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Sample records for 6-month study period

  1. A prospective study of atopic dermatitis managed without topical corticosteroids for a 6-month period

    PubMed Central

    Fukaya, Mototsugu; Sato, Kenji; Yamada, Takahiro; Sato, Mitsuko; Fujisawa, Shigeki; Minaguchi, Satoko; Kimata, Hajime; Dozono, Haruhiko

    2016-01-01

    Topical corticosteroids (TCS) are regarded as the mainstay treatment for atopic dermatitis (AD). As AD has a tendency to heal naturally, the long-term efficacy of TCS in AD management should be compared with the outcomes seen in patients with AD not using TCS. However, there are few long-term studies that consider patients with AD not using TCS. We designed a prospective multicenter cohort study to assess the clinical outcomes in patients with AD who did not use TCS for 6 months and then compared our results with an earlier study by Furue et al which considered AD patients using TCS over 6 months. Our patients’ clinical improvement was comparable with the patients described in Furue’s research. In light of this, it is reasonable for physicians to manage AD patients who decline TCS, as the expected long-term prognosis is similar whether they use TCS or not. PMID:27445501

  2. Summary of Sonic Boom Rise Times Observed During FAA Community Response Studies over a 6-Month Period in the Oklahoma City Area

    NASA Technical Reports Server (NTRS)

    Maglieri, Domenic J.; Sothcott, Victor E.

    1990-01-01

    The sonic boom signature data acquired from about 1225 supersonic flights, over a 6-month period in 1964 in the Oklahoma City area, was enhanced with the addition of data relating to rise times and total signature duration. These later parameters, not available at the time of publication of the original report on the Oklahoma City sonic boom exposures, are listed in tabular form along with overpressure, positive impulse, positive duration, and waveform category. Airplane operating information along with the surface weather observations are also included. Sonic boom rise times include readings to the 1/2, 3/4, and maximum overpressure values. Rise time relative probabilities for various lateral locations from the ground track of 0, 5, and 10 miles are presented along with the variation of rise times with flight altitude. The tabulated signature data, along with corresponding airplane operating conditions and surface and upper level atmospheric information, are also available on electronic files to provide it in the format for more efficient and effective utilization.

  3. A 6-month prospective study of injury in Gaelic football.

    PubMed

    Wilson, F; Caffrey, S; King, E; Casey, K; Gissane, C

    2007-05-01

    To describe the injury incidence in Gaelic football. A total of 83 players from three counties were interviewed monthly about their injury experience, during the 6 months of the playing season. The injury rate was 13.5/1000 h exposure to Gaelic football (95% CI, 10.9 to 16.6). There were nearly twice as many injuries during matches (64.4%, 95% CI, 54.1 to 73.6) as in training (35.6%, 95% CI, 26.4 to 49.5). The ankle was found to be the most commonly injured site (13.3%, 95% CI, 7.8 to 21.9). The musculotendinous unit accounted for nearly 1/3 of all injuries (31.1%). The tackle accounted for 27.8% of the injuries sustained (tackler 10%, 95% CI, 5.4 to 17.9; player being tackled 17.9%, 95% CI, 11.2 to 26.9). Of total match injuries, 56.9% (95% CI, 46.1 to 67.1) were experienced in the second half as opposed to 39.7% (95% CI, 29.8 to 50.5) in the first half. Gaelic footballers are under considerable risk of injury. Greater efforts must be made to reduce this risk so that players miss less time from sport due to injury. Risk factors for injury in Gaelic football must now be investigated so that specific interventions may be established to reduce them.

  4. A 6-month clinical study assessing the safety and efficacy of two cetylpyridinium chloride mouthrinses.

    PubMed

    Stookey, George K; Beiswanger, Bradley; Mau, Melissa; Isaacs, Roger L; Witt, Jon J; Gibb, Roger

    2005-07-01

    To evaluate the effects of two experimental cetylpyridinium chloride (CPC) mouthrinses containing 0.075% and 0.10% CPC on the development of gingivitis and plaque versus a placebo control over a period of 6 months. This was a randomized, single center, parallel group, double blind, positive and placebo controlled clinical trial. A 0.12% chlorhexidine rinse served as the positive control for validation of the methodology. At the beginning of the trial, 366 subjects were balanced and randomly assigned to treatment groups. Subjects received a dental prophylaxis and began rinsing twice a day with 15 ml of their assigned mouthwash for 30 seconds after brushing their teeth. Subjects were assessed for gingivitis and gingival bleeding by the Löe-Silness Gingival Index method and plaque by the Turesky modification of Quigley Hein Plaque Index at baseline and after 3 and 6 months of product use. Oral soft tissue health was also assessed. After 3 and 6 months, subjects rinsing with either 0.075% or 0.10% CPC had significantly (P< 0.0001) less gingivitis, gingival bleeding, and plaque, on average, than those on placebo. The 6-month mean reductions in gingivitis, gingival bleeding, and plaque for the 0.075% and 0.10% CPC rinses versus placebo were 23%, 30% and 17%, and 20%, 27% and 19%, respectively. There was no statistically significant difference in efficacy between the two CPC mouthrinses. Reductions at 3 months were similar to those seen at 6 months. Significant benefits were observed with chlorhexidine, thereby validating the study. This study clearly demonstrates that CPC mouthrinses formulated to deliver therapeutic benefits when used twice daily can significantly prevent the development of gingivitis, gingival bleeding, and plaque over a 6-month period.

  5. The posterior iris-claw lens outcome study: 6-month follow-up

    PubMed Central

    Jare, Nana Madhukar; Kesari, Ashwini Ganesh; Gadkari, Salil S; Deshpande, Madan D

    2016-01-01

    Purpose: The purpose of this study was to evaluate functional and anatomical outcomes of posterior iris-claw intraocular lens (IOL) implant for correction of aphakia in eyes with inadequate capsular support. Materials and Methods: Prospective case series of 108 aphakic eyes with inadequate capsular support which underwent posterior iris-claw IOL with a 6-month follow-up period was conducted. The cases belonged to two clinical settings: elective secondary implantation and those with intraoperative posterior dislocation of cataractous lens or IOL. Main outcome measures were visual acuity, anterior chamber reaction, stability of IOL, endothelial cell count, intraocular pressure (IOP), and cystoid macular edema (CME). Results: The mean best-corrected visual acuity was LogMAR 0.25. None had chronic anterior chamber inflammation. The mean difference in central endothelial counts before surgery and 1 month after surgery was 104.21 cell/mm2 (4.92%). There was no statistically significant difference in central endothelial cell count at 1 and 6 months (P = 0.91) and also in the central macular thickness at preoperative and after 6 months suggestive of CME (P = 0.078). Three eyes had raised IOP which were managed with neodymium-doped yttrium aluminum garnet laser peripheral iridotomy. There were no IOL dislocations or other adverse events in our series. Conclusion: Posterior chamber iris-claw lenses are a good option in eyes with inadequate posterior capsular support. Chronic inflammation, poor lens stability, or significant central endothelial cell loss was not observed during the 6-month follow-up period. PMID:28112126

  6. A prospective study of iron status in exclusively breastfed term infants up to 6 months of age.

    PubMed

    Raj, Shashi; Faridi, Mma; Rusia, Usha; Singh, Om

    2008-03-01

    Can exclusive breastfeeding until six months of age maintain optimum iron status in term babies? We evaluated iron status of exclusively breastfed term infants in relation to breast milk iron and lactoferrin. In this prospective study in Delhi, India, during the period 2003-2004 normally delivered babies of non-anemic [(Hemoglobin (Hb) = 11 g/dl, n = 68] and anemic (Hb 7 - 10.9 g/dl, n = 61) mothers were followed until 6 months of age. Iron parameters were measured in the cord blood at 14 weeks and 6 months. Breast milk iron and lactoferrin were measured at the same intervals. Iron parameters in babies of both groups were within normal limits at birth, 14 weeks and 6 months. Mean breast milk iron and lactoferrin in non-anemic (day 1: 0.89, 6 months: 0.26 mg/l; day 1: 12.02, 6 months: 5.85 mg/ml) and anemic mothers (day 1: 0.86, 6 months: 0.27 mg/l; day 1: 12.91, 6 months: 6.37 mg/ml) were not different on day one or at other times. No relationship was found between breast milk iron, lactoferrin and iron status of the babies. Exclusively breastfed infants of non-anemic and anemic mothers did not develop iron deficiency or iron deficiency anemia by six months of age.

  7. A prospective study of iron status in exclusively breastfed term infants up to 6 months of age

    PubMed Central

    Raj, Shashi; Faridi, MMA; Rusia, Usha; Singh, Om

    2008-01-01

    Background Can exclusive breastfeeding until six months of age maintain optimum iron status in term babies? We evaluated iron status of exclusively breastfed term infants in relation to breast milk iron and lactoferrin. Methods In this prospective study in Delhi, India, during the period 2003–2004 normally delivered babies of non-anemic [(Hemoglobin (Hb) = 11 g/dl, n = 68] and anemic (Hb 7 – 10.9 g/dl, n = 61) mothers were followed until 6 months of age. Iron parameters were measured in the cord blood at 14 weeks and 6 months. Breast milk iron and lactoferrin were measured at the same intervals. Results Iron parameters in babies of both groups were within normal limits at birth, 14 weeks and 6 months. Mean breast milk iron and lactoferrin in non-anemic (day 1: 0.89, 6 months: 0.26 mg/l; day 1: 12.02, 6 months: 5.85 mg/ml) and anemic mothers (day 1: 0.86, 6 months: 0.27 mg/l; day 1: 12.91, 6 months: 6.37 mg/ml) were not different on day one or at other times. No relationship was found between breast milk iron, lactoferrin and iron status of the babies. Conclusion Exclusively breastfed infants of non-anemic and anemic mothers did not develop iron deficiency or iron deficiency anemia by six months of age. PMID:18312681

  8. Comparison of muscle hypertrophy following 6-month of continuous and periodic strength training.

    PubMed

    Ogasawara, Riki; Yasuda, Tomohiro; Ishii, Naokata; Abe, Takashi

    2013-04-01

    To compare the effects of a periodic resistance training (PTR) program with those of a continuous resistance training (CTR) program on muscle size and function, 14 young men were randomly divided into a CTR group and a PTR group. Both groups performed high-intensity bench press exercise training [75 % of one repetition maximum (1-RM); 3 sets of 10 reps] for 3 days per week. The CTR group trained continuously over a 24-week period, whereas the PTR group performed three cycles of 6-week training (or retraining), with 3-week detraining periods between training cycles. After an initial 6 weeks of training, increases in cross-sectional area (CSA) of the triceps brachii and pectoralis major muscles and maximum isometric voluntary contraction of the elbow extensors and 1-RM were similar between the two groups. In the CTR group, muscle CSA and strength gradually increased during the initial 6 weeks of training. However, the rate of increase in muscle CSA and 1-RM decreased gradually after that. In the PTR group, increase in muscle CSA and strength during the first 3-week detraining/6-week retraining cycle were similar to that in the CTR group during the corresponding period. However, increase in muscle CSA and strength during the second 3-week detraining/6-week retraining cycle were significantly higher in the PTR group than in the CTR group. Thus, overall improvements in muscle CSA and strength were similar between the groups. The results indicate that 3-week detraining/6-week retraining cycles result in muscle hypertrophy similar to that occurring with continuous resistance training after 24 weeks.

  9. Hospital discharge bags and breastfeeding at 6 months: data from the infant feeding practices study II.

    PubMed

    Sadacharan, Radha; Grossman, Xena; Matlak, Stephanie; Merewood, Anne

    2014-02-01

    Distribution of industry-sponsored formula sample packs to new mothers undermines breastfeeding. Using data from the Infant Feeding Practices Study II (IFPS II), we aimed to determine whether receipt of 4 different types of bags was associated with exclusive breastfeeding during the first 6 months of life. We extracted data from IFPS II questionnaires. Type of discharge bag received was categorized as "formula bag," "coupon bag," "breastfeeding supplies bag," or "no bag". We examined exclusive breastfeeding status at 10 weeks (post hoc) and at 6 months using univariate descriptive analyses and multivariate logistic regression models, controlling for sociodemographic and attitudinal variables. Overall, 1868 (81.4%) of women received formula bags, 96 (4.2%) received coupon bags, 46 (2.0%) received breastfeeding supplies bags, and 284 (12.4%) received no bag. By 10 weeks, recipients of breastfeeding supplies bags or no bag were significantly more likely to be exclusively breastfeeding than formula bag recipients. In the adjusted model, compared to formula bag/coupon bag recipients, recipients of breastfeeding supplies bag/no bag were significantly more likely to breastfeed exclusively for 6 months (odds ratio = 1.58; 95% confidence interval, 1.06-2.36). The vast majority of new mothers received formula sample packs at discharge, and this was associated with reduced exclusive breastfeeding at 10 weeks and 6 months. Bags containing breastfeeding supplies or no bag at all were positively associated with exclusive breastfeeding at 10 weeks and 6 months.

  10. Multicenter Study of 6-Month Clinical Outcomes After Descemet Membrane Endothelial Keratoplasty.

    PubMed

    Oellerich, Silke; Baydoun, Lamis; Peraza-Nieves, Jorge; Ilyas, Abbas; Frank, Laurence; Binder, Perry S; Melles, Gerrit R J

    2017-09-26

    To report the 6-month clinical outcomes of a large cohort of Descemet membrane endothelial keratoplasty (DMEK) eyes operated by 55 starting or experienced surgeons. This is a retrospective, multicenter, interventional, cohort study with a total of 2485 eyes. Best-corrected visual acuity (BCVA), endothelial cell density (ECD) decrease, and intra- and post-operative complications were evaluated. Three groups based on case order were compared: group I (cases 1-24), group II (cases 25-99), and group III (cases ≥100). Forty-nine percent of the surgeons were in their learning curve (<25 cases), representing 10.4% of the surgeries. Six months after DMEK, BCVA improved in 90.5% of eyes, remained unchanged in 4.6%, and deteriorated in 4.9% (n = 1936); 75.4% of eyes reached a BCVA of ≥20/40 (≥0.5), 45.4% ≥20/25 (≥0.8), and 25.8% ≥20/20 (≥1.0) (n = 1959) and ECD decreased by 40% (±19) (n = 1272, P < 0.05). BCVA and ECD outcomes did not differ between groups I and III (P > 0.05). Intraoperative complications were reported for 9.4% of eyes, whereas graft detachment was the main postoperative complication (27.4%), with lower intra- and post-operative complication rates in group III than group I (P < 0.05). Rebubbling was performed in 20.1% of eyes; 13.8% required secondary keratoplasty within 6 months. DMEK is applicable for surgeons in various settings with good clinical outcomes. After an arbitrary learning curve (<25 cases), virtually all transplant-related complications declined with experience. Notably, surgeons with a higher annual caseload may pass faster through their learning curve than surgeons performing their first surgeries over an extended period.

  11. Infants' responses to arm restraint at 2 and 6 months: a longitudinal study.

    PubMed

    Moscardino, Ughetta; Axia, Giovanna

    2006-01-01

    This study examined the continuity, stability, and change of infants' responses to a frustrating event (i.e., arm restraint) between 2 and 6 months in terms of both negative reactivity and its regulation. Fifty-two healthy, full-term infants and their mothers participated in an arm restraint procedure. Infant behaviors were observed and coded at 3-s intervals. The results showed that infants' reactivity to frustration and their ability to regulate such reactivity significantly changed in level over time. Individual differences in frustration reactivity were stable across the two ages; two regulatory behaviors (i.e., orientation to mother and avoidance) could be observed in the same percentage of babies at both 2 and 6 months. At 6 months, several significant associations between frustration reactivity and infant regulatory behaviors emerged. These findings suggest that the arm restraint procedure may be usefully employed to study individual differences in infants as young as 2 months of age.

  12. A 6-month large-scale study into the safety of tamsulosin

    PubMed Central

    Michel, M C; Bressel, H-U; Goepel, M; Rübben, H

    2001-01-01

    Aims Tamsulosin is an α1-adrenoceptor antagonist for the treatment of symptomatic benign prostatic hyperplasia with a tolerability similar to that of placebo in short-term, placebo-controlled studies with limited patient numbers. The present study was designed to test the safety of tamsulosin treatment in a large cohort of men during a prolonged period of time, particularly with regard to comedications. Methods A multicentre, open-label phase IIIb study with 1784 patients receiving 0.4 mg o.d. tamsulosin for 6 months was performed according to good clinical practice guidelines. The analysis was performed on an intention-to-treat basis and powered to detect adverse events (AE) occurring in 0.15% of patients with 95% confidence. Results During a total drug exposure time of 811 patient years, 386 AE were recorded in 253 patients (14.2%; 95% confidence intervals [CI] 12.0–15.2%). Twenty-nine patients suffered 44 serious AE including five fatal events (CI 0.12–0.73%) due to myocardial infarction (n = 3) and to pneumonia and a car accident (one each), but all deaths were judged to be unlikely to be related to study medication. The frequency of AE in patients without any comedication (n = 1095) was 13.0% (CI 11.3–14.9%). In a logistic regression analysis β-adrenoceptor blockers, converting enzyme inhibitors, antidiabetics and diuretics did not significantly affect the odds ratio for having AE. However, concomitant α-adrenoceptor antagonists (a protocol violation) and treatment with verapamil (which also has α-adrenoceptor antagonist activity) significantly enhanced the odds ratio for having AE to 3.87 (CI 1.52–9.85) and 3.17 (CI 1.52–6.58), respectively. Minor increases in the odds ratio, which did not reach statistical significance, were also observed for Ca2+ antagonists other than verapamil and for nitrates. Conclusions We conclude that tamsulosin has a good safety profile relative to AE rates in the placebo arms of previous studies on tamsulosin even in

  13. Short-burst oxygen therapy for COPD patients: a 6-month randomised, controlled study.

    PubMed

    Eaton, T; Fergusson, W; Kolbe, J; Lewis, C A; West, T

    2006-04-01

    Short-burst oxygen therapy (SBOT) remains widely advocated for patients with chronic obstructive pulmonary disease (COPD), despite a lack of supporting evidence. The aim of this randomised, double-blind, placebo-controlled, parallel group study was to determine whether SBOT improves health-related quality of life (HRQL) or reduces acute healthcare utilisation in patients discharged following an acute exacerbation of COPD. Consecutive patients were screened; 78 of 331 were eligible for randomisation to cylinder oxygen, cylinder air or usual care following discharge. Patients were elderly with high acute healthcare utilisation, forced expiratory volume in one second of <1 L and had dyspnoea limiting daily activity but were not hypoxaemic at rest. Over the 6-month study period, there were no significant differences between patient groups in HRQL (Chronic Respiratory Questionnaire (CRQ), 36-item Short-Form Health Survey, Hospital Anxiety and Depression Scale) except for CRQ emotion domain. There were no significant differences in acute healthcare utilisation. Time to readmission was greatest in the usual care group. Cylinder use was high initially, but rapidly fell to very low levels within weeks in both cylinder oxygen and air groups. In conclusion, the availability of short-burst oxygen therapy for chronic obstructive pulmonary disease patients discharged from hospital following an acute exacerbation did not improve health-related quality of life or reduce acute healthcare utilisation. These results provide no support for the widespread use of short-burst oxygen therapy.

  14. Studies of blood glucose and plasma insulin in "normal" women using mechanical contraception for 6 months.

    PubMed

    Spellacy, W N; Buhi, W C; Birk, S A

    1975-12-15

    A prospective study of carbohydrate metabolism was done with 56 "normal" women who were 4 to 11 weeks post partum. Each had a 3 hour oral glucose tolerance test performed before and after 6 months of using an intrauterine contraceptive device (IUCD). The results showed only slight changes in blood glucose and plasma insulin levels between the two tests. There were elevations of the fasting and 0.5 hour glucose values and the 2 hour plasma insulin value at the 6 month test. These data provide a further understanding of the changing metabolic parameters associated with pregnancy and they also give the "control" baseline information for comparison with other postpartum studies on the metabolic effects of contraceptive steriods.

  15. Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study.

    PubMed

    Triratana, Terdphong; Kraivaphan, Petcharat; Amornchat, Cholticha; Mateo, Luis R; Morrison, Boyce M; Dibart, Serge; Zhang, Yun-Po

    2015-04-01

    To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months. 135 subjects were enrolled in a single-center, double-blind, parallel group, randomized clinical study. Subjects were randomly assigned to one of three treatments: triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base; or fluoride dentifrice containing 450 ppm F as sodium fluoride, and 1,000 ppm F as sodium monofluorophosphate. Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months. After 6 months, subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4% and 48.9%, respectively. There were no statistically significant differences in gingival index and plaque index between subjects in the herbal/ bicarbonate group and those in the fluoride group. The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice, and this difference in efficacy was clinically meaningful.

  16. A phase IV, two-armed, randomized, cross-over study comparing compliance with once-a-month administration of vitamin D3 to compliance with daily administration of a fixed-dose combination of vitamin D3 and calcium during two 6-month periods.

    PubMed

    Bruyère, O; Deroisy, R; Dardenne, N; Cavalier, E; Coffiner, M; Da Silva, S; De Niet, S; Reginster, J-Y

    2015-12-01

    In a randomized, cross-over study, once monthly administration of vitamin D3 was preferred over a once daily administration of a fixed-dose combination of vitamin D3 and calcium, with a better compliance but without any significant difference in the increase in vitamin D levels. The aim of the present study was to compare a once-monthly administration of vitamin D3 to a daily administration of a fixed-dose combination of vitamin D3 and calcium during two treatment periods of 6 months. One hundred volunteers aged 50 years old or older were randomized to receive either one drinkable ampoule containing 25,000 IU vitamin D3 (D-Cure®, SMB) once monthly (group VD) or one chewable tablet containing 1000 mg calcium carbonate + 800 IU vitamin D3 (Steovit Forte®, Takeda) once daily (group VDCa) during 6 months. After the first 6 months of treatment, the groups were reversed according to the randomized cross-over design. Treatment compliance (i.e. the primary outcome), preference, acceptability and vitamin D levels and adverse events were all collected. For the two periods, the patients had a significantly higher compliance in the VD group than in the VDCa group (p < 0.0001). During the study, 50 (56.8 %) patients preferred the VD treatment, 16 (18.2 %) patients preferred the VDCa, and for 22 (25.0 %) patients, neither treatment was preferred. At the end of the first 6 months of treatment, the mean (SD) increase of 25(OH)D was 6.57 ng/mL (8.19) in the VD group and 3.88 ng/mL (10.0) in the VDCa group (p = 0.16 between groups). In this study, a once-monthly administration of vitamin D3 was preferred over a once-daily administration of a fixed-dose combination of vitamin D3 and calcium, with a better compliance but without any significant difference in the increase in vitamin D levels.

  17. Temperament, personality, and treatment outcome in major depression: a 6-month preliminary prospective study

    PubMed Central

    Kudo, Yuka; Nakagawa, Atsuo; Wake, Taisei; Ishikawa, Natsumi; Kurata, Chika; Nakahara, Mizuki; Nojima, Teruo; Mimura, Masaru

    2017-01-01

    Background Despite available treatments, major depression is a highly heterogeneous disorder, which leads to problems in classification and treatment specificity. Previous studies have reported that personality traits predict and influence the course and treatment response of depression. The Temperament and Personality Questionnaire (T&P) assesses eight major constructs of personality traits observed in those who develop depression. The aim of this study was to investigate the influence of T&P’s eight constructs on the treatment outcome of depressed patients. Patients and methods A preliminary 6-month prospective study was conducted with a sample of 51 adult patients with a diagnosis of major depressive disorder (MDD) without remarkable psychomotor disturbance using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. All patients received comprehensive assessment including the T&P at baseline. We compared each T&P construct score between patients who achieved remission and those who did not achieve remission after 6 months of treatment for depression using both subjective and objective measures. All 51 (100%) patients received the 6-month follow-up assessment. Results This study demonstrated that higher scores on T&P personal reserve predicted poorer treatment outcome in patients with MDD. Higher levels of personal reserve, rejection sensitivity, and self-criticism correlated with higher levels of depression. Higher levels of rejection sensitivity and self-criticism were associated with non-remitters; however, when we controlled for baseline depression severity, this relationship did not show significance. Conclusion Although the results are preliminary, this study suggests that high scores on T&P personal reserve predict poorer treatment outcome and T&P rejection sensitivity and self-criticism correlate with the severity of depression. Longer follow-up studies with large sample sizes are required to improve the understanding of these

  18. FDG-PET in Semantic Dementia after 6 Months of Memantine: an Open-Label Pilot Study

    PubMed Central

    Chow, Tiffany W.; Fam, David; Graff-Guerrero, Ariel; Verhoeff, Nicolaas P. G.; Tang-Wai, David F.; Masellis, Mario; Black, Sandra E.; Wilson, Alan A.; Houle, Sylvain; Pollock, Bruce G.

    2012-01-01

    Objectives To follow up on the increases we reported in normalized metabolic activity in salience network hubs from a 2-month open label study of memantine in frontotemporal dementia (FTD). Methods We repeated fluoro-deoxyglucose positron emission tomography (PET) after 6 months of drug use and subjected the data to an SPM analysis to reveal clusters of significant change from baseline. We also sought correlations between changes in behavioral disturbances on the Frontal Behavioral Inventory (FBI). Results Recruitment of one progressive nonfluent aphasia and one behavioral variant FTD precluded statistical analysis for any FTD subtype other than semantic dementia. The baseline-to-6-month interval showed increased normalized metabolic activity in the left orbitofrontal cortex (p<0.002) for 5 participants with semantic dementia. The 2–6 month interval revealed a late increase in normalized metabolic activity in the left insula (p<0.013), right insula (p<0.009), and left anterior cingulate (p<0.005). The right anterior cingulate showed both an initial increase and a delayed, further increase (2–6 month, p<0.016). FBI scores worsened by 43.3%. One participant with semantic dementia opted not to continue memantine beyond 2 months yet showed similar FDG-PET increases. Conclusions Increases in normalized cortical metabolic activity in salience network hubs were sustained in SD over a 6-month period. Since one participant without medication also showed these changes, further investigation is recommended through a double-blind, placebo-controlled study with FDG-PET as an outcome measure. PMID:22674572

  19. An open-label, 6-month study of allopurinol safety in gout: The LASSO study.

    PubMed

    Becker, Michael A; Fitz-Patrick, David; Choi, Hyon K; Dalbeth, Nicola; Storgard, Chris; Cravets, Matt; Baumgartner, Scott

    2015-10-01

    Allopurinol is the most widely prescribed serum uric acid-lowering therapy (ULT) in gout. To achieve serum uric acid (sUA) concentrations associated with clinical benefit, allopurinol is serially uptitrated with sUA monitoring. Suboptimal dosing is a key contributor to poor clinical outcomes, but few data are available on the safety and efficacy of dose-titrated allopurinol, particularly at doses > 300 mg/d. The objective of this open-label study was to investigate the safety and efficacy of allopurinol under conditions where investigators were encouraged to titrate to optimal, medically appropriate doses. Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO) was a large, 6-month, multicenter study of allopurinol (NCT01391325). Adults meeting American Rheumatism Association Criteria for Classification of Acute Arthritis of Primary Gout and ≥ 2 gout flares in the previous year were eligible. Investigators were encouraged (but not required) to titrate allopurinol doses to achieve target sUA < 6.0mg/dL. The primary objective was evaluation of the safety of dose-titrated allopurinol by clinical and laboratory examinations at monthly visits. Secondary objectives included sUA-lowering efficacy and gout flare frequency. Of 1735 patients enrolled, 1732 received ≥ 1 allopurinol doses. The maximal daily allopurinol dose during study was < 300 mg in 14.4%, 300 mg in 65.4%, and > 300 mg in 20.2% of patients; dosing duration was 115.5, 152.0, and 159.7 days, respectively. Overall, baseline demographic characteristics and comorbidity rates were similar across these three categories, but patients receiving > 300-mg maximal dose had more severe gout. Treatment-emergent adverse events possibly related to allopurinol occurred in 15.2%, 9.5%, and 11.4% of patients in the < 300-, 300-, and > 300-mg categories, respectively. Rash incidence was low (1.5%) and allopurinol hypersensitivity syndrome was not reported. No clinically meaningful changes occurred

  20. 6-month evaluation of JinHuang Chinese herbal medicine study in asymptomatic HIV infected Thais.

    PubMed

    Maek-a-nantawat, Wirach; Pitisuttithum, Punnee; Bussaratid, Valai; Chamnachanan, Supat; Naksrisook, Supa; Peonim, Wantanee; Thantamnu, Narumon; Muanaum, Rungrapat; Ngamdee, Vatcharachai

    2003-06-01

    Good results of in vitro study of anti-HIV effects of JinHuang, a Chinese herbal medicine led to in vivo study of safety and efficacy among asymptomatic HIV infected individuals. It was a prospective open study of 21 asymptomatic HIV infected Thai volunteers. Twelve and 9 were female and male, respectively, with mean age of 29.24 +/- 3.94 years. JinHuang preparation, 6 capsules and 2 bottles of liquid formula orally three times a day, was given on an outpatient basis initially for 6 months. Regular close monitoring and follow-up were done. The side effects reported included : increased bowel movements (81%), vague taste, and smell of drug after initiation (52%). No serious adverse event related to JinHuang was detected during study. No significant changes in terms of log viral load and CD4 count were observed after 6-months' duration. Most of the patients felt that the quality of life was better in terms of better appetite, good sleep and healthy during study participation, however, these were subjective.

  1. Effects of a 6-month exercise program on patients with multiple sclerosis: a randomized study.

    PubMed

    Romberg, A; Virtanen, A; Ruutiainen, J; Aunola, S; Karppi, S-L; Vaara, M; Surakka, J; Pohjolainen, T; Seppänen, A

    2004-12-14

    To improve walking and other aspects of physical function with a progressive 6-month exercise program in patients with multiple sclerosis (MS). MS patients with mild to moderate disability (Expanded Disability Status Scale scores 1.0 to 5.5) were randomly assigned to an exercise or control group. The intervention consisted of strength and aerobic training initiated during 3-week inpatient rehabilitation and continued for 23 weeks at home. The groups were evaluated at baseline and at 6 months. The primary outcome was walking speed, measured by 7.62 m and 500 m walk tests. Secondary outcomes included lower extremity strength, upper extremity endurance and dexterity, peak oxygen uptake, and static balance. An intention-to-treat analysis was used. Ninety-one (96%) of the 95 patients entering the study completed it. Change between groups was significant in the 7.62 m (p = 0.04) and 500 m walk tests (p = 0.01). In the 7.62 m walk test, 22% of the exercising patients showed clinically meaningful improvements. The exercise group also showed increased upper extremity endurance as compared to controls. No other noteworthy exercise-induced changes were observed. Exercise adherence varied considerably among the exercisers. Walking speed improved in this randomized study. The results confirm that exercise is safe for multiple sclerosis patients and should be recommended for those with mild to moderate disability.

  2. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study

    PubMed Central

    Duhon, Bradley S; Cher, Daniel J; Wine, Kathryn D; Lockstadt, Harry; Kovalsky, Don; Soo, Cheng-Lun

    2013-01-01

    Background Sacroiliac (SI) joint pain is an often overlooked cause of low back pain. SI joint arthrodesis has been reported to relieve pain and improve quality of life in patients suffering from degeneration or disruption of the SI joint who have failed non-surgical care. We report herein early results of a multicenter prospective single-arm cohort of patients with SI joint degeneration or disruption who underwent minimally invasive fusion using the iFuse Implant System®. Methods The safety cohort includes 94 subjects at 23 sites with chronic SI joint pain who met study eligibility criteria and underwent minimally invasive SI joint fusion with the iFuse Implant System® between August 2012 and September 2013. Subjects underwent structured assessments preoperatively, immediately postoperatively, and at 1, 3, and 6 months postoperatively, including SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQoL-5D (EQ-5D). Patient satisfaction with surgery was assessed at 6 months. The effectiveness cohort includes the 32 subjects who have had 6-month follow-up to date. Results Mean subject age was 51 years (n=94, safety cohort) and 66% of patients were women. Subjects were highly debilitated at baseline (mean VAS pain score 78, mean ODI score 54). Three implants were used in 80% of patients; two patients underwent staged bilateral implants. Twenty-three adverse events occurred within 1 month of surgery and 29 additional events occurred between 30 days and latest follow-up. Six adverse events were severe but none were device-related. Complete 6-month postoperative follow-up was available in 26 subjects. In the effectiveness cohort, mean (± standard deviation) SI joint pain improved from a baseline score of 76 (±16.2) to a 6-month score of 29.3 (±23.3, an improvement of 49 points, P<0.0001), mean ODI improved from 55.3 (±10.7) to 38.9 (±18.5, an improvement of 15.8 points, P<0.0001) and SF-36 PCS improved

  3. Preliminary 6 month results from the Argus II epiretinal prosthesis feasibility study.

    PubMed

    Humayun, Mark S; Dorn, Jessy D; Ahuja, Ashish K; Caspi, Avi; Filley, Eugene; Dagnelie, Gislin; Salzmann, Joël; Santos, Arturo; Duncan, Jacque; daCruz, Lyndon; Mohand-Said, Saddek; Eliott, Dean; McMahon, Matthew J; Greenberg, Robert J

    2009-01-01

    The Argus II 60 channel epiretinal prosthesis has been developed in order to provide partial restoration of vision to subjects blinded from outer retinal degenerative disease. To date the device has been implanted in 21 subjects as part of a feasibility study. In 6 month post-implantation door finding and line tracking orientation and mobility testing, subjects have shown improvements of 86% and 73%, respectively, for system on vs. system off. In high-contrast Square Localization tests using a touch screen monitor 87% of tested subjects performed significantly better with the system on compared with off. These preliminary results show that the Argus II system provides some functional vision to blind subjects.

  4. Tinzaparin in cancer associated thrombosis beyond 6months: TiCAT study.

    PubMed

    Jara-Palomares, Luis; Solier-Lopez, Aurora; Elias-Hernandez, Teresa; Asensio-Cruz, Maribel; Blasco-Esquivias, Isabel; Marin-Barrera, Lucia; de la Borbolla-Artacho, Maria Rodriguez; Praena-Fernandez, Juan Manuel; Montero-Romero, Emilio; Navarro-Herrero, Silvia; Serrano-Gotarredona, Maria Pilar; Sánchez-Díaz, José María; Palacios, Carlos; Otero, Remedios

    2017-09-01

    The safety and efficacy of low-molecular-weight heparin (LMWH) treatment in patients with cancer-associated thrombosis (CAT) beyond 6months are unknown. Our aim was to determine the safety of long-term tinzaparin use in patients with CAT. We performed a prospective, open, single arm, multicentre study in patients with CAT receiving treatment with tinzaparin. We evaluated the rate of clinically relevant bleeding events (major and non-major clinically relevant bleeding) and venous thromboembolism (VTE) recurrence. A total of 247 patients were recruited, with a crude incidence of major bleeding of 4.9% (12/247). The rate of clinically relevant bleeding during months 1-6 and 7-12, was 0.9% [95% confidence interval (95% CI) 0.5 to 1.6%] and 0.6% (95% CI 0.2 to 1.4%) (p=0.5) per patient and month, respectively. Male gender showed greater risk for clinically relevant bleeding with a hazard ratio (HR) of 2.97 (95% CI 1.01 to 8.1; p=0.02). The incidence of VTE recurrence at months 1-6 and 7-12 was 4.5% (95% CI 2.2 to 7.8%) and 1.1% (95% CI 0.1 to 3.9%), respectively. One patient died due to VTE recurrence and two because of severe bleeding. Treatment with tinzaparin beyond 6months is safe in patients with CAT. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  5. What Searches Do Users Run on PEDro? An Analysis of 893,971 Search Commands Over a 6-Month Period.

    PubMed

    Stevens, Matthew L; Moseley, Anne; Elkins, Mark R; Lin, Christine C-W; Maher, Chris G

    2016-08-05

    Clinicians must be able to search effectively for relevant research if they are to provide evidence-based healthcare. It is therefore relevant to consider how users search databases of evidence in healthcare, including what information users look for and what search strategies they employ. To date such analyses have been restricted to the PubMed database. Although the Physiotherapy Evidence Database (PEDro) is searched millions of times each year, no studies have investigated how users search PEDro. To assess the content and quality of searches conducted on PEDro. Searches conducted on the PEDro website over 6 months were downloaded and the 'get' commands and page-views extracted. The following data were tabulated: the 25 most common searches; the number of search terms used; the frequency of use of simple and advanced searches, including the use of each advanced search field; and the frequency of use of various search strategies. Between August 2014 and January 2015, 893,971 search commands were entered on PEDro. Fewer than 18 % of these searches used the advanced search features of PEDro. 'Musculoskeletal' was the most common subdiscipline searched, while 'low back pain' was the most common individual search. Around 20 % of all searches contained errors. PEDro is a commonly used evidence resource, but searching appears to be sub-optimal in many cases. The effectiveness of searches conducted by users needs to improve, which could be facilitated by methods such as targeted training and amending the search interface.

  6. Color Stability of Teeth Restored with Biodentine: A 6-month In Vitro Study.

    PubMed

    Vallés, Marta; Roig, Miguel; Duran-Sindreu, Fernando; Martínez, Syani; Mercadé, Montserrat

    2015-07-01

    White mineral trioxide aggregate (WMTA) has been reported to cause dental discoloration. A previous study on the color stability of 5 calcium silicate-based materials investigated the color stability of Biodentine (Septodont, Saint-Maur-des-Fossés, France) in different experimental environments; however, no data are available on the color stability of teeth restored with Biodentine. In this study, we assessed the color stability under artificial light of ex vivo human teeth restored coronally with WMTA or Biodentine. Cavities were prepared on coronal tooth specimens and restored with WMTA + composite (n = 16), Biodentine + composite (n = 16), or composite alone (control, n = 3). Color was assessed spectrophotometrically at 6 time points (initial, 1 week, 2 weeks, 1 month, 3 months, and 6 months), and color difference values were calculated. Statistical analysis was performed using analysis of variance and the Fisher least significant difference test for which P < .05 was considered statistically significant. The WMTA group showed discoloration at 1 week, which increased over time. The Biodentine and control groups showed color stability and were not significantly different from one another. Teeth treated with WMTA exhibited discoloration, whereas those treated with Biodentine maintained color stability throughout the study. However, further in vivo studies are necessary to corroborate these results. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. Benefits of Diabetes Self-Management for Health Plan Members: A 6-Month Translation Study

    PubMed Central

    Lorig, Kate; Turner, Ralph M; English, Kathleen; Laurent, Diana D; Greenberg, Jay

    2016-01-01

    Background Diabetes self-management education has been shown to be effective in controlled trials. However, few programs that meet American Association of Diabetes Educators standards have been translated into widespread practice. Objective This study examined the translation of the evidence-based Better Choices, Better Health-Diabetes program in both Internet and face-to-face versions. Methods We administered the Internet program nationally in the United States (n=1010). We conducted face-to-face workshops in Atlanta, Georgia; Indianapolis, Indiana; and St. Louis, Missouri (n=232). Self-report questionnaires collected health indicator, health behavior, and health care utilization measures. Questionnaires were administered on the Web or by mail. We determined hemoglobin A1c (HbA1c) from blood samples collected via mailed kits. Paired t tests determined whether changes between baseline and 6 months differed significantly from no change. Subgroup analyses determined whether participants with specific conditions benefited (high HbA1c, depression, hypoglycemia, nonadherence to medication taking, and no aerobic exercise). We calculated the percentage of participants with improvements of at least 0.4 effect size in at least one of the 5 above measures. Results Of the 1242 participants, 884 provided 6-month follow-up questionnaires. There were statistically significant improvements in 6 of 7 health indicators (including HbA1c) and in 7 of 7 behaviors. For each of the 5 conditions, there were significant improvements among those with the condition (effect sizes 0.59–1.1). A total of 662 (75.0%) of study participants improved at least 0.4 effect size in at least one criterion, and 327 (37.1%) improved in 2 or more. Conclusions The Diabetes Self-Management Program, offered in two modes, was successfully disseminated to a heterogeneous national population of members of either insured or administered health plans. Participants had small but significant benefits in multiple

  8. Individual experiences following a 6-month exercise intervention: A qualitative study

    PubMed Central

    Kerkelä, Ellen Staveborg; Jonsson, Linus; Lindwall, Magnus; Strand, Jennifer

    2015-01-01

    Purpose Dropout is a common problem in various exercise interventions. The individual's experience is believed to greatly impact dropout, yet little is known about the individual experiences of taking part in exercise interventions. The aim of this study was to examine individuals’ experiences following a self-determination theory–based exercise intervention in order to gain understanding of how standardized interventions can be adjusted to fit individuals’ specific needs, capacities, and circumstances. Methods A qualitative approach with semi-structured interviews was conducted with eight informants (three male and five female) aged between 26 and 47 years, whom all had participated in a 6-month exercise intervention with individual coaching based on self-determination theory and motivational interviewing. The interviews were analyzed thematically with an inductive approach. Results Aspects that influenced the informants’ motivation and participation in the exercise intervention were linked to three themes: the frames of the intervention, measurable changes, and the individual's context. The themes present information about the process and to what extent the informants felt that the intervention was adapted to fit their lives and needs. Conclusions This study emphasizes the importance of individualizing exercise interventions to support individuals’ diverse capacities and psychological needs. PMID:26282865

  9. Developmentally Delayed Male with Mincer Blade Obstructing the Oesophagus for a Period of Time Suspected to Be 6 Months

    PubMed Central

    Grønhøj Larsen, Christian; Charabi, Birgitte

    2015-01-01

    Introduction. Sharp, retained foreign bodies in the oesophagus are associated with severe complications. Developmentally delayed patients are especially subject to foreign objects. We describe a 37-year-old, developmentally delayed male with a mincer blade obstructing the oesophagus. Six months prior to surgical intervention, the patient was hospitalized in a condition of sepsis and pneumonia where the thoracic X-ray reveals a foreign body in the proximal oesophagus. When rehospitalized 6 months later, a mincer blade of the type used in immersion blenders was surgically removed. During these 6 months the patient's main symptoms were dysphagia, weight loss, and diarrhoea. When developmentally delayed patients present with dysphagia, we strongly encourage the awareness of the possible presence of foreign bodies. To our knowledge this is the first reported case of a mincer blade in the oesophagus. PMID:26236532

  10. A cohort study of developmental polychlorinated biphenyl (PCB) exposure in relation to post-vaccination antibody response at 6-months of age

    SciTech Connect

    Jusko, Todd A.; De Roos, Anneclaire J.; Schwartz, Stephen M.; Paige Lawrence, B.; Palkovicova, Lubica; Nemessanyi, Tomas; Drobna, Beata; Fabisikova, Anna; Kocan, Anton; Sonneborn, Dean; Jahnova, Eva; Kavanagh, Terrance J.; Trnovec, Tomas; Hertz-Picciotto, Irva

    2010-05-15

    Background: Extensive experimental data in animals indicate that exposure to polychlorinated biphenyls (PCBs) during pregnancy leads to changes in offspring immune function during the postnatal period. Whether developmental PCB exposure influences immunologic development in humans has received little study. Methods: The study population was 384 mother-infant pairs recruited from two districts of eastern Slovakia for whom prospectively collected maternal, cord, and 6-month infant blood specimens were available. Several PCB congeners were measured in maternal, cord, and 6-month infant sera by high-resolution gas chromatography with electron capture detection. Concentrations of IgG-specific anti-haemophilus influenzae type b, tetanus toxoid, and diphtheria toxoid were assayed in 6-month infant sera using ELISA methods. Multiple linear regression was used to estimate the relation between maternal, cord, and 6-month infant PCB concentrations and the antibody concentrations evaluated at 6-months of age. Results: Overall, there was little evidence of an association between infant antibody concentrations and PCB measures during the pre- and early postnatal period. In addition, our results did not show specificity in terms of associations limited to a particular developmental period (e.g. pre- vs. postnatal), a particular antibody, or a particular PCB congener. Conclusions: At the PCB concentrations measured in this cohort, which are high relative to most human populations today, we did not detect an association between maternal or early postnatal PCB exposure and specific antibody responses at 6-months of age.

  11. A cohort study of developmental polychlorinated biphenyl (PCB) exposure in relation to post-vaccination antibody response at 6-months of age

    PubMed Central

    Jusko, Todd A.; De Roos, Anneclaire J.; Schwartz, Stephen M.; Lawrence, B. Paige; Palkovicova, Lubica; Nemessanyi, Tomas; Drobna, Beata; Fabisikova, Anna; Kocan, Anton; Sonneborn, Dean; Jahnova, Eva; Kavanagh, Terrance J.; Trnovec, Tomas; Hertz-Picciotto, Irva

    2010-01-01

    Background Extensive experimental data in animals indicate that exposure to polychlorinated biphenyls (PCBs) during pregnancy leads to changes in offspring immune function during the postnatal period. Whether developmental PCB exposure influences immunologic development in humans has received little study. Methods The study population was 384 mother-infant pairs recruited from two districts of eastern Slovakia for whom prospectively collected maternal, cord, and 6-month infant blood specimens were available. Several PCB congeners were measured in maternal, cord, and 6-month infant sera by high-resolution gas chromatography with electron capture detection. Concentrations of IgG-specific anti-haemophilus influenzae type b, tetanus toxoid, and diphtheria toxoid were assayed in 6-month infant sera using ELISA methods. Multiple linear regression was used to estimate the relation between maternal, cord, and 6-month infant PCB concentrations and the antibody concentrations evaluated at 6-months of age. Results Overall, there was little evidence of an association between infant antibody concentrations and PCB measures during the pre- and early postnatal period. In addition, our results did not show specificity in terms of associations limited to a particular developmental period (e.g. pre- vs. postnatal), a particular antibody, or a particular PCB congener. Conclusions At the PCB concentrations measured in this cohort, which are high relative to most human populations today, we did not detect an association between maternal or early postnatal PCB exposure and specific antibody responses at 6-months of age. PMID:20378105

  12. Development of Computer-Aided Cognitive Training Program for Elderly and Its Effectiveness through a 6 Months Group Intervention Study.

    PubMed

    Otsuka, Tsunehiro; Tanemura, Rumi; Noda, Kazue; Nagao, Toru; Sakai, Hiroshi; Luo, Zhi-Wei

    2015-01-01

    Since the increasing population of aging, cognitive training is focused as one of the non-pharmacological preventive approach of cognitive decline. Although the accumulation of the knowledge, they hardly reflect to the programs for clinical use. We developed a task set named "Atama-no-dojo," designed to activate multiple cognitive functions and enhance motivational incentives. The objective of our study is to confirm the effect of our program through a 6 months group intervention program. The intervention program conducted in a day service center for 6 months in the duration of 45 minutes per day, 4 days per month for a total of 25 sessions. Participants worked to the tasks on the screen all together with filling in the answering sheet. Neuropsychological tests, SF36 and GDS were assessed at pre-/post-intervention periods. Participants filled in a questionnaire about impression to the program at the last training session. Fourteen women (82.2 ± 2.9 years old) were analyzed and significant changes were found in the improvement of memory, attention, inhibition, GDS and some items of SF36. All participants recognized the program as fun and wanted to continue. Some of the participants' positive impressions to the program correlated to cognitive improvement. The improved cognitive functions by 6 months intervention of "Atama-no-dojo" were mainly related to prefrontal cortex and the motivational incentives seemed supported the effect of task contents. We recognized the importance of task difficulty setting and motivational incentives to reduce frustration from working on difficult tasks and enhance the effects of improvement from activating brain function.

  13. Safety and efficacy of oral slow release morphine for maintenance treatment in heroin addicts: a 6-month open noncomparative study.

    PubMed

    Vasilev, Georgi N; Alexieva, Daniela Z; Pavlova, Rositsa Z

    2006-01-01

    This open-label, noncomparative, single-center trial evaluated the safety and efficacy of once-daily treatment with slow release oral morphine (SROM) capsules for the maintenance treatment of 20 outpatients with heroin dependency over 6 months at the National Institute for Addictions in Sofia, Bulgaria. Doses were individually titrated up to a mean daily maintenance dose of 760 mg (range 440-1,200 mg). SROM was effective in significantly reducing the signs and symptoms of opioid withdrawal and craving for heroin, with stabilization generally evident within two weeks. Nineteen patients completed 6 months of treatment and illicit opioid use was virtually eliminated. One patient withdrew voluntarily at 22 weeks. Validated questionnaires and tests indicated improvements in patients' well-being from baseline assessments. These included significant improvements with regard to suicidal depression (85%), anxiety and dysphoria (66%), general illness (58%), social dysfunction (54%), sense of hopelessness (34%), attention (25%), and self-reported typical depressive (27%) and disease-related (11%) symptoms. No deaths, serious adverse events, or withdrawals due to adverse events occurred. Five episodes of constipation and one episode of sweating (all nonserious and of mild or moderate severity) were reported. Vital signs were unaffected by SROM and no weight change was evident over the study period. The observations made in this study indicate a promising role for once-daily treatment with SROM in the clinical management of heroin dependency. Copyright 2006 S. Karger AG, Basel.

  14. The use of Straumann Bone Ceramic in a maxillary sinus floor elevation procedure: a clinical, radiological, histological and histomorphometric evaluation with a 6-month healing period.

    PubMed

    Frenken, J W F H; Bouwman, W F; Bravenboer, N; Zijderveld, S A; Schulten, E A J M; ten Bruggenkate, C M

    2010-02-01

    In this study, we evaluated the quality and quantity of bone formation in maxillary sinus floor elevation procedure using a new fully synthetic biphasic calcium phosphate (BCP) consisting of a mixture of 60% hydroxyapatite and 40% of beta-tricalcium phosphate (Straumann Bone Ceramic). A unilateral maxillary sinus floor elevation procedure was performed in six patients using 100% BCP. Biopsy retrieval for histological and histomorphometric analysis was carried out before implant placement after a 6-month healing period. In this study, the maxillary sinus floor elevation procedure with the use of BCP showed uneventful healing. Radiological evaluation after 6 months showed maintenance of vertical height gained immediately after surgery. Primary stability was achieved with all Straumann SLA dental implants of 4.1 mm diameter and 10 or 12 mm length. The implants appeared to be osseointegrated well after a 3-month healing period. Histological investigation showed no signs of inflammation. Cranial from the native alveolar bone, newly formed mineralized tissue was observed. Also, osteoid islands as well as connective tissue were seen around the BCP particles, cranial from the front of newly formed mineralized tissue. Close bone-to-substitute contact was observed. Histomorphometric analysis showed an average bone volume/total volume (BV/TV) of 27.3% [standard deviation (SD) 4.9], bone surface/total volume (BS/TV) 4.5 mm(2)/mm(3) (SD 1.1), trabecula-thickness (TbTh) 132.1 mum (SD 38.4), osteoid-volume/bone volume (OV/BV) 7.5% (SD 4.3), osteoid surface/bone surface (OS/BS) 41.3% (SD 28.5), osteoid thickness (O.Th) 13.3 mum (SD 4.7) and number of osteoclasts/total area (N.Oc/Tar) 4.4 1/mm (SD 5.7). Although a small number of patients were treated, this study provides radiological and histological evidence in humans confirming the suitability of this new BCP for vertical augmentation of the atrophied maxilla by means of a maxillary sinus floor elevation procedure allowing

  15. Correlates of self-report chronic insomnia disorders with 1-6 month and 6-month durations in home-dwelling urban older adults - the Shih-Pai Sleep Study in Taiwan: a cross-sectional community study.

    PubMed

    Chiou, Jing-Hui; Chen, Hsi-Chung; Chen, Kuang-Hung; Chou, Pesus

    2016-06-03

    To examine the correlates of insomnia disorder with different durations in home-dwelling older adults. A cross-sectional survey in the Shih-Pai area of Taipei City, Taiwan (The Shih-Pai Sleep Study). A total 4047 subjects over the age of 65 years completed the study (2259 men and 1788 women). The Pittsburgh Sleep Quality Index and the duration of insomnia symptoms were used to identify DSM-IV 1-6 month and 6-month insomnia disorders. The prevalence of DSM-IV defined insomnia disorder was 5.8 %; two-thirds of these case lasted for ≥6 months. The shared correlates for both 1-6 and 6-month insomnia disorders were gender (women), depression and moderate pain. Pulmonary diseases were exclusively associated with 1-6 month insomnia disorder (OR: 2.57, 95 % CI: 1.46-4.52). In contrast, heart disease (OR: 1.73, 95 % CI: 1.21-2.49) and severe pain (OR: 2.34, 95 % CI: 1.14-4.40) were associated with 6-month insomnia disorder. The prevalence of persistent insomnia disorder is higher than short-term insomnia disorder. Correlates for less persistent and more persistent insomnia disorder appears to be partially different. Duration quantifiers may be important in the identification of the etiology of insomnia and further studies with follow-ups are needed to examine the order of developing insomnia disorder and associated conditions.

  16. Exclusive or Partial Breastfeeding for 6 Months Is Associated With Reduced Milk Sensitization and Risk of Eczema in Early Childhood: The PATCH Birth Cohort Study.

    PubMed

    Chiu, Chih-Yung; Liao, Sui-Ling; Su, Kuan-Wen; Tsai, Ming-Han; Hua, Man-Chin; Lai, Shen-Hao; Chen, Li-Chen; Yao, Tsung-Chieh; Yeh, Kuo-Wei; Huang, Jing-Long

    2016-04-01

    There is insufficient evidence to confirm the association between breastfeeding and allergic outcomes later in life. This study aimed to determine the relationships between different breastfeeding patterns and allergen sensitizations and risk of developing atopic diseases in early childhood. A total of 186 children from a birth cohort in the Prediction of Allergies in Taiwanese Children study for a 4-year follow-up period were enrolled. Total serum immunoglobulin E (IgE) levels and specific IgE antibodies against food and inhalant allergens were measured sequentially at 6 months as well as at 1, 1.5, 2, 3, and 4 years of age. A significantly lower prevalence of milk sensitization was found in children at ages 1 and 1.5 years who were exclusively or partially breastfed for ≥6 months. Breastfeeding ≥6 months was significantly associated with a reduced risk of developing eczema but not allergic rhinitis and asthma at ages 1 and 2 years. Compared with exclusive breastfeeding ≥6 months, partial breastfeeding <6 months was significantly associated with an increased risk of developing eczema at ages 1 and 2 years. As with exclusive breastfeeding, partial breastfeeding for at least 6 months appears to be associated with a reduced prevalence of milk sensitization as well as a reduced risk of developing eczema in early childhood.

  17. Triptorelin embonate (6-month formulation).

    PubMed

    Keating, Gillian M

    2010-02-12

    A 6-month formulation of the gonadotropin-releasing hormone agonist triptorelin embonate (designed to deliver 22.5 mg of triptorelin over a 6-month period) has been developed for use in the treatment of advanced prostate cancer. Following intramuscular administration of the 6-month formulation of triptorelin embonate 22.5 mg to men with advanced prostate cancer (subset of 15 patients from the pivotal clinical trial), serum testosterone levels initially increased, followed by a rapid, sustained decrease. Castrate serum testosterone levels (i.e. < or =1.735 nmol/L) were achieved in a geometric mean time of 18.8 days. The 6-month formulation of triptorelin embonate achieved and maintained castrate serum testosterone levels in patients with advanced prostate cancer (n = 120), according to the results of the pivotal, noncomparative, multicentre trial (patients received intramuscular triptorelin embonate 22.5 mg on day 1 and at month 6 [week 24]). By day 29, 97.5% of patients had castrate serum testosterone levels. Castrate serum testosterone levels were maintained from months 2 to 12 in 93.0% of patients. Prior to the second injection at month 6, 98.3% of patients had castrate serum testosterone levels, and 98.3% of patients had castrate serum testosterone levels at study completion. The 6-month formulation of triptorelin embonate 22.5 mg was generally well tolerated in patients with advanced prostate cancer; adverse events were of mild severity in the majority of patients. Drug-related adverse events (e.g. hot flushes) were consistent with the pharmacological action of triptorelin. Injection-site reactions occurred in 6.7% of triptorelin embonate recipients.

  18. 6-Month Clinical and Angiographic Outcomes of a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold: The FANTOM II Study.

    PubMed

    Abizaid, Alexandre; Carrié, Didier; Frey, Norbert; Lutz, Matthias; Weber-Albers, Joachim; Dudek, Darius; Chevalier, Bernard; Weng, Shu-Chuan; Costa, Ricardo A; Anderson, Jeffrey; Stone, Gregg W

    2017-09-25

    The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months. The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment. The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%). The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease. Copyright © 2017. Published by Elsevier Inc.

  19. Delirium in the Emergency Department and Its Extension into Hospitalization (DELINEATE) Study: Effect on 6-month Function and Cognition.

    PubMed

    Han, Jin H; Vasilevskis, Eduard E; Chandrasekhar, Rameela; Liu, Xulei; Schnelle, John F; Dittus, Robert S; Ely, E Wesley

    2017-06-01

    The natural course and clinical significance of delirium in the emergency department (ED) is unclear. We sought to (1) describe the extent to which delirium in the ED persists into hospitalization (ED delirium duration) and (2) determine how ED delirium duration is associated with 6-month functional status and cognition. Prospective cohort study. Tertiary care, academic medical center. ED patients ≥65 years old who were admitted to the hospital. The modified Brief Confusion Assessment Method was used to ascertain delirium in the ED and hospital. Premorbid and 6-month function were determined using the Older American Resources and Services Activities of Daily Living (OARS ADL) questionnaire which ranged from 0 (completely dependent) to 28 (completely dependent). Premorbid and 6-month cognition were determined using the short form Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) which ranged from 1 to 5 (severe dementia). Multiple linear regression was performed to determine if ED delirium duration was associated with 6-month function and cognition adjusted for baseline OARS ADL and IQCODE, and other confounders. A total of 228 older ED patients were enrolled. Of the 105 patients who were delirious in the ED, 81 (77.1%) patients' delirium persisted into hospitalization. For every ED delirium duration day, the 6-month OARS ADL decreased by 0.63 points (95% CI: -1.01 to -0.24), indicating poorer function. For every ED delirium duration day, the 6-month IQCODE increased 0.06 points (95% CI: 0.01-0.10) indicating poorer cognition. Delirium in the ED is not a transient event and frequently persists into hospitalization. Longer ED delirium duration is associated with an incremental worsening of 6-month functional and cognitive outcomes. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  20. Does exercise intensity affect blood pressure and heart rate in obese adolescents? A 6-month multidisciplinary randomized intervention study.

    PubMed

    Farah, B Q; Ritti-Dias, R M; Balagopal, P B; Hill, J O; Prado, W L

    2014-04-01

    Aerobic exercise improves cardiovascular health in general, but whether the impact varies with exercise intensity is not clear. The aim of the current study was to compare the effects of a high-intensity aerobic exercise training (HIT) vs. a low-intensity aerobic exercise training (LIT) on blood pressure (BP), heart rate (HR) and heart rate variability (HRV) in obese adolescents. Forty-three (13-18 years) Tanner stage (III-IV) matched obese adolescents were studied in a randomized trial of either HIT (corresponding to the ventilatory threshold I; n = 20) or LIT (corresponding to 20% below the ventilatory threshold I; n = 23) programme for a period of 6 months. All participants also received a multidisciplinary therapy that included nutritional, psychological and clinical counselling. Both HIT and LIT sessions were isocaloric, with energy expenditure set at 350 kcal. BP, HR and HRV were measured along with markers of body adiposity and insulin resistance before and after the respective interventions. The participants in both groups had similar physical and clinical characteristics. After the 6-month intervention, systolic, diastolic and mean BP decreased (P < 0.05, for all) similarly in both groups, whereas waist circumference, HR and HRV showed beneficial changes only in the HIT group (P < 0.05). Aerobic exercise training set at a high intensity compared with the low intensity appears to have additional benefits on abdominal obesity and cardiovascular health in that it enhances the parasympathetic and autonomic modulation of the heart in obese adolescents. © 2013 The Authors. Pediatric Obesity © 2013 International Association for the Study of Obesity.

  1. Perceived family functioning, adolescent psychopathology and quality of life in the general population: a 6-month follow-up study.

    PubMed

    Jozefiak, Thomas; Wallander, Jan L

    2016-04-01

    The aim of the study was to investigate whether perceived family functioning of adolescent is moderating or mediating the longitudinal association of adolescent internalizing and externalizing psychopathology with quality of life (QoL) after 6 months in the general population. Using a cluster sampling technique in one Norwegian county 1331, 10- to 16-year-old students were included in the study (51 % girls). Parents completed the Child Behavior Checklist for the assessment of adolescent psychopathology at Time 1. The students completed the General Functioning Scale of the McMaster Family Assessment Device and the Inventory of Life Quality in Children and Adolescents at time 2 6 months later. Psychopathology, family functioning and QoL were treated as latent variables in a structural equation model adjusted for sex, age and parent education. The regression coefficients for paths from psychopathology decreased (β = .199 for the internalizing and β = .102 for the externalizing model) in each case when including the indirect path via family functioning compared with the direct path from psychopathology to QoL. The sum of indirect effects on QoL via family functioning was significant for internalizing β = 0.093 (95 % CI 0.054-0.133) and externalizing β = 0.119 (95 % CI 0.076-0.162) psychopathology. Family functioning significantly mediated the longitudinal association between psychopathology and QoL. Because the family remains an important social domain for adolescents, it must be an important consideration when attempting to reduce or alleviate psychopathology in youth and improve the quality of their life experience throughout this period.

  2. Effects of Acetylcholinesterase Inhibitors on Nutritional Status in Elderly Patients with Dementia: A 6-month Follow-up Study.

    PubMed

    Soysal, P; Isik, A T

    2016-04-01

    Nutritional status is one of the factors that affects disease progression, morbidity and mortality in elderly patients with dementia. The present study aimed to evaluate the effect of acetylcholinesterase inhibitor (AchEI) therapy on nutritional status and food intake in the elderly. Newly diagnosed patients with dementia, who underwent comprehensive geriatric assessment (CGA) and were followed at regular intervals, were retrospectively evaluated. A total of 116 patients, who began to receive AchEI therapy and completed 6-month follow-up period under this treatment, were enrolled in the study. Socio-demographic characteristics and data on comorbidity, polypharmacy, cognitive function, depression, activities of daily living and nutritional status (weight, Body Mass Index (BMI), Mini Nutritional Assessment (MNA)-Short Form) were recorded. The mean age of the patients was 78.0±8.9 years. There was no significant difference between baseline and 6-month BMI, weight and MNA scores of dementia patients who received AchEI therapy (p>0.05). With regard to the relation between changes in BMI, weight and MNA on the 6th month versus baseline, and donepezil, rivastigmine and galantamine therapies, no difference was determined (p>0.05). However, no worsening in food intake was observed (kappa: 0.377). When the effects of each AchEI on food intake were compared, food intake in rivastigmine treated patients was not decreased as much as it was in galantamine or donepezil treated patients (p<0.05). AchEI therapy has no unfavorable effect on nutritional status or weight in elderly patients with different types of dementia, but it seems that food intake is better in those treated by rivastigmine patch.

  3. A 6-Month Assessment of Sleep During Naval Deployment: A Case Study of a Commanding Officer

    DTIC Science & Technology

    2015-05-01

    duration. However, sleep patterns over an extended p riod of time have not been objectively measured. CASE REPORT: This 6-mo study used actigraphy...Association AEROSPACE MEDICINE AND HUMAN PERFORMANCE Vol. 86, No. 5 May 2015 481 C A S E R E P O R T Sleep deprivation is a well-recognized problem in...the naval environment. 10 However, the objective assessment of sleep patterns in operational environments, especially for long periods of time, poses

  4. Remineralization of demineralized bone matrix in critical size cranial defects in rats: A 6-month follow-up study.

    PubMed

    Horváthy, Dénes B; Vácz, Gabriella; Toró, Ildikó; Szabó, Tamás; May, Zoltán; Duarte, Miguel; Hornyák, István; Szabó, Bence T; Dobó-Nagy, Csaba; Doros, Attila; Lacza, Zsombor

    2016-10-01

    The key drawback of using demineralized bone matrix (DBM) is its low initial mechanical stability due to the severe depletion of mineral content. In the present study, we investigated the long-term regeneration of DBM in a critical size bone defect model and investigated the remineralization after 6 months. Bone defects were created in the cranium of male Wistar rats which were filled with DBM or left empty as negative control. In vivo bone formation was monitored with computed tomography after 11, 19, and 26 weeks postoperatively. After 6 months, parietal bones were subjected to micro-CT. Mineral content was determined with spectrophotometric analysis. After 11 weeks the DBM-filled bone defects were completely closed, while empty defects were still open. Density of the DBM-treated group increased significantly while the controls remained unchanged. Quantitative analysis by micro-CT confirmed the in vivo results, bone volume/tissue volume was significantly lower in the controls than in the DBM group. The demineralization procedure depleted the key minerals of the bone to a very low level. Six months after implantation Ca, P, Na, Mg, Zn, and Cr contents were completely restored to the normal level, while K, Sr, and Mn were only partially restored. The remineralization process of DBM is largely complete by the 6th month after implantation in terms of bone density, structure, and key mineral levels. Although DBM does not provide sufficient sources for any of these minerals, it induces a faster and more complete regeneration process. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1336-1342, 2016.

  5. [Efficacy and safety of a single intra-articular injection of 2% hyaluronic acid plus mannitol in knee osteoarthritis over a 6-month period].

    PubMed

    Borrás-Verdera, A; Calcedo-Bernal, V; Ojeda-Levenfeld, J; Clavel-Sainz, C

    2012-01-01

    To evaluate the safety and efficacy of a single intra-articular injection of 2% hyaluronic acid (HA)+mannitol in symptomatic knee osteoarthritis (KOA). Pilot, multicentre, open, non-comparative study performed in eighty patients with painful KOA, of whom 79 completed the study. They received one injection of 2ml of 2% HA+0.5% mannitol (Day 0) and were followed-up for 6 months. On Days 0, 15, 30, 60, 90, 120, 150 and 180, pain and joint function were assessed using a visual analogue scale (VAS) and WOMAC index. Efficacy and safety by investigator and patient, and rescue medication, as an indirect measure of pain, were also recorded. A significant reduction in joint pain, stiffness and functional disability compared with baseline was observed at every follow-up visit (P<.001). Joint function improved by 38.7% on Day 30, reaching 47.5% on Day 180. Rescue medication use decreased from 58.2% at baseline to 2.5% on Day 90, increasing in the last visits. Efficacy and safety were positively evaluated by investigators and patients. No serious adverse events were observed. Mild side effects were reported in 4 patients (local pain and swelling in the infiltration area). There is evidence that repeated intra-articular injections of HA improve symptoms in KOA. However, studies with a single injection of HA have shown mixed results. This study demonstrates that one single intra-articular injection of non-cross-linked HA reduces joint pain and increases function in patients with KOA over a period of at least 6 months. Copyright © 2011 SECOT. Published by Elsevier España, S.L. All rights reserved.

  6. In vivo Spectrophotometric Assessment of the Tooth Whitening Effectiveness of Nite White 10% with Amorphous Calcium Phosphate, Potassium Nitrate and Fluoride, Over a 6-month Period

    PubMed Central

    Grobler, Sias R; Majeed, Abdul; Moola, Mohamad H; Rossouw, Roelof J; van Wyk Kotze, Theuns

    2011-01-01

    To clinically evaluate the effectiveness of Nite White 10% carbamide peroxide with amorphous calcium phosphate, potassium nitrate and fluoride over a 6-month follow-up period. Nite White was applied nightly for 14 days, according to the manufacturer’s instructions. The color of teeth 11 and 21 of twenty one subjects was measured with a spectrophotometer (L*; a*; b*). Subjects were instructed to take note of any tooth sensitivity and gingival irritation. For all three components (L*, a* and b*) statistical significant differences (p<0.05) in the values between base-line (pre-bleaching) and; after treatment, after 1-month, after 3-months as well as after 6-months were found (Wilcoxon Signed Rank Sum Test). Significant differences were also found amongst the ΔE*ab (0-14days) values and; ΔE*ab (0-1 month), ΔE*ab (0-3 months) and ΔE*ab (0-6 months). However, no significant differences were found between pairs of ΔE*ab (0-1 month), ΔE*ab (0-3 months) and ΔE*ab (0-6months). The decrease in ΔE*ab was the highest after 1 month (~30%). The highest decrease in L* was about 58% after 1 month. Over the 14-day treatment period tooth sensitivity was 24.5%. Conclusions: Nite White ACP demonstrated significant tooth-whitening (unit increase = 5.29) with a low tooth sensitivity (25%) probably due to the presence of amorphous calcium phosphate, potassium nitrate, and fluoride. The whitening effect decreased the most after one month and then maintained well even after a 6 month period (units 3.89). Clinical implications The product is a good tooth whitener with a color increase of about 5 units accompanied with a low sensitivity. PMID:21566718

  7. Tomographic ventilation/perfusion lung scintigraphy in the monitoring of the effect of treatment in pulmonary embolism: serial follow-up over a 6-month period.

