self-reported data on work status and income were assessed at baseline, months 6 and 12. Multivariate analysis examined the effects of ART over time, controlling for change in physical health functioning and baseline covariates. Results. Fewer ART patients worked at baseline compared to non-ART patients (25.5% versus 34.2%); 48.8% of those not working at baseline were now working at month 6, and 50% at month 12, with similar improvement in both the ART and non-ART groups. However, multivariate analysis revealed that the ART group experienced greater improvement over time. Average weekly income did not differ between the groups at baseline nor change significantly over time, among those who were working; being male gender and having any secondary education were predictive of higher income. Conclusions. ART was associated with greater improvement in work status, even after controlling for change in physical health functioning, suggesting other factors associated with ART may influence work.

Effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial.

PubMed

Bennell, Kim L; Egerton, Thorlene; Martin, Joel; Abbott, J Haxby; Metcalf, Ben; McManus, Fiona; Sims, Kevin; Pua, Yong-Hao; Wrigley, Tim V; Forbes, Andrew; Smith, Catherine; Harris, Anthony; Buchbinder, Rachelle

2014-05-21

There is limited evidence supporting use of physical therapy for hip osteoarthritis. To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis. Randomized, placebo-controlled, participant- and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm (range, 0-100 mm; 100 indicates worst pain possible) and hip osteoarthritis confirmed by radiograph. Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up (May 2010-February 2013) INTERVENTIONS: Participants attended 10 treatment sessions over 12 weeks. Active treatment included education and advice, manual therapy, home exercise, and gait aid if appropriate. Sham treatment included inactive ultrasound and inert gel. For 24 weeks after treatment, the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly. Primary outcomes were average pain (0 mm, no pain; 100 mm, worst pain possible) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 no difficulty to 68 extreme difficulty) at week 13. Secondary outcomes were these measures at week 36 and impairments, physical performance, global change, psychological status, and quality of life at weeks 13 and 36. Ninety-six patients (94%) completed week 13 measurements and 83 (81%) completed week 36 measurements. The between-group differences for improvements in pain were not significant. For the active group, the baseline mean (SD) visual analog scale score was 58.8 mm (13.3) and the week-13 score was 40.1 mm (24.6); for the sham group, the baseline score was 58.0 mm (11.6) and the week-13 score was 35.2 mm (21.4). The mean difference was 6.9 mm favoring sham treatment (95% CI, -3.9 to 17.7). The function scores were not significantly different between groups. The baseline mean (SD) physical function score for the active group was 32.3 (9.2) and the week-13 score was 27.5 (12.9) units, whereas the baseline score for the sham treatment group was 32.4 (8.4) units and the week-13 score was 26.4 (11.3) units, for a mean difference of 1.4 units favoring sham (95% CI, -3.8 to 6.5) at week 13. There were no between-group differences in secondary outcomes (except greater week-13 improvement in the balance step test in the active group). Nineteen of 46 patients (41%) in the active group reported 26 mild adverse effects and 7 of 49 (14%) in the sham group reported 9 mild adverse events (P = .003). Among adults with painful hip osteoarthritis, physical therapy did not result in greater improvement in pain or function compared with sham treatment, raising questions about its value for these patients. anzctr.org.au Identifier: ACTRN12610000439044.

Accounting for baseline differences and measurement error in the analysis of change over time.

PubMed

Braun, Julia; Held, Leonhard; Ledergerber, Bruno

2014-01-15

If change over time is compared in several groups, it is important to take into account baseline values so that the comparison is carried out under the same preconditions. As the observed baseline measurements are distorted by measurement error, it may not be sufficient to include them as covariate. By fitting a longitudinal mixed-effects model to all data including the baseline observations and subsequently calculating the expected change conditional on the underlying baseline value, a solution to this problem has been provided recently so that groups with the same baseline characteristics can be compared. In this article, we present an extended approach where a broader set of models can be used. Specifically, it is possible to include any desired set of interactions between the time variable and the other covariates, and also, time-dependent covariates can be included. Additionally, we extend the method to adjust for baseline measurement error of other time-varying covariates. We apply the methodology to data from the Swiss HIV Cohort Study to address the question if a joint infection with HIV-1 and hepatitis C virus leads to a slower increase of CD4 lymphocyte counts over time after the start of antiretroviral therapy. Copyright © 2013 John Wiley & Sons, Ltd.

Effect of preoperative incentive spirometry patient education on patient outcomes in the knee and hip joint replacement population.

PubMed

Bergin, Carole; Speroni, Karen Gabel; Travis, Tom; Bergin, John; Sheridan, Michael J; Kelly, Karen; Daniel, Marlon G

2014-02-01

This study examined the effects of preoperative incentive spirometry (IS) education (POISE) on postoperative outcomes for knee and hip total joint replacement patients. In this prospective study, 140 patients were randomized to Group 1 (POISE intervention = 50 completing) or Group 2 (no intervention = 56 completing) (34 dropped). The Group 1 intervention consisted of formal instruction preoperatively for IS home use, postoperative use, and IS volumes documentation. Group 2 patients received no intervention. Patients recorded postoperative IS volumes, which were used to determine return to baseline volume. One hundred six patients completed the study. Most were Caucasian females averaging 64 years. Although IS return to baseline volume time was not significantly different between groups, POISE patients had fewer postoperative complications, hospital days, and charges. POISE patients ranked the intervention as helpful. Although IS volumes were not significantly different between groups, POISE patients had better outcomes and ranked the intervention as helpful. Copyright © 2014 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial.

PubMed

Tanvisut, Rajavadi; Traisrisilp, Kuntharee; Tongsong, Theera

2018-05-01

Many strategies for labor pain management have been studied, including aromatherapy, which is a noninvasive, alternative medicine used as an adjunct for labor pain control. Nevertheless, the results were contradictory. Therefore, we conducted this study to determine the effectiveness of aromatherapy for reducing pain during labor. A randomized controlled trial was carried out on Thai laboring primigravidae who were a low-risk singleton pregnancy undergoing vaginal delivery. All participants, both study and control group, received standard obstetric care. Aromatherapy was only provided to the study group during the first stage of labor. The women rated their pain intensity by rating scales at different stages of labor. The primary outcome was pain scores and the secondary outcomes were necessity of painkiller usage, labor time, aromatherapy-associated complications, route of delivery, and Apgar scores. A total of 104 women were recruited, 52 in each group. Baseline characteristics and baseline pain scores were comparable. The median pain score of latent and early active phase was lower in the aromatherapy group, 5 vs 6 and 7 vs 8, respectively. The mean differences of pain scores between latent and early active phase and the baseline were significantly lower in the aromatherapy group, 1.88 vs 2.6 (p = 0.010) and 3.82 vs 4.39 (p = 0.031), respectively. Late active phase pain scores and other perinatal outcomes were not significantly different. Aromatherapy is helpful in reducing pain in latent and early active phase, and can probably be used as an adjunctive method for labor pain control without serious side effects.

DNA Methylation and Hydroxymethylation Levels in Relation to Two Weight Loss Strategies: Energy-Restricted Diet or Bariatric Surgery.

PubMed

Nicoletti, Carolina Ferreira; Nonino, Carla Barbosa; de Oliveira, Bruno Affonso Parenti; Pinhel, Marcela Augusta de Souza; Mansego, Maria Luisa; Milagro, Fermin Ignacio; Zulet, Maria Angeles; Martinez, José Alfredo

2016-03-01

Weight loss can be influenced by genetic factors and epigenetic mechanisms that participate in the regulation of body weight. This study aimed to investigate whether the weight loss induced by two different obesity treatments (energy restriction or bariatric surgery) may affect global DNA methylation (LINE-1) and hydroxymethylation profile, as well as the methylation patterns in inflammatory genes. This study encompassed women from three differents groups: 1. control group (n = 9), normal weight individuals; 2. energy restriction group (n = 22), obese patients following an energy-restricted Mediterranean-based dietary treatment (RESMENA); and 3. bariatric surgery group (n = 14), obese patients underwent a hypocaloric diet followed by bariatric surgery. Anthropometric measurements and 12-h fasting blood samples were collected before the interventions and after 6 months. Lipid and glucose biomarkers, global hydroxymethylation (by ELISA), LINE-1, SERPINE-1, and IL-6 (by MS-HRM) methylation levels were assessed in all participants. Baseline LINE-1 methylation was associated with serum glucose levels whereas baseline hydroxymethylation was associated with BMI, waist circumference, total cholesterol, and triglycerides. LINE-1 and SERPINE-1 methylation levels did not change after weight loss, whereas IL-6 methylation increased after energy restriction and decreased in the bariatric surgery group. An association between SERPINE-1 methylation and weight loss responses was found. Global DNA methylation and hydroxymethylation might be biomarkers for obesity and associated comorbidities. Depending on the obesity treatment (diet or surgery), the DNA methylation patterns behave differently. Baseline SERPINE-1 methylation may be a predictor of weight loss values after bariatric surgery.

Attention-Deficit/Hyperactivity Disorder Medication Treatment Impact on Response to Growth Hormone Therapy: Results from the ANSWER Program, a Non-Interventional Study.

PubMed

Rose, Susan R; Reeves, Grafton; Gut, Robert; Germak, John

2015-12-01

To examine whether attention-deficit/hyperactivity disorder (ADHD) stimulant medication modified the linear growth response to growth hormone (GH) treatment in children enrolled in the American Norditropin Studies: Web-Enabled Research Program. Short, GH treatment-naive children with or without GH deficiency (GHD) received GH therapy. A subset also received ADHD stimulant medication (n = 1190), and others did not (n = 7230). Linear mixed models (adjusted means) examined height SDS (HSDS) and body mass index (BMI) SDS from baseline through year 4. Analyses were repeated with ADHD groups matched for baseline age, height, weight, BMI, and sex. Groups with and without GHD were compared between ADHD groups. Adjusted change in HSDS for the group receiving ADHD stimulant medication was slightly lower than that for patients not receiving stimulant medication at years 1 to 4 (P < .05). However, adjusted change in HSDS was similar between children receiving and not receiving ADHD stimulant medication when matched for baseline measurements. At year 4, 86.7% of patients receiving ADHD stimulant medication, 86.8% of total patients not receiving ADHD stimulant medication, and 84.6% of matched group patients not receiving ADHD stimulant medication achieved HSDS >-2. Year 4 adjusted change in BMI SDS was greater in the patients receiving ADHD stimulant medication compared with both groups not receiving ADHD stimulant medication (P < .05). Patients with GHD showed comparable differences in adjusted change in BMI SDS among the ADHD groups at year 4, whereas patients without GHD showed no significant differences. ADHD medication did not affect the linear growth response of children treated with GH when those receiving or not receiving ADHD stimulant medication were matched for baseline measurements. Underlying reasons for the observed greater increase in BMI in patients with GHD concomitantly treated with ADHD medication remain to be elucidated. ClinicalTrials.gov: NCT01009905. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Deoxyribonucleic acid telomere length shortening can predict the incidence of non-alcoholic fatty liver disease in patients with type 2 diabetes mellitus.

PubMed

Ping, Fan; Li, Zeng-Yi; Lv, Ke; Zhou, Mei-Cen; Dong, Ya-Xiu; Sun, Qi; Li, Yu-Xiu

2017-03-01

To investigate the effect of telomere shortening and other predictive factors of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus patients in a 6-year prospective cohort study. A total of 70 type 2 diabetes mellitus (mean age 57.8 ± 6.7 years) patients without NAFLD were included in the study, and 64 of them were successfully followed up 6 years later, excluding four cases with significant alcohol consumption. NAFLD was diagnosed by the hepatorenal ratio obtained by a quantitative ultrasound method using NIH image analysis software. The 39 individuals that developed NAFLD were allocated to group A, and the 21 individuals that did not develop NAFLD were allocated to group B. Fluorescent real-time quantitative polymerase chain reaction was used to measure telomere length. There was no significant difference between the two groups in baseline telomere length; however, at the end of the 6th year, telomere length had become shorter in group A compared with group B. There were significant differences between these two groups in baseline body mass index, waistline, systolic blood pressure, glycated hemoglobin and fasting C-peptide level. In addition, the estimated indices of baseline insulin resistance increased in group A. Fasting insulin level, body mass index, systolic blood pressure at baseline and the shortening of telomere length were independent risk factors of NAFLD in type 2 diabetes mellitus patients. Telomere length became shorter in type 2 diabetes mellitus patients who developed NAFLD over the course of 6 years. Type 2 diabetes mellitus patients who developed NAFLD had more serious insulin resistance compared with those who did not develop NAFLD a long time ago. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Dietary supplementation with low-dose omega-3 fatty acids reduces salivary tumor necrosis factor-α levels in patients with chronic periodontitis: a randomized controlled clinical study.

PubMed

Keskiner, I; Saygun, I; Bal, V; Serdar, M; Kantarci, A

2017-08-01

Recent studies have demonstrated the beneficial effects of omega-3 polyunsaturated fatty acids (PUFAs) on physiological processes and on a variety of chronic inflammatory diseases, including periodontal diseases. In this study, we evaluated the impact of omega-3 PUFAs in conjunction with scaling and root planing (SRP) on salivary markers in patients with chronic periodontitis. Thirty systemically healthy subjects with chronic periodontitis were enrolled and randomly allocated into two groups. The control group (n = 15) was treated with SRP + placebo whereas the test group was treated with SRP and dietary supplementation of low-dose omega-3 PUFAs (6.25 mg eicosapentaenoic acid and 19.19 mg docosahexaenoic acid). Clinical parameters were taken at baseline, 1, 3 and 6 mo following therapy. Saliva samples were obtained at the same time intervals and analyzed for tumor necrosis factor-α (TNF-α) and superoxide dismutase (SOD). Both groups showed significant changes in clinical parameters in response to treatment compared to baseline with no significant difference between groups. Salivary TNF-α levels showed a statistically significant decrease in the test group at 6 mo compared to the control group. Salivary SOD levels increased significantly at 3 and 6 mo in the test group and at 6 mo in placebo groups compared to baseline with no statistically significant differences between the groups. The results demonstrated that dietary supplementation with low-dose omega-3 PUFAs improves salivary TNF-α without any significant impact on clinical parameters in patients with chronic periodontitis, suggesting that the systemic benefits of dietary omega-3 PUFAs may not be translated to periodontal health. (ClinicalTrials.gov ID NCT02719587). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Impact of the Arthritis Foundation’s Walk With Ease Program on Arthritis Symptoms in African Americans

PubMed Central

Wyatt, Brooke; Mingo, Chivon A.; Waterman, Mary B.; White, Patience; Cleveland, Rebecca J.

2014-01-01

Introduction Inadequate program design and lack of access to evidence-based programs are major barriers to the management of chronic diseases such as arthritis, particularly for African Americans. This study evaluates the effectiveness of the Arthritis Foundation’s Walk With Ease Program (WWE) in a subsample of African Americans who were part of a larger study that established evidence of the program’s efficacy. Methods Participants were African Americans (N = 117) with self-reported arthritis who chose to participate in either a self-directed (n = 68) or group (n = 49) 6-week WWE program. Arthritis-related symptoms (ie, pain, fatigue, stiffness; measured using visual analog scales) were assessed at baseline, 6 weeks, and 1 year. Independent samples t tests were conducted to examine group differences (ie, self-directed vs group) in arthritis-related symptoms at baseline, and paired sample t tests were conducted to examine differences over time (ie, baseline to 6 weeks and baseline to 1 year) in symptoms. Satisfaction was examined by descriptive statistics. Results Younger, more educated individuals chose the self-directed format (P < .001, P = .008; respectively). After the 6-week intervention, participants reported a decrease in pain (P < .001), fatigue (P = .002), and stiffness (P < .001). At 1 year, the decrease in pain (P = .04) and stiffness (P = .002) remained constant. Overall, participants were satisfied with both program formats. Conclusion The individualized and group formats of the WWE program improved arthritis-related pain, fatigue, and stiffness in African Americans. Culturally appealing arthritis interventions ultimately may increase the use of existing arthritis interventions. PMID:25393747

Health-risk appraisal with or without disease management for worksite cardiovascular risk reduction.

PubMed

Maron, David J; Forbes, Barbara L; Groves, Jay R; Dietrich, Mary S; Sells, Patrick; DiGenio, Andres G

2008-01-01

Worksite health promotion programs use health risk appraisal (HRA) surveys to identify employees at increased risk, then provide a range of interventions to encourage high-risk individuals to improve their health. Our objective was to determine how the intensity of intervention after HRA affected cardiovascular risk after 1 year, comparing individual follow-up counseling with environmental supports. 133 employees of Vanderbilt University with cardiovascular risk factors were randomly assigned to worksite HRA plus targeted disease management (DM group) or HRA plus information about worksite health promotion programs (HRA group). The DM group received longitudinal individualized counseling for risk reduction, whereas the HRA group members received one feedback session about their risk factors and information about free worksite health promotion programs. The main outcome measure was the difference between groups in the change in average Framingham risk score from baseline to 1 year. There was no significant baseline difference between groups in the Framingham risk score. Among DM participants, the mean (SD) Framingham risk score decreased by 22.6%; among HRA participants, the mean score rose by 4.3% (P = .017 for the difference between groups). In this study of employees with cardiovascular risk factors, HRA followed by individual counseling was more effective than providing information about free worksite health promotion programs.

Efficacy of acarbose in different geographical regions of the world: analysis of a real-life database.

PubMed

Weng, Jianping; Soegondo, Sidartawan; Schnell, Oliver; Sheu, Wayne H-H; Grzeszczak, Wladyslaw; Watada, Hirotaka; Yamamoto, Noriyuki; Kalra, Sanjay

2015-02-01

Alpha-glucosidase inhibitors are recommended in some international guidelines as first-line, second-line and third-line treatment options but are not used worldwide due to perceived greater effectiveness in Asians than Caucasians. Data from ten post-marketing non-interventional studies using acarbose, the most widely used alpha-glucosidase inhibitor, from 21 countries, provinces and country groups were pooled. Effects on glycated hemoglobin (HbA1c ) were analysed for four major ethnicity/region groups (European Caucasians and Asians from East, Southeast and South Asia) to identify differences in the response to acarbose. The safety and efficacy populations included 67 682 and 62 905 patients, respectively. Mean HbA1c in the total population decreased by 1.12 ± 1.31% at the 3-month visit from 8.4% at baseline (p < 0.0001). Reductions in HbA1c , fasting plasma glucose and post-prandial plasma glucose were greater in patients with higher baseline values. Acarbose was well tolerated, with few episodes of hypoglycemia (0.03%) and gastrointestinal adverse events (2.76%). Data from 30 730 Caucasians from Europe and Asians from three major regions of Asia with non-missing gender/age information and baseline/3-month HbA1c data were analysed by multivariable analyses of covariance. After adjustment for relevant baseline confounding factors, Southeast and East Asians had slightly better responses to acarbose than South Asians and European Caucasians; however, the differences were small. Acarbose was effective in both European Caucasians and Asians; however, after adjustment for baseline confounding factors, significant small differences in response favoured Southeast and East Asians. © 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.

Comparison of low-energy versus high-energy biphasic defibrillation shocks following prolonged ventricular fibrillation.

PubMed

Walcott, Gregory P; Melnick, Sharon B; Killingsworth, Cheryl R; Ideker, Raymond E

2010-01-01

Since the initial development of the defibrillator, there has been concern that, while delivery of a large electric shock would stop fibrillation, it would also cause damage to the heart. This concern has been raised again with the development of the biphasic defibrillator. To compare defibrillation efficacy, postshock cardiac function, and troponin I levels following 150-J and 360-J shocks. Nineteen swine were anesthetized with isoflurane and instrumented with pressure catheters in the left ventricle, aorta, and right atrium. The animals were fibrillated for 6 minutes, followed by defibrillation with either low-energy (n = 8) or high-energy (n = 11) shocks. After defibrillation, chest compressions were initiated and continued until return of spontaneous circulation (ROSC). Epinephrine, 0.01 mg/kg every 3 minutes, was given for arterial blood pressure < 50 mmHg. Hemodynamic parameters were recorded for four hours. Transthoracic echocardiography was performed and troponin I levels were measured at baseline and four hours following ventricular fibrillation (VF). Survival rates at four hours were not different between the two groups (low-energy, 5 of 8; high-energy, 7 of 11). Results for arterial blood pressure, positive dP/dt (first derivative of pressure measured over time, a measure of left ventricular contractility), and negative dP/dt at the time of lowest arterial blood pressure (ABP) following ROSC were not different between the two groups (p = not significant [NS]), but were lower than at baseline. All hemodynamic measures returned to baseline by four hours. Ejection fractions, stroke volumes, and cardiac outputs were not different between the two groups at four hours. Troponin I levels at four hours were not different between the two groups (12 +/- 11 ng/mL versus 21 +/- 26 ng/mL, p = NS) but were higher at four hours than at baseline (19 +/- 19 ng/mL versus 0.8 +/- 0.5 ng/mL, p < 0.05, groups combined). Biphasic 360-J shocks do not cause more cardiac damage than biphasic 150-J shocks in this animal model of prolonged VF and resuscitation.

A Comparison of Treating Metabolic Acidosis in CKD Stage 4 Hypertensive Kidney Disease with Fruits and Vegetables or Sodium Bicarbonate

PubMed Central

Goraya, Nimrit; Simoni, Jan; Jo, Chan-Hee

2013-01-01

Summary Background and objectives Current guidelines recommend Na+-based alkali for CKD with metabolic acidosis and plasma total CO2 (PTCO2) < 22 mM. Because diets in industrialized societies are typically acid-producing, we compared base-producing fruits and vegetables with oral NaHCO3 (HCO3) regarding the primary outcome of follow-up estimated GFR (eGFR) and secondary outcomes of improved metabolic acidosis and reduced urine indices of kidney injury. Design, setting, participants, & measurements Individuals with stage 4 (eGFR, 15–29 ml/min per 1.73 m2) CKD due to hypertensive nephropathy, had a PTCO2 level < 22 mM, and were receiving angiotensin-converting enzyme inhibition were randomly assigned to 1 year of daily oral NaHCO3 at 1.0 mEq/kg per day (n=35) or fruits and vegetables dosed to reduce dietary acid by half (n=36). Results Plasma cystatin C–calculated eGFR did not differ at baseline and 1 year between groups. One-year PTCO2 was higher than baseline in the HCO3 group (21.2±1.3 versus 19.5±1.5 mM; P<0.01) and the fruits and vegetables group (19.9±1.7 versus 19.3±1.9 mM; P<0.01), consistent with improved metabolic acidosis, and was higher in the HCO3 than the fruits and vegetable group (P<0.001). One-year urine indices of kidney injury were lower than baseline in both groups. Plasma [K+] did not increase in either group. Conclusions One year of fruits and vegetables or NaHCO3 in individuals with stage 4 CKD yielded eGFR that was not different, was associated with higher-than-baseline PTCO2, and was associated with lower-than-baseline urine indices of kidney injury. The data indicate that fruits and vegetables improve metabolic acidosis and reduce kidney injury in stage 4 CKD without producing hyperkalemia. PMID:23393104

Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study.

PubMed

Reinisch, Walter; Panés, Julián; Khurana, Sunil; Toth, Gabor; Hua, Fei; Comer, Gail M; Hinz, Michelle; Page, Karen; O'Toole, Margot; Moorehead, Tara McDonnell; Zhu, Hua; Sun, YanHui; Cataldi, Fabio

2015-06-01

Interleukin 13 (IL-13) is thought to play a key role as an effector cytokine in UC. Anrukinzumab, a humanised antibody that inhibits human IL-13, was evaluated for the treatment of UC. In a multicentre, randomised, double-blind, placebo-controlled study, patients with active UC (Mayo score ≥4 and <10) were randomised to anrukinzumab 200, 400 or 600 mg or placebo. Patients received five intravenous administrations over 14 weeks. The primary endpoint was fold change from baseline in faecal calprotectin (FC) at Week 14. Secondary endpoints included safety, pharmacokinetics and IL-13 levels. The modified intention-to-treat population included 84 patients (21 patients/arm). Fold change of FC from baseline at Week 14 was not significantly different for any treatment groups compared with the placebo. The study had a high dropout rate, in part, related to lack of efficacy. The exploratory comparisons of each dose were not significantly different from placebo in terms of change from baseline in total Mayo score, clinical response, clinical remission and proportion of subjects with mucosal healing. An increase in serum total IL-13 (free and bound to anrukinzumab) was observed for all anrukinzumab groups but not with placebo. This suggests significant binding of anrukinzumab to IL-13. The safety profile was not different between the anrukinzumab and placebo groups. A statistically significant therapeutic effect of anrukinzumab could not be demonstrated in patients with active UC in spite of binding of anrukinzumab to IL-13. ClinicalTrials.gov number NCT01284062. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Change in work day step counts, wellbeing and job performance in Catalan university employees: a randomised controlled trial.

PubMed

Puig-Ribera, Anna; McKenna, Jim; Gilson, Nicholas; Brown, Wendy J

2008-12-01

Using a randomised controlled trial design, this feasibility study assessed the impact of two walking interventions on quality of life (QoL) and job performance of Catalan university employees. A convenience sample of 70 employees completed baseline and intervention measures of step counts (Yamax SW 200 pedometer), wellbeing (SF-12 questionnaire) and work performance (Work Limitations Questionnaire) over 9 weeks. Before intervention, baseline step counts (five working days) were used to randomly allocate participants to a control (n = 26), "walking routes" (n = 19) and "walking while working" (n = 25) groups. Intervention effects were evaluated by calculating differences between pre-intervention and intervention data. One-way ANOVA was used to examine differences between groups. No significant group differences were found for changes in work-day step counts, QoL or work performance. When data from the two intervention groups were pooled (n = 44) there was a significant increase in step counts (+659 steps/day; n = 12; p < 0.01) among participants classified as ;Sedentary-Low active' (0-7499 steps/day) at baseline. In contrast there was a significant decrease (-637 steps/day; p < 0.05) in those initially categorised as ;Active' (> 10,000 steps/day; n = 21) and no change in those categorised as ;Moderately Active' (7500-9999, n = 11). The ;Sedentary-Low activity' group showed consistently greater improvements in QoL and work performance scores than the Moderate and Active groups. Initially low active participants showed the greatest increase in step counts and improved QoL and work productivity profiles. These data indicate the potential for improving QoL and job productivity through workplace walking in inactive Catalan employees.

The impact of MTHFR 677C → T risk knowledge on changes in folate intake: findings from the Food4Me study.

PubMed

O'Donovan, Clare B; Walsh, Marianne C; Forster, Hannah; Woolhead, Clara; Celis-Morales, Carlos; Fallaize, Rosalind; Macready, Anna L; Marsaux, Cyril F M; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Kolossa, Silvia; Mavrogianni, Christina; Lambrinou, Christina P; Moschonis, George; Godlewska, Magdalena; Surwillo, Agnieszka; Bouwman, Jildau; Grimaldi, Keith; Traczyk, Iwona; Drevon, Christian A; Daniel, Hannelore; Manios, Yannis; Martinez, J Alfredo; Saris, Wim H M; Lovegrove, Julie A; Mathers, John C; Gibney, Michael J; Brennan, Lorraine; Gibney, Eileen R

2016-01-01

It is hypothesised that individuals with knowledge of their genetic risk are more likely to make health-promoting dietary and lifestyle changes. The present study aims to test this hypothesis using data from the Food4Me study. This was a 6-month Internet-based randomised controlled trial conducted across seven centres in Europe where individuals received either general healthy eating advice or varying levels of personalised nutrition advice. Participants who received genotype-based personalised advice were informed whether they had the risk (CT/TT) ( n  = 178) or non-risk (CC) ( n  = 141) alleles of the methylenetetrahydrofolate reductase ( MTHFR ) gene in relation to cardiovascular health and the importance of a sufficient intake of folate. General linear model analysis was used to assess changes in folate intake between the MTHFR risk, MTHFR non-risk and control groups from baseline to month 6 of the intervention. There were no differences between the groups for age, gender or BMI. However, there was a significant difference in country distribution between the groups ( p  = 0.010). Baseline folate intakes were 412 ± 172, 391 ± 190 and 410 ± 186 μg per 10 MJ for the risk, non-risk and control groups, respectively. There were no significant differences between the three groups in terms of changes in folate intakes from baseline to month 6. Similarly, there were no changes in reported intake of food groups high in folate. These results suggest that knowledge of MTHFR 677C → T genotype did not improve folate intake in participants with the risk variant compared with those with the non-risk variant. ClinicalTrials.gov NCT01530139.

Effect of a brief training program based on cognitive behavioral therapy in improving work performance: A randomized controlled trial.

PubMed

Kimura, Risa; Mori, Makiko; Tajima, Miyuki; Somemura, Hironori; Sasaki, Norio; Yamamoto, Megumi; Nakamura, Saki; Okanoya, June; Ito, Yukio; Otsubo, Tempei; Tanaka, Katsutoshi

2015-01-01

Efforts to improve performance in the workplace with respect to positive mental health have increased, and cognitive behavioral therapy (CBT) has recently attracted attention as an intervention measure to this end. Here, we conducted a randomized controlled trial to evaluate the effectiveness of a brief training program on CBT for improving work performance of employees. The participants were employees of an electric company in Japan. The intervention consisted of 1 group session of CBT (120 min) and web-based CBT homework for 1 month. We evaluated employees in both the intervention and control groups at baseline and follow-up after three months. The main outcome was work performance, which was evaluated by a subjective score from 1 to 10. The secondary outcome was self-evaluation of cognitive flexibility. Analyses were conducted based on ITT. In the intervention group, 84 participants attended the group session, with 79 subsequently completing at least 1 instance of online homework. ITT analysis showed that the subjective performance of the intervention group was significantly improved compared with that of the control group (1.47 vs. 0.69, mean difference 0.78 [95% confidence interval {CI}, 0.05 to 1.51], Cohen's d=0.31). The ability to recognize dysfunctional thinking patterns and change them to positive ones significantly improved in the intervention group compared to the control group (0.71 vs. 0.26, mean difference 0.45 [95% CI 0.06 to 0.83], d=0.33). However, after adjustment for baseline scores, no significant difference was observed. The ability to view a situation from multiple perspectives and expand one's repertoire of thought patterns in the intervention group also significantly improved (0.83 vs. 0.35, mean difference 0.48 [95% CI 0.35 to 0.95], d=0.29), but here again, significance was lost after adjusting for baseline scores. Our results suggest that a brief training program that combines a group CBT session with web-based CBT homework improved subjective work performance. In addition, this program might help improve employees' cognitive flexibility.

Does Kinesiophobia Modify the Effects of Physical Therapy on Outcomes in Patients With Sciatica in Primary Care? Subgroup Analysis From a Randomized Controlled Trial.

PubMed

Verwoerd, Annemieke J H; Luijsterburg, Pim A J; Koes, Bart W; el Barzouhi, Abdelilah; Verhagen, Arianne P

2015-09-01

A higher level of kinesiophobia appears to be associated with poor recovery in patients with sciatica. The aim of this study was to investigate whether kinesiophobia modifies the effect of physical therapy on outcomes in patients with sciatica. This was a subgroup analysis from a randomized controlled trial. The study was conducted in a primary care setting. A total of 135 patients with acute sciatica participated. Patients were randomly assigned to groups that received (1) physical therapy plus general practitioners' care (intervention group) or (2) general practitioners' care alone (control group). Kinesiophobia at baseline was measured with the Tampa Scale for Kinesiophobia (TSK) and a single substitute question for kinesiophobia (SQK). Pain and recovery were assessed at 3- and 12-month follow-ups. Regression analysis was used to test for interaction between the level of kinesiophobia at baseline and treatment allocation. Subgroup results were calculated for patients classified with high fear of movement and for those classified with low fear of movement. Kinesiophobia at baseline interacted with physical therapy in the analysis with leg pain intensity at 12-month follow-up. Kinesiophobia at baseline did not interact with physical therapy regarding any outcome at 3-month follow-up or recovery at 12-month follow-up. When comparing both treatment groups in the subgroup of patients with high fear of movement (n=73), the only significant result was found for leg pain intensity difference from baseline at 12-month follow-up (intervention group: X̅=-5.0, SD=2.6; control group: X̅=-3.6, SD=2.7). The post hoc study design and relatively small sample size were limitations of the study. In 135 patients with sciatica, evidence shows that patients with a higher level of kinesiophobia at baseline may particularly benefit from physical therapy with regard to decreasing leg pain intensity at 12-month follow-up. © 2015 American Physical Therapy Association.

Oximetry and indications for tracheotomy for amyotrophic lateral sclerosis.

PubMed

Bach, John Robert; Bianchi, Carlo; Aufiero, Elaine

2004-11-01

To explore the use of oximetry as a guide for using respiratory aids and tracheotomy in the treatment of patients with amyotrophic lateral sclerosis (ALS). A retrospective review of all ALS patients presenting to a neuromuscular disease clinic since 1996. Patients who were symptomatic for nocturnal hypoventilation were prescribed noninvasive ventilation (NIV). Patients with assisted cough peak flows of < 300 L/min were prescribed oximeters and access to mechanically assisted coughing (MAC) to prevent or reverse decreases in baseline pulse oximetric saturation (Spo(2)) levels of < 95%. The number of decreases in baseline Spo(2) that could be normalized by any combination of NIV and MAC and the duration of normalization were recorded. When the baseline was not or could not be normalized, the time to acute respiratory failure and tracheotomy or death were recorded. Twenty-five patients became dependent on NIV, including 13 patients who received NIV continuously for a mean (+/- SD) period of 19.7 +/- 16.9 months, without desaturation (group 1). For another 76 patients, the daytime baseline Spo(2) level decreased to < 95% 78 times. For 41 patients, the baseline level was corrected by NIV/MAC (group 2) for a mean duration of 11.1 +/- 8.7 months before desaturation reoccurred for 27 patients. Of the latter patients, 11 underwent tracheotomy, 14 died in < 2 months, and 2 had their condition again corrected by the addition of MAC therapy. For 35 patients, the desaturation was not or could not be normalized (group 3). Thirty-three of these 35 patients required tracheotomy or died within 2 months. The only significant difference between groups 1 and 2 and group 3 was significantly poorer glottic function in the patients in group 3. Tracheotomy or death is highly likely within 2 months of a decrease in baseline Spo(2) that cannot be corrected by NIV or MAC. The long-term use of NIV and MAC, and the avoidance of tracheotomy is dependent on glottic function rather than on inspiratory or expiratory muscle failure.

The effect of kinesio taping versus stretching techniques on muscle soreness, and flexibility during recovery from nordic hamstring exercise.

PubMed

Ozmen, Tarik; Yagmur Gunes, Gokce; Dogan, Hanife; Ucar, Ilyas; Willems, Mark

2017-01-01

The purpose of this study was to examine the effects of static stretching, proprioceptive neuromuscular facilitation (PNF) stretching, or kinesio taping (KT) on muscle soreness and flexibility during recovery from exercise. Sixty-five females were randomly assigned to four groups: PNF stretching (n = 15), static stretching (n = 16), KT (n = 17), and control (n = 17). All participants performed nordic hamstring exercise (5 sets of 8 repetitions). In all groups, hamstring flexibility at 24 h and 48 h was not changed from baseline (p > .05). The muscle soreness was measured higher at 48 h post-exercise compared with baseline in the control group (p = .04) and at 24 h post-exercise compared with baseline in the PNF group (p < .01). No significant differences were found for intervention groups compared with control group in all measurements (p > .05). The KT application and pre-exercise stretching have no contribute to flexibility at 24 h and 48 h after exercise, but may attenuate muscle soreness. Copyright © 2016 Elsevier Ltd. All rights reserved.

Nusinersen versus Sham Control in Later-Onset Spinal Muscular Atrophy.

PubMed

Mercuri, Eugenio; Darras, Basil T; Chiriboga, Claudia A; Day, John W; Campbell, Craig; Connolly, Anne M; Iannaccone, Susan T; Kirschner, Janbernd; Kuntz, Nancy L; Saito, Kayoko; Shieh, Perry B; Tulinius, Már; Mazzone, Elena S; Montes, Jacqueline; Bishop, Kathie M; Yang, Qingqing; Foster, Richard; Gheuens, Sarah; Bennett, C Frank; Farwell, Wildon; Schneider, Eugene; De Vivo, Darryl C; Finkel, Richard S

2018-02-15

Nusinersen is an antisense oligonucleotide drug that modulates pre-messenger RNA splicing of the survival motor neuron 2 ( SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2:1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274. The primary end point was the least-squares mean change from baseline in the Hammersmith Functional Motor Scale-Expanded (HFMSE) score at 15 months of treatment; HFMSE scores range from 0 to 66, with higher scores indicating better motor function. Secondary end points included the percentage of children with a clinically meaningful increase from baseline in the HFMSE score (≥3 points), an outcome that indicates improvement in at least two motor skills. In the prespecified interim analysis, there was a least-squares mean increase from baseline to month 15 in the HFMSE score in the nusinersen group (by 4.0 points) and a least-squares mean decrease in the control group (by -1.9 points), with a significant between-group difference favoring nusinersen (least-squares mean difference in change, 5.9 points; 95% confidence interval, 3.7 to 8.1; P<0.001). This result prompted early termination of the trial. Results of the final analysis were consistent with results of the interim analysis. In the final analysis, 57% of the children in the nusinersen group as compared with 26% in the control group had an increase from baseline to month 15 in the HFMSE score of at least 3 points (P<0.001), and the overall incidence of adverse events was similar in the nusinersen group and the control group (93% and 100%, respectively). Among children with later-onset SMA, those who received nusinersen had significant and clinically meaningful improvement in motor function as compared with those in the control group. (Funded by Biogen and Ionis Pharmaceuticals; CHERISH ClinicalTrials.gov number, NCT02292537 .).

DRUM-PD: The use of a drum circle to improve the symptoms and signs of Parkinson's disease (PD)

PubMed Central

Pantelyat, Alexander; Syres, Candace; Reichwein, Suzanne; Willis, Allison

2015-01-01

Background Physical therapy can improve motor function in patients with PD. Music performance may be used to improve motor skills by rhythmic entrainment. Drumming has long been a part of traditional healing rituals worldwide, and is increasingly being utilized as a therapeutic strategy. Methods This pilot controlled prospective cohort trial assessed feasibility and effects of twice-weekly group West African drum circle classes for 6 weeks on PD patients’ quality of life, symptoms, motor findings, cognition, and mood. Ten patients with PD were recruited into the drum circle group. Ten patients with PD were matched pairwise to each of the drum circle participants, and enrolled in a no-intervention control group. Both groups completed the PD-specific Parkinson Disease Questionnaire (PDQ)-39 quality of life assessment and the Geriatric Depression Scale (GDS), and underwent motor and cognitive assessments by a rater blinded to group at baseline, 6 weeks, and 12 weeks. Results Drummers had significantly improved PDQ-39 scores from baseline to 6 weeks (−5.8, p=0.042), whereas the control group's scores were unchanged. Walking performance was significantly faster at baseline for controls; after 6 weeks of drumming this difference was no longer significant, and remained non-significant at 12 weeks. The drummers trended (p=0.069) toward improvement in walking from baseline to 12 weeks. Other outcomes did not significantly change from baseline to 6 or 12 weeks. Conclusions Drum circle classes significantly and reversibly improved quality of life in patients with PD. This pilot trial's findings merit larger controlled investigations comparing drumming classes to established interventions in PD, such as physical therapy. PMID:27340683

Effect of metronidazole use on tacrolimus concentrations in transplant patients treated for Clostridium difficile.

PubMed

Early, C R; Park, J M; Dorsch, M P; Pogue, K T; Hanigan, S M

2016-10-01

Two case reports suggest that metronidazole treatment for Clostridium difficile infections (CDI) increases tacrolimus (TAC) trough levels. The primary objective of this study was to determine the clinical significance of this potential interaction in transplant patients receiving CDI treatment. Currently, no robust literature exists to estimate a magnitude of pharmacokinetic interaction between metronidazole and TAC. In this retrospective study, the effects of CDI and metronidazole treatment on TAC levels in 52 adult solid organ transplant patients were investigated. The primary outcome was to determine the difference in dose-normalized TAC levels between baseline and symptom resolution in patients treated with metronidazole or vancomycin. The secondary outcome was to determine the difference in dose-normalized TAC levels at baseline and CDI diagnosis. The average change in log-transformed dose-normalized TAC levels from baseline to symptom resolution was 0.99 for metronidazole (n = 35) and 1.04 for vancomycin (n = 17) treatment. The mean difference between the groups was 0.96 (95% confidence interval: 0.74-1.24). No significant difference was found between dose-normalized TAC levels at CDI diagnosis and baseline (P = 0.37). CDI treatment with metronidazole was not associated with a >30% increase in TAC levels compared with vancomycin. Both treatment groups required TAC dose adjustments to maintain goal TAC levels and those treated with metronidazole did not require a significantly greater dose adjustment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Advancing the sleep/wake schedule impacts the sleep of African-Americans more than European-Americans.

