Healing of intrabony defects and its relationship to root canal therapy. A histologic and histometric study in dogs.

PubMed

Lima, L A; Anderson, G B; Wang, M M; Nasjleti, C E; Morrison, E C; Kon, S; Caffesse, R G

1997-03-01

The purpose of this study was to evaluate the importance of root canal therapy in the healing process of severe intrabony defects. Four beagle dogs were used and 32 interproximal intrabony defects, up to the apical third, were created. Wire ligatures were placed into these defects for plaque accumulation. Three weeks later, the ligatures were removed and 4 different treatment modalities were employed: group 1) scaling and root planing (SRP); group 2) modified Widman flap (MWF); group 3) modified Widman flap and root canal therapy performed at the same time (RCT/MWF); and group 4) modified Widman flap and root canal therapy performed 3 weeks after the surgical procedure (MWF + RCT). Postoperative oral hygiene was obtained by spraying a 0.12% chlorhexidine solution 3 times a week. The animals were sacrificed 7 weeks after treatment. Blocks were obtained and processed for routine histology. Results were expressed as a percentage of the total defect length (TDL). No differences were observed when SRP was compared to MWF. New bone formation (BF) presented better results for SRP (43.4%) and MWF (53.4%) when compared to RCT/MWF (15.5%). New cementum formation (CF) presented better results for SRP (59.8%) and MWF (64.6%) when compared to RCT/MWF (19.3%) and MWF + RCT (31.5%). Connective tissue repair (CTR) presented better results for SRP (72.4%) and MWF (74.2%) when compared to RCT/MWF (47.5%) and MWF + RCT (44.4%). Results were statistically significant at the level of 0.05. Within the limits of this study, it was concluded that root canal therapy performed simultaneously or 3 weeks after surgery modified the healing of intrabony defects, impairing new bone formation, new cementum formation and new attachment.

Efficacy of the Greater Occipital Nerve Block for Cervicogenic Headache: Comparing Classical and Subcompartmental Techniques.

PubMed

Lauretti, Gabriela R; Corrêa, Selma W R O; Mattos, Anita L

2015-09-01

The aim of the study was to compare the efficacy of the greater occipital nerve (GON) block using the classical technique and different volumes of injectate with the subcompartmental technique for the treatment of cervicogenic headache (CH). Thirty patients acted as his/her own control. All patients were submitted to the GON block by the classical technique with 10 mg dexamethasone, plus 40 mg lidocaine (5 mL volume). Patients were randomly allocated into 1 of 3 groups (n = 10) when pain VAS was > 3 cm. Each group was submitted to a GON subcompartmental technique (10 mg dexamethasone + 40 mg lidocaine + nonionic iodine contrast + saline) under fluoroscopy using either 5, 10, or 15 mL final volume. Analgesia and quality of life were evaluated. The classical GON technique resulted in 2 weeks of analgesia and less rescue analgesic consumption, compared to 24 weeks after the subcompartmental technique (P < 0.01). Quality of life improved at 2 and 24 weeks after the classical and the suboccipital techniques, respectively (P < 0.05). The data revealed that groups were similar regarding analgesia when compared to volume of injection (P > 0.05). While the classical technique for GON block resulted in only 2 weeks of analgesia, the subcompartmental technique resulted in at least 24 weeks of analgesia, being 5 mL volume sufficient for the performance of the block under fluoroscopy. © 2014 World Institute of Pain.

Audit of thrice- versus twice-weekly ECT.

PubMed

Roche, Eric; Lope, Jasmin; Hughes, Helen; McCullagh, Niamh; Larkin, Terence; Feeney, Larkin

2012-09-01

There is a lack of knowledge regarding some basic differences between different electroconvulsive therapy (ECT) treatment schedules. To examine differences, including ECT technical parameters and length of stay, between thrice- and twice-weekly ECT treatment schedules. Prospective audit of the changeover period of administering thrice- to twice-weekly ECT in a Dublin psychiatric hospital. Twice-weekly ECT was associated with significantly lower total electricity dosage administered, a tendency toward shorter overall hospital stay and fewer ECT treatments compared to thrice-weekly ECT. Our results support the current international trend toward giving ECT twice weekly.

A 4-Week Model of House Dust Mite (HDM) Induced Allergic Airways Inflammation with Airway Remodeling.

PubMed

Woo, L N; Guo, W Y; Wang, X; Young, A; Salehi, S; Hin, A; Zhang, Y; Scott, J A; Chow, C W

2018-05-02

Animal models of allergic airways inflammation are useful tools in studying the pathogenesis of asthma and potential therapeutic interventions. The different allergic airways inflammation models available to date employ varying doses, frequency, duration and types of allergen, which lead to the development of different features of asthma; showing varying degrees of airways inflammation and hyper-responsiveness (AHR) and airways remodeling. Models that also exhibit airway remodeling, a key feature of asthma, in addition to AHR and airway inflammation typically require 5-12 weeks to develop. In this report, we describe a 4-week mouse model of house dust mite (HDM)-induced allergic airways inflammation, and compare the phenotypic features of two different doses of HDM exposures (10 µg and 25 µg) for 5 days/week with a well-characterized 8-week chronic HDM model. We found that 4 weeks of intranasal HDM (25 µg in 35 µl saline; 5 days/week) resulted in AHR, airway inflammation and airway remodeling that were comparable to the 8-week model. We conclude that this new 4-week HDM model is another useful tool in studies of human asthma that offers advantages of shorter duration for development and decreased costs when compared to other models that require longer durations of exposure (5-12 weeks) to develop.

Combined application of BDNF to the eye and brain enhances ganglion cell survival and function in the cat after optic nerve injury.

PubMed

Weber, Arthur J; Viswanáthan, Suresh; Ramanathan, Chidambaram; Harman, Christine D

2010-01-01

To determine whether application of BDNF to the eye and brain provides a greater level of neuroprotection after optic nerve injury than treatment of the eye alone. Retinal ganglion cell survival and pattern electroretinographic responses were compared in normal cat eyes and in eyes that received (1) a mild nerve crush and no treatment, (2) a single intravitreal injection of BDNF at the time of the nerve injury, or (3) intravitreal treatment combined with 1 to 2 weeks of continuous delivery of BDNF to the visual cortex, bilaterally. Relative to no treatment, administration of BDNF to the eye alone resulted in a significant increase in ganglion cell survival at both 1 and 2 weeks after nerve crush (1 week, 79% vs. 55%; 2 weeks, 60% vs. 31%). Combined treatment of the eye and visual cortex resulted in a modest additional increase (17%) in ganglion cell survival in the 1-week eyes, a further significant increase (55%) in the 2-week eyes, and ganglion cell survival levels for both that were comparable to normal (92%-93% survival). Pattern ERG responses for all the treated eyes were comparable to normal at 1 week after injury; however, at 2 weeks, only the responses of eyes receiving the combined BDNF treatment remained so. Although treatment of the eye alone with BDNF has a significant impact on ganglion cell survival after optic nerve injury, combined treatment of the eye and brain may represent an even more effective approach and should be considered in the development of future optic neuropathy-related neuroprotection strategies.

[Mercury and creatinine in urine of employees exposed to magnetic fields. A study of a group electrolysis-operators in Norzink A/S in Odda].

PubMed

Schmidt, F; Mannsåker

1997-01-20

The results described are based on a study of 26 male cell house employees. They were exposed to a combination of static magnetic fields (3-10 mT) and low frequency oscillating magnetic fields of variable frequency and strength for eight hours a day over a period of four weeks. Every fifth week was spent off work. Urine samples collected at the end of the four weeks of exposure were compared with samples collected at the end of the week off work. The results show that the cell house workers excreted significantly more mercury in their urine after exposure to magnetic fields (p = 0.01). The mercury/creatinine ratio was also significantly higher after exposure (p < 0.01). These results support findings by Schmidt in a study from 1992 when the levels of mercury and creatinine in the urine of cell house workers were compared with the levels in office personnel.

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

Reproducibility of objectively measured physical activity and sedentary time over two seasons in children; Comparing a day-by-day and a week-by-week approach

PubMed Central

Andersen, Lars Bo; Skrede, Turid; Ekelund, Ulf; Anderssen, Sigmund Alfred; Resaland, Geir Kåre

2017-01-01

Introduction Knowledge of reproducibility of accelerometer-determined physical activity (PA) and sedentary time (SED) estimates are a prerequisite to conduct high-quality epidemiological studies. Yet, estimates of reproducibility might differ depending on the approach used to analyze the data. The aim of the present study was to determine the reproducibility of objectively measured PA and SED in children by directly comparing a day-by-day and a week-by-week approach to data collected over two weeks during two different seasons 3–4 months apart. Methods 676 11-year-old children from the Active Smarter Kids study conducted in Sogn og Fjordane county, Norway, performed 7 days of accelerometer monitoring (ActiGraph GT3X+) during January-February and April-May 2015. Reproducibility was calculated using a day-by-day and a week-by-week approach applying mixed effect modelling and the Spearman Brown prophecy formula, and reported using intra-class correlation (ICC), Bland Altman plots and 95% limits of agreement (LoA). Results Applying a week-by-week approach, no variables provided ICC estimates ≥ 0.70 for one week of measurement in any model (ICC = 0.29–0.66 not controlling for season; ICC = 0.49–0.67 when controlling for season). LoA for these models approximated a factor of 1.3–1.7 of the sample PA level standard deviations. Compared to the week-by-week approach, the day-by-day approach resulted in too optimistic reliability estimates (ICC = 0.62–0.77 not controlling for season; ICC = 0.64–0.77 when controlling for season). Conclusions Reliability is lower when analyzed over different seasons and when using a week-by-week approach, than when applying a day-by-day approach and the Spearman Brown prophecy formula to estimate reliability over a short monitoring period. We suggest a day-by-day approach and the Spearman Brown prophecy formula to determine reliability be used with caution. Trial Registration The study is registered in Clinicaltrials.gov 7th April 2014 with identification number NCT02132494. PMID:29216318

Improved efficacy of intramuscular weekly administration of clodronate 200 mg (100 mg twice weekly) compared with 100 mg (once weekly) for increasing bone mineral density in postmenopausal osteoporosis.

PubMed

Frediani, Bruno; Bertoldi, Ilaria; Pierguidi, Serena; Nicosia, Antonella; Picerno, Valentina; Filippou, Georgios; Cantarini, Luca; Galeazzi, Mauro

2013-03-01

Clodronate is a bisphosphonate used for the treatment of postmenopausal osteoporosis and all conditions characterized by excess bone resorption. We have previously reported that intramuscular (IM) therapy with clodronate at a dose of 100 mg/week displays significant effects on bone mineral density (BMD) although a plateau effect is observed after 1 year of treatment. Previous reports indicate that the densitometric effects of bisphosphonates directly correlate with the drug dosage and suggest that using IM clodronate at doses higher than 100 mg/week may result in improved efficacy. However, to the best of our knowledge, this has never been proved. The primary endpoint of the study was the effect on BMD of IM clodronate 100 mg once weekly or 100 mg twice weekly in patients with postmenopausal osteoporosis. The incidence of non-traumatic vertebral fractures and adverse events was also reported. The present study was a randomized, open-label, parallel-group trial conducted between January 2007 and December 2009 in the Osteoporosis and Osteoarticular Instrumental Diagnosis Centre (University of Siena, Siena, Italy). The study involved 60 women, aged 57-78 years, with a history of postmenopausal osteoporosis for more than 5 years. Patients were randomized to receive IM clodronate 100 mg once weekly (Group A, 30 patients) or 100 mg twice weekly (Group B, 30 patients), for 2 years. Significant increases compared with baseline in BMD were observed for both groups at 1 and 2 years, with significantly higher increases for Group B compared with Group A. Group B displayed a BMD increase (± SD) at the lumbar spine of +4.0 % (± 2.1) and +5.9 % (± 2.0) at 1 and 2 year(s), respectively, compared with +2.8 % (± 1.7) and +3.5 % (± 2.2), respectively, observed for Group A. Similarly, Group B showed better performance compared with Group A for BMD increase at the femoral neck, with an observed increase of +3.5 % (± 1.7) and +5.4 % (± 1.8) at 1 and 2 year(s), respectively, compared with a change of +2.3 % (± 1.9) and +2.5 % (± 1.9), respectively, registered in Group A. Consistently, the BMD increase measured at the total femur was significantly higher for Group B [+3.4 % (± 1.9) and +4.9 % (± 2.1) at years 1 and 2, respectively] compared with Group A [+1.6 % (± 0.9) and +2.4 % (± 1.9) at years 1 and 2, respectively]. When the change in BMD from year 1 to year 2 was compared, a significant increase of BMD was seen in Group B in all the analysed regions, contrary to that observed for Group A where a plateau effect resulted in no significant change from year 1 to year 2. Three non-traumatic vertebral fractures occurred during the study: two in Group A and one in Group B. The present study indicates the superior performance of IM clodronate 200 mg weekly (100 mg twice weekly) compared with 100 mg once weekly in BMD in women with postmenopausal osteoporosis. This work demonstrated that administration of twice the drug dosage in a week significantly improved the efficacy of the treatment without inducing serious adverse events. Therefore, IM clodronate 200 mg weekly may be considered a valid therapeutic choice for the treatment of postmenopausal osteoporosis.

[IDENTIFICATION OF CAUSES OF EARLY PREGNANCY LOSSES ACCORDING TO HYSTOMORPHOLOGIC FEATURES].

PubMed

Gotsiridze, K; Kintraia, N; Pailodze, M; Gogia, T; Tsaava, F

2017-01-01

Retrospective analysis of the early spontaneous abortions has been conducted (486 cases). Histomorphologic analysis of the curettage material contents erveledinvolutive-regressive developmental chsnges in 108 (22,28%) cases, in 370 cases (77.78%) pathologic changes, like inflammatory changes of deciduas and chorionic villis in 302 cases (80.2%), pathologic prematurity of chorionic vili in 48 cases (12.6%), hydatidiform mole in 28 cases (7.4%). As most cases of pregnancy loss has been reported at 7-9 weeks /172 cases/, we compared histomorphologic data revealed at 7-8 (71 cases) weeks to 5-6 (135 cases) and 10-12 weeks of gestation. Morphologic research data confimed, that at 7-8 weeks compared to 5-6 weeks leading reason ofpregnancy loss was inflammatory changes (OR-1,584), what can be cause of 110 pregnancy losses at 1000 pregnant women (AR-0.11). Data comparing7-9 weeks to 10-12 weeks pregnancy losses, confirm the priority of pathologic immaturity (OR-1,279) and hydatidiform mole (OR-1,557) and could be the risk of 100 cases of pregnancy termination at 1000 pregnant women (AR-0.10).Existing results are of great importance for the preconceptional preparation of women.

In vivo cartilage formation using chondrogenic-differentiated human adipose-derived mesenchymal stem cells mixed with fibrin glue.

PubMed

Jung, Sung-No; Rhie, Jong Won; Kwon, Ho; Jun, Young Joon; Seo, Je-Won; Yoo, Gyeol; Oh, Deuk Young; Ahn, Sang Tae; Woo, Jihyoun; Oh, Jieun

2010-03-01

Human adipose-derived mesenchymal stem cells (MSCs) were differentiated into chondrogenic MSCs, and fibrin glue was used together to explore the feasibility of whether cartilages can be generated in vivo by injecting the differentiated cells. Mesenchymal stem cells extracted from human adipose were differentiated into chondrogenic MSCs, and such differentiated cells mixed with fibrin glue were injected subcutaneously into the back of the nude mouse. In addition to visual evaluation of the tissues formed after 4, 8, and 12 weeks, hematoxylin-eosin staining, Masson trichrome staining, measurement of glycosaminoglycan concentration using dimethylmethylene blue, agreecan through reverse transcriptase-polymerase chain reaction, type II collagen, and expression of SOX-9 were verified. Moreover, the results were compared with 2 groups of controls: 1 control group that received only injection of chondrogenic-differentiated MSC and the supporting control group that received only fibrin glue injection. For the experimental group, cartilage-like tissues were formed after 4, 8, and 12 weeks. Formation of cartilage tissues was not observed in any of 4, 8, and 12 weeks of the control group. The supporting control group had only a small structure formation after 4 weeks, but the formed structure was completely decomposed by the 8th and 12th weeks. The range of staining dramatically increased with time at 4, 8, and 12 weeks in Masson trichrome staining. The concentration of glycosaminoglycan also increased with time. The increased level was statistically significant with more than 3 times more after 8 weeks compared with 4 weeks and more than 2 times more after 12 weeks compared with 8 weeks. Also, in reverse transcriptase-polymerase chain reaction at 4, 8, and 12 weeks, all results expressed a cartilage-specific gene called aggrecan, type II collagen, and SOX-9. The study verified that the chondrogenic-differentiated MSCs derived from human adipose tissues with fibrin glue can proliferate and form new cartilage. Our findings suggest that formation of cartilages in vivo is possible.

Matching-adjusted indirect comparison of efficacy in patients with moderate-to-severe plaque psoriasis treated with ixekizumab vs. secukinumab.

PubMed

Warren, R B; Brnabic, A; Saure, D; Langley, R G; See, K; Wu, J J; Schacht, A; Mallbris, L; Nast, A

2018-05-01

Head-to-head randomized studies comparing ixekizumab and secukinumab in the treatment of psoriasis are not available. To assess efficacy and quality of life using matching-adjusted indirect comparisons for treatment with ixekizumab vs. secukinumab. Psoriasis Area and Severity Index (PASI) improvement of at least 75%, 90% and 100% and Dermatology Life Quality Index (DLQI) 0/1 response rates for approved dosages of ixekizumab (160 mg at Week 0, then 80 mg every two weeks for the first 12 weeks) and secukinumab (300 mg at Weeks 0, 1, 2, 3 and 4, then 300 mg every 4 weeks) treatment were compared using data from active (etanercept and ustekinumab) and placebo-controlled studies. Comparisons were made using the Bucher (BU) method and two modified versions of the Signorovitch (SG) method (SG total and SG separate). Subsequently, results based on active treatment common comparators were combined using generic inverse-variance meta-analysis. In the meta-analysis of studies with active comparators, PASI 90 response rates were 12·7% [95% confidence interval (CI) 5·5-19·8, P = 0·0005], 10·0% (95% CI 2·1-18·0, P = 0·01) and 11·2% (95% CI 3·2-19·1, P = 0·006) higher and PASI 100 response rates were 11·7% (95% CI 5·9-17·5, P < 0·001), 12·7% (95% CI 6·0-19·4, P < 0·001) and 13·1% (95% CI 6·3-19·9, P < 0·001) higher for ixekizumab compared with secukinumab using BU, SG total and SG separate methods. PASI 75 results were comparable when SG methods were used and favoured ixekizumab when the BU method was used. Week 12 DLQI 0/1 response rates did not differ significantly. Ixekizumab had higher PASI 90 and PASI 100 responses at week 12 compared with secukinumab using adjusted indirect comparisons. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain

PubMed Central

Conaghan, Philip G.; Hunter, David J.; Cohen, Stanley B.; Kraus, Virginia B.; Berenbaum, Francis; Lieberman, Jay R.; Jones, Deryk G.; Spitzer, Andrew I.; Jevsevar, David S.; Katz, Nathaniel P.; Burgess, Diane J.; Lufkin, Joelle; Johnson, James R.; Bodick, Neil

2018-01-01

Background: Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). We assessed symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs. Methods: In this Phase-3, multicenter, double-blinded, 24-week study, adults ≥40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average-daily-pain (ADP)-intensity scores of ≥5 and ≤9 (0 to 10 numeric rating scale) were centrally randomized (1:1:1) to a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg). The primary end point was change from baseline to week 12 in weekly mean ADP-intensity scores for FX006 compared with saline-solution placebo. Secondary end points were area-under-effect (AUE) curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with saline-solution placebo, AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, and AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 24 for FX006 compared with saline-solution placebo. Exploratory end points included week-12 changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) subscale scores for FX006 compared with saline-solution placebo and TAcs. Adverse events were elicited at each inpatient visit. Results: The primary end point was met. Among 484 treated patients (n = 161 for FX006, n = 162 for saline-solution placebo, and n = 161 for TAcs), FX006 provided significant week-12 improvement in ADP intensity compared with that observed for saline-solution placebo (least-squares mean change from baseline: −3.12 versus −2.14; p < 0.0001) indicating ∼50% improvement. FX006 afforded improvements over saline-solution placebo for all secondary and exploratory end points (p < 0.05). Improvements in osteoarthritis pain were not significant for FX006 compared with TAcs using the ADP-based secondary measures. Exploratory analyses of WOMAC-A, B, and C and KOOS-QOL subscales favored FX006 (p ≤ 0.05). Adverse events were generally mild, occurring at similar frequencies across treatments. Conclusions: FX006 provided significant, clinically meaningful pain reduction compared with saline-solution placebo at week 12 (primary end point). Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. PMID:29664853

[Treatment of severe intermittent claudication: ORACLE-PGE1 short term study. A randomised 40-week study. Evaluation of efficacy and costs].

PubMed

Cesarone, M R; Belcaro, G; Nicolaides, A N; Griffin, M; Geroulakos, G; Ramaswami, G; Cazaubon, M; Barsotti, A; Vasdekis, S; Christopoulos, D; Agus, G; Bavera, P; Mondani, P; Ippolito, E; Flenda, F

2002-12-01

The efficacy and cost of prostaglandin E1 (PGE1) in severe intermittent claudication was studied comparing a long-term protocol (LTP) with a short-term protocol (STP) in a randomised 40-week study. Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. Treatment was performed with 2-hour infusions (60 micro g PGE1, 5 days each week for 4 weeks. In phase 3 (4-week interval period), PGE1 was administered twice a week (same dosage). In phase 4 (40 weeks), no PGE1 were used. In STP, phase 2 treatment was performed in two days by a 2-hour infusion (60 micro g PGE1 twice a day in 2 days). The same cycle was repeated every 4 weeks. A treadmill test was performed at inclusion, at the beginning of each phase and at the end of weeks 12, 16, 20 32 and 40. A progressive training plan (walking) and reduction in risk factors plan was used in both groups. Out of the 1276 included patients 1165 completed the study (606 in LTP group; 559 in the STP). Drop-outs were 111. The two groups were comparable in distribution, risk factors and smoking. Intention-to-treat analysis indicated an increase in pain free walking distance (PFWD). The absolute and percent increase in pain-free walking distance (PFWD) was comparable in both LTP and STP groups with a significative increase in TWD at 4 weeks. At 20 and 40 weeks increase was up to 219% in the LTP and 460% in the STP group (p<0.02). Comparable results concerning PFWD were obtained in the two groups. Both treatments were well tolerated. No side effect was observed. Local effects were observed in 8.5% of the treated subjects in the LTP and 4% in the STP. The average cost of the LTP protocol was 8786 Euro. For STP the costs was 946 (10.8% of LTP). For both protocols the cost of the infusion was 24% of the total for the LTP and 35% in the STP. Therefore 75% of the cost is not drug-related. In conclusion between-group-analysis favours STP considering walking distance and costs. Results indicate good efficacy and tolerability of PGE1 treatment particularly STP.

Significant Effects of Oral Phenylbutyrate and Vitamin D3 Adjunctive Therapy in Pulmonary Tuberculosis: A Randomized Controlled Trial

PubMed Central

Kamal, S. M. Mostafa; Arifuzzaman, Abu Saleh Mohammad; Rahim, Zeaur; Khan, Lamia; Haq, Md. Ahsanul; Zaman, Khaliqu; Bergman, Peter; Brighenti, Susanna; Gudmundsson, Gudmundur H.; Agerberth, Birgitta; Raqib, Rubhana

2015-01-01

Background Development of new tuberculosis (TB) drugs and alternative treatment strategies are urgently required to control the global spread of TB. Previous results have shown that vitamin D3 (vitD3) and 4-phenyl butyrate (PBA) are potent inducers of the host defense peptide LL-37 that possess anti-mycobacterial effects. Objective To examine if oral adjunctive therapy with 5,000IU vitD3 or 2x500 mg PBA or PBA+vitD3 to standard chemotherapy would lead to enhanced recovery in sputum smear-positive pulmonary TB patients. Methods Adult TB patients (n = 288) were enrolled in a randomized, double-blind, placebo-controlled trial conducted in Bangladesh. Primary endpoints included proportions of patients with a negative sputum culture at week 4 and reduction in clinical symptoms at week 8. Clinical assessments and sputum smear microscopy were performed weekly up to week 4, fortnightly up to week 12 and at week 24; TB culture was performed at week 0, 4 and 8; concentrations of LL-37 in cells, 25-hydroxyvitamin D3 (25(OH)D3) in plasma and ex vivo bactericidal function of monocyte-derived macrophages (MDM) were determined at week 0, 4, 8, 12 and additionally at week 24 for plasma 25(OH)D3. Results At week 4, 71% (46/65) of the patients in the PBA+vitD3-group (p = 0.001) and 61.3% (38/62) in the vitD3-group (p = 0.032) were culture negative compared to 42.2% (27/64) in the placebo-group. The odds of sputum culture being negative at week 4 was 3.42 times higher in the PBA+vitD3-group (p = 0.001) and 2.2 times higher in vitD3-group (p = 0.032) compared to placebo. The concentration of LL-37 in MDM was significantly higher in the PBA-group compared to placebo at week 12 (p = 0.034). Decline in intracellular Mtb growth in MDM was earlier in the PBA-group compared to placebo (log rank 11.38, p = 0.01). Conclusion Adjunct therapy with PBA+vitD3 or vitD3 or PBA to standard short-course therapy demonstrated beneficial effects towards clinical recovery and holds potential for host-directed-therapy in the treatment of TB. Trial Registration clinicaltrials.gov NCT01580007 PMID:26394045

Incidence of skeletal related events in patients with bone metastasis receiving denosumab every four weeks compared to intervals greater than every four weeks.

PubMed

Yerram, Prakirthi; Moore, Russell; Wolf, Steven; Barbour, Sally Y

2017-01-01

Objective Denosumab is a monoclonal antibody used for prevention of skeletal related events in patients with bone metastasis from solid tumors and is administered every four weeks. In our practice, denosumab is often given at different frequencies more similar to patient's chemotherapy regimens to decrease frequency of clinic visits. The purpose of this study is to compare the incidence of skeletal related events, incidence of hypocalcemia, and cost with denosumab given at every four weeks and denosumab given at other frequencies. Methods This retrospective study at Duke University Health System included solid tumor patients with an age ≥18 years who received denosumab for prevention of skeletal related events. Results A total of 94 patients were included, with 29 in the every four-week group and 65 in the greater than every four-week group. Patients who received denosumab every four weeks had a 41.4% incidence of skeletal related events compared to 26.2% incidence of skeletal related events in patients who received denosumab at intervals greater than every four weeks (OR: 0.50; p = 0.14). There was no statistically significant difference in incidence of hypocalcemia. Based on average wholesale price, when the frequency of denosumab is extended to greater than every four weeks, annual cost savings per patient ranged from $4700 (every 5 weeks) to $18,800 (every 12 weeks). Conclusion While this study raises the possibility of decreasing the frequency of denosumab administration, further data are necessary to confirm that less frequent administration is non-inferior to every four-week administration.

Sandalwood Oil and Turmeric-Based Cream Prevents Ionizing Radiation-Induced Dermatitis in Breast Cancer Patients: Clinical Study.

PubMed

Rao, Suresh; Hegde, Sanath Kumar; Baliga-Rao, Manjeshwar Poonam; Lobo, Jyothi; Palatty, Princy Louis; George, Thomas; Baliga, Manjeshwar Shrinath

2017-06-24

Background : The primary objective of this study was to ascertain the benefit of Vicco turmeric Ayurvedic cream (VTC; Vicco Laboratories, Mumbai, India) sandalwood oil and turmeric-based cream in preventing radiodermatitis in women undergoing curative radiotherapy for their breast cancer. Methods and Materials : The study was an investigator-blinded randomized study with Johnsons Baby Oil (JBO; Johnson & Johnson Ltd., Baddi, India) as a comparator, administered daily from the start of radiation therapy for 5 weeks in women receiving breast radiation therapy, 50 Gy in 2 Gy fractions daily for 5 weeks. The endpoints were to ascertain the delay in the appearance and the degree of severity of dermatitis throughout the study period in accordance to the Therapy Oncology Group (RTOG) score. Results : The results indicated that the topical application of VTC delayed and mitigated the radiodermatitis. When compared to the Johnson's Baby Oil, a significant decrease ( p = 0.025) in the incidence of grade 1 was seen at week two, and also in grade 2 and 3 at week 3 ( p = 0.003) and week 4 ( p = 0.02), respectively, in the VTC cohort. A concomitant decrease in the average severity was also observed at week 2 ( p = 0.02), week 3 ( p = 0.05) and week 4 ( p = 0.03). The results indicate that VTC cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy. The result of this study indicates the beneficial effects. Double blind randomized control studies are required to further confirm the beneficial effects of VTC in mitigating radiodermatitis is people undergoing radiation treatment for their cancer.

Sandalwood Oil and Turmeric-Based Cream Prevents Ionizing Radiation-Induced Dermatitis in Breast Cancer Patients: Clinical Study

PubMed Central

Rao, Suresh; Hegde, Sanath Kumar; Baliga-Rao, Manjeshwar Poonam; Lobo, Jyothi; Palatty, Princy Louis; George, Thomas; Baliga, Manjeshwar Shrinath

2017-01-01

Background: The primary objective of this study was to ascertain the benefit of Vicco turmeric Ayurvedic cream (VTC; Vicco Laboratories, Mumbai, India) sandalwood oil and turmeric-based cream in preventing radiodermatitis in women undergoing curative radiotherapy for their breast cancer. Methods and Materials: The study was an investigator-blinded randomized study with Johnsons Baby Oil (JBO; Johnson & Johnson Ltd., Baddi, India) as a comparator, administered daily from the start of radiation therapy for 5 weeks in women receiving breast radiation therapy, 50 Gy in 2 Gy fractions daily for 5 weeks. The endpoints were to ascertain the delay in the appearance and the degree of severity of dermatitis throughout the study period in accordance to the Therapy Oncology Group (RTOG) score. Results: The results indicated that the topical application of VTC delayed and mitigated the radiodermatitis. When compared to the Johnson’s Baby Oil, a significant decrease (p = 0.025) in the incidence of grade 1 was seen at week two, and also in grade 2 and 3 at week 3 (p = 0.003) and week 4 (p = 0.02), respectively, in the VTC cohort. A concomitant decrease in the average severity was also observed at week 2 (p = 0.02), week 3 (p = 0.05) and week 4 (p = 0.03). Conclusions: The results indicate that VTC cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy. The result of this study indicates the beneficial effects. Double blind randomized control studies are required to further confirm the beneficial effects of VTC in mitigating radiodermatitis is people undergoing radiation treatment for their cancer. PMID:28930259

Twice-weekly administration of kisspeptin-54 for 8 weeks stimulates release of reproductive hormones in women with hypothalamic amenorrhea.

PubMed

Jayasena, C N; Nijher, G M K; Abbara, A; Murphy, K G; Lim, A; Patel, D; Mehta, A; Todd, C; Donaldson, M; Trew, G H; Ghatei, M A; Bloom, S R; Dhillo, W S

2010-12-01

Kisspeptin is a novel therapeutic target for infertility. A single kisspeptin-54 (KP-54) injection acutely stimulates the release of reproductive hormones in women with hypothalamic amenorrhea (HA), a commonly occurring condition characterized by absence of menstruation; however, twice-daily administration of KP-54 results in tachyphylaxis. We determined the time course of desensitization to twice-daily KP-54 injections, compared the effects of twice-daily and twice-weekly administration regimens of KP-54, and studied the effects of long-term twice-weekly administration of KP-54 on the release of reproductive hormones in women with HA. When KP-54 was administered twice daily, responsiveness to luteinizing hormone (LH) diminished gradually, whereas responsiveness to follicle-stimulating hormone (FSH) was nearly abolished by day 2. Twice-weekly KP-54 administration resulted in only partial desensitization, in contrast to the complete tolerance achieved with twice-daily administration. Women with HA who were treated with twice-weekly KP-54 injections had significantly elevated levels of reproductive hormones after 8 weeks as compared with treatment with saline. No adverse effects were observed. This study provides novel pharmacological data on the effects of KP-54 on the release of reproductive hormones in women with HA.

The Enhancement of Student's Learning in Both Lower-Division and Upper-Division Classes by a Quiz-Based Approach

ERIC Educational Resources Information Center

Faraji, Sepideh

2012-01-01

In this study, an investigation into the proper use of weekly quizzes in chemical engineering program has been conducted. The traditional weekly homework assignments were replaced with weekly paper quizzes. Achievement levels of students were compared with those students who learn through traditional homework assignments only. The results show the…

Randomized Controlled Trial Comparing Collagen/Oxidized Regenerated Cellulose/Silver to Standard of Care in the Management of Venous Leg Ulcers.

PubMed

Cullen, Breda M; Serena, Thomas E; Gibson, Molly C; Snyder, Robert J; Hanft, Jason R; Yaakov, Raphael A

2017-10-01

To assess healing outcomes in venous leg ulcers (VLUs) treated with a combination of collagen, oxidized regenerated cellulose, and silver in conjunction with standard of care (SOC; intervention group) compared with SOC alone (control group). Standard of care included ADAPTIC nonadhering dressing (Acelity, San Antonio, Texas) and compression. Randomized controlled trial that followed patients in 3 US facilities for 12 weeks or until complete healing. Forty-nine patients with VLUs were randomized to either the intervention group (n = 22) or the control group (n = 27). Wound healing over 12 weeks. Intent-to-treat analysis showed a mean percentage wound area reduction at 12 weeks of 85.6% (SD, 28.6%) for the intervention group and 72.5% (SD, 77.8%) for the control group. There was a higher healing rate in the intervention group compared with patients who received SOC only at both week 4 (23% vs 11%) and week 12 (64% vs 59%). There were no adverse events related to the study therapy. Although the results were not significant, there was a trend toward faster healing in the intervention group. The results of this study indicate that collagen/oxidized regenerated cellulose/silver is a suitable and safe adjunctive intervention for use with SOC to manage VLUs.

Natural Gas Storage Report, Weekly EIA-AGA Comparison

EIA Publications

2002-01-01

This report is intended to aid data users by examining differences between the Energy Information Administration and American Gas Association weekly surveys and comparing the results of the two surveys for the brief period of time in which they overlapped.

Effects of different doses of high-speed resistance training on physical performance and quality of life in older women: a randomized controlled trial

PubMed Central

Ramirez-Campillo, Rodrigo; Diaz, Daniela; Martinez-Salazar, Cristian; Valdés-Badilla, Pablo; Delgado-Floody, Pedro; Méndez-Rebolledo, Guillermo; Cañas-Jamet, Rodrigo; Cristi-Montero, Carlos; García-Hermoso, Antonio; Celis-Morales, Carlos; Moran, Jason; Buford, Thomas W; Rodriguez-Mañas, Leocadio; Alonso-Martinez, Alicia M; Izquierdo, Mikel

2016-01-01

Objective This study aimed to compare the effects of two frequencies of high-speed resistance training (HSRT) on physical performance and quality of life of older women. Methods A total of 24 older women participated in a 12-week HSRT program composed of either two or three sessions/week (equated for volume and intensity). Women were randomized into three arms: a control group (CG, n=8), a resistance training group performing two sessions/week (RT2, n=8), and a resistance training group performing three sessions/week (RT3, n=8). The training program for both experimental groups included exercises that required high-speed concentric muscle actions. Results No baseline differences were observed among groups. Compared with the CG, both training groups showed similar small to moderate improvements (P<0.05) in muscle strength, power, functional performance, balance, and quality of life. Conclusion These results suggest that equated for volume and intensity, two and three training sessions/week of HSRT are equally effective for improving physical performance and quality of life of older women. PMID:28008239

Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: Randomised, double-blind, placebo-controlled trial.

PubMed

Anzić, S A; Turkalj, M; Župan, A; Labor, M; Plavec, D; Baudoin, T

2018-04-01

Gastroesophageal reflux recommended treatment (dose and duration) with proton-pump inhibitor (PPI) compared to placebo significantly reduces the signs and symptoms of laryngopharyngeal reflux (LPR) and comorbid chronic rhinosinusitis (CRS). Double-blind randomised placebo-controlled trial. Eight weeks of treatment with omeprazole 20 mg once daily (OD). Sixty patients (28 women, aged 19-87 years) with diagnosed LPR and comorbid CRS. Significant reduction in signs and symptoms (reflux symptom index (RSI) score as subjective, and reflux finding score (RFS) as objective measure) of LPR after 8 weeks of treatment with omeprazole 20 mg OD when compared to placebo. Secondary objectives were significant reduction in signs and symptoms of comorbid CRS after 8 weeks of treatment with omeprazole 20 mg OD when compared to placebo and the association of the severity of signs and symptoms of LPR with the ones of CRS. RSI and RFS decreased significantly more in the active treatment group after 8 weeks compared to placebo (P < .001 for both). CRS and endoscopy scoring decreased both significantly more in the active group after 8 weeks compared to placebo (P < .001 for both). CRS scoring significantly correlated with RSI (R = 0.312, P = .015) but not with RFS (R = 0.199, P = .127). The results of our trial suggest that omeprazole 20 mg OD for 8 weeks was effective in reducing signs and symptoms of both LPR and CRS, although in most patients still present at the end of the trial. © 2017 John Wiley & Sons Ltd.

A quantitative method to evaluate the donor corneal tissue quality used in a comparative study between two hypothermic preservation media.

PubMed

Parekh, Mohit; Salvalaio, Gianni; Ferrari, Stefano; Amoureux, Marie-Claude; Albrecht, Cecile; Fortier, Denis; Ponzin, Diego

2014-12-01

To standardize a new evaluation technique for calculating the overall quality (OQ) of the donor cornea and validate it using a comparative study of corneas preserved in Optisol-GS and Cornea Cold®. Thirty pairs of donor corneas were selected for a 4 week in vitro comparative study using masked observers. Physiological parameters like thickness, transparency, viable endothelial cell density (VECD) and morphology were transformed to numerical range (0-4) to obtain the OQ. Microbiological examination was performed using Bactec instrument. Students t test showed statistically better results (p < 0.05) from week 3 for thickness, week 2 for transparency and week 1 for morphology and VECD; statistical significance (p < 0.05) was found for OQ from week 2 for the corneas preserved in Cornea Cold® compared to Optisol-GS. Epithelial quality was similar regardless of the medium. Microbiological examination showed absence of aerobic and anaerobic microorganisms in both media. OQ method is efficient, consistent and easy, now validated for comparative studies. Further refinement is necessary for its use at eye-banks, bio-banks and research or transplantation purposes. Cornea Cold® is a promising hypothermic corneal storage medium with preservation time ≤21 days. This permits higher flexibility, evaluation accuracy, longer duration for surgical preparation and ease of transportation.

Nucleotide supplementation and the growth of term small for gestational age infants.

PubMed Central

Cosgrove, M.; Davies, D. P.; Jenkins, H. R.

1996-01-01

A double blind randomised controlled trial in small for gestational age (SGA) infants, whose intestinal mucosa was shown to be functionally impaired as a result of intrauterine undernutrition, was carried out to investigate the hypothesis that nucleotide supplementation of a milk formula could improve catchup growth. Anthropometric data were collected on 74 infants, 39 randomly allocated to the nucleotide supplemented group (group N) and 35 to a standard formula group (group S). From study entry to 2 months of age, infants in group N had significantly higher mean rates of weight gain (106.3 compared with 94.7 g/kg baseline weight/week) and length gain (21.8 v 19.7 mm/m baseline length/week). Over the whole six months for which the trial formula was provided group N had significantly higher mean rates of gain of weight (80.1 compared with 71.8 g/kg baseline weight/week), length (16.2 compared with 15.0 mm/m baseline length/week), and head circumference (11.8 compared with 10.8 mm/m baseline head circumference/week). Catchup growth in SGA infants is therefore improved by nucleotide supplementation of infant formula. PMID:8777659

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

Comparative trial of the canine parvovirus, canine distemper virus and canine adenovirus type 2 fractions of two commercially available modified live vaccines.

PubMed

Bergman, J G H E; Muniz, M; Sutton, D; Fensome, R; Ling, F; Paul, G

2006-11-25

The results of vaccinating two groups of puppies with commercial vaccines, both of which claimed to provide adequate protection with a final vaccination at 10 weeks of age, were compared. Groups of 19 and 20 puppies with similar titres of maternally derived antibodies against canine parvovirus (cpv), canine distemper virus (cdv) and canine adenovirus type 2 (cav-2) at four weeks of age were vaccinated at six and 10 weeks of age and their responses to each vaccination were measured by comparing the titres against cpv, cdv and cav-2 in the serum samples taken immediately before the vaccination and four weeks later. After the vaccination at six weeks of age, all 19 of the puppies in group 1 had responded to cpv and cdv, and 14 had responded to cav-2; in group 2, 17 of the 20 had responded to cpv, 19 to cdv and 15 to cav-2. In both groups the puppies that did not respond to the first vaccination had responded serologically to cpv, cdv and cav-2 at 10 weeks of age.

Weekly Carboplatin Reduces Toxicity During Synchronous Chemoradiotherapy for Merkel Cell Carcinoma of Skin

DOE Office of Scientific and Technical Information (OSTI.GOV)

Poulsen, Michael; Walpole, Euan; Harvey, Jennifer

Purpose: The toxicity of radiotherapy (RT) combined with weekly carboplatin and adjuvant carboplatin and etoposide was prospectively assessed in a group of patients with high-risk Stage I and II Merkel cell carcinoma of the skin. This regimen was compared with the Trans-Tasman Radiation Oncology Group 96:07 study, which used identical eligibility criteria but carboplatin and etoposide every 3 weeks during RT. Patients and Methods: Patients were eligible if they had disease localized to the primary site and lymph nodes, with high-risk features. RT was delivered to the primary site and lymph nodes to a dose of 50 Gy and weeklymore » carboplatin (area under the curve of 2) was given during RT. This was followed by three cycles of carboplatin and etoposide. A total of 18 patients were entered into the study, and their data were compared with the data from 53 patients entered into the Trans-Tasman Radiation Oncology Group 96:07 study. Results: Involved lymph nodes (Stage II) were present in 14 patients (77%). Treatment was completed as planned in 16 patients. The weekly carboplatin dose was delivered in 17 patients, and 15 were able to complete all three cycles of adjuvant carboplatin and etoposide. Grade 3 and 4 neutrophil toxicity occurred in 7 patients, but no cases of febrile neutropenia developed. Compared with the Trans-Tasman Radiation Oncology Group 96:07 protocol (19 of 53 cases of febrile neutropenia), the reduction in the febrile neutropenia rate (p = 0.003) and decrease in Grade 3 skin toxicity (p = 0.006) were highly statistically significant. Conclusion: The results of our study have shown that weekly carboplatin at this dosage is a safe way to deliver synchronous chemotherapy during RT for MCC and results in a marked reduction of febrile neutropenia and Grade 3 skin toxicity compared with the three weekly regimen.« less

Double-blind comparative trial of indoprofen and acetylsalicylic acid in osteoarthritis.

PubMed

Katona, G

1981-01-01

The effectiveness, safety and acceptability of indoprofen (IP) and acetylsalicylic acid (ASA) were assessed in patients with osteoarthritis, in a double-blind comparative trial. Each patient received IP 600 mg/day or ASA 2100 mg/day for a four-week period; after a one-week wash-out period, the same drug was given at a higher dosage (IP 800 or ASA 2800 mg/day) for another four weeks. Seventeen patients on indoprofen and 14 on SAS completed the trial. A significant improvement was obtained with indoprofen in the different parameters measuring pain, from the first treatment period; results were similar at the end of the second period. Results with ASA, at both dosages, appeared less impressive. Two patients on indoprofen and five on ASA complained of side effects.

Short photoperiod-induced ovarian regression is mediated by apoptosis in Siberian hamsters (Phodopus sungorus)

PubMed Central

Moffatt-Blue, C S; Sury, J J; Young, Kelly A

2009-01-01

Siberian hamster reproduction is mediated by photoperiod-induced changes in gonadal activity. However, little is known about how photoperiod induces cellular changes in ovarian function. We hypothesized that exposing female hamsters to short (inhibitory) as opposed to long (control) photoperiods would induce an apoptosis-mediated disruption of ovarian function. Ovaries and plasma from hamsters exposed to either long (LD, 16 h light:8 h darkness) or short (SD, 8 h light:16 h darkness) days were collected during diestrus II after 3, 6, 9 and 12 weeks and processed for histology or RIA respectively. Apoptosis was assessed by in situ TUNEL and active caspase-3 protein immunolabeling. No significant differences were observed among LD hamsters for any parameter; therefore, these control data were pooled. SD exposure induced a decline in preantral follicles (P < 0.05), early antral/antral follicles (P < 0.01) and corpora lutea (P < 0.01) by week 12 as compared with LD. Terminal atretic follicles appeared by SD week 9; by week 12, these had become the predominant ovarian structures. Estradiol concentrations decreased by weeks 9 and 12 SD when compared with both LD and week-3 SD hamsters (P < 0.05); however, no changes were observed for progesterone. TUNEL-positive follicles in SD ovaries increased at week 3 and subsequently declined by week 12 as compared with LD ovaries (P < 0.01). Active capsase-3 protein immunostaining peaked at SD week 3 as compared with all other groups (P < 0.01). TUNEL and capsase-3 immunolabeling were localized to granulosa cells of late-preantral and early-antral/antral follicles. These data indicate that SD exposure rapidly induces follicular apoptosis in Siberian hamsters, which ultimately disrupts both estradiol secretion and folliculogenesis, resulting in the seasonal loss of ovarian function. PMID:16595728

Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial.

PubMed

Yancy, William S; Mayer, Stephanie B; Coffman, Cynthia J; Smith, Valerie A; Kolotkin, Ronette L; Geiselman, Paula J; McVay, Megan A; Oddone, Eugene Z; Voils, Corrine I

2015-06-16

Choosing a diet rather than being prescribed one could improve weight loss. To examine whether offering choice of diet improves weight loss. Double-randomized preference trial of choice between 2 diets (choice) versus random assignment to a diet (comparator) over 48 weeks. (ClinicalTrials.gov: NCT01152359). Outpatient clinic at a Veterans Affairs medical center. Outpatients with a body mass index of at least 30 kg/m2. Choice participants received information about their food preferences and 2 diet options (low-carbohydrate diet [LCD] or low-fat diet [LFD]) before choosing and were allowed to switch diets at 12 weeks. Comparator participants were randomly assigned to 1 diet for 48 weeks. Both groups received group and telephone counseling for 48 weeks. The primary outcome was weight at 48 weeks. Of 105 choice participants, 61 (58%) chose the LCD and 44 (42%) chose the LFD; 5 (3 on the LCD and 2 on the LFD) switched diets at 12 weeks, and 87 (83%) completed measurements at 48 weeks. Of 102 comparator participants, 53 (52%) were randomly assigned to the LCD and 49 (48%) were assigned to the LFD; 88 (86%) completed measurements. At 48 weeks, estimated mean weight loss was 5.7 kg (95% CI, 4.3 to 7.0 kg) in the choice group and 6.7 kg (CI, 5.4 to 8.0 kg) in the comparator group (mean difference, -1.1 kg [CI, -2.9 to 0.8 kg]; P = 0.26). Secondary outcomes of dietary adherence, physical activity, and weight-related quality of life were similar between groups at 48 weeks. Only 2 diet options were provided. Results from this sample of older veterans might not be generalizable to other populations. Contrary to expectations, the opportunity to choose a diet did not improve weight loss.

Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study

PubMed Central

Zhang, Wei; Bansback, Nick; Sun, Huiying; Pedersen, Ronald; Kotak, Sameer; Anis, Aslam H

2016-01-01

Objective To assess changes in work productivity in patients who have achieved response using etanercept (ETN) 50 mg+methotrexate (MTX) (phase I) are randomised to ETN 25 mg+MTX versus MTX versus placebo (phase II) and then withdrawn from treatment (phase III). Methods Patients included in the analysis were in employment entering phase II of the PRIZE trial and had one or more follow-ups. Phase II was a 39-week, randomised and double-blind comparison of the 3 dose-reduction treatments. Phase III was a 26-week observational study where treatment was withdrawn. The Valuation of Lost Productivity was completed approximately every 13 weeks to estimate productivity impacts from a societal perspective. Results A total of 120 participants were included in our analyses. During phase II, ETN25+MTX or MTX improved paid work productivity by over 100 hours compared with placebo, amounting to a gain of €1752 or €1503, respectively. ETN25+MTX compared with placebo gains €1862 in total paid/unpaid productivity. At week 52, the 3-month paid work productivity loss was 21.8, 12.8 and 14.0 hours, respectively. The productivity loss increased at week 64 from week 52, dropped at week 76 for all treatment groups and then continued rising after week 76 for the placebo group (71.9 hours at week 91) but not for the other 2 groups (21.9 hours for ETX25+MTX and 27.6 hours for MTX). Conclusions The work productivity gain in phase I as a result of ETN50+MTX was marginally lost in the dose-reduction treatment groups, ETN25+MTX and MTX, but substantially lost in the placebo group during phase II. Trial registration number NCT00913458; Results. PMID:27486524

Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis

PubMed Central

Takeuchi, Tsutomu; Yamanaka, Hisashi; Tanaka, Yoshiya; Sakurai, Takeo; Saito, Kazuyoshi; Ohtsubo, Hideo; Lee, Sang Joon; Nambu, Yoshihiro

2015-01-01

Objectives. To demonstrate the pharmacokinetic equivalence of CT-P13 and its innovator infliximab (IFX) in Japanese patients with rheumatoid arthritis (RA), and to compare the efficacy and safety of these drugs, administered for 54 weeks. Methods. In a randomized, double-blind, parallel-group, multicenter study, 3 mg/kg of CT-P13 or IFX, in combination with methotrexate (MTX) (6–16 mg/week), was administered for 54 weeks to Japanese active RA patients with an inadequate response to MTX, to demonstrate the pharmacokinetic equivalence, based on the area under the curve (AUCτ) (weeks 6–14) and Cmax (week 6) of these drugs, and to compare their efficacy and safety. Results. The CT-P13-to-IFX ratios (90% confidence intervals) of the geometric mean AUCτ and Cmax values in patients negative for antibodies to infliximab at week 14 were 111.62% (100.24–124.29%) and 104.09% (92.12–117.61%), respectively, demonstrating the pharmacokinetic equivalence of these drugs. In the full analysis set, CT-P13 and IFX showed comparable therapeutic effectiveness, as measured by the American College of Rheumatology, Disease Activity Score in 28 joints, the European League Against Rheumatism, and other efficacy criteria, at weeks 14 and 30. The incidence of adverse events was similar for these drugs. Conclusion. CT-P13 and IFX, administered at a dose of 3 mg/kg in combination with MTX to active RA patients, were pharmacokinetically equivalent and comparable in efficacy and safety. PMID:25736355

Term Elective Induction of Labor and Perinatal Outcomes in Obese Women: Retrospective Cohort Study

PubMed Central

Lee, Vanessa R.; Darney, Blair G.; Snowden, Jonathan M.; Main, Elliott K.; Gilbert, William; Chung, Judith; Caughey, Aaron B.

2015-01-01

Objective To compare perinatal outcomes between elective induction of labor (eIOL) and expectant management in obese women. Design Retrospective cohort study. Setting Deliveries in California in 2007. Population Term, singleton, vertex, nonanomalous deliveries among obese women (n=74,725). Methods Women who underwent eIOL at 37 weeks were compared with women who were expectantly managed at that gestational age. Similar comparisons were made at 38, 39, and 40 weeks. Results were stratified by parity. Chi-square tests and multivariable logistic regression were used for statistical comparison. Main Outcome Measures Method of delivery, severe perineal lacerations, postpartum hemorrhage, chorioamnionitis, macrosomia, shoulder dystocia, brachial plexus injury, respiratory distress syndrome. Results The odds of cesarean delivery were lower among nulliparous women with eIOL at 37 weeks (odds ratio [OR] 0.55, 95% confidence interval [CI] 0.34–0.90) and 39 weeks (OR 0.77, 95% CI 0.63–0.95) compared to expectant management. Among multiparous women with a prior vaginal delivery, eIOL at 37 (OR 0.39, 95% CI 0.24–0.64), 38 (OR 0.65, 95% CI 0.51–0.82), and 39 weeks (OR 0.67, 95% CI 0.56–0.81) was associated with lower odds of cesarean. Additionally, eIOL at 38, 39, and 40 weeks was associated with lower odds of macrosomia. There were no differences in the odds of operative vaginal delivery, lacerations, brachial plexus injury, or respiratory distress syndrome. Conclusions In obese women, term eIOL may decrease the risk of cesarean delivery, particularly in multiparas, without increasing the risks of other adverse outcomes when compared with expectant management. Tweetable Abstract Elective induction of labor in obese women does not increase risk of cesarean or other perinatal morbidities. PMID:26840780

Expectant management compared with physical examination-indicated cerclage (EM-PEC) in selected women with a dilated cervix at 14(0/7)-25(6/7) weeks: results from the EM-PEC international cohort study.

PubMed

Pereira, Leonardo; Cotter, Amanda; Gómez, Ricardo; Berghella, Vincenzo; Prasertcharoensuk, Witoon; Rasanen, Juha; Chaithongwongwatthana, Surasith; Mittal, Suneeta; Daly, Sean; Airoldi, Jim; Tolosa, Jorge E

2007-11-01

The objective of the study was to compare pregnancy outcomes in selected women with a dilated cervix who underwent expectant management or physical examination-indicated cerclage. This was a historical cohort study conducted by the Global Network for Perinatal and Reproductive Health. Women between 14(0/7) and 25(6/7) weeks' gestation with a dilated cervix were identified at 10 centers by ultrasound or digital examination. Primary outcome was time from presentation until delivery (weeks). Secondary outcomes were neonatal survival, birthweight greater than 1500 g and preterm birth less than 28 weeks. Multivariate regression was used to assess the likelihood of neonatal outcomes and control for confounders. Of 225 women, 152 received a physical examination-indicated cerclage, and 73 were managed expectantly without cerclage. Cervical dilation, gestational age at presentation, and antenatal steroid use differed between groups. In the adjusted analyses, cerclage was associated with longer interval from presentation until delivery, improved neonatal survival, birthweight greater than 1500 g and preterm birth less than 28 weeks, compared with expectant management. Similar results were obtained in the analyses limited to women dilated between 2 and 4 cm (n = 122). In this study, the largest cohort reported to date, physical examination-indicated cerclage appears to prolong gestation and improve neonatal survival, compared with expectant management in selected women with cervical dilation between 14(0/7) and 25(6/7) weeks. A randomized, controlled trial should be conducted to determine whether these potential benefits outweigh the risks of cerclage placement in this population.

Endothelial follistatin-like-1 regulates the postnatal development of the pulmonary vasculature by modulating BMP/Smad signaling

PubMed Central

Tania, Navessa P.; Maarsingh, Harm; T. Bos, I. Sophie; Mattiotti, Andrea; Prakash, Stuti; Timens, Wim; Gunst, Quinn D.; Jimenez-Borreguero, Luis J.; Schmidt, Martina; van den Hoff, Maurice J.B.; Gosens, Reinoud

2017-01-01

Bone morphogenetic protein (BMP) signaling regulates vascular smooth muscle maturation, endothelial cell proliferation, and tube formation. The endogenous BMP antagonist Follistatin-like 1 (Fstl1) is highly expressed in pulmonary vascular endothelium of the developing mouse lung, suggesting a role in pulmonary vascular formation and vascular homeostasis. The aim of this study was to investigate the role of Fstl1 in the pulmonary vascular endothelium. To this aim, Fstl1 was conditionally deleted from endothelial and endothelial-derived cells using Tie2-cre driven Fstl1-KO mice (Fstl1-eKO mice). Endothelial-specific Fstl1 deletion was postnatally lethal, as ∼70% of Fstl1-eKO mice died at three weeks after birth. Deletion of Fstl1 from endothelium resulted in a reduction of right ventricular output at three weeks after birth compared with controls. This was associated with pulmonary vascular remodeling, as the percentage of actin-positive small pulmonary vessels was increased at three weeks in Fstl1-eKO mice compared with controls. Endothelial deletion of Fstl1 resulted in activation of Smad1/5/8 signaling and increased BMP/Smad-regulated gene expression of Jagged1, Endoglin, and Gata2 at one week after birth compared with controls. In addition, potent vasoconstrictor Endothelin-1, the expression of which is driven by Gata2, was increased in expression, both on the mRNA and protein levels, at one week after birth compared with controls. At three weeks, Jagged1 was reduced in the Fstl1-eKO mice whereas Endoglin and Endothelin-1 were unchanged. In conclusion, loss of endothelial Fstl1 in the lung is associated with elevated BMP-regulated genes, impaired small pulmonary vascular remodeling, and decreased right ventricular output. PMID:28680581

Endothelial follistatin-like-1 regulates the postnatal development of the pulmonary vasculature by modulating BMP/Smad signaling.

PubMed

Tania, Navessa P; Maarsingh, Harm; T Bos, I Sophie; Mattiotti, Andrea; Prakash, Stuti; Timens, Wim; Gunst, Quinn D; Jimenez-Borreguero, Luis J; Schmidt, Martina; van den Hoff, Maurice J B; Gosens, Reinoud

2017-03-01

Bone morphogenetic protein (BMP) signaling regulates vascular smooth muscle maturation, endothelial cell proliferation, and tube formation. The endogenous BMP antagonist Follistatin-like 1 (Fstl1) is highly expressed in pulmonary vascular endothelium of the developing mouse lung, suggesting a role in pulmonary vascular formation and vascular homeostasis. The aim of this study was to investigate the role of Fstl1 in the pulmonary vascular endothelium. To this aim, Fstl1 was conditionally deleted from endothelial and endothelial-derived cells using Tie2-cre driven Fstl1 -KO mice ( Fstl1 -eKO mice). Endothelial-specific Fstl1 deletion was postnatally lethal, as ∼70% of Fstl1 -eKO mice died at three weeks after birth. Deletion of Fstl1 from endothelium resulted in a reduction of right ventricular output at three weeks after birth compared with controls. This was associated with pulmonary vascular remodeling, as the percentage of actin-positive small pulmonary vessels was increased at three weeks in Fstl1 -eKO mice compared with controls. Endothelial deletion of Fstl1 resulted in activation of Smad1/5/8 signaling and increased BMP/Smad-regulated gene expression of Jagged1, Endoglin, and Gata2 at one week after birth compared with controls. In addition, potent vasoconstrictor Endothelin-1, the expression of which is driven by Gata2, was increased in expression, both on the mRNA and protein levels, at one week after birth compared with controls. At three weeks, Jagged1 was reduced in the Fstl1 -eKO mice whereas Endoglin and Endothelin-1 were unchanged. In conclusion, loss of endothelial Fstl1 in the lung is associated with elevated BMP-regulated genes, impaired small pulmonary vascular remodeling, and decreased right ventricular output.

Comparative study of new bone formation capability of zirconia bone graft material in rabbit calvarial.

PubMed

Kim, Ik-Jung; Shin, Soo-Yeon

2018-06-01

The purpose of this study was to compare the new bone formation capability of zirconia with those of other synthetic bone grafts. Twelve rabbits were used and four 6-mm diameter transcortical defects were formed on each calvaria. Each defect was filled with Osteon II (Os), Tigran PTG (Ti), and zirconia (Zi) bone grafts. For the control group, the defects were left unfilled. The rabbits were sacrificed at 2, 4, and 8 weeks. Specimens were analyzed through micro computed tomography (CT) and histomorphometric analysis. The Ti and Zi groups showed significant differences in the amount of newly formed bone between 2 and 4 weeks and between 2 and 8 weeks ( P <.05). The measurements of total bone using micro CT showed significant differences between the Os and Ti groups and between the Os and Zi groups at 2 and 8 weeks ( P <.05). Comparing by week in each group, the Ti group showed a significant difference between 4 and 8 weeks. Histomorphometric analysis also showed significant differences in new bone formation between the control group and the experimental groups at 2, 4, and 8 weeks ( P <.05). In the comparison of newly formed bone, significant differences were observed between 2 and 4 weeks and between 2 and 8 weeks ( P <.05) in all groups. Zirconia bone graft material showed satisfactory results in new bone formation and zirconia could be used as a new synthetic bone graft material.

Financial incentives and purchase restrictions in a food benefit program affect the types of foods and beverages purchased: results from a randomized trial.

PubMed

French, Simone A; Rydell, Sarah A; Mitchell, Nathan R; Michael Oakes, J; Elbel, Brian; Harnack, Lisa

2017-09-16

This research evaluated the effects of financial incentives and purchase restrictions on food purchasing in a food benefit program for low income people. Participants (n=279) were randomized to groups: 1) Incentive- 30% financial incentive for fruits and vegetables purchased with food benefits; 2) Restriction- no purchase of sugar-sweetened beverages, sweet baked goods, or candies with food benefits; 3) Incentive plus Restriction; or 4) Control- no incentive or restrictions. Participants received a study-specific debit card where funds were added monthly for 12-weeks. Food purchase receipts were collected over 16 weeks. Total dollars spent on grocery purchases and by targeted food categories were computed from receipts. Group differences were examined using general linear models. Weekly purchases of fruit significantly increased in the Incentive plus Restriction ($4.8) compared to the Restriction ($1.7) and Control ($2.1) groups (p <.01). Sugar-sweetened beverage purchases significantly decreased in the Incentive plus Restriction (-$0.8 per week) and Restriction ($-1.4 per week) groups compared to the Control group (+$1.5; p< .0001). Sweet baked goods purchases significantly decreased in the Restriction (-$0.70 per week) compared to the Control group (+$0.82 per week; p < .01). Paired financial incentives and restrictions on foods and beverages purchased with food program funds may support more healthful food purchases compared to no incentives or restrictions. Clinicaltrials.gov Identifier: NCT02643576 .

Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial

PubMed Central

Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

2018-01-01

Abstract Objectives To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Design Prospective, randomized, 52 week, single blind comparative effectiveness trial. Setting Urban tertiary care academic hospital in the United States between March 2012 and September 2016. Participants 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Interventions Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. Main outcome measures The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient’s global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. Results FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient’s global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group difference in FIQR scores=16.2 points, 8.7 to 23.6, P<0.001). The groups who received tai chi for 24 weeks showed greater improvements than those who received it for 12 weeks (difference in FIQR scores=9.6 points, 2.6 to 16.6, P=0.007). There was no significant increase in benefit for groups who received tai chi twice weekly compared with once weekly. Participants attended the tai chi training sessions more often than participants attended aerobic exercise. The effects of tai chi were consistent across all instructors. No serious adverse events related to the interventions were reported. Conclusion Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug treatment, for a variety of outcomes for patients with fibromyalgia. Longer duration of tai chi showed greater improvement. This mind-body approach may be considered a therapeutic option in the multidisciplinary management of fibromyalgia. Trial registration ClinicalTrials.gov NCT01420640. PMID:29563100

Convergence and accommodation development is pre-programmed in premature infants

PubMed Central

Horwood, Anna M; Toor, Sonia S; Riddell, Patricia M

2015-01-01

Purpose This study investigated whether vergence and accommodation development in pre-term infants is pre-programmed or is driven by experience. Methods 32 healthy infants, born at mean 34 weeks gestation (range 31.2-36 weeks) were compared with 45 healthy full-term infants (mean 40.0 weeks) over a 6 month period, starting at 4-6 weeks post-natally. Simultaneous accommodation and convergence to a detailed target were measured using a Plusoptix PowerRefII infra-red photorefractor as a target moved between 0.33m and 2m. Stimulus/response gains and responses at 0.33m and 2m were compared by both corrected (gestational) age and chronological (post-natal) age. Results When compared by their corrected age, pre-term and full-term infants showed few significant differences in vergence and accommodation responses after 6-7 weeks of age. However, when compared by chronological age, pre-term infants’ responses were more variable, with significantly reduced vergence gains, reduced vergence response at 0.33m, reduced accommodation gain, and increased accommodation at 2m, compared to full-term infants between 8-13 weeks after birth. Conclusions When matched by corrected age, vergence and accommodation in pre-term infants show few differences from full-term infants’ responses. Maturation appears pre-programmed and is not advanced by visual experience. Longer periods of immature visual responses might leave pre-term infants more at risk of development of oculomotor deficits such as strabismus. PMID:26275135

Effect of Frequency of Brushing Teeth on Plaque and Calculus Accumulation, and Gingivitis in Dogs.

PubMed

Harvey, Colin; Serfilippi, Laurie; Barnvos, Donald

2015-01-01

The efficacy of brushing the teeth of beagle dogs in a randomized, controlled, blinded study design using a clearly-defined brushing technique was evaluated for 4 brushing frequencies: brushing daily, brushing every other day, brushing weekly and brushing every other week, compared with no brushing in a control group of dogs. All dogs were fed a standard dry kibble diet during the study. Standard plaque, calculus, and gingivitis indices were used to score the teeth. A 'clean tooth' model was used. No gingival or non-gingival lacerations or other signs of injury to oral tissues were found at the end of the 28 day trial period. Brushing more frequently had greater effectiveness in retarding accumulation of plaque and calculus, and reducing the severity of pre-existing gingivitis. Brushing daily or every other day produced statistically significant improved results compared with brushing weekly or every other week. Based on the results of this study, daily brushing is recommended.

Neonatal morbidity by week of gestational age for twins compared to singletons: a population-based cohort study.

PubMed

Wolfe, Katherine; Tabangin, Meredith; Meinzen-Derr, Jareen; Snyder, Candice; Lewis, David; DeFranco, Emily

2014-02-01

Quantify neonatal morbidity by week of gestation for twins compared with singletons. We performed a population-based retrospective cohort study of all Ohio births from 2006 to 2007. Composite neonatal morbidity consisting of Apgar score < 7 at 5 minutes, assisted ventilation > 6 hours, neonatal transport, or seizures was compared between singletons and twins from 34 to 41 weeks. Neonatal morbidity was the lowest in twins delivered at 37 completed weeks and 2 weeks later for singletons at 39 weeks. Twin morbidity rapidly increased after 37 weeks and reached 15.8% at 41 weeks versus the singleton morbidity rate of 3.4% at 41 weeks. Twins delivered at 39 weeks and beyond were more than twice as likely to incur neonatal morbidity compared with singletons. The lowest rate of neonatal morbidity occurs at 37 weeks for twins versus 39 weeks for singleton births. The increased risk after 37 weeks for twins accelerates at a faster rate compared with that for singletons born past 39 weeks. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Enhanced daidzin production from jasmonic and acetyl salicylic acid elicited hairy root cultures of Psoralea corylifolia L. (Fabaceae).

PubMed

Zaheer, Mohd; Reddy, Vudem Dashavantha; Giri, Charu Chandra

2016-07-01

Daidzin (7-O-glucoside of daidzein) has several pharmacological benefits in herbal remedy, as antioxidant and shown antidipsotropic activity. Hairy root culture of Psoralea corylifolia L. was developed for biomass and enhanced daidzin production using signalling compounds such as jasmonic acid (JA) and acetyl salicylic acid (ASA). Best response of 2.8-fold daidzin (5.09% DW) with 1 μM JA treatment after second week and 7.3-fold (3.43% DW) with 10 μM JA elicitation after 10th week was obtained from hairy roots compared to untreated control. ASA at 10 μM promoted 1.7-fold increase in daidzin (1.49% DW) content after seventh week compared to control (0.83% DW). Addition of 25 μM ASA resulted in 1.44% DW daidzin (1.5-fold increase) with 0.91% DW in control after fifth week and 1.44% DW daidzin (2.3-fold increase) after eighth week when compared to untreated control (0.62% DW). Reduced biomass with increased daidzin content was facilitated by elicited hairy root cultures.

Efficacy of combination of ozonated water with oil for treatment of tinea pedis.

PubMed

Lu, Jianyun; Guo, Min; Ligui, Hongfa; Wu, Kathy; Xiang, Yaping; Huang, Jinhua; Gao, Lihua

2018-02-28

To evaluate efficacy of combined therapy with ozonated water and oil on patients with tinea pedis.
 Methods: A total of 60 patients with tinea pedis were divided into 2 groups in a randomized and blinded test. Patients in a control group were treated with naftinfine hydrochloride and ketoconazole cream once a day. Patients in an ozone group were treated with ozonated water bath and then ozonated oil topical application once a day. Patients in the 2 groups were treated for 4 weeks. Clinical and laboratory data were collected for both groups at the end of the 1st week, the 2nd week, and the 4th week. The Pearson chi-square was performed to compare scores of the clinical signs and symptoms (CSS) and the mycological result between the 2 groups. Independent samples T-test was performed to compare the curative effect between the 2 groups.
 Results: After 4 weeks' treatment, 6 patients were positive in the control group determined by mycological examination while 1 patient was positive in the ozone group, with no significant difference between the 2 groups (P>0.05). Changes in CSS at the end of the 1st week, 2nd week, and 4th week were obtained and showed no significant difference between the 2 groups at the 3 different time points (P>0.05). No side effects were observed.
 Conclusion: Combination of ozonated water with oil is effective on treatment of tinea pedis and it shows no side effects.

Budget impact analysis of darbepoetin alfa every 3 weeks versus epoetin alfa every week for the treatment of chemotherapy-induced anaemia from a US payer's perspective.

PubMed

Rubin, Robert J; Glaspy, John A; Adams, John L; Mafilios, Michael S; Wang, Sharon M; Viswanathan, Hema N; Kallich, Joel D

2008-01-01

This analysis was conducted to compare the direct medical costs of treatment with darbepoetin alfa every 3 weeks (Q3W) and epoetin alfa every week (QW) in patients with chemotherapy-induced anaemia (CIA) from the payer's perspective. An analysis was conducted from a US health plan perspective to compare the annual budget impact for CIA with darbepoetin alfa Q3W and epoetin alfa QW over a 16-week treatment period. Dosing regimens were obtained from registration clinical trials. Mean doses, including dose adjustments, were 375.6 microg Q3W for darbepoetin alfa and 43,187 U QW for epoetin alfa. Costs of medical resources included drug acquisition and administration costs. The base case analysis resulted in a per-patient budget impact of $8,544 and $8,667 for darbepoetin alfa and epoetin alfa, respectively. Per member per month cost was $0.90 for darbepoetin alfa and $0.91 for epoetin alfa, based on an estimate of 2,735 CIA patients in a health plan population of 2.17 million. The analysis was most sensitive to drug dose, treatment period and drug price. Results suggest that per-patient direct medical costs of CIA treatment, when initiated at labelled starting doses, are comparable for darbepoetin alfa Q3W and epoetin alfa QW.

Comparing maternal breastfeeding self-efficacy during first week and sixth week postpartum

PubMed Central

Pakseresht, Sedighe; Pourshaban, Farzane; khalesi, Zahra Bostani

2017-01-01

Introduction The ideal nourishment for the first 12 months of a child’s life comes from breastfeeding its mother’s milk, and maternal self-efficacy is one factor which affects breastfeeding duration. Therefore, the present study aimed to compare the maternal breastfeeding self-efficacy during the first week and sixth-week postpartum. Methods This descriptive, analytical study was conducted on 767 women referring to the Family Health Research Center of Rasht in 2014. Mothers were selected through continuous sampling. For data collection, we used demographic questionnaires, and Dennis breastfeeding self-efficacy scale. For data analysis, Chi-square, Mann-Whitney U, Pearson’s correlation coefficient and multiple regression were performed using SPSS version 19. Results In this study, most mothers had scores compatible with moderate self-efficacy in the first week, and in the sixth week had high self-efficacy for breastfeeding. There was a significant relationship between breastfeeding self-efficacy (BSE) score and employment status (p<0.0001). Also, we found significant BSE score differences between primiparous and multiparous women (p<0.001). Conclusion Results of the study indicate that breastfeeding duration increases the breastfeeding self-efficacy levels. So, Developing and implementing appropriate approaches are needed to improve breastfeeding duration in mothers. PMID:28465802

Comparing between results and complications of doing voiding cystourethrogram in the first week following urinary tract infection and in 2-6 weeks after urinary tract infection in children referring to a teaching hospital.

PubMed

Yousefichaijan, Parsa; Dorreh, Fatemeh; Shahsavari, Someyeh; Pakniyat, Abdolghader

2016-01-01

Urinary tract infection is the most common genitourinary disease in children so about 40% of the children with urinary tract infection suffering from reflux that caused some consequences such as pyelonephritis and kidney parenchymal injury. This research was conducted to compare the timing of voiding cystourethrogram (VCUG) in children with urinary tract infection in first week and after the first week of urinary tract infection. This research is a case-control study that both case and control groups include 208 children from 1 month to 12 years old with the complain of urinary tract infection. In case group, the VCUG was performed at the first week of infection and in control group, the VCUG was performed after the first week of infection. complication such as dysuria was observed in two-thirds of children who VCUG was performed during first week after urinary tract infection. Parents stress in case group was more than the other (P=0.015). For overall, the incidence of reflux in case and control groups was 49.5% and 50%, respectively. The mean of reflux grading in right kidney in case group was lower than control group resulting in significant differences between two groups. According to higher grade of stress in parents and complications due to VCUG at the first week of urinary tract infection, it is suggested that VCUG be conducted on selective patients in the hospital at the first week of urinary tract infection and during hospitalization.

Group dynamics and catecholamines during long-duration confinement in an isolated environment

NASA Technical Reports Server (NTRS)

Kraft, Norbert O.; Lyons, Terence J.; Binder, Heidi

2003-01-01

INTRODUCTION: The objectives of this study were to investigate possible relationships between catecholamine excretion and long-duration confinement in an isolated environment. METHODS: Stays of long duration were made by Group I (n = 4, all Russian, weeks 1-34), Group II (n = 4, mixed nationality, weeks 3-18), and Group III (n = 4, mixed nationality, weeks 22-38); other groups joined the residents for 1-wk intervals at weeks #13, #19, and #33. Data were collected from Groups I and III. RESULTS: In both Group I and Group III, the daily epinephrine excretion was significantly elevated during and after confinement compared with the pre-isolation baseline (p < 0.05), but remained mostly within normal limits during the experiment. During isolation, epinephrine excretion was significantly higher, compared with other weeks in isolation, during weeks #19 and #27 for Group I, and during week #30 for Group III. In both Group I and Group II, norepinephrine excretion increased significantly during and after isolation (p < 0.05) and was above the normal range. The daily norepinephrine excretion was significantly higher (p < 0.05) in Group I during weeks #12, #13, and #27, and during week #30 for Group III. DISCUSSION: Epinephrine excretion generally remained in the normal range. However, occasional elevations occurred due to psychological stress, which apparently correlate with changes in group dynamics. Norepinephrine excretion was above the normal range and was correlated with social events. These results suggest that to ensure optimum crew performance, entire crews along with their visiting crews should be selected collectively, rather than individually.

Effect of life-style modification on postmenopausal overweight and obese Indian women: A randomized controlled 24 weeks preliminary study.

PubMed

Tandon, Vishal R; Sharma, Sudhaa; Mahajan, Annil; Mahajan, Shagun

2014-01-01

The aim of the following study is to evaluate the effect of life-style modification on postmenopausal (PM) overweight and obese Indian women in a randomized controlled 24 week study. Two groups were formed Group I (n = 30) was designated as intervention (dietary and exercise group) and Group II (n = 24) served as control. Comparison of weight, waist circumference (WC) and body mass index (BMI) were made and compared among two groups at 4, 8, 16 and 24 weeks. Mean age at menopause was 48.35 years versus 49.65 years; mean number of menopausal symptoms were 5.70 ± 1.76 versus 5.10 ± 1.56 and mean duration since menopause was 2.70 versus 2.90 years in Groups I and II respectively. When the effect of Group I and control on weight was compared at 4, 8, 16 and 24 weeks, there was no significant difference between them up to 8 week. At 8 weeks Group I caused a significant decrease in weight (P ≤ 0.05) when compared with control arm and which continued throughout the study period (P < 0.05) at both 16 and 24 weeks. Group I produced a significant reduction in WC from 8 weeks onwards up to 24 weeks (P ≤ 0.05). BMI was statistically significant in Group I and the effect started at 4(th) week (P ≤ 0.05) and the differences in BMI reduction were highly significant at 16(th) and 24(th) weeks (P ≤ 0.001). The results of the present study strongly recommend the life-style management to be incorporated in daily style of postmenopausal women under controlled supervision.

A Pilot Study of the Head Extension Swallowing Exercise: New Method for Strengthening Swallowing-Related Muscle Activity.

PubMed

Oh, Jong-Chi

2016-10-01

This pilot study examined the effect of a new head extension swallowing exercise (HESE) on submental muscle activity and tongue strength in healthy volunteers. Fifteen young adults (10 females and 5 males) were instructed to extend their head backwards as much as possible, and while watching the ceiling, swallowed their saliva every 10 s for a duration of 20 min. Twenty-four treatments were performed over 8 weeks. The outcome variables evaluated at baseline, 4 and 8 weeks of training, and 12-week follow-up included mean and peak submental muscle activation amplitudes during normal and effortful swallowing measured via surface electromyography, and anterior and posterior isometric tongue pressures were measured with the Iowa Oral Performance Instrument. Results indicated that the muscle activation amplitudes during effortful swallowing increased significantly at 4 and 8 weeks compared to baseline (p < 0.025). However, the increases in amplitudes during normal swallowing were minor (nonsignificant) after 8 weeks compared to baseline. The isometric pressures of the tongue tip and the posterior part of the oral tongue were significantly higher at 8 weeks compared to baseline (p < 0.025). Thus, the 8-week HESE protocol significantly improved suprahyoid muscle activity during effortful swallowing as well as the isometric tongue pressures. The HESE appears effective in exercising and strengthening the suprahyoid muscles and tongue muscles in healthy participants. Although encouraging, these results need to be replicated in clinical trials for testing the therapeutic effects of the HESE in older adults and patients with dysphagia who present with decreased hyolaryngeal elevation.

Increased postprandial glycaemia, insulinemia, and lipidemia after 10 weeks’ sucrose-rich diet compared to an artificially sweetened diet: a randomised controlled trial

PubMed Central

Raben, Anne; Møller, Bente K.; Flint, Anne; Vasilaras, Tatjana H.; Christina Møller, A.; Juul Holst, Jens; Astrup, Arne

2011-01-01

Background The importance of exchanging sucrose for artificial sweeteners on risk factors for developing diabetes and cardiovascular diseases is not yet clear. Objective To investigate the effects of a diet high in sucrose versus a diet high in artificial sweeteners on fasting and postprandial metabolic profiles after 10 weeks. Design Healthy overweight subjects were randomised to consume drinks and foods sweetened with either sucrose (∼2 g/kg body weight) (n = 12) or artificial sweeteners (n = 11) as supplements to their usual diet. Supplements were similar on the two diets and consisted of beverages (∼80 weight%) and solid foods (yoghurts, marmalade, ice cream, stewed fruits). The rest of the diet was free of choice and ad libitum. Before (week 0) and after the intervention (week 10) fasting blood samples were drawn and in week 10, postprandial blood was sampled during an 8-hour meal test (breakfast and lunch). Results After 10 weeks postprandial glucose, insulin, lactate, triglyceride, leptin, glucagon, and GLP-1 were all significantly higher in the sucrose compared with the sweetener group. After adjusting for differences in body weight changes and fasting values (week 10), postprandial glucose, lactate, insulin, GIP, and GLP-1 were significantly higher and after further adjusting for differences in energy and sucrose intake, postprandial lactate, insulin, GIP, and GLP-1 levels were still significantly higher on the sucrose-rich diet. Conclusion A sucrose-rich diet consumed for 10 weeks resulted in significant elevations of postprandial glycaemia, insulinemia, and lipidemia compared to a diet rich in artificial sweeteners in slightly overweight healthy subjects. PMID:21799667

Continuous positive airway pressure deepens sleep in patients with Alzheimer's disease and obstructive sleep apnea

PubMed Central

Cooke, Jana R.; Ancoli-Israel, Sonia; Liu, Lianqi; Loredo, Jose S.; Natarajan, Loki; Palmer, Barton S.; He, Feng; Corey-Bloom, Jody

2009-01-01

Objective Patients with Alzheimer's disease (AD) and obstructive sleep apnea (OSA) experience disrupted sleep. This study examined the effect of continuous positive airway pressure (CPAP) on sleep parameters in AD patients with OSA. Methods A randomized placebo-controlled trial of 3 weeks of therapeutic CPAP (tCPAP) vs. 3 weeks placebo CPAP (pCPAP) followed by 3 weeks tCPAP in patients with AD and OSA. Polysomnography data from screening after one night and after three weeks of treatment were analyzed. Records were scored for percent of each sleep stage, total sleep time (TST), sleep efficiency (SE), sleep period (SP), time in bed (TIB), sleep onset (SO), wake time after sleep onset (WASO), and arousals. A randomized design comparing one night of pCPAP to tCPAP and a paired analysis combining 3 weeks of tCPAP were performed. Results Fifty-two participants (mean age=77.8 years, SD=7.3) with AD and OSA were included. After one treatment night, the tCPAP group had significantly less % Stage 1 (p=0.04) and more % Stage 2 sleep (p=0.02) when compared to the pCPAP group. In the paired analysis, 3-weeks of tCPAP resulted in significant decreases in WASO (p=0.005), % Stage 1 (p=0.001), arousals (p=0.005), and in an increase in % Stage 3 (p=0.006). Conclusion In mild to moderate AD patients with OSA, the use of tCPAP resulted in deeper sleep after just one night, with improvements maintained for three weeks. PMID:19699148

Biochemical Changes in Postmenopausal Women Following a Muscle Fitness Program.

ERIC Educational Resources Information Center

Snow-Harter, Christine

1987-01-01

Twelve postmenopausal women attending a 50 minute exercise class three times a week for eight weeks were compared with 10 controls who maintained sedentary routines. Results showed that the exercise group had higher serum alkaline phosphatase and lower serum calcium than the controls. (Author/CB)

Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study

PubMed Central

Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

2017-01-01

Objectives ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. Methods In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. Results A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Conclusions Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. Trial registration number NCT01970475; Results. PMID:28584187

A randomised, open-label, parallel group phase 2 study of antisense oligonucleotide therapy in acromegaly.

PubMed

Trainer, Peter J; Newell-Price, John; Ayuk, John; Aylwin, Simon; Rees, D Aled; Drake, Wm; Chanson, Philippe; Brue, Thierry; Webb, Susan M; Montañana, Carmen Fajardo; Aller, Javier; McCormack, Ann I; Torpy, David J; Tachas, George; Atley, Lynne; Ryder, David; Bidlingmaier, Martin

2018-05-22

ATL1103 is a second-generation antisense oligomer targeting the human GH receptor. This phase 2 randomised, open-label, parallel-group study assessed the potential of ATL1103 as a treatment for acromegaly. 26 patients with active acromegaly (IGF-I >130% upper limit of normal) were randomised to subcutaneous ATL1103 200 mg either once- or twice-weekly for 13 weeks, and monitored for a further 8-week washout period. The primary efficacy measures were change in IGF-I at week 14, compared to baseline and between cohorts. For secondary endpoints (IGFBP3, ALS, GH, GHBP), comparison was between baseline and week 14. Safety was assessed by reported adverse events. Baseline median IGF-I was 447 and 649 ng/mL in the once- and twice-weekly groups, respectivey. Compared to baseline, at week 14 twice-weekly ATL1103 resulted in a median fall in IGF-I of 27.8% (p=0.0002). Between cohort comparison at week 14 demonstrated the median fall in IGF-I to be 25.8% (p=0.0012) greater with twice-weekly dosing. In the twice-weekly cohort, IGF-I was still declining at week 14, and at week 21 remained lower than at baseline by a median of 18.7% (p=0.0005). Compared to baseline, by week 14 IGFBP3 and ALS had declined by a median of 8.9% (p=0.027) and 16.7% (p=0.017) with twice-weekly ATL1103; GH had increased by a median of 46% at week 14 (p=0.001). IGFBP3, ALS and GH did not change with weekly ATL1103. GHBP fell by a median of 23.6% and 48.8% in the once- and twice-weekly cohorts (p=0.027 and p=0.005), respectively. ATL1103 was well tolerated, although 84.6% of patients experienced mild to moderate injection-site reactions (ISR). This study provides proof-of-concept that ATL1103 is able to significantly lower IGF-I in patients with acromegaly.

A Randomized Controlled Pilot Trial of Different Mobile Messaging Interventions for Problem Drinking Compared to Weekly Drink Tracking

PubMed Central

van Stolk-Cooke, Katherine; Kuerbis, Alexis; Stadler, Gertraud; Baumel, Amit; Shao, Sijing; McKay, James R.; Morgenstern, Jon

2017-01-01

Introduction Recent evidence suggests that text messaging may help to reduce problem drinking as an extension to in-person services, but very little is known about the effectiveness of remote messaging on problem drinking as a stand-alone intervention, or how different types of messages may improve drinking outcomes in those seeking to moderate their alcohol consumption. Methods We conducted an exploratory, single-blind randomized controlled pilot study comparing four different types of alcohol reduction-themed text messages sent daily to weekly drink self-tracking texts in order to determine their impact on drinking outcomes over a 12-week period in 152 participants (≈ 30 per group) seeking to reduce their drinking on the internet. Messaging interventions included: weekly drink self-tracking mobile assessment texts (MA), loss-framed texts (LF), gain-framed texts (GF), static tailored texts (ST), and adaptive tailored texts (TA). Poisson and least squares regressions were used to compare differences between each active messaging group and the MA control. Results When adjusting for baseline drinking, participants in all messaging groups except GF significantly reduced the number of drinks consumed per week and the number of heavy drinking days compared to MA. Only the TA and GF groups were significantly different from MA in reducing the number of drinking days. While the TA group yielded the largest effect sizes on all outcome measures, there were no significant differences between active messaging groups on any outcome measure. 79.6% of individuals enrolled in the study wanted to continue receiving messages for an additional 12 weeks at the end of the study. Discussion Results of this pilot study indicate that remote automated text messages delivered daily can help adult problem drinkers reduce drinking frequency and quantity significantly more than once-a-week self-tracking messages only, and that tailored adaptive texts yield the largest effect sizes across outcomes compared to MA. Larger samples are needed to understand differences between messaging interventions and to target their mechanisms of efficacy. PMID:28146560

Final Results of Local-Regional Control and Late Toxicity of RTOG 9003: A Randomized Trial of Altered Fractionation Radiation for Locally Advanced Head and Neck Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beitler, Jonathan J., E-mail: jjbeitl@emory.edu; Zhang, Qiang; Fu, Karen K.

Purpose: To test whether altered radiation fractionation schemes (hyperfractionation [HFX], accelerated fractionation, continuous [AFX-C], and accelerated fractionation with split [AFX-S]) improved local-regional control (LRC) rates for patients with squamous cell cancers (SCC) of the head and neck when compared with standard fractionation (SFX) of 70 Gy. Methods and Materials: Patients with stage III or IV (or stage II base of tongue) SCC (n=1076) were randomized to 4 treatment arms: (1) SFX, 70 Gy/35 daily fractions/7 weeks; (2) HFX, 81.6 Gy/68 twice-daily fractions/7 weeks; (3) AFX-S, 67.2 Gy/42 fractions/6 weeks with a 2-week rest after 38.4 Gy; and (4) AFX-C, 72 Gy/42 fractions/6 weeks. The 3 experimental arms were to bemore » compared with SFX. Results: With patients censored for LRC at 5 years, only the comparison of HFX with SFX was significantly different: HFX, hazard ratio (HR) 0.79 (95% confidence interval 0.62-1.00), P=.05; AFX-C, 0.82 (95% confidence interval 0.65-1.05), P=.11. With patients censored at 5 years, HFX improved overall survival (HR 0.81, P=.05). Prevalence of any grade 3, 4, or 5 toxicity at 5 years; any feeding tube use after 180 days; or feeding tube use at 1 year did not differ significantly when the experimental arms were compared with SFX. When 7-week treatments were compared with 6-week treatments, accelerated fractionation appeared to increase grade 3, 4 or 5 toxicity at 5 years (P=.06). When the worst toxicity per patient was considered by treatment only, the AFX-C arm seemed to trend worse than the SFX arm when grade 0-2 was compared with grade 3-5 toxicity (P=.09). Conclusions: At 5 years, only HFX improved LRC and overall survival for patients with locally advanced SCC without increasing late toxicity.« less

Cost analytic model to determine the least costly inpatient erythropoiesis stimulating therapy regimen.

PubMed

Sikand, Harminder; Decter, Adam; Greco, Tina; Watson, Sue H; Kang, Yoon Jun; Mody, Samir H; Piech, Catherine Tak; Duh, Mei Sheng; Naeem, Ayesha

2008-01-01

Unlike in outpatient settings, the comparative costs of epoetin alpha (EPO) and darbepoetin alpha (DARB) have not been evaluated broadly from the inpatient hospital perspective. To develop a cost analytic model comparing hospital inpatient costs for erythropoiesis stimulating therapies within the nephrology and oncology settings. A cost analytic model incorporating erythropoietic drug, pharmacy, and nursing costs was developed from the inpatient hospital perspective to evaluate comparative costs of EPO and DARB. Erythropoietic drug costs were calculated using unit wholesale acquisition cost multiplied by the number of units or micrograms while comparing the following dosing regimens: EPO 3 times weekly, EPO once weekly, and DARB once weekly. Pharmacy costs included dispensing and delivery costs, while nursing costs incorporated administration time costs; all were calculated by estimated fractional hours per activity multiplied by hourly wages. The total frequency of erythropoiesis stimulating therapy administrations was determined based on the average hospital length of stay. The first erythropoiesis stimulating therapy dose was assumed to occur on day 3 of hospitalization. For total inpatient costs, a weighted average was calculated across disease states. One-way sensitivity analyses were conducted by varying length of stay, day of initial erythropoiesis stimulating therapy dose, pharmacy and nursing costs, and once-weekly DARB dose. EPO 3 times weekly was the least costly regimen across all disease states evaluated. Threshold analysis indicated that the cost of once-weekly DARB regimens would have to be reduced by 37% to equal the cost of EPO 3 times weekly for an average length of stay. Sensitivity analyses did not considerably affect the results. EPO 3 times weekly was found to be the least costly erythropoiesis stimulating therapy regimen for nephrology and oncology inpatients for the average length of stay as well as most other lengths of stay considered. Once-weekly EPO was the least costly erythropoiesis stimulating therapy regimen for several other lengths of stay, while once-weekly DARB was never found to be the least costly regimen.

COMPARED EFFICACY OF INTRA-ARTICULAR INJECTION OF METHYLPREDNISOLONE AND TRIAMCINOLONE

PubMed Central

BUYUK, ABDUL FETTAH; KILINC, ERAY; CAMURCU, ISMET YALKIN; CAMUR, SAVAS; UCPUNAR, HANIFI; KARA, ADNAN

2017-01-01

ABSTRACT Objective: To compare the effect of two different corticosteroid types in bilateral and symmetrical knee osteoarthritis (OA). Methods: One hundred and twenty-six patients received injections of methylprednisolone acetate (MP) in one knee and triamcinolone hexacetonide (TH) in the contralateral knee. Patients were evaluated before injection and 2, 4, 8, 12, and 24 weeks after. Results: Mean patient age was 68.5±9 years. Mean BMI was 26.3±2.6 kg/m2. At first admission, mean VAS score was 7.7±1.3 for the right side and 7.5±1.5 for the left side, and mean WOMAC score was 67.6±14.4. After bilateral intra-articular injection, VAS scores for both knees and WOMAC scores decreased significantly when initial scores were compared with 2, 4, 8, 12, and 24 weeks after injection (p<0.05). A statistically significant change was seen over time when VAS and WOMAC scores for 2, 4, 8, 12, and 24 weeks post-injection were compared to each other (p<0.05). No significant difference was seen between knee sides (p>0.05). Conclusion: MP and TH have similar efficacy in relieving pain and improving function. The efficacy of intra-articular corticosteroid injection peaks 2 weeks after injection and the effect continues until the 24th week. Level of Evidence II, Comparative Prospective Study. PMID:29081706

Comparative Efficacy of Topical Pertmehrin, Crotamiton and Sulfur Ointment in Treatment of Scabies

PubMed Central

Mila-Kierzenkowska, Celestyna; Woźniak, Alina; Krzyżyńska-Malinowska, Ewa; Kałużna, Lucyna; Wesołowski, Roland; Poćwiardowski, Wojciech; Owcarz, Marcin

2017-01-01

Background: Scabies is an ectoparasitic infection, which occurs because of direct skin-to skin contact. The ideal treatment modality is still unclear and further research on this topic is warranted. The aim of the study was to compare the efficacy and safety of the topical scabicides: permethrin, crotamiton and sulfur ointment. Methods: Fifty four patients with diagnosed scabies were randomly divided into three treatment groups. The first group received 5% permethrin cream twice with one week interval, the patients from the second group were given crotamiton lotion for two days twice with one week interval, while the third group received 10% sulfur ointment for two or three weeks. All patients were followed up at 1, 2 and 4 weeks intervals. Results: At one-week follow up the cure rate was significantly higher at permethrin-treated group when compared to crotamiton group (P< 0.001) and sulfur group (P< 0.001). At the end of two-week interval, the cure rate at permethrin group was 100%, while at crotamiton group, 66.7% and in sulfur group 38.9% (P< 0.001). At 4-week follow up the applied treatment was effective in all studied individuals. Conclusion: The topical application of permethrin, crotamiton and sulfur was equally efficacious at 4-week follow up, however permethrin cream showed faster improvement at first and second follow up. Acquiring permethrin is considered as expensive option and crotamiton lotion seems to be cost-less alternative to this cream. PMID:29018829

Survival of irradiated recipient mice after transplantation of bone marrow from young, old and "early aging" mice.

PubMed

Guest, Ian; Ilic, Zoran; Scrable, Heidi; Sell, Stewart

2015-12-01

Bone marrow transplantation is used to examine survival, hematopoietic stem cell function and pathology in recipients of young and old wild type bone marrow derived stem cells (BMDSCs) as well as cells from p53-based models of premature aging. There is no difference in the long term survival of recipients of 8 week-old p53+/m donor cells compared to recipients of 8 week-old wild-type (WT) donor cells (70 weeks) or of recipients of 16-18 weeks-old donor cells from either p53+/m or WT mice. There is shorter survival in recipients of older versus younger WT donor bone marrow, but the difference is only significant when comparing 8 and 18 week-old donors. In the p44-based model, short term survival/engraftment is significantly reduced in recipients of 11 month-old p44 donor cells compared to 4 week-old p44 or wild type donor cells of either age; mid-life survival at 40 weeks is also significantly less in recipients of p44 cells. BMDSCs are readily detectable within recipient bone marrow, lymph node, intestinal villi and liver sinusoids, but not in epithelial derived cells. These results indicate that recipients of young BMDSCs may survive longer than recipients of old bone marrow, but the difference is marginal at best.

Survival of irradiated recipient mice after transplantation of bone marrow from young, old and “early aging” mice

PubMed Central

Guest, Ian; Ilic, Zoran; Sell, Stewart

2015-01-01

Bone marrow transplantation is used to examine survival, hematopoietic stem cell function and pathology in recipients of young and old wild type bone marrow derived stem cells (BMDSCs) as well as cells from p53-based models of premature aging. There is no difference in the long term survival of recipients of 8 week-old p53+/m donor cells compared to recipients of 8 week-old wild-type (WT) donor cells (70 weeks) or of recipients of 16–18 weeks-old donor cells from either p53+/m or WT mice. There is shorter survival in recipients of older versus younger WT donor bone marrow, but the difference is only significant when comparing 8 and 18 week-old donors. In the p44-based model, short term survival/engraftment is significantly reduced in recipients of 11 month-old p44 donor cells compared to 4 week-old p44 or wild type donor cells of either age; mid-life survival at 40 weeks is also significantly less in recipients of p44 cells. BMDSCs are readily detectable within recipient bone marrow, lymph node, intestinal villi and liver sinusoids, but not in epithelial derived cells. These results indicate that recipients of young BMDSCs may survive longer than recipients of old bone marrow, but the difference is marginal at best. PMID:26796640

Cost-effectiveness of Secukinumab as First Biologic Treatment, Compared with Other Biologics, for Moderate to Severe Psoriasis in Germany.