    PubMed

    Begic, Amela; Jögi, Jonas; Hadziredzepovic, Amra; Kucukalic-Selimović, Elma; Begovic-Hadzimuratovic, Sadzida; Bajc, Marika

    2011-06-01

    Pulmonary embolism (PE) is a severe condition with nonspecific symptoms. Diagnosis relies on medical imaging but follow-up is currently based on clinical symptoms and general risk factors. The duration of anticoagulant treatment after an acute episode of PE is still subject to debate and the best method of identifying the risk of recurrence in individual patients is undefined. Tomographic lung scintigraphy [ventilation/perfusion single photon emission computed tomography (V/P SPECT)] has improved the diagnostic accuracy with regard to PE but has not been evaluated for PE follow-up. The aim of this prospective study was to quantitatively follow the natural history of treated PE using V/P SPECT, which could prove helpful in defining an anticoagulant treatment regime for individual patients. Of 83 consecutive patients with clinically suspected PE examined with V/P SPECT, 23 patients with confirmed PE were followed by serial V/P SPECT examinations over a 6-month period. All patients were also followed clinically. The mean relative decrease in PE extent compared with the time of diagnosis was 54±26% at 2 weeks, 79±30% at 3 months, and 82±30% at 6 months. Significant resolution of mismatched perfusion defects occurred between V/P SPECT controls within the first 3 months of anticoagulation (P<0.001) but not thereafter. V/P SPECT identified four patients with chronic PE, even though all patients were free from symptoms at 3-month follow-up. Follow-up of PE with V/P SPECT is feasible to evaluate treatment effectiveness in individual patients and to identify patients that develop chronic PE. This study also confirms that resolution of perfusion defects after PE occurs within the first 3 months of treatment. It is therefore recommended that V/P SPECT follow-up should be considered at 3 months after diagnosis.

  8. Olfactory function following open rhinoplasty: A 6-month follow-up study

    PubMed Central

    Shemshadi, Hashem; Azimian, Mojtaba; Onsori, Mohammad Ali; AzizAbadi Farahani, Mahdi

    2008-01-01

    Background Patients undergoing any type of nasal surgery may experience degrees of postoperative olfactory dysfunction. We sought to investigate "when" the olfactory function recovers to its preoperative levels. Methods In this cohort design, 40 of 65 esthetic open rhinoplasty candidates with equal gender distribution, who met the inclusion criteria, were assessed for their olfactory function using the Smell Identification Test (SIT) with 40 familiar odors in sniffing bottles. All the patients were evaluated for the SIT scores preoperatively and postoperatively (at week 1, week 6, and month 6). Results At postoperative week one, 87.5% of the patients had anosmia, and the rest exhibited at least moderate levels of hyposmia. The anosmia, which was the dominant pattern at postoperative week 1, resolved and converted to various levels of hyposmia, so that no one at postoperative week 6 showed any such complain. At postoperative week six, 85% of the subjects experienced degrees of hyposmia, almost all being mild to moderate. At postoperative six month, the olfactory function had already reverted to the preoperative levels: no anosmia or moderate to severe hyposmia. A repeated ANOVA was indicative of significant differences in the olfactory function at the different time points. According to our post hoc Benfronney, the preoperative scores had a significant difference with those at postoperative week 1, week 6, but not with the ones at month 6. Conclusion Esthetic open rhinoplasty may be accompanied by some degrees of postoperative olfactory dysfunction. Patients need a time interval of 6 weeks to 6 months to fully recover their baseline olfactory function. PMID:18831771

  9. A 6-month study of the effects of 0.3% triclosan/copolymer dentifrice on dental implants.

    PubMed

    Sreenivasan, Prem K; Vered, Yuval; Zini, Avi; Mann, Jonathan; Kolog, Hilla; Steinberg, Doron; Zambon, Joseph J; Haraszthy, Violet I; da Silva, Maike P; De Vizio, William

    2011-01-01

    Supportive therapy to maintain dental implants is increasingly important. This study examined the effect of a 0.3% triclosan/2% copolymer dentifrice on oral biofilms and gingival inflammation (GI) on dental implants and peri-implant tissues. One hundred and twenty adults with a dental implant and contra-lateral tooth were enrolled in this 6 month, double-blind, two-treatment, parallel group study. Sixty subjects were randomly assigned to a triclosan/copolymer dentifrice test group and 60 subjects to a fluoride dentifrice control group and instructed to brush twice daily for 6 months. At baseline, 3, and 6 months, a calibrated dentist assessed dental plaque, GI and collected supragingival dental plaque for microbiological analysis. Subjects in the triclosan/copolymer group demonstrated significantly lower levels of dental plaque, gingivitis, and bleeding on probing at 3 and 6 months at both the implant and contra-lateral tooth compared with the fluoride group (p<0.05). There were significantly fewer Gram-negative anaerobes in the triclosan/copolymer group (p<0.05) including >90% reductions in Aggregatibacter actinomycetemcomitans, Campylobacter rectus, Eubacterium saburreum, Fusobacterium nucleatum, Porphyromonas gingivalis, Prevotella melaninogenica, Solobacterium moorei, and Tannerella forsythia. Twice daily use of a triclosan/copolymer dentifrice may enhance dental implant maintenance by reducing dental plaque and GI. © 2010 John Wiley & Sons A/S.

  10. Long-term safety and efficacy of armodafinil in bipolar depression: A 6-month open-label extension study.

    PubMed

    Ketter, Terence A; Amchin, Jess; Frye, Mark A; Gross, Nicholas

    2016-06-01

    Safe/well-tolerated treatments for bipolar I depression remain limited. We assessed safety/tolerability of adjunctive open-label armodafinil, a wakefulness-promoting agent evaluated in 3 acute, controlled efficacy studies with variable efficacy results. Completers of three 8-week, double-blind, placebo-controlled adjunctive armodafinil studies (150-200 mg/day added to ongoing stable maintenance doses of 1 or 2 protocol-defined mood stabilizers) in bipolar I depression could enter this 6-month, open-label extension study. Objectives included evaluation of safety/tolerability (primary) and efficacy (secondary). 867 patients enrolled; 863 received ≥1 dose of armodafinil and 506 (58%) completed the 6-month study. Headache, insomnia, and anxiety were the most common adverse events (AEs) reported, whereas akathisia, nausea, sedation/somnolence, and weight increase were uncommon. Mean measures assessing emergence of mania, anxiety, insomnia, or suicidality showed no worsening. Discontinuations due to AEs occurred in 57 (7%) patients. Serious AEs occurred in 27 (3%) patients and were considered treatment-related in 8 (1%) patients. Depressive symptoms improved over the 6 months, as did patient functioning. Lack of placebo control. Adjunctive armodafinil was generally safe and well tolerated over 6 months of open-label treatment at 150-200 mg/day when taken with protocol-defined mood stabilizers for bipolar I depression. This 6-month open-label study suggested that armodafinil augmentation of bipolar maintenance therapies may have a favorable risk profile and may improve depressive symptoms in some patients with bipolar I depression. Copyright © 2016 Elsevier B.V. All rights reserved.

  11. The effect of risedronate treatment on serum cytokines in postmenopausal osteoporosis: a 6-month randomized and controlled study.

    PubMed

    Dundar, Umit; Kavuncu, Vural; Ciftci, Ihsan H; Evcik, Deniz; Solak, Ozlem; Cakir, Tuncay

    2009-01-01

    There is much evidence suggesting that the decline in ovarian function after menopause is associated with spontaneous increases in proinflammatory cytokines. Treatment with risedronate is accompanied by significant changes in bone turnover and bone mineral density. The objective of this study was to determine the effects of risedronate treatment on the level of serum cytokines including receptor activator of nuclear factor-kappaB ligand (RANKL) and osteoprotegerin among postmenopausal women with osteoporosis. The study group consisted of 61 postmenopausal women with osteoporosis. Patients were randomly divided in two groups: In group 1 (n = 41) postmenopausal women received oral risedronate (35 mg/week), calcium (1,000 mg/day), and vitamin D (400 IU/day) for 12 months. In group 2 (control group; n = 20) patients received only oral calcium (1,000 mg/day) and vitamin D (400 IU/day). Bone mineral density (BMD) of lumbar spine (L1-L4) and proximal femur were determined using dual X-ray absorptiometry at baseline and after one year. Venous blood samples were obtained for determination of serum cytokines including interleukin-1beta (IL-1beta), tumor necrosis factor-alpha (TNF-alpha), RANKL, osteoprotegerin, and markers of bone formation and resorption. Levels of serum cytokines were measured before therapy and after three and 6 months. Markers of bone metabolism were studied before therapy and after 6 months. In group 1 (risedronate plus calcium/vitamin D-treated patients), serum levels of RANKL and IL-1beta significantly decreased and the level of osteoprotegerin significantly increased after three and 6 months, but no significant difference was found in TNF-alpha level. In group 2, however, the level of serum cytokines did not change after three and 6 months. In cases of bone turnover, both markers of bone resorption and formation significantly decreased after 6 months in group 1. In conclusion risedronate could improve osteoporosis by increasing osteoprotegerin and

  12. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study.

    PubMed

    Nada, Aml Mohamed; Shaheen, Dalia A

    2017-01-01

    To investigate the effects of vitamin D supplementation on glucose homeostasis and lipid profile in type 2 diabetic patients who have vitamin D deficiency. One hundred twenty-five type 2 diabetic patients taking oral hypoglycemic agents as mono- or combination therapy were recruited from the diabetes and endocrinology clinic. Subject demographics, duration of diabetes, antidiabetic medication, body mass index (BMI), pulse, and blood pressure (BP) were assessed. Laboratory measurements of serum vitamin D3 level, hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and lipid profile were measured. Homeostatic model assessment-insulin resistance (HOMA-IR) was calculated whenever fasting insulin (FI) was available. Forty-one patients (27 males and 14 females) were started on cholecalciferol replacement-45,000 units once weekly for 8 weeks and then 22,500 units once weekly for 16 weeks. Calcium carbonate tablets 500 mg once daily were also prescribed for the initial 2 months of treatment. Measured variables were reassessed after 6 months of replacement therapy. During the trial, subjects were instructed not to change their diabetes drugs or lifestyle. No significant association was found between vitamin D3 level and any of the measured variables apart from a significant positive correlation with blood urea nitrogen. Vitamin D3 replacement was associated with a significant increase in its level (14.0±4.0 vs 31.0 vs 7.9 ng/mL, P<0.001). This was associated with a significant reduction of HbA1c (7.9±1.7 vs 7.4%±1.2%, P=0.001) and FPG (9.1±4.3 vs 7.9±2.4 mmol/L, P=0.034). Mean reduction of HbA1c was 0.54% and that of FPG was 1.22 mmol/L. FI, c-peptide and insulin resistance (IR) were reduced but this was statistically insignificant (P=0.069, 0.376, 0.058, respectively). FI decreased by 22%, HOMA-IR by 27.6%, and c-peptide by 1.83%. Total cholesterol, low-density lipoprotein cholesterol, parathyroid hormone, alkaline phosphatase, serum creatinine, and pulse rate

  13. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study

    PubMed Central

    Nada, Aml Mohamed; Shaheen, Dalia A

    2017-01-01

    Background and purpose To investigate the effects of vitamin D supplementation on glucose homeostasis and lipid profile in type 2 diabetic patients who have vitamin D deficiency. Patients and methods One hundred twenty-five type 2 diabetic patients taking oral hypoglycemic agents as mono- or combination therapy were recruited from the diabetes and endocrinology clinic. Subject demographics, duration of diabetes, antidiabetic medication, body mass index (BMI), pulse, and blood pressure (BP) were assessed. Laboratory measurements of serum vitamin D3 level, hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and lipid profile were measured. Homeostatic model assessment-insulin resistance (HOMA-IR) was calculated whenever fasting insulin (FI) was available. Forty-one patients (27 males and 14 females) were started on cholecalciferol replacement–45,000 units once weekly for 8 weeks and then 22,500 units once weekly for 16 weeks. Calcium carbonate tablets 500 mg once daily were also prescribed for the initial 2 months of treatment. Measured variables were reassessed after 6 months of replacement therapy. During the trial, subjects were instructed not to change their diabetes drugs or lifestyle. Results No significant association was found between vitamin D3 level and any of the measured variables apart from a significant positive correlation with blood urea nitrogen. Vitamin D3 replacement was associated with a significant increase in its level (14.0±4.0 vs 31.0 vs 7.9 ng/mL, P<0.001). This was associated with a significant reduction of HbA1c (7.9±1.7 vs 7.4%±1.2%, P=0.001) and FPG (9.1±4.3 vs 7.9±2.4 mmol/L, P=0.034). Mean reduction of HbA1c was 0.54% and that of FPG was 1.22 mmol/L. FI, c-peptide and insulin resistance (IR) were reduced but this was statistically insignificant (P=0.069, 0.376, 0.058, respectively). FI decreased by 22%, HOMA-IR by 27.6%, and c-peptide by 1.83%. Total cholesterol, low-density lipoprotein cholesterol, parathyroid hormone

  14. Alpha-Lipoic Acid Shows Promise to Improve Migraine in Patients with Insulin Resistance: A 6-Month Exploratory Study.

    PubMed

    Cavestro, Cinzia; Bedogni, Giorgio; Molinari, Filippo; Mandrino, Silvia; Rota, Eugenia; Frigeri, Maria Cristina

    2017-10-04

    Alpha-lipoic acid (ALA) is known to lower insulin resistance (IR), which is common among migraineurs. To assess the effect of ALA on headache in migraineurs with IR, we performed an exploratory study on a cohort of patients with migraine, followed at our Headache Center. The 32 patients took ALA 400 mg b.i.d. for 6 months in addition to their on-going treatment. The percentage of patients with a reduction of at least 50% of the attacks was 0.53 (confidence interval [95% CI] 0.36-0.70) at 2 months, 0.56 (0.39-0.73) at 4 months, and 0.69 (0.53-0.85) at 6 months. The incidence rate ratio of attacks at 6 months versus baseline was 0.48 (0.43-0.53, P < .001), corresponding to a mean (95% CI) number of attacks of 5 (4-6) versus 11 (10-12). The number of days of treatment in the previous month was 7.7 (6.8-8.7) at baseline, 5.4 (4.6-6.2) at 2 months, 5.3 (4.5-6.1) at 4 months, and 4.3 (3.6-5.0) at 6 months. Baseline and 120-min glucose and insulin and quantitative insulin sensitivity check index (QUICKI) and the Stumvoll index did not change at 6 months versus baseline. This exploratory study shows that the administration of ALA may be associated with a reduction in the number of attacks and the days of treatment in migraineurs with IR. A randomized controlled trial is needed to test this possibility.

  15. Lifestyle coaching's effect on 6-month follow-up in recently homeless substance dependent veterans: a randomized study.

    PubMed

    LePage, James P; Garcia-Rea, Elizabeth A

    2012-09-01

    Behaviors and activities consistent with "healthy" lifestyles (i.e., leisure and recreational activities, social and family interactions, coping behaviors) have been shown to be related to prolonged substance dependence recovery. However, there has been little focus on systematically capitalizing on this association in treatment to improve relapse rates. The goal of this study was to determine if the inclusion of healthy lifestyle coaching, that is the encouragement of specific behaviors in a therapeutic setting, could impact time to relapse. Fifty-six veterans who were recently discharged from a Veterans Administration (VA) homeless Domiciliary Residential Rehabilitation and Treatment Program and were substance dependent were evaluated over a 6-month follow-up period. Using a partially randomized design, three groups were evaluated: 1) those followed by a therapist and coached to increase healthy behaviors, 2) those followed by a therapist and receiving only emotional support, and 3) those not followed by a therapist. Survival analyses and nonparametric evaluations were performed. Coached consumers had longer latency to relapse than noncoached and relapsed at a lower rate than those not followed by a therapist. Therapeutic interventions which focus on increasing healthy behaviors chosen by the consumer can be an important component of sustained recovery from substance dependence. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

  16. The prevalence of vitamin D deficiency in consecutive new patients seen over a 6-month period in general rheumatology clinics.

    PubMed

    Haroon, Muhammad; Bond, Ursula; Quillinan, Niamh; Phelan, Mark J; Regan, Michael J

    2011-06-01

    The objectives of this study are to assess: (a) the prevalence of vitamin D deficiency among new patients attending rheumatology outpatient departments, (b) the age profile of these low vitamin D patients and (c) whether any diagnostic category had a particularly high number of vitamin D-deficient patients. All new patients seen consecutively in general rheumatology clinics between January to June 2007 inclusive were eligible to partake in this study, and 231 out of 264 consented to do so. Parathyroid hormone, 25-hydroxyvitamin D, creatinine, calcium, phosphate, albumin and alkaline phosphatase levels were measured. We defined vitamin D deficiency as ≤53 nmol/l and severe deficiency as ≤25 nmol/l. Overall, 70% of 231 patients had vitamin D deficiency, and 26% had severe deficiency. Sixty-five percent of patients aged ≥65 and 78% of patients aged ≤30 years had low vitamin D levels. Vitamin D deficiency in each diagnostic category was as follows: (a) inflammatory joint diseases/connective tissue diseases (IJD/CTD), 69%; (b) soft tissue rheumatism, 77%; (c) osteoarthritis, 62%; (d) non-specific musculoskeletal back pain, 75% and (e) osteoporosis, 71%. Seasonal variation of vitamin D levels was noted in all diagnostic groups apart from IJD/CTD group, where the degree of vitamin D deficiency persisted from late winter to peak summer. Very high prevalence of vitamin D deficiency was noted in all diagnostic categories (p = 0.006), and it was independent of age (p = 0.297). The results suggest vitamin D deficiency as a possible modifiable risk factor in different rheumatologic conditions, and its role in IJD/CTD warrants further attention.

  17. Effects of fixed orthodontic treatment on hair nickel and chromium levels: a 6-month prospective preliminary study.

    PubMed

    Amini, Fariborz; Mollaei, Mobina; Harandi, Saghar; Rakhshan, Vahid

    2015-03-01

    Although nickel and chromium are known as allergen and cytotoxic orthodontic metals, very few and controversial studies have assessed the effect of orthodontic treatment on their systemic levels reflected by their best biomarker of exposure, hair. This prospective preliminary study was conducted to evaluate hair nickel and chromium levels in fixed orthodontic patients. Scalp hair nickel/chromium concentrations of 12 female and 12 male fixed orthodontic patients were measured before treatment and 6 months later, using atomic absorption spectrophotometry. The effects of treatment, gender, and age on hair ions were analyzed statistically (α = 0.05). The patients' mean age was 18.38 ± 3.98 years. The mean nickel levels were 0.1380 ± 0.0570 and 0.6715 ± 0.1785 μg/g dry hair mass, respectively, in the baseline and sixth month of treatment. Chromium concentrations were 0.1455 ± 0.0769 and 0.1683 ± 0.0707 μg/g dry hair mass, respectively. After 6 months, nickel increased for 387 % (paired t test P = 0.0000) and chromium increased for 16 % (P = 0.0002). No significant correlations were observed between any ion levels with age or gender (Spearman P > 0.2). Within the limitations of this preliminary study, it seems that 6 months of fixed orthodontic treatment might increase levels of hair nickel and chromium. Future larger studies are necessary to validate these results.

  18. Predictive Factors of Survival and 6-Month Favorable Outcome of Very Severe Head Trauma Patients; a Historical Cohort Study

    PubMed Central

    Vathanalaoha, Karin; Oearsakul, Thakul; Tunthanathip, Thara

    2017-01-01

    Introduction: Very severe head trauma cases, defined as Glasgow Coma Scale (GCS) scores of less than 6, have a higher mortality rate and poorer outcome. The purpose of this study was to recognize factors associated with survival and 6-month favorable outcome of very severe head trauma patients presenting to emergency department. Methods: In this historical cohort study, the authors retrospectively reviewed medical records of head trauma patients who were admitted to the emergency department with post-resuscitation GCS scores of less than 6. Both univariate and multivariate analyses were used to test the association between various parameters with survival and 6-month outcome. Results: 103 cases with the mean age of 39 ± 16.5 years were studied (80% male). The overall survival rate was 41.7% and the rate of 6-month favorable outcome was 28.2%. In multivariate analysis, brisk pupil light reaction on admission and patent basal cistern on brain computed tomography (CT) scan were significant factors associated with both survival (OR 5.20, 95% CI 1.57-17.246, p = 0.007 and OR 3.65, 95% CI 1.22-10.91, p=0.02 respectively) and favorable outcome (OR 4.07, 95% CI 1.35-12.24, p=0.01 and OR 3.54, 95% CI 1.22-10.26, p 0.02), respectively. Conclusion: Based on the results of present study, the survival rate of patients with very severe head trauma (GCS < 6) was 41.7%. The strong predictors of survival and 6-month favorable outcome of these patients were brisk pupillary reactivity and patent cistern on brain CT scan. It seems that very severe head trauma patients still have a reasonable chance to survive and aggressive management should be continued. PMID:28286831

  19. Individual or group rehabilitaion for people with low back pain: a comparative study with 6-month follow-up.

    PubMed

    Nykänen, Matti; Koivisto, Katri

    2004-11-01

    To compare the effectiveness of group rehabilitation and individually dosed rehabilitation in treating chronic low back pain. Institutional rehabilitation intervention in 2 nonrandomized groups with a 6-month post-intervention follow-up. Persons with chronic low back pain: 64 group-rehabilitated and 66 individually rehabilitated. The rehabilitation period for all subjects was 21 days. Those being group-rehabilitated, about 10 patients per group, had a common programme including 3-5 exercise groups per day, group discussions and lectures including back and neck school. Local physical therapy was given if neeeded. The individually rehabilitated subjects had individually designed programmes: local physical therapy, muscle strengthening programme, group exercises and participating in back school. The duration of the guided programme was 62 hours for group rehabilitation and 45 hours for individual rehabilitation. During the rehabilitation period the strength and flexibility of individually rehabilitated subjects improved more than that of group-rehabilitated subjects (p < 0.05 and p < 0.01, respectively). After the 6-month follow-up period, group-rehabilitated subjects showed a decrease in the Oswestry and pain indexes, while individually rehabilitated subjects showed an increase in the Oswestry index. The group-rehabilitated subjects evaluated the goals of rehabilitation to have been attained better and considered themselves better motivated in self-care. The costs of the 2 rehabilitation programs were approximately equal. These tentative results suggest that group rehabilitation can compete with individual rehabilitation at least in short-term follow-up.

  20. Physical complaints, medical service use, and social and employment changes following mild traumatic brain injury: a 6-month longitudinal study.

    PubMed

    Kraus, Jess; Schaffer, Kathryn; Ayers, Kathi; Stenehjem, Jerome; Shen, Haikang; Afifi, A A

    2005-01-01

    Using a prospective, dual-cohort study design in which selected preinjury factors were controlled, we present outcomes of 235 patients in a case cohort and 235 patients in a comparison cohort following emergency-department-diagnosed mild traumatic brain injury (MTBI). Symptoms, medical services use, and social and employment concerns were evaluated 6 months after the injury. After adjusting for preinjury characteristics, headaches, dizziness, vision difficulties, memory or learning problems, and alcohol intolerance were found to occur significantly more often in the MTBI cohort than in the comparison cohort. Problems sleeping, use of prescribed medications, and changes in employment were less likely in the MTBI cohort. Although MTBI is not life threatening, our findings suggest that 6 months after injury persons still have related health problems that require routine medical management.

  1. Gripe Water Administration in Infants 1-6 months of Age-A Cross-sectional Study

    PubMed Central

    Jain, Keerthi; Gunasekaran, Dhandapany; Soundararajan, Palanisamy

    2015-01-01

    Introduction Gripe water (GW) administration to young infants is common practice in this part of country. In order to ascertain why mothers administer gripe water to their infants and to find out what benefits or health risks it poses, we proposed to study the practice of mothers giving GW to their babies. Materials and Methods Three hundred and thirty five eligible mothers of infants aged 1-6 months (who after qualifying inclusion and exclusion criteria of the study) who attended the well baby clinic during the study period, were interviewed using a semi structured questionnaire which contained both open and close ended questions after obtaining informed written consent. The study population was then divided into two groups based on administration of GW or not and the results were compared and analysed among the two groups using odds ratio with 95% C.I. For calculation of statistics, the statistical package SPSS 13 was used. Results 64.18% of the mothers were administering GW for their infants. Most mothers believed that GW helps in digestion and prevents stomach ache. Infantile colic, vomiting and constipation were common in GW administered infants, when compared to those who did not receive GW and the difference was significant with p-values of 0.0001, 0.0373, 0.0007respectively. Conclusion GW administration is a common problem in infants and remains a significant challenge that thwarts exclusive breast feeding. More over GW administration does not seem to prevent infantile colic and on the other hand, may be associated with vomiting and constipation. Misconceptions prevailing among mothers have to be removed by effective counseling so that the mothers are aware of safe and healthy feeding practices to be adopted for feeding their babies. PMID:26673749

  2. Gripe Water Administration in Infants 1-6 months of Age-A Cross-sectional Study.

    PubMed

    Jain, Keerthi; Gunasekaran, Dhandapany; Venkatesh, Chandrasekaran; Soundararajan, Palanisamy

    2015-11-01

    Gripe water (GW) administration to young infants is common practice in this part of country. In order to ascertain why mothers administer gripe water to their infants and to find out what benefits or health risks it poses, we proposed to study the practice of mothers giving GW to their babies. Three hundred and thirty five eligible mothers of infants aged 1-6 months (who after qualifying inclusion and exclusion criteria of the study) who attended the well baby clinic during the study period, were interviewed using a semi structured questionnaire which contained both open and close ended questions after obtaining informed written consent. The study population was then divided into two groups based on administration of GW or not and the results were compared and analysed among the two groups using odds ratio with 95% C.I. For calculation of statistics, the statistical package SPSS 13 was used. 64.18% of the mothers were administering GW for their infants. Most mothers believed that GW helps in digestion and prevents stomach ache. Infantile colic, vomiting and constipation were common in GW administered infants, when compared to those who did not receive GW and the difference was significant with p-values of 0.0001, 0.0373, 0.0007respectively. GW administration is a common problem in infants and remains a significant challenge that thwarts exclusive breast feeding. More over GW administration does not seem to prevent infantile colic and on the other hand, may be associated with vomiting and constipation. Misconceptions prevailing among mothers have to be removed by effective counseling so that the mothers are aware of safe and healthy feeding practices to be adopted for feeding their babies.

  3. The non-thyroidal illness syndrome after coronary artery bypass grafting: a 6-month follow-up study.

    PubMed

    Cerillo, Alfredo Giuseppe; Storti, Simona; Mariani, Massimiliano; Kallushi, Enkel; Bevilacqua, Stefano; Parri, Maria Serena; Clerico, Aldo; Glauber, Mattia

    2005-01-01

    The non-thyroidal illness syndrome (NTIS) is considered a transient and completely reversible phenomenon, but it has been shown that it may last for several days postoperatively after coronary artery bypass grafting (CABG) surgery. This study was undertaken to assess thyroid function 6 months after uncomplicated CABG. The thyroid profile was evaluated in 40 consecutive patients undergoing CABG preoperatively, at 0, 12, 48, and 120 h postoperatively, and at 6-month follow-up. Triiodothyronine (T3), free T3 (FT3), free thyroxine (FT4) and thyroid stimulating hormone (TSH) were assayed using a microparticle enzyme immunoassay. T4 and total serum thyroid hormone-binding capacity (T-uptake) were measured on the same samples using a fluorescence polarization immunoassay. Patients with severe systemic illness and patients treated with amiodarone were excluded. All patients were euthyroid at admission. Mean age was 67.4+/-9.0 years. There were 31 (77.5%) men. Typical NTIS was observed in all patients, and the FT3 concentration was still reduced by postoperative day 5 (p<0.0001). At 6-month follow-up, all patients were free from cardiac symptoms, and no new cardiac events were recorded. The thyroid profile was normal in 35 patients (87.5%). One patient (4.5%) had developed overt hypothyroidism. Two patients had isolated low T3 and FT3 levels with normal TSH. Two patients had moderately increased FT3 levels with suppressed TSH. In most uncomplicated patients, thyroid function returns to normal 6 months after CABG. However, we observed significant alterations of the thyroid profile in 5 out of 40 patients. Further studies are needed to define the long-term consequences of postoperative NTIS.

  4. Prevalence and factors associated with exclusive breastfeeding at 6 months of life in Tehran: a population-based study.

    PubMed

    Noughabi, Z S; Tehrani, S Golian; Foroushani, A R; Nayeri, F; Baheiraei, A

    2014-02-11

    Exclusive breastfeeding is the best form of nutrition for infants in the first 6 months of life. The aim of this study was to determine the prevalence of exclusive breastfeeding in Tehran, Islamic Republic of Iran in the first 6 months of life, and the factors that influence it. In a population-based, cross-sectional study 538 mothers with children aged 6-24 months completed an interview questionnaire. Only 46.5% of mothers exclusively breastfed their infant in the first 6 months of life. In multivariate analysis formula supplementation in the hospital (OR = 0.41, 95% CI: 0.17-0.95) and mother receiving conflicting infant feeding advice (OR = 0.53, 95% CI: 0.37-0.78) had a negative effect on exclusive breastfeeding. Mother's intention to exclusively breastfeed (OR = 5.85, 95% CI: 2.88-11.9) and infant having first breast contact 6-30 minutes after delivery (OR = 2.35, 95% CI: 1.17-4.72) had positive effects on exclusive breastfeeding.

  5. Shyness and Emotion-Processing Skills in Preschoolers: A 6-Month Longitudinal Study

    ERIC Educational Resources Information Center

    Strand, Paul S.; Cerna, Sandra; Downs, Andrew

    2008-01-01

    The present study utilized a short-term longitudinal research design to examine the hypothesis that shyness in preschoolers is differentially related to different aspects of emotion processing. Using teacher reports of shyness and performance measures of emotion processing, including (1) facial emotion recognition, (2) non-facial emotion…

  6. Shyness and Emotion-Processing Skills in Preschoolers: A 6-Month Longitudinal Study

    ERIC Educational Resources Information Center

    Strand, Paul S.; Cerna, Sandra; Downs, Andrew

    2008-01-01

    The present study utilized a short-term longitudinal research design to examine the hypothesis that shyness in preschoolers is differentially related to different aspects of emotion processing. Using teacher reports of shyness and performance measures of emotion processing, including (1) facial emotion recognition, (2) non-facial emotion…

  7. Feasibility and acceptance of a home telemanagement system in patients with inflammatory bowel disease: a 6-month pilot study.

    PubMed

    Cross, Raymond K; Finkelstein, Joseph

    2007-02-01

    Our purpose was to assess the acceptance and feasibility of a home telemanagement system (HAT) in inflammatory bowel disease (IBD). The HAT consists of a laptop and a scale. Subjects were required to complete weekly self-testing for 6 months. Disease activity, quality of life, and knowledge were assessed at baseline and 6 months. Attitudinal surveys were completed at 6 months. Twenty-five subjects completed the study. Ninety-one percent of patients thought that self-testing was not complicated. Eighty-six percent said that self-testing did not interfere with their usual activities. Ninety-one percent of patients would consider using a HAT in the future. Adherence with self-testing was 91%. Improvements in disease activity and quality of life, and significant improvements in knowledge, were observed after implementation of the HAT. The HAT is feasible and accepted in IBD. We predict that the HAT will positively affect adherence, monitoring, and patient education, resulting in improved disease activity and quality of life.

  8. Rivastigmine patch ameliorates depression in mild AD: preliminary evidence from a 6-month open-label observational study.

    PubMed

    Spalletta, Gianfranco; Gianni, Walter; Giubilei, Franco; Casini, Anna R; Sancesario, Giuseppe; Caltagirone, Carlo; Cravello, Luca

    2013-01-01

    Here we investigated the effect of the rivastigmine patch alone on depression in 50 mild Alzheimer's disease (AD) patients with comorbid major depressive episode (MDE). First diagnosis acetyl-cholinesterase inhibitor and psychoactive drug-free outpatients (n=50) were recruited in memory clinics and reassessed after 3 and 6 months. Global cognitive functioning, depressive symptoms and MDE frequency were evaluated with the Mini Mental State Examination, the CERAD Dysphoria scale and the modified DSM-IV criteria for MDE in AD. MDE frequency reduced significantly from the first diagnostic visit (100%) to the 6-month follow-up (62%). We also found a significant reduction in CERAD Dysphoria scores that decreased from 6.2±3.9 mean±standard deviation to 4.9±4.5 at the 6-month follow-up. In AD patients with MDE rivastigmine alone can have a positive impact on depressive phenomena. Thus, future controlled study are justified to definitively verify if rivastigmine alone may improve depression in AD.

  9. Effect of the different implant protocols on peri-implant bone: a 6-month prospective study in beagle dogs.

    PubMed

    Song, Dandan; Zheng, Hui; Huang, Yan; Ma, Xucheng; Ma, Guowu; Liang, Xin

    2017-08-11

    To compare the effects of different implant placement and loading protocols on the marginal bone loss (MBL) in beagles by intraoral radiography. 61 dental implants were inserted on 9 beagle dogs at bilateral lower posteriors according to 8 different protocols: immediate implant placement and immediate loading for 3 months (IIP + IL3) or 6 months (IIP + IL6) and unloading (IIP + UL), immediate implant placement and delayed loading for 3 months (IIP + DL3) or 6 months (IIP + DL6), delayed implant placement and immediate loading for 3 months (DIP + IL3) or delayed loading for 3 months (DIP + DL3) and unloading (DIP + UL). Intraoral radiography was performed to analyze the MBL during each surgery, before and after the implant placement and at 3-month intervals after the procedure. In total, 57 samples were included. There was less MBL (p<0.05) in the IIP + IL3 group (1.22 ± 0.63 mm) compared to the DIP + IL3 group (1.89 ± 0.9 mm). The longer the loading time, the more bone loss appeared in the IIP + IL group; however, the results were reversed in the IIP + DL group. The MBL during the latter 3-month period was dramatically decreased compared to the former 3-month period in the IIP + DL3 group (p<0.05). The IIP + IL group seems superior to the DL protocol and the MBL changed significantly during the first three months and thereafter became stable.

  10. PROSPECTIVE ASSOCIATIONS OF DEPRESSIVE RUMINATION AND SOCIAL PROBLEM SOLVING WITH DEPRESSION: A 6-MONTH LONGITUDINAL STUDY(.).

    PubMed

    Hasegawa, Akira; Hattori, Yosuke; Nishimura, Haruki; Tanno, Yoshihiko

    2015-06-01

    The main purpose of this study was to examine whether depressive rumination and social problem solving are prospectively associated with depressive symptoms. Nonclinical university students (N = 161, 64 men, 97 women; M age = 19.7 yr., SD = 3.6, range = 18-61) recruited from three universities in Japan completed the Beck Depression Inventory-Second Edition (BDI-II), the Ruminative Responses Scale, Social Problem-Solving Inventory-Revised Short Version (SPSI-R:S), and the Means-Ends Problem-Solving Procedure at baseline, and the BDI-II again at 6 mo. later. A stepwise multiple regression analysis with the BDI-II and all subscales of the rumination and social problem solving measures as independent variables indicated that only the BDI-II scores and the Impulsivity/carelessness style subscale of the SPSI-R:S at Time 1 were significantly associated with BDI-II scores at Time 2 (β = 0.73, 0.12, respectively; independent variables accounted for 58.8% of the variance). These findings suggest that in Japan an impulsive and careless problem-solving style was prospectively associated with depressive symptomatology 6 mo. later, as contrasted with previous findings of a cycle of rumination and avoidance problem-solving style.

  11. A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial.

    PubMed

    Bucci, C; Tremolaterra, F; Gallotta, S; Fortunato, A; Cappello, C; Ciacci, C; Iovino, P

    2014-04-01

    In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul(®)) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture. This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation). Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected. Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.

  12. Comparision of overweight and obesity in medical cadets before and after 6 months studying at Phramongkutklao College.

    PubMed

    Suwan, Kijja; Hatthachote, Panadda; Panichkul, Suthee; Phromphetcharat, Varee

    2012-05-01

    To evaluate prevalence of overweight and obesity in second-year medical cadets and to determine risk behaviors before and after 6 months studying at Phramongkutklao College of Medicine (PCM). MATERIAL AMD METHOD: Data on self-report behavioral questionnaires was collected from 92 medical cadets before and after 6 months studying at PCM in 2008. Body weight, height, waist circumference, blood pressure and body fat were measured according to standard protocols. Overall, prevalence of overweight and obese medical cadets before studying at PCM was 16.30% and 15.22% according to BMI and 27.17% and 15.22% by percent body fat. After 6 months of study, overall mean of body fat and systolic blood pressure were significantly reduced. For males, the mean of weight, BMI and waist circumference were reduced significantly. In contrast, the mean of body weight and BMI of females were significantly increased. The prevalence of overweight in total participants determined by body fat was significantly reduced from 27.17% to 15.22%. Determination by BMI, obesity was significantly reduced from 34.29% to 14.29% only in males. Behaviors that were found to be significantly increased (p < 0.001) were regular physical activity, night eating, sugar-sweet beverage consumption, amount and frequency of coffee or tea consumption. Significant decrease in time of watching TV or using a computer, and duration of sleep was also determined. The present study indicated that overweight, obesity, waist circumference and body fat of medical cadets were decreased after study at PCM which is possibly due to increasing exercise. Nevertheless, behavioral risks for obesity were also increasing, therefore, it might result in increased the prevalence of obesity in the future.

  13. Effectiveness of screening for neuroblastoma at 6 months of age: a retrospective population-based cohort study.

    PubMed

    Hiyama, Eiso; Iehara, Tomoko; Sugimoto, Tohru; Fukuzawa, Masahiro; Hayashi, Yutaka; Sasaki, Fumiaki; Sugiyama, Masahiko; Kondo, Satoshi; Yoneda, Akihiro; Yamaoka, Hiroaki; Tajiri, Tatsuro; Akazawa, Kohei; Ohtaki, Megu

    2008-04-05

    In Japan, a nationwide programme between 1984 and 2003 screened all infants for urinary catecholamine metabolites as a marker for neuroblastoma. Before 1989, this was done by qualitative spot tests for vanillylmandelic acid in urine, and subsequently by quantitative assay with high-performance liquid chromatography (HPLC). However, the Japanese government stopped the mass-screening programme in 2003, after reports that it did not reduce mortality due to neuroblastoma. We aimed to assess the effectiveness of the programme, by comparing the rates of incidence and mortality from neuroblastomas diagnosed before 6 years of age in three cohorts. We did a retrospective population-based cohort study on all children born between 1980 and 1998, except for a 2-year period from 1984. We divided these 22,289,695 children into three cohorts: children born before screening in 1980-83 (n=6,130,423); those born during qualitative screening in 1986-89 (n=5,290,412); and those born during quantitative screening 1990-98 (n=10,868,860). We used databases from hospitals, screening centres, and national cancer registries. Cases of neuroblastoma were followed up for a mean of 78.7 months. 21.56 cases of neuroblastoma per 100,000 births over 72 months were identified in the qualitatively screened group (relative risk [RR] 1.87, 95% CI 1.66-2.10), and 29.80 cases per 100,000 births over 72 months in the quantitatively screened group (RR 2.58, 2.33-2.86). The cumulative incidence of neuroblastoma in the prescreening cohort (11.56 cases per 100,000 births over 72 months) was lower than that in other cohorts (p<0.0001 for all comparisons), but more neuroblastomas were diagnosed after 24 months of age in this cohort (p=0.0002 for qualitative screening vs prescreening, p<0.0001 for quantitative screening vs prescreening). Cumulative mortality was lower in the qualitative screening (3.90 cases per 100,000 livebirths over 72 months) and quantitative screening cohorts (2.83 cases) than in the

  14. Sustained dysfunctional information processing in patients with Internet gaming disorder: 6-month follow-up ERP study.

    PubMed

    Park, Minkyung; Kim, Yeon Jin; Kim, Dai Jin; Choi, Jung-Seok

    2017-09-01

    Internet gaming disorder (IGD), defined as an inability to control Internet-based game play, leads to serious impairment in psychological and social functioning, but few studies have identified the neurophysiological characteristics of patients with IGD. The aim of this study was to determine neurophysiological markers of P300 components associated with changes in symptoms after outpatient management with pharmacotherapy in patients with IGD. The present prospective longitudinal study included 18 patients with IGD and 29 healthy controls. The patients with IGD completed a 6-month outpatient management program including selective serotonin reuptake inhibitor-based pharmacotherapy. Event-related potentials (ERPs) were acquired during the auditory oddball task. ERPs of the patients with IGD were recorded before and after treatment. Between-group differences and the pre-to-post treatment differences in P300 components were investigated using repeated-measures analysis of variance. The primary treatment outcome was a change in score on Young Internet Addiction Test between before and after treatment. At baseline assessments, the IGD group showed significantly reduced P300 amplitudes and delayed latencies at the midline centro-parietal site compared with those in the healthy controls. No significant changes in the P300 indices were observed between pre and post-treatment in the patients with IGD after 6 months of treatment, even though the patients with IGD exhibited significant improvements in their IGD symptoms. Furthermore, no significant difference in ERPs was observed between responders and nonresponders to a 6-month treatment in patients with IGD. These results suggest that reduced P300 amplitudes and delayed latencies are candidate endophenotypes in the pathophysiology of IGD.

  15. Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes.

    PubMed

    Mango, Joseph; Cabiling, Eileen; Jones, Loretta; Lucas-Wright, Aziza; Williams, Pluscedia; Wells, Kenneth; Pulido, Esmeralda; Meldrum, Marcia; Ramos, Ana; Chung, Bowen

    2014-02-25

    "Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes" is a 2 minute, 46 second video summarizing the study rationale, study approach, and the 6-month outcomes. The video was produced by four agencies: Healthy African American Families II, a health advocacy organization in South Los Angeles; Behavioral Health Services, the largest substance/alcohol abuse service provider in LA County; UCLA; and RAND Health; contract filmmakers Eileen Cabiling and Joe Mango handled cinematography, editing, and video support. The individuals appearing in the video are key CPIC community and academic partners. The celebratory tone of the video is consistent with a Community Partnered Participatory Research approach, a local variant of participatory action research, where study findings are celebrated by the partners, and dissemination efforts include approaches intended for general audiences, especially from low-income, low-literacy, minority communities, in addition to traditional academic products like peer-reviewed scientific manuscripts. The CPIC video offers a community perspective on the study results to our partners, the general public, other scientists and policy makers. We designed the video to teach community and healthcare partners how to adapt and implement the CPIC depression care model and to offer other community -academic partnerships an example of a non-traditional product developed for dissemination from an NIH-funded research study.

  16. Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes

    PubMed Central

    Mango, Joseph; Cabiling, Eileen; Jones, Loretta; Lucas-Wright, Aziza; Williams, Pluscedia; Wells, Kenneth; Pulido, Esmeralda; Meldrum, Marcia; Ramos, Ana; Chung, Bowen

    2014-01-01

    “Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes” is a 2 minute, 46 second video summarizing the study rationale, study approach, and the 6-month outcomes. The video was produced by four agencies: Healthy African American Families II, a health advocacy organization in South Los Angeles; Behavioral Health Services, the largest substance/alcohol abuse service provider in LA County; UCLA; and RAND Health; contract filmmakers Eileen Cabiling and Joe Mango handled cinematography, editing, and video support. The individuals appearing in the video are key CPIC community and academic partners. The celebratory tone of the video is consistent with a Community Partnered Participatory Research approach, a local variant of participatory action research, where study findings are celebrated by the partners, and dissemination efforts include approaches intended for general audiences, especially from low-income, low-literacy, minority communities, in addition to traditional academic products like peer-reviewed scientific manuscripts. The CPIC video offers a community perspective on the study results to our partners, the general public, other scientists and policy makers. We designed the video to teach community and healthcare partners how to adapt and implement the CPIC depression care model and to offer other community –academic partnerships an example of a non-traditional product developed for dissemination from an NIH-funded research study. PMID:25364622

  17. Pelvic Floor Disorders 6 Months after Attempted Operative Vaginal Delivery According to the Fetal Head Station: A Prospective Cohort Study

    PubMed Central

    Ducarme, Guillaume; Hamel, Jean-François; Brun, Stéphanie; Madar, Hugo; Merlot, Benjamin; Sentilhes, Loïc

    2016-01-01

    Objective To evaluate the effect of the fetal head station at attempted operative vaginal delivery (aOVD), and specifically midpelvic or low aOVD, on urinary incontinence (UI), anal incontinence (AI), and perineal pain at 6 months. Design Prospective cohort study. Setting 1941 women with singleton term fetuses in vertex presentation with midpelvic or low aOVD between 2008 and 2013 in a tertiary care university hospital. Methods Symptoms of urinary incontinence (UI) using the Bristol Female Lower Urinary Tract Symptoms questionnaire, and symptoms of anal incontinence (AI) severity using Fecal Incontinence Severity Index (FISI) were assessed 6 months after aOVD. We measured the association between midpelvic or low aOVD and symptoms of UI, AI, and perineal pain at 6 months using multiple regression and adjusting for demographics, and risk factors of UI and AI, with adjusted odds ratios (aORs) and 95% confidence intervals (95% CI). Results The study included 907 women (46.7%) who responded to the questionnaire; 18.4% (167/907) had midpelvic aOVD, and 81.6% (740/907) low; and none of women with symptoms of UI (26.6%, and 22.4%, respectively; p = 0.31), AI (15.9%, and 21.8%; p = 0.09), the FISI score, and perineal pain (17.2%, and 12.7%; p = 0.14) differed significantly between groups. The same was true for stress, urge, and mixed-type UI, severe UI and difficulty voiding. Compared with low pelvic aOVD, the aORs for symptoms of UI in midpelvic aOVD were 0.70 (0.46–1.05) and AI 1.42 (0.85–2.39). Third- and fourth-degree tears were a major risk factor of symptoms of UI (aOR 3.08, 95% CI 1.35–7.00) and AI (aOR 3.47, 95% CI 1.43–8.39). Conclusion Neither symptoms of urinary nor anal incontinence differed at 6 months among women who had midpelvic and low pelvic aOVD. These findings are reassuring and need further studies at long-term to confirm these short-term data. PMID:27992558

  18. No association of obesity gene FTO with body composition at the age of 6 months. The Generation R Study.

    PubMed

    Mook-Kanamori, D O; Ay, L; Hofman, A; van Duijn, C M; Moll, H A; Raat, H; Hokken-Koelega, A C S; Jaddoe, V W V

    2011-01-01

    Genome-wide association studies on body mass index (BMI) have identified an FTO polymorphism (rs9939609) as having the strongest effect. We examined the effect of FTO genotype on body composition at the age of 6 months using skinfold thickness measurements and dual energy X-ray absorptiometry (DXA). This study was embedded in a population-based prospective cohort study from early fetal life onwards. FTO genotype was related to anthropometric measurements (weight and height), subcutaneous fat mass measured by skinfold thickness, and total, truncal, and peripheral fat mass and lean mass measured by DXA. Analyses for skinfold thickness and DXA were performed in 695 and 216 children, respectively. Genotype frequency was TT 40.3%, TA 45.5%, and AA 14.2%. No significant differences between FTO genotypes were found in weight, height or BMI. Furthermore, FTO genotype was not associated with any skinfold thickness. Finally, no associations between FTO genotype and body composition measures (fat and lean mass) assessed by DXA were found. We observed no association between this FTO polymorphism and body composition at the age of 6 months. Longer follow-up studies are necessary to examine at which age and by which mechanisms FTO genotype starts to influence fat mass and body composition.

  19. Mood stability in Parkinson disease following deep brain stimulation: a 6-month prospective follow-up study.

    PubMed

    Chopra, Amit; Abulseoud, Osama A; Sampson, Shirlene; Lee, Kendall H; Klassen, Bryan T; Fields, Julie A; Matsumoto, Joseph Y; Adams, Andrea C; Stoppel, Cynthia J; Geske, Jennifer R; Frye, Mark A

    2014-01-01

    Deep brain stimulation for Parkinson disease has been associated with psychiatric adverse effects including anxiety, depression, mania, psychosis, and suicide. The purpose of this study was to evaluate the safety of deep brain stimulation in a large Parkinson disease clinical practice. Patients approved for surgery by the Mayo Clinic deep brain stimulation clinical committee participated in a 6-month prospective naturalistic follow-up study. In addition to the Unified Parkinson's Disease Rating Scale, stability and psychiatric safety were measured using the Beck Depression Inventory, Hamilton Depression Rating Scale, and Young Mania Rating scale. Outcomes were compared in patients with Parkinson disease who had a psychiatric history to those with no co-morbid psychiatric history. The study was completed by 49 of 54 patients. Statistically significant 6-month baseline to end-point improvement was found in motor and mood scales. No significant differences were found in psychiatric outcomes based on the presence or absence of psychiatric comorbidity. Our study suggests that patients with Parkinson disease who have a history of psychiatric co-morbidity can safely respond to deep brain stimulation with no greater risk of psychiatric adverse effect occurrence. A multidisciplinary team approach, including careful psychiatric screening ensuring mood stabilization and psychiatric follow-up, should be viewed as standard of care to optimize the psychiatric outcome in the course of deep brain stimulation treatment. © 2013 Published by The Academy of Psychosomatic Medicine on behalf of The Academy of Psychosomatic Medicine.

  20. Injectable Chemically Crosslinked Hydrogel for the Controlled Release of Bevacizumab in Vitreous: A 6-Month In Vivo Study

    PubMed Central

    Yu, Yu; Lau, Laurence Chi Ming; Lo, Amy Cheuk-yin; Chau, Ying

    2015-01-01

    Purpose To evaluate the biocompatibility and 6-month in vivo release of bevacizumab from a hyaluronic acid/dextran-based in situ hydrogel after intravitreal injection in rabbit eye. Methods The in situ hydrogel was formed by the catalyst-free chemical crosslinking between vinylsulfone functionalized hyaluronic acid (HA-VS) and thiolated dextran (Dex-SH) at physiological condition. The pH 7.4 buffered mixture containing HA-VS, Dex-SH, and bevacizumab were injected into the vitreous of rabbit eyes by a 30-G needle. The biocompatibility was evaluated by intraocular pressure measurement, binocular indirect ophthalmoscope (BIO), full-field electroretinogram (ERG), and histology. The concentrations of both total and active bevacizumab in rabbit vitreous were determined by enzyme-linked immunosorbent assay. The concentration of bevacizumab in rabbit vitreous after bolus injection was simulated by one-compartment first order elimination model. Results A transparent gel was seen in the vitreous after injection. BIO images, ERG, and histology showed that the gel does not induce hemorrhage, retinal detachment, inflammation, or other gross pathological changes in rabbit eyes after injection. While the bolus intravitreal injected bevacizumab follows the first order elimination kinetics in rabbit eye, the in situ gel formation was able to prolong the retention of bevacizumab in rabbit eye at therapeutic relevant concentration for at least 6 months. The concentration of bevacizumab 6 months after injection was about 107 times higher than bolus injection. Conclusions The new in situ hydrogel formulation of bevacizumab was biocompatible and able to prolong the retention of drug in rabbit eyes in vivo at therapeutic relevant concentration for at least 6 months. Translational Relevance Although proven to be effective, monthly intravitreal injection of bevacizumab or other protein drugs may cause various complications. Extending the residence time of protein therapeutics in the eye

  1. Women's experiences of their osteoporosis diagnosis at the time of diagnosis and 6 months later: a phenomenological hermeneutic study.

    PubMed

    Hansen, Carrinna; Konradsen, Hanne; Abrahamsen, Bo; Pedersen, Birthe D

    2014-01-01

    This paper describes a phenomenological hermeneutic study of experiences of women who were recently diagnosed with osteoporosis. The research objective was to investigate women's experiences of living with osteoporosis during the first 6 months after diagnosis when treatment was first prescribed. Fifteen women were included in the study. The inclusion criteria were a DXA scan at one of the two hospitals showing a T-score below -2.5 (lower back or hip), age 65 years or older; no previous known osteoporotic fracture; at least one of the known risk factors for osteoporosis; and prescription of anti-osteoporotic treatment. Exclusion criteria were previous diagnosis of osteoporosis or previous treatment with anti-osteoporotic medication. Data were collected through in-depth interviews shortly after diagnosis and 6 months later. The performed analyses were inspired by Paul Ricoeur's theory of interpretation of texts comprising three levels: naïve reading, structural analysis, and critical interpretation and discussion. Three key themes emerged: 1) being diagnosed, 2) being prescribed medical treatment, and 3) being on the path of learning to live with osteoporosis. The findings suggest a need for improved support for the patients to gain understanding of their diagnosis and the risk of osteoporotic fracture as well as to learn to live with osteoporosis. The study highlights new health promotion areas for targeting interventions at newly diagnosed patients, helping them accept and interpret the diagnosis, and the medical treatment.

  2. Women's experiences of their osteoporosis diagnosis at the time of diagnosis and 6 months later: A phenomenological hermeneutic study

    PubMed Central

    Hansen, Carrinna; Konradsen, Hanne; Abrahamsen, Bo; Pedersen, Birthe D.

    2014-01-01

    This paper describes a phenomenological hermeneutic study of experiences of women who were recently diagnosed with osteoporosis. The research objective was to investigate women's experiences of living with osteoporosis during the first 6 months after diagnosis when treatment was first prescribed. Fifteen women were included in the study. The inclusion criteria were a DXA scan at one of the two hospitals showing a T-score below −2.5 (lower back or hip), age 65 years or older; no previous known osteoporotic fracture; at least one of the known risk factors for osteoporosis; and prescription of anti-osteoporotic treatment. Exclusion criteria were previous diagnosis of osteoporosis or previous treatment with anti-osteoporotic medication. Data were collected through in-depth interviews shortly after diagnosis and 6 months later. The performed analyses were inspired by Paul Ricoeur's theory of interpretation of texts comprising three levels: naïve reading, structural analysis, and critical interpretation and discussion. Three key themes emerged: 1) being diagnosed, 2) being prescribed medical treatment, and 3) being on the path of learning to live with osteoporosis. The findings suggest a need for improved support for the patients to gain understanding of their diagnosis and the risk of osteoporotic fracture as well as to learn to live with osteoporosis. The study highlights new health promotion areas for targeting interventions at newly diagnosed patients, helping them accept and interpret the diagnosis, and the medical treatment. PMID:24559545

  3. Adapting Judicial Supervision to the Risk Level of Drug Offenders: Discharge and 6-month Outcomes from a Prospective Matching Study

    PubMed Central

    Marlowe, Douglas B.; Festinger, David S.; Dugosh, Karen L.; Lee, Patricia A.; Benasutti, Kathleen M.

    2007-01-01

    This article reports recent findings from a program of experimental research examining the effects of adapting judicial supervision to the risk level of drug-abusing offenders. Prior studies revealed that high-risk participants with (1) antisocial personality disorder or (2) a history of drug abuse treatment performed significantly better in drug court when they were scheduled to attend frequent, bi-weekly judicial status hearings in court. Low-risk participants performed equivalently regardless of the schedule of court hearings. The current study prospectively matched misdemeanor drug court clients to the optimal schedule of court hearings based upon an assessment of their risk status, and compared outcomes to those of clients randomly assigned to the standard schedule of court hearings. Results confirmed that high-risk participants graduated at a higher rate, provided more drug-negative urine specimens at 6 months post-admission, and reported significantly less drug use and alcohol intoxication at 6 months post-admission when they were matched to bi-weekly hearings as compared to the usual schedule of hearings. These findings yield practical information for enhancing the efficacy and cost-efficiency of drug court services. Directions for future research on adaptive programming for drug offenders are discussed. PMID:17071020

  4. Adapting judicial supervision to the risk level of drug offenders: discharge and 6-month outcomes from a prospective matching study.

    PubMed

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Lee, Patricia A; Benasutti, Kathleen M

    2007-05-01

    This article reports recent findings from a program of experimental research examining the effects of adapting judicial supervision to the risk level of drug-abusing offenders. Prior studies revealed that high-risk participants with (1) antisocial personality disorder or (2) a history of drug abuse treatment performed significantly better in drug court when they were scheduled to attend frequent, bi-weekly judicial status hearings in court. Low-risk participants performed equivalently regardless of the schedule of court hearings. The current study prospectively matched misdemeanor drug court clients to the optimal schedule of court hearings based upon an assessment of their risk status, and compared outcomes to those of clients randomly assigned to the standard schedule of court hearings. Results confirmed that high-risk participants graduated at a higher rate, provided more drug-negative urine specimens at 6 months post-admission, and reported significantly less drug use and alcohol intoxication at 6 months post-admission when they were matched to bi-weekly hearings as compared to the usual schedule of hearings. These findings yield practical information for enhancing the efficacy and cost-efficiency of drug court services. Directions for future research on adaptive programming for drug offenders are discussed.

  5. Sexual victimization history, depression, and task physiology as predictors of sexual revictimization: results from a 6-month prospective pilot study.

    PubMed

    Waldron, Jonathan C; Wilson, Laura C; Patriquin, Michelle A; Scarpa, Angela

    2015-02-01

    The current study examined depression and physiological reactivity to a sexual threat task as longitudinal predictors of sexual revictimization in women with sexual victimization histories. The sample included 14 young adult women (M(age) = 19.15) who reported child sexual abuse. Heart rate and root mean square of the successive differences were measured at baseline and during the presentation of sexual victimization-related words during an Emotional Stroop task. Results indicated that women who reported a greater history of childhood sexual abuse and adult sexual victimization were at increased risk for sexual revictimization 6 months after initial data collection. Furthermore, even after accounting for their childhood and adult sexual victimization histories and depression symptoms, women who exhibited reduced, or blunted, physiological activity during the sexual victimization stimuli of the Stroop task were more likely to report sexual revictimization during the 6-month follow-up. The findings suggest that sexual victimization survivors may benefit from interventions that address physiological blunting and the recognition of sexual threat cues in their environment.

  6. Impact of first-ever mild stroke on participation at 3 and 6 month post-event: the TABASCO study.

    PubMed

    Adamit, Tal; Maeir, Adina; Ben Assayag, Einor; Bornstein, Natan M; Korczyn, Amos D; Katz, Noomi

    2015-01-01

    This study focused on the relationships between cognition, participation and quality of life (QoL) among first-ever mild ischemic stroke patients 3 months post-event. We hypothesized that significant correlations exist between cognition, executive functions (EF), QoL and participation; and that EF and QoL will significantly contribute to participation beyond demographics and stroke severity at 3 and from 3 to 6 months post-stroke. A prospective cohort study, recruiting consecutive first-ever stroke patients from a large tertiary hospital. The inclusion criteria were first event, mild stroke (NIHSS ≤ 5), and no previous significant neurological or cognitive impairment. In addition to assessment every 6 month at the hospital, an assessment battery was administered at home 3 months post-stroke. Participants showed mild to moderate difficulties in cognition and participation (n = 249). Low to moderate correlations were found between cognition and EF with participation (-0.380, p < 0.05; r = 0.460, p < 0.001, respectively); and cognition with QoL (r = 0.421, p < 0.001). EF and QoL contributed significantly to participation at 3 months (R(2) = 0.961) and in addition education at 6 months (R(2) = 0.701). Participants after mild ischemic stroke experienced cognitive and EF difficulties that affect their participation and QoL. Further studies are needed of mild stroke survivors to enhance our understanding of the variables that affect participation. The findings of the current study have significant implications for the participation of people after mild stroke in the community. Health care systems in general and rehabilitation programs, in particular, do not consider that these clients need rehabilitation as most of them perform basic daily functions independently. Thus, although cognitive and EF deficits are found in people following even mild stroke, but are not externally apparent, these impairments are mostly neglected by the health care system. Mild stroke has long

  7. [Infant nutrition in Switzerland 1978. A prospective study on the nutritional habits during the first 6 months of life. I. Natural nutrition: breast feeding].

    PubMed

    Tönz, O; Schwaninger, U; Holzherr, E; Schafroth, M

    1980-06-14

    With the help of 55 nurses counseling young mothers in northern, central and eastern Switzerland the feeding habits of 371 infants born in March and April 1978 were studied during the first 6 months of life. Infants who were still breastfed at the end of the observation period were monitored for another 6 months. 92% of all infants were breastfed during the puerperium (62% receiving exclusively mother's milk). At the end of the second month some 60% of the infants were breast-fed (40% exclusively). At the end of the fourth month the numbers were 30% (15%) and after 6 months 18% (2%). The "mean corrected nursing period" was 10.25 weeks. The length of this period showed a direct correlation with the socioeconomic class of the family and especially with the educational status of the mother. A small difference in duration of the nursing period between male and female infants was not statistically significant, although during childbed there was a significant difference in favour of boys. There appeared to be a relationship between duration of nursing and age, parity and bodyweight of the mother. There were marked differences in frequency and duration of breast-feeding according to whether rooming-in was practiced during childbed or not. At the end of the first half year of life babies with a long nursing period had a significantly lower body weight than those with partial or no breastfeeding. A much smaller difference in body length resulted in a lower and probably more favourable weight/length ratio. There was no difference in head circumference. As compared with other industralized European countries, the authors regard current nursing habits in Switzerland as satisfactory.

  8. Training Intensity Distribution and Changes in Performance and Physiology of a 2nd Place Finisher Team of the Race across America Over a 6 Month Preparation Period

    PubMed Central

    Manunzio, Christian; Mester, Joachim; Kaiser, Walter; Wahl, Patrick

    2016-01-01

    Aim: To monitor the training intensity distribution (TID) and the development of physiological and performance parameters. Methods: During their preparation period for the RAAM, 4 athletes (plus 1 additional backup racer) performed 3 testing sessions; one before, one after 3, and one after 6 months of training. VO2max, maximal rate of lactate accumulation (dLa/dtmax), critical power, power output at lactate minimum (MLSSP), peak and mean power output during a sprint test, heart rate recovery, isometric strength, jumping height, and body composition were determined. All training sessions were recorded with a power meter. The endurance TID was analyzed based on the time in zone approach, according to a classical 3-zone model, including all power data of training sessions, and a power specific 3-zone model, where time with power output below 50% of MLSSP was not considered. Results: The TID using the classical 3-zone model reflected a pyramidal TID (zone 1: 63 ± 16, zone 2: 28 ± 13 and zone 3: 9 ± 4%). The power specific 3-zone model resulted in a threshold-based TID (zone 1: 48 ± 13, zone 2: 39 ± 10, zone 3: 13 ± 4%). VO2max increased by 7.1 ± 5.3% (P = 0.06). dLa/dtmax decreased by 16.3 ± 8.1% (P = 0.03). Power output at lactate minimum and critical power increased by 10.3 ± 4.1 and 16.8 ± 6.2% (P = 0.01), respectively. No changes were found for strength parameters and jumps. Conclusion: The present study underlines that a threshold oriented TID results in only moderate increases in physiological parameters. The amount of training below 50% of MLSSp (~28% of total training time) is remarkably high. Researchers, trainers, and athletes should pay attention to the different ways of interpreting training power data, to gain realistic insights into the TID and the corresponding improvements in performance and physiological parameters. PMID:28082909

  9. Physical Activity on Prescription (PAP), in patients with metabolic risk factors. A 6-month follow-up study in primary health care.

    PubMed

    Lundqvist, Stefan; Börjesson, Mats; Larsson, Maria E H; Hagberg, Lars; Cider, Åsa

    2017-01-01

    There is strong evidence that inadequate physical activity (PA) leads to an increased risk of lifestyle-related diseases and premature mortality. Physical activity on prescription (PAP) is a method to increase the level of PA of patients in primary care, but needs further evaluation. The aim of this observational study was to explore the association between PAP-treatment and the PA level of patients with metabolic risk factors and the relationship between changes in the PA level and health outcomes at the 6 month follow-up. This study included 444 patients in primary care, aged 27-85 years (56% females), who were physically inactive with at least one component of metabolic syndrome. The PAP-treatment model included: individualized dialogue concerning PA, prescribed PA, and a structured follow-up. A total of 368 patients (83%) completed the 6 months of follow-up. Of these patients, 73% increased their PA level and 42% moved from an inadequate PA level to sufficient, according to public health recommendations. There were significant improvements (p≤ 0.05) in the following metabolic risk factors: body mass index, waist circumference, systolic blood pressure, fasting plasma glucose, cholesterol, and low density lipoprotein. There were also significant improvements regarding health-related quality of life, assessed by the Short Form 36, in: general health, vitality, social function, mental health, role limitation-physical/emotional, mental component summary, and physical component summary. Regression analysis showed a significant association between changes in the PA level and health outcomes. During the first 6-month period, the caregiver provided PAP support 1-2 times. This study indicates that an individual-based model of PAP-treatment has the potential to change people's PA behavior with improved metabolic risk factors and self-reported quality of life at the 6 month follow-up. Thus, PAP seems to be feasible in a clinical primary care practice, with minimum effort

  10. Physical Activity on Prescription (PAP), in patients with metabolic risk factors. A 6-month follow-up study in primary health care

    PubMed Central

    Börjesson, Mats; Larsson, Maria E. H.; Hagberg, Lars; Cider, Åsa

    2017-01-01

    There is strong evidence that inadequate physical activity (PA) leads to an increased risk of lifestyle-related diseases and premature mortality. Physical activity on prescription (PAP) is a method to increase the level of PA of patients in primary care, but needs further evaluation. The aim of this observational study was to explore the association between PAP-treatment and the PA level of patients with metabolic risk factors and the relationship between changes in the PA level and health outcomes at the 6 month follow-up. This study included 444 patients in primary care, aged 27–85 years (56% females), who were physically inactive with at least one component of metabolic syndrome. The PAP-treatment model included: individualized dialogue concerning PA, prescribed PA, and a structured follow-up. A total of 368 patients (83%) completed the 6 months of follow-up. Of these patients, 73% increased their PA level and 42% moved from an inadequate PA level to sufficient, according to public health recommendations. There were significant improvements (p≤ 0.05) in the following metabolic risk factors: body mass index, waist circumference, systolic blood pressure, fasting plasma glucose, cholesterol, and low density lipoprotein. There were also significant improvements regarding health-related quality of life, assessed by the Short Form 36, in: general health, vitality, social function, mental health, role limitation-physical/emotional, mental component summary, and physical component summary. Regression analysis showed a significant association between changes in the PA level and health outcomes. During the first 6-month period, the caregiver provided PAP support 1–2 times. This study indicates that an individual-based model of PAP-treatment has the potential to change people’s PA behavior with improved metabolic risk factors and self-reported quality of life at the 6 month follow-up. Thus, PAP seems to be feasible in a clinical primary care practice, with minimum

  11. Emotional Experiences Predict the Conversion of Individuals with Attenuated Psychosis Syndrome to Psychosis: A 6-Month Follow up Study

    PubMed Central

    Chen, Fa Zhan; Wang, Yi; Sun, Xi Rong; Yao, Yu Hong; Zhang, Ning; Qiao, Hui Fen; Zhang, Lan; Li, Zhan Jiang; Lin, Hong; Lu, Zheng; Li, Jing; Chan, Raymond C. K.; Zhao, Xu Dong

    2016-01-01

    The present study explored the conversion rate in individuals with Attenuated Psychosis Syndrome (APS) and potential predictor for transition in mainland China. Sixty-three participants identified as APS were followed up 6 months later. The results showed that 17% of individuals with APS converted to full-blown psychosis. The converters exhibited significantly poorer emotional experience and expression than the non-converters at baseline. A further binary logistic regression analysis showed that emotional experience could predict the transition (Wald = 4.18, p = 0.041, 95% CI = 1.04~6.82). The present study suggests an important role of emotional processing in the prediction of the development of full-blown psychosis. PMID:27313553

  12. Impact of the method of exposure in total hip arthroplasty on the variability of gait in the first 6months of the postoperative period.

    PubMed

    Holnapy, Gergely; Illyés, Arpád; Kiss, Rita M

    2013-08-01

    Gait analysis has provided important information about the variability of gait for patients prior to and after total hip arthroplasty (THA). The objective of this research was to clarify how the method of exposure in total hip arthroplasty affects the variability of gait. Gait analysis was performed at 0.8m/s, 1.0m/s, and 1.2m/s on 25 patients with direct-lateral exposure (DL), 22 with antero-lateral exposure (AL) and 25 with posterior exposure (P) during total hip arthroplasty. The control group was represented by 45 healthy subjects of identical age. Gait analysis was performed pre-operatively and 3 and 6months after the surgery. Gait parameter variability was characterized by the coefficient of variance (CV) of spatial-temporal parameters and by the mean coefficient of variance (MeanCV) of angular parameters. The variability of gait tends to reach control values during the first 6months of the postoperative period in all three patient groups. Six months after THA, in patients operated with DL and AL exposure the variability of gait differs significantly from control values; however, in patients operated with P exposure, the variability of spatial-temporal and angular parameters - except the rotation of pelvis - was similar to that of controls. The type of surgical technique significantly influences the variability of gait. Difference in the variability of angular parameters predicts gait instability and increased risk of falling after THA without the joint capsule preserved. Joint capsule preservation ensures a recovery of gait variability. It should be taken into account when compiling rehabilitation protocols. Differences related to the method of exposure should be considered when abandoning therapeutic aids. Copyright © 2013 Elsevier Ltd. All rights reserved.

  13. Effectiveness of a brief group cognitive behavioral therapy for auditory verbal hallucinations: a 6-month follow-up study.

    PubMed

    Zanello, Adriano; Mohr, Sylvia; Merlo, Marco C G; Huguelet, Philippe; Rey-Bellet, Philippe

    2014-02-01

    The current study investigated the effectiveness of a group cognitive behavioral therapy for auditory verbal hallucinations (AVHs), the Voices Group. This consists of seven specific sessions. Forty-one participants with schizophrenic or schizoaffective disorders completed a battery of questionnaires. The severity of psychiatric symptoms, beliefs about voices, quality of life, self-esteem, clinical global impression, and functioning were assessed at baseline, before and after intervention, and at the 6-month follow-up. After intervention, there was a statistically significant reduction in the severity of AVHs. This result remained stable at follow-up. The dropout rate was high. Some differences were found in subjective experience of AVHs between the patients who completed the intervention and those who dropped out. Altogether, these findings suggest that a brief intervention has some positive benefits in patients struggling with voices, which remain stable over time.