PubMed

Paech, Gemma M; Crowley, Stephanie J; Fogg, Louis F; Eastman, Charmane I

2017-01-01

There are differences in sleep duration between Blacks/African-Americans and Whites/European-Americans. Recently, we found differences between these ancestry groups in the circadian system, such as circadian period and the magnitude of phase shifts. Here we document the role of ancestry on sleep and cognitive performance before and after a 9-h advance in the sleep/wake schedule similar to flying east or having a large advance in sleep times due to shiftwork, both of which produce extreme circadian misalignment. Non-Hispanic African and European-Americans (N = 20 and 17 respectively, aged 21-43 years) were scheduled to four baseline days each with 8 h time in bed based on their habitual sleep schedule. This sleep/wake schedule was then advanced 9 h earlier for three days. Sleep was monitored using actigraphy. During the last two baseline/aligned days and the first two advanced/misaligned days, beginning 2 h after waking, cognitive performance was measured every 3 h using the Automated Neuropsychological Assessment Metrics (ANAM) test battery. Mixed model ANOVAs assessed the effects of ancestry (African-American or European-American) and condition (baseline/aligned or advanced/misaligned) on sleep and cognitive performance. There was decreased sleep and impaired performance in both ancestry groups during the advanced/misaligned days compared to the baseline/aligned days. In addition, African-Americans obtained less sleep than European-Americans, especially on the first two days of circadian misalignment. Cognitive performance did not differ between African-Americans and European-Americans during baseline days. During the two advanced/misaligned days, however, African-Americans tended to perform slightly worse compared to European-Americans, particularly at times corresponding to the end of the baseline sleep episodes. Advancing the sleep/wake schedule, creating extreme circadian misalignment, had a greater impact on the sleep of African-Americans than European-Americans. Ancestry differences in sleep appear to be exacerbated when the sleep/wake schedule is advanced, which may have implications for individuals undertaking shiftwork and transmeridian travel.

Blood pressure and heart rate response to posteriorly directed pressure applied to the cervical spine in young, pain-free individuals: a randomized, repeated-measures, double-blind, placebo-controlled study.

PubMed

Yung, Emmanuel; Wong, Michael; Williams, Haddie; Mache, Kyle

2014-08-01

Randomized clinical trial. Objectives To compare the blood pressure (BP) and heart rate (HR) response of healthy volunteers to posteriorly directed (anterior-to-posterior [AP]) pressure applied to the cervical spine versus placebo. Manual therapists employ cervical spine AP mobilizations for various cervical-shoulder pain conditions. However, there is a paucity of literature describing the procedure, cardiovascular response, and safety profile. Thirty-nine (25 female) healthy participants (mean ± SD age, 24.7 ± 1.9 years) were randomly assigned to 1 of 2 groups. Group 1 received a placebo, consisting of light touch applied to the right C6 costal process. Group 2 received AP pressure at the same location. Blood pressure and HR were measured prior to, during, and after the application of AP pressure. One-way analysis of variance and paired-difference statistics were used for data analysis. There was no statistically significant difference between groups for mean systolic BP, mean diastolic BP, and mean HR (P >.05) for all time points. Within-group comparisons indicated statistically significant differences between baseline and post-AP pressure HR (-2.8 bpm; 95% confidence interval: -4.6, -1.1) and between baseline and post-AP pressure systolic BP (-2.4 mmHg; 95% confidence interval: -3.7, -1.0) in the AP group, and between baseline and postplacebo systolic BP (-2.6 mmHg; 95% confidence interval: -4.2, -1.0) in the placebo group. No participants reported any adverse reactions or side effects within 24 hours of testing. AP pressure caused a statistically significant physiologic response that resulted in a minor drop in HR (without causing asystole or vasodepression) after the procedure, whereas this cardiovascular change did not occur for those in the placebo group. Within both groups, there was a small but statistically significant reduction in systolic BP following the procedure.

Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study.

PubMed

Lombardi, Francesca; Belmonti, Simone; Fabbiani, Massimiliano; Morandi, Matteo; Rossetti, Barbara; Tordini, Giacinta; Cauda, Roberto; De Luca, Andrea; Di Giambenedetto, Simona; Montagnani, Francesca

2016-01-01

Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) versus the 23-valent polysaccharide vaccine (PPSV23) in HIV-infected adults. We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18-65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50) received two doses of PCV13 eight weeks apart, and group 2 (n = 50) received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100) were also enrolled as baseline controls. Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group. In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated. ClinicalTrials.gov NCT02123433.

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial.

PubMed

Glynn, Liam G; Hayes, Patrick S; Casey, Monica; Glynn, Fergus; Alvarez-Iglesias, Alberto; Newell, John; Ólaighin, Gearóid; Heaney, David; Murphy, Andrew W

2013-05-29

Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic blood pressure, resting heart rate, mental health score using HADS and quality of life score using Euroqol. Randomization and allocation to the intervention and groups will be carried out by an independent researcher, ensuring the allocation sequence is concealed from the study researchers until the interventions are assigned. The primary analysis is based on mean daily step count, comparing the mean difference in daily step count between the baseline and the trial periods in the intervention and control groups at follow up.

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. Methods/design A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic blood pressure, resting heart rate, mental health score using HADS and quality of life score using Euroqol. Randomization and allocation to the intervention and groups will be carried out by an independent researcher, ensuring the allocation sequence is concealed from the study researchers until the interventions are assigned. The primary analysis is based on mean daily step count, comparing the mean difference in daily step count between the baseline and the trial periods in the intervention and control groups at follow up. Trial registration Current Controlled Trials ISRCTN99944116 PMID:23714362

Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies.

PubMed

Staurenghi, Giovanni; Feltgen, Nicolas; Arnold, Jennifer J; Katz, Todd A; Metzig, Carola; Lu, Chengxing; Holz, Frank G

2017-10-19

To evaluate intravitreal aflibercept versus laser in subgroups of patients with baseline Diabetic Retinopathy Severity Scale (DRSS) scores ≤43, 47, and ≥53 in VIVID-DME and VISTA-DME. Patients with diabetic macular oedema were randomised to receive intravitreal aflibercept 2 mg every 4 weeks (2q4), intravitreal aflibercept 2 mg every 8 weeks after five initial monthly doses (2q8), or macular laser photocoagulation at baseline with sham injections at every visit. These post hoc analyses evaluate outcomes based on baseline DRSS scores in patients in the integrated dataset. The 2q4 and 2q8 treatment groups were also pooled. 748 patients had a baseline DRSS score based on fundus photographs (≤43, n=301; 47, n=153; ≥53, n=294). At week 100, the least squares mean difference between treatment groups (effect of intravitreal aflibercept above that of laser, adjusting for baseline best-corrected visual acuity) was 8.9 (95% CI 5.99 to 11.81), 9.7 (95% CI 5.54 to 13.91), and 11.0 (95% CI 7.96 to 14.1) letters in those with baseline DRSS scores ≤43, 47, and ≥53, respectively. The proportions of patients with ≥2 step DRSS score improvement were greater in the intravitreal aflibercept group versus laser, respectively, for those with baseline DRSS scores of ≤43 (13% vs 5.9%), 47 (25.8% vs 4.5%), and ≥53 (64.5% vs 28.4%). Regardless of baseline DRSS score, functional outcomes were superior in intravitreal aflibercept-treated patients, demonstrating consistent treatment benefit across various baseline levels of retinopathy. NCT01331681 and NCT01363440, Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Tenofovir disoproxil fumarate is superior to lamivudine plus adefovir in lamivudine-resistant chronic hepatitis B patients.

PubMed

Yang, Dan-Hong; Xie, Yuan-Jun; Zhao, Nian-Feng; Pan, Hong-Ying; Li, Ming-Wei; Huang, Hai-Jun

2015-03-07

To assess the efficacy of tenofovir disoproxil fumarate (TDF) in lamivudine (LAM)-resistant patients with a suboptimal response to LAM plus adefovir (ADV). We retrospectively analyzed the efficacy of switching to tenofovir disoproxil fumarate in suboptimal responders to lamivudine plus adefovir. Charts were reviewed for LAM-resistant chronic hepatitis B (CHB) patients who visited the Zhejiang Province People's Hospital and The First Affiliated Hospital, College of Medicine, Zhejiang University, from June 2009 to May 2013. Patients whose serum hepatitis B virus (HBV) DNA remained detectable despite at least 6 mo of LAM plus ADV combination therapy were included. Patients with a suboptimal response to LAM plus ADV were randomized to switch to TDF monotherapy (300 mg/d orally; TDF group) or to continuation with LAM (100 mg/d orally) plus ADV (10 mg/d orally; LAM plus ADV group) and were followed for 48 wk. Serum HBV DNA was determined at baseline and weeks 4, 12, 24, 36, and 48. HBV serological markers and biochemistry were assessed at baseline and weeks 12, 24, and 48. Resistance surveillance and side effects were monitored during therapy. Fifty-nine patient were randomized to switch to TDF (n = 28) or continuation with LAM plus ADV (n = 31). No significant differences were found between the groups at baseline. Prior to TDF therapy, all patients had been exposed to LAM plus ADV for a median of 11 mo (range: 6-24 mo). No difference was seen in baseline serum HBV DNA between the two groups [5.13 ± 1.08 log10 copies/mL (TDF) vs 5.04 ± 31.16 log10 copies/mL (LAM + ADV), P = 0.639]. There was no significant difference in the rates of achieving complete virological response (CVR) at week 4 between the TDF and LAM + ADV groups (17.86% vs 6.45%, P = 0.24). The rate of achieving CVR in the TDF and LAM plus ADV groups was 75% vs 16.13% at week 12, 82.14% vs 22.58% at week 24, 89.29% vs 25.81% at week 36, and 96.43% vs 29.03% at week 48, respectively (P < 0.001). The rate of alanine aminotransferase normalization was significantly higher in the TDF than in the LAM plus ADV group at week 12 (75% vs 17.86%, P < 0.001), but not at week 24 (78.57% vs 54.84%, P = 0.097) or 48 (89.26% vs 67.74%, P = 0.062). Patients were hepatitis B e antigen (HBeAg) positive at baseline. There was no significant difference in HBeAg negativity between the TDF and LAM plus ADV groups at week 48 (4% vs 0%, P = 0.481). There were no drug-related adverse effects at week 48 in either group. Switching to TDF monotherapy was superior to continuous add-on therapy in patients with LAM-resistant CHB with a suboptimal response to LAM plus ADV.

Evaluation of renal quantitative T2* changes on MRI following administration of ferumoxytol as a T2* contrast agent.

PubMed

Hedgire, Sandeep S; McDermott, Shaunagh; Wojtkiewicz, Gregory R; Abtahi, Seyed Mahdi; Harisinghani, Mukesh; Gaglia, Jason L

2014-01-01

To evaluate the time-dependent changes in regional quantitative T2* maps of the kidney following intravenous administration of ferumoxytol. Twenty-four individuals with normal kidney function underwent T2*-weighted MRI of the kidney before, immediately after, and 48 hours after intravenous administration of ferumoxytol at a dose of 4 mg/kg (group A, n=12) or 6 mg/kg (group B, n=12). T2* values were statistically analyzed using two-tailed paired t-tests. In group A, the percentage changes from baseline to immediate post and baseline to 48 hours were 85.3% and 64.2% for the cortex and 90.8% and 64.6% for the medulla, respectively. In group B, the percentage changes from baseline to immediate post and baseline to 48 hours were 85.2% and 73.4% for the cortex and 94.5% and 74% for the medulla, respectively. This difference was significant for both groups (P<0.0001). There is significant and differential uptake of ferumoxytol in the cortex and medulla of physiologically normal kidneys. This differential uptake may offer the ability to interrogate renal cortex and medulla with possible clinical applications in medical renal disease and transplant organ assessment. We propose an organ of interest based dose titration of ferumoxytol to better differentiate circulating from intracellular ferumoxytol particles.

Serum Lp-PLA2: as a novel viewpoint in periodontal treatment of hyperlipidaemics.

PubMed

Fentoğlu, Özlem; Kirzioğlu, Fatma Yeşim; Tözüm Bulut, Memduha; Kurgan, Şivge; Koçak, Havva; Sütcü, Recep; Kale Köroğlu, Banu; Günhan, Meral

2015-01-01

To evaluate the effects of periodontal treatment on serum lipoprotein-associated phospholipase A2 (Lp-PLA2) and C-reactive protein (CRP) levels in hyperlipidaemic patients with periodontitis. The study included 52 hyperlipidaemics and 28 systemically healthy controls (C) with periodontitis. Of the 52 hyperlipidaemics, 29 received a suggested diet (HD), and 23 of them were prescribed statin (HS). Clinical periodontal parameters, serum lipids, Lp-PLA2, and CRP levels were assessed at the baseline and 2 months after the completion of the nonsurgical periodontal treatment (2MPT). Serum parameters were also evaluated 1 week following the periodontal treatment (1WPT). At the baseline, patients in the HS group had a higher percentage of bleeding on probing than those in the C and HD groups. Hyperlipidaemics had higher serum triglyceride levels than the control group at 2MPT compared to the baseline. At 2MPT, the levels of Lp-PLA2 in the HS group were significantly higher compared to the baseline and 1WPT. There were no statistically significant differences in CRP levels between study periods for all groups. The periodontal treatment may affect the inflammatory control of hyperlipidaemic patients with periodontitis via increased Lp-PLA2 levels and severity of the impaired lipid metabolism. These findings may be important regarding the therapeutic strategies for hyperlipidaemics with periodontitis.

Association between body mass index and response to a brief interdisciplinary treatment program in fibromyalgia.

PubMed

Kim, Chul-Hyun; Luedtke, Connie A; Vincent, Ann; Thompson, Jeffrey M; Oh, Terry H

2012-07-01

The aim of this study was to evaluate the association between baseline body mass index (BMI) and treatment outcome after a brief interdisciplinary fibromyalgia treatment program. Subjects (n = 477) with fibromyalgia participated in the fibromyalgia treatment program. They completed the Fibromyalgia Impact Questionnaire (FIQ) and the Short Form-36 Health Status Questionnaire (SF-36) at baseline and 6 to 12 mos after the fibromyalgia treatment program. Posttreatment changes in FIQ and SF-36 scores were compared after stratifying participants into four BMI groups: nonobese, overweight, moderately obese, and severely obese. All BMI groups achieved significant improvement in the FIQ total score; the FIQ subscales feel good, pain, fatigue, and morning tiredness; and the SF-36 subscales pain index, vitality, social functioning, and mental health index. Posttreatment changes in mean scores for each subscale generally did not differ significantly across BMI groups after adjusting for age and baseline scores. However, the SF-36 subscale scores of physical functioning and role-emotional were significantly less improved in the severely obese compared with the nonobese. Baseline BMI did not affect response to the fibromyalgia treatment program, as measured by the FIQ total score or SF-36 physical and mental component summary scores. However, the severely obese group showed less improvement compared with the nonobese group in the SF-36 physical functioning and role-emotional subscales.

A Randomized Controlled Clinical Trial to Evaluate Extrinsic Stain Removal of a Whitening Dentifrice.

PubMed

Terézhalmy, Géza; He, Tao; Anastasia, Mary Kay; Eusebio, Rachelle

2016-12-01

To evaluate the extrinsic stain removal efficacy of a new whitening dentifrice containing sodium hexametaphosphate (SHMP) over a two-week period. This study used a controlled and randomized, examiner-blind, single-center, two-treatment, parallel group design. Subjects with visible extrinsic dental stain on facial surfaces of their anterior teeth, and meeting all study criteria, were entered into the trial. The test group received the whitening dentifrice with sodium fluoride and SHMP and an ADA reference soft manual toothbrush. Subjects in the control group received a dental prophylaxis after the initial examination at Baseline and were instructed to use their usual oral hygiene products at home. Subjects returned at Day 3 and Week 2 for re-evaluation of extrinsic dental stain. Extrinsic stain was measured using the Interproximal Modified Lobene (IML) Stain Index; safety was assessed based on clinical examination. Fifty subjects (mean age 32.0 years) completed the study, with 25 in each group. Statistically significant reductions in composite stain for whole tooth, as well as interproximal, gingival, and body surfaces were observed for both groups at Day 3 and Week 2 (p < 0.0001) with no significant differences between the two groups (p > 0.3). At Day 3, median percent reductions in composite IML stain from Baseline were 98% for the prophylaxis group and 100% for the test dentifrice group. At Week 2, median percent reductions in composite IML stain were 100% compared to Baseline for both groups. No adverse events were reported for either group. The whitening dentifrice demonstrated a statistically significant reduction in IML stain after three days and two weeks of use relative to baseline. Stain reduction with the toothpaste was comparable to a dental prophylaxis.

Effects of Sustained Abstinence Among Treated Substance-Abusing Homeless Persons on Housing and Employment

PubMed Central

Schumacher, Joseph E.; Wallace, Dennis; Vuchinich, Rudy; Mennemeyer, Stephen T.; Kertesz, Stefan G.

2010-01-01

Objectives. We examined whether cocaine-dependent homeless persons had stable housing and were employed 6, 12, and 18 months after they entered a randomized controlled trial comparing 2 treatments. Methods. One group (n = 103) received abstinence-contingent housing, vocational training, and work; another group (n = 103) received the same intervention plus cognitive behavioral day treatment. We examined baseline and early treatment variables for association with long-term housing and employment. Results. Although the enhanced-treatment group achieved better abstinence rates, the groups did not differ in long-term housing and employment stability. However, consecutive weeks of abstinence during treatment (and to a lesser extent, older age and male gender) predicted long-term housing and employment stability after adjustment for baseline differences in employment, housing, and treatment. Conclusions. Our data showed a relationship of abstinence with housing stability. Contrasting these results with the increasingly popular Housing First interventions reveals important gaps in our knowledge to be addressed in future research. PMID:19833998

Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial.

PubMed

Carney, Colleen E; Edinger, Jack D; Kuchibhatla, Maragatha; Lachowski, Angela M; Bogouslavsky, Olya; Krystal, Andrew D; Shapiro, Colin M

2017-04-01

To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. A blinded, randomized split-plot experimental study. Two urban academic clinical centers. 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH's sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of CBT-I. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

The Effectiveness of a School-Based Intervention for Adolescents in Reducing Disparities in the Negative Consequences of Substance Use Among Ethnic Groups.

PubMed

Stewart, David G; Moise-Campbell, Claudine; Chapman, Meredith K; Varma, Malini; Lehinger, Elizabeth

2017-06-01

Ethnic minority youth are disproportionately affected by substance use-related consequences, which may be best understood through a social ecological lens. Differences in psychosocial consequences between ethnic majority and minority groups are likely due to underlying social and environmental factors. The current longitudinal study examined the outcomes of a school-based motivational enhancement treatment intervention in reducing disparities in substance use consequences experienced by some ethnic minority groups with both between and within-subjects differences. Students were referred to the intervention through school personnel and participated in a four-session intervention targeting alcohol and drug use. Participants included 122 youth aged 13-19 years. Participants were grouped by ethnicity and likelihood of disparate negative consequences of substance use. African American/Hispanic/Multiethnic youth formed one group, and youth identifying as White or Asian formed a second group. We hypothesized that (1) there would be significant disparities in psychosocial, serious problem behavior, and school-based consequences of substance use between White/Asian students compared to African American/Hispanic/Multiethnic students at baseline; (2) physical dependence consequences would not be disparate at baseline; and (3) overall disparities would be reduced at post-treatment follow-up. Results indicated that African American/Hispanic/Multiethnic adolescents demonstrated statistically significant disparate consequences at baseline, except for physical dependency consequences. Lastly, significant reductions in disparities were evidenced between groups over time. Our findings highlight the efficacy of utilizing school-based substance use interventions in decreasing ethnic health disparities in substance use consequences.

The effects of an amino acid supplement on glucose homeostasis, inflammatory markers, and incretins after laparoscopic gastric bypass.

PubMed

Breitman, Igal; Saraf, Neha; Kakade, Manasi; Yellumahanthi, Kishore; White, Merritt; Hackett, Jo Ann; Clements, Ronald H

2011-04-01

Protein supplements are routinely used after a laparoscopic gastric bypass (LGB). The aim of this study was to evaluate the impact of an amino acid supplement on glucose homeostasis and hormonal and inflammatory markers after LGB. Thirty patients undergoing LGB were randomized to receive or not 24 g of an oral supplement containing a leucine metabolite, glutamine, and arginine twice daily. Changes in weight, glucose, insulin, C-peptide, insulin sensitivity, interleukin (IL) 6, C-reactive protein (CRP), leptin, insulin-like growth factor (IGF) 1, ghrelin, and incretins were assessed preoperatively and 2 weeks and 8 weeks postoperatively. Thirty patients (96.7% female, age 46.9 ± 8.4 years, body mass index 43.3 ± 4.1 kg/m(2)) were randomized. The experimental (n = 14) and control (n = 16) groups were not significantly different at baseline. Weight loss was similar for the 2 groups. Fasting glucose decreased significantly at 2 and 8 weeks compared with base line (p < 0.0001) with no difference between the experimental and control groups (p = 0.8), but insulin and calculated insulin sensitivity, which were similar at baseline, became significantly worse in the experimental group 8 weeks after surgery (p = 0.02 for insulin; p = 0.04 for the homeostasis model assessment of insulin resistance). CRP and IL-6, which were similar at baseline, were found to be significantly higher at 8 weeks in the experimental group (p = 0.018 and p = 0.05, respectively). Leptin and IGF-1 levels decreased significantly from baseline at 2 and 8 weeks (p < 0.0001), but there was no difference between the 2 groups. No significant changes in GLP-1, ghrelin, or gastric inhibitory polypeptide were noticed after 8 weeks. An amino acid supplement had no effect on the early postoperative incretins after LGB. It may have a negative influence on glucose kinetics and degree of inflammation. Future studies are needed to clarify these effects. Copyright © 2011 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Baseline mean deviation and rates of visual field change in treated glaucoma patients.

PubMed

Forchheimer, I; de Moraes, C G; Teng, C C; Folgar, F; Tello, C; Ritch, R; Liebmann, J M

2011-05-01

To evaluate the relationships between baseline visual field (VF) mean deviation (MD) and subsequent progression in treated glaucoma. Records of patients seen in a glaucoma practice between 1999 and 2009 were reviewed. Patients with glaucomatous optic neuropathy, baseline VF damage, and ≥8 SITA-standard 24-2 VF were included. Patients were divided into tertiles based upon baseline MD. Automated pointwise linear regression determined global and localized rates (decibels (dB) per year) of change. Progression was defined when two or more adjacent test locations in the same hemifield showed a sensitivity decline at a rate of >1.0  dB per year, P<0.01. For mild, moderate, and severe groups, progression was noted in 29.5, 31.2, and 26.0% of eyes (P=0.50) and global rates of VF change of progressing eyes were -1.3±1.2, -1.01±0.7, and -0.9±0.5 dB/year (P=0.09, analysis of variance). Within these groups, intraocular pressure (IOP) in stable vs progressing eyes were 15.5±3.3 vs 17.0±3.1 (P<0.01), 15.4±3.3 vs 15.9±2.5 (P=0.28), and 14.0±2.8 vs 14.8±2.3 mm Hg (P=0.07). More glaucoma filtering surgeries were performed in eyes with worse MD. There was no significant difference between groups regarding their risk of progression in both univariate (P=0.50) and multivariate (P=0.26) analyses adjusting for differences in follow-up IOP. After correcting for differences in IOP in treated glaucoma patients, we did not find a relationship between the rate of VF change (dB per year) and the severity of the baseline VF MD. This finding may have been due to more aggressive IOP lowering in eyes with more severe disease. Eyes with lower IOP progressed less frequently across the spectrum of VF loss.

Ethnic differences in cognitive development in the first 7 years: does maternal generational status matter?

PubMed

Smith, Neil R; Kelly, Yvonne J; Nazroo, James Y

2016-05-01

Differences in cognitive development have been observed across a variety of ethnic minority groups but relatively little is known about the persistence of these developmental inequalities over time or generations. A repeat cross-sectional analysis assessed cognitive ability scores of children aged 3, 5 and 7 years from the longitudinal UK Millennium Cohort Study (white UK born n=7630; Indian n=248; Pakistani n=328; Bangladeshi n=87; black Caribbean n=172; and black African n=136). Linear regression estimated ethnic differences in age normed scores at each time point. Multivariable logistic regression estimated within-group generational differences in test scores at each age adjusting stepwise for sociodemographic factors, maternal health behaviours, indicators of the home learning environment and parenting styles. The majority of ethnic minority groups scored lower than the white UK born reference group at 3 years with these differences narrowing incrementally at ages 5 and 7 years. However, the black Caribbean group scored significantly lower than the white UK born reference group throughout early childhood. At 3 years, Pakistani, black Caribbean and black African children with UK born mothers had significantly higher test scores than those with foreign born mothers after baseline adjustment for maternal age and child gender. Controlling for social, behavioural and parenting factors attenuated this generational advantage. By 7 years there were no significant generational differences in baseline models. Ethnic differences in cognitive development diminish throughout childhood for the majority of groups. Cumulative exposure to the UK environment may be associated with higher cognitive development scores. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Effect of blue-blocking glasses in major depressive disorder with sleep onset insomnia: A randomized, double-blind, placebo-controlled study.

PubMed

Esaki, Yuichi; Kitajima, Tsuyoshi; Takeuchi, Ippei; Tsuboi, Soji; Furukawa, Osamu; Moriwaki, Masatsugu; Fujita, Kiyoshi; Iwata, Nakao

2017-01-01

Blue wavelengths form the portion of the visible electromagnetic spectrum that most potently regulates circadian rhythm. We hypothesized that wearing blue-blocking (BB) glasses in the evening may influence circadian rhythm disturbances in patients with major depressive disorder (MDD), resulting in improved sleep and mood. We used a randomized placebo-controlled double-blinded design. Patients with MDD with sleep onset insomnia were randomly assigned to wearing either BB glasses or clear glasses (placebo). Patients were instructed to wear the glasses from 20:00 hours until bedtime for 2 weeks. We assessed sleep state (sleep quality on a visual analog scale, the Morningness-Eveningness Questionnaire [MEQ], and a sleep diary) and depressive symptoms at baseline and after 2 weeks. Data were analyzed with a full analysis set. In total, 20 patients were randomly assigned to the BB and placebo groups (BB group, n = 10; placebo group, n = 10). There were three dropouts (BB group, n = 1; placebo group, n = 2). At baseline, sleep quality, sleep latency (assessed via a sleep diary), and antipsychotics use differed between the groups. To take account of these differences, the baseline sleep state or depressive symptoms and antipsychotics use were used as covariates in the later analysis. The change scores for sleep quality did not show a significant improvement in the BB group compared with the placebo group (mean [standard deviation, SD] scores for BB versus placebo: 36.1 [31.7] versus 16.2 [15.1], p = 0.43), although half of the BB group showed a clear improvement in sleep quality. The change in MEQ scores did not significantly differ between the groups (p = 0.14), although there was a trend of a shift to morning type in the BB group (3.10 [4.95] points) and to evening type in the placebo group (0.50 [3.89] points). There were no statistically significant changes in depressive symptoms in either group. Across both groups, 40% of the participants reported pain or discomfort from wearing the glasses, which were available in only one size. Thus, the failure to find significant differences may have resulted from the glasses used in this study. Glasses fitted to individual patients may improve efficacy and safety. Replication of the study with a larger sample size and size-adjustable glasses is needed.

Depressive Symptoms Moderate Dating Violence Prevention Outcomes Among Adolescent Girls.

PubMed

Collibee, Charlene; Rizzo, Christie J; Kemp, Kathleen; Hood, Erik; Doucette, Hannah; Gittins Stone, Daniel I; DeJesus, Brett

2018-04-01

Few dating violence prevention programs assess how variations in initial violence risk affects responsiveness. This study examines the efficacy of Date SMART, a dating violence and sexual risk prevention program designed to target high-risk adolescent girls, in preventing dating violence in the context of varying initial levels of depressive symptoms. A diverse sample of N = 109 female adolescents with a history of physical dating violence participated in a randomized controlled trial of the Date SMART program and a knowledge only (KO) comparison. Using baseline depression level as a primary risk factor, a series of multilevel models revealed significant main effects of baseline depression such that higher baseline depression was associated with greater physical dating violence perpetration and victimization. Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration. Specifically, those with higher baseline depression in Date SMART showed significantly less physical dating violence perpetration at follow-ups compared with those with higher baseline depression in the KO group. This difference in violence reduction between conditions was not observed for those with lower baseline depression. Date SMART appears to effectively reduce physical dating violence perpetration in those with higher levels of initial risk. Current findings support that adolescents with different risk profiles respond differently to violence prevention programs.

Nutrition education alone improves dietary practices but not hematologic indices of adolescent girls in Iran.

PubMed

Amani, Reza; Soflaei, Maryam

2006-09-01

Iron-deficiency anemia is the most prevalent nutritional deficiency worldwide. Iron-deficiency anemia has particular negative consequences on women in their childbearing years, and its prevention is a high priority in most health systems. This interventional study assessed the effect of nutrition education on hematologic indices, iron status, nutritional knowledge, and nutritional practices of high-school girls in Iran. Sixty healthy 16- to 18-year-old girls were randomly selected from two high schools in the city of Ahvaz and divided into two equally matched groups, one that received nutrition education, and one that did not. The education group received instruction in face-to-face sessions, group discussions, and pamphlets for 2 months. The control group did not receive any information during the study. Hematologic tests, corpuscular indices, and serum ferritin levels were measured at baseline and after 2 months. Food-frequency questionnaires were administered and histories taken, clinical signs of nutritional deficiencies observed, anthropometric measurements taken, nutritional knowledge tested, practices determined, and lifestyle questionnaires administered to all subjects. There were no statistically significant differences in any baseline characteristics between the two groups. Scores for nutritional knowledge and practices of the education group were significantly higher after two months compared with the baseline (31.4 +/- 6 vs. 24.3 +/- 5.9 points, p < .001, and 31.2 +/- 5 vs. 28.4 +/- 5.7 points, p < .05, respectively). The scores in the control group showed no significant changes from baseline to 2 months. Mean corpuscular volume values were elevated in the education group (p < .001) but not in the control group. However, in the control group, serum ferritin concentrations showed about a 17% drop at the end of the study (p < .004). There were no changes in other hematologic, lifestyle, clinical, or anthropometric data compared with baseline after completion of the study in both groups. These findings indicate that nutritional education can improve knowledge of healthy nutrition and lifestyle choices. Focused nutritional education using available resources and correcting current dietary habits in a vulnerable group of young women may result in dietary changes that can ultimately improve iron intake.

Effects of two combined oral contraceptives containing ethinyl estradiol 30 microg combined with either gestodene or drospirenone on hemostatic parameters, lipid profiles and blood pressure.

PubMed

Yildizhan, Recep; Yildizhan, Begum; Adali, Ertan; Yoruk, Pinar; Birol, Fatih; Suer, Necdet

2009-08-01

The aim of this study is to compare the effect of ethinyl estradiol 0.03 mg/gestodene 0.075 mg (EE/GSD) with ethinylestradiol 0.03 mg/drospirenone 3 mg (EE/DRSP) administered according to conventional 21/7 regimen on body mass index (BMI), blood pressure (BP), lipid metabolism and hemostatic parameters. In this study, 160 healthy women were randomized to EE/GSD mg or EE/DRSP for 12 months. Mean differences in BMI, high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C), total cholesterol (TC) levels and BP compared to baseline were assessed. One hundred and forty-five (89%) of the women completed all 12 treatment cycles. The subjects randomly assigned into two treatment groups. Group EE/GSD (n = 71) and group EE/DRSP (n = 72). In group B, BMI values were significantly lower than baseline at the sixth cycle. DRSP/EE had more favorable effects on BP than GSD/EE with the mean systolic and diastolic BPs remaining lower in the DRSP/EE group. The difference between the two preparations was not statistically significant at the end of the study. TC levels remained similar in both groups throughout the study period. In both groups LDL-C levels decreased, triglyceride and HDL-C levels significantly increased from baseline levels. These changes result in increasing HDL-C/LDL-C ratio, demonstrating anti-atherogenic effect. Menstrual cycle patterns and the incidence of adverse events were similar between groups. The duration of withdrawal bleeding decreased during the study for both groups and was similar. The EE/DRSP regimen provides good cycle control with reliable contraceptive efficacy and low incidence of adverse events. Compared with the EE/GSD preparation, the EE/DRSP preparation demonstrated a more favorable effect on BMI and BP with the mean BMI and mean BP remaining lower than baseline mean. The new formulation may be especially beneficial for women susceptible to body weight gain and rise in BP.

Chronically homeless women report high rates of substance use problems equivalent to chronically homeless men.

PubMed

Edens, Ellen Lockard; Mares, Alvin S; Rosenheck, Robert A

2011-01-01

The U.S. federal government recently committed itself to ending chronic homelessness within 5 years. Women constitute one out of four chronically homeless adults and represent a particularly vulnerable group, but have been little studied. To identify potentially unique needs in this group, we report characteristics and 2-year outcomes in a large sample of male and female chronically homeless adults participating in a multisite, supportive housing program. Men and women participating in the outcome evaluation of the 11-site Collaborative Initiative on Chronic Homelessness (n = 714) supportive housing program and who received at least one follow-up assessment were compared on baseline characteristics and up to 2-year follow-up outcomes. Mixed model multivariate regression adjusted outcome findings for baseline group differences. Few significant baseline differences existed between males and females, with both sexes self-reporting very high rates of lifetime mental health (83% women, 74% men) and substance use (68% women, 73% men) problems. Throughout the 2-year follow-up, both men and women dramatically increased the number of days housed, showed minimal changes in substance use patterns, and had modest improvements in mental health outcomes, without significant differences between genders. Unlike other U.S. populations, chronically homeless adults do not demonstrate substantial gender differences on mental health or addiction problems. Policy and service delivery must address these remarkably high rates of substance use and mental illness. Published by Elsevier Inc.

Efficacy of intravitreal bevacizumab for macular edema following branch retinal vein occlusion stratified by baseline visual acuity.

PubMed

Kim, Mirae; Jeong, Seongyong; Sagong, Min

2017-04-01

To compare the clinical features and bevacizumab efficacy for macular edema (ME) following branch retinal vein occlusion (BRVO) stratified by baseline visual acuity. This retrospective study included a total 117 eyes from 117 consecutive patients with ME following BRVO, who received PRN intravitreal bevacizumab injection and were followed for more than 6 months. The eyes were categorized into three groups according to baseline best-corrected visual acuity (BCVA) (group A, BCVA <20/200; group B, BCVA ≥20/200 and ≤20/40; group C, BCVA >20/40). Baseline demographics, clinical features, BCVA, and central retinal thickness (CRT) at 1, 3, 6, and 12 months after injection and the number of injections were compared. Groups A-C included 11, 83, and 23 eyes, respectively. The mean baseline CRT was thickest in group A (810.1, 580.8, and 473.5 μm in groups A-C, respectively; p < 0.001) and the percentage of eyes with macular ischemia increased in the worst BCVA group (45.5, 25.0, and 4.3 % in groups A-C, respectively; p = 0.005). The mean BCVA and CRT improved at 1, 3, 6, and 12 months after treatment compared to baseline values in all groups (all, p < 0.001). The number of injections for 6 months was greater in the worst BCVA group (3.2, 2.3, and 1.9 injections in groups A-C, respectively; p = 0.009). In ME following BRVO, baseline visual acuity correlates with macular ischemia and baseline CRT. Intravitreal bevacizumab treatment results in significant anatomical and functional improvement regardless of baseline visual acuity.

Rivaroxaban versus warfarin in Japanese patients with non-valvular atrial fibrillation in relation to hypertension: a subgroup analysis of the J-ROCKET AF trial.

PubMed

Matsumoto, Masayasu; Hori, Masatsugu; Tanahashi, Norio; Momomura, Shin-Ichi; Uchiyama, Shinichiro; Goto, Shinya; Izumi, Tohru; Koretsune, Yukihiro; Kajikawa, Mariko; Kato, Masaharu; Ueda, Hitoshi; Iekushi, Kazuma; Yamanaka, Satoshi; Tajiri, Masahiro

2014-05-01

The majority of the patients enrolled in the rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation (J-ROCKET AF) trial had hypertension. In this subgroup analysis, we investigated differences in the safety and efficacy of rivaroxaban and warfarin in subjects with and without hypertension. The baseline blood pressure (BP) measurements of patients with hypertension in the rivaroxaban and warfarin groups were 130/77 mm Hg and 131/77 mm Hg, respectively, whereas those of patients without hypertension were 123/74 mm Hg and 124/73 mm Hg, respectively. The incidence rates of the principal safety outcomes in the rivaroxaban and warfarin groups were 18.39% per year and 16.81% per year, respectively, among patients with baseline hypertension (hazard ratio (HR): 1.10; 95% confidence interval (CI): 0.84-1.45) and 16.71% per year and 15.00% per year, respectively, among patients without hypertension at baseline (HR: 1.14; 95% CI: 0.66-1.97), indicating no significant interaction (P=0.933). The incidence rates of the primary efficacy endpoints in the rivaroxaban group and the warfarin group were 0.54% per year and 2.24% per year, respectively, in patients without baseline hypertension (HR: 0.25; 95% CI: 0.03-2.25), and 1.45% per year and 2.71% per year, respectively, in patients with baseline hypertension (HR: 0.54; 95% CI: 0.25-1.16), indicating no significant interaction (P=0.509). In conclusion, the safety and efficacy profile of rivaroxaban was similar to that of warfarin, independent of baseline hypertensive status.

Gender Differences in Psychotic Disorders with Concurrent Substance Use

PubMed Central

Caton, Carol L.M.; Xie, Haiyi; Drake, Robert E.; McHugo, Gregory

2015-01-01

Objective We conducted a comparative analysis of gender differences in patients with primary psychotic disorders with concurrent substance use and in those with substance-induced psychoses. Methods A total of 385 individuals admitted to psychiatric emergency departments with early onset psychosis and recent substance use were interviewed at baseline and at 6-month intervals for two years. Using a standardized research diagnostic assessment instrument, we classified patients at baseline into primary and substance-induced psychosis groups and analyzed the effects of gender on demographic, family, and clinical characteristics at baseline, the interaction of gender and diagnosis, and gender main effects on illness course, adjustment, and service use over the two-year follow-up period. Results Women had better premorbid adjustment, less misattribution of symptoms, and a later age of onset of regular drug use compared to men. Women, however, showed greater depression and histories of abuse compared to men. Men had greater arrest histories. No interactions between gender and diagnosis were significant. Both genders in the primary and substance-induced psychosis groups showed clinical and functional improvement over the follow-up period despite the overall minimal use of mental health and substance abuse treatment services. Conclusions Women and men with psychosis and substance use differ on several dimensions. Our findings suggest the need for gender-specific treatment programming across both diagnostic groups. PMID:25391275

Outcomes of patients in clinical trials with ST-segment elevation myocardial infarction among countries with different gross national incomes.

PubMed

Orlandini, Andrés; Díaz, Rafael; Wojdyla, Daniel; Pieper, Karen; Van de Werf, Frans; Granger, Christopher B; Harrington, Robert A; Boersma, Eric; Califf, Robert M; Armstrong, Paul; White, Harvey; Simes, John; Paolasso, Ernesto

2006-03-01

To evaluate whether there is an association between 30-day mortality in patients with ST-segment elevation myocardial infarction (STEMI) included in clinical trials and country gross national income (GNI). A retrospective analysis of the databases of five randomized trials including 50 310 patients with STEMI (COBALT 7169, GIK-2 2931, HERO-2 17,089, ASSENT-2 17,005, and ASSENT-3 6116 patients) from 53 countries was performed. Countries were divided into three groups according to their GNI based on the World Bank data: low (less than 2900 US dollars), medium (between 2900 US dollars and 9000 US dollars), and high GNI (more than 9000 US dollars per capita). Baseline characteristics, in-hospital management variables, and 30-day outcomes were evaluated. A previously defined logistic regression model was used to adjust for differences in baseline characteristics and to predict mortality. The observed mortality was higher than the predicted mortality in the low (12.1 vs. 11.8%) and in the medium income groups (9.4 vs. 7.9%), whereas it was lower in the high income group (4.9 vs. 5.6%). An inverse relationship between mortality and GNI was observed in STEMI clinical trials. Most of the variability in mortality can be explained by differences in baseline characteristics; however, after adjustment, lower income countries have higher mortality than the expected.

Aniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical study.

PubMed

Senin, U; Abate, G; Fieschi, C; Gori, G; Guala, A; Marini, G; Villardita, C; Parnetti, L

1991-12-01

One hundred and nine elderly patients suffering from mild to moderate cognitive impairment fulfilling NINCDS-ADRDA criteria for probable dementia of the Alzheimer type were treated for 6 months with a new nootropic drug, aniracetam (Ro 13-5057) in a double-blind randomized study versus placebo. The two treatment groups were comparable at baseline for demographic and behaviourial parameters and symptomatology. Patients underwent clinical, behaviourial and psychometric evaluation every other month. The aniracetam group differed significantly from the placebo group by the end of the study and also showed a statistically significant improvement versus baseline in the psychobehavioural parameters, while in the placebo group a steady deterioration was observed. Tolerability to aniracetam was excellent.

Different patterns of longitudinal brain and spinal cord changes and their associations with disability progression in NMO and MS.

PubMed

Liu, Yaou; Duan, Yunyun; Huang, Jing; Ren, Zhuoqiong; Liu, Zheng; Dong, Huiqing; Weiler, Florian; Hahn, Horst K; Shi, Fu-Dong; Butzkueven, Helmut; Barkhof, Frederik; Li, Kuncheng

2018-01-01

To investigate the longitudinal spinal cord and brain changes in neuromyelitis optica (NMO) and multiple sclerosis (MS) and their associations with disability progression. We recruited 28 NMO, 22 MS, and 20 healthy controls (HC), who underwent both spinal cord and brain MRI at baseline. Twenty-five NMO and 20 MS completed 1-year follow-up. Baseline spinal cord and brain lesion loads, mean upper cervical cord area (MUCCA), brain, and thalamus volume and their changes during a 1-year follow-up were measured and compared between groups. All the measurements were also compared between progressive and non-progressive groups in NMO and MS. MUCCA decreased significantly during the 1-year follow-up in NMO not in MS. Percentage brain volume changes (PBVC) and thalamus volume changes in MS were significantly higher than NMO. MUCCA changes were significantly different between progressive and non-progressive groups in NMO, while baseline brain lesion volume and PBVC were associated with disability progression in MS. MUCCA changes during 1-year follow-up showed association with clinical disability in NMO. Spinal cord atrophy changes were associated with disability progression in NMO, while baseline brain lesion load and whole brain atrophy changes were related to disability progression in MS. • Spinal cord atrophy progression was observed in NMO. • Spinal cord atrophy changes were associated with disability progression in NMO. • Brain lesion and atrophy were related to disability progression in MS.

Baseline simple and complex reaction times in female compared to male boxers.

PubMed

Bianco, M; Ferri, M; Fabiano, C; Giorgiano, F; Tavella, S; Manili, U; Faina, M; Palmieri, V; Zeppilli, P

2011-06-01

The aim of the study was to compare baseline cognitive performance of female in respect to male amateur boxers. Study population included 28 female amateur boxers. Fifty-six male boxers, matched for age, employment and competitive level to female athletes, formed the control group. All boxers had no history of head concussions (except boxing). Each boxer was requested to: 1) fulfill a questionnaire collecting demographic data, level of education, occupational status, boxing record and number of head concussions during boxing; 2) undergo a baseline computerized neuropsychological (NP) test (CogSport) measuring simple and complex reaction times (RT). Female were lighter than male boxers (56±7 vs. 73.1±9.8 kg, P<0.0001). No significant differences at CogSport scores were observed between groups. Male boxers showed a longer simple-RT at the end of the NP battery than at the beginning (0.247±0.007 vs. 0.243±0.007 s, P=0.02), however, with a significant lower rate of mistakes (0.7±1.6 vs. 2.0±3.1%, P=0.005), observed also in the female group (0.5±1.1 vs. 2.2±3.0%, P=0.005). No boxing activity parameter (record, number of knock-outs, etc.) correlated with NP scores. Female and male Olympic-style boxers have no (or minimal) differences in baseline cognitive performance. Further research with larger series of female boxers is required to confirm these findings.

Comparative effectiveness of Pilates and yoga group exercise interventions for chronic mechanical neck pain: quasi-randomised parallel controlled study.

PubMed

Dunleavy, K; Kava, K; Goldberg, A; Malek, M H; Talley, S A; Tutag-Lehr, V; Hildreth, J

2016-09-01

To determine the effectiveness of Pilates and yoga group exercise interventions for individuals with chronic neck pain (CNP). Quasi-randomised parallel controlled study. Community, university and private practice settings in four locations. Fifty-six individuals with CNP scoring ≥3/10 on the numeric pain rating scale for >3 months (controls n=17, Pilates n=20, yoga n=19). Exercise participants completed 12 small-group sessions with modifications and progressions supervised by a physiotherapist. The primary outcome measure was the Neck Disability Index (NDI). Secondary outcomes were pain ratings, range of movement and postural measurements collected at baseline, 6 weeks and 12 weeks. Follow-up was performed 6 weeks after completion of the exercise classes (Week 18). NDI decreased significantly in the Pilates {baseline: 11.1 [standard deviation (SD) 4.3] vs Week 12: 6.8 (SD 4.3); mean difference -4.3 (95% confidence interval -1.64 to -6.7); P<0.001} and yoga groups [baseline: 12.8 (SD 7.4) vs Week 12: 8.1 (SD 5.6); mean difference -4.7 (95% confidence interval -2.1 to -7.4); P<0.00], with no change in the control group. Pain ratings also improved significantly. Moderate-to-large effect sizes (0.7 to 1.8) and low numbers needed to treat were found. There were no differences in outcomes between the exercise groups or associated adverse effects. No improvements in range of movement or posture were found. Pilates and yoga group exercise interventions with appropriate modifications and supervision were safe and equally effective for decreasing disability and pain compared with the control group for individuals with mild-to-moderate CNP. Physiotherapists may consider including these approaches in a plan of care. ClinicalTrials.gov NCT01999283. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Using parathyroid hormone spikes during parathyroidectomy to guide intraoperative decision-making.

PubMed

Carr, Azadeh A; Yen, Tina W; Wilson, Stuart D; Evans, Douglas B; Wang, Tracy S

2017-03-01

Intraoperative parathyroid hormone (IOPTH) level monitoring is a useful adjunct to parathyroidectomy for primary hyperparathyroidism (pHPT). Occasionally, increases ("spikes") in IOPTH levels from the preoperative baseline parathyroid hormone may occur, which may lead to longer operative times or more extensive neck exploration or both. The aim of this study was to determine if the extent of IOPTH level increase predicts single gland disease (SGD). This is a retrospective review of a prospective parathyroid database of patients undergoing parathyroidectomy for sporadic pHPT from 1999-2013. Extent of parathyroid hormone spike was calculated by the difference in IOPTH level at the time of gland excision and baseline: group 1 had a decrease in IOPTH level, group 2 had IOPTH level increase one to three times above the baseline, and group 3 had IOPTH level increase greater than three times above the baseline. Of the 900 patients in the cohort, there were 634 patients (70%) in group 1, 234 (26%) in group 2, and 32 (4%) in group 3. SGD was identified in 88%, 78%, and 100% of patients in groups 1, 2, and 3, respectively. The median gland weight in group 3 (920 mg) was significantly larger than those in groups 1 and 2 (440 and 460 mg, respectively; P < 0.001). IOPTH level spikes occur in nearly one-third of patients undergoing parathyroidectomy for sporadic pHPT. Patients with extensive IOPTH level increase are more likely to have larger SGD, whereas patients with moderate IOPTH level increases have increased incidence of multigland disease. In patients with a significant increase in IOPTH levels and larger glands, no further surgical exploration may be indicated. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparison of iron chelation effects of deferoxamine, deferasirox, and combination of deferoxamine and deferiprone on liver and cardiac T2* MRI in thalassemia maior.

PubMed

Ansari, Shahla; Azarkeivan, Azita; Miri-Aliabad, Ghasem; Yousefian, Saeed; Rostami, Tahereh

2017-01-01

Cardiac complications due to iron overload are the most common cause of death in patients with thalassemia major. The aim of this study was to compare iron chelation effects of deferoxamine, deferasirox, and combination of deferoxamine and deferiprone on cardiac and liver iron load measured by T2* MRI. In this study, 108 patients with thalassemia major aged over 10 years who had iron overload in cardiac T2* MRI were studied in terms of iron chelators efficacy on the reduction of myocardial siderosis. The first group received deferoxamine, the second group only deferasirox, and the third group, a combination of deferoxamine and deferiprone. Myocardial iron was measured at baseline and 12 months later through T2* MRI technique. The three groups were similar in terms of age, gender, ferritin level, and mean myocardial T2* at baseline. In the deferoxamine group, myocardial T2* was increased from 12.0±4.1 ms at baseline to 13.5±8.4 ms at 12 months (p=0.10). Significant improvement was observed in myocardial T2* of the deferasirox group (p<0.001). In the combined treatment group, myocardial T2* was significantly increased (p<0.001). These differences among the three groups were not significant at the 12 months. A significant improvement was observed in liver T2* at 12 months compared to baseline in the deferasirox and the combination group. In comparison to deferoxamine monotherapy, combination therapy and deferasirox monotherapy have a significant impact on reducing iron overload and improvement of myocardial and liver T2* MRI.

Beneficial Effects of Vildagliptin on Metabolic Parameters in Patients with Type 2 Diabetes.

PubMed

Shimodaira, Masanori; Niwa, Tomohiro; Nakajima, Koji; Kobayashi, Mutsuhiro

2015-01-01

Blood pressure and lipid profile are important determinants of cardiovascular risk in patients with type 2 diabetes mellitus (T2DM). To identify the pleiotropic effects of vildagliptin other than blood glucose lowering effect, a retrospective study was conducted in 128 patients with T2DM treated with vildagliptin 50 mg twice daily. The patients were separated into two groups: patients who were initiated with vildagliptin as monotherapy or add-on therapy (add-on group, n = 66) and patients who were switched from sitagliptin 100 mg once daily to vildagliptin (switching group, n = 62). Hemoglobin A1c (HbA1c), body mass index (BMI), systolic/diastolic blood pressure, lipid profiles, and uric acid (UA) at 3, 6, and 12 months of vildagliptin therapy were compared with those at baseline in each group. At baseline, there were no significant differences in HbA1c, BMI, blood pressures, lipid profiles, and UA levels between the two groups. After vildagliptin initiation, HbA1c decreased significantly but BMI and blood pressure did not change in both groups. Only in the add-on group, total cholesterol and low density lipoprotein cholesterol decreased significantly from baseline to 3, 6, and 12 months. On the other hand, triglyceride and high-density lipoprotein cholesterol did not change in both groups. Serum UA levels decreased only in the switching group from baseline to 3, 6, and 12 months. These results indicate that vildagliptin add-on treatment may have beneficial effects on lipid profiles, and switching from sitagliptin to vildagliptin reduces UA in patients with T2DM; these are important findings linked to the beneficial effects of vildagliptin on lipid and UA metabolisms in the treatment of T2DM.

Composite Physiologic Index, Percent Forced Vital Capacity and Percent Diffusing Capacity for Carbon Monoxide Could Be Predictors of Pirfenidone Tolerability in Patients with Idiopathic Pulmonary Fibrosis.

PubMed

Konishi, Satoshi; Arita, Machiko; Ito, Isao; Tachibana, Hiromasa; Takaiwa, Takuya; Fukuda, Yasushi; Watanabe, Naoki; Tsubouchi, Kazuya; Masuda, Gen; Tanaka, Maki; Kourogi, Youhei; Kunimasa, Kei; Nishiyama, Akihiro; Iwasaku, Masahiro; Ito, Akihiro; Tokioka, Fumiaki; Yoshioka, Hiroshige; Hashimoto, Toru; Ishida, Tadashi

2015-01-01

The goals of this study were to assess the efficacy and tolerability of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) and to identify predictors of tolerability to pirfenidone. We conducted a retrospective observational study. When the patient showed deterioration in the percent forced vital capacity (%FVC) or experienced acute exacerbations or severe adverse events, treatment of the patient with pirfenidone was discontinued. We classified the patients who did not display progression following six months of pirfenidone treatment as the tolerant group and the patients who did display progression as the intolerant group. We retrospectively analyzed differences between the two groups in terms of baseline characteristics. The efficacy of pirfenidone was evaluated by the changes in vital capacity (VC) and %FVC before and after the start of treatment in the tolerant group. Patients A total of 20 patients who had been diagnosed with IPF were treated with pirfenidone. In the tolerant group, the baseline %FVC (p=0.01) and the percentage diffusing capacity of the lungs for carbon monoxide (DLCO, p=0.02) were significantly higher, and the baseline composite physiologic index (CPI) was significantly lower (p=0.009) than in the intolerant group. In the tolerant group, pirfenidone significantly reduced the decline in VC and %FVC of the patients after treatment. In the intolerant group, five patients discontinued pirfenidone treatment because of anorexia. We found that pirfenidone was better tolerated in patients with milder disease symptoms, as indicated by their baseline CPI, %FVC and %DLCO, and that patients in the tolerant group could benefit from the use of pirfenidone.

Water Drinking Test: Intraocular Pressure Changes after Tube Surgery and Trabeculectomy.

PubMed

Razeghinejad, Mohammad Reza; Tajbakhsh, Zahra; Nowroozzadeh, Mohammad Hossein; Masoumpour, Masoumeh

2017-01-01

To study the effects of filtration surgeries (tube and trabeculectomy) on changes in intraocular pressure after a water-drinking test. In this prospective, non-randomized, comparative clinical study, 30 patients who had tube surgery and 30 age- and sex-matched trabeculectomy patients underwent a water-drinking test. Only one eye of each patient was included. The baseline intraocular pressure was ≤21 mmHg in all enrolled eyes with or without adjunctive topical medications. After the water-drinking test, the intraocular pressure was measured and recorded at 15, 30, 45, and 60 minutes and the results were compared between the two groups. In both groups, intraocular pressure significantly increased from baseline at all measured time-points ( P < 0.001). In the trabeculectomy group, the average intraocular pressure increased from 14.8 ± 2.9 to 18.8 ± 4.7 mmHg at 30 minutes, but decreased at 60 min (18.0 ± 5.2 mmHg). In the Tube group, intraocular pressure increased incrementally until the last measurement (14.2 ± 3.9, 18.8 ± 5.6, and 19.7 ± 6.0 mmHg at baseline, 30, and 60 minutes, respectively). The end-pressure difference (intraocular pressure at 60 minutes vs. baseline) was significantly greater in the tube group (5.6 ± 3.6 mmHg; 41% change) than in the trabeculectomy group (3.2 ± 4.7; 23% change; P = 0.03). Intraocular pressure significantly increased after the water-drinking test in both the groups. Intraocular pressure started to decline 30 minutes after the water-drinking test in the trabeculectomy group, while it continued to increase up to 60 minutes in the Tube group. This finding may have implications regarding the efficacy or safety of the procedures in advanced glaucoma patients.

[Application of rapid prototyping technology on nasoalveolar molding for cleft lip and palate].

PubMed

Shen, Congcong; Chai, Gang

2017-12-01

To apply rapid prototyping (RP) technology on pre-fabricating nasoalveolar molding (NAM) appliances, and compare clinical outcomes and complications with traditional NAM appliances. Between June 2014 and September 2016, 39 children with unilateral cleft lip and palate were included in study. Seventeen children (test group) had received novel NAM protocol by pre-fabricating NAM appliances using RP technology, and the other 22 children (control group) had received traditional NAM protocol. There was no significant difference in gender, age, the side of cleft lip and palate, and the width of the alveolar cleft gap before treatment between 2 groups ( P >0.05). The change of width of the alveolar cleft gap, number of clinic visit, treatment time, and complications were compared between 2 groups. The number of clinic visit was less in test group than in control group ( P <0.05). There was no significant difference in treatment time between 2 groups ( P >0.05). During treatment, there was 16 children (72.2%) of skin irritation, 3 (13.6%) of mucosal ulceration, 1 (4.5%) of intraoral bleeding, 1 (4.5%) of alveolar arch T-shap asymmetry in control group. And there were 11 children (64.7%) of skin irritation, 3 (17.6%) of mucosal ulceration in test group. There was no significant difference in the incidence of complications between 2 groups ( P >0.05). After treatment, the anterior alveolar cleft width, horizontal cleft width, sagittal cleft width, antero-medial alveolar ridges angle of the healthy side, angle between anterior alveolar and posterior alveolar baseline of the healthy side, perpendicular distance from buccal frenum point to sagittal line were significantly reduced when compared with the values before treatment ( P <0.05). The angle between the anterior segments of two sides, angle between buccal frenum point and posterior baseline were significant increased when compared with the values before treatment ( P <0.05). There was no significant difference in the differences between pre- and post-treatment of above indexes between 2 groups ( P >0.05). There also was no significant difference in posterior alveolar width, the width between the middle parts of alveolar, vertical cleft width, antero-medial alveolar ridges angle of the affected side, and angle between anterior alveolar and posterior alveolar baseline of the affected side between pre- and post-treatment in each group ( P >0.05). Clinical outcome of novel approach was equivalent to traditional protocol; however, the number of clinic visit decreased. With improving of RP technology, it would provide a more consistency and convenient way for sequential treatment with cleft lip and palate.

Radiofrequency Thermal Lesioning and Extracorporeal Shockwave Therapy: A Comparison of Two Methods in the Treatment of Plantar Fasciitis.

PubMed

Ozan, Fırat; Koyuncu, Şemmi; Gürbüz, Kaan; Öncel, Eyyüp Sabri; Altay, Taşkın

2017-06-01

We compared the results of radiofrequency thermal lesioning (RTL) and extracorporeal shockwave therapy (ESWT) in patients with chronic plantar fasciitis. This prospective study included 56 patients diagnosed with plantar fasciitis who had complaints for ≥6 months: 40 (group 1) underwent ESWT and 16 (group 2) underwent RTL. The presence of calcaneal spurs was investigated with imaging studies. All patients were followed up clinically at baseline and 1, 3, and 6 months after treatment. Clinical evaluations were performed by the visual analog scale (VAS) and the modified Roles-Maudsley (RM) scoring system. There was no significant difference in the age, sex, body mass index, and side of involvement between the groups (all P > .05). Radiographic evaluation showed calcaneal spurs in 22 patients (55%) in group 1 and 7 patients (43%) in group 2. There was no significant difference in the baseline and posttreatment values between the groups; however, group 2 had significantly different RM values at 1 month than group 1 ( P < .05). In both groups, the VAS scores significantly decreased at 1, 3, and 6 months after treatment ( P < .05). The RM scores at 1, 3, and 6 months after treatment significantly decreased in both groups, except for the RM values at 1 month after treatment in group 1 ( P < .05). Our study results suggest that RTL and ESWT are safe and effective treatments in patients with chronic plantar fasciitis. Level II: Therapeutic study.

Quality of life and client satisfaction as outcomes of the Redesigning Daily Occupations (ReDO) programme for women with stress-related disorders: a comparative study.

PubMed

Eklund, Mona; Erlandsson, Lena-Karin

2013-01-01

The outcomes, in terms of quality of life and satisfaction with rehabilitation, of the 16-week Redesigning Daily Occupations (ReDO) programme as a work rehabilitation method for women with stress-related disorders was evaluated. It was hypothesised that, compared to women who got Care as Usual (CAU), the ReDO group would improve their quality of life and self-mastery more, and that those differences would prevail at follow-ups after 6 and 12 months. Another hypothesis was that the ReDO group would be more satisfied than the CAU group with the rehabilitation received. Forty-two women were recruited to the ReDO intervention and a matched comparison group got CAU. The data consisted of self-ratings of quality of life, self-mastery and satisfaction with the work rehabilitation received. The first hypothesis was only partially verified. No general group differences were identified, but closer examination indicated different trajectories in the two groups. There was an increase in quality of life in the ReDO group from baseline to completion of the work rehabilitation, and further increase at the six-month follow-up, while the quality of life in the CAU group was stable over time. Regarding self-mastery there was an increase from baseline to completed rehabilitation in the ReDO group but a pronounced decrease in the CAU group. Thereafter the group differences levelled out. The second hypothesis was verified. The ratings of client satisfaction were considerably higher in the ReDO group. The ReDO seems a promising work rehabilitation method for strengthening quality of life and self-mastery for the target group. Future research should include larger groups and be based on randomised controlled designs.

Effects of Cervical Kyphosis on Recovery From Dysphagia After Stroke

PubMed Central

2016-01-01

Objective To determine the effects of cervical kyphosis on the recovery of swallowing function in subacute stroke patients. Methods Baseline and 1-month follow-up videofluoroscopic swallowing studies (VFSSs) of 51 stroke patients were retrospectively analyzed. The patients were divided into the cervical kyphosis (Cobb's angle <20°, n=27) and control (n=24) groups. The penetration-aspiration scale (PAS), American Speech-Language-Hearing Association National Outcomes Measurement System swallowing scale (ASHA NOMS), and videofluoroscopic dysphagia scale (VDS) were used to determine the severity of dysphagia. Finally, the prevalence of abnormal VFSS findings was compared between the two groups. Results There were no significant differences in baseline PAS, ASHA NOMS, and VDS scores between the two groups. However, the follow-up VDS scores in the cervical kyphosis group were significantly higher than those in the control group (p=0.04), and a follow-up study showed a tendency towards worse ASHA NOMS scores (p=0.07) in the cervical kyphosis group. In addition, the cervical kyphosis group had a higher occurrence of pharyngeal wall coating in both baseline and follow-up studies, as well as increased aspiration in follow-up studies (p<0.05). Conclusion This study showed that stroke patients who had cervical kyphosis at the time of stroke might have impaired recovery from dysphagia after stroke. PMID:27847711

A prospective comparison of telemedicine versus in-person delivery of an interprofessional education program for adults with inflammatory arthritis.

PubMed

Kennedy, Carol A; Warmington, Kelly; Flewelling, Carol; Shupak, Rachel; Papachristos, Angelo; Jones, Caroline; Linton, Denise; Beaton, Dorcas E; Lineker, Sydney; Hogg-Johnson, Sheilah

2017-02-01

Introduction We evaluated two modes of delivery of an inflammatory arthritis education program ("Prescription for Education" (RxEd)) in improving arthritis self-efficacy and other secondary outcomes. Methods We used a non-randomized, pre-post design to compare videoconferencing (R, remote using telemedicine) versus local (I, in-person) delivery of the program. Data were collected at baseline (T 1 ), immediately following RxEd (T 2 ), and at six months (T 3 ). Self-report questionnaires served as the data collection tool. Measures included demographics, disorder-related, Arthritis Self-Efficacy Scale (SE), previous knowledge (Arthritis Community Research and Evaluation Unit (ACREU) rheumatoid arthritis knowledge questionnaire), coping efficacy, Illness Intrusiveness, and Effective Consumer Scale. Analysis included: baseline comparisons and longitudinal trends (R vs I groups); direct between-group comparisons; and Generalized Estimating Equations (GEE) analysis. Results A total of 123 persons attended the program (I: n = 36; R: n = 87) and 111 completed the baseline questionnaire (T 1 ), with follow-up completed by 95% ( n = 117) at T 2 and 62% ( n = 76) at T 3 . No significant baseline differences were found across patient characteristics and outcome measures. Both groups (R and I) showed immediate effect (improved arthritis SE, mean change (95% confidence interval (CI)): R 1.07 (0.67, 1.48); I 1.48 (0.74, 2.23)) after the program that diminished over six months (mean change (95% CI): R 0.45 (-0.1, 0.1); I 0.73 (-0.25, 1.7)). For each of the secondary outcomes, both groups showed similar trends for improvement (mean change scores (95% CI)) over time. GEE analysis did not show any meaningful differences between groups (R vs I) over time. Discussion Improvements in arthritis self-efficacy and secondary outcomes displayed similar trends for I and R participant groups.

Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial.

PubMed

Cheung, Corjena; Wyman, Jean F; Bronas, Ulf; McCarthy, Teresa; Rudser, Kyle; Mathiason, Michelle A

2017-03-01

Although exercise is often recommended for managing osteoarthritis (OA), limited evidence-based exercise options are available for older adults with OA. This study compared the effects of Hatha yoga (HY) and aerobic/strengthening exercises (ASE) on knee OA. Randomized controlled trial with three arms design was used: HY, ASE, and education control. Both HY and ASE groups involved 8 weekly 45-min group classes with 2-4 days/week home practice sessions. Control group received OA education brochures and weekly phone calls from study staff. Standardized instruments were used to measure OA symptoms, physical function, mood, spiritual health, fear of falling, and quality of life at baseline, 4 and 8 weeks. HY/ASE adherences were assessed weekly using class attendance records and home practice video recordings. Primary analysis of the difference in the change from baseline was based on intent-to-treat and adjusted for baseline values. Eight-three adults with symptomatic knee OA completed the study (84% female; mean age 71.6 ± 8.0 years; mean BMI 29.0 ± 7.0 kg/m 2 ). Retention rate was 82%. Compared to the ASE group at 8 weeks, participants in the HY group had a significant improvement from baseline in perception of OA symptoms (-9.6 [95% CI -15.3, -4]; p = .001), anxiety (-1.4 [95% CI -2.7, -0]; p = .04), and fear of falling (-4.6 [-7.5, -1.7]; p = .002). There were no differences in class/home practice adherence between HY and ASE. Three non-serious adverse events were reported from the ASE group. Both HY and ASE improved symptoms and function but HY may have superior benefits for older adults with knee OA. Trial registration The full trial protocol is available at clinicaltrials.gov (NCT02525341).

Preliminary effects of progressive muscle relaxation on cigarette craving and withdrawal symptoms in experienced smokers in acute cigarette abstinence: a randomized controlled trial.

PubMed

Limsanon, Thatsanee; Kalayasiri, Rasmon

2015-03-01

Cigarette craving usually occurs in conjunction with unpleasant feelings, including stress, as part of a withdrawal syndrome. Progressive muscle relaxation (PMR), a behavioral technique used to reduce stress by concentrating on achieving muscle relaxation, may reduce levels of cigarette craving and other substance-related negative feelings and withdrawal symptoms. Demographic and cigarette use data were collected from 32 experienced smokers at the King Chulalongkorn Memorial Hospital, Bangkok, Thailand using the Semi-Structured Assessment for Drug Dependence and Alcoholism. Participants were asked to refrain from smoking for at least 3 hours before the visit (acute abstinence) and were randomly allocated to a 1-session PMR group (n =16) or a control activity group (e.g., reading newspaper, n =16). The intervention group was instructed to practice PMR individually in a quiet, private, air-conditioned room for about 20minutes. Craving, other substance-related feelings, and autonomic nervous responses (e.g., blood pressure and pulse rate) were assessed immediately before and after the 1-session intervention. There were no differences in demographics, cigarette use/dependence, and baseline craving characteristics between the PMR and control groups. However, the control group had higher levels of high and paranoia feeling, and pulse rate than the PMR group at baseline. After practicing PMR, but not after a control activity, smokers undergoing acute abstinence had significantly lower levels of cigarette craving, withdrawal symptoms, and systolic blood pressure than at baseline. After controlling for baseline differences, abstaining smokers using PMR had lower levels of cigarette craving, withdrawal symptoms, and systolic blood pressure than smokers who undertook a control activity. PMR significantly reduces cigarette craving, withdrawal symptoms, and blood pressure in smokers undergoing acute abstinence. PMR may be used as an adjunct to cigarette dependency treatments. Copyright © 2014. Published by Elsevier Ltd.

Zeaxanthin-based dietary supplement and topical serum improve hydration and reduce wrinkle count in female subjects.

PubMed

Schwartz, Steve; Frank, Emily; Gierhart, Dennis; Simpson, Paula; Frumento, Robert

2016-12-01

Dietary modification, through supplementation and elimination diets, has become an area of interest to help slow skin aging, reduce symptom severity or prevent reoccurrence of certain dermatologic conditions [Clinical Dermatology vol. 31 (2013) 677-700]. Free radical components (reactive oxygen species or ROS) or lipid peroxide (LPO) is involved in the pathogenesis and progression of accelerated skin aging when prolonged oxidative stress occurs. The use of antioxidant-related therapies such as nutraceuticals is of particular interest in restoring skin homeostasis. Antioxidant carotenoid zeaxanthin is concentrated in the eye and skin tissue and believed to decrease the formation of ROS associated with UV light exposure. With zeaxanthin, phytoceramides, and botanical extracts an oral and topical test product (with zeaxanthin, algae extracts, peptides, hyaluronate) have been developed to improve the appearance and condition of skin when used as directed. Subjects were divided into three groups: two tests (skin formula 1 - oral product alone (ZO-1), skin formula 2- oral product with topical product (ZO-2 + ZT)), and one placebo control. The study consisted of a washout visit, baseline (randomization), week two (2), week four (4), week six (6), week eight (8), and week twelve (12). Key parameters measured were as follows: fine lines, deep lines, total wrinkles, wrinkle severity, radiance/skin color (L, a*, b*), discolorations, and skin pigment homogeneity. Thirty-one subjects completed the twelve-week study; no adverse events were recorded during the study. Statistically significant improvements from baseline mean hydration score were observed in active groups at weeks 2, 6, and 8. A statistically significant difference was observed between mean differences from baseline scores for total wrinkle count at week 4 for the combination active groups compared to placebo. A statistically significant difference from baseline scores for fine lines count was also observed at the week 4 visit compared to placebo for both active groups. Statistically significant differences from baseline scores for average wrinkles severity were seen for week 12 visit for both active groups compared to placebo. We have shown that the combination of zeaxanthin-based dietary supplement plus a topical formulation produces superior hydration to that of placebo. Additionally, we have shown that the combination of oral and topical combination vs. oral alone has superior abilities to improve parameters associated with facial lines and wrinkles compared to placebo, although the dietary supplement alone proved most effective in reducing wrinkle count and severity. © 2016 Wiley Periodicals, Inc.

The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

PubMed

Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

2015-07-01

The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

Effect of Urinary Bisphenol A on Androgenic Hormones and Insulin Resistance in Preadolescent Girls: A Pilot Study from the Ewha Birth & Growth Cohort

PubMed Central

Lee, Hye Ah; Kim, Young Ju; Lee, Hwayoung; Gwak, Hye Sun; Park, Eun Ae; Cho, Su Jin; Kim, Hae Soon; Ha, Eun Hee; Park, Hyesook

2013-01-01

To assess the effect of urinary bisphenol A (BPA) on repeated measurements of androgenic hormones and metabolic indices, we used multivariate analysis of variance (MANOVA) adjusted for potential confounders at baseline. During July to August 2011, 80 preadolescent girls enrolled in the Ewha Birth & Growth Cohort study participated in a follow-up study and then forty-eight of them (60.0%) came back one year later. Baseline levels of estradiol and androstenedione were higher in the BPA group than in the non-BPA group. One year later, girls in the high BPA exposure group showed higher levels of androstenedione, testosterone, estradiol, and insulin, and homeostasis model assessment of insulin resistance (HOMA-IR) index, than those in the other groups (p < 0.05). In MANOVA, estradiol and androstenedione showed significant differences among groups, while dehydroepiandrosterone, insulin, and HOMA-IR showed marginally significant differences. Exposure to BPA may affect endocrine metabolism in preadolescents. However, further investigation is required to elucidate the mechanisms linking BPA with regulation of androgenic hormones. PMID:24189184

Effects of game-based virtual reality on health-related quality of life in chronic stroke patients: A randomized, controlled study.

PubMed

Shin, Joon-Ho; Bog Park, Si; Ho Jang, Seong

2015-08-01

In the present study, we aimed to determine whether game-based virtual reality (VR) rehabilitation, combined with occupational therapy (OT), could improve health-related quality of life, depression, and upper extremity function. We recruited 35 patients with chronic hemiparetic stroke, and these participants were randomized into groups that underwent VR rehabilitation plus conventional OT, or the same amount of conventional OT alone, for 20 sessions over 4 weeks. Compared to baseline, the VR rehabilitation plus OT group exhibited significantly improved role limitation due to emotional problems (p=0.047). Compared to baseline, both groups also exhibited significantly improved depression (p=0.017) and upper extremity function (p=0.001), although the inter-group differences were not significant. However, a significant inter-group difference was observed for role limitation due to physical problems (p=0.031). Our results indicate that game-based VR rehabilitation has specific effects on health-related quality of life, depression, and upper extremity function among patients with chronic hemiparetic stroke. Copyright © 2015 Elsevier Ltd. All rights reserved.

Slow Wave Sleep Enhancement with Gaboxadol Reduces Daytime Sleepiness During Sleep Restriction

PubMed Central

Walsh, James K.; Snyder, Ellen; Hall, Janine; Randazzo, Angela C.; Griffin, Kara; Groeger, John; Eisenstein, Rhody; Feren, Stephen D.; Dickey, Pam; Schweitzer, Paula K.

2008-01-01

Study Objectives: To evaluate the impact of enhanced slow wave sleep (SWS) on behavioral, psychological, and physiological changes resulting from sleep restriction. Design: A double-blind, parallel group, placebo-controlled design was used to compare gaboxadol (GBX) 15 mg, a SWS-enhancing drug, to placebo during 4 nights of sleep restriction (5 h/night). Behavioral, psychological, and physiological measures of the impact of sleep restriction were assessed in both groups at baseline, during sleep restriction and following recovery sleep. Setting: Sleep research laboratory. Participants: Forty-one healthy adults; 9 males and 12 females (mean age: 32.0 ± 9.9 y) in the placebo group and 10 males and 10 females (mean age: 31.9 ± 10.2 y) in the GBX group. Interventions: Both experimental groups underwent 4 nights of sleep restriction. Each group received either GBX 15 mg or placebo on all sleep restriction nights, and both groups received placebo on baseline and recovery nights. Measurements and Results: Polysomnography documented a SWS-enhancing effect of GBX with no group difference in total sleep time during sleep restriction. The placebo group displayed the predicted deficits due to sleep restriction on the multiple sleep latency test (MSLT) and on introspective measures of sleepiness and fatigue. Compared to placebo, the GBX group showed significantly less physiological sleepiness on the MSLT and lower levels of introspective sleepiness and fatigue during sleep restriction. There were no differences between groups on the psychomotor vigilance task (PVT) and a cognitive test battery, but these measures were minimally affected by sleep restriction in this study. The correlation between change from baseline in MSLT on Day 6 and change from baseline in SWS on Night 6 was significant in the GBX group and in both groups combined. Conclusions: The results of this study are consistent with the hypothesis that enhanced SWS, in this study produced by GBX, reduces physiological sleep tendency and introspective sleepiness and fatigue which typically result from sleep restriction. Citation: Walsh JK; Snyder E; Hall J; Randazzo AC; Griffin K; Groeger J; Eisenstein R; Feren SD; Dickey P; Schweitzer PK. Slow Wave Sleep Enhancement with Gaboxadol Reduces Daytime Sleepiness During Sleep Restriction. SLEEP 2008;31(5):659–672. PMID:18517036

Effect of nonsurgical periodontal therapy verses oral hygiene instructions on type 2 diabetes subjects with chronic periodontitis: a randomised clinical trial.

PubMed

Raman, Renukanth Patabi Cheta; Taiyeb-Ali, Tara Bai; Chan, Siew Pheng; Chinna, Karuthan; Vaithilingam, Rathna Devi

2014-06-25

40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals. 40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals. 15 subjects from NSPT group and 17 from OHI group completed the study. The difference in plaque index (PI) between NSPT and OHI groups were significant at 2 months recall (p = 0.013). There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters, HbA1c and CRP levels. At 3 months post-therapy, periodontal parameters improved significantly in both groups with sites with probing pocket depth (PPD) < 4 mm reported as 98 ± 1.8% in NSPT group and 92 ± 14.9% in OHI group. Mean PPD and mean probing attachment loss (PAL) within the NSPT group reduced significantly from baseline (2.56 ± 0.57 mm, 3.35 ± 0.83 mm) to final visit (1.94 ± 0.26 mm, 2.92 ± 0.72 mm) (p = 0.003, p < 0.001). For OHI group, improvements in mean PPD and mean PAL were also seen from baseline (2.29 ± 0.69 mm, 2.79 ± 0.96 mm) to final visit (2.09 ± 0.72 mm, 2.62 ± 0.97 mm) (p < 0.001 for both). Similarly, HbA1c levels decreased in both groups with NSPT group recording statistically significant reduction (p = 0.038). Participants who demonstrated ≥ 50% reduction in PPD showed significant reductions of HbA1c and hs-CRP levels (p = 0.004 and p = 0.012). NSPT significantly reduced PI at 2 months post-therapy as compared to OHI. Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels. ClinicalTrials.gov: NCT01951547.

Bioavailability of a heme-iron concentrate product added to chocolate biscuit filling in adolescent girls living in a rural area of Mexico.

PubMed

González-Rosendo, Guillermina; Polo, Javier; Rodríguez-Jerez, José Juan; Puga-Díaz, Rubén; Reyes-Navarrete, Eduardo G; Quintero-Gutiérrez, Adrián G

2010-04-01

A heme-iron concentrate product derived from swine hemoglobin was used to enrich the chocolate-flavored filling of biscuits and the bioavailability of this source of heme-iron was assessed in adolescent girls. The placebo control (PC) group consisted of 35 teenagers with the highest baseline hemoglobin concentrations. The supplemented groups were randomized to receive biscuits fortified with iron sulfate (IS, n = 37) or heme-iron concentrate (HIC, n = 40). Both groups were supplemented with 10.3 mg Fe/d for 7 wk. Blood chemistry and hematology analyses were performed at baseline and at the end of the study. The baseline prevalence of anemia (hemoglobin <12 g/dl) in the entire group was 3.9% and by the end of the study it had fallen to 2.3%. The hemoglobin levels in both supplemented groups increased (P < 0.05) during the study period from 13.6 and 13.5 g/dl for HIC and IS, respectively, at baseline to 14 g/dl at the end of the study. Serum ferritin concentrations decreased by the end of the study in both the PC and IS groups (P < 0.05), but not in the heme group. In conclusion, iron bioavailability from HIC-fortified biscuits was calculated to be 23.7% higher than that observed for IS, as shown by the differences observed in serum ferritin levels during the study. The iron contained in the heme-iron concentrate was well absorbed and tolerated by the adolescents included in the study.

The effect of cisatracurium and rocuronium on lung function in anesthetized children.

PubMed

Yang, Charles I; Fine, Gavin F; Jooste, Edmund H; Mutich, Rebecca; Walczak, Stephen A; Motoyama, Etsuro K

2013-12-01

Neuromuscular blocking drugs have been implicated in intraoperative bronchoconstrictive episodes. We examined the effects of clinically relevant doses of cisatracurium and rocuronium on the lung mechanics of pediatric subjects. We hypothesized that cisatracurium and rocuronium would have bronchoconstrictive effects. We studied ASA physical status I and II pediatric subjects having elective dental or urological procedures, requiring general anesthesia with endotracheal intubations with either cisatracurium or rocuronium. Pulmonary function tests were performed before and after neuromuscular blocking drug dosing and again after albuterol administration. Using forced deflation and passive deflation techniques, forced vital capacity (FVC) and maximum expiratory flow rate at 10% (MEF10) of FVC were obtained. Fractional changes from the baseline were used to compare subjects. Changes in MEF10 of >30% were considered clinically significant. A Shapiro-Wilk test, paired t test, and Wilcoxon rank sum test were used to analyze the data. Twenty-five subjects (median age = 5.25 years; range = 9 months-9.9 years) were studied; 12 subjects received cisatracurium and 13 subjects received rocuronium. Data are shown as mean proportional change ± SD or, in the case of not normally distributed, median proportional change (first, third quartile) with P values. In the cisatracurium group, there were no differences between baseline and postneuromuscular blocker administration in the fractional change from the baselines of FVC (1.00 ± 0.04, P = 0.5), but there was a significant decrease in MEF10 (0.80 ± 0.18, P = 0.002). In the rocuronium group, there were small yet significant decreases of FVC (0.99 [first quartile 0.97, third quartile 1], P = 0.02) and significant decreases in MEF10 (0.78 ± 0.26, P = 0.008). After administration of albuterol in the cisatracurium group, FVC increased slightly but significantly from baseline values (1.02 ± 0.02, P = 0.005). MEF10 increased significantly beyond baseline values (1.24 ± 0.43, P =0.04). In the rocuronium group, there were also significant differences between baseline and postalbuterol administration from the baseline value of FVC (1.02 ± 0.02, P = 0.004) and MEF10 (1.23 ± 0.29, P = 0.01). At clinically relevant doses, both cisatracurium and rocuronium caused changes in lung function, indicating constriction of smaller airways. In general, these changes were mild and not clinically detectable. However, in the rocuronium group, 3 of 13 patients showed more noticeable decreases in MEF10 (≤50%), demonstrating the potential for significant broncho-bronchiolar constriction in susceptible patients.