PubMed

Augustin, Matthias; McBride, Doreen; Gilloteau, Isabelle; O'Neill, Caitriona; Neidhardt, Katja; Graham, Christopher N

2018-05-05

Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A, has demonstrated strong and sustained efficacy in adults with moderate to severe psoriasis in clinical trials. This analysis compared the cost per responder of secukinumab as first biologic treatment of moderate to severe psoriasis, with adalimumab, infliximab, etanercept, and ustekinumab in Germany. A 52-week decision-tree model was developed. Response to treatment was assessed based on the likelihood of achieving a predefined Psoriasis Area and Severity Index (PASI) response to separate the cohort into responders (PASI ≥75), partial responders (PASI 50 to 74), and non-responders (PASI <50). Responders at week 16 continued initial treatment, whereas partial responders and non-responders were switched to standard of care, which included methotrexate, cyclosporine, phototherapy, and topical corticosteroids. Sustained response was defined as 16-week response maintained at week 52. A German health care system perspective was adopted. Clinical efficacy data was obtained from a mixed-treatment comparison; 2016 resource unit costs from national sources; and adverse events and discontinuation rates from the literature. We calculated cost per PASI 90 responder over week 16 and week 52, as well as cost per sustained responder between weeks 16 and 52. Secukinumab had the lowest cost per PASI 90 responder over 16 weeks (€18,026) compared with ustekinumab (€18,080), adalimumab (€23,499), infliximab (€29,599), and etanercept (€34,037). Over 52 weeks, costs per PASI 90 responder ranged from €42,409 (secukinumab) to €70,363 (etanercept). Likewise, secukinumab had the lowest cost per sustained 52-week PASI 90 responder (€22,690) compared with other biologic treatments. Sensitivity analyses, excluding patient copayments, showed similar results. First biologic treatment with secukinumab for moderate to severe psoriasis is cost-effective, with lowest cost per responder compared with other biologic treatments in Germany. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

An Open Label Clinical Trial of a Peptide Treatment Serum and Supporting Regimen Designed to Improve the Appearance of Aging Facial Skin.

PubMed

Draelos, Zoe Diana; Kononov, Tatiana; Fox, Theresa

2016-09-01

A 14-week single-center clinical usage study was conducted to test the efficacy of a peptide treatment serum and supporting skincare regimen in 29 women with mild to moderately photodamaged facial skin. The peptide treatment serum contained gamma-aminobutyric acid (GABA) and various peptides with neurotransmitter inhibiting and cell signaling properties. It was hypothesized that the peptide treatment serum would ameliorate eye and facial expression lines including crow's feet and forehead lines. The efficacy of the supporting skincare regimen was also evaluated. An expert investigator examined the subjects at rest and at maximum smile. Additionally, the subjects completed self-assessment questionnaires. At week 14, the expert investigator found a statistically significant improvement in facial lines, facial wrinkles, eye lines, and eye wrinkles at rest when compared to baseline results. The expert investigator also found statistically significant improvement at week 14 in facial lines, eye lines, and eye wrinkles when compared to baseline results at maximum smile. In addition, there was continued highly statistically significant improvement in smoothness, softness, firmness, radiance, luminosity, and overall appearance at rest when compared to baseline results at the 14-week time point. The test regimen was well perceived by the subjects for efficacy and product attributes. The products were well tolerated with no adverse events.

J Drugs Dermatol. 2016;15(9):1100-1106.

The effect of previous soft contact lens wear on corneal refractive surgery outcomes.

PubMed

Lloyd-McKernan, Aoife; Simo Mannion, Luisa; O'Dwyer, Veronica

2017-10-01

To examine the influence of previous soft contact lens (SCL) wear on corneal refractive surgery (CRS) outcomes when SCL wear is ceased for two weeks versus twenty-four hours, and also when compared to no wear, prior to CRS. A retrospective examination of CRS patient records was carried out for two groups of patients- who ceased SCL wear for two weeks (n=45) and for twenty-four hours (n=49) prior to CRS and compared to a non-contact lens (NCL) control group (n=45 and n=49, respectively). CRS outcomes (efficacy, predictability, visual acuity and refractive error) were compared pre-operatively and one and six months post-operatively. One month post-operative results found unaided distance visual acuity (UDVA) was significantly better for LASEK/PRK patients who had ceased SCL wear for two weeks prior to CRS (-0.05±0.09), compared with the NCL group (0.02±0.09; p=0.04). Furthermore, six month post-operative results found UDVA was significantly better for both LASIK and LASEK/PRK patients who had ceased SCL wear for two weeks prior to CRS, and for LASEK/PRK patients who had ceased SCL wear for twenty-four hours prior to CRS compared with the NCL group. Given the current setup and methods followed, it was concluded that previous SCL wear had no negative impact on visual outcomes following CRS compared with a NCL control group, regardless of previous SCL cessation time prior to CRS. Copyright © 2017 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis

PubMed Central

Evans, E Glyn V; Sigurgeirsson, Bárdur

1999-01-01

Objective To compare the efficacy and safety of continuous terbinafine with intermittent itraconazole in the treatment of toenail onychomycosis. Design Prospective, randomised, double blind, double dummy, multicentre, parallel group study lasting 72 weeks. Setting 35 centres in six European countries. Subjects 496 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte onychomycosis of the toenail. Interventions Study patients were randomly divided into four parallel groups to receive either terbinafine 250 mg a day for 12 or 16 weeks (groups T12 and T16) or itraconazole 400 mg a day for 1 week in every 4 weeks for 12 or 16 weeks (groups I3 and I4). Main outcome measures Assessment of primary efficacy at week 72 was mycological cure, defined as negative results on microscopy and culture of samples from the target toenail. Results At week 72 the mycological cure rates were 75.7% (81/107) in the T12 group and 80.8% (80/99) in the T16 group compared with 38.3% (41/107) in the I3 group and 49.1 % (53/108) in the I4 group. All comparisons (T12 v I3, T12 v I4, T16 v I3, T16 v I4) showed significantly higher cure rates in the terbinafine groups (all P<0.0001). Also, all secondary clinical outcome measures were significantly in favour of terbinafine at week 72. There were no differences in the number or type of adverse events recorded in the terbinafine or itraconazole groups. Conclusion Continuous terbinafine is significantly more effective than intermittent itraconazole in the treatment of patients with toenail onychomycosis. Key messagesGiven a correct diagnosis, fungal nail disease (onychomycosis) is curableTerbinafine is an allylamine antifungal with a primarily fungicidal mode of actionContinuous terbinafine treatment over 12 or 16 weeks achieves higher rates of clinical and mycological cure than intermittent itraconazole given over the same periodsTerbinafine is safe and well tolerated over 12 or 16 weeks of continuous treatmentContinuous terbinafine should be the current treatment of choice for onychomycosis PMID:10205099

Secukinumab Significantly Reduces Psoriasis-Related Work Impairment and Indirect Costs Compared With Ustekinumab and Etanercept in the United Kingdom.

PubMed

Warren, R B; Halliday, A; Graham, C N; Gilloteau, I; Miles, L; McBride, D

2018-05-30

Psoriasis causes work productivity impairment that increases with disease severity. Whether differential treatment efficacy translates into differential indirect cost savings is unknown. To assess work hours lost and indirect costs associated with secukinumab versus ustekinumab and etanercept in the United Kingdom (UK). This was a post hoc analysis of work impairment data collected in the CLEAR study (secukinumab vs. ustekinumab) and applied to the FIXTURE study (secukinumab vs. etanercept). Weighted weekly and annual average indirect costs per patient per treatment were calculated from (1) overall work impairment derived from Work Productivity and Activity Impairment data collected in CLEAR at 16 and 52 weeks by Psoriasis Area and Severity Index (PASI) response level; (2) weekly/annual work productivity loss by PASI response level; (3) weekly and annual indirect costs by PASI response level, based on hours of work productivity loss; and (4) weighted average indirect costs for each treatment. In the primary analysis, work impairment data for employed patients in CLEAR at Week 16 were used to compare secukinumab and ustekinumab. Secondary analyses were conducted at different timepoints and with patient cohorts, including FIXTURE. In CLEAR, 452 patients (67%) were employed at baseline. At Week 16, percentages of weekly work impairment/mean hours lost decreased with higher PASI: PASI <50: 22.8%/7.60 hours; PASI 50-74: 13.3%/4.45 hours; PASI 75-89: 6.4%/2.14 hours; PASI ≥90: 4.9%/1.65 hours. Weighted mean weekly/annual work hours lost were significantly lower for secukinumab than ustekinumab (1.96/102.51 vs. 2.40/125.12; P=0.0006). Results were consistent for secukinumab versus etanercept (2.29/119.67 vs. 3.59/187.17; Ρ<0.0001). Average annual indirect cost savings with secukinumab were £355 versus ustekinumab and £1,061 versus etanercept. Results at 52 weeks were similar. Secukinumab significantly reduced work impairment and associated indirect costs of psoriasis compared with ustekinumab and etanercept at Week 16 through 52 in the UK. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Breastfeeding, Infant Formula, and Introduction to Complementary Foods-Comparing Data Obtained by Questionnaires and Health Visitors' Reports to Weekly Short Message Service Text Messages.

PubMed

Bruun, Signe; Buhl, Susanne; Husby, Steffen; Jacobsen, Lotte Neergaard; Michaelsen, Kim F; Sørensen, Jan; Zachariassen, Gitte

2017-11-01

Studies on prevalence and effects of breastfeeding call for reliable and precise data collection to optimize infant nutrition, growth, and health. Data on breastfeeding and infant nutrition are at risk of, for example, recall bias or social desirability bias. The aim of the present analysis was to compare data on infant nutrition, that is, breastfeeding, use of infant formula, and introduction to complementary foods, obtained by four different methods. We assumed that weekly short message service (SMS) questions were the most reliable method, to which the other methods were compared. The study population was part of the Odense Child Cohort. The four methods used were: (a) self-administered questionnaire 3 months postpartum, (b) self-administered questionnaire 18 months postpartum, (c) registrations from health visitors visiting the families several times within the first year of life, and (d) weekly SMS questions introduced shortly after birth. In total, 639 singleton mothers with data from all four methods were included. The proportion of mothers initiating breastfeeding varied from 86% to 97%, the mean duration of exclusive breastfeeding from 12 to 19 weeks, and the mean age when introduced to complementary foods from 19 to 21 weeks. The mean duration of any breastfeeding was 33 weeks across methods. Compared with the weekly SMS questions, the self-administered questionnaires and the health visitors' reports resulted in a greater proportion of mothers with an unknown breastfeeding status, a longer duration of exclusive breastfeeding and later introduction to complementary foods, while the duration of any breastfeeding did not differ.

Docosahexaenoic acid confers enduring neuroprotection in experimental stroke.

PubMed

Hong, Sung-Ha; Belayev, Ludmila; Khoutorova, Larissa; Obenaus, Andre; Bazan, Nicolas G

2014-03-15

Recently we demonstrated that docosahexaenoic acid (DHA) is highly neuroprotective when animals were allowed to survive during one week. This study was conducted to establish whether the neuroprotection induced by DHA persists with chronic survival. Sprague-Dawley rats underwent 2h of middle cerebral artery occlusion (MCAo) and treated with DHA or saline at 3h after MCAo. Animals received neurobehavioral examination (composite neuroscore, rota-rod, beam walking and Y maze tests) followed by ex vivo magnetic resonance imaging and histopathology at 3 weeks. DHA improved composite neurologic score beginning on day 1 by 20%, which persisted throughout weeks 1-3 by 24-41% compared to the saline-treated group. DHA prolonged the latency in rota-rod on weeks 2-3 by 162-178%, enhanced balance performance in the beam walking test on weeks 1 and 2 by 42-51%, and decreased the number of entries in the Y maze test by 51% and spontaneous alteration by 53% on week 2 compared to the saline-treated group. DHA treatment reduced tissue loss (computed from T2-weighted images) by 24% and total and cortical infarct volumes by 46% and 54% compared to the saline-treated group. These results show that DHA confers enduring ischemic neuroprotection. Copyright © 2013 The Authors. Published by Elsevier B.V. All rights reserved.

Prolonged Culture of Aligned Skeletal Myotubes on Micromolded Gelatin Hydrogels

PubMed Central

Bettadapur, Archana; Suh, Gio C.; Geisse, Nicholas A.; Wang, Evelyn R.; Hua, Clara; Huber, Holly A.; Viscio, Alyssa A.; Kim, Joon Young; Strickland, Julie B.; McCain, Megan L.

2016-01-01

In vitro models of skeletal muscle are critically needed to elucidate disease mechanisms, identify therapeutic targets, and test drugs pre-clinically. However, culturing skeletal muscle has been challenging due to myotube delamination from synthetic culture substrates approximately one week after initiating differentiation from myoblasts. In this study, we successfully maintained aligned skeletal myotubes differentiated from C2C12 mouse skeletal myoblasts for three weeks by utilizing micromolded (μmolded) gelatin hydrogels as culture substrates, which we thoroughly characterized using atomic force microscopy (AFM). Compared to polydimethylsiloxane (PDMS) microcontact printed (μprinted) with fibronectin (FN), cell adhesion on gelatin hydrogel constructs was significantly higher one week and three weeks after initiating differentiation. Delamination from FN-μprinted PDMS precluded robust detection of myotubes. Compared to a softer blend of PDMS μprinted with FN, myogenic index, myotube width, and myotube length on μmolded gelatin hydrogels was similar one week after initiating differentiation. However, three weeks after initiating differentiation, these parameters were significantly higher on μmolded gelatin hydrogels compared to FN-μprinted soft PDMS constructs. Similar results were observed on isotropic versions of each substrate, suggesting that these findings are independent of substrate patterning. Our platform enables novel studies into skeletal muscle development and disease and chronic drug testing in vitro. PMID:27350122

Peripheral Nerve Stimulation Compared to Usual Care for Pain Relief of Hemiplegic Shoulder Pain: A Randomized Controlled Trial

PubMed Central

Wilson, Richard D.; Gunzler, Douglas D.; Bennett, Maria E.; Chae, John

2014-01-01

Objective This study seeks to establish the efficacy of single-lead, 3-week peripheral nerve stimulation (PNS) therapy for pain reduction in stroke survivors with chronic hemiplegic shoulder pain. Design Single-site, pilot, randomized controlled trial for adults with chronic shoulder pain after stroke. Participants were randomized to receive a 3-week treatment of single-lead PNS or usual care (UC). The primary outcome was the worst pain in the last week (Brief Pain Inventory, Short Form question 3) measured at baseline, and weeks 1,4, 12, and 16. Secondary outcomes included pain interference (Brief Pain Inventory, Short Form question 9), pain measured by the ShoulderQ Visual Graphic Rating Scales; and health-related quality of life (SF-36v2). Results Twenty-five participants were recruited, 13 to PNS and 12 to UC. There was a significantly greater reduction in pain for the PNS group compared to controls, with significant differences at 6 and 12 weeks after treatment. Both PNS and UC were associated with significant improvements in pain interference and physical health related quality of life. Conclusions Short-term PNS is a safe and efficacious treatment for shoulder pain. Pain reduction is greater than compared to UC and is maintained for at least 12 weeks after treatment. PMID:24355994

Biochemical and hemato-immunological parameters in juvenile beluga (Huso huso) following the diet supplemented with nettle (Urtica dioica).

PubMed

Binaii, Mohammad; Ghiasi, Maryam; Farabi, Seyed Mohammad Vahid; Pourgholam, Reza; Fazli, Hasan; Safari, Reza; Alavi, Seyed Eshagh; Taghavi, Mohammad Javad; Bankehsaz, Zahra

2014-01-01

The present study investigated the effects of different dietary nettle (Urtica dioica) levels on biochemical, hematological and immunological parameters in beluga (Huso huso). Fish were divided into 4 groups before being fed for 8 weeks with 0%, 3%, 6% and 12% of nettle. The blood samples were collected on week 4 and 8. The use of nettle did not significantly change the mean cell volume, mean cell haemoglobin, lymphocytes, eosinophils, albumin, glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and lysozyme activity on week 4 and 8. After 4 weeks, the total red blood cell (RBC) and hematocrit (Ht) showed a significant increase in 12% nettle group compared to the 3% nettle and control groups but haemoglobin (Hb) had a significant change in 12% nettle compared to the control. At the same time was not found a significant change in the mean cell haemoglobin concentration (MCHC), total white blood cell (WBC), neutrophils, respiratory burst activity (RB), total immunoglobulin (Ig) and total protein (TP), triglyceride (Tri) and cholesterol (Chol). After 8 weeks, the fish treated with nettle exhibited significantly increase in neutrophil and Hb levels compared to the control and between treatment groups, 12% nettle group shown the highest Hb while RBC and Hct values significantly rose in fish fed by 12% compared to the control. Supplementing 6% and 12% nettle increased the WBC and MCHC compared to the other groups. The group fed 12% showed a highly significant difference in RB, TP and Ig after 8 weeks. However, Tri and Chol were significantly decreased in the juvenile beluga fed by the 6% and 12% nettle diet compared to the other groups. The results suggest that by using this herb there will be an improvement in hemato-biochemical parameters and immune function of juvenile beluga.

Rapid Syllable Transitions (ReST) treatment for Childhood Apraxia of Speech: the effect of lower dose-frequency.

PubMed

Thomas, Donna C; McCabe, Patricia; Ballard, Kirrie J

2014-01-01

This study investigated the effectiveness of twice-weekly Rapid Syllable Transitions (ReST) treatment for Childhood Apraxia of Speech (CAS). ReST is an effective treatment at a frequency of four sessions a week for three consecutive weeks. In this study we used a multiple-baselines across participants design to examine treatment efficacy for four children with CAS, aged four to eight years, who received ReST treatment twice a week for six weeks. The children's ability to acquire new skills, generalize these skills to untreated items and maintain the skills after treatment was examined. All four children improved their production of the target items. Two of the four children generalized the treatment effects to similar untreated pseudo words and all children generalized to untreated real words. During the maintenance phase, all four participants maintained their skills to four months post-treatment, with a stable rather than rising profile. This study shows that ReST treatment delivered twice-weekly results in significant retention of treatment effects to four months post-treatment and generalization to untrained but related speech behaviors. Compared to ReST therapy four times per week, the twice-weekly frequency produces similar treatment gains but no ongoing improvement after the cessation of treatment. This implies that there may be a small but significant benefit of four times weekly therapy compared with twice-weekly ReST therapy. Readers will be able to define dose-frequency, and describe how this relates to overall intervention intensity. Readers will be able to explain the acquisition, generalization and maintenance effects in the study and describe how these compare to higher dose frequency treatments. Readers will recognize that the current findings give preliminary support for high dose-frequency CAS treatment. Copyright © 2014 Elsevier Inc. All rights reserved.

Sexual Behavior and Contraceptive Use Among 18 to 19 year old Adolescent Women By Weight Status: A Longitudinal Analysis

PubMed Central

Chang, Tammy; Davis, Matthew M.; Kusunoki, Yasamin; Ela, Elizabeth J.; Hall, Kelli S.; Barber, Jennifer S.

2015-01-01

Objective To describe the association between weight status and sexual practices among 18-19 year-old women. Study design We analyzed a population-based longitudinal study of 18-19 year-old women residing in a Michigan county at cohort inception. Weekly journal surveys measured sexual practices, including contraceptive behaviors. Outcomes included proportion of weeks with a partner, proportion of weeks with sexual intercourse, number of partners, average length of relationships, proportion of weeks with contraception use, and proportion of weeks where contraception was used consistently. We examined 26,545 journal surveys from 900 women over the first study year. Ordinary least squares regression models for each outcome examined differences by weight status, controlling for sociodemographic characteristics. Results The mean proportion of weeks in which adolescents reported sexual intercourse was 52%; there was no difference by weight status. Among weeks in which adolescents reported sexual activity, obese adolescents had a lower proportion of weeks where any contraception was used compared with normal-weight adolescents (84% vs 91%, p=0.011). Among weeks in which adolescents reported sexual activity and contraceptive use, obese adolescents had a lower proportion of weeks with consistent contraceptive use (68% vs 78%, p=0.016) and oral contraceptive pill use (27% vs 45%, p=0.001) compared with normal-weight adolescents. All other relationships by weight status were not statistically significant. Conclusions In this longitudinal study, obese adolescent women were less likely to use contraception, and less likely to use it consistently when compared with normal-weight peers. Findings suggest obesity may be an important factor associated with adolescent women’s sexual behavior. PMID:26143383

Higher efficacy of pegylated interferon-α2b add-on therapy in hepatitis B envelope antigen-positive chronic hepatitis B patients on tenofovir monotherapy.

PubMed

Jindal, Ankur; Vyas, Ashish Kumar; Kumar, Devesh; Kumar, Guresh; Sharma, Manoj Kumar; Sarin, Shiv Kumar

2018-05-01

Monotherapy with pegylated interferon-α (Peg-IFNα) or the nucleos(t)ide analogs (NA) currently approved for treating chronic hepatitis B (CHB) has limited efficacy. Studies on the combination of Peg-IFNα/NA have shown conflicting results. We investigated whether sequentially adding on Peg-IFNα to tenofovir enhances serological response rates. Treatment-naïve, hepatitis B envelope antigen (HBeAg)-positive CHB patients with moderately elevated alanine aminotransferase (ALT; 48-200 IU/mL) were started on tenofovir (300 mg/day) and enrolled at week 12 in a 1:1 ratio to either receive Peg-IFNα2b add-on (1.5 μg/kg/week) from week 12 to 36 (n = 53) or continue tenofovir monotherapy (n = 53). Both treatment arms received tenofovir consolidation therapy until week 72. The primary end-point was HBeAg loss at week 72. At week 72, the rate of HBeAg loss was higher in the Peg-IFNα2b add-on group (35.8%) compared to the tenofovir monotherapy group (17%) (P = 0.028; odds ratio, 2.73, 95% confidence interval, 1.09-6.79), and considerably higher in patients with a baseline hepatitis B virus (HBV)-DNA level >6 log IU/mL (32.6% vs 11.4%; P = 0.021). Rates of HBV-DNA loss (77.4% vs 71.7%; P = 0.51), ALT normalization (62.3% vs 52.8%; P = 0.32), and sustained virologic response (20.8% vs 11.3%; P = 0.18) at week 72 were comparable between the two groups. Significantly more patients in the add-on group had >3 log HBV-DNA reduction at week 36 (92.5% vs 66%; P = 0.001). Four patients treated with Peg-IFNα2b add-on achieved hepatitis B surface antigen (HBsAg) loss compared with one patient receiving tenofovir monotherapy. Decline of HBV-DNA of >2 log at week 4 led to higher HBeAg loss at week 72, independent of treatment arm. No patient had treatment-related adverse effects requiring treatment discontinuation. Twenty-four weeks of Peg-IFNα2b as an add-on sequential regimen to tenofovir is safe and resulted in greater loss of HBeAg and HBsAg compared to tenofovir monotherapy in selected HBeAg-positive patients. Viral load reduction followed by immune modulation is a potentially useful approach. © 2018 The Japan Society of Hepatology.

Assessment of the antidandruff activity of a new shampoo: a randomized, double-blind, controlled study by clinical and instrumental evaluations.

PubMed

Sparavigna, Adele; Setaro, Michele; Caserini, Maurizio; Bulgheroni, Anna

2013-01-01

The aim of this randomized, double-blind, controlled study was to evaluate the antidandruff activity exerted by a new shampoo on patients affected by dandruff and/or mild seborrheic dermatitis by means of both D-squame technique coupled with image analysis and clinical assessments. Thirty-four patients were enrolled and 1:1 randomly assigned to either a test shampoo or a comparative shampoo group. Treatment schedule was twice a week for 4 weeks. The D-squame technique was shown to be able to objectively record variations in scalp desquamation both between test and comparative groups and within the same group over time. The results obtained with this instrumental approach showed a statistically significant reduction by 52% vs baseline after 2 weeks of treatment. There was an even greater reduction after 4 weeks (-66%). This reduction was statistically significant compared with the comparative group at the same time points. The analysis of all the other parameters (except Wood's lamp) confirmed the superiority of the test vs the comparative shampoo. The test shampoo proved to be safe, well tolerated, and accepted by the patients for cosmetic acceptability and efficacy. The study confirmed the antidandruff efficacy of the test shampoo and its superiority vs the comparative shampoo.

Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study

PubMed Central

Park, Won; Yoo, Dae Hyun; Miranda, Pedro; Brzosko, Marek; Wiland, Piotr; Gutierrez-Ureña, Sergio; Mikazane, Helena; Lee, Yeon-Ah; Smiyan, Svitlana; Lim, Mie-Jin; Kadinov, Vladimir; Abud-Mendoza, Carlos; Kim, HoUng; Lee, Sang Joon; Bae, YunJu; Kim, SuYeon; Braun, Jürgen

2017-01-01

Objectives To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS). Methods This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102. Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20. Antidrug antibodies (ADAs) were measured using an electrochemiluminescent method. Data were analysed for patients treated with CT-P13 in the main PLANETAS study and the extension (maintenance group) and those who were switched to CT-P13 during the extension study (switch group). Results Overall, 174 (82.9%) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled. Among these, 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP. In these maintenance and switch groups, respectively, ASAS20 response rates at week 102 were 80.7% and 76.9%. ASAS40 and ASAS partial remission were also similar between groups. ADA positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively. Conclusions This is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS. In the maintenance group, CT-P13 was effective and well tolerated over 2 years of treatment. Trial registration number NCT01571206; Results. PMID:27117698

Estimating the monetary value of the annual productivity gained in patients with early rheumatoid arthritis receiving etanercept plus methotrexate: interim results from the PRIZE study

PubMed Central

Zhang, Wei; Bansback, Nick; Sun, Huiying; Pedersen, Ronald; Kotak, Sameer; Anis, Aslam H

2015-01-01

Objective To measure and value the impact of combined etanercept (ETN) and methotrexate (MTX) therapy on work productivity in patients with early rheumatoid arthritis (RA) over 52 weeks. Methods MTX- and biological-naïve patients with RA (symptom onset ≤12 months; Disease Activity Score based on a 28-joint count (DAS28) >3.2) received open-label ETN50/MTX for 52 weeks. The Valuation of Lost Productivity (VOLP) questionnaire, measuring paid and unpaid work productivity impacts, was completed approximately every 13 weeks. Bootstrapping methods were used to test changes in VOLP outcomes over time. One-year productivity impacts were compared between responders (DAS28 ≤3.2) at week 13 and non-responders using zero-inflated models for time loss and two-part models for total costs of lost productivity. Results 196 patients were employed at baseline and had ≥1 follow-up with VOLP. Compared with baseline, at week 52, patients gained 33.4 h per 3 months in paid work and 4.2 h per week in unpaid work. Total monetary productivity gains were €1322 per 3 months. Over the 1-year period, responders gained paid (231 h) and unpaid work loss (122 h) compared with non-responders, which amounted to a gain of €3670 for responders. Conclusions This is the first clinical trial to measure and value the impact of biological treatment on all the labour input components that affect overall productivity. Combination therapy with ETN50/MTX was associated with a significant productivity gain for patients with early RA who were still observed at week 52. Over the 1-year treatment period, responders at week 13 suffered significantly less productivity loss than non-responders suggesting this gain was related to treatment response. Trial registration number ClinicalTrials.gov number NCT00913458 PMID:26535135

Clinical and Histopathologic Assessment of Facial Melasma After Low-Fluence Q-Switched Neodymium-Doped Yttrium Aluminium Garnet Laser.

PubMed

Hofbauer Parra, Camila Anna; Careta, Mariana Figueroa; Valente, Neusa Yuriko Sakai; de Sanches Osório, Nuno Eduardo Guimaraes; Torezan, Luis Antonio Ribeiro

2016-04-01

Melasma is a frequent and difficult to treat skin disorder. Results of laser therapy are inconsistent. To determine the safety and efficacy of low-fluence Q-switched neodymium-doped yttrium aluminum garnet (QS Nd:YAG) laser for melasma treatment and assess recurrence rates and histopathologic findings before and after treatment. Twenty patients were treated with 10 weekly sessions of low-fluence 1064-nm QS Nd:YAG laser at 1-week intervals. The modified Melasma Area and Severity Index (mMASI) score was evaluated at baseline; 1 week; and 1, 3, and 6 months after treatment. Epidermal melanin quantification was performed on 10 biopsy samples and compared before and after treatment. All patients showed improvement by mMASI scores, range (21%-75%) compared with that at baseline. No permanent side effects occurred. The recurrence rate was 81%. By histopathology, a slight, nonsignificant (p = .305) decrease in melanin deposition was seen in all layers of the epidermis 1 week after the laser treatments ended. The results confirm the safety and effectiveness of low-fluence QS Nd:YAG laser for treating melasma; however, the high recurrence suggests poor long-term results when the laser is used as a monotherapy.

Ultrasound-guided subacromial injections of sodium hyaluronate for the management of rotator cuff tendinopathy: a prospective comparative study with rehabilitation therapy.

PubMed

Merolla, G; Bianchi, P; Porcellini, G

2013-06-01

Rotator cuff (RC) tendinopathy is a common cause of pain and shoulder dysfunction. The literature evidence suggests that a combination of overuse and extrinsic compression may induce chronic RC tendinopathy. Aim of the current study was to compare the results of subacromial sodium hyaluronate injections with rehabilitation therapy. We enrolled 48 patients (M/F: 26/22; mean age: 50 years; shoulder right/left: 29/19) with persistent shoulder pain for at least 4 months. Exclusion criteria were as follows: RC tear, calcifying tendinitis, glenohumeral instability, osteoarthritis, rheumatic diseases, physical therapy and/or injection in the previous 4 months, shoulder surgery, anesthetic nerve block, trauma, and severe medical diseases. The included subjects received either two ultrasound-guided subacromial hyaluronic acid (HA) injections (25 patients, HA group) at baseline and 14 days, or underwent rehabilitation therapy (23 patients, Physio group) including active shoulder mobilization, soft tissue stretching and humeral head positioner and propeller muscles strengthening for 30 days (3 sessions every week). Clinical assessment of shoulder function was performed with visual analog scale score for pain (0-100), Oxford Shoulder Score (OSS), and Constant-Murley Score (CS). Overall, patients were examined at baseline, week 2, week 4, week 12, and week 24. Statistical significance was set at 5 % (p < 0.05). Reduction in overall pain in the HA group was statistically significant at week 2 (p < 0.05) week 4 (p < 0.05), week 12 comparing to baseline. Similarly, pain subscores (at night and with activity) were significantly lower at week 2 (p < 0.05), week 4 (p < 0.05), and week 12 (p < 0.05), respectively. In the Physio group, pain decreased significantly at week 2 (p < 0.05) but not maintained at week 4 (p > 0.05), week 12 (p > 0.05), and week 24 (p > 0.05). CS and OSS in the HA group increased significantly at week 2 (p < 0.05), week 4 (p < 0.05), and week 12 (p < 0.05). A non-statistically significant increase in clinical scores was found at week 24 (p > 0.05). A significant improvement of CS and OSS we found in the Physio group at week 2 (p < 0.05), but not at weeks 4, 12, and 24 (p > 0.05). Subacromial HA injections could be an effective and safe alternative treatment for patients suffering from RC tendinopathy. We believe that the results of this study are encouraging but not lasting and we might suppose that a series of three to four subacromial sodium hyaluronate injections could provide good mid- and long-term clinical benefits.

Six Weeks of Massage Therapy Produces Changes in Balance, Neurological and Cardiovascular Measures in Older Persons

PubMed Central

Sefton, JoEllen M.; Yarar, Ceren; Berry, Jack W.

2012-01-01

Objectives: Falls in older adults represent a primary cause of decreased mobility and independence, increased morbidity, and accidental death. Research and clinical reports indicate that therapeutic massage (TM) may positively influence suggested causative factors. The second in a two-part study, this project assessed the effects of six weeks of TM treatment on balance, nervous system, and cardiovascular measures in older adults. Design: A randomized controlled trial assessed the effects of six weekly 60-minute sessions of TM on balance, cardiovascular, and nervous system measures. Thirty-five volunteers (19 male and 16 female; ages 62.9 ± 4.6) were randomly assigned to relaxation control or TM groups. A 2 × 4 [treatment condition X time (week 1 and 6)] mixed factorial experimental design was utilized for cardiovascular/balance variables assessed at pretreatment baseline, immediate post-treatment, and 20- and 60-minutes post-treatment; nervous system measures were assessed only at pretreatment and at 60-minute follow-up (2 × 2 mixed design). Long-term benefits were assessed by comparing the TM and control groups on pretreatment baseline measures at week six and a follow-up assessment at week seven (2 × 3 mixed design). Setting: Laboratory Intervention: Six weekly 60-minute, full-body TM. Outcome Measures: Postural control/cardiovascular measures were assessed weeks one, six, and seven; pretreatment and immediate, 20- and 60-minutes post-treatment. Motoneuron pool excitability was assessed pretreatment and 60 minutes post-treatment. Results: The TM group showed significant differences relative to controls in cardiovascular and displacement area/velocity after the week six session, with decreasing blood pressure and increasing stability over time from immediate post-TM to 60 minutes post-TM. The TM group revealed lower H-max/M-max ratios 60-minutes post-treatment. Long-term differences between the groups were detected at week seven in displacement area/velocity and systolic blood pressure. Conclusions: Results suggest six weeks of TM resulted in immediate and long-term improvements in postural stability and blood pressure, compared to a controlled condition. PMID:23087776

Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study.

PubMed

Korobelnik, Jean-François; Holz, Frank G; Roider, Johann; Ogura, Yuichiro; Simader, Christian; Schmidt-Erfurth, Ursula; Lorenz, Katrin; Honda, Miki; Vitti, Robert; Berliner, Alyson J; Hiemeyer, Florian; Stemper, Brigitte; Zeitz, Oliver; Sandbrink, Rupert

2014-01-01

To evaluate the efficacy and safety of intravitreal aflibercept injections for treatment of macular edema secondary to central retinal vein occlusion (CRVO). A randomized, multicenter, double-masked phase 3 study. A total of 177 treatment-naive patients with macular edema secondary to CRVO were randomized in a 3:2 ratio. Patients received either 2-mg intravitreal aflibercept or sham injections every 4 weeks for 20 weeks. From week 24 to 48, the aflibercept group received aflibercept as needed (pro re nata [PRN]), and the sham group continued receiving sham injections. The primary efficacy end point was the proportion of patients who gained 15 letters or more in best-corrected visual acuity (BCVA) at week 24. This study reports week 52 results including the proportion of patients who gained 15 letters or more in BCVA and the mean change from baseline BCVA and central retinal thickness. Efficacy end points at week 52 were all exploratory. At week 52, the mean percentage of patients gaining 15 letters or more was 60.2% in the aflibercept group and 32.4% in the sham group (P = 0.0004). Aflibercept patients, compared with sham patients, had a significantly higher mean improvement in BCVA (+16.9 letters vs. +3.8 letters, respectively) and reduction in central retinal thickness (-423.5 μm vs. -219.3 μm, respectively) at week 52 (P < 0.0001 for both). Aflibercept patients received a mean of 2.5 injections (standard deviation, 1.7 injections) during PRN dosing. The most common ocular adverse events in the aflibercept group were related to the injection procedure or the underlying disease, and included macular edema (33.7%), increased intraocular pressure (17.3%), and eye pain (14.4%). Treatment with intravitreal aflibercept provided significant functional and anatomic benefits after 52 weeks as compared with sham. The improvements achieved after 6 monthly doses at week 24 largely were maintained until week 52 with as-needed dosing. Intravitreal aflibercept generally was well tolerated. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Heavy metals in rice samples on the Torbat-Heidarieh market, Iran.

PubMed

Roya, Amiri Qandashtani; Ali, Mohamadi Sani

2017-03-01

Levels of the heavy metals arsenic (As), cadmium (Cd) and lead (Pb) were determined in rice samples imported from India and Pakistan and marketed in Torbat-Heidarieh, Iran. To assess the safety of dietary intake of these metals by rice, the estimated weekly intake (EWI) was calculated and compared with the provisional tolerable weekly intake (PTWI). The results indicated that mean values for Pb and cadmium in imported rice were considerably higher than the safe limit as set by FAO/WHO. EWI for cadmium and As among the consumed types of imported rice was lower than the PTWI. The results also revealed that the weekly intake of Pb was higher than the maximum weekly intake recommended by WHO/FAO.

Efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis who were refractory or intolerant to anti-tumor necrosis factor therapy: Subgroup analysis of a randomized, double-blind, multicenter, phase 3 study (SIRROUND-T).

PubMed

Tanaka, Yoshiya; Takeuchi, Tsutomu; Harigai, Masayoshi; Yamanaka, Hisashi; Nakano, Toshikazu; Akagi, Koshiro; Ukyo, Yoshifumi; Hsu, Benjamin

2018-04-13

To evaluate the efficacy and safety of sirukumab, a human anti-interleukin six monoclonal antibody, in Japanese patients with rheumatoid arthritis who were refractory to anti-tumor necrosis factor therapy. This subgroup analysis, based on a double-blind, placebo-controlled, 52-week phase 3, global study (SIRROUND-T) assessed the American College of Rheumatology (ACR) 20 response at week 16 (primary endpoint). Secondary endpoints: ACR 50, Disease Activity Score in 28 joints-C reactive protein, Health Assessment Questionnaire-Disability Index and safety were assessed. Results 116/878 patients received sirukumab 50 mg/4 weeks (q4w, n = 35), 100 mg/2 weeks (q2w, n = 44) or placebo (n = 37) subcutaneously. Significantly more patients achieved ACR 20 response at week 16 with sirukumab (50 mg q4w:20 [57.1%]; p < .001, 100 mg q2w:24 [54.5%]; p = .001) versus placebo (7 [18.9%]); consistent significant improvement in secondary endpoints at week 24 and 52 was observed. At week 24, incidence of treatment-emergent adverse events (TEAEs) was numerically higher with sirukumab groups (50 mg q4w:29 [82.9%]; 100 mg q2w:38 [86.4%] versus placebo (28 [75.7%]); however, at week 52, sirukumab combined groups had comparable incidence of TEAEs. Efficacy findings through 52 weeks were comparable between sirukumab doses in Japanese patients and consistent with primary SIRROUND-T study results. No new safety signals were observed.

Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study.

PubMed

Brown, David M; Heier, Jeffrey S; Clark, W Lloyd; Boyer, David S; Vitti, Robert; Berliner, Alyson J; Zeitz, Oliver; Sandbrink, Rupert; Zhu, Xiaoping; Haller, Julia A

2013-03-01

To evaluate intravitreal aflibercept injections (IAI; also called VEGF Trap-Eye) for patients with macular edema secondary to central retinal vein occlusion (CRVO). Randomized controlled trial. This multicenter study randomized 189 patients (1 eye/patient) with macular edema secondary to CRVO to receive 6 monthly injections of either 2 mg intravitreal aflibercept (IAI 2Q4) (n = 115) or sham (n = 74). From week 24 to week 52, all patients received 2 mg intravitreal aflibercept as needed (IAI 2Q4 + PRN and sham + IAI PRN) according to retreatment criteria. The primary endpoint was the proportion of patients who gained ≥15 ETDRS letters from baseline at week 24. Additional endpoints included visual, anatomic, and quality-of-life NEI VFQ-25 outcomes at weeks 24 and 52. At week 24, 56.1% of IAI 2Q4 patients gained ≥15 letters from baseline compared with 12.3% of sham patients (P < .001). At week 52, 55.3% of IAI 2Q4 + PRN patients gained ≥15 letters compared with 30.1% of sham + IAI PRN patients (P < .001). At week 52, IAI 2Q4 + PRN patients gained a mean of 16.2 letters of vision vs 3.8 letters for sham + IAI PRN (P < .001). The most common adverse events for both groups were conjunctival hemorrhage, eye pain, reduced visual acuity, and increased intraocular pressure. Monthly injections of 2 mg intravitreal aflibercept for patients with macular edema secondary to CRVO resulted in a statistically significant improvement in visual acuity at week 24, which was largely maintained through week 52 with intravitreal aflibercept PRN dosing. Intravitreal aflibercept injection was generally well tolerated. Copyright © 2013 Elsevier Inc. All rights reserved.

Early virologic response to abacavir/lamivudine and tenofovir/emtricitabine during ACTG A5202

PubMed Central

Grant, Philip M.; Tierney, Camlin; Budhathoki, Chakra; Daar, Eric S.; Sax, Paul E.; Collier, Ann C.; Fischl, Margaret A.; Zolopa, Andrew R.; Balamane, Maya; Katzenstein, David

2014-01-01

Background ACTG A5202 randomized treatment-naive individuals to tenofovir-emtricitabine (TDF/FTC) or abacavir-lamivudine (ABC/3TC) combined with efavirenz (EFV) or atazanavir/ritonavir (ATV/r). Individuals in the high screening viral load (VL) stratum (≥100,000 copies/mL) had increased rates of virologic failure with ABC/3TC. Objective Compare regimen-specific early virologic response. Methods Using Wilcoxon rank-sum tests, we compared regimen-specific VL changes from entry to week 4 in A5202 subjects (n=1813) and from entry to week 1, 2 and 4 in a 179-patient substudy. We evaluated associations between week 4 VL change and time to virologic failure with Cox proportional-hazards models. Results TDF/FTC- and ABC/3TC produced similar Week 4 viral load declines in the entire study population and in the high VL stratum. EFV produced greater VL declines from baseline at week 4 than ATV/r (median −2.1 vs. −1.9 log10 copies/mL; p<0.001). In the substudy of subjects with week 1, 2 and 4 VL data, there was no difference in viral load decline in those randomized to TDF/FTC versus ABC/3TC, but EFV resulted in greater VL decline from entry at each of these timepoints than ATV/r. Smaller Week 4 viral load decline was associated with increased risk of virologic failure. Conclusions Within all treatment arms, a less robust week 4 virologic response was associated with higher risk for subsequent virologic failure. However, between-regimen differences in week 4 VL declines did not parallel the previously reported differences in longer term virologic efficacy in A5202, suggesting that between-regimen differences in responses were not due to intrinsic differences in antiviral activity. PMID:24334181

Comparative clinical evaluation of two professional tooth-whitening products.

PubMed

Kowitz, G M; Nathoo, S A; Wong, R

1994-01-01

A 2-week study was conducted to compare the tooth-whitening efficacy of two 10% carbamide peroxide products: Colgate Platinum Professional Toothwhitening System and Rembrandt Lighten Bleaching Gel. Fifty subjects were divided into two groups and assigned a product to use for 2 weeks. Change in tooth color was measured by reflectance spectroscopy at the initiation of study, at 1 week, and at 2 weeks into the study. Color change was calculated using the color-difference equation established by the Commission International de L'Eclairage. Results showed that Colgate Platinum was 62% more effective at tooth whitening after 1 week and 83% more effective after 2 weeks of treatment vs Rembrandt. At the termination of the study, the mean color difference (deltaE) for Colgate Platinum was 4.29 and 2.34 for Rembrandt. Statistical analysis demonstrated that the Colgate product is significantly superior at increasing tooth whiteness, increasing tooth lightness, reducing redness, and reducing yellowness. In this study, no adverse reactions were noted on clinical examination and none were reported by panelists with normal healthy dentition.

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students.

PubMed

Barbosa, Peter; Raymond, Gaye; Zlotnick, Cheryl; Wilk, James; Toomey, Robert; Mitchell, James

2013-01-01

Graduate healthcare students experience significant stressors during professional training. Mindfulness-Based Stress Reduction (MBSR) is a behavioural intervention designed to teach self-regulatory skills for stress reduction and emotion management. This study examines the impact of MBSR training on students from five healthcare graduate programs in a quasi-experimental trial. A total of 13 students completed the MBSR program and were compared with 15 controls. Both groups answered validated questionnaires measuring anxiety, burnout and empathy at baseline, at conclusion of the course (week 8) and 3 weeks post-course completion (week 11). Significant decrease in anxiety at weeks 8 and 11 compared with baseline (P<0.001 and P<0.01, respectively) was observed using the Burns Anxiety Inventory. Significant increase in empathy at week 8 (P<0.0096) was observed using the Jefferson Scale of Physician Empathy. Week 11 demonstrated a decrease in empathy from baseline (not statistically significant) across all subjects. No significant differences in burnout scores at weeks 8 and 11 were observed between those in the intervention and control groups. These results provide supportive evidence of MBSR as a behavioural intervention to reduce anxiety and increase empathy among graduate healthcare students.

Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

PubMed Central

Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.

2015-01-01

Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C; Milella, Luigi

2015-01-01

Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20-40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits.

Postoperative treatment of metacarpal fractures-Classical physical therapy compared with a home exercise program.

PubMed

Gülke, Joachim; Leopold, Barbara; Grözinger, Daniel; Drews, Björn; Paschke, Stephan; Wachter, Nikolaus J

Prospective cohort randomized controlled trial. Is either a home exercise (HE) program or traditional physical therapy (PT) more effective in the postoperative management of metacarpal fractures? Sixty patients suffering from nonthumb metacarpal fractures who received mobilization-stable open reduction and internal fixation were included. All patients were prospectively randomized into either the PT group or the HE group. Follow-up examinations at 2, 6 and 12 weeks postoperatively. After 2 weeks, the range of motion (ROM) in both groups was still severely reduced. Twelve weeks after surgery the ROM improved to 245° (PT) and 256° (HE). Grip strength after 6 weeks was 68% (PT) and 71% (HE) when compared to the non-injured hand, improving to 91% (PT) and 93% (HE) after 12 weeks. Study results show that both HE program and traditional PT are effective in the postoperative management of metacarpal fractures. II. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis

PubMed Central

Wang, Chenchen; Schmid, Christopher H.; Iversen, Maura D.; Harvey, William F.; Fielding, Roger A.; Driban, Jeffrey B.; Price, Lori Lyn; Wong, John B.; Reid, Kieran F.; Rones, Ramel; McAlindon, Timothy

2016-01-01

Background Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. Objective To compare Tai Chi with standard physical therapy for patients with knee osteoarthritis. Design Randomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985) Setting An urban tertiary care academic hospital. Patients 204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white). Intervention Tai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise). Measurements The primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life. Results At 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, −10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred. Limitation Patients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined. Conclusion Tai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis. Primary Funding Source National Center for Complementary and Integrative Health of the National Institutes of Health. PMID:27183035

Integrated results from the COPERNICUS and GALILEO studies

PubMed Central

Pielen, Amelie; Clark, W Lloyd; Boyer, David S; Ogura, Yuichiro; Holz, Frank G; Korobelnik, Jean-Francois; Stemper, Brigitte; Asmus, Friedrich; Rittenhouse, Kay D; Ahlers, Christiane; Vitti, Robert; Saroj, Namrata; Zeitz, Oliver; Haller, Julia A

2017-01-01

Objectives To report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO. Patients and methods Patients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52. Results At week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in <10% of patients. Conclusion This analysis of integrated data from COPERNICUS and GALILEO confirmed that intravitreal aflibercept is an effective treatment for macular edema following CRVO. PMID:28883712

The effects of visual control whole body vibration exercise on balance and gait function of stroke patients.

PubMed

Choi, Eon-Tak; Kim, Yong-Nam; Cho, Woon-Soo; Lee, Dong-Kyu

2016-11-01

[Purpose] This study aims to verify the effects of visual control whole body vibration exercise on balance and gait function of stroke patients. [Subjects and Methods] A total of 22 stroke patients were randomly assigned to two groups; 11 to the experimental group and 11 to the control group. Both groups received 30 minutes of Neuro-developmental treatment 5 times per week for 4 weeks. The experimental group additionally performed 10 minutes of visual control whole body vibration exercise 5 times per week during the 4 weeks. Balance was measured using the Functional Reach Test. Gait was measured using the Timed Up and Go Test. [Results] An in-group comparison in the experimental group showed significant differences in the Functional Reach Test and Timed Up and Go Test. In comparing the groups, the Functional Reach Test and Timed Up and Go Test of the experimental group were more significantly different compared to the control group. [Conclusion] These results suggest that visual control whole body vibration exercise has a positive effect on the balance and gait function of stroke patients.

Determination of rifaximin treatment period according to lactulose breath test values in nonconstipated irritable bowel syndrome subjects.

PubMed

Bae, Suhyun; Lee, Kwang Jae; Kim, Young-Sang; Kim, Kyu-Nam

2015-06-01

Small intestinal bacterial overgrowth (SIBO) can partly explain irritable bowel syndrome (IBS), and rifaximin has been observed to improve abdominal symptoms in nonconstipated IBS patients. However, there are few reports on the association of the rifaximin treatment periods with the results of a lactulose breath test (LBT). Therefore, we performed a retrospective review of patient charts to investigate the relation between the rifaximin treatment periods with LBT results in nonconstipated IBS patients. We also evaluated the time to achieve a symptomatic improvement in the IBS patients as compared to the changes in the LBT. We reviewed the charts for patients who showed IBS symptoms with documented positive results for LBT during their initial visit and who had a follow-up LBT after treatment with rifaximin. The LBT values were compared to the subjects' symptom scores. A total of 102 subjects had a follow-up LBT to assess LBT normalization. The subjects were divided into groups according to treatment periods of 4 weeks (n = 36), 8 weeks (n = 43), and 12 weeks (n = 23). The groups with a longer treatment exhibited an increase in the hydrogen gas value at 90 min and its sum during 90 min at the initial LBT. There were significant differences in hydrogen gas value at 90 min and in its sum during 90 min at the initial LBT between the groups treated for 4 and 12 weeks. The most significant treatment response was observed during the first 4 weeks for all treatment groups. Symptomatic improvement occurred earlier than LBT normalization in the treatment period over 4 weeks. The results indicate that different rifaximin treatment periods are needed in accordance with LBT levels to effectively eradicate SIBO.

Comparative study on the hepatoprotection to heavy metals of Zingiber officinale

PubMed Central

Nwokocha, Chukwuemeka R.; Owu, Daniel U.; Nwokocha, Magdalene I.; Ufearo, Chibueze S.; Iwuala, Moses O. E.

2012-01-01

Context: Zingiber officinale (Zingiberaceae) is a herb used for culinary and therapeutic purposes due to its anti-inflammatory and antioxidant potentials. Objectives: We examined its protective ability against mercury (Hg), lead (Pb) and cadmium (Cd) accumulation in the liver. Materials & Methods: Ground Zingiber officinale (7%, w/w of feed) was administered to rats either at the same time with the exposure ofheavy metals (group 2), a week after exposure to heavy metals (group 3) or given a week before heavy metal exposure (group 4) for six weeks. Animals were exposed to either of Hg (10 ppm), Cd (200 ppm) and Pb (100 ppm) in drinking water. The heavy metal accumulations in the liver were determined using AAS. Results: Weight losses induced by these metals were not reversed by Zingiber officinale administration. There was a significant (P<0.01) increase in protection to Pb (97%) and Cd (63%) accumulation when compared to Hg (32%) at week 2. The protective ability was significantly (P<0.01) decreased at week 4 when compared to week 2 for Cd and Pb but not to Hg in groups 3 (50%) and 4 (52%). At week 6, hepatoprotection to Hg (44%) and Cd (85%) was significantly (P<0.01) different but not to Pb which was only significant (P<0.05) in week 2 of treatment for all groups. Discussion and Conclusion: Zingiber officinale affected the bioavailability, elimination and uptake of these metals in a time-dependent way with highest beneficial reducing effect to Cd followed by Hg and least protection to Pb in the liver. PMID:23225964

Aging enhances serum cytokine response but not task-induced grip strength declines in a rat model of work-related musculoskeletal disorders

PubMed Central

2011-01-01

Background We previously reported early tissue injury, increased serum and tissue inflammatory cytokines and decreased grip in young rats performing a moderate demand repetitive task. The tissue cytokine response was transient, the serum response and decreased grip were still evident by 8 weeks. Thus, here, we examined their levels at 12 weeks in young rats. Since aging is known to enhance serum cytokine levels, we also examined aged rats. Methods Aged and young rats, 14 mo and 2.5 mo of age at onset, respectfully, were trained 15 min/day for 4 weeks, and then performed a high repetition, low force (HRLF) reaching and grasping task for 2 hours/day, for 12 weeks. Serum was assayed for 6 cytokines: IL-1alpha, IL-6, IFN-gamma, TNF-alpha, MIP2, IL-10. Grip strength was assayed, since we have previously shown an inverse correlation between grip strength and serum inflammatory cytokines. Results were compared to naïve (grip), and normal, food-restricted and trained-only controls. Results Serum cytokines were higher overall in aged than young rats, with increases in IL-1alpha, IFN-gamma and IL-6 in aged Trained and 12-week HRLF rats, compared to young Trained and HRLF rats (p < 0.05 and p < 0.001, respectively, each). IL-6 was also increased in aged 12-week HRLF versus aged normal controls (p < 0.05). Serum IFN-gamma and MIP2 levels were also increased in young 6-week HRLF rats, but no cytokines were above baseline levels in young 12-week HRLF rats. Grip strength declined in both young and aged 12-week HRLF rats, compared to naïve and normal controls (p < 0.05 each), but these declines correlated only with IL-6 levels in aged rats (r = -0.39). Conclusion Aging enhanced a serum cytokine response in general, a response that was even greater with repetitive task performance. Grip strength was adversely affected by task performance in both age groups, but was apparently influenced by factors other than serum cytokine levels in young rats. PMID:21447183

Pediatric Diaphyseal Femur Fractures: Submuscular Plating Compared With Intramedullary Nailing.

PubMed

Sutphen, Sean A; Mendoza, Juan D; Mundy, Andrew C; Yang, Jingzhen G; Beebe, Allan C; Samora, Walter P; Klingele, Kevin E

2016-11-01

This study compared the radiographic and clinical outcomes of pediatric diaphyseal femur fractures treated by submuscular plating, flexible retrograde intramedullary nailing, or rigid antegrade intramedullary nailing with a trochanteric entry point in skeletally immature patients who were 8 years and older. A retrospective review was conducted of skeletally immature patients 8 years and older who were treated for femur fracture with submuscular plating, flexible intramedullary nailing, or rigid intramedullary nailing from 2001 to 2014 with a minimum 12-week follow-up. Treatment outcomes were compared for statistical significance, including time to union, malunion, nonunion, heterotopic ossification, avascular necrosis, time to full weight bearing, limb length discrepancy, residual limp, painful hardware, and infection. The study identified 198 femur fractures in 196 patients (mean age, 11.9 years). Each femur fracture was treated with submuscular plating (35), flexible intramedullary nailing (61), or rigid intramedullary nailing (102). Mean follow-up across the cohort was 48 weeks, ranging from 12 to 225 weeks. Flexible nailing was associated with an increased incidence of malunion (P<.0001) and hardware irritation (P=.0204) and longer time to full weight bearing (P=.0018). Rigid nailing was associated with an increased incidence of limp at 12-week followup (P=.0412). Additionally, 23.5% of patients who were treated with rigid nailing had heterotopic ossification. Of all surgical methods, submuscular plating allowed for the most rapid return to full weight bearing (mean, 7 weeks) and offered the fastest healing rate (mean, 6 weeks). Submuscular plating resulted in faster times to union and full weight bearing, with minimal complication rates. Rigid intramedullary nailing with trochanteric entry resulted in a lower incidence of malunion and hardware-related complications; however, these patients had an increased incidence of heterotopic ossification and residual limp postoperatively. Flexible retrograde intramedullary nailing resulted in the highest rates of malunion and hardware irritation and the longest time to full weight bearing. [Orthopedics. 2016; 39(6):353-358.]. Copyright 2016, SLACK Incorporated.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cooper, Benjamin T.; Formenti-Ujlaki, George F.; Li, Xiaochun

Purpose: To report the results of a prospective randomized trial comparing a daily versus weekly boost to the tumor cavity during the course of accelerated radiation to the breast with patients in the prone position. Methods and Materials: From 2009 to 2012, 400 patients with stage 0 to II breast cancer who had undergone segmental mastectomy participated in an institutional review board–approved trial testing prone breast radiation therapy to 40.5 Gy in 15 fractions 5 d/wk to the whole breast, after randomization to a concomitant daily boost to the tumor bed of 0.5 Gy, or a weekly boost of 2 Gy, on Friday.more » The present noninferiority trial tested the primary hypothesis that a weekly boost produced no more acute toxicity than did a daily boost. The recurrence-free survival was estimated for both treatment arms using the Kaplan-Meier method; the relative risk of recurrence or death was estimated, and the 2 arms were compared using the log-rank test. Results: At a median follow-up period of 45 months, no deaths related to breast cancer had occurred. The weekly boost regimen produced no more grade ≥2 acute toxicity than did the daily boost regimen (8.1% vs 10.4%; noninferiority Z = −2.52; P=.006). No statistically significant difference was found in the cumulative incidence of long-term fibrosis or telangiectasia of grade ≥2 between the 2 arms (log-rank P=.923). Two local and two distant recurrences developed in the daily treatment arm and three local and one distant developed in the weekly arm. The 4-year recurrence-free survival rate was not different between the 2 treatment arms (98% for both arms). Conclusions: A tumor bed boost delivered either daily or weekly was tolerated similarly during accelerated prone breast radiation therapy, with excellent control of disease and comparable cosmetic results.« less

Ingestion of soy-whey blended protein augments sports performance and ameliorates exercise-induced fatigue in a rat exercise model.

PubMed

Ren, Guangxu; Yi, Suqing; Zhang, Hongru; Wang, Jing

2017-02-22

This study sought to determine the effects of soy-whey blended protein supplementation on sports performance and related biochemical parameters after long-term training. After a week of adaptation, eighteen 6-week-old male Wistar rats were randomly assigned to 3 groups: the standard chow diet plus whey protein (Whey) group, the standard chow diet plus soy-whey blended protein (BP) group and the standard chow diet only (control) group. Each group included 6 rats for the seven-week experiment. Before the experiment, the baseline values of body weight, grasping force and time to exhaustion due to the loaded-swimming test were recorded for each group. During the experimental period, all rats performed the loaded-swimming test until exhaustion five days each week. The results showed that the mean maximum grasping force of the BP group significantly increased between the 5 th and the 7 th week (p < 0.05) compared with the other groups. The ingestion of blended protein for 7 weeks significantly increased the mean time to exhaustion due to swimming by 1.5-fold and 1.2-fold compared with the control and Whey groups, respectively. The plasma levels of leucine, isoleucine and valine were significantly higher at 60 min after the blended protein intervention compared with the Whey and control interventions (p < 0.05). Furthermore, the ingestion of soy-whey blended protein enhanced the activities of lactate dehydrogenase and superoxide dismutase and decreased the levels of malondialdehyde in serum. These results collectively suggest that soy-whey blended protein ingestion with resistance exercise can improve sports performance and ameliorate exercise-induced fatigue in rats.

Diabetes attenuates the inhibitory effects of endomorphin-2, but not endomorphin-1 on gastrointestinal transit in mice.

PubMed

Wang, Chang-lin; Diao, Yu-xiang; Xiang, Qiong; Ren, Yu-kun; Gu, Ning

2014-09-05

Diabetes affects the entire gastrointestinal tract from the esophagus to the anus. In the present study, the charcoal meal test was undertaken to evaluate and compare the effects of intracerebroventricular (i.c.v.) administration of endomorphins (EMs) on gastrointestinal transit in non-diabetic and diabetic mice. Significantly delayed gastrointestinal transit was found in both 4 and 8 weeks alloxan-induced diabetes compared to non-diabetes. Moreover, i.c.v. EM-1 and EM-2 dose-dependently delayed gastrointestinal transit in non-diabetes and diabetes. The EM-1-induced inhibitory effects of gastrointestinal transit in 4 weeks diabetes were qualitatively similar to those of non-diabetes. However, at higher doses, the EM-1-induced effects in 8 weeks diabetes were largely enhanced. Different to EM-1, the EM-2-induced inhibition of gastrointestinal transit in diabetic mice was significantly attenuated compared to non-diabetic mice. Moreover, these effects were further decreased in 8 weeks diabetes. The delayed gastrointestinal transit effects caused by EM-1 may be primarily mediated by μ2-opioid receptor in both non-diabetes and 4 weeks diabetes. Interestingly, in 8 weeks diabetes, these effects were mediated by μ2- and δ-receptors. However, the inhibitory effects of EM-2 were mediated by μ1-opioid receptor, which exerted a reduced function in diabetes. Also, poor blood glucose control might result in the attenuated effects of EM-2. Our present results demonstrated that diabetes attenuates the inhibitory effects of EM-2, but not EM-1 on gastrointestinal transit in mice. The different effects of EM-1 and EM-2 on gastrointestinal transit in diabetes may be due to changes of opioid receptor subtypes and their functional responses. Copyright © 2014 Elsevier B.V. All rights reserved.

Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks

PubMed Central

Lim, Soo; Kim, Kyoung Min; Kim, Sin Gon; Kim, Doo Man; Woo, Jeong-Taek; Chung, Choon Hee; Ko, Kyung Soo; Park, Jeong Hyun; Park, Yongsoo; Kim, Sang Jin; Jang, Hak Chul

2017-01-01

Background The aim of this multicenter, randomized, double-blind study was to examine the effect of lobeglitazone, a novel thiazolidinedione, on the changes in bone mineral density (BMD) in patients with type 2 diabetes mellitus. Methods A 24-week, double-blinded phase was followed by a 28-week, open-label phase, in which the placebo group also started to receive lobeglitazone. A total of 170 patients aged 34 to 76 years were randomly assigned in a 2:1 ratio to receive lobeglitazone 0.5 mg or a matching placebo orally, once daily. BMD was assessed using dual-energy X-ray absorptiometry at week 24 and at the end of the study (week 52). Results During the double-blinded phase, the femur neck BMD showed decreasing patterns in both groups, without statistical significance (−0.85%±0.36% and −0.78%±0.46% in the lobeglitazone and placebo groups, respectively). The treatment difference between the groups was 0.07%, which was also not statistically significant. Further, minimal, nonsignificant decreases were observed in both groups in the total hip BMD compared to values at baseline, and these differences also did not significantly differ between the groups. During the open-label phase, the BMD was further decreased, but not significantly, by −0.32% at the femur neck and by −0.60% at the total hip in the lobeglitazone group, and these changes did not significantly differ compared with the original placebo group switched to lobeglitazone. Conclusion Our results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo. PMID:29086536

Antiretroviral Therapy Optimisation without Genotype Resistance Testing: A Perspective on Treatment History Based Models

PubMed Central

Prosperi, Mattia C. F.; Rosen-Zvi, Michal; Altmann, André; Zazzi, Maurizio; Di Giambenedetto, Simona; Kaiser, Rolf; Schülter, Eugen; Struck, Daniel; Sloot, Peter; van de Vijver, David A.; Vandamme, Anne-Mieke; Sönnerborg, Anders

2010-01-01

Background Although genotypic resistance testing (GRT) is recommended to guide combination antiretroviral therapy (cART), funding and/or facilities to perform GRT may not be available in low to middle income countries. Since treatment history (TH) impacts response to subsequent therapy, we investigated a set of statistical learning models to optimise cART in the absence of GRT information. Methods and Findings The EuResist database was used to extract 8-week and 24-week treatment change episodes (TCE) with GRT and additional clinical, demographic and TH information. Random Forest (RF) classification was used to predict 8- and 24-week success, defined as undetectable HIV-1 RNA, comparing nested models including (i) GRT+TH and (ii) TH without GRT, using multiple cross-validation and area under the receiver operating characteristic curve (AUC). Virological success was achieved in 68.2% and 68.0% of TCE at 8- and 24-weeks (n = 2,831 and 2,579), respectively. RF (i) and (ii) showed comparable performances, with an average (st.dev.) AUC 0.77 (0.031) vs. 0.757 (0.035) at 8-weeks, 0.834 (0.027) vs. 0.821 (0.025) at 24-weeks. Sensitivity analyses, carried out on a data subset that included antiretroviral regimens commonly used in low to middle income countries, confirmed our findings. Training on subtype B and validation on non-B isolates resulted in a decline of performance for models (i) and (ii). Conclusions Treatment history-based RF prediction models are comparable to GRT-based for classification of virological outcome. These results may be relevant for therapy optimisation in areas where availability of GRT is limited. Further investigations are required in order to account for different demographics, subtypes and different therapy switching strategies. PMID:21060792

Chronic Hepatitis C Treatment with Daclatasvir Plus Asunaprevir Does Not Lead to a Decreased Quality of Life.

PubMed

Kawakubo, Megumi; Eguchi, Yuichiro; Okada, Michiaki; Iwane, Shinji; Oeda, Satoshi; Otsuka, Taiga; Nakashita, Syunya; Araki, Norimasa; Koga, Akemi

2018-03-09

Objective The aim of this study was to determine if direct-acting antiviral (DAA) treatment with daclatasvir (DCV) plus asunaprevir (ASV) for 24 weeks influenced the health-related quality of life (HRQOL) at 12 and 24 weeks after treatment initiation (end of treatment [EOT]). Methods This was a prospective, longitudinal study comparing the HRQOL of patients receiving DAA treatment at 12 weeks after treatment initiation and EOT with the HRQOL at baseline. We used a Japanese-validated version of the 8-item Short Form Health Survey (SF-8) to assess the HRQOL of patients. This score can be compared to the Japanese normative sample scores of SF-8. Wilcoxon signed-rank tests were used to compare the HRQOL before treatment, 12 weeks after treatment initiation, and at EOT. Patients We enrolled patients who received 24-week combination therapy using DCV and ASV for HCV at Saga University Hospital between November 2014 and July 2015. Those who discontinued treatment due to relapse or adverse reactions during the treatment period were excluded from the study. Results There were no significant changes in any of the SF-8 subscales, Physical component scores (PCS) or mental component scores (MCS) during the treatment period for both males and females. Conclusion Our study makes a significant contribution to the literature because 24-week DAA treatment with DCV plus ASV did not decrease the HRQOL at 12 or 24 weeks after treatment initiation.

Once-a-Week Versus Once-Every-3-Weeks Cisplatin Chemoradiation for Locally Advanced Head and Neck Cancer: A Phase III Randomized Noninferiority Trial.

PubMed

Noronha, Vanita; Joshi, Amit; Patil, Vijay Maruti; Agarwal, Jaiprakash; Ghosh-Laskar, Sarbani; Budrukkar, Ashwini; Murthy, Vedang; Gupta, Tejpal; D'Cruz, Anil K; Banavali, Shripad; Pai, Prathamesh S; Chaturvedi, Pankaj; Chaukar, Devendra; Pande, Nikhil; Chandrasekharan, Arun; Talreja, Vikas; Vallathol, Dilip Harindran; Mathrudev, Vijayalakshmi; Manjrekar, Aparna; Maske, Kamesh; Bhelekar, Arati Sanjay; Nawale, Kavita; Kannan, Sadhana; Gota, Vikram; Bhattacharjee, Atanu; Kane, Shubhada; Juvekar, Shashikant L; Prabhash, Kumar

2018-04-10

Purpose Chemoradiation with cisplatin 100 mg/m 2 given once every 3 weeks is the standard of care in locally advanced head and neck squamous cell cancer (LAHNSCC). Increasingly, low-dose once-a-week cisplatin is substituted because of perceived lower toxicity and convenience. However, there is no level 1 evidence of comparable efficacy to cisplatin once every 3 weeks. Patients and Methods In this phase III randomized trial, we assessed the noninferiority of cisplatin 30 mg/m 2 given once a week compared with cisplatin 100 mg/m 2 given once every 3 weeks, both administered concurrently with curative intent radiotherapy in patients with LAHNSCC. The primary end point was locoregional control (LRC); secondary end points included toxicity, compliance, response, progression-free survival, and overall survival. Results Between 2013 and 2017, we randomly assigned 300 patients, 150 to each arm. Two hundred seventy-nine patients (93%) received chemoradiotherapy in the adjuvant setting. At a median follow-up of 22 months, the estimated cumulative 2-year LRC rate was 58.5% in the once-a-week arm and 73.1% in the once-every-3-weeks arm, leading to an absolute difference of 14.6% (95% CI, 5.7% to 23.5%); P = .014; hazard ratio (HR), 1.76 (95% CI, 1.11 to 2.79). Acute toxicities of grade 3 or higher occurred in 71.6% of patients in the once-a-week arm and in 84.6% of patients in the once-every-3-weeks arm ( P = .006). Estimated median progression-free survival in the once-a-week arm was 17.7 months (95% CI, 0.42 to 35.05 months) and in the once-every-3-weeks arm, 28.6 months (95% CI, 15.90 to 41.30 months); HR, 1.24 (95% CI, 0.89 to 1.73); P = .21. Estimated median overall survival in the once-a-week arm was 39.5 months and was not reached in the once-every-3-weeks arm (HR, 1.14 [95% CI, 0.79 to 1.65]; P = .48). Conclusion Once-every-3-weeks cisplatin at 100 mg/m 2 resulted in superior LRC, albeit with more toxicity, than did once-a-week cisplatin at 30 mg/m 2 , and should remain the preferred chemoradiotherapy regimen for LAHNSCC in the adjuvant setting.

Anti-inflammatory treatment improves high-density lipoprotein function in rheumatoid arthritis

PubMed Central

O'Neill, Francis; Charakida, Marietta; Topham, Eric; McLoughlin, Eve; Patel, Neha; Sutill, Emma; Kay, Christopher W M; D'Aiuto, Francesco; Landmesser, Ulf; Taylor, Peter C; Deanfield, John

2017-01-01

Objective Patients with rheumatoid arthritis (RA) are at increased cardiovascular risk. Recent studies suggest that high-density lipoprotein (HDL) may lose its protective vascular phenotype in inflammatory conditions. However, the effects of common anti-inflammatory treatments on HDL function are not yet known. Methods We compared the function of HDL in 18 patients with RA and 18 matched healthy controls. Subsequently, patients were randomised to (methotrexate+infliximab (M+I) (5 mg/kg)) or methotrexate+placebo (M+P) infusions for 54 weeks. At week 54 and thereafter, all patients received infliximab therapy until completion of the trial (110 weeks), enabling assessment of the impact of 1 year of infliximab therapy in all patients. HDL functional properties were assessed at baseline, 54 weeks and 110 weeks by measuring the impact on endothelial nitric oxide (NO) bioavailability and superoxide production (SO), paraoxonase activity (PON-1) and cholesterol efflux. Results All HDL vascular assays were impaired in patients compared with controls. After 54 weeks, NO in response to HDL was significantly greater in patients who received M+I compared with those who received M+P. Endothelial SO in response to HDL was reduced in both groups, but PON-1 and cholesterol efflux remained unchanged. All vascular measures improved compared with baseline after ≥1 infliximab therapy in the analysis at 110 weeks. No significant trend was noted for cholesterol efflux. Conclusions HDL function can be improved with anti-inflammatory treatment in patients with RA. The M+I combination was superior to the M+P alone, suggesting that the tumour necrosis factor-α pathway may have a role in HDL vascular properties. PMID:27852695

Comparison of a Smartphone App for Alcohol Use Disorders With an Internet-based Intervention Plus Bibliotherapy: A Pilot Study

PubMed Central

Gonzalez, Vivian M.; Dulin, Patrick L.

2015-01-01

Objective To date no research has evaluated the efficacy of a stand-alone, smartphone-based intervention for individuals with an alcohol use disorder. The current pilot study evaluated the short-term outcomes of a smartphone-based intervention for alcohol use disorders compared with an internet-based brief motivational intervention plus bibliotherapy. Method Adults (18 to 45 years old) with an alcohol use disorder received either the Location-Based Monitoring and Intervention for Alcohol Use Disorders (LBMI-A; n = 28), a smartphone-based intervention, or the online Drinker’s Check-up plus bibliotherapy (DCU+bib; n = 26). These groups were compared using the Timeline Followback interview for percent days abstinent (PDA), percent heavy drinking days (PHDD), and drinks per week (DPW) from baseline to six weeks after the introduction of the interventions. Results Multilevel models revealed that the LBMI-A resulted in a significant increase in PDA over the course of the study, while the DCU+bib did not. Effect sizes for change from baseline for PDA suggest that the DCU+bib resulted in moderate a decrease, while the LBMI-A resulted in a large increase in PDA. Both interventions resulted in significant decreases in PHDD and DPW. The LBMI-A produced larger reductions in the first three to four weeks after the intervention was introduced than the DCU+bib. On weeks with greater LBMI-A usage, participants reported less DPW and PHDD. Conclusions Both interventions resulted in significant decreases in alcohol use over the 6-week trial, which is promising for stand-alone technology-based intervention systems aimed at individuals with an alcohol use disorder. PMID:25622202

Optimal duration of risperidone or olanzapine adjunctive therapy to mood stabilizer following remission of a manic episode: A CANMAT randomized double-blind trial.

PubMed

Yatham, L N; Beaulieu, S; Schaffer, A; Kauer-Sant'Anna, M; Kapczinski, F; Lafer, B; Sharma, V; Parikh, S V; Daigneault, A; Qian, H; Bond, D J; Silverstone, P H; Walji, N; Milev, R; Baruch, P; da Cunha, A; Quevedo, J; Dias, R; Kunz, M; Young, L T; Lam, R W; Wong, H

2016-08-01

Atypical antipsychotic adjunctive therapy to lithium or valproate is effective in treating acute mania. Although continuation of atypical antipsychotic adjunctive therapy after mania remission reduces relapse of mood episodes, the optimal duration is unknown. As many atypical antipsychotics cause weight gain and metabolic syndrome, they should not be continued unless the benefits outweigh the risks. This 52-week double-blind placebo-controlled trial recruited patients with bipolar I disorder (n=159) who recently remitted from a manic episode during treatment with risperidone or olanzapine adjunctive therapy to lithium or valproate. Patients were randomized to one of three conditions: discontinuation of risperidone or olanzapine and substitution with placebo at (i) entry ('0-weeks' group) or (ii) at 24 weeks after entry ('24-weeks' group) or (iii) continuation of risperidone or olanzapine for the full duration of the study ('52-weeks' group). The primary outcome measure was time to relapse of any mood episode. Compared with the 0-weeks group, the time to any mood episode was significantly longer in the 24-weeks group (hazard ratio (HR) 0.53; 95% confidence interval (CI): 0.33, 0.86) and nearly so in the 52-weeks group (HR: 0.63; 95% CI: 0.39, 1.02). The relapse rate was similar in the 52-weeks group compared with the 24-weeks group (HR: 1.18; 95% CI: 0.71, 1.99); however, sub-group analysis showed discordant results between the two antipsychotics (HR: 0.48, 95% CI: 0.17; 1.32 olanzapine patients; HR: 1.85, 95% CI: 1.00, 3.41 risperidone patients). Average weight gain was 3.2 kg in the 52-weeks group compared with a weight loss of 0.2 kg in the 0-weeks and 0.1 kg in the 24-weeks groups. These findings suggest that risperidone or olanzapine adjunctive therapy for 24 weeks is beneficial but continuation of risperidone beyond this period does not reduce the risk of relapse. Whether continuation of olanzapine beyond this period reduces relapse risk remains unclear but the potential benefit needs to be weighed against an increased risk of weight gain.

Changes in the structural properties of peripheral nerves after transection.

PubMed

Toby, E B; Meyer, B M; Schwappach, J; Alvine, G

1996-11-01

Changes in peripheral nerve structural properties after transection were measured weekly for 5 weeks in the distal stump of the sciatic nerve in 50 Sprague-Dawley rats. Each week after transection, the distal stump of the transected nerve showed increased stiffness when compared to intact nerves. Linear elastic stiffness reached a maximum at weeks 1 and 2 after transection, when the transected nerves were 15% stiffer than the contralateral control sides. Toughness was also increased and reached a maximum at week 4 with a 50% difference between values for experimental and control sides. Overall failure load was between 21% and 27% greater, peaking at week 3. An increase in stiffness of the distal stump would result in increased tension at the suture line, as the nerve gap is overcome when performing a delayed neurorraphy. These data suggest, with respect to structural properties, that an end-to-end repair should be carried out at the time of injury; after only 1 week, significant stiffness in the distal segment of the nerve developed, which should result in an increase in tension at the repair site.

COMPLEMENT ACTIVATION FRAGMENT Bb IN EARLY PREGNANCY AND SPONTANEOUS PRETERM BIRTH

PubMed Central

LYNCH, ANNE M.; GIBBS, RONALD S.; MURPHY, JAMES R.; BYERS, TIM; NEVILLE, MARGARET C.; GICLAS, PATRICIA C.; SALMON, JANE E.; VAN HECKE, TRISHA M; MICHAEL HOLERS, V.

2008-01-01

Objective To determine if an elevated level of the complement activation fragment Bb in early pregnancy was associated with spontaneous preterm birth (SPTB) at less than 34 weeks gestation or SPTB between 34 and 37 weeks gestation (late SPTB). Study Design Prospective study of 784 women enrolled at < 20 weeks gestation. Results Following exclusions, 13 women (1.7%) had a SPTB at less than 34 weeks gestation and 25 (3.2%) a SPTB between 34 and 37 weeks gestation. Women with Bb in the top quartile were 4.7 times more likely to have an SPTB less than 34 weeks gestation as compared with women who had levels of Bb in the lower three quartiles (95% CI 1.5 to 14, P = 0.003). There was no association between Bb and late SPTB (RR= 0.8, 95% CI = 0.3 to 2). Conclusions A significant relationship was found between an elevated Bb in early pregnancy and SPTB < 34 weeks gestation. These results suggest that inflammatory events in early pregnancy are part of the pathogenic mechanisms of this condition. PMID:18928972

A comparative study of intramedullary interlocking nailing and minimally invasive plate osteosynthesis in extra articular distal tibial fractures.

PubMed

Daolagupu, Arup K; Mudgal, Ashwani; Agarwala, Vikash; Dutta, Kaushik K

2017-01-01

Extraarticular distal tibial fractures are among the most challenging fractures encountered by an orthopedician for treatment because of its subcutaneous location, poor blood supply and decreased muscular cover anteriorly, complications such as delayed union, nonunion, wound infection, and wound dehiscence are often seen as a great challenge to the surgeon. Minimally invasive plate osteosynthesis (MIPO) and intramedullary interlocking nail (IMLN) are two well-accepted and effective methods, but each has been historically related to complications. This study compares clinical and radiological outcome in extraarticular distal tibia fractures treated by intramedullary interlocking nail (IMLN) and minimally invasive plate osteosynthesis (MIPO). 42 patients included in this study, 21 underwent IMLN and 21 were treated with MIPO who met the inclusion criteria and operated between June 2014 and May 2015. Patients were followed up for clinical and radiological evaluation. In IMLN group, average union time was 18.26 weeks compared to 21.70 weeks in plating group which was significant ( P < 0.0001). Average time required for partial and full weight bearing in the nailing group was 4.95 weeks and 10.09 weeks respectively which was significantly less ( P < 0.0001) as compared to 6.90 weeks and 13.38 weeks in the plating group. Lesser complications in terms of implant irritation, ankle stiffness, and infection, were seen in interlocking group as compared to plating group. Average functional outcome according to American Orthopedic Foot and Ankle Society score was measured which came out to be 96.67. IMLN group was associated with lesser duration of surgery, earlier weight bearing and union rate, lesser incidence of infection and implant irritation which makes it a preferable choice for fixation of extra-articular distal tibial fractures. However, larger randomized controlled trials are required for confirming the results.

Anxiety and Anger Symptoms in Hwabyung Patients Improved More following 4 Weeks of the Emotional Freedom Technique Program Compared to the Progressive Muscle Relaxation Program: A Randomized Controlled Trial

PubMed Central

Suh, Jin Woo; Chung, Sun Yong; Kim, Sang Young; Lee, Jung Hwan; Kim, Jong Woo

2015-01-01

Background. The Emotional Freedom Technique (EFT) is a meridian-based psychological therapy. The present clinical trial investigates the effectiveness of EFT as a new treatment option for Hwabyung (HB) patients experiencing anger and compares the efficacy to the Progressive Muscle Relaxation (PMR), the conventional meditation technique. Methods. The EFT and progressive muscle relaxation (PMR) methods were performed on 27 HB patients, and their capacities to alleviate anxiety, anger, and emotional status were compared. After a 4-week program, a survey was conducted; patients then completed a self-training program for 4 weeks, followed by a second survey. Results. During the initial 4 weeks, the EFT group experienced a significant decrease in the HB symptom scale, anger state, and paranoia ideation (p < 0.05). Over the entire 9-week interval, there were significant decreases in the HB symptom scale, anxiety state, anger state, anger trait, somatization, anxiety, hostility, and so on in EFT group (p < 0.05). Conclusion. The EFT group showed improved psychological symptoms and physical symptoms greater than those observed in the PMR group. EFT more effectively alleviated HB symptoms compared to PMR. EFT group showed better maintenance during self-training, suggesting good model of self-control treatment in HB patients. PMID:26539218

Biomechanical adaptations of mice cortical bone submitted to three different exercise modalities

PubMed Central

Frajacomo, Fernando Tadeu Trevisan; Falcai, Maurício José; Fernandes, Cleverson Rodrigues; Shimano, Antonio Carlos; Garcia, Sérgio Britto

2013-01-01

Objective To compare the adaptive effects of three non-weight bearing exercise on bone mechanical properties. Methods 24 male Balb/c mice (22-25g), were randomly divided into four groups (n=6): sedentary group (S); swimming group (N) which performed sessions five times per week for 60 min progressively; resistance group (R), which performed climbing exercise with progressive load, three times per week; and combined group (C), which performed the same protocols aforementioned being three times a week according to N protocol and two times a week the R protocol during eight weeks. Biomechanical tests, load until failure and stiffness evaluation of shinbone was performed after animals have been sacrificed. Results Stiffness values were statistically higher only in the isolated modalities groups (N and R, 41.68 ± 10.43 and 41.21 ± 11.38 N/mm, respectively) compared with the S group (28.48 ± 7.34 N/mm). However, taking into consideration the final body mass, relative values, there was no difference in the biomechanical tests among the groups. Conclusion Data from the present investigation demonstrated a favorable influence of muscle contraction in lower impact isolated exercise modalities on absolute stiffness values, i.e.groups N and R, whereas the combined group (C) did not present any statistical significant difference compared to sedentary group. Level of Evidence II, Prospective Comparative Study. PMID:24453691

Competence and Responsiveness in Mothers of Late Preterm Infants Versus Term Infants

PubMed Central

Baker, Brenda; McGrath, Jacqueline M.; Pickler, Rita; Jallo, Nancy; Cohen, Stephen

2013-01-01

Objective To compare maternal competence and responsiveness in mothers of late preterm infants (LPIs) with mothers of full-term infants. Design A nonexperimental repeated-measures design was used to compare maternal competence and responsiveness in two groups of postpartum mothers and the relationship of the theoretical antecedents to these outcomes. Setting Urban academic medical center. Participants Mothers of late preterm infants (34–36, 6/7-weeks gestation) and mothers of term infants (≥37-weeks gestation), including primiparas and multiparas. Data were collected after delivery during the postpartum hospital stay and again at 6-weeks postpartum. Methods Descriptive and inferential analysis. Results A total of 70 mothers completed both data collection periods: 49 term mothers and 21 LPI mothers. There were no differences between the two groups related to their perception of competence or responsiveness at delivery or 6-weeks postpartum. At 6-weeks postpartum, none of the assessed factors in the model was significantly related to competence or responsiveness. Conclusions The results, which may have been limited by small sample size, demonstrated no difference in the perceptions of LPI and term mothers related to competence or responsiveness. Maternal stress and support were significantly related to other factors in the model of maternal competence and responsiveness. PMID:23601024

The Association of State Law to Physical Education Time Allocation in US Public Schools

PubMed Central

Oh, April; Chriqui, Jamie F.; Mâsse, Louise C.; Atienza, Audie A.; Nebeling, Linda; Agurs-Collins, Tanya; Moser, Richard P.; Dodd, Kevin W.

2012-01-01

Objectives. We examined whether public schools in states with specific and stringent physical education (PE) laws, as assessed by the Physical Education–Related State Policy Classification System (PERSPCS), available on the Classification of Laws Associated with School Students (C.L.A.S.S.) Web site, reported more weekly PE time in the most recent School Health Policies and Programs Survey (SHPPS). Methods. Schools (n = 410) were grouped by their state’s PERSPCS time requirement scores (none, nonspecific requirement, or specific requirement). Average weekly school-level PE was calculated using the SHPPS-reported PE minutes. Weighted analyses determined if PE minutes/week differed by PERSPCS group. Results. Schools in states with specific requirement laws averaged over 27 and 60 more PE minutes/week at the elementary and middle school levels, respectively, compared with schools within states with nonspecific laws and over 40 and 60 more PE minutes per week, respectively, compared with elementary and middle schools in states with no laws. High school results were nonsignificant. Conclusions. Public health guidelines recommend at least 60 minutes of daily physical activity for children, and PE may further this goal. Strong codified law with specific time requirements for PE may be an important tool contributing toward adequate PE time and daily physical activity recommendations. PMID:22594746

Results of a Multicenter, Randomized, Controlled Trial of a Hydrogen Peroxide-based Kit versus a Benzoyl Peroxide-based Kit in Mild-to-moderate Acne

PubMed Central

Micali, Giuseppe; Berardesca, Enzo; Dall’Oglio, Federica; Sinagra, Jo Linda; Guanziroli, Elena

2016-01-01

Objective:To evaluate the efficacy and tolerability of a novel hydrogen peroxide-based regimen versus a benzoyl peroxide-based regimen in mild-to-moderate acne. Methods: In this eight-week multicenter study, patients were randomized to either a hydrogen peroxide-based or a benzoyl peroxide-based regimen.The primary outcome measure of clinical response was assessed using the Global Acne Grading System (GAGS) at baseline,four weeks, and eight weeks. At Week 8, a patient self-satisfaction questionnaire was administered. Investigators were also queried at that time regarding assessment of tolerability and cosmetic acceptability. Tolerability was also measured at each visit. Results: Both treatment regimens were associated with improvement of GAGS score at Week 8 compared to baseline (p<0.0001). GAGS score did not differ significantly between the two regimens over the same period (p=0.7765). No significant adverse events were reported or observed in either treatment arm. Both patients and investigators found both regimens to be similarly effective and cosmetically acceptable. Conclusion: A novel hydrogen peroxide-based regimen was shown to be comparable in efficacy, safety, and cosmetic acceptability to a benzoyl peroxide-based regimen in the treatment of mild-to-moderate acne. PMID:27847549

Police arrest and self-defence skills: performance under anxiety of officers with and without additional experience in martial arts.

PubMed

Renden, Peter G; Landman, Annemarie; Savelsbergh, Geert J P; Oudejans, Raôul R D

2015-01-01

We investigated whether officers with additional martial arts training experience performed better in arrest and self-defence scenarios under low and high anxiety and were better able to maintain performance under high anxiety than officers who just rely on regular police training. We were especially interested to find out whether training once a week would already lead to better performance under high anxiety. Officers with additional experience in kickboxing or karate/jiu-jitsu (training several times per week), or krav maga (training once a week) and officers with no additional experience performed several arrest and self-defence skills under low and high anxiety. Results showed that officers with additional experience (also those who trained once a week) performed better under high anxiety than officers with no additional experience. Still, the additional experience did not prevent these participants from performing worse under high anxiety compared to low anxiety. Implications for training are discussed. Practitioner summary: Dutch police officers train their arrest and self-defence skills only four to six hours per year. Our results indicate that doing an additional martial arts training once a week may lead to better performance under anxiety, although it cannot prevent that performance decreases under high anxiety compared to low anxiety.

Cognitive-behavioral therapy improves weight loss and quality of life in women with polycystic ovary syndrome: a pilot randomized clinical trial.

PubMed

Cooney, Laura G; Milman, Lauren W; Hantsoo, Liisa; Kornfield, Sara; Sammel, Mary D; Allison, Kelly C; Epperson, C Neill; Dokras, Anuja

2018-06-13

To compare the effects of cognitive-behavioral therapy (CBT) and lifestyle modification (LS) versus LS alone on weight, depressive and anxiety symptoms, and stress response in women with polycystic ovary syndrome (PCOS), overweight/obesity, and depressive symptoms. A 16-week pilot randomized clinical trial. Tertiary-care PCOS center. Overweight/obese women with PCOS and depressive symptoms. Weekly CBT (n = 7) or contact only/no therapy (n = 8) for 8 weeks. Both groups received weekly LS for 16 weeks. Changes in weight, depression (Center for Epidemiologic Studies Depression Scale [CES-D]), anxiety (State-Trait Anxiety Inventory [STAI]), quality of life (Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire [PCOSQ]), laboratory tests, and response to a Trier Social Stress Test (TSST). The CBT+LS group lost more weekly weight (-0.35 kg/wk vs. -0.16 kg/wk) compared with the LS group. Overall, the CBT+LS group lost 3.2 kg versus 1.8 kg for the LS group. The CBT+LS group had greater improvement in PCOSQ at 8 weeks (+3.7 vs. +1.2 points). In the overall cohort, STAI and CES-D decreased by -0.27 points per week and -0.31 points/wk, respectfully, and total and free T decreased at week 8. Heart rate response to TSST was lower at 15 minutes after stressor in the CBT+LS group. Weekly CBT+LS for 8 weeks compared with LS alone resulted in significant weight loss and improved quality of life in overweight/obese women with PCOS and depressive symptoms. These interventions were associated with a decreased autonomic response to a laboratory stressor, suggesting a potential link between CBT, weight loss, and modulation of the stress response. NCT01899001. Copyright © 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial.

PubMed

Travier, Noémie; Velthuis, Miranda J; Steins Bisschop, Charlotte N; van den Buijs, Bram; Monninkhof, Evelyn M; Backx, Frank; Los, Maartje; Erdkamp, Frans; Bloemendal, Haiko J; Rodenhuis, Carla; de Roos, Marnix A J; Verhaar, Marlies; ten Bokkel Huinink, Daan; van der Wall, Elsken; Peeters, Petra H M; May, Anne M

2015-06-08

Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue. This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) or supervised aerobic and resistance exercise (n = 102). By design, all patients received chemotherapy between baseline and 18 weeks. Fatigue (i.e., primary outcome at 18 weeks), quality of life, anxiety, depression, and physical fitness were measured at 18 and 36 weeks. Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control (mean between-group differences at 18 weeks: -1.3; 95 % CI -2.5 to -0.1; effect size -0.30). Results for general fatigue were comparable but did not reach statistical significance (-1.0, 95%CI -2.1; 0.1; effect size -0.23). At 18 weeks, submaximal cardiorespiratory fitness and several muscle strength tests (leg extension and flexion) were significantly higher in the intervention group compared to control, whereas peak oxygen uptake did not differ between groups. At 36 weeks these differences were no longer statistically significant. Quality of life outcomes favoured the exercise group but were not significantly different between groups. A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue, submaximal cardiorespiratory fitness, and muscle strength. Exercise early during treatment of breast cancer can be recommended. At 36 weeks, these effects were no longer statistically significant. This might have been caused by the control participants' high physical activity levels during follow-up. Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on December 9th, 2009.

Massage Therapy for Osteoarthritis of the Knee: A Randomized Dose-Finding Trial

PubMed Central

Perlman, Adam I.; Ali, Ather; Njike, Valentine Yanchou; Hom, David; Davidi, Anna; Gould-Fogerite, Susan; Milak, Carl; Katz, David L.

2012-01-01

Background In a previous trial of massage for osteoarthritis (OA) of the knee, we demonstrated feasibility, safety and possible efficacy, with benefits that persisted at least 8 weeks beyond treatment termination. Methods We performed a RCT to identify the optimal dose of massage within an 8-week treatment regimen and to further examine durability of response. Participants were 125 adults with OA of the knee, randomized to one of four 8-week regimens of a standardized Swedish massage regimen (30 or 60 min weekly or biweekly) or to a Usual Care control. Outcomes included the Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analog pain scale, range of motion, and time to walk 50 feet, assessed at baseline, 8-, 16-, and 24-weeks. Results WOMAC Global scores improved significantly (24.0 points, 95% CI ranged from 15.3–32.7) in the 60-minute massage groups compared to Usual Care (6.3 points, 95% CI 0.1–12.8) at the primary endpoint of 8-weeks. WOMAC subscales of pain and functionality, as well as the visual analog pain scale also demonstrated significant improvements in the 60-minute doses compared to usual care. No significant differences were seen in range of motion at 8-weeks, and no significant effects were seen in any outcome measure at 24-weeks compared to usual care. A dose-response curve based on WOMAC Global scores shows increasing effect with greater total time of massage, but with a plateau at the 60-minute/week dose. Conclusion Given the superior convenience of a once-weekly protocol, cost savings, and consistency with a typical real-world massage protocol, the 60-minute once weekly dose was determined to be optimal, establishing a standard for future trials. Trial Registration ClinicalTrials.gov NCT00970008 PMID:22347369

Citalopram and escitalopram in the treatment of major depressive disorder: a pooled analysis of 3 clinical trials.

PubMed

Li, Huafang; Li, Ting; Li, Guanjun; Luo, Jianfeng

2014-11-01

Pooled analysis is a powerful technique that is increasingly used to detect differences in efficacy between pharmacologic agents. Some studies have compared the efficacy and tolerability of citalopram and escitalopram, with contradictory results. The aim of this study was to compare the efficacy and tolerability of citalopram and escitalopram in the treatment of major depressive disorder (MDD) using pooled analyses. Data from 3 randomized, double-blind studies that compared citalopram (20 to 40 mg/d) and escitalopram (10 to 20 mg/d) were pooled and analyzed. The primary efficacy parameter was change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score. Efficacy assessments were made at weeks 0 (baseline), 1, 2, 4, and 6. Based on the mean change from baseline in the HAM-D-17 at weeks 1, 2, 4, and 6, the efficacy of citalopram, 20 to 40 mg/d, was equivalent to escitalopram, 10 to 20 mg/d (P > .05). Similar results were seen for severely depressed patients, with a mean treatment difference of 13.9 (SE = 7.6) vs 15.9 (SE = 7.5). Response and remission rates at week 6 were similar (response, 72.4% for citalopram, compared with 73.5% for escitalopram; remission, 52.6% vs 54.5%, respectively). The pooled analysis showed that over a 6-week treatment period, citalopram, 20 to 40 mg/d, is equivalent to escitalopram, 10 to 20 mg/d, in both efficacy and tolerability.

The effect of triiodothyronine on maturation and differentiation of oligodendrocyte progenitor cells during remyelination following induced demyelination in male albino rat.

PubMed

El-Tahry, H; Marei, H; Shams, A; El-Shahat, M; Abdelaziz, H; Abd El-Kader, M

2016-06-01

Demyelination was induced by two weeks cuprizone treatment. Rats of +ve control and triiodothyronine (T3) then received three subcutaneous injections of either saline or T3 day after day and sacrificed at the end of the third and fifth weeks. Animals in -ve control group received only standard rodent chow. After one week of cuprizone withdrawal the corpus callosum in +ve control and T3 treated rats was still demyelinated as revealed by MBP immunohistochemistry. The assay of PLP gene showed significant increase of T3 treated group compared to both the -ve control and +ve control groups. After three weeks, significant improvement in myelination was detected in T3-treated group compared to +ve control as detected by both MBP immunohistochemistry and electron microscopy. After one week of cuprizone withdrawal, PDGFRα positive cells and gene expression showed significant increase in +ve control and T3-treated groups as compared to -ve control with insignificant difference in between the former two groups. After three weeks of cuprizone withdrawal, PDGFRα positive cells in T3-treated and +ve control groups decreased to the control levels. These results suggest that T3 was effective in improving remyelination when administered during acute phase and might direct progenitor lineage toward oligodendrocytes. Copyright © 2016 Elsevier Ltd. All rights reserved.

At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS).

PubMed

Phibbs, Ciaran S; Love, Sean R; Jacobson, Alan K; Edson, Robert; Su, Pon; Uyeda, Lauren; Matchar, David B

2016-09-01

Effective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. PST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, -$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

Estimating the Clinical Outcomes and Cost Differences Between Standard Care With and Without Cadexomer Iodine in the Management of Chronic Venous Leg Ulcers Using a Markov Model.

PubMed

Nherera, Leo M; Woodmansey, Emma; Trueman, Paul; Gibbons, Garry W

2016-06-01

Chronic venous leg ulcers (VLUs) affect up to 1% of the adult population in the developed world and present a significant financial and resource burden to health care systems. Cadexomer iodine (CI) is an antimicrobial dressing indicated for use in chronic exuding wounds. The aim of this study was to estimate the cost utility of using CI + standard care (SC) - ie, high compression multicomponent bandaging including debridement - compared with SC alone in the management of chronic (>6 months' duration) VLUs from a payer's perspective. A Markov model was constructed to evaluate the cost and clinical benefits (healing and decreased infection rates) of the 2 treatment modalities over a 1-year period using data from 4 randomized, controlled clinical studies (RCTs) included in a recent Cochrane review and cost data from a recently published economic evaluation of VLUs. Costs were calculated using 2014 United States dollars; wound outcomes in- cluded complete healing in 212 patients reported in the Cochrane meta-analysis and quality-adjusted life years (QALYs), with utility values obtained from 200 patients with VLUs calculated using standard gamble. Treatment with CI over 1 year was $7,259 compared to $7,901 for SC. This resulted in a cost savings of $643/patient in favor of CI compared with SC. More patients treated with CI (61%) had their wounds healed compared to 54% treated with SC. Furthermore, patients treated with CI+SC experienced 6 additional ulcer-free weeks compared to persons treated with SC alone (ie, 25 ulcer- free weeks compared to 19 ulcer-free weeks, respectively). Overall, CI resulted in 0.03 more QALYs (ie, 0.86 QALYs compared to 0.83 for SC). The use of CI in addition to SC compared to SC alone over 52 weeks resulted in more wounds healed and more QALYs along with a decrease of overall costs The results of this study suggest CI is cost effective com- pared to SC alone in the management of patients with chronic VLUs. Prospective, controlled clinical studies are needed to elucidate the effect and cost effectiveness of CI on VLUs with and without signs of infection as compared to SC, other antiseptics, and more advanced topical treatment modalities.