  14. Abuse of older persons with dementia by family caregivers: results of a 6-month prospective study in Hong Kong.

    PubMed

    Yan, Elsie

    2014-10-01

    To examine the association between care recipients' agitated behaviors, family caregivers' burnout, and abuse in community dwelling older Chinese with dementia in Hong Kong. This was a 6-month prospective study. One hundred forty-nine caregivers provided information on their demographic characteristics, care recipients' everyday functioning and agitated behaviors, and caregivers' burnout symptoms. Caregivers were re-interviewed 6 months later and provided information on changes in both care recipients' everyday functioning and agitated behaviors, and verbally and physically abusive behaviors directed at care recipients in the past month. The single most significant variable in predicting abuse at 6-month follow-up was abuse at baseline. In addition, verbal abuse was predicted by more co-residing days, a high level of agitated behavior, and a strong sense of caregiver depersonalization. Care recipients were more likely to be physically abused if they were male, had no chronic conditions other than dementia, and demonstrated a high level of agitated behaviors. Entering caregiver burnout into the model did not modify the association between care recipients' agitated behavior and abuse for either verbal or physical abuse. This study is the first to establish an association between care recipients' agitated behaviors, burnout, and abuse by family caregivers using prospective data. The present results confirmed that care recipients' agitated behaviors and caregivers' symptoms of burnout are associated with family caregivers' abusive behaviors. Caregiver burnout did not mediate the association between agitated behaviors and abuse. Proper management of care recipients' agitated behaviors and adequate support provided to family caregivers may help prevent the development of new cases of elder mistreatment. Copyright © 2014 John Wiley & Sons, Ltd.

  15. Movardol® (N-acetylglucosamine, Boswellia serrata, ginger) supplementation in the management of knee osteoarthritis: preliminary results from a 6-month registry study.

    PubMed

    Bolognesi, G; Belcaro, G; Feragalli, B; Cornelli, U; Cotellese, R; Hu, S; Dugall, M

    2016-12-01

    Knee Osteoarthritis (OA) is a chronic disease caused by the deterioration of cartilage in joints, which results in activation of the inflammatory response, pain, and impaired movement. Complementary therapies, particularly supplementation, in the management of moderate/severe knee OA have been gaining attention. This registry study aimed at evaluating the synergistic effect of Movardol®, a supplementation containing active ingredients with recognized anti-inflammatory activities on symptoms and levels of circulating biomarkers of knee OA. 54 subjects with symptomatic, moderate knee OA freely decided to follow either a standard management (SM) (n = 26) or SM plus oral supplementation with Movardol® (n = 28). Movardol® supplementation containing N-acetyl-D-glucosamine, ginger, and Boswellia Serrata extract was taken at the following dosage: 3 tablets/day for one week and then 2 tablets/day. Several parameters were assessed at inclusion and after 1, 3 and 6 months: functional impairment by the Karnofsky Performance Scale Index; pain, stiffness, physical, social and emotional functions by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); total and pain-free walking distance; circulating biomarkers of inflammation and oxidative stress. Significant improvements in the functional outcomes and pain-free walking distance were observed after 1, 3 and 6 months in OA patients supplemented with Movardol®. Moreover, all the signs/symptoms of disease assessed by the WOMAC tended to regress over a 6-month period in patients following SM+supplementation. Inflammatory markers and plasmatic content of reactive oxygen species decreased over 6 months, in supplemented patients. Movardol® supplementation resulted to be safe and well tolerated, also showing the beneficial effect in term of a decrease in pharmacological and non-pharmacological treatments and, consequently, reduction in management costs. These preliminary results indicate the efficacy and

  16. Developmental milestones record - 6 months

    MedlinePlus

    Normal childhood growth milestones - 6 months; Childhood growth milestones - 6 months; Growth milestones for children - 6 months ... the weight on hands (often occurs by 4 months) Able to pick up a dropped object Able ...

  17. Safety assessment of heat-sterilized green tea catechin preparation: a 6-month repeat-dose study in rats.

    PubMed

    Morita, Osamu; Kirkpatrick, Jeannie B; Tamaki, Yasushi; Chengelis, Christopher P; Beck, Melissa J; Bruner, Richard H

    2009-08-01

    Evidence suggests that the purported health benefits associated with green tea consumption are related to tea catechins. In the present study, potential adverse effects of a standardized heat-sterilized green tea catechin (GTC-H) preparation was investigated following gavage administration to rats at doses of 0, 120, 400, 1200 mg/kg/day for 6 months. A decaffeinated high-dose group (1200 mg/kg/day) (GTC-HDC), was included for comparison. A possibly test article-related clinical finding of intermittent increased activity was noted in the 400 and 1200 mg/kg/day GTC-H groups, but was not considered to be adverse. Lower body weight gains without any decrease in food consumption were noted in the high-dose (1200 mg/kg/day)-treated GTC-H and GTC-HDC females. In the high-dose male GTC-H group, a lower total motor activity count for the 60-min session was noted prior to dosing at the study week 25 evaluations compared to the control group. Similar changes were not observed in the GTC-HDC group. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for GTC-H was 1200 mg/kg/day for males, the highest dose tested, and 400mg/kg/day for females based on reduced body weight gains. The NOAEL for GTC-HDC was 1200 mg/kg/day for males and could not be determined in females.

  18. Ridge preservation with the use of Bio-Oss collagen: A 6-month study in the dog.

    PubMed

    Araújo, Maurício G; Lindhe, Jan

    2009-05-01

    In previous short-term studies, it was observed that while the placement of biomaterial in alveolar sockets may promote bone formation and ridge preservation, the graft may in fact also delay healing. The objective of the present experiment was to evaluate the more long-term effect on hard tissue formation and the amount of ridge augmentation that can occur by the placement of a xenogeneic graft in extraction sockets of dogs. Five beagle dogs were used. The third mandibular premolars were hemi-sected. The distal roots were carefully removed. A graft consisting of Bio-Oss collagen was placed in one socket while the contra-lateral site was left without grafting. After 6 months of healing, the dogs were euthanized and biopsies were sampled. From each experimental site, four ground sections - two from the mesial root and two from the healed socket - were prepared, stained and examined under a microscope. The placement of Bio-Oss collagen in the fresh extraction socket served as a scaffold for tissue modeling but did not enhance new bone formation. In comparison with the non-grafted sites, the dimension of the alveolar process as well as the profile of the ridge was better preserved in Bio-Oss-grafted sites. The placement of a biomaterial in an extraction socket may modify modeling and counteract marginal ridge contraction that occurs following tooth removal.

  19. Walking direction triggers visuo-spatial orienting in 6-month-old infants and adults: An eye tracking study.

    PubMed

    Bardi, Lara; Di Giorgio, Elisa; Lunghi, Marco; Troje, Nikolaus F; Simion, Francesca

    2015-08-01

    The present study investigates whether the walking direction of a biological motion point-light display can trigger visuo-spatial attention in 6-month-old infants. A cueing paradigm and the recording of eye movements in a free viewing condition were employed. A control group of adults took part in the experiment. Participants were presented with a central point-light display depicting a walking human, followed by a single peripheral target. In experiment 1, the central biological motion stimulus depicting a walking human could be upright or upside-down and was facing either left or right. Results revealed that the latency of saccades toward the peripheral target was modulated by the congruency between the facing direction of the cue and the position of the target. In infants, as well as in adults, saccade latencies were shorter when the target appeared in the position signalled by the facing direction of the point-light walker (congruent trials) than when the target appeared in the contralateral position (incongruent trials). This cueing effect was present only when the biological motion cue was presented in the upright condition and not when the display was inverted. In experiment 2, a rolling point-light circle with unambiguous direction was adopted. Here, adults were influenced by the direction of the central cue. However no effect of congruency was found in infants. This result suggests that biological motion has a priority as a cue for spatial attention during development.

  20. Exercise, character strengths, well-being, and learning climate in the prediction of performance over a 6-month period at a call center

    PubMed Central

    Moradi, Saleh; Nima, Ali A.; Rapp Ricciardi, Max; Archer, Trevor; Garcia, Danilo

    2014-01-01

    Background: Performance monitoring might have an adverse influence on call center agents' well-being. We investigate how performance, over a 6-month period, is related to agents' perceptions of their learning climate, character strengths, well-being (subjective and psychological), and physical activity. Method: Agents (N = 135) self-reported perception of the learning climate (Learning Climate Questionnaire), character strengths (Values In Action Inventory Short Version), well-being (Positive Affect, Negative Affect Schedule, Satisfaction With Life Scale, Psychological Well-Being Scales Short Version), and how often/intensively they engaged in physical activity. Performance, “time on the phone,” was monitored for 6 consecutive months by the same system handling the calls. Results: Performance was positively related to having opportunities to develop, the character strengths clusters of Wisdom and Knowledge (e.g., curiosity for learning, perspective) and Temperance (e.g., having self-control, being prudent, humble, and modest), and exercise frequency. Performance was negatively related to the sense of autonomy and responsibility, contentedness, the character strengths clusters of Humanity and Love (e.g., helping others, cooperation) and Justice (e.g., affiliation, fairness, leadership), positive affect, life satisfaction and exercise Intensity. Conclusion: Call centers may need to create opportunities to develop to increase agents' performance and focus on individual differences in the recruitment and selection of agents to prevent future shortcomings or worker dissatisfaction. Nevertheless, performance measurement in call centers may need to include other aspects that are more attuned with different character strengths. After all, allowing individuals to put their strengths at work should empower the individual and at the end the organization itself. Finally, physical activity enhancement programs might offer considerable positive work outcomes. PMID:25002853

  1. Exercise, character strengths, well-being, and learning climate in the prediction of performance over a 6-month period at a call center.

    PubMed

    Moradi, Saleh; Nima, Ali A; Rapp Ricciardi, Max; Archer, Trevor; Garcia, Danilo

    2014-01-01

    Performance monitoring might have an adverse influence on call center agents' well-being. We investigate how performance, over a 6-month period, is related to agents' perceptions of their learning climate, character strengths, well-being (subjective and psychological), and physical activity. Agents (N = 135) self-reported perception of the learning climate (Learning Climate Questionnaire), character strengths (Values In Action Inventory Short Version), well-being (Positive Affect, Negative Affect Schedule, Satisfaction With Life Scale, Psychological Well-Being Scales Short Version), and how often/intensively they engaged in physical activity. Performance, "time on the phone," was monitored for 6 consecutive months by the same system handling the calls. Performance was positively related to having opportunities to develop, the character strengths clusters of Wisdom and Knowledge (e.g., curiosity for learning, perspective) and Temperance (e.g., having self-control, being prudent, humble, and modest), and exercise frequency. Performance was negatively related to the sense of autonomy and responsibility, contentedness, the character strengths clusters of Humanity and Love (e.g., helping others, cooperation) and Justice (e.g., affiliation, fairness, leadership), positive affect, life satisfaction and exercise Intensity. Call centers may need to create opportunities to develop to increase agents' performance and focus on individual differences in the recruitment and selection of agents to prevent future shortcomings or worker dissatisfaction. Nevertheless, performance measurement in call centers may need to include other aspects that are more attuned with different character strengths. After all, allowing individuals to put their strengths at work should empower the individual and at the end the organization itself. Finally, physical activity enhancement programs might offer considerable positive work outcomes.

  2. Quality of life in women with cervical precursor lesions and cancer: a prospective, 6-month, hospital-based study in China

    PubMed Central

    Zhao, Zhi-Mei; Pan, Xiong-Fei; Lv, Si-Han; Xie, Yao; Zhang, Shao-Kai; Qiao, You-Lin; Qi, Xiao-Rong; Yang, Chun-Xia; Zhao, Fang-Hui

    2014-01-01

    The overall survival of patients with cervical cancer has improved due to detection at an early stage and availability of comprehensive treatments in China. As patients' lives prolonged, it is important to understand their health-related quality of life (QoL) during and after treatment. We used the EQ-5D questionnaire to assess QoL of 194 patients with cervical lesions at Sichuan University West China Second Hospital between May 2010 and January 2011. Patients were surveyed before primary treatment and at 1, 3, and 6 months after primary treatment. Results showed a consistent decline in EQ-5D scores in the spectrum of cervical lesions at each time point after treatment (all P < 0.05). For patients with precursor lesions, there was an increasing trend along the timeline of treatment (P < 0.01). For patients with early-stage cervical cancer, EQ-5D scores declined in the first month (P = 0.01) and gradually increased to higher levels at 6 months post-treatment than those before treatment (P < 0.01). EQ-5D scores followed a similar trend in patients with advanced cervical cancer (P = 0.04), though they did not statistically rebound after 6 months (0.84 ± 0.19 vs. 0.86 ± 0.11, P = 0.62). Regarding advanced cervical cancer, EQ-5D scores for women above 40 years of age appeared to recover more rapidly and reached higher levels than those for women below 40 years (P = 0.03). Caution and extra care are recommended in the early period of cervical cancer treatment given the slight deterioration in the QoL, and in particular, for younger cervical cancer patients. Our study implies that health care providers may need to improve the health-related QoL of cervical cancer patients. PMID:24698497

  3. Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

    PubMed

    Luciano, Juan V; Guallar, José A; Aguado, Jaume; López-Del-Hoyo, Yolanda; Olivan, Bárbara; Magallón, Rosa; Alda, Marta; Serrano-Blanco, Antoni; Gili, Margalida; Garcia-Campayo, Javier

    2014-04-01

    In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

  4. Exploratory study describing 6 month outcomes for young children with autism who receive treatment as usual in Italy

    PubMed Central

    Muratori, Filippo; Narzisi, Antonio

    2014-01-01

    Background In the last few years, the results of different studies have confirmed, in different ways, the importance of early intervention for autism. This study aims to evaluate the role of early “as usual” interventions in the outcome of toddlers diagnosed with autism spectrum disorder (ASD). Method Seventy children with ASD aged between 24 and 48 months were recruited at different centers in Italy. They were evaluated by blind researchers at baseline and after 6 months of using Autism Diagnostic Observation Schedule-Generic (ADOS-G), Griffiths Mental Developmental Scales, and Vineland Adaptive Behavior scales. Parents filled out the MacArthur Inventory, Social Communication Questionnaire, and Child Behavior Check List. All children were referred to community providers for available interventions. Results At the endpoint, most of the children were still classified as having an ADOS-G classification of ASD. However, 21 (34.2%) passed from autism to autism spectrum, and 3 (4.2%) passed from autism spectrum to no spectrum. Treatment effects were obtained for cognitive functioning, language, adaptive behavior, and child behavior without differences between development-oriented and behavior-oriented interventions. Parent involvement was a mediator for the best clinical outcome. Baseline low impairments of communication, language comprehension, and gesture were predictors of positive outcome. Conclusion Treatment as usual, composed of individual therapy plus school-supported inclusion, may be an effective intervention in ASD. Better initial levels of communication in child and parent involvement during treatment have an important role for a positive outcome. PMID:24748794

  5. Effects on human bronchial epithelial cells following low-dose chronic exposure to nanomaterials: A 6-month transformation study.

    PubMed

    Phuyal, Santosh; Kasem, Mayes; Rubio, Laura; Karlsson, Hanna L; Marcos, Ricard; Skaug, Vidar; Zienolddiny, Shanbeh

    2017-10-01

    The most plausible exposure route to manufactured nanomaterials (MNM) remains pulmonary inhalation. Yet, few studies have attempted to assess carcinogenic properties in vitro following long-term exposure of human pulmonary cells to low and occupationally relevant doses. The most advanced in vitro tests for carcinogenicity, the cell transformation assay (CTA), rely mostly on rodent cells and short-term exposure. We hypothesized that long-term exposure of human bronchial epithelial cells with a normal phenotype could be a valuable assay for testing carcinogenicity of nanomaterials. Therefore, this study (performed within the framework of the FP7-NANoREG project) assessed carcinogenic potential of chronic exposure (up to 6months) to low doses of multi-walled carbon nanotubes (MWCNT, NM-400 and NM-401) and TiO2 materials (NM62002 and KC7000). In order to harmonize and standardize the experiments, standard operating protocols of MNM dispersion (NANOGENOTOX) were used by three different NANoREG project partners. All nanomaterials showed low cytotoxicity in short-term tests for the tested doses (0.96 and 1.92μg/cm(2)). During long-term exposure, however, NM-401 clearly affected cell proliferation. In contrast, no cell transformation was observed for NM-401 by any of the partners. NM-400 and NM62002 formed some colonies after 3months. We conclude that agglomerated NM-401 in low doses affect cell proliferation but do not cause cell transformation in the CTA assay used. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study.

    PubMed

    Jouen, Anne-Lise; Narzisi, Antonio; Xavier, Jean; Tilmont, Elodie; Bodeau, Nicolas; Bono, Valentina; Ketem-Premel, Nabila; Anzalone, Salvatore; Maharatna, Koushik; Chetouani, Mohamed; Muratori, Filippo; Cohen, David

    2017-01-01

    To meet the required hours of intensive intervention for treating children with autism spectrum disorder (ASD), we developed an automated serious gaming platform (11 games) to deliver intervention at home (GOLIAH) by mapping the imitation and joint attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. Here, we report the results of a 6-month matched controlled exploratory study. From two specialized clinics, we included 14 children (age range 5-8 years) with ASD and 10 controls matched for gender, age, sites, and treatment as usual (TAU). Participants from the experimental group received in addition to TAU four 30-min sessions with GOLIAH per week at home and one at hospital for 6 months. Statistics were performed using Linear Mixed Models. Children and parents participated in 40% of the planned sessions. They were able to use the 11 games, and participants trained with GOLIAH improved time to perform the task in most JA games and imitation scores in most imitation games. GOLIAH intervention did not affect Parental Stress Index scores. At end-point, we found in both groups a significant improvement for Autism Diagnostic Observation Schedule scores, Vineland socialization score, Parental Stress Index total score, and Child Behavior Checklist internalizing, externalizing and total problems. However, we found no significant change for by time × group interaction. Despite the lack of superiority of TAU + GOLIAH versus TAU, the results are interesting both in terms of changes by using the gaming platform and lack of parental stress increase. A large randomized controlled trial with younger participants (who are the core target of ESDM model) is now discussed. This should be facilitated by computing GOLIAH for a web platform. Trial registration Clinicaltrials.gov NCT02560415.

  7. Chemotherapy and human chorionic gonadotropin concentrations 6 months after uterine evacuation of molar pregnancy: a retrospective cohort study

    PubMed Central

    Agarwal, Roshan; Teoh, Suliana; Short, Delia; Harvey, Richard; Savage, Philip M; Seckl, Michael J

    2012-01-01

    Summary Background Indications for chemotherapy in gestational trophoblastic disease include raised human chorionic gonadotropin (hCG) concentrations 6 months after uterine evacuation of hydatidiform mole, even when values are falling. We aimed to establish whether chemotherapy is always necessary in these patients. Methods We retrospectively identified women registered between January, 1993, and May, 2008, at Charing Cross Hospital, London, UK, who had persistently high hCG concentrations 6 months after evacuation of hydatidiform mole. Rates of hCG normalisation, relapse, and death were assessed in patients continued under surveillance and those who received chemotherapy after 6 months. We postulated that a surveillance policy would be clinically acceptable if hCG values returned to normal in 75% of patients or more. Findings 76 (<1%) of 13 960 patients with hydatidiform moles had persistently high hCG concentrations of more than 5 IU/L 6 months after evacuation. 66 (87%) patients continued under surveillance and hCG values spontaneously returned to normal without chemotherapy in 65 (98%) of these patients. Values in one patient did not become normal because of chronic renal failure, but she remains healthy. Ten patients received chemotherapy, and hCG concentrations returned to normal in eight (80%) of these individuals (surveillance vs chemotherapy groups p=0·044) and remained slightly high (6–11 IU/L) in two without any associated clinical problems off treatment. We noted no significant differences between individuals in the surveillance and chemotherapy groups, apart from lower median hCG concentrations 6 months after evacuation in those under surveillance than in those given chemotherapy (13 IU/L, range 5–887, vs 157 IU/L, range 6–6438; p=0·004). Overall, there were no deaths in this series. Interpretation A surveillance policy seems to be clinically acceptable in patients with low and declining concentrations of hCG 6 months after evacuation of

  8. Efficacy of the special extract ERr 731 from rhapontic rhubarb for menopausal complaints: a 6-month open observational study.

    PubMed

    Kaszkin-Bettag, Marietta; Beck, Sabine; Richardson, Andy; Heger, Peter W; Beer, André-Michael

    2008-01-01

    The special extract ERr 731 from the roots of rhapontic rhubarb has been in widespread use in Germany since 1993, and the current regulations have required an evaluation of its risk:benefit ratio in daily use. To demonstrate the efficacy and tolerability ofERr 731 in menopausal women in everyday practice. Three hundred sixty-three menopausal women with menopausal symptoms were enrolled at 70 German gynecological practices and received ERr 731 for 6 months. Women visited the practices for a baseline assessment and after 3 and 6 months. Primary outcome criterion was the change of the Menopause Rating Scale (MRS) total score after 6 months. Other assessments included compliance, tolerability, health-related quality of life, and occurrence of adverse events. After 6 months of treatment with ERr 731 in 252 women, there was a significant decrease of the MRS total score from 14.5 points at baseline to 6.5 points (P<.0001). The reduction of the MRS score was more pronounced in women with a score of > or =18 points at baseline. One tablet per day was sufficient to reduce the symptoms significantly in the majority of women. The health-related quality of life improved markedly. A good or very good treatment outcome was reported by the majority of the participating women. One adverse event was reported that was assessed as having no relation to ERr 731 intake. ERr 731 is a well-tolerated and safe medication for the successful treatment of menopausal symptoms in peri- and postmenopausal women.

  9. Coping strategies and self-stigma among adolescents discharged from psychiatric hospitalization: a 6-month follow-up study.

    PubMed

    Moses, Tally

    2015-03-01

    The effects of mental illness stigma on adolescents receiving psychiatric treatment may largely be determined by their coping strategies. Yet, little is known about adolescents' use of stigma-coping strategies, or how helpful these are for addressing stigma-related stress. This study explores how adolescents discharged from psychiatric hospitalization anticipate coping with a hypothetical social stigma event related to hospitalization. We examine how well anticipated coping strategies predict adolescents' self-stigma ratings following 6 months. To evaluate the direction of causality, the reverse order of effects, the influence of self-stigma on coping strategies, is also assessed. A voluntary sample of 80 adolescents participated in two face-to-face interviews that assessed coping and self-stigma. Anticipated (baseline) and actual (follow-up) coping strategies were measured with a modified Response to Stress Questionnaire (primary and secondary control engagement coping, disengagement) and two stigma-specific strategies developed for this study (disconfirming stereotypes and aggression/confrontation). Relationships between anticipated coping strategies and self-stigma were assessed with ordinary least squares (OLS) regression; multivariate general linear modeling (GLM) and structural equation modeling (SEM) explored the reverse associations. Youth reporting higher self-stigma ratings at follow-up anticipated using more disengagement and effort to disconfirm stereotypes and less secondary control engagement coping at baseline. Anticipated use of secondary control engagement coping was uniquely significant in predicting participants' self-stigma when controlling for baseline self-stigma. At the same time, higher baseline self-stigma ratings predicted less adaptive coping (disengagement and effort to disconfirm stereotypes) at follow-up. The results point to the particular importance of secondary control engagement coping for helping to mitigate the impact of peer

  10. A comparison of teriparatide and calcitonin therapy in postmenopausal Asian women with osteoporosis: a 6-month study.

    PubMed

    Kung, A W C; Pasion, E G; Sofiyan, M; Lau, E M C; Tay, B K; Lam, K S; Wilawan, K; Ongphiphadhanakul, B; Thiebaud, D

    2006-05-01

    The number of hip fractures is expected to double in the next 20 years, with current estimates that Asia will account for 37% of these cases. As bone mineral density (BMD) may be used as a measure of fracture risk, we sought to compare the effects of teriparatide with salmon calcitonin treatment on changes in BMD, biochemical bone markers, and safety in postmenopausal Asian women with osteoporosis. A total of 104 patients (n = 47 teriparatide [20 g/day subcutaneously] and n = 57 calcitonin [100 IU/day subcutaneously]) were enrolled in Hong Kong, Singapore, Philippines, Malaysia, and Thailand. Calcium (> or = 500 mg/day) and vitamin D (200-400 IU/day) supplements were taken throughout the 6-month controlled, randomized study. Teriparatide was associated with a 5.03 +/- 4.77% increase in lumbar spine BMD (p < 0.0001, mean +/- SD change from baseline), whereas changes in lumbar spine BMD for patients on calcitonin were not statistically significant (mean change of 0.36 +/- 4.12%, p = 0.16). Comparison of the two groups indicated that teriparatide treatment improved lumbar spine BMD statistically significantly more than calcitonin (p < 0.0001). No statistically significant changes were observed for total hip or femoral neck BMD. Serum bone-specific alkaline phosphatase (BSAP) increased by 55.9% (median change from baseline, p < 0.0001) in the teriparatide group, and remained stable with calcitonin (5.0% change, p = 0.24); osteocalcin increased by 156.15% (median change from baseline, p < 0.0001) with teriparatide, and decreased with calcitonin (-15.25%, p = 0.03). Similar rates of adverse events were observed, with nausea and dizziness the most commonly reported for both groups (teriparatide versus calcitonin, 13.0% versus 23.2% p = 0.21, 10.9% versus 21.4% p = 0.19, respectively). There were no clinically relevant changes observed in laboratory parameters. Both treatments were similarly tolerated, however teriparatide was associated with greater increases in lumbar

  11. The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial.

    PubMed

    Turner-McGrievy, Gabrielle M; Wilcox, Sara; Boutté, Alycia; Hutto, Brent E; Singletary, Camelia; Muth, Eric R; Hoover, Adam W

    2017-08-01

    To examine the use of two different mobile dietary self-monitoring methods for weight loss. Adults with overweight (n = 81; mean BMI 34.7 ± 5.6 kg/m(2) ) were randomized to self-monitor their diet with a mobile app (App, n = 42) or wearable Bite Counter device (Bite, n = 39). Both groups received the same behavioral weight loss information via twice-weekly podcasts. Weight, physical activity (International Physical Activity Questionnaire), and energy intake (two dietary recalls) were assessed at 0, 3, and 6 months. At 6 months, 75% of participants completed the trial. The App group lost significantly more weight (-6.8 ± 0.8 kg) than the Bite group (-3.0 ± 0.8 kg; group × time interaction: P < 0.001). Changes in energy intake (kcal/d) (-621 ± 157 App, -456 ± 167 Bite; P = 0.47) or number of days diet was tracked (90.7 ± 9.1 App, 68.4 ± 9.8 Bite; P = 0.09) did not differ between groups, but the Bite group had significant increases in physical activity metabolic equivalents (+2015.4 ± 684.6 min/wk; P = 0.02) compared to little change in the App group (-136.5 ± 630.6; P = 0.02). Total weight loss was significantly correlated with number of podcasts downloaded (r = -0.33, P < 0.01) and number of days diet was tracked (r = -0.33, P < 0.01). While frequency of diet tracking was similar between the App and Bite groups, there was greater weight loss observed in the App group. © 2017 The Obesity Society.

  12. Carbon-dioxide laser-assisted tonsil ablation for adults with chronic tonsillitis: a 6-month follow-up study.

    PubMed

    Remacle, Marc; Keghian, Jerome; Lawson, Georges; Jamart, Jacques

    2003-09-01

    Sixty-six adult patients with a mean age of 44 years (range: 16-78) with chronic tonsillitis underwent laser-assisted tonsil ablation between January 1998 and January 2002. Instead of vaporization of the tonsil surface, extended serial tonsillectomy was performed, namely, vaporizing 80-90% of the palatine lymphoid tissue. Of the 66 patients, 49 (74%) underwent local anesthesia (LA group) and 17 (26%) general anesthesia (GA group). In the LA group, one surgical session sufficed for 40 patients (82%); two sessions were required for seven patients (14%) and three sessions for two patients (4%). Monopolar electrocautery was necessary to ensure hemostasis in two patients (3%). Median value results revealed a pain-intensity score of 4.5 (range: 0-10) for the GA group and 5 (range: 0-10) for the LA group. Pain lasted for 3 days (range: 0-15) in both groups (nonsignificant difference). A satisfaction score of 10 (range: 1-10) was recorded for the GA group and 8 (range: 1-10) for the LA group (P=0.029). The minimum follow-up was 6 months. Forty of the 49 LA group patients (82%) and 16 of the 17 GA group patients (94%) would recommend the surgical procedure and would accept undergoing the same operation again (nonsignificant difference).

  13. Your Child's Development: 6 Months

    MedlinePlus

    ... to 2-Year-Old Your Child's Development: 6 Months KidsHealth > For Parents > Your Child's Development: 6 Months A A A Notice your baby doing anything new? Big strides in development are happening this month. That's because the left side of the brain ...

  14. Study of Ocean Loading Effects in Brittany, France, From a Multi-Software Analysis of 6-Months GPS Data.

    NASA Astrophysics Data System (ADS)

    Vergnolle, M.; Durand, S.; Morel, L.; Nicolas, J.; Bouin, M.; Masson, F.

    2005-12-01

    In northwestern France, ocean tides can reach up to 10 m and induce crustal displacements up to 12 cm peak-to-peak on the vertical component and cm-level displacements on the horizontal components. Hence, this region is particulary suited for studying ocean loading effects. Former geodetic experiments, which showed 3D crustal displacements with semi-diurnal main period and some non linear terms, were carried out in Brittany in 1998 and 1999 but lasted only 3 days. In order to confirm these former results and to go further in the study of the ocean loading effects in Brittany, a new national multi-techniques campaign (GPS, gravimetry, inclinometry, tide gauges, laser ranging, barometry) was realized in 2004. In particular, the GPS experiment was conducted on 12 and 6 local stations from March to June and September to October 2004 respectively. First, we present the GPS time series obtained from a global analysis with the GAMIT 10.2 GPS software. We show a good first order agreement between these times series and up to date ocean tide model predictions (FES2004) in terms of amplitude and main period. Then, in order to understand the discrepancies and refine our results, we test two other GPS softwares (Gipsy Oasis II (Precise Point Positioning strategy) and Bernese 5.0), and various processing strategies for the positioning and the reference frame definition. The joint analysis of the resulting time series allow us (1) to better determine the GPS resolution we can expect in ocean tide loading studies, (2) to better attribute the discrepancies between GPS time series and model to GPS accuracy, software or strategy limitations and/or to effect not taken into account in the model, and (3) to better understand the geophysical processes that govern the Earth response to ocean tide loading.

  15. Bio-Oss collagen in the buccal gap at immediate implants: a 6-month study in the dog.

    PubMed

    Araújo, Mauricio G; Linder, Elena; Lindhe, Jan

    2011-01-01

    following tooth extraction and immediate implant installation, the edentulous site of the alveolar process undergoes substantial bone modeling and the ridge dimensions are reduced. objective: the objective of the present experiment was to determine whether the process of bone modeling following tooth extraction and immediate implant placement was influenced by the placement of a xenogenic graft in the void that occurred between the implant and the walls of the fresh extraction socket. five beagle dogs about 1 year old were used. The 4th premolar in both quadrants of the mandible ((4) P(4) ) were selected and used as experimental sites. The premolars were hemi-sected and the distal roots removed and, subsequently, implants were inserted in the distal sockets. In one side of the jaw, the marginal buccal-approximal void that consistently occurred between the implant and the socket walls was grafted with Bio-Oss Collagen while no grafting was performed in the contra-lateral sites. After 6 months of healing, biopsies from each experimental site were obtained and prepared for histological analyses. the outline of the marginal hard tissue of the control sites was markedly different from that of the grafted sites. Thus, while the buccal bone crest in the grafted sites was comparatively thick and located at or close to the SLA border, the corresponding crest at the control sites was thinner and located a varying distance below SLA border. it was demonstrated that the placement of Bio-Oss Collagen in the void between the implant and the buccal-approximal bone walls of fresh extraction sockets modified the process of hard tissue healing, provided additional amounts of hard tissue at the entrance of the previous socket and improved the level of marginal bone-to-implant contact.

  16. Perceived work ability, quality of life, and fatigue in patients with rheumatoid arthritis after a 6-month course of TNF inhibitors: prospective intervention study and partial economic evaluation.

    PubMed

    Hoving, J L; Bartelds, G M; Sluiter, J K; Sadiraj, K; Groot, I; Lems, W F; Dijkmans, B A C; Wijbrandts, C A; Tak, P P; Nurmohamed, M T; Voskuyl, A E; Frings-Dresen, M H W

    2009-01-01

    The objective of this exploratory study was to evaluate the effects and costs of a 6-month course of tumour necrosis factor (TNF) inhibitors on work ability, quality of life, and fatigue in patients with rheumatoid arthritis (RA). In this prospective single-arm intervention study 59 consecutive patients of working age with established RA were recruited from an outpatient clinic in Amsterdam, the Netherlands. All patients received fortnightly subcutaneous injections of 40 mg adalimumab. The three outcomes at baseline and 6 months were: perceived work ability [Work Ability Index (WAI)], quality of life [Rheumatoid Arthritis Quality of Life instrument (RAQoL)], and fatigue [Checklist Individual Strength (CIS), Need for Recovery (NFR) scale]. Cost data of the preceding 6 months were collected using a self-administered patient questionnaire at baseline and follow-up. At 6 months, all outcomes showed a statistically significant improvement in mean scores from baseline, ranging from 10.0% (WAI), to 11.7% (RAQoL), to 15% (NFR) (subgroup paid work, n = 26). The total mean costs showed a twofold increase in mean costs per week per patient [difference EUR 169, 95% confidence interval (CI) EUR 113-226]. In this short-term exploratory evaluation, a 6-month course of TNF inhibitors improved work ability and quality of life, and reduced fatigue in patients with established RA. These effects are associated with an increase in total healthcare costs, attributable to the costs of TNF inhibitors. Randomized controlled trials with a longer follow-up are needed to show a long-term effect on work disability and the potential cost-effectiveness of TNF inhibitors.

  17. Your Child's Development: 6 Months

    MedlinePlus

    ... Child Too Busy? Helping Your Child Adjust to Preschool School Lunches Kids and Food: 10 Tips for Parents Healthy Habits for TV, Video Games, and the Internet Your Child's Development: 6 Months KidsHealth > For Parents > Your Child's Development: ...

  18. Effects of the Cessation of Mass Screening for Neuroblastoma at 6 Months of Age: A Population-Based Study in Osaka, Japan.

    PubMed

    Ioka, Akiko; Inoue, Masami; Yoneda, Akihiro; Nakamura, Tetsuro; Hara, Junichi; Hashii, Yoshiko; Sakata, Naoki; Yamato, Kazumi; Tsukuma, Hideaki; Kawa, Keisei

    2016-01-01

    In 2004, the Japanese government halted the 6-month mass screening program for neuroblastoma. We investigated whether its cessation had led to an increase not only in mortality due to this disease but also in the incidence of advanced-stage disease among older children. Study subjects were neuroblastoma patients retrieved from the population-based Osaka Cancer Registry. Trends of incidence and mortality from neuroblastoma were analyzed by calendar year and birth cohort. Prognostic factors, including stage and v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) oncogene status, were compared before and after the cessation of mass screening. Age-standardized incidence rates in 2005-2009 (the cessation period of mass screening; 11.1 per million) were similar to those in 1975-1979 (the pre-screening period; 8.6 per million). Age-standardized mortality rates tended to decrease from 1975-1979 (4.0 per million) to 2005-2009 (2.7 per million) in parallel with the improvement in survival. Analysis by birth cohort indicated that the mortality rates in 2004-2005 (after cessation) for children 0-4 years of age were lower than those in 1975-1979 (O:E ratio 0.25; 95% confidence interval, 0.03-0.90). For children 1-9 years of age, there was a not significant difference in the distribution of stage, MYCN oncogene status, and DNA ploidy between 1991-2003 (the mass screening period) and 2004-2008 (after cessation). The cessation of mass screening for neuroblastoma does not appear to have increased mortality due to this disease or incidence of advanced-stage disease among older children.

  19. Effects of the Cessation of Mass Screening for Neuroblastoma at 6 Months of Age: A Population-Based Study in Osaka, Japan

    PubMed Central

    Ioka, Akiko; Inoue, Masami; Yoneda, Akihiro; Nakamura, Tetsuro; Hara, Junichi; Hashii, Yoshiko; Sakata, Naoki; Yamato, Kazumi; Tsukuma, Hideaki; Kawa, Keisei

    2016-01-01

    Background In 2004, the Japanese government halted the 6-month mass screening program for neuroblastoma. We investigated whether its cessation had led to an increase not only in mortality due to this disease but also in the incidence of advanced-stage disease among older children. Methods Study subjects were neuroblastoma patients retrieved from the population-based Osaka Cancer Registry. Trends of incidence and mortality from neuroblastoma were analyzed by calendar year and birth cohort. Prognostic factors, including stage and v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) oncogene status, were compared before and after the cessation of mass screening. Results Age-standardized incidence rates in 2005–2009 (the cessation period of mass screening; 11.1 per million) were similar to those in 1975–1979 (the pre-screening period; 8.6 per million). Age-standardized mortality rates tended to decrease from 1975–1979 (4.0 per million) to 2005–2009 (2.7 per million) in parallel with the improvement in survival. Analysis by birth cohort indicated that the mortality rates in 2004–2005 (after cessation) for children 0–4 years of age were lower than those in 1975–1979 (O:E ratio 0.25; 95% confidence interval, 0.03–0.90). For children 1–9 years of age, there was a not significant difference in the distribution of stage, MYCN oncogene status, and DNA ploidy between 1991–2003 (the mass screening period) and 2004–2008 (after cessation). Conclusions The cessation of mass screening for neuroblastoma does not appear to have increased mortality due to this disease or incidence of advanced-stage disease among older children. PMID:26548355

  20. [Efficacy and tolerability of 5% minoxidil solution (Carexidil®) in male and female androgenetic alopecia: a 6-month open multicentric study].

    PubMed

    Piraccini, B; Starace, M; Alessandrini, A; Guarrera, M; Fiorucci, M C; Lorenzi, S

    2011-12-01

    The aim of the study was to evaluate efficacy and safety of 5% Carexidil solution®, applied twice a day on the scalp, on male and female androgenetic alopecia. The 6 month-study was performed in three Italian dermatological centers. Evaluation of efficacy was performed with subjective and objective methods, including operator and patient assessments, global photography and videodermoscopy. Global photography revealed that after 6 months of treatment with 5% Carexidil solution®, androgenetic alopecia was improved in all 32 females and 16 males. Alopecia stopped to progress in 6 males. Scalp videodermoscopy confirmed the results. Some patients complained of increased hair greasiness, others complained of mild scalp itching. Two female patients developed contact sensitization to minoxidil, confirmed by patch test, 2 a mild malar-temporal hypertrichosis. All patients were satisfied by treatment and continued it after the end of the study. Our study confirms the data of the literature and the evidence coming from years of clinical experience, that twice a day topical application of 5% minoxidil solution, Carexidil ®, is effective in the treatment of male and female androgenetic alopecia, with evident efficacy already after 6 months.

  1. Success rates with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not intending to quit.

    PubMed

    Polosa, Riccardo; Caponnetto, Pasquale; Maglia, Marilena; Morjaria, Jaymin B; Russo, Cristina

    2014-11-08

    Electronic cigarettes (e-Cigs) are an attractive long-term alternative nicotine source to conventional cigarettes. Although they may assist smokers to remain abstinent during their quit attempt, studies using first generation e-Cigs report low success rates. Second generation devices (personal vaporisers - PVs) may result in much higher quit rates, but their efficacy and safety in smoking cessation and/or reduction in clinical trials is unreported. We conducted a prospective proof-of-concept study monitoring modifications in smoking behaviour of 50 smokers (unwilling to quit) switched onto PVs. Participants attended five study visits: baseline, week-4, week-8, week-12 and week-24. Number of cigarettes/day (cigs/day) and exhaled carbon monoxide (eCO) levels were noted at each visit. Smoking reduction/abstinence rates, product usage, adverse events and subjective opinions of these products were also reviewed. Sustained 50% and 80% reduction in cigs/day at week-24 was reported in 15/50 (30%) and 7/50 (14%) participants with a reduction from 25cigs/day to 6cigs/day (p < 0.001) and 3cigs/day (p < 0.001), respectively. Smoking abstinence (self-reported abstinence from cigarette smoking verified by an eCO ≤10 ppm) at week-24 was observed in 18/50 (36%) participants, with 15/18 (83.3%) still using their PVs at the end of the study. Combined 50% reduction and smoking abstinence was shown in 33/50 (66%) participants. Throat/mouth irritation (35.6%), dry throat/mouth (28.9%), headache (26.7%) and dry cough (22.2%) were frequently reported early in the study, but waned substantially by week-24. Participants' perception and acceptance of the products was very good. The use of second generation PVs substantially decreased cigarette consumption without causing significant adverse effects in smokers not intending to quit. (ClinicalTrials.gov Identifier: NCT02124200).

  2. IDEAL: a 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease.

    PubMed

    Winblad, B; Grossberg, G; Frölich, L; Farlow, M; Zechner, S; Nagel, J; Lane, R

    2007-07-24

    The rivastigmine patch is the first transdermal treatment for Alzheimer disease (AD). By providing continuous delivery of drug into the bloodstream over 24 hours, transdermal delivery may offer benefits superior to those of oral administration. This study compared the efficacy, safety and tolerability of rivastigmine patches with capsules and placebo. IDEAL (Investigation of transDermal Exelon in ALzheimer's disease) was a 24-week, double-blind, double-dummy, placebo- and active-controlled study. Patients with AD were randomized to placebo or one of three active treatment target dose groups: 10-cm(2) rivastigmine patch (delivering 9.5 mg/24 hours); 20-cm(2) rivastigmine patch (17.4 mg/24 hours); or 6-mg BID rivastigmine capsules. Primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Secondary outcome measures assessed a range of domains, including behavior, cognitive performance, attention, executive functions, and activities of daily living. A total of 1,195 AD patients participated. All rivastigmine treatment groups showed significant improvement relative to placebo. The 10-cm(2) patch showed similar efficacy to capsules, with approximately two-thirds fewer reports of nausea (7.2% vs 23.1%) and vomiting (6.2% vs 17.0%), incidences statistically not significantly different from placebo (5.0% and 3.3% for nausea and vomiting, respectively). The 20-cm(2) patch showed earlier improvement and numerically superior cognitive scores vs the 10-cm(2) patch with similar tolerability to capsules. Local skin tolerability was good. The transdermal patch with rivastigmine may offer additional therapeutic benefits and may prove to be the best delivery system for this drug to treat AD.

  3. Association between theta power in 6-month old infants at rest and maternal PTSD severity: A pilot study.

    PubMed

    Sanjuan, Pilar M; Poremba, Carly; Flynn, Lucinda R; Savich, Renate; Annett, Robert D; Stephen, Julia

    2016-09-06

    Compared to infants born to mothers without PTSD, infants born to mothers with active PTSD develop poorer behavioral reactivity and emotional regulation. However, the association between perinatal maternal PTSD and infant neural activation remains largely unknown. This pilot study (N=14) examined the association between perinatal PTSD severity and infant frontal neural activity, as measured by MEG theta power during rest. Results indicated that resting left anterior temporal/frontal theta power was correlated with perinatal PTSD severity (p=0.004). These findings suggest delayed cortical maturation in infants whose mothers had higher perinatal PTSD severity and generate questions regarding perinatal PTSD severity and infant neurophysiological consequences. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Maternal education is associated with vaccination status of infants less than 6 months in Eastern Uganda: a cohort study.

    PubMed

    Nankabirwa, Victoria; Tylleskär, Thorkild; Tumwine, James K; Sommerfelt, Halvor

    2010-12-15

    Despite provision of free childhood vaccinations, less than half of all Ugandan infants are fully vaccinated. This study compares women with some secondary schooling to those with only primary schooling with regard to their infants' vaccination status. A community-based prospective cohort study conducted between January 2006 and May 2008 in which 696 pregnant women were followed up to 24 weeks post partum. Information was collected on the mothers' education and vaccination status of the infants. At 24 weeks, the following vaccinations had been received: bacille Calmette-Guérin (BCG): 92%; polio-1: 91%; Diphteria-Pertussis-Tetanus-Hepatitis B-Haemophilus Influenza b (DPT-HB-Hib) 3 and polio-3: 63%. About 51% of the infants were fully vaccinated (i.e., had received all the scheduled vaccinations: BCG, polio 0, polio 1, DPT-HB-Hib1, polio 2, DPT-HB-Hib 2, polio 3 and DPT-HB-Hib 3). Only 46% of the infants whose mothers' had 5-7 years of primary education had been fully vaccinated compared to 65% of the infants whose mothers' had some secondary education. Infants whose mothers had some secondary education were less likely to miss the DPT-HB-Hib-2 vaccine (RR: 0.5, 95% CI: 0.3, 0.8), Polio-2 (RR: 0.4, 95%CI: 0.3, 0.7), polio-3 (RR: 0.5, 95%CI: 0.4, 0.7) and DPT-HB-Hib-3 (RR: 0.5, 95%CI: 0.4, 0.7). Other factors showing some association with a reduced risk of missed vaccinations were delivery at a health facility (RR = 0.8; 95%CI: 0.7, 1.0) and use of a mosquito net (RR: 0.8; 95%CI: 0.7, 1.0). Infants whose mothers had a secondary education were at least 50% less likely to miss scheduled vaccinations compared to those whose mothers only had primary education. Strategies for childhood vaccinations should specifically target women with low formal education.

  5. Sertraline and fluoxetine treatment of obsessive-compulsive disorder: results of a double-blind, 6-month treatment study.

    PubMed

    Bergeron, Richard; Ravindran, Arun V; Chaput, Yves; Goldner, Elliot; Swinson, Richard; van Ameringen, Michael A; Austin, Carol; Hadrava, Vratislav

    2002-04-01

    The purpose of this study was to evaluate the comparative efficacy and tolerability of sertraline and fluoxetine in the treatment of obsessive-compulsive disorder (OCD). Outpatients meeting DSM-IV criteria for OCD, with a Yale-Brown Obsessive-Compulsive (Y-BOCS) total score >or= 17, an NIMH Global Obsessive-Compulsive (NIMH-OC) scale score >or= 7, and a CGI-Severity score >or= 4 were randomized to 24 weeks of double-blind treatment with sertraline (N = 77) or fluoxetine (N = 73). Primary efficacy measures consisted of the Y-BOCS, the NIMH-OC scale, and the CGI-Severity (CGI-S) and Improvement (CGI-I) scales. Equivalent and significant (p < 0.001) improvement was found at week 24 in Y-BOCS and NIMH-OC scale scores for sertraline and fluoxetine. After 12 weeks, 49.2% of patients on sertraline were rated on the CGI-S scale as being mildly ill or not ill compared to 24.6% on fluoxetine (p < 0.01). A Cox analysis found patients on sertraline to have a statistically nonsignificant 42% greater likelihood of achieving a response by week 12 (CGI-I, much or very much improved; 95% CI, 0.85, 2.38; p = 0.18). Sertraline treatment also resulted in a higher proportion of remissions than fluoxetine (defined as a CGI-I

  6. The Relationship Between Balance Measured With a Modified Bathroom Scale and Falls and Disability in Older Adults: A 6-Month Follow-Up Study

    PubMed Central

    2015-01-01

    Background There are indications that older adults who suffer from poor balance have an increased risk for adverse health outcomes, such as falls and disability. Monitoring the development of balance over time enables early detection of balance decline, which can identify older adults who could benefit from interventions aimed at prevention of these adverse outcomes. An innovative and easy-to-use device that can be used by older adults for home-based monitoring of balance is a modified bathroom scale. Objective The objective of this paper is to study the relationship between balance scores obtained with a modified bathroom scale and falls and disability in a sample of older adults. Methods For this 6-month follow-up study, participants were recruited via physiotherapists working in a nursing home, geriatricians, exercise classes, and at an event about health for older adults. Inclusion criteria were being aged 65 years or older, being able to stand on a bathroom scale independently, and able to provide informed consent. A total of 41 nursing home patients and 139 community-dwelling older adults stepped onto the modified bathroom scale three consecutive times at baseline to measure their balance. Their mean balance scores on a scale from 0 to 16 were calculated—higher scores indicated better balance. Questionnaires were used to study falls and disability at baseline and after 6 months of follow-up. The cross-sectional relationship between balance and falls and disability at baseline was studied using t tests and Spearman rank correlations. Univariate and multivariate logistic regression analyses were conducted to study the relationship between balance measured at baseline and falls and disability development after 6 months of follow-up. Results A total of 128 participants with complete datasets—25.8% (33/128) male—and a mean age of 75.33 years (SD 6.26) were included in the analyses of this study. Balance scores of participants who reported at baseline that

  7. Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study.

    PubMed

    Rajagopalan, Harith; Cherrington, Alan D; Thompson, Christopher C; Kaplan, Lee M; Rubino, Francesco; Mingrone, Geltrude; Becerra, Pablo; Rodriguez, Patricia; Vignolo, Paulina; Caplan, Jay; Rodriguez, Leonardo; Galvao Neto, Manoel P

    2016-12-01

    To assess procedural safety and glycemic indices at 6 months in a first-in-human study of duodenal mucosal resurfacing (DMR), a novel, minimally invasive, upper endoscopic procedure involving hydrothermal ablation of the duodenal mucosa, in patients with type 2 diabetes and HbA1c ≥7.5% (58 mmol/mol) on one or more oral antidiabetic agents. Using novel balloon catheters, DMR was conducted on varying lengths of duodenum in anesthetized patients at a single medical center. A total of 39 patients with type 2 diabetes (screening HbA1c 9.5% [80 mmol/mol]; BMI 31 kg/m(2)) were treated and included in the interim efficacy analysis: 28 had a long duodenal segment ablated (LS; ∼9.3 cm treated) and 11 had a short segment ablated (SS; ∼3.4 cm treated). Overall, DMR was well tolerated with minimal gastrointestinal symptoms postprocedure. Three patients experienced duodenal stenosis treated successfully by balloon dilation. HbA1c was reduced by 1.2% at 6 months in the full cohort (P < 0.001). More potent glycemic effects were observed among the LS cohort, who experienced a 2.5% reduction in mean HbA1c at 3 months postprocedure vs. 1.2% in the SS group (P < 0.05) and a 1.4% reduction at 6 months vs. 0.7% in the SS group (P = 0.3). This occurred despite net medication reductions in the LS cohort between 0 and 6 months. Among LS patients with a screening HbA1c of 7.5-10% (58-86 mmol/mol) and on stable antidiabetic medications postprocedure, HbA1c was reduced by 1.8% at 6 months (P < 0.01). Single-procedure DMR elicits a clinically significant improvement in hyperglycemia in patients with type 2 diabetes in the short-term, with acceptable safety and tolerability. Long-term safety, efficacy, and durability and possible mechanisms of action require further investigation. © 2016 by the American Diabetes Association.

  8. Anti-tumor necrosis factor-alpha therapy improves endothelial function and arterial stiffness in patients with moderate to severe psoriasis: A 6-month prospective study.

    PubMed

    Pina, Trinitario; Corrales, Alfonso; Lopez-Mejias, Raquel; Armesto, Susana; Gonzalez-Lopez, Marcos A; Gómez-Acebo, Ines; Ubilla, Begoña; Remuzgo-Martínez, Sara; Gonzalez-Vela, M Carmen; Blanco, Ricardo; Hernández, Jose L; Llorca, Javier; Gonzalez-Gay, Miguel A

    2016-11-01

    The aim of the present study was to determine if the use of the anti-tumor necrosis factor (TNF)-α monoclonal antibody adalimumab could improve endothelial function and arterial stiffness in patients with moderate to severe psoriasis. This was a prospective study on a series of consecutive patients with moderate to severe psoriasis who completed 6 months of therapy with adalimumab. Patients with history of cardiovascular events, diabetes mellitus, kidney disease, hypertension or body mass index of 35 kg/m(2) or more were excluded. Assessment of endothelial function by brachial artery reactivity measuring flow-mediated endothelial dependent vasodilatation (FMD%), and carotid arterial stiffness by pulse wave velocity (PWV) was performed at the onset of treatment (time 0) and at month 6. Twenty-nine patients were studied. Anti-TNF-α adalimumab therapy yielded a significant improvement of endothelial function. The mean ± standard deviation (SD) FMD% values increased from 6.19 ± 2.44% at the onset of adalimumab to 7.46 ± 2.43% after 6 months of treatment with this biologic agent (P = 0.008). Likewise, following the use of adalimumab, PWV levels decreased from 6.28 ± 1.04 m/s at the onset of adalimumab to 5.69 ± 1.31 m/s at 6 months (P = 0.03). In conclusion, patients with moderate to severe psoriasis exhibit improvement of endothelial function and arterial stiffness following anti-TNF-α therapy. These findings are of potential relevance due to increased risk of cardiovascular disease in patients with severe psoriasis.

  9. Sleep in children with attention-deficit/hyperactivity disorder (ADHD) before and after 6-month treatment with methylphenidate: a pilot study.

    PubMed

    Vigliano, Piernanda; Galloni, Giovanni Battista; Bagnasco, Irene; Delia, Giuliana; Moletto, Alessandra; Mana, Mauro; Cortese, Samuele

    2016-05-01

    Children with ADHD may present with sleep disturbances that add to the impairment of the disorder. The long-term sleep effects of the first-line pharmacological treatment for ADHD, i.e., psychostimulants, are unclear. In this pilot study, we compared polysomnographic variables in children with ADHD (n = 11, aged 6-15 years), before pharmacological treatment, and in children without ADHD (n = 22, aged 5-14 years); we also assessed polysomnographic changes in children with ADHD (n = 7) after a 6-month treatment with methylphenidate immediate-release (once or twice daily). Compared to children without ADHD, those with ADHD at baseline presented with significantly increased duration of awakenings (p = 0.02), reduction in sleep efficiency (p = 0.03), and increase in stage I (N1) (p < 0.01) and reduction in stage II (N2) (p = 0.02) and stage III-IV (N3) percentages. Methylphenidate treatment did not significantly change any parameter of sleep architecture. Preliminary evidence from this pilot study shows that, compared to children without ADHD, those with ADHD presented a more fragmented and less effective sleep at baseline and that the 6-month methylphenidate treatment did not further negatively impact on sleep architecture. • Children with ADHD may present with subjectively reported and/or objectively confirmed disturbances of sleep. • The long-term effects on sleep of the first-line pharmacological treatment for ADHD, i.e., psychostimulants, are not clear. What is new: • Our study showed that the 6-month continuous treatment with methylphenidate did not further negatively impact on sleep architecture in children with ADHD.

  10. Auditing the frequency and the clinical and economic impact of testing for Fabry disease in patients under the age of 70 with a stroke admitted to Saint Vincent's University Hospital over a 6-month period.

    PubMed

    Lambe, J; Noone, I; Lonergan, R; Tubridy, N

    2017-05-03

    Fabry disease is an X-linked recessive lysosomal storage disorder that provokes multi-organ morbidity, including early-onset stroke. Worldwide prevalence may be greater than previously estimated, with many experiencing first stroke prior to diagnosis of Fabry disease. The aim of this study is to screen a cohort of stroke patients under 70 years of age, evaluating the clinical and economic efficacy of such a broad screening programme for Fabry disease. All stroke patients under 70 years of age who were entered into the Saint Vincent's University Hospital stroke database over a 6-month period underwent enzyme analysis and/or genetic testing as appropriate for Fabry disease. Patients' past medical histories were analysed for clinical signs suggestive of Fabry disease. Cost-effectiveness analysis of testing was performed and compared to overall economic impact of young stroke in Ireland. Of 22 patients tested for Fabry disease, no new cases were detected. Few clinical indicators of Fabry disease were identified at the time of testing. Broad screening programmes for Fabry disease are highly unlikely to offset the cost of testing. The efficacy of future screening programmes will depend on careful selection of an appropriate patient cohort of young stroke patients with multi-organ morbidity and a positive family history.

  11. A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management: preliminary results of the impact of diet at 6 months--PREFER study.

    PubMed

    Burke, Lora E; Styn, Mindi A; Steenkiste, Ann R; Music, Edvin; Warziski, Melanie; Choo, Jina

    2006-11-01

    The PREFER study objectives were to examine potential differences in weight loss during a standard behavioral intervention between subjects assigned to one of two calorie- and fat-restricted diets [standard behavior treatment (SBT) and lacto-ovo-vegetarian ([SBT+LOV)], with or without regard to their preferred dietary treatment. This article reports the differences in outcomes between diet groups after the first 6 months of the intervention. The study used a four-group design. Subjects (n = 182) were randomized to a treatment preference group and then to a dietary treatment group. For this report, preference groups were combined to permit comparisons by dietary treatment only (SBT, n = 98; SBT+LOV, n = 84). Additional analyses compared SBT+LOV subjects who were 100% adherent (did not consume any meat, fish, or poultry, n = 47) to those who were <100% adherent (n = 24). Significant differences were seen in the baseline to 6-month change scores between the two groups for carbohydrate consumption (p = 0.013), protein consumption (p < 0.001), polyunsaturated-to-saturated fat ratio (p = 0.009), and low-density lipoprotein-cholesterol (LDL-C) level (p = 0.013). Among SBT+LOV subjects, those who were 100% adherent experienced greater reductions in weight (p < 0.001), total cholesterol (p = 0.026), LDL-C (p = 0.034), and glucose (p = 0.002) and consumed less fat (p = 0.030) compared with those who were <100% adherent. Differences between dietary treatment groups at 6 months were minimal, most likely because one-third of the SBT+LOV group did not follow the vegetarian diet and because both groups had the same calorie and fat restrictions. SBT+LOV subjects who were 100% adherent were more successful at both weight loss and cholesterol reduction than those who were <100% adherent, suggesting that vegetarian diets are efficacious for weight and cholesterol control.

  12. A 6-month follow-up study of the randomized controlled Ma-Pi macrobiotic dietary intervention (MADIAB trial) in type 2 diabetes

    PubMed Central

    Soare, A; Del Toro, R; Khazrai, Y M; Di Mauro, A; Fallucca, S; Angeletti, S; Skrami, E; Gesuita, R; Tuccinardi, D; Manfrini, S; Fallucca, F; Pianesi, M; Pozzilli, P

    2016-01-01

    Background: In the MADIAB trial (a 21-day randomized, controlled trial in patients with type 2 diabetes (T2D)), intervention with the Ma-Pi 2 macrobiotic diet resulted in significantly greater improvements in metabolic control compared with a standard recommended diet for patients with T2D. We report on a 6-month follow-up study, which investigated, whether these benefits extended beyond the 21-day intensive dietary intervention, in real-world conditions. Subjects: At the end of the MADIAB trial (baseline of this follow-up study), all participants continued their assigned diet (Ma-Pi or control) for 6 months. The Ma-Pi 2 group followed the Ma-Pi 4 diet during this follow-up study. Forty of the original 51 subjects (78.4%) participated in the follow-up (body mass index, 27–45 kg m−2; age, 40–75 years). Primary outcome was percentage change from baseline in HbA1c; secondary outcomes were anthropometric data and lipid panel. Results: A significantly greater median percentage reduction was observed for HbA1c in the Ma-Pi group (−11.27% (95% confidence interval (CI): −10.17; −12.36)) compared with the control group (−5.88% (95% CI: −3.79; −7.98)) (P < 0.001). Total and low-density lipoprotein (LDL) cholesterol increased in both groups with no differences between groups (P=0.331 and P=0.082, respectively). After correcting for age and gender, the Ma-Pi diet was associated with a higher percentage reduction in HbA1c (95% CI: 2.56; 7.61) and body weight (95% CI: 0.40; 3.99), and a higher percentage increase in LDL cholesterol (95% CI: −1.52; −33.16). However, all participants' total and LDL cholesterol levels remained within recommended ranges (<200 mg dl−1 and <100 mg dl−1, respectively). The Ma-Pi diet group achieved the target median HbA1c value (<5.7% (39 mmol mol−1)) at 6 months. Conclusions: Both the Ma-Pi and control diets maintained their benefits beyond the 21-day intensive monitored intervention over a 6-month follow

  13. Retrieval Protracts Deferred Imitation by 6-Month-Olds

    ERIC Educational Resources Information Center

    Barr, Rachel; Rovee-Collier, Carolyn; Campanella, Jennifer

    2005-01-01

    Past research using a deferred imitation task has shown that 6-month-olds remember a 3-part action sequence for only 1 day. The concept of a time window suggests that there is a limited period within which additional information can be integrated with a prior memory. Its width tracks the forgetting function of the memory. This study asked if…

  14. Fusion and failure following anterior cervical plating with dynamic or rigid plates: 6-months results of a multi-centric, prospective, randomized, controlled study

    PubMed Central

    Stulik, Jan; Chrobok, Jan; Ruffing, Sabine; Drumm, Jörg; Sova, Laurentius; Kucera, Ravel; Vyskocil, Tomas; Steudel, Wolf Ingo

    2007-01-01

    Anterior cervical plate fixation is an approved surgical technique for cervical spine stabilization in the presence of anterior cervical instability. Rigid plate design with screws rigidly locked to the plate is widely used and is thought to provide a better fixation for the treated spinal segment than a dynamic design in which the screws may slide when the graft is settling. Recent biomechanical studies showed that dynamic anterior plates provide a better graft loading possibly leading to accelerated spinal fusion with a lower incidence of implant complications. This, however, was investigated in vitro and does not necessarily mean to be the case in vivo, as well. Thus, the two major aspects of this study were to compare the speed of bone fusion and the rate of implant complications using either rigid- or dynamic plates. The study design is prospective, randomized, controlled, and multi-centric, having been approved by respective ethic committees of all participating sites. One hundred and thirty-two patients were included in this study and randomly assigned to one of the two groups, both undergoing routine level-1- or level-2 anterior cervical discectomy with autograft fusion receiving either a dynamic plate with screws being locked in ap - position (ABC, Aesculap, Germany), or a rigid plate (CSLP, Synthes, Switzerland). Segmental mobility and implant complications were compared after 3- and 6 months, respectively. All measurements were performed by an independent radiologist. Mobility results after 6 months were available for 77 patients (43 ABC/34 CSLP). Mean segmental mobility for the ABC group was 1.7 mm at the time of discharge, 1.4 mm after 3 months, and 0.8 mm after 6 months. For the CSLP- group the measurements were 1.0, 1.8, and 1.7 mm, respectively. The differences of mean segmental mobility were statistically significant between both groups after 6 months (P = 0.02). Four patients of the CSLP-group demonstrated surgical hardware complications

  15. Effect of androgen deprivation therapy on arterial stiffness and serum lipid profile changes in patients with prostate cancer: a prospective study of initial 6-month follow-up.

    PubMed

    Oka, Ryo; Utsumi, Takanobu; Endo, Takumi; Yano, Masashi; Kamijima, Shuichi; Kamiya, Naoto; Shirai, Kohji; Suzuki, Hiroyoshi

    2016-04-01

    To explore arterial stiffness during the administration of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa), a new indicator, the cardio-ankle vascular index (CAVI), and serum lipid profile changes were monitored. A prospective study assessed the changes in arterial stiffness using the CAVI and clinical laboratory variables among 58 men with prostate cancer treated with ADT for 6 months. Furthermore, patients who had a high risk of developing arterial stiffness after ADT were investigated. The whole cohort had no significant increase in arterial stiffness within 6 months after ADT, but 55.2 % of patients had an increased CAVI. Serum levels of total cholesterol, high-density-lipoprotein cholesterol (HDL-C), and low-density-lipoprotein cholesterol (LDL-C) increased significantly at 1 month after the start of ADT and maintained high values thereafter. At baseline, HDL-C was lower and LDL-C and LDL-C/HDL-C were higher in the group with than without an increased CAVI after 6 months of ADT administration. Although the whole cohort did not show a significant change in arterial stiffness with ADT, some patients showed an increased arterial stiffness monitored with the CAVI. The balance between LDL-C and HDL-C, or LDL-C/HDL-C, might have an impact on the development of arterial stiffness after ADT administration. Thus, clinicians might be able to monitor PCa patients who have a high risk of development of arterial stiffness after ADT administration by referring to LDL-C/HDL-C levels.

  16. The Impact of Structured Mentor Mother Programs on 6-Month Postpartum Retention and Viral Suppression among HIV-Positive Women in Rural Nigeria: A Prospective Paired Cohort Study.

    PubMed

    Sam-Agudu, Nadia A; Ramadhani, Habib O; Isah, Christopher; Anaba, Udochisom; Erekaha, Salome; Fan-Osuala, Chinenye; Galadanci, Hadiza; Charurat, Manhattan

    2017-06-01

    Peer support (PS) has reportedly improved Prevention of mother-to-child transmission (PMTCT) outcomes in high HIV-burden settings; however, evidence of impact on retention in care is limited. Retention in care implies consistent engagement and treatment adherence. The MoMent study evaluated the impact of structured vs unstructured PS on postpartum retention and viral load suppression among rural Nigerian women. A total of 497 HIV-positive pregnant women were consecutively enrolled at 10 primary health care centers with structured mentor mother (MM) support, and at 10 pair-matched primary health care centers with routine, ad hoc PS. The structured MM intervention comprised an outcome-specific scope of work, close MM supervision, standardized documentation, performance evaluations, and retraining as appropriate. Retention was defined by clinic attendance during the first 6-month postpartum. Participants with ≥3 of 6 expected monthly visits were considered retained. Women with a 6-month postpartum plasma viral load of <20 copies/mL were considered suppressed. A logistic regression model with generalized estimating equation was used to assess the effect of MMs on retention and viral suppression. Exposure to structured MM support was associated with higher odds of retention than routine PS (adjusted odds ratio = 5.9, 95% confidence interval: 3.0 to 11.6). Similarly, the odds of viral suppression at 6-month postpartum were higher for MM-supported women (adjusted odds ratio = 4.9, 95% confidence interval: 2.6 to 9.2). Structured PS significantly improved postpartum PMTCT retention and viral suppression rates among women in rural Nigeria. Introduction of structure can enhance the impact of PS interventions on PMTCT outcomes.

  17. The maintenance effect of cognitive-behavioural treatment groups for the Chinese parents of children with intellectual disabilities in Melbourne, Australia: a 6-month follow-up study.

    PubMed

    Wong, D F K; Poon, A; Kwok, Y C Lai

    2011-11-01

    Caring for a child with intellectual disability can be stressful. No data on the longer-term effects of cognitive-behavioural treatment (CBT) on parents from a Chinese-speaking background who have children with intellectual disabilities are available in the literature. This study attempted to fill this research gap by examining the maintenance effect of CBT among the Chinese parents of such children in Melbourne, Australia. Thirty-nine participants took part in our CBT groups and attended follow-up meetings. A questionnaire comprising four instruments, the Parenting Stress Index (PS) - Parent Domain, General Health Questionnaire-12 (GHQ-12), Abbreviated Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18) and Dysfunctional Attitude Scale (DAS), was administered to the participants at the pre- and post-test stage and at the 6-month follow-up. One-way repeated-measures analyses of variance revealed significant time and group effects in the PS (F(2,27) = 16.93, P < 0.001), Q-LES-Q-18 (F(2,27) = 15.98, P < 0.001), GHQ-12 (F(2,27) = 81.93, P < 0.001) and DAS (F(2,27) = 15.50, P < 0.001) scores at the three measurement times. The participants continued to maintain significant improvements in mental health and quality of life and declines in the severity of parenting stress and dysfunctional attitudes at the 6-month follow-up. Effect size analyses revealed mostly large differences in the foregoing measurements (Cohen's d = 0.76-2.18) between the pre-test and 6-month follow-up. Employing a cut-off score of 3/4 in the GHQ-12 to identify at-risk and not-at-risk cases, approximately 90.5% of the participants could be classified as not-at-risk at the follow-up. Lastly, regression analyses showed that changes in DAS scores significantly predicted changes in the GHQ-12 and Q-LES-Q-18 scores at the follow-up. This study provides preliminary evidence of the 6-month maintenance effect of CBT groups for the Melbourne-resident Chinese parents of children with

  18. A preliminary 6-month prospective study examining self-reported religious preference, religiosity/spirituality, and retention at a Jewish residential treatment center for substance-related disorders.

    PubMed

    Parhami, Iman; Davtian, Margarit; Collard, Michael; Lopez, Jean; Fong, Timothy W

    2014-07-01

    Although there is a substantial amount of research suggesting that higher levels of religiosity/spirituality (R/S) are associated with better treatment outcomes of substance-related disorders, no studies have explored this relationship at a faith-based residential treatment center. The objective of this prospective study is to explore the relationship between R/S, self-reported religious preference, and retention at a Jewish residential treatment center for substance-related disorders. Using the Daily Spiritual Experience Scale, R/S levels were assessed for 33 subjects at baseline, 1 month, 3 months, and 6 months. Results demonstrated a significant relationship between baseline R/S level and retention at 6 months, while R/S levels were unchanged during the course of treatment. Notably, no relationship was found between self-reported religious affiliation and retention. This study demonstrates that patients' R/S level, rather than religious affiliation, is a possible predictor for better outcome at faith-based residential centers for substance-related disorders.

  19. A Preliminary 6-Month Prospective Study Examining Self-reported Religious Preference, Religiosity/Spirituality, and Retention at a Jewish Residential Treatment Center for Substance-Related Disorders

    PubMed Central

    Davtian, Margarit; Collard, Michael; Lopez, Jean; Fong, Timothy W.

    2012-01-01

    Although there is a substantial amount of research suggesting that higher levels of religiosity/spirituality (R/S) are associated with better treatment outcomes of substance-related disorders, no studies have explored this relationship at a faith-based residential treatment center. The objective of this prospective study is to explore the relationship between R/S, self-reported religious preference, and retention at a Jewish residential treatment center for substance-related disorders. Using the Daily Spiritual Experience Scale, R/S levels were assessed for 33 subjects at baseline, 1 month, 3 months, and 6 months. Results demonstrated a significant relationship between baseline R/S level and retention at 6 months, while R/S levels were unchanged during the course of treatment. Notably, no relationship was found between self-reported religious affiliation and retention. This study demonstrates that patients’ R/S level, rather than religious affiliation, is a possible predictor for better outcome at faith-based residential centers for substance-related disorders. PMID:22460083

  20. Low self-esteem as a vulnerability differentially predicts symptom dimensions of depression in university students in China: A 6-month longitudinal study.