Lifecourse socioeconomic position and 16 year body mass index trajectories: differences by race and sex.

PubMed

Insaf, Tabassum Z; Shaw, Benjamin A; Yucel, Recai M; Chasan-Taber, Lisa; Strogatz, David S

2014-10-01

The aim of this study is to evaluate the association between lifecourse socioeconomic position (SEP) and changes in body mass index (BMI), and assess disparities in these associations across racial/ethnic groups. With longitudinal data from 4 waves of the Americans' Changing Lives Study (1986-2002), we employed mixed-effects modeling to estimate BMI trajectories for 1174 Blacks and 2323 White adults. We also estimated associations between these trajectories and lifecourse SEP variables, including father's education, perceived childhood SEP, own education, income, wealth, and financial security. Blacks had higher baseline BMIs, and steeper increases in BMI, compared to Whites. Childhood SEP, as measured by high father's education, was associated with lower baseline BMI among Whites. High education was associated with a lower baseline BMI within both race and sex categories. Income had contrasting effects among men and women. Higher income was associated with higher BMI only among males. Associations between indicators of SEP and BMI trajectories were only found for Whites. Our study demonstrates that lifecourse SEP may influence adult BMI differently within different racial and sex groups. Copyright © 2014 Elsevier Inc. All rights reserved.

Dissociating Effects of Global SWS Disruption and Healthy Aging on Waking Performance and Daytime Sleepiness

PubMed Central

Groeger, John A.; Stanley, Neil; Deacon, Stephen; Dijk, Derk-Jan

2014-01-01

Study Objective: To contrast the effects of slow wave sleep (SWS) disruption and age on daytime functioning. Design: Daytime functioning was contrasted in three age cohorts, across two parallel 4-night randomized groups (baseline, two nights of SWS disruption or control, recovery sleep). Setting: Sleep research laboratory. Participants: 44 healthy young (20-30 y), 35 middle-aged (40-55 y), and 31 older (66-83 y) men and women. Interventions: Acoustic stimulation contingent on appearance of slow waves. Measurements and Results: Cognitive performance was assessed before sleep latency tests at five daily time-points. SWS disruption resulted in less positive affect, slower or impaired information processing and sustained attention, less precise motor control, and erroneous implementation, rather than inhibition, of well-practiced actions. These performance impairments had far smaller effect sizes than the increase in daytime sleepiness and differed from baseline to the same extent for each age group. At baseline, younger participants performed better than older participants across many cognitive domains, with largest effects on executive function, response time, sustained attention, and motor control. At baseline, the young were sleepier than other age groups. Conclusions: SWS has been considered a potential mediator of age-related decline in performance, although the effects of SWS disruption on daytime functioning have not been quantified across different cognitive domains nor directly compared to age-related changes in performance. The data imply that two nights of SWS disruption primarily leads to an increase in sleepiness with minor effects on other aspects of daytime functioning, which are different from the substantial effects of age. Citation: Groeger JA, Stanley N, Deacon S, Dijk DJ. Dissociating effects of global sws disruption and healthy aging on waking performance and daytime sleepiness. SLEEP 2014;37(6):1127-1142. PMID:24882908

Unipedal standing exercise and hip bone mineral density in postmenopausal women: a randomized controlled trial.

PubMed

Sakai, Akinori; Oshige, Toshihisa; Zenke, Yukichi; Yamanaka, Yoshiaki; Nagaishi, Hitoshi; Nakamura, Toshitaka

2010-01-01

The aim of this study was to test the effect of unipedal standing exercise on bone mineral density (BMD) of the hip in postmenopausal women. Japanese postmenopausal women (n = 94) were assigned at random to an exercise or control group (no exercise). The 6-month exercise program consisted of standing on a single foot for 1 min per leg 3 times per day. BMD of the hip was measured by dual-energy X-ray absorptiometry. There was no significant difference in age and baseline hip BMD between the exercise group (n = 49) and control group (n = 45). Exercise did not improve hip BMD compared with the control group. Stepwise regression analysis identified old age as a significant determinant (p = 0.034) of increased hip total BMD at 6 months after exercise. In 31 participants aged >/=70 years, the exercise group (n = 20) showed significant increase in the values of hip BMD at the areas of total (p = 0.008), intertrochanteric (p = 0.023), and Ward's triangle (p = 0.032). The same parameters were decreased in the control group (n = 11). The percent changes in hip BMD of the exercise group were not significantly different from those of the control group either in the participants with low baseline hip total BMD (<80% of the young adult mean) or high baseline hip total BMD (> or =80% of the young adult mean). In conclusion, unipedal standing exercise for 6 months did not improve hip BMD in Japanese postmenopausal women. Effect of exercise on hip total BMD was age dependent. In participants aged > or =70 years, the exercise significantly increased hip total BMD.

Teaching in small portions dispersed over time enhances long-term knowledge retention.

PubMed

Raman, Maitreyi; McLaughlin, Kevin; Violato, Claudio; Rostom, Alaa; Allard, J P; Coderre, Sylvain

2010-01-01

A primary goal of education is to promote long-term knowledge storage and retrieval. A prospective interventional study design was used to investigate our research question: Does a dispersed curriculum promote better short- and long-term retention over a massed course? Participants included 20 gastroenterology residents from the University of Calgary (N = 10) and University of Toronto (N = 10). Participants completed a baseline test of nutrition knowledge. The nutrition course was imparted to University of Calgary residents for 4 h occurring 1 h weekly over 4 consecutive weeks: dispersed delivery (DD). At the University of Toronto the course was taught in one 4h academic half-day: massed delivery (MD). Post-curriculum tests were administered at 1 week and 3 months to assess knowledge retention. The baseline scores were 46.39 +/- 6.14% and 53.75 +/- 10.69% in the DD and MD groups, respectively. The 1 week post-test scores for the DD and MD groups were 81.67 +/- 8.57%, p < 0.001 and 78.75 +/- 4.43, p < 0.001 which was significantly higher than baseline. The 3-month score was significantly higher in the DD group, but not in the MD group (65.28 +/- 9.88%, p = 0.02 vs. 58.93 +/- 12.06%, p = 0.18). The absolute pre-test to 1-week post-test difference was significantly higher at 35.28 +/- 7.65% among participants in the DD group compared to 25.0 +/- 11.80% in the MD group, p = 0.048. Similarly, the absolute pre-test to 3-month post-test difference was significantly higher at 18.9 +/- 6.7% among the participants in the DD group, compared to 6.8 +/- 11.8% in the MD group, p = 0.021. Long-term nutrition knowledge is improved with DD compared with MD.

Can a school-based sleep education programme improve sleep knowledge, hygiene and behaviours using a randomised controlled trial.

PubMed

Rigney, Gabrielle; Blunden, Sarah; Maher, Carol; Dollman, James; Parvazian, Somayeh; Matricciani, Lisa; Olds, Timothy

2015-06-01

The present study investigated the effectiveness of a school-based sleep education programme in improving key sleep behaviours, sleep knowledge, and sleep hygiene. A cross-sectional cluster-randomised controlled trial with two groups (Intervention and Control) and three assessment time points [baseline, immediately post intervention (6 weeks post baseline) and follow-up (18 weeks post baseline)] was employed. A total of 296 students (mean age = 12.2 ± 0.6 years; 59% female) from 12 schools in Adelaide, South Australia, were recruited, with 149 participants in the Intervention group and 147 in the Control group. The intervention consisted of four classroom lessons delivered at weekly intervals, followed by a group project on sleep topics, which students presented at a parental information evening. Sleep patterns were assessed objectively (actigraphy, n = 175) and subjectively (time-use recall, n = 251) at three time points. Sleep knowledge and sleep hygiene (n = 296) were also measured. Generalised estimating equations were used to compare changes in the Intervention and Control groups. The programme increased time in bed by 10 min (p = 0.03) for the Intervention group relative to the Control group, due to a 10-min delay in wake time (p = 0.00). These changes were not sustained at follow-up. There was no impact on sleep knowledge or sleep hygiene. Investment in the sleep health of youth through sleep education is important but changes to sleep patterns are difficult to achieve. More intensive programmes, programmes with a different focus or programmes targeting different age groups may be more effective. Copyright © 2015 Elsevier B.V. All rights reserved.

Changes in Gastrointestinal Hormones and Leptin After Roux-en-Y Gastric Bypass Surgery

PubMed Central

Beckman, Lauren M.; Beckman, Tiffany R.; Sibley, Shalamar D.; Thomas, William; Ikramuddin, Sayeed; Kellogg, Todd A.; Ghatei, Mohammad A.; Bloom, Stephen R.; le Roux, Carel W.; Earthman, Carrie P.

2014-01-01

Background Roux-en-Y gastric bypass (RYGB) imparts long-term weight loss, the mechanisms for which are not well understood. Changes in leptin and gastrointestinal (GI) hormones, including glucagon-like peptide 1 (GLP-1), peptide YY (PYY), and ghrelin, may contribute to the relative success of RYGB compared with conventional weight loss methods. This study evaluated changes in GI hormones and leptin post-RYGB. The study also evaluated whether GI hormones differed after a short-term dose of protein or fat. Methods GLP-1, PYY, ghrelin, and leptin were assessed in 16 women before RYGB and up to 1 year after RYGB. Plasma was collected before and at several times after a short-term equicaloric dose of protein or fat. Results GLP-1 area under the curve (AUC) increased at week 6 and 1 year in the fat beverage (FAT-BEV) group compared with baseline. PYY AUC remained elevated at 1 year in the FAT-BEV group. Ghrelin AUC decreased at week 2, week 6, and 1 year in the protein beverage (PRO-BEV) group compared with baseline. Ghrelin AUC was lower in the PRO-BEV group compared with the FAT-BEV group at week 6. Fasted leptin decreased at all visits in both groups and was lower in the FAT-BEV group compared with the PRO-BEV group at 1 year. Conclusions Changes from baseline were evident for all GI hormones and leptin; some differences were evident soon after surgery (ghrelin, leptin), whereas others were maintained long term (GLP-1, PYY, ghrelin, leptin). In response to a short-term stimulus, protein suppressed ghrelin and fat potently stimulated GLP-1 and PYY. Future work in this area is warranted. PMID:21378246

Neurocognitive training in patients with high-grade glioma: a pilot study.

PubMed

Hassler, Marco Ronald; Elandt, Katarzyna; Preusser, Matthias; Lehrner, Johann; Binder, Petra; Dieckmann, Karin; Rottenfusser, Andrea; Marosi, Christine

2010-03-01

Although their neurocognitive performance is one of the major concerns of patients with high-grade gliomas (HGG) and although neurocognitive deficits have been described to be associated with negative outcome, neurocognitive rehabilitation is usually not integrated into the routine care of patients with malignant gliomas. In this pilot trial, a weekly group training session for attention, verbal, and memory skills was offered to patients with HGG with pre and post-training evaluation. Eleven patients, six with glioblastoma multiforme and five with WHO grade III gliomas, median age 50 years, with a Karnofsky performance score of 80-100 participated in ten group training sessions of 90 min. For evaluation at baseline and after the training by a neuropsychologist not involved in care or training of the patients, Trail Making Tests A and B (TMTA and TMTB), Hopkins Verbal Learning Test (HVLT), and the Controlled Oral Word Association Test (COWA) were used. Comparison of mean group differences between baseline and at post-training evaluation after 12 weeks revealed improvement across all neurocognitive variables. The patients showed a great diversity in their performances, with worsening, improvement, and stabilization. However, a significant group difference was detected only for the HVLT (score 19.6 +/- 8.9 at baseline, 23.6 +/- 8.8 after 12 weeks, P = 0.04). This pilot study shows that neurocognitive training in patients with HGG is feasible as group training with weekly sessions and might be able to induce improvements in attention and memory skills.

Baseline values of immunologic parameters in the lizard Salvator merianae (Teiidae, Squamata)

PubMed Central

Mestre, Ana Paula; Amavet, Patricia Susana; Siroski, Pablo Ariel

2017-01-01

The genus Salvator is widely distributed throughout South America. In Argentina, the species most abundant widely distributed is Salvator merianae. Particularly in Santa Fe province, the area occupied by populations of these lizards overlaps with areas where agriculture was extended. With the aim of established baseline values for four immunologic biomarkers widely used, 36 tegu lizards were evaluated tacking into account different age classes and both sexes. Total leukocyte counts were not different between age classes. Of the leucocytes count, eosinophils levels were higher in neonates compared with juvenile and adults; nevertheless, the heterophils group was the most prevalent leukocyte in the peripheral blood in all age classes. Lymphocytes, monocytes, heterophils, azurophils and basophils levels did not differ with age. Natural antibodies titres were higher in the adults compared with neonates and juveniles lizards. Lastly, complement system activity was low in neonates compared with juveniles and adults. Statistical analysis within each age group showed that gender was not a factor in the outcomes. Based on the results, we concluded that S. merianae demonstrated age (but not gender) related differences in the immune parameters analyzed. Having established baseline values for these four widely-used immunologic biomarkers, ongoing studies will seek to optimize the use of the S. merianae model in future research. PMID:28652981

Baseline values of immunologic parameters in the lizard Salvator merianae (Teiidae, Squamata).

PubMed

Mestre, Ana Paula; Amavet, Patricia Susana; Siroski, Pablo Ariel

2017-01-01

The genus Salvator is widely distributed throughout South America. In Argentina, the species most abundant widely distributed is Salvator merianae . Particularly in Santa Fe province, the area occupied by populations of these lizards overlaps with areas where agriculture was extended. With the aim of established baseline values for four immunologic biomarkers widely used, 36 tegu lizards were evaluated tacking into account different age classes and both sexes. Total leukocyte counts were not different between age classes. Of the leucocytes count, eosinophils levels were higher in neonates compared with juvenile and adults; nevertheless, the heterophils group was the most prevalent leukocyte in the peripheral blood in all age classes. Lymphocytes, monocytes, heterophils, azurophils and basophils levels did not differ with age. Natural antibodies titres were higher in the adults compared with neonates and juveniles lizards. Lastly, complement system activity was low in neonates compared with juveniles and adults. Statistical analysis within each age group showed that gender was not a factor in the outcomes. Based on the results, we concluded that S. merianae demonstrated age (but not gender) related differences in the immune parameters analyzed. Having established baseline values for these four widely-used immunologic biomarkers, ongoing studies will seek to optimize the use of the S. merianae model in future research.

Alpha-actinin-3 (ACTN3) R577X polymorphism influences knee extensor peak power response to strength training in older men and women.

PubMed

Delmonico, Matthew J; Kostek, Matthew C; Doldo, Neil A; Hand, Brian D; Walsh, Sean; Conway, Joan M; Carignan, Craig R; Roth, Stephen M; Hurley, Ben F

2007-02-01

The alpha-actinin-3 (ACTN3) R577X polymorphism has been associated with muscle power performance in cross-sectional studies. We examined baseline knee extensor concentric peak power (PP) and PP change with approximately 10 weeks of unilateral knee extensor strength training (ST) using air-powered resistance machines in 71 older men (65 [standard deviation = 8] years) and 86 older women (64 [standard deviation = 9] years). At baseline in women, the XX genotype group had an absolute (same resistance) PP that was higher than the RR (p =.005) and RX genotype groups (p =.02). The women XX group also had a relative (70% of one-repetition maximum [1-RM]) PP that was higher than that in the RR (p =.002) and RX groups (p =.008). No differences in baseline absolute or relative PP were observed between ACTN3 genotype groups in men. In men, absolute PP change with ST in the RR (n = 16) group approached a significantly higher value than in the XX group (n = 9; p =.07). In women, relative PP change with ST in the RR group (n = 16) was higher than in the XX group (n = 17; p =.02). The results indicate that the ACTN3 R577X polymorphism influences the response of quadriceps muscle power to ST in older adults.

Improvement in muscle performance after one-year cessation of low-magnitude high-frequency vibration in community elderly.

PubMed

Cheung, W-H; Li, C-Y; Zhu, T Y; Leung, K-S

2016-03-01

To investigate the effects on muscle performance after one-year cessation of 18-month low-magnitude high-frequency vibration (LMHFV) intervention in the untrained community elderly. This is a case-control study with 59 community elderly women (25 control without any treatment; 34 received 18-month LMHFV but discontinued for 1 year from our previous clinical study). Muscle strength, balancing ability, occurrence of fall/fracture, quality of life (QoL) were assessed 1-year after cessation of intervention. The 30-month results were compared with baseline and 18-month treatment endpoint data between groups. At 30 months (i.e. one year post-intervention), the muscle strengths of dominant and non-dominant legs relative to baseline in treatment group were significantly better than those of control. In balancing ability test, reaction time, movement velocity and maximum excursion of treatment group (relative to baseline) remained significantly better than the control group. The muscle strength, balancing ability and quality of life at 30 months relative to 18 months did not show significant differences between the two groups. The benefits of LMHFV for balancing ability, muscle strength and risk of falling in elderly were retained 1 year after cessation of LMHFV.

Osteoporosis education improves osteoporosis knowledge and dietary calcium: comparison of a 4 week and a one-session education course.

PubMed

Laslett, Laura L; Lynch, Joan; Sullivan, Thomas R; McNeil, Julian D

2011-08-01

Education is ideal for osteoporosis because many risk factors are modifiable. However, the efficacy of shortened education courses compared to a standard 4 week course for improving osteoporosis knowledge and healthy behaviours is not known. This study aimed to assess whether education changed knowledge and healthy behaviours over 3 months of follow-up; and whether changes in these outcomes were different between participants receiving the different education courses. Adults aged ≥ 50 years presenting to Emergency with mild to moderate trauma fractures received either the Osteoporosis Prevention and Self-Management Course (OPSMC) (4 × 2.5 h) (n = 75) or a one-session course (1 × 2.5 h) (n = 71) in a non-randomised prospective study with single-blinded allocation. Participants completed questionnaires measuring osteoporosis knowledge, dietary calcium, physical activity, calcium and exercise self-efficacy, and osteoporosis medications at baseline and 3 months. Data were analysed using mixed models and GEE regression models. Osteoporosis knowledge and calcium from food (% of RDI) increased from baseline to 3 months in both groups (P < 0.01). Use of osteoporosis medications increased between baseline and 3 months in the OPSMC group while decreasing in the one-session group (P = 0.039). There were no differences between the groups or over time in physical activity, calcium or exercise self-efficacy. Osteoporosis education (either the OPSMC or the one-session course) improved osteoporosis knowledge and calcium intake after 3 months. Participants attending the OPSMC maintained medication compliance. We were unable to determine other differences between the courses. This study confirms the value of osteoporosis education for improving osteoporosis knowledge. © 2011 The Authors. International Journal of Rheumatic Diseases © 2011 Asia Pacific League of Associations for Rheumatology and Blackwell Publishing Asia Pty Ltd.

Twelve-month follow-up of cognitive behavioral therapy for children with functional abdominal pain.

PubMed

Levy, Rona L; Langer, Shelby L; Walker, Lynn S; Romano, Joan M; Christie, Dennis L; Youssef, Nader; DuPen, Melissa M; Ballard, Sheri A; Labus, Jennifer; Welsh, Ericka; Feld, Lauren D; Whitehead, William E

2013-02-01

To determine whether a brief intervention for children with functional abdominal pain and their parents' responses to their child's pain resulted in improved coping 12 months later. Prospective, randomized, longitudinal study. Families were recruited during a 4-year period in Seattle, Washington, and Morristown, New Jersey. Two hundred children with persistent functional abdominal pain and their parents. A 3-session social learning and cognitive behavioral therapy intervention or an education and support intervention. Child symptoms and pain-coping responses were monitored using standard instruments, as was parental response to child pain behavior. Data were collected at baseline and after treatment (1 week and 3, 6, and 12 months after treatment). This article reports the 12-month data. Relative to children in the education and support group, children in the social learning and cognitive behavioral therapy group reported greater baseline to 12-month follow-up decreases in gastrointestinal symptom severity (estimated mean difference, -0.36; 95% CI, -0.63 to -0.01) and greater improvements in pain-coping responses (estimated mean difference, 0.61; 95% CI, 0.26 to 1.02). Relative to parents in the education and support group, parents in the social learning and cognitive behavioral therapy group reported greater baseline to 12-month decreases in solicitous responses to their child's symptoms (estimated mean difference, -0.22; 95% CI, -0.42 to -0.03) and greater decreases in maladaptive beliefs regarding their child's pain (estimated mean difference, -0.36; 95% CI, -0.59 to -0.13). Results suggest long-term efficacy of a brief intervention to reduce parental solicitousness and increase coping skills. This strategy may be a viable alternative for children with functional abdominal pain. clinicaltrials.gov Identifier: NCT00494260.

Impact of physical exercise on reaction time in patients with Parkinson's disease-data from the Berlin BIG Study.

PubMed

Ebersbach, Georg; Ebersbach, Almut; Gandor, Florin; Wegner, Brigitte; Wissel, Jörg; Kupsch, Andreas

2014-05-01

To determine whether physical activity may affect cognitive performance in patients with Parkinson's disease by measuring reaction times in patients participating in the Berlin BIG study. Randomized controlled trial, rater-blinded. Ambulatory care. Patients with mild to moderate Parkinson's disease (N=60) were randomly allocated to 3 treatment arms. Outcome was measured at the termination of training and at follow-up 16 weeks after baseline in 58 patients (completers). Patients received 16 hours of individual Lee Silverman Voice Treatment-BIG training (BIG; duration of treatment, 4wk), 16 hours of group training with Nordic Walking (WALK; duration of treatment, 8wk), or nonsupervised domestic exercise (HOME; duration of instruction, 1hr). Cued reaction time (cRT) and noncued reaction time (nRT). Differences between treatment groups in improvement in reaction times from baseline to intermediate and baseline to follow-up assessments were observed for cRT but not for nRT. Pairwise t test comparisons revealed differences in change in cRT at both measurements between BIG and HOME groups (intermediate: -52ms; 95% confidence interval [CI], -84/-20; P=.002; follow-up: 55ms; CI, -105/-6; P=.030) and between WALK and HOME groups (intermediate: -61ms; CI, -120/-2; P=.042; follow-up: -78ms; CI, -136/-20; P=.010). There was no difference between BIG and WALK groups (intermediate: 9ms; CI, -49/67; P=.742; follow-up: 23ms; CI, -27/72; P=.361). Supervised physical exercise with Lee Silverman Voice Treatment-BIG or Nordic Walking is associated with improvement in cognitive aspects of movement preparation. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A prospective, comparative study of the occurrence and severity of constipation with darifenacin and trospium in overactive bladder.

PubMed

Manjunatha, Revanna; Pundarikaksha, Hulikallu Purushotama; Hanumantharaju, Basavanahalli Krishnaiah; Anusha, Satenahalli Javaregowda

2015-03-01

Darifenacin and trospium are the commonly used antimuscarinics in the management of overactive bladder (OAB). Constipation is the second most common treatment related side-effect. Though its incidence with the above two medications is known, data on their comparative severity and impact on patient's well-being is lacking. Sixty subjects with OAB included in the study were randomized in 1:1 fashion to receive either darifenacin 7.5 mg OD or trospium extended release 60 mg OD. Treatment response was monitored using overactive bladder symptom score (OABSS). The severity of constipation was assessed using McMillan & Williams Constipation assessment scale (CAS), Bristol stool form scale and Knowles-Eccersley-Scott-Symptom (KESS) questionnaire score administered at baseline, 2 and 4 weeks of treatment. OABSS improved significantly, -5.80 ± 3.99 (p = 0.0005) and -5.27 ± 2.98 (p = 0.0005) in darifenacin and trospium groups respectively. However, the difference between the two groups was not significant either at 2 weeks (p = 0.952) or 4 weeks (p = 0.654) of treatment. A significant decrease in stool consistency was noted with darifenacin treatment (p < 0.05), but the same was not seen with trospium (p = 0.076). There was no significant difference in scores of KESS questionnaire between baseline, 2 weeks and 4 weeks, both within the group and between the groups (p > 0.05). McMillan & Williams CAS scores increased at week 2 and week 4, in comparison with baseline scores in both darifenacin and trospium treated patients, however, the difference between the two groups was not statistically significant (p > 0.05). Darifenacin and trospium are equally efficacious and comparable in tolerability in terms of constipation severity and its impact on patient well-being.

Pilot Randomized Trial of Integrated Cognitive-Behavioral Therapy and Neuromuscular Training for Juvenile Fibromyalgia: The FIT Teens Program.

PubMed

Kashikar-Zuck, Susmita; Black, William R; Pfeiffer, Megan; Peugh, James; Williams, Sara E; Ting, Tracy V; Thomas, Staci; Kitchen, Katie; Myer, Gregory D

2018-04-17

Cognitive-behavioral therapy (CBT) improves coping and daily functioning in adolescents with juvenile fibromyalgia (JFM), but is less effective in reducing pain. This pilot trial evaluated the efficacy of a novel intervention (Fibromyalgia Integrative Training for Teens; FIT Teens) which integrates CBT with specialized neuromuscular exercise training to enhance the effect of treatment on reducing pain and disability. Forty adolescents with JFM (12-18 years) were randomized to CBT-only or FIT Teens. Treatment was conducted in group-based sessions over 8 weeks with assessments at baseline, post-treatment, and 3-month follow-up (primary end point). Primary outcomes were pain intensity and functional disability. Secondary outcomes were depressive symptoms, fear of movement, and pain catastrophizing. Thirty-six participants (mean age=15.33 years; 90% female) completed the program. Intent to treat analysis was conducted to evaluate differences between the FIT Teens and CBT groups from baseline to 3-month follow-up, controlling for baseline group differences. Participants in the FIT Teens group showed significantly greater decreases in pain than the CBT group. FIT Teens participants also showed significant improvements in disability, but did not differ from CBT-only at the 3-month end point. Results provide preliminary evidence that the FIT Teens intervention provides added benefits beyond CBT in the treatment of JFM, particularly in pain reduction. Results from this pilot randomized controlled trial of a new combined CBT and specialized neuromuscular exercise intervention (FIT Teens), compared with CBT alone suggested that FIT Teens offers stronger treatment benefits than CBT alone at initial treatment follow-up, especially with respect to the outcome of pain reduction. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Cortisol levels at baseline and under stress in adolescent males with attention-deficit hyperactivity disorder, with or without comorbid conduct disorder.

PubMed

Northover, Clare; Thapar, Anita; Langley, Kate; Fairchild, Graeme; van Goozen, Stephanie H M

2016-08-30

Reported findings on cortisol reactivity to stress in young people with ADHD are very variable. This inconsistency may be explained by high rates of comorbidity with Conduct Disorder (CD). The present study examined cortisol responses to a psychosocial stressor in a large sample of adolescent males with ADHD (n=202), with or without a comorbid diagnosis of Conduct Disorder (CD). Associations between stress reactivity and callous-unemotional traits and internalizing symptoms were also assessed. The ADHD only (n=95) and ADHD+CD (n=107) groups did not differ in baseline cortisol, but the ADHD+CD group showed significantly reduced cortisol stress reactivity relative to the ADHD only group. Regression analyses indicated that ADHD symptom severity predicted reduced baseline cortisol, whereas CD symptom severity predicted increased baseline cortisol (ADHD β=-0.24, CD β=0.16, R=0.26) and reduced cortisol stress reactivity (β=-0.17, R=0.17). Callous-unemotional traits and internalizing symptoms were not significantly related to baseline or stress-induced cortisol. Impaired cortisol reactivity is hypothesised to reflect fearlessness and is associated with deficient emotion regulation and inhibition of aggressive and antisocial behaviour. Consequently, it may partly explain the greater severity of problems seen in those with comorbid ADHD and CD. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

The Work Ability Index as a screening tool to identify the need for rehabilitation: longitudinal findings from the Second German Sociomedical Panel of Employees.

PubMed

Bethge, Matthias; Radoschewski, Friedrich Michael; Gutenbrunner, Christoph

2012-11-01

To evaluate the predictive value of the Work Ability Index (WAI) for different indicators of the need for rehabilitation at 1-year follow-up. Cohort study. Data were obtained from the Second German Sociomedical Panel of Employees, a large-scale cohort study with postal surveys in 2009 and 2010. A total of 457 women and 579 men were included. Confirmatory factor analysis confirmed the one-dimensionality of the WAI. Regression analyses showed that poor and moderate baseline WAI scores were associated with lower health-related quality of life and more frequent use of primary healthcare 1 year later. Subjects with poor baseline work ability had 4.6 times higher odds of unemployment and 12.2 times higher odds of prolonged sick leave than the reference group with good or excellent baseline work ability. Moreover, the odds of subjectively perceived need for rehabilitation, intention to request rehabilitation and actual use of rehabilitation services were 9.7, 5.7 and 3 times higher in the poor baseline WAI group and 5.5, 4 and 1.8 times higher in the moderate baseline WAI group, respectively. A WAI score ≤ 37 was identified as the optimal cut-off to predict the need for rehabilitation. The WAI is a valid screening tool for identifying the need for rehabilitation.

Brimonidine 0.2% vs unoprostone 0.15% both added to timolol maleate 0.5% given twice daily to patients with primary open-angle glaucoma or ocular hypertension.

PubMed

Sharpe, E D; Henry, C J; Mundorf, T K; Day, D G; Stewart, J A; Jenkins, J N; Stewart, W C

2005-01-01

To compare the efficacy and safety of brimonidine 0.2% vs unoprostone 0.15%, both added to timolol maleate 0.5% each given twice daily. In this prospective, multi-centred, double-masked, crossover comparison, patients were randomized to one treatment group for a 6-week treatment period, and then crossed over to the opposite treatment. Measurements were performed at 0800, 1000, 1600, 1800, and 2000 h at baseline and at the end of each treatment period. In all, 33 patients entered this trial and 29 completed. The baseline trough intraocular pressure (IOP) was 23.3+/-2.4 and the diurnal curve IOP was 22.0+/-1.3 mmHg. For the brimonidine and timolol maleate treatment group, the trough IOP was 21.6+/-3.3 and the diurnal curve IOP was 19.8+/-2.1 mmHg, while the timolol and unoprostone treatment showed a trough IOP of 20.9+/-3.8 and a diurnal curve IOP of 19.3+/-2.4 mmHg. There was no significant difference between treatment groups at any time point for the diurnal curve, or in the reduction from baseline (P>0.05). Both treatments failed to statistically reduce the IOP from baseline at 1800 h. There was no difference between treatment groups regarding ocular and systemic unsolicited adverse events, but patients admitted to more dryness (P=0.02) and burning upon instillation (P<0.0001) with unoprostone by survey. Brimonidine 0.2% or unoprostone 0.15% added to timolol maleate 0.5% provide similar efficacy and safety throughout the daytime diurnal curve.

Periodontal treatment with an Er:YAG laser compared to ultrasonic instrumentation: a pilot study.

PubMed

Sculean, Anton; Schwarz, Frank; Berakdar, Mohammad; Romanos, George E; Arweiler, Nicole B; Becker, Jürgen

2004-07-01

The aim of the present study was to compare the effectiveness of an Er:YAG laser to that of ultrasonic scaling for non-surgical periodontal treatment. Twenty patients with moderate to advanced periodontal disease were randomly treated in a split-mouth design with a single episode of subgingival debridement using either an Er:YAG laser device (160 mJ/pulse, 10 Hz) combined with a calculus detection system with fluorescence induced by 655 nm InGaAsP diode laser radiation (ERL), or an ultrasonic instrument (UI). Clinical assessments of full-mouth plaque score (FMPS), bleeding on probing (BOP), probing depth (PD), gingival recession (GR), and clinical attachment level (CAL) were made at baseline and at 3 and 6 months following therapy. No differences in any of the investigated parameters were observed at baseline between the two groups. The mean value of BOP decreased in the ERL group from 40% at baseline to 17% after 6 months (P<0.0001) and in the UI group from 46% at baseline to 15% after 6 months (P<0.0001). The sites treated with ERL demonstrated mean CAL gain of 1.48 +/- 0.73 mm (P<0.001) and of 1.11 +/- 0.59 mm (P<0.001) at 3 and 6 months, respectively. The sites treated with UI demonstrated mean CAL gain of 1.53 +/- 0.67 mm (P<0.001) and of 1.11 +/- 0.46 mm (P<0.001) at 3 and 6 months, respectively. No statistically significant differences were observed between the groups (P>0.05). Within the limits of the present study, it can be concluded that both therapies led to significant improvements of the investigated clinical parameters.

Hypertension analysis of stress reduction using mindfulness meditation and yoga: results from the HARMONY randomized controlled trial.

PubMed

Blom, Kimberly; Baker, Brian; How, Maxine; Dai, Monica; Irvine, Jane; Abbey, Susan; Abramson, Beth L; Myers, Martin G; Kiss, Alex; Perkins, Nancy J; Tobe, Sheldon W

2014-01-01

The HARMONY study was a randomized, controlled trial examining the efficacy of an 8-week mindfulness-based stress reduction (MBSR) program for blood pressure (BP) lowering among unmedicated stage 1 hypertensive participants. Participants diagnosed with stage 1 hypertension based on ambulatory BP were randomized to either immediate treatment of MBSR for 8 weeks or wait-list control. Primary outcome analysis evaluated whether change in awake and 24-hour ambulatory BP from baseline to week 12 was significantly different between the 2 groups. A within-group before and after MBSR analysis was also performed. The study enrolled 101 adults (38% male) with baseline average 24-hour ambulatory BP of 135±7.9/82±5.8mm Hg and daytime ambulatory BP of 140±7.7/87±6.3 mmHg. At week 12, the change from baseline in 24-hour ambulatory BP was 0.4±6.7/0.0±4.9mm Hg for the immediate intervention and 0.4±7.8/-0.4±4.6mm Hg for the wait-list control. There were no significant differences between intervention and wait-list control for all ambulatory BP parameters. The secondary within-group analysis found a small reduction in BP after MBSR compared with baseline, a finding limited to female subjects in a sex analysis. MBSR did not lower ambulatory BP by a statistically or clinically significant amount in untreated, stage 1 hypertensive patients when compared with a wait-list control group. It leaves untested whether MBSR might be useful for lowering BP by improving adherence in treated hypertensive participants. NCT00825526.

Benefits of different intensity of aerobic exercise in modulating body composition among obese young adults: a pilot randomized controlled trial.

PubMed

Chiu, Chih-Hui; Ko, Ming-Chen; Wu, Long-Shan; Yeh, Ding-Peng; Kan, Nai-Wen; Lee, Po-Fu; Hsieh, Jenn-Woei; Tseng, Ching-Yu; Ho, Chien-Chang

2017-08-24

The aim of present study was to compare the effects of different aerobic exercise intensities and energy expenditures on the body composition of sedentary obese college students in Taiwan. Forty-eight obese participants [body mass index (BMI) ≥ 27 kg/m 2 , age 18-26 years] were randomized into four equal groups (n = 12): light-intensity training group (LITG), 40%-50% heart rate reserve (HRR); middle-intensity training group (MITG), 50%-70% HRR; high-intensity training group (HITG), 70%-80% HRR; and control group (CG). The aerobic exercise training program was conducted for 60 min per day on a treadmill 3 days per week for 12 weeks. All participant anthropometric data, blood biochemical parameters, and health-related physical fitness components were measured at baseline and after 12 weeks. At baseline, the anthropometric indices did not differ significantly among the four groups (p > 0.05). After 12-week exercise intervention, the HITG and MITG had significantly more changes in body weight, waist circumference (WC), waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR) than the LITG. The changes in BMI and body fat percentage differed among all four groups (p < 0.05). A 12-week high-intensity exercise intervention with high energy expenditure can considerably reduce body weight, body fat, WC, WHR, and WHtR, whereas a light-intensity exercise intervention can significantly reduce body weight and body fat. Current Controlled Trials TPECTR09831410900 , registered on 24 th Dec 2009.

Physiological, biochemical, and multiple-task-performance responses to different alterations of the wake-sleep cycle.

DOT National Transportation Integrated Search

1976-11-01

Three groups, each comprising five healthy, male, paid volunteers (ages 21 to 30), were studied for 11 days. Baseline data were collected for 3 days, during which subjects adhered to a day/night routine. On the fourth day each group took a 'flight' i...

Children's Electrophysiological Responses to Music.

ERIC Educational Resources Information Center

Flohr, John W.; And Others

This study examined the electrophysiological differences between baseline EEG frequencies and EEG frequencies obtained while listening to music stimuli. The experimental group comprised 22 children, ages 4 to 6 years old, who received special music instruction twice a week for 25 minutes for 7 weeks. The control group received no music…

Incidence of Type 2 Diabetes Using Proposed HbA1c Diagnostic Criteria in the European Prospective Investigation of Cancer–Norfolk Cohort

PubMed Central

Chamnan, Parinya; Simmons, Rebecca K.; Forouhi, Nita G.; Luben, Robert N.; Khaw, Kay-Tee; Wareham, Nicholas J.; Griffin, Simon J.

2011-01-01

OBJECTIVE To evaluate the incidence and relative risk of type 2 diabetes defined by the newly proposed HbA1c diagnostic criteria in groups categorized by different baseline HbA1c levels. RESEARCH DESIGN AND METHODS Using data from the European Prospective Investigation of Cancer (EPIC)-Norfolk cohort with repeat HbA1c measurements, we estimated the prevalence of known and previously undiagnosed diabetes at baseline (baseline HbA1c ≥6.5%) and the incidence of diabetes over 3 years. We also examined the incidence and corresponding odds ratios (ORs) by different levels of baseline HbA1c. Incident diabetes was defined clinically (self-report at follow-up, prescribed diabetes medication, or inclusion on a diabetes register) or biochemically (HbA1c ≥6.5% at the second health assessment), or both. RESULTS The overall prevalence of diabetes was 4.7%; 41% of prevalent cases were previously undiagnosed. Among 5,735 participants without diabetes at baseline (identified clinically or using HbA1c criteria, or both), 72 developed diabetes over 3 years (1.3% [95% CI 1.0–1.5]), of which 49% were identified using the HbA1c criteria. In 6% of the total population, the baseline HbA1c was 6.0–6.4%; 36% of incident cases arose in this group. The incidence of diabetes in this group was 15 times higher than in those with a baseline HbA1c of <5.0% (OR 15.5 [95% CI 7.2–33.3]). CONCLUSIONS The cumulative incidence of diabetes defined using a newly proposed HbA1c threshold in this middle-aged British cohort was 1.3% over 3 years. Targeting interventions to individuals with an HbA1c of 6.0–6.4% might represent a feasible preventive strategy, although complementary population-based preventive strategies are also needed to reduce the growing burden of diabetes. PMID:20622160

Hypoxic Challenge Testing (Fitness to Fly) in children with complex congenital heart disease.