Extended vs Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth

PubMed Central

Woody, George E.; Poole, Sabrina A.; Subramaniam, Geetha; Dugosh, Karen; Bogenschutz, Michael; Abbott, Patrick; Patkar, Ashwin; Publicker, Mark; McCain, Karen; Potter, Jennifer Sharpe; Forman, Robert; Vetter, Victoria; McNicholas, Laura; Blaine, Jack; Lynch, Kevin G.; Fudala, Paul

2008-01-01

Context The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful. Objective To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth. Design, Setting, and Patients Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). Interventions Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling. Main Outcome Measure Opioid-positive urine test result at weeks 4, 8, and 12. Results The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 ( χ22 = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; χ12 = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use ( χ12 = 18.45, P < .001), less injecting ( χ12 = 6.00, P = .01), and less nonstudy addiction treatment ( χ12 = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12. Conclusions Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence. PMID:18984887

Diminished Reactivity of Postmature Human Infants to Sucrose Compared with Term Infants.

ERIC Educational Resources Information Center

Smith, Barbara A.; And Others

1992-01-01

This study of healthy 39-week-old infants, so-called term infants, and chronically stressed 42-week-old infants, so-called postmature infants, showed that sucrose was extremely effective in calming term infants but less effective in calming postmature infants. Results supported the hypothesis that sucrose engages an opioid system in infants. (BG)

Some Costs of Caring at Home for an Intellectually Handicapped Child.

ERIC Educational Resources Information Center

Chetwynd, Jane

1985-01-01

Household expenditure patterns of families in the general population were compared with those of 91 families caring for an intellectually handicapped child. Results indicated that handicapped child families spent on average $NZ17 per week more on household items and $NZ7 a week on items related to care of the handicapped child. (Author/CL)

Toxicological Effects of Cypermethrin on Female Albino Rats

PubMed Central

Sangha, G. K.; Kaur, Kamalpreet; Khera, K. S.; Singh, Balwinder

2011-01-01

A study was undertaken to evaluate the effects of cypermethrin on reproduction of female albino rats. The experimental rats were fed cypermethrin at 50 mg/kg b. wt. continuously for a period of 2 and 4 weeks. Feed and water intake was also noted daily for control, vehicle treated and cypermethrin-treated rats. It was observed that there was no effect on feed and water intake in treated rats as compared to the control group. Chronic exposure to cypermethrin for 4 weeks resulted in loose fecal pellets and hyperirritability in the treated rats. Treatment related mortality also occurred at the 4th wk of treatment. Significant changes in body weight and various organ weights due to cypermethrin were observed along with disruption of estrous cycle in rats. The body weight gain in treated rats was lower at both 2 and 4 weeks as compared to the control rats. The weight of liver and spleen decreased, while that of kidneys increased as compared to the control rats. Thyroid and adrenal showed increase in weight at both 2 and 4 weeks of treatments. PMID:21430912

Efficacy and Safety of Lacosamide in Painful Diabetic Neuropathy

PubMed Central

Ziegler, Dan; Hidvégi, Tibor; Gurieva, Irina; Bongardt, Sabine; Freynhagen, Rainer; Sen, David; Sommerville, Kenneth

2010-01-01

OBJECTIVE To evaluate efficacy and safety of lacosamide compared with placebo in painful diabetic polyneuropathy. RESEARCH DESIGN AND METHODS Diabetic patients with at least moderate neuropathic pain were randomized to placebo or lacosamide 400 (in a slow or standard titration) or 600 mg/day over 6-week titration and 12-week maintenance periods. Primary efficacy criterion was intra-individual change in average daily Numeric Pain Rating Scale score from baseline to the last 4 weeks. RESULTS For the primary end point, pain reduction was numerically but not statistically greater with lacosamide compared with placebo (400 mg/day, P = 0.12; 600 mg/day, P = 0.18). Both doses were significantly more effective compared with placebo over the titration (P = 0.03, P = 0.006), maintenance (P = 0.01, P = 0.005), and entire treatment periods (P = 0.03, P = 0.02). Safety profiles between titration schemes were similar. CONCLUSIONS Lacosamide reduced neuropathic pain and was well tolerated in diabetic patients, but the primary efficacy criterion was not met, possibly due to an increased placebo response over the last 4 weeks. PMID:20067958

Promoting participation in physical activity using framed messages: an application of prospect theory.

PubMed

Latimer, Amy E; Rench, Tara A; Rivers, Susan E; Katulak, Nicole A; Materese, Stephanie A; Cadmus, Lisa; Hicks, Althea; Keany Hodorowski, Julie; Salovey, Peter

2008-11-01

Messages designed to motivate participation in physical activity usually emphasize the benefits of physical activity (gain-framed) as well as the costs of inactivity (loss-framed). The framing implications of prospect theory suggest that the effectiveness of these messages could be enhanced by providing gain-framed information only. We compared the effectiveness of gain-, loss-, and mixed-framed messages for promoting moderate to vigorous physical activity. Randomized trial. Sedentary, healthy callers to the US National Cancer Institute's Cancer Information Service (N=322) received gain-, loss-, or mixed-framed messages on three occasions (baseline, Week 1, and Week 5). Social cognitive variables and self-reported physical activity were assessed at baseline, Week 2, and Week 9. Separate regression analyses were conducted to examine message effects at each assessment point. At Week 2, gain- and mixed-framed messages resulted in stronger intentions and greater self-efficacy than loss-framed messages. At Week 9, gain-framed messages resulted in greater physical activity participation than loss- or mixed-framed messages. Social cognitive variables at Week 2 did not mediate the Week 9 framing effects on physical activity participation. Using gain-framed messages exclusively may be a means of increasing the efficacy of physical activity materials.

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study

PubMed Central

Yoo, Dae Hyun; Prodanovic, Nenad; Jaworski, Janusz; Miranda, Pedro; Ramiterre, Edgar; Lanzon, Allan; Baranauskaite, Asta; Wiland, Piotr; Abud-Mendoza, Carlos; Oparanov, Boycho; Smiyan, Svitlana; Kim, HoUng; Lee, Sang Joon; Kim, SuYeon; Park, Won

2017-01-01

Objectives To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions. Methods This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group). Results Overall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively). Conclusions Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years. Trial registration number NCT01571219; Results. PMID:27130908

Home blood-pressure monitoring in a hypertensive pregnant population: cost minimisation study.

PubMed

Xydopoulos, G; Perry, H; Sheehan, E; Thilaganathan, B; Fordham, R; Khalil, A

2018-03-08

Traditional monitoring of blood pressure in hypertensive pregnant women requires frequent visits to the maternity outpatient services. Home blood-pressure monitoring (HBPM) could offer a cost-saving alternative that is acceptable to patients. The main objective of this study was to undertake a health economic analysis of HBPM compared with traditional monitoring in hypertensive pregnant women. This was a case-control study. Cases were pregnant women with hypertension who had HBPM with or without the adjunct of a smartphone app, via a specially designed pathway. The control group were managed as per existing hospital guidelines. Specific outcome measures were the number of outpatient visits, inpatient bed stays and investigations performed. Maternal, fetal and neonatal adverse outcomes were also recorded. Health economic analysis was performed using two methods: direct cost comparison of the study dataset and process scenario modelling. There were 108 women in the HBPM group, of whom 29 recorded their results on the smartphone app (App-HBPM) and 79 in their notes (Non-app HBPM). The control group comprised of 58 patients. There were significantly more women with chronic hypertension in the HBPM group (49.1% vs 25.9%, P = 0.004). The HBPM group had significantly longer duration of monitoring (9 weeks vs 5 weeks P = 0.004) and started monitoring from an earlier gestation (30 weeks vs 33.6 weeks, P = 0.001). Despite these differences, the mean saving per week for HBPM compared with the control group was £200.69. For the App-HBPM cohort, the saving per week compared with the control group was £286.53. The process modelling method predicted savings of between £98.32 and £245.80 per week using HBPM compared to the traditional monitoring. HBPM in hypertensive pregnancies appears to be cost-saving compared with traditional monitoring, without compromising maternal, fetal or neonatal safety. Larger studies are required to confirm these findings. This article is protected by copyright. All rights reserved.

Significant Effects of Oral Phenylbutyrate and Vitamin D3 Adjunctive Therapy in Pulmonary Tuberculosis: A Randomized Controlled Trial.

PubMed

Mily, Akhirunnesa; Rekha, Rokeya Sultana; Kamal, S M Mostafa; Arifuzzaman, Abu Saleh Mohammad; Rahim, Zeaur; Khan, Lamia; Haq, Md Ahsanul; Zaman, Khaliqu; Bergman, Peter; Brighenti, Susanna; Gudmundsson, Gudmundur H; Agerberth, Birgitta; Raqib, Rubhana

2015-01-01

Development of new tuberculosis (TB) drugs and alternative treatment strategies are urgently required to control the global spread of TB. Previous results have shown that vitamin D3 (vitD3) and 4-phenyl butyrate (PBA) are potent inducers of the host defense peptide LL-37 that possess anti-mycobacterial effects. To examine if oral adjunctive therapy with 5,000IU vitD3 or 2x500 mg PBA or PBA+vitD3 to standard chemotherapy would lead to enhanced recovery in sputum smear-positive pulmonary TB patients. Adult TB patients (n = 288) were enrolled in a randomized, double-blind, placebo-controlled trial conducted in Bangladesh. Primary endpoints included proportions of patients with a negative sputum culture at week 4 and reduction in clinical symptoms at week 8. Clinical assessments and sputum smear microscopy were performed weekly up to week 4, fortnightly up to week 12 and at week 24; TB culture was performed at week 0, 4 and 8; concentrations of LL-37 in cells, 25-hydroxyvitamin D3 (25(OH)D3) in plasma and ex vivo bactericidal function of monocyte-derived macrophages (MDM) were determined at week 0, 4, 8, 12 and additionally at week 24 for plasma 25(OH)D3. At week 4, 71% (46/65) of the patients in the PBA+vitD3-group (p = 0.001) and 61.3% (38/62) in the vitD3-group (p = 0.032) were culture negative compared to 42.2% (27/64) in the placebo-group. The odds of sputum culture being negative at week 4 was 3.42 times higher in the PBA+vitD3-group (p = 0.001) and 2.2 times higher in vitD3-group (p = 0.032) compared to placebo. The concentration of LL-37 in MDM was significantly higher in the PBA-group compared to placebo at week 12 (p = 0.034). Decline in intracellular Mtb growth in MDM was earlier in the PBA-group compared to placebo (log rank 11.38, p = 0.01). Adjunct therapy with PBA+vitD3 or vitD3 or PBA to standard short-course therapy demonstrated beneficial effects towards clinical recovery and holds potential for host-directed-therapy in the treatment of TB. clinicaltrials.gov NCT01580007.

Small Acute Benefits of 4 Weeks Processing Speed Training Games on Processing Speed and Inhibition Performance and Depressive Mood in the Healthy Elderly People: Evidence from a Randomized Control Trial

PubMed Central

Nouchi, Rui; Saito, Toshiki; Nouchi, Haruka; Kawashima, Ryuta

2016-01-01

Background: Processing speed training using a 1-year intervention period improves cognitive functions and emotional states of elderly people. Nevertheless, it remains unclear whether short-term processing speed training such as 4 weeks can benefit elderly people. This study was designed to investigate effects of 4 weeks of processing speed training on cognitive functions and emotional states of elderly people. Methods: We used a single-blinded randomized control trial (RCT). Seventy-two older adults were assigned randomly to two groups: a processing speed training game (PSTG) group and knowledge quiz training game (KQTG) group, an active control group. In PSTG, participants were asked to play PSTG (12 processing speed games) for 15 min, during five sessions per week, for 4 weeks. In the KQTG group, participants were asked to play KQTG (four knowledge quizzes) for 15 min, during five sessions per week, for 4 weeks. We measured several cognitive functions and emotional states before and after the 4 week intervention period. Results: Our results revealed that PSTG improved performances in processing speed and inhibition compared to KQTG, but did not improve performance in reasoning, shifting, short term/working memory, and episodic memory. Moreover, PSTG reduced the depressive mood score as measured by the Profile of Mood State compared to KQTG during the 4 week intervention period, but did not change other emotional measures. Discussion: This RCT first provided scientific evidence related to small acute benefits of 4 week PSTG on processing speed, inhibition, and depressive mood in healthy elderly people. We discuss possible mechanisms for improvements in processing speed and inhibition and reduction of the depressive mood. Trial registration: This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (UMIN000022250). PMID:28066229

Small Acute Benefits of 4 Weeks Processing Speed Training Games on Processing Speed and Inhibition Performance and Depressive Mood in the Healthy Elderly People: Evidence from a Randomized Control Trial.

PubMed

Nouchi, Rui; Saito, Toshiki; Nouchi, Haruka; Kawashima, Ryuta

2016-01-01

Background: Processing speed training using a 1-year intervention period improves cognitive functions and emotional states of elderly people. Nevertheless, it remains unclear whether short-term processing speed training such as 4 weeks can benefit elderly people. This study was designed to investigate effects of 4 weeks of processing speed training on cognitive functions and emotional states of elderly people. Methods: We used a single-blinded randomized control trial (RCT). Seventy-two older adults were assigned randomly to two groups: a processing speed training game (PSTG) group and knowledge quiz training game (KQTG) group, an active control group. In PSTG, participants were asked to play PSTG (12 processing speed games) for 15 min, during five sessions per week, for 4 weeks. In the KQTG group, participants were asked to play KQTG (four knowledge quizzes) for 15 min, during five sessions per week, for 4 weeks. We measured several cognitive functions and emotional states before and after the 4 week intervention period. Results: Our results revealed that PSTG improved performances in processing speed and inhibition compared to KQTG, but did not improve performance in reasoning, shifting, short term/working memory, and episodic memory. Moreover, PSTG reduced the depressive mood score as measured by the Profile of Mood State compared to KQTG during the 4 week intervention period, but did not change other emotional measures. Discussion: This RCT first provided scientific evidence related to small acute benefits of 4 week PSTG on processing speed, inhibition, and depressive mood in healthy elderly people. We discuss possible mechanisms for improvements in processing speed and inhibition and reduction of the depressive mood. Trial registration: This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (UMIN000022250).

The Clinical Significance of Digital Examination-Indicated Cerclage in Women with a Dilated Cervix at 14 0/7 - 29 6/7 Weeks

PubMed Central

Ko, Hyun Sun; Jo, Yun Seong; Kil, Ki Cheol; Chang, Ha Kyun; Park, Yong-Gyu; Park, In Yang; Lee, Guisera; Kim, Sajin; Shin, Jong Chul

2011-01-01

Objective. This study was to compare pregnancy outcomes between cerclage and expectant management in wemen with a dilated cervix. Design. Retrospective multicenter cohort study. Setting. Five hospitals of Catholic University Medical Center Network in Korea. Population. A total of 173 women between 14 0/7 and 29 6/7 weeks' gestation with cervical dilation of 1 cm or greater by digital examination. Methods. Pregnancy outcomes were compared according to cerclage or expectant management, with the use of propensity-score matching. Main Outcome Measures. Primary outcome was time from presentation until delivery (weeks). Secondary outcomes were gestational age at delivery, neonatal survival, morbidity, preterm birth, and so on. Results. Of 173 women, 116 received a cerclage (cerclage group), and 57 were managed expectantly without cerclage (expectant group). Cervical dilation at presentation, and the use of amniocentesis performed to exclude subclinical chorioamnionitis differed between two groups. In the overall matched cohort, there was significant difference in the time from presentation until delivery (cerclage vs. expectant group, 10.6±6.2 vs. 2.9±3.2 weeks, p <0.0001). While there was no significant difference in the neonatal survival between two groups, there werelower neonatal morbidity as well as higher pregnancy maintenance rate at 28, 32, 34 and 37 weeks' gestation in the cerclage group, compared with the expectant group. Conclusion. This study suggests that digital examination-indicated cerclage appears to prolong gestation and decrease neonatal morbidity, compared with expectant management in women with cervical dilation between 14 0/7 and 29 6/7 weeks. PMID:21960743

A Comparison of the Effects of Short-Term Plyometric and Resistance Training on Lower Body Muscular Performance.

PubMed

Whitehead, Malcolm T; Scheett, Timothy P; McGuigan, Michael R; Auckland, N Z; Martin, Angel V

2017-11-01

The purpose of this study was to compare effects of short-term plyometric and resistance training on lower body muscular performance. A convenience sample of thirty males aged 21.3 ± 1.8 years, height 177.3 ± 9.4 cm, mass 80.0 ± 2.6 kg, body fat 16.1 ± 1.2 % participated in this investigation. Participants were grouped and participated in progressive plyometric (PLT) or resistance training (SRT) twice per week for eight consecutive weeks or a control (CNT) group that did not participate in any training. Performance tests were administered prior to and following the training period and included measures of high-speed muscular strength (standing long jump, vertical jump), low-speed muscular strength (one-repetition maximal back squat), running speed (20-meter sprint) and running agility (505 agility test agility test-Test). Analysis of variance followed by post hoc analyses was performed to determine significant differences between the groups. Significance set at p ≤ 0.05 for all analyses. Significant improvements were observed in the PLT group for standing long jump, vertical jump, and one-repetition maximal back squat compared to the CNT group, and for vertical jump as compared to the SRT group. Significant improvements were observed in the SRT group one-repetition maximal back squat compared to the CNT group. There were no differences observed between any of the groups for the 20-meter sprint or the 505 agility test following the training. These data indicate eight weeks of progressive plyometric training results in improvements in parameters of high and low-speed muscular strength with no appreciable change in speed or agility. Additionally, the improvement in low-speed muscular strength observed from 8-weeks of progressive plyometric training was comparable to the results observed from 8-weeks of progressive strength training.

Systematic review: proton pump inhibitors (PPIs) for the healing of reflux oesophagitis - a comparison of esomeprazole with other PPIs.

PubMed

Edwards, S J; Lind, T; Lundell, L

2006-09-01

No randomized controlled trial has compared all the licensed standard dose proton pump inhibitors in the healing of reflux oesophagitis. To compare the effectiveness of esomeprazole with licensed standard dose proton pump inhibitors for healing of reflux oesophagitis (i.e. lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg and rabeprazole 20 mg). Systematic review of CENTRAL, BIOSIS, EMBASE and MEDLINE for randomized controlled trials in patients with reflux oesophagitis. Searching was completed in February 2005. Data on endoscopic healing rates at 4 and 8 weeks were extracted and re-analysed if not analysed by intention-to-treat. Meta-analysis was conducted using a fixed effects model. Of 133 papers identified in the literature search, six were of sufficient quality to be included in the analysis. No studies were identified comparing rabeprazole with esomeprazole. A meta-analysis of healing rates of esomeprazole 40 mg compared with standard dose proton pump inhibitors gave the following results: at 4 weeks [relative risk (RR) 0.92; 95% CI: 0.90, 0.94; P < 0.00001], and 8 weeks (RR 0.95; 95% CI: 0.94, 0.97; P < 0.00001). Publication bias did not have a significant impact on the results. The results were robust to changes in the inclusion/exclusion criteria and using a random effects model. Esomeprazole consistently demonstrates higher healing rates when compared with standard dose proton pump inhibitors.

The impact of PASI 75 and PASI 90 on quality of life in moderate to severe psoriasis patients.

PubMed

Abrouk, Michael; Nakamura, M; Zhu, T H; Farahnik, B; Koo, J; Bhutani, T

2017-09-01

It is well known that psoriasis significantly impacts patients' quality of life (QoL). With the introduction of improved treatment modalities with biologic agents, more patients with moderate to severe psoriasis are able to achieve better results as measured by the Psoriasis Area and Severity Index (PASI). PASI 75 indicates a 75% or greater reduction in PASI scores from baseline and is indicative of excellent disease improvement. With newer biologic agents such as secukinumab, ixekizumab and brodalumab, patients are now capable of achieving PASI 90, introducing additional clinical decisions for physicians when considering treatment options. However, little is known regarding how the difference between achieving PASI-75 versus PASI-90 impacts patients' QoL. The purpose of this study was to compare how achieving PASI 75 versus PASI 90 impacts QoL for patients with moderate to severe plaque psoriasis by using validated psychometric instruments that have been widely used in both dermatologic and non-dermatologic settings. Two separate open-label clinical trials were conducted to specifically assess QoL in patients with moderate to severe psoriasis on adalimumab or ustekinumab over 24 weeks. In addition to clinical assessments of psoriasis, patients completed two surveys: The Psychological General Well-Being (PGWB) Index and the Dermatology Life Quality Index (DLQI). Changes in total PGWB score and DLQI score at weeks 12 and 24 compared to baseline were compared between groups achieving PASI 75 and PASI 90. There was no statistically significant difference in PGWB scores between patients achieving PASI 75 and patients achieving PASI 90 in the adalimumab treatment group (week 12 p = .21, but there was at week 24 p = .05). There was a statistically significant difference in DLQI between the patients achieving PASI 75 and the patients achieving PASI 90 in the adalimumab treatment group at week 24 (p = .01), but not week 12 (p = .11). There was no statistically significant difference in PGWB scores between patients achieving PASI 75 and patients achieving PASI 90 in the ustekinumab treatment group (week 12 p = .11, week 24 p = .35). There was no statistically significant difference in DLQI between the patients achieving PASI 75 and the patients achieving PASI 90 in the ustekinumab treatment group at week 24 (week 12 p = .49, week 24 p = .11). There has been tremendous attention surrounding newer biologic agents that can achieve PASI 90 and even PASI 100. Although the results are impressive with regard to physical improvement of psoriasis, there may not be a clinically significant difference in QoL when comparing patients who achieve PASI-75 versus PASI 90.

Clinical efficacy of omalizumab in chronic spontaneous urticaria is associated with a reduction of FcεRI-positive cells in the skin.

PubMed

Metz, Martin; Staubach, Petra; Bauer, Andrea; Brehler, Randolf; Gericke, Janine; Kangas, Michael; Ashton-Chess, Joanna; Jarvis, Philip; Georgiou, Panayiotis; Canvin, Janice; Hillenbrand, Rainer; Erpenbeck, Veit J; Maurer, Marcus

2017-01-01

Background. Treatment with omalizumab, a humanized recombinant monoclonal anti-IgE antibody, results in clinical efficacy in patients with Chronic Spontaneous Urticaria (CSU). The mechanism of action of omalizumab in CSU has not been elucidated in detail. Objectives. To determine the effects of omalizumab on levels of high affinity IgE receptor-positive (FcεRI + ) and IgE-positive (IgE + ) dermal cells and blood basophils. Treatment efficacy and safety were also assessed. Study design. In a double-blind study, CSU patients aged 18‑75 years were randomized to receive 300 mg omalizumab (n=20) or placebo (n=10) subcutaneously every 4 weeks for 12 weeks. Changes in disease activity were assessed by use of the weekly Urticaria Activity Score (UAS7). Circulating IgE levels, basophil numbers and levels of expression of FcεRI + and IgE + cells in the skin and in blood basophils were determined. Results. Patients receiving omalizumab showed a significantly greater decrease in UAS7 compared with patients receiving placebo. At Week 12 the mean difference in UAS7 between treatment groups was -14.82 (p=0.0027), consistent with previous studies. Total IgE levels in serum were increased after omalizumab treatment and remained elevated up to Week 12. Free IgE levels decreased after omalizumab treatment. Mean levels of FcεRI + skin cells in patients treated with omalizumab 300 mg were decreased at Week 12 compared with baseline in the dermis of both non-lesional and lesional skin, reaching levels comparable with those seen in healthy volunteers (HVs). There were no statistically significant changes in mean FcɛRI + cell levels in the placebo group. Similar results were seen for changes in IgE + cells, although the changes were not statistically significant. The level of peripheral blood basophils increased immediately after treatment start and returned to Baseline values after the follow-up period. The levels of FcεRI and IgE expression on peripheral blood basophils were rapidly reduced by omalizumab treatment up to Week 12. Conclusions. Treatment with omalizumab resulted in rapid clinical benefits in patients with CSU. Treatment with omalizumab was associated with reduction in FcɛRI + and IgE + basophils and intradermal cells.

The effect of modified trampoline training on balance, gait, and falls efficacy of stroke patients

PubMed Central

Hahn, Joohee; Shin, Seonhae; Lee, Wanhee

2015-01-01

[Purpose] This research was conducted to investigate the effects of modified trampoline training on the balance, gait, and falls efficacy of stroke patients. [Subjects] Twenty-four stroke patients participated in this study. The subjects were randomly allocated to one of two groups: the trampoline group (n=12) or the control group (n=12). [Methods] Both groups participated in conventional physical therapy for thirty minutes per day, three times a week for six weeks. The trampoline group also took part in trampoline training for thirty minutes per day, three times a week for six weeks. We evaluated balance (Berg balance scale, timed up and go test), gait (dynamic gait index), and falls efficacy (falls efficacy scale-K) to confirm the effects of the intervention. [Results] Both the trampoline and the control group showed significant improvements in balance, gait, and falls efficacy compared to before the intervention, and the improvements were significantly greater in the trampoline group than in the control group. [Conclusion] Modified trampoline training resulted in significantly improved balance, dynamic gait, and falls efficacy of stroke patients compared to the control group. These results suggest that modified trampoline training is feasible and effective at improving balance, dynamic gait, and falls efficacy after stroke. PMID:26696696

The effect of modified trampoline training on balance, gait, and falls efficacy of stroke patients.

PubMed

Hahn, Joohee; Shin, Seonhae; Lee, Wanhee

2015-11-01

[Purpose] This research was conducted to investigate the effects of modified trampoline training on the balance, gait, and falls efficacy of stroke patients. [Subjects] Twenty-four stroke patients participated in this study. The subjects were randomly allocated to one of two groups: the trampoline group (n=12) or the control group (n=12). [Methods] Both groups participated in conventional physical therapy for thirty minutes per day, three times a week for six weeks. The trampoline group also took part in trampoline training for thirty minutes per day, three times a week for six weeks. We evaluated balance (Berg balance scale, timed up and go test), gait (dynamic gait index), and falls efficacy (falls efficacy scale-K) to confirm the effects of the intervention. [Results] Both the trampoline and the control group showed significant improvements in balance, gait, and falls efficacy compared to before the intervention, and the improvements were significantly greater in the trampoline group than in the control group. [Conclusion] Modified trampoline training resulted in significantly improved balance, dynamic gait, and falls efficacy of stroke patients compared to the control group. These results suggest that modified trampoline training is feasible and effective at improving balance, dynamic gait, and falls efficacy after stroke.

Termination of short term melatonin treatment in children with delayed Dim Light Melatonin Onset: effects on sleep, health, behavior problems, and parenting stress.

PubMed

van Maanen, Annette; Meijer, Anne Marie; Smits, Marcel G; Oort, Frans J

2011-10-01

To investigate the effects of termination of short term melatonin treatment on sleep, health, behavior, and parenting stress in children with delayed Dim Light Melatonin Onset. Forty-one children (24 boys, 17 girls; mean age=9.43 years) entered melatonin treatment for 3 weeks and then discontinued treatment by first taking a half dose for 1 week and then stopping completely for another week. Sleep was measured with sleep diaries filled in by parents and with actometers worn by children. Analyses were conducted with linear mixed models. Sleep latency was longer during the stop week compared to the treatment weeks. Sleep start was later and actual sleep time was shorter during the half dose and stop weeks compared to the treatment weeks. Sleep efficiency deteriorated in the stop week. Dim Light Melatonin Onset was earlier after treatment, but this effect disappeared after the stop week. In addition to the effects on sleep, results from questionnaires completed by parents showed that melatonin treatment also had positive effects on children's health and behavior problems and parenting stress. While health deteriorated after treatment discontinuation, the effects on behavior problems and parenting stress remained. Behavior problems at baseline did not influence the effect of melatonin treatment. This study showed that complete termination of treatment after 4 weeks of melatonin use was too early. However, clinicians may advise a lower dose after a successful treatment trial of several weeks. Copyright © 2011 Elsevier B.V. All rights reserved.

Dark nights reverse metabolic disruption caused by dim light at night.

PubMed

Fonken, L K; Weil, Z M; Nelson, R J

2013-06-01

The increasing prevalence of obesity and related metabolic disorders coincides with increasing exposure to light at night. Previous studies report that mice exposed to dim light at night (dLAN) develop symptoms of metabolic syndrome. This study investigated whether mice returned to dark nights after dLAN exposure recover metabolic function. Male Swiss-Webster mice were assigned to either: standard light-dark (LD) conditions for 8 weeks (LD/LD), dLAN for 8 weeks (dLAN/dLAN), LD for 4 weeks followed by 4 weeks of dLAN (LD/dLAN), and dLAN for 4 weeks followed by 4 weeks of LD (dLAN/LD). After 4 weeks in their respective lighting conditions both groups initially placed in dLAN increased body mass gain compared to LD mice. Half of the dLAN mice (dLAN/LD) were then transferred to LD and vice versa (LD/dLAN). Following the transfer dLAN/dLAN and LD/dLAN mice gained more weight than LD/LD and dLAN/LD mice. At the conclusion of the study dLAN/LD mice did not differ from LD/LD mice with respect to weight gain and had lower fat pad mass compared to dLAN/dLAN mice. Compared to all other groups dLAN/dLAN mice decreased glucose tolerance as indicated by an intraperitoneal glucose tolerance test at week 7, indicating that dLAN/LD mice recovered glucose metabolism. dLAN/dLAN mice also increased MAC1 mRNA expression in peripheral fat as compared to both LD/LD and dLAN/LD mice, suggesting peripheral inflammation is induced by dLAN, but not sustained after return to LD. These results suggest that re-exposure to dark nights ameliorates metabolic disruption caused by dLAN exposure. Copyright © 2013 The Obesity Society.

Multi-arm Cost-Effectiveness Analysis (CEA) comparing different durations of adjuvant trastuzumab in early breast cancer, from the English NHS payer perspective.

PubMed

Clarke, Caroline S; Hunter, Rachael M; Shemilt, Ian; Serra-Sastre, Victoria

2017-01-01

Trastuzumab improves survival in HER2+ breast cancer patients, with some evidence of adverse cardiac side effects. Current recommendations are to give adjuvant trastuzumab for one year or until recurrence, although trastuzumab treatment for only 9 or 10 weeks has shown similar survival rates to 12-month treatment. We present here a multi-arm joint analysis examining the relative cost-effectiveness of different durations of adjuvant trastuzumab. Network meta-analysis (NMA) was used to examine which trials' data to include in the cost-effectiveness analysis (CEA). A network using FinHer (9 weeks vs. zero) and BCIRG006 (12 months vs. zero) trials offered the only jointly randomisable network so these trials were used in the CEA. The 3-arm CEA compared costs and quality-adjusted life-years (QALYs) associated with zero, 9-week and 12-month adjuvant trastuzumab durations in early breast cancer, using a decision tree followed by a Markov model that extrapolated the results to a lifetime time horizon. Pairwise incremental cost-effectiveness ratios (ICERs) were also calculated for each pair of regimens and used in budget impact analysis, and the Bucher method was used to check face validity of the findings. Addition of the PHARE trial (6 months vs. 12 months) to the network, in order to create a 4-arm CEA including the 6-month regimen, was not possible as late randomisation in this trial resulted in recruitment of a different patient population as evidenced by the NMA findings. The CEA results suggest that 9 weeks' trastuzumab is cost-saving and leads to more QALYs than 12 months', i.e. the former dominates the latter. The cost-effectiveness acceptability frontier (CEAF) favours zero trastuzumab at willingness-to-pay levels below £2,500/QALY and treatment for 9 weeks above this threshold. The combination of the NMA and Bucher investigations suggests that the 9-week duration is as efficacious as the 12-month duration for distant-disease-free survival and overall survival, and safer in terms of fewer adverse cardiac events. Our CEA results suggest that 9-week trastuzumab dominates 12-month trastuzumab in cost-effectiveness terms at conventional thresholds of willingness to pay for a QALY, and the 9-week regimen is also suggested to be as clinically effective as the 12-month regimen according to the NMA and Bucher analyses. This finding agrees with the results of the E2198 head-to-head study that compared 10 weeks' with 14 months' trastuzumab and found no significant difference. Appropriate trial design and reporting is critical if results are to be synthesisable with existing evidence, as selection bias can lead to recruitment of a different patient population from existing trials. Our analysis was not based on head-to-head trials' data, so the results should be viewed with caution. Short-duration trials would benefit from recruiting larger numbers of participants to reduce uncertainty in the synthesised results.

Efficacy of Extracorporeal Shock Wave Therapy for the Treatment of Chronic Pelvic Pain Syndrome: A Randomized, Controlled Trial

PubMed Central

Vahdatpour, Babak; Moayednia, Amir; Emadi, Masoud; Khorami, Mohammad Hatef; Haghdani, Saeid

2013-01-01

Objectives. To investigate the effectiveness of extracorporeal shock wave therapy (ESWT) for symptoms alleviation in chronic pelvic pain syndrome (CPPS). Materials and Methods. 40 patients with CPPS were randomly allocated into either the treatment or sham group. In the first group, patients were treated by ESWT once a week for 4 weeks by a defined protocol. In the sham group, the same protocol was applied but with the probe being turned off. The follow-up assessments were done at 1, 2, 3, and 12 weeks by Visual Analogue Scale (VAS) for pain and NIH-developed Chronic Prostatitis Symptom Index (NIH-CPSI). Results. Pain domain scores at follow-up points in both treatment and sham groups were reduced, more so in the treatment group, which were significant at weeks 2, 3, and 12. Urinary scores became significantly different at weeks 3 and 12. Also, quality of life (QOL) and total NIH-CPSI scores at all four follow-up time points reduced more significantly in the treatment group as compared to the sham group. Noticeably, at week 12 a slight deterioration in all variables was observed compared to the first 3 weeks of the treatment period. Conclusions. our findings confirmed ESWT therapy as a safe and effective method in CPPS in short term. PMID:24000311

Efficacy of extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome: a randomized, controlled trial.

PubMed

Vahdatpour, Babak; Alizadeh, Farshid; Moayednia, Amir; Emadi, Masoud; Khorami, Mohammad Hatef; Haghdani, Saeid

2013-01-01

Objectives. To investigate the effectiveness of extracorporeal shock wave therapy (ESWT) for symptoms alleviation in chronic pelvic pain syndrome (CPPS). Materials and Methods. 40 patients with CPPS were randomly allocated into either the treatment or sham group. In the first group, patients were treated by ESWT once a week for 4 weeks by a defined protocol. In the sham group, the same protocol was applied but with the probe being turned off. The follow-up assessments were done at 1, 2, 3, and 12 weeks by Visual Analogue Scale (VAS) for pain and NIH-developed Chronic Prostatitis Symptom Index (NIH-CPSI). Results. Pain domain scores at follow-up points in both treatment and sham groups were reduced, more so in the treatment group, which were significant at weeks 2, 3, and 12. Urinary scores became significantly different at weeks 3 and 12. Also, quality of life (QOL) and total NIH-CPSI scores at all four follow-up time points reduced more significantly in the treatment group as compared to the sham group. Noticeably, at week 12 a slight deterioration in all variables was observed compared to the first 3 weeks of the treatment period. Conclusions. our findings confirmed ESWT therapy as a safe and effective method in CPPS in short term.

Temporal distribution of blood donations in three Brazilian blood centers and its repercussion on the blood supply

PubMed Central

Oliveira, Claudia Di Lorenzo; de Almeida-Neto, Cesar; Liu, Emily Jing; Sabino, Ester Cerdeira; Leão, Silvana Carneiro; Loureiro, Paula; Wright, David; Custer, Brian; Gonçalez, Thelma Therezinha; Capuani, Ligia; Busch, Michael; Proietti, Anna Bárbara de Freitas Carneiro

2013-01-01

Background Seasonal distribution of blood donation hinders efforts to provide a safe and adequate blood supply leading to chronic and persistent shortages. This study examined whether holidays, geographical area and donation type (community versus replacement) has any impact on the fluctuation of donations. Methods The numbers of blood donations from 2007 through 2010 in three Brazilian Retrovirus Epidemiological Donor Study II (REDS-II) participating centers were analyzed according to the week of donation. The weeks were classified as holiday or non-holiday. To compare donations performed during holiday versus non-holiday weeks, tabulations and descriptive statistics for weekly donations by blood center were examined and time series analysis was conducted. Results The average weekly number of donations varied according to the blood center and type of week. The average number of donations decreased significantly during Carnival and Christmas and increased during the Brazilian National Donor Week. The fluctuation was more pronounced in Recife and Belo Horizonte when compared to São Paulo and higher among community donors. Conclusion National bank holidays affect the blood supply by reducing available blood donations. Blood banks should take into account these oscillations in order to plan local campaigns, aiming at maintaining the blood supply at acceptable levels. PMID:24106441

Congenital heart disease infant death rates decrease as gestational age advances from 34 to 40 weeks.

PubMed

Cnota, James F; Gupta, Resmi; Michelfelder, Erik C; Ittenbach, Richard F

2011-11-01

To describe congenital heart disease death rates in infants born between 34 and 40 weeks, estimate the relationship between gestational age and congenital heart disease infant death rates, and compare congenital heart disease death rates across 1- and 2-week intervals in gestational age. The 2000 to 2003 national linked birth/infant death cohort datasets were obtained. Congenital heart disease deaths were identified by using International Statistical Classification of Diseases, 10th Revision codes. Proportional death rates were calculated by using congenital heart disease deaths and all live births. The relationship between congenital heart disease death rates and gestational age was determined. Death rates were compared across intervals. A total of 14.9 million records were analyzed. Congenital heart disease deaths occurred in 4736 infants (0.04%) born between 34 and 40 weeks. There was a significant, negative linear relationship between congenital heart disease death rate and gestational age (R(2) = 0.97). Comparisons across 1-week intervals varied (P = .02-.23). All 2-week intervals were statistically significant (P < .01). Congenital heart disease death rates decrease as gestational age approaches 40 weeks. These results should be considered before elective delivery for the sole indication of prenatally diagnosed congenital heart disease. Copyright © 2011 Mosby, Inc. All rights reserved.

Timing of Delivery and Pregnancy Outcomes Among Laboring Nulliparous Women

PubMed Central

Tita, Alan Thevenet N.; Lai, Yinglei; Bloom, Steven L.; Spong, Catherine Y.; Varner, Michael W.; Ramin, Susan M.; Caritis, Steve N.; Grobman, William A; Sorokin, Yoram; Sciscione, Anthony; Carpenter, Marshall W.; Mercer, Brian M.; Thorp, John M.; Malone, Fergal D.; Harper, Margaret; Iams, Jay D.

2011-01-01

OBJECTIVE To compare pregnancy outcomes by completed week of gestation after 39 weeks with outcomes at 39 weeks. STUDY DESIGN Secondary analysis of a multicenter trial of fetal pulse oximetry in spontaneously laboring or induced nulliparous women ≥36 weeks’ gestation. Maternal outcomes included a composite (treated uterine atony, blood transfusion and peripartum infections) and cesarean delivery. Neonatal outcomes included a composite of death, neonatal respiratory and other morbidities and neonatal ICU admission. RESULTS Among the 4086 women studied, the risks of the composite maternal outcome (p-value for trend<0.001), cesarean delivery (p<0.001) and composite neonatal outcome (p=0.047) increased with increasing gestational age from 39 to ≥41 completed weeks. Adjusted odds ratios (95% CI) for 40 and ≥41 weeks respectively compared with 39 weeks were 1.29 (1.03–1.64) and 2.05 (1.60–2.64) for composite maternal outcome, 1.28 (1.05–1.57) and 1.75 (1.41–2.16) for cesarean delivery and 1.25 (0.86–1.83) and 1.37 (0.90–2.09) for composite neonatal outcome. CONCLUSIONS Risks of maternal morbidity and cesarean delivery but not neonatal morbidity increased significantly beyond 39 weeks. PMID:22244471

Effectiveness of cross polarized light and fluorescence diagnosis for detection of sub-clinical and clinical actinic keratosis during imiquimod treatment.

PubMed

Ortonne, Jean-Paul; Gupta, Girish; Ortonne, Nicolas; Duteil, Luc; Queille, Catherine; Mallefet, Pascal

2010-07-01

During treatment of actinic keratosis (AK) lesions with imiquimod sub-clinical lesions often become visible. It is, however, unclear whether these sub-clinical lesions would be detectable beforehand. The aim of this pilot study was to compare two techniques, cross polarized light photography (CPL) and fluorescence diagnosis (FD) using methyllevulinic acid and illumination with Wood's lamp for their ability to detect sub-clinical lesions. These findings were also compared with biopsy results taken before and after treatment with imiquimod 5% cream or vehicle. Twelve patients with at least five clinically visible AK lesions in a single contiguous 20 cm(2) area on the head were recruited. Patient eligibility was determined at the screening visit, when they were randomized to treatment. The randomization was 3:1, active to vehicle (nine treated with imiquimod, three with vehicle cream) for a total duration of 24 weeks (six clinic visits). Patients were assessed for baseline AK lesion counts (clinical and sub-clinical) at the screening visit and final counts at week 20. The number of clinically observed AK lesions was significantly lower at week 12 and week 20 compared with baseline following imiquimod treatment versus vehicle. The number of counted lesions were significantly higher using the CPL method compared with clinical counting with imiquimod treatment at baseline (8.3 +/- 3.4 vs 5.8 +/- 1.3; P = 0.027) and week 20 (4.8 +/- 2.4 vs 3.0 +/- 1.7; P = 0.02) but not in the vehicle group. The FD lesion counting method did not show a significant increase in the number of detected lesions compared with clinical analysis in the imiquimod and placebo groups but when comparisons were performed using pooled data (treatments and visits combined) the results were significant. The number of sub-clinical and clinical AK lesions detected during treatment with imiquimod can be better demonstrated using the methods of CPL and FD, but statistical significance was reached only using the CPL method. This is only a preliminary study with a small number of patients and as a result it is difficult to conclude both statistical and clinical significance. However, results were encouraging and indicate that larger studies are needed to demonstrate the relevance of these two new methods for improved detection of clinical and especially sub-clinical AK lesions.

The Effectiveness of A School-Based Nutrition Intervention on Children's Fruit, Vegetables, and Dairy Product Intake.

PubMed

Drapeau, Vicky; Savard, Mathieu; Gallant, Annette; Nadeau, Luc; Gagnon, Jocelyn

2016-05-01

Most Canadian children do not meet daily recommendations for consumption of vegetables and fruits (V/F) and dairy products (DP). The aim of this study was to evaluate the impact of Team Nutriathlon on V/F and DP consumption of children. Participants were 404 children from grades 5 and 6 (intervention group [IG] N = 242, control group [CG] N = 162). Teams of children were guided to increase their consumption and variety of V/F and DP over an 8-week period. Daily servings of V/F and DP were compared between groups at 4 time points: baseline (week 0), during (week 6), immediately after (week 9 or 10), and a follow-up 10 weeks after (week 20) the intervention. During and after the program and at follow-up, children in the IG consumed more servings of V/F and DP compared to the CG (group × time, p < .0001). Sex, baseline consumption levels, and school socioeconomic status did not influence the results (p > .05). Team Nutriathlon is an innovative school-based nutrition program that can help to increase the V/F and DP consumption of children. © 2016, American School Health Association.

Spatially offset raman spectroscopy for non-invasive assessment of fracture healing

NASA Astrophysics Data System (ADS)

Ding, Hao; Lu, Guijin; West, Christopher; Gogola, Gloria; Kellam, James; Ambrose, Catherine; Bi, Xiaohong

2016-02-01

Fracture non-unions and bone re-fracture are common challenges for post-fracture management. To achieve better prognosis and treatment evaluation, it is important to be able to assess the quality of callus over the time course of healing. This study evaluated the potential of spatially offset Raman spectroscopy for assessing the fracture healing process in situ. We investigated a rat model of fracture healing at two weeks and 4 weeks post fracture with a fractured femur and a contralateral control in each animal. Raman spectra were collected from the depilated thighs on both sides transcutaneously in situ with various source/detection offsets. Bone signals were recovered from SORS spectra, and then compared with those collected from bare bones. The relative intensity of mineral from fractured bone was markedly decreased compared to the control. The fractured bones demonstrated lower mineral and carbonate level and higher collagen content in the callus at the early time point. Compared to week 2, collagen mineralization and mineral carbonation increased at 4 weeks post fracture. Similarly, the material properties of callus determined by reference point indentation also increased in the 4-week group, indicating improved callus quality with time. The results from Raman analysis are in agreement with radiographic and material testing, indicating the potential of this technique in assessing fracture healing in vivo.

[Evaluation of cadmium, mercury and lead intake with reproduced weekly food rations].

PubMed

Marzec, Z; Buliński, R

1991-01-01

In Lublin, Olsztyn, Poznań, Warszawa and Wrocław, weekly food rations characteristic of families other than those of manual workers, with medium incomes, were reproduced. Food rations comprised ca. 90 food products whose average weekly intakes were established consistently with the results of questionnaires of the Chief Census Bureau. Namely, from these results we calculated and prepared the average weekly food rations (from 11 470 g to 14 732 g), in which cadmium, mercury and lead were assayed by the ASA method. These average food rations afforded weekly intakes of 105-147 micrograms Cd, 441-931 micrograms Pb and 50.5-119.0 micrograms Hg. According to these results, the average food rations from the above-mentioned cities are moderately contaminated with the heavy metals tested, because in no case 50% of the provisional tolerable weekly intake (PTWI) were exceeded. The present results are lower than those obtained in the same year for families of manual workers; this is probably due to the fact that in the families of manual workers, as compared with other families, the weight of meals is usually higher. It is noteworthy that in the cities with greater numbers of industrial plants the contents of the metals tested, particularly of mercury and lead, in food are higher.

Prophylaxis vs. on-demand treatment with BAY 81-8973, a full-length plasma protein-free recombinant factor VIII product: results from a randomized trial (LEOPOLD II)

PubMed Central

Kavakli, K; Yang, R; Rusen, L; Beckmann, H; Tseneklidou-Stoeter, D; Maas Enriquez, M

2015-01-01

Background BAY 81-8973 is a new full-length human recombinant factor VIII product manufactured with technologies to improve consistency in glycosylation and expression to optimize clinical performance. Objectives To demonstrate superiority of prophylaxis vs. on-demand therapy with BAY 81-8973 in patients with severe hemophilia A. Patients/Methods In this multinational, randomized, open-label crossover study (LEOPOLD II; ClinicalTrials.gov identifier: NCT01233258), males aged 12–65 years with severe hemophilia A were randomized to twice-weekly prophylaxis (20–30 IU kg−1), 3-times-weekly prophylaxis (30–40 IU kg−1), or on-demand treatment with BAY 81-8973. Potency labeling for BAY 81-8973 was based on the chromogenic substrate assay or adjusted to the one-stage assay. Primary efficacy endpoint was annualized number of all bleeds (ABR). Adverse events (AEs) and immunogenicity were also assessed. Results Eighty patients (on demand, n = 21; twice-weekly prophylaxis, n = 28; 3-times-weekly prophylaxis, n = 31) were treated and analyzed. Mean ± SD ABR was significantly lower with prophylaxis (twice-weekly, 5.7 ± 7.2; 3-times-weekly, 4.3 ± 6.5; combined, 4.9 ± 6.8) vs. on-demand treatment (57.7 ± 24.6; P < 0.0001, anova). Median ABR was reduced by 97% with prophylaxis (twice-weekly, 4.0; 3-times-weekly, 2.0; combined, 2.0) vs. on-demand treatment (60.0). Median ABR was higher with twice-weekly vs. 3-times-weekly prophylaxis during the first 6-month treatment period (4.1 vs. 2.0) but was comparable in the second 6-month period (1.1 vs. 2.0). Few patients reported treatment-related AEs (4%); no treatment-related serious AEs or inhibitors were reported. Conclusions Twice-weekly or 3-times-weekly prophylaxis with BAY 81-8973 reduced median ABR by 97% compared with on-demand therapy, confirming the superiority of prophylaxis. Treatment with BAY 81-8973 was well tolerated. PMID:25546368

Efficacy of a polyurethane dressing versus a soft silicone sheet on hypertrophic scars.

PubMed

Wigger-Albert, W; Kuhlmann, M; Wilhelm, D; Mrowietz, U; Eichhorn, K; Ortega, J; Bredehorst, A; Wilhelm, K-P

2009-05-01

To compare the efficacy and safety of a polyurethane dressing with a silicone sheet in the treatment of hypertrophic scars. Sixty patients participated in this intra-individual 12-week clinical trial. Each scar was divided into two areas, to which the polyurethane dressing and the silicone sheet were randomly allocated. The primary outcome measure was the percentage change in the overall scar index (SI) between baseline and week 12. Secondary outcome measures included changes in skin redness, objectively measured by chromametry, and patients views on the aesthetic outcome of treatment. Both therapies achieved favourable results for all of the above outcome measures. Results were comparable for the primary outcome measure: 29.4% versus 33.7% for the silicone sheet and polyurethane product respectively. The decrease in the overall SI was significantly more pronounced for the polyurethane product after week 4 (5.6% versus 15.8% for the silicone sheet; p<0.0001) and week 8 (20.2% versus 27.1%; p=0.012). Both regimens were associated with a significant reduction in the clinical signs of hypertrophic scars over 12 weeks of treatment. The polyurethane dressing demonstrated a significantly more pronounced reduction in severity of these clinical signs after four and eight weeks of treatment and was better tolerated than the silicone sheet. l This study was funded by Beiersdorf AG. proDERM is an independent research company, and none of the authors have an interest in the sponsors commercial activities.

Effect of modified atmosphere packaging on quality and shelf life of 'Robusta' banana (Musa sp.) stored at low temperature.

PubMed

Kudachikar, V B; Kulkarni, S G; Prakash, M N Keshava

2011-06-01

Banana (Musa sp var. 'Robusta') stored under active and passive modified atmosphere packaging (MAP) at 12 ± 1°C and 85-90% RH for 2 seasons were evaluated for fruit quality and shelf-life. A steady state of about 8.6 and 8.2% of CO2 and 2.8 and 2.6% of O2 in passive MAP and MAP+GK (Green Keeper) packages, respectively, were established after 3 weeks of storage. Passive MAP and MAP+GK treatments of banana resulted in reduction in physiological loss in weight (PLW) of 0.7 and 0.8% after 5 and 7 weeks of storage, respectively as against 5% PLW in openly kept green banana after 3 weeks. Both MAP and MAP+GK treatments delayed colour, texture, pulp to peel ratio and total soluble solids (TSS) content as compared to openly kept control banana. Results indicated that the shelf life of fruits packed under MAP and MAP+GK could be extended up to 5 and 7 weeks, respectively as compared to 3 weeks for openly kept control fruits. Sensory quality of fully ripe fruits of both passive MAP and MAP+GK treatments, 5 days after ethrel dip was very good. Thus, MAP+GK at 12 ± 1°C and 85-90% RH could be commercially used for long term storage and long distance transportation of banana with maximum shelf-life of 7 weeks.

Targeting Dietary Fat or Glycemic Load in the Treatment of Obesity and Type 2 Diabetes: A Randomized Controlled Trial

PubMed Central

Fabricatore, AN; Wadden, TA; Ebbeling, CB; Thomas, JG; Stallings, VA; Schwartz, S; Ludwig, DS

2011-01-01

Aims To compare the effects of lifestyle modification programs that prescribe low-glycemic load (GL) vs. low-fat diets in a randomized trial. Methods Seventy-nine obese adults with type 2 diabetes received low-fat or low-GL dietary instruction, delivered in 40-week lifestyle modification programs with identical goals for calorie intake and physical activity. Changes in weight, HbA1c, and other metabolic parameters were compared at weeks 20 and 40. Results Weight loss did not differ between groups at week 20 (low-fat: −5.7 ± 3.7%, low-GL: −6.7 ± 4.4%, p = .26) or week 40 (low-fat: −4.5 ± 7.5%, low-GL: −6.4 ± 8.2%, p = .28). Adjusting for changes in antidiabetic medications, subjects on the low-GL diet had larger reductions in HbA1c than those on the low-fat diet at week 20 (low-fat: −0.3 ± 0.6%, low-GL: −0.7 ± 0.6%, p = .01), and week 40 (low-fat: −0.1 ± 1.2%, low-GL: −0.8 ± 1.3%, p = .01). Groups did not differ significantly on any other metabolic outcomes (p ≥ .06). Conclusions Results suggest that targeting GL, rather than dietary fat, in a low-calorie diet can significantly enhance the effect of weight loss on HbA1c in patients with type 2 diabetes. PMID:21208675

The impact of exercise on depression and anxiety symptoms among abstinent methamphetamine-dependent individuals in a residential treatment setting

PubMed Central

Rawson, Richard A.; Chudzynski, Joy; Gonzales, Rachel; Mooney, Larissa; Dickerson, Daniel; Ang, Alfonso; Dolezal, Brett; Cooper, Christopher B.

2015-01-01

Background This paper reports data from a study designed to determine the impact of an 8-week exercise program on depression and anxiety symptoms among newly abstinent methamphetamine (MA)-dependent individuals in residential treatment. Methods One hundred thirty-five MA-dependent individuals, newly enrolled in residential treatment, were randomly assigned to receive either a 3-times-per-week, 60-minute structured exercise program for 8 weeks (24 sessions) or an equivalent number of health education sessions. Using mixed-modeling repeated-measures regression, we examined changes in weekly total depression and anxiety scores as measured by the Beck Depression Inventory and Beck Anxiety Inventory over the 8-week study period. Results Mean age of participants was 31.7 (SD = 6.9); 70.4% were male and 48% Latino. Analyses indicate a significant effect of exercise on reducing depression (β = −0.63, P = 0.001) and anxiety (β = −0.95, P = 0.001) symptoms (total scores) over the 8-week period compared to a health education control group. A significant dose interaction effect between session attendance and exercise was found as well on reducing depression (β = −0.61, P < 0.001) and anxiety symptoms (β = −0.22, P = 0.009) over time compared to the control group. Conclusions Results support the role of a structured exercise program as an effective intervention for improving symptoms of depression and anxiety associated with MA abstinence. PMID:25934458

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity

PubMed Central

Catenacci, Victoria A.; Pan, Zhaoxing; Ostendorf, Danielle; Brannon, Sarah; Gozansky, Wendolyn S.; Mattson, Mark P.; Martin, Bronwen; MacLean, Paul S.; Melanson, Edward L.; Donahoo, William Troy

2016-01-01

Objective To evaluate the safety and tolerability of alternate-day fasting (ADF) and to compare changes in weight, body composition, lipids, and insulin sensitivity index (Si) to those produced by a standard weight loss diet, moderate daily caloric restriction (CR). Methods Adults with obesity (BMI ≥30 kg/m2, age 18-55) were randomized to either zero-calorie ADF (n=14) or CR (-400 kcal/day, n=12) for 8 weeks. Outcomes were measured at the end of the 8-week intervention and after 24 weeks of unsupervised follow-up. Results No adverse effects were attributed to ADF and 93% completed the 8-week ADF protocol. At 8 weeks, ADF achieved a 376 kcal/day greater energy deficit, however there were no significant between-group differences in change in weight (mean±SE; ADF -8.2±0.9 kg, CR -7.1±1.0 kg), body composition, lipids, or Si. After 24 weeks of unsupervised follow-up, there were no significant differences in weight regain, however changes from baseline in % fat mass and lean mass were more favorable in ADF. Conclusions ADF is a safe and tolerable approach to weight loss. ADF produced similar changes in weight, body composition, lipids and Si at 8 weeks and did not appear to increase risk for weight regain 24 weeks after completing the intervention. PMID:27569118

An Analysis of the NSW Midwives Data Collection over an 11-Year Period to Determine the Risks to the Mother and the Neonate of Induced Delivery for Non-Obstetric Indication at Term.

PubMed

Raviraj, Padmini; Shamsa, Aiat; Bai, Jun; Gyaneshwar, Rajanishwar

2013-01-01

Objective. To determine the risks of induced term delivery to the mother and neonate at different gestational ages in the absence of obstetric indications. Study Design. All deliveries in New South Wales (NSW) between 1998 and 2008 were reviewed from the MDC. Uncomplicated pregnancies which were induced for non-obstetric reasons after 37 completed weeks were reviewed. This was a retrospective, historical cohort study, and both maternal and neonatal outcomes were analysed and compared between different gestational age groups. Results. An analysis of the data shows that induction of labour after 37 completed weeks exposes the fetus and mother to different levels of risk at different gestations. Conclusion. In an uncomplicated pregnancy, induction of labour is associated with the highest rate of neonatal complication at 37 weeks as compared with rates at later gestations. With each ensuing week, the neonatal outcome improves. At 40 weeks the likelihood of neonatal intensive care admission, low Apgar scores, and perinatal death rate is at its lowest, and then there is a slight but not significant rise after 41 weeks. The likelihood of caesarean section is the lowest when inductions are carried out at 39 weeks and is the highest at 41 weeks and over.

Effect of consuming a purple-fleshed sweet potato beverage on health-related biomarkers and safety parameters in Caucasian subjects with elevated levels of blood pressure and liver function biomarkers: a 4-week, open-label, non-comparative trial

PubMed Central

OKI, Tomoyuki; KANO, Mitsuyoshi; WATANABE, Osamu; GOTO, Kazuhisa; BOELSMA, Esther; ISHIKAWA, Fumiyasu; SUDA, Ikuo

2016-01-01

An open-label study with one treatment arm was conducted to investigate changes in health-related biomarkers (blood pressure and liver enzyme activity) and the safety of 4 weeks of consuming a purple-fleshed sweet potato beverage in Caucasian subjects. Twenty healthy adults, 18–70 years of age, with a body mass index >25 kg/m2, elevated blood pressure and elevated levels of liver function biomarkers consumed two cartons of purple-fleshed sweet potato beverage (125 ml, including 117 mg anthocyanin per carton) daily for 4 weeks. Hematology, serum clinical profile, dipstick urinalysis and blood pressure were determined before consumption, at 2 and 4 weeks of consumption and after a 2-week washout period. A trend was found toward lowering systolic blood pressure during the treatment period (p=0.0590). No significant changes were found in diastolic blood pressure throughout the study period. Systolic blood pressure was significantly lower after 4 weeks of consumption compared with before consumption (p=0.0125) and was significantly higher after the 2-week washout period compared with after consumption (p=0.0496). The serum alanine aminotransferase level significantly increased over time, but aspartate aminotransferase and γ-glutamyltransferase levels stayed within the normal range of reference values. Safety parameters of the blood and urine showed no clinically relevant changes. The consumption of a purple-fleshed sweet potato beverage for 4 weeks resulted in no clinically relevant changes in safety parameters of the blood and urine and showed a trend toward lowering systolic blood pressure. PMID:27508114

A late wake time phase delays the human dim light melatonin rhythm.

PubMed

Burgess, Helen J; Eastman, Charmane I

2006-03-13

Short sleep/dark durations, due to late bedtimes or early wake times or both, are common in modern society. We have previously shown that a series of days with a late bedtime phase delays the human dim light melatonin rhythm, as compared to a series of days with an early bedtime, despite a fixed wake time. Here we compared the effect of an early versus late wake time with a fixed bedtime on the human dim light melatonin rhythm. Fourteen healthy subjects experienced 2 weeks of short 6h nights with an early wake time fixed at their habitual weekday wake time and 2 weeks of long 9 h nights with a wake time that occurred 3h later than the early wake time, in counterbalanced order. We found that after 2 weeks with the late wake time, the dim light melatonin onset delayed by 2.4 h and the dim light melatonin offset delayed by 2.6 h (both p < 0.001), as compared to after 2 weeks with the early wake time. These results highlight the substantial influence that wake time, likely via the associated morning light exposure, has on the timing of the human circadian clock. Furthermore, the results suggest that when people truncate their sleep by waking early their circadian clocks phase advance and when people wake late their circadian clocks phase delay.

PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial

PubMed Central

Voskuijl, W; de Lorijn, F; Verwijs, W; Hogeman, P; Heijmans, J; Mäkel, W; Taminiau, J; Benninga, M

2004-01-01

Background: Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative. Aims: To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects. Patients: One hundred patients (aged 6 months–15 years) with paediatric constipation were included in an eight week double blinded, randomised, controlled trial. Methods: After faecal disimpaction, patients <6 years of age received PEG 3350 (2.95 g/sachet) or lactulose (6 g/sachet) while children ⩾6 years started with 2 sachets/day. Primary outcome measures were: defecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency ⩾3/week and encopresis ⩽1 every two weeks. Secondary outcome measures were side effects after eight weeks of treatment. Results: A total of 91 patients (49 male) completed the study. A significant increase in defecation frequency (PEG 3350: 3 pre v 7 post treatment/week; lactulose: 3 pre v 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 pre v 3 post/week; lactulose: 8 pre v 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group. Conclusions: PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation. PMID:15479678

Levetiracetam for the treatment of hot flashes: a phase II study.

PubMed

Thompson, Susan; Bardia, Aditya; Tan, Angelina; Barton, Debra L; Kottschade, Lisa; Sloan, Jeff A; Christensen, Brad; Smith, DeAnne; Loprinzi, Charles L

2008-01-01

The objectives of this pilot trial were to assess the potential efficacy and safety of levetiracetam for the treatment of hot flashes, a major cause of morbidity among breast cancer survivors. Women, aged 18 years or more, with a history of breast cancer or those who wished to avoid estrogen because of a perceived increased risk of breast cancer, who were experiencing bothersome hot flashes (more than or equal to 14 times per week, for more than or equal to 1 month before study entry), were included. During the baseline week, general demographic characteristics, hot flash information, and quality of life data were obtained. At the beginning of week 2, patients were started on levetiracetam for a total of 4 weeks. Information about hot flashes, quality of life, and toxicity were collected during these 4 weeks and compared with the baseline week. After treatment with levetiracetam for 4 weeks (N = 19), mean hot flash scores (frequency times mean severity) were reduced by 57%, and mean hot flash frequencies were reduced by 53%, compared to the baseline week; both these reductions were greater than what would be expected with a placebo (20-25% reduction). There were significant improvements in abnormal sweating (p = 0.004), hot flash distress (p = 0.0002), and satisfaction of hot flash control (p = 0.0001), when comparing data from the fourth week of treatment to the baseline week. Twenty-nine percent of the subjects did not complete the study because of treatment-related adverse events, with the most frequently reported side effects being somnolence, fatigue, and dizziness, usually with mild to moderate intensity. The results of this pilot trial suggest that levetiracetam might be an effective therapy for the treatment of hot flashes. Further data are needed to test this hypothesis, evaluating the efficacy and toxicity of this agent.

Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial.

PubMed

Wang, Chenchen; Iversen, Maura D; McAlindon, Timothy; Harvey, William F; Wong, John B; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Rones, Ramel; Gamache, Tressa; Schmid, Christopher H

2014-09-08

Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs. Results of this study are expected to have important public health implications for the large and growing population with knee OA. ClinicalTrials.gov identifier: NCT01258985.

17-alpha Hydroxyprogesterone Caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study

PubMed Central

Nelson, David B.; McIntire, Donald D.; McDonald, Jeffrey; Gard, John; Turrichi, Paula; Leveno, Kenneth J.

2017-01-01

Background 17-alpha hydroxyprogesterone caproate for prevention of recurrent preterm birth is recommended for use in the United States. Objective To assess the clinical effectiveness of 17-alpha hydroxyprogesterone caproate to prevent recurrent preterm birth ≤ 35 weeks compared to similar births in our obstetric population prior to the implementation of 17-alpha hydroxyprogesterone caproate. Study Design This was a prospective cohort study of 17-alpha hydroxyprogesterone caproate in our obstetric population. The primary outcome was the recurrence of birth ≤ 35 weeks for the entire study cohort compared to a historical referent rate of 16.8% of recurrent preterm birth in our population. There were three secondary outcomes. First, did 17-alpha hydroxyprogesterone caproate modify a woman’s history of preterm birth when taking into account her prior number and sequence of preterm and term births? Second, was recurrence of preterm birth related to 17-alpha hydroxyprogesterone caproate plasma concentration? Third, was duration of pregnancy modified by 17-alpha hydroxyprogesterone caproate treatment compared to a prior preterm birth? Results Between January 2012 and March 2016, 430 consecutive women with prior births ≤ 35 weeks were treated with 17-alpha hydroxyprogesterone caproate. Nearly two-thirds of the women (N=267) began injections ≤ 18 weeks and 394 (92%) received a scheduled weekly injection within 10 days of reaching 35 weeks or delivery. The overall rate of recurrent preterm birth was 25% (N=106) for the entire cohort compared to the 16.8% expected rate (P = 1.0). The three secondary outcomes were also negative. First, 17-alpha hydroxyprogesterone caproate did not significantly reduce the rates of recurrence regardless of prior preterm birth number or sequence. Second, plasma concentrations of 17-alpha hydroxyprogesterone caproate were not different (P=0.17 at 24 weeks; P=0.38 at 32 weeks) between women delivered ≤ 35 weeks and those delivered later in pregnancy. Third, the mean (± standard deviation) interval in weeks of recurrent preterm birth before 17-alpha hydroxyprogesterone caproate use was 0.4 ± 5.3 weeks and the interval of recurrent preterm birth after 17-alpha hydroxyprogesterone caproate treatment was 0.1 ± 4.7 weeks (P=0.63). A side effect of weekly 17-alpha hydroxyprogesterone caproate injections was an increase in gestational diabetes. Specifically, the rate of gestational diabetes was 13.4% in 17-alpha hydroxyprogesterone caproate treated women compared to 8% in case-matched controls (P=0.001). Conclusions 17-alpha hydroxyprogesterone caproate was ineffective for prevention of recurrent preterm birth and was associated with increased rates of gestational diabetes. PMID:28223163

[Effects of hypoxia inducible factor-2α on promoting angiogenesis of residual hepatocellular carcinoma after high-intensity focused ultrasound ablation].

PubMed

Wu, Lun; Zhou, Wenbo; Zhou, Shiji; Liu, Chang'an; Li, Shengwei

2015-02-01

To investigate the dynamic features of angiogenesis in residual tumors after high intensity focused ultrasound (HIFU),and to determine the temporal effect and mechanism of hypoxia inducible factor-2 alpha (HIF-2a) in the angiogenic process of residual tumors. Xenograft tumors of HepG2 cells were generated by subcutaneously inoculating athymic BALB/c nu/nu mice with the hepatoma cells.About 30 days after inoculation,all mice (except in the control group) were treated by HIFU and assigned randomly to the following 7 groups according to various time intervals post-treatment:1st,3rd,5th day and 1st,2nd,3rd,4th week when the residual tumor tissues were obtained from the experimental groups.Protein levels of HIF-2a and vascular growth factor A (VEGF-A) were quantified by immunohistochemistry and western blotting,and mRNA levels were measured by (real-time quantitative) qPCR. Microvascular density (MVD) was calculated by counting the CD31-positive vascular endothelial cells identified by means of an immunohistochemical staining method. Compared with results from the control group,the protein and mRNA levels of HIF-2a expression reached the highest level in the experimental mice at the 2nd week (P=0.000 and P < 0.01 respectively),and were decreased thereafter(3rd week and 4th week, P=0.000 and P < 0.05).VEGF-A expression in the residual tumor tissues group that received HIFU was significantly decreased,compared with the control group,at all time points uPto 1 week (all P=0.000 and P < 0.01),but the levels increased compared to controls in the 2nd through 4th week (all P=0.000, P < 0.05). Similar results were obtained for MVD. HIFU treatment can inhibit angiogenesis in residual hepatoma tissues in the short-term (1 to 2 weeks post-treatment) in mice with hepatocellular carcinoma,but can promote angiogenesis overtime (2 to 4 weeks post-treatment); the angiogenic process may involve the HIF-2α/VEGFA pathway.

An open-label clinical trial assessing the efficacy and safety of Bend Skincare Anti-Aging Formula on minimal erythema dose in skin.

PubMed

Morse, Nancy L; Reid, Anna-Jean; St-Onge, Marc

2018-03-01

Sunburn and other health risks associated with excess sun exposure place huge economic burdens on societies, and create discomfort and disease within susceptible individuals. Oral supplements that reduce sunburn may be advantageous. This study evaluated the safety and efficacy of Bend Skincare Anti-Aging Formula to ameliorate sunburn induced with a solar simulator. Subjects (n = 28) with Fitzpatrick skin phototypes I, II, or III took 4 capsules daily of the supplement providing 1400 mg of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA), 120 mg of gamma-linolenic acid (GLA), 5 mg of lutein, 2.5 mg of zeaxanthin, and 1000 IU of vitamin D3 for 8 weeks. Skin on each subject's back was exposed to a progressive sequence of timed ultraviolet (UV) radiation exposure doses at baseline, and after 4- and 8-week treatment to determine their minimal erythema dose (MED). Results were compared before and after treatment using 3 paired t tests and subsequently 3 linear mixed models. Treatment significantly improved tolerance to UV exposure as evidenced by increased MED at 4 and 8 weeks compared with baseline (P < .001). This protection increased with prolonged use of Bend Skincare Anti-Aging Formula as demonstrated by progressively increased MED between baseline and 4 weeks, and again between 4 and 8 weeks (P < .001). Nearly 86% of patients responded to treatment within 4 weeks and 100% of patients responded by the end of the study, resulting in a 39% mean increase in MED at 4 weeks, and an 84% mean increase in MED at 8 weeks compared with baseline. Treatment was well tolerated with no product associated adverse events (AE) and only a few mild and expected side effects. Bend Skincare Anti-Aging Formula safely and effectively provides significant skin photoprotection that increases with continued use. © 2017 The Authors. Photodermatology, Photoimmunology & Photomedicine Published by John Wiley & Sons Ltd.

Comparison of Clinical Efficacy Between Interlaminar and Transforaminal Epidural Injection in Patients With Axial Pain due to Cervical Disc Herniation.

PubMed

Lee, Jung Hwan; Lee, Sang-Ho

2016-01-01

Transforaminal (TF) approach is preferred by physician to interlaminar (IL) approach because it can deliver injectates directly around nerve root and dorsal root ganglion, which is regarded as main pain sources. Axial neck pain is originated from sinuvertebral nerve located in ventral epidural spaces, which has been described to be related to central or paramedian disc herniation. It is very questionable that TF injection is also more effective than IL injection in the patients with axial neck or interscapular pain. This study was to evaluate clinical efficacy of cervical epidural injection in patients with axial pain due to cervical disc herniation and to compare the clinical outcomes between TF and IL approaches. Fifty-six and 52 patients who underwent IL and TF epidural injections, respectively, for axial neck/interscapular pain due to central or paramedian cervical disc herniation were included. Numeric Rating Scale (NRS) and Neck Disability Index (NDI) were compared between both groups at 2 and 8 weeks after treatment. Successful pain relief was defined if a 50% or more reduction of NRS score was achieved in comparison with pretreatment one. Successful functional improvement was defined if at least a 40% reduction of NDI was obtained. Overall, 79 (73.1%) and 57 (52.8%) among 108 patients showed successful pain relief at 2 and 8 weeks, respectively. Seventy-six (70.4%) and 52 (48.1%) had successful functional improvement at 2 and 8 weeks, respectively. The IL and TF groups showed no significant difference in proportion of successful results of NRS 2 weeks (73.2% vs 67.3%) and 8 weeks (48.2% vs 48.1%). Also, no significant difference was obtained in proportion of successful NDI between 2 groups at 2 weeks (75.0% vs 71.2%) and 8 weeks (53.6% vs 51.9%). Cervical epidural injection showed favorable results in 2 weeks and moderate results in 8 weeks in patients with axial pain due to cervical disc herniation. IL and TF showed no significant difference in clinical efficacy. Considering TF was relevant to more serious side effects, IL was more recommendable in these patients.

Natural Oil-Based Emulsion Containing Allantoin Versus Aqueous Cream for Managing Radiation-Induced Skin Reactions in Patients With Cancer: A Phase 3, Double-Blind, Randomized, Controlled Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chan, Raymond Javan, E-mail: email.rchan@gmail.com; School of Nursing, Queensland University of Technology, Kelvin Grove; Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove

Purpose: To investigate the effects of a natural oil-based emulsion containing allantoin versus aqueous cream for preventing and managing radiation-induced skin reactions. Methods and Materials: A total of 174 patients were randomized and participated in the study. Patients received either cream 1 (the natural oil-based emulsion containing allantoin) or cream 2 (aqueous cream). Skin toxicity, pain, itching, and skin-related quality of life scores were collected for up to 4 weeks after radiation treatment. Results: Patients who received cream 1 had a significantly lower average level of Common Terminology Criteria for Adverse Events at week 3 (P<.05) but had statistically higher averagemore » levels of skin toxicity at weeks 7, 8, and 9 (all P<.001). Similar results were observed when skin toxicity was analyzed by grades. With regards to pain, patients in the cream 2 group had a significantly higher average level of worst pain (P<.05) and itching (P=.046) compared with the cream 1 group at week 3; however, these differences were not observed at other weeks. In addition, there was a strong trend for cream 2 to reduce the incidence of grade 2 or more skin toxicity in comparison with cream 1 (P=.056). Overall, more participants in the cream 1 group were required to use another topical treatment at weeks 8 (P=.049) and 9 (P=.01). Conclusion: The natural oil-based emulsion containing allantoin seems to have similar effects for managing skin toxicity compared with aqueous cream up to week 5; however, it becomes significantly less effective at later weeks into the radiation treatment and beyond treatment completion (week 6 and beyond). There were no major differences in pain, itching, and skin-related quality of life. In light of these results, clinicians and patients can base their decision on costs and preferences. Overall, aqueous cream seems to be a more preferred option.« less

The effects of once-weekly teriparatide on hip geometry assessed by hip structural analysis in postmenopausal osteoporotic women with high fracture risk.

PubMed

Sone, Teruki; Ito, Masako; Fukunaga, Masao; Tomomitsu, Tatsushi; Sugimoto, Toshitsugu; Shiraki, Masataka; Yoshimura, Takeshi; Nakamura, Toshitaka

2014-07-01

Weekly administration of teriparatide has been shown to reduce the risk of vertebral and non-vertebral fractures in patients with osteoporosis at higher fracture risk in Japan. However, its efficacy for hip fracture has not been established. To gain insight into the effect of weekly teriparatide on the hip, hip structural analysis (HSA) based on dual-energy X-ray absorptiometry (DXA) was performed using the data of 209 postmenopausal osteoporotic women who had participated in the original randomized, multicenter, double-blind, placebo-controlled trial assessing the effects of once-weekly 56.5 μg teriparatide for 72 weeks. The DXA scans, obtained at baseline, 48 weeks and 72 weeks, were analyzed to extract bone mineral density (BMD) and cross-sectional geometrical indices at the narrowest point on the neck (NN), the intertrochanteric region (IT), and the proximal shaft. Compared with placebo after 72 weeks, the teriparatide group showed significantly higher BMD, average cortical thickness, bone cross-sectional area, and section modulus, and lower buckling ratio at both the NN and IT regions. No significant expansion of periosteal diameter was observed at these regions. There were no significant differences in BMD and HSA indices at the shaft region. The results indicate that overall structural strength in the proximal femur increased compared to placebo, suggesting that once-weekly teriparatide effectively reverses changes in hip geometry and strength with aging. Copyright © 2014. Published by Elsevier Inc.

Long-Term Results of Cartilage Repair after Allogeneic Transplantation of Cartilaginous Aggregates Formed from Bone Marrow-Derived Cells for Large Osteochondral Defects in Rabbit Knees.

PubMed

Yoshioka, Tomokazu; Mishima, Hajime; Sakai, Shinsuke; Uemura, Toshimasa

2013-10-01

The purpose of this study was to evaluate the long-term results of cartilage repair after allogeneic transplantation of cartilaginous aggregates formed from bone marrow-derived cells. Bone marrow cells were harvested from 12-day-old rabbits. The cells were subjected to a monolayer culture, and the spindle-shaped cells attached to the flask surface were defined as bone marrow-derived mesenchymal cells. After the monolayer culture, a 3-dimensional cartilaginous aggregate was formed using a bioreactor with chondrogenesis. We created osteochondral defects, measuring 5 mm in diameter and 4 mm in depth, at the femoral trochlea of 10-week-old rabbits. Two groups were established, the transplanted group in which the cartilaginous aggregate was transplanted into the defect, and the control group in which the defect was left untreated. Twenty-six and 52 weeks after surgery, the rabbits were sacrificed and their tissue repair status was evaluated macroscopically (International Cartilage Repair Society [ICRS] score) and histologically (O'Driscoll score). The ICRS scores were as follows: at week 26, 7.2 ± 0.5 and 7.6 ± 0.8; at week 52, 7.6 ± 1.1 and 9.7 ± 0.7, for the transplanted and control groups, respectively. O'Driscoll scores were as follows: at week 26, 12.6 ± 1.9 and 10.1 ± 1.9; at week 52, 9.6 ± 3.0 and 14.0 ± 1.4, each for transplanted and control groups, respectively. No significant differences were observed between the groups. This study demonstrates that allogeneic transplantation of cartilaginous aggregates formed from bone marrow-derived cells produces comparable long-term results based on macroscopic and histological outcome measures when compared with osteochondral defects that are left untreated.

A comparative study of efficacy and safety of febuxostat and allopurinol in pyrazinamide-induced hyperuricemic tubercular patients

PubMed Central

Pichholiya, Meenu; Yadav, Arvind Kumar; Luhadia, S. K.; Tahashildar, Jameela; Aseri, M. L.

2016-01-01

Objectives: To compare the efficacy and safety of febuxostat and allopurinol in pyrazinamide (PZA)-induced hyperuricemia in patients taking antitubercular therapy (ATT). Methods: This randomized controlled study was conducted at a tertiary care teaching institute of Rajasthan in all the sputum-positive tubercular patients aged between 18 and 65 years of either sex. Serum uric acid level was monitored at 0th, 2nd, 4th, 6th, and 8th week of ATT. Patients whose uric acid level was found to be increased at 2nd week were finally recruited in the study. Ninety patients who developed hyperuricemia due to ATT were divided randomly into three groups (Group A - febuxostat, Group B - allopurinol, and Group C - control) of thirty patients each. Mean serum uric acid levels were calculated at all the weeks in all the groups, and serum uric acid levels were compared by applying student's t-test and ANOVA. Results: Mean serum uric acid level decreased from 10.698 mg/dl (at 2nd week) to 7.846 mg/dl (at 8th week) in Group A and from 11.34 mg/dl (at 2nd week) to 7.280 mg/dl (at 8th week) in Group B. Numbers of adverse events encountered across both the treatment groups were same with both the drugs. Conclusion: Allopurinol and febuxostat were equally efficacious in lowering PZA induced raised serum uric acid level in tubercular patients, and it was possible to continue ATT without withdrawing PZA. PMID:27721537

Pre rigor processing, ageing and freezing on tenderness and colour stability of lamb loins.

PubMed

Kim, Yuan H Brad; Luc, Genevieve; Rosenvold, Katja

2013-10-01

Forty eight lamb carcasses with temperature and pH monitored were obtained from two commercial plants. At 24h post mortem both loins (M. longissimus) from each carcass were randomly allocated to a) unaged frozen at -18°C, (b) aged at -1.5°C for 2weeks before freezing, (c) aged for 3 weeks before freezing and (d) aged for 9 weeks without freezing. Shear force, colour stability and proteolysis were analyzed. Carcasses with a slower temperature and more rapid pH decline had more calpain autolysis, slightly higher shear force and less colour stable compared to that counterpart in general (P<0.05). However, the shear force values of the loins were all acceptable (<6 kgF) regardless of different pre rigor processing and ageing/freezing treatments. Furthermore, the loins aged for 2 weeks-then-frozen/thawed had a similar shear force to the loins aged only for 9 weeks suggesting that ageing-then-freezing would result in equivalent tenderness compared to aged only loins for the long-term storage. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effects of different doses of high-speed resistance training on physical performance and quality of life in older women: a randomized controlled trial.

PubMed

Ramirez-Campillo, Rodrigo; Diaz, Daniela; Martinez-Salazar, Cristian; Valdés-Badilla, Pablo; Delgado-Floody, Pedro; Méndez-Rebolledo, Guillermo; Cañas-Jamet, Rodrigo; Cristi-Montero, Carlos; García-Hermoso, Antonio; Celis-Morales, Carlos; Moran, Jason; Buford, Thomas W; Rodriguez-Mañas, Leocadio; Alonso-Martinez, Alicia M; Izquierdo, Mikel

2016-01-01

This study aimed to compare the effects of two frequencies of high-speed resistance training (HSRT) on physical performance and quality of life of older women. A total of 24 older women participated in a 12-week HSRT program composed of either two or three sessions/week (equated for volume and intensity). Women were randomized into three arms: a control group (CG, n=8), a resistance training group performing two sessions/week (RT2, n=8), and a resistance training group performing three sessions/week (RT3, n=8). The training program for both experimental groups included exercises that required high-speed concentric muscle actions. No baseline differences were observed among groups. Compared with the CG, both training groups showed similar small to moderate improvements ( P <0.05) in muscle strength, power, functional performance, balance, and quality of life. These results suggest that equated for volume and intensity, two and three training sessions/week of HSRT are equally effective for improving physical performance and quality of life of older women.

Cost-effectiveness of brexpiprazole adjunctive treatment for major depressive disorder.

PubMed

Sussman, Matthew; Yu, Jeffrey; Kamat, Siddhesh A; Hartry, Ann; Legacy, Susan; Duffy, Ruth; Aigbogun, Myrlene Sanon

2017-01-01

Major depressive disorder (MDD) is a debilitating psychiatric illness with a high cost burden. This analysis evaluates the cost-effectiveness of adjunctive brexpiprazole versus comparator branded adjunctive treatment for MDD and background antidepressant therapy (ADT) alone from a US payer perspective. An economic model was developed to assess the cost-effectiveness of brexpiprazole versus comparator adjunctive treatment and ADT alone on total direct medical costs using a 6-week cycle time frame for a total of 48 weeks, with treatment response and remission as primary outcomes. The model consisted of 3 parts, 1 to represent the acute treatment phase and 2 to represent the maintenance stage. In the base-case analysis, brexpiprazole as reference treatment resulted in cost per additional responder ranging from $19,442-$48,745 and cost per additional remitter ranging from $27,196-$71,839 versus comparator treatments over 48 weeks. Sensitivity analyses showed treatment with brexpiprazole was more costly, but more clinically effective in all probabilistic simulations. This representation of disease natural history over 48 weeks may not account for all possible health states. Resource utilization on treatment was estimated using the resource use data from previous trials, and may overestimate medical costs compared to the real-world setting. Treatment comparators were limited to branded therapies, and head-to-head studies were not available to obtain data inputs. Compared to other branded adjunctive therapies, brexpiprazole increases response and remission at 6 weeks; medical care cost savings were observed with the use of brexpiprazole. These findings may assist clinicians and formulary decision makers when selecting treatment for MDD. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

New Year’s Res-Illusions: Food Shopping in the New Year Competes with Healthy Intentions

PubMed Central

Pope, Lizzy; Hanks, Andrew S.; Just, David R.; Wansink, Brian

2014-01-01

Objective How do the holidays – and the possible New Year’s resolutions that follow – influence a household’s purchase patterns of healthier foods versus less healthy foods? This has important implications for both holiday food shopping and post-holiday shopping. Methods 207 households were recruited to participate in a randomized-controlled trial conducted at two regional-grocery chain locations in upstate New York. Item-level transaction records were tracked over a seven-month period (July 2010 to March 2011). The cooperating grocer’s proprietary nutrient-rating system was used to designate “healthy,” and “less healthy” items. Calorie data were extracted from online nutritional databases. Expenditures and calories purchased for the holiday period (Thanksgiving-New Year’s), and the post-holiday period (New Year’s-March), were compared to baseline (July-Thanksgiving) amounts. Results During the holiday season, household food expenditures increased 15% compared to baseline ($105.74 to $121.83; p<0.001), with 75% of additional expenditures accounted for by less-healthy items. Consistent with what one would expect from New Year’s resolutions, sales of healthy foods increased 29.4% ($13.24/week) after the holiday season compared to baseline, and 18.9% ($9.26/week) compared to the holiday period. Unfortunately, sales of less-healthy foods remained at holiday levels ($72.85/week holiday period vs. $72.52/week post-holiday). Calories purchased each week increased 9.3% (450 calories per serving/week) after the New Year compared to the holiday period, and increased 20.2% (890 calories per serving/week) compared to baseline. Conclusions Despite resolutions to eat more healthfully after New Year’s, consumers may adjust to a new “status quo” of increased less-healthy food purchasing during the holidays, and dubiously fulfill their New Year’s resolutions by spending more on healthy foods. Encouraging consumers to substitute healthy items for less-healthy items may be one way for practitioners and public health officials to help consumers fulfill New Year’s resolutions, and reverse holiday weight gain. PMID:25514158

Muscle contractility decrement and correlated morphology during the pathogenesis of streptozotocin-diabetic mice.

PubMed

Fahim, M A; el-Sabban, F; Davidson, N

1998-06-01

Peripheral neuropathy of both motor and sensory nerves has been well documented in diabetes mellitus, but the evidence for physiological and correlated morphological changes during the pathogenesis of myopathy is scarce. In the present report, we have chosen the dorsiflexor muscle of adult male mice as a model for studying in situ muscle contraction and neuromuscular ultrastructure during the pathogenesis of streptozotocin-induced diabetes. Thirty mice (30 g bodyweight) were injected once i.p. with streptozotocin solution (200 mg/Kg) to induce experimental diabetes mellitus. Comparative analyses of in situ muscle isometric contractile characteristics were studied (at 1 Hz, 5 Hz and 30 Hz nerve stimulation) in urethane-anesthetized (2 mg/g, i.p.) control and diabetic mice at three time points, 2 weeks, 4 weeks, and 8 weeks postinjection. Synaptic delay was also recorded in diabetic and age-matched control mice. There was a significant increase in synaptic delay in both 4-week and 8-week diabetic mice compared with control mice (8.9 +/- 1.2 msec and 7.6 +/- 0.6 msec, respectively, compared with 6.1 +/- 0.5 msec). At all three stimulation frequencies, diabetes did not affect muscle contractile speed but significantly reduced the twitch tension after 8 weeks, with no changes at 2 weeks or 4 weeks. The recorded single-twitch tension values were 2.6 +/- 0.3 g, 2.1 +/- 0.6 g, 2.2 +/- 0.7 g, and 1.2 +/- 0.1 g for control, 2 weeks, 4 weeks, and 8 weeks, respectively. At 30 Hz, the recorded tension values were 4.6 +/- 1.6 g, 3.1 +/- 1.2 g, 3.1 +/- 1.1 g, and 2.1 +/- 1.0 g for control, 2 weeks, 4 weeks, and 8 weeks, respectively. Ultrastructural changes in neuromuscular junctions were similar to those that have been described in disuse and aging. These changes were observed after 8 weeks and included serve loss of synaptic vesicles, electron-dense bodies, and myelin-like figures as well as degeneration of mitochondria. The results reveal that streptozotocin-induced diabetes affects presynaptically the neuromuscular junction as well as muscle itself. Actions at both sites may contribute to the functional alterations seen in muscle contractile properties and may play a role in the pathogenesis of diabetic neuromyopathy.

Materials emission of chemicals--PVC flooring materials.

PubMed

Lundgren, B; Jonsson, B; Ek-Olausson, B

1999-09-01

Data of chemical emissions from flooring materials have been collected and investigated in a database known as METS. The emission tests are performed using the Field and Laboratory Emission Cell (FLEC). The emission rates of total volatile organic compounds (TVOC) in the boiling point range of hexane to octadecane varies from around 4,000 micrograms/(m2.h) to less than 10 micrograms/(m2.h). Results obtained 1994/95 are presented and compared with the results obtained in 1992 for similar materials. The tests are performed 4 weeks and 26 weeks after the manufacturing of the material. The emission rates of TVOC decrease on the average approximately 60% from 4 to 26 weeks. The differences and trends in emission rates of individual chemicals and their use are discussed. For many VOCs emission rates decrease rapidly and become near to or below 2 micrograms/(m2.h) (the detection limit) after 26 weeks. For a small number of individual compounds the emission rate decrease little over 26 weeks. A small number of chemicals are singled out for particular interest in a health and comfort evaluation based on the emission results.

Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.

PubMed

Woody, George E; Poole, Sabrina A; Subramaniam, Geetha; Dugosh, Karen; Bogenschutz, Michael; Abbott, Patrick; Patkar, Ashwin; Publicker, Mark; McCain, Karen; Potter, Jennifer Sharpe; Forman, Robert; Vetter, Victoria; McNicholas, Laura; Blaine, Jack; Lynch, Kevin G; Fudala, Paul

2008-11-05

The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful. To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth. Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling. Opioid-positive urine test result at weeks 4, 8, and 12. The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (chi(2)(2) = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; chi(2)(1) = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (chi(2)(1) = 18.45, P < .001), less injecting (chi(2)(1) = 6.00, P = .01), and less nonstudy addiction treatment (chi(2)(1) = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12. Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence. clinicaltrials.gov Identifier: NCT00078130.

The Pullout Program Day a Week School for Gifted Children: Effects on Social-Emotional and Academic Functioning

ERIC Educational Resources Information Center

van der Meulen, Rachel T.; van der Bruggen, Corine O.; Spilt, Jantine L.; Verouden, Jaap; Berkhout, Maria; Bögels, Susan M.

2014-01-01

Background: Gifted children learn differently compared to their peers in several ways. However, their educational needs are often not met in regular schools, which may result in underachievement and social-emotional and behavioral problems. A pullout program, the "Day a Week School" (DWS), was offered to gifted children in 25 elementary…

Early Comparative Outcomes of Carbon Fiber Reinforced Polymer Plate in the Fixation of Distal Femur Fractures.

PubMed

Mitchell, Phillip M; Lee, Adam K; Collinge, Cory A; Ziran, Bruce H; Hartley, Kate G; Jahangir, A Alex

2018-05-16

To evaluate the early clinical results of distal femur fractures treated with carbon fiber reinforced - polyetheretherketone (CFR-PEEK) plates compared to stainless steel (SS) lateral locking plates. Retrospective comparative cohort study SETTING:: ACS Level I trauma center. Twenty-two patients (11 SS, 11 CFR-PEEK) with closed distal femur fractures treated by a single surgeon over a 6-year period. Nonunion, hardware failure, reoperation, time to full weight bearing, and time ` union were assessed. The CFR-PEEK cohort was on average older (71 vs. 57 years, p=0.03) and more likely to have diabetes (p=0.02). Nonunion was diagnosed in 4/11 (36%) patients in the SS group and 1/11 (9%) patients in the CFR-PEEK group (p=0.12). Hardware failure occurred in two SS patients (18%) compared to none in the CFR-PEEK group (p=0.14). Time to full weight bearing was similar between groups occurring at 9.9 weeks and 12.4 weeks in the CFR-PEEK and SS groups, respectively (p=0.23). Time to radiographic union averaged 12.4 weeks in the SS group and 18.7 weeks in the CFR-PEEK group (p=0.26). There were 4 reoperations in the SS group and one in the CFR-PEEK group (p=0.12). CFR-PEEK plates show encouraging short-term results in the treatment of distal femur fractures with a comparable nonunion, reoperation, and hardware failure rates to those treated with SS plates. This data suggests CFR-PEEK plates may be a viable alternative to SS plates in fixation of these fractures. Level III.

Effect of oral health education in the form of Braille and oral health talk on oral hygiene knowledge, practices, and status of 12–17 years old visually impaired school girls in Pune city: A comparative study

PubMed Central

Bhor, K.; Shetty, V.; Garcha, V.; Nimbulkar, G. C.

2016-01-01

Aim: To assess the effect of oral health education (OHE) in the form of Braille and combination with Oral health talk (OHT) on oral hygiene knowledge, practices, and status of 12–17 years old visually impaired school girls in Pune city. Materials and Methods: A 6-week comparative study was conducted among 74 residential visually impaired school girls aged 12–17 years, who were trained to read Braille. The participants were divided into two groups, namely, Group A (n = 37) receiving OHE only in the form of Braille and Group B (n = 37) receiving OHE in form of Braille and OHT at baseline, 2, and 4-week interval. Oral health knowledge was assessed using a self-administered, pre-validated, pre-tested questionnaire typed in Marathi Braille. Assessment of oral hygiene practices and status was done using standardized proforma and simplified oral hygiene index (OHI-S), respectively, at baseline and at the end of 6 weeks. Data was analyzed using paired and unpaired Student's t-test. Results: The results showed a statistically significant increase in oral health knowledge levels in Group B (4.95 ± 1.66) as compared to Group A (2.97 ± 1.28). There was a significant increase in the frequency of mouth-rinsing in Group B (97.3%) as compared to Group A (86.5%) as well as in the tongue cleaning practice in Group B (100%) as compared to Group A (81.1%) at the end of 6 weeks. Conclusion: OHE in the form of Braille and OHT was more effective than OHE using only Braille. PMID:27891313

Does Nordic walking improves the postural control and gait parameters of women between the age 65 and 74: a randomized trial

PubMed Central

Kocur, Piotr; Wiernicka, Marzena; Wilski, Maciej; Kaminska, Ewa; Furmaniuk, Lech; Maslowska, Marta Flis; Lewandowski, Jacek

2015-01-01

[Purpose] To assess the effect of 12-weeks Nordic walking training on gait parameters and some elements of postural control. [Subjects and Methods] Sixty-seven women aged 65 to 74 years were enrolled in this study. The subjects were divided into a Nordic Walking group (12 weeks of Nordic walking training, 3 times a week for 75 minutes) and a control group. In both study groups, a set of functional tests were conducted at the beginning and at the end of the study: the Forward Reach Test (FRT) and the Upward Reach Test (URT) on a stabilometric platform, and the analysis of gait parameters on a treadmill. [Results] The NW group showed improvements in: the range of reach in the FRT test and the URT test in compared to the control group. The length of the gait cycle and gait cycle frequency also showed changes in the NW group compared to the control group. [Conclusion] A 12-week NW training program had a positive impact on selected gait parameters and may improve the postural control of women aged over 65 according to the results selected functional tests. PMID:26834341

Does Nordic walking improves the postural control and gait parameters of women between the age 65 and 74: a randomized trial.

PubMed

Kocur, Piotr; Wiernicka, Marzena; Wilski, Maciej; Kaminska, Ewa; Furmaniuk, Lech; Maslowska, Marta Flis; Lewandowski, Jacek

2015-12-01

[Purpose] To assess the effect of 12-weeks Nordic walking training on gait parameters and some elements of postural control. [Subjects and Methods] Sixty-seven women aged 65 to 74 years were enrolled in this study. The subjects were divided into a Nordic Walking group (12 weeks of Nordic walking training, 3 times a week for 75 minutes) and a control group. In both study groups, a set of functional tests were conducted at the beginning and at the end of the study: the Forward Reach Test (FRT) and the Upward Reach Test (URT) on a stabilometric platform, and the analysis of gait parameters on a treadmill. [Results] The NW group showed improvements in: the range of reach in the FRT test and the URT test in compared to the control group. The length of the gait cycle and gait cycle frequency also showed changes in the NW group compared to the control group. [Conclusion] A 12-week NW training program had a positive impact on selected gait parameters and may improve the postural control of women aged over 65 according to the results selected functional tests.

Comparative Effectiveness of a Bioengineered Living Cellular Construct and Cryopreserved Cadaveric Skin Allograft for the Treatment of Venous Leg Ulcers in a Real-World Setting

PubMed Central

Treadwell, Terry; Sabolinski, Michael L.; Skornicki, Michelle; Parsons, Nathan B.