    PubMed

    Zheng, Xinyue; Wang, Danyang; Yu, Ping; Yao, Shuqiao; Xiao, Jing

    2014-12-01

    This 6-month longitudinal study examined how self-esteem as a vulnerability differentially predicts symptom dimensions of depression in a sample of university students from Hunan Province, China. Baseline and 6-month follow-up data were obtained from 659 university students. During an initial assessment, participants completed measures assessing their low self-esteem, depressive symptoms, and the occurrence of daily hassle. Participants subsequently completed measures assessing daily hassle and depressive symptoms once per month for 6 months. Higher low self-esteem scores were associated with greater increases in the somatic complaints and positive affect dimensions, but not the depressed affect and interpersonal problem dimensions of depressive symptoms following daily hassle in Chinese university students. The results of the current study suggest that low self-esteem plays a significant role in the etiology and course of depressive symptoms that develop in response to exposure to daily hassles. Consistent with the vulnerability-stress model of depression, the results suggest that low self-esteem serves as a risk factor and daily hassles serve as a precipitating factor.

  1. The connecting health and technology study: a 6-month randomized controlled trial to improve nutrition behaviours using a mobile food record and text messaging support in young adults.

    PubMed

    Kerr, Deborah A; Harray, Amelia J; Pollard, Christina M; Dhaliwal, Satvinder S; Delp, Edward J; Howat, Peter A; Pickering, Mark R; Ahmad, Ziad; Meng, Xingqiong; Pratt, Iain S; Wright, Janine L; Kerr, Katherine R; Boushey, Carol J

    2016-04-21

    Early adulthood represents the transition to independent living which is a period when changes in diet and body weight are likely to occur. This presents an ideal time for health interventions to reduce the effect of health problems and risk factors for chronic disease in later life. As young adults are high users of mobile devices, interventions that use this technology may improve engagement. The Connecting Health and Technology study aimed to evaluate the effectiveness of tailored dietary feedback and weekly text messaging to improve dietary intake of fruit, vegetables and junk food over 6 months among a population-based sample of men and women (aged 18-30 years). A three-arm, parallel, randomized control trial was conducted. After baseline assessments, participants were randomized to one of three groups: A) dietary feedback and weekly text messages, B) dietary feedback only or C) control group. Dietary intake was assessed using a mobile food record App (mFR) where participants captured images of foods and beverages consumed over 4-days at baseline and post-intervention. The primary outcomes were changes in serves of fruits, vegetables, energy-dense nutrient-poor (EDNP) foods and sugar-sweetened beverages (SSB). The intervention effects were assessed using linear mixed effect models for change in food group serves. Young adults (n = 247) were randomized to group A (n = 82), group B (n = 83), or group C (n = 82). Overall, no changes in food group serves for either intervention groups were observed. An unanticipated outcome was a mean weight reduction of 1.7 kg (P = .02) among the dietary feedback only. Men who received dietary feedback only, significantly reduced their serves of EDNP foods by a mean of 1.4 serves/day (P = .02). Women who received dietary feedback only significantly reduced their intake of SSB (P = .04) by an average of 0.2 serves/day compared with controls. Tailored dietary feedback only resulted in a decrease in EDNP

  2. Beliefs about Supporting Mothers to Exclusively Breastfeed for 6 Months: An Elicitation Study of Health Professionals Working in Maternal-Child Health Clinics in Nairobi, Kenya.

    PubMed

    Nyawade, Susan A; Middlestadt, Susan E; Peng, Chao-Ying Joanne

    2016-08-01

    Exclusive breastfeeding rates remain low in Kenya and determinants influencing mothers' practice are documented. Little is known about factors underlying health professionals' intention to support mothers to continue exclusive breastfeeding. Effective behavior modification requires designing interventions at multiple levels of influence, informed by theory-based research to identify relevant determinants. To identify salient beliefs held by health professionals about support of mothers to exclusively breastfeed for 6 months and to explore definitions of the term support. This qualitative study was conducted in 6 public health facilities in Nairobi, Kenya. We used open-ended questions based on the reasoned action approach to elicit salient consequences, referents, and circumstances perceived by 15 health professionals about support for mothers to exclusively breastfeed for 6 months. The most frequently mentioned consequences were healthier babies (87%) and reduced childhood ailments (67%). The main disadvantage was human immunodeficiency virus transmission through breast milk (33%). Colleagues (80%) and managers (67%) were perceived as approving referents, whereas some mothers/couples (40%) and the breast milk substitute industry (20%) were perceived as disapproving. Facilitating circumstances included lighter workload, better training, and more time. Definitions of support were varied and included giving information and demonstrating positioning and attachment techniques. Overall, health professionals perceived positive consequences toward supporting exclusive breastfeeding continuation and identified a number of approving referents. However, they reported challenging circumstances in the work environment, which managers need to address to help health professionals provide the support needed by Kenyan mothers to continue exclusive breastfeeding. © The Author(s) 2016.

  3. Effects of a Psychoeducational Intervention for Direct Care Workers Caring for People With Dementia: Results From a 6-Month Follow-Up Study.

    PubMed

    Barbosa, Ana; Nolan, Mike; Sousa, Liliana; Marques, Alda; Figueiredo, Daniela

    2016-03-01

    This study aimed to assess the effects of a psychoeducational intervention, designed to improve direct care workers' stress, burnout and job satisfaction, and person-centered communicative behavior in people with dementia. A pretest-posttest control group design was conducted in 4 aged-care facilities. Two experimental facilities received a psychoeducational intervention, and 2 control facilities received an education only. Data were gathered from 53 care workers at baseline, immediately, and 6 months after the intervention, through self-administrated instruments and video-recorded morning care sessions. The experimental group showed a significant decrease in care workers' burnout and a significant improvement in several communicative behaviors (e.g., involvement). Stress levels deteriorated at 6 months, and no intervention effects were found for job satisfaction. The findings highlight the importance of providing care workers with both technical competences and tools for stress management, as this might be associated with a reduction in their levels of exhaustion and improved communicative behaviors. © The Author(s) 2015.

  4. Effect of percutaneous transvenous mitral commissurotomy on left atrial appendage function: an immediate and 6-month follow-up transesophageal Doppler study.

    PubMed

    Vijayvergiya, Rajesh; Sharma, Rajat; Shetty, Ranjan; Subramaniyan, Anand; Karna, Sunil; Chongtham, Dhanraj

    2011-11-01

    The left atrial appendage (LAA) is a common site of thrombus formation and is the source of systemic thromboembolism in patients with rheumatic mitral stenosis. LAA contractile dysfunction is a common finding in these patients. The aim of this study was to assess immediate and 6-month follow-up LAA function by transesophageal Doppler echocardiography in patients who underwent percutaneous transvenous mitral commissurotomy (PTMC). Forty-seven consecutive patients with symptomatic critical mitral stenosis who underwent PTMC were enrolled. All had underwent transthoracic and transesophageal echocardiography before, 24 hours after, and 6 months after PTMC. Pulse Doppler velocities of the LAA were measured, including peak early diastolic (E wave), peak late diastolic (A wave), and peak systolic (S wave). The corresponding tissue Doppler velocities of the LAA, including peak early diastolic (E(LAA)), peak late diastolic (A(LAA)), and peak systolic (S(LAA)), were also measured. LAA ejection fraction was measured using the modified Simpson's method. The mean age of the 47 enrolled patients was 31.7 ± 10.26 years. Thirty-eight patients were in sinus rhythm, and the remaining nine were in atrial fibrillation. PTMC was successful in all patients. The pulse Doppler velocities of the LAA at baseline, after PTMC, and at 6-month follow-up were as follows: for the E wave, 15.29 ± 2.26, 17.02 ± 2.25, and 17.97 ± 2.55 cm/sec, respectively (P < .001); for the A wave 22.45 ± 4.11, 24.19 ± 4.21, and 25.99 ± 4.51 cm/sec, respectively (P < .001); and for the S wave, 28.52 ± 4.37, 31.45 ± 5.37, and 33.06 ± 4.99 cm/sec, respectively (P < .001). The corresponding tissue Doppler velocities of LAA were as follows: for E(LAA), 4.65 ± 0.91, 5.28 ± 0.85, and 5.80 ± 0.84 cm/sec, respectively (P < .001); for A(LAA), 6.67 ± 1.12, 7.33 ± 1.17, and 7.88 ± 1.22 cm/sec, respectively (P < .001); and for S(LAA), 4.67 ± 1.12, 5.52 ± 1.18, 6.07 ± 1.11 cm/sec, respectively (P < .001

  5. Impact of 6-month aerobic exercise on Alzheimer's symptoms.

    PubMed

    Yu, Fang; Thomas, William; Nelson, Nathaniel W; Bronas, Ulf G; Dysken, Maurice; Wyman, Jean F

    2015-06-01

    Little is known about how aerobic exercise affects Alzheimer's disease (AD). The purpose of this pilot study was to test the impact of 6-month cycling on AD symptoms in community-dwelling older adults with mild-to-moderate AD, using a single-group, repeated-measures design (n = 26). AD symptoms were measured with the AD Assessment Scale-Cognitive (ADAS-Cog), Disability in AD (DAD), and Neuropsychiatric Inventory-Caregiver (NPI-Q) scales at baseline, 3 and 6 months. Data were analyzed using mixed linear models. The ADAS-Cog, DAD, and NPI-Q severity scores remained unchanged over the 6-month period, while caregiver distress decreased 40% (p < .05). We conclude that aerobic exercise may reduce AD symptoms and appears effective in decreasing caregiver distress. Further randomized controlled trials are needed to examine the effects of aerobic exercise in AD. © The Author(s) 2013.

  6. Comparative clinical and radiographic evaluation of mineralized cancellous bone allograft (puros®) and autogenous bone in the treatment of human periodontal intraosseous defects: 6-months follow-up study

    PubMed Central

    Reddy, B. Ravinder; Sudhakar, J.; Rajesh, Nichenametla; Sandeep, V.; Reddy, Y. Muralidhar; Gnana Sagar, W. R.

    2016-01-01

    Aims: Several materials have been introduced as bone grafts, i.e., autografts, allograft, xenografts, and alloplastic grafts, and studies have shown them to produce greater clinical bone defect fill than open flap debridement alone. The aim of this clinical and radiological 6-month study was to compare and evaluate the clinical outcome of deep intraosseous defects following reconstructive surgery with the use of mineralized cancellous bone allograft (Puros®) or autogenous bone. Materials and Methods: Ten patients with 12 sites exhibiting signs of moderate generalized chronic periodontitis were enrolled in the study. The investigations were confined to two and three-walled intra bony defects with a preoperative probing depth of ≥5 mm. Six of these defects were treated with Puros® (group A) the remaining six were treated with autogenous bone graft (group B). Allocation to the two groups was randomized. The clinical parameters, plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), and bone fill, were recorded at different time intervals at the baseline, 1 month, 3 months, and 6 months. Intraoral radiographs were taken using standardized paralleling cone technique at baseline, 1, 3, and 6 months. Statistical analysis was done by using the one-way analysis of variance (ANOVA) followed by Tukey highly significant difference. Results: Both groups resulted in decrease in probing depth (group A, 3.0 mm; group B, 2.83 mm) and gain in clinical attachment level (group A, 3.33 mm; group B, 3.0 mm) over a period of 6 months, which was statistically insignificant. Conclusion: Within the limitations of the present study, it can be concluded that both mineralized cancellous bone allograft (Puros®) or autogenous bone result in significant clinical improvements. PMID:28217545

  7. The brain-in-motion study: effect of a 6-month aerobic exercise intervention on cerebrovascular regulation and cognitive function in older adults.

    PubMed

    Tyndall, Amanda V; Davenport, Margie H; Wilson, Ben J; Burek, Grazyna M; Arsenault-Lapierre, Genevieve; Haley, Eryka; Eskes, Gail A; Friedenreich, Christine M; Hill, Michael D; Hogan, David B; Longman, R Stewart; Anderson, Todd J; Leigh, Richard; Smith, Eric E; Poulin, Marc J

    2013-02-28

    Aging and physical inactivity are associated with declines in some cognitive domains and cerebrovascular function, as well as an elevated risk of cerebrovascular disease and other morbidities. With the increase in the number of sedentary older Canadians, promoting healthy brain aging is becoming an increasingly important population health issue. Emerging research suggests that higher levels of physical fitness at any age are associated with better cognitive functioning and this may be mediated, at least in part, by improvements in cerebrovascular reserve. We are currently conducting a study to determine: if a structured 6-month aerobic exercise program is associated with improvements or maintenance of both cerebrovascular function and cognitive abilities in older individuals; and, the extent to which any changes seen persist 6 months after the completion of the structured exercise program. Two hundred and fifty men and women aged 55-80 years are being enrolled into an 18-month combined quasi-experimental and prospective cohort study. Participants are eligible for enrollment into the study if they are inactive (i.e., not participating in regular physical activity), non-smokers, have a body mass index <35.0 kg/m(2), are free of significant cognitive impairment (defined as a Montreal Cognitive Assessment score of 24 or more), and do not have clinically significant cardiovascular, cerebrovascular disease, or chronic obstructive pulmonary airway disease. Repeated measurements are done during three sequential six-month phases: 1) pre-intervention; 2) aerobic exercise intervention; and 3) post-intervention. These outcomes include: cardiorespiratory fitness, resting cerebral blood flow, cerebrovascular reserve, and cognitive function. This is the first study to our knowledge that will examine contemporaneously the effect of an exercise intervention on both cerebrovascular reserve and cognition in an older population. This study will further our understanding of whether

  8. Mexican Cervical Cancer Screening Study II: 6-month and 2-year follow-up of HR-HPV women treated with cryotherapy in a low-resource setting.

    PubMed

    Starks, David; Arriba, Lucybeth Nieves; Enerson, Christine L; Brainard, Jennifer; Nagore, Norma; Chiesa-Vottero, Andres; Uribe, Jesús Villagran; Belinson, Jerome

    2014-10-01

    To determine the efficacy and tolerance of cryotherapy in a visual inspection with acetic acid (VIA) triage protocol after primary human papillomavirus (HPV) screening in a low-resource setting. This continuous series conducted over 2 years enrolled nonpregnant, high-risk HPV (HR-HPV)-positive women between the ages of 30 and 50 years, who resided in the state of Michoacán, Mexico, and had a history of no Pap smear screening or knowledge of Pap smear results within the last 3 years. These women were initially enrolled in the Mexican Cervical Cancer Screening Study II (MECCS II) trial and were treated with cryotherapy after VIA triage. They subsequently followed up at 6 months and 2 years for repeat VIA, colposcopy, and biopsy. A total of 291 women were treated with cryotherapy, of whom 226 (78%) followed up at 6 months. Of these 226 women, 153 (68%) were HR-HPV-negative; there were no findings of cervical intraepithelial neoplasia grade 2 (CIN2) or worse. The remaining 73 women (32%) were HR-HPV-positive; of these women, 2 had CIN2 and 3 had CIN3. Only 137 women followed up at 2 years. Of these 137 women, 116 were HR-HPV-negative and 21 were HR-HPV-positive. Of the 21 women positive for HR-HPV, 9 had negative biopsy results, 11 had CIN1, and 1 had no biopsy. The clearance rate of HR-HPV was 83% (95% confidence interval: 0.78-0.87). There were no biopsy findings of CIN2 or worse at 2 years. Before cryotherapy, of the 226 women, 15 (6.6%) were positive for endocervical curettage (ECC) and 5 (2.2%) were referred for surgical management. Of these 15 ECC-positive women, 10 (67%) followed up at 6 months and it was shown that no patient was ECC positive at that time point. Moreover, of the 15 ECC-positive women, 11 (73%) followed up at 2 years and it was shown that no patient was ECC positive at that time point. In our study, VIA had a false-positive rate of 5%. Cryotherapy was an effective, acceptable, and well-tolerated means of treating cervical dysplasia in a low

  9. Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study.

    PubMed

    Lundström, Eija A; Rencken, Rupert K; van Wyk, Johann H; Coetzee, Lance J E; Bahlmann, Johann C M; Reif, Simon; Strasheim, Erdam A; Bigalke, Martin C; Pontin, Alan R; Goedhals, Louis; Steyn, Douw G; Heyns, Chris F; Aldera, Luigi A; Mackenzie, Thomas M; Purcea, Daniela; Grosgurin, Pierre Y; Porchet, Hervé C

    2009-01-01

    Triptorelin 6-month formulation was developed to offer greater convenience to both patients and physicians by reducing the injection frequency. The efficacy, pharmacokinetics and safety of a new 6-month formulation of triptorelin were investigated over 12 months (48 weeks). The primary objective was to evaluate the formulation in achieving castrate serum testosterone levels (< or = 1.735 nmol/L or < or = 50 ng/dL) on day 29 and in maintaining castration at months 2-12. Absence of luteinizing hormone (LH) stimulation and change in prostate-specific antigen (PSA) level were also assessed. An open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa. Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5 mg at an interval of 24 weeks. In all patients, testosterone (primary outcome measurement) was measured at baseline and then every 4 weeks; LH was measured before and 2 hours after the two injections. PSA was measured on day 1 and at weeks 12, 24, 36 and 48. Adverse events were recorded at each visit. In the intent-to-treat population, 97.5% (95% CI 92.9, 99.5) of patients achieved castrate serum testosterone levels by day 29, and 93.0% (95% CI 86.8, 97.0) maintained castration at months 2-12. After the second injection, 98.3% of patients showed absence of LH stimulation. The most frequent drug-related adverse events were hot flushes (71.7% of patients). No patient withdrew from the study as a result of an adverse event. The triptorelin 6-month formulation was well tolerated and was able to achieve and maintain castration for the treatment of locally advanced and metastatic prostate cancer. By reducing the frequency of required injections, this new formulation offers a more convenient treatment regimen. (Clinical Trial Registration,NCT00751790 at www.clinicaltrials.gov).

  10. Cognitive and affective changes in mild to moderate Alzheimer's disease patients undergoing switch of cholinesterase inhibitors: a 6-month observational study.

    PubMed

    Spalletta, Gianfranco; Caltagirone, Carlo; Padovani, Alessandro; Sorbi, Sandro; Attar, Mahmood; Colombo, Delia; Cravello, Luca

    2014-01-01

    Patients with Alzheimer's disease after an initial response to cholinesterase inhibitors may complain a later lack of efficacy. This, in association with incident neuropsychiatric symptoms, may worsen patient quality of life. Thus, the switch to another cholinesterase inhibitor could represent a valid therapeutic strategy. The aim of this study was to investigate the effectiveness of the switch from one to another cholinesterase inhibitor on cognitive and affective symptoms in mild to moderate Alzheimer disease patients. Four hundred twenty-three subjects were included from the EVOLUTION study, an observational, longitudinal, multicentre study conducted on Alzheimer disease patients who switched to different cholinesterase inhibitor due either to lack/loss of efficacy or response, reduced tolerability or poor compliance. All patients underwent cognitive and neuropsychiatric assessments, carried out before the switch (baseline), and at 3 and 6-month follow-up. A significant effect of the different switch types was found on Mini-Mental State Examination score during time, with best effectiveness on mild Alzheimer's disease patients switching from oral cholinesterase inhibitors to rivastigmine patch. Depressive symptoms, when measured using continuous Neuropsychiatric Inventory values, decreased significantly, while apathy symptoms remained stable over the 6 months after the switch. However, frequency of both depression and apathy, when measured categorically using Neuropsychiatric Inventory cut-off scores, did not change significantly during time. In mild to moderate Alzheimer disease patients with loss of efficacy and tolerability during cholinesterase inhibitor treatment, the switch to another cholinesterase inhibitor may represent an important option for slowing cognitive deterioration. The evidence of apathy stabilization and the positive tendency of depressive symptom improvement should definitively be confirmed in double-blind controlled studies.

  11. Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure.

    PubMed

    Uriel, Nir; Colombo, Paolo C; Cleveland, Joseph C; Long, James W; Salerno, Christopher; Goldstein, Daniel J; Patel, Chetan B; Ewald, Gregory A; Tatooles, Antone J; Silvestry, Scott C; John, Ranjit; Caldeira, Christiano; Jeevanandam, Valluvan; Boyle, Andrew J; Sundareswaran, Kartik S; Sood, Poornima; Mehra, Mandeep R

    2017-05-23

    The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (Abbott) is a centrifugal, fully magnetically levitated, continuous-flow blood pump engineered to enhance hemocompatibility and reduce shear stress on blood components. The MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) compares the HM3 LVAS with the HeartMate II (HMII) LVAS (Abbott) in advanced heart failure refractory to medical management, irrespective of therapeutic intention (bridge to transplant versus destination therapy). This investigation reported its primary outcome in the short-term cohort (n=294; 6-month follow-up), demonstrating superiority of the HM3 for the trial primary end point (survival free of a disabling stroke or reoperation to replace the pump for malfunction), driven by a reduced need for reoperations. The aim of this analysis was to evaluate the aggregate of hemocompatibility-related clinical adverse events (HRAEs) between the 2 LVAS. We conducted a secondary end point evaluation of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n=289) at 6 months. The net burden of HRAE was also assessed by using a previously described hemocompatibility score, which uses 4 escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient. In 289 patients in the as-treated group (151 the HM3 and 138 the HMII), survival free of any HRAE was achieved in 69% of the HM3 group and in 55% of the HMII group (hazard ratio, 0.62; confidence interval, 0.42-0.91; P=0.012). Using the hemocompatibility score, the HM3 group demonstrated less pump thrombosis requiring reoperation (0 versus 36 points, P<0.001) or medically managed pump thrombosis (0 versus 5 points, P=0.02), and fewer nondisabling strokes (6 versus 24 points, P=0.026) than the

  12. Perinatal Parenting Stress, Anxiety, and Depression Outcomes in First-Time Mothers and Fathers: A 3- to 6-Months Postpartum Follow-Up Study

    PubMed Central

    Vismara, Laura; Rollè, Luca; Agostini, Francesca; Sechi, Cristina; Fenaroli, Valentina; Molgora, Sara; Neri, Erica; Prino, Laura E.; Odorisio, Flaminia; Trovato, Annamaria; Polizzi, Concetta; Brustia, Piera; Lucarelli, Loredana; Monti, Fiorella; Saita, Emanuela; Tambelli, Renata

    2016-01-01

    Objective: Although there is an established link between parenting stress, postnatal depression, and anxiety, no study has yet investigated this link in first-time parental couples. The specific aims of this study were 1) to investigate whether there were any differences between first-time fathers’ and mothers’ postnatal parenting stress, anxiety, and depression symptoms and to see their evolution between three and 6 months after their child’s birth; and 2) to explore how each parent’s parenting stress and anxiety levels and the anxiety levels and depressive symptoms of their partners contributed to parental postnatal depression. Method: The sample included 362 parents (181 couples; mothers’ MAge = 35.03, SD = 4.7; fathers’ MAge = 37.9, SD = 5.6) of healthy babies. At three (T1) and 6 months (T2) postpartum, both parents filled out, in a counterbalanced order, the Parenting Stress Index-Short Form, the Edinburgh Postnatal Depression Scale, and the State-Trait Anxiety Inventory. Results: The analyses showed that compared to fathers, mothers reported higher scores on postpartum anxiety, depression, and parenting stress. The scores for all measures for both mothers and fathers decreased from T1 to T2. However, a path analysis suggested that the persistence of both maternal and paternal postnatal depression was directly influenced by the parent’s own levels of anxiety and parenting stress and by the presence of depression in his/her partner. Discussion: This study highlights the relevant impact and effects of both maternal and paternal stress, anxiety, and depression symptoms during the transition to parenthood. Therefore, to provide efficacious, targeted, early interventions, perinatal screening should be directed at both parents. PMID:27445906

  13. PDE5 inhibitor treatment persistence and adherence in Brazilian men: post-hoc analyses from a 6-month, prospective, observational study.

    PubMed

    Cairoli, Carlos; Reyes, Luis Antonio; Henneges, Carsten; Sorsaburu, Sebastian

    2014-01-01

    Characterize persistence and adherence to phosphodiesterase type - 5 inhibitor (PDE5I) on-demand therapy over 6 months among Brazilian men in an observational, non-interventional study of Latin American men naïve to PDE5Is with erectile dysfunction (ED). Men were prescribed PDE5Is per routine clinical practice. Persistence was defined as using ≥ 1 dose during the previous 4 - weeks, and adherence as following dosing instructions for the most recent dose, assessed using the Persistence and Adherence Questionnaire. Other measures included the Self - Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence/adherence. 104 Brazilian men were enrolled; mean age by treatment was 53 to 59 years, and most presented with moderate ED (61.7%). The prescribed PDE5I was sildenafil citrate for 50 (48.1%), tadalafil for 36 (34.6%), vardenafil for 15 (14.4%), and lodenafil for 3 patients (2.9%). Overall treatment persistence was 69.2% and adherence was 70.2%; both were numerically higher with tadalafil (75.0%) versus sildenafil or vardenafil (range 60.0% to 68.0%). Potential associations of persistence and/or adherence were observed with education level, ED etiology, employment status, and coronary artery disease. Improvements in all IIEF domain scores, and both SEAR domain scores were observed for all treatments. Study limitations included the observational design, brief duration, dependence on patient self - reporting, and limited sample size. Approximately two-thirds of PDE5I-naive, Brazilian men with ED were treatment persistent and adherent after 6 months. Further study is warranted to improve long-term outcomes of ED treatment.

  14. Factors Related to Relapse After 6 Months of Smoking Cessation Among Men in the Republic of Korea: A Cross-Sectional Study.

    PubMed

    Park, Eun Young; Lim, Min Kyung; Kim, Byung-Mi; Jeong, Bo Yoon; Oh, Jin-Kyoung; Yun, E Hwa

    2015-07-01

    We identified factors associated with relapse after 6 months of smoking cessation (late relapse) among males of the Republic of Korea. Of the 222,707 smokers who visited public health center-based smoking cessation clinics (SCCs) between January 1, 2009 and mid-December 2009, we included 1720 individuals who successfully completed a 6-month smoking cessation program at an SCC. These participants were selected via a random stratified sampling design and completed an SCC user satisfaction survey between December 31, 2009 and January 6, 2010. Multiple logistic regression was used to identify factors associated with late relapse, and path analysis was employed to explore relationships among these factors. The frequency of late relapse was 21.6% (n = 372). Residence in a metropolitan area, low socioeconomic status, and the use of nicotine replacement therapy (NRT) were associated with statistically significant increases in late relapse, whereas greater access to counseling and more satisfaction with the SCC were associated with reduced late relapse. The path analysis showed that a greater number of cigarettes smoked daily and a younger age at smoking initiation exerted significant indirect effects on late relapse when NRT was employed. Residence in a metropolitan area indirectly prevented late relapse as counseling frequency increased. NRT use, counseling frequency, and SCC user satisfaction were affected by both smoking behavior and socioeconomic status. Relapse prevention efforts should concentrate on increasing both counseling frequency and SCC user satisfaction. Future studies should focus on the effect of NRT on the maintenance of long-term cessation at the population level in real-world settings.

  15. Sexual Function 6 Months After First Delivery

    PubMed Central

    Brubaker, Linda; Handa, Victoria L.; Bradley, Catherine S.; Connolly, AnnaMarie; Moalli, Pamela; Brown, Morton B.; Weber, Anne

    2008-01-01

    OBJECTIVE To explore the association of anal sphincter laceration and sexual function 6 months postpartum in the Childbirth and Pelvic Symptoms (CAPS) cohort. METHODS The primary CAPS study, a prospective cohort study, was designed to estimate the postpartum prevalence and incidence of urinary and fecal incontinence. Three cohorts of new mothers (vaginal delivery with a third- or fourth-degree anal sphincter tear, vaginal delivery without a third- or fourth-degree anal sphincter tear, and cesarean delivery without labor) were compared at 6 months postpartum. Sexual function was assessed with the Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Short Form Questionnaire (PISQ-12). Urinary and fecal incontinence were assessed using the Medical Epidemiological and Social Aspects of Aging questionnaire and the Fecal Incontinence Severity Index, which is embedded within the Modified Manchester Health Questionnaire. RESULTS Most women (459 [90%]) of those with partners reported sexual activity at the 6-month visit. Fewer women whose delivery was complicated by anal sphincter laceration reported sexual activity when compared with those who delivered vaginally without sphincter laceration (88 compared with 94%, P=.028). The mean PISQ-12 score (39±4) did not differ between delivery groups (P=.92). Pain (responses of “sometimes,” “usually,” or “always”) during sex affected one of three sexually active women (164 [36%]). CONCLUSION At 6 months postpartum, primiparous women who delivered with anal sphincter laceration are less likely to report sexual activity. PMID:18448733

  16. Bergamot Reduces Plasma Lipids, Atherogenic Small Dense LDL, and Subclinical Atherosclerosis in Subjects with Moderate Hypercholesterolemia: A 6 Months Prospective Study

    PubMed Central

    Toth, Peter P.; Patti, Angelo M.; Nikolic, Dragana; Giglio, Rosaria V.; Castellino, Giuseppa; Biancucci, Teresa; Geraci, Fabiana; David, Sabrina; Montalto, Giuseppe; Rizvi, Ali; Rizzo, Manfredi

    2016-01-01

    Background: Some patients experience statin-induced side effects or prefer nutraceutical approaches for the treatment of dyslipidemia. This has led to a search for alternative therapeutic approaches for dyslipidemia management. In recent studies Citrus bergamia (known as Bergamot) juice was able to reduce serum levels of lipids. Such benefit may be attributed to high amounts of flavonoids contained in Bergamot fruit juice (neoeriocitrin, neohesperidin, naringin). The aim of the present study was to fully investigate the effects of a Bergamot extract on cardio-metabolic parameters, including plasma lipids, atherogenic lipoproteins and subclinical atherosclerosis. Methods: Eighty subjects (42 men and 38 women, mean age: 55 ± 13 years) with moderate hypercholesterolemia [e.g., with plasma LDL-cholesterol concentrations between 160 and 190 mg/dl (between 4.1 and 4.9 mmol/l)] were included. A Bergamot-derived extract (Bergavit R®) was given at a fixed dose daily (150 mg of flavonoids, with 16% of neoeriocitrin, 47% of neohesperidin and 37% of naringin) for 6 months. Lipoprotein subfractions were assessed by gel electrophoresis. With this methodology low density lipoprotein (LDL) subclasses are distributed as seven bands (LDL-1 and -2 as large LDL, and LDL-3 to -7 as atherogenic small, dense LDL). Subclinical atherosclerosis was assessed by carotid intima-media thickness (cIMT) using B-mode ultrasound. Results: After 6 months, Bergavit R® reduced total cholesterol (from 6.6 ± 0.4 to 5.8 ± 1.1 mmol/l, p < 0.0001), triglycerides (from 1.8 ± 0.6 to 1.5 ± 0.9 mmol/l, p = 0.0020), and LDL-cholesterol (from 4.6 ± 0.2 to 3.7 ± 1.0 mmol/l, p < 0.0001), while HDL- cholesterol increased (from 1.3 ± 0.2 to 1.4 ± 0.4 mmol/l, p < 0.0007). In addition, a significant increase in LDL-1 (from 41.2 ± 0.2 to 49.6 ± 0.2%, p < 0.0001) was accompanied by decreased small, dense LDL-3, -4, and 5 particles (from 14.5 ± 0.1 to 9.0 ± 0.1% p < 0.0001; 3.2 ± 0.1 to 1.5 ± 0.1% p = 0

  17. The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial.

    PubMed

    Young, Barnaby; Sadarangani, Sapna; Yew, Haur Sen; Yung, Chee Fu; Leo, Yee Sin; Chen, Mark I-Cheng; Wilder-Smith, Annelies

    2017-02-10

    The seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activity. This study aims to assess the effect of a trivalent inactivated influenza vaccine (IIV3) booster at 180 days on haemagglutination-inhibition (HI) antibody titres for each of the influenza strains present in the administered vaccine in older people aged 65 years or above in Singapore. This is a single-centre, randomised, observer-blind, active-comparator controlled, parallel-group, phase IV trial in 200 adults aged 65 years or older. Study participants will be assigned to one of two groups in a 1:1 ratio and followed for 1 year, with five scheduled visits. The control group will receive IIV3 at day 1, and an active comparator (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group will receive IIV3 containing the same strains at day 1 and day 180. Endpoints are immunological, and include measures of HI titres, microneutralisation titres (MN) and cell-mediated immunity from first vaccination up to day 360. If superiority of 6-monthly influenza vaccination is demonstrated, this study could form the basis for a larger clinical trial with influenza infection as the primary endpoint. ClinicalTrials.gov, ID: NCT02655874 . Registered on 12 January 2016.

  18. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study.

    PubMed

    Nüßlein, Hubert G; Alten, Rieke; Galeazzi, Mauro; Lorenz, Hanns-Martin; Boumpas, Dimitrios; Nurmohamed, Michael T; Bensen, William G; Burmester, Gerd R; Peter, Hans-Hartmut; Rainer, Franz; Pavelka, Karel; Chartier, Melanie; Poncet, Coralie; Rauch, Christiane; Bars, Manuela Le

    2014-01-11

    Discontinuation of rheumatoid arthritis (RA) treatment for lack or loss of initial response, tolerability issues, or development of antibodies against the therapeutic agent remains a challenge in clinical practice. Here we present a 6-month interim analysis of a 2-year prospective observational trial in Europe and Canada aiming to assess the real-world effectiveness, safety, and tolerability of intravenous abatacept for the treatment of moderate-to-severe RA. ACTION (AbataCepT In rOutiNe clinical practice) is a prospective, observational study assessing effectiveness, safety, and tolerability of abatacept in patients with RA enrolled in Europe and Canada between May 2008 and January 2011. The patient population was divided into two groups: biologic naïve ('first-line') patients and patients who had previously failed treatment with at least one biologic agent ('second-line'). Retention rates were calculated using Kaplan-Meier curve estimates. Effectiveness was measured using European League Against Rheumatism (EULAR) response criteria, the 28-item Disease Activity Score, the Clinical Disease Activity Index (CDAI), and physical function, as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI). Serious adverse events (SAEs) were reported for all enrolled patients. Of 1138 consecutively enrolled patients, 1114 and 1079 patients were evaluable for retention and effectiveness, respectively. Overall, retention rates were 88.6% (95% confidence interval [CI]: 86.4, 90.4); 67.4% of patients achieved good/moderate EULAR response; 32.8% had a CDAI Low Disease Activity State (LDAS); and 44.7% a HAQ-DI response. Retention rates among first- and second-line patients were 93.0% (95% CI: 85.9, 96.6) and 88.1% (95% CI: 85.7, 90.0), respectively. The percentage of patients achieving CDAI LDAS was 40.0% (95% CI: 26.4, 53.6) for first- and 32.2% (95% CI: 28.4, 36.0) for second-line patients and the proportion achieving a HAQ-DI response was 60.3% (95% CI: 47.8, 72

  19. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study

    PubMed Central

    2014-01-01

    Background Discontinuation of rheumatoid arthritis (RA) treatment for lack or loss of initial response, tolerability issues, or development of antibodies against the therapeutic agent remains a challenge in clinical practice. Here we present a 6-month interim analysis of a 2-year prospective observational trial in Europe and Canada aiming to assess the real-world effectiveness, safety, and tolerability of intravenous abatacept for the treatment of moderate-to-severe RA. Methods ACTION (AbataCepT In rOutiNe clinical practice) is a prospective, observational study assessing effectiveness, safety, and tolerability of abatacept in patients with RA enrolled in Europe and Canada between May 2008 and January 2011. The patient population was divided into two groups: biologic naïve (‘first-line’) patients and patients who had previously failed treatment with at least one biologic agent (‘second-line’). Retention rates were calculated using Kaplan–Meier curve estimates. Effectiveness was measured using European League Against Rheumatism (EULAR) response criteria, the 28-item Disease Activity Score, the Clinical Disease Activity Index (CDAI), and physical function, as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI). Serious adverse events (SAEs) were reported for all enrolled patients. Results Of 1138 consecutively enrolled patients, 1114 and 1079 patients were evaluable for retention and effectiveness, respectively. Overall, retention rates were 88.6% (95% confidence interval [CI]: 86.4, 90.4); 67.4% of patients achieved good/moderate EULAR response; 32.8% had a CDAI Low Disease Activity State (LDAS); and 44.7% a HAQ-DI response. Retention rates among first- and second-line patients were 93.0% (95% CI: 85.9, 96.6) and 88.1% (95% CI: 85.7, 90.0), respectively. The percentage of patients achieving CDAI LDAS was 40.0% (95% CI: 26.4, 53.6) for first- and 32.2% (95% CI: 28.4, 36.0) for second-line patients and the proportion achieving a HAQ

  20. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder.

    PubMed

    Siegel, Steven; Noblett, Karen; Mangel, Jeffrey; Griebling, Tomas L; Sutherland, Suzette E; Bird, Erin T; Comiter, Craig; Culkin, Daniel; Bennett, Jason; Zylstra, Samuel; Berg, Kellie Chase; Kan, Fangyu; Irwin, Christopher P

    2015-03-01

    This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (≥2 leaks/72 hr) and/or urgency-frequency (≥8 voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT. Overall, 147 subjects were randomized (70 to SNM and 77 to SMT); 93% were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group (61%) than the SMT group (42%; P = 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (P = 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P < 0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device-related adverse event rate was 30.5% and the medication-related adverse event rate was 27.3%. This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms. Neurourol. Urodynam. 34:224-230, 2015. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

  1. The acceptance and feasibility of replacement feeding at 6 months as an HIV prevention method in Lilongwe, Malawi: Results from the BAN Study

    PubMed Central

    Parker, Megan E.; Bentley, Margaret E.; Chasela, Charles; Adair, Linda; Piwoz, Ellen G.; Jamieson, Denise J.; Ellington, Sascha; Kayira, Dumbani; Soko, Alice; Mkhomawanthu, Chimwemwe; Tembo, Martin; Martinson, Francis; van der Horst, Charles M.

    2011-01-01

    International guidelines recommend exclusive breastfeeding to 6 months among HIV-infected mothers choosing to breastfeed and cessation thereafter if replacement feeding is acceptable, feasible, affordable, sustainable and safe. When mothers wean they are challenged to provide an adequate replacement diet. This study investigates the use and acceptability of a lipid-based nutrient supplement (LNS) as a breastmilk substitute when provided to infants (6-12mo) of HIV-positive mothers, as part of the Breastfeeding, Antiretroviral, and Nutrition (BAN) Study. A sub-sample of mothers (n=45) participated in interviews that explored exclusive breastfeeding, weaning, and strategies to feed LNS. Mothers reported several weaning strategies, including gradual reduction of breastfeeding, expressing breastmilk into a cup, and separation of mother and child. LNS, a peanut-based micronutrient fortified paste, was highly accepted and incorporated into the traditional diet. Weaning is a feasible HIV prevention method among this population in Malawi when supported by the provision of LNS as a breastmilk substitute. PMID:21696245

  2. Frontal theta cordance predicts 6-month antidepressant response to subcallosal cingulate deep brain stimulation for treatment-resistant depression: a pilot study.

    PubMed

    Broadway, James M; Holtzheimer, Paul E; Hilimire, Matthew R; Parks, Nathan A; Devylder, Jordan E; Mayberg, Helen S; Corballis, Paul M

    2012-06-01

    Deep brain stimulation (DBS) of subcallosal cingulate white matter (SCC) may be an effective approach for treatment-resistant depression (TRD) that otherwise fails to respond to more conventional therapies, but DBS is invasive, costly, and has potential for adverse effects. Therefore, it is important to identify potential biomarkers for predicting antidepressant response before intervention. Resting-state EEG was recorded from 12 TRD patients at pre-treatment baseline, after 4 weeks SCC DBS, and after 24 weeks SCC DBS. Lower frontal theta cordance (FTC) at baseline (and higher FTC after 4 weeks) predicted lower depression severity scores after 24 weeks. Greater FTC increases (baseline-4 weeks) predicted greater decreases in depression severity scores subsequently (4-24 weeks) and over the course of the study (baseline-24 weeks). Predictive relationships were topographically specific to theta cordance for frontal electrodes. Thus, results from this pilot study suggest that baseline FTC and changes early in treatment each have utility as biomarkers for predicting 6-month clinical response to SCC DBS for TRD.

  3. Frontal Theta Cordance Predicts 6-Month Antidepressant Response to Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Depression: A Pilot Study

    PubMed Central

    Broadway, James M; Holtzheimer, Paul E; Hilimire, Matthew R; Parks, Nathan A; DeVylder, Jordan E; Mayberg, Helen S; Corballis, Paul M

    2012-01-01

    Deep brain stimulation (DBS) of subcallosal cingulate white matter (SCC) may be an effective approach for treatment-resistant depression (TRD) that otherwise fails to respond to more conventional therapies, but DBS is invasive, costly, and has potential for adverse effects. Therefore, it is important to identify potential biomarkers for predicting antidepressant response before intervention. Resting-state EEG was recorded from 12 TRD patients at pre-treatment baseline, after 4 weeks SCC DBS, and after 24 weeks SCC DBS. Lower frontal theta cordance (FTC) at baseline (and higher FTC after 4 weeks) predicted lower depression severity scores after 24 weeks. Greater FTC increases (baseline–4 weeks) predicted greater decreases in depression severity scores subsequently (4–24 weeks) and over the course of the study (baseline–24 weeks). Predictive relationships were topographically specific to theta cordance for frontal electrodes. Thus, results from this pilot study suggest that baseline FTC and changes early in treatment each have utility as biomarkers for predicting 6-month clinical response to SCC DBS for TRD. PMID:22414813

  4. Early life stress predicts negative urgency through brooding, depending on 5-HTTLPR genotype: A pilot study with 6-month follow-up examining suicide ideation.

    PubMed

    Valderrama, Jorge; Miranda, Regina

    2017-09-01

    The present study examined the interaction between early life stress and 5-HTT genotypes in predicting two risk factors for suicidal behavior - the brooding subtype of rumination and impulsivity, in the form of negative urgency - over time. Furthermore, we examined early life stress, brooding, and impulsivity as predictors of suicidal ideation over time. Participants with and without a history of early life stress were genotyped for the 5-HTTLPR polymorphism and completed assessments assessing brooding and negative urgency at baseline and 6-month follow up. Early life emotional abuse was associated with negative urgency at follow-up. We found an indirect effect of early life emotional abuse on negative urgency through brooding among individuals with 5-HTT low expressing genotypes but not among individuals with 5-HTT high expressing genotypes. Further, a logistic regression analysis revealed that negative urgency was associated with higher odds (O.R. = 16.2) of reporting suicide ideation (versus no ideation) at follow-up. Our findings suggest that brooding and negative urgency may result from the interaction between early life emotional abuse and 5-HTT low expressing genotypes. Further research is necessary to understand how early life stress interacts with 5-HTT genotypes to confer risk for suicidal behavior through psychological mechanisms. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Walking ability following knee arthroplasty: a prospective pilot study of factors affecting the maximal walking distance in 18 patients before and 6 months after total knee arthroplasty.

    PubMed

    Rosenberg, N; Nierenberg, G; Lenger, R; Soudry, M

    2007-12-01

    Functional assessment of patients before and after prosthetic knee arthroplasty is based on clinical examination, which is usually summarized in various knee scores. The present study proposes a different and more subject orientated assessment for functional grading of these patients by measuring their maximal distance of walking ability, which is not apparent from the conventional outcome scores. Eighteen consecutive patients with knee osteoarthritis were evaluated for their knee and knee functional scores (The Knee Society clinical rating system) and for the maximal distance of their walking ability before and 6 months after knee arthroplasty. Specially designed walking ability grading was used for evaluation of walking on walkway. The pre- and post-operative knee scores and maximal walking distance and grading were statistically compared. A significant improvement in the knee and functional scores following surgery was observed. But the maximal walking ability grades and distances did not change significantly following surgery, showing a high relation between pre- and post-operative values. The limitation in post-operative walking was due to the revealed additional health disabilities, not related to the affected knee. Therefore we suggest that pre-operative evaluation of walking abilities should be taken into consideration both for patients' selection and timing of surgery and also for matching of patients' expectation from outcome of prosthetic knee arthroplasty.

  6. Prospective comparative study of tapered implants with SLA surfaces in the maxillary posterior area according to 3- and 6-month loading time.

    PubMed

    Kim, Young-Kyun; Kim, Jong-Hwa; Yi, Yang-Jin; Kwon, Min-Jung; Yun, Pil-Young

    2015-01-01

    The purpose of this study was to demonstrate clinical outcomes of sandblasted, large-grit, acid-etched (SLA)-surfaced tapered implants when early loaded in partially edentulous spaces in the maxilla. SLA-surfaced implants were placed in participants in the maxillary posterior edentulous area. At the time of definitive restoration, participants were allocated either to group 1 (3-month loading group) or group 2 (6-month loading group). A total of 36 participants (18 people [35 implants] in group 1 and 18 [33 implants] in group 2) were analyzed. Clinical outcomes, including survival rate and peri-implant parameters such as marginal bone loss were measured 1 year after loading. The survival rate was 97.0% in group 1 and 100% in group 2. Marginal bone loss was 0.22 ± 0.34 mm in group 1 and 0.17 ± 0.25 mm in group 2 at 1 year after loading (P = .488). There were no significant differences between groups in keratinized mucosal width (P = .206), Plaque Index (P = .677), or Gingival Index (P = .558). With adequate remaining bone height and primary implant stability achieved, the 3-month early loading of SLA-surface tapered implants may be a viable choice when restoring posterior maxillary edentulous areas.

  7. Face Detection in Complex Visual Displays: An Eye-Tracking Study with 3- and 6-Month-Old Infants and Adults

    ERIC Educational Resources Information Center

    Di Giorgio, Elisa; Turati, Chiara; Altoe, Gianmarco; Simion, Francesca

    2012-01-01

    The ability to detect and prefer a face when embedded in complex visual displays was investigated in 3- and 6-month-old infants, as well as in adults, through a modified version of the visual search paradigm and the recording of eye movements. Participants "(N" = 43) were shown 32 visual displays that comprised a target face among 3 or 5…

  8. Immunotoxicological Evaluation of Genetically Modified Rice Expressing Cry1Ab/Ac Protein (TT51-1) by a 6-Month Feeding Study on Cynomolgus Monkeys

    PubMed Central

    Tan, Xiaoyan; Zhou, Xiaobing; Tang, Yao; Lv, Jianjun; Zhang, Lin; Sun, Li; Yang, Yanwei; Miao, Yufa; Jiang, Hua; Chen, Gaofeng; Huang, Zhiying; Wang, Xue

    2016-01-01

    The present study was performed to evaluate the food safety of TT51-1, a new type of genetically modified rice that expresses the Cry1Ab/Ac protein (Bt toxin) and is highly resistant to most lepidopteran pests. Sixteen male and 16 female cynomolgus monkeys were randomly divided into four groups: conventional rice (non-genetically modified rice, non-GM rice), positive control, 17.5% genetically modified rice (GM rice) and 70% GM rice. Monkeys in the non-GM rice, positive control, and GM rice groups were fed on diets containing 70% non-GM rice, 17.5% GM rice or 70% GM rice, respectively, for 182 days, whereas animals in the positive group were intravenously injected with cyclophosphamide every other day for a total of four injections before the last treatment. Six months of treatment did not yield abnormal observations. Specifically, the following parameters did not significantly differ between the non-GM rice group and GM rice groups: body weight, food consumption, electrocardiogram, hematology, immuno-phenotyping of lymphocytes in the peripheral blood, mitogen-induced peripheral blood lymphocyte proliferation, splenocyte proliferation, KLH-T cell-dependent antibody response, organ weights and ratios, and histological appearance (p>0.05). Animals from the GM rice group differed from animals in the non-GM rice group (p<0.05) in several parameters: specifically, their body temperatures and serum alanine aminotransferase (ALT) levels were higher, whereas their levels of serum K+, Cl- and cytokines (IL-2, IL-4 and IL-5) were lower. Because dose- or time-dependent changes were not observed in this study and animals appeared histologically normal, the aforementioned differences were not considered to be adverse or related to the treatment with GM rice. In conclusion, a 6-month feeding study of TT51-1 did not show adverse immunotoxicological effects on cynomolgus monkeys. PMID:27684490

  9. Activity of chemotherapy in mucinous ovarian cancer with a recurrence free interval of more than 6 months: results from the SOCRATES retrospective study.

    PubMed

    Pignata, Sandro; Ferrandina, Gabriella; Scarfone, Giovanna; Scollo, Paolo; Odicino, Franco; Cormio, Gennaro; Katsaros, Dionyssios; Villa, Antonella; Mereu, Liliana; Ghezzi, Fabio; Manzione, Luigi; Lauria, Rossella; Breda, Enrico; Alletti, Desiderio Gueli; Ballardini, Michela; Lombardi, Alessandra Vernaglia; Sorio, Roberto; Mangili, Giorgia; Priolo, Domenico; Magni, Giovanna; Morabito, Alessandro

    2008-09-01

    Mucinous ovarian carcinoma have a poorer prognosis compared with other histological subtypes. The aim of this study was to evaluate, retrospectively, the activity of chemotherapy in patients with platinum sensitive recurrent mucinous ovarian cancer. The SOCRATES study retrospectively assessed the pattern of care of a cohort of patients with recurrent platinum-sensitive ovarian cancer observed in the years 2000-2002 in 37 Italian centres. Data were collected between April and September 2005. Patients with recurrent ovarian cancer with > 6 months of platinum free interval were considered eligible. Twenty patients with mucinous histotype and 388 patients with other histotypes were analyzed. At baseline, mucinous tumours differed from the others for an higher number of patients with lower tumor grading (p = 0.0056) and less advanced FIGO stage (p = 0.025). At time of recurrence, a statistically significant difference was found in performance status (worse in mucinous, p = 0.024). About 20% of patients underwent secondary cytoreduction in both groups, but a lower number of patients were optimally debulked in the mucinous group (p = 0.03). Patients with mucinous cancer received more frequently single agent platinum than platinum based-combination therapy or other non-platinum schedules as second line therapy (p = 0.026), with a response rate lower than in non-mucinous group (36.4% vs 62.6%, respectively, p = 0.04). Median time to progression and overall survival were worse for mucinous ovarian cancer. Finally, mucinous cancer received a lower number of chemotherapy lines (p = 0.0023). This analysis shows that platinum sensitive mucinous ovarian cancer has a poor response to chemotherapy. Studies dedicated to this histological subgroup are needed.

  10. Activity of chemotherapy in mucinous ovarian cancer with a recurrence free interval of more than 6 months: results from the SOCRATES retrospective study

    PubMed Central

    Pignata, Sandro; Ferrandina, Gabriella; Scarfone, Giovanna; Scollo, Paolo; Odicino, Franco; Cormio, Gennaro; Katsaros, Dionyssios; Villa, Antonella; Mereu, Liliana; Ghezzi, Fabio; Manzione, Luigi; Lauria, Rossella; Breda, Enrico; Alletti, Desiderio Gueli; Ballardini, Michela; Lombardi, Alessandra Vernaglia; Sorio, Roberto; Mangili, Giorgia; Priolo, Domenico; Magni, Giovanna; Morabito, Alessandro

    2008-01-01

    Background Mucinous ovarian carcinoma have a poorer prognosis compared with other histological subtypes. The aim of this study was to evaluate, retrospectively, the activity of chemotherapy in patients with platinum sensitive recurrent mucinous ovarian cancer. Methods The SOCRATES study retrospectively assessed the pattern of care of a cohort of patients with recurrent platinum-sensitive ovarian cancer observed in the years 2000–2002 in 37 Italian centres. Data were collected between April and September 2005. Patients with recurrent ovarian cancer with > 6 months of platinum free interval were considered eligible. Results Twenty patients with mucinous histotype and 388 patients with other histotypes were analyzed. At baseline, mucinous tumours differed from the others for an higher number of patients with lower tumor grading (p = 0.0056) and less advanced FIGO stage (p = 0.025). At time of recurrence, a statistically significant difference was found in performance status (worse in mucinous, p = 0.024). About 20% of patients underwent secondary cytoreduction in both groups, but a lower number of patients were optimally debulked in the mucinous group (p = 0.03). Patients with mucinous cancer received more frequently single agent platinum than platinum based-combination therapy or other non-platinum schedules as second line therapy (p = 0.026), with a response rate lower than in non-mucinous group (36.4% vs 62.6%, respectively, p = 0.04). Median time to progression and overall survival were worse for mucinous ovarian cancer. Finally, mucinous cancer received a lower number of chemotherapy lines (p = 0.0023). Conclusion This analysis shows that platinum sensitive mucinous ovarian cancer has a poor response to chemotherapy. Studies dedicated to this histological subgroup are needed. PMID:18761742

  11. Immunotoxicological Evaluation of Genetically Modified Rice Expressing Cry1Ab/Ac Protein (TT51-1) by a 6-Month Feeding Study on Cynomolgus Monkeys.

    PubMed

    Tan, Xiaoyan; Zhou, Xiaobing; Tang, Yao; Lv, Jianjun; Zhang, Lin; Sun, Li; Yang, Yanwei; Miao, Yufa; Jiang, Hua; Chen, Gaofeng; Huang, Zhiying; Wang, Xue

    The present study was performed to evaluate the food safety of TT51-1, a new type of genetically modified rice that expresses the Cry1Ab/Ac protein (Bt toxin) and is highly resistant to most lepidopteran pests. Sixteen male and 16 female cynomolgus monkeys were randomly divided into four groups: conventional rice (non-genetically modified rice, non-GM rice), positive control, 17.5% genetically modified rice (GM rice) and 70% GM rice. Monkeys in the non-GM rice, positive control, and GM rice groups were fed on diets containing 70% non-GM rice, 17.5% GM rice or 70% GM rice, respectively, for 182 days, whereas animals in the positive group were intravenously injected with cyclophosphamide every other day for a total of four injections before the last treatment. Six months of treatment did not yield abnormal observations. Specifically, the following parameters did not significantly differ between the non-GM rice group and GM rice groups: body weight, food consumption, electrocardiogram, hematology, immuno-phenotyping of lymphocytes in the peripheral blood, mitogen-induced peripheral blood lymphocyte proliferation, splenocyte proliferation, KLH-T cell-dependent antibody response, organ weights and ratios, and histological appearance (p>0.05). Animals from the GM rice group differed from animals in the non-GM rice group (p<0.05) in several parameters: specifically, their body temperatures and serum alanine aminotransferase (ALT) levels were higher, whereas their levels of serum K+, Cl- and cytokines (IL-2, IL-4 and IL-5) were lower. Because dose- or time-dependent changes were not observed in this study and animals appeared histologically normal, the aforementioned differences were not considered to be adverse or related to the treatment with GM rice. In conclusion, a 6-month feeding study of TT51-1 did not show adverse immunotoxicological effects on cynomolgus monkeys.

  12. Polydeoxyribonucleotide Injection in the Treatment of Chronic Supraspinatus Tendinopathy: A Case-Controlled, Retrospective, Comparative Study With 6-Month Follow-Up.

    PubMed

    Yoon, Young Chun; Lee, Doo-Hyung; Lee, Michael Young; Yoon, Seung-Hyun

    2017-05-01

    To determine the efficacy of polydeoxyribonucleotide (PDRN) injection for rotator cuff disease (RCD). Case-controlled, retrospective, comparative study. Outpatient clinic at a university-affiliated tertiary care hospital. Patients (N=106) with chronic nontraumatic refractory RCD who were unresponsive to at least 1 month of conservative treatment: 55 patients received PDRN injection (PDRN group) and 51 continued conservative treatment (control group). Not applicable. Shoulder Pain and Disability Index, score on a visual analog scale of the average shoulder pain level, number of analgesic ingestions per day, isometric strength of shoulder abductor, active range of motion (flexion, abduction, internal rotation, external rotation), and maximal tear size of tendon on ultrasonography at pretreatment and 3 and 6 months postinjection. There was no significant difference between the 2 groups in terms of age, sex, shoulder affected, duration of symptoms, and ultrasonographic findings at pretreatment. Compared with the control group, the treatment group showed a significant improvement in Shoulder Pain and Disability Index, visual analog scale score, and number of analgesic ingestions per day. However, there was no difference in isometric strength, active range of motion, and maximal tear size of tendon. No adverse events were reported. To our knowledge, this is the first study to assess the efficacy of PDRN injection for patients with RCD. The PDRN injection group showed improvement in pain and subjective disability in patients with RCD and continued to show improvement for 3 months thereafter; the PDRN injection can be an optional treatment for patients with chronic RCD who show no response to other treatments. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  13. A CASE CONTROL STUDY OF THE EFFECTIVENESS OF TISSUE PLASMINOGEN ACTIVATOR ON 6 MONTH PATIENT-REPORTED OUTCOMES AND HEALTHCARE UTILIZATION

    PubMed Central

    Lang, Catherine E.; Bland, Marghuretta D.; Cheng, Nuo; Corbetta, Maurizio; Lee, Jin-Moo

    2014-01-01

    We examined the benefit of tissue plasminogen activator (tPA), delivered as part of usual stroke management, on patient-reported outcomes and healthcare utilization. Using a case control design, patients who received tPA as part of usual stroke management were compared with patients who would have received tPA had they arrived to the hospital within the therapeutic time window. Data were collected from surveys 6 months post stroke using standardized patient-reported outcome measures and questions about healthcare utilization. Demographic and medical data were acquired from hospital records. Patients were matched on stroke severity, age, race, and gender. Matching was done with 1:2 ratio of tPA to controls. Results were compared between groups with 1-tailed tests due to directionally-specific hypothesis in favor of the tPA group. The tPA (n = 78) and control (n = 156) groups were matched across the variables, except for stroke severity, which was better in the control group; subsequent analyses controlled for this mismatch. The tPA group reported better physical function, communication, cognitive ability, depressive symptomatology, and quality of life/participation compared to the control group. Fewer people in the tPA group reported skilled nursing facility stays, emergency department visits, and re-hospitalizations after their stroke compared to controls. Reports of other post-acute services were not different between groups. While it is known that tPA reduces disability, this is the first study to demonstrate the effectiveness of tPA in improving meaningful, patient-reported outcomes. Thus, use of tPA provides a large benefit to the daily lives of people with ischemic stroke. PMID:25440368

  14. The brain-in-motion study: effect of a 6-month aerobic exercise intervention on cerebrovascular regulation and cognitive function in older adults

    PubMed Central

    2013-01-01

    Background Aging and physical inactivity are associated with declines in some cognitive domains and cerebrovascular function, as well as an elevated risk of cerebrovascular disease and other morbidities. With the increase in the number of sedentary older Canadians, promoting healthy brain aging is becoming an increasingly important population health issue. Emerging research suggests that higher levels of physical fitness at any age are associated with better cognitive functioning and this may be mediated, at least in part, by improvements in cerebrovascular reserve. We are currently conducting a study to determine: if a structured 6-month aerobic exercise program is associated with improvements or maintenance of both cerebrovascular function and cognitive abilities in older individuals; and, the extent to which any changes seen persist 6 months after the completion of the structured exercise program. Methods/design Two hundred and fifty men and women aged 55–80 years are being enrolled into an 18-month combined quasi-experimental and prospective cohort study. Participants are eligible for enrollment into the study if they are inactive (i.e., not participating in regular physical activity), non-smokers, have a body mass index <35.0 kg/m2, are free of significant cognitive impairment (defined as a Montreal Cognitive Assessment score of 24 or more), and do not have clinically significant cardiovascular, cerebrovascular disease, or chronic obstructive pulmonary airway disease. Repeated measurements are done during three sequential six-month phases: 1) pre-intervention; 2) aerobic exercise intervention; and 3) post-intervention. These outcomes include: cardiorespiratory fitness, resting cerebral blood flow, cerebrovascular reserve, and cognitive function. Discussion This is the first study to our knowledge that will examine contemporaneously the effect of an exercise intervention on both cerebrovascular reserve and cognition in an older population. This study

  15. 25-Hydroxyvitamin D concentrations in children with Crohn's disease supplemented with either 2000 or 400 IU daily for 6 months: a randomized controlled study.

    PubMed

    Wingate, Kirstin E; Jacobson, Kevan; Issenman, Robert; Carroll, Matthew; Barker, Collin; Israel, David; Brill, Herbert; Weiler, Hope; Barr, Susan I; Li, Wangyang; Lyon, Michael R; Green, Timothy J

    2014-04-01

    To assess vitamin D status of pediatric patients with Crohn's disease (CD) and to compare their serum 25-hydroxyvitamin D (s-25OHD) with established cutoffs and assess whether 6 months of supplementation with 2000 IU/d, vs 400 IU/d, would reduce the group prevalence of vitamin D below these cutoffs. Subjects 8-18 years (n = 83) with quiescent CD were randomized to either 400 or 2000 IU vitamin D3/d for 6 months. Baseline mean ± SD s-25OHD was 24 ± 8 ng/mL; 13 subjects (16%) had an s-25OHD <16 ng/mL, 27 (33%) < 20 ng/mL, and 65 (79%) < 30 ng/mL. There was no significant difference between groups in achieving the cutoffs of 16 ng/mL or 20 ng/mL at 6 months; however, only 35% of the 400 IU group achieved the greater cutoff of 30 ng/mL compared with 74% in the 2000 IU group (P < .001). Baseline adjusted mean s-25OHD concentrations at 6 months were 9.6 ng/mL (95% CI 6.0-13.2, P < .001) greater in the 2000 IU than the 400 IU group. Disease activity was not affected by supplement dose. Few subjects exceeded safety marker cutoffs, and this did not differ by dose. At baseline, a high proportion of patients had a mean s-25OHD >20 ng/mL. 2000 IU vitamin D3/d is more effective in raising s-25OHD concentrations to > 30 ng/mL in children with CD than 400 IU/d, but both treatments were equally effective at achieving 16 or 20 ng/mL. Copyright © 2014 Mosby, Inc. All rights reserved.

  16. Impact of associative word learning on phonotactic processing in 6-month-old infants: A combined EEG and fNIRS study.

    PubMed

    Obrig, Hellmuth; Mock, Julia; Stephan, Franziska; Richter, Maria; Vignotto, Micol; Rossi, Sonja

    2017-06-01

    During early language development native phonotactics are acquired in a 'bottom-up' fashion, relying on exquisite auditory differentiation skills operational from birth. Since basic lexico-semantic abilities have been demonstrated from 6 months onwards, 'top-down' influences on phonotactic learning may complement the extraction of transitional probabilities in phonotactic learning. Such a bidirectional acquisition strategy predicts, that familiarization with (proto)words should affect processing of untrained word-forms of similar phonological structure. We investigated 6-month-old infants undergoing an associative training to establish a pseudoword-pseudoobject link. Comparison between pre- and post-training responses to trained and untrained items allowed investigating training effects. Additionally phonotactic status (50% legal, 50% illegal with regard to German) allowed investigating influences of previous language experience. EEG and functional near-infrared spectroscopy (fNIRS) provided measures of electrophysiological and hemodynamic responses. We find evidence for a robust effect of associative training on pseudoword processing when presented in isolation. This transferred to untrained items. Previous linguistic experience showed a much weaker effect. Taken together the results suggest that sensitivity to phonotactic contrasts is present at 6 months, but that acceptance as lexical candidates is rapidly modulated when word forms following non-native phonotactics become potentially meaningful due to repeated exposure in a semantic context. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  17. Fast gait speed and self-perceived balance as valid predictors and discriminators of independent community walking at 6 months post-stroke--a preliminary study.

    PubMed

    Rosa, Marlene Cristina; Marques, Alda; Demain, Sara; Metcalf, Cheryl D

    2015-01-01

    To determine the validity of walking speed, muscle strength, function of the hemiparetic lower limb and self-perceived balance to predict and discriminate independent community walkers (ICW) within the first 6 months post-stroke. Inpatients with a first ischemic stroke (<3 months), able to walk, were evaluated (T0) and re-evaluated after 6 months post-stroke (T1). Comfortable, fast speed and the difference between fast and comfortable speed, muscle strength of knee flexors and extensors, sensory-motor function of the hemiparetic lower limb and self-perceived balance were assessed at T0 and T1. At T1, a self-reported question was used to discriminate ICW versus Dependent Community Walkers (DCW). ROC curve analysis was used to determine valid predictive (T0) and discriminative (T1) cut-offs of ICW. Only 25.7% of the 35 participants were ICW at T1. Valid predictive cut-offs at T0 were found for fast speed (≥0.42 m/s) and Falls Efficacy Scale (<57). Valid discriminators were found at T1 for fast speed (>0.84 m/s) and FES (<18.50). Fast speed and self-perceived balance appear to be important characteristics of ICW at 6 months and may be useful early predictors of the potential for patients to achieve this. Further research is needed to ensure the precision of these functional cut-offs.

  18. Effects of a 6-month caloric restriction induced-weight loss program in obese postmenopausal women with and without the metabolic syndrome: a MONET study.

    PubMed

    Ghachem, Ahmed; Prud'homme, Denis; Rabasa-Lhoret, Rémi; Brochu, Martin

    2017-08-01

    To compare the effects of a caloric restriction (CR) on body composition, lipid profile, and glucose homeostasis in obese postmenopausal women with and without metabolic syndrome (MetS). Secondary analyses were performed on 73 inactive obese postmenopausal women (age 57.7 ± 4.8 years; body mass index 32.4 ± 4.6 kg/m) who participated in the 6-month CR arm of a study of the Montreal-Ottawa New Emerging Team. The harmonized MetS definition was used to categorize participants with MetS (n = 20, 27.39%) and without MetS (n = 53, 72.61%). Variables of interest were: body composition (dual-energy X-ray absorptiometry), body fat distribution (computed tomography scan), glucose homeostasis at fasting state and during a euglycemic/hyperinsulinemic clamp, fasting lipids, and resting blood pressure. By design, the MetS group had a worse cardiometabolic profile, whereas both groups were comparable for age. Fifty-five participants out of 73 displayed no change in MetS status after the intervention. Twelve participants out of 20 (or 60.0%) in the MetS group had no more MetS after weight loss (P = NS), whereas 6 participants out of 53 (or 11.3%) in the other group developed the MetS after the intervention (P = NS). Overall, indices of body composition and body fat distribution improved significantly and similarly in both groups (P between 0.03 and 0.0001). Furthermore, with the exception of triglyceride levels and triglycerides/high-density lipoprotein cholesterol ratio, which decrease significantly more in the MetS group (P ≤ 0.05), no difference was observed between groups for the other variables of the cardiometabolic profile. Despite no overall significant effects on MetS, heteregeneous results were obtained in response to weight loss in the present study, with some improving the MetS, whereas other displaying deteriorations. Further studies are needed to identify factors and phenotypes associated with positive and negative cardiometabolic

  19. Efficacy and safety of leuprorelin acetate 6-month depot in prostate cancer patients: a Phase III, randomized, open-label, parallel-group, comparative study in Japan.

    PubMed

    Suzuki, Kazuhiro; Namiki, Mikio; Fujimoto, Tsukasa; Takabayashi, Nobuyoshi; Kudou, Kentarou; Akaza, Hideyuki

    2015-12-01

    Leuprorelin acetate (TAP-144-SR) is commonly used worldwide in prostate cancer patients. This study was conducted to assess the non-inferiority of a 6-month depot formulation of TAP-144-SR (TAP-144-SR [6M]) 22.5 mg to a 3-month depot formulation of TAP-144-SR (TAP-144-SR [3M]) 11.25 mg in prostate cancer patients in Japan. This was a 48-week Phase III, open-label, parallel-group comparative study. TAP-144-SR (6M) 22.5 mg (6M group) and TAP-144-SR (3M) 11.25 mg (3M group) were administered to 81 and 79 subjects, respectively. The primary endpoint was the rate of serum testosterone suppression to the castrate level (≤100 ng/dl). Serum testosterone of all subjects excluding one subject in the 3M group was suppressed to the castrate level throughout 48 weeks. The estimated between-group difference (6M group - 3M group) in suppression rate was 1.3% (95% confidence interval: -3.4, 6.8), and its lower confidence interval was more than -10% of the pre-determined allowable limit value to judge the non-inferiority. The prostate-specific antigen concentrations were stable throughout the study in both groups. Progressive disease in the best overall response based on the Response Evaluation Criteria In Solid Tumors was 0.0% for the 6M group and 2.6% for the 3M group. Adverse events occurred in 92.6% in the 6M group and 89.9% in the 3M group. Adverse events leading to discontinuation were reported in 2.5% in the 6M group and 3.8% in the 3M group. TAP-144-SR (6M) was not inferior to TAP-144-SR (3M) for the suppressive effect on serum testosterone level. TAP-144-SR (6M) was also as well tolerated as TAP-144-SR (3M). © The Author 2015. Published by Oxford University Press.