PubMed

Naqvi, Nitha; Doughty, Victoria L; Starling, Luke; Franklin, Rodney C; Ward, Simon; Daubeney, Piers E F; Balfour-Lynn, Ian M

2018-02-14

Commercial airplanes fly with an equivalent cabin fraction of inspired oxygen of 0.15, leading to reduced oxygen saturation (SpO 2 ) in passengers. How this affects children with complex congenital heart disease (CHD) is unknown. We conducted Hypoxic Challenge Testing (HCT) to assess need for inflight supplemental oxygen. Children aged <16 years had a standard HCT. They were grouped as (A) normal versus abnormal baseline SpO 2 (≥95% vs <95%) and (B) absence versus presence of an actual/potential right-to-left (R-L) shunt. We measured SpO 2 , heart rate, QT interval corrected for heart rate and partial pressure of carbon dioxide measured transcutaneously (PtcCO 2 ). A test failed when children with (1) normal baseline SpO 2 desaturated to 85%, (2) baseline SpO 2 85%-94% desaturated by 15% of baseline; and (3) baseline SpO 2 75%-84% desaturated to 70%. There were 68 children, mean age 3.3 years (range 10 weeks-14.5 years). Children with normal (n=36) baseline SpO 2 desaturated from median 99% to 91%, P<0.0001, and 3/36 (8%) failed the test. Those with abnormal baseline SpO 2 (n=32) desaturated from median 84% to 76%, P<0.0001, and 5/32 (16%) failed (no significant difference between groups). Children with no R-L shunt (n=25) desaturated from median 99% to 93%, P<0.0001, but 0/25 failed. Those with an actual/potential R-L shunt (n=43) desaturated from median 87% to 78%, P<0.0001, and 8/43 (19%) failed (difference between groups P<0.02). PtcCO 2 , heart rate and QT interval corrected for heart rate were unaffected by the hypoxic state. This is the first evidence to help guide which children with CHD need a preflight HCT. We suggest all children with an actual or potential R-L shunt should be tested. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Mandibular single-implant overdentures: preliminary results of a randomised-control trial on early loading with different implant diameters and attachment systems.

PubMed

Alsabeeha, Nabeel H M; Payne, Alan G T; De Silva, Rohana K; Thomson, W Murray

2011-03-01

To determine surgical and prosthodontic outcomes of mandibular single-implant overdentures, opposing complete maxillary dentures, using a wide diameter implant and large ball attachment system compared with different regular diameter implants with standard attachment systems. Thirty-six edentulous participants (mean age 68 years, SD 9.2) were randomly assigned into three treatment groups (n=12). A single implant was placed in the mandibular midline of participants to support an overdenture using a 6-week loading protocol. The control group received Southern regular implants and standard ball attachments. One group received Southern 8-mm-wide implants and large ball attachments. Another group received Neoss regular implants and Locator attachments. Parametric and non-parametric tests of a statistical software package (SPSS) were used to determine between groups differences in marginal bone loss, implant stability, implant, and prosthodontic success (P<0.05). Implant success after 1 year was 75% for Southern regular implant (control) group; and 100% for the Southern wide and Neoss regular implant groups (P=0.038). Mean marginal bone loss at 1 year was 0.19 mm (SD 0.39) without significant differences observed. Implant stability quotient (ISQ) at baseline was significantly lower for the Southern regular (control) group than the other two groups (P=0.001; P=0.009). At 1 year, no significant difference in implant stability was observed (mean ISQ 74.6, SD 6.1). The change in implant stability from baseline to 1 year was significant for the control group (P=0.025). Prosthodontic success was comparable between the groups but the maintenance (41 events overall, mean 1.2) was greater for the Locator and the standard ball attachments. Mandibular single-implant overdentures are a successful treatment option for older edentulous adults with early loading protocol using implants of different diameters and with different attachment systems. © 2010 John Wiley & Sons A/S.

Focus on function: a cluster, randomized controlled trial comparing child- versus context-focused intervention for young children with cerebral palsy

PubMed Central

LAW, MARY C; DARRAH, JOHANNA; POLLOCK, NANCY; WILSON, BRENDA; RUSSELL, DIANNE J; WALTER, STEPHEN D; ROSENBAUM, PETER; GALUPPI, BARB

2011-01-01

AIM This study evaluated the efficacy of a child-focused versus context-focused intervention in improving performance of functional tasks and mobility in young children with cerebral palsy. METHOD A randomized controlled trial cluster research design enrolled 128 children (49 females, 79 males; age range 12mo to 5y 11mo; mean age 3y 6mo, SD −1y 5mo) who were diagnosed with cerebral palsy. Children across levels I to V on the Gross Motor Classification System (GMFCS) were included in the study. Children were excluded if there were planned surgical or medication changes during the intervention period. Therapists from 19 children's rehabilitation centers were block randomized (by occupational therapist or physical therapist) to a treatment arm. Children from consenting families followed their therapists into their assigned group. Children received child-focused (n=71) or context-focused intervention (n=57) over 6 months, returning to their regular therapy schedule and approach between 6 and 9 months. The primary outcome measure was the Pediatric Evaluation of Disability Inventory (PEDI). Secondary outcome measures included the Gross Motor Function Measure (GMFM-66), range of motion of hip abduction, popliteal angle and ankle dorsiflexion, the Assessment of Preschool Children's Participation (APCP), and the Family Empowerment Scale (FES). Outcome evaluators were masked to group assignment and completed assessments at baseline, 6 months, and 9 months. RESULTS Ten children did not complete the full intervention, six in the child group and four in context group. GMFCS levels for children in the study were level I (n=37), level II (n=23), level III (n=21), level IV (n=21), and level V (n=26). There were no significant differences at baseline between the treatment groups for GMFCS level, parental education, or parental income. For the PEDI, there was no significant difference between the treatment groups, except for a small effect (p<0.03) on the Caregiver Assistance Mobility subscale between baseline and 9 months. The mean scores of both groups changed significantly on the Functional Skills Scales (p<0.001) and Caregiver Assistance Scales (p<0.02) of the PEDI after the 6-month intervention. There was no additional statistically significant change on the PEDI during the follow-up period from 6 to 9 months. A subgroup effect was found for age (p<0.001), with children younger than 3 years changing significantly more than older children. GMFCS level at baseline did not influence the amount of change on the PEDI scales. There were no significant differences between the treatment groups on the GMFM, range of motion measures, APCP or FES assessments. For the GMFM, there was a significant change over time from baseline to 6 months (p<0.001) and no significant change between 6 and 9 months. There was no adverse side effect as range of motion did not decrease in either group. Hip abduction increased significantly (p<0.01) at the 9-month assessment for both groups. For the APCP, significant changes for both treatment groups were found between baseline and 6 months for play intensity (p<0.04), physical activity intensity and diversity (p<0.001), and total score intensity (p<0.01). INTERPRETATION This study shows that child- or context-focused therapy approaches are equally effective and that frequency of intervention may be a critical component of successful intervention. Further evaluation is required to identify the various `dose-response' relations of amount of treatment and changes in functional abilities. PMID:21569012

Recovery from work-related stress: a randomized controlled trial of a stress management intervention in a clinical sample.

PubMed

Glasscock, David J; Carstensen, Ole; Dalgaard, Vita Ligaya

2018-05-28

Randomized controlled trials (RCTs) of interventions aimed at reducing work-related stress indicate that cognitive behavioural therapy (CBT) is more effective than other interventions. However, definitions of study populations are often unclear and there is a lack of interventions targeting both the individual and the workplace. The aim of this study was to determine whether a stress management intervention combining individual CBT and a workplace focus is superior to no treatment in the reduction of perceived stress and stress symptoms and time to lasting return to work (RTW) in a clinical sample. Patients with work-related stress reactions or adjustment disorders were randomly assigned to an intervention group (n = 57, 84.2% female) or a control group (n = 80, 83.8% female). Subjects were followed via questionnaires and register data. The intervention contained individual CBT and the offer of a workplace meeting. We examined intervention effects by analysing group differences in score changes on the Perceived Stress Scale (PSS-10) and the General Health Questionnaire (GHQ-30). We also tested if intervention led to faster lasting RTW. Mean baseline values of PSS were 24.79 in the intervention group and 23.26 in the control group while the corresponding values for GHQ were 21.3 and 20.27, respectively. There was a significant effect of time. 10 months after baseline, both groups reported less perceived stress and improved mental health. 4 months after baseline, we found significant treatment effects for both perceived stress and mental health. The difference in mean change in PSS after 4 months was - 3.09 (- 5.47, - 0.72), while for GHQ it was - 3.91 (- 7.15, - 0.68). There were no group differences in RTW. The intervention led to faster reductions in perceived stress and stress symptoms amongst patients with work-related stress reactions and adjustment disorders. 6 months after the intervention ended there were no longer differences between the groups.

Shoulder arthroscopy simulator training improves shoulder arthroscopy performance in a cadaveric model.

PubMed

Henn, R Frank; Shah, Neel; Warner, Jon J P; Gomoll, Andreas H

2013-06-01

The purpose of this study was to quantify the benefits of shoulder arthroscopy simulator training with a cadaveric model of shoulder arthroscopy. Seventeen first-year medical students with no prior experience in shoulder arthroscopy were enrolled and completed this study. Each subject completed a baseline proctored arthroscopy on a cadaveric shoulder, which included controlling the camera and completing a standard series of tasks using the probe. The subjects were randomized, and 9 of the subjects received training on a virtual reality simulator for shoulder arthroscopy. All subjects then repeated the same cadaveric arthroscopy. The arthroscopic videos were analyzed in a blinded fashion for time to task completion and subjective assessment of technical performance. The 2 groups were compared by use of Student t tests, and change over time within groups was analyzed with paired t tests. There were no observed differences between the 2 groups on the baseline evaluation. The simulator group improved significantly from baseline with respect to time to completion and subjective performance (P < .05). Time to completion was significantly faster in the simulator group compared with controls at the final evaluation (P < .05). No difference was observed between the groups on the subjective scores at the final evaluation (P = .98). Shoulder arthroscopy simulator training resulted in significant benefits in clinical shoulder arthroscopy time to task completion in this cadaveric model. This study provides important additional evidence of the benefit of simulators in orthopaedic surgical training. There may be a role for simulator training in shoulder arthroscopy education. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Shoulder Arthroscopy Simulator Training Improves Shoulder Arthroscopy Performance in a Cadaver Model

PubMed Central

Henn, R. Frank; Shah, Neel; Warner, Jon J.P.; Gomoll, Andreas H.

2013-01-01

Purpose The purpose of this study was to quantify the benefits of shoulder arthroscopy simulator training with a cadaver model of shoulder arthroscopy. Methods Seventeen first year medical students with no prior experience in shoulder arthroscopy were enrolled and completed this study. Each subject completed a baseline proctored arthroscopy on a cadaveric shoulder, which included controlling the camera and completing a standard series of tasks using the probe. The subjects were randomized, and nine of the subjects received training on a virtual reality simulator for shoulder arthroscopy. All subjects then repeated the same cadaveric arthroscopy. The arthroscopic videos were analyzed in a blinded fashion for time to task completion and subjective assessment of technical performance. The two groups were compared with students t-tests, and change over time within groups was analyzed with paired t-tests. Results There were no observed differences between the two groups on the baseline evaluation. The simulator group improved significantly from baseline with respect to time to completion and subjective performance (p<0.05). Time to completion was significantly faster in the simulator group compared to controls at final evaluation (p<0.05). No difference was observed between the groups on the subjective scores at final evaluation (p=0.98). Conclusions Shoulder arthroscopy simulator training resulted in significant benefits in clinical shoulder arthroscopy time to task completion in this cadaver model. This study provides important additional evidence of the benefit of simulators in orthopaedic surgical training. Clinical Relevance There may be a role for simulator training in shoulder arthroscopy education. PMID:23591380

The Scandinavian Solutions for Wellness study - a two-arm observational study on the effectiveness of lifestyle intervention on subjective well-being and weight among persons with psychiatric disorders.

PubMed

Porsdal, Vibeke; Beal, Catherine; Kleivenes, Ole Kristian; Martinsen, Egil W; Lindström, Eva; Nilsson, Harriet; Svanborg, Pär

2010-06-10

Solutions for Wellness (SfW) is an educational 3-month program concerning nutrition and exercise for persons with psychiatric disorders on psychotropic medication, who have weight problems. This observational study assessed the impact of SfW on subjective well-being, weight and waist circumference (WC). Data was collected at 49 psychiatric clinics. Where the SfW program was offered patients could enter the intervention group; where not, the control group. Subjective well-being was measured by the Subjective Well-being under Neuroleptics scale (SWN), at baseline, at the end of SfW participation, and at a follow-up 6 months after baseline. Demographic, disease and treatment data was also collected. 314 patients enrolled in the SfW group, 59 in the control group. 54% of the patients had schizophrenia, 67% received atypical antipsychotics, 56% were female. They averaged 41 +/- 12.06 years and had a BMI of 31.4 +/- 6.35. There were significant differences at baseline between groups for weight, SWN total score and other factors. Stepwise logistic models controlling for baseline covariates yielded an adjusted non-significant association between SfW program participation and response in subjective well-being (SWN increase). However, statistically significant associations were found between program participation and weight-response (weight loss or gain < 1 kg) OR = 2; 95% CI [1.1; 3.7] and between program participation and WC-response (WC decrease or increase < 2 cm) OR = 5; 95% CI [2.4; 10.3]), at 3 months after baseline. SfW program participation was associated with maintaining or decreasing weight and WC but not with improved subjective well-being as measured with the SWN scale.

Effects of dog-assisted intervention on behavioural and psychological symptoms of dementia.

PubMed

Nordgren, Lena; Engström, Gabriella

2014-04-01

To evaluate the effect of a dog-assisted intervention on the behavioural and psychological symptoms of residents with dementia during a six-month period. The study was conducted in eight nursing homes in Sweden. A total of 33 residents with dementia, 20 in the intervention group and 13 in the control group, were recruited. The Cohen-Mansfield Agitation Inventory (CMAI) and the Multi-Dimensional Dementia Assessment Scale (MDDAS) were used to assess the effects of a dog-assisted intervention on participants' behavioural and psychological symptoms. The intervention comprised ten sessions, lasting between 45 and 60 minutes, once or twice a week. Descriptive statistics were used to analyse background data, comparisons between groups at baseline were performed using the Mann-Whitney U test, and the Wilcoxon rank sum test was used to test differences in groups over time. In the intervention group changes from baseline to follow up immediately after the intervention were not significant, possibly because of the small sample size. Some positive tendencies were observed: the CMAI mean score for physical non-aggressive behaviours decreased from 18.5 at baseline to 15.3 at follow up immediately after the intervention; lower scores indicate fewer symptoms. Mean and median MDDAS scores for behavioural symptoms decreased from 15.3 and 13.5 respectively at baseline to 13.1 and 12.0 respectively at follow up immediately after the intervention; lower scores indicate fewer symptoms. The CMAI mean score for verbal agitation increased significantly (P=0.035) from 17.2 at baseline to 20.6 at follow up six months after the intervention. Dog-assisted intervention may provide an alternative or a complement to pharmacological treatments to reduce behavioural symptoms in people with dementia, but its value and place in care require further evaluation.

The Effect of Ultralow-Dose Transdermal Estradiol on Urinary Incontinence in Postmenopausal Women

PubMed Central

Waetjen, L. Elaine; Brown, Jeanette S.; Vittinghoff, Eric; Ensrud, Kristine E.; Pinkerton, JoAnn; Wallace, Robert; Macer, Judith L.; Grady, Deborah

2006-01-01

OBJECTIVE To estimate the effect of 2 years of treatment with ultralow-dose transdermal estradiol (E2) on incontinence in postmenopausal women. METHODS Ultra Low Dose Transdermal estRogen Assessment (ULTRA) was a multicenter, randomized, double-blinded, placebo-controlled trial of unopposed ultralow-dose (0.014 mg/d) transdermal E2 for prevention of osteoporosis in 417 postmenopausal women aged 60 to 80 years. Frequency of incontinence episodes was assessed at baseline and after 4 months and 2 years of treatment using a self-reported questionnaire. We used an intention-to-treat analysis to compare change in incontinence frequency, improved (decreased 2 or more episodes per week), unchanged (increased or decreased no more than 1 episode per week), or worsened (increased 2 or more episodes per week) between the E2 and placebo groups among women with and without at least weekly incontinence at baseline. RESULTS At baseline, the prevalence of at least weekly incontinence was similar between E2 and placebo groups (43%). After 2 years, there was no difference between groups in the proportions of women with incontinence at baseline whose incontinence improved, worsened, or was unchanged. The odds ratio for worsening incontinence in the E2 compared with placebo group was 1.35 (95% confidence interval 0.75–2.42. In women without incontinence at baseline, the odds of developing at least weekly incontinence after 2 years in the E2 compared with placebo group was not significant (odds ratio 1.2, 95% confidence interval 0.7–2.2). CONCLUSION Two years of treatment with unopposed ultralow-dose transdermal E2 did not substantially change the frequency of incontinence symptoms or alter the risk of developing at least weekly incontinence. PMID:16260511

Esophageal intraluminal baseline impedance is associated with severity of acid reflux and epithelial structural abnormalities in patients with gastroesophageal reflux disease.

PubMed

Zhong, Chanjuan; Duan, Liping; Wang, Kun; Xu, Zhijie; Ge, Ying; Yang, Changqing; Han, Yajing

2013-05-01

The esophageal intraluminal baseline impedance may be used to evaluate the status of mucosa integrity. Esophageal acid exposure decreases the baseline impedance. We aimed to compare baseline impedance in patients with various reflux events and with different acid-related parameters, and investigate the relationships between epithelial histopathologic abnormalities and baseline impedance. A total of 229 GERD patients and 34 controls underwent 24-h multichannel intraluminal impedance and pH monitoring (MII-pH monitoring), gastroendoscopy, and completed a GERD questionnaire (GerdQ). We quantified epithelial intercellular spaces (ICSs) and expression of tight junction (TJ) proteins by histologic techniques. Mean baseline values in reflux esophagitis (RE) (1752 ± 1018 Ω) and non-erosive reflux disease (NERD) (2640 ± 1143 Ω) were significantly lower than in controls (3360 ± 1258 Ω; p < 0.001 and p = 0.001, respectively). Among NERD subgroups, mean baselines in the acid reflux group (2510 ± 1239 Ω) and mixed acid/weakly acidic reflux group (2393 ± 1009 Ω) were much lower than in controls (3360 ± 1258 Ω; p = 0.020 and p < 0.001, respectively). The mean baseline in severe RE patients was significantly lower than in mild RE patients (LA-C/D vs. LA-A/B: 970 ± 505 Ω vs. 1921 ± 1024 Ω, p < 0.001). There was a significant negative correlation between baseline value and acid exposure time (AET) (r = -0.41, p < 0.001), and a weak but significant correlation (r = -0.20, p = 0.007) between baseline value and weakly AET. Negative correlations were observed between ICS and the baseline impedance (r = -0.637, p < 0.001) and claudin-1 and the baseline impedance (r = -0.648, p < 0.001). Patients with dominant acid reflux events and with longer AET have low baseline impedance. Baseline values are correlated with esophageal mucosal histopathologic changes such as dilated ICS and TJ alteration.

[Diagnostic value of baseline serum luteinizing hormone level for central precocious puberty in girls].

PubMed

Ou-Yang, Li-Xue; Yang, Fan

2017-07-01

To evaluate the diagnostic value of baseline serum luteinizing hormone (LH) level for central precocious puberty (CPP) in girls. A total of 279 girls with precocious puberty were subjected to assessment of growth and development, bone age determination, baseline LH test, and follicle-stimulating hormone (FSH) test, gonadotropin-releasing hormone stimulation test, and other related examinations. Of the 279 patients, 175 were diagnosed with CPP and 104 with premature thelarche (PT). The receiver operating characteristic (ROC) curve was used to evaluate the diagnostic value of baseline LH and FSH levels and their peak levels for CPP, and the correlation between the baseline LH level and the peak LH level was analyzed. The CPP group had significantly higher bone age, baseline LH and FSH levels, peak LH and FSH levels, and ratio of peak LH level to peak FSH level than the PT group (P<0.01). The ROC curve proved that baseline LH level and peak LH level had good diagnostic values for CPP. Among the three bone age subgroups in the CPP group (7.0-9.0 years, 9.0-11.0 years, and >11.0 years), baseline LH level showed the best diagnostic value in the >11.0 years subgroup, with the largest area under the ROC curve. At a baseline LH level of 0.45 IU/L, the Youden index reached the peak value, and the sensitivity and specificity were 66.7% and 80% respectively, for the diagnosis of CPP. At a peak LH level of 9.935 IU/L, the Youden index reached the peak value, and the sensitivity and specificity were 74.8% and 100% respectively, for the diagnosis of CPP. The baseline LH level was positively correlated with the peak LH level (r=0.440, P<0.01). Baseline LH level can be used as an primary screening index for the diagnosis of CPP. It has a certain diagnostic value for CPP at different bone ages, and may be used as a monitoring index during the treatment and follow-uP.

Evaluation of alternative school feeding models on nutrition, education, agriculture and other social outcomes in Ghana: rationale, randomised design and baseline data.

PubMed

Gelli, Aulo; Masset, Edoardo; Folson, Gloria; Kusi, Anthoni; Arhinful, Daniel K; Asante, Felix; Ayi, Irene; Bosompem, Kwabena M; Watkins, Kristie; Abdul-Rahman, Lutuf; Agble, Rosanna; Ananse-Baden, Getrude; Mumuni, Daniel; Aurino, Elisabetta; Fernandes, Meena; Drake, Lesley

2016-01-20

'Home-grown' school feeding programmes are complex interventions with the potential to link the increased demand for school feeding goods and services to community-based stakeholders, including smallholder farmers and women's groups. There is limited rigorous evidence, however, that this is the case in practice. This evaluation will examine explicitly, and from a holistic perspective, the simultaneous impact of a national school meals programme on micronutrient status, alongside outcomes in nutrition, education and agriculture domains. The 3-year study involves a cluster-randomised control trial designed around the scale-up of the national school feeding programme, including 116 primary schools in 58 districts in Ghana. The randomly assigned interventions are: 1) a school feeding programme group, including schools and communities where the standard government programme is implemented; 2) 'home-grown' school feeding, including schools and communities where the standard programme is implemented alongside an innovative pilot project aimed at enhancing nutrition and agriculture; and 3) a control group, including schools and households from communities where the intervention will be delayed by at least 3 years, preferably without informing schools and households. Primary outcomes include child health and nutritional status, school participation and learning, and smallholder farmer income. Intermediate outcomes along the agriculture and nutrition pathways will also be measured. The evaluation will follow a mixed-method approach, including child-, household-, school- and community-level surveys as well as focus group discussions with project stakeholders. The baseline survey was completed in August 2013 and the endline survey is planned for November 2015. The tests of balance show significant differences in the means of a number of outcome and control variables across the intervention groups. Important differences across groups include marketed surplus, livestock income, per capita food consumption and intake, school attendance, and anthropometric status in the 2-5 and 5-15 years age groups. In addition, approximately 19 % of children in the target age group received some form of free school meals at baseline. Designing and implementing the evaluation of complex interventions is in itself a complex undertaking, involving a multi-disciplinary research team working in close collaboration with programme- and policy-level stakeholders. Managing the complexity from an analytical and operational perspective is an important challenge. The analysis of the baseline data indicates that the random allocation process did not achieve statistically comparable treatment groups. Differences in outcomes and control variables across groups will be controlled for when estimating treatment effects. ISRCTN66918874 (registered on 5 March 2015).

Efficacy of acarbose and metformin in newly diagnosed type 2 diabetes patients stratified by HbA1c levels.

PubMed

Zhang, Jin-Ping; Wang, Na; Xing, Xiao-Yan; Yang, Zhao-Jun; Wang, Xin; Yang, Wen-Ying

2016-07-01

The aim of the present study was to investigate whether the therapeutic efficacy of acarbose and metformin is correlated with baseline HbA1c levels in Chinese patients with newly diagnosed type 2 diabetes mellitus (T2DM). Data for 711 subjects were retrieved from the MARCH (Metformin and AcaRbose in Chinese as initial Hypoglycemic treatment) trial database and reviewed retrospectively. Patients were grouped according to baseline HbA1c levels (<7%, 7%-8%, and >8%) and the results for these three groups were compared between acarbose and metformin treatments. Acarbose and metformin treatment significantly improved T2DM-associated parameters (weight, fasting plasma glucose [FPG], postprandial glucose [PPG], glucagon-like peptide-1 [GLP-1], HOMA-IR, and total cholesterol) across all HbA1c levels. Acarbose decreased PPG and HOMA-β significantly more than metformin, but only in subjects with lower baseline HbA1c (PPG in the <7% and 7%-8%, HOMA-β in the <7% groups; all P < 0.05). Acarbose decreased triglyceride (TG) levels, and the areas under the curve (AUC) for insulin and glucagon more than metformin at all HbA1c levels (P < 0.05). After 24 weeks treatment, metformin decreased FPG levels significantly more than acarbose for all baseline HbA1c groups (all P < 0.001). With the exception of FPG, PPG, and TG levels, differences between the two treatment groups observed at 24 weeks were not detected at 48 weeks. Acarbose decreased PPG and TG and spared the AUC for insulin more effectively in patients with low-to-moderate baseline HbA1c levels, whereas metformin induced greater reductions in FPG. These results may help guide selection of initial therapy based on baseline HbA1c. © 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

Effect of Baseline Exercise Capacity on Outcomes in Patients With Stable Coronary Heart Disease (A Post Hoc Analysis of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation Trial)

PubMed Central

Padala, Santosh K.; Sidhu, Mandeep S.; Hartigan, Pamela M.; Maron, David J.; Teo, Koon K.; Spertus, John A.; John Mancini, G.B.; Sedlis, Steven P.; Chaitman, Bernard R.; Heller, Gary V.; Weintraub, William S.; Boden, William E.

2017-01-01

The impact of baseline exercise capacity on clinical outcomes in patients with stable ischemic heart disease randomized to an initial strategy of optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI) in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial has not been studied. A post hoc analysis was performed in 1,052 patients of COURAGE (PCI + OMT: n = 527, OMT: n = 525) who underwent exercise treadmill testing at baseline. Patients were categorized into 2 exercise capacity groups based on metabolic equivalents (METs) achieved during baseline exercise treadmill testing (<7 METs: n = 464, ≥7 METs: n = 588) and were followed for a median of 4.6 years. The primary composite end point of death or myocardial infarction was similar in the PCI + OMT group and the OMT group for patients with exercise capacity <7 METs (19.1% vs 16.1%, p = 0.31) and ≥7 METs (13.3% vs 10.3%, p = 0.27). After adjusting for baseline covariates, the hazard ratio (99% confidence interval) for the primary end point for the PCI + OMT group versus the OMT group was 1.42 (0.90 to 2.23, p = 0.05) and for the exercise capacity subgroups of ≥7 METs and <7 METs was 0.75 (0.46 to 1.22, p = 0.13). There was no statistically significant interaction between the original treatment arm allocation (PCI + OMT vs OMT) and baseline exercise capacity. In conclusion, there was no difference in the long-term clinical outcomes in patients with exercise capacity <7 METs compared with ≥7 METs, irrespective of whether they were assigned to initial PCI. Patients with exercise capacity <7 METs did not derive a proportionately greater clinical benefit from PCI + OMT compared with those patients who received OMT alone. Published by Elsevier Inc. (Am J Cardiol 2015;116:1509–1515) PMID:26410604

Effects of selenium on short-term control of hyperthyroidism due to Graves' disease treated with methimazole: results of a randomized clinical trial.

PubMed

Leo, M; Bartalena, L; Rotondo Dottore, G; Piantanida, E; Premoli, P; Ionni, I; Di Cera, M; Masiello, E; Sassi, L; Tanda, M L; Latrofa, F; Vitti, P; Marcocci, C; Marinò, M

2017-03-01

In spite of previous conflicting results, an adjuvant role of selenium in the treatment of Graves' disease (GD) hyperthyroidism has been proposed. To address this issue, a randomized clinical trial was carried out aimed at investigating whether selenium is beneficial on the short-term control of GD hyperthyroidism treated with methimazole (MMI). Thirty newly diagnosed hyperthyroid GD patients were randomly assigned to treatment with: (i) MMI or (ii) MMI plus selenium. Primary outcomes were: control of hyperthyroidism and clinical and biochemical manifestations of hyperthyroidism [heart rate, cholesterol, sex hormone-binding globulin (SHBG), hyperthyroidism symptoms] at 90 days. Baseline features of the two groups did not differ. Serum selenium at baseline was similar in the two groups and within the recommended range to define selenium sufficiency. Selenium increased with treatment in the MMI-selenium group and became significantly higher than in the MMI group. Serum malondialdehyde, a marker of oxidative stress, was similar in the two groups and decreased significantly with treatment, with no difference between groups. Administration of MMI was followed by a reduction of FT 3 and FT 4 , with no difference between groups. Heart rate, SHBG and symptoms of hyperthyroidism decreased, whereas total cholesterol increased in both groups with no difference between groups. Our study, carried out in a selenium-sufficient cohort of GD patients, failed to show an adjuvant role of selenium in the short-term control of hyperthyroidism. However, selenium might be beneficial in patients from selenium-deficient areas, as well as in the long-term outcome of antithyroid treatment.

A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.

PubMed

Ezenwa, Miriam O; Yao, Yingwei; Engeland, Christopher G; Molokie, Robert E; Wang, Zaijie Jim; Suarez, Marie L; Wilkie, Diana J

2016-06-01

To test feasibility of a guided audio-visual relaxation intervention protocol for reducing stress and pain in adults with sickle cell disease. Sickle cell pain is inadequately controlled using opioids, necessitating further intervention such as guided relaxation to reduce stress and pain. Attention-control, randomized clinical feasibility pilot study with repeated measures. Randomized to guided relaxation or control groups, all patients recruited between 2013-2014 during clinical visits, completed stress and pain measures via a Galaxy Internet-enabled Android tablet at the Baseline visit (pre/post intervention), 2-week posttest visit and also daily at home between the two visits. Experimental group patients were asked to use a guided relaxation intervention at the Baseline visit and at least once daily for 2 weeks. Control group patients engaged in a recorded sickle cell discussion at the Baseline visit. Data were analysed using linear regression with bootstrapping. At baseline, 27/28 of consented patients completed the study protocol. Group comparison showed that guided relaxation significantly reduced current stress and pain. At the 2-week posttest, 24/27 of patients completed the study, all of whom reported liking the study. Patients completed tablet-based measures on 71% of study days (69% in control group, 72% in experiment group). At the 2-week posttest, the experimental group had significantly lower composite pain index scores, but the two groups did not differ significantly on stress intensity. This study protocol appears feasible. The tablet-based guided relaxation intervention shows promise for reducing sickle cell pain and warrants a larger efficacy trial. The ClinicalTrials.gov Identifier is: NCT02501447. © 2016 John Wiley & Sons Ltd.

Pomegranate (Punicagranatum) juice decreases lipid peroxidation, but has no effect on plasma advanced glycated end-products in adults with type 2 diabetes: a randomized double-blind clinical trial.

PubMed

Sohrab, Golbon; Angoorani, Pooneh; Tohidi, Maryam; Tabibi, Hadi; Kimiagar, Masoud; Nasrollahzadeh, Javad

2015-01-01

Diabetes mellitus characterized by hyperglycemia could increase oxidative stress and formation of advanced glycated end-products (AGEs), which contribute to diabetic complications. The purpose of this study was to assess the effect of pomegranate juice (PJ) containing natural antioxidant on lipid peroxidation and plasma AGEs in patients with type 2 diabetes (T2D). In a randomized, double-blind, placebo-controlled trial, 44 patients (age range 56±6.8 years), T2D were randomly assigned to one of two groups: group A (PJ, n=22) and group B (Placebo, n=22). At the baseline and the end of 12-week intervention, biochemical markers including fasting plasma glucose, insulin, oxidative stress, and AGE markers including carboxy methyl lysine (CML) and pentosidine were assayed. At baseline, there were no significant differences in plasma total antioxidant capacity (TAC) levels between the two groups, but malondialdehyde (MDA) decreased levels were significantly different (P<0.001). After 12 weeks of intervention, TAC increased (P<0.05) and MDA decreased (P<0.01) in the PJ group when compared with the placebo group. However, no significant differences were observed in plasma concentration of CML and pentosidine between the two groups. The study showed that PJ decreases lipid peroxidation. Therefore, PJ consumption may delay onset of T2D complications related to oxidative stress.

Does socioeconomic status predict course and outcome in patients with psychosis?

PubMed

Samele, C; van Os, J; McKenzie, K; Wright, A; Gilvarry, C; Manley, C; Tattan, T; Murray, R

2001-12-01

We examined the relationship between socioeconomic status (SES) and course and outcome of patients with psychosis. Two hypotheses were examined: a) patients with higher best-ever SES will have better course and outcome than those with lower best-ever SES, and b) patients with greater downward drift in SES will have poorer course and outcome than those with less downward drift. Data were drawn from the baseline and 2-year follow-up assessments of the UK700 Case Management Trial of 708 patients with severe psychosis. The indicators of SES used were occupational status and educational achievement. Drift in SES was defined as change from best-ever occupation to occupation at baseline. For the baseline data highly significant differences were found between best-ever groups and negative symptoms (non-manual vs. unemployed--coef -10.5, p=0.000, 95% CIs 5.1-15.8), functioning (non-manual vs. unemployed--coef -0.6, p=0.000, 95% CIs 0.3 to -0.8) and unmet needs (manual vs. unemployed - coef 0.5, p=0.004, 95% CIs 0.2-0.9). No significant differences between best-ever groups were found for days in hospital, symptoms, perceived quality of life and dissatisfaction with services. Significant differences for clinical and social variables were found between drift and non-drift SES groups. There were no significant findings between educational groups and clinical and social variables. Best-ever occupation, but not educational qualifications, appeared to predict prognosis in patients with severe psychosis. Downward drift in occupational status did not result in poorer illness course and outcome.

Effect of Vibram FiveFingers Minimalist Shoes on the Abductor Hallucis Muscle.

PubMed

Campitelli, Nicholas A; Spencer, Scott A; Bernhard, Kaitlyn; Heard, Kristen; Kidon, Alan

2016-09-02

This study investigated the effect of Vibram FiveFingers Bikila minimalist shoes on intrinsic foot musculature. We hypothesized that a gradual transition into minimalist shoes will increase the thickness of the abductor hallucis muscle. Forty-one individuals were divided into four groups: control (traditional shod) (n = 9), restricted walking in Vibram FiveFingers (n = 11), running in Vibram FiveFingers (n = 10), and unlimited walking in Vibram FiveFingers (n = 11). At baseline, 12 weeks, and 24 weeks, the thickness of the abductor hallucis muscle was determined using ultrasound. Statistical analysis was performed to determine the significance of differences in muscle thickness at the three different time points. The mean thickness of the abductor hallucis muscle at 24 weeks was significantly greater than that at baseline for the restricted walking (P = .005) and running (P < .001) groups. In the unlimited walking group, the mean thickness of the muscle at 12 weeks was significantly greater than that at baseline (P < .05) but not at 24 weeks. There were no significant differences in muscle thickness among the three time points for the control group (P = .432). This study demonstrated that wearing Vibram FiveFinger Bikila footwear over a controlled period of time, an unlimited amount of time, as well as transitioning runners over a 6-month period of time using the 10% philosophy for increasing mileage, significantly increases intrinsic muscle thickness of the abductor hallucis. The abductor hallucis muscle aids in support of the medial longitudinal arch, and an increase in this muscle thickness may help reduce running-related injuries thought to arise from arch weakness.

Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study.

PubMed

Kinoshita, Shigeru; Awamura, Saki; Oshiden, Kazuhide; Nakamichi, Norihiro; Suzuki, Hiroyuki; Yokoi, Norihiko

2012-12-01

To investigate the dose response for efficacy of 1% and 2% rebamipide ophthalmic suspension compared with placebo in patients with dry eye. A randomized, double-masked, multicenter, placebo-controlled, parallel-group, dose-response phase II study. A total of 308 patients with dry eye. After a 2-week screening period, patients were randomized to receive placebo or 1% rebamipide or 2% rebamipide administered as 1 drop in each eye 4 times daily for 4 weeks. The primary objective end point was change in fluorescein corneal staining (FCS) score from baseline to last observation carried forward (LOCF). Secondary objective end points were lissamine green conjunctival staining (LGCS) score, tear film break-up time (TBUT), and the Schirmer's test. Secondary subjective end points included dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision) score and patients' overall treatment impression score. Rebamipide dose response was observed in FCS, LGCS, and TBUT scores. Both 1% and 2% rebamipide were significantly more effective than the placebo in terms of the change from baseline to LOCF for FCS, LGCS, and TBUT scores. There was no significant difference between the rebamipide and placebo groups from baseline to LOCF in Schirmer's test values, and dose response was not observed. In the predefined dry eye subpopulation with a baseline FCS score of 10 to 15, the mean change from baseline in the 2% rebamipide group was larger than that in the 1% rebamipide group. Change from baseline to LOCF for all 5 dry eye-related ocular symptom scores and patients' overall treatment impression showed significant improvements in the 1% and 2% rebamipide groups compared with the placebo group, except for photophobia in the 1% rebamipide group. No deaths or drug-related serious adverse events occurred in any treatment group. The incidence of ocular abnormalities was similar across the rebamipide and placebo groups. Rebamipide was effective in treating both objective signs and subjective symptoms of dry eye and were well tolerated in this 4-week study. Although 1% and 2% rebamipide were both efficacious, 2% rebamipide may be more effective than 1% rebamipide in some measures. Proprietary or commercial disclosure may be found after the references. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Effectiveness of massage therapy as co-adjuvant treatment to exercise in osteoarthritis of the knee: a randomized control trial.

PubMed

Cortés Godoy, Virginia; Gallego Izquierdo, Tomás; Lázaro Navas, Irene; Pecos Martín, Daniel

2014-01-01

The effectiveness of exercise therapy in the treatment of osteoarthritis of the knee (KOA) is widely evidenced. The current study aims to compare the effectiveness of massage therapy as a co-adjuvant treatment for KOA. A blind, randomized controlled trial design was used. Eighteen women were randomly allocated to two different groups. Group A was treated with massage therapy and an exercise program, and Group B was treated with the exercise program alone. The intervention lasted for 6 weeks. Outcomes were assessed using a verbal analogue scale (VAS), the WOMAC index, and the Get-Up and Go test. Baseline, post-treatment, and 1- and 3- month follow-up data were collected. Values were considered statistically significant at a p < 0.05. The Mann-Whitney U test was applied in order to find out the differences between groups, and to verify the existence of such differences, the Friedman Test for repeated measures complemented with multiple comparisons tests was carried out. In both groups, significant differences were found in the three variables between the baseline measurement and three months after treatment, with the exception of the WOMAC variable in group B (p=0.064) No significant differences were found between both groups in the WOMAC index (p=0.508) and VAS (p=0.964) variables and the Get-Up and Go test (p=0.691). Combining exercise-based therapy with massage therapy may lead to clinical improvement in patients with KOA. The use of massage therapy combined with exercise as a treatment for gonarthrosis does not seem to have any beneficial effects.

Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial

PubMed Central

Zhao, Jingyuan; Song, Xueqin; Ai, Xiaoqing; Gu, Xiaojing; Huang, Guangbiao; Li, Xue; Pang, Lijuan; Ding, Minli; Ding, Shuang; Lv, Luxian

2015-01-01

Objective The present study aimed to evaluate the efficacy and safety of adjunctive aripiprazole treatment in schizophrenia patients with risperidone-induced hyperprolactinemia. Methods One hundred and thirteen patients who were receiving a stable dose of risperidone were randomly assigned to either adjunctive aripiprazole treatment (10 mg/day) (aripiprazole group) or no additional treatment (control group) at a 1:1 ratio for 8 weeks. Schizophrenia symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Rating scales and safety assessments (RSESE, BARS, UKU) were performed at baseline and at weeks 4 and 8. Serum levels of prolactin were determined at baseline and at weeks 2, 4, 6 and 8. Metabolic parameters were determined at baseline and again at weeks 4 and 8. Results One hundred and thirteen patients were enrolled in this study, and 107 patients completed the study (54 in the aripiprazole group, and 53 in the control group). PANSS-total scores in the aripiprazole group decreased significantly at week 4 (P = 0.003) and week 8 (P = 0.007) compared with the control group. PANSS-negative scores in the aripiprazole group also decreased significantly at week 4 (P = 0.005) and week 8 (P< 0.001) compared with the control group. Serum levels of prolactin in the aripiprazole group decreased significantly at week 2 (P< 0.001), week 4 (P< 0.001), week 6 (P< 0.001) and week 8 (P< 0.001) compared with the control group. There were no significant differences in changes of Fasting Plasma Glucose, Total cholesterol, Triglycerides and High Density Lipoprotein within each group at week 4 and 8 execpt low density lipoproteins. There was no significant difference in the incidence of adverse reactions between the two groups. Conclusions Adjunctive aripiprazole treatment may be beneficial in reducing serum levels of prolactin and improving negative symptoms in schizophrenia patients with risperidone-induced hyperprolactinemia. Trial Registration chictr.org ChiCTR-IOR-15006278 PMID:26448615

High Baseline Postconcussion Symptom Scores and Concussion Outcomes in Athletes.