2018-01-01

Objective: A variety of advanced biological therapies are available for the treatment of chronic wounds such as venous leg ulcers (VLUs), but real-world comparative effectiveness data that can help guide decisions around treatments are currently lacking. Approach: This analysis was designed to compare the effectiveness of a bioengineered living cellular construct (BLCC) to a cryopreserved cadaveric skin allograft (CCSA) for the treatment of VLUs. Treatment records were collected from a large wound care-specific electronic medical record database on 717 patients (799 VLUs) receiving treatment at 177 wound care centers. Ulcers ≥28 days duration, between ≥1 and < 40 cm2 that closed ≤40% within the 28 days before treatment were included. Results: Patient baseline demographics and wound characteristics were comparable between groups. The median time to wound closure was 52% faster with BLCC compared with CCSA (15 weeks vs. 31 weeks). In addition, the proportion of wounds healed were significantly higher for BLCC by 12 weeks (42% vs. 24%) and 24 weeks (65% vs. 41%) (p = 0.0002). Treatment with BLCC increased the probability of healing by 97% compared with CCSA (hazard ratio = 1.97 [95% confidence interval 1.39–2.79], p = 0.0002). Innovation: This is the first real-world comparative effectiveness analysis to evaluate BLCC and CCSA for the treatment of VLUs. Conclusion: Treatment with a bioengineered cellular technology significantly improved the incidence and speed of wound closure compared with a CCSA. PMID:29644144

Cost-effectiveness analysis of antimuscarinics in the treatment of patients with overactive bladder in Spain: A decision-tree model

PubMed Central

2011-01-01

Background Fesoterodine, a new once daily antimuscarinic, has proven to be an effective, safe, and well-tolerated treatment in patients with overactive bladder (OAB). To date, no analysis has evaluated the economic costs and benefits associated with fesoterodine, compared to antimuscarinics in Spain. The purpose of this analysis was to assess the economic value of OAB treatment with fesoterodine relative to extended release tolterodine and solifenacin, from the societal perspective. Methods The economic model was based on data from two 12-week, randomized, double-blind, and multicenter trials comparing fesoterodine and tolterodine extended released (ER). Treatment response rates for solifenacin were extracted from the published literature. Discontinuation and efficacy were based on the results of a 12-week multinational randomized clinical trial extrapolated to 52 weeks. Changes in health related quality of life were assessed with the King's Health Questionnaire, which was transformed into preference-based utility values. Medical costs included (expressed in € 2010) were antimuscarinics, physician visits, laboratory tests, incontinence pads and the costs of OAB-related comorbidities, fractures, skin infections, urinary tract infections, depression, and nursing home admissions associated with incontinence. Time lost from work was also considered. Univariate sensitivity analyses were also performed. Results At week 12, continents accounted for 50.6%, 40.6% and 47.2% of patients in the fesoterodine, tolterodine, and solifenacin groups, respectively. By week 52, the projected proportions of patients remaining on therapy were 33.1%, 26.5% and 30.8%, respectively. The projected quality- adjusted life years (QALY) gain (compared to baseline) over the 52-week simulation period were 0.01014, 0.00846 and 0.00957, respectively. The overall treatment cost was estimated at €1,937, €2,089 and €1,960 for fesoterodine, tolterodine and solifenacin, respectively. Therefore, treatment with fesoterodine resulted in similar overall costs and greater QALY gain than treatment with either tolterodine or solifenacin. Sensitivity analysis showed that these results were robust to all changes performed. Conclusions The results of this economic analysis suggest that fesoterodine is a cost-effective alternative to tolterodine and solifenacin for the treatment of patients with OAB in Spain. Fesoterodine provides additional health benefits while maintain a similar level of costs being a cost-effective treatment strategy from a societal perspective. PMID:21599928

Analysis of fracture healing in osteopenic bone caused by disuse: experimental study.

PubMed

Paiva, A G; Yanagihara, G R; Macedo, A P; Ramos, J; Issa, J P M; Shimano, A C

2016-03-01

Osteoporosis has become a serious global public health issue. Hence, osteoporotic fracture healing has been investigated in several previous studies because there is still controversy over the effect osteoporosis has on the healing process. The current study aimed to analyze two different periods of bone healing in normal and osteopenic rats. Sixty, 7-week-old female Wistar rats were randomly divided into four groups: unrestricted and immobilized for 2 weeks after osteotomy (OU2), suspended and immobilized for 2 weeks after osteotomy (OS2), unrestricted and immobilized for 6 weeks after osteotomy (OU6), and suspended and immobilized for 6 weeks after osteotomy (OS6). Osteotomy was performed in the middle third of the right tibia 21 days after tail suspension, when the osteopenic condition was already set. The fractured limb was then immobilized by orthosis. Tibias were collected 2 and 6 weeks after osteotomy, and were analyzed by bone densitometry, mechanical testing, and histomorphometry. Bone mineral density values from bony calluses were significantly lower in the 2-week post-osteotomy groups compared with the 6-week post-osteotomy groups (multivariate general linear model analysis, P<0.000). Similarly, the mechanical properties showed that animals had stronger bones 6 weeks after osteotomy compared with 2 weeks after osteotomy (multivariate general linear model analysis, P<0.000). Histomorphometry indicated gradual bone healing. Results showed that osteopenia did not influence the bone healing process, and that time was an independent determinant factor regardless of whether the fracture was osteopenic. This suggests that the body is able to compensate for the negative effects of suspension.

Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.

PubMed

Wang, Chenchen; Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

2018-03-21

To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Prospective, randomized, 52 week, single blind comparative effectiveness trial. Urban tertiary care academic hospital in the United States between March 2012 and September 2016. 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group difference in FIQR scores=16.2 points, 8.7 to 23.6, P<0.001). The groups who received tai chi for 24 weeks showed greater improvements than those who received it for 12 weeks (difference in FIQR scores=9.6 points, 2.6 to 16.6, P=0.007). There was no significant increase in benefit for groups who received tai chi twice weekly compared with once weekly. Participants attended the tai chi training sessions more often than participants attended aerobic exercise. The effects of tai chi were consistent across all instructors. No serious adverse events related to the interventions were reported. Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug treatment, for a variety of outcomes for patients with fibromyalgia. Longer duration of tai chi showed greater improvement. This mind-body approach may be considered a therapeutic option in the multidisciplinary management of fibromyalgia. ClinicalTrials.gov NCT01420640. 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.

Modification of high saturated fat diet with n-3 polyunsaturated fat improves glucose intolerance and vascular dysfunction

PubMed Central

Lamping, KL; Nuno, DW; Coppey, LJ; Holmes, AJ; Hu, S; Oltman, CL; Norris, AW; Yorek, MA

2013-01-01

Aims The ability of dietary enrichment with monounsaturated (MUFA), n-3, or n-6 polyunsaturated fatty acids (PUFA) to reverse glucose intolerance and vascular dysfunction resulting from excessive dietary saturated fatty acids is not resolved. We hypothesized that partial replacement of dietary saturated fats with n-3 PUFA enriched menhaden oil (MO) would provide greater improvement in glucose tolerance and vascular function compared to n-6 enriched safflower oil (SO) or MUFA-enriched olive oil (OO). Material and Methods We fed mice a high saturated fat diet (60% kcal from lard) for 12 weeks before substituting half the lard with MO, SO or OO for an additional 4 weeks. At the end of 4 weeks, we assessed glucose tolerance, insulin signaling and reactivity of isolated pressurized gracilis arteries. Results After 12 weeks of saturated fat diet, body weights were elevated and glucose tolerance abnormal compared to mice on control diet (13% kcal lard). Diet substituted with MO restored basal glucose levels, glucose tolerance, and indices of insulin signaling (phosphorylated Akt) to normal whereas restoration was limited for SO and OO substitutions. Although dilation to acetylcholine was reduced in arteries from mice on HF, OO and SO diets compared to normal diet, dilation to acetylcholine was fully restored and constriction to phenylephrine reduced in MO fed mice compared to normal. Conclusion We conclude that short term enrichment of an ongoing high fat diet with n-3 PUFA rich MO but not MUFA rich OO or n-6 PUFA rich SO reverses glucose tolerance, insulin signaling, and vascular dysfunction. PMID:22950668

Open-field study comparing an essential oil-based shampoo with miconazole/chlorhexidine for haircoat disinfection in cats with spontaneous microsporiasis.

PubMed

Nardoni, Simona; Costanzo, Angela Grazia; Mugnaini, Linda; Pisseri, Francesca; Rocchigiani, Guido; Papini, Roberto; Mancianti, Francesca

2017-06-01

Objectives The goal of the present study was to compare the antifungal efficacy of an essential oil (EO) shampoo proven to be effective against Microsporum canis with miconazole/chlorhexidine for topical haircoat disinfection in cats treated concurrently with oral itraconazole. Methods Cats received treatment with oral itraconazole (Itrafungol) at a dose of 5 mg/kg/day pulse administration for 1 week, every 2 weeks for at least 6 weeks and were washed twice a week with a neutral shampoo with added EOs of Thymus serpyllum (2%), Origanum vulgare and Rosmarinus officinalis (5% each) for the period of systemic treatment. This protocol was compared with a conventional treatment (oral itraconazole + 2% miconazole/2% chlorhexidine shampoo). Results The treatment was well tolerated and adverse effects were not recorded. All cats were clinically negative at week 11. With respect to animals with extensive lesions, the speed of resolution was higher in cats with focal lesions. The animals showing diffuse lesions required more than a course of treatment to achieve a mycological cure. There was no significant difference between the number of weeks to obtain mycological cure for cats treated with EOs and animals treated conventionally. Conclusions and relevance The treatment appeared to be effective and well appreciated by the owners. The use of shampoo with the added EOs of T serpyllum, O vulgare and R officinalis would seem an interesting, natural alternative to conventional topical treatment.

Assessing effects of a semi-customized experimental cervical pillow on symptomatic adults with chronic neck pain with and without headache

PubMed Central

Erfanian, Parham; Tenzif, Siamak; Guerriero, Rocco C

2004-01-01

Objective To determine the effects of a semi-customized experimental cervical pillow on symptomatic adults with chronic neck pain (with and without headache) during a four week study. Design A randomized controlled trial. Sample size Thirty-six adults were recruited for the trial, and randomly assigned to experimental or non-experimental groups of 17 and 19 participants respectively. Subjects Adults with chronic biomechanical neck pain who were recruited from the Canadian Memorial Chiropractic College (CMCC) Walk-in Clinic. Outcome measures Subjective findings were assessed using a mail-in self-report daily pain diary, and the CMCC Neck Disability Index (NDI). Statistical analysis Using repeated measure analysis of variance weekly NDI scores, average weekly AM and PM pain scores between the experimental and non-experimental groups were compared throughout the study. Results The experimental group had statistically significant lower NDI scores (p < 0.05) than the non-experimental group. The average weekly AM scores were lower and statistically significant (p < 0.05) in the experimental group. The PM scores in the experimental group were lower but not statistically significant than the other group. Conclusions The study results show that compared to conventional pillows, this experimental semi-customized cervical pillow was effective in reducing low-level neck pain intensity, especially in the morning following its use in a 4 week long study. PMID:17549216

Association of alcohol use and loneliness frequency among middle-aged and older adult drinkers

PubMed Central

Canham, Sarah L.; Mauro, Pia M.; Kaufmann, Christopher N.; Sixsmith, Andrew

2015-01-01

Objectives We examined the association between alcohol use, at-risk drinking, and binge drinking, and loneliness in a sample of middle-aged and older adults. Methods We studied participants aged 50+ years from the 2008 wave of the Health and Retirement Study who reported alcohol use. We ran separate multinomial logistic regressions to assess the association of three alcohol use outcomes (i.e., weekly alcohol consumption, at-risk drinking, and binge drinking) and loneliness. Results After adjusting for covariates, being lonely was associated with reduced odds of weekly alcohol consumption 4–7 days per week, but not 1–3 days per week, compared to average alcohol consumption 0 days per week in the last 3 months. No association was found between at-risk drinking or binge drinking and loneliness. Discussion Results suggest that among a sample of community-based adults aged 50+, loneliness was associated with reduced alcohol use frequency, but not with at-risk or binge drinking. PMID:26082130

Covered Metallic Stents With an Anti-Migration Design vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: A Multicenter, Randomized Trial

PubMed Central

Lee, Hyuk; Min, Byung-Hoon; Lee, Jeong Hoon; Shin, Cheol Min; Kim, Younjoo; Chung, Hyunsoo; Lee, Sang Hyub

2015-01-01

OBJECTIVES: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO. METHODS: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement. RESULTS: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency. CONCLUSIONS: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer. PMID:26372507

Incentive spirometry with expiratory positive airway pressure reduces pulmonary complications, improves pulmonary function and 6-minute walk distance in patients undergoing coronary artery bypass graft surgery.

PubMed

Haeffener, Mauren Porto; Ferreira, Glória Menz; Barreto, Sérgio Saldanha Menna; Arena, Ross; Dall'Ago, Pedro

2008-11-01

The use of the incentive spirometry (IS) with expiratory positive airway pressure (EPAP) to prevent postoperative pulmonary complications (PPC) after coronary artery bypass graft (CABG) is not well established. This study sought to determine the effects of IS+EPAP after CABG. Thirty-four patients undergoing CABG were randomly assigned to a control group or IS+EPAP group. Maximal respiratory pressures, pulmonary function test, 6-minute walk test and chest x-ray were performed at baseline as well as 1 week and 1 month after CABG. Maximal inspiratory pressure was significantly higher in the IS+EPAP group compared to controls at both 1 week and 1 month (P<.001). Maximal expiratory pressure was significantly higher at 1 month compared to 1 week in IS+EPAP group (P<.01). At 1 month, forced vital capacity and forced expiratory volume in 1 second was significantly higher in IS+EPAP compared to controls (P<.05). Inspiratory capacity was higher at 1 month in IS+EPAP group compared to controls (P<.05). The distance walked in 6-minute walk test was higher at 1 month in IS+EPAP group (P<.001) compared to controls. Lastly, radiological injury score at 1 week was lower in IS+EPAP compared to controls (P<.004). In patients undergoing CABG, IS+EPAP results in improved pulmonary function and 6-minute walk distance as well as a reduction in PPC.

Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study

PubMed Central

Kavanaugh, A; Gladman, D; van der Heijde, D; Purcaru, O; Mease, P

2015-01-01

Objectives To evaluate the effect of certolizumab pegol (CZP) on productivity outside and within the home, and on participation in family, social and leisure activities in adult patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) is a phase 3, double-blind, placebo-controlled trial. 409 patients with active PsA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). The arthritis-specific Work Productivity Survey (WPS) assessed the impact of PsA on paid work and household productivity, and participation in social activities during the preceding month. WPS responses were compared between treatment arms using a non-parametric bootstrap-t method. Results At baseline, 56.6%, 60.1% and 61.5% of placebo, CZP 200 mg Q2W and CZP 400 mg Q4W patients were employed. By week 24, employed CZP patients reported an average of 1.0–1.8 and 3.0–3.9 fewer days of absenteeism and presenteeism, respectively, per month compared with 1.0 and 0.3 fewer days for placebo patients (p<0.05). Within the home, by week 24, CZP patients reported an average of 3.0–3.5 household work days gained per month versus 1.0 day for placebo (p<0.05). CZP patients also reported fewer days with reduced household productivity or days lost for participation in family, social and leisure activities. Improvements with CZP were seen as early as week 4 and continued to week 24. Conclusions CZP treatment significantly improved productivity at paid work and within the home, and resulted in greater participation in social activities for PsA patients. Trial registration number NCT01087788. PMID:24942382

A randomized, controlled comparative study of the wrinkle reduction benefits of a cosmetic niacinamide/peptide/retinyl propionate product regimen vs. a prescription 0·02% tretinoin product regimen

PubMed Central

Fu, JJJ; Hillebrand, GG; Raleigh, P; Li, J; Marmor, MJ; Bertucci, V; Grimes, PE; Mandy, SH; Perez, MI; Weinkle, SH; Kaczvinsky, JR

2010-01-01

Background Tretinoin is considered the benchmark prescription topical therapy for improving fine facial wrinkles, but skin tolerance issues can affect patient compliance. In contrast, cosmetic antiwrinkle products are well tolerated but are generally presumed to be less efficacious than tretinoin. Objectives To compare the efficacy of a cosmetic moisturizer regimen vs. a prescription regimen with 0·02% tretinoin for improving the appearance of facial wrinkles. Methods An 8-week, randomized, parallel-group study was conducted in 196 women with moderate to moderately severe periorbital wrinkles. Following 2 weeks washout, subjects on the cosmetic regimen (n=99) used a sun protection factor (SPF) 30 moisturizing lotion containing 5% niacinamide, peptides and antioxidants, a moisturizing cream containing niacinamide and peptides, and a targeted wrinkle product containing niacinamide, peptides and 0·3% retinyl propionate. Subjects on the prescription regimen (n=97) used 0·02% tretinoin plus moisturizing SPF 30 sunscreen. Subject cohorts (n=25) continued treatment for an additional 16 weeks. Changes in facial wrinkling were assessed by both expert grading and image analysis of digital images of subjects’ faces and by self-assessment questionnaire. Product tolerance was assessed via clinical erythema and dryness grading, subject self-assessment, and determinations of skin barrier integrity (transepidermal water loss) and stratum corneum protein changes. Results The cosmetic regimen significantly improved wrinkle appearance after 8 weeks relative to tretinoin, with comparable benefits after 24 weeks. The cosmetic regimen was significantly better tolerated than tretinoin through 8 weeks by all measures. Conclusions An appropriately designed cosmetic regimen can improve facial wrinkle appearance comparably with the benchmark prescription treatment, with improved tolerability. PMID:20374604

Term elective induction of labour and perinatal outcomes in obese women: retrospective cohort study.

PubMed

Lee, V R; Darney, B G; Snowden, J M; Main, E K; Gilbert, W; Chung, J; Caughey, A B

2016-01-01

To compare perinatal outcomes between elective induction of labour (eIOL) and expectant management in obese women. Retrospective cohort study. Deliveries in California in 2007. Term, singleton, vertex, nonanomalous deliveries among obese women (n = 74 725). Women who underwent eIOL at 37 weeks were compared with women who were expectantly managed at that gestational age. Similar comparisons were made at 38, 39, and 40 weeks. Results were stratified by parity. Chi-square tests and multivariable logistic regression were used for statistical comparison. Method of delivery, severe perineal lacerations, postpartum haemorrhage, chorioamnionitis, macrosomia, shoulder dystocia, brachial plexus injury, respiratory distress syndrome. The odds of caesarean delivery were lower among nulliparous women with eIOL at 37 weeks [odds ratio (OR) 0.55, 95% confidence interval (CI) 0.34-0.90] and 39 weeks (OR 0.77, 95% CI 0.63-0.95) compared to expectant management. Among multiparous women with a prior vaginal delivery, eIOL at 37 (OR 0.39, 95% CI 0.24-0.64), 38 (OR 0.65, 95% CI 0.51-0.82), and 39 weeks (OR 0.67, 95% CI 0.56-0.81) was associated with lower odds of caesarean. Additionally, eIOL at 38, 39, and 40 weeks was associated with lower odds of macrosomia. There were no differences in the odds of operative vaginal delivery, lacerations, brachial plexus injury or respiratory distress syndrome. In obese women, term eIOL may decrease the risk of caesarean delivery, particularly in multiparas, without increasing the risks of other adverse outcomes when compared with expectant management. © 2015 Royal College of Obstetricians and Gynaecologists.

Kinetics of Hemagglutination-Inhibiting Antibodies Following Maternal Influenza Vaccination Among Mothers With and Those Without HIV Infection and Their Infants

PubMed Central

Nunes, Marta C.; Cutland, Clare L.; Dighero, Bonnie; Bate, Janie; Jones, Stephanie; Hugo, Andrea; van Niekerk, Nadia; Kuwanda, Locadiah; Izu, Alane; Weinberg, Adriana; Madhi, Shabir A.

2015-01-01

Background. We evaluated the immunogenicity of trivalent inactivated influenza vaccine (IIV3) in pregnant women with and those without human immunodeficiency virus (HIV) infection and the persistence of hemagglutination-inhibiting antibodies in mothers and infants. Methods. Antibodies were measured before vaccination, 1 month after vaccination, at delivery, and at postpartum week 24 in mothers and within 1 week of birth and at 8, 16, and 24 weeks of age in infants. Results. We enrolled 98 HIV-uninfected and 100 HIV-infected pregnant women, including 93% with a CD4+ T-cell count of ≥200 cells/µL. Compared with HIV-uninfected women, HIV-infected women had lower seroconversion rates (ranging from 63%–92% vs 36%–40%), lower antibody titers through postpartum week 24, and overlapping antibody half-lives (ranging from 106–121 vs 87–153 days). Infant titers were lower than the maternal titers within 1 week of delivery, regardless of vaccine strain and HIV exposure status. Compared with HIV-unexposed infants, HIV-exposed infants had a similar transplacental influenza virus antibody transfer ratio, lower titers, and a lower frequency of titers ≥1:40 (ranging from 82%–95% vs 43%–79%) at birth and higher antibody half-lives (ranging from 43–45 vs 56–65 days). Conclusions. Compared with HIV-uninfected pregnant women, HIV-infected pregnant women had lower antibody responses and persistence. Compared with HIV-unexposed infants, HIV-exposed infants had lower antibody levels at birth but similar antibody levels after 8 weeks of life. Early IIV3 administration during pregnancy did not decrease antibody titers among infants at birth. PMID:26080370

Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))

PubMed Central

Emery, P; Deodhar, A; Rigby, W F; Isaacs, J D; Combe, B; Racewicz, A J; Latinis, K; Abud-Mendoza, C; Szczepański, L J; Roschmann, R A; Chen, A; Armstrong, G K; Douglass, W; Tyrrell, H

2010-01-01

Objectives This phase III study evaluated the efficacy and safety of rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to MTX and who were naïve to prior biological treatment. Methods Patients with active disease on stable MTX (10–25 mg/week) were randomised to rituximab 2×500 mg (n=168), rituximab 2×1000 mg (n=172), or placebo (n=172). From week 24, patients not in remission (Disease Activity Score (28 joints) ≥2.6) received a second course of rituximab; patients initially assigned to placebo switched to rituximab 2×500 mg. The primary end point was American College of Rheumatology 20 (ACR20) response at week 24. All patients were followed until week 48. Results At week 24, both doses of rituximab showed statistically superior efficacy (p<0.0001) to placebo (ACR20: 54%, 51% and 23%; rituximab (2×500 mg) + MTX, rituximab (2×1000 mg) + MTX and placebo + MTX, respectively). Secondary end points were also significantly improved for both rituximab groups compared with placebo. Further improvements in both rituximab arms were observed from week 24 to week 48. Rituximab + MTX was well tolerated, demonstrating comparable safety to placebo + MTX through to week 24, and between rituximab doses through to week 48. Conclusions Rituximab (at 2×500 mg and 2×1000 mg) plus MTX significantly improved clinical outcomes at week 24, which were further improved by week 48. No significant differences in either clinical or safety outcomes were apparent between the rituximab doses. PMID:20488885

A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers

PubMed Central

Zelen, Charles M; Serena, Thomas E; Snyder, Robert J

2014-01-01

The aim of this study is to determine if weekly application of dehydrated human amnion/chorion membrane allograft reduce time to heal more effectively than biweekly application for treatment of diabetic foot ulcers. This was an institutional review board-approved, registered, prospective, randomised, comparative, non-blinded, single-centre clinical trial. Patients with non-infected ulcers of ≥ 4 weeks duration were included for the study. They were randomised to receive weekly or biweekly application of allograft in addition to a non-adherent, moist dressing with compressive wrapping. All wounds were offloaded. The primary study outcome was mean time to healing. Overall, during the 12-week study period, 92·5% (37/40) ulcers completely healed. Mean time to complete healing was 4·1 ± 2·9 versus 2·4 ± 1·8 weeks (P = 0·039) in the biweekly versus weekly groups, respectively. Complete healing occurred in 50% versus 90% by 4 weeks in the biweekly and weekly groups, respectively (P = 0·014). Number of grafts applied to healed wounds was similar at 2·4 ± 1·5 and 2·3 ± 1·8 for biweekly versus weekly groups, respectively (P = 0·841). These results validate previous studies showing that the allograft is an effective treatment for diabetic ulcers and show that wounds treated with weekly application heal more rapidly than with biweekly application. More rapid healing may decrease clinical operational costs and prevent long-term medical complications. PMID:24618401

A Phase III, Multicenter, Parallel-Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam Versus Vehicle in Women With Female Pattern Hair Loss.

PubMed

Bergfeld, Wilma; Washenik, Ken; Callender, Valerie; Zhang, Paul; Quiza, Carlos; Doshi, Uday; Blume-Peytavi, Ulrike

2016-07-01

BACKGROUND Female pattern hair loss (FPHL) is a common hair disorder that affects millions of women. A new 5% minoxidil topical foam (MTF) formulation, which does not contain propylene glycol, has been developed.
To compare the efficacy and safety of once-daily 5% MTF with vehicle foam for the treatment of FPHL.
This was a Phase III, randomized, double-blind, vehicle-controlled, parallel-group, international multicenter trial (17 sites) in women aged at least 18 years with FPHL (grade D3 to D6 on the Savin Density Scale), treated once daily with 5% MTF or vehicle foam for 24 weeks. The co-primary efficacy endpoints were the change from baseline at week 24 in target area hair count (TAHC) and subject assessment of scalp coverage. Also evaluated were TAHC at week 12, expert panel review of hair regrowth at week 24, and change from baseline in total unit area density (TUAD, sum of hair diameters/cm²) at weeks 12 and 24.
A total of 404 women were enrolled. At 12 and 24 weeks, 5% MTF treatment resulted in regrowth of 10.9 hairs/cm² and 9.1 hairs/cm² more than vehicle foam, respectively (both P<.0001). Improved scalp coverage at week 24 was observed by both subject self-assessment (0.69-point improvement over vehicle foam; P<.0001) and expert panel review (0.36-point improvement over the vehicle foam; P<.0001). TUAD increased by 658 μm/cm² and 644 μm/cm² more with 5% MTF than with vehicle foam at weeks 12 and 24, respectively (both P<.0001). MTF was well tolerated. A low incidence of scalp irritation and facial hypertrichosis was observed, with no clinically significant differences between groups.
Five percent MTF once daily for 24 weeks was well tolerated and promoted hair regrowth in women with FPHL, resulting in improved scalp coverage and increased hair density compared with vehicle foam. ClinicalTrials.gov identifier: nCT01226459

J Drugs Dermatol. 2016;15(7):874-881.

Contralesional homotopic activity negatively influences functional recovery after stroke (Conference Presentation)

NASA Astrophysics Data System (ADS)

Bauer, Adam Q.; Kraft, Andrew; Baxter, Grant A.; Bruchas, Michael R.; Lee, Jin-Moo; Culver, Joseph P.

2017-02-01

Recent fcMRI studies examining spontaneous brain activity after stoke have revealed disrupted global patterns of functional connectivity (FC). Interestingly, acute interhemispheric homotopic FC has been shown to be predictive of recovery potential. While substantial indirect evidence also suggests that homotopic brain activity may directly impact recovery, results in humans are extremely varied. A better understanding of how activity within networks functionally-connected to lesioned tissue influences brain plasticity might improve therapeutic strategies. We combine cell-type specific optogenetic targeting with optical intrinsic signal (OIS) imaging to assess the effects of homotopic contralesional activity (specifically in excitatory CamKIIa pyramidal neurons) on FC, cortical remapping, and behavior after stroke. Thirty-one mice were housed in enriched cages for the experiment. OIS imaging was performed before, 1, and 4 weeks after photothrombosis of left forepaw somatosensory cortex (S1fp). On day 1 after stroke, 17 mice were subjected to chronic, intermittent optical stimulation of right S1fp for 10 min, 5 days/week for 4 weeks. New cortical representations of left S1fp appeared in non-stimulated mice at week 1, but not in stimulated mice (p=0.005). Evoked responses were comparable in both groups at week 4 (p=0.57). Homotopic FC between left and right S1fp regions was equally reduced in both groups (p=0.012) at week 1. However, in non-stimulated mice, behavioral performance and FC between right S1fp and left perilesional S1 cortex was significantly higher by 4 weeks compared to stimulated mice (p=0.009). Our results suggest that increased homotopic, contralesional activity in excitatory neurons negatively influences spontaneous recovery following ischemic stroke.

[An oral sensitization food allergy model in Brown-Norway rats].

PubMed

Huang, Juan; Zhong, Yan; Cai, Wei; Zhang, Hongbo

2009-01-01

To develop an oral-sensitized animal model of food allergy using Brown-Norway (BN) rats and evaluate the sensitivity of ELISA and passive cutaneous anaphylaxis (PCA) in detecting ovalbumin-specific IgE antibody (OVA-IgE) level in sensitized animals. Sixteen 3-week old female BN rats were randomly divided into 3 groups: negative control group orally gavaged with saline, positive control group sensitized by intraperitoneal injection of 0. lmg/d OVA, and, study group sensitized by daily gavage of 1 mg/d ovalbumin (OVA). OVA-IgE was analyzed by ELISA and PCA method at week 4, 5, 6, 7, 8 and 9. At week 13, OVA-IgE level was analyzed after orally challenged by 1.0 ml of 100 mg/ml OVA. The ELISA result showed that the OVA-IgE level in study group was significantly increased at week 6, 7 and week 8 compared with negative control group (P < 0.05), and the highest level was found at week 6. There was no significant difference for the level of OVA-IgE between study group and positive control group. The sensitization rate in study group was 60%, 80% and 80% at week 6, 7 and 8 respectively, which was similar to positive control group. All PCA results in study group were negative, while in positive control group it was positive. Oral sensitization could be used as a suitable method to establish an animal model of food allergy, which is more comparable with the natural sensitization process in food allergy patients. ELISA method is more sensitive in detecting OVA-IgE level in oral sensitized animal model than PCA method.

Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial.

PubMed

Goertz, Christine M; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Pohlman, Katherine A; Weeks, William B; Lamas, Gervasio A

2016-06-01

The purpose of this pilot sham-controlled clinical trial was to estimate the treatment effect and safety of toggle recoil spinal manipulation for blood pressure management. Fifty-one participants with prehypertension or stage 1 hypertension (systolic blood pressure ranging from 135 to 159 mm Hg or diastolic blood pressure ranging from 85 to 99 mm Hg) were allocated by an adaptive design to 2 treatments: toggle recoil spinal manipulation or a sham procedure. Participants were seen by a doctor of chiropractic twice weekly for 6 weeks and remained on their antihypertensive medications, as prescribed, throughout the trial. Blood pressure was assessed at baseline and after study visits 1, 6 (week 3), and 12 (week 6), with the primary end point at week 6. Analysis of covariance was used to compare mean blood pressure changes from baseline between groups at each end point, controlling for sex, age, body mass index, and baseline blood pressure. Adjusted mean change from baseline to week 6 was greater in the sham group (systolic, -4.2 mm Hg; diastolic, -1.6 mm Hg) than in the spinal manipulation group (systolic, 0.6 mm Hg; diastolic, 0.7 mm Hg), but the difference was not statistically significant. No serious and few adverse events were noted. Six weeks of toggle recoil spinal manipulation did not lower systolic or diastolic blood pressure when compared with a sham procedure. No serious adverse events from either treatment were reported. Our results do not support a larger clinical trial. Further research to understand the potential mechanisms of action involving upper cervical manipulation on blood pressure is warranted before additional clinical investigations are conducted. Copyright © 2016. Published by Elsevier Inc.

Evaluation of a spot-on imidacloprid-moxidectin formulation (Advocate®) for the treatment of naturally occurring esophageal spirocercosis in dogs: a double-blinded, placebo-controlled study.

PubMed

Segev, Gilad; Rojas, Alicia; Lavy, Eran; Yaffe, Marganit; Aroch, Itamar; Baneth, Gad

2018-03-05

Dogs are the definitive hosts of Spirocerca lupi. Spirocercosis is treated by prolonged avermectin administration by injection or daily oral doses. In this prospective, double-blinded, placebo-controlled, clinical trial, the efficacy of imidacloprid and moxidectin spot-on formulation (Advocate®) was compared to injectable doramectin (Dectomax®). Dogs diagnosed with benign esophageal spirocercosis were divided randomly into doramectin (400 μg/kg IM) or moxidectin and imidacloprid spot-on (2.5-6.25 mg/kg and 10-25 mg/kg, respectively) groups and treated weekly for 12 consecutive weeks. Dogs were followed for 20 weeks by physical examination, owners' questionnaire, blood work, fecal floatation, PCR and endoscopy. All the doramectin group dogs (n = 10) completed the treatment and follow-up, and the disease had completely resolved in all by week 12. Of the Advocate® group (n = 10), four had complete resolution at week 12, four had partial resolution, one dog did not respond to treatment, and one dog was switched to the doramectin protocol on week 5 due to persistent severe clinical signs. PCR analysis was more sensitive in detecting S. lupi eggs compared to fecal floatation. Discrepancies were detected on 22 occasions, of which on 20 occasions, the PCR was positive while fecal floatation was negative, and only on two occasions the PCR results were negative while fecal flotation was positive. The present results indicate that weekly Advocate® spot-on administration may be effective for treating benign esophageal spirocercosis, but is less effective than the currently used injectable doramectin therapy at the dose and duration used herein.

MicroRNAs as serum biomarkers for periodontitis.

PubMed

Tomofuji, Takaaki; Yoneda, Toshiki; Machida, Tatsuya; Ekuni, Daisuke; Azuma, Tetsuji; Kataoka, Kota; Maruyama, Takayuki; Morita, Manabu

2016-05-01

Studies demonstrated that periodontitis modulates microRNA (miRNAs) expression rates in periodontal tissue. However, the relationship between periodontitis and miRNAs profile in circulation remains unclear. In this study, we investigated the effects of periodontitis on serum miRNAs profile in a rat model. Male Wistar rats (n = 32, 8 weeks old) were divided into four groups of eight rats each. The control groups received no treatment for 2 or 4 weeks. In the other two groups, periodontitis was ligature induced for 2 or 4 weeks. Serum miRNAs expression profiles of each group were compared. Ligation around teeth induced periodontal inflammation at 2 weeks and periodontal tissue destruction at 4 weeks. Microarray results showed that 25 miRNAs were expressed with a <0.5 or >2 difference between the control and periodontitis groups at 4 weeks. Results of real-time PCR revealed that the periodontitis group up-regulated expression rates of serum miR-207 and miR-495 at 2 weeks, and miR-376b-3p at 4 weeks (p < 0.05). Serum miRNAs (miR-207, miR-495, and miR-376b-3p) could be valuable biomarkers for periodontitis. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Integrated results from the COPERNICUS and GALILEO studies.

PubMed

Pielen, Amelie; Clark, W Lloyd; Boyer, David S; Ogura, Yuichiro; Holz, Frank G; Korobelnik, Jean-Francois; Stemper, Brigitte; Asmus, Friedrich; Rittenhouse, Kay D; Ahlers, Christiane; Vitti, Robert; Saroj, Namrata; Zeitz, Oliver; Haller, Julia A

2017-01-01

To report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO. Patients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52. At week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in <10% of patients. This analysis of integrated data from COPERNICUS and GALILEO confirmed that intravitreal aflibercept is an effective treatment for macular edema following CRVO.

Early Changes of Articular Cartilage and Subchondral Bone in The DMM Mouse Model of Osteoarthritis.

PubMed

Fang, Hang; Huang, Lisi; Welch, Ian; Norley, Chris; Holdsworth, David W; Beier, Frank; Cai, Daozhang

2018-02-12

To examine the early changes of articular cartilage and subchondral bone in the DMM mouse model of osteoarthritis, mice were subjected to DMM or SHAM surgery and sacrificed at 2-, 5- and 10-week post-surgery. Catwalk gait analyses, Micro-Computed Tomography, Toluidine Blue, Picrosirius Red and Tartrate-Resistant Acid Phosphatase (TRAP) staining were used to investigate gait patterns, joint morphology, subchondral bone, cartilage, collagen organization and osteoclasts activity, respectively. Results showed OA progressed over 10-week time-course. Gait disparity occurred only at 10-week post-surgery. Osteophyte formed at 2-week post-surgery. BMDs of DMM showed no statistical differences comparing to SHAM at 2 weeks, but BV/TV is much higher in DMM mice. Increased BMD was clearly found at 5- and 10-week post-surgery in DMM mice. TRAP staining showed increased osteoclast activity at the site of osteophyte formation of DMM joints at 5- and 10-week time points. These results showed that subchondral bone turnover might occurred earlier than 2 weeks in this mouse DMM model. Gait disparity only occurred at later stage of OA in DMM mice. Notably, patella dislocation could occur in some of the DMM mice and cause a different pattern of OA in affected knee.

An evaluation of a rapid real time polymerase chain reaction assay for detection of group B streptococcus as part of a neonatal group B streptococcus prevention strategy.

PubMed

Money, Deborah; Dobson, Simon; Cole, Lesley; Karacabeyli, Eda; Blondel-Hill, Edith; Milner, Ruth; Thomas, Eva

2008-09-01

To evaluate the sensitivity, specificity, and feasibility of a rapid real-time polymerase chain reaction (PCR) test for group B streptococcus (GBS) completed during labour, compared with the standard culture test performed at 35 to 37 weeks' gestation. Women presenting to the maternity unit for term vaginal delivery had two vaginal/rectal samples collected. One swab was tested using a rapid PCR method (IDI-Strep B, Infectio Diagnostic [IDI] Inc., Sainte-Foy QC ), and the other was cultured after enrichment (intrapartum culture). Comparisons were made between these results and those of a culture-based screen at 35 to 37 weeks' gestation. Of the 190 women enrolled, 85% had results of the standard screen at 35 to 37 weeks available for comparison. The sensitivity and specificity of the standard 35- to 37-week screen were 84.3% (95% confidence interval [CI], 71.4-93.0) and 93.2% (95% CI 86.5-97.2) respectively, whereas the sensitivity and specificity of the rapid PCR were 90.7% (95% CI 79.7-96.9) and 97.6% (95% CI 93.1-99.5), respectively. The median reporting time for the rapid PCR test was 99 minutes (range 50-255). Results were available more than four hours before delivery in 81% of cases. In this Canadian centre, a rapid PCR test done at the time of labour (IDI-Strep B) demonstrated high sensitivity and specificity, comparable to the 35- to 37-week screen. The time to reporting results was acceptably short, allowing for timely administration of intrapartum prophylactic antibiotics.

Financial consequences of a payment-by-results scheme in Catalonia: gefitinib in advanced EGFR-mutation positive non-small-cell lung cancer.

PubMed

Clopes, Ana; Gasol, Montse; Cajal, Rosana; Segú, Luis; Crespo, Ricard; Mora, Ramón; Simon, Susana; Cordero, Luis A; Calle, Candela; Gilabert, Antoni; Germà, Josep R

2017-01-01

In 2011 the first payment-by-results (PbR) scheme in Catalonia was signed between the Catalan Institute of Oncology (ICO), the Catalan Health Service, and AstraZeneca (AZ) for the introduction of gefitinib in the treatment of advanced EGFR-mutation positive non-small-cell lung cancer. The PbR scheme includes two evaluation points: at week 8, responses, stabilization and progression were evaluated, and at week 16 stabilization was confirmed. AZ was to reimburse the total treatment cost of patients that failed treatment, defined as progression at weeks 8 or 16. To estimate the financial consequences of this PbR reimbursement model and determine the perception of the stakeholders involved in the agreement. Differential drug costs between two scenarios, with and without the PbR, were calculated. A qualitative investigation of the organizational elements was performed by interviewing the parties involved in the agreement. Forty-one patients were included from June 2011 to October 2013 and assessed at two evaluation points. Clinical results were comparable to those observed in the pivotal studies of gefitinib. The difference in the cost of gefitinib using the PbR compared to the traditional purchasing scenario was 6.17% less at 8 weeks, 11.18% at 16 weeks and 4.15% less for the overall treatment. The PbR resulted in total savings of around €36,000 (€880 per patient). From an operational and organizational perspective, the availability of adequate data systems to measure outcomes and monitor accountability and the involvement of healthcare professionals were acknowledged as crucial. Tangible and intangible benefits were identified with respect to the interests of the parties involved. This has led to the incorporation of innovation for patients under acceptable conditions.

Comparison of Pharmaceutical Calculations Learning Outcomes Achieved Within a Traditional Lecture or Flipped Classroom Andragogy.

PubMed

Anderson, H Glenn; Frazier, Lisa; Anderson, Stephanie L; Stanton, Robert; Gillette, Chris; Broedel-Zaugg, Kim; Yingling, Kevin

2017-05-01

Objective. To compare learning outcomes achieved from a pharmaceutical calculations course taught in a traditional lecture (lecture model) and a flipped classroom (flipped model). Methods. Students were randomly assigned to the lecture model and the flipped model. Course instructors, content, assessments, and instructional time for both models were equivalent. Overall group performance and pass rates on a standardized assessment (Pcalc OSCE) were compared at six weeks and at six months post-course completion. Results. Student mean exam scores in the flipped model were higher than those in the lecture model at six weeks and six months later. Significantly more students passed the OSCE the first time in the flipped model at six weeks; however, this effect was not maintained at six months. Conclusion. Within a 6 week course of study, use of a flipped classroom improves student pharmacy calculation skill achievement relative to a traditional lecture andragogy. Further study is needed to determine if the effect is maintained over time.

Intrascrotal CGRP 8-37 causes a delay in testicular descent in mice.

PubMed

Samarakkody, U K; Hutson, J M

1992-07-01

The genitofemoral nerve is a key factor in the inguinoscrotal descent of the testis. The effect of androgens may be mediated via the central nervous system, which in turn secretes the neurotransmitter calcitonin gene-related peptide (CGRP) at the genitofemoral nerve endings, to cause testicular descent. The effect of endogenous CGRP was examined by weekly injections of a vehicle with or without synthetic antagonist (CGRP 8-37) into the developing scrotum of neonatal mice. The descent of the testis was delayed in the experimental group compared with the control group. At 2 weeks of age 43% of controls had descended testes compared with 0% of experimental animals. At 3 weeks of age 17% of experimentals still had undescended testes, whereas all testes were descended in controls. At 4 weeks 3 testes remained undescended in the experimental group. It is concluded that the CGRP antagonist can retard testicular descent. This result is consistent with the hypothesis that CGRP is an important intermediary in testicular descent.

Comparison of Pharmaceutical Calculations Learning Outcomes Achieved Within a Traditional Lecture or Flipped Classroom Andragogy

PubMed Central

Frazier, Lisa; Anderson, Stephanie L.; Stanton, Robert; Gillette, Chris; Broedel-Zaugg, Kim; Yingling, Kevin

2017-01-01

Objective. To compare learning outcomes achieved from a pharmaceutical calculations course taught in a traditional lecture (lecture model) and a flipped classroom (flipped model). Methods. Students were randomly assigned to the lecture model and the flipped model. Course instructors, content, assessments, and instructional time for both models were equivalent. Overall group performance and pass rates on a standardized assessment (Pcalc OSCE) were compared at six weeks and at six months post-course completion. Results. Student mean exam scores in the flipped model were higher than those in the lecture model at six weeks and six months later. Significantly more students passed the OSCE the first time in the flipped model at six weeks; however, this effect was not maintained at six months. Conclusion. Within a 6 week course of study, use of a flipped classroom improves student pharmacy calculation skill achievement relative to a traditional lecture andragogy. Further study is needed to determine if the effect is maintained over time. PMID:28630511

Long-Term Results of Cartilage Repair after Allogeneic Transplantation of Cartilaginous Aggregates Formed from Bone Marrow–Derived Cells for Large Osteochondral Defects in Rabbit Knees

PubMed Central

Mishima, Hajime; Sakai, Shinsuke; Uemura, Toshimasa

2013-01-01

Objective: The purpose of this study was to evaluate the long-term results of cartilage repair after allogeneic transplantation of cartilaginous aggregates formed from bone marrow–derived cells. Methods: Bone marrow cells were harvested from 12-day-old rabbits. The cells were subjected to a monolayer culture, and the spindle-shaped cells attached to the flask surface were defined as bone marrow–derived mesenchymal cells. After the monolayer culture, a 3-dimensional cartilaginous aggregate was formed using a bioreactor with chondrogenesis. We created osteochondral defects, measuring 5 mm in diameter and 4 mm in depth, at the femoral trochlea of 10-week-old rabbits. Two groups were established, the transplanted group in which the cartilaginous aggregate was transplanted into the defect, and the control group in which the defect was left untreated. Twenty-six and 52 weeks after surgery, the rabbits were sacrificed and their tissue repair status was evaluated macroscopically (International Cartilage Repair Society [ICRS] score) and histologically (O’Driscoll score). Results: The ICRS scores were as follows: at week 26, 7.2 ± 0.5 and 7.6 ± 0.8; at week 52, 7.6 ± 1.1 and 9.7 ± 0.7, for the transplanted and control groups, respectively. O’Driscoll scores were as follows: at week 26, 12.6 ± 1.9 and 10.1 ± 1.9; at week 52, 9.6 ± 3.0 and 14.0 ± 1.4, each for transplanted and control groups, respectively. No significant differences were observed between the groups. Conclusions: This study demonstrates that allogeneic transplantation of cartilaginous aggregates formed from bone marrow–derived cells produces comparable long-term results based on macroscopic and histological outcome measures when compared with osteochondral defects that are left untreated. PMID:26069678

Comparing the Rigor of Compressed Format Courses to Their Regular Semester Counterparts

ERIC Educational Resources Information Center

Lutes, Lyndell; Davies, Randall

2013-01-01

This study compared workloads of undergraduate courses taught in 16-week and 8-week sessions. A statistically significant difference in workload was found between the two. Based on survey data from approximately 29,000 students, on average students spent about 17 minutes more per credit per week on 16-week courses than on similar 8-week courses.…

Cost-effectiveness of sofosbuvir-based treatments for chronic hepatitis C in the US.

PubMed

Zhang, Sai; Bastian, Nathaniel D; Griffin, Paul M

2015-08-05

The standard care of treatment of interferon plus ribavirin (plus protease inhibitor for genotype 1) are effective in 50 % to 70 % of patients with CHC. Several new treatments including Harvoni, Olysio + Sovaldi, Viekira Pak, Sofosbuvir-based regimens characterized with potent inhibitors have been approved by the Food and Drug Administration (FDA) providing more options for CHC patients. Trials have shown that the new treatments increased the rate to 80% to 95%, though with a substantial increase in cost. In particular, current market pricing of a 12-week course of sofosbuvir is approximately US$84,000. We determine the cost-effectiveness of new treatments in comparison with the standard care of treatments. A Markov simulation model of CHC disease progression is used to evaluate the cost-effectiveness of different treatment strategies based on genotype. The model calculates the expected lifetime medical costs and quality adjusted life years (QALYs) of hypothetical cohorts of identical patients receiving certain treatments. For genotype 1, we compare: (1) peginterferon + ribavirin + telaprevir for 12 weeks, followed by 12 or 24 weeks treatment of peginterferon + ribavirin dependent on HCV RNA level at week 12; (2) Harvoni treatment, 12 weeks; (3) Olysio + Sovaldi, 12 weeks for patients without cirrhosis, 24 weeks for patients with cirrhosis; (4) Viekira Pak + ribavirin, 12 weeks for patients without cirrhosis, 24 weeks for patients with cirrhosis; (5) sofosbuvir + peginterferon + ribavirin, 12 weeks for patients with or without cirrhosis. For genotypes 2 and 3, treatment strategies include: (1) peginterferon + ribavirin, 24 weeks for treatment-naïve patients; (2) sofosbuvir + ribavirin, 12 weeks for patients with genotype 2, 24 weeks for genotype 3; (3) peginterferon + ribavirin as initial treatment, 24 weeks for patients with genotype 2/3, follow-up treatment with sofosbuvir + ribavirin for 12/16 weeks are performed on non-responders and relapsers. Viekira Pak is cost-effective for genotype 1 patients without cirrhosis, whereas Harvoni is cost-effective for genotype 1 patients with cirrhosis. Sofosbuvir-based treatments for genotype 1 in general are not cost-effective due to its substantial high costs. Two-phase treatments with 12-week and 16-week follow-ups are cost-effective for genotype 3 patients and for genotype 2 patients with cirrhosis. The results were shown to be robust over a broad range of parameter values through sensitivity analysis. For genotype 1, sofosbuvir-based treatments are not cost-effective compared to Viekira Pak and Harvoni, although a 30% reduction in sofosbuvir price would change this result. Sofosbuvir + ribavirin are cost-effective as second-phase treatments following peginterferon + ribavirin initial treatment for genotypes 2 and 3. However, there is limited data on sofosbuvir-involved treatment, and the results obtained in this study must be interpreted within the model assumptions.

Comparative Quantitative Studies on the Microvasculature of the Heart of a Highly Selected Meat-Type and a Wild-Type Turkey Line

PubMed Central

Kattanek, Maria; Richardson, Kenneth C.; Hafez, Hafez Mohamed; Plendl, Johanna; Hünigen, Hana

2017-01-01

In this study the macroscopic and microscopic structure of the heart of a fast growing, meat-type turkey line (British United turkeys BUT Big 6) and a wild-type turkey line (Canadian Wild turkey) were compared. At 8 and 16 weeks of age, 10 birds of each genotype and sex were sampled. The body mass and heart mass of the meat-type turkey both increased at a faster rate than those of the wild-type turkey. However in both turkey lines, the relative heart mass decreased slightly with age, the decrease was statistically significant only in the male turkeys. Furthermore meat-type turkeys had a significantly (p < 0.01) lower relative heart mass and relative thickness of the left ventricle compared to the wild-type turkeys of the same age. The wild-type turkeys showed no significant change in the size of cardiomyocytes (cross sectional area and diameter) from 8 weeks to 16 weeks. In contrast, the size of cardiomyocytes increased significantly (p < 0.001) with age in the meat-type turkeys. The number of capillaries in the left ventricular wall increased significantly (p < 0.001) in wild-type turkeys from 2351 per mm2 at the age of 8 weeks to 2843 per mm2 at 16 weeks. However, in the meat-type turkeys there were no significant changes, capillary numbers being 2989 per mm2 at age 8 weeks and 2915 per mm2 at age 16 weeks. Correspondingly the area occupied by capillaries in the myocardium increased in wild-type turkeys from 8.59% at the age of 8 weeks to 9.15% at 16 weeks, whereas in meat-type turkeys this area decreased from 10.4% at 8 weeks to 9.95% at 16 weeks. Our results indicate a mismatch in development between body mass and heart mass and a compromised cardiac capillary density and architecture in the meat-type turkeys in comparison to the wild-type turkeys. PMID:28118415

Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.

PubMed

Park, Won; Yoo, Dae Hyun; Jaworski, Janusz; Brzezicki, Jan; Gnylorybov, Andriy; Kadinov, Vladimir; Sariego, Irmgadt Goecke; Abud-Mendoza, Carlos; Escalante, William Jose Otero; Kang, Seong Wook; Andersone, Daina; Blanco, Francisco; Hong, Seung Suh; Lee, Sun Hee; Braun, Jürgen

2016-01-20

CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5 mg/kg) or RP (5 mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed. Of 250 randomized patients (n = 125 per group), 210 (84.0 %) completed 54 weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 -3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54 weeks, 19.5 % and 23.0 % of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54 weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events, infections and infusion-related reactions. CT-P13 and RP have highly comparable efficacy (including PROs) and PK up to week 54. Over a 1-year period, CT-P13 was well tolerated and displayed a safety profile comparable to RP; no differences in immunogenicity were observed. ClinicalTrials.gov identifier: NCT01220518 . Registered 4 October 2010.

Fertility drugs and young-onset breast cancer: results from the Two Sister Study.

PubMed

Fei, Chunyuan; Deroo, Lisa A; Sandler, Dale P; Weinberg, Clarice R

2012-07-03

Fertility drugs stimulate hyperovulation, which may have implications for breast cancer. We examined the association between use of fertility drugs (clomiphene citrate [CC] and follicle-stimulating hormone [FSH]) and subsequent risk of young-onset (<50 years at diagnosis) breast cancer. We conducted the Two Sister Study, a sister-matched case-control study, by enrolling 1422 women between September 2008 and December 2010, who were younger than age 50 years at diagnosis with breast cancer and were enrolled within 4 years of diagnosis, and 1669 breast cancer-free control sisters from the Sister Study. Participants reported their use of fertility drugs (CC and FSH) and ever-users reported whether a pregnancy had resulted that lasted 10 or more (10+) weeks. Conditional logistic regression was used to estimate confounder-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for fertility drug use with or without conception of a 10+ week pregnancy. A total of 288 participants reported having used ovulation-stimulating drugs (193 CC only, 29 FSH only, and 66 both). Overall, women who had used fertility drugs showed a non-statistically significantly decreased risk of breast cancer, compared with nonusers (OR = 0.82, 95% CI = 0.63 to 1.08). Women who had used fertility drugs but had not conceived a 10+ week pregnancy under treatment showed a statistically significantly decreased risk of breast cancer compared with nonusers (OR = 0.62, 95% CI = 0.43 to 0.89). Women who had used fertility drugs and conceived a 10+ week pregnancy under treatment showed a statistically significantly increased risk of breast cancer compared with unsuccessfully treated women (OR = 1.82, 95% CI = 1.10 to 3.00), although their risk was not increased compared with women who had not used fertility drugs (OR = 1.13, 95% CI = 0.78 to 1.64). In the absence of a 10+ week pregnancy under treatment, exposure to ovulation-stimulating fertility drugs was associated with reduced risk of young-onset breast cancer. This apparent association was absent in women who conceived a 10+ week pregnancy under treatment, for whom risk was higher than that of unsuccessfully treated women, but similar to that of untreated women.

Description and Evaluation of the 2009–2010 Pennsylvania Influenza Sentinel School Monitoring System

PubMed Central

Marriott, Chandra K.; Ostroff, Stephen; Waller, Kirsten

2011-01-01

Objectives. We described and evaluated the 2009–2010 Pennsylvania Influenza Sentinel School Monitoring System, a voluntary sentinel network of schools that report data on school absenteeism and visits to the school nurse for influenza-like illness (ILI). Methods. Participating schools provided daily absenteeism and ILI data on a weekly basis through an online survey. We used participation and weekly response rates to determine acceptability, timeliness, and simplicity. We assessed representativeness by comparing participating schools with nonparticipating schools. We compared monitoring system data with statewide reports of laboratory-confirmed influenza. Results. Of the 3244 Pennsylvania public schools, 367 (11%) enrolled in the system. On average, 79% of enrolled schools completed the survey each week. Although the peak week of elevated absenteeism coincided with the peak of statewide laboratory-confirmed influenza cases, the correlation between absenteeism and state data was nonsignificant (correlation coefficient = 0.10; P = .56). Trends in ILI correlated significantly with state data (correlation coefficient = 0.67; P < .001). Conclusions. The school-based sentinel system is a simple, acceptable, reliable device for tracking absenteeism and ILI in schools. Further analyses are necessary to determine the comparative value of this system and other influenza surveillance systems. PMID:21566024

Impact of Prolonged Mechanical Ventilation in Very Low Birth Weight Infants: Results From a National Cohort Study.

PubMed

Choi, Young-Bin; Lee, Juyoung; Park, Jisun; Jun, Yong Hoon

2018-03-01

To evaluate the in-hospital consequences of prolonged respiratory support with invasive mechanical ventilation in very low birth weight infants. A cohort study was performed using prospectively collected data from 69 neonatal intensive care units participating in the Korean national registry. In total, 3508 very low birth weight infants born between January 1, 2013 and December 31, 2014 were reviewed. The adjusted hazard ratio for death increased significantly for infants who received mechanical ventilation for more than 2 weeks compared with those were mechanically ventilated for 7 days or less. The individual mortality rate increased after 8 weeks, reaching 50% and 60% at 14 and 16 weeks of cumulative mechanical ventilation, respectively. After adjusting for potential confounders, the cumulative duration of mechanical ventilation was associated with a clinically significant increase in the odds of bronchopulmonary dysplasia and pulmonary hypertension. Mechanical ventilation exposure for longer than 2 weeks, compared with 7 days or less, was associated with retinopathy of prematurity requiring laser coagulation and periventricular leukomalacia. The odds of abnormal auditory screening test results were significantly increased in infants who needed mechanical ventilation for more than 4 weeks. A longer cumulative duration of mechanical ventilation was associated with increased lengths of hospitalization and parenteral nutrition and a higher probability of discharge with poor achievement of physical growth. Although mechanical ventilation is a life-saving intervention for premature infants, these results indicate that it is associated with negative consequences when applied for prolonged periods. Copyright © 2017 Elsevier Inc. All rights reserved.

Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

PubMed

Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

2017-10-01

ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. NCT01970475; 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.

Effect of vanadium on colonic aberrant crypt foci induced in rats by 1,2 Dimethyl hydrazine

PubMed Central

Kanna, P Suresh; Mahendrakumar, CB; Chakraborty, T; Hemalatha, P; Banerjee, Pratik; Chatterjee, M

2003-01-01

AIM: To investigate the chemo preventive effects of vanadium on rat colorectal carcinogenesis induced by 1,2-dimethylhydrazine (DMH). METHODS: Male Sprague-Dawley Rats were randomly divided into four groups. Rats in Group A received saline vehicle alone for 16 weeks. Rats in Group B were given DMH injection once a week intraperitoneally for 16 weeks; rats in Group C, with the same DMH treatment as in the Group B, but received 0.5-ppm vanadium in the form ammonium monovanadate ad libitum in drinking water. Rats in the Group D received vanadium alone as in the Group C without DMH injection. RESULTS: Aberrant crypt foci (ACF) were formed in animals in DMH-treated groups at the end of week 16. Compared to DMH group, vanadium treated group had less ACF (P < 0.001). At the end of week 32, all rats in DMH group developed large intestinal tumors. Rats treated with vanadium contained significantly few colonic adenomas and carcinomas (P < 0.05) compared to rats administered DMH only. In addition, a significant reduction (P < 0.05) in colon tumor burden (sum of tumor sizes per animal) was also evident in animals of Group C when compared to those in rats of carcinogen control Group B. The results also showed that vanadium significantly lowered PCNA index in ACF (P < 0.005). Furthermore, vanadium supplementation also elevated liver GST and Cyt P-450 activities (P < 0.001 and P < 0.02, respectively). CONCLUSION: Vanadium in the form of ammonium monovanadate supplemented in drinking water ad libitum has been found to be highly effective in reducing tumor incidence and preneoplastic foci on DMH-induced colorectal carcinogenesis. These findings suggest that vanadium administration can suppress colon carcinogenesis in rats. PMID:12717849

Comparative in vivo antioxidant levels in Schistosoma mansoni infected mice treated with praziquantel or the essential oil of Melaleuca armillaris leaves.

PubMed

Rizk, M; Ibrahim, N; El-Rigal, N

2012-10-15

Plant extracts are continuously investigated for their extensive inclusion of biologically active constituents that exert therapeutic activities against many diseases. The aim of this study was to assess the antioxidant/anti-schistosomal activities of the essential oil of the fresh leaves of Melaleuca armillaris (M. armillaris) compared to Praziquantel (PZQ) on normal and Schistosoma mansoni-infected mice. The oil was isolated by hydrodistillation and analyzed by gas chromatography/mass spectrometry (GC/MS). The oil was rich in 1,8-cineole (33.93%), terpinen-4-ol (18.79%), limonene (10.37%) and B-pinene (6.59%). M. armillaris oil (150 mg kg(-1), orally) was administered from the second week post infection twice per week for six weeks. PZQ (500 mg kg(-1), orally) was administered for two successive days 8 weeks post infection and mice sacrificed one week later. Total protein, Malondialdehyde (MDA), Glutathione (GSH), vitamins C and E, the antioxidant enzymes catalase and superoxide dismutase, as well as liver weights and liver/body weight were determined in the liver tissues. Results showed that, both treatments significantly ameliorated the disturbed levels ofGSH and MDA in infected mice. Both vitamins were significantly elevated after treatment with the oil while a significant increase in catalase accompanied by a pronounced decrease in SOD were obtained after treatment with PZQ. Both treatments markedly improved liver and body weights in infected mice compared to the infected-untreated ones. In conclusion, natural plant sources may be used as promising alternative agents to chemical drugs for schistosomiasis treatment, since the latter may result in drug-induced resistance arising from repeated use.

Cost-effectiveness of Ingenol Mebutate Gel for the Treatment of Actinic Keratosis in Greece.

PubMed

Athanasakis, Kostas; Boubouchairopoulou, Nadia; Tarantilis, Filippos; Tsiantou, Vasiliki; Kontodimas, Stathis; Kyriopoulos, John

2017-05-01

The present study aimed to perform a cost-effectiveness analysis of ingenol mebutate (IM) versus other topical alternatives for the treatment of actinic keratosis (AK). The analysis used a decision tree to calculate the clinical effects and costs of AK first-line treatments, IM (2-3 days), diclofenac 3% (for 8 or 12 weeks), imiquimod 5% (for 4 or 8 weeks), during a 24-month horizon, using discrete intervals of 6 months. A hypothetical cohort of immunocompetent adult patients with clinically confirmed AK on the face and scalp or trunk and extremities was considered. Clinical data on the relative efficacy were obtained from a network meta-analysis. Inputs concerning resource use derived from an expert panel. All costs were calculated from a Greek third-party payer perspective. IM 0.015% and 0.05% were both cost-effective compared with diclofenac and below a willingness-to-pay threshold of €30,000 per quality-adjusted life-year (QALY) (€199 and €167 per QALY, respectively). Comparing IM on the face and scalp AK lesions for 3 days versus imiquimod for 4 weeks resulted in an incremental cost-effectiveness ratio of €10,868 per QALY. IM was dominant during the 8-week imiquimod period. IM use on the trunk and extremities compared with diclofenac (8 or 12 weeks) led to incremental cost-effectiveness ratios estimated at €1584 and €1316 per QALY accordingly. Results remained robust to deterministic and probabilistic sensitivity analyses. From a social insurance perspective in Greece, IM 0.015% and IM 0.05% could be the most cost-effective first-line topical field treatment options in all cases for AK treatment. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Skeletal maturation substantially affects elastic tissue properties in the endosteal and periosteal regions of loaded mice tibiae.

PubMed

Checa, Sara; Hesse, Bernhard; Roschger, Paul; Aido, Marta; Duda, Georg N; Raum, Kay; Willie, Bettina M

2015-07-01

Although it is well known that the bone adapts to changes in the mechanical environment by forming and resorbing the bone matrix, little is known about the influence of mechanical loading on tissue material properties of the pre-existing and newly formed bone. In this study, we analyzed the newly formed and pre-existing tissue after two weeks of controlled in vivo axial compressive loading in tibia of young (10 week-old) and adult (26 week-old) female mice and compared to the control contralateral limb, by means of scanning acoustic microscopy. Additionally, we used quantitative backscattered electron imaging to determine the bone mineral density distribution within the newly formed and pre-existing bone of young mice. No significant differences were found in tissue stiffness or mineral density in the pre-existing bone tissue as a result of external loading. In the endosteal region, 10 and 26 week loaded animals showed a 9% reduction in bone tissue stiffness compared to control animals. An increase of 200% in the mineral apposition rate in this region was observed in both age groups. In the periosteal region, the reduction in bone tissue stiffness and the increase in bone mineral apposition rate as a result of loading were two times higher in the 10 compared to the 26 week old animals. These data suggest that, during growth and skeletal maturation, the response of bone to mechanical loading is a deposition of new bone matrix, where the tissue amount but not its mineral or elastic properties are influenced by animal age. Copyright © 2015 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Placental transfusion in preterm neonates of 30-33 weeks' gestation: a randomized controlled trial.

PubMed

Das, Bikramjit; Sundaram, Venkataseshan; Tarnow-Mordi, William; Ghadge, Alpana; Dhaliwal, Lakhbir Kaur; Kumar, Praveen

2018-02-06

To compare effect of placental transfusion by delayed cord clamping (DCC) or cord milking (CM) with early cord clamping (ECC) on a composite of mortality or abnormal neurological status at 40 weeks' post-menstrual age (PMA) and 24-30 months' chronological age in neonates of 30-33 weeks' gestation. Randomized, controlled trial. A composite of mortality or abnormal neurological status at 40 weeks PMA and survival free of neurodevelopmental abnormalities at 24-30 months' chronological age. A total of 461 neonates were randomized to placental transfusion (n = 233) or to ECC (n = 228). Among those assigned to placental transfusion group, 173 underwent DCC while in the remaining 60, CM was done. Incidence of mortality or abnormal neurological status at 40 weeks PMA (43 (18%) vs 35 (15%), RR (95% CI) 1.2 (0.8, 1.8), p = 0.4) and survival free of neurodevelopmental impairment at 24-30 months of chronological age (99 (47%) vs. 100 (50%); RR (95% CI): 0.9 (0.8, 1.2); P = 0.9) was similar between the study groups. The placental transfusion group showed a trend towards lower incidence of necrotizing enterocolitis. In 30-33 weeks' gestation preterm neonates, placental transfusion as compared to early cord clamping resulted in similar mortality or abnormal neurological status at 40 weeks PMA and at 24-30 months of chronological age.

How is the weather? Forecasting inpatient glycemic control

PubMed Central

Saulnier, George E; Castro, Janna C; Cook, Curtiss B; Thompson, Bithika M

2017-01-01

Aim: Apply methods of damped trend analysis to forecast inpatient glycemic control. Method: Observed and calculated point-of-care blood glucose data trends were determined over 62 weeks. Mean absolute percent error was used to calculate differences between observed and forecasted values. Comparisons were drawn between model results and linear regression forecasting. Results: The forecasted mean glucose trends observed during the first 24 and 48 weeks of projections compared favorably to the results provided by linear regression forecasting. However, in some scenarios, the damped trend method changed inferences compared with linear regression. In all scenarios, mean absolute percent error values remained below the 10% accepted by demand industries. Conclusion: Results indicate that forecasting methods historically applied within demand industries can project future inpatient glycemic control. Additional study is needed to determine if forecasting is useful in the analyses of other glucometric parameters and, if so, how to apply the techniques to quality improvement. PMID:29134125

A Randomized Clinical Trial of Comparing Monophasic Monodensified and Biphasic Nonanimal Stabilized Hyaluronic Acid Dermal Fillers in Treatment of Asian Nasolabial Folds.

PubMed

Zhou, Shuang-Bai; Xie, Yun; Chiang, Cheng-An; Liu, Kai; Li, Qing-Feng

2016-09-01

Cross-linked hyaluronic acids (HAs) with varying characteristics and formulations are available. Despite the popularity of HA, limited studies compared the effectiveness of monophasic monodensified hyaluronic acid (MMHA) and biphasic nonanimal stabilized hyaluronic acid (BHA) products in correcting nasolabial folds (NLFs) in the Asian population. This double-blinded, randomized research aimed at evaluating the outcomes of MMHA and BHA products in treating Asian NLFs. Subjects aged between 18 and 65 years with moderate-to-severe NLFs were randomized to receive MMHA or BHA treatment. A touch-up treatment with the same product was performed at the 4-week follow-up, if needed. The effectiveness was evaluated for 24 weeks by masked investigators. All adverse events were recorded for safety evaluation. Twenty-five subjects in the MMHA Group and twenty-four subjects in the BHA Group finished 24-week follow-up. Results showed that subjects from both groups obtained satisfactory outcome in NLF correction. A lower amount of MMHA was required to achieve a similar result as that of BHA (p < .01). Both HA products maintained the effectiveness at the end of the 24-week follow-up. Both MMHA and BHA are effective for correcting NLF in Asian patients, producing satisfactory results. Monophasic monodensified hyaluronic acid provides similar satisfaction to BHA while requiring less injection volume.

Loss of dopaminergic neurons occurs in the ventral tegmental area and hypothalamus of rats following chronic stress: Possible pathogenetic loci for depression involved in Parkinson's disease.

PubMed

Sugama, Shuei; Kakinuma, Yoshihiko

2016-10-01

Parkinson's disease (PD) is a neurodegenerative disease characterized by loss of dopaminergic (DA) neurons in the nigrostriatal and mesolimbic pathways including ventral tegmental area (VTA). Although several factors for the neuronal loss have been suggested, most of the PD cases are sporadic and idiopathic. In our previous study, we demonstrated the first evidence that solely chronic restraint stress (RS) induced the DA neuronal loss in the substantia nigra (SN). In this study, we further investigated whether chronic stress could affect other major DA systems, VTA and tuberoinfundibular system (TIDA), by using immunohistochemical and in situ hybridization techniques. The present study showed that, in the VTA, tyrosine hydroxylase (TH) immunoreactive neurons decreased by 9.8% at 2nd week, 19.2% at 4th week, 39.5% at 8th week, and 40.6% at 16th week during chronic RS as compared to control. Similarly, in the TIDA, the TH neurons decreased by 10.9% at 2nd week, 38.2% at 4th week, 56.3% at 8th week, and 57.1% at 16th week. The in situ hybridization results consistently demonstrated decreases in Th mRNA expressing cells in the VTA and TIDA in a comparable time dependent manner. Thus, exposure to chronic stress may simultaneously induce multiple neuronal loss of DA systems. Copyright © 2016 Elsevier Ireland Ltd and Japan Neuroscience Society. All rights reserved.

Mirror therapy combined with functional electrical stimulation for rehabilitation of stroke survivors' ankle dorsiflexion.

PubMed

Salhab, Ghadir; Sarraj, Ahmad Rifaii; Saleh, Soha

2016-08-01

This study investigates the effect of combining both mirror therapy with Electrical Stimulation (ES) on improvement of the function of lower extremity compared to conventional therapy. 18 stroke survivors (sub acute stage) were recruited, 9 of them were randomly assigned to receive conventional treatment and another 9 started the mirror therapy combined with ES treatment. Duration of each session in both interventions was 50 minutes, done 4 times per week over two weeks. After 2 weeks, subjects took one week rest before switching they type of treatment; those started with conventional therapy continued with mirror therapy combined with ES, and vice versa. The duration of this phase was 2 weeks with same schedule as the 1st one. Ankle dorsi-flexion range of motion, lower extremity sensory-motor function, and walking duration were measured at baseline, after 1st 2 weeks, and immediately after the last two weeks, and 4 weeks after end of training (retention test). Repeated Measures ANCOVA was done to compare outcome measures scores in both groups and between all testing days, and paired T-test was used measure the difference between groups. Significant increase in all outcome measures was found after the (MT+ES) training, which is higher than conventional therapy training (p<;0.0001). In conclusion, the results suggest that combination of mirror therapy and ES is more effective than conventional therapy in improving lower limb motor function after stroke.

Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept.

PubMed

Strober, Bruce; Gottlieb, Alice B; Sherif, Bintu; Mollon, Patrick; Gilloteau, Isabelle; McLeod, Lori; Fox, Todd; Mordin, Margaret; Gnanasakthy, Ari; Papavassilis, Charis; Lebwohl, Mark G

2017-04-01

Psoriasis is a chronic condition with negative impact on patients' quality of life that most often requires lifelong effective and safe treatment. This analysis focused on the effect of secukinumab treatment on patient-reported health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis. The proportion of subjects achieving DLQI score 0/1 response at week 24, time to DLQI score 0/1 response, and sustained DLQI score 0/1 response up to week 52 were compared between secukinumab and etanercept. Of 1470 subjects, 1144 received secukinumab and 326 received etanercept. DLQI score 0/1 response rates were significantly higher for secukinumab than for etanercept at week 24. The median time to DLQI score 0/1 response was significantly shorter for secukinumab versus etanercept (12 vs 24 weeks; P < .01). The majority of secukinumab-treated subjects achieved DLQI score 0/1 response at week 24 and sustained it through week 52 along with a 90% to 100% reduction in the Psoriasis Area and Severity Index total score response. Placebo comparisons are limited during the maintenance period because of rerandomization at week 12. Secukinumab treatment provided faster and greater sustained improvements in quality of life than etanercept over 52 weeks, consistent with greater clinical response. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Effects of high- and low-energy radial shock waves therapy combined with physiotherapy in the treatment of rotator cuff tendinopathy: a retrospective study.

PubMed

Su, Xiangzheng; Li, Zhongli; Liu, Zhengsheng; Shi, Teng; Xue, Chao

2017-06-09

The aim of this study was to investigate the efficacy of high- and low-energy radial shock waves combined with physiotherapy for rotator cuff tendinopathy patients. Data from rotator cuff tendinopathy patients received high- or low-energy radial shock waves combined with physiotherapy or physiotherapy alone were collected. The Constant and Murley score and visual analog scale score were collected to assess the effectiveness of treatment in three groups at 4, 8, 12, and 24 weeks. In total, 94 patients were involved for our retrospective study. All groups showed remarkable improvement in the visual analog scale and Constant and Murley score compared to baseline at 24 weeks. The high-energy radial shock waves group had more marked improvement in the Constant and Murley score compared to the physiotherapy group at 4 and 8 weeks and at 4 weeks when compared with low-energy group. Furthermore, high-energy radial shock waves group had superior results on the visual analog scale at 4, 8, and 12 weeks compared to low-energy and physiotherapy groups. This retrospective study supported the usage of high-energy radial shock waves as a supplementary therapy over physiotherapy alone for rotator cuff tendinopathy by relieving the symptoms rapidly and maintaining symptoms at a satisfactory level for 24 weeks. Implications for Rehabilitation High-energy radial shock waves can be a supplemental therapy to physiotherapy for rotator cuff tendinopathy. We recommend the usage of high-energy radial shock waves during the first 5 weeks, at an interval of 7 days, of physiotherapy treatment. High-energy radial shock waves treatment combined with physiotherapy can benefit rotator cuff tendinopathy by relieving symptoms rapidly and maintain these improvements at a satisfactory level for quite a long time.

Comparison of treatment outcomes of transnasal vocal fold polypectomy versus microlaryngoscopic surgery.

PubMed

Wang, Chi-Te; Liao, Li-Jen; Huang, Tsung-Wei; Lo, Wu-Chia; Cheng, Po-Wen

2015-05-01

Office-based procedures have been proposed for the treatment of vocal polyps, including indirect laryngoscopic surgery and angiolytic laser photocoagulation. Our previous report documented good treatment outcomes by combining the two aforementioned procedures. This study was intended to further compare the treatment outcomes of office transnasal vocal fold polypectomy (VFP) with those of microlaryngoscopic surgery (MLS). A matched cohort study. This study retrospectively enrolled 50 age-, gender-, and size-matched patients with vocal polyps treated by VFP or MLS at a tertiary teaching hospital from January 2012 to October 2013. Treatment outcomes were evaluated before, 2 weeks, and 6 weeks after the procedures via perceptual rating of voice quality, acoustic measurement of the speech signal, 10-item voice-handicap index, maximal phonation time, subjective rating of voice quality, and videolaryngostroboscopic evaluation. Both VFP and MLS resulted in significant clinical improvements 2 and 6 weeks postoperatively. Study results exhibited similar objective outcomes between VFP and MLS, whereas patients who received VFP reported higher subjective voice quality than those receiving MLS 2 weeks postoperatively. Six weeks after the procedures, the objective and subjective treatment outcomes were not significantly different between the two treatment groups. This study shows that transnasal VFP may be used as an effective alternative treatment for small vocal polyps. Patients who received office VFP experienced rapid symptomatic relief with a higher degree of subjective effectiveness than MLS 2 weeks postoperatively, whereas the overall treatment outcomes showed a comparable level of effectiveness for both modalities. 3B. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Transition into and out of daylight saving time and spontaneous delivery: a population-based study

PubMed Central

László, Krisztina D; Cnattingius, Sven; Janszky, Imre

2016-01-01

Objective To investigate whether the circadian rhythm disruption following the transition into and out of daylight saving time (DST) is associated with an increased risk of spontaneous delivery. Design We compared the number of spontaneous deliveries in the Swedish Medical Birth Register during the week after the change to and the week after the change from DST (exposure periods) with the average number of spontaneous deliveries in the control period, defined as the week before and the week after each exposure period. Setting Sweden, 1993–2006. Primary and secondary outcome measures The primary outcomes were the weekly and the daily number of spontaneous deliveries in the exposure and the control periods. In secondary analyses we also compared the mean length of pregnancy of the women with spontaneous deliveries in the exposure and control periods. Results The number of deliveries during the week after the transition into or out of DST was similar to that in the comparison period (18 519 observed vs 18 434 expected in case of the spring shift and 19 073 observed vs 19 122 expected in case of the autumn shift); the corresponding incidence ratio and 95% CIs were 1.005 (0.990 to 1.019) and 0.997 (0.983 to 1.012), respectively. There were no differences in the length of gestation of the deliveries in the exposure and the control periods. Conclusions Our results do not support the hypothesis that a minor circadian rhythm disruption is associated with an increased short-term risk of spontaneous delivery. PMID:27630067

Effect of Sequential Treatment with Bisphosphonates After Teriparatide in Ovariectomized Rats: A Direct Comparison Between Risedronate and Alendronate.

PubMed

Yano, Tetsuo; Yamada, Mei; Inoue, Daisuke

2017-07-01

Teriparatide (TPTD), a recombinant human parathyroid hormone N-terminal fragment (1-34), is a widely used bone anabolic drug for osteoporosis. Sequential treatment with antiresorptives such as bisphosphonates after TPTD discontinuation is generally recommended. However, relative effects of bisphosphonates have not been determined. In the present study, we directly compared effects of risedronate (RIS) and alendronate (ALN) on bone mineral density (BMD), bone turnover, structural property and strength in ovariectomized (OVX) rats, when administered after TPTD. Female Sprague Dawley rats were divided into one sham-operated and eight ovariectomized groups. TPTD, RIS, and ALN were given subcutaneously twice per week for 4 or 8 weeks after 4 week treatment with TPTD. TPTD significantly increased BMD (+9.6%) in OVX rats after 4 weeks of treatment. 8 weeks after TPTD withdrawal, vehicle-treated group showed a blunted BMD increase of +8.4% from the baseline. In contrast, 8 weeks of treatment with RIS and ALN significantly increased BMD to 17.4 and 21.8%, respectively. While ALN caused a consistently larger increase in BMD, sequential treatment with RIS resulted in lower Tb.Sp compared to ALN in the fourth lumbar vertebra as well as in greater stiffness in compression test. In conclusion, the present study demonstrated that sequential therapy with ALN and RIS after TPTD both improved bone mass and structure. Our results further suggest that RIS may have a greater effect on improving bone quality and stiffness than ALN despite less prominent effect on BMD. Further studies are necessary to determine clinical relevance of these findings to fracture rate.

Monitoring programme on toxic metal in bluefish (Pomatomus saltatrix), anchovy (Engraulis encrasicolus) and sardine (Sardina pilchardus) from Istanbul, Turkey: levels and estimated weekly intake.

PubMed

Özden, Özkan

2013-05-01

Toxic metal (Hg, Cd, Pb, Cu and Zn) concentrations of small-medium bluefish, anchovy and sardine in Istanbul, Turkey, were determined using inductively coupled plasma-mass spectrometry (ICP-MS) throughout 1 year. The concentrations of pollutants were found to vary according to season and species. Estimates of weekly intake levels of the metals were calculated and compared to recommended safe limits for fish consumption by humans. The levels of Cd, Pb, Cu and Zn in the fillets of all species resulted in estimates of weekly intake levels that were lower than the recommended safe limits. The concentrations of Hg of small bluefish in September, of medium bluefish in June and September, of anchovy in March, and of sardine in August and September resulted in estimates of weekly intake levels that were higher than the recommended safe limits for human consumption.

Lecture: fotemustine in brain tumors.

PubMed

Silvani, A; Gaviani, P; Lamperti, E; Botturi, A; Ferrari, D; Simonetti, G; Salmaggi, A

2011-11-01

Fotemustine (FTMS) is a third-generation nitrosourea, in preclinical studies, FTMS compared favorably with carmustine (BCNU) and lomustine (CCNU) against several human tumor cell lines. In conventional schedule, FTMS is administered at a dose of 100 mg/sqm/week for three consecutive weeks as induction (I) treatment, followed by 100 mg/sqm every three weeks, after a 5-week rest, as maintenance (M). Several Italian groups reported the results using FTMS in malignant glioma patients recurring after temozolomide standard treatment. In these papers, the 6-progression free survival are ranging from 20 to 52%. With the schedule (I + M) myelosuppression is observed in more than 30% of patients, and thrombocytopenia and leukopenia are more frequent and significant in Temozolomide pretreated patients. On the bases of the hematological toxicities several authors experimented new schedules of FTMS administrated at low doses. Recently, some authors reported the interesting results of a multicenter study on recurrent glioblastoma multiforme patients combining FTMS with new antiangiogentic agent bevacizumab.

Early cessation of pressure garment therapy results in scar contraction and thickening

PubMed Central

DeBruler, Danielle M.; Zbinden, Jacob C.; Baumann, Molly E.; Blackstone, Britani N.; Malara, Megan M.; Bailey, J. Kevin

2018-01-01

Pressure garment therapy is often prescribed to improve scar properties following full-thickness burn injuries. Pressure garment therapy is generally recommended for long periods of time following injury (1–2 years), though it is plagued by extremely low patient compliance. The goal of this study was to examine the effects of early cessation of pressure garment therapy on scar properties. Full-thickness burn injuries were created along the dorsum of red Duroc pigs. The burn eschar was excised and wound sites autografted with split-thickness skin. Scars were treated with pressure garments within 1 week of injury and pressure was maintained for either 29 weeks (continuous pressure) or for 17 weeks followed by cessation of pressure for an additional 12 weeks (pressure released); scars receiving no treatment served as controls. Scars that underwent pressure garment therapy were significantly smoother and less contracted with decreased scar height compared to control scars at 17 weeks. These benefits were maintained in the continuous pressure group until week 29. In the pressure released group, grafts significantly contracted and became more raised, harder and rougher after the therapy was discontinued. Pressure cessation also resulted in large changes in collagen fiber orientation and increases in collagen fiber thickness. The results suggest that pressure garment therapy effectively improves scar properties following severe burn injury; however, early cessation of the therapy results in substantial loss of these improvements. PMID:29897933

Early cessation of pressure garment therapy results in scar contraction and thickening.

PubMed

DeBruler, Danielle M; Zbinden, Jacob C; Baumann, Molly E; Blackstone, Britani N; Malara, Megan M; Bailey, J Kevin; Supp, Dorothy M; Powell, Heather M

2018-01-01

Pressure garment therapy is often prescribed to improve scar properties following full-thickness burn injuries. Pressure garment therapy is generally recommended for long periods of time following injury (1-2 years), though it is plagued by extremely low patient compliance. The goal of this study was to examine the effects of early cessation of pressure garment therapy on scar properties. Full-thickness burn injuries were created along the dorsum of red Duroc pigs. The burn eschar was excised and wound sites autografted with split-thickness skin. Scars were treated with pressure garments within 1 week of injury and pressure was maintained for either 29 weeks (continuous pressure) or for 17 weeks followed by cessation of pressure for an additional 12 weeks (pressure released); scars receiving no treatment served as controls. Scars that underwent pressure garment therapy were significantly smoother and less contracted with decreased scar height compared to control scars at 17 weeks. These benefits were maintained in the continuous pressure group until week 29. In the pressure released group, grafts significantly contracted and became more raised, harder and rougher after the therapy was discontinued. Pressure cessation also resulted in large changes in collagen fiber orientation and increases in collagen fiber thickness. The results suggest that pressure garment therapy effectively improves scar properties following severe burn injury; however, early cessation of the therapy results in substantial loss of these improvements.

Longitudinal effects of Parathyroid Hormone treatment on morphological, densitometric and mechanical properties of mouse tibia.

PubMed

Lu, Yongtao; Boudiffa, Maya; Dall'Ara, Enrico; Liu, Yue; Bellantuono, Ilaria; Viceconti, Marco

2017-11-01

The use of Parathyroid Hormone (PTH) as bone anabolic is limited due to cost-benefit assessments. Preclinical studies evaluating the effects of PTH on bone have reported variable and often contradictory results. Here, we have applied a new approach using a combination of in-vivo longitudinal µCT, image processing techniques and finite element models to monitor early local changes in the whole tibia (divided in 40 compartments) and mechanical properties of female C57BL/6J mice treated with PTH 1-34, compared to controls. Compared with standard 3D bone morphometric analysis, our new approach allowed detection of much smaller and localised changes in bone mineral content (BMC) at very early time points (1 week vs 3 weeks with standard methods) and showed that changes do not occur uniformly over time and across the anatomical space. Indeed, in the PTH treated mice, significant changes in BMC were observed in the medial and posterior sectors of the proximal tibia, a week after treatment, and in the medial sector of the tibia midshaft region a week later (p < 0.05). By the third week, two thirds of the regions showed significantly higher values of BMC (p < 0.05). The effect of PTH on bone regional volume is similar to that on BMC, but there is almost no effect of PTH on bone tissue mineral density. The differences in estimated mechanical properties became significant after three weeks of treatment (p < 0.05). These results provide the first evidence of an early and localised PTH effect on murine bone, and show that our novel partitioning approach, compared to the standard evaluation protocol, allows a more precise quantification of bone changes following treatment, which would facilitate preclinical testing of novel mono- and/or combination therapies throughout the bone. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

The potential of prolonged tissue culture to reduce stress generation and retraction in engineered heart valve tissues.

PubMed

van Vlimmeren, Marijke A A; Driessen-Mol, Anita; Oomens, Cees W J; Baaijens, Frank P T

2013-03-01

In tissue-engineered (TE) heart valves, cell-mediated processes cause tissue compaction during culture and leaflet retraction at time of implantation. We have quantified and correlated stress generation, compaction, retraction, and tissue quality during a prolonged culture period of 8 weeks. Polyglycolic acid/poly-4-hydroxybutyrate strips were seeded with vascular-derived cells and cultured for 4-8 weeks. Compaction in width, generated force, and stress was measured during culture. Retraction in length, generated force, and stress was measured after release of constraints at weeks 4, 6, and 8. Further, the amount of DNA, glycosaminoglycans (GAGs), collagen, and collagen cross-links was assessed. During culture, compaction and force generation increased to, respectively, 63.9% ± 0.8% and 43.7 ± 4.3 mN at week 4, after which they remained stable. Stress generation reached 27.7 ± 3.2 kPa at week 4, after which it decreased to ∼8.5 kPa. At release of constraints, tissue retraction was 44.0% ± 3.7% at week 4 and decreased to 29.2% ± 2.8% and 26.1% ± 2.2% at, respectively, 6 and 8 weeks. Generated force (8-16 mN) was lower at week 6 than at weeks 4 and 8. Generated stress decreased from 11.8 ± 0.9 kPa at week 4 to 1.4 ± 0.3 and 2.4 ± 0.4 kPa at, respectively, weeks 6 and 8. The amount of GAGs increased at weeks 6 and 8 compared to week 4 and correlated to the reduced stress and retraction. In summary, prolonged culture resulted in decreased stress generation and retraction, likely as a result of the increased amount of GAGs. These results demonstrate the potential of prolonged tissue culture in developing functional, nonretracting, TE heart valves.

Long-term maintenance therapy for vulvar lichen sclerosus: the results of a randomized study comparing topical vitamin E with an emollient.

PubMed

Virgili, Annarosa; Minghetti, Sara; Borghi, Alessandro; Corazza, Monica

2013-04-01

The chronic and relapsing nature of vulvar lichen sclerosus (VLS) represents a challenge for its long-term management after an effective treatment with topical corticosteroids. To compare the effect of topical vitamin E with that of an emollient in reducing the risk of VLS relapse over a 52-week maintenance treatment. 156 patients with VLS were enrolled in a 12-week active treatment phase on topical 0.1% mometasone furoate ointment once daily. Those who achieved disease remission entered a 52-week maintenance phase in which patients were randomized to apply either an emollient or topical vitamin E once daily. 80 patients entered the maintenance phase. At 52 weeks, for the vitamin E maintenance group, the cumulative crude relapse rate was 27.8% and the cumulative modified crude relapse rate was 55.6%. For the emollient maintenance group, the cumulative crude relapse rate was 22.7% and the cumulative modified crude relapse rate was 50.0%. The median time to relapse was 20 weeks for the vitamin E group and 18.7 weeks for the emollient group. Once VLS has been stabilized with topical corticosteroids, long-term treatment with both vitamin E and emollients may be considered in maintain LS remission.

Carryover effect of hip and knee exercises program on functional performance in individuals with patellofemoral pain syndrome

PubMed Central

Ahmed Hamada, Hamada; Hussein Draz, Amira; Koura, Ghada Mohamed; Saab, Ibtissam M.

2017-01-01

[Purpose] This study was carried out to investigate the carryover effect of hip and knee exercises program on functional performance (single legged hop test as functional performance test and Kujala score for functional activities). [Subjects and Methods] Thirty patients with patellofemoral pain syndrome were randomly assigned into two equal groups. Group (A) consisted of 15 patients undergoing hip strengthening exercises for four weeks then measuring all variables followed by additional four weeks of knee exercises program then measuring all variables again. Group (B): consisted of 15 patients undergoing knee exercises program for four weeks then measuring all variables followed by additional four weeks of hip strengthening exercises then measuring all variables. Functional abilities and knee muscles performance were assessed using Kujala questionnaire and single legged hop test respectively pre and after the completion of the first 4 weeks then after 8 weeks for both groups. [Results] Significantly increase in Kujala questionnaire in group A compared with group B was observed. While, there were significant increase in single legged hop performance test in group B compared with group A. [Conclusion] Starting with hip exercises improve the performance of subjects more than functional activities while starting with knee exercises improve the functional activities of subjects more than performance. PMID:28878459

Carryover effect of hip and knee exercises program on functional performance in individuals with patellofemoral pain syndrome.

PubMed

Ahmed Hamada, Hamada; Hussein Draz, Amira; Koura, Ghada Mohamed; Saab, Ibtissam M

2017-08-01

[Purpose] This study was carried out to investigate the carryover effect of hip and knee exercises program on functional performance (single legged hop test as functional performance test and Kujala score for functional activities). [Subjects and Methods] Thirty patients with patellofemoral pain syndrome were randomly assigned into two equal groups. Group (A) consisted of 15 patients undergoing hip strengthening exercises for four weeks then measuring all variables followed by additional four weeks of knee exercises program then measuring all variables again. Group (B): consisted of 15 patients undergoing knee exercises program for four weeks then measuring all variables followed by additional four weeks of hip strengthening exercises then measuring all variables. Functional abilities and knee muscles performance were assessed using Kujala questionnaire and single legged hop test respectively pre and after the completion of the first 4 weeks then after 8 weeks for both groups. [Results] Significantly increase in Kujala questionnaire in group A compared with group B was observed. While, there were significant increase in single legged hop performance test in group B compared with group A. [Conclusion] Starting with hip exercises improve the performance of subjects more than functional activities while starting with knee exercises improve the functional activities of subjects more than performance.

Comparison of spinal manipulation methods and usual medical care for acute and subacute low back pain: a randomized clinical trial.

PubMed

Schneider, Michael; Haas, Mitchell; Glick, Ronald; Stevans, Joel; Landsittel, Doug

2015-02-15

Randomized controlled trial with follow-up to 6 months. This was a comparative effectiveness trial of manual-thrust manipulation (MTM) versus mechanical-assisted manipulation (MAM); and manipulation versus usual medical care (UMC). Low back pain (LBP) is one of the most common conditions seen in primary care and physical medicine practice. MTM is a common treatment for LBP. Claims that MAM is an effective alternative to MTM have yet to be substantiated. There is also question about the effectiveness of manipulation in acute and subacute LBP compared with UMC. A total of 107 adults with onset of LBP within the past 12 weeks were randomized to 1 of 3 treatment groups: MTM, MAM, or UMC. Outcome measures included the Oswestry LBP Disability Index (0-100 scale) and numeric pain rating (0-10 scale). Participants in the manipulation groups were treated twice weekly during 4 weeks; subjects in UMC were seen for 3 visits during this time. Outcome measures were captured at baseline, 4 weeks, 3 months, and 6 months. Linear regression showed a statistically significant advantage of MTM at 4 weeks compared with MAM (disability = -8.1, P = 0.009; pain = -1.4, P = 0.002) and UMC (disability = -6.5, P = 0.032; pain = -1.7, P < 0.001). Responder analysis, defined as 30% and 50% reductions in Oswestry LBP Disability Index scores revealed a significantly greater proportion of responders at 4 weeks in MTM (76%; 50%) compared with MAM (50%; 16%) and UMC (48%; 39%). Similar between-group results were found for pain: MTM (94%; 76%); MAM (69%; 47%); and UMC (56%; 41%). No statistically significant group differences were found between MAM and UMC, and for any comparison at 3 or 6 months. MTM provides greater short-term reductions in self-reported disability and pain scores compared with UMC or MAM. 2.

Production traits of artificially and naturally hatched geese in intensive and free-range systems: I. Growth traits.

PubMed

Boz, M A; Sarica, M; Yamak, U S

2017-04-01

1. This study investigated the effect of incubation type and production system on geese growth traits. 2. A total of 216 geese were either naturally (114) or artificially (102) hatched and reared in intensive or free-range production systems (4 replicates each) until 18 weeks of age. 3. Weights of naturally hatched goslings (NHG) were significantly higher than artificially hatched goslings (AHG) at 2 weeks (644 vs. 536 g); however, weights of AHG were significantly higher than NHG at both 6 weeks (3245 vs. 3010 g) and 18 weeks (5212 vs. 4353 g). 4. AHG had better feed conversion ratios (FCRs) than NHG (6.21 vs. 6.46 at 18 weeks). Feed consumption of naturally hatched geese was found higher in first 4 weeks when compared to artificially hatched geese and artificially hatched geese consumed more feed than naturally hatched geese after 8 weeks. 5. Production system had insignificant effects on feed consumption, FCRs, viability and mutilation rates. 6. Slipped wings were more frequent in NHG than AHG (8.32% vs. 1.68% at 6 weeks; 23.84% vs. 5.12% between 7 and 18 weeks) and in free-range production when compared to intensive production (17.88% vs. 11.08% over the course of the production period). 7. The study results indicate that both artificially and NHG can be reared in free-range production systems without any loss in performance and in deference to animal welfare.

Anxiolytic Effect of Aromatherapy Massage in Patients with Breast Cancer

PubMed Central

Kuriyama, Hiroko; Shigemori, Ichiro; Watanabe, Satoko; Aihara, Yuka; Kita, Masakazu; Sawai, Kiyoshi; Nakajima, Hiroo; Yoshida, Noriko; Kunisawa, Masahiro; Kawase, Masanori; Fukui, Kenji

2009-01-01

We examined how aromatherapy massage influenced psychologic and immunologic parameters in 12 breast cancer patients in an open semi-comparative trial. We compared the results 1 month before aromatherapy massage as a waiting control period with those during aromatherapy massage treatment and 1 month after the completion of aromatherapy sessions. The patients received a 30 min aromatherapy massage twice a week for 4 weeks (eight times in total). The results showed that anxiety was reduced in one 30 min aromatherapy massage in State-Trait Anxiety Inventory (STAI) test and also reduced in eight sequential aromatherapy massage sessions in the Hospital Anxiety and Depression Scale (HADS) test. Our results further suggested that aromatherapy massage ameliorated the immunologic state. Further investigations are required to confirm the anxiolytic effect of aromatherapy in breast cancer patients. PMID:18955225

Phosphate-binding efficacy of crushed vs. chewed lanthanum carbonate in hemodialysis patients.

PubMed

How, Priscilla P; Anattiwong, Prathana; Mason, Darius L; Arruda, Jose A; Lau, Alan H

2011-01-01

Lanthanum carbonate, a chewable noncalcium-containing phosphorus (P) binder, is useful for treating secondary hyperparathyroidism in patients who have hypercalcemia and cannot swallow whole tablets. However, some patients cannot chew tablets or prefer to crush and mix them with food. This study was conducted to determine the P-binding efficacy of crushed lanthanum and compare it with chewed lanthanum in hemodialysis (HD) patients. After a 1-week washout period, 11 hemodialysis patients (7 men, 4 women) were randomized to receive, in a crossover fashion, lanthanum 1000 mg 3 times daily chewed with meals and lanthanum 1000 mg 3 times daily crushed into a fine powder, mixed with applesauce and taken with meals, for 4 weeks each. Serum P was measured at the end of each washout (baseline) and weekly during treatment. Changes in serum P from baseline for crushed lanthanum were compared with chewed lanthanum using paired sample t test. Administration of crushed lanthanum resulted in a significant reduction in serum P from baseline (P reduction [mg/dL] for crushed lanthanum in week 1: 2.1 ± 0.4, week 2: 1.7 ± 0.5, week 3: 1.7 ± 0.5, week 4: 1.7 ± 0.4, P<0.05). No statistically significant differences were observed in serum P reduction from baseline and serum P attained during treatment with crushed when compared with chewed lanthanum. Crushed lanthanum is effective in reducing serum P and have similar P-binding efficacy to chewed lanthanum. Crushing lanthanum and mixing it with food can thus be an option for patients who are unable to chew or swallow whole tablets. © 2010 The Authors. Hemodialysis International © 2010 International Society for Hemodialysis.

Efficacy and Safety of Adalimumab in Moderately to Severely Active Cases of Ulcerative Colitis: A Meta-Analysis of Published Placebo-Controlled Trials

PubMed Central

Zhang, Zong Mei; Li, Wei; Jiang, Xue Liang

2016-01-01

Background/Aims To evaluate the efficacy and safety of adalimumab (ADA) in moderately to severely active ulcerative colitis (UC) patients who are unresponsive to traditional therapy. Methods Electronic databases, including the PubMed, Embase, and Cochrane databases, were searched to April 20, 2014. UC-related randomized controlled trials (RCTs) that compared ADA with placebo were eligible. Review Manager 5.1 was used for data analysis. Results This meta-analysis included three RCTs. ADA was considerably more effective compared with a placebo, and it increased the ratio of patients with clinical remission, clinical responses, mucosal healing and inflammatory bowel disease questionnaire responses in the induction and maintenance phases (p<0.05), as well as patients with steroid-free remission (p<0.05) during the maintenance phase. Clinical remission was achieved in a greater number of UC cases in the ADA 160/80/40 mg groups (0/2/4 week, every other week) compared with the placebo group at week 8 (p=0.006) and week 52 (p=0.0002), whereas the week 8 clinical remission rate was equivalent between the ADA 80/40 mg groups and the placebo group. Among the patients who received immunomodulators (IMM) at baseline, ADA was superior to the placebo in terms of inducing clinical remission (p=0.01). Between-group differences were not observed in terms of serious adverse events (p=0.61). Conclusions ADA, particularly at doses of 160/80/40 mg (0/2/4 week, every other week), is effective and safe in patients with moderate-to-severe UC who are unresponsive to traditional treatment. Concomitant IMM therapy may improve the short-term therapeutic efficacy of ADA. PMID:26780088

Comparison of two self-directed weight loss interventions: Limited weekly support vs. no outside support.