  20. Efficacy and safety of leuprorelin acetate 6-month depot in prostate cancer patients: a Phase III, randomized, open-label, parallel-group, comparative study in Japan

    PubMed Central

    Suzuki, Kazuhiro; Namiki, Mikio; Fujimoto, Tsukasa; Takabayashi, Nobuyoshi; Kudou, Kentarou; Akaza, Hideyuki

    2015-01-01

    Objective Leuprorelin acetate (TAP-144-SR) is commonly used worldwide in prostate cancer patients. This study was conducted to assess the non-inferiority of a 6-month depot formulation of TAP-144-SR (TAP-144-SR [6M]) 22.5 mg to a 3-month depot formulation of TAP-144-SR (TAP-144-SR [3M]) 11.25 mg in prostate cancer patients in Japan. Methods This was a 48-week Phase III, open-label, parallel-group comparative study. TAP-144-SR (6M) 22.5 mg (6M group) and TAP-144-SR (3M) 11.25 mg (3M group) were administered to 81 and 79 subjects, respectively. The primary endpoint was the rate of serum testosterone suppression to the castrate level (≤100 ng/dl). Results Serum testosterone of all subjects excluding one subject in the 3M group was suppressed to the castrate level throughout 48 weeks. The estimated between-group difference (6M group − 3M group) in suppression rate was 1.3% (95% confidence interval: −3.4, 6.8), and its lower confidence interval was more than −10% of the pre-determined allowable limit value to judge the non-inferiority. The prostate-specific antigen concentrations were stable throughout the study in both groups. Progressive disease in the best overall response based on the Response Evaluation Criteria In Solid Tumors was 0.0% for the 6M group and 2.6% for the 3M group. Adverse events occurred in 92.6% in the 6M group and 89.9% in the 3M group. Adverse events leading to discontinuation were reported in 2.5% in the 6M group and 3.8% in the 3M group. Conclusions TAP-144-SR (6M) was not inferior to TAP-144-SR (3M) for the suppressive effect on serum testosterone level. TAP-144-SR (6M) was also as well tolerated as TAP-144-SR (3M). PMID:26486824

  1. Predictors of remission in the treatment of major depressive disorder: real-world evidence from a 6-month prospective observational study

    PubMed Central

    Novick, Diego; Hong, Jihyung; Montgomery, William; Dueñas, Héctor; Gado, Magdy; Haro, Josep Maria

    2015-01-01

    Background This study examined potential predictors of remission among patients treated for major depressive disorder (MDD) in a naturalistic clinical setting, mostly in the Middle East, East Asia, and Mexico. Methods Data for this post hoc analysis were taken from a 6-month prospective, noninterventional, observational study that involved 1,549 MDD patients without sexual dysfunction at baseline in 12 countries worldwide. Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16). Depression-related pain was measured using the pain-related items of the Somatic Symptom Inventory. Remission was defined as a QIDS-SR16 score ≤5. Generalized estimating equation regression models were used to examine baseline factors associated with remission during follow-up. Results Being from East Asia (odds ratio [OR] 0.48 versus Mexico; P<0.001), a higher level of depression severity at baseline (OR 0.77, P=0.003, for Clinical Global Impression of Severity; OR 0.92, P<0.001, for QIDS-SR16), more previous MDD episodes (OR 0.92, P=0.007), previous treatments/therapies for depression (OR 0.78, P=0.030), and having any significant psychiatric and medical comorbidity at baseline (OR 0.60, P<0.001) were negatively associated with remission, whereas being male (OR 1.29, P=0.026) and treatment with duloxetine (OR 2.38 versus selective serotonin reuptake inhibitors, P<0.001) were positively associated with remission. However, the association between Somatic Symptom Inventory pain scores and remission no longer appeared to be significant in this multiple regression (P=0.580), (P=0.008 in descriptive statistics), although it remained significant in a subgroup of patients treated with selective serotonin reuptake inhibitors (OR 0.97, P=0.023), but not in those treated with duloxetine (P=0.182). Conclusion These findings are largely consistent with previous reports from the USA and

  2. Burden of Influenza and Respiratory Syncytial Virus Infection in Pregnant Women and Infants Under 6 Months in Mongolia: A Prospective Cohort Study

    PubMed Central

    Chaw, Liling; Kamigaki, Taro; Burmaa, Alexanderyn; Urtnasan, Chuluunbatiin; Od, Ishiin; Nyamaa, Gunregjaviin; Nymadawa, Pagbajabyn; Oshitani, Hitoshi

    2016-01-01

    Background Pregnant women and infants under 6 months are at risk of influenza-related complications. Limited information exists on their community burden of respiratory viruses. Methods and Findings This prospective, observational open cohort study was conducted in Baganuur district, Ulaanbaatar, Mongolia during 2013/14 and 2014/15 influenza seasons. Influenza-like illness (ILI) and severe acute respiratory infection (sARI) were identified by follow-up calls twice a week. For those identified, influenza and respiratory syncytical virus (RSV) were tested by point-of-care test kits. We calculated overall and stratified (by trimester or age group) incidence rates (IR) and used Cox proportional hazard regression for risk factor analyses. Among 1260 unvaccinated pregnant women enrolled, overall IRs for ILI, sARI and influenza A were 11.8 (95% confidence interval (C.I):11.2–12.4), 0.1 (95%C.I:0.0–0.4), and 1.7 (95%C.I:1.5–1.9) per 1,000person-days, respectively. One sARI case was influenza A positive. IRs and adjusted hazard ratios (Adj.HR) for ILI and influenza A were lowest in the third trimester. Those with co-morbidity were 1.4 times more likely to develop ILI [Adj.HR:1.4 (95%C.I:1.1–1.9)]. Among 1304 infants enrolled, overall ILI and sARI IRs were 15.2 (95%C.I:14.5–15.8) and 20.5 (95%C.I:19.7–21.3) per 1,000person-days, respectively. From the tested ILI (77.6%) and sARI (30.6%) cases, the overall positivity rates were 6.3% (influenza A), 1.1% (influenza B) and 9.3% (RSV). Positivity rates of influenza A and RSV tend to increase with age. sARI cases were 1.4 times more likely to be male [Adj.HR:1.4 (95%C.I:1.1–1.8)]. Among all influenza A and RSV positive infants, 11.8% and 68.0% were respectively identified among sARI hospitalized cases. Conclusion We observed low overall influenza A burden in both groups, though underestimation was likely due to point-of-care tests used. For infants, RSV burden was more significant than influenza A. These findings

  3. Botulinum Toxin A Injections Into Pelvic Floor Muscles Under Electromyographic Guidance for Women With Refractory High-Tone Pelvic Floor Dysfunction: A 6-Month Prospective Pilot Study.

    PubMed

    Morrissey, Darlene; El-Khawand, Dominique; Ginzburg, Natasha; Wehbe, Salim; O'Hare, Peter; Whitmore, Kristene

    2015-01-01

    High-tone pelvic floor dysfunction (HTPFD) is a debilitating chronic pain disorder for many women with significant impact on their quality of life (QoL). Our objective was to determine the efficacy of electromyography-guided onabotulinumtoxinA (Botox; Allergan, Irvine, Calif) injections in treating patient's perception of pelvic pain and improving QoL measurement scores. This is a prospective pilot open-label study of women with chronic pelvic pain and HTPFD who have failed conventional therapy between January 2011 and August 2013. Botox injections (up to 300 U) were done using needle electromyography guidance, from a transperineal approach, to localize spastic pelvic floor muscles (PFMs). Data were collected at baseline, 4, 8, 12, and 24 weeks after injections. This included demographics; Visual Analog Scale (VAS) scores for pain and dyspareunia; validated questionnaires for symptoms, QoL, and sexual function; Global Response Assessment scale for pelvic pain; digital examination of PFM for tone and tenderness; and vaginal manometry. Side effects were also recorded. Out of 28 women who enrolled in the study, 21 completed the 6-month follow-up and qualified for analysis. The mean (SD) age was 35.1 (9.4) years (range, 22-50 years), and the mean (SD) body mass index was 25 (4.4). Comorbidities included interstitial cystitis/bladder pain syndrome (42.9%) and vulvodynia (66.7%). Overall, 61.9% of subjects reported improvement on Global Response Assessment at 4 weeks and 80.9% at 8, 12, and 24 weeks post injection, compared with baseline. Of the subjects who were sexually active at baseline, 58.8% (10/17), 68.8% (11/16), 80% (12/15), and 83.3% (15/18) reported less dyspareunia at 4, 8, 12, and 24 weeks, respectively. Dyspareunia Visual Analog Scale score significantly improved at weeks 12 (5.6, P = 0.011) and 24 (5.4, P = 0.004) compared with baseline (7.8). Two of the 4 patients who avoided sexual activity at baseline secondary to dyspareunia resumed and tolerated

  4. Cost-Utility of Group Acceptance and Commitment Therapy for Fibromyalgia Versus Recommended Drugs: An Economic Analysis Alongside a 6-Month Randomized Controlled Trial Conducted in Spain (EFFIGACT Study).

    PubMed

    Luciano, Juan V; D'Amico, Francesco; Feliu-Soler, Albert; McCracken, Lance M; Aguado, Jaume; Peñarrubia-María, María T; Knapp, Martin; Serrano-Blanco, Antoni; García-Campayo, Javier

    2017-07-01

    The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy (GACT) in patients with fibromyalgia (FM) compared with patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, a randomized controlled trial that focused on clinical outcomes. Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory, respectively. Analyses included quality-adjusted life years, direct and indirect cost differences, and incremental cost effectiveness ratios. A total of 156 FM patients were randomized (51 GACT, 52 RPT, 53 WL). GACT was related to significantly less direct costs over the 6-month study period compared with both control arms (GACT €824.2 ± 1,062.7 vs RPT €1,730.7 ± 1,656.8 vs WL €2,462.7 ± 2,822.0). Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications. The incremental cost effectiveness ratios were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM. Decision-makers have to prioritize their budget on the treatment option that is the most cost effective for the management of a specific patient group. From government as well as health care perspectives, this study shows that a GACT is more cost effective than pharmacological treatment in management of FM. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

  5. Life-Space Mobility Change Predicts 6-Month Mortality.

    PubMed

    Kennedy, Richard E; Sawyer, Patricia; Williams, Courtney P; Lo, Alexander X; Ritchie, Christine S; Roth, David L; Allman, Richard M; Brown, Cynthia J

    2017-04-01

    To examine 6-month change in life-space mobility as a predictor of subsequent 6-month mortality in community-dwelling older adults. Prospective cohort study. Community-dwelling older adults from five Alabama counties in the University of Alabama at Birmingham (UAB) Study of Aging. A random sample of 1,000 Medicare beneficiaries, stratified according to sex, race, and rural or urban residence, recruited between November 1999 and February 2001, followed by a telephone interview every 6 months for the subsequent 8.5 years. Mortality data were determined from informant contacts and confirmed using the National Death Index and Social Security Death Index. Life-space was measured at each interview using the UAB Life-Space Assessment, a validated instrument for assessing community mobility. Eleven thousand eight hundred seventeen 6-month life-space change scores were calculated over 8.5 years of follow-up. Generalized linear mixed models were used to test predictors of mortality at subsequent 6-month intervals. Three hundred fifty-four deaths occurred within 6 months of two sequential life-space assessments. Controlling for age, sex, race, rural or urban residence, and comorbidity, life-space score and life-space decline over the preceding 6-month interval predicted mortality. A 10-point decrease in life-space resulted in a 72% increase in odds of dying over the subsequent 6 months (odds ratio = 1.723, P < .001). Life-space score at the beginning of a 6-month interval and change in life-space over 6 months were each associated with significant differences in subsequent 6-month mortality. Life-space assessment may assist clinicians in identifying older adults at risk of short-term mortality. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

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

    PubMed

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

    2012-02-01

    To investigate whether the long-term use (6 months) of an arginine-calcium carbonate-MFP toothpaste would affect calculus formation and/or gingivitis when compared to a calcium carbonate-MFP toothpaste. This was a double-blind clinical study. Eligible adult subjects (120) entered a 2-month pre-test phase of the study. After receiving an evaluation of oral tissue and a dental prophylaxis, the subjects were provided with a regular fluoride toothpaste, a soft-bristled adult toothbrush with instructions to brush their teeth for 1-minute twice daily (morning and evening) for 2 months. The subjects were then examined for baseline calculus using the Volpe-Manhold Calculus Index (VMI) and gingivitis using the Löe-Silness Gingival Index (GI), along with an oral tissue examination. Qualifying subjects were randomized to two treatment groups: (1) Colgate Sensitive Pro-Relief toothpaste containing 8.0% arginine, 1450 ppm MFP and calcium carbonate (Test group), or (2) Colgate Cavity Protection toothpaste containing 1450 ppm MFP and calcium carbonate (Control group). Subjects were stratified by the VMI score and gender. After a dental prophylaxis (VMI=0), the subjects entered a 6-month test phase. Each received the assigned toothpaste and a soft-bristled adult toothbrush for home use with instructions of brushing teeth for 1 minute twice daily (morning and evening). The examinations of VMI, Löe-Silness GI and oral tissues were conducted after 3 and 6 months. Prior to each study visit, subjects refrained from brushing their teeth as well as eating and drinking for 4 hours. 99 subjects complied with the study protocol and completed the 6-month test phase. No within-treatment comparison was performed for the VMI because it was brought down to zero after the prophylaxis at the baseline of the test phase. For the Löe-Silness GI, subjects of the Test group exhibited a significant difference from baseline at the 3- and 6-month examinations. The 3-month Löe-Silness GI of the Control

  7. Percutaneous Image-Guided Cryoablation as Second-Line Therapy of Soft-Tissue Venous Vascular Malformations of Extremities: A Prospective Study of Safety and 6-Month Efficacy.

    PubMed

    Cornelis, F H; Labrèze, C; Pinsolle, V; Le Bras, Y; Castermans, C; Bader, C; Thiebaut, R; Midy, D; Grenier, N

    2017-09-01

    To report the safety and short-term efficacy of percutaneous image-guided cryoablation performed as second-line therapy of venous vascular malformations (VVM) of extremities. In this non-blinded, no-randomized trial, cryoablation was proposed in 14 patients presenting with symptomatic VVM for recurrences after treatment. Eligibility criteria were: cryoablation feasible, localization at least 5 mm from skin and nerves, absence of contra-indication for anesthesia. Safety was evaluated by the common terminology criteria for adverse events (AE). Clinical response was assessed by evaluating pain at day 7, month 2 and 6 using visual analog scale; quality of life before cryoablation and at 2 and 6 months after using questionnaire. Evolution of volume was evaluated by MRI at 6 months. Comparison was performed using the Wilcoxon test. A technical success was observed in all cases. While 11 patients (78.6%) presented AE (13 grade 1-2 and 3 grade 3), only two severe AE (grade 3) related to cryoablation occurred in two patients (14.3%) during the 6-month follow-up: one immediate sciatic paralysis and one delayed paresthesia. A clinical response was observed in 12 patients (85.7%) at 6 months. Pain decreased significantly from 42.5 ± 14.2 mm before the intervention to 11.8 ± 17.9 mm at 6 months (P = 0.002). A significant decrease in the mean volume from 12.8 ± 14.3 to 3 ± 2.7 cm(3) was observed at 6 months (P = 0.002). Percutaneous cryoablation is a promising alternative treatment for sclerotherapy-resistant venous malformations. However, to improve safety, careful patient selection and treatment planning will be mandatory.

  8. A 6-month, randomized, double-blind, placebo-controlled study evaluating the ability of a marine complex supplement to promote hair growth in men with thinning hair.

    PubMed

    Ablon, Glynis

    2016-12-01

    Male pattern baldness, or androgenetic alopecia, affects approximately 50% of the adult population and can cause poor self-image, low self-esteem and have a significant negative impact on the quality of life. An oral nutraceutical supplement based on a marine complex formulation has previously been reported to significantly increase the number of terminal hairs in women with thinning hair. The objective of this double-blind, placebo-controlled study was to confirm the beneficial effects of a similar marine complex supplement in adult male subjects with thinning hair (Viviscal(®) Man; Lifes2good, Inc., Chicago, IL, USA). Healthy adult male subjects with thinning hair associated with clinically diagnosed male pattern hair loss were enrolled and randomized to receive study drug or placebo twice daily. At Day 90, subjects indicated a significant improvement in three of six quality of life measures as well as a significant overall improvement in quality of life. After 180 days, significant increases were observed for total hair count, total hair density, and terminal hair density (for each, P = 0.001). The investigator assessments revealed significant improvements in terminal and vellus hair count and terminal hair density. Hair pull test results were significantly lower (fewer hairs removed) for study drug vs. placebo at Days 90 (P < 0.05) and 180 (P < 0.01). There were no reports of treatment-emergent adverse events. The results of this study showed for the first time that a dietary supplement containing a marine complex and other ingredients can decrease hair shedding and promote hair growth in men with thinning hair. © 2016 Wiley Periodicals, Inc.

  9. Therapeutic effects of prolotherapy with intra-articular dextrose injection in patients with moderate knee osteoarthritis: a single-arm study with 6 months follow up

    PubMed Central

    Amouzandeh, Bahman

    2015-01-01

    Objectives: Prolotherapy is an injection-based complementary treatment, which has shown promising results in the treatment of different musculoskeletal disorders. The aim of this study was to determine the therapeutic efficacy of dextrose prolotherapy on pain, range of motion, and function in patients with knee osteoarthritis (OA). Methods: In this single-arm prospective study, participants with symptomatic moderate knee osteoarthritis underwent prolotherapy with intra-articular injection of 20% dextrose water at baseline, and at 4 weeks and 8 weeks later. Patients were followed for 24 weeks. Pain severity at rest and activity, according to the visual analog scale (VAS), articular range of motion (ROM), and Western Ontario and McMaster Universities arthritis index (WOMAC) scores were measured at baseline, 4, 8, and 24 weeks later. Results: A total of 24 female patients (average age: 58.37 ± 11.8 years old) received 3-monthly injection therapies. Before the treatment, the mean articular range of motion was 105.41 ± 11.22°. Mean VAS scale at rest and activity was 8.83 ± 1.37 and 9.37 ± 1.31, respectively. At the end of week 24, knee ROM increased by 8°. Pain severity in rest and activity decreased to 4.87 ± 1.39, 45.86%, and 44.23%, respectively (p < 0.001). Total WOMAC score and its subcategories showed a continuous improvement trend in all the evaluation sessions, so that at the end of the study, the total score decreased by 30.5 ± 14.27 points (49.58%) (p < 0.001). Improvements of all parameters were considerable until week 8, and were maintained throughout the study period. Conclusions: Prolotherapy with three intra-articular injections of hypertonic dextrose given 4 weeks apart for selected patients with knee OA, resulted in significant improvement of validated pain, ROM, and WOMAC-based function scores, when baseline levels were compared at 24 weeks. Further studies with randomized controlled trials involving a comparison group are suggested to confirm

  10. Therapeutic effects of prolotherapy with intra-articular dextrose injection in patients with moderate knee osteoarthritis: a single-arm study with 6 months follow up.

    PubMed

    Eslamian, Fariba; Amouzandeh, Bahman

    2015-04-01

    Prolotherapy is an injection-based complementary treatment, which has shown promising results in the treatment of different musculoskeletal disorders. The aim of this study was to determine the therapeutic efficacy of dextrose prolotherapy on pain, range of motion, and function in patients with knee osteoarthritis (OA). In this single-arm prospective study, participants with symptomatic moderate knee osteoarthritis underwent prolotherapy with intra-articular injection of 20% dextrose water at baseline, and at 4 weeks and 8 weeks later. Patients were followed for 24 weeks. Pain severity at rest and activity, according to the visual analog scale (VAS), articular range of motion (ROM), and Western Ontario and McMaster Universities arthritis index (WOMAC) scores were measured at baseline, 4, 8, and 24 weeks later. A total of 24 female patients (average age: 58.37 ± 11.8 years old) received 3-monthly injection therapies. Before the treatment, the mean articular range of motion was 105.41 ± 11.22°. Mean VAS scale at rest and activity was 8.83 ± 1.37 and 9.37 ± 1.31, respectively. At the end of week 24, knee ROM increased by 8°. Pain severity in rest and activity decreased to 4.87 ± 1.39, 45.86%, and 44.23%, respectively (p < 0.001). Total WOMAC score and its subcategories showed a continuous improvement trend in all the evaluation sessions, so that at the end of the study, the total score decreased by 30.5 ± 14.27 points (49.58%) (p < 0.001). Improvements of all parameters were considerable until week 8, and were maintained throughout the study period. Prolotherapy with three intra-articular injections of hypertonic dextrose given 4 weeks apart for selected patients with knee OA, resulted in significant improvement of validated pain, ROM, and WOMAC-based function scores, when baseline levels were compared at 24 weeks. Further studies with randomized controlled trials involving a comparison group are suggested to confirm these findings.

  11. Older Australians Can Achieve High Adherence to the Mediterranean Diet during a 6 Month Randomised Intervention; Results from the Medley Study.

    PubMed

    Davis, Courtney; Hodgson, Jonathan; Bryan, Janet; Garg, Manohar; Woodman, Richard; Murphy, Karen

    2017-05-24

    Adherence to a Mediterranean diet (MedDiet) is thought to be achievable in non-Mediterranean regions, but this has yet to be investigated. We aimed to determine if an older Australian population could adhere to a MedDiet for six months. We conducted a randomised, parallel dietary intervention trial with two dietary arms: the Mediterranean diet (MedDiet) group and the habitual diet (HabDiet) control group. A 15-point Mediterranean diet adherence score and food and nutrient intakes were estimated from three-day weighed food records collected at baseline, two and four months. Erythrocyte fatty acids, serum carotenoids and urinary metabolites were assessed at baseline, three and six months. We enrolled 166 participants; 152 commenced and 137 completed the study (70 in the MedDiet group, 67 in the HabDiet group). Adherence scores were significantly higher in the MedDiet group at two months (between group difference 2.2, 95% CI 1.3, 2.9) and four months (between group difference 2.6, 95% CI 1.9, 3.3). Consumption of vegetables, fruits, fish, legumes, nuts and olive oil significantly increased in the MedDiet group compared to the control, and discretionary food intake decreased (p < 0.01). Measures of compliance including serum β-carotene, lycopene and erythrocyte monounsaturated fatty acids were significantly higher in the MedDiet group at three and six months (p < 0.05). Our results indicate that a population of older Australians can adopt a Mediterranean diet over a six month period.

  12. Older Australians Can Achieve High Adherence to the Mediterranean Diet during a 6 Month Randomised Intervention; Results from the Medley Study

    PubMed Central

    Davis, Courtney; Hodgson, Jonathan; Bryan, Janet; Garg, Manohar; Woodman, Richard; Murphy, Karen

    2017-01-01

    Adherence to a Mediterranean diet (MedDiet) is thought to be achievable in non-Mediterranean regions, but this has yet to be investigated. We aimed to determine if an older Australian population could adhere to a MedDiet for six months. We conducted a randomised, parallel dietary intervention trial with two dietary arms: the Mediterranean diet (MedDiet) group and the habitual diet (HabDiet) control group. A 15-point Mediterranean diet adherence score and food and nutrient intakes were estimated from three-day weighed food records collected at baseline, two and four months. Erythrocyte fatty acids, serum carotenoids and urinary metabolites were assessed at baseline, three and six months. We enrolled 166 participants; 152 commenced and 137 completed the study (70 in the MedDiet group, 67 in the HabDiet group). Adherence scores were significantly higher in the MedDiet group at two months (between group difference 2.2, 95% CI 1.3, 2.9) and four months (between group difference 2.6, 95% CI 1.9, 3.3). Consumption of vegetables, fruits, fish, legumes, nuts and olive oil significantly increased in the MedDiet group compared to the control, and discretionary food intake decreased (p < 0.01). Measures of compliance including serum β-carotene, lycopene and erythrocyte monounsaturated fatty acids were significantly higher in the MedDiet group at three and six months (p < 0.05). Our results indicate that a population of older Australians can adopt a Mediterranean diet over a six month period. PMID:28538676

  13. Efficacy and Safety of Linagliptin in Black/African American Patients with Type 2 Diabetes: A 6-month, Randomized, Double-blind, Placebo-controlled Study.

    PubMed

    Thrasher, James; Daniels, Kristen; Patel, Sanjay; Whetteckey, Jacqueline; Woerle, Hans-Juergen

    2014-05-01

    Although black/African American individuals are disproportionately affected by type 2 diabetes, there is scant clinical trial information available on antidiabetes therapies in this group. We compared linagliptin with placebo in black/African American adults who were treatment-naïve or receiving one oral antidiabetes drug. Of 226 patients randomized to 24 weeks' linagliptin 5 mg/day or placebo, 208 had baseline and at least one on-treatment glycated hemoglobin (HbA1c) measurement. Mean baseline HbA1c was 8.6% in the linagliptin group (n = 98) and 8.68% in the placebo group (n = 110). The primary outcome was change in HbA1c from baseline to week 24. By week 24, mean HbA1c changes were -0.84% with linagliptin and -0.25% with placebo (treatment difference, -0.58%; P<.001), and more patients in the linagliptin group achieved HbA1c <7.0% (26.8% vs. 8.3%; P = .001) or an HbA1c reduction ≥0.5% (54.1% vs. 30.0%; P<.001). Mean weight loss was -1.1 kg in both groups. During the treatment period, 8 of 98 linagliptin-group patients and 17 of 110 placebo-group patients required rescue therapy (odds ratio, 0.5; P = .14). For postprandial glucose, values were available for few patients (11 placebo, 10 linagliptin), and thus the between-group difference was associated with wide confidence intervals (CIs) (difference, -1.97 mg/dL; 95% CI, -53.80 to 49.86; P = .94). In the overall study population, a similar proportion of patients in both groups had adverse events (58.5% vs. 61.7%); most events were mild or moderate and considered unrelated to study drug. Investigator-defined hypoglycemia was rare (3 linagliptin-group patients and 1 placebo-group patient), with no severe events (requiring external assistance). This study confirms that linagliptin is efficacious and well tolerated in black/African American patients with type 2 diabetes.

  14. Feeding infants directly at the breast during the postpartum hospital stay is associated with increased breastfeeding at 6 months postpartum: a prospective cohort study.

    PubMed

    Forster, Della A; Johns, Helene M; McLachlan, Helen L; Moorhead, Anita M; McEgan, Kerri M; Amir, Lisa H

    2015-05-07

    To explore whether feeding only directly from the breast in the first 24-48 h of life increases the proportion of infants receiving any breast milk at 6 months. A prospective cohort study. Three maternity hospitals in Melbourne, Australia. 1003 postpartum English-speaking women with a healthy singleton term infant, who intended to breast feed, were recruited between 2009 and 2011. Women were excluded if they or their infant were seriously ill. 92% (n=924) were followed up at 6 months postpartum. Main exposure variable - type of infant feeding in hospital up to time of study recruitment (24-48 h postpartum), categorised as 'fed directly at the breast only' or 'received at least some expressed breast milk (EBM) or infant formula'. Primary outcome - proportion of infants receiving any breast milk feeding at 6 months postpartum. Secondary outcomes - proportion of infants receiving only breast milk feeding at 6 months; breast milk feeding duration; and maternal characteristics associated with giving any breast milk at 6 months. Infants who had fed only at the breast prior to recruitment were more likely to be continuing to have any breast milk at 6 months than those who had received any EBM and/or infant formula (76% vs 59%; adjusted OR 1.76, 95% CI 1.24 to 2.48 (adjusted for parity, type of birth, breastfeeding intention, breastfeeding problems at recruitment, public/private status, epidural for labour or birth, maternal body mass index and education)). Healthy term infants that fed only directly at the breast 24-48 h after birth were more likely to be continuing to breast feed at 6 months than those who received any EBM and/or formula in the early postpartum period. Support and encouragement to initiate breastfeeding directly at the breast is important. 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.

  15. A prospective clinical study on titanium implants in the zygomatic arch for prosthetic rehabilitation of the atrophic edentulous maxilla with a follow-up of 6 months to 5 years.

    PubMed

    Aparicio, Carlos; Ouazzani, Wafaa; Garcia, Roberto; Arevalo, Xabier; Muela, Rosa; Fortes, Vanessa

    2006-01-01

    Prosthetic rehabilitation with implant-supported prostheses in the atrophic edentulous maxilla often requires a bone augmentation procedure to enable implant placement and integration. However, a rigid anchorage can also be achieved by using so-called zygomatic implants placed in the zygomatic arch in combination with regular implants placed in residual bone. The aim of the present study was to report on the clinical outcome of using zygomatic and regular implants for prosthetic rehabilitation of the severely atrophic edentulous maxilla. Sixty-nine consecutive patients with severe maxillary atrophy were, during a 5-year period, treated with a total of 69 fixed full-arch prostheses anchored on 435 implants. Of these, 131 were zygomatic implants and 304 were regular implants. Fifty-seven bridges were screw-retained and 12 were cemented. The screw-retained bridges were removed at the examination appointments and each implant was tested for mobility. In addition, the zygomatic implants were subjected to Periotest (Siemens AG, Bensheim, Germany) measurements. The patients had at the time of this report been followed for at least 6 months up to 5 years in loading. Two regular implants failed during the study period giving a cumulative survival rate of 99.0%. None of the zygomatic implants was removed. All patients received and maintained a fixed full-arch bridge during the study. Periotest measurements of zygomatic implants showed a decreased Periotest values value with time, indicating an increased stability. Three patients presented with sinusitis 14-27 months postoperatively, which could be resolved with antibiotics. Loosening of the zygomatic implant gold screws was recorded in nine patients. Fracture of one gold screw as well as the prosthesis occurred twice in one patient. Fracture of anterior prosthetic teeth was experienced in four patients. The results from the present study show that the use of zygomatic and regular implants represents a predictable alternative

  16. Functional and anatomical results after a single intravitreal Ozurdex injection in retinal vein occlusion: a 6-month follow-up -- the SOLO study.

    PubMed

    Bezatis, Athanasios; Spital, Georg; Höhn, Fabian; Maier, Mathias; Clemens, Christoph R; Wachtlin, Joachim; Lehmann, Florian; Hattenbach, Lars Olof; Feltgen, Nicolas; Meyer, Carsten H

    2013-08-01

    To evaluate the efficacy of intravitreal dexamethasone implants in eyes with cystoid macular oedema (CME) secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in the clinical everyday practice, examine the effects of early retreatment and compare the results with the GENEVA study. The charts of 102 patients (102 eyes) with CME secondary to BRVO (n = 54) or CRVO (n = 48) treated with Ozurdex at 8 centres were retrospectively reviewed. The patients were examined monthly over a 24-week period. Slit-lamp biomicroscopy, measurement of best-corrected visual acuity (BCVA) and measurement of the central retinal thickness (CRT) with spectral-domain optical coherence tomography (SD-OCT) were performed at baseline and at every follow-up examination. With progression of the disease (loss of one line or increased central retinal thickness (CRT) of 150 μm), a reinjection of Ozurdex or anti-VEGF was offered. Additional supplementing sectorial or panretinal laser photocoagulation was considered based on the individual status of the retina. In the BRVO group, the median BCVA was 0.6 logMAR (Snellen equivalent of 0.25) at baseline and improved to 0.4 logMAR (Snellen equivalent of 0.40) after 4 weeks, 0.3 logMAR (Snellen equivalent of 0.50) after 8 weeks, 0.4 logMAR (Snellen equivalent of 0.40) after 12 weeks, 0.5 logMAR (Snellen equivalent of 0.32) after 16 weeks, 0.4 logMAR (Snellen equivalent of 0.40) after 20 weeks and 0.45 logMAR (Snellen equivalent of 0.35) after 24 weeks. The mean CRT was 559 ± (SD) 209 μm at baseline and it decreased to 335 ± 148 μm after 4 weeks, 316 ± 137 μm after 8 weeks, 369 ± 126 μm after 12 weeks, 407 ± 161 μm after 16 weeks, 399 ± 191 μm after 20 weeks and 419 ± 196 μm after 24 weeks. In the CRVO group, the median BCVA was 0.7 logMAR (Snellen equivalent of 0.20) at baseline and improved to 0.4 logMAR (Snellen equivalent of 0.40) after 4 weeks, 0.4 logMAR (Snellen equivalent of 0.40) after 8 weeks, 0

  17. Comparative assessment of fluoride varnish and fluoride film for remineralization of postorthodontic white spot lesions in adolescents and adults over a 6-month period: A single-center, randomized controlled clinical trial.

    PubMed

    He, Tao; Li, Xue; Dong, Ying; Zhang, Na; Zhong, Yisi; Yin, Wei; Hu, Deyu

    2016-06-01

    The objective of this 3-arm parallel randomized trial was to evaluate the effects of a fluoride varnish and a fluoride film on the remineralization of white spot lesions around orthodontic brackets after orthodontic treatment. Patients who had recently completed orthodontic treatment were randomly assigned to the varnish, film, and control groups. Eligibility criteria included age of 12 to 25 years, good general health, and at least 1 maxillary anterior tooth with a white spot lesion. The primary outcome was the decrease in the lesion volume of each patient after 6 months of treatment; fluorescence loss and area were the secondary outcome measures. Randomization was accomplished according to a computer-generated randomization schedule, and allocation concealment was achieved with nontransparent concealed envelopes. Blinding was applicable for the treatments only. The test groups received fluoride varnish or film treatment once a month for 6 months, and the control group received a placebo treatment. All patients received oral hygiene education and were required to use fluoride toothpaste daily. Quantitative light-induced fluorescence images were taken at baseline and at the 3-month and 6-month follow-ups. A mixed-effects linear model was used to analyze quantitative light-induced fluorescence parameters with confounders integrated into the model. Two hundred forty patients (mean age, 16.9 years; range, 12-25 years) with 597 teeth with a white spot lesion were randomized 1:1:1 to the varnish, film, and control groups. Baseline demographics were similar between groups, and 29 patients were lost to follow-up. The primary analysis was carried out on a per-protocol basis involving 72 patients in the control group, 69 patients in the varnish group, and 70 patients in the film group who completed the study. The product of fluorescence loss and lesion area values were statistically associated with time (estimate, -4.58; 95% confidence interval [CI], -5.84 to -3.31; P

  18. The comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the control of gingivitis: a 6-month randomized clinical study.

    PubMed

    Archila, Luis; Bartizek, Robert D; Winston, J Leslie; Biesbrock, Aaron R; McClanahan, Stephen F; He, Tao

    2004-12-01

    Antimicrobial agents such as stannous fluoride and triclosan have been incorporated into dentifrice formulations and have been shown to be effective in reducing gingivitis. The objective of this study was to compare the anti-gingivitis efficacy of a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice to a positive control triclosan/copolymer dentifrice. This was a 6-month, randomized, double-masked, parallel-group study conducted according to the American Dental Association guidelines for evaluating chemotherapeutic products for the control of gingivitis. A 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available positive control dentifrice (0.30% triclosan/2.0% Gantrez copolymer). Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 seconds using their assigned product. Tooth brushing was supervised for 3 days of each week. Clinical examinations using a gingival index were performed at baseline and at 3 and 6 months. A total of 199 subjects were enrolled and 186 completed the 6-month study. Average baseline gingivitis and bleeding scores were similar for the two treatment groups. After 6 months, the experimental group had statistically significantly less gingivitis (25.8%) and statistically significantly less bleeding (27.4%) on average compared to the control group. Neither adverse oral soft tissue effects nor tooth staining were reported. Within the limits of the study protocol, the results demonstrated superior therapeutic benefits for the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice in reducing gingivitis compared to the triclosan/copolymer control in this partially supervised study.

  19. Diet and Gender Influences on Processing and Discrimination of Speech Sounds in 3- and 6-Month-Old Infants: A Developmental ERP Study

    ERIC Educational Resources Information Center

    Pivik, R. T.; Andres, Aline; Badger, Thomas M.

    2011-01-01

    Early post-natal nutrition influences later development, but there are no studies comparing brain function in healthy infants as a function of dietary intake even though the major infant diets differ significantly in nutrient composition. We studied brain responses (event-related potentials; ERPs) to speech sounds for infants who were fed either…

  20. Diet and gender influences on processing and discrimination of speech sounds in 3 and 6 month-old infants: A developmental ERP study

    USDA-ARS?s Scientific Manuscript database

    Although early post-natal nutrition influences later development, there are no studies comparing brain function in healthy infants fed the three major infant diets (breast milk, milk-based and soy-based formula) even though these diets differ significantly in nutrient composition. We have studied br...

  1. Diet and Gender Influences on Processing and Discrimination of Speech Sounds in 3- and 6-Month-Old Infants: A Developmental ERP Study

    ERIC Educational Resources Information Center

    Pivik, R. T.; Andres, Aline; Badger, Thomas M.

    2011-01-01

    Early post-natal nutrition influences later development, but there are no studies comparing brain function in healthy infants as a function of dietary intake even though the major infant diets differ significantly in nutrient composition. We studied brain responses (event-related potentials; ERPs) to speech sounds for infants who were fed either…

  2. A randomized trial assessing the effect of coumarins started before coronary angioplasty on restenosis: results of the 6-month angiographic substudy of the Balloon Angioplasty and Anticoagulation Study (BAAS).

    PubMed

    ten Berg, Jurriën M; Kelder, Johannes C; Suttorp, Maarten Jan; Verheugt, Freek W A; Plokker, H W Thijs

    2003-01-01

    Thrombus formation during coronary angioplasty may play a role in the restenosis process. The effect of pretreatment with coumarins on 6-month angiographic outcome was studied. In addition, the effect of "optimal" anticoagulation, defined as an international normalized ratio >70% of the follow-up time in the target range, was studied. A total of 261 patients were assigned to aspirin alone (ASA group) and 270 patients to aspirin plus coumarins started 1 week before the procedure (coumarin group). The mean international normalized ratio was 2.7 +/- 1.2 at the start of the procedure and 3.1 +/- 0.5 during follow up. Quantitative coronary analysis was performed on 301 lesions in the ASA group and of 297 lesions in the coumarin group. At 6 months, the minimal luminal diameter was similar in the ASA and coumarin groups. Optimal anticoagulation, however, was an independent predictor of a larger minimal luminal diameter at follow up (P =.01). Overall, coumarins do not improve angiographic outcome 6 months after coronary angioplasty.

  3. Assessment of Cognitive Scales to Examine Memory, Executive Function and Language in Individuals with Down Syndrome: Implications of a 6-month Observational Study.

    PubMed

    Liogier d'Ardhuy, Xavier; Edgin, Jamie O; Bouis, Charles; de Sola, Susana; Goeldner, Celia; Kishnani, Priya; Nöldeke, Jana; Rice, Sydney; Sacco, Silvia; Squassante, Lisa; Spiridigliozzi, Gail; Visootsak, Jeannie; Heller, James; Khwaja, Omar

    2015-01-01

    Down syndrome (DS) is the most commonly identifiable genetic form of intellectual disability. Individuals with DS have considerable deficits in intellectual functioning (i.e., low intellectual quotient, delayed learning and/or impaired language development) and adaptive behavior. Previous pharmacological studies in this population have been limited by a lack of appropriate endpoints that accurately measured change in cognitive and functional abilities. Therefore, the current longitudinal observational study assessed the suitability and reliability of existing cognitive scales to determine which tools would be the most effective in future interventional clinical studies. Subtests of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Cambridge Neuropsychological Test Automated Battery (CANTAB), and Clinical Evaluation of Language Fundamentals-Preschool-2 (CELF-P-2), and the Observer Memory Questionnaire-Parent Form (OMQ-PF), Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF-P) and Leiter International Performance Scale-Revised were assessed. The results reported here have contributed to the optimization of trial design and endpoint selection for the Phase 2 study of a new selective negative allosteric modulator of the GABAA receptor α5-subtype (Basmisanil), and can be applied to other studies in the DS population.

  4. Assessment of Cognitive Scales to Examine Memory, Executive Function and Language in Individuals with Down Syndrome: Implications of a 6-month Observational Study

    PubMed Central

    Liogier d'Ardhuy, Xavier; Edgin, Jamie O.; Bouis, Charles; de Sola, Susana; Goeldner, Celia; Kishnani, Priya; Nöldeke, Jana; Rice, Sydney; Sacco, Silvia; Squassante, Lisa; Spiridigliozzi, Gail; Visootsak, Jeannie; Heller, James; Khwaja, Omar

    2015-01-01

    Down syndrome (DS) is the most commonly identifiable genetic form of intellectual disability. Individuals with DS have considerable deficits in intellectual functioning (i.e., low intellectual quotient, delayed learning and/or impaired language development) and adaptive behavior. Previous pharmacological studies in this population have been limited by a lack of appropriate endpoints that accurately measured change in cognitive and functional abilities. Therefore, the current longitudinal observational study assessed the suitability and reliability of existing cognitive scales to determine which tools would be the most effective in future interventional clinical studies. Subtests of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Cambridge Neuropsychological Test Automated Battery (CANTAB), and Clinical Evaluation of Language Fundamentals-Preschool-2 (CELF-P-2), and the Observer Memory Questionnaire-Parent Form (OMQ-PF), Behavior Rating Inventory of Executive Function®–Preschool Version (BRIEF-P) and Leiter International Performance Scale-Revised were assessed. The results reported here have contributed to the optimization of trial design and endpoint selection for the Phase 2 study of a new selective negative allosteric modulator of the GABAA receptor α5-subtype (Basmisanil), and can be applied to other studies in the DS population. PMID:26635554

  5. The Maintenance Effect of Cognitive-Behavioural Treatment Groups for the Chinese Parents of Children with Intellectual Disabilities in Melbourne, Australia: A 6-Month Follow-Up Study

    ERIC Educational Resources Information Center

    Wong, D. F. K.; Poon, A.; Kwok, Y. C. Lai

    2011-01-01

    Background: Caring for a child with intellectual disability can be stressful. No data on the longer-term effects of cognitive-behavioural treatment (CBT) on parents from a Chinese-speaking background who have children with intellectual disabilities are available in the literature. This study attempted to fill this research gap by examining the…

  6. The Influence of Stimulus Material on Attention and Performance in the Visual Expectation Paradigm: A Longitudinal Study with 3- And 6-Month-Old Infants

    ERIC Educational Resources Information Center

    Teubert, Manuel; Lohaus, Arnold; Fassbender, Ina; Vierhaus, Marc; Spangler, Sibylle; Borchert, Sonja; Freitag, Claudia; Goertz, Claudia; Graf, Frauke; Gudi, Helene; Kolling, Thorsten; Lamm, Bettina; Keller, Heidi; Knopf, Monika; Schwarzer, Gudrun

    2012-01-01

    This longitudinal study examined the influence of stimulus material on attention and expectation learning in the visual expectation paradigm. Female faces were used as attention-attracting stimuli, and non-meaningful visual stimuli of comparable complexity (Greebles) were used as low attention-attracting stimuli. Expectation learning performance…

  7. The Influence of Stimulus Material on Attention and Performance in the Visual Expectation Paradigm: A Longitudinal Study with 3- And 6-Month-Old Infants

    ERIC Educational Resources Information Center

    Teubert, Manuel; Lohaus, Arnold; Fassbender, Ina; Vierhaus, Marc; Spangler, Sibylle; Borchert, Sonja; Freitag, Claudia; Goertz, Claudia; Graf, Frauke; Gudi, Helene; Kolling, Thorsten; Lamm, Bettina; Keller, Heidi; Knopf, Monika; Schwarzer, Gudrun

    2012-01-01

    This longitudinal study examined the influence of stimulus material on attention and expectation learning in the visual expectation paradigm. Female faces were used as attention-attracting stimuli, and non-meaningful visual stimuli of comparable complexity (Greebles) were used as low attention-attracting stimuli. Expectation learning performance…

  8. The Maintenance Effect of Cognitive-Behavioural Treatment Groups for the Chinese Parents of Children with Intellectual Disabilities in Melbourne, Australia: A 6-Month Follow-Up Study

    ERIC Educational Resources Information Center

    Wong, D. F. K.; Poon, A.; Kwok, Y. C. Lai

    2011-01-01

    Background: Caring for a child with intellectual disability can be stressful. No data on the longer-term effects of cognitive-behavioural treatment (CBT) on parents from a Chinese-speaking background who have children with intellectual disabilities are available in the literature. This study attempted to fill this research gap by examining the…

  9. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study.

    PubMed

    Janicak, Philip G; Nahas, Ziad; Lisanby, Sarah H; Solvason, H Brent; Sampson, Shirlene M; McDonald, William M; Marangell, Lauren B; Rosenquist, Peter; McCall, W Vaughn; Kimball, James; O'Reardon, John P; Loo, Colleen; Husain, Mustafa H; Krystal, Andrew; Gilmer, William; Dowd, Sheila M; Demitrack, Mark A; Schatzberg, Alan F

    2010-10-01

    Although transcranial magnetic stimulation (TMS) can be an effective acute antidepressant treatment, few studies systematically examine persistence of benefit. We assessed the durability of antidepressant effect after acute response to TMS in patients with major depressive disorder (MDD) using protocol-specified maintenance antidepressant monotherapy. Three hundred one patients were randomly assigned to active or sham TMS in a 6-week, controlled trial. Nonresponders could enroll in a second, 6-week, open-label study. Patients who met criteria for partial response (i.e., >25% decrease from the baseline HAMD 17) during either the sham-controlled or open-label study (n = 142) were tapered off TMS over 3 weeks, while simultaneously starting maintenance antidepressant monotherapy. Patients were then followed for 24 weeks in a naturalistic follow-up study examining the long-term durability of TMS. During this durability study, TMS was readministered if patients met prespecified criteria for symptom worsening (i.e., a change of at least one point on the CGI-S scale for 2 consecutive weeks). Relapse was the primary outcome measure. Ten of 99 (10%; Kaplan-Meier survival estimate = 12.9%) patients relapsed. Thirty-eight (38.4%) patients met criteria for symptom worsening and 32/38 (84.2%) reachieved symptomatic benefit with adjunctive TMS. Safety and tolerability were similar to acute TMS monotherapy. These initial data suggest that the therapeutic effects of TMS are durable and that TMS may be successfully used as an intermittent rescue strategy to preclude impending relapse. Copyright © 2010 Elsevier Inc. All rights reserved.

  10. [Changes in quality of life and work function during phase prophylactic lamotrigine treatment in bipolar patients: 6 month, prospective, observational study].

    PubMed

    Gonda, Xenia; Kalman, Janos; Dome, Peter; Rihmer, Zoltan

    2016-03-01

    Bipolar disorder is a lifelong illness requiring lifelong pharmacotherapy. Therefore besides symptomatic remission, achievement of full work-related functioning and restoration of quality of life is a priority during successful treatment. The present prospective, observational, non-intervention study focused on investigating the effect of lamotrigine therapy on the quality of life and work-related function of bipolar patients in outpatient care. 969 bipolar or schizoaffective outpatients participated in the study who previously did not receive lamotrigine therapy. Our present phase-prophylactic study was a prospective, observational, non-intervention study with a six-month follow-up. Evaluations took place at baseline and at months 1, 2, 3 and 6. Patients were followed with a Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I). Changes in work-related function was evaluated using Social Adjustment Scale (SAS), while quality of life was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale. SAS scoreds showed a consistent decrease in the overall sample and in all CGI-S initial groups reflecting the improvement of work-related function during the six months of the follow-up. Q-LES-Q values in the whole sample and in all initial CGI-S groups showed a steady increase indicating a continuous increase in quality of life during the study. Our results indicate that during long-term prophylactic lamotrigine therapy the work function and quality of life of bipolar patients shows a significant improvement, therefore lamotrigine provides a possibility for full functional remission and restoration of quality of life.

  11. Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Balance Dysfunction in Parkinson Disease: A Randomized Controlled Study With 6-Month Follow-Up.

    PubMed

    Palamara, Grazia; Gotti, Francesco; Maestri, Roberto; Bera, Rossana; Gargantini, Roberto; Bossio, Fabiola; Zivi, Ilaria; Volpe, Daniele; Ferrazzoli, Davide; Frazzitta, Giuseppe

    2017-06-01

    To assess whether a specific land-based physical intervention with the inclusion of aquatic therapy is more effective than land-based rehabilitation alone for the treatment of balance dysfunction in patients with Parkinson disease (PD), immediately after therapy and at 6 months' follow-up. Randomized controlled study with 6-month follow-up. A PD and brain injury rehabilitation department in a general hospital. Patients (N=34) with moderate-stage PD. Seventeen patients underwent a land-based rehabilitation protocol called multidisciplinary intensive rehabilitation treatment (MIRT), and 17 underwent MIRT plus aquatic therapy (MIRT-AT). The primary outcome measure was the Berg Balance Scale (BBS); secondary outcome measures were the Unified Parkinson Disease Rating Scale parts II and III (UPDRS II/III) and the Timed Up and Go (TUG) test. These measures were assessed in both groups at admission, at discharge, and after 6 months. BBS improved after treatment in both groups. Even though no statistically significant difference between groups was observed at each observation time, BBS scores at follow-up were significantly higher than at baseline in MIRT-AT patients. Both groups also showed an improvement in UPDRS II/III and TUG at the end of treatment compared with baseline, but these findings were lost at the 6-month follow-up. Aquatic therapy added to land-based rehabilitation could provide a contribution to the treatment of balance dysfunction in patients with moderate-stage PD. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  12. Incidence and risk factors of functional upper airway complications of primary esthetic closed rhinoplasty in two residency programs: A 6-month preliminary prospective cohort study

    PubMed Central

    Mohajerani, Hassan; Karimi, Fatemeh; Mohajerani, Alireza; Rakhshan, Vahid

    2013-01-01

    Background: Although esthetic rhinoplasty has many advantages, it might lead to some complications as well. The literature includes scarce and severely controversial studies on these issues, and there is no research on complications of cosmetic closed rhinoplasty. In addition, some complications are not assessed after any rhinoplasty types. Besides, there is no investigation on the outcome of rhinoplasty carried out by graduate students. The purpose of this study was to determine these. Materials and Methods: In this preliminary prospective cohort study, 96 healthy patients underwent closed esthetic rhinoplasty by senior residents of otolaryngology and maxillofacial surgery at Taleghani Hospital (Tehran, 2004-2006). Afterward, at 11 follow-up sessions (the 1st, 2nd, 3rd, 4th, 6th, 8th, 10th, 12th, 16th, 20th, and 24th postoperative weeks), five functional complications (hyposmia/anosmia, nasal obstruction, unpleasant voice changes, recurrent colds, and synechiae) were questioned/examined. The presence of a symptom during at least four subsequent sessions (without elimination until the sixth postoperative month) and the appearance of synechiae in any session were regarded as positive. The data were assessed using Spearman's correlation coefficient (α = 0.05). Results: The incidence rates of synechiae, nasal obstruction, unpleasant voice changes, hyposmia/anosmia, and recurrent colds were 56.25%, 37.5%, 0%, 1.04%, and 29.17%, respectively. No statistically significant relationship was found between the complications with age, gender, or the surgeon's specialty (P > 0.05), but the correlation with home care compliance was significant (ρ = –0.29, P = 0.01). Conclusions: High complication rates were observed in both residency programs. Failure to follow home care instructions might prevent/delay recovery. Further in-depth studies are needed to assess this. PMID:23878567

  13. Variability of spatial temporal gait parameters and center of pressure displacements during gait in elderly fallers and nonfallers: A 6-month prospective study.

    PubMed

    Svoboda, Zdenek; Bizovska, Lucia; Janura, Miroslav; Kubonova, Eliska; Janurova, Katerina; Vuillerme, Nicolas

    2017-01-01

    Considering that most of the falls in elderly population arise during walking, tests derived from walking performance would be desirable for comprehensive fall risk assessment. The analysis of spatial temporal parameters and the center of pressure displacement, which represents the interaction between the human body and the ground, would be beneficial. The aim of this study was to compare spatial temporal gait parameters and their variability and the variability of the center of pressure displacement between elderly fallers and nonfallers during gait at self-selected, defined and fast speeds. A prospective study design was used. At the baseline, measurements of ground reaction force during gait at self-selected, defined and fast walking speeds by two force plates were performed. In addition, the Tinetti balance assessment tool, the Falls Efficacy Scale-International and the Activities-Specific Balance Confidence Scale were used. Mean and coefficient of variation of spatial temporal gait parameters and standard deviations of center of pressure displacement during loading response, midstance, terminal stance and preswing phases were calculated. Comparison of the fallers and nonfallers exhibited no significant difference in clinical tool, scales or spatial temporal parameters. Compared to nonfallers' increased variability of walking speed at self-selected and defined speed, step width at fast walking speed and center of pressure displacement during preswing phase in medial-lateral directions at defined walking speed was found in fallers. However, application of the Holm-Bonferroni procedure for multiple comparisons exhibited no significant effect of group in any of the gait parameters. In general, our study did not observe an effect of group (fallers vs. nonfallers) on variability of spatial temporal parameters and center of pressure movement during gait. However, walking speed, step width as well as standard deviation of COP displacement in the medial

  14. Variability of spatial temporal gait parameters and center of pressure displacements during gait in elderly fallers and nonfallers: A 6-month prospective study

    PubMed Central

    Bizovska, Lucia; Janura, Miroslav; Kubonova, Eliska; Janurova, Katerina; Vuillerme, Nicolas

    2017-01-01

    Considering that most of the falls in elderly population arise during walking, tests derived from walking performance would be desirable for comprehensive fall risk assessment. The analysis of spatial temporal parameters and the center of pressure displacement, which represents the interaction between the human body and the ground, would be beneficial. The aim of this study was to compare spatial temporal gait parameters and their variability and the variability of the center of pressure displacement between elderly fallers and nonfallers during gait at self-selected, defined and fast speeds. A prospective study design was used. At the baseline, measurements of ground reaction force during gait at self-selected, defined and fast walking speeds by two force plates were performed. In addition, the Tinetti balance assessment tool, the Falls Efficacy Scale-International and the Activities-Specific Balance Confidence Scale were used. Mean and coefficient of variation of spatial temporal gait parameters and standard deviations of center of pressure displacement during loading response, midstance, terminal stance and preswing phases were calculated. Comparison of the fallers and nonfallers exhibited no significant difference in clinical tool, scales or spatial temporal parameters. Compared to nonfallers’ increased variability of walking speed at self-selected and defined speed, step width at fast walking speed and center of pressure displacement during preswing phase in medial-lateral directions at defined walking speed was found in fallers. However, application of the Holm-Bonferroni procedure for multiple comparisons exhibited no significant effect of group in any of the gait parameters. In general, our study did not observe an effect of group (fallers vs. nonfallers) on variability of spatial temporal parameters and center of pressure movement during gait. However, walking speed, step width as well as standard deviation of COP displacement in the medial

  15. The Mediterranean Diet and Cognitive Function among Healthy Older Adults in a 6-Month Randomised Controlled Trial: The MedLey Study

    PubMed Central

    Knight, Alissa; Bryan, Janet; Wilson, Carlene; Hodgson, Jonathan M.; Davis, Courtney R.; Murphy, Karen J.

    2016-01-01

    Evidence from a limited number of randomised controlled intervention trials (RCTs) have shown that a Mediterranean dietary pattern may reduce the risk of cognitive decline and enhance cognitive function among healthy older adults. However, there are currently no data in non-Mediterranean older adult populations. The present study aimed to address this gap by examining the effect of a Mediterranean dietary pattern (MedDiet) for six months on aspects of cognitive function in a randomised controlled intervention trial (the MedLey study) that extended for a duration of 18 months. In the final analysed cohort, a total of 137 men and women (mean age of 72.1 ± 5.0 years) randomly assigned to either a MedDiet or control diet (HabDiet) (i.e., habitual dietary intake), were assessed on a comprehensive neuropsychological test battery, including 11 individual tests. In multivariable-adjusted models, the MedDiet group did not perform significantly better than the HabDiet control group for executive functioning (adjusted mean differences: +2.53, 95% CI −2.59 to 7.65, p = 0.33); speed of processing (adjusted mean differences: +3.24, 95% CI −1.21 to 7.70, p = 0.15); memory (adjusted mean differences: +2.00, 95% CI −3.88 to 7.88, p = 0.50); visual-spatial ability (adjusted mean differences: +0.21, 95% CI −0.38 to 0.81, 0.48); and overall age-related cognitive performance (adjusted mean differences: +7.99, 95% CI −4.00 to 19.9, p = 0.19). In conclusion, this study did not find evidence of a beneficial effect of a MedDiet intervention on cognitive function among healthy older adults. PMID:27657119

  16. Clinical features of patients diagnosed with degenerative rotator cuff tendon disease: a 6-month prospective-definitive clinical study from turkey.

    PubMed

    Koca, Tuba Tülay; Arslan, Aydın; Özdemir, Filiz; Acet, Günseli

    2017-08-01

    [Purpose] In rotator cuff tendon disease (RCTD), anamnesis is as important as clinical findings and anatomic/radio diagnostic examination. This study aimed to investigate the clinical features of patients diagnosed with RCTD using clinical and radiological methods between March 2015 and August 2015 at Malatya Research and Training Hospital Physical Medicine and Rehabilitation department. [Subjects and Methods] The study included 178 patients who were diagnosed with RCTD (128 females and 50 males). A questionnaire comprising 33 questions was given to each patient. [Results] Eighty-eight of the patients (49.9%) had an involvement on their right side, eighty-four (47.1%) had an involvement on their left side, and 6 had bilateral involvement. Mean visual analog scale (VAS) score was found to be statistically significant in favor of female patients. A statistically significant correlation was found between educational status and VAS. The body mass index (BMI) of the female patients was found to be higher than that of the male patients. Statistically significant correlation between doing risky work and gender showed that males were at a higher risk. [Conclusion] RCDT is more seen in people who have high BMI and are at their 50s. Pain complaint and BMI were found higher in female patients. DM, thyroid and cardiac diseases were seen more in the patients who are diagnosed with RCTD relative to the healthy population.

  17. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study.

    PubMed

    Holz, Frank G; Roider, Johann; Ogura, Yuichiro; Korobelnik, Jean-François; Simader, Christian; Groetzbach, Georg; Vitti, Robert; Berliner, Alyson J; Hiemeyer, Florian; Beckmann, Karola; Zeitz, Oliver; Sandbrink, Rupert

    2013-03-01

    To evaluate intravitreal VEGF Trap-Eye (VTE) in patients with macular oedema secondary to central retinal vein occlusion (CRVO). In this double-masked study, 177 patients were randomised (3:2 ratio) to intravitreal injections of VTE 2 mg or sham procedure every 4 weeks for 24 weeks. Best-corrected visual acuity was evaluated using the Early Treatment Diabetic Retinopathy Study chart. Central retinal thickness (CRT) was measured with optical coherence tomography. From baseline until week 24, more patients receiving VTE (60.2%) gained ≥ 15 letters compared with those receiving sham injections (22.1%) (p<0.0001). VTE patients gained a mean of 18.0 letters compared with 3.3 letters with sham injections (p<0.0001). Mean CRT decreased by 448.6 and 169.3 µm in the VTE and sham groups (p<0.0001). The most frequent ocular adverse events in the VTE arm were typically associated with the injection procedure or the underlying disease, and included eye pain (11.5%), increased intraocular pressure (9.6%) and conjunctival haemorrhage (8.7%). VTE 2 mg every 4 weeks was efficacious in CRVO with an acceptable safety profile. Vision gains with VTE were significantly higher than with observation/panretinal photocoagulation if needed. Based on these data, VTE may provide a new treatment option for CRVO.

  18. Predictors of psychiatric hospitalization during 6 months of maintenance treatment with olanzapine long-acting injection: post hoc analysis of a randomized, double-blind study

    PubMed Central

    2013-01-01

    Background Hospitalization is a costly and distressing event associated with relapse during schizophrenia treatment. No information is available on the predictors of psychiatric hospitalization during maintenance treatment with olanzapine long-acting injection (olanzapine-LAI) or how the risk of hospitalization differs between olanzapine-LAI and oral olanzapine. This study aimed to identify the predictors of psychiatric hospitalization during maintenance treatment with olanzapine-LAI and assessed four parameters: hospitalization prevalence, incidence rate, duration, and the time to first hospitalization. Olanzapine-LAI was also compared with a sub-therapeutic dose of olanzapine-LAI and with oral olanzapine. Methods This was a post hoc exploratory analysis of data from a randomized, double-blind study comparing the safety and efficacy of olanzapine-LAI (pooled active depot groups: 405 mg/4 weeks, 300 mg/2 weeks, and 150 mg/2 weeks) with oral olanzapine and sub-therapeutic olanzapine-LAI (45 mg/4 weeks) during 6 months’ maintenance treatment of clinically stable schizophrenia outpatients (n=1064). The four psychiatric hospitalization parameters were analyzed for each treatment group. Within the olanzapine-LAI group, patients with and without hospitalization were compared on baseline characteristics. Logistic regression and Cox’s proportional hazards models were used to identify the best predictors of hospitalization. Comparisons between the treatment groups employed descriptive statistics, the Kaplan–Meier estimator and Cox’s proportional hazards models. Results Psychiatric hospitalization was best predicted by suicide threats in the 12 months before baseline and by prior hospitalization. Compared with sub-therapeutic olanzapine-LAI, olanzapine-LAI was associated with a significantly lower hospitalization rate (5.2% versus 11.1%, p < 0.01), a lower mean number of hospitalizations (0.1 versus 0.2, p = 0.01), a shorter mean duration of hospitalization (1.5 days

  19. Comparative efficacy of intra-articular hyaluronic acid and corticoid injections in osteoarthritis of the first carpometacarpal joint: results of a 6-month single-masked randomized study.

    PubMed

    Monfort, Jordi; Rotés-Sala, Delfin; Segalés, Nuria; Montañes, Francisco-Jose; Orellana, Cristobal; Llorente-Onaindia, Jone; Mojal, Sergi; Padró, Isabel; Benito, Pere

    2015-03-01

    The study aim was to compare the efficacy and safety of ultrasound-guided intra-articular injections of hyaluronic acid and betamethasone in the management of patients with osteoarthritis of the thumb. Eighty-eight evaluable patients diagnosed with osteoarthritis of the thumb (Kellgren-Lawrence grade II-III) received ultrasound-guided intra-articular treatment with hyaluronic acid (48) or betamethasone (40). In total, 3 local injections were scheduled at 7-day intervals. Assessments were performed at baseline and at 7, 14, 30, 90, and 180 days. In both study groups, the pain Visual Analogue Scale and Functional Index for Hand Osteoarthritis scores decreased significantly during follow-up compared to baseline. There were no significant differences between the groups. However, at 90 days, the functional score showed a trend towards greater clinical improvement in the hyaluronic acid group (P 0.071). A subanalysis of patients with Functional Index score≥5 and Visual Analogue Scale score≥3 at baseline showed a significantly higher median functionality score in the hyaluronic acid group (P 0.005 at 90 days and P 0.020 at 180 days). Further limiting analysis to a baseline pain score≥5 showed significantly greater improvement in functionality score (P 0.004 at 180 days), which was already apparent after the second intra-articular injection at 14 days (P 0.028). In this patient subset, the mean pain score also improved significantly at 180 days (P 0.02). Both hyaluronic acid and betamethasone were effective and well-tolerated for the management of rhizarthrosis. Hyaluronic acid was more effective over time and more efficiently improved functionality and pain in patients with more severe symptoms. Copyright © 2014 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

  20. Predictors of non-exclusive breastfeeding at 6 months among rural mothers in east Ethiopia: a community-based analytical cross-sectional study

    PubMed Central

    2013-01-01

    Background Exclusive breastfeeding in infants aged under six months is a simple and cost-effective feeding method that ensures better infant and child survival and boosts the achievement of child related Millennium Development Goals in the developing world. Identifying factors associated with good breastfeeding practice helps to increase its coverage and maximize its advantages through improved advocacy. The objective of this study was to identify the predictors of non-exclusive breastfeeding in the rural areas of eastern Ethiopia. Methods A community-based analytical cross-sectional study was conducted on mother/caregiver–child pairs in east Ethiopia from July to August 2011. Data on infant feeding practices were collected by trained interviewers who used a pretested and structured questionnaire. Odds ratio with a 95% confidence interval was estimated for the predictors of non-exclusive breastfeeding using the multivariable logistic regression. Results The prevalence of non-exclusive breastfeeding in infants aged under six months, was 28.3%. Non-exclusive breastfeeding was more likely to be practiced by mothers who were not married at the moment [AOR (95% CI) = 2.6 (1.1, 6.0)], mothers who had no access to health facility [AOR (95% CI) = 2.9 (1.9, 4.3)], and mothers whose knowledge about infant and young child feeding practices was low [AOR (95% CI) = 3.4 (2.4, 4.7)]. Conclusion Non–exclusive breastfeeding was more common among mothers with no marital relationships, poor access to health facilities, and inadequate knowledge about infant and young child feeding practices. Family support, education, and behavior change communication on infant feeding, especially on exclusive breastfeeding, at the community level may improve the knowledge, behavior, and practice of mothers on optimal infant and young child feeding practices. PMID:23919800

  1. Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study

    PubMed Central

    2014-01-01

    Background For persons with multiple sclerosis (MS) it is important to preserve their autonomy, in spite of increasing disability. A major factor mediating autonomy is self-efficacy. According to the social cognitive theory stressors are crucial determinants of self-efficacy, as well as the interaction with partners. Methods In an explorative observational study we assessed in 47 persons with MS (PwMS) the effect of an intense, multidisciplinary, 3-day, social cognitive wellness program with the participation of support partners, after 1, 3 and 6 months. Primary outcomes: self-efficacy-control and -function (Multiple Sclerosis Self-Efficacy Scale [MSSES]),limitations to and problems with participation and autonomy (Impact on Participation and Autonomy [IPA] scale). Secondary outcomes: health-related quality of life (HRQoL) (MS Quality of Life-54 Items [MSQoL-54] questionnaire), anxiety, depression (Hospital Anxiety and Depression Scale [HADS]), and fatigue (Modified Fatigue Impact Scale-5 Items [MFIS-5]). Disability was measured with the Expanded Disability Status Scale (EDSS). Percentage changes from baseline were tested with T-tests, level of significance 0.05. Results In the whole group the MSQoL-54 Mental score was increased at 1, 3 and 6 months (+16.0%, +13.2%, +12.2%), and the MSQoL-54 Physical (+10.2%) at 6 months, with no changes in other outcomes. The relapsing remitting (RR) subgroup (n = 20) had at 6 months an increase in the MSSES-Control score (+24.8%) and in the MSQoL54 Mental and Physical scores (+22.3%, +17.6%). Progressive patients (n = 22) only showed an increase in the MSQoL-54 Mental score (+11.5%) at 1 month. In the low-disability (EDSS < 4.0) subgroup the MSSES-Control score was increased (+23.8%) at 6 months, and the IPA-Limitations and -Problems scores decreased at 3 months (−6.1%, −8.8%); the MSQoL-54 Mental score had increased at 1, 3 and 6 months (+19.3%, +21.5%, +19.3%). In the high-disability (EDSS > =4

  2. Expressive timing in infant-directed singing between 3 and 6 months.

    PubMed

    Delavenne, Anne; Gratier, Maya; Devouche, Emmanuel

    2013-02-01

    This longitudinal study compared the temporal characteristics of maternal singing at 3 and then at 6 months. Infant-directed (ID) singing is claimed to have different functions in preverbal communication. However few studies have focused on the specific characteristics of ID singing that change across the first months of life. We aimed to explore these changes between 3 and 6 months because musical routines become prominent in the repertoire of games parents and infants spontaneously play during a period referred to as 'the period of games'. We focused specifically on expressive timing because it reflects how mothers dynamically adapt their singing to their infant's states of attention and involvement. We aimed to determine whether the expressive timing cues of maternal singing would be different at 3 and then at 6 months. To this end, the interactions of 18 mother-infant dyads were recorded while mothers were singing a popular French playsong for their infant at 3 and then at 6 months. Acoustic analyses revealed that mothers showed final-lengthening and tempo slowing for both age groups, but marked the ends of the hierarchical structural units of the song more saliently with their 6-month-olds. Unexpectedly, infant sex was also found to affect maternal singing: more exaggerated phrase-lengthening patterns were observed in singing to girls. Copyright © 2012 Elsevier Inc. All rights reserved.

  3. Cryptosporidium Prevalence and Risk Factors among Mothers and Infants 0 to 6 Months in Rural and Semi-Rural Northwest Tanzania: A Prospective Cohort Study

    PubMed Central

    Pedersen, Sarah H.; Wilkinson, Amanda L.; Andreasen, Aura; Warhurst, David C.; Kinung'hi, Safari M.; Urassa, Mark; Mkwashapi, Denna M.; Todd, Jim; Changalucha, John; McDermid, Joann M.

    2014-01-01

    Background Cryptosporidium epidemiology is poorly understood, but infection is suspected of contributing to childhood malnutrition and diarrhea-related mortality worldwide. Methods/Findings A prospective cohort of 108 women and their infants in rural/semi-rural Tanzania were followed from delivery through six months. Cryptosporidium infection was determined in feces using modified Ziehl-Neelsen staining. Breastfeeding/infant feeding practices were queried and anthropometry measured. Maternal Cryptosporidium infection remained high throughout the study (monthly proportion = 44 to 63%). Infection did not differ during lactation or by HIV-serostatus, except that a greater proportion of HIV-positive mothers were infected at Month 1. Infant Cryptosporidium infection remained undetected until Month 2 and uncommon through Month 3 however, by Month 6, 33% of infants were infected. There were no differences in infant infection by HIV-exposure. Overall, exclusive breastfeeding (EBF) was limited, but as the proportion of infants exclusively breastfed declined from 32% at Month 1 to 4% at Month 6, infant infection increased from 0% at Month 1 to 33% at Month 6. Maternal Cryptosporidium infection was associated with increased odds of infant infection (unadjusted OR = 3.18, 95% CI 1.01 to 9.99), while maternal hand washing prior to infant feeding was counterintuitively also associated with increased odds of infant infection (adjusted OR = 5.02, 95% CI = 1.11 to 22.78). Conclusions Both mothers and infants living in this setting suffer a high burden of Cryptosporidium infection, and the timing of first infant infection coincides with changes in breastfeeding practices. It is unknown whether this is due to breastfeeding practices reducing pathogen exposure through avoidance of contaminated food/water consumption; and/or breast milk providing important protective immune factors. Without a Cryptosporidium vaccine, and facing considerable diagnostic challenges and

  4. Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study.