PubMed

Custer, Aimee; Sufrinko, Alicia; Elbin, R J; Covassin, Tracey; Collins, Micky; Kontos, Anthony

2016-02-01

Some healthy athletes report high levels of baseline concussion symptoms, which may be attributable to several factors (eg, illness, personality, somaticizing). However, the role of baseline symptoms in outcomes after sport-related concussion (SRC) has not been empirically examined. To determine if athletes with high symptom scores at baseline performed worse than athletes without baseline symptoms on neurocognitive testing after SRC. Cohort study. High school and collegiate athletic programs. A total of 670 high school and collegiate athletes participated in the study. Participants were divided into groups with either no baseline symptoms (Postconcussion Symptom Scale [PCSS] score = 0, n = 247) or a high level of baseline symptoms (PCSS score > 18 [top 10% of sample], n = 68). Participants were evaluated at baseline and 2 to 7 days after SRC with the Immediate Post-concussion Assessment and Cognitive Test and PCSS. Outcome measures were Immediate Post-concussion Assessment and Cognitive Test composite scores (verbal memory, visual memory, visual motor processing speed, and reaction time) and total symptom score on the PCSS. The groups were compared using repeated-measures analyses of variance with Bonferroni correction to assess interactions between group and time for symptoms and neurocognitive impairment. The no-symptoms group represented 38% of the original sample, whereas the high-symptoms group represented 11% of the sample. The high-symptoms group experienced a larger decline from preinjury to postinjury than the no-symptoms group in verbal (P = .03) and visual memory (P = .05). However, total concussion-symptom scores increased from preinjury to postinjury for the no-symptoms group (P = .001) but remained stable for the high-symptoms group. Reported baseline symptoms may help identify athletes at risk for worse outcomes after SRC. Clinicians should examine baseline symptom levels to better identify patients for earlier referral and treatment for their injury. Additional investigation of baseline symptoms is warranted to help delineate the type and severity of premorbid symptoms.

The Combination of Atracurium and Vecuronium Compared to Vecuronium Administered Alone: Evaluation of the Time of Onset, Duration of Action, Intubating Conditions, and Cardiovascular Effects

DTIC Science & Technology

1990-06-01

10 minutes after injection. No significant differences detected between the groups. 18 0 Table 7. Systolic Blood Pressure Group Atracurium 0.40 mg/kg...Table 8. Diastolic Blood Pressure Group Atracurium 0.40 mg/kg + Vecuronium 0.28 mg/kg Vecuronium 0.10 mg/kg (n=20) (n=20) Baseline(a) 72 + 2.4 72...significant differences detected between the groups. 20 0 Table 9. Mean Blood Pressure Group Atracurium 0.40 mg/kg + Vecuronium 0.28 mg/kg Vecuronium 0.10

12-month color stability of enamel, dentine, and enamel-dentine samples after bleaching.

PubMed

Wiegand, Annette; Drebenstedt, Steffi; Roos, Malgorzata; Magalhães, Ana Carolina; Attin, Thomas

2008-12-01

The study aimed to quantify the color regression of enamel (E), dentine (D), and combined enamel-dentine (ED) of differently bleached ED specimens over a period of 12 months in vitro. Two ED samples were obtained from the labial surfaces of bovine teeth and prepared to a standardized thickness with the enamel and dentine layer each 1 mm. The ED samples were distributed on four groups (each n = 80), in which the different bleaching products were applied on enamel (1, Whitestrips; 2, Illuminé 15%; 3, Opalescence Xtra Boost) or dentine surfaces (4, mixture of sodium perborate/distilled water). Eighty ED samples were not bleached (control). Color (L*a*b*) of ED was assessed at baseline, subsequently after bleaching and at 3, 6, and 12 months of storage after bleaching (each 20 samples/group). E and D samples were prepared by removing the dentine or enamel layer of ED samples to allow for separate color analysis. Bleaching resulted in a significant color change (Delta E) of ED specimens. Within the observation period, Delta L but not Delta b declined to baseline. L* values of E and D samples also declined and were not significantly different from control samples after 12 months, while b* values did not decrease to baseline. Generally, no differences between the bleaching agents could be observed. Color change of enamel, dentine, and combined ED of in vitro bleached tooth samples is not stable over time with regard to lightness. However, yellowness did not return to baseline within 1 year.

Platelet reactivity in response to loading dose of atorvastatin or rosuvastatin in patients with stable coronary disease before percutaneous coronary intervention: The STATIPLAT randomized study.

PubMed

Godino, Cosmo; Pavon, Anna Giulia; Mangieri, Antonio; Salerno, Anna; Cera, Michela; Monello, Alberto; Chieffo, Alaide; Magni, Valeria; Cappelletti, Alberto; Margonato, Alberto; Colombo, Antonio

2017-08-01

The acute effects of statin loading dose (LD) on platelet reactivity in patients with chronic stable angina (CSA) are not completely clear. We hypothesized that LDs of atorvastatin and rosuvastatin have different pharmacodynamic acute effects on platelet aggregability in CSA patients with baseline normal platelet reactivity while on dual antiplatelet therapy (DAPT). From September 2011 to February 2014, all consecutive CSA patients on chronic DAPT (aspirin and clopidogrel) were evaluated before elective percutaneous coronary intervention (PCI). An initial assessment of platelet reactivity in response to thrombin receptor agonist, ADP, and ASP (respectively, indicative of the response to clopidogrel and aspirin) was performed with impedance aggregometry. Patients with high platelet reactivity to ADP test (area under the curve >47) were excluded. The remaining patients were randomized into 3 treatment groups: Group A, atorvastatin LD 80 mg; Group B, rosuvastatin LD 40 mg; and Group C, no statin LD (control group). A second assessment of platelet reactivity was performed ≥12 hours after statin LD. 682 patients were screened and 145 were randomized into the 3 groups. At baseline and after statin LD, no significant difference was found in platelet reactivity in response to 3 different agonists between the 3 groups. Subgroup analysis showed that platelet reactivity to ADP test was significantly lower in patients chronically treated with low-dose statins (n = 94) compared with statin-naïve patients (n = 51; 15.32 ± 1.50 vs 18.59 ± 1.30; P = 0.007). Loading dose of atorvastatin (80 mg) or rosuvastatin (40 mg) did not induce significant variation in platelet reactivity in CSA patients with baseline reduced platelet reactivity as in chronic DAPT. Our data confirm that chronic concomitant treatment with low-dose statins and clopidogrel resulted in significantly lower platelet reactivity compared with clopidogrel alone. © 2017 Wiley Periodicals, Inc.

Effect of enamel matrix derivative on collagen guided tissue regeneration-based root coverage procedure.

PubMed

Trabulsi, Manal; Oh, Tae-Ju; Eber, Robert; Weber, Daniel; Wang, Hom-Lay

2004-11-01

Enamel matrix derivative (EMD) has been shown to promote periodontal wound healing and/or regeneration when applied to tooth root surfaces in soft tissue dehiscence models. In addition, guided tissue regeneration (GTR)-based root coverage using collagen membrane (GTRC) has shown promising results. However, limited information is available regarding how EMD may influence GTRC outcome. Twenty-six patients with Miller's Class I or II gingival recession defects of 2.5 mm were recruited for the study. Subjects were randomly assigned to receive either EMD + collagen (EMDC; test group) or collagen membrane (GTRC; control group). Clinical parameters, including plaque index (PI), gingival index (GI), relative clinical attachment levels (RCAL) to the stent, recession depth (RD), recession width (RW), probing depth (PD), gingival tissue thickness (GTT), and width of keratinized gingiva (KG) were assessed at baseline, and 3 and 6 months after surgery. A repeated measure of analysis of variance (ANOVA) was used to determine differences between treatment groups and time effect. Both treatments (GTRC and EMDC) resulted in a statistically significant decrease in RD and RW between baseline and 6 months (P <0.05). However, no difference was noted between treatment groups. The percent of root coverage after 6 months was 75% for GTRC and 63% for EMDC. Complete 100% root coverage was achieved in five patients in the GTRC group, compared to only one patient in the EMDC group. There was a statistically significant gain (P <0.05) in the clinical attachment level (CAL) between baseline and 6 months in both groups, as reflected on the RCAL data. No other significant differences were noted on other clinical parameters (PD, GTT, KG, GI, and PI). GTR-based root coverage utilizing collagen membrane, with or without enamel matrix derivative, can be successfully used in obtaining gingival recession coverage. The application of EMD during GTRC procedures did not add additional benefit to the final clinical outcome.

A multicomponent quality improvement intervention to improve blood pressure and reduce racial disparities in rural primary care practices.

PubMed

Cené, Crystal W; Halladay, Jacqueline R; Gizlice, Ziya; Donahue, Katrina E; Cummings, Doyle M; Hinderliter, Alan; Miller, Cassandra; Johnson, Larry F; Garcia, Beverly; Tillman, Jim; Little, Edwin P; Rachide, Marjorie R; Keyserling, Thomas C; Ammerman, Alice; Zhou, Haibo; Wu, Jia-Rong; DeWalt, Darren

2017-04-01

The Southeastern United States has the highest prevalence of hypertension and African Americans have disproportionately worse blood pressure control. The authors sought to evaluate the effect of a multicomponent practice-based quality improvement intervention on lowering mean systolic blood pressure (SBP) at 12 and 24 months compared with baseline among 525 patients, and to assess for a differential effect of the intervention by race (African Americans vs white). At 12 months, both African Americans (-5.0 mm Hg) and whites (-7.8 mm Hg) had a significant decrease in mean SBP compared with baseline, with no significant between-group difference. Similarly, at 24 months, mean SBP decreased in both African Americans (-6.0 mm Hg) and whites (-7.2 mm Hg), with no significant difference between groups. Notably, no significant racial disparity in mean SBP at baseline was shown. The intervention was effective in lowering mean SBP in both African Americans and whites but there was no differential effect of the intervention by race. ©2016 Wiley Periodicals, Inc.

Lack of evidence for post-vaccine onset of autoimmune/lymphoproliferative disorders, during a nine-month follow-up in multiply vaccinated Italian military personnel.

PubMed

Ferlito, Claudia; Barnaba, Vincenzo; Abrignani, Sergio; Bombaci, Mauro; Sette, Alessandro; Sidney, John; Biselli, Roberto; Tomao, Enrico; Cattaruzza, Maria Sofia; Germano, Valentina; Biondo, Michela Ileen; Salerno, Gerardo; Lulli, Patrizia; Caporuscio, Sara; Picchianti Diamanti, Andrea; Falco, Mirella; Biselli, Valentina; Cardelli, Patrizia; Autore, Alberto; Lucertini, Elena; De Cesare, Donato Pompeo; Peragallo, Mario Stefano; Lista, Florigio; Martire, Carmela; Salemi, Simonetta; Nisini, Roberto; D'Amelio, Raffaele

2017-08-01

Anecdotal case reports, amplified by mass media and internet-based opinion groups, have recently indicated vaccinations as possibly responsible for autoimmunity/lymphoproliferation development. Multiply vaccinated Italian military personnel (group 1, operating in Italy, group 2, operating in Lebanon) were followed-up for nine months to monitor possible post-vaccine autoimmunity/lymphoproliferation onset. No serious adverse event was noticed in both groups. Multivariate analysis of intergroup differences only showed a significant association between lymphocyte increase and tetanus/diphtheria vaccine administration. A significant post-vaccine decrease in autoantibody positivity was observed. Autoantibodies were also studied by microarray analysis of self-proteins in subjects exposed to ≥4 concurrent vaccinations, without observing significant difference among baseline and one and nine months post-vaccine. Moreover, HLA-A2 subjects have been analyzed for the possible CD8T-cell response to apoptotic self-epitopes, without observing significant difference between baseline and one month post-vaccine. Multiple vaccinations in young adults are safe and not associated to autoimmunity/lymphoproliferation onset during a nine-month-long follow-up. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of the Effect of Toothbrushing Education Via Video, Lecture and Pamphlet on the Dental Plaque Index of 12-Year-Old Children.

PubMed

Ramezaninia, Javad; Naghibi Sistani, Mohammad Mehdi; Ahangari, Zohreh; Gholinia, Hemmat; Jahanian, Iman; Gharekhani, Samaneh

2018-04-11

The aim of this study was to compare the effect of different modes of toothbrushing education (lecture, video and pamphlet) on the dental plaque index (PI) of adolescents. The cluster randomized intervention was performed on 128 participants aged 12 years, who were allocated into four groups based on the type of intervention. Group 1: no intervention; and groups 2, 3, 4: education via lecture, video, and pamphlet, respectively (n = 32). Their plaque index was measured at the baseline, 24 h and two months later. Data were analyzed by repeated measures analysis of variance (ANOVA), one-way ANOVA, independent and paired t-test. The plaque indices of groups 2, 3, 4 at 24 h (p values < 0.001) and two months (p values < 0.001) showed a significant reduction when compared to the baseline. The lowest PI score was observed in the pamphlet, video and lecture groups at 24 h, respectively. After 2 months, the lowest score of PI was measured in lecture, video and pamphlet groups, respectively; however, these differences were non-significant. Therefore, toothbrushing education via lecture, video and pamphlet reduced the dental plaque index with the same effectiveness.

A simple technique investigating baseline heterogeneity helped to eliminate potential bias in meta-analyses.

PubMed

Hicks, Amy; Fairhurst, Caroline; Torgerson, David J

2018-03-01

To perform a worked example of an approach that can be used to identify and remove potentially biased trials from meta-analyses via the analysis of baseline variables. True randomisation produces treatment groups that differ only by chance; therefore, a meta-analysis of a baseline measurement should produce no overall difference and zero heterogeneity. A meta-analysis from the British Medical Journal, known to contain significant heterogeneity and imbalance in baseline age, was chosen. Meta-analyses of baseline variables were performed and trials systematically removed, starting with those with the largest t-statistic, until the I 2 measure of heterogeneity became 0%, then the outcome meta-analysis repeated with only the remaining trials as a sensitivity check. We argue that heterogeneity in a meta-analysis of baseline variables should not exist, and therefore removing trials which contribute to heterogeneity from a meta-analysis will produce a more valid result. In our example none of the overall outcomes changed when studies contributing to heterogeneity were removed. We recommend routine use of this technique, using age and a second baseline variable predictive of outcome for the particular study chosen, to help eliminate potential bias in meta-analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

Differences in treatment outcome between male alcohol dependent offenders of domestic violence with and without positive drug screens.

PubMed

Easton, Caroline J; Mandel, Dolores; Babuscio, Theresa; Rounsaville, Bruce J; Carroll, Kathleen M

2007-10-01

Men who are violent toward their partners tend to have a dual problem with alcohol and drug use, yet little is known about differences between men with single rather than dual problems. This study was one of the first to evaluate differences between alcohol dependent men who were arrested for Intimate Partner Violence (IPV) with and without concurrent illicit drug use. Seventy-eight participants were randomly assigned to manual-guided group behavioral therapies (Cognitive Behavioral Therapy or Twelve Step Facilitation) and assessed across 12 weeks of treatment. Despite denying drug use at baseline, thirty-two clients (43%) tested positive for illicit drug use (cocaine and marijuana) during the 12 weeks of treatment. The study specifically addressed whether there were differences between clients using alcohol only versus individuals using both alcohol + drugs in terms of 1) baseline characteristics; 2) treatment compliance (e.g., attendance and substance use during treatment; and 3) treatment outcomes (alcohol, drug use, anger management, and aggression at the completion of treatment). The results showed that there were comparatively few differences between the alcohol versus the alcohol + drug using groups at baseline. Regarding treatment compliance and retention, alcohol + drug using participants attended significantly fewer sessions, had significantly fewer percent days abstinence from alcohol use, significantly more total days of positive breathalyzer results. Regarding treatment outcomes across anger management and aggression scores, the alcohol + drug using participants had significantly more impairments in anger management styles from pre- to post-treatment. However, there were no differences between the groups across verbal or physical aggression. Both groups improved in their verbal aggression from pre- to post-treatment. The findings suggest that alcohol dependent men who continue to use illicit drugs may require additional interventions to effectively control their drug use and, their anger management styles.

Effects of low-level laser therapy on burning mouth syndrome.

PubMed

Valenzuela, S; Lopez-Jornet, P

2017-02-01

To investigate low-level laser therapy (LLLT) applied to treat burning mouth syndrome (BMS). This prospective, comparative, partially blinded, single-centre, clinical trial of GaAlAs Laser, with 815 nm wavelength, included 44 BMS patients divided randomly into three groups: Group I (n = 16): GaAlAs laser 815 nm wavelength, 1 W output power, continuous emissions, 4 s, 4 J and fluence rate 133·3 J cm -2 ; Group II (n = 16): GaAlAs infrared laser, 815 nm wavelength, 1 W output power, continuous emissions, 6 s, 6 J and fluence rate 200 J cm -2 ; Group III (n = 12) placebo group, sham laser. All groups received a weekly dose for 4 weeks. Pain intensity was recorded using a 10-cm visual analogue scale; patients responded to the oral health impact profile (OHIP-14), xerostomia severity test and the hospital anxiety-depression scale (HAD). These assessments were performed at baseline, 2 and 4 weeks. LLLT decreased pain intensity and improved OHIP-14 scores significantly from baseline to 2 weeks in groups I and II compared with the placebo group. No statistically significant differences were found from 2 to 4 weeks. Overall improvements in visual analogue scale (VAS) scores from baseline to the end of treatment were as follows: Group I 15·7%; Group II 15·6%; Group III placebo 7·3%. LLLT application reduces symptoms slightly in BMS patients. © 2016 John Wiley & Sons Ltd.

Use of the OSCE to Evaluate Brief Communication Skills Training for Dental Students

PubMed Central

Cannick, Gabrielle F.; Horowitz, Alice M.; Garr, David R.; Reed, Susan G.; Neville, Brad W.; Day, Terry A.; Woolson, Robert F.; Lackland, Daniel T.

2009-01-01

Although communications competency is recommended by the American Dental Education Association, only a few (n=5) dental schools report evaluating students’ skills using a competency examination for communication. This study used an objective structured clinical examination (OSCE) to evaluate dental students’ competency in interpersonal and tobacco cessation communication skills. All students were evaluated on their interpersonal communication skills at baseline and at six months post-OSCE by standardized patients and on their tobacco cessation communication skills by two independent raters. First- and second-year dental students (n=104) were randomized to a control or intervention group. One month after the baseline OSCE, students in the intervention group participated in a two-hour training session in which faculty members communicated with a standardized patient during a head and neck examination and counseled the patient about tobacco cessation. There were no statistically significant differences from baseline to post-test between the intervention and control group students as measured by the OSCE. However, among first-year students, both the intervention (n=23) and control (n=21) groups significantly increased in tobacco cessation communication scores. Second-year students in both intervention (n=24) and control (n=28) groups declined in interpersonal communication skills from baseline to post-test. Overall, this one-shot intervention was not successful, and results suggest that a comprehensive communication skills training course may be more beneficial than a single, brief training session for improving dental students’ communication skills. PMID:17761627

Limb venous compliance responses to lower body negative pressure in humans with high blood pressure.

PubMed

Goulopoulou, S; Deruisseau, K C; Carhart, R; Kanaley, J A

2012-05-01

This study tested the hypothesis that limb venous responses to baroreceptor unloading are altered in individuals with high blood pressure (HBP) compared with normotensive (NT) controls. Calf venous compliance was assessed in 20 subjects with prehypertension and stage-1 hypertension (mean arterial pressure, MAP: 104±1 mm Hg) and 13 NT controls (MAP: 86±2 mm Hg) at baseline and during lower body negative pressure (LBNP), using venous occlusion plethysmography. Baroreflex sensitivity (BRS) was measured using the sequence technique and total peripheral resistance (TPR) was estimated from finger plethysmography. Baseline venous compliance was not different between groups, but the HBP group had lower baseline lnBRS (2.22±0.14 vs 2.7±0.18 ms mm Hg(-1)) and greater baseline TPR (3828±138 vs 3250±111 dyn sec(-1) cm(-5) m(2), P<0.05). Calf venous compliance was reduced in response to LBNP only in the NT group (P<0.05). The HBP group had a greater increase in TPR (ΔTPR) compared with the NT group (+1649±335 vs +718±196 dyn sec(-1) cm(-5) m(2), P<0.05). In conclusion, the early stages of hypertension are characterized by an attenuated venoconstrictor response to baroreceptor unloading, which may compensate for an exaggerated vasoconstrictor response and protect against further increases in blood pressure.

Pulmonary Hypertension After Heart Transplantation in Patients Bridged with the Total Artificial Heart.

PubMed

Shah, Rachit; Patel, Dhavalkumar B; Mankad, Anit K; Rennyson, Stephen L; Tang, Daniel G; Quader, Mohammed A; Smallfield, Melissa C; Kasirajan, Vigneshwar; Shah, Keyur B

2016-01-01

Pulmonary hypertension (PH) among heart transplant recipients is associated with an increased risk of mortality. Pulmonary hemodynamics improves after left ventricular assist device (LVAD) implantation; however, the impact of PH before total artificial heart (TAH) implantation on posttransplant hemodynamics and survival is unknown. This is a single center retrospective study aimed to evaluate the impact of TAH implantation on posttransplant hemodynamics and mortality in two groups stratified according to severity of PH: high (≥3 Woods units [WU]) and low (<3 WU) baseline pulmonary vascular resistance (PVR). Hemodynamic data were obtained from right heart catheterization performed at baseline (before TAH) and posttransplant at 1 and 12 months. Patients in the high PVR group (n = 12) experienced improvement in PVR (baseline = 4.31 ± 0.7; 1-month = 1.69 ± 0.7, p < 0.001; 12-month = 48 ± 0.9, p < 0.001) and transpulmonary gradient (baseline = 15.8 ± 3.3; 1-month = 11.57 ± 5.0, p = 0.07; 12-month = 8.50 ± 4.0, p = 0.008) after transplantation, reaching similar values as the low PVR group at 12 months. The filling pressures improved in the high PVR group after heart transplantation (HT), but remained elevated. There was no significant difference in survival between the two groups at 12 months follow-up. Patients with high PVR who are bridged to transplant with TAH had improvement in PVR at 12 months after transplant, and the degree of PVR did not impact posttransplant survival.

Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in comparison to one containing levonorgestrel and ethinylestradiol on markers of endocrine function.

PubMed

Ågren, Ulla M; Anttila, Marjatta; Mäenpää-Liukko, Kristiina; Rantala, Maija-Liisa; Rautiainen, Hilkka; Sommer, Werner F; Mommers, Ellen

2011-12-01

To compare the effects of two monophasic combined oral contraceptives, containing either nomegestrol acetate/17β-oestradiol (NOMAC/E2) or levonorgestrel/ ethinylestradiol (LNG/EE) on endocrine function, androgens, and sex hormone-binding globulin (SHBG). Randomised, open-label, multi-centre trial involving 121 healthy women, aged 18-50 years old. Participants received NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=60) or LNG/EE (150 μg/30 μg) in a 21/7-day regimen (n=61) for six cycles. The primary outcome was the change from baseline to cycle 6 in markers of adrenal and thyroid function, androgens, and SHBG. Total cortisol, corticosteroid-binding globulin (CBG), and thyroxine-binding globulin (TBG) increased from baseline in both groups, with significantly greater increases in the LNG/EE group. No relevant changes from baseline or differences between the groups were observed for thyroid-stimulating hormone (TSH) and free thyroxine (T4). Androgens and androgen precursors decreased from baseline in both groups, with significantly greater decreases in the LNG/EE group (except for free testosterone). A greater increase in SHBG was observed with NOMAC/E2 than with LNG/EE. NOMAC/E2 has significantly less influence on markers of adrenal and thyroid function and androgens than LNG/EE. The clinical relevance of these findings requires further study.

Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in comparison to one containing levonorgestrel and ethinylestradiol on markers of endocrine function

PubMed Central

Ågren, Ulla M; Anttilat, Marjatta; Mäenpää-Liukko, Kristiina; Rantala, Maija-Liisa; Rautiainen, Hilkka; Sommer, Werner F; Mommers, Ellen

2011-01-01

Objectives To compare the effects of two monophasic combined oral contraceptives, containing either nomegestrol acetate/17β-oestradiol (NOMAC/E2) or levonorgestrel/ ethinylestradiol (LNG/EE) on endocrine function, androgens, and sex hormone-binding globulin (SHBG). Methods Randomised, open-label, multi-centre trial involving 121 healthy women, aged 18-50 years old. Participants received NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n = 60) or LNG/EE (150 μg/30 μg) in a 21/7-day regimen (n = 61) for six cycles. The primary outcome was the change from baseline to cycle 6 in markers of adrenal and thyroid function, androgens, and SHBG. Results Total cortisol, corticosteroid-binding globulin (CBG), and thyroxine-binding globulin (TBG) increased from baseline in both groups, with significantly greater increases in the LNG/EE group. No relevant changes from baseline or differences between the groups were observed for thyroid-stimulating hormone (TSH) and free thyroxine (T4). Androgens and androgen precursors decreased from baseline in both groups, with significantly greater decreases in the LNG/EE group (except for free testosterone). A greater increase in SHBG was observed with NOMAC/E2 than with LNG/EE. Conclusions NOMAC/E2 has significantly less influence on markers of adrenal and thyroid function and androgens than LNG/EE. The clinical relevance of these findings requires further study. PMID:21942708

Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

PubMed

Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

2013-01-01

Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P < 0.001). Follow-up also found a significant reduction in pain intensity in the electroacupuncture group compared with the control group (P < 0.001). Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Impact of Receiving Secondary Results from Genomic Research: A 12-Month Longitudinal Study.

PubMed

Wynn, Julia; Martinez, Josue; Bulafka, Jessica; Duong, Jimmy; Zhang, Yuan; Chiuzan, Codruta; Preti, Jain; Cremona, Maria L; Jobanputra, Vaidehi; Fyer, Abby J; Klitzman, Robert L; Appelbaum, Paul S; Chung, Wendy K

2018-06-01

The impact of returning secondary results from exome sequencing (ES) on patients/participants is important to understand as ES is increasingly utilized in clinical care and research. Participants were recruited from studies using ES and were separated into two arms: 107 who had ES and were offered the choice to learn secondary results (ES group) and 85 who had not yet had ES (No ES group). Questionnaires were administered at baseline and 1 and 12 months, following results disclosure (ES group) or enrollment (No ES group). While the majority (65%) elected to learn all results following pre-test counseling, it was reduced from the 76% who indicated a desire for all results at baseline. Thirty-seven percent received results associated with an increased personal disease risk. There were no differences in changes in any of the psychological and social measures from baseline to post-results disclosure between the ES and No ES groups. Receiving a wide range of secondary findings appeared to have little measurable impact on most participants. The experience of learning secondary results may be related to participants' previous experiences with genetics, as well as the genetic counseling provided. Future research with a more diverse, genetically naïve group, as well as scalable methods of delivery, is needed.

Antioxidative Activity of Onion Peel Extract in Obese Women: A Randomized, Double-blind, Placebo Controlled Study.

PubMed

Kim, Kyung-Ah; Yim, Jung-Eun

2015-09-01

Quercetin, found abundantly in onion peel, has been known to have anticholesterol, antithrombotic and insulin-sensitizing properties. Here, we investigated the effect of quercetin-rich onion peel extract (OPE) on reactive oxygen species (ROS) production and antioxidative defense in obese woman. This study was randomized, double-blind, placebo controlled study. Thirty-seven healthy obese participants were randomly assigned that eighteen subjects received red soft capsuled OPE (100 mg/d, 50 mg bis in die), while the other nineteen subjects received same capsuled placebo for 12 weeks. ROS production and superoxide dismutase (SOD) activity in plasma were determined by using ROS and SOD assay kits, respectively. Baseline characteristics of anthropometric indicators and blood metabolic profiles were not significantly different between the two groups. Compared with baseline values, OPE consumption significantly reduced waist and hip circumference. Plasma ROS level and SOD activity were decreased in both placebo and OPE groups compared with baseline values. However, plasma ROS level in OPE group was significantly lower than in placebo group while plasma SOD activity in OPE group was significantly higher than in placebo group after 12 weeks of consumption. These findings indicate that OPE consumption may exert antioxidative effect by preventing the decrease of SOD activity as well as the production of ROS in obese women.

Baseline performance and learning rate of conceptual and perceptual skill-learning tasks: the effect of moderate to severe traumatic brain injury.

PubMed

Vakil, Eli; Lev-Ran Galon, Carmit

2014-01-01

Existing literature presents a complex and inconsistent picture of the specific deficiencies involved in skill learning following traumatic brain injury (TBI). In an attempt to address this difficulty, individuals with moderate to severe TBI (n = 29) and a control group (n = 29) were tested with two different skill-learning tasks: conceptual (i.e., Tower of Hanoi Puzzle, TOHP) and perceptual (i.e., mirror reading, MR). Based on previous studies of the effect of divided attention on these tasks and findings regarding the effect of TBI on conceptual and perceptual priming tasks, it was predicted that the group with TBI would show impaired baseline performance compared to controls in the TOHP task though their learning rate would be maintained, while both baseline performance and learning rate on the MR task would be maintained. Consistent with our predictions, overall baseline performance of the group with TBI was impaired in the TOHP test, while the learning rate was not. The learning rate on the MR task was preserved but, contrary to our prediction, response time of the group with TBI was slower than that of controls. The pattern of results observed in the present study was interpreted to possibly reflect an impairment of both the frontal lobes as well as that of diffuse axonal injury, which is well documented as being affected by TBI. The former impairment affects baseline performance of the conceptual learning skill, while the latter affects the overall slower performance of the perceptual learning skill.

Type of homogenization and fat loss during continuous infusion of human milk.

PubMed

García-Lara, Nadia Raquel; Escuder-Vieco, Diana; Alonso Díaz, Clara; Vázquez Román, Sara; De la Cruz-Bértolo, Javier; Pallás-Alonso, Carmen Rosa

2014-11-01

Substantial fat loss may occur during continuous feeding of human milk (HM). A decrease of fat loss has been described following homogenization. Well-established methods of homogenization of HM for routine use in the neonatal intensive care unit (NICU) would be desirable. We compared the loss of fat based on the use of 3 different methods for homogenizing thawed HM during continuous feeding. Sixteen frozen donor HM samples were thawed, homogenized with ultrasound and separated into 3 aliquots ("baseline agitation," "hourly agitation," and "ultrasound"), and then frozen for 48 hours. Aliquots were thawed again and a baseline agitation was applied. Subsequently, aliquots baseline agitation and hourly agitation were drawn into a syringe, while ultrasound was applied to aliquot ultrasound before it was drawn into a syringe. The syringes were loaded into a pump (2 mL/h; 4 hours). At hourly intervals the hourly agitation infusion was stopped, the syringe was disconnected and gently shaken. During infusion, samples from the 3 groups were collected hourly for analysis of fat and caloric content. The 3 groups of homogenization showed similar fat content at the beginning of the infusion. For fat, mean (SD) hourly changes of -0.03 (0.01), -0.09 (0.01), and -0.09 (0.01) g/dL were observed for the hourly agitation, baseline agitation, and ultrasound groups, respectively. The decrease was smaller for the hourly agitation group (P < .001). When thawed HM is continuously infused, a smaller fat loss is observed when syringes are agitated hourly versus when ultrasound or a baseline homogenization is used. © The Author(s) 2014.

EFFECTS OF RELIGIOUS VERSUS STANDARD COGNITIVE-BEHAVIORAL THERAPY ON OPTIMISM IN PERSONS WITH MAJOR DEPRESSION AND CHRONIC MEDICAL ILLNESS.

PubMed

Koenig, Harold G; Pearce, Michelle J; Nelson, Bruce; Daher, Noha

2015-11-01

We compared the effectiveness of religiously integrated cognitive behavioral therapy (RCBT) versus standard CBT (SCBT) on increasing optimism in persons with major depressive disorder (MDD) and chronic medical illness. Participants aged 18-85 were randomized to either RCBT (n = 65) or SCBT (n = 67) to receive ten 50-min sessions remotely (94% by telephone) over 12 weeks. Optimism was assessed at baseline, 12 and 24 weeks by the Life Orientation Test-Revised. Religiosity was assessed at baseline using a 29-item scale composed of religious importance, individual religious practices, intrinsic religiosity, and daily spiritual experiences. Mixed effects growth curve models were used to compare the effects of treatment group on trajectory of change in optimism. In the intention-to-treat analysis, both RCBT and SCBT increased optimism over time, although there was no significant difference between treatment groups (B = -0.75, SE = 0.57, t = -1.33, P = .185). Analyses in the highly religious and in the per protocol analysis indicated similar results. Higher baseline religiosity predicted an increase in optimism over time (B = 0.07, SE = 0.02, t = 4.12, P < .0001), and higher baseline optimism predicted a faster decline in depressive symptoms over time (B = -0.61, SE = 0.10, t = -6.30, P < .0001), both independent of treatment group. RCBT and SCBT are equally effective in increasing optimism in persons with MDD and chronic medical illness. While baseline religiosity does not moderate this effect, religiosity predicts increases in optimism over time independent of treatment group. © 2015 Wiley Periodicals, Inc.

On the differentiation of N2 components in an appetitive choice task: evidence for the revised Reinforcement Sensitivity Theory.

PubMed

Leue, Anja; Chavanon, Mira-Lynn; Wacker, Jan; Stemmler, Gerhard

2009-11-01

Task- and personality-related modulations of the N2 were probed within the framework of the revised Reinforcement Sensitivity Theory (RST). Using an appetitive choice task, we investigated 58 students with extreme scores on the behavioral inhibition system and behavioral approach system (BIS/BAS) scales. The baseline-to-peak N2 amplitude was sensitive to the strength of decision conflict and demonstrated RST-related personality differences. In addition to the baseline N2 amplitude, temporal PCA results suggested two N2 components accounting for a laterality effect and capturing different N2 patterns for BIS/BAS groups with increasing conflict level. Evidence for RST-related personality differences was obtained for baseline-to-peak N2 and tPCA components in the present task. The results support the RST prediction that BAS sensitivity modulates conflict processing and confirm the cognitive-motivational conflict concept of RST.

Estimated cardiovascular relative risk reduction from fixed-dose combination pill (polypill) treatment in a wide range of patients with a moderate risk of cardiovascular disease.

PubMed

Lafeber, Melvin; Webster, Ruth; Visseren, Frank Lj; Bots, Michiel L; Grobbee, Diederick E; Spiering, W; Rodgers, Anthony

2016-08-01

Recent data indicate that fixed-dose combination (FDC) pills, polypills, can produce sizeable risk factor reductions. There are very few published data on the consistency of the effects of a polypill in different patient populations. It is unclear for example whether the effects of the polypill are mainly driven by the individuals with high individual risk factor levels. The aim of the present study is to examine whether baseline risk factor levels modify the effect of polypill treatment on low-density lipoprotein (LDL)-cholesterol, blood pressure (BP), calculated cardiovascular relative risk reduction and adverse events. This paper describes a post-hoc analysis of a randomised, placebo-controlled trial of a polypill (containing aspirin 75 mg, simvastatin 20 mg, lisinopril 10 mg and hydrochlorothiazide 12.5 mg) in 378 individuals without an indication for any component of the polypill, but who had an estimated five-year risk for cardiovascular disease ≥7.5%. The outcomes considered were effect modification by baseline risk factor levels on change in LDL-cholesterol, systolic BP, calculated cardiovascular relative risk reduction and adverse events. The mean LDL-cholesterol in the polypill group was 0.9 mmol/l (95% confidence interval (CI): 0.8-1.0) lower compared with the placebo group during follow-up. Those with a baseline LDL-cholesterol >3.6 mmol/l achieved a greater absolute LDL-cholesterol reduction with the polypill compared with placebo, than patients with an LDL-cholesterol ≤3.6 mmol/l (-1.1 versus -0.6 mmol/l, respectively). The mean systolic BP was 10 mm Hg (95% CI: 8-12) lower in the polypill group. In participants with a baseline systolic BP >135 mm Hg the polypill resulted in a greater absolute systolic BP reduction with the polypill compared with placebo, than participants with a systolic BP ≤ 135 mm Hg (-12 versus -7 mm Hg, respectively). Calculated from individual risk factor reductions, the mean cardiovascular relative risk reduction was 48% (95% CI: 43-52) in the polypill group. Both baseline LDL-cholesterol and estimated cardiovascular risk were significant modifiers of the estimated cardiovascular relative risk reduction caused by the polypill. Adverse events did not appear to be related to baseline risk factor levels or the estimated cardiovascular risk. This study demonstrated that the effect of a cardiovascular polypill on risk factor levels is modified by the level of these risk factors. Groups defined by baseline LDL-cholesterol or systolic BP had large differences in risk factor reductions but only moderate differences in estimated cardiovascular relative risk reduction, suggesting also that patients with mildly increased risk factor levels but an overall raised cardiovascular risk benefit from being treated with a polypill. © The European Society of Cardiology 2016.

Rural women, technology, and self-management of chronic illness.

PubMed

Weinert, Clarann; Cudney, Shirley; Hill, Wade G

2008-09-01

The objective of this study was to determine the differences in the psychosocial status of 3 groups of chronically ill rural women participating in a computer intervention. The 3 groups were: intense intervention, less-intense intervention, and control. At baseline and following the intervention, measures were taken for social support, self-esteem, empowerment, self-efficacy, depression, stress, and loneliness. ANCOVA results showed group differences for social support and self-efficacy among the overall group. The findings differed for a vulnerable subgroup, with significant between-group differences for social support and loneliness. It was concluded that a computer-delivered intervention can improve social support and self-efficacy and reduce loneliness in rural women, enhancing their ability to self-manage and adapt to chronic illness.

Red blood cell fatty acid analysis for determining compliance with omega3 supplements in dry eye disease trials.

PubMed

Gadaria-Rathod, Neha; Dentone, Peter G; Peskin, Ellen; Maguire, Maureen G; Moser, Ann; Asbell, Penny A

2013-11-01

To evaluate pill counts and red blood cell (RBC) membrane fatty acid profiles as measures of compliance with oral omega3 polyunsaturated fatty acids (ω3 PUFAs) and to compare the two techniques. Sixteen dry eye disease subjects were given oral ω3 PUFA or placebo for 3 months. Compliance was measured by pill counts and blood tests at baseline and 3 months. The Wilcoxon signed-rank tests and rank-sum tests were used to compare changes from baseline and the difference between the two groups; Spearman correlation coefficients were used to assess the relationship of pill counts to changes in blood FAs. Pill counts for the ω3 (n=7) and placebo (n=9) groups showed a mean consumption of 4.39 and 4.76 pills per day, respectively. In the ω3 group, the median change from baseline was +1.46% for eicosapentaenoic acid (EPA) (P=0.03), +1.49% for docosahexaenoic acid (DHA) (P=0.08), and -1.91% for arachidonic acids (AA) (P=0.02). In the placebo group, median changes in all measured FAs were small and not statistically significant. The difference in change in FA levels between the two groups was significantly greater for EPA (P=0.01) and AA (P=0.04). The correlations between pill counts and changes in EPA (r=0.36, P=0.43) and DHA (r=0.17, P=0.70) were not strong. RBC FA analysis can be used to measure compliance in the active group and also monitor the placebo group for nonstudy ω3 intake. Low correlation of pill counts with blood levels suggests that pill counts alone may be inaccurate and should be replaced or supplemented with objective measures.

Preventive effect of pretreatment with intravenous nicorandil on contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography (PRINCIPLE Study).