PubMed

Smith, Bryan K; Van Walleghen, Emily L; Cook-Wiens, Galen; Martin, Rachael N; Curry, Chelsea R; Sullivan, Debra K; Gibson, Cheryl A; Donnelly, Joseph E

2009-08-01

The purpose of this study was to compare the efficacy of two home-based weight loss interventions that differ only in the amount of outside support provided. This was a 12-week, randomized, controlled trial. One group received limited support (LWS, n = 35) via a single 10 min phone call each week while another group received no weekly support (NWS, n = 28). Both the LWS and NWS received pre-packaged meals (PM) and shakes. A third group served as control (CON, n = 30) and received no components of the intervention. Weight loss at 12 weeks was the primary outcome. Diet (PM, shake, and fruit/vegetable (F/V) intake) and physical activity (PA) were self-monitored, recorded daily and reported weekly. An exit survey was completed by participants in the intervention groups upon completion of the study. Weight loss and percent weight loss in the LWS, NWS, and CON groups were 7.7 ± 4.4 kg (8.5 ± 4.2%), 5.9 ± 4.1 kg (6.0 ± 4.2%), and 0.3 ± 1.9 kg (0.4 ± 1.2%), respectively. The decrease in body weight and percent weight loss was significantly greater in the LWS and NWS groups when compared to the CON group and the percent weight loss was significantly greater in the LWS when compared to both the NWS and CON groups. A home-based weight loss program utilizing PM and shakes results in clinically significant percent weight loss and the addition of a brief weekly call promotes additional percent weight loss. © 2009 Asian Oceanian Association for the Study of Obesity . Published by Elsevier Ltd. All rights reserved.

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

Strengthening of the Hip and Core Versus Knee Muscles for the Treatment of Patellofemoral Pain: A Multicenter Randomized Controlled Trial

PubMed Central

Ferber, Reed; Bolgla, Lori; Earl-Boehm, Jennifer E.; Emery, Carolyn; Hamstra-Wright, Karrie

2015-01-01

Context: Patellofemoral pain (PFP) is the most common injury in running and jumping athletes. Randomized controlled trials suggest that incorporating hip and core strengthening (HIP) with knee-focused rehabilitation (KNEE) improves PFP outcomes. However, no randomized controlled trials have, to our knowledge, directly compared HIP and KNEE programs. Objective: To compare PFP pain, function, hip- and knee-muscle strength, and core endurance between KNEE and HIP protocols after 6 weeks of rehabilitation. We hypothesized greater improvements in (1) pain and function, (2) hip strength and core endurance for patients with PFP involved in the HIP protocol, and (3) knee strength for patients involved in the KNEE protocol. Design: Randomized controlled clinical trial. Setting: Four clinical research laboratories in Calgary, Alberta; Chicago, Illinois; Milwaukee, Wisconsin; and Augusta, Georgia. Patients or Other Participants: Of 721 patients with PFP screened, 199 (27.6%) met the inclusion criteria (66 men [31.2%], 133 women [66.8%], age = 29.0 ± 7.1 years, height = 170.4 ± 9.4 cm, weight = 67.6 ± 13.5 kg). Intervention(s): Patients with PFP were randomly assigned to a 6-week KNEE or HIP protocol. Main Outcome Measure(s): Primary variables were self-reported visual analog scale and Anterior Knee Pain Scale measures, which were conducted weekly. Secondary variables were muscle strength and core endurance measured at baseline and at 6 weeks. Results: Compared with baseline, both the visual analog scale and the Anterior Knee Pain Scale improved for patients with PFP in both the HIP and KNEE protocols (P < .001), but the visual analog scale scores for those in the HIP protocol were reduced 1 week earlier than in the KNEE group. Both groups increased in strength (P < .001), but those in the HIP protocol gained more in hip-abductor (P = .01) and -extensor (P = .01) strength and posterior core endurance (P = .05) compared with the KNEE group. Conclusions: Both the HIP and KNEE rehabilitation protocols produced improvements in PFP, function, and strength over 6 weeks. Although outcomes were similar, the HIP protocol resulted in earlier resolution of pain and greater overall gains in strength compared with the KNEE protocol. PMID:25365133

Diffusion-Weighted Magnetic Resonance Imaging Early After Chemoradiotherapy to Monitor Treatment Response in Head-and-Neck Squamous Cell Carcinoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vandecaveye, Vincent, E-mail: Vincent.Vandecaveye@uzleuven.be; Dirix, Piet; De Keyzer, Frederik

2012-03-01

Purpose: To evaluate diffusion-weighted imaging (DWI) for assessment of treatment response in head and neck squamous cell carcinoma (HNSCC) three weeks after the end of chemoradiotherapy (CRT). Methods and Materials: Twenty-nine patients with HNSCC underwent magnetic resonance imaging (MRI) prior to and 3 weeks after CRT, including T{sub 2}-weighted and pre- and postcontrast T{sub 1}-weighted sequences and an echo-planar DWI sequence with six b values (0 to 1,000 s/mm{sup 2}), from which the apparent diffusion coefficient (ADC) was calculated. ADC changes 3 weeks posttreatment compared to baseline ( Increment ADC) between responding and nonresponding primary lesions and adenopathies were correlatedmore » with 2 years locoregional control and compared with a Mann-Whitney test. In a blinded manner, the Increment ADC was compared to conventional MRI 3 weeks post-CRT and the routinely implemented CT, on average 3 months post-CRT, which used size-related and morphological criteria. Positive and negative predictive values (PPV and NPV, respectively) were compared between the Increment ADC and anatomical imaging. Results: The Increment ADC of lesions with later tumor recurrence was significantly lower than lesions with complete remission for both primary lesions (-2.3% {+-} 0.3% vs. 80% {+-} 41%; p < 0.0001) and adenopathies (19.9% {+-} 32% vs. 63% {+-} 36%; p = 0.003). The Increment ADC showed a PPV of 89% and an NPV of 100% for primary lesions and a PPV of 70% and an NPV of 96% for adenopathies per neck side. DWI improved PPV and NPV compared to anatomical imaging. Conclusion: DWI with the Increment ADC 3 weeks after concluding CRT for HNSCC allows for early assessment of treatment response.« less

A pilot randomized controlled trial comparing effectiveness of prism glasses, visual search training and standard care in hemianopia.

PubMed

Rowe, F J; Conroy, E J; Bedson, E; Cwiklinski, E; Drummond, A; García-Fiñana, M; Howard, C; Pollock, A; Shipman, T; Dodridge, C; MacIntosh, C; Johnson, S; Noonan, C; Barton, G; Sackley, C

2017-10-01

Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only). Prospective, multicentre, parallel, single-blind, three-arm RCT across fifteen UK acute stroke units. Stroke survivors with homonymous hemianopia. Arm a (Fresnel prisms) for minimum 2 hours, 5 days per week over 6 weeks. Arm b (visual search training) for minimum 30 minutes, 5 days per week over 6 weeks. Arm c (standard care-information only). Adult stroke survivors (>18 years), stable hemianopia, visual acuity better than 0.5 logMAR, refractive error within ±5 dioptres, ability to read/understand English and provide consent. Primary outcomes were change in visual field area from baseline to 26 weeks and calculation of sample size for a definitive trial. Secondary measures included Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual, Short Form-12 questionnaires and Radner reading ability. Measures were post-randomization at baseline and 6, 12 and 26 weeks. Randomization block lists stratified by site and partial/complete hemianopia. Allocations disclosed to patients. Primary outcome assessor blind to treatment allocation. Eighty-seven patients were recruited: 27-Fresnel prisms, 30-visual search training and 30-standard care; 69% male; mean age 69 years (SD 12). At 26 weeks, full results for 24, 24 and 22 patients, respectively, were compared to baseline. Sample size calculation for a definitive trial determined as 269 participants per arm for a 200 degree 2 visual field area change at 90% power. Non-significant relative change in area of visual field was 5%, 8% and 3.5%, respectively, for the three groups. Visual Function Questionnaire responses improved significantly from baseline to 26 weeks with visual search training (60 [SD 19] to 68.4 [SD 20]) compared to Fresnel prisms (68.5 [SD 16.4] to 68.2 [18.4]: 7% difference) and standard care (63.7 [SD 19.4] to 59.8 [SD 22.7]: 10% difference), P=.05. Related adverse events were common with Fresnel prisms (69.2%; typically headaches). No significant change occurred for area of visual field area across arms over follow-up. Visual search training had significant improvement in vision-related quality of life. Prism therapy produced adverse events in 69%. Visual search training results warrant further investigation. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Acute effects of single and multiple level thoracic manipulations on chronic mechanical neck pain: a randomized controlled trial

PubMed Central

Puntumetakul, Rungthip; Suvarnnato, Thavatchai; Werasirirat, Phurichaya; Uthaikhup, Sureeporn; Yamauchi, Junichiro; Boucaut, Rose

2015-01-01

Background Thoracic spine manipulation has become a popular alternative to local cervical manipulative therapy for mechanical neck pain. This study investigated the acute effects of single-level and multiple-level thoracic manipulations on chronic mechanical neck pain (CMNP). Methods Forty-eight patients with CMNP were randomly allocated to single-level thoracic manipulation (STM) at T6–T7 or multiple-level thoracic manipulation (MTM), or to a control group (prone lying). Cervical range of motion (CROM), visual analog scale (VAS), and the Thai version of the Neck Disability Index (NDI-TH) scores were measured at baseline, and at 24-hour and at 1-week follow-up. Results At 24-hour and 1-week follow-up, neck disability and pain levels were significantly (P<0.05) improved in the STM and MTM groups compared with the control group. CROM in flexion and left lateral flexion were increased significantly (P<0.05) in the STM group when compared with the control group at 1-week follow-up. The CROM in right rotation was increased significantly after MTM compared to the control group (P<0.05) at 24-hour follow-up. There were no statistically significant differences in neck disability, pain level at rest, and CROM between the STM and MTM groups. Conclusion These results suggest that both single-level and multiple-level thoracic manipulation improve neck disability, pain levels, and CROM at 24-hour and 1-week follow-up in patients with CMNP. PMID:25624764

Effect of vitamin E (Tri E®) on antioxidant enzymes and DNA damage in rats following eight weeks exercise

PubMed Central

2011-01-01

Background Exercise is beneficial to health, but during exercise the body generates reactive oxygen species (ROS) which are known to result in oxidative stress. The present study analysed the effects of vitamin E (Tri E®) on antioxidant enzymes; superoxide dismutase (SOD), glutathione peroxidase (GPx), catalase (Cat) activity and DNA damage in rats undergoing eight weeks exercise. Methods Twenty four Sprague-Dawley rats (weighing 320-370 gm) were divided into four groups; a control group of sedentary rats which were given a normal diet, second group of sedentary rats with oral supplementation of 30 mg/kg/d of Tri E®, third group comprised of exercised rats on a normal diet, and the fourth group of exercised rats with oral supplementation of 30 mg/kg/d of Tri E®. The exercising rats were trained on a treadmill for 30 minutes per day for 8 weeks. Blood samples were taken before and after 8 weeks of the study to determine SOD, GPx, Cat activities and DNA damage. Results SOD activity decreased significantly in all the groups compared to baseline, however both exercised groups showed significant reduction in SOD activity as compared to the sedentary groups. Sedentary control groups showed significantly higher GPx and Cat activity compared to baseline and exercised groups. The supplemented groups, both exercised and non exercised groups, showed significant decrease in Cat activity as compared to their control groups with normal diet. DNA damage was significantly higher in exercising rats as compared to sedentary control. However in exercising groups, the DNA damage in supplemented group is significantly lower as compared to the non-supplemented group. Conclusions In conclusion, antioxidant enzymes activity were generally reduced in rats supplemented with Tri E® probably due to its synergistic anti-oxidative defence, as evidenced by the decrease in DNA damage in Tri E® supplemented exercise group. PMID:21513540

Treadmill exercise after social isolation increases the levels of NGF, BDNF, and synapsin I to induce survival of neurons in the hippocampus, and improves depression-like behavior

PubMed Central

Hong, Young-Pyo; Lee, Hyo-Chul; Kim, Hyun-Tae

2015-01-01

[Purpose] We investigated the effects of 8 weeks of treadmill exercise on nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), and synapsin I protein expression and on the number of 5-bromo-2'-deoxyuridine-5'-mono-phosphate (BrdU)-positive cells in the dentate gyrus of the hippocampus in socially isolated rats. Additionally, we examined the effects of exercise on the number of serotonin (5-HT)- and tryptophan hydroxylase (TPH)-positive cells in the raphe nuclei and on depression behaviors induced by social isolation. [Methods] Forty male Sprague-Dawley rats were divided into four groups: (1) group housing and control group (GCG, n = 10); (2) group housing and exercise group (GEG, n = 10); (3) isolated housing and control group (ICG, n = 10); and (4) isolated housing and exercise group (IEG, n = 10). After 1 week of housing under the normal condition of 3 animals per cage, rats were socially isolated via transfer to individual cages for 8 weeks. Rats were then subjected to treadmill exercise for 5 days per week for 8 weeks during which time the speed of the treadmill was gradually increased. [Results] Compared to the GCG, levels of NGF, BDNF, and synapsin I were significantly decreased in the ICG and significantly increased in the IEG (p < 0.001 respectively). Significantly more BrdU-positive cells in the GEG were present as compared to the GCG and ICG, and more BrdU-positive cells were found in the IEG as compared to the ICG (p < 0.001). 5-HT-positive cells in the GEG were significantly increased compared to the GCG and ICG, and more of these cells were found in the IEG as compared to the ICG (p < 0.01). TPH-positive cells in the GEG were significantly increased compared to those in the GCG and ICG (p < 0.05). In the forced swim test, immobility time was significantly increased in the ICG and significantly decreased in the IEG as compared to the ICG (p < 0.01). [Conclusion] These results showed that regular treadmill exercise following social isolation not only increased the levels of NGF, BDNF, and synapsin I to induce survival of neurons in the hippocampus but also improved depression by increasing the number of serotonergic cells in the raphe nuclei. PMID:25960950

Reduction of Intimal Hyperplasia with Re-188-labeled Stents in a Rabbit Model at 7 and 26 Weeks: An Experimental Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tepe, Gunnar, E-mail: gunnar.tepe@med.uni-tuebingen.de; Dietrich, Tobias; Grafen, Franziska

2005-06-15

The aim of this study was to analyze the feasibility of {sup 188}Re-labeled stents to reduce neointimal formation in a rabbit atherosclerosis model and to test the long-term effects at 7 and 26 weeks. Fifty-nine male New Zealand White rabbits were fed a 0.5% cholesterol diet for 4 weeks before balloon angioplasty and insertion of Palmaz stents in the infrarenal aorta. The animals were sacrificed 7 and 26 weeks after stent implantation. Control stents were compared with {sup 188}Re stents: (dose 1) 11.3 {+-} 1.8 MBq; (dose 2) 37.3 {+-} 4.2 MBq, and (dose 3) 80.1 {+-} 7.8 MBq. Eachmore » activity group consisted of a short-term (7 weeks) and a long-term group (26 weeks), resulting in a total of eight study groups. No thrombotic occlusion was observed. The neointimal formation in the control group was 2.11 [95% confidence interval (CI): 0.68-6.52] mm{sup 2} at 7 weeks and 2.10 (0.62-7.11) at 26 weeks. In the treatment groups, neointima reduction was detectable at 7 weeks [dose 1: 0.33 (0.09-1.22) mm{sup 2}; dose 2: 0.17 (0.05-0.57) mm{sup 2}; dose 3: 0.03 (0.01-0.13) mm{sup 2}]. After 26 weeks, a catch-up of neointimal formation in the radioactive groups was most obvious in the low-dose group [dose 1: 0.80 (0.28-2.29) mm{sup 2}; dose 2: 0.18([0.06-0.52) mm{sup 2}; dose 3: 0.50 (0.17-1.42) mm{sup 2}]. Compared to the long-term control group, neointimal reduction was still >60%. No induction of neointimal formation was observed at the edges of the stents. Radiation resulted in delayed re-endothelialization. {sup 188}Re stents were capable to reduce intimal hyperplasia and did not cause thrombosis. The edge effect, which was the major limitation of {sup 32}P stents, was not observed in {sup 188}Re stents.« less

Effects of a Creative Expression Intervention on Emotions, Communication, and Quality of Life in Persons with Dementia

PubMed Central

Phillips, Lorraine J.; Reid-Arndt, Stephanie A.; Pak, Youngju

2010-01-01

Background Effective nonpharmacological interventions are needed to treat neuropsychiatric symptoms and improve quality of life for the 5.3 million Americans affected by dementia. Objective To test the effect of a storytelling program, TimeSlips, on communication, neuropsychiatric symptoms, and quality of life in long-term care residents with dementia. Method A quasi-experimental, two-group, repeated measures design was used to compare persons with dementia who were assigned to the twice-weekly, 6-week TimeSlips intervention (n = 28) or usual care (n = 28) group at baseline and postintervention at Weeks 7 and 10. Outcome measures included the Cornell Scale for Depression in Dementia, Neuropsychiatric Inventory-Nursing Home Version, Functional Assessment of Communication Skills, Quality of Life–AD, and Observed Emotion Rating Scale (this last measure was collected also at Weeks 3 and 6 during TimeSlips for the treatment group and during mealtime for the control group). Results Compared to the control group, the treatment group exhibited significantly higher pleasure at Week 3 (p < .001), Week 6 (p < .001), and Week 7 (p < .05). Small to moderate treatment effects were found for Week 7 Social Communication (d = .49) and Basic Needs Communication (d = .43). A larger effect was found for pleasure at Week 7 (d = .58). Discussion As expected given the engaging nature of the TimeSlips creative story-telling intervention, analyses revealed increased positive affect during and at 1-week post-intervention. In addition, perhaps associated with the intervention’s reliance on positive social interactions and verbal communication, participants evidenced improved communication skills. However, more frequent dosing and booster sessions of TimeSlips may be needed to show significant differences between treatment and control groups on long-term effects and other outcomes. PMID:21048483

Influence of high dose of phytase and an emulsifier on performance, apparent metabolisable energy and nitrogen retention in broilers fed on diets containing soy oil or tallow.

PubMed

Zaefarian, F; Romero, L F; Ravindran, V

2015-01-01

The effects of high dose of microbial phytase and an emulsifier on the performance, apparent metabolisable energy (AME) and nitrogen (N) retention in broilers fed on diets containing different fat sources were examined in a 5-week trial. Two fat sources (soy oil and tallow), two inclusion levels of E. coli phytase (500 or 1000 phytase units (FTU)/kg diet) and two inclusion levels of lysolecithin emulsifier (0 or 3.5 g/kg of diet) were evaluated in a 2 × 2 × 2 factorial arrangement of treatments. Throughout the 5-week trial, soy oil supplementation improved weight gain and feed per gain compared with tallow, but had no effect on feed intake. The high dose of phytase increased the weight gain and feed intake and lowered the feed per gain during d 1-21, but had no effect on performance parameters over the whole trial period. An effect of emulsifier was observed for feed intake during d 1-21 and over the whole trial period. Addition of emulsifier increased feed intake compared with diets without emulsifier. During weeks 1, 2, 3 and 5, birds fed on soy oil-based diets had higher nitrogen-corrected AME (AMEN) compared with those fed on tallow-based diets. During weeks 2, 3 and 5, the effect of phytase was significant for AMEN, with the high dose increasing the AMEN. During week 2, AMEN was increased with emulsifier addition. During weeks 1, 2, 3 and 5, birds fed on soy oil-based diets had higher fat retention compared with those fed on tallow-based diets. The high dose of phytase improved the retention of fat during week 5 and the addition of emulsifier resulted in higher fat retention during week 1. During weeks 2, 3 and 5, an interaction between fat source × phytase × emulsifier was observed for N retention. In soy oil-based diets, emulsifier plus 1000 FTU/kg phytase increased N retention compared with other groups, while in tallow-based diets, emulsifier addition increased N retention in diets with 500 FTU/kg, but not in 1000 FTU/kg diet. Overall, the present data suggest that the dietary fat source influenced performance, AMEN and fat retention in broiler chickens. There is opportunity to improve bird performance during d 1-21, AMEN and fat retention with higher doses of microbial phytase. Addition of the emulsifier increased the AMEN during week 2 and tract retention of fat during week 1, but this effect was not translated into improvements in performance.

Peginterferon lambda for the treatment of HBeAg-positive chronic hepatitis B: A randomized phase 2b study (LIRA-B).

PubMed

Chan, Henry L Y; Ahn, Sang Hoon; Chang, Ting-Tsung; Peng, Cheng-Yuan; Wong, David; Coffin, Carla S; Lim, Seng Gee; Chen, Pei-Jer; Janssen, Harry L A; Marcellin, Patrick; Serfaty, Lawrence; Zeuzem, Stefan; Cohen, David; Critelli, Linda; Xu, Dong; Wind-Rotolo, Megan; Cooney, Elizabeth

2016-05-01

Peginterferon lambda-1a (lambda) is a Type-III interferon, which, like alfa interferons, has antiviral activity in vitro against hepatitis B virus (HBV) and hepatitis C virus (HCV); however, lambda has a more limited extra-hepatic receptor distribution. This phase 2b study (LIRA-B) evaluated lambda in patients with chronic HBV infection. Adult HBeAg+ interferon-naive patients were randomized (1:1) to weekly lambda (180 μg) or peginterferon alfa-2a (alfa) for 48 weeks. The primary efficacy endpoint was HBeAg seroconversion at week 24 post-treatment; lambda non-inferiority was demonstrated if the 80% confidence interval (80% CI) lower bound was >-15%. Baseline characteristics were balanced across groups (lambda N=80; alfa N=83). Early on-treatment declines in HBV-DNA and qHBsAg through week 24 were greater with lambda. HBeAg seroconversion rates were comparable for lambda and alfa at week 48 (17.5% vs. 16.9%, respectively); however lambda non-inferiority was not met at week 24 post-treatment (13.8% vs. 30.1%, respectively; lambda vs. alfa 80% CI lower bound -24%). Results for other key secondary endpoints (virologic, serologic, biochemical) and post hoc combined endpoints (HBV-DNA <2000 IU/ml plus HBeAg seroconversion or ALT normalization) mostly favored alfa. Overall adverse events (AE), serious AE, and AE-discontinuation rates were comparable between arms but AE-spectra differed (more cytopenias, flu-like, and musculoskeletal symptoms observed with alfa, more ALT flares and bilirubin elevations seen with lambda). Most on-treatment flares occurred early (weeks 4-12), associated with HBV-DNA decline; all post-treatment flares were preceded by HBV-DNA rise. On-treatment, lambda showed greater early effects on HBV-DNA and qHBsAg, and comparable serologic/virologic responses at end-of-treatment. However, post-treatment, alfa-associated HBeAg seroconversion rates were higher, and key secondary results mostly favored alfa. ClinicalTrials.gov number: NCT01204762. Copyright © 2016 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: A randomized, observer-blind, parallel group study

PubMed Central

Chatterjee, Dattatreyo; Ghosh, Sudip Kumar; Sen, Sukanta; Sarkar, Saswati; Hazra, Avijit; De, Radharaman

2016-01-01

Objective: Epidermal dermatophyte infections most commonly manifest as tinea corporis or tinea cruris. Topical azole antifungals are commonly used in their treatment but literature suggests that most require twice-daily application and provide lower cure rates than the allylamine antifungal terbinafine. We conducted a head-to-head comparison of the effectiveness of the once-daily topical azole, sertaconazole, with terbinafine in these infections. Materials and Methods: We conducted a randomized, observer-blind, parallel group study (Clinical Trial Registry India [CTRI]/2014/09/005029) with adult patients of either sex presenting with localized lesions. The clinical diagnosis was confirmed by potassium hydroxide smear microscopy of skin scrapings. After baseline assessment of erythema, scaling, and pruritus, patients applied either of the two study drugs once daily for 2 weeks. If clinical cure was not seen at 2 weeks, but improvement was noted, application was continued for further 2 weeks. Patients deemed to be clinical failure at 2 weeks were switched to oral antifungals. Results: Overall 88 patients on sertaconazole and 91 on terbinafine were analyzed. At 2 weeks, the clinical cure rates were comparable at 77.27% (95% confidence interval [CI]: 68.52%–86.03%) for sertaconazole and 73.63% (95% CI 64.57%–82.68%) for terbinafine (P = 0.606). Fourteen patients in either group improved and on further treatment showed complete healing by another 2 weeks. The final cure rate at 4 weeks was also comparable at 93.18% (95% CI 88.75%–97.62%) and 89.01% (95% CI 82.59%–95.44%), respectively (P = 0.914). At 2 weeks, 6 (6.82%) sertaconazole and 10 (10.99%) terbinafine recipients were considered as “clinical failure.” Tolerability of both preparations was excellent. Conclusion: Despite the limitations of an observer-blind study without microbiological support, the results suggest that once-daily topical sertaconazole is as effective as terbinafine in localized tinea infections. PMID:28066103

Decrease of Perivascular Adipose Tissue Browning Is Associated With Vascular Dysfunction in Spontaneous Hypertensive Rats During Aging.

PubMed

Kong, Ling-Ran; Zhou, Yan-Ping; Chen, Dong-Rui; Ruan, Cheng-Chao; Gao, Ping-Jin

2018-01-01

Functional perivascular adipose tissue (PVAT) is necessary to maintain vascular physiology through both mechanical support and endocrine or paracrine ways. PVAT shows a brown adipose tissue (BAT)-like feature and the browning level of PVAT is dependent on the anatomic location and species. However, it is not clear whether PVAT browning is involved in the vascular tone regulation in spontaneously hypertensive rats (SHRs). In the present study, we aimed to illustrate the effect of aging on PVAT browning and subsequent vasomotor reaction in SHRs. Herein we utilized histological staining and western blot to detect the characteristics of thoracic PVAT (tPVAT) in 8-week-old and 16-week-old SHR and Wistar-Kyoto (WKY) rats. We also detected vascular reactivity analysis to determine the effect of tPVAT on vasomotor reaction during aging. The results showed that tPVAT had a similar phenotype to BAT, including smaller adipocyte size and positive uncoupling protein-1 (UCP1) staining. Interestingly, the tPVAT of 8-week-old SHR showed increased BAT phenotypic marker expression compared to WKY, whereas the browning level of tPVAT had a more dramatic decrease from 8 to 16 weeks of age in SHR than age-matched WKY rats. The vasodilation effect of tPVAT on aortas had no significant difference in 8-week-old WKY and SHR, whereas this effect is obviously decreased in 16-week-old SHR compared to WKY. In contrast, tPVAT showed a similar vasoconstriction effect in 8- or 16-week-old WKY and SHR rats. Moreover, we identified an important vasodilator adenosine, which regulates adipocyte browning and may be a potential PVAT-derived relaxing factor. Adenosine is dramatically decreased from 8 to 16 weeks of age in the tPVAT of SHR. In summary, aging is associated with a decrease of tPVAT browning and adenosine production in SHR rats. These may result in attenuated vasodilation effect of the tPVAT in SHR during aging.

A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes

PubMed Central

Barnard, Neal D.; Gloede, Lise; Cohen, Joshua; Jenkins, David J.A.; Turner-McGrievy, Gabrielle; Green, Amber A.; Ferdowsian, Hope

2009-01-01

Background Although therapeutic diets are critical to diabetes management, their acceptability to patients is largely unstudied. Objective To quantify adherence and acceptability for two types of diets for diabetes. Design Controlled trial conducted 2004 – 2006. Subjects/setting Individuals with type 2 diabetes (n = 99) at a community-based research facility. Intervention Participants were randomly assigned to a diet following 2003 American Diabetes Association (ADA) guidelines or a low-fat, vegan diet for 74 weeks. Main outcome measures Attrition, adherence, dietary behavior, diet acceptability, and cravings. Statistical analyses For nutrient intake and questionnaire scores, t-tests determined between-group differences. For diet-acceptability measures, the related samples Wilcoxon rank test assessed within-group changes; the independent samples Mann-Whitney U test compared the diet groups. Chi-square for independent samples compared the groups for changes in reported symptoms. Results All participants completed the initial 22 weeks; 90% (45/50) of ADA-group and 86% (42/49) of vegan-group participants completed 74 weeks. Fat and cholesterol intake fell more and carbohydrate and fiber intake increased more in the vegan group. At 22 weeks, group-specific diet adherence criteria were met by 44% (22/50) of ADA-group and 67% (33/49) of vegan-group participants (P=0.019); the ADA group reported a greater increase in dietary restraint; this difference was not significant at 74 weeks. Both groups reported reduced hunger and reduced disinhibition. Questionnaire responses rated both diets as satisfactory, with no significant differences between groups, except for ease of preparation, for which the 22-week ratings marginally favored the ADA group. Cravings for fatty foods diminished more in the vegan group at 22 weeks, with no significant difference at 74 weeks. Conclusions Despite its greater influence on macronutrient intake, a low-fat, vegan diet has an acceptability similar to that of a more conventional diabetes diet. Acceptability appears to be no barrier to its use in medical nutrition therapy. PMID:19167953

Six-month trial of bupropion with contingency management for cocaine dependence in a methadone-maintained population.

PubMed

Poling, James; Oliveto, Alison; Petry, Nancy; Sofuoglu, Mehmet; Gonsai, Kishorchandra; Gonzalez, Gerardo; Martell, Bridget; Kosten, Thomas R

2006-02-01

No effective pharmacotherapies exist for cocaine dependence, although contingency management (CM) has demonstrated efficacy. To compare the efficacy of bupropion hydrochloride and CM for reducing cocaine use in methadone hydrochloride-maintained individuals. This 25-week, placebo-controlled, double-blind trial randomly assigned participants to 1 of 4 treatment conditions: CM and placebo (CMP), CM and 300 mg/d of bupropion hydrochloride (CMB), voucher control and placebo (VCP), or voucher control and bupropion (VCB). Outpatient clinic at the Veterans Affairs Connecticut Healthcare System. A total of 106 opiate-dependent, cocaine-abusing individuals. All study participants received methadone hydrochloride (range, 60-120 mg). Participants receiving bupropion hydrochloride were given 300 mg/d beginning at week 3. In the CM conditions, each urine sample negative for both opioids and cocaine resulted in a monetary-based voucher that increased for consecutively drug-free urine samples during weeks 1 to 13. Completion of abstinence-related activities also resulted in a voucher. During weeks 14 to 25, only completion of activities was reinforced in the CM group, regardless of sample results. The voucher control groups received vouchers for submitting urine samples, regardless of results, throughout the study. Thrice-weekly urine toxicologic test results for cocaine and heroin. Groups did not differ in baseline characteristics or retention rates. Opiate use decreased significantly, with all treatment groups attaining equivalent amounts of opiate use at the end of the study. In the CMB group, the proportion of cocaine-positive samples significantly decreased during weeks 3 to 13 (P<.001) relative to week 3 and remained low during weeks 14 to 25. In the CMP group, cocaine use significantly increased during weeks 3 to 13 (P<.001) relative to week 3, but then cocaine use significantly decreased relative to the initial slope during weeks 14 to 25 (P<.001). In contrast, by treatment end, the VCB and VCP groups showed no significant improvement in cocaine use. These findings suggest that combining CM with bupropion for the treatment of cocaine addiction may significantly improve outcomes relative to bupropion alone.

In vivo biomechanical evaluation of a novel angle-stable interlocking nail design in a canine tibial fracture model.

PubMed

Déjardin, Loïc M; Cabassu, Julien B; Guillou, Reunan P; Villwock, Mark; Guiot, Laurent P; Haut, Roger C

2014-03-01

To compare clinical outcome and callus biomechanical properties of a novel angle stable interlocking nail (AS-ILN) and a 6 mm bolted standard ILN (ILN6b) in a canine tibial fracture model. Experimental in vivo study. Purpose-bred hounds (n = 11). A 5 mm mid-diaphyseal tibial ostectomy was stabilized with an AS-ILN (n = 6) or an ILN6b (n = 5). Orthopedic examinations and radiographs were performed every other week until clinical union (18 weeks). Paired tibiae were tested in torsion until failure. Callus torsional strength and toughness were statistically compared and failure mode described. Total and cortical callus volumes were computed and statistically compared from CT slices of the original ostectomy gap. Statistical significance was set at P < .05 RESULTS: From 4 to 8 weeks, lameness was less pronounced in AS-ILN than ILN6b dogs (P < .05). Clinical union was reached in all AS-ILN dogs by 10 weeks and in 3/5 ILN6b dogs at 18 weeks. Callus mechanical properties were significantly greater in AS-ILN than ILN6b specimens by 77% (failure torque) and 166% (toughness). Failure occurred by acute spiral (control and AS-ILN) or progressive transverse fractures (ILN6b). Cortical callus volume was 111% greater in AS-ILN than ILN6b specimens (P < .05). Earlier functional recovery, callus strength and remodeling suggest that the AS-ILN provides a postoperative biomechanical environment more conducive to bone healing than a comparable standard ILN. © Copyright 2014 by The American College of Veterinary Surgeons.

A comparative study of efficacy of emg bio-feedback and progressive muscular relaxation in tension headache.

PubMed

Gada, M T

1984-04-01

The aim of the present study was to find out efficacy of frontalis EMG Biofeedback therapy, deep muscular relaxation therapy and compare the efficacy of both in cases of tension headache. During two week basal-data recording period all patients were taught deep muscular relaxation by Jacobson's technique. Simultaneously patients were instructed to keep headache diary. Headache diary yielded three different parameters a) number of headache-free days per week, b) peak headache intensity (or each week and c) average daily headache activity score per week. These parameters were used to find out therapeutic efficacy of each treatment. Patients were randomly divided in two groups. EMG Biofeedback group was given frontalis EMG feedback through EMG J 33 muscle trainer of Cyborg Corporation (U.S.A.). Patients in each group were given 20 sessions (two sessions per week); each session lasting 30 minutes. Patients were instructed to practice at least one 30 minute session of relaxation at home. The data were subjected to statistical calculation. The results indicate that frontalis EMG Biofeedback therapy and deep muscle relaxation therapy are significantly effective in cases of tension headache. Both treatments are equally effective. The findings are discussed in relation to Indian situation.

Optimal visualization of the fetal four-chamber and outflow tract views with transabdominal ultrasound in the morbidly obese: Are we there yet?

PubMed

Adekola, Henry; Soto, Eleazar; Dai, Jing; Lam-Rachlin, Jennifer; Gill, Navleen; Leon-Peters, Jocelyn; Puder, Karoline; Abramowicz, Jacques S

2015-01-01

To compare optimal visualization of the four-chamber and outflow-tract views of the fetal heart on sonographic examination between morbidly obese (body mass index [BMI] ≥ 40 kg/m(2) ) and nonobese (BMI < 25 kg/m(2) ) pregnant women. In this retrospective cohort study, we included records and images from 509 pregnant women who had first undergone sonographic examination between 18 and 36 weeks' fetal gestational age. Compared with the nonobese women, morbidly obese women had lower optimal visualization of the four-chamber and outflow-tract heart views: four-chamber view, morbidly obese, 83/186 (44.6%), versus nonobese, 283/323 (87.6%), and outflow-tract view, morbidly obese, 80/186 (43%) versus nonobese, 258/290 (89%); p < 0.0001 for each comparison. Similar outcomes were observed when the results from each subcategory of morbidly obese women (ie, BMI 40-49.9, 50-59.9, and ≥60 kg/m(2) ) were compared with that from nonobese women; p < 0.0001 for each comparison. These outcomes remained the same regardless of whether this comparison was made among those who had their examination before or at 19 weeks' or more gestational age. Among the morbidly obese women, there was no difference in optimal visualization of the four-chamber or outflow-tract views regardless of whether the examination was performed at <23 weeks' or at ≥23 weeks' gestational age: four-chamber view <23 weeks, 44.8% (78/174), versus four-chamber view ≥23 weeks, 41.7% (5/12); p = 0.8, and outflow-tract view <23 weeks, 43.1% (75/174), versus outflow-tract view ≥23 weeks, 41.7% (5/12); p = 0.9. After controlling for maternal age and race, the odds of visualizing the four-chamber and outflow-tract views in the morbidly obese were reduced compared with those in their nonobese counterparts: odds ratio (OR) for four-chamber, 0.13; 95% confidence interval (CI), 0.08-0.21, and OR for outflow-tract, 0.11; 95% CI, 0.07-0.17. Optimal visualization of the fetal four-chamber and outflow-tract views was achieved in less than 50% of morbidly obese women, compared with almost 90% in nonobese women. © 2015 Wiley Periodicals, Inc.

Prematurity and Genetic Testing for Neonatal Diabetes.

PubMed

Besser, Rachel E J; Flanagan, Sarah E; Mackay, Deborah G J; Temple, I K; Shepherd, Maggie H; Shields, Beverley M; Ellard, Sian; Hattersley, Andrew T

2016-09-01

Hyperglycemia in premature infants is usually thought to reflect inadequate pancreatic development rather than monogenic neonatal diabetes. No studies, to our knowledge, have investigated the prevalence of monogenic forms of diabetes in preterm infants. We studied 750 patients with diabetes diagnosed before 6 months of age. We compared the genetic etiology and clinical characteristics of 146 preterm patients born <37 weeks and compared them with 604 born ≥37 weeks. A genetic etiology was found in 97/146 (66%) preterm infants compared with 501/604 (83%) born ≥37weeks, P < .0001. Chromosome 6q24 imprinting abnormalities (27% vs 12%, P = .0001) and GATA6 mutations (9% vs 2%, P = .003) occurred more commonly in preterm than term infants while mutations in KCNJ11 were less common (21 vs 34%, P = .008). Preterm patients with an identified mutation were diagnosed later than those without an identified mutation (median [interquartile range] 35 [34 to 36] weeks vs 31 [28 to 36] weeks, P < .0001). No difference was seen in other clinical characteristics of preterm patients with and without an identified mutation including age of presentation, birth weight, and time to referral. Patients with neonatal diabetes due to a monogenic etiology can be born preterm, especially those with 6q24 abnormalities or GATA6 mutations. A genetic etiology is more likely in patients with less severe prematurity (>32 weeks). Prematurity should not prevent referral for genetic testing as 37% have a potassium channel mutation and as a result can get improved control by replacing insulin with sulphonylurea therapy. Copyright © 2016 by the American Academy of Pediatrics.

Comparative Efficacy of Platelet Rich Plasma Injection, Corticosteroid Injection and Ultrasonic Therapy in the Treatment of Periarthritis Shoulder

PubMed Central

Srikumar, Venkataraman; Singh, Neha

2017-01-01

Introduction Periarthritis (PA) shoulder characterised by pain and restricted range of motion has a plethora of treatment options with inconclusive evidence. Platelet Rich Plasma (PRP) is an emerging treatment option and its efficacy needs to be examined and compared with other routine interventions. Aim To assess the efficacy of PRP injection and compare it with corticosteroid injection and ultrasonic therapy in the treatment of PA shoulder. Materials and Methods Patients with PA shoulder (n=195) were randomised to receive single injection of PRP (2 ml) or corticosteroid (80 mg of methylprednisolone) or ultrasonic therapy (seven sittings in two weeks; 1.5 W/cm2, 1 MHz, continuous mode). All participants were also advised to perform a home based 10 minute exercise therapy. The primary outcome measure was active range of motion of the shoulder. Secondary outcome measures used were Visual Analogue Scale (VAS) for pain and a shortened version of Disabilities of the Arm, Shoulder and Hand (QuickDASH) for function. Participants were evaluated at 0, 3, 6 and 12 weeks. Chi-square test, one way and repeated measures of ANOVA tests were used to determine significant differences. Results PRP treatment resulted in statistically significant improvements over corticosteroid and ultrasonic therapy in active as well as passive range of motion of shoulder, VAS and QuickDASH at 12 weeks. At six weeks, PRP treatment resulted in statistically significant improvements over ultrasonic therapy in VAS and QuickDASH. No major adverse effects were observed. Conclusion This study demonstrates that single injection of PRP is effective and better than corticosteroid injection or ultrasonic therapy in treatment of PA shoulder. PMID:28658861

Tamoxifen mutagenesis and carcinogenesis in livers of lambda/lacI transgenic rats: selective influence of phenobarbital promotion.

PubMed

Styles, J A; Davies, R; Fenwick, S; Walker, J; White, I N; Smith, L L

2001-01-10

Administration of tamoxifen (TAM) (20 mg/kg per day p.o.) for 6 weeks to female lambda/lacI transgenic rats caused a 4-fold increase in mutation frequency (MF) at the lacI gene locus in the livers of dosed animals compared with controls. After cessation of dosing, the MF showed a further increase with time at 2, 12 and 24 weeks, respectively. Phenobarbital promotion of similarly treated animals resulted in no increase in mutation frequency compared with TAM alone. Treatment with phenobarbital or TAM+phenobarbital resulted in time-dependent increases in liver weight compared with the corresponding controls. There was an increase in cell proliferation in the phenobarbital and TAM+phenobarbital groups, and at 24 weeks in the TAM dosed animals compared with controls. There was also a progressive increase in the number of GST-P expressing foci in the livers of TAM and TAM + phenobarbital rats compared with controls. The induction of cell proliferation and GSTP foci in the rat liver by phenobarbital is consistent with its ability to promote tamoxifen-initiated liver tumours in the rat. If the lacI gene is regarded as being representative of the rat genome in general (albeit that the gene is bacterial) the above observations suggest that promotion by tamoxifen confers selective advantage on mutated genes at loci that contribute to the tumour phenotype and that promotion of rat liver tumours by tamoxifen is not dependent simply upon the enhancement of cellular proliferation.

The effect of an intervention program on functional movement screen test scores in mixed martial arts athletes.

PubMed

Bodden, Jamie G; Needham, Robert A; Chockalingam, Nachiappan

2015-01-01

This study assessed the basic fundamental movements of mixed martial arts (MMA) athletes using the functional movement screen (FMS) assessment and determined if an intervention program was successful at improving results. Participants were placed into 1 of the 2 groups: intervention and control groups. The intervention group was required to complete a corrective exercise program 4 times per week, and all participants were asked to continue their usual MMA training routine. A mid-intervention FMS test was included to examine if successful results were noticed sooner than the 8-week period. Results highlighted differences in FMS test scores between the control group and intervention group (p = 0.006). Post hoc testing revealed a significant increase in the FMS score of the intervention group between weeks 0 and 8 (p = 0.00) and weeks 0 and 4 (p = 0.00) and no significant increase between weeks 4 and 8 (p = 1.00). A χ analysis revealed that the intervention group participants were more likely to have an FMS score >14 than participants in the control group at week 4 (χ = 7.29, p < 0.01) and week 8 (χ = 5.2, p ≤ 0.05). Finally, a greater number of participants in the intervention group were free from asymmetry at week 4 and week 8 compared with the initial test period. The results of the study suggested that a 4-week intervention program was sufficient at improving FMS scores. Most if not all, the movements covered on the FMS relate to many aspects of MMA training. The knowledge that the FMS can identify movement dysfunctions and, furthermore, the fact that the issues can be improved through a standardized intervention program could be advantageous to MMA coaches, thus, providing the opportunity to adapt and implement new additions to training programs.

A Randomized Case-Series Study Comparing the Stability of Implant with Two Different Surfaces Placed in Fresh Extraction Sockets and Immediately Loaded

PubMed Central

Vanden Bogaerde, Leonardo; Sennerby, Lars

2016-01-01

Background. Hydrophilic and moderately rough implant surfaces have been proposed to enhance the osseointegration response. Aim. The aim of this study was to compare early changes of stability for two implants with identical macrodesign but with different surface topographies. Materials and Methods. In 11 patients, a total of 22 implants (11 bimodal (minimally rough, control) and 11 proactive (moderately rough and hydrophilic, test), Neoss Ltd., Harrogate, UK) were immediately placed into fresh extraction sockets and immediately loaded. The peak insertion torque (IT) was measured in Ncm at placement. Resonance Frequency Analysis (RFA) measurements were made at baseline and 2, 4, 6, and 12 weeks after surgery. Results. The two implant types showed similar IT and RFA values at placement (NS). A dip of RFA values after 2 weeks followed by an increase was observed, where the test implant showed a less pronounced decrease and a more rapid recovery than the control implant. The test implants were significantly more stable than the control ones after 12 weeks. Conclusions. The results from the present study indicated that the hydrophilic and rougher test implant was more resistant to immediate loading and showed a significantly higher stability than the smoother control implant after 12 weeks. PMID:27042180

Oral hyaluronan relieves wrinkles: a double-blinded, placebo-controlled study over a 12-week period

PubMed Central

Oe, Mariko; Sakai, Seigo; Yoshida, Hideto; Okado, Nao; Kaneda, Haruna; Masuda, Yasunobu; Urushibata, Osamu

2017-01-01

Background Hyaluronan (HA) has critical moisturizing property and high water retention capacity especially for human skin. This study aimed to evaluate the effect of oral intake of HA. Methods The mean molecular weight (MW) of HA is 2 k and 300 k. Sixty Japanese male and female subjects aged 22–59 years who presented with crow’s feet wrinkles were randomly assigned to the HA 2 k or HA 300 k at 120 mg/day or the placebo group. The subjects were administered HA at a rate of 120 mg/day or a placebo for 12 weeks. The skin wrinkles were evaluated by image analysis of skin wrinkle replicas, and their skin condition was evaluated using a questionnaire survey. Results During the study period, the HA groups showed better level of the whole sulcus volume ratio, wrinkle area ratio, and wrinkle volume ratio than the placebo group. After 8 weeks of ingestion, the HA 300 k group showed significantly diminished wrinkles compared with the placebo group. Skin luster and suppleness significantly improved after 12 weeks in all groups compared with the baseline. Conclusion The results suggest that oral HA (both HA 2 k and HA 300 k) inhibits skin wrinkles and improves skin condition. PMID:28761365

Sinus Microanatomy and Microbiota in a Rabbit Model of Rhinosinusitis

PubMed Central

Cho, Do-Yeon; Mackey, Calvin; Van Der Pol, William J.; Skinner, Daniel; Morrow, Casey D.; Schoeb, Trenton R.; Rowe, Steven M.; Swords, William E.; Tearney, Guillermo J.; Woodworth, Bradford A.

2018-01-01

Background: Rabbits are useful for preclinical studies of sinusitis because of similar physiologic features to humans. The objective of this study is to develop a rabbit model of sinusitis that permits assessment of microanatomy and sampling for evaluating shifts in the sinus microbiota during the development of sinusitis and to test how the mucociliary clearance (MCC) defect might lead to dysbiosis and chronic rhinosinusitis (CRS). Methods: Generation of CRS was accomplished with an insertion of a sterile sponge into the left middle meatus of New Zealand white rabbits (n = 9) for 2 weeks. After sponge removal, 4 rabbits were observed for another 10 weeks and evaluated for CRS using endoscopy, microCT, visualization of the functional micro-anatomy by micro-optical coherence tomography (μOCT), and histopathological analysis of the sinus mucosa. Samples were taken from the left middle meatus and submitted for microbiome analysis. Results: CT demonstrated opacification of all left sinuses at 2 weeks in all rabbits (n = 9), which persisted in animals followed for another 12 weeks (n = 4). Histology at week 2 showed mostly neutrophils. On week 14, significant infiltration of plasma cells and lymphocytes was noted with increased submucosal glands compared to controls (p = 0.02). Functional microanatomy at 2 weeks showed diminished periciliary layer (PCL) depth (p < 0.0001) and mucus transport (p = 0.0044) compared to controls despite a thick mucus layer. By 12 weeks, the thickened mucus layer was resolved but PCL depletion persisted in addition to decreased ciliary beat frequency (CBF; p < 0.0001). The mucin fermenting microbes (Lactobacillales, Bacteroidales) dominated on week 2 and there was a significant shift to potential pathogens (e.g., Pseudomonas, Burkholderia) by week 14 compared to both controls and the acute phase (p < 0.05). Conclusion: We anticipate this reproducible model will provide a means for identifying underlying mechanisms of airway-surface liquid (ASL) depletion and fundamental changes in sinus microbial communities that contribute to the development of CRS. The rabbit model of sinusitis exhibited diminished PCL depth with delayed mucus transport and significant alterations and shift in the sinus microbiome during the development of chronic inflammation. PMID:29376039

Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles to an ADA Reference Toothbrush on Gingival Abrasion over a 12-Week Period.

PubMed

Gallob, John; Petrone, Dolores M; Mateo, Luis R; Chaknis, Patricia; Morrison, Boyce M; Panagakos, Foti; Williams, Malcolm

2016-06-01

Evaluation of the impact of a soft toothbrush with tapered-tip (Test Toothbrush) bristles and an ADA reference toothbrush (ADA Toothbrush) on gingival abrasion over a 12-week period. This was a randomized, single-center, examiner-blind, two-cell, parallel clinical research study and used the Danser Gingival Abrasion Index to assess the level of gingival abrasion after a single brushing, as well as after six weeks and 12 weeks of twice-daily brushing. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Following a qualifying examination using plaque and gingivitis scores along with a baseline gingival abrasion examination, subjects were randomized into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute, under supervision, with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for gingival abrasion. Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for gingival abrasion. Seventy-one (71) subjects complied with the protocol and completed the clinical study. The results of this study showed that the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions in gingival abrasion scores as compared to the gingival abrasion scores of the ADA Toothbrush after a single tooth brushing, after six weeks, and after 12 weeks of product use (75.0%, 85.5%, 73.9%, respectively). The soft toothbrush with tapered-tip bristles produced significantly less gingival abrasion after 12 weeks of product use as compared to the ADA reference toothbrush.

Rapid Improvement of Glycemic Control in Type 2 Diabetes Using Weekly Intensive Multifactorial Interventions: Structured Glucose Monitoring, Patient Education, and Adjustment of Therapy—A Randomized Controlled Trial

PubMed Central

Rodbard, David; Zanella, Maria Teresa

2011-01-01

Abstract Background We evaluated intensive intervention in poorly controlled patients with type 2 diabetes mellitus involving weekly clinic visits and adjustment of therapy with analysis of three seven-point glucose profiles and intervention from an interdisciplinary staff. Methods Sixty-three patients were randomized to an intensive treatment group that obtained self-monitoring of blood glucose (SMBG) profiles (six or seven values per day, 3 days/week) and were seen in the clinic at Weeks 1–6 and 12. SMBG results were downloaded, analyzed using Accu-Chek® 360° software (Roche Diagnostics, Indianapolis, IN), and used to adjust therapy. Control group subjects obtained glucose profiles and had clinic visits only at Weeks 0, 6, and 12. Results There were highly statistically significant improvements in the intensive treatment group compared with the control group between Weeks 0 and 6 with greater reductions in weekly mean glycemia (WMG) (−76.7±8.9 mg/dL vs. −20.5±8.1 mg/dL), glycemic variability (SD) (−16.3±3.1 mg/dL vs. −5.0±3.1 mg/dL), and glycated hemoglobin (−1.82±0.16% vs. −0.66±0.22%) without significant changes in frequency of hypoglycemia or weight. Improvements were sustained in the intensive treatment group through Week 12. A minimal but statistically significant degree of improvement was seen in the control group at Week 12. Conclusions This short-term pilot study of an intensive monitoring, educational, and pharmacological interventions program resulted in dramatic improvement of glycemic control within 6 weeks, and these effects are sustained through Week 12. SMBG glucose profiles, calculation of WMG and SD, and graphical displays of glucose data can improve the effectiveness of adjustment of therapy at weekly clinic visits when combined with intensive support from a multidisciplinary team. PMID:21751888

Effects of local vibration and pulsed electromagnetic field on bone fracture: A comparative study.

PubMed

Bilgin, Hakkı Murat; Çelik, Ferhat; Gem, Mehmet; Akpolat, Veysi; Yıldız, İsmail; Ekinci, Aysun; Özerdem, Mehmet Siraç; Tunik, Selçuk

2017-07-01

The effectiveness of various therapeutic methods on bone fracture has been demonstrated in several studies. In the present study, we tried to evaluate the effect of local low-magnitude, high-frequency vibration (LMHFV) on rat tibia fracture in comparison with pulsed electromagnetic fields (PEMF) during the healing process. Mid-diaphysis tibiae fractures were induced in 30 Sprague-Dawley rats. The rats were assigned into groups such as control (CONT), LMHFV (15 min/day, 7 days/week), and PEMF (3.5 h/day, 7 days/week) for a three-week treatment. Nothing was applied to control group. Radiographs, serum osteocalcin levels, and stereological bone analyses of the three groups were compared. The X-rays of tibiae were taken 21 days after the end of the healing process. PEMF and LMHFV groups had more callus formation when compared to CONT group; however, the difference was not statistically significant (P = 0.375). Serum osteocalcin levels were elevated in the experimental groups compared to CONT (P ≤ 0.001). Stereological tests also showed higher osteogenic results in experimental groups, especially in LMHFV group. The results of the present study suggest that application of direct local LMHFV on fracture has promoted bone formation, showing great potential in improving fracture outcome. Bioelectromagnetics. 38:339-348, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Rebamipide May Be Comparable to H2 Receptor Antagonist in Healing Iatrogenic Gastric Ulcers Created by Endoscopic Mucosal Resection: A Prospective Randomized Pilot Study

PubMed Central

Kim, Yu Jin; Lee, Sang Kil; Kim, Jie Hyun; Lee, Yong Chan

2010-01-01

Endoscopic mucosal resection (EMR) results in the formation of iatrogenic gastric ulcers and the optimal treatments for such ulcers are still unclear. We aimed to evaluate the efficacy of rebamipide in the management of EMR-induced ulcers by comparing it with an H2 receptor antagonist. After EMR, patients were randomly assigned into either rebamipide or famotidine groups. All patients received a one-week lansoprazole 30 mg q.d. therapy followed by three-week famotidine (20 mg b.i.d.) or rebamipide (100 mg t.i.d.) therapy. Four weeks after the treatments, ulcer sizes, stages, bleeding rates, and ulcer-related symptoms were compared using endoscopy and a questionnaire. A total of 63 patients were enrolled in this study. Finally, 51 patients were analyzed, 26 in rebamipide and 25 in famotidine group. Baseline characteristics were not significantly different between the two groups. Four weeks after EMR, the two groups were comparable in terms of ulcer reduction ratio (P=0.297), and ulcer stage (P=1.000). Moreover, no difference was observed with regard to ulcer-related symptoms, drug compliance, adverse drug event rates, and bleeding rates. Our data suggest that rebamipide is not inferior to famotidine in healing iatrogenic gastric ulcers, and could be a therapeutic option in the treatment of such ulcers. PMID:20358002

No Difference in Effectiveness of 8 vs 12 Weeks of Ledipasvir and Sofosbuvir for Treatment of Hepatitis C in Black Patients.

PubMed

Marcus, Julia L; Hurley, Leo B; Chamberland, Scott; Champsi, Jamila H; Gittleman, Laura C; Korn, Daniel G; Lai, Jennifer B; Lam, Jennifer O; Pauly, Mary Patricia; Quesenberry, Charles P; Ready, Joanna; Saxena, Varun; Seo, Suk I; Witt, David J; Silverberg, Michael J

2018-06-01

Treatment with the combination of ledipasvir and sofosbuvir for 12 weeks has been approved by the Food and Drug Administration for patients with genotype 1 hepatitis C virus (HCV) infection; some patients can be treated with an 8-week course. Guidelines recommend a 12-week treatment course for black patients, but studies have not compared the effectiveness of 8 vs 12 weeks in black patients who are otherwise eligible for an 8-week treatment regimen. We conducted an observational study of Kaiser Permanente Northern California members with HCV genotype 1 infection who were eligible for 8 weeks of treatment with ledipasvir and sofosbuvir (treatment-naïve, no cirrhosis, no HIV infection, level of HCV RNA <6 million IU/mL) and were treated for 8 or 12 weeks from October 2014 through December 2016. We used χ 2 analyses to compare sustained virologic response 12 weeks after the end of treatment (SVR12) among patients treated for 8 vs 12 weeks, and adjusted Poisson models to identify factors associated with receipt of 12 weeks of therapy among patients eligible for 8 weeks. Of 2653 patients eligible for 8 weeks of treatment with ledipasvir and sofosbuvir, 1958 (73.8%) received 8 weeks of treatment and 695 (26.2%) received 12 weeks; the proportions of patients with SVR12 were 96.3% and 96.3%, respectively (P = .94). Among 435 black patients eligible for the 8-week treatment regimen, there was no difference in the proportions who achieved an SVR12 following 8 vs 12 weeks' treatment (95.6% vs 95.8%; P = .90). Male sex, higher transient elastography or FIB-4 scores, higher INR and level of bilirubin, lower level of albumin, obesity, diabetes, and ≥15 alcohol drinks consumed/week were independently associated with receiving 12 weeks of treatment among patients eligible for the 8-week treatment regimen, but were not associated with reduced SVR12 after 8 weeks of treatment. In an observational study of patients who received ledipasvir and sofosbuvir treatment for HCV genotype 1 infection, we found that contrary to guidelines, 8-week and 12-week treatment regimens do not result in statistically significant differences in SVR12 in black patients. Patient characteristics were associated with receipt of 12-week regimens among patients eligible for 8 weeks, but were not associated with reduced SVR12 after 8 weeks. Shorter treatment courses might therefore be more widely used without compromising treatment effectiveness. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

[Effects of foot reflexology on essential hypertension patients].

PubMed

Park, Hyoung-Sook; Cho, Gyoo-Yeong

2004-08-01

This study was to evaluate the effects of foot reflexology on blood pressure, serum lipids level and life satisfaction in essential hypertension patients. The research design used was a nonequivalent control group pretest-posttest design. Foot Reflexology was used as the experimental treatment from June 23rd, 2003 until August 31st, 2003. Thirty-four subjects were assigned to an experimental group(18) and control group(16). Foot Reflexology was administered twice a week for 6 weeks and self foot Reflexology was administered twice a week for 4 weeks on the experimental group. There was a significant decrease in systolic blood pressure but no significant decrease in diastolic pressure in the experimental group compared to the control group. The total cholesterol level in the experimental group compared to the control group was not significantly decreased after foot reflexology. However, the triglyceride level in the experimental group compared to the control group was significantly decreased after foot reflexology. On the other hand, high density lipoprotein and low density lipoprotein levels in the experimental group compared to the control group was not significantly decreased after foot reflexology. Life satisfaction in the experimental group compared to the control group was significantly improved after foot reflexology. The results proved that foot reflexology was an effective nursing intervention to decrease systolic pressure, and triglyceride but not for the blood cholesterol and to improve life satisfaction. Therefore, blood cholesterol should be further evaluated in a larger group of subjects and for a longer period. Further research is regarded as necessary to evaluate and to compare effects of self-foot reflexology and foot reflexology.

Treatment satisfaction in type 2 diabetes patients taking empagliflozin compared with patients taking glimepiride.

PubMed

Chirila, Costel; Zheng, Qingyao; Davenport, Eric; Kaschinski, Dagmar; Pfarr, Egon; Hach, Thomas; Palencia, Roberto

2016-05-01

This exploratory analysis assessed and compared patients' treatment satisfaction with empagliflozin plus metformin versus glimepiride plus metformin, using data obtained from the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs) collected in a randomized, double-blind, double-dummy clinical trial. Observed values for DTSQs scale score and each of its eight items were summarized by visit and treatment arm. Changes from baseline in these scores were analyzed using linear mixed models for repeated measures. The baseline scale score and item scores were comparable between empagliflozin plus metformin (n = 765) and glimepiride plus metformin (n = 780). Compared with baseline, patients reported significant treatment satisfaction increases and significant decreases in perceived hyperglycemia with both treatments at all visits. Also, compared with baseline, a significant increase in perceived frequency of hypoglycemia was observed in the glimepiride treatment group at all visits. No statistically significant treatment difference was observed in DTSQs scale score and its items at week 104. The difference between the treatment groups was significant and in favor of empagliflozin from week 28 onward for perceived frequency of hyperglycemia (P ≤ 0.006) and perceived frequency of hypoglycemia (P ≤ 0.011). Despite positive trends in favor of empagliflozin, there was no significant difference in DTSQs scale score between empagliflozin and glimepiride at 104 weeks. However, when compared with glimepiride, empagliflozin demonstrated significantly lower perceived frequency of hyperglycemia and hypoglycemia at all visits from week 28 onward. This finding is consistent with the clinical results reported for the EMPA-REG H2H-SU trial.

A prospective randomised trial comparing mesh types and fixation in totally extraperitoneal inguinal hernia repairs.

PubMed

Cristaudo, Adam; Nayak, Arun; Martin, Sarah; Adib, Reza; Martin, Ian

2015-05-01

The totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias has emerged as a popular technique. We conducted a prospective randomised trial to compare patient comfort scores using different mesh types and fixation using this technique. Over a 14 month period, 146 patients underwent 232 TEP inguinal hernia repairs. We compared the comfort scores of patients who underwent these procedures using different types of mesh and fixation. A non-absorbable 15 × 10 cm anatomical mesh fixed with absorbable tacks (Control group) was compared with either a non-absorbable 15 × 10 cm folding slit mesh with absorbable tacks (Group 2), a partially-absorbable 15 × 10 cm mesh with absorbable tacks (Group 3) or a non-absorbable 15 × 10 cm anatomical mesh fixed with 2 ml fibrin sealant (Group 4). Outcomes were compared at 1, 2, 4 and 12 weeks using the Carolina Comfort Scale (CCS) scores. At 1, 2, 4 and 12 weeks, the median global CCS scores were low for all treatment groups. Statistically significant differences were seen only for median CCS scores and subscores with the use of partially-absorbable mesh with absorbable tacks (Group 3) at weeks 2 and 4. However, these were no longer significant at week 12. In this study, the TEP inguinal hernia repair with minimal fixation results in low CCS scores. There were no statistical differences in CCS scores when comparing types of mesh, configuration of the mesh or fixation methods. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Estimating the cost-effectiveness of 54 weeks of infliximab for rheumatoid arthritis.

PubMed

Wong, John B; Singh, Gurkirpal; Kavanaugh, Arthur

2002-10-01

To estimate the cost-effectiveness of infliximab plus methotrexate for active, refractory rheumatoid arthritis. We projected the 54-week results from a randomized controlled trial of infliximab into lifetime economic and clinical outcomes using a Markov computer simulation model. Direct and indirect costs, quality of life, and disability estimates were based on trial results; Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS) database outcomes; and published data. Results were discounted using the standard 3% rate. Because most well-accepted medical therapies have cost-effectiveness ratios below $50,000 to $100,000 per quality-adjusted life-year (QALY) gained, results below this range were considered to be "cost-effective." At 3 mg/kg, each infliximab infusion would cost $1393. When compared with methotrexate alone, 54 weeks of infliximab plus methotrexate decreased the likelihood of having advanced disability from 23% to 11% at the end of 54 weeks, which projected to a lifetime marginal cost-effectiveness ratio of $30,500 per discounted QALY gained, considering only direct medical costs. When applying a societal perspective and including indirect or productivity costs, the marginal cost-effectiveness ratio for infliximab was $9100 per discounted QALY gained. The results remained relatively unchanged with variation of model estimates over a broad range of values. Infliximab plus methotrexate for 54 weeks for rheumatoid arthritis should be cost-effective with its clinical benefit providing good value for the drug cost, especially when including productivity losses. Although infliximab beyond 54 weeks will likely be cost-effective, the economic and clinical benefit remains uncertain and will depend on long-term results of clinical trials.

Efficacy of lycopene in the treatment of gingivitis: a randomised, placebo-controlled clinical trial.

PubMed

Chandra, Rampalli Viswa; Prabhuji, M L Venkatesh; Roopa, D Adinarayana; Ravirajan, Sandhya; Kishore, Hadal C

2007-01-01

The aim of the present study was to compare the effect of systemically administered lycopene (LycoRed) as a monotherapy and as an adjunct to scaling and root planing in gingivitis patients. Twenty systemically healthy patients showing clinical signs of gingivitis were involved in a randomised, double-blind, parallel, split-mouth study. The subjects were randomly distributed between the two treatment groups: experimental group (n = 10), 8 mg lycopene/day for 2 weeks; and controls (n = 10), placebo for 2 weeks. Quadrant allocation within each group was randomised with two quadrants treated with oral prophylaxis (OP) and two quadrants not receiving any form of treatment (non-OP). Bleeding index (SBI) and non-invasive measures of plaque (PI) and gingivitis (GI) were assessed at baseline, 1 and 2 weeks. Salivary uric acid levels were also measured. All the treatment groups demonstrated statistically significant reductions in the GI, SBI and PI. Treatment with OP-lycopene resulted in a statistically significant decrease in GI when compared with OP-placebo (p < 0.05) and non-OP-placebo (p < 0.01). Treatment with non-OP-lycopene resulted in a statistically significant decrease in GI when compared with non-OP-placebo (p < 0.01). The OP-lycopene group showed a statistically significant reduction in SBI values when compared with the non-OP-lycopene group (p < 0.05) and the non-OP-placebo group (p < 0.001). There was a strong negative correlation between the salivary uric acid levels and the percentage reduction in GI at 1 and 2 weeks in the OP-lycopene group (r = -0.852 and -0.802 respectively) and in the non-OP-lycopene group (r = -0.640 and -0.580 respectively). The results presented in this study suggest that lycopene shows great promise as a treatment modality in gingivitis. The possibility of obtaining an additive effect by combining routine oral prophylaxis with lycopene is also an exciting possibility, which deserves further study.

Postoperative cognitive changes after total knee arthroplasty under regional anesthesia

PubMed Central

Jeon, Young-Tae; Kim, Byung-Gun; Park, Young Ho; Sohn, Hye-Min; Kim, Jungeun; Kim, Seung Chan; An, Seong Soo; Kim, SangYun

2016-01-01

Abstract Background: The type of postoperative cognitive decline after surgery under spinal anesthesia is unknown. We investigated the type of postoperative cognitive decline after total knee arthroplasty (TKA). Neuropsychological testing was conducted and the changes in cerebrospinal fluid (CSF) biomarkers after surgery were evaluated. Methods: Fifteen patients who required bilateral TKA at a 1-week interval under spinal anesthesia were included. Neuropsychological tests were performed twice, once the day before the first operation and just before the second operation (usually 1 week after the first test) to determine cognitive decline. Validated neuropsychological tests were used to examine 4 types of cognitive decline: memory, frontal-executive, language-semantic, and others. Concentrations of CSF amyloid peptide, tau protein, and S100B were measured twice during spinal anesthesia at a 1-week interval. The patients showed poor performance in frontal-executive function (forward digit span, semantic fluency, letter-phonemic fluency, and Stroop color reading) at the second compared to the first neuropsychological assessment. Results: S100B concentration decreased significantly 1 week after the operation compared to the basal value (638 ± 178 vs 509 ± 167 pg/mL) (P = 0.019). Amyloid protein β1–42, total tau, and phosphorylated tau concentrations tended to decrease but the changes were not significant. Conclusion: Our results suggest that frontal-executive function declined 1 week after TKA under spinal anesthesia. The CSF biomarker analysis indicated that TKA under regional anesthesia might not cause neuronal damage. PMID:28033253

A Randomized Clinical Trial Comparing the Effectiveness of Electroacupuncture versus Medium-Frequency Electrotherapy for Discogenic Sciatica.

PubMed

Zhang, Xue; Wang, Yang; Wang, Zhao; Wang, Chao; Ding, Wentao; Liu, Zhishun

2017-01-01

Objective . To investigate the short- and long-term effects of electroacupuncture (EA) compared with medium-frequency electrotherapy (MFE) on chronic discogenic sciatica. Methods . One hundred participants were randomized into two groups to receive EA ( n = 50) or MFE ( n = 50) for 4 weeks. A 28-week follow-up of the two groups was performed. The primary outcome measure was the average leg pain intensity. The secondary outcome measures were the low back pain intensity, Oswestry Disability Index (ODI), patient global impression (PGI), drug use frequency, and EA acceptance. Results . The mean changes in the average leg pain numerical rating scale (NRS) scores were 2.30 (1.86-2.57) and 1.06 (0.62-1.51) in the EA and MFE groups at week 4, respectively. The difference was significant ( P < 0.001). The long-term follow-up resulted in significant differences. The average leg pain NRS scores decreased by 2.12 (1.70-2.53) and 0.36 (-0.05-0.78) from baseline in the EA and MFE groups, respectively, at week 28. However, low back pain intensity and PGI did not differ significantly at week 4. No serious adverse events occurred. Conclusions . EA showed greater short-term and long-term benefits for chronic discogenic sciatica than MFE, and the effect of EA was superior to that of MFE. The study findings warrant verification. This trial was registered under identifier ChiCTR-IPR-15006370.

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study.

PubMed

Conaghan, Philip G; Hunter, David J; Cohen, Stanley B; Kraus, Virginia B; Berenbaum, Francis; Lieberman, Jay R; Jones, Deryk G; Spitzer, Andrew I; Jevsevar, David S; Katz, Nathaniel P; Burgess, Diane J; Lufkin, Joelle; Johnson, James R; Bodick, Neil

2018-04-18

Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). We assessed symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs. In this Phase-3, multicenter, double-blinded, 24-week study, adults ≥40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average-daily-pain (ADP)-intensity scores of ≥5 and ≤9 (0 to 10 numeric rating scale) were centrally randomized (1:1:1) to a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg). The primary end point was change from baseline to week 12 in weekly mean ADP-intensity scores for FX006 compared with saline-solution placebo. Secondary end points were area-under-effect (AUE) curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with saline-solution placebo, AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, and AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 24 for FX006 compared with saline-solution placebo. Exploratory end points included week-12 changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) subscale scores for FX006 compared with saline-solution placebo and TAcs. Adverse events were elicited at each inpatient visit. The primary end point was met. Among 484 treated patients (n = 161 for FX006, n = 162 for saline-solution placebo, and n = 161 for TAcs), FX006 provided significant week-12 improvement in ADP intensity compared with that observed for saline-solution placebo (least-squares mean change from baseline: -3.12 versus -2.14; p < 0.0001) indicating ∼50% improvement. FX006 afforded improvements over saline-solution placebo for all secondary and exploratory end points (p < 0.05). Improvements in osteoarthritis pain were not significant for FX006 compared with TAcs using the ADP-based secondary measures. Exploratory analyses of WOMAC-A, B, and C and KOOS-QOL subscales favored FX006 (p ≤ 0.05). Adverse events were generally mild, occurring at similar frequencies across treatments. FX006 provided significant, clinically meaningful pain reduction compared with saline-solution placebo at week 12 (primary end point). Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Zidovudine/Lamivudine vs. Abacavir/Lamivudine vs. Tenofovir/Emtricitabine in fixed-dose combinations as initial treatment for HIV patients: a systematic review and network meta-analysis

PubMed Central

Duque Molina, Marcela María; García García, Héctor Iván

2017-01-01

Abstract Introduction: Initial treatment of the HIV is based on the use of three drugs, two of which are nucleoside analog reverse-transcriptase inhibitors. There are three combinations of these drugs which have been approved by different guidelines, each with divergent results in terms of efficacy and safety. Objective: To compare the efficacy and safety of these three combinations. Methods: Systematic review and network meta-analysis of randomized clinical trials comparing fixed doses of Tenofovir Disoproxil Fumarate / Emtricitabine (TDF/FTC), Abacavir / Lamivudine (ABC/3TC) and Zidovudine / Lamivudine (ZDV/3TC). Results: Seven clinical trials met the eligibility criteria. The results suggested higher efficacy with TDF/FTC vs. ABC/3TC at 96 weeks and vs. ZDV/3TC at 48 weeks. However, there is clinical and statistical heterogeneity. Subgroup analysis were performed by third drug and by level of viral load prior to treatment, and found no differences in virological control. Network meta-analysis could only be carried out with TDF/FTC vs. ZDV/3TC, and the proportion of patients with virological response, with no differences at 48 weeks nor at 96 weeks. Direct comparisons showed an increased risk of bone marrow suppression of ZDV/3TC vs. TDF/FTC and of ABC/3TC hypersensitivity reactions vs. ZDV/3TC Conclusions: The results did not show differences in effectiveness among the interventions. However, due to the heterogeneity of the third drug and the follow-up time between the included studies, this result is not definitive. The results raise the need for further studies to help improve treatment recommendations in patients infected with HIV. PMID:29021641

A Randomized Controlled Trial of 7-Day Intensive and Standard Weekly Cognitive Therapy for PTSD and Emotion-Focused Supportive Therapy

PubMed Central

Ehlers, Anke; Hackmann, Ann; Grey, Nick; Wild, Jennifer; Liness, Sheena; Albert, Idit; Deale, Alicia; Stott, Richard; Clark, David M.

2014-01-01

Objective Psychological treatments for posttraumatic stress disorder (PTSD) are usually delivered once or twice weekly over several months. It is unclear whether they can be successfully delivered over a shorter period of time. This clinical trial had two goals, (1) to investigate the acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD, and (2) to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment. Method Patients with chronic PTSD (N=121) were randomly allocated to 7-day intensive or standard 3-month weekly cognitive therapy for PTSD, 3-month weekly emotion-focused supportive therapy, or a 14-week waitlist condition. Primary outcomes were PTSD symptoms and diagnosis as assessed by independent assessors and self-report. Secondary outcomes were disability, anxiety, depression, and quality of life. Measures were taken at initial assessment, 6 weeks and 14 weeks (post-treatment/wait). For groups receiving treatment, measures were also taken at 3 weeks, and follow-ups at 27 and 40 weeks after randomization. All analyses were intent-to-treat. Results At post-treatment/wait assessment, 73%, 77%, 43%, 7% of the intensive cognitive therapy, standard cognitive therapy, supportive therapy, and waitlist groups, respectively, had recovered from PTSD. All treatments were well tolerated and were superior to waitlist on all outcome measures, with the exception of no difference between supportive therapy and waitlist on quality of life. For primary outcomes, disability and general anxiety, intensive and standard cognitive therapy were superior to supportive therapy. Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy. Conclusions Cognitive therapy for PTSD delivered intensively over little more than a week is as effective as cognitive therapy delivered over 3 months. Both had specific effects and were superior to supportive therapy. Intensive cognitive therapy for PTSD is a feasible and promising alternative to traditional weekly treatment. PMID:24480899

Run Clever – No difference in risk of injury when comparing progression in running volume and running intensity in recreational runners: A randomised trial

PubMed Central

Rasmussen, Sten; Sørensen, Henrik; Parner, Erik Thorlund; Lind, Martin; Nielsen, Rasmus Oestergaard

2018-01-01

Background/aim The Run Clever trial investigated if there was a difference in injury occurrence across two running schedules, focusing on progression in volume of running intensity (Sch-I) or in total running volume (Sch-V). It was hypothesised that 15% more runners with a focus on progression in volume of running intensity would sustain an injury compared with runners with a focus on progression in total running volume. Methods Healthy recreational runners were included and randomly allocated to Sch-I or Sch-V. In the first eight weeks of the 24-week follow-up, all participants (n=839) followed the same running schedule (preconditioning). Participants (n=447) not censored during the first eight weeks entered the 16-week training period with a focus on either progression in intensity (Sch-I) or volume (Sch-V). A global positioning system collected all data on running. During running, all participants received real-time, individualised feedback on running intensity and running volume. The primary outcome was running-related injury (RRI). Results After preconditioning a total of 80 runners sustained an RRI (Sch-I n=36/Sch-V n=44). The cumulative incidence proportion (CIP) in Sch-V (reference group) were CIP2 weeks 4.6%; CIP4 weeks 8.2%; CIP8 weeks 13.2%; CIP16 weeks 28.0%. The risk differences (RD) and 95% CI between the two schedules were RD2 weeks=2.9%(−5.7% to 11.6%); RD4 weeks=1.8%(−9.1% to 12.8%); RD8 weeks=−4.7%(−17.5% to 8.1%); RD16 weeks=−14.0% (−36.9% to 8.9%). Conclusion A similar proportion of runners sustained injuries in the two running schedules. PMID:29527322

Prophylaxis vs. on-demand treatment with BAY 81-8973, a full-length plasma protein-free recombinant factor VIII product: results from a randomized trial (LEOPOLD II).

PubMed

Kavakli, K; Yang, R; Rusen, L; Beckmann, H; Tseneklidou-Stoeter, D; Maas Enriquez, M

2015-03-01

BAY 81-8973 is a new full-length human recombinant factor VIII product manufactured with technologies to improve consistency in glycosylation and expression to optimize clinical performance. To demonstrate superiority of prophylaxis vs. on demand therapy with BAY 81-8973 in patients with severe hemophilia A. In this multinational,randomized, open-label crossover study (LEOPOLD II;ClinicalTrials.gov identifier: NCT01233258), males aged 12–65 years with severe hemophilia A were randomized to twice-weekly prophylaxis (20-30 IU kg(-1)), 3-times-weekly prophylaxis (30-40 IU kg(-1)), or on-demand treatment with BAY 81-8973. Potency labeling for BAY 81-8973 was based on the chromogenic substrate assay or adjusted to the one-stage assay. Primary efficacy endpoint was annualized number of all bleeds (ABR). Adverse events (AEs)and immunogenicity were also assessed. Eighty patients (on demand, n = 21; twice-weekly prophylaxis, n = 28; 3-times-weekly prophylaxis, n = 31) were treated and analyzed. Mean ± SD ABR was significantly lower with prophylaxis (twice-weekly, 5.7 ± 7.2; 3-times-weekly, 4.3 ± 6.5; combined, 4.9 ± 6.8) vs. on-demand treatment (57.7 ± 24.6; P < 0.0001, ANOVA). Median ABR was reduced by 97% with prophylaxis (twice-weekly, 4.0;3-times-weekly, 2.0; combined, 2.0) vs. on-demand treatment (60.0). Median ABR was higher with twice-weekly vs. 3-times-weekly prophylaxis during the first 6-month treatment period (4.1 vs. 2.0) but was comparable in the second 6-month period (1.1 vs. 2.0). Few patients reported treatment-related AEs (4%); no treatment-related serious AEs or inhibitors were reported. Twice weekly or 3-times-weekly prophylaxis with BAY 81-8973 reduced median ABR by 97% compared with on-demand therapy, confirming the superiority of prophylaxis. Treatment with BAY 81-8973 was well tolerated.

MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study.

PubMed

Peterfy, Charles; Emery, Paul; Tak, Paul P; Østergaard, Mikkel; DiCarlo, Julie; Otsa, Kati; Navarro Sarabia, Federico; Pavelka, Karel; Bagnard, Marie-Agnes; Gylvin, Lykke Hinsch; Bernasconi, Corrado; Gabriele, Annarita

2016-01-01

To evaluate changes in structural damage and joint inflammation assessed by MRI following rituximab treatment in a Phase 3 study of patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) who were naive to biological therapy. Patients were randomised to receive two infusions of placebo (n=63), rituximab 500 mg (n=62), or rituximab 1000 mg (n=60) intravenously on days 1 and 15. MRI scans and radiographs of the most inflamed hand and wrist were acquired at baseline, weeks 12 (MRI only), 24 and 52. The primary end point was the change in MRI erosion score from baseline at week 24. Patients treated with rituximab demonstrated significantly less progression in the mean MRI erosion score compared with those treated with placebo at weeks 24 (0.47, 0.18 and 1.60, respectively, p=0.003 and p=0.001 for the two rituximab doses vs placebo) and 52 (-0.30, 0.11 and 3.02, respectively; p<0.001 and p<0.001). Cartilage loss at 52 weeks was significantly reduced in the rituximab group compared with the placebo group. Other secondary end points of synovitis and osteitis improved significantly with rituximab compared with placebo as early as 12 weeks and improved further at weeks 24 and 52. This study demonstrated that rituximab significantly reduced erosion and cartilage loss at week 24 and week 52 in MTX-inadequate responder patients with active RA, suggesting that MRI is a valuable tool for assessing inflammatory and structural damage in patients with established RA receiving rituximab. NCT00578305. 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/

Determining gestational age and preterm birth in rural Guatemala: A comparison of methods

PubMed Central

Thompson, Lisa M.; Díaz Artiga, Anaité; Bryan, Joe P.; Arriaga, William E.; Omer, Saad B.; McCracken, John P.

2018-01-01

Background Preterm birth is the leading cause of death among children <5 years of age. Accurate determination of prematurity is necessary to provide appropriate neonatal care and guide preventive measures. To estimate the most accurate method to identify infants at risk for adverse outcomes, we assessed the validity of two widely available methods—last menstrual period (LMP) and the New Ballard (NB) neonatal assessment—against ultrasound in determining gestational age and preterm birth in highland Guatemala. Methods Pregnant women (n = 188) were recruited with a gestational age <20 weeks and followed until delivery. Ultrasound was performed by trained physicians and LMP was collected during recruitment. NB was performed on infants within 96 hours of birth by trained study nurses. LMP and NB accuracy at determining gestational age and identifying prematurity was assessed by comparing them to ultrasound. Results By ultrasound, infant mean gestational age at birth was 38.3 weeks (SD = 1.6) with 16% born at less than 37 gestation. LMP was more accurate than NB (mean difference of +0.13 weeks for LMP and +0.61 weeks for NB). However, LMP and NB estimates had low agreement with ultrasound-determined gestational age (Lin’s concordance<0.48 for both methods) and preterm birth (κ<0.29 for both methods). By LMP, 18% were judged premature compared with 6% by NB. LMP underestimated gestational age among women presenting later to prenatal care (0.18 weeks for each additional week). Gestational age for preterm infants was overestimated by nearly one week using LMP and nearly two weeks using NB. New Ballard neuromuscular measurements were more predictive of preterm birth than those measuring physical criteria. Conclusion In an indigenous population in highland Guatemala, LMP overestimated prematurity by 2% and NB underestimated prematurity by 10% compared with ultrasound estimates. New, simple and accurate methods are needed to identify preterm birth in resource-limited settings worldwide. PMID:29554145

Early Preterm Birth Across Generations Among Whites and African-Americans: A Population-Based Study.

PubMed

Dorner, Rebecca A; Rankin, Kristin M; Collins, James W

2017-11-01

Objectives To determine the extent to which non-Latina White and African-American mother's gestational age is associated with extremely early (<30 weeks), modestly early (30-33 weeks), and late (34-36 weeks) infant preterm birth (PTB) rates. Methods Race-specific stratified and multivariable logistic regression analyses were performed on the Illinois Transgenerational Birth File of non-Latino White and African-American infants (born 1989-1991) and their mothers (born 1956-1976). Results White mothers (n = 184) born at <30 weeks had a greater extremely early infant PTB rate than White mothers (n = 131,980) born at term: 1.6 versus 0.5%, respectively; RR = 3.6 (1.2, 11.0). African-American mothers (n = 269) born at <30 weeks had a greater extremely early infant PTB rate than African-American mothers (n = 34,885) born at term: 4.1 versus 2.1%, respectively; RR = 2.0 (1.1, 3.6). In logistic regression models the adjusted (controlling for maternal age, education, parity, prenatal care, marital status, and cigarette smoking) OR of extremely early PTB for White and African-American mothers born <30 (compared to ≥37) weeks equaled 4.0 (1.2, 12.6) and 2.3 (1.2, 4.3), respectively. The adjusted OR of modestly early PTB for White and African-American mothers born 30-33 (compared to ≥37) weeks equaled 1.6 (1.0, 2.5) and 1.3 (0.9, 1.7), respectively. The adjusted OR of late PTB for White and African-American mothers born 34-36 (compared to ≥37) weeks equaled 1.2 (1.0, 1.3) and 1.1 (1.0, 1.2), respectively. Conclusions A generational association of extremely early, but not modestly early or late, PTB exists among non-Latino Whites and African-Americans.

Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye.

PubMed

Tauber, J; Davitt, W F; Bokosky, J E; Nichols, K K; Yerxa, B R; Schaberg, A E; LaVange, L M; Mills-Wilson, M C; Kellerman, D J

2004-11-01

To investigate the safety and efficacy of diquafosol tetrasodium, a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular surface, as a novel topical treatment of dry eye disease. Subjects with dry eye (n=527) were evaluated in a randomized, double-masked, parallel-group trial comparing 24 weeks of treatment with 2 concentrations of diquafosol (1% and 2%) versus placebo instilled 4 times daily. Corneal staining, conjunctival staining, Schirmer tests, and subjective symptoms of dry eye were evaluated. Use of artificial tears was permitted as necessary. Subjects treated with 2% diquafosol had significantly lower corneal staining scores compared with placebo at the 6-week, primary efficacy time point (P<0.001), and superiority continued throughout the 24-week study. Reductions in corneal staining were observed as early as after 2 weeks of treatment, were maintained throughout the 24-week study, and were observed to worsen slightly (toward baseline) when diquafosol treatment was discontinued (week 25). Results for conjunctival staining were consistent with those observed for corneal staining. Schirmer scores at week 6 were significantly higher with diquafosol treatment than with placebo (P

A four-week clinical study to evaluate and compare the effectiveness of a baking soda dentifrice and an antimicrobial dentifrice in reducing plaque.

PubMed

Ghassemi, Annahita; Vorwerk, Linda M; Hooper, William J; Putt, Mark S; Milleman, Kimberly R

2008-01-01

To evaluate and compare the effectiveness in reducing plaque of a fluoride dentifrice containing baking soda and a non-baking soda fluoride dentifrice containing an antimicrobial (triclosan/copolymer) system after a single brushing and over a four-week period of daily brushing. A total of 207 subjects completed this randomized, blinded, parallel-group clinical study. Twenty-four hour plaque buildup was scored at baseline and after two and four weeks of twice-daily use of the products. Additionally, controlled single brushing with the assigned dentifrice, followed by post-brushing plaque assessment, was performed at the start (baseline visit) and end (Week-4 visit) of the study. Plaque was scored using the Turesky, et al. modification of Quigley-Hein Index at six sites per tooth, according to Soparkar's modification. Mean baseline whole mouth plaque scores for the baking soda and triclosan dentifrice groups were 2.90 +/- 0.40 and 2.90 +/- 0.39, respectively, and the difference was not statistically significant. Within-group analysis showed that both products significantly reduced the amount of plaque over the four-week period (p < 0.001). Between-group analysis showed that brushing with the baking soda dentifrice exhibited significantly greater reduction in plaque scores (p < 0.001) after two and four weeks of brushing as compared to the triclosan dentifrice. After four weeks, the mean plaque reduction for the baking soda dentifrice group (0.34 +/- 0.32) was 2.22-fold greater than that observed for the triclosan dentifrice group (0.15 +/- 0.24). Similarly, single brushing with the baking soda dentifrice showed a 1.88- to 2.08-fold greater pre- to post-brushing plaque difference as compared to the triclosan dentifrice at the baseline visit (mean plaque reduction: baking soda 0.54 +/- 0.26; triclosan 0.28 +/- 0.18; ratio 1.88X) and Week-4 visit (baking soda 0.47 +/- 0.21; triclosan 0.23 +/- 0.15; ratio 2.08X). Similar to the whole mouth scores, evaluation of various tooth sites (facial, lingual, proximal, and gingival) showed a significantly greater reduction in plaque scores for brushing with the baking soda dentifrice as compared to brushing with the triclosan dentifrice. The results of this study indicate that the baking soda dentifrice was more effective than the non-baking soda, antimicrobial dentifrice in plaque removal after a single tooth brushing, and in maintaining significantly lower plaque levels during a four-week period of twice daily, unsupervised tooth brushing.

[Streptozotocin-induced maternal intrauterine hyperglycemia environment and its influence on development and metabolic in adult offspring with high birth weight in rats].

PubMed

Li, Xin; Luo, Shu-jing; Zhang, Kai; Yang, Hui-xia

2012-10-01

To establish and assess the high-birth-weight offspring model of the diabetic rat induced by stueptozotocin, and the long-term metabolic impact of maternal hyperglycemia of those offsprings. Streptozotocin (STZ, 25 mg/kg) was given to Wistar rats (G group, n = 14) once intraperitoneally to induce maternal hyperglycemia model (blood glucose between 10 - 20 mmol/L), and there still had a number of rats defined as severe hyperglycemia model group (SG group, n = 5). The Control group (C group, n = 7) were given the same volume citrate buffer solution. The body weight and blood glucose were recorded, and the lavaging glucose tolerance test (LGTT) was performed by a glucose meter in the gestation. The offsprings were corresponding allocated into 2 groups, and the birth weight were recorded. All the offsprings were observated body weight, blood glucose blood pressure (male rats only), and so on. (1) The blood glucose of G group (16.8 ± 5.4 mmol/L) and SG group (20.5 ± 5.6 mmol/L) were increased significantly as compared with C group (7.0 ± 1.4 mmol/L) 5 days after the model was established (P < 0.01); and the average blood glucose of G group (16.6 ± 3.4 mmol/L) and SG group (23.8 ± 1.5 mmol/L) increased too as comparede with C group (5.8 ± 1.1 mmol/L), the difference was significance according to statistics (P < 0.01). (2) According to the LGTT result, which operationed on generation day 4 and day 10, the blood glucose of every time point of G group were increased significantly as compared with C group (P < 0.01). (3) The male and female birth weight of G group was remarkably higher than the C group and the SG group (P < 0.05), and the blood glucose of SG/G/C group was (6.5 ± 1.2) mmol/L, (4.1 ± 0.8) mmol/L, (4.1 ± 0.8) mmol/L respectively, according to the statistics results, the difference between SG group and G/C group respectively both remarkable (P < 0.05). (4) The body weight, Lee's index, fat weight, and the fat weight of mass ratio in C group mother rats after lactation presented dressed compared with the SG group (P < 0.05), and so as to the G group compared with the SG group (P < 0.05). (5) In the female offsprings of G group, the birth weight was remarkably increased compared with the C group (P < 0.05); the body weight of the female offsprings presented an increased trend compared with the C group since the 12 weeks, but had no statistical significance; there were significant differences of body weight between G group and C group since 15 weeks (P < 0.05), and the trend kept up until 26 weeks; in the male offsprings of G group, the body weight on birth day and 4 weeks had a marked rise compared with the C group (P < 0.05); and from then on, the body weight of the male offsprings presented an increased trend compared with the C group, but had no statistical significance until 26 weeks (P > 0.05). (6) In G group, the blood glucose on 30 min and 60 min of LGTT in female offsprings were increased than the C group since 20 weeks (P < 0.05); the blood glucose of LGTT (30 min) still had a marked rise until 24 weeks (P < 0.05); in G group, the blood glucose on 30 min of LGTT in male offsprings was remarkably increased than the C group since 16 weeks (P < 0.05) ; the blood glucose of LGTT (30 min) still had a marked rise until 24 weeks (P < 0.05). (7) The blood pressure of male offsprings in G group had a marked rise on 12 weeks compared with the C group (P < 0.05); from then on the blood pressure of G group kept up a rise trend until 26 weeks, but had no statistical significance (P > 0.05). The diabetic high-birth-weight rat model could be duplicated with STZ (25 mg/kg) once intrapertoneally on the first day of gestation, which were observed some evidently metabolic changes in weight, glucose tolerance and blood pressure. These results could represent an forward step in the clinical study of human gestational diabetes mellitus and their macrosomia babies, which may suffer some metabolic disease in their later life.

Open-label pilot study on vitamin D₃ supplementation for antipsychotic-associated metabolic anomalies.

PubMed

Thakurathi, Neelam; Stock, Shannon; Oppenheim, Claire E; Borba, Christina P C; Vincenzi, Brenda; Seidman, Larry J; Stone, William S; Henderson, David C

2013-09-01

Previous studies have linked vitamin D deficiency to hypertension, dyslipidemia, diabetes mellitus, and cardiovascular disease. The aim of this study was to investigate the short-term effects of vitamin D₃ supplementation on weight and glucose and lipid metabolism in antipsychotic-treated patients. A total of 19 schizophrenic or schizoaffective patients (BMI>27 kg/m²) taking atypical antipsychotics were recruited and dispensed a 2000 IU daily dose of vitamin D₃. On comparing baseline with week 8 (study end) results, we found a statistically significant increase in vitamin D₃ and total vitamin D levels but no statistically significant changes in weight, glucose, or lipids measurements. Patients whose vitamin D₃ level at week 8 was 30 ng/ml or more achieved a significantly greater decrease in total cholesterol levels compared with those whose week 8 vitamin D₃ measurement was less than 30 ng/ml. These results suggest that a randomized trial with a longer follow-up period would be helpful in further evaluating the effects of vitamin D₃ on weight, lipid metabolism, and on components of metabolic syndrome in antipsychotic-treated patients.

The efficacy of a theory-based, participatory recycling intervention on a college campus.

PubMed

Largo-Wight, Erin; Johnston, Dedee DeLongpre; Wight, Jeff

2013-11-01

Recycling solid waste is an important primary prevention focus to protect environmental resources and human health. Recycling reduces energy consumption and emissions and the need to harvest raw material, which protects air, water, and land. In the study described in this article, the authors conducted an eight week field study to test the efficacy of an intervention aimed to increase can and bottle recycling on a college campus. Recycling volume was assessed in three campus buildings (two treatments and one control) over eight weeks. The control building had standard outdoor-only recycling. The treatment buildings had standard outdoor recycling plus four weeks with the treatment indoor recycling. Total can and bottle recycling volume increased 65%-250% in the treatment buildings compared to the control building. Recycling significantly increased in both the classroom (t = -2.9, p < .05) and administrative (t = -12.4, p < .001) treatment buildings compared to the control building (t = -.13, p = .91). Results suggest that convenience of receptacles alone, without education or additional promotion, resulted in significantly more recycling. Health promoters should prioritize efforts to make recycling easy and convenient.

Repair of articular cartilage defects in the knee with autologous iliac crest cartilage in a rabbit model.

PubMed

Jing, Lizhong; Zhang, Jiying; Leng, Huijie; Guo, Qinwei; Hu, Yuelin

2015-04-01

To demonstrate that iliac crest cartilage may be used to repair articular cartilage defects in the knees of rabbits. Full-thickness cartilage defects were created in the medial femoral condyle on both knees of 36 New Zealand white rabbits. The 72 defects were randomly assigned to be repaired with ipsilateral iliac crest cartilage (Group I), osteochondral tissues removed at defect creation (Group II), or no treatment (negative control, Group III). Animals were killed at 6, 12, and 24 weeks post-operatively. The repaired tissues were harvested for magnetic resonance imaging (MRI), histological studies (haematoxylin and eosin and immunohistochemical staining), and mechanical testing. At 6 weeks, the iliac crest cartilage graft was not yet well integrated with the surrounding articular cartilage, but at 12 weeks, the graft deep zone had partial ossification. By 24 weeks, the hyaline cartilage-like tissue was completely integrated with the surrounding articular cartilage. Osteochondral autografts showed more rapid healing than Group I at 6 weeks and complete healing at 12 weeks. Untreated defects were concave or partly filled with fibrous tissue throughout the study. MRI showed that Group I had slower integration with surrounding normal cartilage compared with Group II. The mechanical properties of Group I were significantly lower than those of Group II at 12 weeks, but this difference was not significant at 24 weeks. Iliac crest cartilage autografts were able to repair knee cartilage defects with hyaline cartilage and showed comparable results with osteochondral autografts in the rabbit model.

The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma.

PubMed

Buhl, R; Hanf, G; Solèr, M; Bensch, G; Wolfe, J; Everhard, F; Champain, K; Fox, H; Thirlwell, J

2002-11-01

The aim of the present study was to determine the effect of treatment with omalizumab, an anti-immunoglobulin E antibody, on asthma-related quality of life (AQoL) in patients with moderate-to-severe allergic asthma. A total of 546 patients with allergic asthma were randomised to double-blind subcutaneous treatment with either placebo or omalizumab for 52 weeks. A constant beclomethasone dipropionate dose was maintained during the first 16 weeks (steroid-stable phase). This was followed by a 12-week steroid-reduction phase. The core study was followed by a 24-week double-blind extension phase. AQoL was evaluated at baseline and at the end of the steroid-stable (week 16), steroid-reduction (week 28) and extension phases (week 52) using the Juniper Asthma Quality of Life Questionnaire (AQLQ). Baseline AQLQ scores were comparable for the two treatment groups. Relative to placebo, omalizumab-treated patients demonstrated statistically significant improvements from baseline across all four AQLQ domains, as well as overall AQoL score, at weeks 16 (except environmental exposure), 28 and 52. Patients on omalizumab were also more likely to achieve clinically significant improvements in AQoL during the course of the study. Overall, almost 70% of patients and investigators rated treatment with omalizumab as "excellent/good", compared with approximately 40% of placebo recipients. Clinical studies show that omalizumab enhances disease control whilst reducing corticosteroid consumption in patients with allergic asthma. The results of the present study show that these changes are paralleled by improvements in asthma-related quality of life that are meaningful to such patients.

Effects of Increased Vigilance for Locomotion Disorders on Lameness and Production in Dairy Cows.