    PubMed

    Benucci, Maurizio; Gobbi, Francesca Li; Bandinelli, Francesca; Damiani, Arianna; Infantino, Maria; Grossi, Valentina; Manfredi, Mariangela; Parisi, Simone; Fusaro, Enrico; Batticciotto, Alberto; Sarzi-Puttini, Piercarlo; Atzeni, Fabiola; Meacci, Francesca

    2016-07-23

    Biosimilar infliximab (INX) was recently approved by the European Medicine Agency for the treatment of rheumatoid arthritis, ankylosing spondylitis (AS), Crohn's disease, ulcerative colitis, psoriatic arthritis (PsA), and psoriasis on the grounds that its pharmacokinetics, safety, and efficacy were comparable to those of innovator INX. The aim of this study was to investigate the real-life efficacy, safety, and immunogenicity of switching from innovator to biosimilar INX in patients with spondyloarthritis (SpA). Forty-one patients attending three Italian rheumatology centres with a previous diagnosis of SpA and clinically inactive or moderate disease activity (ASDAS-CRP < 2.1; 22 with AS, five with enteropathic arthritis, 10 with PsA, and four with undifferentiated SpA), who had been treated for more than 6 months with innovator INX in accordance with the ASAS/EULAR guidelines, were switched to biosimilar INX for pharmaco-economic reasons (Tuscany Law No. 450 of 7 April 2015) and followed up for 6 months. A record was kept of their BASDAI, BASFI, ASDAS-CRP, DAS28-CRP (in the presence of peripheral disease), MASES, VAS pain scores, the duration of morning stiffness, and adverse events (AEs). At the time of the switch, the patients had a median age of 50.9 years (range 23-80), a median disease duration of 124.5 months (range 14-372), and a median duration of treatment with innovator INX of 73.7 months (range 6-144). After 6 months of biosimilar INX therapy, there were no statistical differences in their median BASDAI (2.73 ± 1.5 vs. 2.6 ± 1.3, p = .27), BASFI (2.34 ± 1.3 vs. 2.17 ± 1.2, p = 0.051), ASDAS-CRP (1.35 ± 0.3 vs. 1.28 ± 0.2, p = 0.24), DAS28-CRP (2.66 ± 0.67 vs. 2.67 ± 0.35, p = 0.92), MASES (0.35 ± 0.7 vs. 0.17 ± 0.4, p = 0.08), or VAS pain scores (18 ± 14.7 vs. 16.7 ± 11.3, p = 0.55), whereas the median duration of morning stiffness had significantly decreased (7.2 ± 6.9 vs. 5.8 ± 6, p = 0

  5. Improved nutritional status in elderly patients 6 months after stroke.

    PubMed

    Brynningsen, P K; Damsgaard, E M S; Husted, S E

    2007-01-01

    Nutritional status among stroke patients has received limited attention despite the fact, that it may have an influence on clinical outcome. Previous studies have estimated that 15-20 % of patients suffer from malnutrition in the acute phase of stroke, but so far no studies have focused on the late rehabilitation phase after stroke in the patients own home, where the attention on nutrition may be reduced. To determine the prevalence of malnutrition during 6 months of stroke rehabilitation, and to investigate the association between nutritional status, functional recovery, length of stay in hospital and infectious complications. 89 patients with ischemic stroke consecutively admitted to a geriatric stroke rehabilitation unit had their nutritional status evaluated in the hospital at 1 week and 5 weeks after stroke, and in their own home at 3 months and 6 months. Nutritional status was evaluated by body weight, body mass index (BMI), mid upper arm circumference (MAC), triceps skinfold thickness (TSF) and serum concentrations of albumin and transferrin. Malnutrition was defined if the patients had 2 or more abnormal nutritional variables. We found a significant increase in albumin from 1 week to 6 months (P < 0.0001), and a significant increase in transferrin form 5 weeks to 6 months (P < 0.05). There was no significant change in weight or BMI from 1 week to 6 months. The number of patients with 2 or more abnormal nutritional variables was 31 (35 %) at 1 week and was reduced to 20 (22 %) at 6 months. 35 % of elderly patients with ischemic stroke admitted to a geriatric rehabilitation unit were malnourished 1 week after stroke. Particularly serum proteins and body fat were affected. Follow-up of nutritional variables showed improvement for serum proteins, and 22 % of the patients were malnourished 6 months after stroke.

  6. Effects of 1- and 6-month spaceflight on bone mass and biochemistry in two humans.

    PubMed

    Collet, P; Uebelhart, D; Vico, L; Moro, L; Hartmann, D; Roth, M; Alexandre, C

    1997-06-01

    The bone mineral density and the biochemical parameters exploring bone cell activities were analyzed in two cosmonauts who spent 1 and 6 months, respectively, in the Russian MIR station. Measurements were performed before the flight, after the flight, and after a recovery period. At the end of the first month, peripheral QCT measurements indicated a slight decrease of trabecular bone mass in the distal tibial metaphysis. However, after 6 months of spaceflight, a more marked loss of trabecular and cortical bones was observed in the tibia, and was still significant after 6 month recovery in the trabecular compartment, whereas a decrease was no longer observed in the cortical envelope. No change was observed in either compartment of the distal radius at any time. Ultrasound BUA of the calcaneus was greatly reduced by the first month, followed by a more dramatic decrease after month 6. Ultrasound SOS detected no change. Parameters reflecting bone formation activity appeared to be depressed after both missions. In contrast, no dramatic change in resorption parameters was observed, except for a trend toward an increase in pyridinoline. In conclusion, the lower weight-bearing bones appeared more sensitive than the upper ones in terms of spaceflight-induced bone loss. This probably explained the absence of marked systemic biochemical data changes. This study further suggests that recovery in the tibial trabecular compartment 6 months after landing was not completed after a 6 month mission.

  7. A randomized, double-blind, safety and tolerability study to assess the ophthalmic and renal effects of tafenoquine 200 mg weekly versus placebo for 6 months in healthy volunteers.

    PubMed

    Leary, Kevin J; Riel, Michael A; Roy, Michael J; Cantilena, Louis R; Bi, Daoqin; Brater, D Craig; van de Pol, Corina; Pruett, Khadeeja; Kerr, Caron; Veazey, James M; Beboso, Ronnie; Ohrt, Colin

    2009-08-01

    A randomized, double-blind, placebo-controlled study was conducted to assess the effect of tafenoquine, 200 mg weekly for 6 months on ophthalmic and renal safety. This trial was carried out after observations in previous clinical trials that tafenoquine may be associated with the development of corneal deposits and elevations in serum creatinine. In 120 healthy volunteers who received tafenoquine or placebo in a 2:1 randomization, there was no effect on night vision or other ophthalmic indices measured. Persons taking tafenoquine also showed no difference in mean change in glomerular filtration rate (GFR, mL/s/1.73 m(2)) after 6 months of dosing, with a treatment difference of -0.061 (95% confidence interval, -0.168, 0.045), and non-inferiority margin of -0.247 mL/s/1.73 m(2). Tafenoquine was well tolerated over the course of the study. The results of this study showed no clinically significant effects of tafenoquine on ophthalmic or renal function, and support its continued development as an antimalarial drug.

  8. The Use of Immersive Virtual Reality (VR) to Predict the Occurrence 6 Months Later of Paranoid Thinking and Posttraumatic Stress Symptoms Assessed by Self-Report and Interviewer Methods: A Study of Individuals Who Have Been Physically Assaulted

    PubMed Central

    2014-01-01

    Presentation of social situations via immersive virtual reality (VR) has the potential to be an ecologically valid way of assessing psychiatric symptoms. In this study we assess the occurrence of paranoid thinking and of symptoms of posttraumatic stress disorder (PTSD) in response to a single neutral VR social environment as predictors of later psychiatric symptoms assessed by standard methods. One hundred six people entered an immersive VR social environment (a train ride), presented via a head-mounted display, 4 weeks after having attended hospital because of a physical assault. Paranoid thinking about the neutral computer-generated characters and the occurrence of PTSD symptoms in VR were assessed. Reactions in VR were then used to predict the occurrence 6 months later of symptoms of paranoia and PTSD, as assessed by standard interviewer and self-report methods. Responses to VR predicted the severity of paranoia and PTSD symptoms as assessed by standard measures 6 months later. The VR assessments also added predictive value to the baseline interviewer methods, especially for paranoia. Brief exposure to environments presented via virtual reality provides a symptom assessment with predictive ability over many months. VR assessment may be of particular benefit for difficult to assess problems, such as paranoia, that have no gold standard assessment method. In the future, VR environments may be used in the clinic to complement standard self-report and clinical interview methods. PMID:24708073

  9. The use of immersive virtual reality (VR) to predict the occurrence 6 months later of paranoid thinking and posttraumatic stress symptoms assessed by self-report and interviewer methods: a study of individuals who have been physically assaulted.

    PubMed

    Freeman, Daniel; Antley, Angus; Ehlers, Anke; Dunn, Graham; Thompson, Claire; Vorontsova, Natasha; Garety, Philippa; Kuipers, Elizabeth; Glucksman, Edward; Slater, Mel

    2014-09-01

    Presentation of social situations via immersive virtual reality (VR) has the potential to be an ecologically valid way of assessing psychiatric symptoms. In this study we assess the occurrence of paranoid thinking and of symptoms of posttraumatic stress disorder (PTSD) in response to a single neutral VR social environment as predictors of later psychiatric symptoms assessed by standard methods. One hundred six people entered an immersive VR social environment (a train ride), presented via a head-mounted display, 4 weeks after having attended hospital because of a physical assault. Paranoid thinking about the neutral computer-generated characters and the occurrence of PTSD symptoms in VR were assessed. Reactions in VR were then used to predict the occurrence 6 months later of symptoms of paranoia and PTSD, as assessed by standard interviewer and self-report methods. Responses to VR predicted the severity of paranoia and PTSD symptoms as assessed by standard measures 6 months later. The VR assessments also added predictive value to the baseline interviewer methods, especially for paranoia. Brief exposure to environments presented via virtual reality provides a symptom assessment with predictive ability over many months. VR assessment may be of particular benefit for difficult to assess problems, such as paranoia, that have no gold standard assessment method. In the future, VR environments may be used in the clinic to complement standard self-report and clinical interview methods.

  10. Maternal Regulation of Infant Reactivity From 2 to 6 Months.

    ERIC Educational Resources Information Center

    Jahromi, Laudan B.; Putnam, Samuel P.; Stifter, Cynthia A.

    2004-01-01

    Previous research has investigated the effect of maternal soothing behaviors on reducing infant reactivity but not the differential effects of specific maternal behaviors on infant stress responses. The present study investigated maternal regulation of 2- and 6-month-olds' responses to an inoculation and found a significant decline with age in…

  11. Baseline Factors Associated With 6-Month Visual Acuity and Retinal Thickness Outcomes in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion: SCORE2 Study Report 4.

    PubMed

    Scott, Ingrid U; VanVeldhuisen, Paul C; Ip, Michael S; Blodi, Barbara A; Oden, Neal L; King, Jacqueline; Antoszyk, Andrew N; Peters, Mark A; Tolentino, Michael

    2017-06-01

    Macular edema (ME) is the leading cause of decreased visual acuity (VA) associated with retinal vein occlusion (RVO). Identifying factors associated with better outcomes in RVO eyes treated with anti-vascular endothelial growth factor (VEGF) therapy may provide information useful in counseling patients. To investigate baseline characteristics associated with 6-month VA and central subfield thickness (CST) outcomes in participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2). A total of 362 patients with central RVO or hemi-RVO were enrolled between September 17, 2014, and November 18, 2015, and randomized 1:1 in a masked fashion to receive bevacizumab or aflibercept. At month 6, 348 participants (96%) had VA outcomes measured and 335 participants (93%) had spectral domain optical coherence tomography outcomes measured. The current data analysis was conducted from February 27, 2017, to April 7, 2017. Eyes were randomly assigned to receive an intravitreal injection of bevacizumab, 1.25 mg, or aflibercept, 2.0 mg, at baseline and every 4 weeks, with the primary outcome measured at 6 months. Change from baseline in VA letter score (VALS), VALS gain of 15 or more, change from baseline in CST, CST less than 300 µm, and resolution of ME. Baseline factors associated with 6-month outcome at the 0.05 level in univariate regressions were included in multivariate regressions, with those significant after multiplicity control by the Hochberg method reported. The mean (SD) age of patients was 69 (12) years, and 43% were women. Younger patient age (odds ratio [OR], 0.95 per year of age; 95% CI, 0.93-0.98; P = .007) and lower baseline VALS (OR, 0.96 per letter; 95% CI, 0.94-0.98; P < .001) were associated with a 6-month VALS gain of 15 or greater. Compared with bevacizumab, aflibercept treatment was associated with a higher odds of ME resolution (OR, 3.59; 95% CI, 2.22-5.80; P < .001) and CST less than 300 µm (OR,  5.30; 95% CI, 2

  12. Maternal cortisol slope at 6 months predicts infant cortisol slope and EEG power at 12 months.

    PubMed

    St John, Ashley M; Kao, Katie; Liederman, Jacqueline; Grieve, Philip G; Tarullo, Amanda R

    2017-09-01

    Physiological stress systems and the brain rapidly develop through infancy. While the roles of caregiving and environmental factors have been studied, implications of maternal physiological stress are unclear. We assessed maternal and infant diurnal cortisol when infants were 6 and 12 months. We measured 12-month infant electroencephalography (EEG) 6-9 Hz power during a social interaction. Steeper 6-month maternal slope predicted steeper 12-month infant slope controlling for 6-month infant slope and breastfeeding. Steeper 6-month maternal slope predicted lower 6-9 Hz power. Six-month maternal area under the cuve (AUCg) was unrelated to 12-month infant AUCg and 6-9 Hz power. Psychosocial, caregiving, and breastfeeding variables did not explain results. At 6 months, maternal and infant slopes correlated, as did maternal and infant AUCg. Twelve-month maternal and infant cortisol were unrelated. Results indicate maternal slope is an informative predictor of infant physiology and suggest the importance of maternal physiological stress in this developmental period. © 2017 Wiley Periodicals, Inc.

  13. Effect of a 6-month pedometer-based walking intervention on functional capacity in patients with chronic heart failure with reduced (HFrEF) and with preserved (HFpEF) ejection fraction: study protocol for two multicenter randomized controlled trials.

    PubMed

    Vetrovsky, Tomas; Siranec, Michal; Parenica, Jiri; Griva, Martin; Stastny, Jiri; Precek, Jan; Pelouch, Radek; Bunc, Vaclav; Linhart, Ales; Belohlavek, Jan

    2017-07-03

    Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chronic diseases, but it is unknown whether a pedometer-based intervention improves functional capacity and neurohumoral modulation in heart failure patients. Two multicenter randomized controlled trials will be conducted in parallel: one in patients with chronic heart failure with reduced ejection fraction (HFrEF), the other in patients with chronic heart failure with preserved ejection fraction (HFpEF). Each trial will consist of a 6-month intervention with an assessment at baseline, at 3 months, at the end of the intervention, and 6 months after completing the intervention. Each trial will aim to include a total of 200 physically inactive participants with chronic heart failure who will be randomly assigned to intervention or control arms. The 6-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback). The primary outcome is the change in 6-min walk distance at the end of the 6-month intervention. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC risk score. To our knowledge, these are the first studies to evaluate a pedometer-based walking intervention in patients with chronic heart failure with either reduced or preserved ejection fraction. The studies will contribute to a better understanding of physical

  14. The effect of body mass index on clinical response to abatacept as a first-line biologic for rheumatoid arthritis: 6-month results from the 2-year, observational, prospective ACTION study.

    PubMed

    Mariette, Xavier; Alten, Rieke; Nüßlein, Hubert G; Galeazzi, Mauro; Lorenz, Hanns-Martin; Cantagrel, Alain; Chartier, Melanie; Poncet, Coralie; Rauch, Christiane; Le Bars, Manuela

    2017-10-01

    To assess the impact of baseline body mass index (BMI) on the efficacy and retention of intravenous abatacept at 6 months in biologic-naïve patients with rheumatoid arthritis (RA). This was a 6-month analysis of a 2-year, non-interventional, international, prospective study. Baseline characteristics, clinical response and retention rates were compared by BMI subgroup: underweight/normal, overweight and obese (<25, 25 to <30 and ≥30kg/m(2), respectively). BMI was reported in 643/672 (96%) patients: 264 (41%) were underweight/normal, 224 (35%) overweight and 155 (24%) obese. At baseline, the obese group had more active disease (mean [95% confidence intervals] 28-joint Disease Activity Score [C-reactive protein; derived] 4.6 [4.5, 4.7], 4.8 [4.7, 5.0] and 5.1 [4.9, 5.2] for underweight/normal, overweight and obese groups, respectively), a higher prevalence of metabolic disorders, a greater proportion of women and a lower proportion of patients with rheumatoid factor positivity. There were no significant differences in the percentages of patients achieving a good/moderate European League Against Rheumatism response by BMI group (80.7, 86.1 and 77.0% for underweight/normal, overweight and obese groups, respectively; P=0.178). Overall retention rates at 6 months did not differ across groups (89, 92 and 89% for underweight/normal, overweight and obese groups, respectively; log-rank P=0.382). After adjustment for baseline characteristics, BMI was not significantly associated with risk of discontinuation (reference BMI<25kg/m(2); hazard ratio [95% confidence intervals] 0.46 [0.22, 0.99] and 0.69 [0.34, 1.41] for overweight and obese patients, respectively). BMI does not impact abatacept clinical response or retention in biologic-naïve patients with RA. Copyright © 2016 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

  15. Overcoming the need for a cold chain with conjugated meningococcal Group C vaccine: A controlled, randomized, double-blind study in toddlers on the safety and immunogenicity of Menjugate, stored at room temperature for 6 months.

    PubMed

    Schöndorf, Ines; Banzhoff, Angelika; Nicolay, Uwe; Diaz-Mitoma, Francisco

    2007-01-26

    Millions of vaccine doses are wasted each year due to a lapse in recommended storage conditions. Maintaining the cold chain for vaccines is both expensive and difficult, especially in developing countries. The present study investigated the safety and immunogenicity of a single dose of the conjugated meningococcal Group C vaccine, Menjugate, stored for 6 months at room temperature (25+/-2 degrees C, N=250) or at 2-8 degrees C (N=250) when administered to 12-23 months toddlers. In the two respective groups, 87 and 88% of toddlers reached bactericidal antibodies titers of at least 1:8. The immunogenicity of Menjugate stored at room temperature was not inferior to that stored at 2-8 degrees C. The safety profile and immunogenicity of the vaccine was not influenced by the storage condition.

  16. Normalization of the heart rate response to exercise 6 months after cardiac transplantation.

    PubMed

    Buendía Fuentes, F; Martínez-Dolz, L; Almenar Bonet, L; Sánchez-Lázaro, I; Navarro Manchón, J; Sánchez-Gómez, J M; Raso Raso, R; Agüero-Ramón-Llin, J; Sancho-Tello de Carranza, M J; Salvador Sanz, A

    2010-10-01

    Heart transplant recipients show an abnormal heart rate (HR) response to exercise due to complete cardiac denervation after surgery. They present elevated resting HR, minimal increase in HR during exercise, with maximal HR reached during the recovery period. The objective of this study was to study the frequency of normalization of the abnormal HR in the first 6 months after transplantation. We prospectively studied 27 heart transplant recipients who underwent treadmill exercise tests at 2 and 6 months after heart transplantation (HT). HR responses to exercise were classified as normal or abnormal, depending on achieving all of the following criteria: (1) increased HR for each minute of exercise, (2) highest HR at the peak exercise intensity, and (3) decreased HR for each minute of the recovery period. The HR response at 2 months was compared with the results at 6 months post-HT. At 2 months post-HT, 96.3% of the patients showed abnormal HR responses to exercise. Four months later, 11 patients (40.7%) had normalized HR responses (P<.001), which also involved a significant decrease in the time to achieve the highest HR after exercise (124.4±63.8 seconds in the first test and 55.6±44.6 seconds in the second). A significant improvement in exercise capacity and chronotropic competence was also shown in tests performed at 6 months after surgery. We observed important improvements in HR responses to exercise at 6 months after HT, which may represent early functional cardiac reinnervation. Copyright © 2010 Elsevier Inc. All rights reserved.

  17. Anti-Drug Antibodies, Drug Levels, Interleukin-6 and Soluble TNF Receptors in Rheumatoid Arthritis Patients during the First 6 Months of Treatment with Adalimumab or Infliximab: A Descriptive Cohort Study.

    PubMed

    Eng, Grith Petersen; Bouchelouche, Pierre; Bartels, Else Marie; Bliddal, Henning; Bendtzen, Klaus; Stoltenberg, Michael

    2016-01-01

    With the present study we wanted to explore the impact of treatment with a tumor necrosis factor-α -inhibitor (TNFi) on levels of soluble biomarkers in rheumatoid arthritis (RA) patients and to identify predictors of impaired drug levels and development of anti-TNFi antibodies (anti-TNFi Abs). Blood samples from 26 patients with established RA were taken at baseline and following 6 months of treatment with adalimumab or infliximab. Samples were analyzed for levels of TNFi, interleukin (IL)-6, and soluble TNF-receptors 1 and -2 (sTNF-R1 and -2) and for presence of anti-TNFi Abs. Clinical and demographic data were recorded as well. During the initial 6 months treatment, DAS28(CRP) (Disease activity score in 28 joints using C-reactive protein) and levels of IL-6 and sTNF-R2 decreased significantly in patients without anti-TNFi Abs and in patients retaining detectable drug levels. The levels of other tested cytokines (TNF-α, TNF-β, IL-1ra, IL-1b, IL-8, IL-10, IL-12(p70), IL-13, IL-17A, IL-17F, and IL-33) were generally below detection limits. Higher baseline levels of IL-6 associated with undetectable levels of TNFi at follow-up. Anti-TNFi Abs were associated with decreased drug levels, but no predictors for anti-TNFi Ab development could be found. The effect of treatment with TNFi on RA disease activity depends on levels of active drug, and by presence of anti-TNFi Abs. In patients who retain detectable drug levels, and in the absence of anti-TNFi Abs, clinical outcome is improved during treatment, and circulating levels of IL-6 and sTNF-R2 decrease. Baseline levels of IL-6 may predict depletion of TNFi and may identify patients at risk of treatment failure.

  18. A Randomized Double-Blind Controlled Trial Comparing Davanloo Intensive Short-Term Dynamic Psychotherapy as Internet-Delivered Vs Treatment as Usual for Medically Unexplained Pain: A 6-Month Pilot Study.

    PubMed

    Chavooshi, Behzad; Mohammadkhani, Parvaneh; Dolatshahi, Behrouz

    2016-01-01

    Research has shown that Intensive Short-Term Dynamic Psychotherapy (ISTDP) can effectively decrease pain intensity and improve quality of life in patients with medically unexplained pain. Understanding that not all patients with medically unexplained pain have access to in-person ISTDP, this study aims to investigate the efficacy of an Internet-delivered ISTDP for individuals with medically unexplained pain using Skype in comparison with treatment as usual. In this randomized controlled trial, 100 patients were randomly allocated into Internet-delivered ISTDP (n = 50) and treatment-as- usual (n = 50) groups. Treatment intervention consisted of 16 weekly, hour-long therapy sessions. The primary outcome was perceived pain assessed using the Numeric Pain Rating Scale. The secondary outcome included Depression Anxiety Stress Scale-21, Emotion Regulation Questionnaire, Mindful Attention Awareness Scale, and Quality-of-Life Inventory. Blind assessments were conducted at the baseline, posttreatment, and at a 6-month follow-up. In the intention-to-treat analysis, pain symptoms in the intervention group were significantly reduced (p < 0.001), whereas a reduction was not observed in the treatment as usual group (p = 0.651). Moreover, there were significant decreases in depression, anxiety, and stress, as well as a greater increase in emotion regulation functioning, mindfulness, and quality of life observed in the intervention group 6 months after the treatment compared with the treatment as usual condition. The results of this pilot trial demonstrate that 16 weeks of ISTDP delivered by Skype can significantly improve pain intensity and clinical symptoms of medically unexplained pain. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

  19. Symptom-modifying effects of oral avocado/soybean unsaponifiables in routine treatment of knee osteoarthritis in Poland. An open, prospective observational study of patients adherent to a 6-month treatment.

    PubMed

    Głuszko, Piotr; Stasiek, Małgorzata

    2016-01-01

    Observational studies provide insights into real-life situations. Therefore, we assessed the effects of oral avocado/soybean unsaponifiable (ASU) capsules on pain relief and functional ability in patients, while they were receiving a routine treatment for knee osteoarthritis (OA). An open, prospective, observational 6-month study was conducted in 99 centers in Poland in a group of 4822 patients with symptomatic knee OA receiving one 300 mg ASU capsule/day as a routine medication. The patients had no diagnoses of other rheumatic diseases and were not treated with other symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). Data on OA symptoms and therapy were collected from the initiation of ASU treatment (visit 0) and during 3 consecutive control visits performed every 2 months (visits 1-3). Functional Lequesne index, severity of joint pain of one symptomatic knee (Laitinen index and VAS), use of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), adherence to treatment and adverse events were evaluated and recorded using electronic Case Report Forms. Four thousand one hundred and eighty-six patients (86.8%) attended all 4 visits. In 94.2% of patients (mean age 60.7 ±11.6 years SD, 73.4% female) at least one OA risk factor was identified. There was a significant improvement in functional ability between the last and baseline visits as evidenced by the median Lequesne index decreasing from 8 to 4 points (p < 0.001). Measures of pain intensity also fell significantly (p < 0.001) throughout the study: median Laitinen score decreased from 6 to 3 points, median pain at rest VAS - from 1.8 to 0 cm and median pain during walking VAS - from 5.6 to 1.9 cm. The significant differences were also noted between consecutive visits. The proportion of patients using analgesics and NSAIDs declined from 58.8% at the baseline visit to 24.9% at the last visit 3 (p < 0.001). Defined daily dose of NSAIDs decreased significantly from 1 at the baseline visit to 0.67 at

  20. Symptom-modifying effects of oral avocado/soybean unsaponifiables in routine treatment of knee osteoarthritis in Poland. An open, prospective observational study of patients adherent to a 6-month treatment

    PubMed Central

    Głuszko, Piotr

    2016-01-01

    Objectives Observational studies provide insights into real-life situations. Therefore, we assessed the effects of oral avocado/soybean unsaponifiable (ASU) capsules on pain relief and functional ability in patients, while they were receiving a routine treatment for knee osteoarthritis (OA). Material and methods An open, prospective, observational 6-month study was conducted in 99 centers in Poland in a group of 4822 patients with symptomatic knee OA receiving one 300 mg ASU capsule/day as a routine medication. The patients had no diagnoses of other rheumatic diseases and were not treated with other symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). Data on OA symptoms and therapy were collected from the initiation of ASU treatment (visit 0) and during 3 consecutive control visits performed every 2 months (visits 1–3). Functional Lequesne index, severity of joint pain of one symptomatic knee (Laitinen index and VAS), use of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), adherence to treatment and adverse events were evaluated and recorded using electronic Case Report Forms. Results Four thousand one hundred and eighty-six patients (86.8%) attended all 4 visits. In 94.2% of patients (mean age 60.7 ±11.6 years SD, 73.4% female) at least one OA risk factor was identified. There was a significant improvement in functional ability between the last and baseline visits as evidenced by the median Lequesne index decreasing from 8 to 4 points (p < 0.001). Measures of pain intensity also fell significantly (p < 0.001) throughout the study: median Laitinen score decreased from 6 to 3 points, median pain at rest VAS – from 1.8 to 0 cm and median pain during walking VAS – from 5.6 to 1.9 cm. The significant differences were also noted between consecutive visits. The proportion of patients using analgesics and NSAIDs declined from 58.8% at the baseline visit to 24.9% at the last visit 3 (p < 0.001). Defined daily dose of NSAIDs decreased

  1. Exclusive or Partial Breastfeeding for 6 Months Is Associated With Reduced Milk Sensitization and Risk of Eczema in Early Childhood

    PubMed Central

    Chiu, Chih-Yung; Liao, Sui-Ling; Su, Kuan-Wen; Tsai, Ming-Han; Hua, Man-Chin; Lai, Shen-Hao; Chen, Li-Chen; Yao, Tsung-Chieh; Yeh, Kuo-Wei; Huang, Jing-Long

    2016-01-01

    Abstract There is insufficient evidence to confirm the association between breastfeeding and allergic outcomes later in life. This study aimed to determine the relationships between different breastfeeding patterns and allergen sensitizations and risk of developing atopic diseases in early childhood. A total of 186 children from a birth cohort in the Prediction of Allergies in Taiwanese Children study for a 4-year follow-up period were enrolled. Total serum immunoglobulin E (IgE) levels and specific IgE antibodies against food and inhalant allergens were measured sequentially at 6 months as well as at 1, 1.5, 2, 3, and 4 years of age. A significantly lower prevalence of milk sensitization was found in children at ages 1 and 1.5 years who were exclusively or partially breastfed for ≥6 months. Breastfeeding ≥6 months was significantly associated with a reduced risk of developing eczema but not allergic rhinitis and asthma at ages 1 and 2 years. Compared with exclusive breastfeeding ≥6 months, partial breastfeeding <6 months was significantly associated with an increased risk of developing eczema at ages 1 and 2 years. As with exclusive breastfeeding, partial breastfeeding for at least 6 months appears to be associated with a reduced prevalence of milk sensitization as well as a reduced risk of developing eczema in early childhood. PMID:27082611

  2. Still nursing at 6 months: a survey of breastfeeding mothers.

    PubMed

    Augustin, Amy L; Donovan, Kathleen; Lozano, Emily A; Massucci, Diane J; Wohlgemuth, Fran

    2014-01-01

    To learn about the duration of breastfeeding and to describe the variables influencing breastfeeding practices of mothers who gave birth at a suburban community hospital. An Institutional Review Board approved this descriptive anonymous survey with 20 questions concerning patients' characteristics and experiences with breastfeeding, which was developed based on current literature. The survey was distributed to mothers through Survey Monkey via email 6 months after birth. The survey link was sent to 806 mothers, with a response rate of 50%. Over 59% were still breastfeeding at 6 months. Mothers who initiated skin-to-skin contact in the first hour had a higher rate of breastfeeding during this time frame compared to mothers who did not perform skin-to-skin contact. Women who had cesarean births and women who were primiparas reported a higher use of formula while in the hospital, and breastfed for a shorter duration. The primary reasons for stopping breastfeeding were low milk supply, returned to work, and baby did not latch and nurse well. This study adds to the knowledge base of what practices influence rates and duration of breastfeeding in the first 6 months of a baby's life. The information could enhance the care provided to mothers and babies through improving lactation programs and thereby increasing breastfeeding success rates.

  3. Consumption of low-fat dairy foods for 6 months improves insulin resistance without adversely affecting lipids or bodyweight in healthy adults: a randomized free-living cross-over study

    PubMed Central

    2013-01-01

    Background Given the highly debated role of dairy food consumption in modulating biomarkers of metabolic syndrome, this study was conducted to examine the influence of long-term (6 month) dairy consumption on metabolic parameters in healthy volunteers under free-living conditions without energy restriction. Methods Twenty-three healthy subjects completed a randomized, crossover trial of 12 months. Participants consumed their habitual diets and were randomly assigned to one of two treatment groups: a high dairy supplemented group instructed to consume 4 servings of dairy per day (HD); or a low dairy supplemented group limited to no more than 2 servings of dairy per day (LD). Baseline, midpoint, and endpoint metabolic responses were examined. Results Endpoint measurements of body weight and composition, energy expenditure, blood pressure, blood glucose, and blood lipid and lipoprotein responses did not differ (p > 0.05) between the LD and HD groups. HD consumption improved (p < 0.05) plasma insulin (-9%) and insulin resistance (-11%, p = 0.03) as estimated by HOMA-IR compared with the LD group. Conclusions Study results suggest that high dairy consumption (4 servings/d) may improve insulin resistance without negatively impacting bodyweight or lipid status under free-living conditions. Trial registration Trial registration: NCT01761955 PMID:23638799

  4. [A phase II pharmacological study of leuprolide acetate 6-month depot, TAP-144-SR (6M), in treatment-Nazve patients with prostatic cancer who received a single subcutaneous or intramuscular injection].

    PubMed

    Komura, Emiko; Fujimoto, Tsukasa; Takabayashi, Nobuyoshi; Okamoto, Hiroyuki; Akaza, Hideyuki

    2014-05-01

    The aim of this phase II study was to evaluate the pharmacokinetics, pharmacodynamics, efficacy, and safety of a 6- month depot formulation of a luteinizing hormone-releasing hormone (LH-RH) agonist, TAP-144-SR (6M), in Japanese treatment-naÏve patients with prostatic cancer. Each subject received a single subcutaneous or intramuscular injection of TAP- 144-SR (6M) and was monitored for 24 weeks. The primary endpoint was the change in serum testosterone levels. The serum testosterone level in six subjects who received 22.5 mg of TAP-144 (SR) subcutaneously decreased below the castrate level after 4 weeks and remained suppressed during the 24 weeks of follow-up. With regard to safety, TAP-144-SR (6M)was not associated with any additional concerns compared to those reported for the approved 1-month and 3-month depot formulations of TAP-144-SR. In addition, 30 mg of TAP-144-SR (6M) was administered subcutaneously to six subjects, and, on the basis of the results, the optimal clinical dosage of TAP-144-SR (6M) in Japan was considered to be 22.5 mg. Outcomes with 22.5mg TAP-144-SR (6M) administered intramuscularly were similar to those with TAP-144-SR (6M) administered subcutaneously.

  5. Health Monitor Instrument 6 Months Post Deployment

    DTIC Science & Technology

    2004-06-01

    Wyer M, Morano R. Perception bias in cohort studies of environmental exposures: a major methodological problem. Abstract presented at the annual...measurement in cohort studies : the challenges of prospective data collection. Epidemiol Rev 1998, 20: 43-56. Wolfe J, Proctor, SP, Friedman MJ. Re: Is

  6. Effects of Diet on Early Stage Cortical Perception and Discrimination of Syllables Differing in Voice-Onset Time: A Longitudinal ERP Study in 3 and 6 Month Old Infants

    ERIC Educational Resources Information Center

    Pivik, R. T.; Andres, Aline; Badger, Thomas M.

    2012-01-01

    The influence of diet on cortical processing of syllables was examined at 3 and 6 months in 239 infants who were breastfed or fed milk or soy-based formula. Event-related potentials to syllables differing in voice-onset-time were recorded from placements overlying brain areas specialized for language processing. P1 component amplitude and latency…

  7. Efficacy of As-Needed Nalmefene in Alcohol-Dependent Patients with at Least a High Drinking Risk Level: Results from a Subgroup Analysis of Two Randomized Controlled 6-Month Studies

    PubMed Central

    van den Brink, Wim; Aubin, Henri-Jean; Bladström, Anna; Torup, Lars; Gual, Antoni; Mann, Karl

    2013-01-01

    Aims: The aim of the study was to investigate the efficacy and safety of as-needed use of nalmefene 18 mg versus placebo in reducing alcohol consumption in patients who did not reduce their alcohol consumption after an initial assessment, i.e. the pooled subgroup of patients with at least a high drinking risk level (men: >60 g/day; women: >40 g/day) at both screening and randomization from the two randomized controlled 6-month studies ESENSE 1 (NCT00811720) and ESENSE 2 (NCT00812461). Methods: Nalmefene 18 mg and placebo were taken on an as-needed basis. All the patients also received a motivational and adherence-enhancing intervention (BRENDA). The co-primary outcomes were number of heavy drinking days (HDDs) and mean total alcohol consumption (g/day) in Month 6 measured using the Timeline Follow-back method. Additionally, data on clinical improvement, liver function and safety were collected throughout the study. Results: The pooled population consisted of 667 patients: placebo n = 332; nalmefene n = 335. There was a superior effect of nalmefene compared with placebo in reducing the number of HDDs [treatment difference: −3.2 days (95% CI: −4.8; −1.6); P < 0.0001] and total alcohol consumption [treatment difference: −14.3 g/day (−20.8; −7.8); P < 0.0001] at Month 6. Improvements in clinical status and liver parameters were greater in the nalmefene group compared with the placebo group. Adverse events and adverse events leading to dropout were more common with nalmefene than placebo. Conclusion: As-needed nalmefene was efficacious in reducing alcohol consumption in patients with at least a high drinking risk level at both screening and randomization, and the effect in this subgroup was larger than in the total population. PMID:23873853

  8. Kept clinical visits, as scheduled in the first 6 months of antiretroviral treatment, determine long-term treatment outcomes in people living with HIV: a large retrospective cohort study in China.

    PubMed

    Su, Shu; Mao, Limin; He, Jianmei; Wei, Xiuqing; Jing, Jun; Chen, Xi; Zhang, Lei

    2017-09-14

    Background: Routine HIV clinical monitoring is vital for people living with HIV (PLHIV) after treatment initiation. The relationship between clinical visits during the first 6 months after initial antiretroviral therapy (ART) and long-term, HIV-related mortality and service retention was investigated. Methods: A retrospective ART observational research database was established based on de-identified data extracted from 6959 records of adult HIV-positive registrants held by Hunan CDC (Center for Disease Control and Prevention) between 2003 and 2013. Results: During the first 6 months of initiation into ART, 2364 (34.0%) of PLHIV had completed four scheduled visits, meeting the Chinese ART clinical monitoring standards. From 6 months onwards (up to 36 months), this group had the lowest HIV-related mortality (4.4%) compared with those who had more or less than four kept visits in the first 6 months [one visit only: adjusted hazards ratio (AHR)=3.15, 95% CI 2.24-3.88; two visits: AHR=2.24, 95% CI 1.80-3.01; three visits: AHR=1.86, 95% CI 1.69-2.05; and >4 visits: AHR=1.37, 95% CI 1.11-1.72]. Those with less than three kept visits were also at increased risk of cohort loss to follow up (ART discontinuation, prolonged service disengagement or death). A myriad of personal, clinical and social factors are identified to be associated with increased HIV-related mortality and clinical retention. Conclusions: Enabling PLHIV to complete four scheduled clinical visits during the first 6 months of ART initiation, as recommended by the Chinese CDC, is critical.

  9. Preliminary report: the effect of a 6-month dietary glycemic index manipulation in addition to healthy eating advice and weight loss on arterial compliance and 24-hour ambulatory blood pressure in men: a pilot study.

    PubMed

    Philippou, Elena; Bovill-Taylor, Candace; Rajkumar, Chakravarthi; Vampa, Maria Luisa; Ntatsaki, Eleana; Brynes, Audrey E; Hickson, Mary; Frost, Gary S

    2009-12-01

    We aimed to determine whether altering dietary glycemic index (GI) in addition to healthy eating and weight loss advice affects arterial compliance and 24-hour blood pressure (BP), both coronary heart disease (CHD) risk factors. Middle-aged men with at least 1 CHD risk were randomized to a 6-month low-GI (LGI) or high-GI (HGI) diet. All were advised on healthy eating and weight loss. They were seen monthly to assess dietary compliance and anthropometrics. Carotid-femoral pulse wave velocity (PWV), fasting blood lipid profile, and glucose and insulin concentrations were measured at baseline and at months 3 and 6. Six-hour postprandial glucose and insulin responses and 24-hour ambulatory BP were also assessed at baseline and month 6. Thirty-eight subjects (HGI group, n = 16; LGI group, n = 22) completed the study. At month 6, groups differed in dietary GI, glycemic load, and carbohydrate intake (P < .001). Fasting insulin concentration and insulin resistance (calculated by homeostatic model assessment) were lower in the LGI than the HGI group (P < .01). The reduction in total cholesterol and 24-hour BP was bigger in the LGI than the HGI group (P < .05); and only the LGI group had significant reductions (P < .05) in PWV, low-density lipoprotein cholesterol, and triacylglycerol concentration. There were no differences in postprandial glucose or insulin responses between the groups. The results suggest that an LGI diet may be more beneficial in reducing CHD risk, including PWV and 24-hour BP, even in the setting of healthy eating and weight loss; and thus, further study is warranted.

  10. Swashzone Fellowships: a 6-month research experience

    NASA Astrophysics Data System (ADS)

    Raubenheimer, B.

    2011-12-01

    The Swashzone Fellowships funded by the CAREER program were designed to provide sufficient time for undergraduates with little knowledge of ocean processes and minimal prior research experience to participate in observational nearshore oceanographic studies. The fellows learned background material, developed hypotheses, planned field experiments, designed sensor arrays, tested and debugged instrumentation, collected and analyzed data, and communicated the results through oral and written presentations. The program funded 12 undergraduate student fellows (4 male and 8 female), with backgrounds in math (3 students), physics (4), geology (1), and environmental sciences (4). Preference was given to applicants who had not taken oceanography classes and who were unsure of career plans. All the students presented their results at department seminars, and most presented their results at a professional conference (eg, AGU or Ocean Sciences). The results often were incorporated in peer-reviewed manuscripts. Evaluations conducted following the fellowships and again several years after each fellowship indicated that many of the students pursued STEM careers: 5 are pursuing PhD degrees, including bio-mathematics, physics, atmospheric physics, and ocean physics; 2 are employed at environmental engineering and consulting firms; 4 are employed as research technicians at WHOI; and 1 is a lawyer (currently being considered as a clerk for the Supreme Court). Many of the students were excited to learn about the range of oceanographic career options, including engineering and technical staff, as well as science research. The graduating seniors expressed their appreciation for the fellowship opportunity, stating that there were few science positions available to students without significant prior research experience. Several students noted that the fellowships were critical to their later employment and to their decisions to pursue careers in science. In particular, the students noted

  11. Biochemical markers of cartilage metabolism are associated with walking biomechanics 6-months following anterior cruciate ligament reconstruction.

    PubMed

    Pietrosimone, Brian; Loeser, Richard F; Blackburn, J Troy; Padua, Darin A; Harkey, Matthew S; Stanley, Laura E; Luc-Harkey, Brittney A; Ulici, Veronica; Marshall, Stephen W; Jordan, Joanne M; Spang, Jeffery T

    2017-02-02

    The purpose of our study was to determine the association between biomechanical outcomes of walking gait (peak vertical ground reaction force [vGRF], vGRF loading rate [vGRF-LR], and knee adduction moment [KAM]) 6 months following anterior cruciate ligament reconstruction (ACLR) and biochemical markers of serum type-II collagen turnover (collagen type-II cleavage product to collagen type-II C-propeptide [C2C:CPII]), plasma degenerative enzymes (matrix metalloproteinase-3 [MMP-3]), and a pro-inflammatory cytokine (interleukin-6 [IL-6]). Biochemical markers were evaluated within the first 2 weeks (6.5 ± 3.8 days) following ACL injury and again 6 months following ACLR in eighteen participants. All peak biomechanical outcomes were extracted from the first 50% of the stance phase of walking gait during a 6-month follow-up exam. Limb symmetry indices (LSI) were used to normalize the biomechanical outcomes in the ACLR limb to that of the contralateral limb (ACLR/contralateral). Bivariate correlations were used to assess associations between biomechanical and biochemical outcomes. Greater plasma MMP-3 concentrations after ACL injury and at the 6-month follow-up exam were associated with lesser KAM LSI. Lesser KAM was associated with greater plasma IL-6 at the 6-month follow-up exam. Similarly, lesser vGRF-LR LSI was associated with greater plasma MMP-3 concentrations at the 6-month follow-up exam. Lesser peak vGRF LSI was associated with higher C2C:CPII after ACL injury, yet this association was not significant after accounting for walking speed. Therefore, lesser biomechanical loading in the ACLR limb, compared to the contralateral limb, 6 months following ACLR may be related to deleterious joint tissue metabolism that could influence future cartilage breakdown. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

  12. A 6-month analysis of training-intensity distribution and physiological adaptation in Ironman triathletes.

    PubMed

    Neal, Craig M; Hunter, Angus M; Galloway, Stuart D R

    2011-11-01

    In the present study, we analysed the training-intensity distribution and physiological adaptations over a 6-month period preceding an Ironman triathlon race. Ten athletes (mean ± s: age 43 ± 3 years, mass 78.3 ± 10.3 kg, stature 1.79 ± 0.05 m) participated in the study. The study consisted of three training periods (A, B, C), each of approximately 2 months' duration, and four testing weeks. Testing consisted of incremental tests to exhaustion for swimming, cycling and running, and assessments for anthropometry plus cardiovascular and pulmonary measures. The lactate threshold and the lactate turnpoint were used to demarcate three discipline-specific, exercise-intensity zones. The mean percentage of time spent in zones 1, 2, and 3 was 69 ± 9%, 25 ± 8%, and 6 ± 2% for periods A-C combined. Only modest physiological adaptation occurred throughout the 6-month period, with small to moderate effect sizes at best. Relationships between the training volume/training load and the training-intensity distribution with the changes in key measures of adaptation were weak and probably reflect differences in initial training status. Our results suggest that the effects of intensity distribution are small over short-term training periods and future experimental research is needed to clarify the potential impact of intensity distribution on physiological adaptation.

  13. Breastfeeding at 6 months and effects on infections.

    PubMed

    Chye, J K; Lim, C T

    1998-12-01

    To examine the pattern of and the influence of some socio-demographic factors on infant milk feedings, and the protective role of breastfeeding against infections. Mothers who breastfed their infants (exclusively or partially) at 6 weeks postpartum, and who had singleton pregnancies and healthy infants at birth, were interviewed when their infants had reached 6 months of age. Of the 234 mothers studied, only 31 (13%) mothers were practising exclusive breastfeeding (EBF) and 133 (57%) mothers were using exclusive infant formula feeding (EIF). Solid and semi-solid foods were introduced between 4 to 6 months of life in 89% of the infants. On logistic regression analysis, mothers who were in paid employment [OR 0.25, 95% CI 0.15, 0.42] and not breast feeding at 6 weeks [OR 0.32, 95% CI 0.19, 0.54] had decreased odds of EBF. Antenatal plans to breastfeed, breast-feeding difficulties, ethnicity, level of parental education, parental ages, fathers' income, primigravida status and infants' gender were not significant co-variates. In comparison, EIF was more likely in mothers who worked, practised mixed feedings at 6 weeks and of Chinese descent. There were no significant differences in the rates of upper respiratory tract infections (URTI) or diarrhoeal illnesses between the infants who were or were not being breast-fed. Most mothers were unable to breastfeed their infants exclusively in the recommended first 4 to 6 months of life. Complementary changes outside the hospital and maternity services are essential in improving breastfeeding rates. Breastfeeding does not appear to confer significant protection to either URTI or gastrointestinal tract infections.

  14. Adherence to controller asthma medications: 6-month prevalence across a US community pharmacy chain.

    PubMed

    Feehan, M; Ranker, L; Durante, R; Cooper, D K; Jones, G J; Young, D C; Munger, M A

    2015-08-20

    Non-adherence to controller asthma medications is an important public health problem. It is estimated to occur in 30-70% of individuals and is a significant risk factor for asthma morbidity and mortality. The aim of this study was to determine the level of adherence, as indicated by refill rates, to controller asthma medications in a community pharmacy setting. Secondary analyses of a community pharmacy dispensing database in 15 locations throughout Utah. The dispensing records of 2193 patients who received controller medications for asthma in a 12-month period, and had a minimum of 6-month potential coverage (180 days) from the date of their first receipt of a controller medication in that period, were examined. Using standard metrics to gauge adherence, the proportion of days covered (PDC) and the medication possession ratio (MPR), the average coverage for controller asthma medications across a 6-month period (180 days) was poor, averaging less than 50% of days' availability. Standard cut-offs (≥80% medication availability) indicated that only 14-16% of patients had 'satisfactory' adherence over their 6-month follow-on period. Females and older patients had significantly greater satisfactory adherence. Medication adherence was significantly greater with inhaled corticosteroid (ICS)-long-acting β2 -agonist (LABA) combinations than with ICS alone. This study confirms the considerable scope of the asthma therapy non-adherence problem. Therefore, it is imperative to conduct survey-based research linked directly to pharmacy-based dispensing data to derive patient behavioural, attitudinal and environmental factors that may contribute to the issue, and then pilot and evaluate interventions for change. © 2015 John Wiley & Sons Ltd.

  15. Taking Orlistat: Predicting Weight Loss over 6 Months.

    PubMed

    Hollywood, Amelia; Ogden, Jane

    2011-01-01

    This study explored the predictors of weight loss following orlistat with a focus on both baseline variables and changes in beliefs and behaviours occurring over the course of taking the drug. Patients (n = 566) prescribed orlistat completed a questionnaire at baseline and after 6 months concerning their weight, beliefs and behaviours. By 6 months the majority had lost some weight and showed improvements in diet. Many had also stopped taking the drug and a large minority reported using it flexibly as a lifestyle drug. Those who lost most weight showed a decrease in beliefs in a medical solution, a decrease in unhealthy eating, an increased belief in treatment control and an increased belief that the unpleasant consequences are both due to their eating behaviour and just part of the drug. When taken with fatty food orlistat causes symptoms such as anal leakage and oily stools. These may encourage some patients to focus on the behavioural aspects of their weight problem thus promoting the dietary changes needed for both short and longer term weight loss. When prescribing orlistat, clinicians should encourage patients to see the consequences as an education as a means to promote the effectiveness of this form of medical management.

  16. Edema index-guided disease management improves 6-month outcomes of patients with acute heart failure.

    PubMed

    Liu, Min-Hui; Wang, Chao-Hung; Huang, Yu-Yen; Tung, Tao-Hsin; Lee, Chii-Ming; Yang, Ning-I; Wang, Jong-Shyan; Kuo, Li-Tang; Cherng, Wen-Jin

    2012-01-01

    The efficacy of heart failure (HF) management programs is compromised by the challenge of early identification of patients at imminent risk. Segmental multifrequency bioelectrical impedance analysis can generate an "edema index" (EI) as a surrogate for the body fluid status. In this study, we tested whether integration of EI-guided management improved the 6-month outcomes of HF patients under multidisciplinary care. In total, 159 patients with acute HF were randomized into control, case management (CM), and EI-guided CM (EI) groups (n = 53 in each group). In the EI group, a management algorithm was designed based on the measured EI. The analyzed endpoints included HF-related and all cause-related events during the 6-month follow-up period. In the 6 months, there were 11 (6.9%) deaths, 19 (11.9%) HF-related rehospitalizations, and 45 (28.3%) all-cause-related rehospitalizations. Compared to the control (26.4%) and CM groups (15.1%), the EI group had a lower rate of HF-related death and rehospitalization (3.8%, P = 0.004). Multivariate analysis revealed that EI-guided management was an independent predictor of a lower HF-related event rate (hazard ratio = 0.15, 95%CI = 0.03~0.66, P = 0.012). Patients with a higher pre-discharge EI were older, had lower blood albumin and hemoglobin levels, and had a higher functional class and incidences of diabetes mellitus and chronic kidney disease. An increase in the pre-discharge EI by 0.001 increased the HF-related event rate by 6% (P = 0.002). Use of EI-guided management lowered this risk (P = 0.03). In conclusion, an EI-based HF management program demonstrated an event-lowering effect superior to traditional nurse-led multidisciplinary care in 6 months after an acute HF episode.

  17. Impact of medical consultation frequency on risk factors and medications 6 months after acute coronary syndrome.

    PubMed

    Hyun, Karice; Brieger, David; Chow, Clara K; Ilton, Marcus; Amos, David; Alford, Kevin; Roberts-Thomson, Philip; Santo, Karla; Atkins, Emily R; Redfern, Julie

    2016-01-28

    Initiatives that support primary care to better enable delivery of optimal prevention services are of great importance. The purpose of this study was to examine the frequency of medical consultations by patients with acute coronary syndrome (ACS) in the 6 months after hospital discharge and to determine whether the frequency of visits was associated with differences in lifestyle, clinical measures and medication prescription. We conducted a retrospective subgroup analysis of data collected in the Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events (CONCORDANCE), which is an ongoing (prospective) clinical initiative providing continuous real-time reporting on the clinical characteristics, management and outcomes of patients admitted to Australian hospitals with ACS. We compared clinical measures, medications, smoking status and receipt of cardiac rehabilitation with frequency of medical consultations 6 months after hospital discharge. Patients with ACS visited their general practitioner (GP) a mean of 4.4 (± 3.8) times and their cardiologist 1.2 (± 0.9) times in the 6-month period after their index admission. Patients who saw a GP in the 6-month period had significantly higher rates of participation in cardiac rehabilitation, receipt of dietary advice and prescription of cardioprotective medications. Factors associated with increased frequency of GP visits were older age groups (oldest fourth vs youngest fourth incidence rate ratio (IRR) 1.08; 95% CI 1.01, 1.14), being female (male vs female IRR 0.83; 95% CI 0.80, 0.86), diagnosis of ST-segment elevation myocardial infarction (STEMI) (STEMI vs non-STEMI IRR 1.08; 95% CI 1.04, 1.13; STEMI vs unstable angina IRR 1.01; 95% CI 0.95, 1.06), being a current smoker (IRR 1.09; 95% CI 1.05, 1.15), history of cardiovascular disease (IRR 1.06; 95% CI 1.01, 1.12), history of diabetes (IRR 1.25; 95% CI 1.21, 1.31), inpatient revascularisation (IRR 0.95; 95% CI 0.91, 0.99), receipt of

  18. FCGR2A/CD32A and FCGR3A/CD16A variants and EULAR response to tumor necrosis factor-α blockers in psoriatic arthritis: a longitudinal study with 6 months of followup.

    PubMed

    Ramírez, Julio; Fernández-Sueiro, José Luis; López-Mejías, Raquel; Montilla, Carlos; Arias, Maite; Moll, Concepción; Alsina, Mercé; Sanmarti, Raimon; Lozano, Francisco; Cañete, Juan D

    2012-05-01

    The efficacy of antibody-based biological therapies currently used in psoriatic arthritis (PsA) depends not only on their blocking effect on the targeted molecule but also on their binding affinity to genetically defined variants of cell-surface Fc-γ receptors. Our objective was to assess the potential influence of functionally relevant FCGR2A/CD32A (H131R) and FCGR3A/CD16A (V158F) genetic polymorphisms on the EULAR response to tumor necrosis factor-α (TNF-α) blocker therapy in PsA. In total 103 patients with PsA starting anti-TNF-α therapy were included. The efficacy of therapy was evaluated according to EULAR response criteria at 3 and 6 months. FCGR2A-R131H and FCGR3A-F158V polymorphisms were genotyped. Potential correlations between clinical response and the FCGR2A-R131H and FCGR3A-F158V polymorphisms were evaluated. EULAR response (moderate plus good) was 85.4% at 3 months and 87.4% at 6 months, while good EULAR response was 61.2% and 62.1%, respectively. More patients with high-affinity FCGR2A genotypes (homozygous or heterozygous combinations) achieved a EULAR response at 6 months compared to patients with the low-affinity genotype (RR; p = 0.034, adjusted comparison error rate < 0.025). This association was due mainly to the group of patients treated with etanercept. No correlation was found for the FCGR3A polymorphism. Similarly, no effect of C-reactive protein levels was observed. Our data indicate that FCGR2A polymorphism may influence the response to TNF-α blockers (namely etanercept) in PsA in a direction opposite to that previously found in patients with rheumatoid arthritis.

  19. Data analysis of 87 tic patients for 6 months' treatment in a Korean medicine clinic.

    PubMed

    Chun, Young-Ho; Kim, Won-Ill; Kim, Bo-Kyung

    2013-10-01

    This study was carried out to investigate the relationship between the therapeutic effects of treatment for tic disorder and Korean medicine clinical tests, including body mass index (BMI) and heart variability rate (HRV). This study was not a clinical trial, but a data analysis of 87 tic patients who were treated for 6 months during the time period from Nov. 2010 to Jan. 2012. The clinical evaluation of the symptoms was recorded using the Korean version of the Yale Global Tic Severity Scale (YGTSS). The BMI and the HRV were measured according to a schedule, and various kinds of statistical methods were used. Among the 87 patients, the number of males was 3.34 times the number of females, and 58 patients (66.7%) had been suffering for more than 12 months. The onset age of the males was significantly lower than that of the females, and males had the symptoms longer than females had. Also, males with a family history of tics were 2.5 times as many as females, and their onset ages were substantially lower. At the first medical examinations, the average score on the YGTSS was 34.08, and it decreased linearly as the treatment progressed. After 4 and 6 months of treatment, it had decreased significantly. The YGTSS score and the period of suffering correlated positively. At the first visit, each HRV datum was in the normal range. After the 6 months' treatment, Ln (TP), Ln (LF), and Ln (HF) had dropped substantially in the normal range while Ln (VLF) and the LF/HF ratio had not changed in a meaningful way. During the treatment period, the BMI stayed relatively constant without any meaningful changes.

  20. A 6-month follow-up study of posttraumatic stress and anxiety/depressive symptoms in Korean children after direct or indirect exposure to a single incident of trauma.

    PubMed

    Kim, Boong-Nyun; Kim, Jae-Won; Kim, Hyo-Won; Shin, Min-Sup; Cho, Soo-Churl; Choi, Nam Hee; Ahn, Hyunnie; Lee, Seung-Yeon; Ryu, Jeong; Yun, Myoung-Joo

    2009-08-01

    The aims of this study were to examine the symptoms of posttraumatic stress and anxiety/depression in Korean children after direct or indirect exposure to a single incident of trauma during a fire-escape drill and to assess the incidence of psychiatric disorders in this population. A total of 1,394 students who attended the elementary school at which the traumatic event took place were evaluated using self-administered questionnaires (the Child Posttraumatic Stress Disorder-Reaction Index [CPTSD-RI], State Anxiety Scale of the State-Trait Anxiety Inventory for Children [STAIC], and Children's Depression Inventory [CDI]), as well as structured diagnostic interviews (Diagnostic Interview Schedule for Children, Version-IV [DISC-IV]) at 2 days (time point 1), 2 months (time point 2), and 6 months (time point 3) after the incident. The 335 students who witnessed the accident were defined as the direct-exposure group, and the remaining students (n = 1,059) were defined as the indirect-exposure group. The study was conducted from May to November 2007. At time point 1, the prevalence of severe posttraumatic stress disorder (PTSD), anxiety, and depressive symptoms was 18.2%, 5.5%, and 3.4%, respectively. The prevalence of severe PTSD symptoms, as measured by the CPTSD-RI, was significantly higher in the direct-exposure group than in the indirect-exposure group (36.6% vs 12.7%, respectively; P < .001). At time point 2, the prevalence of severe PTSD symptoms was 7.4% (14.0% in the direct-exposure group and 4.9% in the indirect-exposure group, P < .001). The mean total CPTSD-RI score was significantly higher (P < .001) in the direct-exposure group than in the indirect-exposure group. At time point 3, thirty-eight of the 58 subjects (65.5%) evaluated with the DISC-IV in the direct-exposure group had 1 or more of the 7 anxiety/depressive disorders assessed, including subthreshold diagnoses. Among the diagnoses meeting full DSM-IV criteria for each disorder, agoraphobia was the

  1. Caudal vs transforaminal epidural steroid injections as short-term (6 months) pain relief in lumbar spinal stenosis patients with sciatica.

    PubMed

    Ploumis, Avraam; Christodoulou, Pavlos; Wood, Kirkham B; Varvarousis, Dimitrios; Sarni, James L; Beris, Alexander

    2014-03-01

    The aim of this study is to evaluate prospectively the efficacy of caudal epidural steroid injection (CESI) and transforaminal epidural steroid injection (TFESI) in lumbar spinal stenosis patients with sciatic pain. Prospective clinical study. Thirty-one patients (average age 62 years) from two hospitals, with single dermotomal distribution of sciatic pain due to spinal stenosis were included in the study. Patients underwent epidural steroid injections done by the same injectionist. Eleven patients from one hospital were included in the CESI group, while the TFESI group consisted of 20 comparable patients from the second site. Primary outcome measure was the complete relief or at least 50% reduction of pain (visual analog scale [VAS]) at 6 months postinjection. Secondary outcome measures were the improvement of function (of at least 15 points of Oswestry Disability Index [ODI]) at 6 months and the changes of VAS and ODI and at 2 weeks, at 3 months, and at 6 months postinjection. A significantly greater number of stenosis patients showed pain relief at 6 months postinjection with TFSI (90%) than with CESI (54.54%). All patients with TFSI showed improvement of function at 6 months while only three (27.27%) patients with caudal epidural improved functionally. Out of the total 31 patients, two patients from group A underwent a second CESI at 15 days postinjection and decompressive spine surgery between 3 and 6 months postinjection. The effectiveness of transforaminal steroid injection for the stenosis patients with sciatica was superior to caudal at 6 months postinjection. Wiley Periodicals, Inc.

  2. Atypical antipsychotic drug treatment for 6 months restores N-acetylaspartate in left prefrontal cortex and left thalamus of first-episode patients with early onset schizophrenia: A magnetic resonance spectroscopy study.

    PubMed

    Gan, Jing-Li; Cheng, Zheng-Xiang; Duan, Hui-Feng; Yang, Jia-Ming; Zhu, Xi-Quan; Gao, Cun-You

    2014-07-30

    Early onset schizophrenia (EOS) is often associated with poorer outcomes, including lack of school education, higher risk of mental disability and resistance to treatment. But the knowledge of the neurobiological mechanism of EOS is limited. Here, using proton magnetic resonance spectroscopy, we investigated the possible neurochemical abnormalities in prefrontal cortex (PFC) and thalamus of first-episode drug-naïve patients with EOS, and followed up the effects of atypical antipsychotic treatment for 6 months on neurochemical metabolites and clinical symptoms. We measured the ratios of N-acetylaspartate (NAA), choline (Cho) to creatine (Cr) in 41 adolescents with first episode of EOS and in 28 healthy controls matched for age, gender, and years of education. The EOS patients presented with abnormally low NAA/Cr values in the left PFC and left thalamus with a reduced tendency in the right PFC compared with healthy controls. No significant differences were detected between groups for Cho/Cr in PFC and thalamus in any hemisphere. After atypical antipsychotic treatment for 6 months, the reduced NAA/Cr in the left PFC and left thalamus in EOS patients was elevated to the normal level in healthy controls, without any alteration in Cho/Cr. We also found that there was no significant correlation between the neurochemical metabolite ratios in the PFC and thalamus in patients with EOS, and clinical characteristics. Our results suggest that there was neurochemical metabolite abnormalities in PFC and thalamus in EOS patients, atypical antipsychotic treatment can effectively relieve the symptoms and restore the reduced NAA in PFC and thalamus.

  3. Feeding patterns and diet -- children 6 months to 2 years

    MedlinePlus

    ... patterns and diet - children 6 months to 2 years To use the sharing features on this page, ... Clinical Assistant Professor of Pediatrics, University of Washington School of Medicine, Seattle, WA. Also reviewed by David ...

  4. In Vivo Remodeling of Fibroblast-Derived Vascular Scaffolds Implanted for 6 Months in Rats

    PubMed Central

    Tondreau, Maxime Y.; Laterreur, Véronique; Vallières, Karine; Gauvin, Robert; Bourget, Jean-Michel; Tremblay, Catherine; Lacroix, Dan; Germain, Lucie; Ruel, Jean

    2016-01-01

    There is a clinical need for tissue-engineered small-diameter (<6 mm) vascular grafts since clinical applications are halted by the limited suitability of autologous or synthetic grafts. This study uses the self-assembly approach to produce a fibroblast-derived decellularized vascular scaffold (FDVS) that can be available off-the-shelf. Briefly, extracellular matrix scaffolds were produced using human dermal fibroblasts sheets rolled around a mandrel, maintained in culture to allow for the formation of cohesive and three-dimensional tubular constructs, and decellularized by immersion in deionized water. The FDVSs were implanted as an aortic interpositional graft in six Sprague-Dawley rats for 6 months. Five out of the six implants were still patent 6 months after the surgery. Histological analysis showed the infiltration of cells on both abluminal and luminal sides, and immunofluorescence analysis suggested the formation of neomedia comprised of smooth muscle cells and lined underneath with an endothelium. Furthermore, to verify the feasibility of producing tissue-engineered blood vessels of clinically relevant length and diameter, scaffolds with a 4.6 mm inner diameter and 17 cm in length were fabricated with success and stored for an extended period of time, while maintaining suitable properties following the storage period. This novel demonstration of the potential of the FDVS could accelerate the clinical availability of tissue-engineered blood vessels and warrants further preclinical studies. PMID:27999795

  5. Comparative clinical evaluation of combination anorganic bovine-derived hydroxyapatite matrix (ABM)/cell binding peptide (P-15) and open flap debridement (DEBR) in human periodontal osseous defects: a 6 month pilot study.

    PubMed

    Radhakrishnan, Sujatha; Anusuya, C N

    2004-07-01

    A synthetic cell binding peptide (P-15) combined with anorganic bovine-derived hydroxyapatite bone matrix (ABM) was compared to open flap debridement (DEBR) in human periodontal osseous defects. Following initial preparation procedures, two osseous defects per patient were treated randomly with one of the two procedures after surgical preparation. Appropriate periodontal maintenance schedules were followed, and at 6 months clinical and radiographic assessments for soft tissue and hard tissue were performed for documentation and finalization of treatment. Statistical analysis using Student's paired t-test analyses of patient mean value from 10 patients revealed that the combination ABM/P-15 grafts demonstrated significantly better mean defect fill of 3.4+/-1.7 mm (73.2%) versus a mean defect fill of 0.6 mm (15.8%) for defects treated with DEBR. Soft tissue findings showed significant differences among treatments with ABM/P-15 compared to DEBR. These results suggest that the use of the P-15 synthetic cell-binding peptide combined with ABM yields better clinical results than DEBR.

  6. AGE AND GENDER DIFFERENCES AND FACTORS RELATED TO CHANGE IN HEALTH-RELATED QUALITY OF LIFE FROM BEFORE TO 6 MONTHS AFTER LVAD IMPLANTATION: FINDINGS FROM INTERMACS

    PubMed Central

    Grady, Kathleen L.; Wissman, Sherri; Naftel, David C.; Myers, Susan; Gelijins, Annetine; Moskowitz, Alan; Pagani, Francis D.; Young, James B.; Spertus, John A.; Kirklin, James K.

    2016-01-01

    Background Gaps in the literature exist regarding health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) surgery. The purposes of our study were to describe HRQOL over time, by age and gender, and identify risk factors for poor HRQOL early after LVAD implant. Methods Patients (n=7,353) from INTERMACS received a continuous flow LVAD as a primary implant at 133 U.S. hospitals. Of these, 5,640 patients had pre LVAD HRQOL data, and 3,353 patients had 6 month post LVAD HRQOL data. There were 2,748 patients with data at both time periods. HRQOL was measured using the EQ-5D-3L instrument. Data were collected pre-implant and 3 and 6 months post-operatively. Statistical analyses included chi square, t-tests, Pearson correlation coefficients, and multiple regression. Results Overall HRQOL and dimensions of HRQOL improved from before to 6 months after device implant when examined by age and gender. However, younger patients and women reported significantly more problems regarding all dimensions before implant and significantly more problems regarding pain/discomfort and anxiety/depression at both 3 and 6 months after implant. An increase in overall HRQOL from before to 6 months after implant was related to pre implant INTERMACS level 1. Factors related to a decrease in HRQOL from before to 6 months after implant were listed for heart transplant before surgery, co-morbidities, better preoperative HRQOL, adverse events within 6 months after implant, and bridge to transplant moderately likely and unlikely, and NYHA class 4 at 6 months post LVAD (R2=41%). Conclusions Overall HRQOL and dimensions of HRQOL improve in subgroups of patients from before to 6 months after surgery, although differences in improvement exist. Adverse events are risk factors for decreased HRQOL across time and support the ongoing need to improve device technology with the aim of reducing adverse events. PMID:27068037

  7. Continuation of copper-containing intrauterine devices at 6 months.

    PubMed

    Garbers, Samantha; Haines-Stephan, Jessica; Lipton, Yael; Meserve, Allison; Spieler, Leah; Chiasson, Mary Ann

    2013-01-01

    Intrauterine devices (IUDs) are highly effective at preventing pregnancy and cost-effective. Suboptimal continuation of IUDs places women at risk of unintended pregnancy. Little is known about prevalence or predictors of discontinuation of IUDs within the first 6 months. A retrospective cohort analysis was conducted among 306 family planning patients who had a CuT380A IUD inserted from November 2008-August 2011. Rates of continuation among 283 users were calculated using survival analyses, and predictors of removal within 6 months of insertion were assessed using logistic regression. Among 306 IUD insertions, 13 (4.2%) full or partial expulsions occurred within the first 6 months: 9 (10.7%) among nulliparous and 4 (2.0%) among parous women (chi-square, p<.001). In the first 6 months, four (1.3%) pregnancies occurred among women without prior removal or expulsion of the device (unadjusted Pearl Index: 2.61 per 100 woman-years at 6 months), all among parous women. Of 283 women in continuation analyses, 26% were under 20 years old and 29% nulliparous. Most (84%) received health education specific to IUDs before insertion. Overall, 11% had their IUD removed within 6 months of insertion. In an adjusted logistic regression model, women who did not receive health education were significantly more likely (Adjusted Odds Ratio=3.37, 95% confidence interval: 1.35-8.39) to have a removal within 6 months, but no significant association was found for age, race/ethnicity or parity. Early discontinuation of IUDs was prevalent but lower among women who received method-specific health education. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. The effect of double-coating and times on the immediate and 6-month dentin bonding of universal adhesives.