PubMed

Ko, Young-Guk; Lee, Byoung-Kwon; Kang, Woong Chol; Moon, Jae-Youn; Cho, Yun Hyeong; Choi, Seong Hun; Hong, Myeong-Ki; Jang, Yangsoo; Kim, Jong-Youn; Min, Pil-Ki; Kwon, Hyuck-Moon

2013-07-01

To investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy (CIN) in patients with renal dysfunction undergoing coronary angiography. This randomized controlled multicenter study enrolled a total of 166 patients (nicorandil n=81; control n=85) with an estimated glomerular filtration rate <60 mL/min. Nicorandil 12 mg dissolved in 100 mL of 0.9% saline was administered intravenously for 30 minutes just prior to coronary angiography in the nicorandil group. The same volume of only saline was given to the control group. The primary endpoint was the incidence of CIN, defined as >0.5 mg/dL increase or >25% rise in serum creatinine (SCr) concentration within 48 hours of contrast exposure compared to baseline. The final analysis included 149 patients (nicorandil n=73; control n=76). The baseline characteristics and the total volume of the used contrast (Iodixanol, 125.6±69.1 mL vs. 126.9±74.6 mL, p=0.916) were similar between the two groups. The incidence of CIN also did not differ between the nicorandil and control groups (6.8% vs. 6.6%, p=0.794). There was no difference between the two groups in the relative change in SCr from baseline to peak level within 48 hours after coronary angiography (-1.58±24.07% vs. 0.96±17.49%, p=0.464), although the nicorandil group showed less absolute change in SCr than the control group (-0.01±0.43 mg/mL vs. 0.02±0.31 mg/mL, p=0.005). Prophylactic intravenous infusion of nicorandil did not decrease the incidence of CIN in patients with renal dysfunction undergoing coronary angiography.

Improved guideline adherence to pharmacotherapy of chronic systolic heart failure in general practice--results from a cluster-randomized controlled trial of implementation of a clinical practice guideline.

PubMed

Peters-Klimm, Frank; Müller-Tasch, Thomas; Remppis, Andrew; Szecsenyi, Joachim; Schellberg, Dieter

2008-10-01

Clinical practice guidelines (CPG) reflect the evidence of effective pharmacotherapy of chronic (systolic) heart failure (CHF) which needs to be implemented. This study aimed to evaluate the effect of a new, multifaceted intervention (educational train-the-trainer course plus pharmacotherapy feedback = TTT) compared with standard education on guideline adherence (GA) in general practice. Thirty-seven participating general practitioners (GPs) were randomized (18 vs. 19) and included 168 patients with ascertained symptomatic CHF [New York Heart Association (NYHA) II-IV]. Groups received CPG, the TTT intervention consisted of four interactive educational meetings and a pharmacotherapy feedback, while the control group received a usual lecture (Standard). Outcome measure was GA assessed by prescription rates and target dosing of angiotensin converting enzyme (ACE) inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers (BB) and aldosterone antagonists (AA) at baseline and 7-month follow-up. Group comparisons at follow-up were adjusted to GA, sex, age and NYHA stage at baseline. Prescription rates at baseline (n = 168) were high (ACE-I/ARB 90, BB 79 and AA 29%) in both groups. At follow up (n = 146), TTT improved compared with Standard regarding AA (43% vs. 23%, P = 0.04) and the rates of reached target doses of ACE-I/ARB (28% vs. 15%, P = 0.04). TTT group achieved significantly higher mean percentages of daily target dose (52% vs. 42%, mean difference 10.3%, 95% CI 0.84-19.8, P = 0.03). Despite of pre-existing high GA in both groups and an active control group, the multifaceted intervention was effective in quality of care measured by GA. Further research is needed on the choice of interventions in different provider populations.

Effects of Yoga on Attention, Impulsivity, and Hyperactivity in Preschool-Aged Children with Attention-Deficit Hyperactivity Disorder Symptoms.

PubMed

Cohen, Samantha C L; Harvey, Danielle J; Shields, Rebecca H; Shields, Grant S; Rashedi, Roxanne N; Tancredi, Daniel J; Angkustsiri, Kathleen; Hansen, Robin L; Schweitzer, Julie B

2018-04-01

Behavioral therapies are first-line for preschoolers with attention-deficit hyperactivity disorder (ADHD). Studies support yoga for school-aged children with ADHD; this study evaluated yoga in preschoolers on parent- and teacher-rated attention/challenging behaviors, attentional control (Kinder Test of Attentional Performance [KiTAP]), and heart rate variability (HRV). This randomized waitlist-controlled trial tested a 6-week yoga intervention in preschoolers with ≥4 ADHD symptoms on the ADHD Rating Scale-IV Preschool Version. Group 1 (n = 12) practiced yoga first; Group 2 (n = 11) practiced yoga second. We collected data at 4 time points: baseline, T1 (6 weeks), T2 (12 weeks), and follow-up (3 months after T2). At baseline, there were no significant differences between groups. At T1, Group 1 had faster reaction times on the KiTAP go/no-go task (p = 0.01, 95% confidence interval [CI], -371.1 to -59.1, d = -1.7), fewer distractibility errors of omission (p = 0.009, 95% CI, -14.2 to -2.3, d = -1.5), and more commission errors (p = 0.02, 95% CI, 1.4-14.8, d = 1.3) than Group 2. Children in Group 1 with more severe symptoms at baseline showed improvement at T1 versus control on parent-rated Strengths and Difficulties Questionnaire hyperactivity inattention (β = -2.1, p = 0.04, 95% CI, -4.0 to -0.1) and inattention on the ADHD Rating Scale (β = -4.4, p = 0.02, 95% CI, -7.9 to -0.9). HRV measures did not differ between groups. Yoga was associated with modest improvements on an objective measure of attention (KiTAP) and selective improvements on parent ratings.

Six weeks of multi-station program on the knee proprioception and performance of futsal players.

PubMed

Pérez-Silvestre, Ángel; Albert-Lucena, Daniel; Gómez-Chiguano, Guido F; Plaza-Manzano, Gustavo; Pecos-Martín, Daniel; Gallego-Izquierdo, Tomás; Martín-Casas, Patricia; Romero-Franco, Natalia

2018-03-27

Proprioception and vertical jump are important parameters in the performance and prevention of injuries in futsal. However, very few studies have analyzed the role of multi-station exercises to improve these variables. The purpose of this study was to assess the effects of a six-week multi-station exercise program on knee joint position sense (JPS) and countermovement jump (CMJ) of futsal players. Thirty-four male futsal players randomly classified into experimental (n = 17) or control group (n = 17). The experimental group included a multi-station exercise protocol to their training routines (2 times/week - 6 weeks); the control group continued their training routines. All the players completed similar training routines outside of the multi-station exercises. Before (baseline), just after the intervention (Post6Wk) and four weeks later (Post10Wk), CMJ and knee JPS (absolute, relative and variable angular error: AAE, RAE and VAE, respectively) were evaluated. ANOVA showed that the experimental group significantly decreased VAE at Post10Wk compared to baseline, suggestive of greater proprioceptive precision, while the control group significantly increased AAE, RAE and VAE at Post10Wk compared to baseline. The experimental group exhibited lower and thus, better AAE and VAE than the control group at Post10Wk, although no significant differences were found at Post6Wk. No significant differences was found in the CMJ. A six weeks of multi-station program may help improve proprioceptive precision of futsal players, even one month after finishing the 6-wk multi-station training program. However, this is not long enough to improve proprioceptive acuity and maximum vertical jump. Therefore, the meaningful of these results in term of performance are unclear.

Three-Year Change in the Wellbeing of Orphaned and Separated Children in Institutional and Family-Based Care Settings in Five Low- and Middle-Income Countries

PubMed Central

Whetten, Kathryn; Ostermann, Jan; Pence, Brian W.; Whetten, Rachel A.; Messer, Lynne C.; Ariely, Sumedha; O'Donnell, Karen; Wasonga, Augustine I.; Vann, Vanroth; Itemba, Dafrosa; Eticha, Misganaw; Madan, Ira; Thielman, Nathan M.

2014-01-01

Background With more than 2 million children living in group homes, or “institutions”, worldwide, the extent to which institution-based caregiving negatively affects development and wellbeing is a central question for international policymakers. Methods A two-stage random sampling methodology identified community representative samples of 1,357 institution-dwelling orphaned and separated children (OSC) and 1,480 family-dwelling OSC aged 6–12 from 5 low and middle income countries. Data were collected from children and their primary caregivers. Survey-analytic techniques and linear mixed effects models describe child wellbeing collected at baseline and at 36 months, including physical and emotional health, growth, cognitive development and memory, and the variation in outcomes between children, care settings, and study sites. Findings At 36-month follow-up, institution-dwelling OSC had statistically significantly higher height-for-age Z-scores and better caregiver-reported physical health; family-dwelling OSC had fewer caregiver-reported emotional difficulties. There were no statistically significant differences between the two groups on other measures. At both baseline and follow-up, the magnitude of the differences between the institution- and family-dwelling groups was small. Relatively little variation in outcomes was attributable to differences between sites (11–27% of total variation) or care settings within sites (8–14%), with most variation attributable to differences between children within settings (60–75%). The percent of variation in outcomes attributable to the care setting type, institution- versus family-based care, ranged from 0–4% at baseline, 0–3% at 36-month follow-up, and 0–4% for changes between baseline and 36 months. Interpretation These findings contradict the hypothesis that group home placement universally adversely affects child wellbeing. Without substantial improvements in and support for family settings, the removal of institutions, broadly defined, would not significantly improve child wellbeing and could worsen outcomes of children who are moved from a setting where they are doing relatively well to a more deprived setting. PMID:25162410

77 FR 3288 - International Mail Contract

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... commitment, term, assignment, number of rate groups, and solicitation of reseller's customers. Id. at 4-6. The Postal Service states that the differences, which include price variations based on updated... functionally equivalent to the baseline GREP contract. It states that the differences do not affect the...

Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study – a randomized controlled trial

PubMed Central

Oliveras, Anna; Armario, Pedro; Clarà, Albert; Sans-Atxer, Laia; Vázquez, Susana; Pascual, Julio; De la Sierra, Alejandro

2016-01-01

Objective: Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension. Methods: A total of 24 patients with office SBP at least 150 mmHg and 24-h SBP at least 140 mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values. Results: Spironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were −17.9 mmHg (95%CI −30.9 to −4.9); P = 0.010 and −6.6 mmHg (95%CI −12.9 to −0.3); P = 0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were −12.1 mmHg (95%CI −29.1 to 5.1); P = 0.158 and of −5.3 mmHg (95%CI −16.3 to 5.8); P = 0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was −10.7 ml/min per 1.73 m2 (95%CI −20.1 to −1.4); P = 0.027. Conclusion: We conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated’ in all patients with resistant hypertension before considering RDN. PMID:27327441

Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study - a randomized controlled trial.

PubMed

Oliveras, Anna; Armario, Pedro; Clarà, Albert; Sans-Atxer, Laia; Vázquez, Susana; Pascual, Julio; De la Sierra, Alejandro

2016-09-01

Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension. A total of 24 patients with office SBP at least 150 mmHg and 24-h SBP at least 140 mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values. Spironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were -17.9 mmHg (95%CI -30.9 to -4.9); P = 0.010 and -6.6 mmHg (95%CI -12.9 to -0.3); P = 0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were -12.1 mmHg (95%CI -29.1 to 5.1); P = 0.158 and of -5.3 mmHg (95%CI -16.3 to 5.8); P = 0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was -10.7 ml/min per 1.73 m (95%CI -20.1 to -1.4); P = 0.027. We conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated' in all patients with resistant hypertension before considering RDN.

Influence of Baseline Psychological Health on Muscle Pain During Atorvastatin Treatment.

PubMed

Zaleski, Amanda L; Taylor, Beth A; Pescatello, Linda S; Dornelas, Ellen A; White, Charles Michael; Thompson, Paul D

3-hydroxy-3-methylglutaryl coenzyme A reductase reductase inhibitors (statins) are generally well tolerated, with statin-associated muscle symptoms (SAMS) the most common side effect (~10%) seen in statin users. However, studies and clinical observations indicate that many of the self-reported SAMS appear to be nonspecific (ie, potentially not attributable to statins). Mental health and well-being influence self-perception of pain, so we sought to assess the effect of baseline well-being and depression on the development of muscle pain with 6 months of atorvastatin 80 mg/d (ATORVA) or placebo in healthy, statin-naive adults. The Psychological General Well-being Index (n = 83) and Beck Depression Inventory (n = 55) questionnaires were administered at baseline in participants (aged 59.5 ± 1.2 years) from the effect of Statins on Skeletal Muscle Function and Performance (STOMP) trial (NCT00609063). Muscle pain (Short-Form McGill Pain Questionnaire [SF-MPQ]), pain that interferes with daily life (Brief Pain Inventory [BPI]), and pain severity (BPI) were then measured before, throughout, and after treatment. At baseline, there were no differences in well-being (Psychological General Well-being Index), depression (Beck Depression Inventory), or pain measures (SF-MPQ and BPI) (P values ≥ .05) between the placebo and ATORVA groups. Baseline well-being correlated negatively with baseline BPI pain severity (r = -0.290, P = .008). Baseline depression correlated with baseline pain (SF-MPQ; r = 0.314, P = .020). Baseline well-being and depression did not predict the change in pain severity or interference after 6 months among the total sample or between groups (P values ≥ .05). Baseline well-being and depression were not significant predictors of pain after 6 months of ATORVA (P values ≥ .05). Thus, they do not appear to increase the risk of SAMS in otherwise healthy adults.

Effect of monophasic pulsed current on heel pain and functional activities caused by plantar fasciitis.

PubMed

Alotaibi, Abdullah K; Petrofsky, Jerrold S; Daher, Noha S; Lohman, Everett; Laymon, Michael; Syed, Hasan M

2015-03-20

Plantar fasciitis (PF) is a soft tissue disorder considered to be one of the most common causes of inferior heel pain. The aim of this study was to investigate the effect of monophasic pulsed current (MPC) and MPC coupled with plantar fascia-specific stretching exercises (SE) on the treatment of PF. Forty-four participants (22 women and 22 men, with a mean age of 49 years) diagnosed with PF were randomly assigned to receive MPC (n=22) or MPC coupled with plantar fascia-specific SE (n=22). Prior to and after 4 weeks of treatment, participants underwent baseline evaluation; heel pain was evaluated using a visual analogue scale (VAS), heel tenderness threshold was quantified using a handheld pressure algometer (PA), and functional activities level was assessed using the Activities of Daily Living subscale of the Foot and Ankle Ability Measure (ADL/FAAM). Heel pain scores showed a significant reduction in both groups compared to baseline VAS scores (P<0.001). Heel tenderness improved significantly in both groups compared with baseline PA scores (P<0.001). Functional activity level improved significantly in both groups compared with baseline (ADL/FAAM) scores (P<0.001). However, no significant differences existed between the 2 treatment groups in all post-intervention outcome measures. This trial showed that MPC is useful in treating inferior heel symptoms caused by PF.

Effect of Monophasic Pulsed Current on Heel Pain and Functional Activities caused by Plantar Fasciitis

PubMed Central

Alotaibi, Abdullah K.; Petrofsky, Jerrold S.; Daher, Noha S.; Lohman, Everett; Laymon, Michael; Syed, Hasan M.

2015-01-01

Background Plantar fasciitis (PF) is a soft tissue disorder considered to be one of the most common causes of inferior heel pain. The aim of this study was to investigate the effect of monophasic pulsed current (MPC) and MPC coupled with plantar fascia-specific stretching exercises (SE) on the treatment of PF. Material/Methods Forty-four participants (22 women and 22 men, with a mean age of 49 years) diagnosed with PF were randomly assigned to receive MPC (n=22) or MPC coupled with plantar fascia-specific SE (n=22). Prior to and after 4 weeks of treatment, participants underwent baseline evaluation; heel pain was evaluated using a visual analogue scale (VAS), heel tenderness threshold was quantified using a handheld pressure algometer (PA), and functional activities level was assessed using the Activities of Daily Living subscale of the Foot and Ankle Ability Measure (ADL/FAAM). Results Heel pain scores showed a significant reduction in both groups compared to baseline VAS scores (P<0.001). Heel tenderness improved significantly in both groups compared with baseline PA scores (P<0.001). Functional activity level improved significantly in both groups compared with baseline (ADL/FAAM) scores (P<0.001). However, no significant differences existed between the 2 treatment groups in all post-intervention outcome measures. Conclusions This trial showed that MPC is useful in treating inferior heel symptoms caused by PF. PMID:25791231

Effects of vitamin D supplementation on strength, physical function, and health perception in older, community-dwelling men.

PubMed

Kenny, Anne M; Biskup, Bradley; Robbins, Bertha; Marcella, Glenn; Burleson, Joseph A

2003-12-01

To study the effects of vitamin D supplementation in healthier populations of men. : Randomized, controlled trial. General clinical research center. Sixty-five healthy, community-dwelling men (mean age+/-standard deviation=76+/-4, range 65-87). Cholecalciferol (1,000 IU/d) or placebo supplementation for 6 months; all received 500 mg supplemental calcium. Upper and lower extremity muscle strength and power, physical performance and activity, health perception, calcium and vitamin D intake, and biochemical assessment, including 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), and ionized calcium levels. The levels of 25OHD increased and PTH decreased in the cholecalciferol group, whereas there were no significant changes in the control group (P<.001). Baseline 25OHD levels correlated with baseline single-leg stance time and physical activity score. Baseline PTH levels correlated with baseline 8-foot walk time and physical activity score. No significant difference in strength, power, physical performance, or health perception was found between groups. The 25OHD or PTH levels correlated with physical activity and physical performance in older, community-dwelling men with normal 25OHD status. Vitamin D supplementation increased 25OHD levels and decreased PTH levels but did not increase muscle strength or improve physical performance or health perception in this group of healthy, older men. Further investigations of the effects of vitamin D supplementation should focus on individuals with low levels of vitamin D.

Effects of tailoring health messages on physical activity.

PubMed

Smeets, Tamara; Brug, J; de Vries, H

2008-06-01

Computer-tailored printed education can be a promising way of promoting physical activity. The present study tested whether computer-tailored feedback on physical activity is effective and whether there are differences between respondents with low and high motivation to change. Respondents (n = 487) were randomly assigned to a tailored intervention group or a no information control group. Physical activity and determinants were measured at baseline and after 3 months. At post-test, the motivated respondents in the control group were more likely not to meet the recommendation for physical activity than to meet it, and motivated respondents in the experimental group were more likely to engage in transport-related activities and showed more improvement over time for the total activity score than respondents in the control group (beta = 0.24, P = 0.02). Both groups improved their behaviour over time. No group differences in physical activity were found for the unmotivated respondents. The results showed that the effects of the tailored feedback were restricted to respondents who had a positive motivation to change at baseline. Possible explanations could be that unmotivated respondents were unwilling to read and process the information because they felt 'no need to change'. Alternatively, one tailored feedback letter may not have been sufficient for this unmotivated group.

The effect of heart rate reduction by ivabradine on collateral function in patients with chronic stable coronary artery disease.

PubMed

Gloekler, Steffen; Traupe, Tobias; Stoller, Michael; Schild, Deborah; Steck, Hélène; Khattab, Ahmed; Vogel, Rolf; Seiler, Christian

2014-01-01

To evaluate the effect of heart rate reduction by ivabradine on coronary collateral function in patients with chronic stable coronary artery disease (CAD). This was a prospective randomised placebo-controlled monocentre trial in a university hospital setting. 46 patients with chronic stable CAD received placebo (n=23) or ivabradine (n=23) for the duration of 6 months. The main outcome measure was collateral flow index (CFI) as obtained during a 1 min coronary artery balloon occlusion at study inclusion (baseline) and at the 6-month follow-up examination. CFI is the ratio between simultaneously recorded mean coronary occlusive pressure divided by mean aortic pressure both subtracted by mean central venous pressure. During follow-up, heart rate changed by +0.2±7.8 beats/min in the placebo group, and by -8.1±11.6 beats/min in the ivabradine group (p=0.0089). In the placebo group, CFI decreased from 0.140±0.097 at baseline to 0.109±0.067 at follow-up (p=0.12); it increased from 0.107±0.077 at baseline to 0.152±0.090 at follow-up in the ivabradine group (p=0.0461). The difference in CFI between the 6-month follow-up and baseline examination amounted to -0.031±0.090 in the placebo group and to +0.040±0.094 in the ivabradine group (p=0.0113). Heart rate reduction by ivabradine appears to have a positive effect on coronary collateral function in patients with chronic stable CAD. NCT01039389.

Trunk postural adjustments: Medium-term reliability and correlation with changes of clinical outcomes following an 8-week lumbar stabilization exercise program.

PubMed

Boucher, Jean-Alexandre; Preuss, Richard; Henry, Sharon M; Nugent, Marilee; Larivière, Christian

2018-04-22

Low back pain (LBP) has been previously associated with delayed anticipatory postural adjustments (APAs) determined by trunk muscle activation. Lumbar stabilization exercise programs (LSEP) for patients with LBP may restore the trunk neuromuscular control of the lumbar spine, and normalize APAs. This exploratory study aimed at testing the reliability of EMG and kinematics-based postural adjustment measures over an 8-week interval, assessing their sensitivity to LBP status and treatment and examining their relationship with clinical outcomes. Muscle activation of 10 trunk muscles, using surface electromyography (EMG), and lumbar angular kinematics were recorded during a rapid arm-raising/lowering task. Patients with LBP were tested before and after an 8-week LSEP. Healthy controls receiving no treatment were assessed over the same interval to determine the reliability of the measures and act as a control group at baseline. Muscle activation onsets and reactive range of motion, range of velocities and accelerations were assessed for between group differences at baseline and pre- to post-treatment effects within patients with LBP using t-tests. Correlations between these dependent variables and the change of clinical outcomes (pain, disability) over treatment were also explored. Kinematic-based measures showed comparable reliability to EMG-based measures. Between-group differences were found in lumbar lateral flexion ROM at baseline (patients < controls). In the patients with LBP, lateral flexion velocity and acceleration significantly increased following the LSEP. Correlational analyses revealed that lumbar angular kinematics were more sensitive to changes in pain intensity following the LSEP compared to EMG measures. These findings are interpreted in from the perspective of guarding behaviors and lumbar stability hypotheses. Future clinical trials are needed to target patients with and without delayed APAs at baseline and to explore the sensitivity of different outcome measures related to APAs. Different tasks more challenging to postural stability may need to be explored to more effectively reveal APA dysfunction. Copyright © 2018. Published by Elsevier Ltd.

Sembragiline in Moderate Alzheimer’s Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD)

PubMed Central

Nave, Stephane; Doody, Rachelle S.; Boada, Mercè; Grimmer, Timo; Savola, Juha-Matti; Delmar, Paul; Pauly-Evers, Meike; Nikolcheva, Tania; Czech, Christian; Borroni, Edilio; Ricci, Benedicte; Dukart, Juergen; Mannino, Marie; Carey, Tracie; Moran, Emma; Gilaberte, Inma; Muelhardt, Nicoletta Milani; Gerlach, Irene; Santarelli, Luca; Ostrowitzki, Susanne; Fontoura, Paulo

2017-01-01

Background: Sembragiline is a potent, selective, long-acting, and reversible MAO-B inhibitor developed as a potential treatment for Alzheimer’s disease (AD). Objective: To evaluate the safety, tolerability, and efficacy of sembragiline in patients with moderate AD. Methods: In this Phase II study (NCT01677754), 542 patients with moderate dementia (MMSE 13–20) on background acetylcholinesterase inhibitors with/without memantine were randomized (1:1:1) to sembragiline 1 mg, 5 mg, or placebo once daily orally for 52 weeks. Results: No differences between treated groups and placebo in adverse events or in study completion. The primary endpoint, change from baseline in ADAS-Cog11, was not met. At Week 52, the difference between sembragiline and placebo in ADAS-Cog11 change from baseline was – 0.15 (p = 0.865) and 0.90 (p = 0.312) for 1 and 5 mg groups, respectively. Relative to placebo at Week 52 (but not at prior assessment times), the 1 mg and 5 mg sembragiline groups showed differences in ADCS-ADL of 2.64 (p = 0.051) and 1.89 (p = 0.160), respectively. A treatment effect in neuropsychiatric symptoms (as assessed by the difference between sembragiline and placebo on BEHAVE-AD-FW) was also seen at Week 52 only: – 2.80 (p = 0.014; 1 mg) and – 2.64 (p = 0.019; 5 mg), respectively. A post hoc subgroup analysis revealed greater treatment effects on behavior and functioning in patients with more severe baseline behavioral symptoms (above the median). Conclusions: This study showed that sembragiline was well-tolerated in patients with moderate AD. The study missed its primary and secondary endpoints. Post hoc analyses suggested potential effect on neuropsychiatric symptoms and functioning in more behaviorally impaired study population at baseline. PMID:28550255

First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT.

PubMed

Hofmann, Reiner; Völler, Heinz; Nagels, Klaus; Bindl, Dominik; Vettorazzi, Eik; Dittmar, Ronny; Wohlgemuth, Walter; Neumann, Till; Störk, Stefan; Bruder, Oliver; Wegscheider, Karl; Nagel, Eckhard; Fleck, Eckart

2015-08-11

Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva®). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System. ClinicalTrials.gov NCT02293252 ; date of registration: 10 November 2014.

The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial

PubMed Central

2016-01-01

Background Depressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are common in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Internet-based cognitive behavioral therapy (ICBT), as guided self-help CBT programs, has shown good effects in the treatment of depression. Until now, ICBT has not been evaluated in patients with HF with depressive symptoms. Objective The aims of this study were to (1) evaluate the effect of a 9-week guided ICBT program on depressive symptoms in patients with HF; (2) investigate the effect of the ICBT program on cardiac anxiety and QoL; and (3) assess factors associated with the change in depressive symptoms. Methods Fifty participants were randomized into 2 treatment arms: ICBT or a Web-based moderated discussion forum (DF). The Patient Health Questionnaire-9 was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire was used to measure QoL. Data were collected at baseline and at follow-up at the end of the 9-week intervention. Intention-to-treat analysis was used, and missing data were imputed by the Expectation-Maximization method. Between-group differences were determined by analysis of covariance with control for baseline score and regression to the mean. Results No significant difference in depressive symptoms between the ICBT and the DF group at the follow-up was found, [F(1,47)=1.63, P=.21] and Cohen´s d=0.26. Secondary within-group analysis of depressive symptoms showed that such symptoms decreased significantly in the ICBT group from baseline to the follow-up (baseline M=10.8, standard deviation [SD]=5.7 vs follow-up M=8.6, SD=4.6, t(24)=2.6, P=.02, Cohen´s d=0.43), whereas in the DF group, there was no significant change (baseline M=10.6, SD=5.0, vs follow-up M=9.8, SD=4.3, t(24)=0.93, P=.36. Cohen´s d=0.18). With regard to CAQ and QoL no significant differences were found between the groups (CAQ [d(1,47)=0.5, P=.48] and QoL [F(1,47)=2.87, P=.09]). In the ICBT group in the CAQ subscale of fear, a significant within-group decrease was shown (baseline M=1.55 vs follow-up M=1.35, P=.04). In the ICBT group, the number of logins to the Web portal correlated significantly with improvement in depressive symptoms (P=.02), whereas higher age (P=.01) and male sex (P=.048) were associated with less change in depressive symptoms. This study is underpowered because of difficulties in the recruitment of patients. Conclusions Guided ICBT adapted for persons with HF and depressive symptoms was not statistically superior to participation in a Web-based DF. However, within the ICBT group, a statically significant improvement of depressive symptoms was detected. ClinicalTrial Clinicaltrials.gov NCT01681771; https://clinicaltrials.gov/ct2/show/NCT01681771 (Archived by WebCite at http://www.webcitation.org/6ikzbcuLN) PMID:27489077

Investigating the effectiveness of postural muscle electrostimulation and static posturography feedback exercises in elders with balance disorder.

PubMed

Alptekin, Kerem; Karan, Ayse; Dıracoglu, Demirhan; Yildiz, Aysel; Baskent, Akin; Eskiyurt, Nurten

2016-01-01

Deterioration associated with aging in the erect posture and balance to change the location of the center increased the rate of fall in older age is one of the reasons. Loss of muscle strength is one of the major factors affecting the posture. In this prospective, randomized and controlled study, it was aimed to investigate the effectiveness of strengthening postural muscles through electrostimulation or by applying biofeedback exercises with static posturography in patients aged 60 years and over with balance disorder. Patients aged between 60-80 years, who applied to Istanbul Faculty of Medicine Physical Medicine and Rehabilitation Department outpatient clinic and had been diagnosed with balance disorder using the Timed Up and Go (TUG) test, were included. 250 patients were screened, from them 67 patients were enrolled and 57 of them completed the study. Patients were randomized to three groups. The patients in Tetrax® group (TG) group (n:18) participated in a 15-minute exercise with Tetrax® which consisted of 15 minutes exercise session 3 times weekly for 4 weeks. The patients in EG group (n:19) received an electrostimulation program of postural muscles of 40 minutes per session 3 times weekly for 4 weeks. Patients in the control group (n:20) did 6-week balance exercises which were performed by other groups as well. 48 out of 57 patients attended the 6th-month control. As determinants of balance status Timed Up and Go Test (TUG), Berg Balance Scale (BBS) and Fall Index measured by Tetrax® were calculated at baseline, 1-month and 6-month follw up assesments. The patient's quality of life was assesed by Turkish version of World Health Organisation Quality of Life Questionnaire in Older Adults (WHOQOL-OLD.TR) at baseline and 6-month follow up assesments. TUG values in both EG and TG decreased significantly between baseline assesment and 1-month (mean differences for TG: -4,00 ± 1,309 and EG -2,588 ± 1,839 p= 0,002 for the each of groups) and baseline assesment and 6-month (mean differences for TG: -2,933± 1,223 and EG -2,058 ± 1,477 p= 0,003 for the each of groups). A significant increase was determined in BBS values between baseline and 1-month (mean differences for TG: 4.000 ± 2,360 and EG: 3,529 ± 2,672 p= 0,031 for the each of groups). Fall Index (FI) measured by Tetrax® decreased between baseline assesment and 1-month (p= 0,185), and 6-month (p= 0,086) respectively, also between 1-month and 6-month follow up assesments (p= 0,627), but all of them were not significant changes. In all three groups the quality of life (p= 0,951) improved. Exercises conducted with Tetrax® were more effective than electrostimulation of postural muscles in increasing TUG values and decreasing BBS values. Even though applying electrostimulation to postural muscles affected patients positively compared to pre-treatment, exercises performed with Tetrax® were more effective than the electrostimulation protocol to postural muscles in reducing balance disorder and this well-being continued even in the 6th month.

The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial.

PubMed

Lundgren, Johan Gustav; Dahlström, Örjan; Andersson, Gerhard; Jaarsma, Tiny; Kärner Köhler, Anita; Johansson, Peter

2016-08-03

Depressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are common in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Internet-based cognitive behavioral therapy (ICBT), as guided self-help CBT programs, has shown good effects in the treatment of depression. Until now, ICBT has not been evaluated in patients with HF with depressive symptoms. The aims of this study were to (1) evaluate the effect of a 9-week guided ICBT program on depressive symptoms in patients with HF; (2) investigate the effect of the ICBT program on cardiac anxiety and QoL; and (3) assess factors associated with the change in depressive symptoms. Fifty participants were randomized into 2 treatment arms: ICBT or a Web-based moderated discussion forum (DF). The Patient Health Questionnaire-9 was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire was used to measure QoL. Data were collected at baseline and at follow-up at the end of the 9-week intervention. Intention-to-treat analysis was used, and missing data were imputed by the Expectation-Maximization method. Between-group differences were determined by analysis of covariance with control for baseline score and regression to the mean. No significant difference in depressive symptoms between the ICBT and the DF group at the follow-up was found, [F(1,47)=1.63, P=.21] and Cohen´s d=0.26. Secondary within-group analysis of depressive symptoms showed that such symptoms decreased significantly in the ICBT group from baseline to the follow-up (baseline M=10.8, standard deviation [SD]=5.7 vs follow-up M=8.6, SD=4.6, t(24)=2.6, P=.02, Cohen´s d=0.43), whereas in the DF group, there was no significant change (baseline M=10.6, SD=5.0, vs follow-up M=9.8, SD=4.3, t(24)=0.93, P=.36. Cohen´s d=0.18). With regard to CAQ and QoL no significant differences were found between the groups (CAQ [d(1,47)=0.5, P=.48] and QoL [F(1,47)=2.87, P=.09]). In the ICBT group in the CAQ subscale of fear, a significant within-group decrease was shown (baseline M=1.55 vs follow-up M=1.35, P=.04). In the ICBT group, the number of logins to the Web portal correlated significantly with improvement in depressive symptoms (P=.02), whereas higher age (P=.01) and male sex (P=.048) were associated with less change in depressive symptoms. This study is underpowered because of difficulties in the recruitment of patients. Guided ICBT adapted for persons with HF and depressive symptoms was not statistically superior to participation in a Web-based DF. However, within the ICBT group, a statically significant improvement of depressive symptoms was detected. Clinicaltrials.gov NCT01681771; https://clinicaltrials.gov/ct2/show/NCT01681771 (Archived by WebCite at http://www.webcitation.org/6ikzbcuLN).

Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study.

PubMed

Palomba, S; Giallauria, F; Falbo, A; Russo, T; Oppedisano, R; Tolino, A; Colao, A; Vigorito, C; Zullo, F; Orio, F

2008-03-01

Lifestyle modifications are successfully employed to treat obese and overweight women with polycystic ovary syndrome (PCOS). The aims of the current pilot study were (i) to compare the efficacy on reproductive functions of a structured exercise training (SET) programme with a diet programme in obese PCOS patients and (ii) to study their clinical, hormonal and metabolic effects to elucidate potentially different mechanisms of action. Forty obese PCOS patients with anovulatory infertility underwent a SET programme (SET group, n = 20) and a hypocaloric hyperproteic diet (diet group, n = 20). Clinical, hormonal and metabolic data were assessed at baseline, and at 12- and 24-week follow-ups. Primary endpoint was cumulative pregnancy rate. The two groups had similar demographic, anthropometric and biochemical parameters. After intervention, a significant improvement in menstrual cycles and fertility was noted in both groups, with no differences between groups. The frequency of menses and the ovulation rate were significantly (P < 0.05) higher in the SET group than in diet group but the increased cumulative pregnancy rate was not significant. Body weight, body mass index, waist circumference, insulin resistance indexes and serum levels of sex hormone-binding globulin, androstenedione and dehydroepiandrosterone sulphate changed significantly (P < 0.05) from baseline and were significantly different (P < 0.05) between the two groups. Both SET and diet interventions improve fertility in obese PCOS patients with anovulatory infertility. We hypothesize that in both interventions an improvement in insulin sensitivity is the pivotal factor involved in the restoration of ovarian function but potentially acting through different mechanisms.

Effect of a multi-level education intervention model on knowledge and attitudes of accidental injuries in rural children in Zunyi, Southwest China.

PubMed

Cao, Bo-Ling; Shi, Xiu-Quan; Qi, Yong-Hong; Hui, Ya; Yang, Hua-Jun; Shi, Shang-Peng; Luo, Li-Rong; Zhang, Hong; Wang, Xin; Yang, Ying-Ping

2015-04-08

To explore the effect of a school-family-individual (SFI) multi-level education intervention model on knowledge and attitudes about accidental injuries among school-aged children to improve injury prevention strategies and reduce the incidence of pediatric injuries. The random sample of rural school-aged children were recruited by using a multistage, stratified, cluster sampling method in Zunyi, Southwest China from 2012 to 2014, and 2342 children were randomly divided into intervention and control groups. Then children answered a baseline survey to collect knowledge and attitude scores (KAS) of accidental injuries. In the intervention group, children, their parents/guardians and the school received a SFI multi-level education intervention, which included a children's injury-prevention poster at schools, an open letter about security instruction for parents/guardians and multiple-media health education (Microsoft PowerPoint lectures, videos, handbooks, etc.) to children. Children in the control group were given only handbook education. After 16 months, children answered a follow-up survey to collect data on accidental injury types and accidental injury-related KAS for comparing the intervention and control groups and baseline and follow-up data. The distribution of gender was not significantly different while age was different between the baseline and follow-up survey. At baseline, the mean KAS was lower for the intervention than control group (15.37 ± 3.40 and 18.35 ± 5.01; p < 0.001). At follow-up, the mean KAS was higher for the intervention than control group (21.16 ± 3.05 and 20.02 ± 3.40; p < 0.001). The increase in KAS in the intervention and control groups was significant (p < 0.001; KAS: 5.79 vs. 1.67) and suggested that children's injury-related KAS improved in the intervention group. Moreover, the KAS between the groups differed for most subtypes of incidental injuries (based on International Classification of Diseases 10, ICD-10) (p < 0.05). Before intervention, 350 children had reported their accident injury episodes, while after intervention 237 children had reported their accidental injury episodes in the follow-up survey. SFI multi-level education intervention could significantly increase KAS for accidental injuries, which should improve children's prevention-related knowledge and attitudes about such injuries. It should help children change their risk behaviors and reduce the incidence of accidental injuries. Our results highlight a new intervention model of injury prevention among school-aged children.

Comparison of the effectiveness of three different treatment methods for temporomandibular joint disc displacement without reduction.

PubMed

Tatli, U; Benlidayi, M E; Ekren, O; Salimov, F

2017-05-01

The aim of this study was to compare the effectiveness of three treatment methods for unilateral temporomandibular joint (TMJ) disc displacement without reduction (DDwoR). One hundred and twenty patients with unilateral TMJ DDwoR were assigned randomly to one of three treatment groups (40 patients in each): group 1 received arthrocentesis, group 2 received stabilization splint therapy following arthrocentesis, and group 3 received splint therapy only. The groups were compared in terms of pain (visual analogue scale), joint function (maximum mouth opening and laterotrusive movements), disability and psychological status (validated questionnaire), and success rates. These were recorded before treatment and during follow-up after treatment (1, 3, and 6 months). The between-group and within-group differences in the data were analyzed statistically. The baseline characteristics were similar in all groups (P>0.05). Significant improvements were noted in all parameters compared to baseline values in all groups (all P<0.01). Groups 1 and 2 showed comparable outcomes that were superior to those of group 3. Arthrocentesis reduces pain and functional impairment more rapidly and effectively than splint therapy. Simultaneous splint application has no additional effect on the effectiveness of arthrocentesis for the treatment of unilateral DDwoR. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial

PubMed Central

2012-01-01

Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Conclusion Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. Trial registration National Medical Research Registration (NMRR) Number: NMRR-08-287-1442 Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370 PMID:23046818

The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial.

PubMed

Selvaraj, Francis Jude; Mohamed, Mafauzy; Omar, Khairani; Nanthan, Sudha; Kusiar, Zainab; Subramaniam, Selvaraj Y; Ali, Norsiah; Karanakaran, Kamalakaran; Ahmad, Fauziah; Low, Wilson H H

2012-10-10

To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were -30.09% and -27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. National Medical Research Registration (NMRR) Number: NMRR-08-287-1442Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370.

CHOROIDAL THICKNESS CHANGES IN PROLIFERATIVE DIABETIC RETINOPATHY TREATED WITH PANRETINAL PHOTOCOAGULATION VERSUS PANRETINAL PHOTOCOAGULATION WITH INTRAVITREAL BEVACIZUMAB.

PubMed

Roohipoor, Ramak; Sharifian, Elaheh; Ghassemi, Fariba; Riazi-Esfahani, Mohammad; Karkhaneh, Reza; Fard, Masoud Aghsaei; Zarei, Mohammad; Modjtahedi, Bobeck S; Moghimi, Sasan

2016-10-01

To compare choroidal thickness (CT) and retinal thickness (RT) between eyes with proliferative diabetic retinopathy treated with panretinal photocoagulation (PRP) or PRP with intravitreal bevacizumab (PRP + IVB). Thirty-three patients with proliferative diabetic retinopathy were randomized to have one eye treated with PRP and the other with PRP + IVB. Change in CT was compared with baseline using enhanced depth imaging-optical coherence tomography at baseline and Months 1, 3, 6, and 10 after treatment. Change in RT was similarly assessed using spectral domain optical coherence tomography. Changes in both CT and RT were assessed in all nine macular areas as defined by Early Treatment Diabetic Retinopathy Study subfields. The PRP + IVB group had a significant decrease in subfoveal CT at 3 and 10 months (323.9 ± 62 μm at baseline vs. 320.7 ± 64.8 μm at Month 3 [P = 0.024] and 304.7 ± 65.6 μm at Month 10 [P = 0.003]). Subfoveal CT significantly decreased at 10 months compared with baseline in the PRP group (320.8 ± 57.7 at baseline to 297 ± 66.3 μm at 10 months, P = 0.01). Subfoveal CT was not significantly different between the 2 groups at 10 months. The best-corrected visual acuity did not change after treatment in the two groups, and there was no correlation between BCVA and CT changes (r = 0.222, P = 0.37 in the PRP group and r = 0.387, P = 0.12 in the PRP + IVB group). Significant increases in RT were seen in the PRP + IVB group at 6 months and in the PRP group at Months 1, 3, 6, and 10. A correlation between changes in CT and RT was only seen in the PRP group at 10 months after treatment. Eyes with proliferative diabetic retinopathy treated with PRP + IVB and PRP both had significant reduction in CT at 10 months; however, the eyes that were also treated with IVB also underwent an earlier but transient reduction at 3 months. Patients treated with IVB underwent less increase in RT.