PubMed

Gundelach, Yasmin; Schulz, Timo; Feldmann, Maren; Hoedemaker, Martina

2013-09-13

The objective of this study was to determine the influence of weekly locomotion scoring and, thus, early detection and treatment of lame cows by a veterinarian on lameness prevalence, incidence, duration of lameness, fertility and milk yield on one dairy farm in Northern Germany. Cows were distributed to two groups. Cows in Group A (n = 99) with a locomotion score (LS) > 1 were examined and treated. In Group B (n = 99), it was solely in the hands of the farmer to detect lame cows and to decide which cows received treatment. Four weeks after the beginning of the experimental period, the prevalence of cows with LS = 1 was higher in Group A compared with Group B. Prevalence of lame cows (LS > 1) increased in Group B (47.6% in Week 2 to 84.0% in Week 40) and decreased in Group A from Week 2 to Week 40 (50% to 14.4%; P < 0.05). Within groups, the monthly lameness incidence did not differ. The average duration of lameness for newly lame cows was 3.7 weeks in Group A and 10.4 weeks in Group B (P < 0.001). There was no effect on fertility and incidence of puerperal disorders. The 100-day milk yield was calculated from cows having their first four Dairy Herd Improvement (DHI) test day results during the experimental period. The mean 100-day milk yield tended to be higher in Group A compared with Group B (3,386 kg vs. 3,359 kg; P = 0.084).

Disturbed Cartilage and Joint Homeostasis Resulting From a Loss of Mitogen-Inducible Gene 6 in a Mouse Model of Joint Dysfunction

PubMed Central

Pest, Michael A.; Russell, Bailey A.; Zhang, Yu-Wen; Jeong, Jae-Wook; Beier, Frank

2017-01-01

Objective Mitogen-inducible gene 6 (MIG-6) regulates epidermal growth factor receptor (EGFR) signaling in synovial joint tissues. Whole-body knockout of the Mig6 gene in mice has been shown to induce osteoarthritis and joint degeneration. To evaluate the role of chondrocytes in this process, Mig6 was conditionally deleted from Col2a1-expressing cell types in the cartilage of mice. Methods Bone and cartilage in the synovial joints of cartilage-specific Mig6-deleted (knockout [KO]) mice and control littermates were compared. Histologic staining and immunohistochemical analyses were used to evaluate joint pathology as well as the expression of key extracellular matrix and regulatory proteins. Calcified tissue in synovial joints was assessed by micro–computed tomography (micro-CT) and whole-skeleton staining. Results Formation of long bones was found to be normal in KO animals. Cartilage thickness and proteoglycan staining of articular cartilage in the knee joints of 12-week-old KO mice were increased as compared to controls, with higher cellularity throughout the tissue. Radiopaque chondro-osseous nodules appeared in the knees of KO animals by 12 weeks of age and progressed to calcified bone–like tissue by 36 weeks of age. Nodules were also observed in the spine of 36-week-old animals. Erosion of bone at ligament entheses was evident by 12 weeks of age, by both histologic and micro-CT assessment. Conclusion MIG-6 expression in chondrocytes is important for the maintenance of cartilage and joint homeostasis. Dysregulation of EGFR signaling in chondrocytes results in anabolic activity in cartilage, but erosion of ligament entheses and the formation of ectopic chondro-osseous nodules severely disturb joint physiology. PMID:24966136

Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy.

PubMed

Simpson, David M; Brown, Stephen; Tobias, Jeffrey

2008-06-10

HIV-associated distal sensory polyneuropathy (HIV-DSP) is a painful condition with limited effective treatment. Capsaicin desensitizes cutaneous nociceptors resulting in reduced pain. We report a placebo-controlled study of a high-concentration capsaicin dermal patch (NGX-4010) for the treatment of painful HIV-DSP. This double-blind multicenter study randomized 307 patients with painful HIV-DSP to receive NGX-4010 or control, a low-concentration capsaicin patch. After application of a topical anesthetic, NGX-4010 or control was applied once for 30, 60, or 90 minutes to painful areas on the feet. The primary efficacy endpoint was percent change in Numeric Pain Rating Scale (NPRS) from baseline in mean "average pain for past 24 hours" scores from weeks 2 to 12. A single NGX-4010 application resulted in a mean pain reduction of 22.8% during weeks 2 to 12 as compared to a 10.7% reduction for controls (p = 0.0026). Following a transient treatment-related pain increase, pain was reduced; significant improvement was apparent by week 2 and continued throughout the controlled 12-week observation period. Mean pain reductions in the NGX-4010 30-, 60- and 90-minute groups were 27.7%, 15.9%, and 24.7% (p = 0.0007, 0.287, and 0.0046 vs control). One third of NGX-4010-treated patients reported >or=30% pain decrease from baseline as compared to 18% of controls (p = 0.0092). Self-limited, mild-to-moderate local skin reactions were commonly observed. A single NGX-4010 application was safe and provided at least 12 weeks of pain reduction in patients with HIV-associated distal sensory polyneuropathy. These results suggest that NGX-4010 could provide a promising new treatment for painful HIV neuropathy.

Pulsed Compared to Thermal Radiofrequency to the Medial Calcaneal Nerve for Management of Chronic Refractory Plantar Fasciitis: A Prospective Comparative Study.

PubMed

Osman, Ayman M; El-Hammady, Dina H; Kotb, Mohamed M

2016-01-01

Radiofrequency (RF) treatment is a minimally invasive procedure that has been used for more than 3 decades in treating various chronic pain syndromes. Conventional (continuous) RF treatment occasionally results in worsening or even initiating a new type of pain. The use of pulsed radiofrequency (PRF), which has a non- or minimally neurodestructive neuromodulatory effect, serves as an alternative to conventional RF therapy in many medical situations. To evaluate the effect of applying PRF for 6 minutes vs. thermal radiofrequency (TRF) for 90 seconds to the medial calcaneal nerve for treatment of chronic refractory plantar fasciitis pain. Prospective comparative study. Pain, Orthopedic, and Rheumatology and Rehabilitation Clinics of Assiut University Hospital. Twenty patients with refractory chronic bilateral plantar fasciitis received PRF to the medial calcaneal nerve for 6 minutes for one heel and TRF to the same nerve on the other heel (as their own control) for 90 seconds. Numerical verbal rating scale (NVRS) at waking up from bed and after prolonged walking, and satisfaction score were used for assessment of studied patients at one, 3, 6, 12, and 24 weeks from the intervention. All studied patients showed significant improvement in their pain scale after the intervention that lasted for 24 weeks; however, the PRF heels had significantly better pain scale and satisfaction scores at the first and third weeks assessments when compared to the TRF heels. Effective analgesia was achieved after one week or less after PRF compared to 3 weeks for the TRF (P < 0.001). No randomization. PRF to the medial calcaneal nerve is a safe and effective method for treatment of chronic plantar fasciitis pain. The onset of effective analgesia can be achieved more rapidly with PRF compared to TRF on the same nerve. Further randomized trials are needed to confirm the therapeutic effect and optimizing the dose of RF needed.Key words: Pulsed radiofrequency, thermal radiofrequency, medial calcaneal nerve, plantar fasciitis, plantar aponeurosis, visual analogue scale.

A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients.

PubMed

Bhandari, Sunil; Kalra, Philip A; Kothari, Jatin; Ambühl, Patrice M; Christensen, Jeppe H; Essaian, Ashot M; Thomsen, Lars L; Macdougall, Iain C; Coyne, Daniel W

2015-09-01

Iron deficiency anaemia is common in patients with chronic kidney disease, and intravenous iron is the preferred treatment for those on haemodialysis. The aim of this trial was to compare the efficacy and safety of iron isomaltoside 1000 (Monofer®) with iron sucrose (Venofer®) in haemodialysis patients. This was an open-label, randomized, multicentre, non-inferiority trial conducted in 351 haemodialysis subjects randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sucrose (Group B). Subjects in Group A were equally divided into A1 (500 mg single bolus injection) and A2 (500 mg split dose). Group B were also treated with 500 mg split dose. The primary end point was the proportion of subjects with haemoglobin (Hb) in the target range 9.5-12.5 g/dL at 6 weeks. Secondary outcome measures included haematology parameters and safety parameters. A total of 351 subjects were enrolled. Both treatments showed similar efficacy with >82% of subjects with Hb in the target range (non-inferiority, P = 0.01). Similar results were found when comparing subgroups A1 and A2 with Group B. No statistical significant change in Hb concentration was found between any of the groups. There was a significant increase in ferritin from baseline to Weeks 1, 2 and 4 in Group A compared with Group B (Weeks 1 and 2: P < 0.001; Week 4: P = 0.002). There was a significant higher increase in reticulocyte count in Group A compared with Group B at Week 1 (P < 0.001). The frequency, type and severity of adverse events were similar. Iron isomaltoside 1000 and iron sucrose have comparative efficacy in maintaining Hb concentrations in haemodialysis subjects and both preparations were well tolerated with a similar short-term safety profile. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA.

Left ventricular hypertrophy in ascending aortic stenosis mice: anoikis and the progression to early failure

NASA Technical Reports Server (NTRS)

Ding, B.; Price, R. L.; Goldsmith, E. C.; Borg, T. K.; Yan, X.; Douglas, P. S.; Weinberg, E. O.; Bartunek, J.; Thielen, T.; Didenko, V. V.;

Actigraphy-defined Measures of Sleep and Movement Across the Menstrual Cycle In Midlife Menstruating Women: SWAN Sleep Study

PubMed Central

Zheng, Huiyong; Harlow, Siobán D; Kravitz, Howard M; Bromberger, Joyce; Buysse, Daniel J; Matthews, Karen A; Gold, Ellen B; Owens, Jane F; Hall, Martica

2014-01-01

Objective To evaluate patterns in actigraphy-defined sleep measures across the menstrual cycle, testing the hypothesis that sleep would be more disrupted in the premenstrual period, i.e. in the 14 days prior to menses. Methods A community-based, longitudinal study of wrist actigraphy-derived sleep measures was conducted with 163 women (58 African-American, 78 White, and 27 Chinese) of late reproductive age (mean=51.5, SD=2.0 years) from the Study of Women's Health Across the Nation (SWAN) Sleep Study. Daily measures of sleep [sleep efficiency (%) and total sleep time (minutes)] and movement during sleep [mean activity score (counts)] were characterized using wrist actigraphy across a menstrual cycle or 35 days, whichever was shorter. Data were standardized to 28 days to account for the variation of unequal cycle lengths and divided into four weekly segments for analyses. Results Sleep efficiency percentage declined gradually across the menstrual cycle, but the decline became pronounced in fourth week, the premenstrual period. Compared with third week, sleep efficiency declined by 5% (p<0.0001) and mean total sleep time was 25 minutes less (p=0.0002) in fourth week. No significant mean differences were found when comparing the means of second week versus third week. The association of weekly segments with sleep efficiency or minutes of total sleep time was modified by sociodemographic and lifestyle factors, including body mass index (BMI), race, study site, financial strain, marital status, and smoking. Conclusions Sleep varied systematically across the menstrual cycle in women of late reproductive age, including a gradual decline in sleep efficiency across all weeks, with a more marked change premenstrually during the last week of the menstrual cycle. These sleep changes may be modifiable by altering lifestyle factors. PMID:24845393

Moderate Aerobic Training Improves Cardiorespiratory Parameters in Elastase-Induced Emphysema

PubMed Central

Henriques, Isabela; Lopes-Pacheco, Miquéias; Padilha, Gisele A.; Marques, Patrícia S.; Magalhães, Raquel F.; Antunes, Mariana A.; Morales, Marcelo M.; Rocha, Nazareth N.; Silva, Pedro L.; Xisto, Débora G.; Rocco, Patricia R. M.

2016-01-01

Aim: We investigated the therapeutic effects of aerobic training on lung mechanics, inflammation, morphometry and biological markers associated with inflammation, and endothelial cell damage, as well as cardiac function in a model of elastase-induced emphysema. Methods: Eighty-four BALB/c mice were randomly allocated to receive saline (control, C) or 0.1 IU porcine pancreatic elastase (emphysema, ELA) intratracheally once weekly for 4 weeks. After the end of administration period, once cardiorespiratory impairment associated with emphysema was confirmed, each group was further randomized into sedentary (S) and trained (T) subgroups. Trained mice ran on a motorized treadmill, at moderate intensity, 30 min/day, 3 times/week for 4 weeks. Results: Four weeks after the first instillation, ELA animals, compared to C, showed: (1) reduced static lung elastance (Est,L) and levels of vascular endothelial growth factor (VEGF) in lung tissue, (2) increased elastic and collagen fiber content, dynamic elastance (E, in vitro), alveolar hyperinflation, and levels of interleukin-1β and tumor necrosis factor (TNF)-α, and (3) increased right ventricular diastolic area (RVA). Four weeks after aerobic training, ELA-T group, compared to ELA-S, was associated with reduced lung hyperinflation, elastic and collagen fiber content, TNF-α levels, and RVA, as well as increased Est,L, E, and levels of VEGF. Conclusion: Four weeks of regular and moderate intensity aerobic training modulated lung inflammation and remodeling, thus improving pulmonary function, and reduced RVA and pulmonary arterial hypertension in this animal model of elastase-induced emphysema. PMID:27536247

Shi-style cervical manipulations for cervical radiculopathy

PubMed Central

Cui, Xue-jun; Yao, Min; Ye, Xiu-lan; Wang, Ping; Zhong, Wei-hong; Zhang, Rui-chun; Li, Hui-ying; Hu, Zhi-jun; Tang, Zhan-ying; Wang, Wei-min; Qiao, Wei-ping; Sun, Yue-li; Li, Jun; Gao, Yang; Shi, Qi; Wang, Yongjun

2017-01-01

Abstract Background: There is a lack of high-quality evidence supporting the use of manipulation therapy for patients with cervical radiculopathy (CR). This study aimed to evaluate the effectiveness of Shi-style cervical manipulations (SCMs) versus mechanical cervical traction (MCT) for CR. Methods: This was a randomized, open-label, controlled trial carried out at 5 hospitals in patients with CR for at least 2 weeks and neck pain. The patients received 6 treatments of SCM (n = 179) or MCT (n = 180) over 2 weeks. The primary outcome was participant-rated disability (neck disability index), measured 2 weeks after randomization. The secondary outcomes were participant-rated pain (visual analog scale) and health-related quality of life (36-Item Short Form Health Survey [SF-36]). Assessments were performed before, during, and after (2, 4, 12, and 24 weeks) intervention. Results: After 2 weeks of treatment, the SCM group showed a greater improvement in participant-rated disability compared with the control group (P = .018). The SCM group reported less disability compared with the control group (P < .001) during the 26-week follow-up. The difference was particularly important at 6 months (mean −28.91 ± 16.43, P < .001). Significant improvements in SF-36 were noted in both groups after 2 weeks of treatment, but there were no differences between the 2 groups. Conclusion: SCM could be a better option than MCT for the treatment of CR-related pain and disability. PMID:28767566

Comparison of Fibrin Glue and Sutures for Conjunctival Wound Closure in Strabismus Surgery

PubMed Central

Lee, Jae Hyung

2011-01-01

Purpose To evaluate and compare the efficacy and tolerance of fibrin glue and sutures for closing conjunctival wounds in strabismus surgery. Methods In a prospective trial, we performed strabismus surgery using limbal incisions. Conjunctival wounds were closed with fibrin glue in 20 eyes of 20 patients (fibrin group) and 8-0 polyglactin suture in 20 eyes of 20 patients (suture group). Postoperative pain, tearing, and inflammation were compared at 1 day, 1 week, 3 weeks, and 6 weeks after surgery. Conjunctival incision healing was also investigated. Results One day and one week post-operatively, pain and tearing scores were lower in the fibrin group (p = 0.000, respectively). Mean surgery time was significantly shorter in the fibrin (48 ± 5 minutes) than the suture group (63 ± 7 minutes) (p = 0.000). Inflammation was significantly more severe in the suture group until 3 weeks postoperative (p = 0.000, respectively), but conjunctival healing did not differ between the groups. Hyperemia appeared more prominent in the fibrin group 3 and 6 weeks after surgery (p = 0.087 and 0.000, respectively). Two eyes in the fibrin group showed conjunctival gaps of more than 2 mm, which closed spontaneously by three weeks after surgery. No allergic reactions or infections developed. Conclusions Fibrin glue proved to be as effective as sutures in closing conjunctival wounds. It provides more comfortable early postoperative courses and might be considered as an alternative to sutures in strabismus surgery. PMID:21655043

Effects of plasma rich in growth factors (PRGF) on biomechanical properties of Achilles tendon repair.

PubMed

López-Nájera, Diego; Rubio-Zaragoza, Mónica; Sopena-Juncosa, Joaquín J; Alentorn-Geli, Eduard; Cugat-Bertomeu, Ramón; Fernández-Sarmiento, J Andrés; Domínguez-Pérez, Juan M; García-Balletbó, Montserrat; Primo-Capella, Víctor J; Carrillo-Poveda, José M

2016-12-01

To assess the biomechanical effects of intra-tendinous injections of PRGF on the healing Achilles tendon after repair in a sheep model. Thirty sheep were randomly assigned into one of the six groups depending on the type of treatment received (PRGF or placebo) and survival time (2, 4 and 8 weeks). The Achilles tendon injury was repaired by suturing the tendinous edges employing a three-loop pulley pattern. A trans-articular external fixation system was then used for immobilization. The PRGF or placebo was administered on a weekly basis completing a maximum of three infiltrations. The force, section and tension values were compared between the operated and healthy Achilles tendons across all groups. The PRGF-treated tendons had higher force at 8 weeks compared with the placebo group (p = 0.007). Between 2 and 4 weeks, a significant increase in force in both the PRGF-treated tendon (p = 0.0027) and placebo group (p = 0.0095) occurred. No significant differences were found for section ratio between PRGF-treated tendons and the placebo group for any of the time periods evaluated. At 2 weeks, PRGF-treated tendons had higher tension ratio compared with placebo group tendons (p = 0.0143). Both PRGF and placebo treatments significantly improved the force (p < 0.001 and p = 0.0095, respectively) and tension (p = 0.009 and p = 0.0039, respectively) ratios at 8 weeks compared with 2 weeks. The application of PRGF increases Achilles tendon repair strength at 8 weeks compared with the use of placebo. The use of PRGF does not modify section and tension ratios compared with placebo at 8 weeks. The tension ratio progressively increases between 2 and 8 weeks compared with the placebo.

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.

Efficacy of an asynchronous electronic curriculum in emergency medicine education in the United States.

PubMed

Wray, Alisa; Bennett, Kathryn; Boysen-Osborn, Megan; Wiechmann, Warren; Toohey, Shannon

2017-01-01

The aim of this study was to measure the effect of an iPad-based asynchronous curriculum on emergency medicine resident performance on the in-training exam (ITE). We hypothesized that the implementation of an asynchronous curriculum (replacing 1 hour of weekly didactic time) would result in non-inferior ITE scores compared to the historical scores of residents who had participated in the traditional 5-hour weekly didactic curriculum. The study was a retrospective, non-inferiority study. conducted at the University of California, Irvine Emergency Medicine Residency Program. We compared ITE scores from 2012 and 2013, when there were 5 weekly hours of didactic content, with scores from 2014 and 2015, when 1 hour of conference was replaced with asynchro-nous content. Examination results were compared using a non-inferiority data analysis with a 10% margin of difference. Using a non-inferiority test with a 95% confidence interval, there was no difference between the 2 groups (before and after implementation of asynchronous learning), as the confidence interval for the change of the ITE was -3.5 to 2.3 points, whereas the 10% non-inferiority margin was 7.8 points. Replacing 1 hour of didactic conference with asynchronous learning showed no negative impact on resident ITE scores.

A Randomized, Multicenter, Phase III Trial to Evaluate the Efficacy and Safety of Polmacoxib Compared with Celecoxib and Placebo for Patients with Osteoarthritis.

PubMed

Lee, Myungchul; Yoo, Juhyung; Kim, Jin Goo; Kyung, Hee-Soo; Bin, Seong-Il; Kang, Seung-Baik; Choi, Choong Hyeok; Moon, Young-Wan; Kim, Young-Mo; Han, Seong Beom; In, Yong; Choi, Chong Hyuk; Kim, Jongoh; Lee, Beom Koo; Cho, Sangsook

2017-12-01

The aim of this study was to evaluate the safety and analgesic efficacy of polmacoxib 2 mg versus placebo in a superiority comparison or versus celecoxib 200 mg in a noninferiority comparison in patients with osteoarthritis (OA). This study was a 6-week, phase III, randomized, double-blind, and parallel-group trial followed by an 18-week, single arm, open-label extension. Of the 441 patients with knee or hip OA screened, 362 were randomized; 324 completed 6 weeks of treatment and 220 completed the extension. Patients were randomized to receive oral polmacoxib 2 mg (n = 146), celecoxib 200 mg (n = 145), or placebo (n = 71) once daily for 6 weeks. During the extension, all participants received open-label polmacoxib 2 mg. The primary endpoint was the change in Western Ontario and McMaster Universities (WOMAC)-pain subscale score from baseline to week 6. Secondary endpoints included WOMAC-OA Index, OA subscales (pain, stiffness, and physical function) and Physician's and Subject's Global Assessments at weeks 3 and 6. Other outcome measures included adverse events (AEs), laboratory tests, vital signs, electrocardiograms, and physical examinations. After 6 weeks, the polmacoxib-placebo treatment difference was -2.5 (95% confidence interval [CI], -4.4 to -0.6; p = 0.011) and the polmacoxib-celecoxib treatment difference was 0.6 (CI, -0.9 to 2.2; p = 0.425). According to Physician's Global Assessments, more subjects were "much improved" at week 3 with polmacoxib than with celecoxib or placebo. Gastrointestinal and general disorder AEs occurred with a greater frequency with polmacoxib or celecoxib than with placebo. Polmacoxib 2 mg was relatively well tolerated and demonstrated efficacy superior to placebo and noninferior to celecoxib after 6 weeks of treatment in patients with OA. The results obtained during the 18-week trial extension with polmacoxib 2 mg were consistent with those observed during the 6-week treatment period, indicating that polmacoxib can be considered safe for long-term use based on this relatively small scale of study in a Korean population. More importantly, the results of this study showed that polmacoxib has the potential to be used as a pain relief drug with reduced gastrointestinal side effects compared to traditional nonsteroidal anti-inflammatory drugs for OA.

Predicting warfarin dosage in European–Americans and African–Americans using DNA samples linked to an electronic health record

PubMed Central

Ramirez, Andrea H; Shi, Yaping; Schildcrout, Jonathan S; Delaney, Jessica T; Xu, Hua; Oetjens, Matthew T; Zuvich, Rebecca L; Basford, Melissa A; Bowton, Erica; Jiang, Min; Speltz, Peter; Zink, Raquel; Cowan, James; Pulley, Jill M; Ritchie, Marylyn D; Masys, Daniel R; Roden, Dan M; Crawford, Dana C; Denny, Joshua C

2012-01-01

Aim Warfarin pharmacogenomic algorithms reduce dosing error, but perform poorly in non-European–Americans. Electronic health record (EHR) systems linked to biobanks may allow for pharmacogenomic analysis, but they have not yet been used for this purpose. Patients & methods We used BioVU, the Vanderbilt EHR-linked DNA repository, to identify European–Americans (n = 1022) and African–Americans (n = 145) on stable warfarin therapy and evaluated the effect of 15 pharmacogenetic variants on stable warfarin dose. Results Associations between variants in VKORC1, CYP2C9 and CYP4F2 with weekly dose were observed in European–Americans as well as additional variants in CYP2C9 and CALU in African–Americans. Compared with traditional 5 mg/day dosing, implementing the US FDA recommendations or the International Warfarin Pharmacogenomics Consortium (IWPC) algorithm reduced error in weekly dose in European–Americans (13.5–12.4 and 9.5 mg/week, respectively) but less so in African–Americans (15.2–15.0 and 13.8 mg/week, respectively). By further incorporating associated variants specific for European–Americans and African–Americans in an expanded algorithm, dose-prediction error reduced to 9.1 mg/week (95% CI: 8.4–9.6) in European–Americans and 12.4 mg/week (95% CI: 10.0–13.2) in African–Americans. The expanded algorithm explained 41 and 53% of dose variation in African–Americans and European–Americans, respectively, compared with 29 and 50%, respectively, for the IWPC algorithm. Implementing these predictions via dispensable pill regimens similarly reduced dosing error. Conclusion These results validate EHR-linked DNA biorepositories as real-world resources for pharmacogenomic validation and discovery. PMID:22329724

Randomized Controlled Trial of Adding Telephone Follow-Up to an Occupational Rehabilitation Program to Increase Work Participation.

PubMed

Hara, Karen Walseth; Bjørngaard, Johan Håkon; Brage, Søren; Borchgrevink, Petter Christian; Halsteinli, Vidar; Stiles, Tore Charles; Johnsen, Roar; Woodhouse, Astrid

2018-06-01

Purpose Transfer from on-site rehabilitation to the participant's daily environment is considered a weak link in the rehabilitation chain. The main objective of this study is to see if adding boosted telephone follow-up directly after completing an occupational rehabilitation program effects work participation. Methods A randomized controlled study included participants with chronic pain, chronic fatigue or common mental disorders on long-term sick leave. After completing 3½ weeks of acceptance and commitment therapy based occupational rehabilitation, participants were randomized to boosted follow-up or a control group before returning to their daily environment. The intervention was delivered over 6 months by on-site RTW coordinators mainly via telephone. Primary outcome was RTW categorized as participation in competitive work ≥1 day per week on average over 8 weeks. Results There were 213 participants of mean age 42 years old. Main diagnoses of sick leave certification were mental disorders (38%) and musculoskeletal disorders (30%). One year after discharge the intervention group had 87% increased odds (OR 1.87, 95% confidence interval 1.06-3.31, p = 0.031), of (re)entry to competitive work ≥1 day per week compared with the controls, with similar positive results for sensitivity analysis of participation half time (≥2.5 days per week). The cost of boosted follow-up was 390.5 EUR per participant. Conclusion Participants receiving boosted RTW follow-up had higher (re)entry to competitive work ≥1 day per week at 1 year when compared to the control group. Adding low-cost boosted follow-up by telephone after completing an occupational rehabilitation program augmented the effect on return-to-work.

Inhaled indacaterol for the treatment of COPD patients with destroyed lung by tuberculosis and moderate-to-severe airflow limitation: results from the randomized INFINITY study

PubMed Central

Kim, Cheong-Ju; Yoon, Hyoung-Kyu; Park, Myung-Jae; Yoo, Kwang-Ha; Jung, Ki-Suck; Park, Jeong-Woong; Lim, Seong Yong; Shim, Jae Jeong; Lee, Yong Chul; Kim, Young-Sam; Oh, Yeon-Mok; Kim, Song; Yoo, Chul-Gyu

2017-01-01

Background and objective Pulmonary tuberculosis (TB) is a risk factor for chronic obstructive pulmonary disease (COPD); however, few clinical studies have investigated treatment effectiveness in COPD patients with destroyed lung by TB. The Indacaterol effectiveness in COPD patients with Tuberculosis history (INFINITY) study assessed the efficacy and safety of once-daily inhaled indacaterol 150 µg for the treatment of Korean COPD patients with destroyed lung by TB and moderate-to-severe airflow limitation. Methods This was a multicenter, double-blind, parallel-group study, in which eligible patients were randomized (1:1) to receive either once-daily indacaterol 150 µg or placebo for 8 weeks. The primary efficacy endpoint was change from baseline in trough forced expiratory volume in 1 s at Week 8; the secondary endpoints included changes in transition dyspnea index score and St George’s Respiratory Questionnaire for COPD score at Week 8. Safety was evaluated over 8 weeks. Results Of the 136 patients randomized, 119 (87.5%) completed the study treatment. At Week 8, indacaterol significantly improved trough forced expiratory volume in 1 s versus placebo (treatment difference [TD] 140 mL, P<0.001). Statistically significant improvement in transition dyspnea index score (TD =0.78, P<0.05) and numerical improvement in St George’s Respiratory Questionnaire for COPD score (TD =−2.36, P=0.3563) were observed with indacaterol versus placebo at Week 8. Incidence of adverse events was comparable between the treatment groups. Conclusion Indacaterol provided significantly superior bronchodilation, significant improvement in breathlessness and improved health status with comparable safety versus placebo in Korean COPD patients with destroyed lung by TB and moderate-to-severe airflow limitation. PMID:28615931

Anti-Pigmentation Effects of Eight Phellinus linteus-Fermented Traditional Crude Herbal Extracts on Brown Guinea Pigs of Ultraviolet B-Induced Hyperpigmentation.

PubMed

Ahn, Hee-Young; Choo, Young-Moo; Cho, Young-Su

2018-03-28

We have previously found that mycelia culture broth of eight kinds of traditional herbal extracts fermented with Phellinus linteus (previously named as 8-HsPLCB) not only inhibited melanin and tyrosinase activity, but also reduced the contents of melanogenesis-related proteins, including tyrosinase and microphthalmia-associated transcription factor, in 3-isobutyl-1-methylxanthine-stimulated B16F0 melanoma cells. For a further study, the effect of 8-HsPLCB against skin pigmentation in brown guinea pigs with ultraviolet B (UVB)-induced hyperpigmentation was investigated. 8-HsPLCB (3%) and arbutin (2%) as positive controls were applied topically twice daily for 4 weeks to the hyperpigmented areas. 8-HsPLCB showed skin-lightening effect as effective as arbutin, one of the most widely used in whitening cosmetics. Melanin index values as the degree of pigmentation showed a significant reduction week by week post 8-HsPLCB treatment and then substantially reduced by 4 weeks. The degree of depigmentation after 4 weeks of topical application with 8-HsPLCB was 32.2% as compared with before treatment (0 week). Moreover, using Fontana-Masson staining and hematoxylin-eosin staining, 8-HsPLCB reduced melanin pigmentation in the basal layer of the epidermis and epidermal thickness changes exposed to the UV-B irradiation as compared with non-treatment and vehicle treatment. The intensity of the skin-lightening effect of 8-HsPLCB was similar to arbutin. These results suggest that the skin-lightening effect of 8-HsPLCB might be resulted from inhibition of melanin synthesis by tyrosinase in melanocytes. To conclude, 8-HsPLCB treatment showed reduction of the melanin pigment and histological changes induced by UV irradiation in brown guinea pigs.

Interval Between Surgery and Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer: Does Delayed Surgery Have an Impact on Outcome?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Habr-Gama, Angelita; Perez, Rodrigo Oliva; Proscurshim, Igor

Background: The optimal interval between neoadjuvant chemoradiation therapy (CRT) and surgery in the treatment of patients with distal rectal cancer is controversial. The purpose of this study is to evaluate whether this interval has an impact on survival. Methods and Materials: Patients who underwent surgery after CRT were retrospectively reviewed. Patients with a sustained complete clinical response (cCR) 1 year after CRT were excluded from this study. Clinical and pathologic characteristics and overall and disease-free survival were compared between patients undergoing surgery 12 weeks or less from CRT and patients undergoing surgery longer than 12 weeks from CRT completion andmore » between patients with a surgery delay caused by a suspected cCR and those with a delay for other reasons. Results: Two hundred fifty patients underwent surgery, and 48.4% had CRT-to-surgery intervals of 12 weeks or less. There were no statistical differences in overall survival (86% vs. 81.6%) or disease-free survival rates (56.5% and 58.9%) between patients according to interval ({<=}12 vs. >12 weeks). Patients with intervals of 12 weeks or less had significantly higher rates of Stage III disease (34% vs. 20%; p = 0.009). The delay in surgery was caused by a suspected cCR in 23 patients (interval, 48 {+-} 10.3 weeks). Five-year overall and disease-free survival rates for this subset were 84.9% and 51.6%, not significantly different compared with the remaining group (84%; p = 0.96 and 57.8%; p = 0.76, respectively). Conclusions: Delay in surgery for the evaluation of tumor response after neoadjuvant CRT is safe and does not negatively affect survival. These results support the hypothesis that shorter intervals may interrupt ongoing tumor necrosis.« less

Short and long effects of Citrullus colocynthis L. on reproductive system and fertility in female Spague-Dawley rats.

PubMed

Qazan, Walid Sh; Almasad, Motasem M; Daradka, Haytham

2007-08-15

Aim of this study is to investigate the toxic effects of Citrullus colocynthis L. (400 mg/kg/body wight) on the reproductive system after administration to female Sprague-Dawley rats weighting 250-300 g for two time periods 4 and 12 weeks. Twenty adult female rats were divided into two groups and Citrullus colocynthis L. were intraperitoneally injected to experimental animals in dose of 400 mg/kg/body wight. First group containing 10 rats received treatment for 4 weeks and a second group of 10 rats received the same dose of treatment for a period of 12 weeks and compared with twenty non-exposed female rats received vehicle treatment. Female rats were allowed mating with males after 10 days prior to the last administration dose. Animals were autopsied under light anesthesia after mating and several parameters were determined including: number of pregnant rats, body and reproductive organ weight, number of implantation sites, viable fetuses and resorption sites. Assessment of pregnancies in females was measured and the significance of these results was calculated using students t and Chi-square tests. The effect of Citrullus colocynthis L. exposure on fertility was assessed in terms of pregnant rats number, implantation sites, viable fetuses and resorption sites. Exposure to Citrullus colocynthis L. for 4 weeks did not have much effect on fertility. Significant decrease in the relative ovarian weights and embryo weights in rats exposed to Citrullus colocynthis L. were observed. Exposure to Citrullus colocynthis L. for a 12 weeks resulted in a reduction in the percentage of pregnancies and in the number of implantation sites when compared with controls in both treatment periods. Rats receiving 12 weeks treatment showed a decrease in ovarian weights and a decrease in viable fetus's number. These results indicate that long-term exposure of female rats to Citrullus colocynthis L. causes adverse effects on the reproductive system and fertility.

Integration of HIV Testing into Maternal, Newborn, and Child Health Weeks for Improved Case Finding and Linkage to Prevention of Mother-to-Child Transmission Services in Benue State, Nigeria.

PubMed

Akinleye, Olusoji; Dura, Gideon; de Wagt, Arjan; Davies, Abiola; Chamla, Dick

2017-01-01

In Nigeria, maternal, newborn, and child health (MNCH) weeks are campaign-like events designed to accelerate progress toward Millennium Development Goals. The authors examined whether integrating HIV testing into MNCH weeks was feasible and could lead to increased case finding and linkage to prevention of mother-to-child transmission (PMTCT) services. Pregnant women attending MNCH week during the first week of December 2014 in 13 local government areas in Benue State were provided with HIV tests and referrals to PMTCT services. Demographic, past antenatal care (ANC), and HIV testing information were collected using a structured questionnaire. We used routine ANC/PMTCT data from national electronic system (DHIS-2) to compare with the results obtained from MNCH week. A total of 50,271 pregnant women with a median age of 25 years (IQR: 21-29) were offered HIV testing. About 50,253 (99.96%) agreed to get HIV testing, with 1,063 (2.1%) testing positive. Six hundred forty-four (60.6%) of those with positive results were linked to PMTCT. In multivariate analysis, marital status, gestation age, and those with no ANC visit during this pregnancy were associated with a positive HIV test. Approximately 30% (50,253 versus 39,080) more pregnant women received HIV testing in MNCH week compared to those who received HIV testing in routine ANC services in 2013. Of the 50,253 who accepted testing, 15,611 (31.1%) did not attend ANC during this pregnancy, of which 9,615 (61.6%) had not had any previous HIV tests. Four hundred forty-two (4.6%) of these 9,615 tested HIV-positive. Integration of HIV testing into MNCH weeks is feasible and improved uptake of HIV testing and linkage to care. However, the rate of HIV positivity was lower than that reported by previous studies. The findings indicate that MNCH weeks provides opportunity to reach those who do not attend ANC services for HIV care.

[A comparison between effects of aroma massage and meridian massage on constipation and stress in women college students].

PubMed

Chung, Miyoung; Choi, Euysoon

2011-02-01

This study was done to compare the effects of abdominal aroma massage and meridian massage on constipation and stress in college women with functional constipation. The participants were 38 college women, 18 were in the aroma group and 20 in the meridian group. The aroma massage was given using aroma oil which was a mixture of lemon, lavender, rosemary, and cyprus. The meridian massage was given at 9 accupoints which influence intestinal functions. The treatment was given 5 days a week for 4 weeks. A constipation severity score, weekly defecation frequency, and a stress response score were measured before and every week of 4 weeks of the experiment. While there was no significant difference between two groups, there was a significant difference within the groups in the constipation severity (aroma group: 1st week, meridian group: except 4th week), defecation frequency (aroma group: 3rd week, meridian group: 2nd and 3rd week), and stress (aroma group: all weeks, meridian group: except 4th week) after different duration of experiment. Based on these results, both abdominal massages relieved constipation and stress. Resorting to either types of massage will contribute to the reduction of use of stool softeners, suppositories, or enemas.

A Comparative Study of the Efficacy of Group Equine Assisted Counseling with At-Risk Children and Adolescents

ERIC Educational Resources Information Center

Trotter, Kay Sudekum; Chandler, Cynthia K.; Goodwin-Bond, Deborah; Casey, Janie

2008-01-01

This study demonstrates the efficacy of Equine Assisted Counseling (EAC) by comparing EAC to classroom-based counseling. Students (n = 164) identified as being at high risk for academic and/or social failure participated in 12 weekly counseling sessions. Within-group paired sample t-test results comparing pre- and post-treatment scores for…

Food Choice Architecture: An Intervention in a Secondary School and its Impact on Students' Plant-based Food Choices.

PubMed

Ensaff, Hannah; Homer, Matt; Sahota, Pinki; Braybrook, Debbie; Coan, Susan; McLeod, Helen

2015-06-02

With growing evidence for the positive health outcomes associated with a plant-based diet, the study's purpose was to examine the potential of shifting adolescents' food choices towards plant-based foods. Using a real world setting of a school canteen, a set of small changes to the choice architecture was designed and deployed in a secondary school in Yorkshire, England. Focussing on designated food items (whole fruit, fruit salad, vegetarian daily specials, and sandwiches containing salad) the changes were implemented for six weeks. Data collected on students' food choice (218,796 transactions) enabled students' (980 students) selections to be examined. Students' food choice was compared for three periods: baseline (29 weeks); intervention (six weeks); and post-intervention (three weeks). Selection of designated food items significantly increased during the intervention and post-intervention periods, compared to baseline (baseline, 1.4%; intervention 3.0%; post-intervention, 2.2%) χ(2)(2) = 68.1, p < 0.001. Logistic regression modelling also revealed the independent effect of the intervention, with students 2.5 times as likely (p < 0.001) to select the designated food items during the intervention period, compared to baseline. The study's results point to the influence of choice architecture within secondary school settings, and its potential role in improving adolescents' daily food choices.

Motivational Factors Underlying Problem Solving: Comparing Wolf and Dog Puppies' Explorative and Neophobic Behaviors at 5, 6, and 8 Weeks of Age.

PubMed

Marshall-Pescini, Sarah; Virányi, Zsófia; Kubinyi, Enikő; Range, Friederike

2017-01-01

Background: Wolves have been shown to be better in independent problem-solving tasks than dogs, however it is unclear whether cognitive or motivational factors underlie such differences. In a number of species problem solving has been linked to both persistence in exploration and neophobia, suggesting both these aspects may underlie dog-wolf differences in problem solving. Indeed adult wolves have been shown to be more likely to approach a novel object and more persistent in their investigation of it, but also slower in making contact with it and more fearful of it than dogs. Methods: In the current study we investigated potential differences in equally-raised dogs' and wolves' explorative and neophobic behaviors in a novel environment and with novel objects at 5, 6, and 8 weeks of age. Results: Results showed that wolves were more persistent in exploring both the environment and the objects than dogs, and this was the case at all ages. There were no differences in the frequency of fear-related behaviors and time spent in proximity to humans. Stress-related behaviors were similarly expressed at 5 and 6 weeks, although wolves showed a higher frequency of such behaviors at 8 weeks. Discussion: Overall, results with puppies confirm those with adult animals: wolves appear to be more explorative than dogs. Such motivational differences need to be taken into account when comparing dogs and wolves in cognitive tasks.

Motivational Factors Underlying Problem Solving: Comparing Wolf and Dog Puppies' Explorative and Neophobic Behaviors at 5, 6, and 8 Weeks of Age

PubMed Central

Marshall-Pescini, Sarah; Virányi, Zsófia; Kubinyi, Enikő; Range, Friederike

2017-01-01

Background: Wolves have been shown to be better in independent problem-solving tasks than dogs, however it is unclear whether cognitive or motivational factors underlie such differences. In a number of species problem solving has been linked to both persistence in exploration and neophobia, suggesting both these aspects may underlie dog-wolf differences in problem solving. Indeed adult wolves have been shown to be more likely to approach a novel object and more persistent in their investigation of it, but also slower in making contact with it and more fearful of it than dogs. Methods: In the current study we investigated potential differences in equally-raised dogs' and wolves' explorative and neophobic behaviors in a novel environment and with novel objects at 5, 6, and 8 weeks of age. Results: Results showed that wolves were more persistent in exploring both the environment and the objects than dogs, and this was the case at all ages. There were no differences in the frequency of fear-related behaviors and time spent in proximity to humans. Stress-related behaviors were similarly expressed at 5 and 6 weeks, although wolves showed a higher frequency of such behaviors at 8 weeks. Discussion: Overall, results with puppies confirm those with adult animals: wolves appear to be more explorative than dogs. Such motivational differences need to be taken into account when comparing dogs and wolves in cognitive tasks. PMID:28232814

Effect of German chamomile oil application on alleviating atopic dermatitis-like immune alterations in mice

PubMed Central

Lee, Soon-Hee; Heo, Yong

2010-01-01

Historically, German chamomile (GC) oil has been used for treatment of skin disorders. BALB/c mice were sensitized twice a week with 100 µL of 1% 2,4-dinitrochlorobenzene (DNCB) and challenged twice the following week with 100 µL of 0.2% DNCB for atopic dermatitis induction. Thereafter, 3% GC oil was applied daily (70 µL, 6 times week) on the dorsal skin for 4 weeks. Saline or jojoba oil was used for the control mice. Blood was collected after second DNCB challenge, and at 2 and 4 weeks after initiating oil application. Serum IgE levels were significantly lowered in the GC oil application group at the end of the 4-week application period. The GC oil application for 4 weeks resulted in reduction in serum IgG1 level compared with that after 2-week application. The GC oil application group showed a significantly lower serum histamine level than the control group 2 weeks after oil application. Scratching frequency of the GC oil application group was significantly lower than either control groups. This study is to demonstrate GC oil's immunoregulatory potential for alleviating atopic dermatitis through influencing of Th2 cell activation. PMID:20195063

Effect of German chamomile oil application on alleviating atopic dermatitis-like immune alterations in mice.

PubMed

Lee, Soon-Hee; Heo, Yong; Kim, Young-Chul

2010-03-01

Historically, German chamomile (GC) oil has been used for treatment of skin disorders. BALB/c mice were sensitized twice a week with 100 microL of 1% 2,4-dinitrochlorobenzene (DNCB) and challenged twice the following week with 100 microL of 0.2% DNCB for atopic dermatitis induction. Thereafter, 3% GC oil was applied daily (70 microL, 6 times week) on the dorsal skin for 4 weeks. Saline or jojoba oil was used for the control mice. Blood was collected after second DNCB challenge, and at 2 and 4 weeks after initiating oil application. Serum IgE levels were significantly lowered in the GC oil application group at the end of the 4-week application period. The GC oil application for 4 weeks resulted in reduction in serum IgG1 level compared with that after 2-week application. The GC oil application group showed a significantly lower serum histamine level than the control group 2 weeks after oil application. Scratching frequency of the GC oil application group was significantly lower than either control groups. This study is to demonstrate GC oil's immunoregulatory potential for alleviating atopic dermatitis through influencing of Th2 cell activation.

Recovery from impaired muscle growth arises from prolonged postnatal accretion of myonuclei in Atrx mutant mice

PubMed Central

Yan, Keqin; Price-O’Dea, Tina

2017-01-01

Reduced muscle mass due to pathological development can occur through several mechanisms, including the loss or reduced proliferation of muscle stem cells. Muscle-specific ablation of the α-thalassemia mental retardation syndrome mutant protein, Atrx, in transgenic mice results in animals with a severely reduced muscle mass at three weeks of age; yet this muscle mass reduction resolves by adult age. Here, we explore the cellular mechanism underlying this effect. Analysis of Atrx mutant mice included testing for grip strength and rotorod performance. Muscle fiber length, fiber volume and numbers of myofiber-associated nuclei were determined from individual EDL or soleus myofibers isolated at three, five, or eight weeks. Myofibers from three week old Atrx mutant mice are smaller with fewer myofiber-associated nuclei and reduced volume compared to control animals, despite similar fiber numbers. Nonetheless, the grip strength of Atrx mutant mice was comparable to control mice when adjusted for body weight. Myofiber volume remained smaller at five weeks, becoming comparable to controls by 8 weeks of age. Concomitantly, increased numbers of myofiber-associated nuclei and Ki67+ myoblasts indicated that the recovery of muscle mass likely arises from the prolonged accretion of new myonuclei. This suggests that under disease conditions the muscle satellite stem cell niche can remain in a prolonged active state, allowing for the addition of a minimum number of myonuclei required to achieve a normal muscle size. PMID:29095838

Effectiveness of aquatic exercises compared to patient-education on health status in individuals with knee osteoarthritis: a randomized controlled trial.

PubMed

Taglietti, Marcelo; Facci, Ligia Maria; Trelha, Celita Salmaso; de Melo, Fernanda Cristiane; da Silva, Daniela Wosiack; Sawczuk, Geovane; Ruivo, Thamires Marques; de Souza, Thaisley Barbosa; Sforza, Chiarella; Cardoso, Jefferson Rosa

2018-06-01

To compare the effectiveness of aquatic exercises with patient-education in individuals with knee osteoarthritis. Randomized controlled trial with blinded assessor and intention-to-treat analysis. Aquatic Physiotherapy Centre and Primary Health Care Unit. A total of 60 patients, aged 68.3 (SD = 4.8) with clinical symptoms and radiographic grading (Kellgren-Lawrence 1-4) of knee osteoarthritis were included. An eight-week treatment protocol of aquatic exercise ( n = 31) (16 individual sessions, twice a week) and an educational program (group sessions, once a week) ( n = 29). Before, after eight-week intervention, and a three-month follow-up with results for the following outcome measures: pain, function, quality of life, functional mobility, and depression. At the end of treatment, the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) functional capacity values reduced in favour of the aquatic exercise group for both the total score MD (mean difference) = -14.2; 95% CI (confidence interval) (-18; -10.5), P = 0.04 and the pain domain MD = -3.8 points; 95% CI (-8.71; -1), P = 0.021. The total score also reduced in the follow-up: MD = -12.3 points; 95% CI (-24.7; -6.1), P = 0.017. No differences were found for the outcomes functional mobility or depression. Aquatic exercise improved pain and function after eight weeks, and function at the three-month follow-up compared to the patient-education program.

Effects of mirror therapy combined with motor tasks on upper extremity function and activities daily living of stroke patients.

PubMed

Kim, Kyunghoon; Lee, Sukmin; Kim, Donghoon; Lee, Kyoungbo; Kim, Youlim

2016-01-01

[Purpose] The objective of this study was to investigate the effects of mirror therapy combined with exercise tasks on the function of the upper limbs and activities of daily living. [Subjects and Methods] Twenty-five stroke patients who were receiving physical therapy at K Hospital in Gyeonggi-do, South Korea, were classified into a mirror therapy group (n=12) and a conventional therapy group (n=13). The therapies were applied for 30 minutes per day, five times per week, for a total of four weeks. Upper limb function was measured with the Action Research Arm test, the Fugl-Meyer Assessment, and the Box and Block test, and activities of daily living were measured with the Functional Independence Measure. A paired test was performed to compare the intragroup differences between before training and after four weeks of therapy, and an independent t-test was performed to compare the differences between the two groups before and after four weeks of therapy. [Results] In the intragroup comparison, both groups showed significant differences between measurements taken before and after four weeks of therapy. In the intergroup comparison, the mirror therapy group showed significant improvements compared with the conventional therapy group, both in upper limb function and activities of daily living. [Conclusion] The findings of this study demonstrated that mirror therapy is more effective than conventional therapy for the training of stroke patients to improve their upper limb function and activities of daily living.

Efficacy and safety of intravenous belimumab in Japanese patients with systemic lupus erythematosus: a subgroup analysis of a Phase 3 randomized placebo-controlled trial.

PubMed

Tanaka, Yoshiya; Bass, Damon; Chu, Myron; Egginton, Sally; Ji, Beulah; Struemper, Herbert; Roth, David

2018-05-24

To assess the efficacy and safety of intravenous belimumab plus standard systemic lupus erythematosus (SLE) therapy (SoC) in Japanese patients with SLE. A Phase 3, multicenter, double-blind, placebo-controlled, 52-week study (BEL 113750; NCT01345253) in patients with SLE, randomized 2:1 to belimumab 10 mg/kg plus SoC or placebo plus SoC to Week 48. Sixty of 707 randomized patients were enrolled from study centers in Japan (belimumab, n = 39; placebo, n = 21). In this cohort, more patients achieved SLE Responder Index 4 response at Week 52 in the belimumab group compared with placebo (46.2% [18/39] vs 25.0% [5/20]; odds ratio, 2.57 [95% confidence interval: 0.78, 8.47]; p = 0.1204). Fewer patients receiving belimumab experienced a severe flare through Week 52, with longer median time to flare compared with placebo. More patients with baseline prednisone dose >7.5 mg/day receiving belimumab had a dose reduction of ≥25% from baseline to ≤7.5 mg/day during Weeks 40 to 52, compared with placebo. No new safety issues were identified within the Japanese cohort. In Japanese patients with SLE, belimumab improved disease activity, with efficacy and safety results similar and consistent to the pivotal Phase 3 trials, suggesting that belimumab is a potential treatment option in this population.

Rearing Laying Hens in Aviaries Reduces Fearfulness following Transfer to Furnished Cages

PubMed Central

Brantsæter, Margrethe; Tahamtani, Fernanda M.; Moe, Randi O.; Hansen, Tone B.; Orritt, Rachel; Nicol, Christine; Janczak, Andrew M.

2016-01-01

Appropriate rearing is essential for ensuring the welfare and productivity of laying hens. Early experience has the potential to affect the development of fearfulness. This study tested whether rearing in aviaries, as opposed to cages, reduces the fearfulness of laying hens after transfer to furnished cages. Fear responses were recorded as avoidance of a novel object in the home cage. Lohmann Selected Leghorns were reared in an aviary system or conventional rearing cages and then transported to furnished cages at 16 weeks, before the onset of lay. Observations of a selection of birds were conducted at 19 (N = 50 independent cages) and 21 (N = 48 independent cages) weeks of age. At 19 and 21 weeks, cage-reared birds showed higher levels of fearfulness indicated by spending more time away from the novel object compared to aviary-reared birds. These results suggest that rearing in an enriched aviary environment reduces fearfulness up to the fifth week after transfer to a new housing system, compared to rearing in cages. PMID:26955634

Treadmill training with partial body-weight support after anterior cruciate ligament reconstruction: a randomized controlled trial.

PubMed

Luo, Yuan; Shen, Weizhong; Jiang, Zhong; Sha, Jiao

2016-12-01

[Purpose] To compare the effects of treadmill training with partial body weight support (TTPBWS) and conventional physical therapy (PT) on subjects with anterior cruciate ligament reconstructions. [Subjects and Methods] A total of 40 subjects were randomly allocated to either a treatment group or a control group. Subjects received either treadmill training with partial body weight support (treatment group) or conventional physical therapy (control group). The circumferences of the lower extremities, Holden classifications, 10-meter walking times and the International Knee Documentation Committee (IKDC) scores were compared at 12 and 24 weeks post-operation. The knee joint stability was tested at 24 weeks post-operation using a KT-1000. [Results] Significant differences were found between the two groups at the 12 weeks post-operation. For most of the measures, there was no significant difference between the groups at 24 weeks post-operation. Interestingly, for most of the measures, there was no significant difference between their values in the treatment group at 12 weeks and their values in the control group at 24 weeks post-operation. [Conclusion] The function of a subject's lower extremities can be improved and the improvement was clearly accelerated by the intervention of treadmill training with partial body weight support, without compromising the stability of the knee joints in a given follow-up period.

Recombinant methioninase combined with doxorubicin (DOX) regresses a DOX-resistant synovial sarcoma in a patient-derived orthotopic xenograft (PDOX) mouse model

PubMed Central

Igarashi, Kentaro; Kawaguchi, Kei; Li, Shukuan; Han, Qinghong; Tan, Yuying; Gainor, Emily; Kiyuna, Tasuku; Miyake, Kentaro; Miyake, Masuyo; Higuchi, Takashi; Oshiro, Hiromichi; Singh, Arun S.; Eckardt, Mark A.; Nelson, Scott D.; Russell, Tara A.; Dry, Sarah M.; Li, Yunfeng; Yamamoto, Norio; Hayashi, Katsuhiro; Kimura, Hiroaki; Miwa, Shinji; Tsuchiya, Hiroyuki; Eilber, Fritz C.; Hoffman, Robert M.

2018-01-01

Synovial sarcoma (SS) is a recalcitrant subgroup of soft tissue sarcoma (STS). A tumor from a patient with high grade SS from a lower extremity was grown orthotopically in the right biceps femoris muscle of nude mice to establish a patient-derived orthotopic xenograft (PDOX) mouse model. The PDOX mice were randomized into the following groups when tumor volume reached approximately 100 mm3: G1, control without treatment; G2, doxorubicin (DOX) (3 mg/kg, intraperitoneal [i.p.] injection, weekly, for 2 weeks; G3, rMETase (100 unit/mouse, i.p., daily, for 2 weeks); G4 DOX (3mg/kg), i.p. weekly, for 2 weeks) combined with rMETase (100 unit/mouse, i.p., daily, for 2 weeks). On day 14 after treatment initiation, all therapies significantly inhibited tumor growth compared to untreated control, except DOX: (DOX: p = 0.48; rMETase: p < 0.005; DOX combined with rMETase < 0.0001). DOX combined with rMETase was significantly more effective than both DOX alone (p < 0.001) and rMETase alone (p < 0.05). The relative body weight on day 14 compared with day 0 did not significantly differ between any treatment group or untreated control. The results indicate that r-METase can overcome DOX-resistance in this recalcitrant disease. PMID:29721200

Outcomes of Term Induction in Trial of Labor After Cesarean Delivery: Analysis of a Modern Obstetric Cohort.

PubMed

Lappen, Justin R; Hackney, David N; Bailit, Jennifer L

2015-07-01

To evaluate outcomes of induction of labor, compared with expectant management, in women attempting trial of labor after cesarean delivery (TOLAC) in a large obstetric cohort. We performed a secondary analysis of data from the Consortium on Safe Labor that included women with term (37 weeks of gestation or greater) singleton gestations and a history of one prior cesarean delivery who attempted TOLAC. Induction of labor was compared with expectant management by week of gestation from 37 to 40 weeks in both high- and low-risk cohorts. The primary outcome was failed TOLAC. Secondary outcomes included composite maternal morbidity (hysterectomy, transfusion, intensive care unit (ICU) transfer, venous thromboembolism, death), composite neonatal morbidity (5-minute Apgar score less than 5, cord pH less than 7.0, asphyxia, hypoxic ischemic encephalopathy, neonatal death), and neonatal ICU admission. Multivariate logistic regression was performed with adjustment for confounding factors. We identified 6,033 women attempting TOLAC of whom 1,626 (27.0%) underwent induction of labor and 4,407 (73.0%) did not. Compared with expectant management, induction was associated with an increased risk of failed TOLAC at 37-39 weeks of gestation but not at 40 weeks of gestation (37 weeks of gestation, 48.5% compared with 34.3%, adjusted odds ratio [OR] 1.53, 95% confidence interval [CI] 1.02-2.28]; 38 weeks of gestation, 47.0% compared with 33.0%, adjusted OR 1.74, 95% CI 1.29-2.34; 39 weeks of gestation, 45.6% compared with 29.8%, adjusted OR 2.16, 95% CI 1.76-2.67; 40 weeks of gestation, 37.9% compared with 29.4%, adjusted OR 1.21, 95% CI 0.90-1.66). Induction was associated with an increased risk of composite maternal morbidity at 39 weeks of gestation (adjusted OR 1.87, 95% CI 1.22-2.87) and neonatal ICU admission at 37 weeks of gestation (adjusted OR 2.51, 95% CI 1.62-3.90). Induction was not associated with an increased risk of neonatal morbidity. Induction of labor in women with one prior cesarean delivery, compared with expectant management, is associated with an increased risk of failed TOLAC. Apart from small increases in maternal morbidity at 39 weeks and neonatal ICU admission at 37 weeks of gestation, induction is not associated with an increased risk of severe maternal or neonatal morbidity. II.

A pilot study on mindfulness based stress reduction for smokers

PubMed Central

Davis, James M; Fleming, Michael F; Bonus, Katherine A; Baker, Timothy B

2007-01-01

Background Mindfulness means paying attention in the present moment, non-judgmentally, without commentary or decision-making. We report results of a pilot study designed to test the feasibility of using Mindfulness Based Stress Reduction (MBSR) (with minor modifications) as a smoking intervention. Methods MBSR instructors provided instructions in mindfulness in eight weekly group sessions. Subjects attempted smoking cessation during week seven without pharmacotherapy. Smoking abstinence was tested six weeks after the smoking quit day with carbon monoxide breath test and 7-day smoking calendars. Questionnaires were administered to evaluate changes in stress and affective distress. Results 18 subjects enrolled in the intervention with an average smoking history of 19.9 cigarettes per day for 26.4 years. At the 6-week post-quit visit, 10 of 18 subjects (56%) achieved biologically confirmed 7-day point-prevalent smoking abstinence. Compliance with meditation was positively associated with smoking abstinence and decreases in stress and affective distress. Discussions and conclusion The results of this study suggest that mindfulness training may show promise for smoking cessation and warrants additional study in a larger comparative trial. PMID:17254362

The influence of different types of brackets and efficacy of two chlorhexidine mouthwashes on oral hygiene and the incidence of white spot lesions in adolescents during the orthodontic therapy.

PubMed

Jurišić, Sanja; Kozomara, Davorin; Jurić, Hrvoje; Verzak, Željko; Jurišić, Gordan

2016-12-01

To detect the effect of two different types of brackets (ceramic and stainless steel) and investigate the effectiveness of two chlorhexidine mouthwashes 0.2% (CHX) on oral hygiene status and incidence of white spot lesions (WSLs) in adolescents wearing fixed orthodontic appliance. One hundred and twenty subjects (aged 11 to 18 years, mean age 14.5 years) were divided into six equal groups according to brackets type and to different mouthwashes: Group 1: metal brackets and conventional CHX, Group 2: metal brackets and CHX with anti-discoloration system (CHX-ADS), Group 3: ceramic brackets and conventional CHX, Group 4: ceramic brackets and CHX-ADS, Group 5: metal brackets and water correction flavors mouthwash (placebo), Group 6: ceramic brackets and placebo. Four weeks after the placement of fixed orthodontic appliance the subjects were provided with three different mouthwashes for use during the next two weeks. Assessment was carried out according to oral hygiene index-simplified (OHI-S) and WSL index performed: prior to placement of the appliance (baseline), four weeks, six weeks, eighteen weeks, and thirty weeks after the placement. The data were then subjected to statistical analysis. Group 4 showed reduction in the OHI-S scores when compared to the Group 5 (in the 6 th week), and Group 6 (in the 6 th and 18 th week), which was statistically significant, P<0.05. Group 4 showed decrease in the WSLs scores when compared to the Group 1 (in the 4 th , 6 th , 18 th and 30 th week), Group 5 (in the 18 th and 30 th week) and Group 6 (in the 6 th , 18 th and 30 th week), which was statistically significant, P<0.05. The ceramic brackets and the usage of CHX-ADS resulted in better oral hygiene status and lower incidence of WSLs.

Comparative Efficacy of Platelet Rich Plasma Injection, Corticosteroid Injection and Ultrasonic Therapy in the Treatment of Periarthritis Shoulder.

PubMed

Kothari, Shashank Yeshwant; Srikumar, Venkataraman; Singh, Neha

2017-05-01

Periarthritis (PA) shoulder characterised by pain and restricted range of motion has a plethora of treatment options with inconclusive evidence. Platelet Rich Plasma (PRP) is an emerging treatment option and its efficacy needs to be examined and compared with other routine interventions. To assess the efficacy of PRP injection and compare it with corticosteroid injection and ultrasonic therapy in the treatment of PA shoulder. Patients with PA shoulder (n=195) were randomised to receive single injection of PRP (2 ml) or corticosteroid (80 mg of methylprednisolone) or ultrasonic therapy (seven sittings in two weeks; 1.5 W/cm 2 , 1 MHz, continuous mode). All participants were also advised to perform a home based 10 minute exercise therapy. The primary outcome measure was active range of motion of the shoulder. Secondary outcome measures used were Visual Analogue Scale (VAS) for pain and a shortened version of Disabilities of the Arm, Shoulder and Hand (QuickDASH) for function. Participants were evaluated at 0, 3, 6 and 12 weeks. Chi-square test, one way and repeated measures of ANOVA tests were used to determine significant differences. PRP treatment resulted in statistically significant improvements over corticosteroid and ultrasonic therapy in active as well as passive range of motion of shoulder, VAS and QuickDASH at 12 weeks. At six weeks, PRP treatment resulted in statistically significant improvements over ultrasonic therapy in VAS and QuickDASH. No major adverse effects were observed. This study demonstrates that single injection of PRP is effective and better than corticosteroid injection or ultrasonic therapy in treatment of PA shoulder.

Gut Microbiota Composition Before and After Use of Proton Pump Inhibitors.

PubMed

Hojo, Mariko; Asahara, Takashi; Nagahara, Akihito; Takeda, Tsutomu; Matsumoto, Kohei; Ueyama, Hiroya; Matsumoto, Kenshi; Asaoka, Daisuke; Takahashi, Takuya; Nomoto, Koji; Yamashiro, Yuichiro; Watanabe, Sumio

2018-05-24

Recently, problems associated with proton pump inhibitor (PPI) use have begun to surface. PPIs influence the gut microbiota; therefore, PPI use may increase the risk of enteric infections and cause bacterial translocation. In this study, we investigated fecal microbiota composition, fecal organic acid concentrations and pH, and gut bacteria in the blood of the same patients before and after PPI use. Twenty patients with reflux esophagitis based on endoscopic examination received 8 weeks of treatment with PPIs. To analyze fecal microbiota composition and gut bacteria in blood and organic acid concentrations, 16S and 23S rRNA-targeted quantitative RT-PCR and high-performance liquid chromatography were conducted. Lactobacillus species were significantly increased at both 4 and 8 weeks after PPI treatment compared with bacterial counts before treatment (P = 0.011 and P = 0.002, respectively). Among Lactobacillus spp., counts of the L. gasseri subgroup, L. fermentum, the L. reuteri subgroup, and the L. ruminis subgroup were significantly increased at 4 and 8 weeks after treatment compared with counts before treatment. Streptococcus species were also significantly increased at 4 and 8 weeks after PPI treatment compared with counts before treatment (P < 0.01 and P < 0.001, respectively). There was no significant difference in the total organic acid concentrations before and after PPI treatment. Detection rates of bacteria in blood before and after PPI treatment were 22 and 28%, respectively, with no significant differences. Our quantitative RT-PCR results showed that gut dysbiosis was caused by PPI use, corroborating previous results obtained by metagenomic analysis.

Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis

PubMed Central

Takeuchi, Tsutomu; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Kobayashi, Mariko; Shoji, Toshiharu; Togo, Osamu; Miyasaka, Nobuyuki; Koike, Takao

2016-01-01

Abstract Objectives: To compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies. Methods: Data from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies. Results: In both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]). Conclusions: Despite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile. PMID:26472043

Intensive Versus Distributed Aphasia Therapy: A Nonrandomized, Parallel-Group, Dosage-Controlled Study.

PubMed

Dignam, Jade; Copland, David; McKinnon, Eril; Burfein, Penni; O'Brien, Kate; Farrell, Anna; Rodriguez, Amy D

2015-08-01

Most studies comparing different levels of aphasia treatment intensity have not controlled the dosage of therapy provided. Consequently, the true effect of treatment intensity in aphasia rehabilitation remains unknown. Aphasia Language Impairment and Functioning Therapy is an intensive, comprehensive aphasia program. We investigated the efficacy of a dosage-controlled trial of Aphasia Language Impairment and Functioning Therapy, when delivered in an intensive versus distributed therapy schedule, on communication outcomes in participants with chronic aphasia. Thirty-four adults with chronic, poststroke aphasia were recruited to participate in an intensive (n=16; 16 hours per week; 3 weeks) versus distributed (n=18; 6 hours per week; 8 weeks) therapy program. Treatment included 48 hours of impairment, functional, computer, and group-based aphasia therapy. Distributed therapy resulted in significantly greater improvements on the Boston Naming Test when compared with intensive therapy immediately post therapy (P=0.04) and at 1-month follow-up (P=0.002). We found comparable gains on measures of participants' communicative effectiveness, communication confidence, and communication-related quality of life for the intensive and distributed treatment conditions at post-therapy and 1-month follow-up. Aphasia Language Impairment and Functioning Therapy resulted in superior clinical outcomes on measures of language impairment when delivered in a distributed versus intensive schedule. The therapy progam had a positive effect on participants' functional communication and communication-related quality of life, regardless of treatment intensity. These findings contribute to our understanding of the effect of treatment intensity in aphasia rehabilitation and have important clinical implications for service delivery models. © 2015 American Heart Association, Inc.

The role of early magnetic resonance imaging in predicting survival on bevacizumab for recurrent glioblastoma: Results from a prospective clinical trial (CABARET).

PubMed

Field, Kathryn M; Phal, Pramit M; Fitt, Greg; Goh, Christine; Nowak, Anna K; Rosenthal, Mark A; Simes, John; Barnes, Elizabeth H; Sawkins, Kate; Cher, Lawrence M; Hovey, Elizabeth J; Wheeler, Helen

2017-09-15

Bevacizumab has been associated with prolonged progression-free survival for patients with recurrent glioblastoma; however, not all derive a benefit. An early indicator of efficacy or futility may allow early discontinuation for nonresponders. This study prospectively assessed the role of early magnetic resonance imaging (eMRI) and its correlation with subsequent routine magnetic resonance imaging (MRI) results and survival. Patients were part of a randomized phase 2 clinical trial (CABARET) comparing bevacizumab with bevacizumab plus carboplatin for recurrent glioblastoma. eMRI was conducted after 4 weeks in the trial (after 2 treatments with bevacizumab [10 mg/kg every 2 weeks]). The results were compared with the results of the subsequent 8-week MRI standard. For 119 of 122 patients, eMRI was available, and 111 had subsequent MRI for comparison. Thirty-six (30%) had an early radiological response, and 17 (14%) had progressive disease. The concordance between eMRI and 8-week MRI was moderate (κ = 0.56), with most providing the same result (n = 79 [71%]). There was strong evidence that progression-free survival and overall survival were predicted by the eMRI response (both P values < .001). The median survival was 8.6 months for an eMRI response, 6.6 months for stable disease, and 3.7 months for progressive disease; the hazard ratio (progressive disease vs stable disease) was 3.4 (95% confidence interval, 1.9-6.0). Landmark analyses showed that eMRI progression was a strong predictor of mortality independent of other potential baseline predictors. In this study, early progression on MRI appears to be a robust marker of a poor prognosis for patients on bevacizumab. Cancer 2017;123:3576-82. © 2017 American Cancer Society. © 2017 American Cancer Society.

Effect of Sexual Counseling on Marital Satisfaction of Pregnant Women Referring to Health Centers in Malayer (Iran): An educational randomized experimental study

PubMed Central

Masoumi, Seyedeh Zahra; Kazemi, Farideh; Nejati, Behnaz; Parsa, Parisa; Karami, Manoochehr

2017-01-01

Introduction One of the most important factors in marital satisfaction is the satisfaction of a healthy sexual relationship between spouses. During pregnancy marital satisfaction may decrease due to sexual problems. Sexual counseling to pregnant women may reduce the complications of these problems at this time. This study aimed to investigate the effects of sexual counseling on marital satisfaction of pregnant women. This article is sponsored by the Hamadan University of Medical Sciences. Methods This educational randomized experimental study was conducted on 80 pregnant women referring to health centers of Malayer. Samples were two groups of experimental and control, with forty participants in each group, four consultation sessions were held, and each session lasted 40 to 90 minutes Data gathering tools were demographic questionnaire and Enriching Relationship Issues Communication and Happiness (ENRICH), a short form of marital satisfaction questionnaire with 47 items. Data were analyzed by Software SPSS 22 and the results were compared by independent t-test, chi-square test, and repeated measure ANOVA. Results Comparing the marital satisfaction mean scores in the experimental group showed a significant difference between pre-consultation, and the consultation after two and four weeks. Marital satisfaction score of 8.05 ± 51.20 before the consultation was increased to 7.76 ± 54.52 after two weeks and 6.48 ± 59.20 after four weeks (respectively p < 0.001, p < 0.001). In addition, mean and standard deviation of marital satisfaction in the control group before the intervention, two weeks and four weeks after the intervention were respectively 10.10 ± 45.67, 11.75 ± 47.75, and 10.02 ± 46.30 and Bonferroni post hoc test showed a significant difference between before and two weeks after intervention (p = 0.03). However, marital satisfaction before and four weeks after the intervention was not significant (p = 0.59). The results showed that sexual counseling was associated with marital satisfaction and was effective in its promotion. Conclusion Sexual counseling can be used as a method of intervention in sexual relationship of spouses particularly in marital dissatisfaction. PMID:28243412

The influence of vascularization of transplanted processed allograft nerve on return of motor function in rats.

PubMed

Giusti, Guilherme; Lee, Joo-Yup; Kremer, Thomas; Friedrich, Patricia; Bishop, Allen T; Shin, Alexander Y

2016-02-01

Processed nerve allografts have become an alternative to repair segmental nerve defects, with results comparable with autografts regarding sensory recovery; however, they have failed to reproduce comparable motor recovery. The purpose of this study was to determine how revascularizaton of processed nerve allograft would affect motor recovery. Eighty-eight rats were divided in four groups of 22 animals each. A unilateral 10-mm sciatic nerve defect was repaired with allograft (group I), allograft wrapped with silicone conduit (group II), allograft augmented with vascular endothelial growth factor (group III), or autograft (group IV). Eight animals from each group were sacrificed at 3 days, and the remaining animals at 16 weeks. Revascularization was evaluated by measuring the graft capillary density at 3 days and 16 weeks. Measurements of ankle contracture, compound muscle action potential, tibialis anterior muscle weight and force, and nerve histomorphometry were performed at 16 weeks. All results were normalized to the contralateral side. The results of capillary density at 3 days were 0.99% ± 1.3% for group I, 0.33% ± 0.6% for group II, 0.05% ± 0.1% for group III, and 75.6% ± 45.7% for group IV. At 16 weeks, the results were 69.9% ± 22.4% for group I, 37.0% ± 16.6% for group II, 84.6% ± 46.6% for group III, and 108.3% ± 46.8% for group IV. The results of muscle force were 47.5% ± 14.4% for group I, 21.7% ± 13.5% for group II, 47.1% ± 7.9% for group III, and 54.4% ± 10.6% for group IV. The use of vascular endothelial growth factor in the fashion used in this study improved neither the nerve allograft short-term revascularization nor the functional motor recovery after 16 weeks. Blocking allograft vascularization from surrounding tissues was detrimental for motor recovery. The processed nerve allografts used in this study showed similar functional motor recovery compared with that of the autograft. © 2014 Wiley Periodicals, Inc.

The impact of a new universal postpartum program on breastfeeding outcomes.

PubMed

Sheehan, Debbie; Watt, Susan; Krueger, Paul; Sword, Wendy

2006-11-01

The Ontario Mother and Infant Study II examined changes in postpartum health outcomes, including breastfeeding initiation and discontinuation, for mothers and their infants and compared these results to data collected prior to the initiation of the Universal Hospital Stay and Postpartum Home Visiting Program policy change in 1998. Data were collected using cross-sectional surveys before discharge and at 4 weeks postdischarge. Ninety percent of the women surveyed at 4 weeks postpartum initiated breastfeeding. Of these, 84% were still breastfeeding at 4 weeks postpartum. None of the 3 major program components-extended length of stay, a postpartum phone call from a public health worker, or a postpartum in-home visit-were associated with breastfeeding continuation to 4 weeks. Discontinuation before 4 weeks postdischarge was associated with maternal attitudes toward breastfeeding, formula feeding or supplementation in hospital, infant readmission, and use of walk-in clinics for infant care.

Effect of Aromatherapy Massage on Agitation and Depressive Mood in Individuals With Dementia.

PubMed

Yang, Ya-Ping; Wang, Chi-Jane; Wang, Jing-Jy

2016-09-01

The current study examined the effects of aromatherapy massage on alleviating agitation and depressive mood in individuals with dementia. A randomized controlled trial and repeated measures design was conducted. A total of 59 participants were randomly assigned to intervention or control groups. The intervention group received aromatherapy massage once per week for 8 weeks. Results indicated no significant changes over time in overall agitation for either group, but agitation decreased from Week 1 to Week 5 for the intervention group. In addition, the overall depressive symptoms decreased significantly over time for the intervention group compared to the control group (p < 0.001). However, changes in agitation within 24 hours following aromatherapy massage showed some significant changes in Weeks 5 and 9. Aromatherapy massage can be an effective and safe intervention to alleviate specific agitated behaviors and depressive mood in individuals with dementia. [Journal of Gerontological Nursing, 42(9), 38-46.]. Copyright 2016, SLACK Incorporated.

Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation

PubMed Central

Lobley, Grace; Worrall, Sandra; Powell, Richard; Kimani, Peter K; Banerjee, Prithwish; Barker, Thomas

2018-01-01

Introduction Current guidelines recommend abstinence from supervised cardiac rehabilitation (CR) exercise training for 6 weeks post-sternotomy. This practice is not based on empirical evidence, thus imposing potentially unnecessary activity restrictions. Delayed participation in CR exercise training promotes muscle atrophy, reduces cardiovascular fitness and prolongs recovery. Limited data suggest no detrimental effect of beginning CR exercise training as early as 2 weeks post-surgery, but randomised controlled trials are yet to confirm this. The purpose of this trial is to compare CR exercise training commenced early (2 weeks post-surgery) with current usual care (6 weeks post-surgery) with a view to informing future CR guidelines for patients recovering from sternotomy. Methods and analysis In this assessor-blind randomised controlled trial, 140 cardiac surgery patients, recovering from sternotomy, will be assigned to 8 weeks of twice-weekly supervised CR exercise training commencing at either 2 weeks (early CR) or 6 weeks (usual care CR) post-surgery. Usual care exercise training will adhere to current UK recommendations. Participants in the early CR group will undertake a highly individualised 2–3 week programme of functional mobility, strength and cardiovascular exercise before progressing to a usual care CR programme. Outcomes will be assessed at baseline (inpatient), pre-CR (2 or 6 weeks post-surgery), post-CR (10 or 14 weeks post-surgery) and 12 months. The primary outcome will be change in 6 min walk distance. Secondary outcomes will include measures of functional fitness, quality of life and cost-effectiveness. Ethics and dissemination Recruitment commenced on July 2017 and will complete by December 2019. Results will be disseminated via national governing bodies, scientific meetings and peer-reviewed journals. Trial registration number NCT03223558; Pre-results. PMID:29574443

Effects of briakinumab treatment for moderate to severe psoriasis on health-related quality of life and work productivity and activity impairment: results from a randomized phase III study.

PubMed

Papp, K A; Sundaram, M; Bao, Y; Williams, D A; Gu, Y; Signorovitch, J E; Wang, Y; Valdes, J M; Mulani, P M

2014-06-01

Psoriasis is known to have a significant negative impact on a patient's health-related quality of life, including social, recreational and work activities. To evaluate the effects of briakinumab on quality of life and work productivity measures in patients with moderate to severe psoriasis. Patients received either briakinumab (n = 981) or placebo (n = 484) during the 12-week induction phase of trial M06-890. At week 12, patients with a Physician's Global Assessment score of 'Clear' or 'Minimal' entered the 40-week maintenance phase and were to receive briakinumab every 4 weeks, briakinumab every 12 weeks, or placebo. At weeks 12 and 52, treatment groups were compared using mean change from baseline in health-related quality of life and Work Productivity and Activity Impairment Questionnaire scores and the percentage of patients with minimum clinically important differences. At week 12, more than half of the briakinumab-treated patients achieved improvements meeting or exceeding minimum clinically important differences for Dermatology Life Quality Index (75.9%), and psoriasis- (64.8%), and psoriatic arthritis-related (54.1%) pain scores; 48.4% achieved improvements for activity impairment. Although improvements in quality of life and work productivity measures were maintained at week 52 for both briakinumab regimens, responder rates were consistently greater in the every-4-week group than in the every-12-week group. Briakinumab treatment resulted in clinically significant improvements in quality of life and work productivity in adults with moderate to severe psoriasis. Maintenance therapy was associated with a more pronounced benefit for the every-4-week briakinumab regimen. © 2013 European Academy of Dermatology and Venereology.

Protein-Pacing Caloric-Restriction Enhances Body Composition Similarly in Obese Men and Women during Weight Loss and Sustains Efficacy during Long-Term Weight Maintenance.

PubMed

Arciero, Paul J; Edmonds, Rohan; He, Feng; Ward, Emery; Gumpricht, Eric; Mohr, Alex; Ormsbee, Michael J; Astrup, Arne

2016-07-30

Short-Term protein-pacing (P; ~6 meals/day, >30% protein/day) and caloric restriction (CR, ~25% energy deficit) improves total (TBF), abdominal (ABF) and visceral (VAT) fat loss, energy expenditure, and biomarkers compared to heart healthy (HH) recommendations (3 meals/day, 15% protein/day) in obese adults. Less is known whether obese men and women respond similarly to P-CR during weight loss (WL) and whether a modified P-CR (mP-CR) is more efficacious than a HH diet during long-term (52 week) weight maintenance (WM). The purposes of this study were to evaluate the efficacy of: (1) P-CR on TBF, ABF, resting metabolic rate (RMR), and biomarkers between obese men and women during WL (weeks 0-12); and (2) mP-CR compared to a HH diet during WM (weeks 13-64). During WL, men (n = 21) and women (n = 19) were assessed for TBF, ABF, VAT, RMR, and biomarkers at weeks 0 (pre) and 12 (post). Men and women had similar reductions (p < 0.01) in weight (10%), TBF (19%), ABF (25%), VAT (33%), glucose (7%-12%), insulin (40%), leptin (>50%) and increase in % lean body mass (9%). RMR (kcals/kg bodyweight) was unchanged and respiratory quotient decreased 9%. Twenty-four subjects (mP-CR, n = 10; HH, n = 14) completed WM. mP-CR regained significantly less body weight (6%), TBF (12%), and ABF (17%) compared to HH (p < 0.05). Our results demonstrate P-CR enhances weight loss, body composition and biomarkers, and maintains these changes for 52-weeks compared to a traditional HH diet.

Protein-Pacing Caloric-Restriction Enhances Body Composition Similarly in Obese Men and Women during Weight Loss and Sustains Efficacy during Long-Term Weight Maintenance

PubMed Central

Arciero, Paul J.; Edmonds, Rohan; He, Feng; Ward, Emery; Gumpricht, Eric; Mohr, Alex; Ormsbee, Michael J.; Astrup, Arne

2016-01-01

Short-Term protein-pacing (P; ~6 meals/day, >30% protein/day) and caloric restriction (CR, ~25% energy deficit) improves total (TBF), abdominal (ABF) and visceral (VAT) fat loss, energy expenditure, and biomarkers compared to heart healthy (HH) recommendations (3 meals/day, 15% protein/day) in obese adults. Less is known whether obese men and women respond similarly to P-CR during weight loss (WL) and whether a modified P-CR (mP-CR) is more efficacious than a HH diet during long-term (52 week) weight maintenance (WM). The purposes of this study were to evaluate the efficacy of: (1) P-CR on TBF, ABF, resting metabolic rate (RMR), and biomarkers between obese men and women during WL (weeks 0–12); and (2) mP-CR compared to a HH diet during WM (weeks 13–64). During WL, men (n = 21) and women (n = 19) were assessed for TBF, ABF, VAT, RMR, and biomarkers at weeks 0 (pre) and 12 (post). Men and women had similar reductions (p < 0.01) in weight (10%), TBF (19%), ABF (25%), VAT (33%), glucose (7%–12%), insulin (40%), leptin (>50%) and increase in % lean body mass (9%). RMR (kcals/kg bodyweight) was unchanged and respiratory quotient decreased 9%. Twenty-four subjects (mP-CR, n = 10; HH, n = 14) completed WM. mP-CR regained significantly less body weight (6%), TBF (12%), and ABF (17%) compared to HH (p < 0.05). Our results demonstrate P-CR enhances weight loss, body composition and biomarkers, and maintains these changes for 52-weeks compared to a traditional HH diet. PMID:27483317

Physical activity and academic achievement across the curriculum: Results from a 3-year cluster-randomized trial.

PubMed

Donnelly, Joseph E; Hillman, Charles H; Greene, Jerry L; Hansen, David M; Gibson, Cheryl A; Sullivan, Debra K; Poggio, John; Mayo, Matthew S; Lambourne, Kate; Szabo-Reed, Amanda N; Herrmann, Stephen D; Honas, Jeffery J; Scudder, Mark R; Betts, Jessica L; Henley, Katherine; Hunt, Suzanne L; Washburn, Richard A

2017-06-01

We compared changes in academic achievement across 3years between children in elementary schools receiving the Academic Achievement and Physical Activity Across the Curriculum intervention (A+PAAC), in which classroom teachers were trained to deliver academic lessons using moderate-to-vigorous physical activity (MVPA) compared to a non-intervention control. Elementary schools in eastern Kansas (n=17) were cluster randomized to A+PAAC (N=9, target ≥100min/week) or control (N=8). Academic achievement (math, reading, spelling) was assessed using the Wechsler Individual Achievement Test-Third Edition (WIAT-III) in a sample of children (A+PAAC=316, Control=268) in grades 2 and 3 at baseline (Fall 2011) and repeated each spring across 3years. On average 55min/week of A+PACC lessons were delivered each week across the intervention. Baseline WIAT-III scores (math, reading, spelling) were significantly higher in students in A+PAAC compared with control schools and improved in both groups across 3years. However, linear mixed modeling, accounting for baseline between group differences in WIAT-III scores, ethnicity, family income, and cardiovascular fitness, found no significant impact of A+PAAC on any of the academic achievement outcomes as determined by non-significant group by time interactions. A+PAAC neither diminished or improved academic achievement across 3-years in elementary school children compared with controls. Our target of 100min/week of active lessons was not achieved; however, students attending A+PAAC schools received an additional 55min/week of MVPA which may be associated with both physical and mental health benefits, without a reduction in time devoted to academic instruction. Copyright © 2017. Published by Elsevier Inc.

Non-severe Hypoglycemia Risk Difference between Sulfonylurea and Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2-I) as an Add-On to Metformin in Randomized Controlled Trials.

PubMed

Farahani, Pendar

2017-05-23

Non-severe hypoglycemia reduces well-being, lowers quality of life, reduces productivity and increases treatment costs. The non-severe hypoglycemia rate, attributable to sulfonylurea (SU) utilization compared with newer classes such as SGLT2-I, could be of clinical significance. To explore the non-severe hypoglycemia risk difference (RD) for SU use compared with SGLT2-I in randomized controlled trials (RCTs) as an add on to metformin. A search was conducted for RCTs of SGLT2-I. PubMed database were utilized for this search. The search was limited to RCTs reported in English language for canagliflozin, dapagliflozin, and empagliflozin. SU dose comparison was utilized to convert the dose of SUs to glimepiride equivalent doses. Totally, 118 RCTs were reviewed; 6 articles had an arm for a SU as add on to metformin. Six articles belong to 3 RCTs, which reported results for 52 weeks and 104 weeks. Average non-severe hypoglycemia rate for SU arm was 30% (5.5%) [Mean (SD)] for 52 weeks and 35.6% (6.1%) for 104 weeks. RD for non-severe hypoglycemia events for SU compared to SGLT2-I was 26.7% (4.9%) for 52 weeks (p-value less than 0.001) and 30.6% (5.5%) for 104 weeks (p-value less than 0.001). There was a significant correlation between dose of SU and hypoglycemia rate (Pearson correlation 0.995; R-square 99%). This study illustrated that a large proportion of patients who had exposure to SU in RCTs of SGLT2-I experienced non-severe hypoglycemia compared to SGLT2-I. There was a close relation between SU dose and increased probability of non-severe hypoglycemia events. © 2017 Journal of Population Therapeutics and Clinical Pharmacology. All rights reserved.

Randomized open-labbel non-inferiority trial of acetaminophen or loxoprofen for patients with acute low back pain.

PubMed

Miki, Kenji; Ikemoto, Tatsunori; Hayashi, Kazuhiro; Arai, Young-Chang; Sekiguchi, Miho; Shi, Kenrin; Ushida, Takahiro

2018-05-01

Current worldwide clinical practice guidelines recommend acetaminophen as the first option for the treatment of acute low back pain. However, there is no concrete evidence regarding whether acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) is more effective for treating acute low back pain (LBP) in Japan. The present study aimed to investigate whether acetaminophen treatment for acute musculoskeletal pain was comparable with loxoprofen (a traditional NSAID in Japan) treatment. Of the 140 patients with acute LBP who visited out-patient hospitals, 127 were considered eligible and were randomly allocated to a group taking acetaminophen or one taking loxoprofen. As primary outcome measure, pain intensity was measured using a 0-10-numeric rating scale (NRS). Moreover, pain disability, pain catastrophizing, anxiety, depression, and quality of life, as well as adverse events, were assessed as secondary outcomes. The primary outcome was tested with a noninferiority margin (0.84 on changes in pain-NRS), and the secondary outcomes were compared using conventional statistical methods at week 2 and week 4. Seventy patients completed the study (acetaminophen: 35, loxoprofen: 35). The dropout rates showed no significant difference between the two medication-groups. We found that the mean differences of changes in pain-NRS from baseline to week 2 or 4 between the two medication groups were not statistically beyond the noninferiority margin (mean [95% confidence interval]: -0.51 [-1.70, 0.67], at week 2 and -0.80 [-2.08, 0.48] at week 4). There were no consistent differences between the two medication groups in terms of secondary outcomes. The results suggest that acetaminophen has comparable analgesic effects on acute LBP, based on at least a noninferiority margin, compared with loxoprofen at 4 weeks. Acetaminophen seems to be a reasonable first-line option for patients with acute LBP in Japan. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg.

PubMed

Katz, Philip O; Le Moigne, Anne; Pollack, Charles

2017-05-01

These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44.5 and 22.3 mg, respectively) or placebo once daily for 4 weeks. Subjects recorded the severity of heartburn in a daily diary, and investigators assessed subjects at each study visit. Two-week assessments were the primary end points of interest in these analyses and included the percentage of subjects with complete heartburn resolution (no episodes during 7 consecutive days), time to sustained complete heartburn resolution (the first of 7 consecutive episode-free days), and heartburn relief (no episodes other than ≤1 mild episode during 7 consecutive days). At week 2, the percentages of subjects who experienced complete heartburn resolution were significantly greater with esomeprazole 40 mg (study 1, 26.1%; study 2, 35.3%) and 20 mg (study 1, 25.2%; study 2, 35.7%) compared with placebo (study 1, 9.0%; study 2, 3.4%) (all, P ≤ 0.001). Beginning on day 1, the percentages of subjects who experienced sustained heartburn resolution was significantly greater in the groups treated with esomeprazole 40 mg (study 1, 19%; study 2, 19%; P < 0.0001) and 20 mg (study 1, 10%; study 2, 15%; P < 0.05) compared with the group that received placebo (study 1, 2%; study 2, 1%). Additionally, at week 2, the percentages of subjects experiencing heartburn relief were significantly greater with esomeprazole 40 mg (study 1, 35.3%; study 2, 40.5%) and 20 mg (study 1, 34.5%; study 2, 46.4%) compared with placebo (study 1, 16.5%; study 2, 8.6%) (all, P ≤ 0.001). The results of this study demonstrate that once-daily treatment with esomeprazole 20 mg for 2 weeks effectively resolved subjects׳ heartburn compared with placebo, beginning on day 1. Studies precede FDA Act 801 clinical trial registration and results submission requirements. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

The effects of neural mobilization on cervical radiculopathy patients' pain, disability, ROM, and deep flexor endurance.

PubMed

Kim, Dong-Gyu; Chung, Sin Ho; Jung, Ho Bal

2017-09-22

Cervical radiculopathy (CR) is a disease of the cervical spine and a space-occupying lesion that occurs because of pathological problems with cervical nerve roots. Nerve root injury to produce functional disability. The purpose of this study was to examine the effects of neural mobilization with manual cervical traction (NMCT) compared with manual cervical traction (MCT) on pain, functional disability, muscle endurance, and range of motion (ROM) in individuals with CR patients. A blinded randomized clinical trial was conducted. Thirty CR patients were divided into two groups - those who received NMCT and those who received MCT. The intervention was applied three times per week for eight weeks. It was measured in order to determine the pain and functional disability in patients with CR. The numeric pain rating scale (NPRS), neck disability index (NDI), ROM, and deep flexor endurance of patients were measured prior to the experiment, four weeks, and eight weeks after the experiment to compare the time points. A repeated-measures analysis of variance was used to compare differences within each group prior to the experiment. And Bonferroni test was performed to examine the significance of each time point. There were significant differences within each group prior to the intervention, four weeks after the intervention, and eight weeks after the intervention in NPRS, NDI, ROM, and deep flexor endurance (P< 0.05). NPRS and NDI more decreased, and, ROM and deep flexor endurance increased in the NMCT group than the MCT group (P< 0.05). These results suggest that the NMCT can pain relief, recovery from neck disability, ROM, and deep flexor endurance for patients with CR.

Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.

PubMed

Hanselman, Andrew E; Tidwell, John E; Santrock, Robert D

2015-02-01

Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes. A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM. Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort. Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation. Level I, prospective randomized trial. © The Author(s) 2014.

Anti-adhesive effect of poloxamer-based thermo-sensitive sol-gel in rabbit laminectomy model.

PubMed

Shin, Sung Joon; Lee, Jae Hyup; So, Jungwon; Min, Kyungdan

2016-11-01

Poloxamer-based thermo-sensitive sol-gel has been developed to reduce the incidence of postoperative scar formation at the laminectomy site. The purpose of this study was to evaluate the anti-adhesive effect of poloxamer based thermo-sensitive sol-gel compared to hyaluronate based solution after laminectomy, using a rabbit model. A thermo-sensitive anti-adhesive with a property of sol-gel transition was manufactured by a physical mixture of Poloxamer188/407, Chitosan and Gelatin. The viscosity in different temperatures was assessed. 72 adult New Zealand rabbits underwent lumbar laminectomy and were randomly divided into experimental (treated with the newly developed agent), positive (treated with hyaluronate based solution), and negative control groups. Each group was subdivided into 1 and 4-week subgroups. Gross and histological evaluations were performed to assess the extent of epidural adhesion. The experimental group showed significantly higher viscosity compared to the positive control group and showed a significant increase of viscosity as the temperature increased. Gross evaluation showed no statistically significant differences between the 1- and 4-week subgroups. However, histologic evaluation showed significant differences both in 1- and 4-week subgroups. Although the 4-week histologic results of the experimental and the positive control subgroups showed no significant difference, both subgroups revealed higher value compared to the negative control subgroup with regard to the ratio of adhesion less than 50 %. The new poloxamer based thermo-sensitive agent showed superior efficacy over the hyaluronate based agent at 1 week postoperatively. At 4 weeks postoperatively, there were no statistically significant differences between the two agents, although both showed efficacy over the sham group.

Multi-arm Cost-Effectiveness Analysis (CEA) comparing different durations of adjuvant trastuzumab in early breast cancer, from the English NHS payer perspective

PubMed Central

Hunter, Rachael M.; Shemilt, Ian; Serra-Sastre, Victoria

2017-01-01

Background Trastuzumab improves survival in HER2+ breast cancer patients, with some evidence of adverse cardiac side effects. Current recommendations are to give adjuvant trastuzumab for one year or until recurrence, although trastuzumab treatment for only 9 or 10 weeks has shown similar survival rates to 12-month treatment. We present here a multi-arm joint analysis examining the relative cost-effectiveness of different durations of adjuvant trastuzumab. Methods and findings Network meta-analysis (NMA) was used to examine which trials’ data to include in the cost-effectiveness analysis (CEA). A network using FinHer (9 weeks vs. zero) and BCIRG006 (12 months vs. zero) trials offered the only jointly randomisable network so these trials were used in the CEA. The 3-arm CEA compared costs and quality-adjusted life-years (QALYs) associated with zero, 9-week and 12-month adjuvant trastuzumab durations in early breast cancer, using a decision tree followed by a Markov model that extrapolated the results to a lifetime time horizon. Pairwise incremental cost-effectiveness ratios (ICERs) were also calculated for each pair of regimens and used in budget impact analysis, and the Bucher method was used to check face validity of the findings. Addition of the PHARE trial (6 months vs. 12 months) to the network, in order to create a 4-arm CEA including the 6-month regimen, was not possible as late randomisation in this trial resulted in recruitment of a different patient population as evidenced by the NMA findings. The CEA results suggest that 9 weeks’ trastuzumab is cost-saving and leads to more QALYs than 12 months’, i.e. the former dominates the latter. The cost-effectiveness acceptability frontier (CEAF) favours zero trastuzumab at willingness-to-pay levels below £2,500/QALY and treatment for 9 weeks above this threshold. The combination of the NMA and Bucher investigations suggests that the 9-week duration is as efficacious as the 12-month duration for distant-disease-free survival and overall survival, and safer in terms of fewer adverse cardiac events. Conclusions Our CEA results suggest that 9-week trastuzumab dominates 12-month trastuzumab in cost-effectiveness terms at conventional thresholds of willingness to pay for a QALY, and the 9-week regimen is also suggested to be as clinically effective as the 12-month regimen according to the NMA and Bucher analyses. This finding agrees with the results of the E2198 head-to-head study that compared 10 weeks’ with 14 months’ trastuzumab and found no significant difference. Appropriate trial design and reporting is critical if results are to be synthesisable with existing evidence, as selection bias can lead to recruitment of a different patient population from existing trials. Our analysis was not based on head-to-head trials’ data, so the results should be viewed with caution. Short-duration trials would benefit from recruiting larger numbers of participants to reduce uncertainty in the synthesised results. PMID:28248984

Evaluation of fenbendazole for treatment of Giardia infection in cats concurrently infected with Cryptosporidium parvum.

PubMed

Keith, Carey L; Radecki, Steven V; Lappin, Michael R

2003-08-01

To determine whether fenbendazole effectively eliminates Giardia organisms from chronically infected cats that have a concurrent Cryptosporidium parvum infection. 16 clinically normal cats. Eight cats with chronic concurrent Giardia and C parvum infections received fenbendazole (50 mg/kg, PO, q 24 h) for 5 days (treatment-group cats). Feces from each cat were collected and processed 3 days weekly for 23 days after treatment. By use of an immunofluorescent assay for detection of Giardia lamblia cysts and C parvum oocysts, organism numbers were counted and scored. Fecal results from treatment-group cats were compared with those of 8 untreated cats with Giardia infection but no C parvum infection (control-group cats). Four of 8 treatment-group cats had consistently negative results for Giardia infection after treatment. These 4 cats had consistently positive results for C parvum oocysts prior to treatment and consistently negative results after treatment. One treatment-group cat had positive results for cysts on all fecal samples, and 3 treatment-group cats had 1 to 3 negative results and then resumed shedding large numbers of cysts; each of these cats had consistently positive results for C parvum oocysts. When compared with control-group cats, treatment-group cats shed less Giardia cysts during week 1 after treatment but not during week 2. Administration of fenbendazole decreases Giardia cyst shedding to less than detectable numbers in some cats. In our study, persistent C parvum infection may have been associated with failure of fenbendazole to eliminate Giardia infection.

Randomized Trial Comparing Two Treatment Strategies Using Prize-Based Reinforcement of Abstinence in Cocaine and Opiate Users

ERIC Educational Resources Information Center

Preston, Kenzie L.; Ghitza, Udi E.; Schmittner, John P.; Schroeder, Jennifer R.; Epstein, David H.

2008-01-01

We compared two strategies of prize-based contingency management (CM) in methadone-maintained outpatients. Urine was tested thrice weekly for 5 weeks pre-CM, 12 weeks CM, and 8 weeks post-CM. Participants were randomly assigned to a cocaine contingency (four prize draws for each cocaine-negative urine, N = 29) or an opiate-cocaine contingency (one…

Neurotrophins and electrical stimulation for protection and repair of spiral ganglion neurons following sensorineural hearing loss

PubMed Central

Shepherd, Robert K.; Coco, Anne; Epp, Stephanie B.