    PubMed

    Pashaev, Diial; Demirci, Mustafa; Tekçe, Neslihan; Tuncer, Safa; Baydemir, Canan

    2017-01-01

    The purpose of this study was to evaluate the effect of double-application coats and times on microtensile bond strength (μTBS) and adhesive-dentin interfaces created by dentin adhesive systems after 6 months of storage in water. Two-hundred sixteen extracted non-carious human third molars were selected for the study. Single-Bond Universal (SU) and All-Bond Universal (AU), Adper Easy One (Eo) Self-Etch adhesive and Adper Single-Bond 2 (Sb) etch-and-rinse adhesive were applied to a flat dentin surface using three methods (1): dentin adhesives were applied as recommended by the manufacturers; (2): two consecutive coats of dentin adhesives were applied before photo-polymerization; and (3): a single coat of adhesive was applied but with twice the manufacturers recommended application time. Microtensile bond strength was determined either immediately or after 6 months of water storage. Data were analyzed using one-way analysis of variance and Tukey's post-hoc tests. At 24 h, groups 1, 2, and 3 exhibited statistically similar results for all dentin adhesive systems. For AU-Er, group 3 showed significantly higher bond strength than all group of AU-Se after 6 months. Universal adhesives seemed more stable against water degradation than traditional two-step etch-and-rinse and all-in-one systems within the 6-month period.

  9. Bone height measurements around a dental implant after a 6-month space flight: a case report.

    PubMed

    Haigneré, Claire; Jonas, Pierre; Khayat, Philippe; Girot, Gérard

    2006-01-01

    In space, astronauts are subject to microgravity, which reduces skeletal loading and osteoblast function and can cause bone resorption and a decrease in bone density. No known research to date has studied the effect of microgravity on dental implants. This study evaluated peri-implant bone changes around a dental implant placed in a French astronaut who spent 6 months in Russia's Mir Space Station. Measurements were performed by 2 examiners before the flight (baseline), after the flight (stage 1), and following a recovery period (stage 2). Standardized periapical radiographs were taken, and data were recorded using a photomicroscope and a measuring scale. Cumulatively, the implant sustained 0.43 mm of mesial bone gain and 0.31 mm of distal bone loss. The observed peri-implant bone height changes were within normal limits and the implant appeared very stable during the course of this study. Peri-implant bone levels remained stable after 6 months in microgravity, and the implant continued to function without complications.

  10. Effects of 6 months of aging in water on hardness and surface roughness of two microhybrid dental composites.

    PubMed

    de Moraes, Rafael Ratto; Marimon, José Laurindo Machado; Schneider, Luis Felipe; Sinhoreti, Mário Alexandre Coelho; Correr-Sobrinho, Lourenço; Bueno, Márcia

    2008-06-01

    This study assessed the effect of 6 months of aging in water on surface roughness and surface/subsurface hardness of two microhybrid resin composites. Filtek Z250 and Charisma were tested. Cylindrical specimens were obtained and stored in distilled water for 24 hours or 6 months, at 37 degrees C. For Knoop hardness evaluation, the specimens were transversely wet-flattened, and indentations were made on surface and subsurface layers. Data were submitted to three-way ANOVA and Tukey's test (alpha < or = 0.05). Surface roughness baseline measurements were made at 24 hours and repeated after 6 months of storage. Data were submitted to repeated measures ANOVA and Tukey's test (alpha < or = 0.05). Surface hardness (KHN, kg/mm(2)) means (+/- standard deviation) ranged from 55 +/- 1 to 49 +/- 4 for Z250 and from 50 +/- 2 to 41 +/- 3 for Charisma, at 24 hours and 6 months, respectively. Subsurface means ranged from 58 +/- 2 to 61 +/- 3 for Z250 and from 50 +/- 1 to 54 +/- 2 for Charisma, at 24 hours and 6 months. For both composites, the aged specimens presented significantly softer surfaces (p < 0.01). For the subsurface hardness, alteration after storage was detected only for Charisma, which presented a significant rise in hardness (p < 0.01). Z250 presented significantly harder surface and subsurface layers in comparison with Charisma. Surface roughness (Ra, mum) means ranged from 0.07 +/- 0.00 to 0.07 +/- 0.01 for Z250 and from 0.06 +/- 0.01 to 0.07 +/- 0.01 for Charisma, at 24 hours and 6 months, respectively. For both composites, no significant roughness alteration was detected during the study (p= 0.386). The 6-month period of storage in water presented a significant softening effect on the surfaces of the composites, although no significant deleterious alteration was detected for the subsurface hardness. In addition, the storage period had no significant effect on the surface roughness of the materials.

  11. Unexpectedly high early prevalence of anaemia in 6-month-old breast-fed infants in rural Bangladesh.

    PubMed

    Shakur, Yaseer A; Choudhury, Nuzhat; Hyder, S M Ziauddin; Zlotkin, Stanley H

    2010-01-01

    To determine the prevalence of anaemia and maternal and infant factors associated with Hb values in infants at 6 months of age in rural Bangladesh. Infants (born to mothers supplemented with Fe-folic acid from mid-pregnancy) were visited at birth and 6 months of age. Mothers' anthropometric status, and infants' birth weight, gestational age at birth, weight and Hb concentration at 6 months were measured. Household socio-economic and demographic data, infant feeding practices and health status were collected using a pre-tested structured questionnaire. Rural Bangladesh. Four hundred and two infants. For the total cohort (n 402), the range of anaemia prevalence values was from 30.6 % using a cut-off value of Hb < 95 g/l to 71.9 % using a value of Hb < 110 g/l. Birth weight and month of birth were the only factors positively associated with infant Hb in a linear regression model (P = 0.008 and 0.011, respectively). There was an unexpectedly high prevalence of anaemia in infants at 6 months of age, before the assumed period of vulnerability. Hb at this age tended to be higher in those with higher birth weight. We also found a season effect on Hb, as it tended to be higher as the study progressed. The high prevalence of anaemia at such an early age needs to be addressed to minimize the disease's long-term consequences.

  12. Reliability of gait in multiple sclerosis over 6 months.

    PubMed

    Sosnoff, Jacob J; Klaren, Rachel E; Pilutti, Lara A; Dlugonski, Deirdre; Motl, Robert W

    2015-03-01

    Gait impairment is ubiquitous in multiple sclerosis (MS) and is often characterized by alterations in spatiotemporal parameters of gait. There is limited information concerning reliability of spatiotemporal gait parameters over clinical timescales (e.g. 6 months). The current report provides novel evidence that gait parameters of 74 ambulatory persons with MS with mild-to-moderate disability are reliable over 6-months (ICC's for overall sample range from 0.56 to 0.91) in the absence of any intervention above and beyond standard care. Such data can inform clinical decision-making and power analyses for designing RCTs (i.e., sample size estimates) involving persons with MS.

  13. Increases in kidney volume in autosomal dominant polycystic kidney disease can be detected within 6 months.

    PubMed

    Kistler, Andreas D; Poster, Diane; Krauer, Fabienne; Weishaupt, Dominik; Raina, Shagun; Senn, Oliver; Binet, Isabelle; Spanaus, Katharina; Wüthrich, Rudolf P; Serra, Andreas L

    2009-01-01

    Kidney volume growth is considered the best surrogate marker predicting the decline of renal function in autosomal dominant polycystic kidney disease. To assess the therapeutic benefit of new drugs more rapidly, changes in kidney volume need to be determined over a short time interval. Here we measured renal volume changes by manual segmentation volumetry applied to magnetic resonance imaging scans obtained with an optimized T1-weighted acquisition protocol without gadolinium-based contrast agents. One hundred young patients with autosomal dominant polycystic kidney disease and preserved renal function had a significant increase in total kidney volume by 2.71+/-4.82% in 6 months. Volume measurements were highly reproducible and accurate, as indicated by correlation coefficients of 1.000 for intra-observer and 0.996 for inter-observer agreement, with acceptable within-subject standard deviations. The change in renal volume correlated with baseline total kidney volume in all age subgroups. Total kidney volume positively correlated with male gender, hypertension, albuminuria and a history of macrohematuria but negatively with creatinine clearance. Albuminuria was associated with accelerated volume progression. Our study shows that increases in kidney volume can be reliably measured over a 6 month period in early autosomal dominant polycystic kidney disease using unenhanced magnetic resonance imaging sequences.

  14. Large Number Discrimination in 6-Month-Old Infants.

    ERIC Educational Resources Information Center

    Xu, Fei; Spelke, Elizabeth S.

    2000-01-01

    Two experiments examined 6-month-olds' ability to discriminate between visual displays of various number of dots varying in size and position, and with controls for other extraneous variables. Findings indicated that infants could discriminate between large sets on the basis of numerosity if they differed by a large ratio (8 versus 16, but not 8…

  15. Effects of a brief, pedometer-based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6-week and 6-month objectively measured physical activity: study protocol for a randomized controlled trial.

    PubMed

    Geidl, Wolfgang; Semrau, Jana; Streber, René; Lehbert, Nicola; Wingart, Silke; Tallner, Alexander; Wittmann, Michael; Wagner, Rupert; Schultz, Konrad; Pfeifer, Klaus

    2017-08-29

    Pulmonary rehabilitation programs often fail to substantially enhance long-term physical activity in patients with chronic obstructive pulmonary disease (COPD). The reasons for successful physical activity changes in patients with COPD are not well understood. The need to better understand the determinants of physical activity in patients with COPD and effective rehabilitation strategies to improve physical activity is evident. The STAR study (Stay Active after Rehabilitation) investigates, in a randomized controlled trial, the additional effect of a pedometer-based behavior-change intervention during inpatient pulmonary rehabilitation on objectively measured physical activity 6 weeks and 6 months post rehabilitation. The intervention uses the behavior-change techniques (1) instruction on how, where and when to perform the behavior, (2) prompt goal setting for physical activity, (3) prompt self-monitoring of behavior, and (4) feedback on behavior. The primary outcome of physical activity will be measured using a physical activity monitor (Actigraph wGT3X-BT) for a period of 7 days, firstly 2 weeks before rehabilitation begins (t0) as well as 6 weeks and 6 months after rehabilitation (t3, t4). Additionally, to predict physical activity progression after rehabilitation, a complex personal diagnostics battery, including questionnaires as well as functional assessments, is to be carried out at the start and end of rehabilitation (t1, t2). This battery is based on the foundational ideas of the Physical Activity-Related health Competence model. Five hundred and two patients with COPD, aged 18 years or older and admitted for an approved pulmonary rehabilitation, will be enrolled in the STAR study. The STAR study is designed as a randomized controlled trial to gain a better understanding of the personal determinants of physical activity in patients with COPD and to evaluate a pedometer-based physical activity-change intervention in the context of inpatient pulmonary

  16. Posttraumatic stress disorder following traumatic injury at 6 months: associations with alcohol use and depression.

    PubMed

    Warren, Ann Marie; Foreman, Michael L; Bennett, Monica M; Petrey, Laura B; Reynolds, Megan; Patel, Sarita; Roden-Foreman, Kenleigh

    2014-02-01

    Posttraumatic stress disorder (PTSD) is progressively recognized as a psychological morbidity in injured patients. Participants in a longitudinal study were identified as PTSD positive or PTSD negative at 6 months following injury. Risky alcohol use, depression, demographic, and injury-related variables were explored. This prospective cohort included patients 18 years or older, admitted to our Level I trauma center. Outcome measures included PTSD Checklist-Civilian Version (PCL-C), Alcohol Use Disorders Identification Test (AUDIT-C), and Patient Health Questionnaire (PHQ-8). Demographic and injury variables were collected. A total of 211 participants enrolled in the study, and 118 participants completed measures at both baseline and 6 months. Of the participants, 25.4% (n = 30) screened positive for PTSD at 6 months. The entire sample showed a decline in risky alcohol use at 6 months (p = 0.0043). All PTSD-positive participants at 6 months were also positive for depression (p < 0.0001). For the entire sample, there was a 10% increase in depression from baseline to 6 months (p = 0.03). However, for those participants who were PTSD positive at 6 months, there was a 53% increase in depression from baseline (p = 0.0002) as compared with the group at 6 months without PTSD. Statistically significant differences were found between PTSD-positive and PTSD-negative participants regarding age (40.1 [15.9] vs. 50.9 [18.2], p = 0.0047), male (77% vs. 50%, p = 0.0109), penetrating injury (30% vs. 4%, p < 0.0001), PTSD history (17% vs. 4%, p = 0.0246), or other psychiatric condition (63% vs. 19%, p ≤ 0.001). PTSD was not associated with risky alcohol use at 6 months. Surprisingly, risky alcohol use declined in both groups. Incidence of PTSD (25.4%, n = 30) and risky alcohol use (25%, n = 29) were equal at 6 months. Although the American College of Surgeons' Committee on Trauma requires brief screening and intervention for risky alcohol use owing to societal impact, reinjury

  17. Triptorelin embonate: a 6-month formulation for prostate cancer.

    PubMed

    Whelan, Peter

    2010-12-01

    Luteinizing hormone releasing hormone (LH RH) agonists are the major agent for androgen deprivation therapy in advanced and metastatic prostate cancer. They also have a role in endometriosis, uterine fibroids and central precocious puberty. Triptorelin embonate 22.5 mg is a new, sustained-release, 6-month formulation of an LH RH agonist. It possesses longer duration of action than the current standard 3-month preparation and appears to have similar efficacy and side effects. The use of LH RH agonists for androgen deprivation in prostate cancer has increased considerably in the last 20 years. Recent work has shown that some of this usage has constituted overtreatment and it is within these newer paradigms of therapy that the new 6-month preparation is situated. The new 6-month LH RH preparation - triptorelin embonate - will be of help in several key areas of therapy for prostate cancer, notably as an adjunct to radiation therapy and chemotherapy. It possesses a similar effect, but with fewer side effects, than those that are now commonly available.

  18. Good outcome after liver transplantation for ALD without a 6 months abstinence rule prior to transplantation including post-transplant CDT monitoring for alcohol relapse assessment - a retrospective study.

    PubMed

    Kollmann, Dagmar; Rasoul-Rockenschaub, Susanne; Steiner, Irene; Freundorfer, Edith; Györi, Georg Philipp; Silberhumer, Gerd; Soliman, Thomas; Berlakovich, Gabriela Andrea

    2016-05-01

    Alcoholic liver disease (ALD) is the second most common indication for liver transplantation (LT). The utility of fixed intervals of abstinence prior to listing is still a matter of discussion. Furthermore, post-LT long-term observation is challenging, and biomarkers as carbohydrate-deficient transferrin (CDT) may help to identify alcohol relapse. We retrospectively analyzed data from patients receiving LT for ALD from 1996 to 2012. A defined period of alcohol abstinence prior to listing was not a precondition, and abstinence was evaluated using structured psychological interviews. A total of 382 patients received LT for ALD as main (n = 290) or secondary (n = 92) indication; median follow-up was 73 months (0-213). One- and five-year patient survival and graft survival rates were 82% and 69%, and 80% and 67%, respectively. A total of 62 patients (16%) experienced alcohol relapse. Alcohol relapse did not have a statistically significant effect on patient survival (P = 0.10). Post-transplant CDT measurements showed a sensitivity and specificity of 84% and 85%, respectively. In conclusion, this large single-center analysis showed good post-transplant long-term results in patients with ALD when applying structured psychological interviews before listing. Relapse rates were lower than those reported in the literature despite using a strict definition of alcohol relapse. Furthermore, post-LT CDT measurement proved to be a useful supplementary tool for detecting alcohol relapse. © 2016 Steunstichting ESOT.

  19. Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical Trial.

    PubMed

    Iorio-Siciliano, Vincenzo; Blasi, Andrea; Nicolò, Michele; Iorio-Siciliano, Alessandro; Riccitiello, Francesco; Ramaglia, Luca

    The aim of this study was to evaluate the clinical remodeling of the alveolar socket following the application of bovine-derived xenograft collagen and collagen membrane compared to natural spontaneous healing during the first 6 months following tooth extraction. A total of 20 patients with 20 fresh alveolar sockets were randomly allocated into a test or control group. After a 6-month follow-up period, surgical reentry was performed and implants were placed. Significant statistical differences were recorded in terms of vertical and horizontal bone changes between the test and control groups. Within the limitations of this study, socket preservation procedures may provide more favorable conditions for subsequent implant placement.

  20. Efficacy and augmentation during 6 months of double-blind pramipexole for restless legs syndrome.

    PubMed

    Högl, Birgit; Garcia-Borreguero, Diego; Trenkwalder, Claudia; Ferini-Strambi, Luigi; Hening, Wayne; Poewe, Werner; Brenner, Stefanie S; Fraessdorf, Mandy; Busse, Michael; Albrecht, Stefan; Allen, Richard P

    2011-04-01

    Pramipexole is an effective treatment for restless legs syndrome (RLS), but no controlled studies have lasted >12 weeks. RLS patients (N=331) with pretreatment serum ferritin >30 ng/mL were randomly assigned to take double-blind optimized pramipexole (0.125-0.75 mg/d) or placebo for 26 weeks. The primary efficacy endpoint was change in International RLS Study Group Rating Scale (IRLS) score. Other endpoints assessed global change, symptoms, and QoL. Patients maintained symptom diaries. Cases meeting predefined criteria for suspected augmentation were reviewed by a blinded expert panel, which used a predefined algorithm. Among 321 patients providing post-baseline data, of whom 234 completed 26 weeks, pramipexole was more effective than placebo by multiple endpoints, including an adjusted mean IRLS score change of -13.7 vs. -11.1 (p=0.0077) and an IRLS responder rate (≥50% score reduction) of 58.6% vs. 42.8% (p=0.0044). Efficacy showed considerable country-to-country variability. Six-month incidence of confirmed augmentation was 9.2% for pramipexole and 6.0% for placebo. The rate increased with treatment duration for pramipexole but not placebo. Treatment-related adverse events (AEs) were more likely for pramipexole than for placebo, but discontinuation due to AEs was less likely. During a 6-month period, pramipexole was effective, safe, and generally well tolerated. Because risk of augmentation may have increased over 6 months, it should be studied in longer trials. Beginning or mild augmentation is difficult to distinguish from natural RLS fluctuation, at least in a non-iron-deficient population. Copyright © 2011 Elsevier B.V. All rights reserved.

  1. Bone-anchored hearing implant loading at 3 weeks: stability and tolerability after 6 months.

    PubMed

    Faber, Hubert T; Dun, Catharina A J; Nelissen, Rik C; Mylanus, Emmanuel A M; Cremers, Cor W R J; Hol, Myrthe K S

    2013-01-01

    To clinically evaluate the performance of a titanium percutaneous bone-anchored hearing implant (BAHI) using a 3-week healing period. Short-term implant survival, stability changes, and skin reactions are evaluated from the initial implantation to 6 months postimplantation. Thirty patients eligible for a BAHI were included in an open, prospective clinical investigation. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis (RFA) at the time of implantation and at 10 days; at 3, 6, and 12 weeks; and at 6 months after placement of the implant. Sound processor fitting was performed 3 weeks after implantation. Skin reactions were evaluated according to the Holgers classification. One implant was lost 3 days after implantation because of poor bone quality. No implant loss occurred in the remaining 29 patients (96.7%). The mean ISQ value at the time of implantation was 67.1 (range, 44-71). Compared with baseline, there was a significant dip of -2.2 ISQ units at 10 days (mean, 65.7; p = 0.0093). There was a positive change in mean ISQ compared with baseline over the subsequent visits. No reduction in mean ISQ values was observed after implant loading. Skin reactions were observed incidentally (mean over all visits, 9.7%) and were generally mild (Holgers Grade 1; mean 9.0%). An adverse skin reaction (Holgers Grade 2) was observed only once (mean, 0.7%). The current study suggests that loading the implant and 6-mm abutment with the sound processor at 3 weeks is safe. The stability of the implant as measured by ISQ values had reached its baseline value within 3 weeks after implantation. The degree of stability was not affected by implant loading. Only mild skin reactions were observed incidentally. This study supports the use of early loading at 3 weeks as current practice in healthy adults with good bone quality; thus, these adults can benefit from the rehabilitation of their hearing at an earlier stage.

  2. Family problem solving interactions and 6-month symptomatic and functional outcomes in youth at ultra-high risk for psychosis and with recent onset psychotic symptoms: A longitudinal study

    PubMed Central

    O'Brien, Mary P.; Zinberg, Jamie L.; Ho, Lorena; Rudd, Alexandra; Kopelowicz, Alex; Daley, Melita; Bearden, Carrie E.; Cannon, Tyrone D.

    2009-01-01

    This study prospectively examined the relationship between social problem solving behavior exhibited by youths at ultra-high risk for psychosis (UHR) and with recent onset psychotic symptoms and their parents during problem solving discussions, and youths' symptoms and social functioning six months later. Twenty-seven adolescents were administered the Structured Interview for Prodromal Syndromes and the Strauss-Carpenter Social Contact Scale at baseline and follow-up assessment. Primary caregivers participated with youth in a ten minute discussion that was videotaped, transcribed, and coded for how skillful participants were in defining problems, generating solutions, and reaching resolution, as well as how constructive and/or conflictual they were during the interaction. Controlling for social functioning at baseline, adolescents' skillful problem solving and constructive communication, and parents' constructive communication, were associated with youths' enhanced social functioning six months later. Controlling for symptom severity at baseline, we found that there was a positive association between adolescents' conflictual communications at baseline and an increase in positive symptoms six months later. Taken together, findings from this study provide support for further research into the possibility that specificfamily interventions, such as problem solving and communication skills training, may improve the functional prognosis of at-risk youth, especially in terms of their social functioning. PMID:18996681

  3. Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study

    PubMed Central

    Wolf, Dörte; Otto, Joachim

    2015-01-01

    Lidocaine is a well-accepted topical anaesthetic, also used in minors to treat painful conditions on mucosal membranes. This randomized, double-blind, placebo-controlled study (registered prospectively as EudraCT number 2011-005336-25) was designed to generate efficacy and safety data for a lidocaine gel (2%) in younger children with painful conditions in the oral cavity. One hundred sixty-one children were included in two subgroups: 4–8 years, average age 6.4 years, treated with verum or placebo and 6 months–<4 years, average age 1.8 years, treated only with verum. Pain reduction was measured from the time prior to administration to 10 or 30 minutes after. In addition, adverse events and local tolerability were evaluated. In group I, pain was reduced significantly after treatment with verum compared to placebo at both time points. In group II, the individual pain rating shift showed statistically significant lower pain after treatment. Only seven out of 161 patients reported an adverse event but none were classified as being related to the study medication. The local tolerability was assessed as very good in over 97% of cases. For painful sites in the oral cavity, a 2% lidocaine gel is a meaningful tool for short-term treatment in the paediatric population. PMID:26693229

  4. Infant sleep development from 3 to 6 months postpartum: links with maternal sleep and paternal involvement.

    PubMed

    Tikotzky, Liat; Sadeh, Avi; Volkovich, Ella; Manber, Rachel; Meiri, Gal; Shahar, Golan

    2015-03-01

    The aims of this longitudinal study were to examine (a) development of infant sleep and maternal sleep from 3 to 6 months postpartum; (b) concomitant and prospective links between maternal sleep and infant sleep; and (c) triadic links between paternal involvement in infant caregiving and maternal and infant sleep. The study included 57 families that were recruited during pregnancy. Maternal and infant sleep was assessed using actigraphy and sleep diaries for 5 nights. Both fathers and mothers completed a questionnaire assessing the involvement of fathers relative to mothers in infant caregiving. The results demonstrated moderate improvement in infant and maternal sleep percent between 3 and 6 months. Maternal sleep percent at 3 months significantly predicted infant sleep percent at 6 months. Greater paternal involvement in infant daytime and nighttime caregiving at 3 months significantly predicted more consolidated maternal and infant sleep at 6 months. These findings suggest that maternal sleep is an important predictor of infant sleep and that increased involvement of fathers in infant caregiving responsibilities may contribute to improvements in both maternal and infant sleep during the first 6 months postpartum.

  5. An antiretroviral regimen containing 6 months of stavudine followed by long-term zidovudine for first-line HIV therapy is optimal in resource-limited settings: a prospective, multicenter study in China.

    PubMed

    Li, Taisheng; Guo, Fuping; Li, Yijia; Zhang, Chengda; Han, Yang; Lye, Wei; He, Yun; Lu, Hongzhou; Xie, Jing; Huang, Aiqiong; Li, Yanling; Tang, Xiaoping; Wang, Hui; Zhang, Tong; Gao, Guiju; Lei, Junkang; Zhang, Xiaoying; Wu, Xinhua; Sun, Yongtao; Bai, Jinsong; Luo, Ling; Wang, Huanling

    2014-01-01

    An zidovudine (AZT)-substitution regimen containing 24-week stavudine (d4T) followed by long-term AZT for HIV therapy is potential to trade off short-term AZT-related anemia and long-term risks associated with d4T in resource-limited settings. However, evidence is scarce. This study aims to assess the efficacy and safety of AZT-substitution regimen, aiming to find a regimen with better efficacy, less adverse events, and more affordability in resource-limited settings. This prospective, multicenter study enrolled 499 (190 on d4T regimen, 172 on AZT regimen, and 137 on AZT-substitution regimen) HIV-1-infected subjects who initiated combined antiretroviral therapy and attended follow-up visits over 96 weeks from 2009 to 2011. Lamivudine (3TC) and either nevirapine (NVP) or efavirenz (EFV) were the other two drugs in the antiretroviral regimens. Virologic and immunologic responses and adverse events were monitored at baseline and at weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96. In terms of hematological adverse effects, AZT-substitution group had similar safety profiles to d4T group and was superior to AZT group. In comparison with AZT-substitution group, AZT group was associated with higher risk of developing anemia (adjusted hazard ratio (aHR) for anemia ≥ grade II, 8.44, 95% CI 1.81-39.46) and neutropenia (aHR for neutropenia ≥ grade II, 1.86, 95% CI 1.19-2.93). The prevalence of lipodystrophy in d4T group was 19.5%, while that in AZT-substitution group was zero. As to antiretroviral efficacy, these three groups showed no differences. AZT-substitution regimen provides a relatively safe and effective first-line antiretroviral strategy in resource-limited settings.

  6. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study.

    PubMed

    Bachmann, Alexander; Tubaro, Andrea; Barber, Neil; d'Ancona, Frank; Muir, Gordon; Witzsch, Ulrich; Grimm, Marc-Oliver; Benejam, Joan; Stolzenburg, Jens-Uwe; Riddick, Antony; Pahernik, Sascha; Roelink, Herman; Ameye, Filip; Saussine, Christian; Bruyère, Franck; Loidl, Wolfgang; Larner, Tim; Gogoi, Nirjan-Kumar; Hindley, Richard; Muschter, Rolf; Thorpe, Andrew; Shrotri, Nitin; Graham, Stuart; Hamann, Moritz; Miller, Kurt; Schostak, Martin; Capitán, Carlos; Knispel, Helmut; Thomas, J Andrew

    2014-05-01

    The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax) at 6 mo and the proportion of patients who were complication free. Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. 180-W GL XPS system or TURP. Measurements used were IPSS, Qmax, prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level. The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax, and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS (p<0.001). Early reintervention rate within 30 d was three times higher after TURP (p=0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up. XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax, and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. ClinicalTrials.gov, identifier NCT01218672. Copyright © 2013. Published by Elsevier B.V.

  7. Perception of neon color spreading in 3-6-month-old infants.

    PubMed

    Yang, Jiale; Kanazawa, So; Yamaguchi, Masami K

    2009-12-01

    Although lots of studies about neon color spreading have been reported, few of these studies have focused on the perceptual development of it in human infants. Therefore, this study explores the perceptual development of neon color spreading in infants. In experiment 1, we examined 3-6-month-olds' perception of neon color spreading in static conditions. In experiment 2, we examined 3-6-month-olds' perception of neon color spreading in moving conditions. Our results suggest that while only 5-6-month-old infants show a preference for neon color spreading in the static condition, 3-4-month-old infants also prefer neon color spreading if motion information is available.

  8. Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naïve: 6-month results from a real-world, international, prospective study

    PubMed Central

    Nüßlein, Hubert G; Mariette, Xavier; Galeazzi, Mauro; Lorenz, Hanns-Martin; Cantagrel, Alain; Chartier, Melanie; Poncet, Coralie; Rauch, Christiane; Le Bars, Manuela

    2017-01-01

    Objectives To determine the impact of baseline rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) status on the clinical efficacy of intravenous abatacept in biologic-naïve patients with rheumatoid arthritis (RA) enrolled in the real-world ACTION study. Methods Clinical outcomes (European League Against Rheumatism (EULAR) response, mean Clinical Disease Activity Index (CDAI) and Boolean remission) at 6 months were compared by baseline RF and anti-CCP status. Results Of 672 biologic-naïve patients, RF status was reported in 577 (86%) (412 (71%) positive) and anti-CCP status in 552 (82%) (364 (66%) positive); of 511 patients for whom data were available, 308/511 (60%) were double positive and 127/511 (25%) were double negative. Clinical outcomes were improved with RF-positive or anti-CCP-positive versus RF-negative/anti-CCP-negative status—good or moderate EULAR response: RF: 84.6 vs 72.9%, p=0.012; anti-CCP: 85.2 vs 74.2%, p=0.015; mean CDAI (calculated): RF: 10.8 vs 15.3, p<0.001; anti-CCP: 10.9 vs 14.3, p=0.002; and Boolean remission: RF: 13.3 vs 4.0%, p=0.008; anti-CCP: 12.5 vs 6.3%, p=0.096. Clinical outcomes were also improved with single or double RF-positive/anti-CCP-positive versus double-negative status. Conclusions In biologic-naïve patients with RA, RF-positive and/or anti-CCP-positive status is associated with greater efficacy of intravenous abatacept than seronegative status. Trial registration number NCT02109666. PMID:28243468

  9. Decrease in plasma cyclophilin A concentration at 1 month after myocardial infarction predicts better left ventricular performance and synchronicity at 6 months: a pilot study in patients with ST elevation myocardial infarction.

    PubMed

    Huang, Ching-Hui; Chang, Chia-Chu; Kuo, Chen-Ling; Huang, Ching-Shan; Lin, Chih-Sheng; Liu, Chin-San

    2015-01-01

    Cyclophilin A (CyPA) concentration increases in acute coronary syndrome. In an animal model of acute myocardial infarction, administration of angiotensin-converting-enzyme inhibitor was associated with lower left ventricular (LV) CyPA concentration and improved LV performance. This study investigated the relationships between changes in plasma CyPA concentrations and LV remodeling in patients with ST-elevation myocardial infarction (STEMI). We enrolled 55 patients who underwent percutaneous coronary intervention for acute STEMI. Plasma CyPA, matrix metalloproteinase (MMP), interleukin-6 and high-sensitivity C-reactive protein concentrations were measured at baseline and at one-month follow-up. Echocardiography was performed at baseline and at one-, three-, and six-month follow-up. Patients with a decrease in baseline CyPA concentration at one-month follow-up (n = 28) had a significant increase in LV ejection fraction (LVEF) (from 60.2 ± 11.5% to 64.6 ± 9.9%, p < 0. 001) and preserved LV synchrony at six months. Patients without a decrease in CyPA concentration at one month (n = 27) did not show improvement in LVEF and had a significantly increased systolic dyssynchrony index (SDI) (from 1.170 ± 0.510% to 1.637 ± 1.299%, p = 0.042) at six months. Multiple linear regression analysis showed a significant association between one-month CyPA concentration and six-month LVEF. The one-month MMP-2 concentration was positively correlated with one-month CyPA concentration and LV SDI. Conclusions : Decreased CyPA concentration at one-month follow-up after STEMI was associated with better LVEF and SDI at six months. Changes in CyPA, therefore, may be a prognosticator of patient outcome.

  10. Decrease in Plasma Cyclophilin A Concentration at 1 Month after Myocardial Infarction Predicts Better Left Ventricular Performance and Synchronicity at 6 Months: A Pilot Study in Patients with ST Elevation Myocardial Infarction

    PubMed Central

    Huang, Ching-Hui; Chang, Chia-Chu; Kuo, Chen-Ling; Huang, Ching-Shan; Lin, Chih-Sheng; Liu, Chin-San

    2015-01-01

    Background: Cyclophilin A (CyPA) concentration increases in acute coronary syndrome. In an animal model of acute myocardial infarction, administration of angiotensin-converting-enzyme inhibitor was associated with lower left ventricular (LV) CyPA concentration and improved LV performance. This study investigated the relationships between changes in plasma CyPA concentrations and LV remodeling in patients with ST-elevation myocardial infarction (STEMI). Methods and Results: We enrolled 55 patients who underwent percutaneous coronary intervention for acute STEMI. Plasma CyPA, matrix metalloproteinase (MMP), interleukin-6 and high-sensitivity C-reactive protein concentrations were measured at baseline and at one-month follow-up. Echocardiography was performed at baseline and at one-, three-, and six-month follow-up. Patients with a decrease in baseline CyPA concentration at one-month follow-up (n = 28) had a significant increase in LV ejection fraction (LVEF) (from 60.2 ± 11.5% to 64.6 ± 9.9%, p < 0. 001) and preserved LV synchrony at six months. Patients without a decrease in CyPA concentration at one month (n = 27) did not show improvement in LVEF and had a significantly increased systolic dyssynchrony index (SDI) (from 1.170 ± 0.510% to 1.637 ± 1.299%, p = 0.042) at six months. Multiple linear regression analysis showed a significant association between one-month CyPA concentration and six-month LVEF. The one-month MMP-2 concentration was positively correlated with one-month CyPA concentration and LV SDI. Conclusions: Decreased CyPA concentration at one-month follow-up after STEMI was associated with better LVEF and SDI at six months. Changes in CyPA, therefore, may be a prognosticator of patient outcome. PMID:25552928

  11. Impact of Maternal Selenium Status on Infant Outcome during the First 6 Months of Life

    PubMed Central

    Varsi, Kristin; Bolann, Bjørn; Torsvik, Ingrid; Rosvold Eik, Tina Constanse; Høl, Paul Johan; Bjørke-Monsen, Anne-Lise

    2017-01-01

    Pregnant women and infants are at risk for selenium deficiency, which is known to have negative effects on immune and brain function. We have investigated selenium levels in 158 healthy never-pregnant women and in 114 pregnant and lactating women and their infants at age 6 months and related this to clinical outcomes during the first 6 months of life. Neurodevelopment was assessed with the parental questionnaire Ages and Stages (ASQ) at 6 months. A maternal selenium level ≤0.90 µmol/L in pregnancy week 18 was negatively related to infant neurodevelopment at 6 months (B = −20, p = 0.01), whereas a selenium level ≤0.78 µmol/L in pregnancy week 36 was associated with an increased risk (odds ratio 4.8) of having an infant infection during the first 6 weeks of life. A low maternal selenium status in pregnancy was found to be associated with an increased risk of infant infection during the first 6 weeks of life and a lower psychomotor score at 6 months. We suggest a cutoff for maternal serum selenium deficiency of 0.90 µmol/L in pregnancy week 18 and 0.78 µmol/L in pregnancy week 36. This should be reevaluated in an intervention study. PMID:28492511

  12. Eye Movement Patterns for Novice Teen Drivers Does 6 Months of Driving Experience Make a Difference?

    PubMed Central

    Olsen, Erik C. B.; Lee, Suzanne E.; Simons-Morton, Bruce G.

    2009-01-01

    Attention to the road is essential to safe driving, but the development of appropriate eye glance scanning behaviors may require substantial driving experience. Novice teen drivers may focus almost exclusively on the road ahead rather than scanning the mirrors, and when performing secondary tasks, they may spend more time with eyes on the task than on the road. This paper examines the extent to which the scanning of novice teens improves with experience. For this study, 18 novice teen (younger than 17.5 years old) and 18 experienced adult drivers performed a set of in-vehicle tasks and a baseline driving segment on a test track, the teens within 4 weeks of licensure and then again 6 months later. This paper addresses the following questions: Did teen eye glance performance improve from initial assessment? Did teens and adults still differ after 6 months? Results for some tasks showed that rearview and left mirror–window (LM-W) glances improved for teens from initial testing to the 6-month follow-up and that some differences between teens and adults at initial testing were no longer significant at the 6-month follow-up, suggesting significant learning effects. The frequency of rearview and LM-W glances during secondary tasks improved among teens at the 6-month follow-up, but teens still had significantly fewer glances to mirrors than did adults when engaged in a secondary task. PMID:19763225

  13. [Prediction of Severe Course in Infants with RSV Bronchiolitis under 6 Months. Spain].

    PubMed

    Ramos-Fernández, José Miguel; Moreno-Pérez, David; Gutiérrez-Bedmar, Mario; Hernández-Yuste, Alexandra; Cordón-Martínez, Ana María; Milano-Manso, Guillermo; Urda-Cardona, Antonio

    2017-01-19

    The need for mechanical ventilation (MV) in acute bronchiolitis (AB) by respiratory syncytial virus (RSV) varies depending on the series (6-18%). Our goal is to determine the admissions to PICU for MV in patients under 6 months with AB and define the risk factors for building a prediction model. Retrospective study of patients younger than 6 months admitted by BA-VRS between the periods April 1, 2010 and March 31, 2015 was made. The primary variable was the admission to PICU for MV. Related addition, to find risk factors in a model of binary logistic regression clinical variables were collected. A ROC curve model was developed and optimal cutoff point was identified. In 695 cases, the need of MV in the PICU (Y) was 56 (8.1%). Risk factors (Xi) included in the equation were: 1. male sex (OR 4.27) 2. postmenstrual age (OR: 0.76) 3. Weight income less than p3 (OR: 5.53) 4. intake lees than 50% (OR: 12.4) 5. Severity by scale (OR: 1.58) 6. apneas before admission (OR: 25.5) 7. bacterial superinfection (OR 5.03) and 8. gestational age more than 37 weeks OR (0.32). The area under the curve, sensitivity and specificity were 0.943, 0.84 and 0.93 respectively. The PICU admission for MV was 8.1 in every 100 healthy infants hospitalized for AB and year. The prediction model equation can help to predict patients at increased risk of severe evolution.

  14. Short-term results of early (before 6 months) open reduction of dislocated hips in arthrogryposis multiplex congenita.

    PubMed

    Aydin, Bahattin K; Yilmaz, Guney; Senaran, Hakan; Durgut, Fatih

    2016-11-01

    The aim of this study was to report the results of early open reduction of hip dislocations in infants with arthrogryposis multiplex congenita. Seven patients who were under 6 months of age at the time of hip reduction, with a mean follow-up period of 47.5±11.3 months after surgery, were included in this study. Four of seven patients (six of 13 hips) required additional hip surgeries during their follow-up. The short-term results of early open reduction of hips were not promising as most of the patients required additional hip surgeries.

  15. Endoscopic, deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial.

    PubMed

    Johnson, David A; Ganz, Robert; Aisenberg, James; Cohen, Lawrence B; Deviere, Jacques; Foley, T Raymond; Haber, Gregory B; Peters, Jeffrey H; Lehman, Glen A

    2003-02-01

    This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

  16. Pain and emotions reported after childbirth and recalled 6 months later: the role of controllability.

    PubMed

    Tinti, Carla; Schmidt, Susanna; Businaro, Nicoletta

    2011-06-01

    The aim of this longitudinal study was twofold: to investigate the relationship between subjectively evaluated control, positive and negative emotional feelings, and pain intensity during childbirth; to assess the recall of these aspects of childbirth experience 6 months after delivery. Participants were 123 women who delivered naturally and spoke fluent Italian. Results showed that both immediately after delivery and 6 months later, higher subjective controllability was related to less severe reported pain, more intense positive emotions and less intense negative emotions. Furthermore, although there was no significant bias in the vividness of the recall, 6 months after delivery women reported higher subjective controllability, more intense positive emotions, less intense negative emotions and less intense pain. It is concluded that in preparing women for childbirth, two aspects deserve particular attention: the enhancement of subjectively perceived controllability and the possibility to work on both negative and positive emotions.

  17. Mini Nutritional Assessment predicts gait status and mortality 6 months after hip fracture.

    PubMed

    Gumieiro, David N; Rafacho, Bruna P M; Gonçalves, Andrea F; Tanni, Suzana E; Azevedo, Paula S; Sakane, Daniel T; Carneiro, Carlos A S; Gaspardo, David; Zornoff, Leonardo A M; Pereira, Gilberto J C; Paiva, Sergio A R; Minicucci, Marcos F

    2013-05-01

    The aim of the present study was to evaluate the Mini Nutritional Assessment (MNA), the Nutritional Risk Screening (NRS) 2002 and the American Society of Anesthesiologists Physical Status Score (ASA) as predictors of gait status and mortality 6 months after hip fracture. A total of eighty-eight consecutive patients over the age of 65 years with hip fracture admitted to an orthopaedic unit were prospectively evaluated. Within the first 72 h of admission, each patient's characteristics were recorded, and the MNA, the NRS 2002 and the ASA were performed. Gait status and mortality were evaluated 6 months after hip fracture. Of the total patients, two were excluded because of pathological fractures. The remaining eighty-six patients (aged 80·2 (sd 7·3) years) were studied. Among these patients 76·7 % were female, 69·8 % walked with or without support and 12·8 % died 6 months after the fracture. In a multivariate analysis, only the MNA was associated with gait status 6 months after hip fracture (OR 0·773, 95 % CI 0·663, 0·901; P= 0·001). In the Cox regression model, only the MNA was associated with mortality 6 months after hip fracture (hazard ratio 0·869, 95 % CI 0·757, 0·998; P= 0·04). In conclusion, the MNA best predicts gait status and mortality 6 months after hip fracture. These results suggest that the MNA should be included in the clinical stratification of patients with hip fracture to identify and treat malnutrition in order to improve the outcomes.

  18. Malignant hyperthermia in a 6-month-old infant.

    PubMed

    Mathur, P R; Rundla, M; Jain, N; Mathur, V

    2016-01-01

    Malignant hyperthermia (MH) is a rare hypermetabolic disorder of skeletal muscles that manifests as a life-threatening crisis in susceptible individuals, after exposure to triggering agents, most commonly halothane and succinylcholine. MH presents with multiple nonspecific signs and laboratory findings such as tachycardia, hyperthermia, hypercarbia, acidosis, and muscle rigidity. Caffeine halothane contracture test is not available at most centers in India. Larach et al. have described a clinical grading scale for determining the MH raw score based on clinical findings and biochemical tests. The high degree of suspicion, early recognition and aggressive treatment should commence immediately. It is imperative to avoid triggering agents, such as volatile anesthetics and succinylcholine, and promote the use of total intravenous anesthesia in MH susceptible patients. We report a case of 6-month-old child undergoing laparotomy under general anesthesia, who presented with signs and symptoms of MH, had MH rank 5 and raw score 36.

  19. Improved Squat and Gait Biomechanics 6-Months Post-Arthroscopic Surgery for Femoroacetabular Impingement

    PubMed Central

    Cvetanovich, Gregory; Farkas, Gary Jordan; Rajan, Kumar; Espinoza, Alejandro; Nho, Shane Jay

    2016-01-01

    Objectives: This study aimed to assess gait and squat biomechanics 6-months following arthroscopic surgery for femoroacetabular impingement. Methods: Symptomatic patients with clinical and radiographic diagnosis of FAI who had failed non-operative treatment underwent gait and squat analysis preoperatively and at 6-months postoperatively following arthroscopic surgery for FAI. Age- and BMI-matched controls without radiographic FAI or other lumbar or lower extremity pathology underwent a single analysis for comparison. Comparisons between preoperative and 6-month postoperative gait and squat parameters as well as comparison to the control group were performed using paired and independent sample t-tests. Statistical significance was set at p<0.05. Results: Fifteen FAI patients and 9 controls were analyzed. Age for the patients vs. controls was 28.7±9.6 y vs. 27.8±6.5 y (p>0.05), respectively; while BMI was 23.5±5.1 kg/m2 vs. 22.8±3.5 kg/m2 (p>0.05). All gait parameters were unchanged between preoperative and 6-month postoperative testing (p>0.05), with a trend toward significance for hip external rotation moment (p=0.056) (Table 1). Squat testing revealed that FAI arthroscopic surgery increased maximum hip extension (p=0.011), with a trend toward significance for hip adduction moment (p=0.059). All other squat parameters did not differ from preoperative to 6-month follow-up (p>0.05). Compared to the control group, preoperative FAI patients had reduced hip external rotation moment during gait (p=0.024), with a trend toward significance for hip abduction moment (p=0.082). No other gait or squat differences were detected between FAI patients preoperatively or 6-months postoperatively compared to controls (p>0.05). Conclusion: Biomechanical gait and squat analysis at 6-month follow-up from arthroscopic FAI surgery revealed a tendency to improve external hip rotation during gait and maximum hip extension and hip adduction during squat. Arthroscopic surgery for FAI may

  20. Behavioral Management of Sleep Problems in Infants Under 6 Months--What Works?

    PubMed

    Crichton, Georgina E; Symon, Brian

    2016-01-01

    Crying and unsettled behavior in infancy is common. Prolonged disturbed infant sleep can have significant negative effects on the development of the child, and on the psychological well-being of the mother. Compared to studies examining the effects of behavioral sleep programs such as extinction-based techniques in infants over 6 months of age, fewer studies have looked at such strategies in infants under 6 months of age. The aim of this article is to summarize the literature examining the effects of behavioral techniques on infant sleep outcomes in the first 6 months of life and provide evidence based recommendations for the management of infant sleep disturbance. An electronic search of the literature was performed to identify studies which examined the effects of a behavioral intervention aimed at improving sleep in infants under 6 months of age. Eleven studies were identified, of which 8 demonstrated improvements in infant sleep outcomes subsequent to the implementation of an educational behavioral program. Education directed to parents about the use of simple, prescriptive, behavioral techniques is effective in improving infant sleep. Long term follow-up studies have failed to find any negative effects on the child, either from a psychological or physical perspective.

  1. Prospective evaluation of the psychosocial impact of the first 6 months of orthodontic treatment with fixed appliance among young adults.

    PubMed

    Prado, Renata França; Ramos-Jorge, Joana; Marques, Leandro Silva; de Paiva, Saul Martins; Melgaço, Camilo Aquino; Pazzini, Camila Alessandra

    2016-07-01

    To evaluate the psychosocial impact of the first 6 months of orthodontic treatment with a fixed appliance among young adults and compare the results with those of a control group of patients awaiting treatment for malocclusion. A study was conducted with a sample of 120 patients on a waiting list for orthodontic treatment at a university. The participants were allocated to an experimental group submitted to treatment and a control group awaiting treatment. The groups were matched for sex and age. All participants were instructed to answer the Brazilian version of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) at baseline and after 6 months. Statistical analysis involved the Wilcoxon test for the total PIDAQ score and the score of each subscale. All patients participated until the end of the study. Significant differences between baseline and the 6-month evaluation were found for the total PIDAQ score as well as the dental self-confidence and social impact subscales in both groups. No differences between baseline and the 6-month evaluation were found regarding the psychological impact or esthetic concern subscales in the control group. The patients in the experimental group reported greater esthetic impact 6 months after beginning treatment (P < .001). The first 6 months of orthodontic treatment seem to improve psychosocial impact. The first 6 months of orthodontic treatment seem to improve the psychosocial impact of malocclusion. The patients analyzed in the present study reported a greater esthetic impact and less psychological impact after 6 months of using an orthodontic appliance.

  2. Perception and Production of Object-Related Grasping in 6-Month-Olds

    ERIC Educational Resources Information Center

    Daum, Moritz M.; Prinz, Wolfgang; Aschersleben, Gisa

    2011-01-01

    In this study, 6-month-olds' perception of an object-related human grasping action was compared with their level of grasping performance using a within-participants design. In the action perception task, infants were presented with the video of an actor's grasping movement toward an occluded target object. Subsequently, an expected and an…

  3. Night Waking in 6-Month-Old Infants and Maternal Depressive Symptoms

    ERIC Educational Resources Information Center

    Karraker, Katherine Hildebrandt; Young, Marion

    2007-01-01

    Relations between night waking in infants and depressive symptoms in their mothers at 6 months postpartum were examined using the data from the National Institute for Child Health and Human Development Study of Early Child Care. Although more depressive symptoms were only weakly correlated with a higher frequency of infant waking, longer wake…

  4. Conditioning 1-6 Month Old Infants by Means of Myoelectrically Controlled Reinforcement.

    ERIC Educational Resources Information Center

    Stack, Dale M.; McDonnell, Paul M.

    1995-01-01

    In order to evaluate possibilities of fitting myoelectrically controlled prosthetic arms on infants, this study examined whether 32 infants (1-6 months) could learn to control environmental contingencies by means of contracting the forearm flexor muscle group. Results indicated that older subjects (age greater than 104 days) demonstrated learning,…

  5. Determining the Impact of Prenatal Tobacco Exposure on Self-Regulation at 6 Months

    ERIC Educational Resources Information Center

    Wiebe, Sandra A.; Fang, Hua; Johnson, Craig; James, Karen E.; Espy, Kimberly Andrews

    2014-01-01

    Our goal in the present study was to examine the effects of maternal smoking during pregnancy on infant self-regulation, exploring birth weight as a mediator and sex as a moderator of risk. A prospective sample of 218 infants was assessed at 6 months of age. Infants completed a battery of tasks assessing working memory/inhibition, attention, and…

  6. Determining the Impact of Prenatal Tobacco Exposure on Self-Regulation at 6 Months

    ERIC Educational Resources Information Center

    Wiebe, Sandra A.; Fang, Hua; Johnson, Craig; James, Karen E.; Espy, Kimberly Andrews

    2014-01-01

    Our goal in the present study was to examine the effects of maternal smoking during pregnancy on infant self-regulation, exploring birth weight as a mediator and sex as a moderator of risk. A prospective sample of 218 infants was assessed at 6 months of age. Infants completed a battery of tasks assessing working memory/inhibition, attention, and…

  7. Conditioning 1-6 Month Old Infants by Means of Myoelectrically Controlled Reinforcement.

    ERIC Educational Resources Information Center

    Stack, Dale M.; McDonnell, Paul M.

    1995-01-01

    In order to evaluate possibilities of fitting myoelectrically controlled prosthetic arms on infants, this study examined whether 32 infants (1-6 months) could learn to control environmental contingencies by means of contracting the forearm flexor muscle group. Results indicated that older subjects (age greater than 104 days) demonstrated learning,…

  8. Night Waking in 6-Month-Old Infants and Maternal Depressive Symptoms

    ERIC Educational Resources Information Center

    Karraker, Katherine Hildebrandt; Young, Marion

    2007-01-01

    Relations between night waking in infants and depressive symptoms in their mothers at 6 months postpartum were examined using the data from the National Institute for Child Health and Human Development Study of Early Child Care. Although more depressive symptoms were only weakly correlated with a higher frequency of infant waking, longer wake…

  9. Older patients' depressive symptoms 6 months after prolonged hospitalization: course and interrelationships with major associated factors.

    PubMed

    Chen, Chun-Min; Huang, Guan-Hua; Chen, Cheryl Chia-Hui

    2014-01-01

    The aim of this study was to examine the course of depressive symptoms in older patients 6 months following a prolonged, acute hospitalization, especially the interrelationships among depressive symptoms and its major associated factors. For this study, we conducted a secondary analysis of data from a prospective cohort study of 351 patients aged 65 years and older. Participants were recruited from five surgical and medical wards at a tertiary medical center in northern Taiwan and assessed at three time points: within 48 h of admission, before discharge, and 6 months post-discharge. The course of depressive symptoms was dynamic with symptoms increased spontaneously and substantially during hospitalization and subsided at 6 months after discharge, but still remained higher than at admission. Overall, 26.7% of older patients at hospital discharge met established criteria for minor depression (15-item Geriatric Depressive Scale (GDS-15) scores 5-9) and 21.2% for major depression (GDS-15 scores >10). As the strongest associated factors, functional dependence and nutritional status influenced depressive symptoms following hospitalization. Depressive symptoms at discharge showed significant cross-lagged effects on functional dependence and nutritional status at 6 months after discharge, suggesting a reciprocal, triadic relationship. Thus, treating one condition might improve the other. Targeting the triad of depressive symptoms, functional dependence, and nutritional status, therefore, is essential for treating depressive symptoms and improving the overall health of older adults hospitalized for acute illness. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  10. Low-Dose Chemoreduction for Infants Diagnosed with Retinoblastoma before 6 Months of Age

    PubMed Central

    Berry, Jesse L.; Jubran, Rima; Lee, Thomas C.; Murphree, A. Linn; Lee, Diana; Kim, Jonathan W.

    2015-01-01

    Aim The purpose of this study was to evaluate the outcomes of infants diagnosed with retinoblastoma before 6 months of age, including the need for chemoreduction (CRD). In this age group, dosage of CRD was reduced due to its potential for toxicity. Methods This is a retrospective review from 2000 to 2009 that includes 126 eyes of 72 infants (18 unilateral, 54 bilateral). Systemic CRD was administered when local modalities failed or were considered inadequate. Primary outcome measures were the need for CRD and globe salvage. Results Of the 72 infants diagnosed before 6 months of age, 48 (67%) ultimately required CRD for globe salvage, 40 (56%) patients before 6 months of age. Globe salvage was achieved in 62% (78/126) of eyes overall and in 93% (68/73) of eyes with Group A-C disease. No patient was hospitalized for CRD-related illness; survival was 100%. The mean follow-up was 52.9 months (range 1-148 months). Conclusion Utilizing a combination of focal modalities and reduced-dose CRD, children diagnosed with retinoblastoma before 6 months of age attain globe salvage rates comparable to those of older age groups. Two thirds of the infants ultimately required CRD for globe salvage. Bilateral disease as well as Group D and E classification in at least one eye at presentation increased the chance of requiring CRD (p < 0.0001 and p < 0.016, respectively). PMID:27172253

  11. HIV Transmission Risk Persists During the First 6 Months of Antiretroviral Therapy

    PubMed Central

    Mujugira, Andrew; Celum, Connie; Coombs, Robert W.; Campbell, James D.; Ndase, Patrick; Ronald, Allan; Were, Edwin; Bukusi, Elizabeth A.; Mugo, Nelly; Kiarie, James; Baeten, Jared M.

    2016-01-01

    Objective Combination antiretroviral therapy (ART) decreases the risk of sexual HIV transmission by suppressing blood and genital HIV RNA concentrations. We sought to determine HIV transmission risk prior to achieving complete viral suppression. Design Prospective cohort study. Methods Using data from the Partners PrEP Study, a prospective study of 4747 heterosexual HIV-serodiscordant couples in Kenya and Uganda, we examined multiple markers of HIV transmission risk during the first months after ART initiation: time to viral suppression in blood, persistence of HIV RNA in genital specimens, sexual risk behavior, pregnancy incidence, and HIV transmission using survival analysis and GEE logistic regression. Results The cumulative probabilities of achieving blood viral suppression (<80 copies/ml) 3, 6 and 9-months after ART initiation were 65.3%, 84.8% and 89.1%, respectively. Endocervical and seminal HIV RNA were detectable in 12% and 21% of samples obtained within 6-months of ART. Pregnancy incidence was 8.8 per 100 person-years during the first 6-months of ART, and sex unprotected by condoms was reported at 10.5% of visits. Among initially uninfected partners, HIV incidence before ART was 2.08 per 100 person-years (55 infections; 2644 person-years), 1.79 for 0–6 months after ART initiation (3 infections; 168 person-years), and 0.00 with >6 months of ART (0 infections; 167 person-years). Conclusions Residual HIV transmission risk persists during the first 6-months of ART, with incomplete viral suppression in blood and genital compartments. For HIV-serodiscordant couples in which the infected partner starts ART, other prevention options are needed, such as pre-exposure prophylaxis, until viral suppression is achieved. PMID:27070123

  12. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-elevation Myocardial Infarction) 1995 to 2015.

    PubMed

    Puymirat, Etienne; Simon, Tabassome; Cayla, Guillaume; Cottin, Yves; Elbaz, Meyer; Coste, Pierre; Lemesle, Gilles; Motreff, Pascal; Popovic, Batric; Khalife, Khalife; Labeque, Jean Noel; Perret, Thibault; Le Ray, Christophe; Orion, Laurent; Jouve, Bernard; Blanchard, Didier; Peycher, Patrick; Silvain, Johanne; Steg, P Gabriel; Goldstein, Patrick; Gueret, Pascal J; Belle, Loic; Aissaoui, Nadia; Ferrières, Jean; Schiele, Francois; Danchin, Nicolas

    2017-08-27

    Background -ST-segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI) management has evolved considerably over the past 2 decades. Little information on mortality trends in the most recent years is available. We assessed trends in characteristics, treatments, and outcomes for acute myocardial infarction in France between 1995 and 2015. Methods - We used data from 5 one-month registries, conducted 5 years apart, from 1995 to 2015, including 14 423 patients with acute myocardial infarction (59% STEMI) admitted to cardiac intensive care units in metropolitan France. Results -From 1995 to 2015, mean age decreased from 66±14 to 63±14 years in patients with STEMI; it remained stable (68±14 years) in patients with NSTEMI, whereas diabetes mellitus, obesity, and hypertension increased. At the acute stage, intended primary percutaneous coronary intervention increased from 12% (1995) to 76% (2015) in patients with STEMI. In patients with NSTEMI, percutaneous coronary intervention ≤72 hours from admission increased from 9% (1995) to 60% (2015). Six-month mortality consistently decreased in patients with STEMI from 17.2% in 1995 to 6.9% in 2010 and 5.3% in 2015; it decreased from 17.2% to 6.9% in 2010 and 6.3% in 2015 in patients with NSTEMI. Mortality still decreased after 2010 in patients with STEMI without reperfusion therapy, whereas no further mortality gain was found in patients with STEMI with reperfusion therapy or in patients with NSTEMI, whether or not they were treated with percutaneous coronary intervention. Conclusions -Over the past 20 years, 6-month mortality after acute myocardial infarction has decreased considerably for patients with STEMI and NSTEMI. Mortality figures continued to decline in atients with STEMI until 2015, whereas mortality in patients with NSTEMI appears stable since 2010.

  13. Quit rates at 6 months in a pharmacist-led smoking cessation service in Malaysia

    PubMed Central

    Fai, Sui Chee; Yen, Gan Kim; Malik, Nurdiyana

    2016-01-01

    Background: Smoking cessation clinics have been established in Malaysia since 2004, but wide variations in success rates have been observed. This study aimed to evaluate the proposed pharmacist-led Integrated Quit Smoking Service (IQSS) in Sabah, Malaysia, and identify factors associated with successful smoking cessation. Methods: Data from 176 participants were collected from one of the quit-smoking centres in Sabah, Malaysia. Pharmacists, doctors and nurses were involved throughout the study. Any health care provider can refer patients for smoking cessation, and free pharmacotherapy and counselling was provided during the cessation period for up to 3 months. Information on demographic characteristics, smoking behaviours, follow-up and pharmacotherapy were collected. The main outcome measure was the abstinence from smoking, which was verified through carbon monoxide in expired air during the 6-month follow-up. Results: A 42.6% success rate was achieved in IQSS. Smoking behaviour such as lower cigarette intake and lower Fagerström score were identified as factors associated with success. On top of that, a longer duration of follow-up and more frequent visits were significantly associated with success in quitting smoking. Conclusion: Collaboration among health care practitioners should be the main focus, and we need a combination of proven effective modalities in order to create an ideal smoking cessation module. PMID:27708676

  14. Developmental Changes in Neonatal and Infant Skin Structures During the First 6 Months: In Vivo Observation.

    PubMed

    Miyauchi, Yuki; Shimaoka, Yayoi; Fujimura, Tsutomu; Koike, Yumi; Yatabe, Michio; Nishikawa, Masakatsu; Hayashi, Masaru; Sugata, Keiichi; Moriwaki, Shigeru; Hatamochi, Atsushi

    2016-05-01

    Developmental changes of structures in neonatal and infant skin have not been well characterized. The purpose of this study was to clarify changes in skin structures during neonatal and infant growth in vivo. Fifteen healthy, full-term neonates (seven girls, eight boys) were studied. The measurements were performed 4 to 7 days (neonate) and 1, 3, and 6 months after birth on the buttock, upper thigh, and ventral forearm skin using a confocal laser scanning microscope. Developmental changes in dermoepidermal junction structures, stratum corneum thickness, epidermal thickness, and microvascular development were investigated. A significant decrease in stratum corneum thickness was observed over the 3 months after birth. Dermal papillae were not observed in neonatal skin but were observed gradually over the next 3 months. Epidermal thickness, determined from the skin surface to the bottom of the epidermal layer, increased significantly from 4 to 7 days to 1 month of age, indicating the formation of dermal papillae and rete ridges. Complicated microvascular structures were observed in neonatal skin but disappeared gradually and were observed only at the dermal papillae at 3 months of age. Our results reveal that infant skin is in a developmental stage structurally up to 3 months of age, paralleling skin functional and developmental maturation. © 2016 Wiley Periodicals, Inc.

  15. Mechanism of injury affects 6-month functional outcome in children hospitalized because of severe injuries.

    PubMed

    Macpherson, Alison K; Rothman, Linda; McKeag, Alexandra Moses; Howard, Andrew

    2003-09-01

    The burden of childhood injury is often described using vital statistics for mortality and hospital admissions as a measure of morbidity. Hospital admissions, however, reflect the process of care and do not directly measure children's functional disability. The purpose of this study was to determine the influence of mechanism of injury on the functional outcome 6 months after injury in children in an inpatient trauma unit of a pediatric referral hospital. A retrospective cohort of 357 children aged 2 to 15 with an Injury Severity Score (ISS) > 12 was studied to determine the relationship between mechanism of injury (based on International Classification of Diseases, Ninth Revision e-code) and functional outcome 6 months after hospital discharge. Wee Functional Independence Measure (WeeFIM) was used to assess functional outcome. Any child with a WeeFIM score less than the maximum (of 126) attainable was classed as requiring assistance, and the relative risk of requiring assistance at 6 months was calculated for each injury mechanism. Poisson regression analysis was used to assess the importance of mechanism of injury, after adjusting for age, gender, ISS, and a primary diagnosis of central nervous system (CNS) injury. Mechanism of injury had a significant effect on the functional outcome at 6 months: 72% of pedestrians, 64% of cyclists struck by cars, and 59% of injured motor vehicle occupants required assistance during daily activities. By contrast, only 27% of those injured playing sports and 22% of cyclists injured without motor vehicle involvement required assistance. The relative risk of children requiring assistance was similar with or without adjustment for age, gender, ISS, and CNS injury. Mechanism of injury is significantly associated with requiring assistance 6 months postdischarge, even after controlling for age, injury severity, and the presence of a CNS injury. These data are important both when discussing the prognosis for an individual patient and

  16. Fructose in Breast Milk Is Positively Associated with Infant Body Composition at 6 Months of Age

    PubMed Central

    Goran, Michael I.; Martin, Ashley A.; Alderete, Tanya L.; Fujiwara, Hideji; Fields, David A.

    2017-01-01

    Dietary sugars have been shown to promote excess adiposity among children and adults; however, no study has examined fructose in human milk and its effects on body composition during infancy. Twenty-five mother–infant dyads attended clinical visits to the Oklahoma Health Sciences Center at 1 and 6 months of infant age. Infants were exclusively breastfed for 6 months and sugars in breast milk (i.e., fructose, glucose, lactose) were measured by Liquid chromatography-mass spectrometry (LC-MS/MS) and glucose oxidase. Infant body composition was assessed using dual-energy X-ray absorptiometry at 1 and 6 months. Multiple linear regression was used to examine associations between breast milk sugars and infant body composition at 6 months of age. Fructose, glucose, and lactose were present in breast milk and stable across visits (means = 6.7 μg/mL, 255.2 μg/mL, and 7.6 g/dL, respectively). Despite its very low concentration, fructose was the only sugar significantly associated with infant body composition. A 1-μg/mL higher breast milk fructose was associated with a 257 g higher body weight (p = 0.02), 170 g higher lean mass (p = 0.01), 131 g higher fat mass (p = 0.05), and 5 g higher bone mineral content (p = 0.03). In conclusion, fructose is detectable in human breast milk and is positively associated with all components of body composition at 6 months of age. PMID:28212335

  17. Influenza vaccination during the first 6 months after solid organ transplantation is efficacious and safe.

    PubMed

    Pérez-Romero, P; Bulnes-Ramos, A; Torre-Cisneros, J; Gavaldá, J; Aydillo, T A; Moreno, A; Montejo, M; Fariñas, M C; Carratalá, J; Muñoz, P; Blanes, M; Fortún, J; Suárez-Benjumea, A; López-Medrano, F; Barranco, J L; Peghin, M; Roca, C; Lara, R; Cordero, E

    2015-11-01

    Preventing influenza infection early after transplantation is essential, given the disease's high mortality. A multicentre prospective cohort study in adult solid organ transplant recipients (SOTR) receiving the influenza vaccine during four consecutive influenza seasons (2009-2013) was performed to assess the immunogenicity and safety of influenza vaccination in SOTR before and 6 months after transplantation. A total of 798 SOTR, 130 of them vaccinated within 6 months of transplantation and 668 of them vaccinated more than 6 months since transplantation. Seroprotection was similar in both groups: 73.1% vs. 76.5% for A/(H1N1)pdm (p 0.49), 67.5% vs. 74.1% for A/H3N2 (p 0.17) and 84.2% vs. 85.2% for influenza B (p 0.80), respectively. Geometric mean titres after vaccination did not differ among groups: 117.32 (95% confidence interval (CI) 81.52, 168.83) vs. 87.43 (95% CI 72.87, 104.91) for A/(H1N1)pdm, 120.45 (95% CI 82.17, 176.57) vs. 97.86 (95% CI 81.34, 117.44) for A/H3N2 and 143.32 (95% CI 103.46, 198.53) vs. 145.54 (95% CI 122.35, 174.24) for influenza B, respectively. After adjusting for confounding factors, time since transplantation was not associated with response to vaccination. No cases of rejection or severe adverse events were detected in patients vaccinated within the first 6 months after transplantation. In conclusion, influenza vaccination within the first 6 months after transplantation is as safe and immunogenic as vaccination thereafter. Thus, administration of the influenza vaccine can be recommended as soon as 1 month after transplantation.

  18. Fructose in Breast Milk Is Positively Associated with Infant Body Composition at 6 Months of Age.

    PubMed

    Goran, Michael I; Martin, Ashley A; Alderete, Tanya L; Fujiwara, Hideji; Fields, David A

    2017-02-16

    Dietary sugars have been shown to promote excess adiposity among children and adults; however, no study has examined fructose in human milk and its effects on body composition during infancy. Twenty-five mother-infant dyads attended clinical visits to the Oklahoma Health Sciences Center at 1 and 6 months of infant age. Infants were exclusively breastfed for 6 months and sugars in breast milk (i.e., fructose, glucose, lactose) were measured by Liquid chromatography-mass spectrometry (LC-MS/MS) and glucose oxidase. Infant body composition was assessed using dual-energy X-ray absorptiometry at 1 and 6 months. Multiple linear regression was used to examine associations between breast milk sugars and infant body composition at 6 months of age. Fructose, glucose, and lactose were present in breast milk and stable across visits (means = 6.7 μg/mL, 255.2 μg/mL, and 7.6 g/dL, respectively). Despite its very low concentration, fructose was the only sugar significantly associated with infant body composition. A 1-μg/mL higher breast milk fructose was associated with a 257 g higher body weight (p = 0.02), 170 g higher lean mass (p = 0.01), 131 g higher fat mass (p = 0.05), and 5 g higher bone mineral content (p = 0.03). In conclusion, fructose is detectable in human breast milk and is positively associated with all components of body composition at 6 months of age.

  19. Preterm infants fed nutrient-enriched formula until 6 months show improved growth and development.

    PubMed

    Jeon, Ga Won; Jung, Yu Jin; Koh, Sun Young; Lee, Yeon Kyung; Kim, Kyung Ah; Shin, Son Moon; Kim, Sung Shin; Shim, Jae Won; Chang, Yun Sil; Park, Won Soon

    2011-10-01

    The purpose of the present study was to determine the effect of feeding nutrient-enriched preterm formula to preterm infants until 6 months' corrected age (CA) on growth and development in the first 18 months of life. Very low-birthweight preterm infants were fed preterm formula until term (40 weeks CA). Infants were then assigned to one of three groups and were fed term formula until 6 months' CA (group 1, n= 29); preterm formula to 3 months' CA and then term formula to 6 months' CA (group 2, n= 30); or preterm formula until 6 months' CA (group 3, n= 31). Anthropometry was performed at term, 3, 6, 9, 12, 15, and at s18 months' CA. Mental and psychomotor development were assessed using the Bayley Scales of Infant Development II at 18 months' CA. Although body weight, length, head circumference and z score for CA at term in group 3 were significantly lower than those of groups 1 and 2, growth rates of these parameters were significantly higher in group 3 up to 18 months CA', as compared to groups 1 and 2. The mental developmental index and psychomotor developmental index of the Bayley test were not significantly different between the three groups. Very low-birthweight preterm infants fed nutrient-enriched preterm formula until 6 months' CA demonstrated significantly improved growth rates for bodyweight, length and head circumference, and comparable mental and psychomotor development throughout the first 18 months of life. © 2011 The Authors. Pediatrics International © 2011 Japan Pediatric Society.