Efficacy of telbivudine in HBeAg-positive chronic hepatitis B patients with high baseline ALT levels

PubMed Central

Lv, Guo-Cai; Ma, Wen-Jiang; Ying, Lin-Jung; Jin, Xi; Zheng, Lin; Yang, Yi-Da

2010-01-01

AIM: To evaluate the efficacy and safety of telbivudine (LDT) in hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) patients who have high baseline alanine aminotransferase (ALT) levels between 10 and 20 times the upper limit of normal. METHODS: Forty HBeAg-positive CHB patients with high baseline ALT levels between 10 and 20 times the upper limit of normal were enrolled and received LDT monotherapy for 52 wk. Another forty patients with baseline ALT levels between 2 and 10 times the upper limit of normal were included as controls. We compared the virological, biochemical, serological and side effect profiles between the two groups at 52 wk. RESULTS: By week 52, the mean decrease in hepatitis B virus (HBV) DNA level compared with baseline was 7.03 log10 copies/mL in the high baseline ALT group and 6.17 log10 copies/mL in the control group, respectively (P < 0.05). The proportion of patients in whom serum HBV DNA levels were undetectable by polymerase chain reaction assay was 72.5% in the high baseline ALT group and 60% in the control group, respectively (P < 0.05). In addition, 45.0% of patients in the high baseline ALT group and 27.5% of controls became HBeAg-negative, and 37.5% of those in the high baseline group and 22.5% of controls, respectively, had HBeAg seroconversion (P < 0.05) at week 52. Moreover, in the high baseline group, 4 out of 40 patients (10%) became hepatitis B surface antigen (HBsAg)-negative and 3 (7.5%) of them seroconverted (became HBsAg-positive). Only 1 patient in the control group became HBsAg-negative, but had no seroconversion. The ALT normalization rate, viral breakthrough, genotypic resistance to LDT, and elevations in creatine kinase levels were similar in the two groups over the 52 wk. CONCLUSION: High baseline ALT level is a strong predictor for optimal results during LDT treatment. PMID:20731026

Exercise or Social Intervention for Nursing Home Residents with Dementia: A Pilot Randomized, Controlled Trial.

PubMed

de Souto Barreto, Philipe; Cesari, Matteo; Denormandie, Philippe; Armaingaud, Didier; Vellas, Bruno; Rolland, Yves

2017-09-01

To compare the effects of exercise with those of a structured nonphysical intervention on ability to perform activities of daily living (ADLs) and physical and cognitive function of persons with dementia (PWDs) living in nursing homes (NH). Cluster-randomized pilot-controlled trial. Seven French NHs. PWDs living in NHs. NHs were randomized to an exercise group (4 NHs, n = 47) or structured social activity group (3 NHs, n = 50) for a 24-week intervention performed twice per week for 60 minutes per session. The main endpoint was ADL performance (Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease Scale (ADCS-ADL-sev); range 0-54, higher is better); secondary endpoints were overall cognitive function (Mini-Mental State Examination (MMSE)) and performance-based tests of physical function (Short Physical Performance Battery (SPPB), usual gait speed). Ninety-one participants with at least one postbaseline ADL assessment were included in efficacy analysis. Groups differed at baseline in terms of sex, neuropsychiatric symptoms, and nutritional status. Multilevel analysis adjusted for baseline differences between groups found no significant difference between effects of exercise and social activity (group-by-time interaction), with adjusted mean differences at 6 months of 1.9 points for ADCS-ADL-sev and 0.55 points for MMSE favoring social activity and 0.6 points for SPPB and 0.05 m/s favoring exercise. Adverse events did not differ between groups, except that the social activity group had more falls than the exercise group. A larger, longer trial is required to determine whether exercise has greater health benefits than nonphysical interventions for institutionalized PWDs. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Relation Between Six-Minute Walk Test Performance and Outcomes After Transcatheter Aortic Valve Implantation (from the PARTNER Trial)

PubMed Central

Green, Philip; Cohen, David J.; Généreux, Philippe; McAndrew, Tom; Arnold, Suzanne V.; Alu, Maria; Beohar, Nirat; Rihal, Charanjit S.; Mack, Michael J.; Kapadia, Samir; Dvir, Danny; Maurer, Mathew S.; Williams, Mathew R.; Kodali, Susheel; Leon, Martin B.; Kirtane, Ajay J.

2013-01-01

Functional capacity as assessed by 6-minute walk test distance (6MWTD) has been shown to predict outcomes in selected cohorts with cardiovascular disease. To evaluate the association between 6MWTD and outcomes after transcatheter aortic valve implantation (TAVI) among participants in the Placement of AoRTic TraNscathetER valve (PARTNER) trial, TAVI recipients (n = 484) were stratified into 3 groups according to baseline 6MWTD: unable to walk (n = 218), slow walkers (n = 133), in whom 6MWTD was below the median (128.5 meters), and fast walkers (n = 133) with 6MWTD >128.5 meters. After TAVI, among fast walkers, follow-up 6MWTD decreased by 44 ± 148 meters at 12 months (p <0.02 compared with baseline). In contrast, among slow walkers, 6MWTD improved after TAVI by 58 ± 126 meters (p <0.001 compared with baseline). Similarly, among those unable to walk, 6MWTD distance increased by 66 ± 109 meters (p <0.001 compared with baseline). There were no differences in 30-day outcomes among 6MWTD groups. At 2 years, the rate of death from any cause was 42.5% in those unable to walk, 31.2% in slow walkers, and 28.8% in fast walkers (p = 0.02), driven primarily by differences in noncardiac death. In conclusion, among high-risk older adults undergoing TAVI, baseline 6MWTD does not predict procedural outcomes but does predict long-term mortality. Nonetheless, patients with poor baseline functional status exhibit the greatest improvement in 6MWTD. Additional work is required to identify those with poor functional status who stand to benefit the most from TAVI. PMID:23725996

Epstein-Barr and other herpesvirus infections in patients with early onset type 1 diabetes treated with daclizumab and mycophenolate mofetil.

PubMed

Loechelt, Brett J; Boulware, David; Green, Michael; Baden, Lindsey R; Gottlieb, Peter; Krause-Steinrauf, Heidi; Weinberg, Adriana

2013-01-01

We assessed the morbidity of herpesviruses in patients with type 1 diabetes mellitus (T1D) enrolled in immunosuppressive treatment studies. Epstein-Barr virus (EBV), cytomegalovirus (CMV), herpes simplex virus (HSV), and varicella zoster virus (VZV) infections were monitored in 126 participants of a randomized, double-blind, placebo-controlled study of daclizumab (DZB) and mycophenolate mofetil (MMF) including DZB(+)MMF(+), DZB(-)MMF(+), DZB(+)MMF(-), and DZB(-)MMF(-). During the 2-year follow-up, herpesviral infections were monitored clinically, by serology and blood DNA polymerase chain reaction. Among 57 baseline EBV-seronegative participants, 9 developed EBV primary infections, including 2 with infectious mononucleosis syndrome. There were no appreciable differences in the course of the primary EBV infections across treatment groups. Among 69 baseline EBV-seropositive participants, 22 had virologic reactivations, including 1 symptomatic DZB(-)MMF(+) subject. Compared with 7 DZB(-)MMF(-) EBV reactivators, the 9 DZB(+)MMF(+) reactivators tended to have more prolonged viremia (11.4 vs 4.4 months; P = .06) and higher cumulative viral burden (14.2 vs 12.5 log EBV copies/mL; P = .06). Four of 85 baseline CMV-seronegative subjects developed asymptomatic primary CMV infections. There were no CMV reactivations. Of 30 baseline HSV-seropositive subjects, 8 developed ≥1 episode of herpes labialis; 1 subject had a primary HSV infection; and 1 subject without baseline serology information had a new diagnosis of genital HSV. There were no significant differences in the incidence of HSV recurrences across treatment groups. Of 100 baseline VZV-seropositive subjects, 1 DZB(-)MMF(-) subject developed herpes zoster and 1 DZB(-)MMF(+) subject had Bell's palsy possibly related to VZV. The use of DZB alone or in combination with MMF was not associated with increased morbidity due to herpesviruses. NCT00100178.

Effect of supplemental vitamin D and calcium on serum sclerostin levels.

PubMed

Dawson-Hughes, Bess; Harris, Susan S; Ceglia, Lisa; Palermo, Nancy J

2014-04-01

Serum sclerostin levels have been reported to be inversely associated with serum 25OHD levels, but the effect of vitamin D and calcium supplementation on serum sclerostin levels is unknown. This study was carried out to determine whether vitamin D and calcium supplementation altered serum sclerostin levels in healthy older adults. We measured serum sclerostin levels at baseline and after 2 years in 279 men and women who participated in a placebo-controlled vitamin D (700 IU/day) and calcium (500 mg/day) intervention trial carried out in men and women aged ≥65 years. Serum sclerostin levels were measured using the MesoScale Discovery chemiluminescence assay. In the men, sclerostin levels increased over 2 years by 4.11±1.81 ng/l (13.1%) in the vitamin D plus calcium-supplemented group and decreased by 3.16±1.78 ng/l (10.9%) in the placebo group (P=0.005 for difference in change). Adjustments for the season of measurement, baseline physical activity levels, baseline serum sclerostin levels, and total body bone mineral content did not substantially alter the changes. In the women, there was no significant group difference in change in serum sclerostin levels either before or after the above-mentioned adjustments. In both the sexes, vitamin D and calcium supplementation significantly increased serum ionized calcium levels and decreased parathyroid hormone levels. Men and women appear to have different serum sclerostin responses to vitamin D and calcium supplementation. The reason for this difference remains to be determined.

Exploring methods for comparing the real-world effectiveness of treatments for osteoporosis: adjusted direct comparisons versus using patients as their own control.

PubMed

Karlsson, Linda; Mesterton, Johan; Tepie, Maurille Feudjo; Intorcia, Michele; Overbeek, Jetty; Ström, Oskar

2017-09-21

Using Swedish and Dutch registry data for women initiating bisphosphonates, we evaluated two methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for differences in patient baseline characteristics. Each method has advantages and disadvantages; both are potential complements to clinical trial analyses. We evaluated methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for both observed and unobserved confounding. Swedish and Dutch registry data for women initiating zoledronate or oral bisphosphonates (OBPs; alendronate/risedronate) were used; the primary outcome was fracture. In adjusted direct comparisons (ADCs), regression and matching techniques were used to account for baseline differences in known risk factors for fracture (e.g., age, previous fracture, comorbidities). In an own-control analysis (OCA), for each treatment, fracture incidence in the first 90 days following treatment initiation (the baseline risk period) was compared with fracture incidence in the 1-year period starting 91 days after treatment initiation (the treatment exposure period). In total, 1196 and 149 women initiating zoledronate and 14,764 and 25,058 initiating OBPs were eligible in the Swedish and Dutch registries, respectively. Owing to the small Dutch zoledronate sample, only the Swedish data were used to compare fracture incidences between treatment groups. ADCs showed a numerically higher fracture incidence in the zoledronate than in the OBPs group (hazard ratio 1.09-1.21; not statistically significant, p > 0.05). For both treatment groups, OCA showed a higher fracture incidence in the baseline risk period than in the treatment exposure period, indicating a treatment effect. OCA showed a similar or greater effect in the zoledronate group compared with the OBPs group. ADC and OCA each possesses advantages and disadvantages. Combining both methods may provide an estimate of real-world treatment efficacy that could potentially complement clinical trial findings.

Home blood pressure monitoring with nurse-led telephone support among patients with hypertension and a history of stroke: a community-based randomized controlled trial

PubMed Central

Kerry, Sally M.; Markus, Hugh S.; Khong, Teck K.; Cloud, Geoffrey C.; Tulloch, Jenny; Coster, Denise; Ibison, Judith; Oakeshott, Pippa

2013-01-01

Background: Adequate control of blood pressure reduces the risk of recurrent stroke. We conducted a randomized controlled study to determine whether home blood pressure monitoring with nurse-led telephone support would reduce blood pressure in patients with hypertension and a history of stroke. Methods: We recruited 381 participants (mean age 72 years) from outpatient and inpatient stroke clinics between Mar. 1, 2007, and Aug. 31, 2009. Nearly half (45%, 170) of the participants had some disability due to stroke. Participants were visited at home for a baseline assessment and randomly allocated to home blood pressure monitoring (n = 187) or usual care (n = 194). Those in the intervention group were given a monitor, brief training and telephone support. Participants who had home blood pressure readings consistently over target (target < 130/80 mm Hg) were advised to consult their family physician. The main outcome measure was a fall in systolic blood pressure after 12 months, measured by an independent researcher unaware of group allocation. Results: Despite more patients in the intervention group than in the control group having changes to antihypertensive treatment during the trial period (60.1% [98/163] v. 47.6% [78/164], p = 0.02), the fall in systolic blood pressure from baseline did not differ significantly between the groups (adjusted mean difference 0.3 mm Hg, 95% confidence interval –3.6 to 4.2 mm Hg). Subgroup analysis showed significant interaction with disability due to stroke (p = 0.03 at 6 months) and baseline blood pressure (p = 0.03 at 12 months). Interpretation: Overall, home monitoring did not improve blood pressure control in patients with hypertension and a history of stroke. It was associated with a fall in systolic pressure in patients who had uncontrolled blood pressure at baseline and those without disability due to stroke. Trial registration: ClinicalTrials.gov registration NCT00514800 PMID:23128283

Pharmacodynamic Effects of Low-Dose Pioglitazone in Patients with the Metabolic Syndrome without Diabetes Mellitus.

PubMed

Vu, Anh; Kosmiski, Lisa A; Beitelshees, Amber L; Prigeon, Ronald; Sidhom, Maha S; Bredbeck, Brooke; Predhomme, Julie; Deininger, Kimberly M; Aquilante, Christina L

2016-03-01

To determine the effects of low-dose pioglitazone on plasma adipocyte-derived cytokines, high-sensitivity C-reactive protein (hs-CRP), and components of the metabolic syndrome in adults with the metabolic syndrome without diabetes mellitus. Prospective, randomized, double-blind, placebo-controlled study. University of Colorado Clinical and Translational Research Center. Thirty-two men and women, aged 30-60 years, without diabetes who had a clinical diagnosis of the metabolic syndrome, as defined by the American Heart Association/National Heart, Lung, and Blood Institute criteria. Patients were randomly assigned to receive oral pioglitazone 7.5 mg daily or matching placebo for 8 weeks. The primary end point was the change in plasma high-molecular-weight (HMW) adiponectin level from baseline to week 8. Other end points were changes in plasma total adiponectin, omentin, and hs-CRP levels, and changes in components of the metabolic syndrome (e.g., insulin sensitivity) from baseline to week 8. Pioglitazone was associated with a significant increase in plasma HMW adiponectin from baseline to week 8 compared with placebo (+47% vs -10%, p<0.001). Insulin sensitivity increased significantly from baseline to week 8 in the pioglitazone group (+88%, p=0.02) but not in the placebo group (+15%, p=0.14). Change in HMW adiponectin was significantly correlated with the change in insulin sensitivity in the pioglitazone group (r = 0.784, p=0.003). No significant differences in mean percentage changes in plasma total adiponectin, omentin, and hs-CRP levels were observed between the pioglitazone and placebo groups. Likewise, changes in body weight, insulin sensitivity, glucose, lipids, and blood pressure did not differ significantly between the groups. Low-dose pioglitazone favorably modulates plasma HMW adiponectin, which was associated with an improvement in insulin sensitivity, in patients with the metabolic syndrome without diabetes. © 2016 Pharmacotherapy Publications, Inc.

Effect of Medicaid Policy Changes on Medication Adherence: Differences by Baseline Adherence.

PubMed

Amin, Krutika; Farley, Joel F; Maciejewski, Matthew L; Domino, Marisa E

2017-03-01

In 2001, the North Carolina (NC) Medicaid program reduced the number of days prescription supply that enrollees could fill from 100 days to 34 days and increased copayments for brand-name medications. Previous work has shown that a change in these policies led to a decrease in medication adherence from 2.9 to 8.0 percentage points in specific populations with chronic conditions. Studies have also shown that days supply limits and copayment increases have heterogeneous effects based on enrollees' baseline characteristics, including baseline adherence. However, this phenomenon has not been studied in the Medicaid population. We undertook this study to assess the heterogeneous effect of the NC Medicaid policy changes in groups with varying levels of baseline adherence. To examine whether restrictions on days supply had heterogeneous effects in subgroups defined by medication adherence before the policy changes. A partial difference-in-difference-in-differences model with fixed effects was used to compare medication adherence before and after the NC Medicaid policy changes among Medicaid enrollees subject to the policy changes because of their use of long prescriptions (> 40 days) as compared with (a) NC Medicaid enrollees using short prescriptions (< 40 days) before policy adoption, as well as (b) Medicaid enrollees in Georgia restricted to a 31 days supply through the study period. Medicaid enrollees were included if they filled a prescription for 1 of the following medication classes: antihypertensives, lipid-lowering drugs, or antipsychotics. The effect of the policy changes on medication adherence, calculated using the proportion of days covered (PDC) each quarter by baseline adherence level and clinical condition group, was studied. Average adherence levels over the 18-month prechange period were used to stratify individuals into 3 baseline adherence groups: fully adherent (PDC ≥ 80%), partially adherent (50%-79%), and nonadherent (PDC ≤ 50%). Enrollees fully adherent at baseline observed a 2.0 (P = 0.001) and 1.2 (P < 0.001) percentage-point decline in adherence for the lipid-lowering drug and antihypertensive cohorts, respectively, in the period after the policy changes. The nonadherent and partially adherent cohorts in the statin group observed an increase in adherence by 1.7-2.6 (P < 0.05) percentage points in the post-index period. Adherence changes after cost containment policies have a heterogeneous effect on individuals with varying baseline adherence in the Medicaid population. Individuals fully adherent at baseline decreased adherence following policy changes, while individuals partially adherent and nonadherent at baseline either had no change or showed increases in adherence, possibly because of increased contact with pharmacists and clinicians required by shorter prescription lengths. Managed care strategies to control costs should take into consideration the heterogeneity of responses by the enrollees to these policies. Furthermore, policies that consider baseline characteristics of enrollees may be more effective in improving adherence. This study was partly funded by a grant from the Robert Wood Johnson Foundation for use in data creation. Maciejewski was supported by a Research Career Scientist Award from the Department of Veterans Affairs (RCS 10-391) and owns stock in Amgen. Farley reports consultancy fees from Daiichi Sankyo outside of the conduct of this study. The other authors report no financial or other conflicts of interest related to the subject of this article. The views expressed in this article are those of the authors and do not reflect the position or policy of the Centers for Medicare & Medicaid Services, University of North Carolina at Chapel Hill, Department of Veteran Affairs, or Duke University. Study design and concept were contributed by Amin and Domino, along with Farley and Maciejewski. Domino collected the data, and data interpretation was performed primarily by Amin, along with Domino, with assistance from Farley and Maciejewski. The manuscript was primarily written by Amin, along with Domino, and revised by all the authors.

The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration.

PubMed

Gao, Yan; Luquez, Cecilia; Lynggaard, Helle; Andersen, Henning; Saboo, Banshi

2014-12-01

The study aimed to confirm the efficacy, through non-inferiority, of patient-driven versus investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) in terms of glycemic control assessed by HbA1c change. SimpleMix was a 20 week, open-label, randomized, two-armed, parallel-group, multicenter study in five countries (Argentina, China, India, Poland, and the UK). Patients with type 2 diabetes were randomized into either patient-driven or investigator-driven BIAsp 30 titration groups. Non-inferiority of patient-driven vs. investigator-driven titration based on change in HbA1c from baseline to week 20 could not be demonstrated. Mean (SE) estimated change from baseline to week 20 was -0.72 (0.08)% in the patient-driven group and -0.97 (0.08)% in the investigator-driven group; estimated difference 0.25% (95% CI: 0.04; 0.46). Estimated mean change (SE) in fasting plasma glucose from baseline to week 20 was similar between groups: -0.94 (0.21) mmol/L for patient-driven and -1.07 (0.22) mmol/L for investigator-driven (difference non-significant). Both treatment arms were well tolerated, and hypoglycemic episode rates were similar between groups, with a rate ratio of 0.77 (95% CI: 0.54; 1.09; p = 0.143) for all hypoglycemic episodes and 0.78 (95% CI: 0.42; 1.43; p = 0.417) for nocturnal hypoglycemic episodes. Non-inferiority of patient-driven versus investigator-driven titration with regard to change from baseline to end-of-treatment HbA1c could not be confirmed. It is possible that a clinic visit 12 weeks after intensification of treatment with BIAsp 30 in patients with type 2 diabetes inadequately treated with basal insulin may benefit patient-driven titration of BIAsp 30. A limitation of the study was the relatively small number of patients recruited in each country, which does not allow country-specific analyses to be performed. Overall, treatment with BIAsp 30 was well tolerated in both treatment groups.

Interleukin-6 is an independent predictor of progressive atherosclerosis in the carotid artery: The Tromsø Study.

PubMed

Eltoft, Agnethe; Arntzen, Kjell Arne; Wilsgaard, Tom; Mathiesen, Ellisiv B; Johnsen, Stein Harald

2018-04-01

Novel biomarkers are linked to cardiovascular disease (CVD). The aim of the present study was to investigate the association between 28 blood biomarkers and the formation and progression of carotid plaque. In a nested case control study with 703 participants from the population based Tromsø Study, a large biomarker panel was measured in blood obtained at baseline. Carotid ultrasound was assessed both at baseline and at 6 years of follow-up. Four groups were defined: Group 1: no plaque at baseline or at follow-up (reference group); Group 2: novel plaque at follow-up; Group 3: stable plaque at follow-up; Group 4: progression of plaque at follow-up. By multinomial logistic regression analyses, we assessed the risk of being in the different plaque groups with regard to traditional cardiovascular risk factors and levels of biomarkers at baseline. Adjusted for traditional risk factors, interleukin-6 (IL-6) was an independent predictor of plaque progression (OR 1.44, 95% CI 1.12-1.85 per SD increase in IL-6 level). This result remained significant after inclusion of other novel biomarkers to the model, and when subjects with former CVD were excluded. Neopterin was protective of novel plaque formation (OR 0.73, 95% CI 0.57-0.93). Myeloperoxidase and Caspase-1 were independent predictors of plaque progression, but this effect disappeared when excluding subjects with former CVD. IL-6 is an independent predictor of plaque progression, suggesting that it may be a marker of progressive atherosclerosis in the general population and that its central role in CVD may be related to promotion of plaque growth. Copyright © 2018 Elsevier B.V. All rights reserved.

Clinical evaluation of the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity.

PubMed

Schiff, Thomas; Delgado, Evaristo; Zhang, Yun Po; Cummins, Diane; DeVizio, William; Mateo, Luis R

2009-03-01

To determine the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate relative to that of a commercially-available pumice prophylaxis paste in reducing dentin hypersensitivity instantly after a single application following a dental scaling procedure and to establish the duration of sensitivity relief over a period of 4 weeks and 12 weeks. This was a single-center, parallel group, double-blind, stratified clinical study conducted in San Francisco, California, USA. Qualifying adult male and female subjects who presented two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10-50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were stratified according to their baseline hypersensitivity scores and randomly assigned within strata to one of two treatment groups: (1) A Test Paste, a desensitizing paste containing 8% arginine and calcium carbonate (Colgate-Palmolive Co); and (2) A Control Paste, Nupro pumice prophylaxis paste (Dentsply Professional). Subjects received a professionally-administered scaling procedure, after which they were re-examined for tactile and air blast dentin hypersensitivity (Post-Scaling Examinations). The assigned pastes were then applied as the final step to the professional dental cleaning procedure. Tactile and air blast dentin hypersensitivity examinations were again performed immediately after paste application. Subjects were provided with a commercially-available non-desensitizing dentifrice containing 0.243% sodium fluoride (Crest Cavity Protection, Procter & Gamble Co.) and an adult soft-bristled toothbrush and were instructed to brush their teeth for 1 minute, twice daily at home using only the toothbrush and dentifrice provided, for the next 12 weeks. Subjects returned to the testing facility 4 and 12 weeks after the single application of Test or Control paste, having refrained from all oral hygiene procedures and chewing gum for 8 hours and from eating and drinking for 4 hours, prior to each follow-up visit. Assessments of tactile and air blast hypersensitivity, and examinations of oral soft and hard tissue were repeated at these 4- and 12-week examinations. 68 subjects completed the 12-week study. No statistically significant differences from baseline scores were indicated at the Post-Scaling Examinations for either the Test Paste or Control Paste groups. Immediately following product application and 4 weeks after product application, subjects assigned to the Test Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (44.1% and 45.9% respectively) and mean tactile hypersensitivity scores (156.2% and 170.3% respectively). At the same time points, subjects assigned to the Control Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (15.1% and 8.9% respectively) and mean tactile hypersensitivity scores (43.1% and 8.3% respectively). Immediately following application of the assigned paste and 4 weeks later, the Test Paste group demonstrated statistically significant reductions in dentin hypersensitivity with respect to baseline-adjusted mean air blast (34.1% and 40.6% respectively) and mean tactile hypersensitivity scores (79.0% and 149.6% respectively), compared to the Control Paste group. No statistically significant differences were exhibited between paste groups at the Post-Scaling and 12-week examinations with respect to mean tactile and baseline-adjusted mean air blast hypersensitivity scores.

Impact of hemostasis methods, electrocoagulation versus suture, in laparoscopic endometriotic cystectomy on the ovarian reserve: a randomized controlled trial.

PubMed

Tanprasertkul, Chamnan; Ekarattanawong, Sophapun; Sreshthaputra, Opas; Vutyavanich, Teraporn

2014-08-01

To evaluate the impact on ovarian reserve between two different methods ofhemostasis after laparoscopic ovarian endometrioma excision. A randomized controlled study was conducted from January to December 2013 in Thammasat University Hospital, Thailand. Reproductive women, age 18-45years who underwent laparoscopic ovarian cystectomy were randomized in electrocoagulation and suture groups. Clinical baseline data and ovarian reserve outcome (anti-Mullerian hormone (AMH)) were evaluated. Fifty participants were recruited and randomized in two groups. Electrocoagulation and suture groups consisted of 25 participants. Baseline characteristics between 2 groups (age, weight, BMI, height, cyst diameter, duration and estimated blood loss) were not statistically different. There were no significant difference of AMIH between electrocoagulation and suture group atpre-operative (2.90±2.26 vs. 2.52±2.37 ng/ml), 1 week (1.78±1.51 vs. 1.99±1.71 ng/ml), 1 month (1.76±1.50 vs. 2.09±1.62 ng/ml), 3 months (2.09±1.66 vs. 1.96±1.68 ng/ml) and 6 months (2.11±1.84 vs 1.72±1.68 ng/ml), respectively. However mean AMH ofboth groups significantly decreased since the first week of operation. Effect oflaparoscopic ovarian surgery had significantly declined and sustained AMH level until 6 months. Laparoscopic cystectomy of ovarian endometrioma has negative impact to ovarian reserve. Either electroco- agulation or suture method had no different effects.

Change of Nutritional Status Assessed Using Subjective Global Assessment Is Associated With All-Cause Mortality in Incident Dialysis Patients.

PubMed

Kwon, Young Eun; Kee, Youn Kyung; Yoon, Chang-Yun; Han, In Mee; Han, Seung Gyu; Park, Kyoung Sook; Lee, Mi Jung; Park, Jung Tak; Han, Seung H; Yoo, Tae-Hyun; Kim, Yong-Lim; Kim, Yon Su; Yang, Chul Woo; Kim, Nam-Ho; Kang, Shin-Wook

2016-02-01

Subjective global assessment (SGA) is associated with mortality in end-stage renal disease (ESRD) patients. However, little is known whether improvement or deterioration of nutritional status after dialysis initiation influences the clinical outcome. We aimed to elucidate the association between changes in nutritional status determined by SGA during the first year of dialysis and all-cause mortality in incident ESRD patients. This was a multicenter, prospective cohort study. Incident dialysis patients with available SGA data at both baseline and 12 months after dialysis commencement (n = 914) were analyzed. Nutritional status was defined as well nourished (WN, SGA A) or malnourished (MN, SGA B or C). The patients were divided into 4 groups according to the change in nutritional status between baseline and 12 months after dialysis commencement: group 1, WN to WN; group 2, MN to WN; group 3, WN to MN; and group 4, MN to MN. Cox proportional hazard analysis was performed to clarify the association between changes in nutritional status and mortality. Being in the MN group at 12 months after dialysis initiation, but not at baseline, was a significant risk factor for mortality. There was a significant difference in the 3-year survival rates among the groups (group 1, 92.2%; group 2, 86.0%; group 3, 78.2%; and group 4, 63.5%; log-rank test, P < 0.001). Multivariate Cox regression analysis revealed that the mortality risk was significantly higher in group 3 than in group 1 (hazard ratio [HR] 2.77, 95% confidence interval [CI] 1.27-6.03, P = 0.01) whereas the mortality risk was significantly lower in group 2 compared with group 4 (HR 0.35, 95% CI 0.17-0.71, P < 0.01) even after adjustment for confounding factors. Moreover, mortality risk of group 3 was significantly higher than in group 2 (HR 2.89, 95% CI 1.22-6.81, P = 0.02); there was no significant difference between groups 1 and 2. The changes in nutritional status assessed by SGA during the first year of dialysis were associated with all-cause mortality in incident ESRD patients.

Non-Dependent and Dependent Daily Cannabis Users Differ in Mental Health but Not Prospective Memory Ability

PubMed Central

Braidwood, Ruth; Mansell, Samantha; Waldron, Jon; Rendell, Peter G.; Kamboj, Sunjeev K.; Curran, H. Valerie

2018-01-01

Research suggests that daily cannabis users have impaired memory for past events, but it is not clear whether they are also impaired in prospective memory (PM) for future events. The present study examined PM in daily cannabis users who were either dependent (n = 18) or non-dependent (n = 18), and compared them with non-using controls (n = 18). The effect of future event simulation (FES) on PM performance was also examined. Participants were matched across groups on age, gender, and highest level of education. The virtual week (VW) was used to objectively assess PM abilities, both at baseline and following FES. Other measures used were: cannabis use variables, immediate and delayed prose recall, phonemic and category fluency, spot-the-word test (premorbid intelligence), Beck Depression Inventory, Beck Anxiety Inventory, and a measure of schizotypy (Oxford-Liverpool Inventory of Feelings and Experiences: unusual experiences subscale). No group differences were found in PM performance on the VW, and FES did not improve PM performance in any group. Dependent cannabis users scored higher on depression, anxiety, and schizotypy than both other groups with non-dependent cannabis users scoring at a similar level to controls. There were no group differences in alcohol use. Findings suggest that when carefully matched on baseline variables, and not differing in premorbid IQ or alcohol use, young, near-daily cannabis users do not differ from non-using controls in PM performance. PMID:29636705

A blinded randomised trial of acupuncture (manual and electroacupuncture) compared with a non-penetrating sham for the symptoms of osteoarthritis of the knee.

PubMed

Jubb, Ronald W; Tukmachi, Emad S; Jones, Peter W; Dempsey, Emma; Waterhouse, Lynn; Brailsford, Sue

2008-06-01

To compare the effect of acupuncture (manual and electroacupuncture) with that of a non-penetrating sham ('placebo' needle) in patients with osteoarthritic knee pain and disability who are blind to the treatment allocation. Acupuncture naïve patients with symptomatic and radiological evidence of osteoarthritis of the knee were randomly allocated to a course of either acupuncture or non-penetrating sham acupuncture using a sheathed 'placebo' needle system. Acupuncture points for pain and stiffness were selected according to acupuncture theory for treating Bi syndrome. Both manual and electrical stimulation were used. Response was assessed using the WOMAC index for osteoarthritis of the knee, self reported pain scale, the EuroQol score and plasma beta-endorphin. The effectiveness of blinding was assessed. There were 34 patients in each group. The primary end point was the change in WOMAC pain score after the course of treatment. Comparison between the two treatment groups found a significantly greater improvement with acupuncture (mean difference 60, 95% CI 5 to 116, P= 0.035) than with sham. Within the acupuncture group there was a significant improvement in pain (baseline 294, mean change 95, 95% CI 60 to 130, P<0.001) which was not seen by those who had sham acupuncture (baseline 261, mean change 35, 95% CI -10 to 80, P=0.12). Similar effects within group, but not between groups, were seen with the secondary end points of WOMAC stiffness, WOMAC function, and self reported pain. One month after treatment the between group pain difference had been lost (mean difference 46; 95% CI -9 to 100, P=0.10) although the acupuncture group was still benefiting compared to baseline (mean difference 59; 95% CI 16 to 102, P=0.009). The EuroQol score, a generic measure of health related quality of life, was not altered by the treatments. A minority of patients correctly guessed their treatment group (41% in the acupuncture group and 44% in the control group). Plasma beta-endorphin levels were not affected by either treatment. Acupuncture gives symptomatic improvement for patients with osteoarthritis of the knee, and is significantly superior to non-penetrating sham acupuncture. The study did not confirm earlier reports of release of plasma beta-endorphin during acupuncture.

Acute and chronic effects of flavanol-rich cocoa on vascular function in subjects with coronary artery disease: a randomized double-blind placebo-controlled study.

PubMed

Farouque, H M Omar; Leung, Michael; Hope, Sarah A; Baldi, Mauro; Schechter, Clyde; Cameron, James D; Meredith, Ian T

2006-07-01

Evidence suggests that flavonoid-containing diets reduce cardiovascular risk, but the mechanisms responsible are unclear. In the present study, we sought to determine the effect of flavanol-rich cocoa on vascular function in individuals with CAD (coronary artery disease). Forty subjects (61+/-8 years; 30 male) with CAD were recruited to a 6-week randomized double-blind placebo-controlled study. Subjects consumed either a flavanol-rich chocolate bar and cocoa beverage daily (total flavanols, 444 mg/day) or matching isocaloric placebos daily (total flavanols, 19.6 mg/day) for 6 weeks. Brachial artery FMD (flow-mediated dilation) and SAC (systemic arterial compliance) were assessed at baseline, 90 min following the first beverage and after 3 and 6 weeks of daily consumption. Soluble cellular adhesion molecules and FBF (forearm blood flow) responses to ACh (acetylcholine chloride; 3-30 microg/min) and SNP (sodium nitroprusside; 0.3-3 microg/min) infusions, forearm ischaemia and isotonic forearm exercise were assessed at baseline and after 6 weeks. FMD, SAC and FBF responses did not differ between groups at baseline. No acute or chronic changes in FMD or SAC were seen in either group. No difference in soluble cellular adhesion molecules, FBF responses to ischaemia, exercise, SNP or ACh was seen in the group receiving flavanol-rich cocoa between baseline and 6 weeks. These data suggest that over a 6-week period, flavanol-rich cocoa does not modify vascular function in patients with established CAD.

The effects of acceptance and commitment therapy on eating behavior and diet delivered through face-to-face contact and a mobile app: a randomized controlled trial.

PubMed

Järvelä-Reijonen, Elina; Karhunen, Leila; Sairanen, Essi; Muotka, Joona; Lindroos, Sanni; Laitinen, Jaana; Puttonen, Sampsa; Peuhkuri, Katri; Hallikainen, Maarit; Pihlajamäki, Jussi; Korpela, Riitta; Ermes, Miikka; Lappalainen, Raimo; Kolehmainen, Marjukka

2018-02-27

Internal motivation and good psychological capabilities are important factors in successful eating-related behavior change. Thus, we investigated whether general acceptance and commitment therapy (ACT) affects reported eating behavior and diet quality and whether baseline perceived stress moderates the intervention effects. Secondary analysis of unblinded randomized controlled trial in three Finnish cities. Working-aged adults with psychological distress and overweight or obesity in three parallel groups: (1) ACT-based Face-to-face (n = 70; six group sessions led by a psychologist), (2) ACT-based Mobile (n = 78; one group session and mobile app), and (3) Control (n = 71; only the measurements). At baseline, the participants' (n = 219, 85% females) mean body mass index was 31.3 kg/m 2 (SD = 2.9), and mean age was 49.5 years (SD = 7.4). The measurements conducted before the 8-week intervention period (baseline), 10 weeks after the baseline (post-intervention), and 36 weeks after the baseline (follow-up) included clinical measurements, questionnaires of eating behavior (IES-1, TFEQ-R18, HTAS, ecSI 2.0, REBS), diet quality (IDQ), alcohol consumption (AUDIT-C), perceived stress (PSS), and 48-h dietary recall. Hierarchical linear modeling (Wald test) was used to analyze the differences in changes between groups. Group x time interactions showed that the subcomponent of intuitive eating (IES-1), i.e., Eating for physical rather than emotional reasons, increased in both ACT-based groups (p = .019); the subcomponent of TFEQ-R18, i.e., Uncontrolled eating, decreased in the Face-to-face group (p = .020); the subcomponent of health and taste attitudes (HTAS), i.e., Using food as a reward, decreased in the Mobile group (p = .048); and both subcomponent of eating competence (ecSI 2.0), i.e., Food acceptance (p = .048), and two subcomponents of regulation of eating behavior (REBS), i.e., Integrated and Identified regulation (p = .003, p = .023, respectively), increased in the Face-to-face group. Baseline perceived stress did not moderate effects on these particular features of eating behavior from baseline to follow-up. No statistically significant effects were found for dietary measures. ACT-based interventions, delivered in group sessions or by mobile app, showed beneficial effects on reported eating behavior. Beneficial effects on eating behavior were, however, not accompanied by parallel changes in diet, which suggests that ACT-based interventions should include nutritional counseling if changes in diet are targeted. ClinicalTrials.gov ( NCT01738256 ), registered 17 August, 2012.

Pupillary Response to Negative Emotional Stimuli Is Differentially Affected in Meditation Practitioners

PubMed Central

Vasquez-Rosati, Alejandra; Brunetti, Enzo P.; Cordero, Carmen; Maldonado, Pedro E.

2017-01-01

Clinically, meditative practices have become increasingly relevant, decreasing anxiety in patients and increasing antibody production. However, few studies have examined the physiological correlates, or effects of the incorporation of meditative practices. Because pupillary reactivity is a marker for autonomic changes and emotional processing, we hypothesized that the pupillary responses of mindfulness meditation practitioners (MP) and subjects without such practices (non-meditators (NM)) differ, reflecting different emotional processing. In a group of 11 MP and 9 NM, we recorded the pupil diameter using video-oculography while subjects explored images with emotional contents. Although both groups showed a similar pupillary response for positive and neutral images, negative images evoked a greater pupillary contraction and a weaker dilation in the MP group. Also, this group had faster physiological recovery to baseline levels. These results suggest that mindfulness meditation practices modulate the response of the autonomic nervous system, reflected in the pupillary response to negative images and faster physiological recovery to baseline levels, suggesting that pupillometry could be used to assess the potential health benefits of these practices in patients. PMID:28515685

Musical Training and Late-Life Cognition

PubMed Central

Gooding, Lori F; Abner, Erin L; Jicha, Gregory A; Kryscio, Richard J; Schmitt, Fredrick A

2014-01-01

This study investigated effects of early- to mid-life musical training on cognition in older adults. A Musical Training Survey examined self-reported musical experience and objective knowledge in 237 cognitively intact participants. Responses were classified into Low, Medium, and High knowledge groups. Linear mixed models compared the groups’ longitudinal performance on the Animal Naming Test (ANT; semantic verbal fluency) and Logical Memory Story A Immediate Recall (LMI; episodic memory) controlling for baseline age, time since baseline, education, sex, and full-scale IQ. Results indicate that High knowledge participants had significantly higher LMI scores at baseline and over time compared to Low knowledge participants. ANT scores did not differ among the groups. Ability to read music was associated with higher mean scores for both ANT and LMI over time. Early-to mid-life musical training may be associated with improved late-life episodic and semantic memory as well as a useful marker of cognitive reserve. PMID:24375575