2008-01-01

Exogenous neurotrophins (NTs) have been shown to rescue spiral ganglion neurons (SGNs) from degeneration following a sensorineural hearing loss (SNHL). Furthermore, chronic electrical stimulation (ES) has been shown to retard SGN degeneration in some studies but not others. Since there is evidence of even greater SGN rescue when NT administration is combined with ES, we examined whether chronic ES can maintain SGN survival long after cessation of NT delivery. Young adult guinea pigs were profoundly deafened using ototoxic drugs; five days later they were unilaterally implanted with an electrode array and drug delivery system. Brain derived neurotrophic factor (BDNF) was continuously delivered to the scala tympani over a four week period while the animal simultaneously received ES via bipolar electrodes in the basal turn (i.e. turn 1) scala tympani. One cohort (n=5) received ES for six weeks (i.e. including a two week period after the cessation of BDNF delivery; ES6); a second cohort (n=5) received ES for 10 weeks (i.e. a six week period following cessation of BDNF delivery; ES10). The cochleae were harvested for histology and SGN density determined for each cochlear turn for comparison with normal hearing controls (n=4). The withdrawal of BDNF resulted in a rapid loss of SGNs in turns 2–4 of the deafened/BDNF-treated cochleae; this was significant as early as two weeks following removal of the NT when compared with normal controls (p<0.05). Importantly, there was not a significant reduction in SGNs in turn 1 (i.e. adjacent to the electrode array) two and six weeks after NT removal, as compared with normal controls. This result suggests that chronic ES can prevent the rapid loss of SGNs that occurs after the withdrawal of exogenous NTs. Implications for the clinical delivery of NTs are discussed. PMID:18243608

The combination of temozolomide-irinotecan regresses a doxorubicin-resistant patient-derived orthotopic xenograft (PDOX) nude-mouse model of recurrent Ewing's sarcoma with a FUS-ERG fusion and CDKN2A deletion: Direction for third-line patient therapy.

PubMed

Miyake, Kentaro; Murakami, Takashi; Kiyuna, Tasuku; Igarashi, Kentaro; Kawaguchi, Kei; Miyake, Masuyo; Li, Yunfeng; Nelson, Scott D; Dry, Sarah M; Bouvet, Michael; Elliott, Irmina A; Russell, Tara A; Singh, Arun S; Eckardt, Mark A; Hiroshima, Yukihiko; Momiyama, Masashi; Matsuyama, Ryusei; Chishima, Takashi; Endo, Itaru; Eilber, Fritz C; Hoffman, Robert M

2017-11-28

The aim of the present study was to determine the usefulness of a patient-derived orthotopic xenograft (PDOX) nude-mouse model of a doxorubicin-resistant metastatic Ewing's sarcoma, with a unique combination of a FUS-ERG fusion and CDKN2A deletion, to identify effective drugs for third-line chemotherapy of the patient. Our previous study showed that cyclin-dependent kinase 4/6 (CDK4/6) and insulin-like growth factor-1 receptor (IGF-1R) inhibitors were effective on the Ewing's sarcoma PDOX, but not doxorubicin, similar to the patient's resistance to doxorubicin. The results of the previous PDOX study were successfully used for second-line therapy of the patiend. In the present study, the PDOX mice established with the Ewing's sarcoma in the right chest wall were randomized into 5 groups when the tumor volume reached 60 mm 3 : untreated control; gemcitabine combined with docetaxel (intraperitoneal [i.p.] injection, weekly, for 2 weeks); irinotecan combined with temozolomide (irinotecan: i.p. injection; temozolomide: oral administration, daily, for 2 weeks); pazopanib (oral administration, daily, for 2 weeks); yondelis (intravenous injection, weekly, for 2 weeks). All mice were sacrificed on day 15. Body weight and tumor volume were assessed 2 times per week. Tumor weight was measured after sacrifice. Irinotecan combined with temozolomide was the most effective regimen compared to the untreated control group (p=0.022). Gemcitabine combined with docetaxel was also effective (p=0.026). Pazopanib and yondelis did not have significant efficacy compared to the untreated control (p=0.130, p=0.818). These results could be obtained within two months after the physician's request and were used for third-line therapy of the patient.

A retrospective study of Ganoderma Lucidum Spore Powder for patients with epilepsy

PubMed Central

Wang, Guo-hui; Li, Xin; Cao, Wen-hui; Li, Jing; Wang, Li-hua

2018-01-01

Abstract This study firstly investigated the feasibility effect and safety of Ganoderma Lucidum Spore Powder (GLSP) for treating patients with epilepsy. Eighteen eligible patients with epilepsy were included. They all received GLSP treatment for a total of 8 weeks. The primary outcome included weekly seizure frequency. The secondary outcomes consisted of each seizure episode, and quality of life, measured by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), as well as the adverse events (AEs). After treatment, GLSP can significant reduce the weekly seizure frequency, compared with it before the treatment (P = .04). However, GLSP did not exert promising effect in each seizure episode (P = .13), and quality of life, measured by the QOLIE-31 scale (P = .11). Additionally, only minor AEs occurred during the treatment period. The results of this study showed that GLSP may be effective for reducing the weekly seizure frequency. Further studies are still needed to warrant this result. PMID:29879039

Placental hormone profiles as predictors of preterm birth in twin pregnancy: A prospective cohort study

PubMed Central

Lim, Hui; Powell, Sioned; Mcnamara, Helen C.; Howie, A. Forbes; Doust, Ann; Bowman, Maria E.; Smith, Roger; Norman, Jane E.

2017-01-01

Objective The objective of the study was to analyse placental hormone profiles in twin pregnancies to determine if they could be used to predict preterm birth. Study design Progesterone, estradiol, estriol and corticotropin-releasing hormone were measured using competitive immunoassay and radioimmunoassay in serum and saliva samples of 98 women with twin pregnancies,at 3 or more gestational timepoints. Hormone profiles throughout gestation were compared between very preterm (<34 weeks; n = 8), preterm (<37 weeks; n = 40) and term (37+ weeks; n = 50) deliveries. Results No significant differences were found between preterm and term deliveries in either absolute hormone concentrations or ratios. Estimated hormone concentrations and ratios at 26 weeks did not appear to predict preterm delivery. Salivary and serum hormone concentrations were generally poorly correlated. Conclusion Our results suggest that serial progesterone, estradiol, estriol and corticotropin-releasing hormone measurements in saliva and serum are not robust biomarkers for preterm birth in twin pregnancies. PMID:28278220

Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer.

PubMed

Poort, Hanneke; Verhagen, Constans A H H V M; Peters, Marlies E W J; Goedendorp, Martine M; Donders, A Rogier T; Hopman, Maria T E; Nijhuis-van der Sanden, Maria W G; Berends, Thea; Bleijenberg, Gijs; Knoop, Hans

2017-01-28

Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer. The TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants. To our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients. NTR3812 ; date of registration: 23/01/2013.

Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

PubMed

Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

2017-07-01

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and European Academy of Andrology.

Aerobic Exercise Training and Arterial Changes in African-Americans versus Caucasians

PubMed Central

Ranadive, Sushant M.; Yan, Huimin; Lane, Abbi D.; Kappus, Rebecca M.; Cook, Marc D.; Sun, Peng; Harvey, Idethia; Ploutz-Synder, Robert; Woods, Jeffrey A.; Wilund, Kenneth R.; Fernhall, Bo

2015-01-01

African-Americans (AA) have increased carotid artery intima-media thickness and decreased vascular function compared to their Caucasian (CA) peers. Aerobic exercise prevents and potentially reverses arterial dysfunction. Purpose The purpose of this study was to examine the effect of 8 weeks of moderate-high intensity aerobic training in young healthy sedentary AA and CA men and women. Methods Sixty-four healthy volunteers (men = 28, women = 36) with mean age = 24 underwent measures of arterial structure, function and blood pressure variables at baseline, post-4 week control period and 8 weeks post-training. Results There was a significant increase in VO2peak amongst both groups post exercise training. Brachial systolic blood pressure decreased significantly following control period in both groups but not following exercise training. Carotid pulse pressure decreased significantly in both groups post exercise training as compared to baseline. There was no change in any of the other blood pressure variables. AAs had a higher intima-media thickness at baseline and post-control period, but significantly decreased following exercise training compared to CAs. AAs had significantly lower baseline forearm blood flow and RH compared to CAs, but exercise training had no effect on these variables. There was no significant difference in arterial stiffness (cPWV) and wave-reflection (AIx) between the two groups at any time point. Conclusions This is the first study to show that, 8 weeks of aerobic exercise training causes significant improvement in the arterial structure in young, healthy AAs, making it comparable to the CAs and with minimal effects on blood pressure variables. PMID:26225767

Response to narrow-band UVB--vitiligo-melasma versus vitiligo: a comparative study.

PubMed

Sharma, Parikshit; Pai, Harsha S; Pai, Ganesh S; Kuruvila, Maria; Kolar, Reshma

2011-04-01

Vitiligo is the most common depigmentary disorder of the skin and hair, resulting from selective destruction of melanocytes. Melasma, a hyperpigmentary disorder, presents as irregular, brown, macular hypermelanosis. A small subset of vitiligo patients paradoxically also have melasma. To evaluate and compare the response to narrow-band UVB in a group of patients with vitiligo, and another group of patients with vitiligo and coexisting melasma (vitiligo-melasma). Patients in both groups were treated with narrow-band UVB and a comparison of the zonal repigmentation was made at 4, 8, and 12 weeks after the initiation of therapy. At the end of 12 weeks, 86% of patients in the vitiligo-melasma group attained ≥75% pigmentation on the face, whereas this was achieved in only 12.5% of patients in the vitiligo group. Over the limbs, 73% of patients in the vitiligo-melasma group attained 75% or more pigmentation at the end of 12 weeks compared with only 9% in the vitiligo group. On the trunk, only 20% of vitiligo-melasma patients showed ≥75% pigmentation at 12 weeks compared with 63% of patients in the vitiligo group. Patients having both vitiligo and melasma have a significantly better prognosis for repigmentation on the face and limbs with narrow-band UVB compared with patients with vitiligo alone; the vitiligo-melasma patients achieve repigmentation much earlier and also attain a greater level of repigmentation. Unexpectedly, for truncal lesions, patients with vitiligo alone responded better than those with both conditions. Although the vitiligo-melasma group with truncal lesions started repigmenting earlier, the final pigmentation was more extensive in the vitiligo group.

Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial.

PubMed

Dodick, David W; Silberstein, Stephen D; Bigal, Marcelo E; Yeung, Paul P; Goadsby, Peter J; Blankenbiller, Tricia; Grozinski-Wolff, Melissa; Yang, Ronghua; Ma, Yuju; Aycardi, Ernesto

2018-05-15

Fremanezumab, a fully humanized monoclonal antibody that targets calcitonin gene-related peptide, may be effective for treating episodic migraine. To assess the efficacy of fremanezumab compared with placebo for prevention of episodic migraine with a monthly dosing regimen or a single higher dose. Randomized, double-blind, placebo-controlled, parallel-group trial conducted at 123 sites in 9 countries from March 23, 2016 (first patient randomized), to April 10, 2017, consisting of a screening visit, 28-day pretreatment period, 12-week treatment period, and final evaluation at week 12. Study participants were aged 18 to 70 years with episodic migraine (6-14 headache days, with at least 4 migraine days, during 28-day pretreatment period). Patients who had previous treatment failure with 2 classes of migraine-preventive medication were excluded. Patients were randomized 1:1:1 to receive subcutaneous monthly dosing of fremanezumab (n = 290; 225 mg at baseline, week 4, and week 8); a single higher dose of fremanezumab, as intended to support a quarterly dose regimen (n = 291; 675 mg of fremanezumab at baseline; placebo at weeks 4 and 8); or placebo (n = 294; at baseline, week 4, and week 8). The primary end point was mean change in mean number of monthly migraine days during the 12-week period after the first dose. Among 875 patients who were randomized (mean age, 41.8 [SD, 12.1] years; 742 women [85%]), 791 (90.4%) completed the trial. From baseline to 12 weeks, mean migraine days per month decreased from 8.9 days to 4.9 days in the fremanezumab monthly dosing group, from 9.2 days to 5.3 days in the fremanezumab single-higher-dose group, and from 9.1 days to 6.5 days in the placebo group. This resulted in a difference with monthly dosing vs placebo of -1.5 days (95% CI, -2.01 to -0.93 days; P < .001) and with single higher dosing vs placebo of -1.3 days (95% CI, -1.79 to -0.72 days; P < .001). The most common adverse events that led to discontinuation were injection site erythema (n = 3), injection site induration (n = 2), diarrhea (n = 2), anxiety (n = 2), and depression (n = 2). Among patients with episodic migraine in whom multiple medication classes had not previously failed, subcutaneous fremanezumab, compared with placebo, resulted in a statistically significant 1.3- to 1.5-day reduction in the mean number of monthly migraine days over a 12-week period. Further research is needed to assess effectiveness against other preventive medications and in patients in whom multiple preventive drug classes have failed and to determine long-term safety and efficacy. clinicaltrials.gov Identifier: NCT02629861.

Clinical consequences of initial duloxetine dosing strategies: Comparison of 30 and 60 mg QD starting doses

PubMed Central

Dunner, David L.; Wohlreich, Madelaine M.; Mallinckrodt, Craig H.; Watkin, John G.; Fava, Maurizio

2005-01-01

Background: To reduce the risk for treatment-emergent adverse events and increase patient compliance, clinicians frequently prescribe a suboptimal starting dose of antidepressants, with the goal of increasing the dose once the patient has demonstrated tolerability. Objective: The aim of this study was to examine the tolerability and effectiveness associated with an initial week of duloxetine hydrochloride treatment at 30 mg QD and subsequent dose increase to 60 mg QD, compared with a starting dose of 60 mg QD. Methods: In this open-label study, all patients met the criteria for major depressive disorder (MDD) described in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Patients were required to wash out from previous antidepressant medications for 21 days, and were then randomized to receive duloxetine 30 or 60 mg QD for 1 week. After 1 week, patients receiving duloxetine 30 mg QD had their dose increased to 60 mg QD. Patients returned for assessments at weeks 2, 4, 6, 8, and 12. During the remainder of the 12-week study period, the duloxetine dose could be titrated based on the degree of response from 60 mg QD (minimum) to 120 mg QD (maximum), with 90 mg QD as an intermediate dose. Tolerability was assessed by means of discontinuation rates, spontaneously reported adverse events, changes in vital signs, and laboratory tests. Effectiveness measures included the 17-item Hamilton Rating Scale for Depression (HAMD17) total score, HAMD17 core and Maier subscales, individual HAMD17 items, the Hamilton Rating Scale for Anxiety total score, and the Clinical Global Impression of Severity. Results: One hundred thirty-seven patients were enrolled (82 women, 55 men; mean age, 42 years; duloxetine 30 mg QD, 67 patients; duloxetine 60 mg QD, 70 patients). The rate of discontinuation due to adverse events did not differ significantly between patients starting duloxetine at 30 mg QD and 60 mg QD (13.4% vs 18.6%). The most frequently reported adverse events across both treatment groups were nausea, headache, dry mouth, insomnia, and diarrhea. In the first week of treatment, patients receiving duloxetine 30 mg QD had a significantly lower rate of nausea compared with patients receiving 60 mg QD (16.4% vs 32.9%; P = 0.03). Over the 12-week acute-treatment phase, patients starting duloxetine treatment at 30 mg QD had a significantly lower rate of nausea compared with patients initiating treatment at 60 mg QD (P = 0.047). Although between-group differences in the HAMD17 total score were not statistically significant at any visit, patients starting at 30 mg QD experienced significantly less improvement in HAMD17 core and Maier subscales at week 1 compared with patients starting at 60 mg QD (core, P= 0.044; Maier, P = 0.047). After 2 weeks of treatment, the magnitude of improvement among patients starting at 30 mg QD did not differ significantly from that observed in patients who started treatment at 60 mg QD, and there were no significant between-group differences in effectiveness at any subsequent visit. Conclusions: Results from this open-label study in patients with MDD suggest that starting duloxetine treatment at 30 mg QD for 1 week, followed by escalation to 60 mg QD, might reduce the risk for treatment-emergent nausea in these patients while producing only a transitory impact on effectiveness compared with a starting dose of 60 mg QD. PMID:24678074

Clinical Hypnosis in the Treatment of Post-Menopausal Hot Flashes: A Randomized Controlled Trial

PubMed Central

Elkins, Gary R.; Fisher, William I.; Johnson, Aimee K.; Carpenter, Janet S.; Keith, Timothy Z.

2012-01-01

Objective The use of estrogen and progesterone to manage vasomotor symptoms (i.e., hot flashes, night sweats) has declined due to concerns over their risks and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized, controlled trial of clinical hypnosis in treating vasomotor symptoms among post-menopausal women. Methods Randomized, single-blind, controlled, clinical trial involving 187 post-menopausal women reporting a minimum of seven hot flashes per day, or at least 50 hot flashes a week at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries at weeks 2–6, and 12. Secondary outcomes included measures of hot flash related daily interference, sleep quality and treatment satisfaction. Results In a modified intent-to-treat analysis that included all randomized participants that provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 hot flashes for the clinical hypnosis intervention (74.16%), versus a 12.89 hot flash reduction (17.13%) for the control (p<.001, 95% CI, 36.15–49.67). Mean reduction in hot flash score was 18.83 (80.32%) for the clinical hypnosis intervention as compared to 3.53 (15.38%) for the control (p<.001, 95% CI, 12.60–17.54). At 12 week follow-up, the mean reduction in physiologically monitored hot flashes was 5.92 (56.86%) for clinical hypnosis and .88 (9.94%) for the control (p<.001, 95% CI, 2.00–5.46). Secondary outcomes were significantly improved compared to control at 12 week follow-up in hot flash related interference (p<.001, 95% CI, 2.74–4.02), sleep quality (p<.001, 95% CI, 3.65–5.84), and treatment satisfaction (p<.001, 95% CI, 7.79–8.59). Conclusion Compared to a structured attention control, clinical hypnosis resulted in significant reductions in self-reported and physiologically measured hot flashes as well as hot flash scores in post-menopausal women. PMID:23435026

Association between physical activity and academic performance in Korean adolescent students

PubMed Central

2012-01-01

Background Recently, physical activity (PA) was found to improve cognitive and memory functions in the brain; however, no epidemiological studies have specifically investigated this phenomenon in the Korean adolescent student population. The purpose of this study was to investigate the effects of various types of PA undertaken at various frequencies, on the academic performance of Korean adolescent students. Methods A total of 75,066 adolescent students (39,612 males and 35,454 females) from the 7th to the 12th grades took part in the 5th Korea Youth Risk Behavior Web-based Survey (KYRBWS-V) project, conducted in 2009. Using data acquired by that survey, potential relations between PA and academic performance were explored in this current study through multivariate logistic regression analysis incorporating adjustment for covariate variables including age, body mass index, the parents’ education level, and the income status of the family. Results Compared with boys who did not regularly participate in any vigorous PA, those who did so 2, 3, or 4 times a week had greater odds of reporting an average or above-average academic performance. Compared with boys who did not participate in any moderate PA, those who did so 1, 2, 3, 4, or ≥5 times a week also had greater odds of reporting an average or above-average academic performance. Interestingly, when compared with boys who did not participate in any strengthening exercises, those undertaking strengthening exercises ≥5 times a week had lesser odds of reporting a below-average academic performance. Compared with girls who did not regularly participate in any vigorous PA, those who did so ≥5 times a week had greater odds of reporting an average or above-average academic performance. Compared with girls who did not participate in any moderate PA, those that did so 2 or 3 times a week had greater odds of reporting an average or above-average academic performance. Interestingly, when compared with girls who did not regularly participate in any strengthening exercises, those undertaking strengthening exercises ≥5 times a week had lesser odds of reporting a below-average academic performance. Conclusions Our analyses of the relevant data from the KYRBWS-V suggested that vigorous PA was positively correlated with academic performance in the case of boys, and moderate PA was positively correlated with academic performance in both boys and girls. However, strengthening exercises were not positively correlated with academic performance in boys or girls. Furthermore, when undertaken 5 or more times a week, vigorous PA in boys and strengthening exercises in both boys and girls were negatively correlated with academic performance. The results from this study are potentially relevant to the development of future education policies in Korean schools, particularly with regard to early intervention strategies designed to identify and counteract potential factors contributing to academic underachievement. PMID:22471711

Effect of low-dose versus higher-dose antenatal iron supplementation on child health outcomes at 36 months of age in Viet Nam: longitudinal follow-up of a cluster randomised controlled trial.

PubMed

Hanieh, Sarah; Ha, Tran T; Simpson, Julie A; Braat, Sabine; Thuy, Tran T; Tran, Thach D; King, Janet; Tuan, Tran; Fisher, Jane; Biggs, Beverley-Ann

2017-01-01

Intermittent iron-folic acid supplementation (IFA) is currently recommended for pregnant women in populations where anaemia prevalence among pregnant women is <20% or if daily iron is not acceptable. The effect of providing lower doses of antenatal elemental iron through intermittent regimes on longer-term health outcomes in childhood is unclear. A prospective cohort study conducted between May 2012 and May 2014 in Viet Nam among children of 36 months of age, born to women previously enrolled in a cluster randomised controlled trial of antenatal micronutrient supplementation (daily IFA (60 mg elemental iron) vs twice-weekly IFA (60 mg elemental iron) vs twice-weekly multiple micronutrient (MMN) supplementation (60 mg elemental iron)). Primary outcomes were height-for-age z-scores (HAZ), according to WHO growth standards and cognitive composite scores (Bayley Scales of Infant and Toddler Development, third edition) at 36 months of age. A total of 1017 children born to mothers enrolled in the cluster randomised trial were assessed at 36 months of age. Adjusted mean differences (MDs) in HAZ were -0.14 (95% CI -0.28 to -0.01) and -0.15 (95% CI -0.29 to -0.01) in children born to mothers who received twice-weekly IFA or MMN compared with those who received daily IFA. Children born to mothers who received twice-weekly MMN had lower composite motor scores compared with those who received daily IFA (MD -2.07, 95% CI -4.11 to -0.03). There were no differences in composite cognitive scores in the twice-weekly compared with daily regimens. Low-dose antenatal IFA supplementation (120 mg elemental iron per week) resulted in lower HAZ and motor composite scores in children compared with higher-dose antenatal IFA supplementation (420 mg elemental iron per week). This highlights the importance of adequate iron stores during pregnancy and the need for careful monitoring when lower-dose antenatal iron regimens are used. Australia New Zealand Clinical Trials Registry: 12610000944033.

Cohort study of depressed mood during pregnancy and after childbirth

PubMed Central

Evans, Jonathan; Heron, Jon; Francomb, Helen; Oke, Sarah; Golding, Jean

2001-01-01

Objective To follow mothers' mood through pregnancy and after childbirth and compare reported symptoms of depression at each stage. Design Longitudinal cohort study. Setting Avon. Participants Pregnant women resident within Avon with an expected date of delivery between 1 April 1991 and 31 December 1992. Main outcome measures Symptom scores from the Edinburgh postnatal depression scale at 18 and 32 weeks of pregnancy and 8 weeks and 8 months postpartum. Proportion of women above a threshold indicating probable depressive disorder. Results Depression scores were higher at 32 weeks of pregnancy than 8 weeks postpartum (difference in means 0.88, 95% confidence interval 0.79 to 0.97). There was no difference in the distribution of total scores or scores for individual items at the four time points. 1222 (13.5%) women scored above threshold for probable depression at 32 weeks of pregnancy, 821 (9.1%) at 8 weeks postpartum, and 147 (1.6%) throughout. More mothers moved above the threshold for depression between 18 weeks and 32 weeks of pregnancy than between 32 weeks of pregnancy and 8 weeks postpartum. Conclusions Symptoms of depression are not more common or severe after childbirth than during pregnancy. Research and clinical efforts need to be moved towards understanding, recognising, and treating antenatal depression. PMID:11485953

Binge Eating, Purging, or Both: Eating Disorder Psychopathology Findings from an Internet Community Survey

PubMed Central

Roberto, Christina A.; Grilo, Carlos M.; Masheb, Robin M.; White, Marney A.

2010-01-01

Objective This study aimed to compare bulimia nervosa (BN), binge eating disorder (BED), and purging disorder (PD) on clinically significant variables and examine the utility of once versus twice-weekly diagnostic thresholds for disturbed eating behaviors. Method 234 women with BN, BED, or PD were identified through self-report measures via an online survey and categorized based on either once-weekly or twice-weekly disturbed eating behaviors. Results BN emerged as a more severe disorder than BED and PD. The three groups differed significantly in self-reported restraint and disinhibition and the BN and BED groups reported higher levels of depression than PD. For BN, those engaging in behaviors twice-weekly versus once-weekly were more symptomatic. Discussion The BN, BED, and PD groups differed in clinically meaningful ways. Future research need to clarify the relationship between mood disturbances and eating behaviors. Reducing the twice-weekly behavior threshold for BN would capture individuals with clinically significant eating disorders, though the twice-weekly threshold may provide important information about disorder severity for both BN and BED. PMID:19862702

Complement activation fragment Bb in early pregnancy and spontaneous preterm birth.

PubMed

Lynch, Anne M; Gibbs, Ronald S; Murphy, James R; Byers, Tim; Neville, Margaret C; Giclas, Patricia C; Salmon, Jane E; Van Hecke, Trisha M; Holers, V Michael

2008-10-01

The objective of this study was to determine whether an elevated level of the complement activation fragment Bb in early pregnancy was associated with spontaneous preterm birth (SPTB) at less than 34 weeks' gestation or SPTB between 34 and 37 weeks' gestation (late SPTB). This was a prospective study of 784 women enrolled at less than 20 weeks' gestation. Following exclusions, 13 women (1.7%) had a SPTB at less than 34 weeks' gestation and 25 (3.2%) a SPTB between 34 and 37 weeks' gestation. Women with Bb in the top quartile were 4.7 times more likely to have an SPTB less than 34 weeks' gestation as compared with women who had levels of Bb in the lower 3 quartiles (95% confidence interval [CI] 1.5-14, P = .003). There was no association between Bb and late SPTB (relative risk 0.8, 95% CI 0.3-2). A significant relationship was found between an elevated Bb in early pregnancy and SPTB less than 34 weeks' gestation. These results suggest that inflammatory events in early pregnancy are part of the pathogenic mechanisms of this condition.

Increments in plasma homovanillic acid concentrations after neuroleptic discontinuation are associated with worsening of schizophrenic symptoms.

PubMed

Khan, R S; Amin, F; Powchik, P; Knott, P; Goldstein, M; Apter, S; Kerman, B; Jaff, S; Davidson, M

1990-01-01

1. Thirty-two male schizophrenic patients participated in this study. 2. Plasma concentrations of the dopamine metabolite, homovanillic acid (pHVA) were assessed once on neuroleptic medication and twice a week for a maximum of six weeks after its discontinuation. 3. Psychiatric symptomatology was assessed once on neuroleptic medication and once a week for a maximum of six weeks after its discontinuation, using the brief psychiatric rating scale (BPRS). 4. pHVA and total BPRS score increased significantly after discontinuation of neuroleptic as compared to baseline. 5. The magnitude of pHVA and BPRS increments after discontinuation of neuroleptic correlated significantly. 6. Results of this study suggest that worsening of schizophrenic symptoms after discontinuation of neuroleptic treatment is associated with increased pHVA concentrations.

A cost-effectiveness analysis of calcipotriol plus betamethasone dipropionate aerosol foam versus gel for the topical treatment of plaque psoriasis.

PubMed

Foley, Peter; Garrett, Sinead; Ryttig, Lasse

2018-01-24

Calcipotriol 50 µg/g and betamethasone 0.5 mg/g dipropionate (Cal/BD) aerosol foam formulation provides greater effectiveness and improved patient preference compared with traditional Cal/BD formulations for the topical treatment of plaque psoriasis. To determine the cost-effectiveness of Cal/BD foam compared with Cal/BD gel from the Australian perspective. A Markov model was developed to evaluate the cost-effectiveness of topical Cal/BD foam and gel for the treatment of people with plaque psoriasis. Treatment effectiveness, safety, and utilities were based on a randomized control trial, resource use was informed by expert opinion, and unit costs were obtained from public sources. Outcomes were reported in terms of 1-year costs, quality-adjusted life years, and incremental cost-effectiveness ratios. All costs were reported in 2017 Australian Dollars. The model showed that patients using Cal/BD foam had more QALYs and higher costs over 1 year compared with patients using Cal/BD gel, resulting in a cost of $13,609 per QALY gained at 4-weeks. When 4 weeks of Cal/BD foam was compared with 8 weeks of Cal/BD gel treatment, Cal/BD foam was $8 less expensive and resulted in 0.006 more QALYs gained. Sensitivity analyses showed that, compared with Cal/BD ointment, Cal/BD foam was associated with an incremental cost of $15,091 per QALY gained. Cal/BD foam is the most cost-effective Cal/BD formulation for the topical treatment of patients with plaque psoriasis.

A comparative evaluation of propolis and 5.0% potassium nitrate as a dentine desensitizer: A clinical study

PubMed Central

Purra, Aamir Rashid; Mushtaq, Mubashir; Acharya, Shashi Rashmi; Saraswati, Vidya

2014-01-01

Aim: The purpose of this clinical study was to evaluate the efficacy of saturated ethanolic solution of Propolis for the treatment of dentin hypersensitivity. Materials and Methods: Ten patients aged 20-40 years with 156 hypersensitive teeth were selected for a 3-month study. Each patient was subjected to treatment with saturated ethanolic solution of Propolis, 5% potassium nitrate and distilled water. The patients were recalled at seventh day, 2 weeks and 4 weeks for the application of the agent and re-evaluation. The final re-evaluation of the patients was done after 3 months from the first application. The responses of the patients to the test temperatures were converted to a ranking and data was statistically analyzed. A statistical analysis was done using ANOVA and Bonferroni test and Tukey HSD test for multicomparison. Results: The results between the Propolis group and the potassium nitrate group showed no significant difference in the immediate post-treatment period; however, the results were significant at the end of first week and second week. At 4 weeks and 3 months period, a comparison between the groups again showed no significant difference. Conclusion: It was concluded that Propolis was more effective than 5% potassium nitrate in relieving dentinal hypersensitivity and had an immediate and sustained effect. PMID:25210261

The effect of age on hamstring passive properties after a 10-week stretch training

PubMed Central

Haab, Thomas; Wydra, Georg

2017-01-01

[Purpose] Degenerative changes take place in the musculoskeletal system of elderly people, resulting in a reduced range of motion. For this reason, stretch training is recommended for elderly individuals. To date, there have been no studies of the adaptations of the passive properties of muscles following long-term stretch training. The aim of this study is to investigate the hamstring elasticity of elderly people following a 10-week stretch training and compare the results to a younger cohort. [Subjects and Methods] The experimental groups consisted of 15 younger (24.0 ± 4.0 years) and 14 older (65.1 ± 7.9 years) individuals. Both experimental groups undertook a standardised 10-week static passive hamstring stretch training. Passive properties of the hamstring were measured with an instrumented Straight Leg Raise Test. [Results] After a 10-week stretch training, there were increases in range of motion, passive resistive force and passive elastic energy in both age groups. Passive elastic stiffness decreased. Changes of hamstring passive properties did not differ significantly between age groups after a 10-week stretch training. [Conclusion] Increasing age has a negative effect on muscle passive properties, but older individuals benefit from regular stretch training, just as younger individuals do. PMID:28626322

Comparative study of 5 % potassium hydroxide solution versus 0.05% tretinoin cream for Molluscum Contagiosum in children.

PubMed

Rajouria, E A; Amatya, A; Karn, D

2011-01-01

Molluscum contagiosum is one of the commonest cutaneous viral infections in children. All treatment modalities are associated with substantial pain, tissue destruction, and frequent recurrence. To compare the efficacy and side effects of KOH 5% solution with tretinoin 0.05% cream for the treatment of molluscum contagiosum in children. Fifty patients were randomly divided into 2 groups; 25 each for 5% KOH solution and 0.05% tretinoin cream. The given medication was applied at bed time over molluscum lesions. The assessment of response and side effects were performed weekly for 4 weeks. At the end of 4 weeks, the mean lesion count decreased from 9.48 +/- 3.00 SD to 1.67 +/- 0.58 SD and from 8.35 +/- 2.82 SD to 2.00 +/- 1.00 SD in patients treated with 5% KOH solution and 0.05% tretinoin cream respectively. The result of both KOH and tretinoin showed good response, well tolerated by children but between the two, KOH showed fast recovery and most lesions were resolved before 4 week. The side effects could be minimized if applied as stated above. On the other hand, tretinoin showed delayed response and even some of lesion extended beyond 4 week but the side effect were less, and hence can be used in recurrent cases.

Endotoxemia and the host systemic response during experimental gingivitis

PubMed Central

Wahaidi, Vivian Y.; Kowolik, Michael J.; Eckert, George J.; Galli, Dominique M.

2011-01-01

Aim To assess endotoxemia episodes and subsequent changes in serum inflammatory biomarkers using the experimental gingivitis model Materials and Methods Data from 50 healthy black and white adult males and females were compared for serum concentrations of endotoxin, and serum biomarkers [neutrophil oxidative activity, interleukin (IL)-1β, IL-6, IL-8, C-reactive protein, and fibrinogen] at baseline, at 3 weeks of experimental gingivitis, and after 2 weeks of recovery. Means were compared using repeated measures ANOVA. Results Endotoxemia was reported in 56% of the serum samples at three weeks of induced gingivitis. At two weeks of recovery, endotoxin levels decreased to levels similar to those reported at baseline. Neutrophil oxidative activity increased significantly following three weeks of gingivitis versus baseline (p<0.05). In the endotoxin-negative group this increase was associated with the black subjects whereas in the endotoxin-positive group change in neutrophil activity was driven by the female subpopulation. Serum cytokines, CRP, and fibrinogen levels did not change during the study. Conclusions Experimental gingivitis was associated with endotoxemia and hyperactivity of circulating neutrophils, but not with changes in systemic levels of cytokines and acute phase proteins. This may be attributed to the mild nature and the short duration of the induced gingivitis. PMID:21320151

A COMPARATIVE STUDY OF EFFICACY OF EMG BIO-FEEDBACK AND PROGRESSIVE MUSCULAR RELAXATION IN TENSION HEADACHE1

PubMed Central

Gada, M.T.

1984-01-01

SUMMARY The aim of the present study was to find out efficacy of frontalis EMG Biofeedback therapy, deep muscular relaxation therapy and compare the efficacy of both in cases of tension headache. During two week basal-data recording period all patients were taught deep muscular relaxation by Jacobson′s technique. Simultaneously patients were instructed to keep headache diary. Headache diary yielded three different parameters a) number of headache-free days per week, b) peak headache intensity (or each week and c) average daily headache activity score per week. These parameters were used to find out therapeutic efficacy of each treatment. Patients were randomly divided in two groups. EMG Biofeedback group was given frontalis EMG feedback through EMG J 33 muscle trainer of Cyborg Corporation (U.S.A.). Patients in each group were given 20 sessions (two sessions per week); each session lasting 30 minutes. Patients were instructed to practice at least one 30 minute session of relaxation at home. The data were subjected to statistical calculation. The results indicate that frontalis EMG Biofeedback therapy and deep muscle relaxation therapy are significantly effective in cases of tension headache. Both treatments are equally effective. The findings are discussed in relation to Indian situation. PMID:21965970

Use of plasma exchange or double filtration plasmapheresis to reduce body burden of polychlorinated biphenyls: A pilot trial.

PubMed

Gube, Monika; Schettgen, Thomas; Kraus, Thomas; Schikowsky, Christian; Heibges, Andreas; Klingel, Reinhard; Hoffmann, Christian; Wiemeyer, Andreas; Jacobson, Jewgeni; Esser, André

2017-07-01

The aim of the study was to examine whether plasma exchange (PE) or selective double filtration plasmapheresis (DFPP) is able to reduce the internal Polychlorinated biphenyl (PCB) burden of highly exposed participants of the health effects in high-level exposure to PCB (HELPcB) cohort. HELPcB is a surveillance program for former PCB-exposed workers of a German capacitor recycling company. After comparative evaluation of PE and DFPP in a phase I, DFPP was chosen as method for further treatment. In phase II, five participants underwent DFPP at weekly intervals for the duration of 12 weeks. Six PCB species were selected as indicators and were analyzed in the plasma before and after each treatment and 4 weeks after the last treatment. The PCB levels before and after each DFPP treatment showed a significant reduction in PCB blood levels; however, there was no significant change in PCB levels within the samples collected before each treatment as compared with the samples collected in the following week before treatment. Even the difference between PCB levels at the onset of the study and 4 weeks after the last treatment was not significant. The results of this pilot trial do not encourage further investigations in using therapeutic apheresis to reduce the PCB body burden.

Clinical Impact and Cost-effectiveness of Diagnosing HIV Infection During Early Infancy in South Africa: Test Timing and Frequency.

PubMed

Francke, Jordan A; Penazzato, Martina; Hou, Taige; Abrams, Elaine J; MacLean, Rachel L; Myer, Landon; Walensky, Rochelle P; Leroy, Valériane; Weinstein, Milton C; Parker, Robert A; Freedberg, Kenneth A; Ciaranello, Andrea

2016-11-01

 Diagnosis of human immunodeficiency virus (HIV) infection during early infancy (commonly known as "early infant HIV diagnosis" [EID]) followed by prompt initiation of antiretroviral therapy dramatically reduces mortality. EID testing is recommended at 6 weeks of age, but many infant infections are missed.  We simulated 4 EID testing strategies for HIV-exposed infants in South Africa: no EID (diagnosis only after illness; hereafter, "no EID"), testing once (at birth alone or at 6 weeks of age alone; hereafter, "birth alone" and "6 weeks alone," respectively), and testing twice (at birth and 6 weeks of age; hereafter "birth and 6 weeks"). We calculated incremental cost-effectiveness ratios (ICERs), using discounted costs and life expectancies for all HIV-exposed (infected and uninfected) infants.  In the base case (guideline-concordant care), the no EID strategy produced a life expectancy of 21.1 years (in the HIV-infected group) and 61.1 years (in the HIV-exposed group); lifetime cost averaged $1430/HIV-exposed infant. The birth and 6 weeks strategy maximized life expectancy (26.5 years in the HIV-infected group and 61.4 years in the HIV-exposed group), costing $1840/infant tested. The ICER of the 6 weeks alone strategy versus the no EID strategy was $1250/year of life saved (19% of South Africa's per capita gross domestic product); the ICER for the birth and 6 weeks strategy versus the 6 weeks alone strategy was $2900/year of life saved (45% of South Africa's per capita gross domestic product). Increasing the proportion of caregivers who receive test results and the linkage of HIV-positive infants to antiretroviral therapy with the 6 weeks alone strategy improved survival more than adding a second test.  EID at birth and 6 weeks improves outcomes and is cost-effective, compared with EID at 6 weeks alone. If scale-up costs are comparable, programs should add birth testing after strengthening 6-week testing programs. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Influence of combined dust reducing carpet and compact air filtration unit on the indoor air quality of a classroom.

PubMed

Scheepers, Paul T J; de Hartog, Jeroen J; Reijnaerts, Judith; Beckmann, Gwendolyn; Anzion, Rob; Poels, Katrien; Godderis, Lode

2015-02-01

Primary schools mostly rely on natural ventilation but also have an interest in affordable technology to improve indoor air quality (IAQ). Laboratory tests show promising results for dust reducing carpets and compact air filtration systems but there is no information available on the performance of these interventions in actual operating classrooms. An exploratory study was performed to evaluate a combination of the two systems in a primary school. Measurements of PM-10 and PM-2.5 were performed by filter sampling and aerosol spectrometry. Other IAQ parameters included black smoke (BS), volatile organic compounds (VOC), nitrogen dioxide (NO2) and formaldehyde. Both interventions were introduced in one classroom during one week, using another classroom as a reference. In a second week the interventions were moved to the other classroom, using the first as a reference (cross-over design). In three remaining weeks the classrooms were compared without interventions. Indoor IAQ parameters were compared to the corresponding outdoor parameters using the indoor/outdoor (I/O) ratio. When the classrooms were occupied (teaching hours) interventions resulted in 27-43% reductions of PM-10, PM-2.5 and BS values. During the weekends the systems reduced these levels by 51-87%. Evaluations using the change in I/O ratios gave comparable results. Levels of VOC, NO2 and formaldehyde were rather low and a contribution of the interventions to the improvement of these gas phase IAQ parameters was inconclusive.

Baricitinib in adult patients with moderate-to-severe atopic dermatitis: a phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study.

PubMed

Guttman-Yassky, Emma; Silverberg, Jonathan I; Nemoto, Osamu; Forman, Seth B; Wilke, August; Prescilla, Randy; de la Peña, Amparo; Nunes, Fabio P; Janes, Jonathan; Gamalo, Margaret; Donley, David; Paik, Jim; DeLozier, Amy M; Nickoloff, Brian J; Simpson, Eric L

2018-02-01

Baricitinib, an oral selective inhibitor of Janus kinase (JAK)1 and JAK2, modulates pro-inflammatory cytokine signaling. The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD). In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCS) for 4 weeks before randomization to once daily placebo, baricitinib 2 mg, or baricitinib 4 mg for 16 weeks. Use of TCS was permitted during the study. Primary outcome was the proportion of patients achieving ≥50% reduction in the Eczema Area and Severity Index (EASI-50) compared to placebo. Significantly more baricitinib 4-mg patients achieved EASI-50 compared to placebo (61% vs 37%; P=0.027) at 16 weeks. The proportion of baricitinib 2- and 4-mg patients achieving EASI-50 compared to placebo was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 (49%) placebo, 17 (46%) baricitinib 2-mg, and 27 (71%) baricitinib 4-mg patients. A TCS standardization period prior to randomization reduced disease severity, limiting the ability to compare results to baricitinib monotherapy. Longer studies are required to confirm baricitinib efficacy and safety in AD patients. Baricitinib used with TCS reduced inflammation and pruritus in patients with moderate-to-severe atopic dermatitis (AD). Copyright © 2018. Published by Elsevier Inc.

A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers.

PubMed

Zelen, Charles M; Gould, Lisa; Serena, Thomas E; Carter, Marissa J; Keller, Jennifer; Li, William W

2015-12-01

A prospective, randomised, controlled, parallel group, multi-centre clinical trial was conducted at three sites to compare the healing effectiveness of treatment of chronic lower extremity diabetic ulcers with either weekly applications of Apligraf(®) (Organogenesis, Inc., Canton, MA), EpiFix(®) (MiMedx Group, Inc., Marietta, GA), or standard wound care with collagen-alginate dressing. The primary study outcome was the percent change in complete wound healing after 4 and 6 weeks of treatment. Secondary outcomes included percent change in wound area per week, velocity of wound closure and a calculation of the amount and cost of Apligraf or EpiFix used. A total of 65 subjects entered the 2-week run-in period and 60 were randomised (20 per group). The proportion of patients in the EpiFix group achieving complete wound closure within 4 and 6 weeks was 85% and 95%, significantly higher (all adjusted P-values ≤ 0·003) than for patients receiving Apligraf (35% and 45%), or standard care (30% and 35%). After 1 week, wounds treated with EpiFix had reduced in area by 83·5% compared with 53·1% for wounds treated with Apligraf. Median time to healing was significantly faster (all adjusted P-values ≤0·001) with EpiFix (13 days) compared to Apligraf (49 days) or standard care (49 days). The mean number of grafts used and the graft cost per patient were lower in the EpiFix group campared to the Apligraf group, at 2·15 grafts at a cost of $1669 versus 6·2 grafts at a cost of $9216, respectively. The results of this study demonstrate the clinical and resource utilisation superiority of EpiFix compared to Apligraf or standard of care, for the treatment of diabetic ulcers of the lower extremities. © 2014 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Comparative study of the effects of organic selenium on hen performance and productivity of broiler breeders.

PubMed

Rajashree, K; Muthukumar, T; Karthikeyan, N

2014-01-01

1. A 10-week experiment was conducted with Ross 308 broiler breeder chickens in cages to evaluate the influence of organic and inorganic sources of selenium (Se) supplementation. A total of 600 birds at 29 weeks of age were divided at random into 4 groups and fed on a maize-soya basal diet supplemented with different forms of Se. 2. The first (control) group was given the basal diet without Se supplementation, whereas the second, third and fourth groups were given, respectively, the basal diet with 0.3 mg/kg of inorganic Se in the form of sodium selenite or 0.3 and 0.5 mg/kg of organic Se in the form of Se enriched yeast (Se-yeast). 3. The experiment was carried out for 10 weeks to compare and evaluate the influence of Se supplementation on breeder performance, egg production, hatchability and the quality of eggs. Samples were collected for analysis at weeks 0, 5 and 10 of the experimental period. 4. At the end of the experiment (39 weeks), there was a reduction in mortality in breeders given diets supplemented with 0.5 mg/kg of Se-yeast. Supplementation of feed with 0.5 mg/kg organic Se increased egg production, percentage of settable eggs and hatchability. 5. Selenium supplementation increased egg weight and specific gravity compared to the control diet. However, no significant variation was found in albumen or yolk protein content at the end of week 10. 6. Selenium accumulation and glutathione peroxidase (GSHPx) activity were lower in the egg albumen and yolk of control compared with Se-supplemented treatments. Se accumulation and GSHPx activity were higher in the group given 0.3 mg/kg organic compared to 0.3 mg/kg of inorganic Se. 7. The results favour the use of Se-yeast at the dose of 0.5 mg/kg in broiler breeder diets for better productivity of eggs, settable eggs, hatchability and higher Se accumulation and antioxidant status in eggs.

Effect of proprioceptive training on foot posture, lower limb alignment, and knee adduction moment in patients with degenerative knee osteoarthritis: a randomized controlled trial

PubMed Central

Cho, Yumi; Kim, Minkyu; Lee, Wanhee

2015-01-01

[Purpose] The purpose of this study was to determine the effect of proprioceptive training on foot progression angle, weight-bearing ratio, and knee adduction moment in patients with degenerative osteoarthritis of the knee. [Subjects] The subjects were 37 patients diagnosed with Kellgren-Lawrence grade 2 or 3 degenerative knee osteoarthritis. They were randomly allocated to three groups: a proprioceptive training group (PT group), quadriceps strengthening group (QS group), and control group. [Methods] The study parameters of the three groups were compared before and after a 12-week training period. Therapeutic exercises were performed twice per week for 12 weeks. Outcomes included the foot progression angle, weight-bearing ratio, and knee adduction moment. [Results] First, a significant difference in the foot progression angle was observed among the groups, significantly increasing in the PTG compared with the CG. Second, a significant difference in the weight-bearing ratio was observed among the groups, significantly increasing in the PTG compared with the CG. Third, a significant difference in the first peak knee adduction moment was observed among the groups, significantly decreasing in the PTG compared with the CG. [Conclusion] The results of the present study indicate that proprioceptive training increased the foot progression angle and weight-bearing ratio and decreased the first peak knee adduction moment. Moreover, incorporating proprioceptive training into a physical therapy exercise program could improve functional ability and delay the progression of degenerative osteoarthritis. PMID:25729170

A Prospective Comparative Study of Arthroscopic Versus Mini-Open Latarjet Procedure With a Minimum 2-Year Follow-up.

PubMed

Marion, Blandine; Klouche, Shahnaz; Deranlot, Julien; Bauer, Thomas; Nourissat, Geoffroy; Hardy, Philippe

2017-02-01

To compare postoperative pain during the first postoperative week and the position of the coracoid bone block at the anterior aspect of the glenoid after the arthroscopic and the mini-open Latarjet procedure. The secondary purpose was to assess functional results and recurrence after at least 2 years of follow-up. This comparative prospective study included patients who underwent a Latarjet-Bristow procedure for anterior shoulder instability in 2012. The Latarjet procedure was performed by a mini-open approach (G1) in one center and by an arthroscopic approach (G2) in the other. The main evaluation criterion was average shoulder pain during the first postoperative week assessed by the patient on a standard 10-cm visual analog scale (0-10). Secondary criteria were consumption of analgesics during the first week, the position of the coracoid bone block on radiograph and computed tomography scan at the 3-month follow-up and clinical outcomes (Western Ontario Score Index and new surgery) after at least 2 years of follow-up. Fifty-eight patients were included, 22 G1 and 36 G2, 13 women and 45 men, mean age 26.9 ± 7.7 years. The mean follow-up was 29.8 ± 4.4 months. There was significantly less pain in the arthroscopic Latarjet group than in the mini-open group during the first postoperative week (2.5 ± 1.4 vs 1.2 ± 1.2, P = .002) with comparable consumption of analgesics (P > .05). The arthroscopic Latarjet procedure resulted in a more lateral coracoid bone block (P = .04) and a better equatorial position than the mini-open technique (P = .02). Three patients underwent revision surgery (1 recurrence [2.8%], 1 block fracture, 1 screw ablation) in the arthroscopic group, none in the mini-open group (P = .54). At the final follow-up, the Western Ontario Score Index score was good in all patients (G1: 78.5 ± 7.5% vs G2: 82.3 ± 7%, P = .03). This prospective comparative study showed that the arthroscopic Latarjet procedure was significantly less painful than the mini-open procedure during the first postoperative week. The clinical outcomes were comparable after at least 2 years of follow-up. Level II, prospective comparative study. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Eribulin regresses a doxorubicin-resistant Ewing's sarcoma with a FUS-ERG fusion and CDKN2A-deletion in a patient-derived orthotopic xenograft (PDOX) nude mouse model.

PubMed

Miyake, Kentaro; Murakami, Takashi; Kiyuna, Tasuku; Igarashi, Kentaro; Kawaguchi, Kei; Li, Yunfeng; Singh, Arun S; Dry, Sarah M; Eckardt, Mark A; Hiroshima, Yukihiko; Momiyama, Masashi; Matsuyama, Ryusei; Chishima, Takashi; Endo, Itaru; Eilber, Fritz C; Hoffman, Robert M

2018-01-01

Ewing's sarcoma is a recalcitrant tumor greatly in need of more effective therapy. The aim of this study was to determine the efficacy of eribulin on a doxorubicin (DOX)-resistant Ewing's sarcoma patient derived orthotopic xenograft (PDOX) model. The Ewing's sarcoma PDOX model was previously established in the right chest wall of nude mice from tumor resected form the patient's right chest wall. In the previous study, the Ewing's sarcoma PDOX was resistant to doxorubicin (DOX) and sensitive to palbociclib and linsitinib. In the present study, the PDOX models were randomized into three groups when the tumor volume reached 60 mm 3 : G1, untreated control (n = 6); G2, DOX treated (n = 6), intraperitoneal (i.p.) injection, weekly, for 2 weeks); G3, Eribulin treated (n = 6, intravenous (i.v.) injection, weekly for 2 weeks). All mice were sacrificed on day 15. Changes in body weight and tumor volume were assessed two times per week. Tumor weight was measured after sacrifice. DOX did not suppress tumor growth compared to the control group (P = 0.589), consistent with the previous results in the patient and PDOX. Eribulin regressed tumor size significantly compared to G1 and G2 (P = 0.006, P = 0.017) respectively. No significant difference was observed in body weight among any group. Our results demonstrate that eribulin is a promising novel therapeutic agent for Ewing's sarcoma. © 2017 Wiley Periodicals, Inc.

Multi-feature classifiers for burst detection in single EEG channels from preterm infants

NASA Astrophysics Data System (ADS)

Navarro, X.; Porée, F.; Kuchenbuch, M.; Chavez, M.; Beuchée, Alain; Carrault, G.

2017-08-01

Objective. The study of electroencephalographic (EEG) bursts in preterm infants provides valuable information about maturation or prognostication after perinatal asphyxia. Over the last two decades, a number of works proposed algorithms to automatically detect EEG bursts in preterm infants, but they were designed for populations under 35 weeks of post menstrual age (PMA). However, as the brain activity evolves rapidly during postnatal life, these solutions might be under-performing with increasing PMA. In this work we focused on preterm infants reaching term ages (PMA  ⩾36 weeks) using multi-feature classification on a single EEG channel. Approach. Five EEG burst detectors relying on different machine learning approaches were compared: logistic regression (LR), linear discriminant analysis (LDA), k-nearest neighbors (kNN), support vector machines (SVM) and thresholding (Th). Classifiers were trained by visually labeled EEG recordings from 14 very preterm infants (born after 28 weeks of gestation) with 36-41 weeks PMA. Main results. The most performing classifiers reached about 95% accuracy (kNN, SVM and LR) whereas Th obtained 84%. Compared to human-automatic agreements, LR provided the highest scores (Cohen’s kappa  =  0.71) using only three EEG features. Applying this classifier in an unlabeled database of 21 infants  ⩾36 weeks PMA, we found that long EEG bursts and short inter-burst periods are characteristic of infants with the highest PMA and weights. Significance. In view of these results, LR-based burst detection could be a suitable tool to study maturation in monitoring or portable devices using a single EEG channel.

Resistance training inhibits the elevation of skeletal muscle derived-BDNF level concomitant with improvement of muscle strength in zucker diabetic rat

PubMed Central

Kim, Hee-Jae; So, Byunghun; Son, Jun Seok; Song, Han Sol; Oh, Seung Lyul; Seong, Je Kyung; Lee, Hoyoung; Song, Wook

2015-01-01

[Purpose] In the present study, we investigated the effects of 8 weeks of progressive resistance training on the level of skeletal muscle derived BDNF as well as glucose intolerance in Zucker diabetic rats. [Methods] Six week-old male Zucker diabetic fatty (ZDF) and Zucker lean control (ZLC) rats were randomly divided into 3 groups: sedentary ZLC (ZLC-Con), sedentary ZDF (ZDF-Con), and exercised ZDF (ZDF-Ex). Progressive resistance training using a ladder and tail weights was performed for 8 weeks (3 days/week). [Results] After 8 weeks of resistance training, substantial reduction in body weight was observed in ZDF-Ex compared to ZDF-Con. Though the skeletal muscle volume did not change, grip strength grip strength was significantly higher in ZDF-Ex compared to ZDF-Con. In the soleus, the level of BDNF was increased in ZDF-Con, but was significantly decreased (p<0.05) in ZDF-Ex, showing a training effect. Moreover, we found that there was a negative correlation (r=-0.657; p=0.004) between grip strength and BDNF level whereas there was a positive correlation (r=0.612; p=0.008) between plasma glucose level and BDNF level in skeletal muscle. [Conclusion] Based upon our results, we demonstrated that resistance training inhibited the elevation of skeletal muscle derived-BDNF expression concomitant with the improvement of muscle strength in zucker diabetic rats. In addition, muscle-derived BDNF might be a potential mediator for the preventive effect of resistance training on the progress of type 2 diabetes. PMID:27274460

Efficacy and safety of Chlorella supplementation in adults with chronic hepatitis C virus infection

PubMed Central

Azocar, Jose; Diaz, Arley

2013-01-01

AIM: To evaluate the safety and efficacy of Chlorella in 18 patients chronically infected with hepatitis C virus (HCV) genotype 1. METHODS: Eighteen adults with chronic infection by HCV genotype 1 received daily oral supplementation of Chlorella for 12 wk. Changes in the RNA levels of HCV, as well as those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were evaluated following this treatment period. Paired t tests were conducted to compare the means of the different variables at the beginning and end of the study. Side effects and quality of life aspects were also compared between weeks 0 and 12 of the study period. RESULTS: A majority 84.61% of the patients had a significant decrease in their ALT levels from week 0 to week 12. Evaluation of side effects showed that Chlorella was well tolerated. Quality of life assessment showed that 76.9 of the participants reported an improvement in their energy levels and 46.1% reported an improvement in their perception of general health. Although 69.23% also showed a decrease in their AST levels, this was not statistically significant. Most patients that exhibited an improvement in their ALT and AST levels also showed a tendency toward a decreased HCV viral load. The HCV RNA levels showed a decrease in 69.23% of the patients, which along with changes in AST/ALT ratios from week 0 to week 12, these results were not statistically significant. CONCLUSION: Chlorella supplementation was well tolerated in patients with chronic HCV and associated with a significant decrease in ALT liver enzyme levels. PMID:23467073

Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea: results of two 40-week controlled, investigator-blinded trials.

PubMed

Stein Gold, Linda; Kircik, Leon; Fowler, Joseph; Jackson, J Mark; Tan, Jerry; Draelos, Zoe; Fleischer, Alan; Appell, Melanie; Steinhoff, Martin; Lynde, Charles; Sugarman, Jeffrey; Liu, Hong; Jacovella, Jean

2014-11-01

Papulopustular rosacea (PPR) is characterized by facial erythema and inflammatory lesions believed to be primarily caused by dysregulation of the innate immune system. More recent evidence also suggests that Demodex folliculorum mites may contribute to the etiology of PPR. Ivermectin (IVM) 1% cream is a novel topical treatment developed to treat PPR. Two phase 3 trials have demonstrated that IVM 1% cream was significantly better than vehicle at investigator global assessment (IGA) success rate and lesion reductions and that it was safe and well tolerated. Two 40-week extension studies of those trials were conducted to assess the long-term safety of IVM 1% cream vs azelaic acid (AzA) 15% gel. Subjects originally treated with IVM 1% continued on IVM 1% and those originally treated with vehicle switched to AzA 15% gel. IVM 1% cream was safe throughout the study with a lower incidence of related adverse events (AEs) compared to AzA 15% gel. No subjects in the IVM 1% cream group discontinued either study due to a related AE. IVM 1% also continued to be efficacious during the 40-week extension studies as the percentage of subjects with IGA scores of clear or almost clear was higher at the end of the study compared to baseline. The results of these 40-week extension studies support the use of IVM 1% cream as a long-term therapy for PPR as IVM 1% cream was shown to be safe and effective for up to 52 weeks of total treatment.

TVT-Secur (Hammock) Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

PubMed Central

Hota, Lekha S.; Hanaway, Katherine; Hacker, Michele R.; Disciullo, Anthony; Elkadry, Eman; Dramitinos, Patricia; Shapiro, Alexander; Ferzandi, Tanaz; Rosenblatt, Peter L.

2013-01-01

Objectives This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI). Methods This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year. Results Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3–16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5–128.0) at 12 weeks and 3.5 (95% CI, 1.1–11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36). Conclusions The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms. PMID:22453267

Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil.

PubMed

Kim, Edward; Seftel, Allen; Goldfischer, Evan; Baygani, Simin; Burns, Patrick

2015-02-01

Phosphodiesterase type-5 inhibitors (PDE5Is) are first-line therapies for erectile dysfunction (ED). Sildenafil (SIL) and vardenafil (VAR) are approved for as-needed (PRN) dosing; tadalafil (TAD) is approved for both PRN and once-a-day (OaD) dosing for ED. Recent evidence suggests that TAD-OaD may be effective as therapy in men with an incomplete response to PRN-PDE5I therapy. This study evaluated whether TAD-OaD provides similar efficacy in men with ED who had previously demonstrated a partial response to PRN-PDE5I therapy. In this randomized, double-blind, placebo-controlled trial, men with a ≥3 month ED history received SIL 100 mg, TAD 20 mg, or VAR 20 mg during a 4 week open-label lead-in period. Those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain scores <26 following lead-in treatment completed a 4 week washout period, then randomized to TAD 2.5 mg up-titrated to 5 mg, TAD 5 mg, or placebo (PBO) OaD for 12 weeks. MAIN OUTCOME MEASURES obtained from patients treated with TAD-OaD were compared to PBO-treated patients. Additionally, results of treatment with TAD-OaD were compared to results obtained from 4 week PRN-PDE5I therapy to determine whether OaD and PRN regimens provided comparable efficacy. NCT01130532. International Index of Erectile Function (IIEF) domain scores; Sexual Encounter Profile (SEP) questions 2-5. Endpoint data was obtained from 590 men (391 TAD; 199 PBO). RESULTS for all IIEF and SEP measures were significantly better for TAD-OaD (p < 0.001 for all) compared to PBO and were comparable to those observed during PRN-PDE5I treatment. TAD 2.5 mg and TAD 5 mg OaD therapy were safe and generally well tolerated. Tadalafil once daily is a viable alternative to as-needed PDE5I therapy in men with ED. Key limitations include the lack of a PRN PDE5I study group during the double-blind period, and that many more patients took tadalafil than sildenafil or vardenafil during the PRN period.

Randomized phase 3 trial comparing 2 cisplatin dose schedules in 326 patients with locally advanced squamous cell cervical carcinoma: long-term follow-up.

PubMed

Nagy, Viorica Magdalena; Ordeanu, Claudia; Coza, Ovidiu; Alin, Cristian Rancea; Traila, Alexandru; Todor, Nicolae

2012-11-01

The evaluation of 5-year results obtained through 2 radiochemotherapy (RCT) regimens: cisplatin (CDDP), 20 mg/m × 5 days every 21 days; and CDDP, 40 mg/m per week in locally advanced cervical carcinoma. In this single-institution prospective randomized phase 3 study, 326 patients with stage IIB to IIIB squamous cell cervical carcinoma treated from March 2003 to March 2005 were included. One hundred sixty patients (49%) had stage IIB cervical carcinoma, 103 patients (31.5%) had stage IIIA cervical carcinoma, and 63 patients (19.5%) had stage IIIB cervical carcinoma. The patients were randomly assigned to 2 therapeutic arms: 164 patients in arm A (5 days) concurrent RCT with CDDP, 20 mg/m per day, days 1 to 5 every 21 days; and 162 patients in arm B (weekly), concurrent RCT with CDDP, 40 mg/m per day weekly. All patients were treated with external beam radiotherapy on the abdominopelvic region using 15-MV x-rays and a cervical boost using the x-rays arch technique or medium-dose-rate intracavitary brachytherapy. The 5-year survival rate obtained through the 2 RCT regimens are not statistically different, even if a tendency of superiority can be observed in the 5-day arm as far as overall survival (78% in arm A vs 72% in arm B; p = 0.14) and disease-free survival (73% in arm A and 69% in arm B; p = 0.09) are concerned. Five-year local relapse-free survival was significantly superior in the 5-day CDDP arm (87%) in comparison with the weekly CDDP arm (77%); p < 0.01. In the 5-day arm, local relapse rate was twice lower, 21/164 (13%), compared with the weekly arm, 40/162 (25%); p < 0.01). Distance failures were identical in the 2 therapeutic groups: 22/164 (13%) and 21/162 (13%), respectively, which shows the superiority of arm A regarding local control. The results of our study demonstrate that RCT with cisplatin, 20 mg/m × 5 days every 21 days, is superior regarding local efficacy and is less toxic compared with the weekly chemotherapy regimen.

Development of doxorubicin-induced chronic cardiotoxicity in the B6C3F{sub 1} mouse model

DOE Office of Scientific and Technical Information (OSTI.GOV)

Desai, Varsha G., E-mail: varsha.desai@fda.hhs.gov; Herman, Eugene H.; Moland, Carrie L.

2013-01-01

Serum levels of cardiac troponins serve as biomarkers of myocardial injury. However, troponins are released into the serum only after damage to cardiac tissue has occurred. Here, we report development of a mouse model of doxorubicin (DOX)-induced chronic cardiotoxicity to aid in the identification of predictive biomarkers of early events of cardiac tissue injury. Male B6C3F{sub 1} mice were administered intravenous DOX at 3 mg/kg body weight, or an equivalent volume of saline, once a week for 4, 6, 8, 10, 12, and 14 weeks, resulting in cumulative DOX doses of 12, 18, 24, 30, 36, and 42 mg/kg, respectively.more » Mice were sacrificed a week following the last dose. A significant reduction in body weight gain was observed in mice following exposure to a weekly DOX dose for 1 week and longer compared to saline-treated controls. DOX treatment also resulted in declines in red blood cell count, hemoglobin level, and hematocrit compared to saline-treated controls after the 2nd weekly dose until the 8th and 9th doses, followed by a modest recovery. All DOX-treated mice had significant elevations in cardiac troponin T concentrations in plasma compared to saline-treated controls, indicating cardiac tissue injury. Also, a dose-related increase in the severity of cardiac lesions was seen in mice exposed to 24 mg/kg DOX and higher cumulative doses. Mice treated with cumulative DOX doses of 30 mg/kg and higher showed a significant decline in heart rate, suggesting drug-induced cardiac dysfunction. Altogether, these findings demonstrate the development of DOX-induced chronic cardiotoxicity in B6C3F{sub 1} mice. -- Highlights: ► 24 mg/kg was a cumulative cardiotoxic dose of doxorubicin in male B6C3F{sub 1} mice. ► Doxorubicin-induced hematological toxicity was in association with splenomegaly. ► Doxorubicin induced severe testicular toxicity in B6C3F{sub 1} male mice.« less

Age-dependent changes in nitric oxide synthase activity and protein expression in striata of mice transgenic for the Huntington's disease mutation.

PubMed

Pérez-Severiano, Francisca; Escalante, Bruno; Vergara, Paula; Ríos, Camilo; Segovia, José

2002-09-27

Huntington's disease (HD) is an autosomal hereditary neurodegenerative disorder caused by an abnormal expansion of the CAG repeats that code for a polyglutamine tract in a novel protein called huntingtin (htt). Both patients and experimental animals exhibit oxidative damage in specific areas of the brain, particularly the striatum. Nitric oxide (NO) is involved in many different physiological processes, and under pathological conditions it may promote oxidative damage through the formation of the highly reactive metabolite peroxynitrite; however, it may also play a role protecting cells from oxidative damage. We previously showed a correlation between the progression of the neurological phenotype and striatal oxidative damage in a line of transgenic mice, R6/1, which expresses a human mutated htt exon 1 with 116 CAG repeats. The purpose of the present work was to explore the participation of NO in the progressive oxidative damage that occurs in the striata of R6/1 mice. We analyzed the role of NO by measuring the activity of nitric oxide synthase (NOS) in the striata of transgenic and control mice at different ages. There was no difference in NOS activity between transgenic and wild-type mice at 11 weeks of age. In contrast, 19-week-old transgenic mice showed a significant increase in NOS activity, compared with same age controls. By 35 weeks of age, there was a decrease in NOS activity in transgenic mice when compared with wild-type controls. NOS protein expression was also determined in 11-, 19- and 35-week-old transgenic mice and wild-type littermates. Our results show increased neuronal NOS expression in 19-week-old transgenic mice, followed by a decreased level in 35-week-old mice, compared with controls, a phenomenon that parallels the changes in NOS enzyme activity. The present results suggest that NO is involved in the process leading to striatal oxidative damage and that it is associated with the onset of the progressive neurological phenotype in mice transgenic for the HD mutation.

Effects of virtual reality-based training and task-oriented training on balance performance in stroke patients.

PubMed

Lee, Hyung Young; Kim, You Lim; Lee, Suk Min

2015-06-01

[Purpose] This study aimed to investigate the clinical effects of virtual reality-based training and task-oriented training on balance performance in stroke patients. [Subjects and Methods] The subjects were randomly allocated to 2 groups: virtual reality-based training group (n = 12) and task-oriented training group (n = 12). The patients in the virtual reality-based training group used the Nintendo Wii Fit Plus, which provided visual and auditory feedback as well as the movements that enabled shifting of weight to the right and left sides, for 30 min/day, 3 times/week for 6 weeks. The patients in the task-oriented training group practiced additional task-oriented programs for 30 min/day, 3 times/week for 6 weeks. Patients in both groups also underwent conventional physical therapy for 60 min/day, 5 times/week for 6 weeks. [Results] Balance and functional reach test outcomes were examined in both groups. The results showed that the static balance and functional reach test outcomes were significantly higher in the virtual reality-based training group than in the task-oriented training group. [Conclusion] This study suggested that virtual reality-based training might be a more feasible and suitable therapeutic intervention for dynamic balance in stroke patients compared to task-oriented training.

Effects of virtual reality-based training and task-oriented training on balance performance in stroke patients

PubMed Central

Lee, Hyung Young; Kim, You Lim; Lee, Suk Min

2015-01-01

[Purpose] This study aimed to investigate the clinical effects of virtual reality-based training and task-oriented training on balance performance in stroke patients. [Subjects and Methods] The subjects were randomly allocated to 2 groups: virtual reality-based training group (n = 12) and task-oriented training group (n = 12). The patients in the virtual reality-based training group used the Nintendo Wii Fit Plus, which provided visual and auditory feedback as well as the movements that enabled shifting of weight to the right and left sides, for 30 min/day, 3 times/week for 6 weeks. The patients in the task-oriented training group practiced additional task-oriented programs for 30 min/day, 3 times/week for 6 weeks. Patients in both groups also underwent conventional physical therapy for 60 min/day, 5 times/week for 6 weeks. [Results] Balance and functional reach test outcomes were examined in both groups. The results showed that the static balance and functional reach test outcomes were significantly higher in the virtual reality-based training group than in the task-oriented training group. [Conclusion] This study suggested that virtual reality-based training might be a more feasible and suitable therapeutic intervention for dynamic balance in stroke patients compared to task-oriented training. PMID:26180341

A randomized controlled trial of Kundalini yoga in mild cognitive impairment

PubMed Central

Eyre, Harris A.; Siddarth, Prabha; Acevedo, Bianca; Van Dyk, Kathleen; Paholpak, Pattharee; Ercoli, Linda; Cyr, Natalie St.; Yang, Hongyu; Khalsa, Dharma S.; Lavretsky, Helen

2017-01-01

Background Global population aging will result in increasing rates of cognitive decline and dementia. Thus, effective, low-cost, and low side-effect interventions for the treatment and prevention of cognitive decline are urgently needed. Our study is the first to investigate the effects of Kundalini yoga (KY) training on mild cognitive impairment (MCI). Methods Older participants (≥55 years of age) with MCI were randomized to either a 12-week KY intervention or memory enhancement training (MET; gold-standard, active control). Cognitive (i.e. memory and executive functioning) and mood (i.e. depression, apathy, and resilience) assessments were administered at baseline, 12 weeks and 24 weeks. Results At baseline, 81 participants had no significant baseline group differences in clinical or demographic characteristics. At 12 weeks and 24 weeks, both KY and MET groups showed significant improvement in memory; however, only KY showed significant improvement in executive functioning. Only the KY group showed significant improvement in depressive symptoms and resilience at week 12. Conclusion KY group showed short- and long-term improvements in executive functioning as compared to MET, and broader effects on depressed mood and resilience. This observation should be confirmed in future clinical trials of yoga intervention for treatment and prevention of cognitive decline (NCT01983930). PMID:28088925

Genetic Correlation between Alcohol Preference and Conditioned Fear: Exploring a Functional Relationship

PubMed Central

Chester, Julia A.; Weera, Marcus M.

2016-01-01

Post-traumatic stress disorder (PTSD) and alcohol-use disorders have a high rate of co-occurrence, possibly because they are regulated by common genes. In support of this idea, mice selectively bred for high (HAP) alcohol preference show greater fear potentiated startle (FPS), a model for fear-related disorders such as PTSD, compared to mice selectively bred for low (LAP) alcohol preference. This positive genetic correlation between alcohol preference and FPS behavior suggests that the two traits may be functionally related. This study examined the effects of fear conditioning on alcohol consumption and the effects of alcohol consumption on the expression of FPS in male and female HAP2 and LAP2 mice. In experiment 1, alcohol consumption (g/kg) under continuous-access conditions was monitored daily for 4 weeks following a single fear-conditioning or control treatment (foot shock and no shock). FPS was assessed three times (once at the end of the 4-week alcohol access period, once at 24 h after removal of alcohol, and once at 6–8 days after removal of alcohol), followed by two more weeks of alcohol access. Results showed no change in alcohol consumption, but alcohol-consuming, fear-conditioned, HAP2 males showed increased FPS at 24 h during the alcohol abstinence period compared to control groups. In experiment 2, alcohol consumption under limited-access conditions was monitored daily for 4 weeks. Fear-conditioning or control treatments occurred four times during the first 12 days and FPS testing occurred four times during the second 12 days of the 4-week alcohol consumption period. Results showed that fear conditioning increased alcohol intake in both HAP2 and LAP2 mice immediately following the first conditioning session. Fear-conditioned HAP2 but not LAP2 mice showed greater alcohol intake compared to control groups on drinking days that occurred between fear conditioning and FPS test sessions. FPS did not change as a function of alcohol consumption in either line. These results in mice help shed light on how a genetic propensity toward high alcohol consumption may be related to the risk for developing PTSD and co-morbid alcohol-use disorders in humans. PMID:27908524

Psychological interventions to reduce suicidality in high-risk patients with major depression: a randomized controlled trial

PubMed Central

Celano, C. M.; Beale, E. E.; Mastromauro, C. A.; Stewart, J. G.; Millstein, R. A.; Auerbach, R. P.; Bedoya, C. A.; Huffman, J. C.

2016-01-01

Background Positive psychological constructs have been associated with reduced suicidal ideation, and interventions to cultivate positive feelings have the potential to reduce suicide risk. This study compares the efficacy of a 6-week, telephone-based positive psychology (PP) intervention against a cognition-focused (CF) control intervention among patients recently hospitalized for depression and suicidal ideation or behavior. Method A total of 65 adults with a current major depressive episode reporting suicidal ideation or a recent suicide attempt were enrolled from participating in-patient psychiatric units. Prior to discharge, participants were randomized to the PP (n = 32) or CF (n = 33) intervention. In both interventions, participants received a treatment manual, performed weekly PP (e.g. gratitude letter) or CF (e.g. recalling daily events) exercises, and completed weekly one-on-one telephone sessions over 6 weeks. Between-group differences in hopelessness (primary outcome), depression, suicidality and positive psychological constructs at 6 and 12 weeks were tested using mixed-effects models accounting for intensity of post-hospitalization psychiatric treatment. Results Compared with PP, the CF intervention was associated with significantly greater improvements in hopelessness at 6 weeks (β = −3.15, 95% confidence interval −6.18 to −0.12, effect size = −0.84, p = 0.04), but not 12 weeks. Similarly, the CF intervention led to greater improvements in depression, suicidal ideation, optimism and gratitude at 6 and 12 weeks. Conclusions Contrary to our hypothesis, the CF intervention was superior to PP in improving hopelessness, other suicide risk factors and positive psychological constructs during a key post-discharge period among suicidal patients with depression. Further study of this CF intervention is warranted in populations at high suicide risk. PMID:27876105

Specific serum protein changes associated with primary and secondary Strongylus vulgaris infections in pony yearlings.

PubMed

Kent, J E

1987-03-01

The concentrations of haptoglobin, immunoglobin (Ig)G(T) and IgG were measured in the serum of four previously parasite-free pony yearlings following a single dose of 700 (Group H) or 200 (Group L) stage three Strongylus vulgaris larvae (L3) and following a reinfection with the same doses 34 weeks later. The results are compared with an uninfected control pony. The haptoglobin concentration increased during Weeks 1 to 6 and 14 to 17 after infection in the serum of the ponies receiving 200 L3, but in only one pony dosed with 700 L3 (during Weeks 1 to 16). The serum haptoglobin also increased during the first seven weeks after the second infection, in three of the four ponies following the second dose of larvae. The serum IgG(T) concentration started to increase from Week 6 or 9 in the ponies given 700 L3, reaching peaks of 44 and 32 g/litre respectively, eight to nine weeks later, compared with a peak of 16 g/litre 20 to 22 weeks after infection in ponies dosed with 200 L3. The IgG(T) concentration increased to a maximum of 25 g/litre in the serum of only one of the four ponies after the reinfection. The serum IgG concentration in all ponies increased nearly twofold during the first eight weeks after both the primary and secondary dose of larvae. It is concluded that the measurement of specific proteins is more reliable and quicker than the electrophoretic separation and quantitation of protein bands, in tracing changes in serum proteins following the artificial infection of ponies with S vulgaris larvae.

Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia

PubMed Central

Tornheim, Jeffrey A.; Lozano Beltran, Daniel F.; Gilman, Robert H.; Castellon, Mario; Solano Mercado, Marco A.; Sullca, Walter; Torrico, Faustino; Bern, Caryn

2013-01-01

Background Chagas disease treatment is limited by drug availability, adverse side effect profiles of available medications, and poor adherence. Methods Adult Chagas disease patients initiating 60-days of benznidazole were randomized to weekly or twice-weekly evaluations of medication adherence and screening for adverse drug events (ADEs). Mid-week evaluations employed phone-based evaluations. Adherence was measured by self-report, pill counts with intentional over-distribution, and Medication Event Monitoring Systems (MEMS). Prospective data were compared to historical controls treated with benznidazole at the same hospital. Results 162 prospective patients were compared to 172 historical patients. Pill counts correlated well with MEMS data (R = 0.498 for 7-day intervals, R = 0.872 for intervals >7 days). Treatment completion rates were higher among prospective than historical patients (82.1% vs. 65.1%), primarily due to lower abandonment rates. Rates of ADEs were lower among prospective than historical patients (56.8% vs. 66.9%). Twice-weekly evaluations increased identification of mild ADEs, prompting higher suspension rates than weekly evaluations. While twice-weekly evaluations identified ADEs earlier, they did not reduce incidence of moderate or severe ADEs. Many dermatologic ADEs were moderately severe upon presentation (35.6%), were not reduced by use of antihistamines, occurred among adult patients of all ages, and occurred throughout treatment, rather than the first few weeks alone. Conclusions Intensive management improved completion and identified more ADEs, but did not reduce moderate or severe ADEs. Risk of dermatologic ADEs cannot be reduced by selecting younger adults or monitoring only during the first few weeks of treatment. Pill counts and phone-based encounters are reliable tools for treatment programming in rural Bolivia. PMID:24069472

Natural history of bacterial vaginosis and intermediate flora in pregnancy and effect of oral clindamycin.

PubMed

Ugwumadu, Austin; Reid, Fiona; Hay, Phillip; Manyonda, Isaac

2004-07-01

We sought to describe the natural history of abnormal vaginal flora in pregnancy and estimate the efficacy of oral clindamycin in eradicating it and preventing relapse. This was a subanalysis of a randomized trial of oral clindamycin for abnormal vaginal flora in pregnancy. All 494 enrolled women were asked to provide a vaginal smear 2 weeks after treatment and every second participant to provide further smears at 20, 24, 28, 32, and 36 weeks of gestation. We used Nugent score of Gram-stained smears to assess the cure rate among the clindamycin group and the rate of spontaneous resolution among the placebo group. Posttreatment smears were available for 462 women (231 in each of the clindamycin and placebo arms). The prevalence of abnormal flora posttreatment was 10% (22 of 231) in the clindamycin group compared with 93% (214 of 231) in the placebo group (P <.001). Two hundred nineteen women obtained 4 weekly smears; slides for 84 women were lost, and results were available for 135 women (69 clindamycin, 66 placebo). In the clindamycin group, the prevalence of abnormal flora was 15% at 20 weeks of gestation and 17% at 36 weeks of gestation compared with 69% at 20 weeks of gestation and 43% at 36 weeks of gestation in the placebo group. Oral clindamycin eradicated abnormal flora in 90% of treated pregnant women and maintained a normal flora in two thirds of women throughout pregnancy. Almost one third of untreated women in our study had spontaneous resolution of abnormal flora by 20 weeks of gestation. Because previous research has shown that spontaneous resolution does not modify the risk of preterm birth, early screening is essential.

Effect of Saccharomyces boulardii and Mode of Delivery on the Early Development of the Gut Microbial Community in Preterm Infants

PubMed Central

Zeber-Lubecka, Natalia; Kulecka, Maria; Ambrozkiewicz, Filip; Paziewska, Agnieszka; Lechowicz, Milosz; Konopka, Ewa; Majewska, Urszula; Borszewska-Kornacka, Maria; Mikula, Michal; Cukrowska, Bozena; Ostrowski, Jerzy

2016-01-01

Background Recent advances in culture-independent approaches have enabled insights into the diversity, complexity, and individual variability of gut microbial communities. Objectives To examine the effect of oral administration of Saccharomyces (S.) boulardii and mode of delivery on the intestinal microbial community in preterm infants. Study Design Stool samples were collected from preterm newborns randomly divided into two groups: a probiotic-receiving group (n = 18) or a placebo group (n = 21). Samples were collected before probiotic intake (day 0), and after 2 and 6 weeks of supplementation. The composition of colonizing bacteria was assessed by 16S ribosomal RNA (rRNA) gene sequencing of fecal samples using the Ion 16S Metagenomics Kit and the Ion Torrent Personal Genome Machine platform. Results A total of 11932257 reads were generated, and were clustered into 459, 187, and 176 operational taxonomic units at 0 days, 2 weeks, and 6 weeks, respectively. Of the 17 identified phyla, Firmicutes Actinobacteria, Proteobacteria, and Bacteroidetes were universal. The microbial community differed at day 0 compared with at 2 weeks and 6 weeks. There was a tendency for increased bacterial diversity at 2 weeks and 6 weeks compared with day 0, and infants with a gestational age of 31 weeks or higher presented increased bacterial diversity prior to S. boulardii administration. Firmicutes and Proteobacteria remained stable during the observation period, whereas Actinobacteria and Bacteroidetes increased in abundance, the latter particularly more sharply in vaginally delivered infants. Conclusion While the mode of delivery may influence the development of a microbial community, this study had not enough power to detect statistical differences between cohorts supplemented with probiotics, and in a consequence, to speculate on S. boulardii effect on gut microbiome composition in preterm newborns. PMID:26918330

Cost-Effectiveness of Diagnostic Strategies for Suspected Scaphoid Fractures.

PubMed

Yin, Zhong-Gang; Zhang, Jian-Bing; Gong, Ke-Tong

2015-08-01

The aim of this study was to assess the cost effectiveness of multiple competing diagnostic strategies for suspected scaphoid fractures. With published data, the authors created a decision-tree model simulating the diagnosis of suspected scaphoid fractures. Clinical outcomes, costs, and cost effectiveness of immediate computed tomography (CT), day 3 magnetic resonance imaging (MRI), day 3 bone scan, week 2 radiographs alone, week 2 radiographs-CT, week 2 radiographs-MRI, week 2 radiographs-bone scan, and immediate MRI were evaluated. The primary clinical outcome was the detection of scaphoid fractures. The authors adopted societal perspective, including both the costs of healthcare and the cost of lost productivity. The incremental cost-effectiveness ratio (ICER), which expresses the incremental cost per incremental scaphoid fracture detected using a strategy, was calculated to compare these diagnostic strategies. Base case analysis, 1-way sensitivity analyses, and "worst case scenario" and "best case scenario" sensitivity analyses were performed. In the base case, the average cost per scaphoid fracture detected with immediate CT was $2553. The ICER of immediate MRI and day 3 MRI compared with immediate CT was $7483 and $32,000 per scaphoid fracture detected, respectively. The ICER of week 2 radiographs-MRI was around $170,000. Day 3 bone scan, week 2 radiographs alone, week 2 radiographs-CT, and week 2 radiographs-bone scan strategy were dominated or extendedly dominated by MRI strategies. The results were generally robust in multiple sensitivity analyses. Immediate CT and MRI were the most cost-effective strategies for diagnosing suspected scaphoid fractures. Economic and Decision Analyses Level II. See Instructions for Authors for a complete description of levels of evidence.

Optimal timing and frequency of bone marrow soup therapy for functional restoration of salivary glands injured by single-dose or fractionated irradiation.

PubMed

Fang, Dongdong; Shang, Sixia; Liu, Younan; Bakkar, Mohammed; Sumita, Yoshinori; Seuntjens, Jan; Tran, Simon D

2018-02-01

Injections of bone marrow (BM) cell extract, known as 'BM soup', were previously reported to mitigate ionizing radiation (IR) injury to salivary glands (SGs). However, the optimal starting time and frequency to maintain BM soup therapeutic efficacy remains unknown. This study tested the optimal starting time and frequency of BM soup injections in mice radiated with either a single dose or a fractionated dose. First, BM soup treatment was started at 1, 3 or 7 weeks post-IR; positive (non-IR) and negative (IR) control mice received injections of saline (vehicle control). Second, BM soup-treated mice received injections at different frequencies (1, 2, 3 and 5 weekly injections). Third, a 'fractionated-dose radiation' model to injure mouse SGs was developed (5 Gy × 5 days) and compared with the single high dose radiation model. All mice (n = 65) were followed for 16 weeks post-IR. The results showed that starting injections of BM soup between 1 and 3 weeks mitigated the effect of IR-induced injury to SGs and improved the restoration of salivary function. Although the therapeutic effect of BM soup lessens after 8 weeks, it can be sustained by increasing the frequency of weekly injections. Moreover, both single-dose and fractionated-dose radiation models are efficient and comparable in inducing SG injury and BM soup treatments are effective in restoring salivary function in both radiation models. In conclusion, starting injections of BM soup within 3 weeks post-radiation, with 5 weekly injections, maintains 90-100% of saliva flow in radiated mice. Copyright © 2017 John Wiley & Sons, Ltd.

A multi-centered randomized trial of the treatment of pemphigus vulgaris patients with infliximab and prednisone compared to prednisone alone

PubMed Central

Hall, R.P.; Fairley, J.; Woodley, D.; Werth, V.P.; Hannah, D.; Streilein, R.D.; McKillip, J.; Okawa, J.; Rose, M.; Keyes-Elstein, L.L.; Pinckney, A.; Overington, A.; Wedgwood, J.; Ding, L.; Welch, B.

2014-01-01

Background Pemphigus vulgaris (PV) is a blistering disease in which TNF-α has a role in the pathogenesis. Objectives The objective was to evaluate the safety of infliximab (IFX) with prednisone compared to prednisone alone in the treatment of PV. In addition, treatment response was assessed and mechanistic studies were performed. Methods PV subjects who had ongoing disease activity while maintained on prednisone were randomized to receive either IFX or placebo in addition to prednisone. Response status and IgG anti-DSG1 and DSG3 antibodies were assessed at 18 and 26 weeks. . Results 10 subjects were randomized to each group. There were no safety signals during the course of the study. At week 18, 1 subject in each group had responded. At week 26, 3 IFX treated subjects vs. none in the placebo group had responded (p =0 .21). At weeks 18 and 26, the median IgG anti-DSG1 and anti-DSG3 levels were lower in the IFX treated-patients (IgG anti DSG-1: week 18 p =0.035, week 26 p = 0.022; IgG anti-DSG3; week 18 p=0.035, week 26 p = 0.05)). Limitations This study is limited by the relative small sample size. Conclusions There was no significant difference between study arms in the proportion of subjects with treatment-related Adverse Events > Grade 3. IFX therapy was not shown to be effective for the treatment of patients with PV in this randomized, placebo-controlled trial, although IFX treatment may be associated with a decrease in anti-DSG1 and DSG3 antibodies. PMID:25123295

Time course of the dependence of associative memory retrieval on the entorhinal cortex.

PubMed

Chen, Xi; Liao, Zhengli; Wong, Yin Ting; Guo, Yiping; He, Jufang

2014-12-01

As the gateway between the hippocampal system and the neocortex, the entorhinal cortex (EC) is hypothesized to be the hub in which the transformation of recent memory to remote memory is processed. We explored the role of the EC on the retrieval of recent and remote associative fear memory. A within-subject approach was adopted to compare the freezing rates of rats in EC intact and EC inactivated conditions following trace fear conditioning. The EC was inactivated by infusing an AMPA antagonist. The fear conditioning used a combined visual and auditory conditioned stimulus with a foot shock. On week 1 following the conditioning, the rats in the EC intact condition exhibited a freezing rate of 92.4±9.5% in response to the light stimulus compared with a 6.3±7.9% freezing rate in the EC inactivated condition. The freezing rates were 87.0±17.8% and 4.7±6.5% on week 2 in the EC intact and inactivated conditions, respectively. These results indicate that the EC participates in the retrieval of associative memory. Extinction of the fear memory was observed in the EC intact condition, as the mean freezing rate decreased to 62.7±23.0% on week 4 and 41.2±26.4% on week 5. However, the freezing rate increased to 26.8±14.2% on week 4 and 22.3±14.4% on week 5 in the EC inactivated condition. The normalized dependence of fear memory retrieval on the EC was 93.2±8.3% on week 1, and significantly decreased on weeks 4 and 5. In summary, the retrieval of associative memory depends on the EC, but this dependence decreases over time. Copyright © 2014 Elsevier Inc. All rights reserved.

Timing and Determinants of the Introduction of Complementary Foods in Kuwait: Results of a Prospective Cohort Study.

PubMed

Scott, Jane A; Dashti, Manal; Al-Sughayer, Mona; Edwards, Christine A

2015-08-01

The early introduction of complementary foods is common in Middle Eastern countries but little is known about the determinants of this practice in this region. This prospective cohort study conducted from October 2007 to October 2008 investigated the determinants of the very early (before 17 weeks) introduction of complementary foods in Kuwait and compared rates of this practice against rates reported in the mid-1990s. A total of 373 women were recruited from maternity hospitals in Kuwait City and followed to 26 weeks postpartum. Data on complementary feeding practices were available from 303 women. Multivariate logistic regression was used to estimate the association of very early introduction of complementary foods with infant sex and maternal characteristics including age, years of education, employment intentions at 6 months postpartum, parity, prepregnancy body mass index, and prepregnancy smoking status. All infants had received complementary foods by 26 weeks of age, with 30.4% receiving complementary foods before 17 weeks of age. Women born in other Arabic countries were less likely to introduce complementary foods before 17 weeks (adjusted odds ratio [adj OR] = 0.40; 95% confidence interval [CI], 0.22-0.73) than women born in Kuwait. Women who were exclusively formula feeding at 6 weeks postpartum were less likely to introduce complementary foods before 17 weeks (adj OR = 0.40; 95% CI, 0.23-0.71) than women who were still breastfeeding. Compared to the mid-1990s, fewer infants in Kuwait were receiving complementary foods before 17 weeks. Nevertheless, all infants had received complementary foods by 6 months of age. © The Author(s) 2015.

Aggression and increased glutamate in the mPFC during withdrawal from intermittent alcohol in outbred mice

PubMed Central

Hwa, Lara S.; Nathanson, Anna J.; Shimamoto, Akiko; Tayeh, Jillian K.; Wilens, Allison R.; Holly, Elizabeth N.; Newman, Emily L.; DeBold, Joseph F.; Miczek, Klaus A.

2015-01-01

Rationale Disrupted social behavior, including occasional aggressive outbursts, is characteristic of withdrawal from long-term alcohol (EtOH) use. Heavy EtOH use and exaggerated responses during withdrawal may be treated using glutamatergic N-methyl-D-aspartate receptor (NMDAR) antagonists. Objectives The current experiments explore aggression and medial prefrontal cortex (mPFC) glutamate as consequences of withdrawal from intermittent access to EtOH, and changes in aggression and mPFC glutamate caused by NMDAR antagonists memantine and ketamine. Methods Swiss male mice underwent withdrawal following 1-8 weeks of intermittent access to 20% EtOH. Aggressive and non-aggressive behaviors with a conspecific were measured 6-8 h into EtOH withdrawal after memantine or ketamine (0-30 mg/kg, i.p.) administration. In separate mice, extracellular mPFC glutamate after memantine was measured during withdrawal using in vivo microdialysis. Results At 6-8 h withdrawal from EtOH, mice exhibited more convulsions and aggression, and decreased social contact compared to age-matched water controls. Memantine, but not ketamine, increased withdrawal aggression at the 5 mg/kg dose in mice with a history of 8 weeks EtOH but not 1 or 4 weeks of EtOH or in water drinkers. Tonic mPFC glutamate was higher during withdrawal after 8 weeks EtOH compared to 1 week EtOH or 8 weeks water. Five mg/kg memantine increased glutamate in 8 week EtOH mice, but also in 1 week EtOH and water drinkers. Conclusions These studies reveal aggressive behavior as a novel symptom of EtOH withdrawal in outbred mice and confirm a role of NMDARs during withdrawal aggression and for disrupted social behavior. PMID:25899790

Interventions for treating chronic ankle instability.

PubMed

de Vries, Jasper S; Krips, Rover; Sierevelt, Inger N; Blankevoort, Leendert; van Dijk, C N

2011-08-10

Chronic lateral ankle instability occurs in 10% to 20% of people after an acute ankle sprain. Initial treatment is conservative but if this fails and ligament laxity is present, surgical intervention is considered. To compare different treatments, conservative or surgical, for chronic lateral ankle instability. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL and reference lists of articles, all to February 2010. All identified randomised and quasi-randomised controlled trials of interventions for chronic lateral ankle instability were included. Two review authors independently assessed risk of bias and extracted data from each study. Where appropriate, results of comparable studies were pooled. Ten randomised controlled trials were included. Limitations in the design, conduct and reporting of these trials resulted in unclear or high risk of bias assessments relating to allocation concealment, assessor blinding, incomplete and selective outcome reporting. Only limited pooling of the data was possible.Neuromuscular training was the basis of conservative treatment evaluated in four trials. Neuromuscular training compared with no training resulted in better ankle function scores at the end of four weeks training (Ankle Joint Functional Assessment Tool (AJFAT): mean difference (MD) 3.00, 95% CI 0.3 to 5.70; 1 trial, 19 participants; Foot and Ankle Disability Index (FADI) data: MD 8.83, 95% CI 4.46 to 13.20; 2 trials, 56 participants). The fourth trial (19 participants) found no significant difference in the functional outcome after six weeks training programme on a cyclo-ergometer with a bi-directional compared with a traditional uni-directional pedal. Longer-term follow-up data were not available for these four trials.Four studies compared surgical procedures for chronic ankle instability. One trial (40 participants) found more nerve injuries after tenodesis than anatomical reconstruction (risk ratio (RR) 5.50, 95% CI 1.39 to 21.71). One trial (99 participants) comparing dynamic versus static tenodesis excluded 17 patients allocated dynamic tenodesis because their tendons were too thin. The same trial found that dynamic tenodesis resulted in higher numbers of people with unsatisfactory function (RR 8.62, 95% CI 1.97 to 37.77, 82 participants). One trial comparing techniques of lateral ankle ligament reconstruction (60 participants) found that operating time was shorter using the reinsertion technique than the imbrication method (MD -9.00 minutes, 95% CI -13.48 to -4.52). Two trials (70 participants) compared functional mobilisation with immobilisation after surgery. These found early mobilisation led to earlier return to work (MD -2.00 weeks, 95% CI -3.06 to -0.94; 1 trial) and to sports (MD -3.00 weeks, 95% CI -4.49 to -1.51; 1 trial). Neuromuscular training alone appears effective in the short term but whether this advantage would persist on longer-term follow-up is not known. While there is insufficient evidence to support any one surgical intervention over another surgical intervention for chronic ankle instability, it is likely that there are limitations to the use of dynamic tenodesis. After surgical reconstruction, early functional rehabilitation appears to be superior to six weeks immobilisation in restoring early function.

Cost-effectiveness analysis of docetaxel versus weekly paclitaxel in adjuvant treatment of regional breast cancer in New Zealand.

PubMed

Webber-Foster, Rachel; Kvizhinadze, Giorgi; Rivalland, Gareth; Blakely, Tony

2014-07-01

There have been recent important changes to adjuvant regimens and costs of taxanes for the treatment of early breast cancer, requiring a re-evaluation of comparative cost effectiveness. In particular, weekly paclitaxel is now commonly used but has not been subjected to cost-effectiveness analysis. Our aim was to estimate the cost effectiveness of adjuvant docetaxel and weekly paclitaxel versus each other, and compared with standard 3-weekly paclitaxel, in women aged ≥25 years diagnosed with regional breast cancer in New Zealand. A macrosimulation Markov model was used, with a lifetime horizon and health system perspective. The model compared 3-weekly docetaxel and weekly paclitaxel versus standard 3-weekly paclitaxel (E1199 regimen) in the hospital setting. Data on overall survival and toxicities (febrile neutropenia and peripheral neuropathy) were derived from relevant published clinical trials. Epidemiological and cost data were derived from New Zealand datasets. Health outcomes were measured with health-adjusted life-years (HALYs), similar to quality-adjusted life-years (QALYs). Costs included intervention and health system costs in year 2011 values, with 3% per annum discounting on costs and HALYs. The mean HALY gain per patient compared with standard 3-weekly paclitaxel was 0.51 with weekly paclitaxel and 0.21 with docetaxel, while incremental costs were $NZ 12,284 and $NZ 4,021, respectively. The incremental cost-effectiveness ratio (ICER) of docetaxel versus 3-weekly paclitaxel was $NZ 19,400 (purchasing power parity [PPP]-adjusted $US 13,100) per HALY gained, and the ICER of weekly paclitaxel versus docetaxel was $NZ 27,100 ($US 18,300) per HALY gained. In terms of net monetary benefit, weekly paclitaxel was the optimal strategy for willingness-to-pay (WTP) thresholds >$NZ 27,000 per HALY gained. However, the model was highly sensitive to uncertainty around survival differences, while toxicity-related morbidity had little impact. Thus, if it was assumed that weekly paclitaxel and docetaxel had the same efficacy, docetaxel would be favoured over weekly paclitaxel. Both weekly paclitaxel and docetaxel are likely to be cost effective compared with standard 3-weekly paclitaxel. Weekly paclitaxel was the optimal choice for WTP thresholds greater than $NZ27,000 per HALY gained (PPP-adjusted $US 18,000). However, uncertainty remains around relative survival benefits, and weekly paclitaxel becomes cost ineffective versus docetaxel if it is assumed that the two regimens have equal effectiveness. Reduced uncertainty about the relative survival benefits may improve decision making for funding.

Griseofulvin versus terbinafine in the treatment of tinea capitis: a meta-analysis of randomized, clinical trials.

PubMed

Fleece, David; Gaughan, John P; Aronoff, Stephen C

2004-11-01

Tinea capitis, a common pediatric infection in the United States, is caused mainly by Trichophyton species and affects many urban children. Although the current treatment of choice is oral griseofulvin, terbinafine has been shown to be variably effective in several comparative, randomized trials. The purpose of this study was to perform a meta-analysis of randomized, clinical trials comparing the efficacies of oral terbinafine and oral griseofulvin for the treatment of childhood tinea capitis. The Medline database was searched for randomized, clinical studies comparing griseofulvin and terbinafine for the treatment of tinea capitis. Acceptance criteria included oral administration of griseofulvin for at least 6 weeks and the identification of a pathogenic dermatophyte from the scalp at the time of enrollment in the study. Scalp culture status at least 8 weeks after enrollment was used as the outcome. The common odds ratio (OR) with 95% confidence intervals (CIs), the Cochran-Mantel-Haenszel test for significance, and the Breslow-Day test for homogeneity were calculated. Six articles that satisfied all inclusion criteria were identified. These studies were combined by using outcomes at 12 to 16 weeks after enrollment. The common OR was 0.86 (95% CI: 0.57-1.27). When the 5 studies that identified Trichophyton species as the predominant pathogen were combined, using outcomes 12 weeks after enrollment, the results nearly favored terbinafine (OR: 0.65 [95% CI: 0.42-1.01]). For outcomes at 8 weeks after enrollment, no difference was found between the agents (OR: 0.84 [95% CI: 0.54-1.32]). Consclusions.A 2- to 4-week course of terbinafine is at least as effective as a 6- to 8-week course of griseofulvin for the treatment of Trichophyton infections of the scalp. Griseofulvin is likely to be superior to terbinafine for the rare cases caused by Microsporum species.

Serum Polychlorinated Biphenyls Increase and Oxidative Stress Decreases with a Protein-Pacing Caloric Restriction Diet in Obese Men and Women.

PubMed

He, Feng; Zuo, Li; Ward, Emery; Arciero, Paul J

2017-01-10

The purposes were to compare the effects of a: (1) 12-week P-CR weight loss (WL) diet (Phase 1) between obese men and women and; (2) 52-week modified P-CR (mP-CR) vs. heart healthy (HH) weight maintenance (WM) diet (Phase 2) on serum PCBs and oxidative stress biomarkers (thiobarbituric acid reactive substances, TBARS; total antioxidant capacity, TAC) in 40 obese participants (men, n = 21; women, n = 19). Participants received dietary counseling and monitoring of compliance. PCBs, TBARS, and TAC were assessed at weeks -1 (CON), 12 (WL), and 64 (WM). Following WL (Week 12), concomitant with reductions in TBARS (0.24 ± 0.15 vs. 0.18 ± 0.11 µM; p < 0.01), PCB serum concentrations (86.7 ± 45.6 vs. 115.6 ± 65.9 ng/g lipid; p < 0.01) and TAC (18.9 ± 2.6 vs. 19.9 ± 2.3 nmol/mL; p < 0.02) were increased similarly in men and women. At the end of WM (Week 64), a significant effect of time × group interaction was observed for % change in PCB 170 and 187; whereby mP-CR values were higher compared to HH (PCB170: 19.31% ± 26.48% vs. -6.61% ± 28.88%, p = 0.02; PCB187: -3.04% ± 17.78% vs. -21.4% ± 27.31%, p = 0.04). PCB changes were positively correlated with TBARS levels ( r > 0.42, p < 0.05) and negatively correlated with body weight, fat mass, and abdominal fat ( r < -0.46, p < 0.02). Our results support mobilization of stored PCBs as well as enhanced redox status following a 12-week P-CR WL diet. Additionally, a 52-week mP-CR WM diet demonstrated an advantage in preventing weight gain relapse accompanied by an increase in circulating PCBs compared to a traditional HH diet.

[Predictive factors of mortality in extremely preterm infants].

PubMed

Lin, L; Fang, M C; Jiang, H; Zhu, M L; Chen, S Q; Lin, Z L

2018-04-02

Objective: To investigate the predictive factors of mortality in extremely preterm infants. Methods: The retrospective case-control study was accomplished in the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University. A total of 268 extremely preterm infants seen from January 1, 1999 to December 31, 2015 were divided into survival group (192 cases) and death group (76 cases). The potential predictive factors of mortality were identified by univariate analysis, and then analyzed by multivariate unconditional Logistic regression analysis. The mortality and predictive factors were also compared between two time periods, which were January 1, 1999 to December 31, 2007 (65 cases) and January 1, 2008 to December 31, 2015 (203 cases). Results: The median gestational age (GA) of extremely preterm infants was 27 weeks (23 +3 -27 +6 weeks). The mortality was higher in infants with GA of 25-<26 weeks ( OR= 2.659, 95% CI: 1.211-5.840) and<25 weeks ( OR= 10.029, 95% CI: 3.266-30.792) compared to that in infants with GA> 26 weeks. From January 1, 2008 to December 31, 2015, the number of extremely preterm infants was increased significantly compared to the previous 9 years, while the mortality decreased significantly ( OR= 0.490, 95% CI: 0.272-0.884). Multivariate unconditional Logistic regression analysis showed that GA below 25 weeks ( OR= 6.033, 95% CI: 1.393-26.133), lower birth weight ( OR= 0.997, 95% CI: 0.995-1.000), stage Ⅲ necrotizing enterocolitis (NEC) ( OR= 15.907, 95% CI: 3.613-70.033), grade Ⅰ and Ⅱ intraventricular hemorrhage (IVH) ( OR= 0.260, 95% CI: 0.117-0.575) and dependence on invasive mechanical ventilation ( OR= 3.630, 95% CI: 1.111-11.867) were predictive factors of mortality in extremely preterm infants. Conclusions: GA below 25 weeks, lower birth weight, stage Ⅲ NEC and dependence on invasive mechanical ventilation are risk factors of mortality in extremely preterm infants. But grade ⅠandⅡ IVH is protective factor.

Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model

DOE Office of Scientific and Technical Information (OSTI.GOV)

Radeleff, Boris, E-mail: Boris.radeleff@med.uni-heidelberg.de; Thierjung, Heidi; Stampfl, Ulrike

2008-09-15

PurposeTo date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model.MethodsThe three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks.ResultsStent placement was successful in all animals; nomore » thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 {+-} 62.52 {mu}m) versus the TAXUS (74.864 {+-} 66.03 {mu}m) and versus the CCPS (63.542 {+-} 39.57 {mu}m). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks.ConclusionsThe CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.« less

A Prospective, Comparative Study of the Occurrence and Severity of Constipation with Darifenacin and Trospium in Overactive Bladder

PubMed Central

Pundarikaksha, Hulikallu Purushotama; Hanumantharaju, Basavanahalli Krishnaiah; Anusha, Satenahalli Javaregowda

2015-01-01

Introduction: 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. Materials and Methods: 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. Results: 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). Conclusion: Darifenacin and trospium are equally efficacious and comparable in tolerability in terms of constipation severity and its impact on patient well-being. PMID:25954630

Serum Polychlorinated Biphenyls Increase and Oxidative Stress Decreases with a Protein-Pacing Caloric Restriction Diet in Obese Men and Women

PubMed Central

He, Feng; Zuo, Li; Ward, Emery; Arciero, Paul J.

2017-01-01

The purposes were to compare the effects of a: (1) 12-week P-CR weight loss (WL) diet (Phase 1) between obese men and women and; (2) 52-week modified P-CR (mP-CR) vs. heart healthy (HH) weight maintenance (WM) diet (Phase 2) on serum PCBs and oxidative stress biomarkers (thiobarbituric acid reactive substances, TBARS; total antioxidant capacity, TAC) in 40 obese participants (men, n = 21; women, n = 19). Participants received dietary counseling and monitoring of compliance. PCBs, TBARS, and TAC were assessed at weeks −1 (CON), 12 (WL), and 64 (WM). Following WL (Week 12), concomitant with reductions in TBARS (0.24 ± 0.15 vs. 0.18 ± 0.11 µM; p < 0.01), PCB serum concentrations (86.7 ± 45.6 vs. 115.6 ± 65.9 ng/g lipid; p < 0.01) and TAC (18.9 ± 2.6 vs. 19.9 ± 2.3 nmol/mL; p < 0.02) were increased similarly in men and women. At the end of WM (Week 64), a significant effect of time × group interaction was observed for % change in PCB 170 and 187; whereby mP-CR values were higher compared to HH (PCB170: 19.31% ± 26.48% vs. −6.61% ± 28.88%, p = 0.02; PCB187: −3.04% ± 17.78% vs. −21.4% ± 27.31%, p = 0.04). PCB changes were positively correlated with TBARS levels (r > 0.42, p < 0.05) and negatively correlated with body weight, fat mass, and abdominal fat (r < −0.46, p < 0.02). Our results support mobilization of stored PCBs as well as enhanced redox status following a 12-week P-CR WL diet. Additionally, a 52-week mP-CR WM diet demonstrated an advantage in preventing weight gain relapse accompanied by an increase in circulating PCBs compared to a traditional HH diet. PMID:28075418

Comparative effectiveness of glycemic control in patients with type 2 diabetes treated with GLP-1 receptor agonists: a network meta-analysis of placebo-controlled and active-comparator trials

PubMed Central

Orme, Michelle E; Nguyen, Hiep; Lu, Jackie Y; Thomas, Susan A

2017-01-01

Background Clinical studies of patients with type 2 diabetes show that GLP-1 receptor agonists (GLP-1 RAs) improve glycemic control and promote weight loss. We conducted a Bayesian network meta-analysis (NMA) of placebo- and active-controlled randomized trials to assess the comparative effectiveness of liraglutide, albiglutide, dulaglutide, and exenatide twice daily and once weekly, with a focus on glycemic control. Materials and methods We searched Medline, Embase, and the Cochrane Library (up to December 2014) for core registration programs for US-approved GLP-1 RAs. Patients reaching an A1C target of <7% were analyzed with a binomial model and change in A1C from baseline with a normal model. A covariate analysis assessed the impact of baseline A1C and treatment background on outcomes. Results The base-case NMA used 23 trials reporting A1C outcomes at ~6 month follow-up. The results, unadjusted and adjusted for baseline A1C, indicated that all GLP-1 RAs resulted in statistically significantly lower A1C at follow-up compared with placebo. The odds of reaching the <7% target were also significantly better compared with placebo. With dulaglutide, exenatide once weekly, and liraglutide, the absolute reduction in A1C at 6 months was 0.9%–1.4%, and was significantly better than exenatide twice daily. Albiglutide was not significantly different from exenatide twice daily. We estimate that ~50% of patients will meet the <7% A1C target within 6 months of commencing GLP-1 RAs. Conclusion This was a comprehensive assessment of the comparative effectiveness of GLP-1 RAs and A1C outcome. GLP-1 RAs are a viable addition to oral antidiabetes therapy, and dulaglutide, exenatide once weekly, and liraglutide are the most effective. PMID:28435304

Role of low-level laser therapy added to facial expression exercises in patients with idiopathic facial (Bell's) palsy.

PubMed

Ordahan, Banu; Karahan, Ali Yavuz

2017-05-01

The aim of the present study was to investigate the efficacy of low-level laser therapy in conjunction with conventional facial exercise treatment on functional outcomes during the early recovery period in patients with facial paralysis. Forty-six patients (mean age 41 ± 9.7 years; 40 women and 6 men) were randomized into two groups. Patients in the first group received low-level laser treatment as well as facial exercise treatment, while patients in the second group participated in facial exercise intervention alone. Laser treatment was administered at a wavelength of 830 nm, output power of 100 Mw, and frequency of 1 KHz using a gallium-aluminum-arsenide (GaAIAs, infrared laser) diode laser. A mean energy density of 10 J/cm 2 was administered to eight points of the affected side of the face three times per week, for a total of 6 weeks. The rate of facial improvement was evaluated using the facial disability index (FDI) before, 3 weeks after, and 6 weeks after treatment. Friedman analysis of variance was performed to compare the data from the parameters repeatedly measured in the inner-group analysis. Bonferroni correction was performed to compare between groups as a post hoc test if the variance analysis test result was significant. To detect the group differences, the Bonferroni Student t test was used. The Mann-Whitney U test was used to compare numeric data between the groups. In the exercise group, although no significant difference in FDI scores was noted between the start of treatment and week 3 (p < 0.05), significant improvement was observed at week 6 (p < 0.001). In the laser group, significant improvement in FDI scores relative to baseline was observed at 3 and 6 weeks (p < 0.001). Improvements in FDI scores were significantly greater at weeks 3 and 6 in the laser group than those in the exercise group (p < 0.05). Our findings indicate that combined treatment with low-level laser therapy (LLLT) and exercise therapy is associated with significant improvements in FDI when compared with exercise therapy alone.

The effects of electromyography-triggered electrical stimulation on shoulder subluxation, muscle activation, pain, and function in persons with stroke: A pilot study.

PubMed

Jeon, Somyung; Kim, Young; Jung, Kyoungsim; Chung, Yijung

2017-01-01

The purpose of this study was to examine the effects of task-oriented electromyography-triggered stimulation for shoulder subluxation, muscle activation, pain and upper extremity function in hemiparetic stroke patients. Twenty participants with subacute hemiparetic stroke were recruited for this study and were randomly divided into two groups: experimental group (n = 10) and control group (n = 10). Subjects in the experimental group participated in task-oriented electromyography triggered stimulation for 30 minutes, five times a week for four weeks, whereas the control group received cyclic functional electrical stimulation for 30 minutes, five times a week for four weeks. Subjects in both groups received conventional physical therapy for four weeks (30 min/day, five times/week). Data collected included the degree of shoulder subluxation which had been confirmed by X-ray, muscle activation of the supraspinatus and posterior deltoid muscles by electromyography, pain by the Visual Analogue Scale (VAS), and hand function by the Fugl-Meyer Assessment (FMA) before and after the four week exercise period. The results showed significant improvement in shoulder subluxation, muscle activation, and VAS results in the experimental group, compared with the control group(p < 0.05). FMA scores showed no significant differences between the two groups. In conclusion, task-oriented electromyography-triggered stimulation improved shoulder subluxation, muscle activation, pain and upper extremity function. These results suggest that task-oriented electromyography-triggered stimulation is effective and beneficial for individuals with subacute stroke, and that further studies should be conducted on multivarious anatomical regions.

Long-Acting C-Terminal Peptide-Modified hGH (MOD-4023): Results of a Safety and Dose-Finding Study in GHD Children.

PubMed

Zelinska, Nataliya; Iotova, Violeta; Skorodok, Julia; Malievsky, Oleg; Peterkova, Valentina; Samsonova, Lubov; Rosenfeld, Ron G; Zadik, Zvi; Jaron-Mendelson, Michal; Koren, Ronit; Amitzi, Leanne; Raduk, Dmitri; Hershkovitz, Oren; Hart, Gili

2017-05-01

Daily injections are required for growth hormone (GH) replacement therapy, which may cause low compliance as a result of inconvenience and distress in patients. C-terminal peptide-modified human GH (MOD-4023) is developed for once-a-week dosing regimen in GH-deficient (GHD) adults and children. The present trial was a safety and dose-finding study for weekly MOD-4023 in GHD children. A multicenter, open-label, randomized, controlled phase 2 study in children with GHD, evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy of three different weekly MOD-4023 doses, compared with daily recombinant human GH (r-hGH). The trial was conducted in 14 endocrinology centers in Europe. Fifty-three prepubertal children with GHD completed 12 months of treatment with either MOD-4023 (N = 42) or r-hGH (N = 11). C-terminal peptide-modified hGH (MOD-4023) was administered weekly at a dose of either 0.25, 0.48, or 0.66 mg/kg/wk and compared with daily hGH at a dose of 0.24 mg/kg/wk. MOD-4023 showed an estimated half-life approximately fivefold to 10-fold longer when compared with daily r-hGH. Insulin-like growth factor (IGF)-I and IGF-binding peptide 3 showed a dose-dependent increase during MOD-4023 treatment. IGF-I standard deviation score for MOD-4023 did not exceed +2. All MOD-4023 cohorts demonstrated adequate catch-up growth. The 0.66 mg/kg/wk dose demonstrated efficacy closest to daily r-hGH. No serious adverse events were observed during MOD-4023 treatment, and its tolerability was consistent with known properties of r-hGH. This study confirms the long-acting properties of MOD-4023 and shows a promising safety and tolerability profile. This provides support for initiation of a phase 3 study in GHD children using a single weekly injection of MOD-4023. Copyright © 2017 by the Endocrine Society

Oxidative Stress Induced Age Dependent Meibomian Gland Dysfunction in Cu, Zn-Superoxide Dismutase-1 (Sod1) Knockout Mice

PubMed Central

Ibrahim, Osama M. A.; Dogru, Murat; Matsumoto, Yukihiro; Igarashi, Ayako; Kojima, Takashi; Wakamatsu, Tais Hitomi; Inaba, Takaaki; Shimizu, Takahiko; Shimazaki, Jun; Tsubota, Kazuo

2014-01-01

Purpose The purpose of our study was to investigate alterations in the meibomian gland (MG) in Cu, Zn-Superoxide Dismutase-1 knockout (Sod1 −/−) mouse. Methods Tear function tests [Break up time (BUT) and cotton thread] and ocular vital staining test were performed on Sod1 −/− male mice (n = 24) aged 10 and 50 weeks, and age and sex matched wild–type (+/+) mice (n = 25). Tear and serum samples were collected at sacrifice for inflammatory cytokine assays. MG specimens underwent Hematoxylin and Eosin staining, Mallory staining for fibrosis, Oil Red O lipid staining, TUNEL staining, immunohistochemistry stainings for 4HNE, 8-OHdG and CD45. Transmission electron microscopic examination (TEM) was also performed. Results Corneal vital staining scores in the Sod1 −/− mice were significantly higher compared with the wild type mice throughout the follow-up. Tear and serum IL-6 and TNF-α levels also showed significant elevations in the 10 to 50 week Sod1 −/− mice. Oil Red O staining showed an accumulation of large lipid droplets in the Sod1 −/− mice at 50 weeks. Immunohistochemistry revealed both increased TUNEL and oxidative stress marker stainings of the MG acinar epithelium in the Sod1 −/− mice compared to the wild type mice. Immunohistochemistry staining for CD45 showed increasing inflammatory cell infiltrates from 10 to 50 weeks in the Sod1 −/− mice compared to the wild type mice. TEM revealed prominent mitochondrial changes in 50 week Sod1 −/− mice. Conclusions Our results suggest that reactive oxygen species might play a vital role in the pathogensis of meibomian gland dysfunction. The Sod1 −/− mouse appears to be a promising model for the study of reactive oxygen species associated MG alterations. PMID:25036096

Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis

PubMed Central

Wechsler, M.E.; Akuthota, P.; Jayne, D.; Khoury, P.; Klion, A.; Langford, C.A.; Merkel, P.A.; Moosig, F.; Specks, U.; Cid, M.C.; Luqmani, R.; Brown, J.; Mallett, S.; Philipson, R.; Yancey, S.W.; Steinfeld, J.; Weller, P.F.; Gleich, G.J.

2017-01-01

Background Eosinophilic granulomatosis with polyangiitis is an eosinophilic vasculitis. Mepolizumab, an anti–interleukin-5 monoclonal antibody, reduces blood eosinophil counts and may have value in the treatment of eosinophilic granulomatosis with polyangiitis. Methods In this multicenter, double-blind, parallel-group, phase 3 trial, we randomly assigned participants with relapsing or refractory eosinophilic granulomatosis with polyangiitis who had received treatment for at least 4 weeks and were taking a stable prednisolone or prednisone dose to receive 300 mg of mepolizumab or placebo, administered subcutaneously every 4 weeks, plus standard care, for 52 weeks. The two primary end points were the accrued weeks of remission over a 52-week period, according to categorical quantification, and the proportion of participants in remission at both week 36 and week 48. Secondary end points included the time to first relapse and the average daily glucocorticoid dose (during weeks 48 through 52). The annualized relapse rate and safety were assessed. Results A total of 136 participants underwent randomization, with 68 participants assigned to receive mepolizumab and 68 to receive placebo. Mepolizumab treatment led to significantly more accrued weeks of remission than placebo (28% vs. 3% of the participants had ≥ 24 weeks of accrued remission; odds ratio, 5.91; 95% confidence interval [CI], 2.68 to 13.03; P<0.001) and a higher percentage of participants in remission at both week 36 and week 48 (32% vs. 3%; odds ratio, 16.74; 95% CI, 3.61 to 77.56; P<0.001). Remission did not occur in 47% of the participants in the mepolizumab group versus 81% of those in the placebo group. The annualized relapse rate was 1.14 in the mepolizumab group, as compared with 2.27 in the placebo group (rate ratio, 0.50; 95% CI, 0.36 to 0.70; P<0.001). A total of 44% of the participants in the mepolizumab group, as compared with 7% of those in the placebo group, had an average daily dose of prednisolone or prednisone of 4.0 mg or less per day during weeks 48 through 52 (odds ratio, 0.20; 95% CI, 0.09 to 0.41; P<0.001). The safety profile of mepolizumab was similar to that observed in previous studies. Conclusions In participants with eosinophilic granulomatosis with polyangiitis, mepolizumab resulted in significantly more weeks in remission and a higher proportion of participants in remission than did placebo, thus allowing for reduced glucocorticoid use. Even so, only approximately half the participants treated with mepolizumab had protocol-defined remission. (Funded by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT02020889.) PMID:28514601

Is Escitalopram Really Relevantly Superior to Citalopram in Treatment of Major Depressive Disorder? A Meta-analysis of Head-to-head Randomized Trials

PubMed Central

Trkulja, Vladimir

2010-01-01

Aim To evaluate clinical relevance of differences between escitalopram and citalopram (equimolar) for major depressive disorder. Methods Review and meta-analysis of comparative randomized controlled trials (RCT). Comparisons were in relation to Montgomery-Asberg depression rating scale (MADRS) score reduction at weeks 1 (5 RCTs), 4 (5 RCTs), 6 (4 RCTs), 8 (5 RCTs), and 24 (1 RCT); proportion of responders at weeks 2, 4, 6 (2 RCTs for each time point), 8 (5 RCTs), and 24 (1 RCT); clinical global impression-severity (CGI-S) reduction at weeks 6 (1 RCT), 8 (5 RCTs), and 24 (1 RCT), and discontinuation due to adverse events or inefficacy during short-term (up to 8 weeks) and medium-term (24 weeks) treatment. Results MADRS reduction was greater with escitalopram, but 95% confidence intervals (CI) around the mean difference were entirely or largely below 2 scale points (minimally important difference) and CI around the effect size (ES) was below 0.32 (“small”) at all time points. Risk of response was higher with escitalopram at week 8 (relative risk, 1.14; 95% CI, 1.04 to 1.26) but number needed to treat was 14 (95% CI, 7 to 111). All 95% CIs around the mean difference and ES of CGI-S reduction at week 8 were below 0.32 points and the limit of “small,” respectively. Data for severe patients (MADRS≥30) are scarce (only 1 RCT), indicating somewhat greater efficacy (response rate and MADRS reduction at week 8, but not CGI-S reduction) of escitalopram, but without compelling evidence of clinically relevant differences. Discontinuations due to adverse events or inefficacy up to 8 weeks of treatment were comparable. Data for the period up to 24 weeks are scarce and inconclusive. Conclusion Presently, the claims about clinically relevant superiority of escitalopram over citalopram in short-to-medium term treatment of major depressive disorder are not supported by evidence. PMID:20162747

Comparative analysis of the effects of alogliptin and vildagliptin on glucose metabolism in type 2 diabetes mellitus.

PubMed

Tanaka, Kenichi; Okada, Yosuke; Mori, Hiroko; Miyazaki, Megumi; Kuno, Fumi; Sonoda, Satomi; Sugai, Kei; Hajime, Maiko; Kurozumi, Akira; Narisawa, Manabu; Torimoto, Keiichi; Arao, Tadashi; Mine, Shinichiro; Tanaka, Yoshiya

2017-02-27

The aim of this 24-week, prospective randomized open-label study was to compare the effects of alogliptin and vildagliptin on glucose control, renal function, and lipid metabolism. In Study 1, DPP-4 inhibitor-naive type 2 diabetes (T2DM) were randomly assigned to alogliptin 25 mg/day or vildagliptin 50 mg twice daily. In Study 2, T2DM on treatment with 50 mg/day sitagliptin were switched to either 25 mg/day alogliptin or 50 mg twice daily vildagliptin. The primary endpoint was change in glycosylated hemoglobin (HbA1c) level at 24 weeks, while the secondary endpoints were changes in urinary albumin excretion and low-density lipoprotein cholesterol (LDL-C) levels at 24 weeks. In Study 1, HbA1c levels changed at 24-week by -0.5±0.7% in the alogliptin group (p=0.002, relative to baseline) and -0.7±0.9% in the vildagliptin group (p=0.001, relative to baseline), and the extent of these changes were comparable between the two groups (p=0.219). The decrease in log urinary albumin excretion was more significant in the vildagliptin group (p=0.008). In Study 2, HbA1c levels at 24-week changed by 0.2±0.7% in the switch-to-alogliptin group (p=0.007) and 0.0±0.6% in the switch-to-vildagliptin group (p=0.188), indicating a significant difference between the groups (p=0.003). In both studies, the changes in LDL-C levels were comparable between the two groups. The two drugs had comparable glucose-lowering effects in DPP-4 inhibitor-naive patients but the effect was more pronounced for vildagliptin in patients switched from sitagliptin. The results may point to subtle yet important differences between the two DPP-4 inhibitors. This trial was registered with UMIN (no. #000019022).

Combination Superficial Peels With Salicylic Acid and Post-Peel Retinoids.

PubMed

Kligman, Douglas E; Draelos, Zoe D

2016-04-01

Salicylic acid (SA) and retinoids, tretinoin (all-trans retinoic acid [ATRA]), and retinol (all-trans retinol) are widely used as topical agents for the improvement of photodamage and acne vulgaris. They can be used in daily take-home products or as part of an in-office procedure, combining the benefits of a keratolytic (SA) and a retinoid. The objective of this research was to compare the efficacy for ameliorating photodamage of topical tretinoin (0.25%) and retinol (0.25%) to baseline and with each other when applied after a 30% salicylic acid peel on human facial skin. Twenty female subjects received a full face 30% SA peel followed by the overnight application of tretinoin to a 1 randomized half-face and retinol to the opposite side (split-face study). The identical procedure was repeated at week 2. Double-blinded subject and investigator assessments of the results were captured at weeks 2 and 4. By investigator evaluation, both peeling regimens were effective in improving photodamage parameters compared to baseline. (ATRA P-values at week 4 were: P=.00008 texture, P=.00013 roughness, P=.00221 pores, P=.00098 dryness, P=.02770 erythema, and P=.00008 overall appearance. Retinol P-values at week 4 were: P=.00019 texture, P=.00053 roughness, P=.00221 pores, P=.00147 dryness, P=.02770 erythema, and P=.0043 overall appearance.) By subject self-assessment compared with baseline, both tretinoin and retinol were effective in improving overall appearance (ATRA P=.0229 and retinol P=.0190). By investigator evaluation comparing tretinoin with retinol, tretinoin was slightly better than retinol at week 4 in improving texture P=.00506, roughness P=.01171, and overall appearance P=.00506. By subject self-assessment comparing tretinoin with retinol, there was no difference in overall appearance (ATRA P=.2367 and retinol P=.3613). Either topical tretinoin (0.25%) or retinol (0.25%) can be used safely and effectively when applied in office immediately after SA peeling to ameliorate signs of photoaging.

Comparing office and telephone follow-up after medical abortion.

PubMed

Chen, Melissa J; Rounds, Kacie M; Creinin, Mitchell D; Cansino, Catherine; Hou, Melody Y

2016-08-01

Compare proportion lost to follow-up, successful abortion, and staff effort in women who choose office or telephone-based follow-up evaluation for medical abortion at a teaching institution. We performed a chart review of all medical abortions provided in the first three years of service provision. Women receiving mifepristone and misoprostol could choose office follow-up with an ultrasound evaluation one to two weeks after mifepristone or telephone follow-up with a scheduled telephone interview at one week post abortion and a second telephone call at four weeks to review the results of a home urine pregnancy test. Of the 176 medical abortion patients, 105 (59.7%) chose office follow-up and 71 (40.3%) chose telephone follow-up. Office evaluation patients had higher rates of completing all required follow-up compared to telephone follow-up patients (94.3% vs 84.5%, respectively, p=.04), but proportion lost to follow-up was similar in both groups (4.8% vs 5.6%, respectively, p=1.0). Medical abortion efficacy was 94.0% and 92.5% in women who chose office and telephone follow-up, respectively. We detected two (1.2%) ongoing pregnancies, both in the office group. Staff rescheduled 15.0% of appointments in the office group. For the telephone follow-up cohort, staff made more than one phone call to 43.9% and 69.4% of women at one week and four weeks, respectively. Proportion lost to follow-up is low in women who have the option of office or telephone follow-up after medical abortion. Women who choose telephone-based evaluation compared to office follow-up may require more staff effort for rescheduling of contact, but overall outcomes are similar. Although women who choose telephone evaluation may require more rescheduling of contact as compared to office follow-up, having alternative follow-up options may decrease the proportion of women who are lost to follow-up. Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of sustained gene delivery of platelet-derived growth factor or its antagonist (PDGF-1308) on tissue-engineered cementum.

PubMed

Anusaksathien, Orasa; Jin, Qiming; Zhao, Ming; Somerman, Martha J; Giannobile, William V

2004-03-01

Cementum, a mineralized tissue lining the tooth root surface, is destroyed during the inflammatory process of periodontitis. Restoration of functional cementum is considered a criterion for successful regeneration of periodontal tissues, including formation of periodontal ligament, cementum, and alveolar bone. Short-term administration of platelet-derived growth factor (PDGF) has been shown to partially regenerate periodontal structures. Nonetheless, the role of PDGF in cementogenesis is not well understood. The aim of the present study was to determine the effect of sustained PDGF gene transfer on cementum formation in an ex vivo ectopic biomineralization model. Osteocalcin (OC) promoter-driven SV40 transgenic mice were used to obtain immortalized cementoblasts (OCCM). The OCCM cells were transduced with adenoviruses (Ad) encoding either PDGF-A, an antagonist of PDGF signaling (PDGF-1308), a control virus (green fluorescent protein, GFP), or no treatment (NT). The transduced cells were incorporated into polymer scaffolds and implanted subcutaneously into severe combined immunodeficient (SCID) mice. The implants were harvested at 3 and 6 weeks for histomorphometric analysis of the newly formed mineralized tissues. Northern blot analysis was performed to determine the expression levels of mineral-associated genes including bone sialoprotein (BSP), OC, and osteopontin (OPN) in the cell-implant specimens at 3 and 6 weeks. The results indicated mineralization was significantly reduced in both the Ad/PDGF-A and Ad/PDGF-1308 treated specimens when compared to the NT or Ad/GFP groups at 3 and 6 weeks (P<0.01). In addition, the size of the implants treated with Ad/PDGF-A and Ad/PDGF-1308 was significantly reduced compared to implants from Ad/GFP and NT groups at 3 weeks (P<0.05). At 6 weeks, the size of implants and mineral formation increased in NT, Ad/GFP, and Ad/PDGF-A groups, while the Ad/PDGF-1308 treated implants continued to decrease in size and mineral formation (P<0.01). Northern blot analysis revealed that in the Ad/PDGF-A treated implants OPN was increased, whereas OC gene expression was downregulated at 3 weeks. In the Ad/PDGF-1308 treated implants, BSP, OC, and OPN were all downregulated at 3 weeks. At 3 weeks, the Ad/PDGF-A treated implants contained significantly higher multinucleated giant cell (MNGC) density compared to NT, Ad/GFP, and Ad/PDGF-1308 specimens. The MNGC density in NT, Ad/GFP, and Ad/PDGF-A treated groups reduced over time, while the Ad/PDGF-1308 transduced implants continued to exhibit significantly higher MNGC density compared with the other treatment groups at 6 weeks. The results showed that continuous exposure to PDGF-A had an inhibitory effect on cementogenesis, possibly via the upregulation of OPN and subsequent enhancement of MNGCs at 3 weeks. On the other hand, Ad/PDGF-1308 inhibited mineralization of tissue-engineered cementum possibly due to the observed downregulation of BSP and OC and a persistence of stimulation of MNGCs. These findings suggest that continuous exogenous delivery of PDGF-A may delay mineral formation induced by cementoblasts, while PDGF is clearly required for mineral neogenesis.

[Correlation between growth rate of corpus callosum and neuromotor development in preterm infants].

PubMed

Liu, Rui-Ke; Sun, Jie; Hu, Li-Yan; Liu, Fang

2015-08-01

To investigate the growth rate of corpus callosum by cranial ultrasound in very low birth weight preterm infants and to provide a reference for early evaluation and improvement of brain development. A total of 120 preterm infants under 33 weeks' gestation were recruited and divided into 26-29(+6) weeks group (n=64) and 30-32(+6) weeks group (n=56) according to the gestational age. The growth rate of corpus callosum was compared between the two groups. The correlation between the corpus callosum length and the cerebellar vermis length and the relationship of the growth rate of corpus callosum with clinical factors and the neuromotor development were analyzed. The growth rate of corpus callosum in preterm infants declined since 2 weeks after birth. Compared with the 30-32(+6) weeks group, the 26-29(+6) weeks group had a significantly lower growth rate of corpus callosum at 3-4 weeks after birth, at 5-6 weeks after birth, and from 7 weeks after birth to 40 weeks of corrected gestational age. There was a positive linear correlation between the corpus callosum length and the cerebellar vermis length. Small-for-gestational age infants had a low growth rate of corpus callosum at 2 weeks after birth. The 12 preterm infants with severe abnormal intellectual development had a lower growth rate of corpus callosum compared with the 108 preterm infants with non-severe abnormal intellectual development at 3-6 weeks after birth. The 5 preterm infants with severe abnormal motor development had a significantly lower growth rate of corpus callosum compared with the 115 preterm infants with non-severe abnormal motor development at 3-6 weeks after birth. The decline of growth rate of corpus callosum in preterm infants at 2-6 weeks after birth can increase the risk of severe abnormal neuromotor development.

Treatment of Adolescent Panic Disorder: A Nonrandomized Comparison of Intensive versus Weekly CBT

ERIC Educational Resources Information Center

Chase, Rhea M.; Whitton, Sarah W.; Pincus, Donna B.

2012-01-01

This study compared the relative efficacy of intensive versus weekly panic control treatment (PCT) for adolescent panic disorder with agoraphobia (PDA). Twenty-six adolescents participated in weekly sessions and 25 received intensive treatment involving daily sessions. Both groups demonstrated significant and comparable reductions in panic…

Effect of Aromatherapy Massage on Chemotherapy-Induced Peripheral Neuropathic Pain and Fatigue in Patients Receiving Oxaliplatin: An Open Label Quasi-Randomized Controlled Pilot Study.

PubMed

Izgu, Nur; Ozdemir, Leyla; Bugdayci Basal, Fatma

2017-12-02

Patients receiving oxaliplatin may experience peripheral neuropathic pain and fatigue. Aromatherapy massage, a nonpharmacological method, may help to control these symptoms. The aim of this open-label, parallel-group, quasi-randomized controlled pilot study was to investigate the effect of aromatherapy massage on chemotherapy-induced peripheral neuropathic pain and fatigue in patients receiving oxaliplatin. Stratified randomization was used to allocate 46 patients to 2 groups: intervention (n = 22) and control (n = 24). Between week 1 and week 6, participants in the intervention group (IG) received aromatherapy massage 3 times a week. There was no intervention in weeks 7 and 8. The control group (CG) received routine care. Neuropathic pain was identified using the Douleur Neuropathique 4 Questions; severity of painful paresthesia was assessed with the numerical rating scale; fatigue severity was identified with the Piper Fatigue Scale. At week 6, the rate of neuropathic pain was significantly lower in the IG, when compared with the CG. The severity of painful paresthesia based on numerical rating scale in the IG was significantly lower than that in the CG at weeks 2, 4, and 6. At week 8, fatigue severity in the IG was significantly lower when compared with CG (P < .05). Aromatherapy massage may be useful in the management of chemotherapy-induced peripheral neuropathic pain and fatigue. This pilot study suggests that aromatherapy massage may be useful to relieve neuropathic pain and fatigue. However, there is a need for further clinical trials to validate the results of this study.

Meniscus Induced Cartilaginous Damage and Non-linear Gross Anatomical Progression of Early-stage Osteoarthritis in a Canine Model

PubMed Central

Kahn, David; Mittelstaedt, Daniel; Matyas, John; Qu, Xiangui; Lee, Ji Hyun; Badar, Farid; Les, Clifford; Zhuang, Zhiguo; Xia, Yang

2016-01-01

Background: The predictable outcome of the anterior cruciate ligament transection (ACLT) canine model, and the similarity to naturally occurring osteoarthritis (OA) in humans, provide a translatable method for studying OA. Still, evidence of direct meniscus-induced cartilaginous damage has not been identified, and gross-anatomical blinded scoring of early-stage OA has not been performed. Objective: A gross anatomical observation and statistical analysis of OA progression to determine meniscus induced cartilaginous damage, to measure the macroscopic progression of OA, and to address matters involving arthroscopic and surgical procedures of the knee. Method: Unblinded assessment and blinded scoring of meniscal, tibial, femoral, and patellar damage were performed for control and at four time points following unilateral ACLT: 3-week (N=4), 8-week (N=4), 12-week (N=5), and 25-week (N=4). Mixed-model statistics illustrates damage (score) progression; Wilcoxon rank-sum tests compared time-point scores; and Wilcoxon signed-rank tests compared ACLT and contralateral scores, and meniscus and tibia scores. Result: Damage was manifest first on the posterior aspect of the medial meniscus and subsequently on the tibia and femur, implying meniscal damage can precede, coincide with, and aggravate cartilage damage. Damage extent varied chronologically and was dependent upon the joint component. Meniscal damage was evident at 3 weeks and progressed through 25-weeks. Meniscal loose bodies corresponded to tibial cartilage damage location and extent through 12 weeks, followed by cartilage repair activity after complete meniscal degeneration. Conclusion: This study provides additional information for understanding OA progression, identifying OA biomarkers, and arthroscopic and meniscectomy procedures. PMID:28144379

Comparative effects of proprioceptive and isometric exercises on pain intensity and difficulty in patients with knee osteoarthritis: A randomised control study.

PubMed

Ojoawo, Adesola O; Olaogun, Matthew O B; Hassan, Mariam A

2016-11-14

The study compared the effects of isometric quadriceps exercise and proprioceptive exercise on pain, joint stiffness and physical difficulties of patients with knee osteoarthritis. Forty-five patients with history of knee osteoarthritis were randomly allocated into two groups; A with 23 subjects and B with 22 subjects. All subjects received infrared radiation for 20 minutes and kneading massage with methyl salicylate ointment. Group A underwent proprioceptive exercises while Group B had isometric quadriceps exercise. Each exercise session lasted for 10 minutes according to standard protocol, twice in a week for six weeks. Pre-treatment, 3rd week and 6th week pain intensity, joint stiffness and physical difficulties were assessed using Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Statistical package for social sciences (SPSS) version 17 was used to analyse the data while descriptive and inferential statistics were used to summarise the result. Proprioceptive exercises reduced pain intensity significantly (F = 4.76; p = 0.00) at 6th week with effect size of 2.79, and physical difficulty (F = 3.69; p < 0.04) with effect size of 7.53 better than isometric exercises. There was a significant reduction in the pain intensity (F = 12.08; p < 0.001), and physical difficulties (F = 3.69, p = 0.04) in pre-treatment, 3rd week and 6th week in both Group A and B. Both exercises are effective but proprioceptive exercises may be more effective in the management of patients with knee osteoarthritis (KOA) than isometric exercises.

Preclinical evaluation of novel urinary biomarkers of cadmium nephrotoxicity

DOE Office of Scientific and Technical Information (OSTI.GOV)

Prozialeck, Walter C.; Edwards, Joshua R.; Vaidya, Vishal S.

2009-08-01

As a result of the widespread use of Cd in industry and its extensive dissemination in the environment, there has been considerable interest in the identification of early biomarkers of Cd-induced kidney injury. Kim-1 is a transmembrane glycoprotein that is not detectable in normal kidney, but is up-regulated and shed into the urine following ischemic or nephrotoxic injury. Recent studies utilizing a sub-chronic model of Cd exposure in the rat have shown that Kim-1 is an early urinary marker of Cd-induced kidney injury. Kim-1 was detected in the urine 4-5 weeks before the onset of proteinuria and 1-3 weeks beforemore » the appearance of urinary metallothionein and Clara cell protein 16, which are standard markers of Cd nephrotoxicity. In the present study, we have compared the time course for the appearance of Kim-1 in the urine with the time course for the appearance of alpha glutathione-S-transferase ({alpha}-GST), N-acetyl-{beta}-D-glucose amidase (NAG) and Cd, each of which have been used or proposed as urinary markers of Cd nephrotoxicity. Adult male Sprague-Dawley rats were given daily subcutaneous injections of 0.6 mg (5.36 {mu}moles)/kg Cd, 5 days per week for up to 12 weeks. One day each week, 24 h urine samples were collected and analyzed for protein, creatinine and the various markers. The results showed that significant levels of Kim-1 appeared in the urine as early as 6 weeks into the treatment protocol and then continued to rise for the remainder of the 12 week treatment period. By contrast, significant levels of {alpha}-GST and NAG did not appear in the urine until 8 and 12 weeks, respectively, while proteinuria was not evident until 10 weeks. The urinary excretion of Cd was below the level of detection until week 4 and then showed a slow, linear increase over the next 6 weeks before increasing markedly between weeks 10 and 12. These results provide additional evidence that Kim-1 is a sensitive biomarker of the early stages of Cd-induced proximal tubule injury.« less

Prospective comparison of sinonasal outcomes after microscopic sublabial or endoscopic endonasal transsphenoidal surgery for nonfunctioning pituitary adenomas.

PubMed

Pledger, Carrie L; Elzoghby, Mohamed A; Oldfield, Edward H; Payne, Spencer C; Jane, John A

2016-08-01

OBJECT Both endoscopic and microscopic transsphenoidal approaches are accepted techniques for the resection of pituitary adenomas. Although studies have explored patient outcomes for each technique individually, none have prospectively compared sinonasal and quality of life outcomes in a concurrent series of patients at the same institution, as has been done in the present study. METHODS Patients with nonfunctioning adenomas undergoing transsphenoidal surgery were assessed for sinonasal function, quality of life, and pain using the Sino-Nasal Outcome Test-20 (SNOT-20), the short form of the Nasal Obstruction Symptom Evaluation (NOSE) instrument, the SF-36, and a headache scale. Eighty-two patients undergoing either endoscopic (47 patients) or microscopic (35 patients) surgery were surveyed preoperatively and at 24-48 hours, 2 weeks, 4 weeks, 8 weeks, and 1 year after surgery. RESULTS Patients who underwent endoscopic and microscopic transsphenoidal surgery experienced a similar recovery pattern, showing an initial increase in symptoms during the first 2 weeks, followed by a return to baseline by 4 weeks and improvement beyond baseline functioning by 8 weeks. Patients who underwent endoscopic surgery experienced better sinonasal outcomes at 24-48 hours (SNOT total p = 0.015, SNOT rhinologic subscale [ssRhino] p < 0.001), 2 weeks (NOSE p = 0.013), and 8 weeks (SNOT total p = 0.032 and SNOT ssRhino p = 0.035). By 1 year after surgery, no significant differences in sinonasal outcomes were observed between the 2 groups. Headache scales at 1 year improved in all dimensions except duration for both groups (total result 73%, p = 0.004; severity 46%, p < 0.001; frequency 53%, p < 0.001), with 80% of either microscopic or endoscopic patients experiencing improvement or resolution of headache symptoms. Endoscopic and microscopic patients experienced reduced vitality preoperatively compared with US population norms and remained low postoperatively. By 8 weeks after surgery, both groups experienced significant improvements in mental health (13%, p = 0.005) and vitality (15%, p = 0.037). By 1 year after surgery, patients improved significantly in mental health (14%, p = 0.03), role physical (14%, p = 0.036), social functioning (16%, p = 0.009), vitality (22%, p = 0.002), and SF-36 total (10%, p = 0.024) as compared with preoperative measures. There were no significant differences at any time point between the 2 groups for the total SF-36 or for any of the 8 subscales. CONCLUSIONS Patients who underwent either an endoscopic or a microscopic approach experienced the greatest nasal symptoms at 2 weeks postoperatively and exhibited similar time courses of recovery in nasal, headache, and quality of life assessments. Although patients who underwent endoscopic surgery experienced significantly fewer nasal symptoms during the first 8 weeks, by 1 year after surgery, there were no significant differences between the 2 groups.

Early Removal of Double-J Stents Decreases Urinary Tract Infections in Living Donor Renal Transplantation: A Prospective, Randomized Clinical Trial.

PubMed

Liu, S; Luo, G; Sun, B; Lu, J; Zu, Q; Yang, S; Zhang, X; Dong, J

2017-03-01

The optimal timing for stent removal after renal transplantation remains controversial. This article describes an interim analysis of a randomized, prospective, double-blind trial aimed at detecting differences in urological complications between early ureteral stent removal at 1 week and routine ureteral stent removal at 4 weeks. Between October 2010 and March 2015, 103 patients who underwent living donor renal transplantation at a single center were pre-operatively randomly assigned to the early ureteral stent removal (at 1 week) group or the routine ureteral stent removal (at 4 weeks) group. Urinary symptoms, auxiliary examination results, and obstruction events were recorded during 3 months of follow-up. A cost analysis of both the hospitalization and postoperative periods was discussed. In total, 52 patients in the 1-week stent group and 51 patients in the 4-week stent group were analyzed. No serious adverse events were reported. Three episodes of urinary tract infections (UTIs) occurred in the 1-week stent group, and 18 such episodes were recorded in the 4-week stent group (5.8% vs 29.4%; P = .002). After adjusting for age, sex, ischemia time, renal artery number, body mass index, multiple arteries, and associated medical illness, regression analysis indicated that only stent duration was associated with UTI (OR, 8.791; 95% CI, 1.984-38.943; P = .004). The results of our study demonstrate that ureteral stent removal at 1 week reduces the risk of UTIs compared with routine removal at 4 weeks. Similar effects of ureteral stent removal on complication rates are observed for these two removal times. Copyright © 2016 Elsevier Inc. All rights reserved.

Do pregnant women follow exercise guidelines? Prevalence data among 3482 women, and prediction of low-back pain, pelvic girdle pain and depression.

PubMed

Gjestland, Kristin; Bø, Kari; Owe, Katrine Mari; Eberhard-Gran, Malin

2013-05-01

We describe exercise level in mid-pregnancy, associated sociodemographic variables, and investigate the association between exercise in mid-pregnancy and subsequent low-back pain, pelvic girdle pain and depression at 32 weeks of pregnancy. The study included 3482 pregnant women participating in the Akershus Birth Cohort study (response rate 80.5%). Data were collected by a questionnaire in pregnancy weeks 17-21, pregnancy week 32 and electronic birth journal. The results were analysed by logistic regression and are presented as crude (cOR) and adjusted OR (aOR) with 95% CI. Only 14.6% of the respondents followed the current exercise prescription for exercise during pregnancy (≥3 times a week, >20 min at moderate intensity). One-third of the study sample exercised less than once a week at pregnancy weeks 17-21. Women exercising either 1-2 times or ≥3 times a week at mid-pregnancy were more often primiparous, higher-educated and had less often prepregnacy body mass index >30 kg/m2 compared with women exercising less than once a week. Women who exercised ≥3 times a week were less likely to report pelvic girdle pain (aOR: 0.76, 95% CI 0.61 to 0.96), while women exercising 1-2 times a week were less likely to report low-back pain (aOR: 0.80, 95% CI 0.66 to 0.97) and depression (aOR: 0.66, 95% CI 0.48 to 0.91). Few Norwegian women follow current exercise prescriptions for exercise in mid-pregnancy. The results may indicate an association between exercising mid-pregnancy and lower prevalence of low-back pain, pelvic girdle pain and depression in late pregnancy.

Prospective Randomized Trial of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid for Prevention of Radiation-Induced Liver Toxicity

PubMed Central

Seidensticker, Max; Seidensticker, Ricarda; Damm, Robert; Mohnike, Konrad; Pech, Maciej; Sangro, Bruno; Hass, Peter; Wust, Peter; Kropf, Siegfried; Gademann, Günther; Ricke, Jens

2014-01-01

Background/Aim Targeted radiotherapy of liver malignancies has found to be effective in selected patients. A key limiting factor of these therapies is the relatively low tolerance of the liver parenchyma to radiation. We sought to assess the preventive effects of a combined regimen of pentoxifylline (PTX), ursodeoxycholic acid (UDCA) and low-dose low molecular weight heparin (LMWH) on focal radiation-induced liver injury (fRILI). Methods and Materials Patients with liver metastases from colorectal carcinoma who were scheduled for local ablation by radiotherapy (image-guided high-dose-rate interstitial brachytherapy) were prospectively randomized to receive PTX, UDCA and LMWH for 8 weeks (treatment) or no medication (control). Focal RILI at follow-up was assessed using functional hepatobiliary magnetic resonance imaging (MRI). A minimal threshold dose, i.e. the dose to which the outer rim of the fRILI was formerly exposed to, was quantified by merging MRI and dosimetry data. Results Results from an intended interim-analysis made a premature termination necessary. Twenty-two patients were included in the per-protocol analysis. Minimal mean hepatic threshold dose 6 weeks after radiotherapy (primary endpoint) was significantly higher in the study treatment-group compared with the control (19.1 Gy versus 14.6 Gy, p = 0.011). Qualitative evidence of fRILI by MRI at 6 weeks was observed in 45.5% of patients in the treatment versus 90.9% of the control group. No significant differences between the groups were observed at the 12-week follow-up. Conclusions The post-therapeutic application of PTX, UDCA and low-dose LMWH significantly reduced the extent and incidence fRILI at 6 weeks after radiotherapy. The development of subsequent fRILI at 12 weeks (4 weeks after cessation of PTX, UDCA and LMWH during weeks 1–8) in the treatment group was comparable to the control group thus supporting the observation that the agents mitigated fRILI. Trial Registration EU clinical trials register 2008-002985-70 ClinicalTrials.gov NCT01149304 PMID:25393877

Early Disease Activity or Clinical Response as Predictors of Long‐Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis

PubMed Central

Deodhar, A.; Fleischmann, R.; Mease, P. J.; Rudwaleit, M.; Nurminen, T.; Davies, O.

2017-01-01

Objective Early identification of patients unlikely to achieve good long‐term disease control with anti–tumor necrosis factor therapy in axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) is important for physicians following treat‐to‐target recommendations. Here we assess associations between disease activity or clinical response during the first 12 weeks of treatment and attainment of treatment targets at week 48 in axial SpA and PsA patients receiving certolizumab pegol. Methods The relationship between disease activity or clinical response during the first 12 weeks of treatment and achievement of week‐48 targets (for axial SpA: inactive disease based on Ankylosing Spondylitis Disease Activity Score [ASDAS] using the C‐reactive protein [CRP] level, or Bath Ankylosing Spondylitis Disease Activity Index <2 with normal CRP level; and for PsA: minimal disease activity) was assessed post hoc using RAPID‐axSpA and RAPID‐PsA trial data. Results A clear relationship between disease activity from week 2 to 12 and achievement of week‐48 treatment targets was observed in both axial SpA and PsA populations. In axial SpA, week‐48 ASDAS inactive disease was achieved by 0% of patients (0 of 21) with ASDAS very high disease activity at week 12, compared to 68% of patients (34 of 50) with week‐12 ASDAS inactive disease. For PsA, week‐48 minimal disease activity was achieved by 0% of patients (0 of 26) with Disease Activity Score in 28 joints (DAS28) using the CRP level >5.1 at week 12, compared to 73% of patients (57 of 78) with DAS28‐CRP <2.6. Similar results were observed regardless of the disease activity measure used. Clinical response at week 12 also predicted week‐48 outcomes, though to a lesser extent than disease activity. Conclusion Using disease activity and the clinical response state during the first 12 weeks of certolizumab pegol treatment, it was possible to identify a subset of axial SpA and PsA patients unlikely to achieve long‐term treatment goals. PMID:27696727

Effects of Increased Vigilance for Locomotion Disorders on Lameness and Production in Dairy Cows

PubMed Central

Gundelach, Yasmin; Schulz, Timo; Feldmann, Maren; Hoedemaker, Martina

2013-01-01

Simple Summary For animal welfare reasons, reducing the prevalence of lameness should be one of the most important goals in dairy farming. In this study, the influence of early detection and treatment of lame cows on lameness prevalence, incidence and duration of lameness in comparison with routine lameness management practiced on a dairy farm was determined. The results suggest that early detection and treatment of lame cows significantly reduced the duration of lameness, and, therefore, the prevalence of lameness. Abstract The objective of this study was to determine the influence of weekly locomotion scoring and, thus, early detection and treatment of lame cows by a veterinarian on lameness prevalence, incidence, duration of lameness, fertility and milk yield on one dairy farm in Northern Germany. Cows were distributed to two groups. Cows in Group A (n = 99) with a locomotion score (LS) > 1 were examined and treated. In Group B (n = 99), it was solely in the hands of the farmer to detect lame cows and to decide which cows received treatment. Four weeks after the beginning of the experimental period, the prevalence of cows with LS = 1 was higher in Group A compared with Group B. Prevalence of lame cows (LS > 1) increased in Group B (47.6% in Week 2 to 84.0% in Week 40) and decreased in Group A from Week 2 to Week 40 (50% to 14.4%; P < 0.05). Within groups, the monthly lameness incidence did not differ. The average duration of lameness for newly lame cows was 3.7 weeks in Group A and 10.4 weeks in Group B (P < 0.001). There was no effect on fertility and incidence of puerperal disorders. The 100-day milk yield was calculated from cows having their first four Dairy Herd Improvement (DHI) test day results during the experimental period. The mean 100-day milk yield tended to be higher in Group A compared with Group B (3,386 kg vs. 3,359 kg; P = 0.084). PMID:26479543

Impact of oesophagitis classification in evaluating healing of erosive oesophagitis after therapy with proton pump inhibitors: a pooled analysis.

PubMed

Yaghoobi, Mohammad; Padol, Sara; Yuan, Yuhong; Hunt, Richard H

2010-05-01

The results of clinical trials with proton pump inhibitors (PPIs) are usually based on the Hetzel-Dent (HD), Savary-Miller (SM), or Los Angeles (LA) classifications to describe the severity and assess the healing of erosive oesophagitis. However, it is not known whether these classifications are comparable. The aim of this study was to review systematically the literature to compare the healing rates of erosive oesophagitis with PPIs in clinical trials assessed by the HD, SM, or LA classifications. A recursive, English language literature search in PubMed and Cochrane databases to December 2006 was performed. Double-blind randomized control trials comparing a PPI with another PPI, an H2-RA or placebo using endoscopic assessment of the healing of oesophagitis by the HD, SM or LA, or their modified classifications at 4 or 8 weeks, were included in the study. The healing rates on treatment with the same PPI(s), and same endoscopic grade(s) were pooled and compared between different classifications using Fisher's exact test or chi2 test where appropriate. Forty-seven studies from 965 potential citations met inclusion criteria. Seventy-eight PPI arms were identified, with 27 using HD, 29 using SM, and 22 using LA for five marketed PPIs. There was insufficient data for rabeprazole and esomeprazole (week 4 only) to compare because they were evaluated by only one classification. When data from all PPIs were pooled, regardless of baseline oesophagitis grades, the LA healing rate was significantly higher than SM and HD at both 4 and 8 weeks (74, 71, and 68% at 4 weeks and 89, 84, and 83% at 8 weeks, respectively). The distribution of different grades in study population was available only for pantoprazole where it was not significantly different between LA and SM subgroups. When analyzing data for PPI and dose, the LA classification showed a higher healing rate for omeprazole 20 mg/day and pantoprazole 40 mg/day (significant at 8 weeks), whereas healing by SM classification was significantly higher for omeprazole 40 mg/day (no data for LA) and lansoprazole 30 mg/day at 4 and 8 weeks. The healing rate by individual oesophagitis grade was not always available or robust enough for meaningful analysis. However, a difference between classifications remained. There is a significant, but not always consistent, difference in oesophagitis healing rates with the same PPI(s) reported by the LA, SM, or HD classifications. The possible difference between grading classifications should be considered when interpreting or comparing healing rates for oesophagitis from different studies.

WEEKLY RUNNING VOLUME AND RISK OF RUNNING‐RELATED INJURIES AMONG MARATHON RUNNERS

PubMed Central

Nielsen, Rasmus Oestergaard; Juul, Martin Serup; Rasmussen, Sten

2013-01-01

Purpose/Background: The purpose of this study was to investigate if the risk of injury declines with increasing weekly running volume before a marathon race. Methods: The study was a retrospective cohort study on marathon finishers. Following a marathon, participants completed a web‐based questionnaire. The outcome of interest was a self‐reported running‐related injury. The injury had to be severe enough to cause a reduction in distance, speed, duration or frequency of running for at least 14 days. Primary exposure was self‐reported average weekly volume of running before the marathon categorized into below 30 km/week, 30 to 60 km/week, and above 60 km/week. Results: A total of 68 of the 662 respondents sustained an injury. When adjusting for previous injury and previous marathons, the relative risk (RR) of suffering an injury rose by 2.02 [95% CI: 1.26; 3.24], p < 0.01, among runners with an average weekly training volume below 30 km/week compared with runners with an average weekly training volume of 30‐60 km/week. No significant differences were found between runners exceeding 60 km/week and runners running 30‐60 km/week (RR=1.13 [0.5;2.8], p=0.80). Conclusions: Runners may be advised to run a minimum of 30 km/week before a marathon to reduce their risk of running‐related injury. Level of Evidence: 2b PMID:23593549

Novel Rat Model of Repetitive Portal Venous Embolization Mimicking Human Non-Cirrhotic Idiopathic Portal Hypertension.

PubMed

Klein, Sabine; Hinüber, Christian; Hittatiya, Kanishka; Schierwagen, Robert; Uschner, Frank Erhard; Strassburg, Christian P; Fischer, Hans-Peter; Spengler, Ulrich; Trebicka, Jonel

2016-01-01

Non-cirrhotic idiopathic portal hypertension (NCIPH) is characterized by splenomegaly, anemia and portal hypertension, while liver function is preserved. However, no animal models have been established yet. This study assessed a rat model of NCIPH and characterized the hemodynamics, and compared it to human NCIPH. Portal pressure (PP) was measured invasively and coloured microspheres were injected in the ileocecal vein in rats. This procedure was performed weekly for 3 weeks (weekly embolization). Rats without and with single embolization served as controls. After four weeks (one week after last embolization), hemodynamics were investigated, hepatic fibrosis and accumulation of myofibroblasts were analysed. General characteristics, laboratory analyses and liver histology were collected in patients with NCIPH. Weekly embolization induced a hyperdynamic circulation, with increased PP. The mesenteric flow and hepatic hydroxyproline content was significantly higher in weekly embolized compared to single embolized rats (mesenteric flow +54.1%, hydroxyproline +41.7%). Mesenteric blood flow and shunt volumes increased, whereas splanchnic vascular resistance was decreased in the weekly embolization group. Fibrotic markers αSMA and Desmin were upregulated in weekly embolized rats. This study establishes a model using repetitive embolization via portal veins, comparable with human NCIPH and may serve to test new therapies.

The Effects of a Daily Skincare Regimen on Maintaining the Benefits Obtained from Previous Chemical Resurfacing Treatments.

PubMed

Bruce, Suzanne; Roberts, Wendy; Teller, Craig; Colvan, Lora

2016-09-01

Chemical peels are versatile treatments that involve chemical exfoliation of the skin for cosmetic improvement. Deeper peels produce more significant results, but can be associated with longer healing time and potential complications. Novel chemical resurfacing treatments (AGE and MELA) were developed in Europe to produce skin resurfacing via controlled inflammation to promote cell regeneration with minimum negative effects associated with conventional peelings. The AGE Resurfacing regimen is indicated for the treatment of photoaging, and consists of multi-ingredient peeling solution with trichloroacetic acid, pyruvic acid, salicylic acid, mandelic acid, and lactobionic acid. The MELA Resurfacing regimen addresses hyperpigmentation concerns and contains mandelic acid, potassium azeloyl diglycinate, retinol, salicylic acid, phytic acid, lactobionic acid, and lactic acid. Results of previously conducted US clinical experience trial of AGE and MELA resurfacing protocols rated 81% of subjects with some level of improvement according to physician assessment.
To evaluate whether a daily skin care regimen used for 12 weeks could maintain the benefits achieved with AGE and MELA chemical resurfacing treatments.
Subjects who completed participation in the AGE and MELA skin resurfacing clinical trial were recruited to participate in a continuation trial and used a daily regimen of MDRejuvena facial products for 12 weeks. No other facial products were permitted. Physicians assessed the severity of individual skin parameters at baseline and week 12 and provided global assessment. Subjects assessed improvement of individual skin parameters at week 12 and provided an overall assessment.
Thirteen subjects participated in the 12-week continuation trial. According to the physician's global assessment, all subjects demonstrated some level of improvement at week 12 compared to baseline. Physician assessment showed a decrease in severity of all skin parameters assessed at week 12 compared to baseline. According to the subject overall assessment at week 12, 11 of 12 subjects noted some level of improvement, 1 subject saw no improvement, and 1 subject did not provide an overall assessment. Mild to moderate improvement was observed by subjects in all individual skin parameters assessed except for skin discoloration.
The results of the continuation study demonstrate that use of a daily skin care regimen, which include combination of 2 various strengths of MDRejuvena Rejuvaphyl^® Rejuvenating Complex: low strength (LS) and high strength (HS), not only maintains but can enhance the beneficial effects of skin resurfacing treatments for at least 12 weeks.

J Drugs Dermatol. 2016;15(9):1145-1150.

Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial.

PubMed

Marsen, Tobias A; Beer, Justinus; Mann, Helmut

2017-02-01

Protein-energy wasting (PEW) is increasingly becoming a clinical problem in maintenance hemodialysis patients and guidelines call for nutritional interventions. Serum prealbumin (transthyretin) represents a critical nutritional marker positively correlated with patient survival and negatively correlated with morbidity. Nutritional counseling, oral supplementation as well as intradialytic parenteral nutrition (IDPN) are recommended to fight PEW, however clinical trials on their use are scarce. We conducted a prospective, multicenter, randomized, open-label, controlled, parallel-group Phase IV clinical trial in 107 maintenance hemodialysis patients suffering from PEW to assess the impact of IDPN on prealbumin and other biochemical and clinical parameters reflecting nutritional status. Patients randomized to the intervention group received standardized nutritional counseling plus IDPN three times weekly over 16 weeks followed by a treatment-free period of 12 weeks. The control group received standardized nutritional counseling only. Main trial inclusion criteria included moderate to severe malnutrition (SGA score B or C), maintenance hemodialysis therapy (3 times per week) for more than six months, and presence of two out of the following three criteria: albumin <35 g/L, prealbumin <250 mg/L, phase angle alpha <4.5° assessed by bioelectrical impedance analysis (BIA). Changes in serum prealbumin, albumin, transferrin, phase angle alpha, subjective global assessment (SGA) score and health-related quality of life using the 12-item short form health survey (SF-12) were investigated. IDPN significantly increased prealbumin (p < 0.05), showing rapid rise within 16 weeks of treatment and sustained response thereafter. In the full analysis set (n = 83), 41.0% of 39 patients receiving IDPN achieved a relevant (i.e., at least ≥15%) increase in prealbumin over baseline at week 4 compared to 20.5% of 44 patients in the control group. Considerably more patients with IDPN therapy achieved an increment of prealbumin >30 mg/L at week 16 (48.7% vs. 31.8%). Prealbumin response to IDPN therapy was more prominent in patients suffering from moderate malnutrition (SGA score B) compared to patients with severe malnutrition (SGA score C). The results of this trial demonstrate for the first time that IDPN therapy, given three times weekly in a 16-week short-term intervention, results in a statistically significant and clinically relevant increase in mean serum prealbumin, a surrogate marker for outcome and survival in hemodialysis patients suffering from PEW, and is superior to nutritional counseling. Clinical trial registry:www.clinicaltrials.gov (NCT00501956). Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Neuromotor Development of Children Aged 6 and 7 Years Born before the 30th Week Gestation.

PubMed

Majewska, Joanna; Zajkiewicz, Katarzyna; Wacław-Abdul, Kamila; Baran, Joanna; Szymczyk, Daniel

2018-01-01

The aim of this study was to evaluate and compare the level of neuromotor function and somatic development in 6- and 7-year-old children born before the 30th week gestation with that in full-term children at the same age, as well as the correlation between prematurity and motor development. The study group consisted of prematurely born 40 children. Their mean gestational age at birth was 27.8 ± 1.6 weeks (range 24-30 weeks). The control group consisted of 40 healthy children born with normal birth weight (>2500 g). The neuromotor function was assessed using Touwen neurological examination criteria. During the examination, the attention was focused on the hand preference, laterality, synkinesis, and asymmetry. In addition, children's weight, height, and BMI index were measured. Premature children showed much worse results than full-term ones in hand function ( p < 0,001). They obtained the best results in paper tearing while crossing the body midline turned out to be the most difficult. Considering the quality of walking, the biggest difficulty for the premature children was to walk backwards along the straight line while during normal walking they showed the best results. The results for the muscle tone subcategory in the study group were also significantly worse than those in control group ( p < 0,001), as well as the total outcome for the movement coordination and diadochokinesis subcategories ( p < 0,001). The nondisabled, prematurely born children have significantly lower average outcomes regarding hand function, quality of walking, muscle tone, coordination, and diadochokinesis at age of six to seven, compared to the full-term peers.

Comparison of three baseball-specific 6-week training programs on throwing velocity in high school baseball players.

PubMed

Escamilla, Rafael F; Ionno, Michele; deMahy, M Scott; Fleisig, Glenn S; Wilk, Kevin E; Yamashiro, Kyle; Mikla, Tony; Paulos, Lonnie; Andrews, James R

2012-07-01

Throwing velocity is an important baseball performance variable for baseball pitchers, because greater throwing velocity results in less time for hitters to make a decision to swing. Throwing velocity is also an important baseball performance variable for position players, because greater throwing velocity results in decreased time for a runner to advance to the next base. This study compared the effects of 3 baseball-specific 6-week training programs on maximum throwing velocity. Sixty-eight high school baseball players 14-17 years of age were randomly and equally divided into 3 training groups and a nontraining control group. The 3 training groups were the Throwers Ten (TT), Keiser Pneumatic (KP), and Plyometric (PLY). Each training group trained 3 d·wk(-1) for 6 weeks, which comprised approximately 5-10 minutes for warm-up, 45 minutes of resistance training, and 5-10 for cool-down. Throwing velocity was assessed before (pretest) and just after (posttest) the 6-week training program for all the subjects. A 2-factor repeated measures analysis of variance with post hoc paired t-tests was used to assess throwing velocity differences (p < 0.05). Compared with pretest throwing velocity values, posttest throwing velocity values were significantly greater in the TT group (1.7% increase), the KP group (1.2% increase), and the PLY group (2.0% increase) but not significantly different in the control group. These results demonstrate that all 3 training programs were effective in increasing throwing velocity in high school baseball players, but the results of this study did not demonstrate that 1 resistance training program was more effective than another resistance training program in increasing throwing velocity.

Practical application of kangaroo mother care in preterm infants: clinical characteristics and safety of kangaroo mother care.

PubMed

Park, Hyun-kyung; Choi, Byeong Seon; Lee, Seung Jin; Son, In-A; Seol, In-Joon; Lee, Hyun Ju

2014-03-01

To determine the clinical characteristics and safety of kangaroo mother care (KMC) according to the gestational age (GA) or postmenstrual age (PMA). We conducted a prospective clinical study in 31 infants between 25 and 32 weeks' GA. The subjects were categorized into two groups (25-28 weeks' and 29-32 weeks' GA groups) to compare the clinical characteristics associated with KMC. Heart rate, respiratory rate, oxygen saturation, blood pressure and body temperature (BT) were longitudinally assessed for 60 min with respect to the PMA group (29-32 weeks' and 33-36 weeks' PMA groups). The authors analyzed 70 sessions with 31 infants (25-32 weeks' GA, birth weight 760-1740 g, 29-36 weeks' PMA). All infants had statistically significant higher temperatures during KMC than before KMC within clinically acceptable limits (P<0.001). We found a significantly lower variation of BT in the 25-28 weeks' GA group compared with the 29-32 weeks' GA group at 33-36 weeks' PMA, suggesting accelerated skin maturation in more premature infants (P<0.001). Our intermittent KMC was a safe and feasible method for preterm infants. Notably, at the same PMA, preterm infants in the lower at-birth GA group showed an advanced maturation of thermoregulation compared with those in the higher GA group.

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures.

PubMed

Hota, Lekha S; Hanaway, Katherine; Hacker, Michele R; Disciullo, Anthony; Elkadry, Eman; Dramitinos, Patricia; Shapiro, Alexander; Ferzandi, Tanaz; Rosenblatt, Peter L

2012-01-01

This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI). This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year. Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3-16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5-128.0) at 12 weeks and 3.5 (95% CI, 1.1-11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36). The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.

Efficacy of ankle control balance training on postural balance and gait ability in community-dwelling older adults: a single-blinded, randomized clinical trial.

PubMed

Lee, Kyeongjin; Lee, Yong Woo

2017-09-01

[Purpose] This study was conducted to investigate the effects of ankle control balance training (ACBT) on postural balance and gait ability in community-dwelling older adults. [Subjects and Methods] Fifty-four subjects were randomly divided into two groups, with 27 subjects in the ACBT group and 27 subjects in the control group. Subjects in the ACBT group received ACBT for 60 minutes, twice per week for 4 weeks, and all subjects had undergone fall prevention education for 60 minutes, once per week for 4 weeks. The main outcome measures, including the Berg balance scale; the functional reach test and one leg stance test for postural balance; and the timed up-and-go test and 10-meter walking test for gait ability, were assessed at baseline and after 4 weeks of training. [Results] The postural balance and gait ability in the ACBT group improved significantly compared to those in the control group, except BBS. [Conclusion] The results of this study showed improved postural balance and gait abilities after ACBT and that ACBT is a feasible method for improving postural balance and gait ability in community-dwelling older adults.

Efficacy of ankle control balance training on postural balance and gait ability in community-dwelling older adults: a single-blinded, randomized clinical trial

PubMed Central

Lee, Kyeongjin; Lee, Yong Woo

2017-01-01

[Purpose] This study was conducted to investigate the effects of ankle control balance training (ACBT) on postural balance and gait ability in community-dwelling older adults. [Subjects and Methods] Fifty-four subjects were randomly divided into two groups, with 27 subjects in the ACBT group and 27 subjects in the control group. Subjects in the ACBT group received ACBT for 60 minutes, twice per week for 4 weeks, and all subjects had undergone fall prevention education for 60 minutes, once per week for 4 weeks. The main outcome measures, including the Berg balance scale; the functional reach test and one leg stance test for postural balance; and the timed up-and-go test and 10-meter walking test for gait ability, were assessed at baseline and after 4 weeks of training. [Results] The postural balance and gait ability in the ACBT group improved significantly compared to those in the control group, except BBS. [Conclusion] The results of this study showed improved postural balance and gait abilities after ACBT and that ACBT is a feasible method for improving postural balance and gait ability in community-dwelling older adults. PMID:28931994

Postangioplasty restenosis followed with magnetic resonance imaging in an atherosclerotic rabbit model.

PubMed

Hänni, Mari; Leppänen, Olli; Smedby, Orjan

2012-01-01

Rationale and Objectives. Testing a quantitative, noninvasive method to assess postangioplasty vessel wall changes in an animal model. Material and Methods. Six New Zealand white rabbits were subjected to atherosclerotic injury, including cholesterol-enriched diet, deendothelialization, and percutaneous transluminal angioplasty (PTA) in the distal part of abdominal aorta (four weeks after deendothelialization). The animals were examined with a 1.5T MRI scanner at three times as follows: baseline (six weeks after diet start and two days after PTA) and four weeks and 10 weeks after-PTA. Inflow angiosequence (M2DI) and proton-density-weighted sequence (PDW) were performed to examine the aorta with axial slices. To identify the inner and outer vessel wall boundaries, a dynamic contour algorithm (Gradient Vector Flow Snakes) was applied to the images, followed by calculation of the vessel wall dimensions. The results were compared with histopathological analysis. Results. The wall thickness in the lesion was significantly higher than in the control region at 4 and 10 weeks, reflecting induction of experimentally created after-angioplasty lesion. At baseline, no significant difference between the two regions was present. Conclusions. It is possible to follow the development of vessel wall changes after-PTA with MRI in this rabbit model.

A comparison of forward and concurrent chaining strategies in teaching laundromat skills to students with severe handicaps.

PubMed

McDonnell, J; McFarland, S

1988-01-01

This study compared the relative efficiency of forward and concurrent chaining strategies in teaching the use of a commercial washing machine and laundry soap dispenser to four high school students with severe handicaps. Acquisition and maintenance of the laundromat skills were assessed through a multielement, alternating treatment within subject design. Results indicated that the concurrent chaining strategy was more efficient than forward chaining in facilitating acquisition of the activities. Four week and eight week follow-up probes indicated that concurrent chaining resulted in better maintenance of the activities. The implications of these results for teaching community activities and future research in building complex chains are discussed.

Rotator cuff healing after continuous subacromial bupivacaine infusion: an in vivo rabbit study

PubMed Central

FRIEL, NICOLE A.; WANG, VINCENT M.; SLABAUGH, MARK A.; WANG, FANCHIA; CHUBINSKAYA, SUSAN; COLE, BRIAN J.

2013-01-01

Background The objective of this study was to evaluate the effects of continuous subacromial bupivacaine infusion on supraspinatus muscle and rotator cuff tendon healing via gross, biomechanical, and histologic analyses. Methods Thirty-three New Zealand White rabbits underwent unilateral supraspinatus transection and rotator cuff repair (RCR). Rabbits were assigned to 1 of 3 groups: (1)RCR only, (2)RCR with continuous saline infusion for 48 hours, or (3)RCR with continuous 0.25% bupivacaine with epinephrine (1:200,000) infusion for 48 hours. Rabbits were sacrificed at either 2 (for histologic assessment) or 8 weeks post-operatively (for biomechanical and histologic assessment). Results Tensile testing showed significantly higher load to failure in intact tendons compared to repaired tendons (p<0.01); however, no statistical differences were detected among RCR only, RCR Saline, and RCR Bupivacaine groups. Histologically, the enthesis of repaired tendons showed increased cellularity and disorganized collagen fibers compared to intact tendons, with no differences between treatment groups. Muscle histology demonstrated scattered degenerative muscle fibers at 2 weeks in both RCR Saline and RCR Bupivacaine, but no degeneration was noted at 8 weeks. Conclusions The healing supraspinatus tendons exposed to bupivacaine infusion showed similar histologic and biomechanical characteristics compared to untreated and saline infused RCR groups. Muscle histology showed fiber damage at 2 weeks for both the saline and bupivacaine treated groups, with no apparent disruption at 8 weeks, suggesting a recovery process. Therefore, subacromial bupivacaine infusion in this rabbit rotator cuff model does not appear to impair muscle or tendon following acute injury and repair. Level Of Evidence Basic science study PMID:22818894

Changes in Knee Biomechanics After a Hip-Abductor Strengthening Protocol for Runners With Patellofemoral Pain Syndrome

PubMed Central

Ferber, Reed; Kendall, Karen D.; Farr, Lindsay

2011-01-01

Abstract Context: Very few authors have investigated the relationship between hip-abductor muscle strength and frontal-plane knee mechanics during running. Objective: To investigate this relationship using a 3-week hip-abductor muscle-strengthening program to identify changes in strength, pain, and biomechanics in runners with patellofemoral pain syndrome (PFPS). Design: Cohort study. Setting: University-based clinical research laboratory. Patients or Other Participants: Fifteen individuals (5 men, 10 women) with PFPS and 10 individuals without PFPS (4 men, 6 women) participated. Intervention(s): The patients with PFPS completed a 3-week hip-abductor strengthening protocol; control participants did not. Main Outcome Measure(s): The dependent variables of interest were maximal isometric hip-abductor muscle strength, 2-dimensional peak knee genu valgum angle, and stride-to-stride knee-joint variability. All measures were recorded at baseline and 3 weeks later. Between-groups differences were compared using repeated-measures analyses of variance. Results: At baseline, the PFPS group exhibited reduced strength, no difference in peak genu valgum angle, and increased stride-to-stride knee-joint variability compared with the control group. After the 3-week protocol, the PFPS group demonstrated increased strength, less pain, no change in peak genu valgum angle, and reduced stride-to-stride knee-joint variability compared with baseline. Conclusions: A 3-week hip-abductor muscle-strengthening protocol was effective in increasing muscle strength and decreasing pain and stride-to-stride knee-joint variability in individuals with PFPS. However, concomitant changes in peak knee genu valgum angle were not observed. PMID:21391799

Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial.

PubMed

Teut, M; Ullmann, A; Ortiz, M; Rotter, G; Binting, S; Cree, M; Lotz, F; Roll, S; Brinkhaus, B

2018-04-02

We aimed to investigate the effectiveness of two different forms of dry pulsatile cupping in patients with chronic low back pain (cLBP) compared to medication on demand only in a three-armed randomized trial. 110 cLBP patients were randomized to regular pulsatile cupping with 8 treatments plus paracetamol on demand (n = 37), minimal cupping with 8 treatments plus paracetamol on demand (n = 36) or the control group with paracetamol on demand only (n = 37). Primary outcome was the pain intensity on a visual analogue scale (VAS, 0-100 mm) after 4 weeks, secondary outcome parameter included VAS pain intensity after 12 weeks, back function as measured with the 'Funktionsfragebogen Hannover Rücken' (FFbH-R) and health related quality of life questionnaire Short form 36 (SF-36) after 4 and 12 weeks. The mean baseline-adjusted VAS after 4 weeks was 34.9 mm (95% CI: 28.7; 41.2) for pulsatile cupping, 40.4 (34.2; 46.7) for minimal cupping and 56.1 (49.8; 62.4) for control group, resulting in statistically significant differences between pulsatile cupping vs. control (21.2 (12.2; 30.1); p < 0.001) and minimal cupping vs. control (15.7 (6.9; 24.4); p = 0.001). After 12 weeks, mean adjusted VAS difference between pulsatile cupping vs. control was 15.1 ((3.1; 27.1); p = 0.014), and between minimal cupping vs. control 11.5 ((- 0.44; 23.4); p = 0.059). Differences of VAS between pulsatile cupping and minimal cupping showed no significant differences after 4 or 12 weeks. Pulsatile cupping was also better (- 5.8 (- 11.5;-0.1); p = 0.045) compared to control for back function after 4 weeks, but not after 12 weeks (- 5.4 (- 11.7;0.8); p = 0.088), pulsatile cupping also showed better improvements on SF-36 physical component scale compared to control at 4 and 12 weeks (- 5.6 (- 9.3;-2.0); p = 0.003; - 6.1 (- 9.9;-2.4); p = 0.002). For back function and quality of life minimal cupping group was not statistically different to control after 4 and 12 weeks. Paracetamol intake did not differ between the groups (cupping vs. control (7.3 (- 0.4;15.0); p = 0.063); minimal cupping vs. control (6.3 (- 2.0;14.5); p = 0.133). Both forms of cupping were effective in cLBP without showing significant differences in direct comparison after four weeks, only pulsatile cupping showed effects compared to control after 12 weeks. The study was registered at ClinicalTrials.gov (identifier: NCT02090686 ).

Increased childhood morbidity after measles is short-term in urban Bangladesh.

PubMed

Akramuzzaman, S M; Cutts, F T; Wheeler, J G; Hossain, M J

2000-04-01

In a 1995-1996 cohort study in the city of Dhaka, Bangladesh, morbidity in 117 hospitalized and 137 acute measles cases compared with age-matched children without measles (unexposed) was determined by weekly interview for 6 months. Compared with unexposed children, there were higher incidences of hospitalization (adjusted rate ratio (RR) = 3.1, 95% confidence interval (CI): 1.3, 7.6) and bloody diarrhea (adjusted RR = 2.7, 95% CI: 1.4, 5.1) in hospital measles cases during the 6 weeks after recruitment. Among community cohorts, there were higher incidences of bloody diarrhea (adjusted RR = 4.1, 95% CI: 1.1, 14.6), watery diarrhea (adjusted RR = 1.6, 95% CI: 0.9, 2.7), fast breathing (adjusted RR = 3.8, 95% CI: 2.1, 6.9), and the weekly point prevalence of pneumonia (adjusted prevalence ratio = 3.1, 95% CI: 1.0, 9.8) in measles cases during the same period. All measles cases regained lost weight within about 6 weeks. The prevalence of anergy to seven recall antigens 6 weeks after recruitment was higher in both hospital (adjusted odds ratio = 2.8, 95% CI: 1.2, 6.4) and community (adjusted odds ratio = 3.1, 95% CI: 1.1, 8.9) measles cases. Morbidity increased during the first 6-8 weeks after measles, but the authors found no consistent evidence of longer-term morbidity or wasting. The results support recent findings that measles is not associated with increased delayed mortality.

Stable Mercury Isotopes in Polished Rice (Oryza sativa L.) and Hair from Rice Consumers

PubMed Central

2017-01-01

Mercury (Hg) isotopic signatures were characterized in polished rice samples from China, U.S., and Indonesia (n = 45). Hg isotopes were also analyzed in paired hair samples for participants from China (n = 21). For the latter, we also quantified the proportion of methylmercury intake through rice (range: 31–100%), and the weekly servings of fish meals (range: 0–5.6 servings/weekly). For these participants, 29% (n = 6) never ingested fish, 52% (n = 11) ingested fish < twice/weekly, and 19% (n = 4) ingested fish ≥ twice/weekly. In rice and hair, both mass-dependent fractionation (MDF, reported as δ202Hg) and mass-independent fractionation (MIF, reported as Δ199Hg) of Hg isotopes were observed. Compared to rice, hair δ202Hg values were enriched on average (±1 standard deviation) by 1.9 ± 0.61‰, although the range was wide (range: 0.45‰, 3.0‰). Hair Δ199Hg was significantly inversely associated with %methylmercury intake from rice (Spearman’s rho = −0.61, p < 0.01, n = 21), i.e., as the proportion of methylmercury intake from rice increased, MIF decreased. Additionally, hair Δ199Hg was significantly higher for participants ingesting fish ≥ twice/weekly compared to those who did not ingest fish or ingested fish < twice/weekly (ANOVA, p < 0.05, n = 21); Overall, results suggest that Hg isotopes (especially MIF) in human hair can be used to distinguish methylmercury intake from rice versus fish. PMID:28482656

Birth weight centiles by gestational age for twins born in south India.

PubMed

Premkumar, Prasanna; Antonisamy, Belavendra; Mathews, Jiji; Benjamin, Santhosh; Regi, Annie; Jose, Ruby; Kuruvilla, Anil; Mathai, Mathews

2016-03-24

Birth weight centile curves are commonly used as a screening tool and to assess the position of a newborn on a given reference distribution. Birth weight of twins are known to be less than those of comparable singletons and twin-specific birth weight centile curves are recommended for use. In this study, we aim to construct gestational age specific birth weight centile curves for twins born in south India. The study was conducted at the Christian Medical College, Vellore, south India. The birth records of all consecutive pregnancies resulting in twin births between 1991 and 2005 were reviewed. Only live twin births between 24 and 42 weeks of gestation were included. Birth weight centiles for gestational age were obtained using the methodology of generalized additive models for location, scale and shape (GAMLSS). Centiles curves were obtained separately for monochorionic and dichorionic twins. Of 1530 twin pregnancies delivered during the study period (1991-2005), 1304 were included in the analysis. The median gestational age at birth was 36 weeks (1st quartile 34, 3rd quartile 38 weeks). Smoothed percentile curves for birth weight by gestational age increased progressively till 38 weeks and levels off thereafter. Compared with dichorionic twins, monochorionic twins had lower birth weight for gestational age from after 27 weeks. We provide centile values of birth weight at 24 to 42 completed weeks of gestation for twins born in south India. These charts could be used both in routine clinical assessments and epidemiological studies.

The Impact of Exercise On Depression and Anxiety Symptoms Among Abstinent Methamphetamine-Dependent Individuals in A Residential Treatment Setting.

PubMed

Rawson, Richard A; Chudzynski, Joy; Gonzales, Rachel; Mooney, Larissa; Dickerson, Daniel; Ang, Alfonso; Dolezal, Brett; Cooper, Christopher B

2015-10-01

This paper reports data from a study designed to determine the impact of an 8-week exercise program on depression and anxiety symptoms among newly abstinent methamphetamine (MA)-dependent individuals in residential treatment. One hundred thirty-five MA-dependent individuals, newly enrolled in residential treatment, were randomly assigned to receive either a 3-times-per-week, 60-minute structured exercise program for 8 weeks (24 sessions) or an equivalent number of health education sessions. Using mixed-modeling repeated-measures regression, we examined changes in weekly total depression and anxiety scores as measured by the Beck Depression Inventory and Beck Anxiety Inventory over the 8-week study period. Mean age of participants was 31.7 (SD = 6.9); 70.4% were male and 48% Latino. Analyses indicate a significant effect of exercise on reducing depression (β = -0.63, P = 0.001) and anxiety (β = -0.95, P=0.001) symptoms (total scores) over the 8-week period compared to a health education control group. A significant dose interaction effect between session attendance and exercise was found as well on reducing depression (β = -0.61, P < 0.001) and anxiety symptoms (β = -0.22, P=0.009) over time compared to the control group. Results support the role of a structured exercise program as an effective intervention for improving symptoms of depression and anxiety associated with MA abstinence. Copyright © 2015 Elsevier Inc. All rights reserved.

Rifaximin has a Marginal Impact on Microbial Translocation, T-cell Activation and Inflammation in HIV-Positive Immune Non-responders to Antiretroviral Therapy – ACTG A5286

PubMed Central

Tenorio, Allan R.; Chan, Ellen S.; Bosch, Ronald J.; Macatangay, Bernard J. C.; Read, Sarah W.; Yesmin, Suria; Taiwo, Babafemi; Margolis, David M.; Jacobson, Jeffrey M.; Landay, Alan L.; Wilson, Cara C.; Mellors, John W.; Keshavarzian, Ali; Rodriguez, Benigno; Aziz, Mariam; Presti, Rachel; Deeks, Steven; Ebiasah, Ruth; Myers, Laurie; Borowski, LuAnn; Plants, Jill; Palm, David A.; Weibel, Derek; Putnam, Beverly; Lindsey, Elizabeth; Player, Amy; Albrecht, Mary; Kershaw, Andrea; Sax, Paul; Keenan, Cheryl; Walton, Patricia; Baum, Jane; Stroberg, Todd; Hughes, Valery; Coster, Laura; Kumar, Princy N.; Yin, Michael T.; Noel-Connor, Jolene; Tebas, Pablo; Thomas, Aleshia; Davis, Charles E.; Redfield, Robert R.; Sbrolla, Amy; Flynn, Teri; Davis, Traci; Whitely, Kim; Singh, Baljinder; Swaminathan, Shobha; McGregor, Donna; Palella, Frank; Aberg, Judith; Cavanagh, Karen; Santana Bagur, Jorge L.; Flores, Olga Méndez; Fritsche, Janice; Sha, Beverly; Slamowitz, Debbie; Valle, Sandra; Tashima, Karen; Patterson, Helen; Harber, Heather; Para, Michael; Eaton, Molly; Maddox, Dale; Currier, Judith; Cajahuaringa, Vanessa; Luetkemeyer, Annie; Dwyer, Jay; Fichtenbaum, Carl J.; Saemann, Michelle; Ray, Graham; Campbell, Thomas; Fischl, Margaret A.; Bolivar, Hector; Oakes, Jonathan; Chicurel-Bayard, Miriam; Tripoli, Christine; Weinman, D. Renee; Adams, Mary; Hurley, Christine; Dunaway, Shelia; Storey, Sheryl; Klebert, Michael; Royal, Michael

2015-01-01

Background. Rifaximin, a nonabsorbable antibiotic that decreases lipopolysaccharide (LPS) in cirrhotics, may decrease the elevated levels of microbial translocation, T-cell activation and inflammation in human immunodeficiency virus (HIV)-positive immune nonresponders to antiretroviral therapy (ART). Methods. HIV-positive adults receiving ART for ≥96 weeks with undetectable viremia for ≥48 weeks and CD4+ T-cell counts <350 cells/mm3 were randomized 2:1 to rifaximin versus no study treatment for 4 weeks. T-cell activation, LPS, and soluble CD14 were measured at baseline and at weeks 2, 4, and 8. Wilcoxon rank sum tests compared changes between arms. Results. Compared with no study treatment (n = 22), rifaximin (n = 43) use was associated with a significant difference between study arms in the change from baseline to week 4 for CD8+T-cell activation (median change, 0.0% with rifaximin vs +0.6% with no treatment; P = .03). This difference was driven by an increase in the no-study-treatment arm because there was no significant change within the rifaximin arm. Similarly, although there were significant differences between study arms in change from baseline to week 2 for LPS and soluble CD14, there were no significant changes within the rifaximin arm. Conclusions. In immune nonresponders to ART, rifaximin minimally affected microbial translocation and CD8+T-cell activation. Trial registration number. NCT01466595. PMID:25214516

Limitations of ultrasonography for diagnosing white matter damage in preterm infants

PubMed Central

Debillon, T; N'Guyen, S; Muet, A; Quere, M; Moussaly, F; Roze, J

2003-01-01

Objectives: To compare the accuracy of ultrasonography (US) and magnetic resonance imaging (MRI) in diagnosing white matter abnormalities in preterm infants and to determine the specific indications for MRI. Design: Prospective cohort study. Setting: A neonatal intensive care unit in France. Patients: All preterm infants (≤ 33 weeks gestation) without severe respiratory distress syndrome precluding MRI. Main outcome measures: US and MRI performed contemporaneously during the third postnatal week were analysed by an independent observer. The findings were compared with those of a term MRI scan, the results of which were taken as the final diagnosis. Statistical analysis was performed to determine which early imaging study best predicted the term MRI findings. Results: The early US and MRI findings (79 infants) correlated closely for severe lesions (cystic periventricular leucomalacia and parenchymal infarction; κ coefficient = 0.86) but not for moderate lesions (non-cystic leucomalacia and parenchymal punctate haemorrhages; κ = 0.62). Overall, early MRI findings predicted late MRI findings in 98% of patients (95% confidence interval (CI) 89.5 to 99.9) compared with only 68% for early US (95% CI 52.1 to 79.2). Conclusions: US is highly effective in detecting severe lesions of the white matter in preterm infants, but MRI seems to be necessary for the diagnosis of less severe damage. MRI performed at about the third week of life is highly predictive of the final diagnosis at term. PMID:12819157

Twice versus thrice weekly ECT in a clinical population: an evaluation of patient outcomes.

PubMed

Siskind, Dan; Charlson, Fiona; Saraf, Sudeep; Scheurer, Roman; Lie, David Charles

2012-10-30

Increasing demand on electroconvulsive therapy (ECT) services led to a recommendation that low risk patients be considered for twice weekly ECT rather than the usual thrice weekly. We evaluated whether practice changed and compared patient clinical outcomes for twice and thrice weekly ECT. Medical records for all patients receiving ECT in the 2-year study period (1/9/08 to 30/8/10) were reviewed to determine ECT protocol, diagnosis, admission duration and readmission rates. During the study period, 119 patients received 150 treatment courses. Patient outcomes were compared for twice weekly ECT and thrice weekly ECT protocols, as well as for 1 year before and after the recommendation (1/9/09). Twice weekly ECT courses increased (8-20) after the recommendation while thrice weekly ECT courses decreased (64-30). The recommendation had no significant effect on patient outcomes. Comparing twice and thrice weekly ECT, patient clinical outcomes were similar between the two groups, though non-affective twice weekly patients waited longer before starting ECT. In the context of resource constraints, psychiatrists can be influenced to examine and change their ECT prescribing practice. This bodes well for the implementation of evidence-based treatment into mental health services. Secondly, for adults, there appear to be no significant differences in clinical outcomes for twice versus thrice weekly ECT. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment.

PubMed

Friedrich, Sven O; Rachow, Andrea; Saathoff, Elmar; Singh, Kasha; Mangu, Chacha D; Dawson, Rodney; Phillips, Patrick Pj; Venter, Amour; Bateson, Anna; Boehme, Catharina C; Heinrich, Norbert; Hunt, Robert D; Boeree, Martin J; Zumla, Alimuddin; McHugh, Timothy D; Gillespie, Stephen H; Diacon, Andreas H; Hoelscher, Michael

2013-08-01

An accurate biomarker is urgently needed to monitor the response to treatment in patients with pulmonary tuberculosis. The Xpert MTB/RIF assay is a commercially available real-time PCR that can be used to detect Mycobacterium-tuberculosis-specific DNA sequences in sputum samples. We therefore evaluated this assay with serial sputum samples obtained over 26 weeks from patients undergoing treatment for tuberculosis. We analysed sputum samples from 221 patients with smear-positive tuberculosis enrolled at two sites (Cape Town, South Africa, and Mbeya, Tanzania) of a multicentre randomised clinical trial REMoxTB of antituberculosis treatment on a weekly basis (weeks 0 to 8), then at weeks 12, 17, 22, and 26 after treatment initiation. The Xpert MTB/RIF results over time were compared with the results of standard smear microscopy and culture methods. We obtained and analysed 2741 sputum samples from 221 patients. The reduction in positivity rates with Xpert MTB/RIF were slower than those with the standard methods. At week 8, positive results were obtained for 62 (29%) of 212 sputum samples with smear microscopy, 46 (26%) of 175 with solid culture (Löwenstein-Jensen medium), 77 (42%) of 183 with liquid culture (Bactec MGIT960 system), and 174 (84%) of 207 with Xpert MTB/RIF; at 26 weeks, positive results were obtained for ten (5%) of 199, four (3%) of 157, seven (4%) of 169, and 22 (27%) of 83 sputum samples, respectively. The reduction in detection of quantitative M tuberculosis DNA with Xpert MTB/RIF correlated with smear grades (ρ=-0·74; p<0·0001), solid culture grades (ρ=-0·73; p<0·0001), and time to liquid culture positivity (ρ=0·73; p<0·0001). Compared with the combined binary smear and culture results as a reference standard, the Xpert MTB/RIF assay had high sensitivity (97·0%, 95% CI 95·8-97·9), but poor specificity (48·6%, 45·0-52·2). The poor specificity precludes the use of the Xpert MTB/RIF assay as a biomarker for monitoring tuberculosis treatment, and should not replace standard smear microscopy and culture. Global Alliance for TB Drug Development, Bill & Melinda Gates Foundation, UK Medical Research Council, German Ministry of Science and Technology. Copyright © 2013 Elsevier Ltd. All rights reserved.

Trial of Tocilizumab in Giant-Cell Arteritis.

PubMed

Stone, John H; Tuckwell, Katie; Dimonaco, Sophie; Klearman, Micki; Aringer, Martin; Blockmans, Daniel; Brouwer, Elisabeth; Cid, Maria C; Dasgupta, Bhaskar; Rech, Juergen; Salvarani, Carlo; Schett, Georg; Schulze-Koops, Hendrik; Spiera, Robert; Unizony, Sebastian H; Collinson, Neil

2017-07-27

Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis. In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed. Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P<0.001 for the comparisons of either active treatment with placebo). The cumulative median prednisone dose over the 52-week period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the placebo group that underwent the 26-week taper (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent the 52-week taper (P<0.001 for both comparisons). Serious adverse events occurred in 15% of the patients in the group that received tocilizumab weekly, 14% of those in the group that received tocilizumab every other week, 22% of those in the placebo group that underwent the 26-week taper, and 25% of those in the placebo group that underwent the 52-week taper. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week. Tocilizumab, received weekly or every other week, combined with a 26-week prednisone taper was superior to either 26-week or 52-week prednisone tapering plus placebo with regard to sustained glucocorticoid-free remission in patients with giant-cell arteritis. Longer follow-up is necessary to determine the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT01791153 .).