  20. Effects of a 6-month incentive-based exercise program on adherence and work capacity.

    PubMed

    Robison, J I; Rogers, M A; Carlson, J J; Mavis, B E; Stachnik, T; Stoffelmayr, B; Sprague, H A; McGrew, C R; Van Huss, W D

    1992-01-01

    The purpose of the study was to evaluate the effect of behavioral management techniques on exercise adherence linked to improvements in work capacity and maximal oxygen consumption (VO2max). One hundred thirty-seven participants in six different worksites on a university campus (five experimental and one comparison site) completed 6 months of a minimally supervised, incentive-based endurance exercise program. All participants in the experimental group contracted to engage in at least four bouts of 30 min of verified aerobic exercise within a prescribed target heart rate range each week for the duration of the program. Forty dollars deposited at the beginning of the program served as a response cost that could be lost as a result of failure to fulfill the weekly contracts. Individuals in the comparison group participated in a similar 6-month program but without the contracts and response cost strategies. Weekly adherence for both groups was strictly defined as verified fulfillment of all four bouts of exercise. Adherence for the experimental group was 97% by this definition, and adherence for the comparison group was 19% (P less than 0.01). VO2max increased 2.6% (P less than 0.01), and treadmill test time increased 16% (P less than 0.01) in the experimental group after the 6-month program, with no significant changes in the comparison group. Recovery heart rates at 2 and 4 min post-exercise were significantly lower at 6 months in the experimental group but not in the comparison group. These data provide evidence that adherence to a 6-month endurance exercise program can be improved significantly through the use of well conceived behavior management strategies.(ABSTRACT TRUNCATED AT 250 WORDS)

  1. Soft tissue augmentation in connection to dental implant treatment using a synthetic, porous material--a case series with a 6-month follow-up.

    PubMed

    Friberg, Bertil; Jemt, Torsten

    2012-12-01

    Bony defects/concavities in the aesthetic zone of maxillae may interfere with the results of prosthetic procedures by producing shading superior to the crown. Such regions can be augmented either by bone or soft tissue autografts, allografts, or xenografts. Tissue shrinkage is thus anticipated, and a method to objectively measure the tissue change is valuable. The aim of this study was to evaluate the use of a synthetic, porous material made of polyurethaneurea for buccal soft tissue augmentation in connection with implant placement in the maxillary front region. Further, to measure over time the change in buccal contour using a computerized technique. Ten patients received 12 Artelon® cylinders (5 × 10 mm) in connection to implant placement. Preoperative and postoperative (at 3 and 6 months) study casts were obtained for computer measurements, using the preoperative reference model as a base. The volume created between the surfaces of the reference model and each of the two following superimposed models was measured in cubic millimeter. Differences in volume from pretreatment to 3 and 6 months, respectively, were compared. The clinical observation during follow-up showed normal healing. The increase in mean buccal tissue volume was 50 mm(3) (SD 18) after 3 months and 43 mm(3) (SD 21) after 6 months, measured over a 6 mm × 8 mm area in the maxillary front region, in comparison to before insertion of the cylinder. The reduction from 3 to 6 months was not statistically significant (p = .17). A synthetic, porous material for soft tissue augmentation was tested in connection to implant placement in the aesthetic zone of maxillae. The buccal contour was followed-up for 6 months using a computer volumetric technique on preoperative and postoperative study casts. Measured tissue volume showed an obvious increase during the study period. The material was biologically well received. © 2010 Wiley Periodicals, Inc.

  2. A stringent preemptive protocol reduces cytomegalovirus disease in the first 6 months after kidney transplantation.

    PubMed

    Greiner, M; Cusini, A; Ruesch, M; Schiesser, M; Ledergerber, B; Fehr, T; Mueller, N J

    2012-12-01

    The optimal strategy to prevent cytomegalovirus (CMV) disease after kidney transplantation continues to be open to debate. The preemptive approach requires regular determination of CMV viremia and prompt initiation of therapy. We retrospectively compared the incidence of CMV disease during two periods at our center: A first phase (P1, n = 84 kidney recipients), during which time the intensity of surveillance was determined by the responsible physician, was compared to a second phase (P2, n = 74), when a stringent protocol of CMV surveillance was required for all patients. The preemptive approach was applied for all CMV risk groups; prophylaxis was optional in the case of treatment for rejection or delayed graft function in the intermediate- and high-risk group. Follow-up was truncated at 6 months after transplant surgery. CMV syndrome was differentiated from asymptomatic replication by the presence of at least one systemic symptom, while diagnosis of CMV end-organ disease required histological confirmation. Immunosuppression was similar in the two periods. CMV prophylaxis was used equally (26 %) in both periods. The probability for asymptomatic viremia episodes was not different for patients in P1 and P2 regardless of the prevention strategy. For patients following the preemptive strategy, the probability for CMV disease was increased during P1 (p = 0.016), despite fewer PCR assays being performed in phase 2. Protocol violations were only observed during P1. The probability of CMV disease episodes (CMV syndrome and CMV end-organ disease) was substantially reduced using a very stringent protocol. This study highlights the crucial importance of a stringent protocol with optimal adherence by all caregivers if the preemptive strategy is to be successful.

  3. Nanocrystalline hydroxyapatite bone substitute leads to sufficient bone tissue formation already after 3 months: histological and histomorphometrical analysis 3 and 6 months following human sinus cavity augmentation.

    PubMed

    Ghanaati, Shahram; Barbeck, Mike; Willershausen, Ines; Thimm, Benjamin; Stuebinger, Stefan; Korzinskas, Tadas; Obreja, Karina; Landes, Constantin; Kirkpatrick, Charles J; Sader, Robert A

    2013-12-01

    In this study the de novo bone formation capacity of a nanocrystalline hydroxyapatite bone substitute was assessed 3 and 6 months after its insertion into the human sinus cavity. Sinus cavity augmentation was performed in a total of 14 patients (n = 7 implantation after 3 months; n = 7 implantation after 6 months) with severely atrophic maxillary bone. The specimens obtained after 3 and 6 months were analyzed histologically and histomorphometrically with special focus on bone metabolism within the residual bone and the augmented region. This study revealed that bone tissue formation started from the bone-biomaterial-interface and was directed into the most cranial parts of the augmented region. There was no statistically significant difference in new bone formation after 3 and 6 months (24.89 ± 10.22% vs 31.29 ± 2.29%), respectively. Within the limits of the present study and according to previously published data, implant insertion in regions augmented with this bone substitute material could be considered already after 3 months. Further clinical studies with bone substitute materials are necessary to validate these findings. © 2012 Wiley Periodicals, Inc.

  4. Development of Specific Aspects of Spirituality during a 6-Month Intensive Yoga Practice

    PubMed Central

    Büssing, Arndt; Hedtstück, Anemone; Khalsa, Sat Bir S.; Ostermann, Thomas; Heusser, Peter

    2012-01-01

    The majority of research on yoga focuses on its psychophysiological and therapeutic benefits, while the spiritual aspects are rarely addressed. Changes of specific aspects of spirituality were thus investigated among 160 individuals (91% women, mean age 40.9 ± 8.3 years; 57% Christians) starting a 2-year yoga teacher training. We used standardized questionnaires to measure aspects of spirituality (ASP), mindfulness (FMI—Freiburg Mindfulness Inventory), life satisfaction (BMLSS—Brief Multidimensional Life Satisfaction Scale), and positive mood (lightheartedness/relief). At the start of the course, scores of the respective ASP subscales for search for insight/wisdom, transcendence conviction, and conscious interactions/compassion were high, while those for religious orientation were low. Within the 6 month observation period, both conscious interactions/compassion (effect size, Cohen's d = .33), Religious orientation (d = .21), Lightheartedness/Relief (d = .75) and mindfulness (d = .53) increased significantly. Particularly non-religious/non-spiritual individuals showed moderate effects for an increase of conscious interactions/compassion. The results from this study suggest that an intensive yoga practice (1) may significantly increase specific aspects of practitioners' spirituality, mindfulness, and mood, (2) that these changes are dependent in part on their original spiritual/religious self-perception, and (3) that there are strong correlations amongst these constructs (i.e., conscious interactions/compassion, and mindfulness). PMID:22852023

  5. Percutaneous atrial shunt closure using the novel Occlutech Figulla device: 6-month efficacy and safety.

    PubMed

    Van Den Branden, Ben J L; Post, Martijn C; Plokker, Herbert W M; Ten Berg, Jurriën M; Suttorp, Maarten J

    2011-06-01

    The Occlutech Figulla Occluder is a new innovative device for percutaneous closure of a patent foramen ovale (PFO) and an atrial septum defect (ASD). We describe the safety and efficacy of this new device at 6-month follow-up. All 82 consecutive patients (51% female, mean age 49.0 ± 13.6 years) who underwent percutaneous PFO (n = 48) or ASD (n = 34) closure between October 2008 and October 2009 were included. Implantation success was 100%. The in-hospital complications were two new onset supraventricular tachycardia (SVT) (2.4%, both ASD patients), nine minimal groin hematoma's (11.0%, 4 PFO and 5 ASD patients), and one transient ST elevation during the procedure (1.2%, ASD patient). During 6 months follow-up (n = 79), no major complications or reoccurrences of cerebral thrombo-embolic events did occur. Seven patients (8.9%, 6 PFO and 1 ASD patient) experienced a new SVT. One patient developed a recurrent cerebral hemorrhage 5 months after ASD closure, which appeared not to be related to the procedure. Using contrast transthoracic echocardiography 6 months after PFO closure (n = 45), a residual shunt was present in 30.2% of the patients (small 25.6%, moderate 4.6%, severe 0%). In the ASD group (n = 34), a residual shunt was observed in 32.5% (small 17.7%, moderate 14.7%, severe 2.9%). The Occlutech Figulla Occluder appears to be easy to use, effective, and safe for percutaneous closure of PFO and ASD. We report a low complication rate but a relative high percentage of small residual shunts 6 months after closure. ©2010, Wiley Periodicals, Inc.

  6. Preventive analgesia is associated with reduced pain disability 3 weeks but not 6 months after major gynecologic surgery by laparotomy.

    PubMed

    Katz, Joel; Cohen, Lorenzo

    2004-07-01

    Most studies of preemptive or preventive analgesia restrict outcomes to pain and analgesic consumption in the acute postoperative period. The potential longer-term effects on these and other domains of functioning have received little empirical attention. The purpose of this study was to follow up patients who had received general anesthesia plus epidural fentanyl and lidocaine before (group 1) or after (group 2) incision or general anesthesia plus a sham epidural (group 3). Patients were contacted approximately 3 weeks and 6 months after surgery. A follow-up pain questionnaire and the McGill Pain Questionnaire were administered by telephone. The Mental Health Inventory and Pain Disability Index were mailed to patients, completed, and mailed back. One hundred thirty-one of the 141 patients (93%) were reached 3 weeks after surgery (n = 41, n = 48, and n = 42 in groups 1, 2, and 3, respectively), and 109 (77%) were reached at 6 months (n = 35, n = 37, and n = 37 in groups 1, 2, and 3, respectively). Multivariate analysis of covariance indicated that that even after controlling for age and presence or absence of preoperative pain, Pain Disability Index scores (mean +/- SD) at the first follow-up were significantly lower in group 1 (17.3 +/-12.8) and group 2 (18.1 +/-17.0) compared with group 3 (26.3 +/- 18.3). McGill Pain Questionnaire and Mental Health Inventory scores did not differ significantly among the groups. There were no significant differences at the 6-month follow-up. The short-term beneficial effects of preventive epidural analgesia translated into less pain disability 3 weeks after surgery. Progress in understanding the processes involved in postsurgical recovery and the risk factors for chronic postsurgical pain would be aided by baseline and postsurgical measures of relevant psychological, emotional, and physical variables.

  7. Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months.

    PubMed

    Genco, Alfredo; Maselli, Roberta; Frangella, Francesca; Cipriano, Massimiliano; Forestieri, Pietro; Delle Piane, Daniela; Furbetta, Francesco; Micheletto, Giancarlo; Ciampaglia, Franco; Granelli, Paola; Zilli, Maurizio; Lorenzo, Michele; Di Rocco, Giorgio; Giannotti, Domenico; Redler, Adriano

    2015-08-01

    Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.

  8. Infant sleep and paternal involvement in infant caregiving during the first 6 months of life.

    PubMed

    Tikotzky, Liat; Sadeh, Avi; Glickman-Gavrieli, Tamar

    2011-01-01

    The goals of this study were to assess: (a) the involvement of fathers and mothers in overall and nighttime infant caregiving; (b) the links between paternal involvement in infant care and infant sleep patterns during the first 6 months. Fifty-six couples recruited during their first pregnancy, participated in the study. After delivery (1 and 6 months), both parents completed a questionnaire assessing the involvement of fathers relative to mothers in infant caregiving. Infant sleep was assessed using actigraphy and sleep diaries. Mothers were significantly more involved than fathers in daytime and nighttime caregiving. A higher involvement of fathers in overall infant care predicted and was associated with fewer infant night-wakings and with shorter total sleep time after controlling for breastfeeding. The findings highlight the importance of including fathers in developmental sleep research. Future studies should explore mechanisms underlying the relations between paternal involvement and infant sleep.

  9. Internalized stigma of mental illness and depressive and psychotic symptoms in homeless veterans over 6 months.

    PubMed

    Boyd, Jennifer E; Hayward, H'Sien; Bassett, Elena D; Hoff, Rani

    2016-06-30

    We investigated the relationship between internalized stigma of mental illness at baseline and depressive and psychotic symptoms 3 and 6 months later, controlling for baseline symptoms. Data on homeless veterans with severe mental illness (SMI) were provided by the Northeast Program Evaluation Center (NEPEC) Special Needs-Chronic Mental Illness (SN-CMI) study (Kasprow and Rosenheck, 2008). The study used the Internalized Stigma of Mental Illness (ISMI) scale to measure internalized stigma at baseline and the Symptom Checklist-90-R (SCL-90-R) to measure depressive and psychotic symptoms at baseline and 3 and 6 month follow-ups. Higher levels of internalized stigma were associated with greater levels of depressive and psychotic symptoms 3 and 6 months later, even controlling for symptoms at baseline. Alienation and Discrimination Experience were the subscales most strongly associated with symptoms. Exploratory analyses of individual items yielded further insight into characteristics of potentially successful interventions that could be studied. Overall, our findings show that homeless veterans with SMI experiencing higher levels of internalized stigma are likely to experience more depression and psychosis over time. This quasi-experimental study replicates and extends findings of other studies and has implications for future controlled research into the potential long-term effects of anti-stigma interventions on mental health recovery.

  10. Effects of perioperative factors and hip geometry on hip abductor muscle strength during the first 6 months after anterolateral total hip arthroplasty

    PubMed Central

    Ikeda, Takashi; Jinno, Tetsuya; Aizawa, Junya; Masuda, Tadashi; Hirakawa, Kazuo; Ninomiya, Kazunari; Suzuki, Kouji; Morita, Sadao

    2017-01-01

    [Purpose] The importance and effect of hip joint geometry on hip abductor muscle strength are well known. In addition, other perioperative factors are also known to affect hip abductor muscle strength. This study examined the relative importance of factors affecting hip abductor muscle strength after total hip arthroplasty. [Subjects and Methods] The subjects were 97 females with osteoarthritis scheduled for primary unilateral THA. The following variables were assessed preoperatively and 2 and 6 months after surgery: isometric hip abductor strength, radiographic analysis (Crowe class, postoperative femoral offset (FO)), Frenchay Activities Index, compliance rate with home exercise, Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire (JHEQ), and demographic data. Factors related to isometric hip abductor muscle strength 2 and 6 months after surgery were examined. [Results] Significant factors related to isometric hip abductor muscle strength at 2 and 6 months after surgery were, in extraction order: 1. isometric hip abductor muscle strength in the preoperative period; 2. BMI; and 3. the JHEQ mental score at 2 and 6 months after surgery. [Conclusion] Preoperative factors and postoperative mental status were related to postoperative isometric hip abductor strength. FO was not extracted as a significant factor related to postoperative isomeric hip abductor strength. PMID:28265161

  11. Effects of perioperative factors and hip geometry on hip abductor muscle strength during the first 6 months after anterolateral total hip arthroplasty.

    PubMed

    Ikeda, Takashi; Jinno, Tetsuya; Aizawa, Junya; Masuda, Tadashi; Hirakawa, Kazuo; Ninomiya, Kazunari; Suzuki, Kouji; Morita, Sadao

    2017-02-01

    [Purpose] The importance and effect of hip joint geometry on hip abductor muscle strength are well known. In addition, other perioperative factors are also known to affect hip abductor muscle strength. This study examined the relative importance of factors affecting hip abductor muscle strength after total hip arthroplasty. [Subjects and Methods] The subjects were 97 females with osteoarthritis scheduled for primary unilateral THA. The following variables were assessed preoperatively and 2 and 6 months after surgery: isometric hip abductor strength, radiographic analysis (Crowe class, postoperative femoral offset (FO)), Frenchay Activities Index, compliance rate with home exercise, Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire (JHEQ), and demographic data. Factors related to isometric hip abductor muscle strength 2 and 6 months after surgery were examined. [Results] Significant factors related to isometric hip abductor muscle strength at 2 and 6 months after surgery were, in extraction order: 1. isometric hip abductor muscle strength in the preoperative period; 2. BMI; and 3. the JHEQ mental score at 2 and 6 months after surgery. [Conclusion] Preoperative factors and postoperative mental status were related to postoperative isometric hip abductor strength. FO was not extracted as a significant factor related to postoperative isomeric hip abductor strength.

  12. Histological assessment of porous custom-made hydroxyapatite implants 6 months and 2.5 years after cranioplasty

    PubMed Central

    Ono, Hajime; Sase, Taigen; Tanaka, Yuichiro; Takasuna, Hiroshi

    2017-01-01

    Background: In cranial reconstruction, the features of artificial bone differ. Custom-made porous hydroxyapatite (HAp) implants for cranioplasty have been used all over the world because of their good cosmetic, biocompatibility, and osteoconductive properties. Surgical techniques were analyzed, and histological assessment of new bone formation in the hydroxyapatite was performed. Methods: Over a 6-year time period, 41 patients underwent cranioplasty using a custom-made three-dimensional hybrid pore structured hydroxyapatite (3DHPoHAp) implant. The surgical techniques and histological evaluations of 3DHPoHAp in 2 cases, removed 6 months and 2.5 years after cranioplasty, are described. Results: Using 3DHPoHAp, cranioplasty was successfully performed for all patients. The implant fit the bone defect exactly, and surgical manoeuvres were simple and easy. All implants were firmly fixed using a titanium plate, and postoperative infection occurred in 1 patient (2.4%). New bone formation was seen in 2 cases 6 months and 2.5 years after cranioplasty. Osteoblasts were progressing to the stoma at various depths, and bone tissue had ripened. Furthermore, lamellar structure was observed in the case at 2.5 years. Conclusions: In this study, there was a low infection rate, and new bone formation was seen in vivo after cranioplasty. This study also demonstrated that the 3DHPoHAp implant is a good candidate for cranial bone implants because its good osteoconductivity and biocompatibility. PMID:28217387

  13. Lack of long-term benefits of a 6-month heart failure disease management program.

    PubMed

    Nguyen, Viviane; Ducharme, Anique; White, Michel; Racine, Normand; O'Meara, Eileen; Zhang, Bin; Rouleau, Jean L; Brophy, James

    2007-05-01

    Heart failure (HF) represents a major burden on the health care system, causing repeated hospitalizations and numerous emergency department (ED) visits. In a 6-month randomized study of a multidisciplinary HF clinic, we have previously shown decreased hospital readmissions and improved quality of life. Despite these encouraging results, it is unknown if these beneficial effects are sustained. To assess long-term recurrent ED visits, readmissions, and mortality among HF patients who were discharged after a 6-month intensive HF management program (HFMP). Of the 230 subjects (New York Heart Association Class II-IV) who were initially randomized to standard follow-up care or to a HFMP for 6 months, 190 were studied retrospectively for long-term evaluation. Long-term data was obtained from the Quebec administrative health databases. We compared the intervention and control groups for the number of recurrent ED visits, hospital readmissions, and all-cause deaths. After a mean follow-up of 2.8 +/- 1.7 years, there was no difference in the composite end point of all-cause death, hospital admissions, and ED visits between those patients initially in the HFMP group and the controls. After multivariable adjustment, there was no difference in the composite primary endpoint (HR 1.01, 95% CI: 0.75-1.37) or in the secondary end point of all-cause death alone (HR 1.09, 95%CI:0.69-1.72) between those initially assigned to the HF clinic and those receiving usual care. For severely ill patients, the clinical and resource benefits of a 6-month HFMP are not sustained upon program cessation. Further research into the benefits of long-term HFMP is required.

  14. Scar outcome of children with partial thickness burns: A 3 and 6 month follow up.

    PubMed

    Gee Kee, E L; Kimble, R M; Cuttle, L; Stockton, K A

    2016-02-01

    There is a paucity of research investigating the scar outcome of children with partial thickness burns. The aim of this study was to assess the scar outcome of children with partial thickness burns who received a silver dressing acutely. Children aged 0-15 years with an acute partial thickness burn, ≤10% TBSA were included. Children were originally recruited for an RCT investigating three dressings for partial thickness burns. Children were assessed at 3 and 6 months after re-epithelialization. 3D photographs were taken of the burn site, POSAS was completed and skin thickness was measured using ultrasound imaging. Forty-three children returned for 3 and 6 month follow-ups or returned a photo. Days to re-epithelialization was a significant predictor of skin/scar quality at 3 and 6 months (p<0.01). Patient-rated color and observer-rated vascularity and pigmentation POSAS scores were comparable at 3 months (color vs. vascularity 0.88, p<0.001; color vs. pigmentation 0.64, p<0.001), but patients scored higher than the observer at 6 months (color vs. vascularity 0.57, p<0.05; color vs. pigmentation 0.15, p=0.60). Burn depth was significantly correlated with skin thickness (r=0.51, p<0.01). Hypopigmentation of the burn site was present in 25.8% of children who re-epithelialized in ≤ 2 weeks. This study has provided information on outcomes for children with partial thickness burns and highlighted a need for further education of this population. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  15. Factors affecting exclusive breast-feeding during the first 6 months in Korea.

    PubMed

    Kim, Myo Jing; Kim, Yu-Mi; Yoo, Jae-Ho

    2013-04-01

    The aim of this study was to identify the status of exclusive breast-feeding (EBF) in Korea and analyze the factors affecting exclusive breast-feeding at 6 months of age. This study was based on data obtained from the Korea National Health and Nutrition Examination Survey (KNHANES) IV, conducted from January 2007 to December 2008. A total of 404 mother-infant pairs were recruited. Exclusive breast-feeding was defined according to the criteria established by the World Health Organization. The rate of EBF was 60.9% for 1 month, 55.0% for 3 months, 35.4% for 6 months, 3.7% for 9 months and 1.2% for 12 months after birth. According to a stepwise logistic regression analysis, factors that were positively associated with EBF at 6 months were younger maternal age (odds ratio [OR] = 0.85, 95% confidence interval [CI]: 0.79-0.92), higher maternal education level (OR = 2.29, 95%CI: 1.17-4.46) and living in a capital city (OR = 2.64, 95%CI: 1.46-4.75). The rate of EBF in Korea is still suboptimal. To promote EBF, persistent and systematic education and campaigns for breast-feeding should be provided, particularly in vulnerable regions. © 2012 The Authors. Pediatrics International © 2012 Japan Pediatric Society.

  16. Hardwood smoke alters murine splenic T cell responses to mitogens following a 6-month whole body inhalation exposure

    SciTech Connect

    Burchiel, Scott W. . E-mail: Sburchiel@salud.unm.edu; Lauer, Fredine T.; Dunaway, Sandy L.; Zawadzki, Jerome; McDonald, Jacob D.; Reed, Matthew D.

    2005-02-01

    The purpose of these studies was to assess the effects of hardwood smoke (HWS) inhalation (30-1000 {mu}g/m{sup 3}) on the systemic immune responses of A/J mice evaluated after 6 months of daily exposures. Spleen cells obtained from mice were assessed for changes in cell number, cell surface marker expression [B, T, macrophage, and natural killer (NK) cells], and responses to B cell (LPS, endotoxin) and T cell (Con A) mitogens. Results showed that HWS smoke increased T cell proliferation in the 100 {mu}g/m{sup 3} exposure group and produced a concentration-dependent suppression of T cell proliferation at concentrations >300 {mu}g/m{sup 3}. There were no effects on B cell proliferation or in spleen cell surface marker expression. Analyses of the exposure atmospheres revealed the presence of significant levels of naphthalene and methylated napthalenes, fluorene, phenanthrene, and anthracene in the exposure chambers, as well as low concentrations of several metals (K, Ca, and Fe). Our results demonstrate that environmentally relevant concentrations of HWS may be immunosuppressive to the immune system of mice exposed during a 6-month period.

  17. Effects of 6 months of moderate aerobic exercise training on immune function in the elderly.

    PubMed

    Woods, J A; Ceddia, M A; Wolters, B W; Evans, J K; Lu, Q; McAuley, E

    1999-06-01

    The purpose of this study was to determine the effects of 6 months of moderate aerobic exercise on age-dysregulated measures of T lymphocyte and natural killer (NK) cell number and function. Previously sedentary elderly (age = 65 +/- 0.8 years) subjects were randomly assigned to supervised 3 time/week exercise intervention group (EXC, n = 14) or flexibility/toning control group (FT-CON, n = 15). Fasting resting blood samples were drawn prior to and after the 6 month intervention. The EXC group exhibited a significant (P < 0.05) 20% increase in VO2 max, whereas the FT-CON group had a smaller non-significant (P = 0.07) increase (9%). Immune results revealed that, in general, changes in immune function in response to 6 months of exercise training at an average intensity of 52% heart rate reserve (HRR) were similar when compared to FT-CON who exercised at approximately 21% HRR. There were no intervention-induced changes in total white blood cell, neutrophil, lymphocyte, monocyte, eosinophil, or basophil blood counts. Furthermore, the percentage and number of CD3+, CD4+ and CD8+ T cells in the blood remained unchanged. There was a tendency for the percentage and number of CD4+ and CD8+ näive cells (CD45RA+) to increase and for CD4+ memory cells (CD45RO+) to decrease post-intervention, especially in FT-CON. Both groups exhibited a small intervention-induced increase in the T-cell proliferative response to mitogenic stimulation: the percentage change of which was higher in the EXC group at several doses of Con A. Unstimulated NK cell cytolysis versus K562 cells tended to increase (P < 0.1) in the EXC group with little change in FT-CON. We conclude that 6 months of supervised exercise training can lead to nominal increases in some measures of immune function, while not affecting others, in previously sedentary elderly.

  18. Validated Risk Score for Predicting 6-Month Mortality in Infective Endocarditis.

    PubMed

    Park, Lawrence P; Chu, Vivian H; Peterson, Gail; Skoutelis, Athanasios; Lejko-Zupa, Tatjana; Bouza, Emilio; Tattevin, Pierre; Habib, Gilbert; Tan, Ren; Gonzalez, Javier; Altclas, Javier; Edathodu, Jameela; Fortes, Claudio Querido; Siciliano, Rinaldo Focaccia; Pachirat, Orathai; Kanj, Souha; Wang, Andrew

    2016-04-18

    Host factors and complications have been associated with higher mortality in infective endocarditis (IE). We sought to develop and validate a model of clinical characteristics to predict 6-month mortality in IE. Using a large multinational prospective registry of definite IE (International Collaboration on Endocarditis [ICE]-Prospective Cohort Study [PCS], 2000-2006, n=4049), a model to predict 6-month survival was developed by Cox proportional hazards modeling with inverse probability weighting for surgery treatment and was internally validated by the bootstrapping method. This model was externally validated in an independent prospective registry (ICE-PLUS, 2008-2012, n=1197). The 6-month mortality was 971 of 4049 (24.0%) in the ICE-PCS cohort and 342 of 1197 (28.6%) in the ICE-PLUS cohort. Surgery during the index hospitalization was performed in 48.1% and 54.0% of the cohorts, respectively. In the derivation model, variables related to host factors (age, dialysis), IE characteristics (prosthetic or nosocomial IE, causative organism, left-sided valve vegetation), and IE complications (severe heart failure, stroke, paravalvular complication, and persistent bacteremia) were independently associated with 6-month mortality, and surgery was associated with a lower risk of mortality (Harrell's C statistic 0.715). In the validation model, these variables had similar hazard ratios (Harrell's C statistic 0.682), with a similar, independent benefit of surgery (hazard ratio 0.74, 95% CI 0.62-0.89). A simplified risk model was developed by weight adjustment of these variables. Six-month mortality after IE is ≈25% and is predicted by host factors, IE characteristics, and IE complications. Surgery during the index hospitalization is associated with lower mortality but is performed less frequently in the highest risk patients. A simplified risk model may be used to identify specific risk subgroups in IE. © 2016 The Authors. Published on behalf of the American Heart

  19. Opioid use among low back pain patients in primary care: Is opioid prescription associated with disability at 6-month follow-up?

    PubMed

    Ashworth, Julie; Green, Daniel J; Dunn, Kate M; Jordan, Kelvin P

    2013-07-01

    Opioid prescribing for chronic noncancer pain is increasing, but there is limited knowledge about longer-term outcomes of people receiving opioids for conditions such as back pain. This study aimed to explore the relationship between prescribed opioids and disability among patients consulting in primary care with back pain. A total of 715 participants from a prospective cohort study, who gave consent for review of medical and prescribing records and completed baseline and 6month follow-up questionnaires, were included. Opioid prescription data were obtained from electronic prescribing records, and morphine equivalent doses were calculated. The primary outcome was disability (Roland-Morris Disability Questionnaire [RMDQ]) at 6months. Multivariable linear regression was used to examine the association between opioid prescription at baseline and RMDQ score at 6months. Analyses were adjusted for potential confounders using propensity scores reflecting the probability of opioid prescription given baseline characteristics. In the baseline period, 234 participants (32.7%) were prescribed opioids. In the final multivariable analysis, opioid prescription at baseline was significantly associated with higher disability at 6-month follow-up (P<.022), but the magnitude of this effect was small, with a mean RMDQ score of 1.18 (95% confidence interval: 0.17 to 2.19) points higher among those prescribed opioids compared to those who were not. Our findings indicate that even after adjusting for a substantial number of potential confounders, opioids were associated with slightly worse functioning in back pain patients at 6-month follow-up. Further research may help us to understand the mechanisms underlying these findings and inform clinical decisions regarding the usefulness of opioids for back pain.

  20. Age-specific average head template for typically developing 6-month-old infants.

    PubMed

    Akiyama, Lisa F; Richards, Todd R; Imada, Toshiaki; Dager, Stephen R; Wroblewski, Liv; Kuhl, Patricia K

    2013-01-01

    Due to the rapid anatomical changes that occur within the brain structure in early human development and the significant differences between infant brains and the widely used standard adult templates, it becomes increasingly important to utilize appropriate age- and population-specific average templates when analyzing infant neuroimaging data. In this study we created a new and highly detailed age-specific unbiased average head template in a standard MNI152-like infant coordinate system for healthy, typically developing 6-month-old infants by performing linear normalization, diffeomorphic normalization and iterative averaging processing on 60 subjects' structural images. The resulting age-specific average templates in a standard MNI152-like infant coordinate system demonstrate sharper anatomical detail and clarity compared to existing infant average templates and successfully retains the average head size of the 6-month-old infant. An example usage of the average infant templates transforms magnetoencephalography (MEG) estimated activity locations from MEG's subject-specific head coordinate space to the standard MNI152-like infant coordinate space. We also created a new atlas that reflects the true 6-month-old infant brain anatomy. Average templates and atlas are publicly available on our website (http://ilabs.washington.edu/6-m-templates-atlas).

  1. Repairing the Brain by SCF+G-CSF Treatment at 6 Months Postexperimental Stroke

    PubMed Central

    Cui, Lili; Wang, Dandan; McGillis, Sandra; Kyle, Michele

    2016-01-01

    Stroke, a leading cause of adult disability in the world, is a severe medical condition with limited treatment. Physical therapy, the only treatment available for stroke rehabilitation, appears to be effective within 6 months post-stroke. Here, we have mechanistically determined the efficacy of combined two hematopoietic growth factors, stem cell factor (SCF) and granulocyte-colony stimulating factor (G-CSF; SCF + G-CSF), in brain repair 6 months after cortical infarct induction in the transgenic mice carrying yellow fluorescent protein in Layer V pyramidal neurons (Thy1-YFP-H). Using a combination of live brain imaging, whole brain imaging, molecular manipulation, synaptic and vascular assessments, and motor function examination, we found that SCF + G-CSF promoted mushroom spine formation, enlarged postsynaptic membrane size, and increased postsynaptic density-95 accumulation and blood vessel density in the peri-infarct cavity cortex; and that SCF + G-CSF treatment improved motor functional recovery. The SCF + G-CSF-enhanced motor functional recovery was dependent on the synaptic and vascular regeneration in the peri-infarct cavity cortex. These data suggest that a stroke-damaged brain is repairable by SCF + G-CSF even 6 months after the lesion occurs. This study provides novel insights into the development of new restorative strategies for stroke recovery. PMID:27511907

  2. Thymus size at 6 months of age and subsequent child mortality.

    PubMed

    Garly, May-Lill; Trautner, Sisse Lecanda; Marx, Charlotte; Danebod, Kamilla; Nielsen, Jens; Ravn, Henrik; Martins, Cesário Lourenco; Balé, Carlito; Aaby, Peter; Lisse, Ida Maria

    2008-11-01

    To examine determinants of thymus size at age 6 months and investigate whether thymus size at this age is a determinant of subsequent mortality. Thymus size was measured by transsternal sonography in 923 6-month-old children participating in a measles vaccination trial in Guinea-Bissau. Thymus size was strongly associated with anthropometric measurements. Boys had larger thymuses than girls, controlling for anthropometry. Crying during sonography made the thymus appear smaller. Children who were not vaccinated with Bacille Calmette-Guérin (BCG) or were vaccinated with BCG in the preceding 4 weeks before inclusion into the study had larger thymuses. Children who had malaria or had been treated with chloroquine or Quinimax in the previous week before inclusion had smaller thymuses. Controlled for background factors associated with thymus size and mortality, small thymus size remained a strong and independent risk factor for mortality (hazard ratio = 0.31; 95% confidence interval = 0.18 to 0.52). Small thymus size at age 6 months is a strong risk factor for mortality. To prevent unnecessary deaths, it is important to identify preventable factors predisposing to small thymus size.

  3. Aspartate aminotransferase activity in the pulp of teeth treated for 6 months with fixed orthodontic appliances

    PubMed Central

    Latkauskiene, Dalia; Racinskaite, Vilma; Skucaite, Neringa; Machiulskiene, Vita

    2015-01-01

    Objective To measure aspartate aminotransferase (AST) activity in the pulp of teeth treated with fixed appliances for 6 months, and compare it with AST activity measured in untreated teeth. Methods The study sample consisted of 16 healthy subjects (mean age 25.7 ± 4.3 years) who required the extraction of maxillary premolars for orthodontic reasons. Of these, 6 individuals had a total of 11 sound teeth extracted without any orthodontic treatment (the control group), and 10 individuals had a total of 20 sound teeth extracted after 6 months of orthodontic alignment (the experimental group). Dental pulp samples were extracted from all control and experimental teeth, and the AST activity exhibited by these samples was determined spectrophotometrically at 20℃. Results Mean AST values were 25.29 × 10-5 U/mg (standard deviation [SD] 9.95) in the control group and 27.54 × 10-5 U/mg (SD 31.81) in the experimental group. The difference between these means was not statistically significantly (p = 0.778), and the distribution of the AST values was also similar in both groups. Conclusions No statistically significant increase in AST activity in the pulp of mechanically loaded teeth was detected after 6 months of orthodontic alignment, as compared to that of teeth extracted from individuals who had not undergone orthodontic treatment. This suggests that time-related regenerative processes occur in the dental pulp. PMID:26445721

  4. Sinus Augmentation with Biomimetic Nanostructured Matrix: Tomographic, Radiological, Histological and Histomorphometrical Results after 6 Months in Humans

    PubMed Central

    Scarano, Antonio; Lorusso, Felice; Staiti, Giorgio; Sinjari, Bruna; Tampieri, Anna; Mortellaro, Carmen

    2017-01-01

    Background: Many bone substitutes have been applied for sinus regeneration procedures, such as autogenous bone, inorganic bovine bone, porous and resorbable hydroxyapatite, tricalcium phosphate, bioactive glass, and blood clots. The aim of the present study was a tomographic, histological and histomorphometrical evaluation in humans, of specimens retrieved from sinuses augmented with MgHA/collagen-based scaffolds, after a healing period of 6 months. Materials and Methods: Eleven healthy patients and a total of 15 sinuses were included in this study. The maxillary sinuses were filled with commercial MgHA/collagen-based scaffolds (RegenOss) with a porous three-dimensional (3D) structure (Fin-Ceramica Faenza S.p.A., Faenza, Italy). These grafts have a composite design, that replicate the organization of bone structure, obtained by a technique in which a specific hybrid organic–inorganic composite is spontaneously built by a biological mechanism. The CBCT scans were done before the procedure, after the surgical protocol (T1), and 6 months after sinus surgery (T2) for implantology. Bone specimens were stored in 10% formalin solution, embedded in a glycolmethacrylate resin and sectioned by a high-precision diamond disc. Histologic and histomorphometric analysis were carried out to evaluate the graft reabsorption and bone healing. Results: The mean volume after graft elevation, calculated for each of the 15 sinuses, was 2,906 mm3 in the immediate postoperative period (5–7 days), ranging from 2,148.8 to 3,146.4 mm3. In the late postoperative period (6 months) it was 2,806.7 mm3, ranging from 2,010.9 to 3,008.9 mm3. The sinuses were completely healed and no residual MgHA/collagen-based scaffolds were visible. Osteoblasts appeared actively secreting bone matrix and marrow spaces contained moderate numbers of stromal cells and vascular network. Osteoblasts were observed actively secreting osteoid matrix. The tissues present in the samples were composed of 1.9 ± 1.9% of

  5. Sinus Augmentation with Biomimetic Nanostructured Matrix: Tomographic, Radiological, Histological and Histomorphometrical Results after 6 Months in Humans.

    PubMed

    Scarano, Antonio; Lorusso, Felice; Staiti, Giorgio; Sinjari, Bruna; Tampieri, Anna; Mortellaro, Carmen

    2017-01-01

    Background: Many bone substitutes have been applied for sinus regeneration procedures, such as autogenous bone, inorganic bovine bone, porous and resorbable hydroxyapatite, tricalcium phosphate, bioactive glass, and blood clots. The aim of the present study was a tomographic, histological and histomorphometrical evaluation in humans, of specimens retrieved from sinuses augmented with MgHA/collagen-based scaffolds, after a healing period of 6 months. Materials and Methods: Eleven healthy patients and a total of 15 sinuses were included in this study. The maxillary sinuses were filled with commercial MgHA/collagen-based scaffolds (RegenOss) with a porous three-dimensional (3D) structure (Fin-Ceramica Faenza S.p.A., Faenza, Italy). These grafts have a composite design, that replicate the organization of bone structure, obtained by a technique in which a specific hybrid organic-inorganic composite is spontaneously built by a biological mechanism. The CBCT scans were done before the procedure, after the surgical protocol (T1), and 6 months after sinus surgery (T2) for implantology. Bone specimens were stored in 10% formalin solution, embedded in a glycolmethacrylate resin and sectioned by a high-precision diamond disc. Histologic and histomorphometric analysis were carried out to evaluate the graft reabsorption and bone healing. Results: The mean volume after graft elevation, calculated for each of the 15 sinuses, was 2,906 mm(3) in the immediate postoperative period (5-7 days), ranging from 2,148.8 to 3,146.4 mm(3). In the late postoperative period (6 months) it was 2,806.7 mm(3), ranging from 2,010.9 to 3,008.9 mm(3). The sinuses were completely healed and no residual MgHA/collagen-based scaffolds were visible. Osteoblasts appeared actively secreting bone matrix and marrow spaces contained moderate numbers of stromal cells and vascular network. Osteoblasts were observed actively secreting osteoid matrix. The tissues present in the samples were composed of 1.9 ± 1

  6. The role of anxiety and other factors in predicting postnatal fatigue: from birth to 6 months.

    PubMed

    Taylor, Jan; Johnson, Maree

    2013-05-01

    to explore the role of anxiety and other factors in predicting postnatal fatigue from birth to 6 months. a prospective longitudinal correlational survey design. Canberra, Australian Capital Territory, Australia. 504 well women, 233 primipara and 271 multipara, aged 20-40 years who gave birth during the study period. the Postpartum Fatigue Scale, the State-Trait Anxiety Inventory, the Edinburgh Postnatal Depression Scale, and the Support Behavior Inventory were used to measure the relationship between the predictive factors and the intensity of fatigue at the various time points. an explanatory model of fatigue development was applied to all participants, and then to primiparas and multiparas, explaining 27-44% of the variance in fatigue from 1 to 24 weeks in the total sample (p>.001). State anxiety was a consistently strong predictor of fatigue intensity across time and group. the contribution that state anxiety made to the development of fatigue in this group of low risk women highlights the importance of assessing symptoms of anxiety in all childbearing women. Focusing on depressive symptoms limits the extent to which anxiety symptoms, which occur in parallel with depressive symptoms, are addressed. Anxiety is a normal response to the changes in roles and responsibilities that occur following birth. However the belief that all new mothers worry excessively and that anxiety is not as harmful as depression may have influenced the way midwives and maternal child health nurses view postnatal anxiety. Assessment of anxiety, and use of interventions such as cognitive and behavioural strategies and self-care practices, can be used to assist women to reduce anxiety levels. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. Progression of brain atrophy in PSP and CBS over 6 months and 1 year.

    PubMed

    Dutt, Shubir; Binney, Richard J; Heuer, Hilary W; Luong, Phi; Attygalle, Suneth; Bhatt, Priyanka; Marx, Gabe A; Elofson, Jonathan; Tartaglia, Maria C; Litvan, Irene; McGinnis, Scott M; Dickerson, Bradford C; Kornak, John; Waltzman, Dana; Voltarelli, Lisa; Schuff, Norbert; Rabinovici, Gil D; Kramer, Joel H; Jack, Clifford R; Miller, Bruce L; Rosen, Howard J; Boxer, Adam L

    2016-11-08

    To examine the utility and reliability of volumetric MRI in measuring disease progression in the 4 repeat tauopathies, progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS), to support clinical development of new tau-directed therapeutic agents. Six- and 12-month changes in regional MRI volumes and PSP Rating Scale scores were examined in 55 patients with PSP and 33 patients with CBS (78% amyloid PET negative) compared to 30 normal controls from a multicenter natural history study. Longitudinal voxel-based morphometric analyses identified patterns of volume loss, and region-of-interest analyses examined rates of volume loss in brainstem (midbrain, pons, superior cerebellar peduncle), cortical, and subcortical regions based on previously validated atlases. Results were compared to those in a replication cohort of 226 patients with PSP with MRI data from the AL-108-231 clinical trial. Patients with CBS exhibited greater baseline atrophy and greater longitudinal atrophy rates in cortical and basal ganglia regions than patients with PSP; however, midbrain and pontine atrophy rates were similar. Voxel-wise analyses showed distinct patterns of regional longitudinal atrophy in each group as compared to normal controls. The midbrain/pons volumetric ratio differed between diagnoses but remained stable over time. In both patient groups, brainstem atrophy rates were correlated with disease progression measured using the PSP Rating Scale. Volume loss is quantifiable over a period of 6 months in CBS and PSP. Future clinical trials may be able to combine CBS and PSP to measure therapeutic effects. © 2016 American Academy of Neurology.

  8. The effects of continuous antidepressant treatment during the first 6 months on relapse or recurrence of depression.

    PubMed

    Kim, Kyoung-Hoon; Lee, Seung-Mi; Paik, Jong-Woo; Kim, Nam-Soon

    2011-07-01

    To examine whether continuous antidepressant treatment during the first 6 month reduces the risk of relapse/recurrence of depression in South Korea. We used National Health Insurance Data covering the period from 2001 through 2004. The study population consisted of 117,087 adult patients who received antidepressants after being diagnosed with depression. The continuous antidepressant was defined as evidence of antidepressant prescriptions for 75% of the first 6 months of treatment. Relapse or recurrence during the next 18-month period was defined by evidence of a new episode requiring antidepressant treatment, psychiatric hospitalization, electroconvulsive therapy, emergency department visit or attempted suicide. We compared the relapse/recurrence rate during the 18-month follow-up period in patients receiving continuous treatment and those who discontinued early using a Cox's proportional hazard model. Patients receiving continuous antidepressant treatment experienced a lower risk of relapse/recurrence (Hazard ratio: 0.42, 95% CI: 0.40-0.44). Three or more follow-up visits in the first 3 months also reduced the risk of relapse/recurrence. Factors associated with a significant increase of relapse/recurrence were comorbid medical illness, anxiety disorder, and alcohol abuse. The small benefit of SSRIs was appeared only in the early discontinued treatment subgroup, not in the continuous treatment subgroup. We were not able to consider the antidepressant utilization pattern. Continuous antidepressant treatment and frequent follow-up visits during the acute phase were associated with a significant reduction in the likelihood of relapse or recurrence of depression. Our results provide important evidence on the effectiveness of antidepressant treatment in South Korea. Copyright © 2011 Elsevier B.V. All rights reserved.

  9. Finding the 'who' in whooping cough: vaccinated siblings are important pertussis sources in infants 6 months of age and under.

    PubMed

    Bertilone, Christina; Wallace, Tania; Selvey, Linda A

    2014-09-30

    To describe the epidemiology of pertussis, and to identify changes in the source of pertussis in infants 6 months of age and under, during the 2008-2012 epidemic in south metropolitan Perth. Analysis of all pertussis cases notified to the South Metropolitan Population Health Unit and recorded on the Western Australian Notifiable Infectious Disease Database over the study period. Information on the source of pertussis was obtained from enhanced surveillance data. Notification rates were highest in the 5-9 years age group, followed by the 0-4 years and 10-14 years age groups. There was a significant increase in the proportion of known sources who were siblings from the early epidemic period of 2008-2010, compared with the peak epidemic period of 2011-2012 (14.3% versus 51.4%, p = 0.002). The majority of sibling sources were fully vaccinated children aged 2 and 3 years. The incidence of pertussis was highest in children aged 12 years and under in this epidemic. At its peak, siblings were the most important sources of pertussis in infants 6 months and younger, particularly fully vaccinated children aged 2 and 3 years. Waning immunity before the booster at 4 years may leave this age group susceptible to infection. Even if cocooning programs could achieve full vaccination coverage of parents and ensure all siblings were fully vaccinated according to national schedules, waning immunity in siblings could provide a means for ongoing transmission to infants. Recent evidence suggests that maternal antenatal vaccination would significantly reduce the risk of pertussis in infants 3 months of age and under.

  10. To Compare the Microleakage Among Experimental Adhesives Containing Nanoclay Fillers after the Storages of 24 Hours and 6 Months

    PubMed Central

    Mousavinasab, Seyed Mostafa; Atai, Mohammad; Alavi, Bagher

    2011-01-01

    Objectives: To compare the microleakage among experimental adhesives containing nanoclay fillers after the storages of 24 hours and 6 months. Materials and Methods: Class V cavities were prepared on extracted human molars with the occlusal margins located in enamel and the cervical margins in cementum. Phosphoric acid was applied to the enamel and dentin margins.Subsequently, the cavities were treated using four groups of experimental adhesive systems and restored with a resin composite. Adper Single Bond® was used as control group. After 24- hour and 6- month storages, the samples were subjected to thermocycling shocks and then immersed in silver nitrate as well as developer solution and finally evaluated for leakage. The data were analyzed using SPSS software. Results: Based on Kruskal –Wallis test, significant differences were found between groups regarding microleakage. The Mann- Whitney test showed that Leakage was significantly lower in Adper Single Bond® compared to the other groups in dentinal margins after 24 hours and 6 months and in enamel margins after 6 months. The Wilcoxon Signed Ranks test showed that the enamel leakage in experimental adhesives was significantly lower than dentinal leakage after 24 hours as well as enamel leakage in Adper Single Bond and adhesive with 0.5% PMAA-g-nanoclay was significantly lower than dentinal margins after storage period of 6 months. Conclusion: All the experimental adhesives were effective in reducing enamel leakage after 24 hours, but were not effective in reducing dentinal leakage after 24 hours as well as in enamel and dentinal leakage after a 6-month storage. No improvement was observed in the microleakage in dentin in both short (24 hrs) and long times (6 months). The high microleakage in the adhesives is probably attributed to the high concentration of HEMA in the recipe of the bonding agent. PMID:21566692

  11. Responses of juvenile European flounder (Platichthys flesus) to multistress in the Vilaine estuary, during a 6-month survey.

    PubMed

    Evrard, Estérine; Devaux, Alain; Bony, Sylvie; Cachot, Jérôme; Charrier, Grégory; Quiniou, Louis; Laroche, Jean

    2013-02-01

    Physiological and genetic responses of age 0+ Platichthys flesus were investigated in the eutrophicated and moderately contaminated Vilaine estuary, during a 6-month survey. The main objective of this study was to explore the biological responses of fishes during their juvenile period in an estuarine system in order to detect a possible selective pressure induced by the environmental stress. Our results showed a general convergence in physiological responses along the survey: an increase in genotoxicity was associated with an increase in mRNA expression of ATPase and betaine homocysteine methyltransferase. These results could suggest an increase of cellular damage, energetic request, and detoxification rate related to the growing exposure time to stress. Considering the aging of the cohort, the genetic characteristics of the Vilaine flounder cohort came closer to the one observed in a highly stressed system, the Seine estuary, suggesting a potential selective pressure mainly induced by the chemical stress.

  12. Zero-Flow Pressure Measured Immediately After Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction Provides the Best Invasive Index for Predicting the Extent of Myocardial Infarction at 6 Months: An OxAMI Study (Oxford Acute Myocardial Infarction).

    PubMed

    Patel, Niket; Petraco, Ricardo; Dall'Armellina, Erica; Kassimis, George; De Maria, Giovanni Luigi; Dawkins, Sam; Lee, Regent; Prendergast, Bernard D; Choudhury, Robin P; Forfar, John C; Channon, Keith M; Davies, Justin; Banning, Adrian P; Kharbanda, Rajesh K

    2015-09-01

    The aim of this study was to define which measure of microvascular best predicts the extent of left ventricular (LV) infarction. Microvascular injury after ST-segment elevation myocardial infarction (STEMI) is an important determinant of outcome. Several invasive measures of the microcirculation at primary percutaneous coronary intervention (PPCI) have been described. One such measure is zero-flow pressure (Pzf), the calculated pressure at which coronary flow would cease. In 34 STEMI patients, Pzf, hyperemic microvascular resistance (hMR), and index of microcirculatory resistance (IMR) were derived using thermodilution flow/pressure and Doppler flow/pressure wire assessment of the infarct-related artery following PPCI. The extent of infarction was determined by blinded late gadolinium enhancement on cardiac magnetic resonance at 6 months post-PPCI. Infarction of ≥24% total LV mass was used as a categorical cutoff in receiver-operating characteristic curve analysis. Pzf was superior to both hMR and IMR for predicting ≥24% infarction area under the curve: 0.94 for Pzf versus 0.74 for hMR (p = 0.04) and 0.54 for IMR (p = 0.003). Pzf ≥42 mm Hg was the optimal cutoff value, offering 100% sensitivity and 73% specificity. Patients with Pzf ≥42 mm Hg also had a lower salvage index (61.3 ± 8.1 vs. 44.4 ± 16.8, p = 0.006) and 6-month ejection fraction (62.4 ± 3.6 vs. 49.9 ± 9.6, p = 0.002). In addition, there were significant direct relationships between Pzf and troponin area under the curve (rho = 0.55, p = 0.002), final infarct mass (rho = 0.75, p < 0.0001), percentage of LV infarction and percent transmurality of infarction (rho = 0.77 and 0.74, respectively, p < 0.0001), and inverse relationships with myocardial salvage index (rho = -0.53, p = 0.01) and 6-month ejection fraction (rho = -0.73, p = 0.0001). Pzf measured at the time of PPCI is a better predictor of the extent of myocardial infarction than hMR or IMR. Pzf may provide

  13. The Testing Effect on Skills Learning Might Last 6 Months

    ERIC Educational Resources Information Center

    Kromann, C. B.; Bohnstedt, C.; Jensen, M. L.; Ringsted, C.

    2010-01-01

    In a recent study we found that testing as a final activity in a skills course increases the learning outcome compared to spending an equal amount of time practicing. Whether this testing effect measured as skills performance can be demonstrated on long-term basis is not known. The research question was: does testing as a final activity in a…

  14. The Testing Effect on Skills Learning Might Last 6 Months

    ERIC Educational Resources Information Center

    Kromann, C. B.; Bohnstedt, C.; Jensen, M. L.; Ringsted, C.

    2010-01-01

    In a recent study we found that testing as a final activity in a skills course increases the learning outcome compared to spending an equal amount of time practicing. Whether this testing effect measured as skills performance can be demonstrated on long-term basis is not known. The research question was: does testing as a final activity in a…

  15. Association between depression in carers and malnutrition in children aged 6 months to 5 years

    PubMed Central

    Ganiyu, Adewale B.; Firth, Jacqueline A.

    2017-01-01

    Background Childhood malnutrition is an important risk factor for child mortality and underlies close to 50% of child deaths worldwide. Previous studies have found an association between maternal depression and child malnutrition, but it is not known whether this association exists in Botswana. In addition, previous studies excluded non-maternal primary caregivers (PCGs). It is unclear whether the association between primary caregiver depression and child malnutrition remains when non-maternal PCGs are included. Aim The aim of this study was to determine if there is an association between PCG depression and malnutrition in children aged between 6 months and 5 years in Mahalapye, Botswana. Setting The study was conducted in the child welfare clinics of Xhosa and Airstrip clinics, two primary health care facilities in Mahalapye, Botswana. Methods This was a case control study. Cases were malnourished children aged between 6 months and 5 years, and controls were non-malnourished children matched for age and gender. The outcome of interest was depression in the PCGs of the cases and controls, which was assessed using the Patient Health Questionnaire 9 (PHQ 9), a depression screening tool. Results From a sample of 171 children, 84 of whom were malnourished, we found that the malnourished children were significantly more likely to have depressed PCGs (odds ratio = 4.33; 95% CI: 1.89, 9.89) than non-malnourished children in the 6-month to 5-year age group; the PCGs of malnourished children also had lower educational status. Conclusion This study found a significant association between PCG depression and child malnutrition. PMID:28155288

  16. Cervical muscle area measurements in whiplash patients: Acute, 3, and 6 months of follow-up.

    PubMed

    Ulbrich, Erika J; Aeberhard, Ramon; Wetli, Sylvia; Busato, Andre; Boesch, Chris; Zimmermann, Heinz; Hodler, Juerg; Anderson, Suzanne E; Sturzenegger, Matthias

    2012-12-01

    To investigate the role of the cervical spine muscles in whiplash injury. We hypothesized that (i) cervical muscle hypotrophy would be evident after a 6-month follow-up and, (ii) cervical muscle hypotrophy would correlate with symptom persistence probably related to pain or inactivity. Ninety symptomatic patients (48 females) were recruited from our emergency department and examined within 48 h, and at 3, and 6 months after a motor vehicle accident. MRI cross-sectional muscle area (CSA) measurements were performed bilaterally of the cervical extensor and sternocleidomastoid muscles using transverse STIR (Short Tau inversion Recovery) sequences at the C2 (deep and total dorsal cervical extensor muscles), C4 (sternocleidomastoid muscles) and C5 (deep and total dorsal cervical extensor muscles) levels. Two blinded raters independently performed the measurements at each time point. First, CSA changes over time were analyzed and, second, CSAs were correlated with clinical outcomes (EuroQuol, Whiplash Disability Score, neck pain intensity [VAS], cervical spine mobility). There was a high agreement of CSA measurements between the two raters. Women consistently had smaller CSAs than men. There were no significant changes of CSAs over time at any of the three levels. There were no consistent significant correlations of CSA values with the clinical scores at all time points except with the body mass index. Our results do not support a major role of cervical muscle volume in the genesis of symptoms after whiplash injury. Copyright © 2012 Wiley Periodicals, Inc.

  17. Implications of newborn amygdala connectivity for fear and cognitive development at 6-months-of-age.

    PubMed

    Graham, Alice M; Buss, Claudia; Rasmussen, Jerod M; Rudolph, Marc D; Demeter, Damion V; Gilmore, John H; Styner, Martin; Entringer, Sonja; Wadhwa, Pathik D; Fair, Damien A

    2016-04-01

    The first year of life is an important period for emergence of fear in humans. While animal models have revealed developmental changes in amygdala circuitry accompanying emerging fear, human neural systems involved in early fear development remain poorly understood. To increase understanding of the neural foundations of human fear, it is important to consider parallel cognitive development, which may modulate associations between typical development of early fear and subsequent risk for fear-related psychopathology. We, therefore, examined amygdala functional connectivity with rs-fcMRI in 48 neonates (M=3.65 weeks, SD=1.72), and measured fear and cognitive development at 6-months-of-age. Stronger, positive neonatal amygdala connectivity to several regions, including bilateral anterior insula and ventral striatum, was prospectively associated with higher fear at 6-months. Stronger amygdala connectivity to ventral anterior cingulate/anterior medial prefrontal cortex predicted a specific phenotype of higher fear combined with more advanced cognitive development. Overall, findings demonstrate unique profiles of neonatal amygdala functional connectivity related to emerging fear and cognitive development, which may have implications for normative and pathological fear in later years. Consideration of infant fear in the context of cognitive development will likely contribute to a more nuanced understanding of fear, its neural bases, and its implications for future mental health.

  18. Implications of newborn amygdala connectivity for fear and cognitive development at 6-months-of-age

    PubMed Central

    Graham, Alice M.; Buss, Claudia; Rasmussen, Jerod M.; Rudolph, Marc D.; Demeter, Damion V.; Gilmore, John H.; Styner, Martin; Entringer, Sonja; Wadhwa, Pathik D.; Fair, Damien A.

    2015-01-01

    The first year of life is an important period for emergence of fear in humans. While animal models have revealed developmental changes in amygdala circuitry accompanying emerging fear, human neural systems involved in early fear development remain poorly understood. To increase understanding of the neural foundations of human fear, it is important to consider parallel cognitive development, which may modulate associations between typical development of early fear and subsequent risk for fear-related psychopathology. We, therefore, examined amygdala functional connectivity with rs-fcMRI in 48 neonates (M=3.65 weeks, SD=1.72), and measured fear and cognitive development at 6-months-of-age. Stronger, positive neonatal amygdala connectivity to several regions, including bilateral anterior insula and ventral striatum, was prospectively associated with higher fear at 6-months. Stronger amygdala connectivity to ventral anterior cingulate/anterior medial prefrontal cortex predicted a specific phenotype of higher fear combined with more advanced cognitive development. Overall, findings demonstrate unique profiles of neonatal amygdala functional connectivity related to emerging fear and cognitive development, which may have implications for normative and pathological fear in later years. Consideration of infant fear in the context of cognitive development will likely contribute to a more nuanced understanding of fear, its neural bases, and its implications for future mental health. PMID:26499255

  19. Functional Outcome at 6 Months in Surgical Treatment of Spontaneous Supratentorial Intracerebral Haemorrhage

    PubMed Central

    Ghani, Abdul Rahman Izaini; John, John Tharakan Kalappurakkal; Idris, Zamzuri; Ghazali, Mazira Mohamad; Murshid, Nur-Leem; Musa, Kamarul Imran

    2008-01-01

    A prospective cohort study was done to evaluate the role of surgery in patients with spontaneous supratentorial intracerebral haemorrhage (SICH) and to identify predictors of outcome including the use of invasive regional cortical cerebral blood flow (rCoBF) and microdialysis. Surgery consisted of craniotomy or decompressive craniectomy. The ventriculostomy for intracranial pressure (ICP) monitoring and drainage and regional cortical cerebral blood flow (rCoBF) and microdialysis were performed in all subjects. Pre and post operative information on subjects were collected. The study end points was functional outcome at 6 months based on a dichotomised Glasgow Outcome Scale (GOS).The selected clinical, radiological, biochemical and treatment factors that may influence the functional outcome were analysed for their significance. A total of 36 patients were recruited with 27(75%) patients had Glasgow Coma Score (GCS) between 5 to 8 on admission and 9(25%) were admitted with GCS of 9. At 6 months, 86 % had a poor or unfavourable outcome (GOS I–III) and 14% had good or favourable outcome (GOS IV–V). The mortality rate at 6 months was 55%. Univariate analysis for the functional outcome identified 2 significant variables, the midline shift (p=0.013) and mean lactate:pyruvate ratio (p=0.038). Multivariate analysis identified midline shift as the single significant independent predictor of functional outcome (p=0.013).Despite aggressive regional cortical cerebral blood flow (rCoBF) and microdialysis study for detection of early ischemia, surgical treatment for spontaneous intracerebral haemorrhage only benefited a small number of patients in terms of favourable outcome (14%) and in the majority of patients (86%), the outcome was unfavourable. Patients with midline shift > 5mm has almost 21 times higher chances (adj) OR 20.8 of being associated with poor outcome (GOS I–III). PMID:22589638

  20. Prenatal maternal depression alters amygdala functional connectivity in 6-month-old infants

    PubMed Central

    Qiu, A; Anh, T T; Li, Y; Chen, H; Rifkin-Graboi, A; Broekman, B F P; Kwek, K; Saw, S-M; Chong, Y-S; Gluckman, P D; Fortier, M V; Meaney, M J

    2015-01-01

    Prenatal maternal depression is associated with alterations in the neonatal amygdala microstructure, shedding light on the timing for the influence of prenatal maternal depression on the brain structure of the offspring. This study aimed to examine the association between prenatal maternal depressive symptomatology and infant amygdala functional connectivity and to thus establish the neural functional basis for the transgenerational transmission of vulnerability for affective disorders during prenatal development. Twenty-four infants were included in this study with both structural magnetic resonance imaging (MRI) and resting-state functional MRI (fMRI) at 6 months of age. Maternal depression was assessed at 26 weeks of gestation and 3 months after delivery using the Edinburgh Postnatal Depression Scale. Linear regression was used to identify the amygdala functional networks and to examine the associations between prenatal maternal depressive symptoms and amygdala functional connectivity. Our results showed that at 6 months of age, the amygdala is functionally connected to widespread brain regions, forming the emotional regulation, sensory and perceptual, and emotional memory networks. After controlling for postnatal maternal depressive symptoms, infants born to mothers with higher prenatal maternal depressive symptoms showed greater functional connectivity of the amygdala with the left temporal cortex and insula, as well as the bilateral anterior cingulate, medial orbitofrontal and ventromedial prefrontal cortices, which are largely consistent with patterns of connectivity observed in adolescents and adults with major depressive disorder. Our study provides novel evidence that prenatal maternal depressive symptomatology alters the amygdala's functional connectivity in early postnatal life, which reveals that the neuroimaging correlates of the familial transmission of phenotypes associated with maternal mood are apparent in infants at 6 months of age. PMID:25689569

  1. Efficacy and Safety of 6-Month Nightly Ramelteon Administration in Adults with Chronic Primary Insomnia

    PubMed Central

    Mayer, Geert; Wang-Weigand, Sherry; Roth-Schechter, Barbara; Lehmann, Reiner; Staner, Corinne; Partinen, Markku

    2009-01-01

    Study Objectives: Long-duration ( ≥ 6 months) polysomnographic studies of insomnia medications are lacking. This study evaluated the long-term efficacy of ramelteon, a selective MT1/MT2 melatonin-receptor agonist used for insomnia treatment. Design: Six-month, randomized, double-blind, placebo-controlled study. Setting: Forty-six investigative sites in the United States, Europe, Russia, and Australia. Participants: Four hundred fifty-one adults (age ≥ 18 years) with chronic primary insomnia. Interventions: Ramelteon, 8 mg, or placebo 30 minutes before bedtime nightly for 6 months. Measurements: Sleep was evaluated by polysomnography and morning questionnaires on the first 2 nights of Week 1; the last 2 nights of Months 1, 3, 5, and 6; and Nights 1 and 2 of the placebo run-out. Next-morning residual effects as well as adverse effects and vital signs were recorded at each visit. Rebound insomnia and withdrawal effects were evaluated during placebo run-out. Results: Over the 6 months of treatment, ramelteon consistently reduced latency to persistent sleep compared with baseline and with placebo; significant decreases were observed at Week 1 and Months 1, 3, 5, and 6 (P < 0.05). Ramelteon significantly reduced subjective sleep latency relative to placebo at Week 1, Month 1, and Month 5 (P < 0.05), with reductions nearing statistical significance at Months 3 and 6 (P ≤ 0.08). No significant next-morning residual effects were detected during ramelteon treatment. No withdrawal symptoms or rebound insomnia were detected after ramelteon discontinuation. Most adverse events were mild or moderate in severity. Conclusions: In adults with chronic insomnia, long-term ramelteon treatment consistently reduced sleep onset, with no next-morning residual effects or rebound insomnia or withdrawal symptoms upon discontinuation. Citation: Mayer G; Wang-Weigand S; Roth-Schechter B; Lehmann R; Staner C; Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in

  2. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release

    PubMed Central

    Gordon, Michael S.; Kinlock, Timothy W.; Schwartz, Robert P.; O’Grady, Kevin E.

    2008-01-01

    Aims This study examined the effectiveness of methadone maintenance initiated prior to or just after release from prison at 6 months post-release. Design A three-group randomized controlled trial was conducted between September 2003 and June 2005. Setting A Baltimore pre-release prison. Participants Two hundred and eleven adult pre-release inmates who were heroin-dependent during the year prior to incarceration. Intervention Participants were assigned randomly to the following: counseling only: counseling in prison, with passive referral to treatment upon release (n = 70); counseling + transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and counseling + methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71). Measurements Addiction Severity Index at study entry and follow-up. Additional assessments at 6 months post-release were treatment record review; urine drug testing for opioids, cocaine and other illicit drugs. Findings Counseling + methadone participants were significantly more likely than both counseling only and counseling + transfer participants to be retained in drug abuse treatment (P = 0.0001) and significantly less likely to have an opioid-positive urine specimen compared to counseling only participants (P = 0.002). Furthermore, counseling + methadone participants reported significantly fewer days of involvement in self-reported heroin use and criminal activity than counseling only participants. Conclusions Methadone maintenance, initiated prior to or immediately after release from prison, increases treatment entry and reduces heroin use at 6 months post-release compared to counseling only. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories. PMID:18855822

  3. Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty.

    PubMed

    Klein, Karen; Yang, Joshua; Aisenberg, Javier; Wright, Nancy; Kaplowitz, Paul; Lahlou, Najiba; Linares, Jeannete; Lundström, Eija; Purcea, Daniela; Cassorla, Fernando

    2016-11-01

    Triptorelin is an established treatment for central precocious puberty (CPP) as 1- and 3-month formulations. The current triptorelin 22.5 mg 6-month formulation is approved for prostate cancer therapy. This is the first study in patients with CPP. The efficacy and safety of the triptorelin 6-month formulation in CPP were investigated. The primary objective was to evaluate the efficacy in achieving luteinizing hormone (LH) suppression to pre-pubertal levels at month 6. This was an international, non-comparative phase III study over 48 weeks. Eighteen medical centers in the US, Chile and Mexico participated. Forty-four treatment naïve patients (39 girls and five boys) aged at treatment start 2-8 years for girls and 2-9 years for boys with an advancement of bone age over chronological age ≥1 year were to be included. Triptorelin was administered im twice at an interval of 24 weeks. LH, follicle stimulating hormone (FSH) (basal and stimulated), estradiol (girls), testosterone (boys), auxological parameters, clinical signs of puberty and safety were assessed. Forty-one patients (93.2%) showed pre-pubertal LH levels (stimulated LH ≤5 IU/L) at month 6 and maintained LH suppression through month 12. The percentage of patients with LH suppression exceeded 93% at each time point and reached 97.7% at month 12. No unexpected drug-related adverse events were reported. The triptorelin 6-month formulation was safe and effective in suppressing the pituitary-gonadal axis in children with CPP. The extended injection interval may improve compliance and increase comfort in the management of CPP.

  4. Trajectories of suicidal ideation over 6 months among 482 outpatients with bipolar disorder.

    PubMed

    Köhler-Forsberg, Ole; Madsen, Trine; Behrendt-Møller, Ida; Sylvia, Louisa; Bowden, Charles L; Gao, Keming; Bobo, William V; Trivedi, Madhukar H; Calabrese, Joseph R; Thase, Michael; Shelton, Richard C; McInnis, Melvin; Tohen, Mauricio; Ketter, Terence A; Friedman, Edward S; Deckersbach, Thilo; McElroy, Susan L; Reilly-Harrington, Noreen A; Nierenberg, Andrew A

    2017-12-01

    Suicidal ideation occurs frequently among individuals with bipolar disorder; however, its course and persistence over time remains unclear. We aimed to investigate 6-months trajectories of suicidal ideation among adults with bipolar disorder. The Bipolar CHOICE study randomized 482 outpatients with bipolar disorder to 6 months of lithium- or quetiapine-based treatment including other psychotropic medications as clinically indicated. Participants were asked at 9 visits about suicidal ideation using the Concise Health Risk Tracking scale. We performed latent Growth Mixture Modelling analysis to empirically identify trajectories of suicidal ideation. Multinomial logistic regression analyses were applied to estimate associations between trajectories and potential predictors. We identified four distinct trajectories. The Moderate-Stable group represented 11.1% and was characterized by constant suicidal ideation. The Moderate-Unstable group included 2.9% with persistent thoughts about suicide with a more fluctuating course. The third (Persistent-low, 20.8%) and fourth group (Persistent-very-low, 65.1%) were characterized by low levels of suicidal ideation. Higher depression scores and previous suicide attempts (non-significant trend) predicted membership of the Moderate-Stable group, whereas randomized treatment did not. No specific treatments against suicidal ideation were included and suicidal thoughts may persist for several years. More than one in ten adult outpatients with bipolar disorder had moderately increased suicidal ideation throughout 6 months of pharmacotherapy. The identified predictors may help clinicians to identify those with additional need for treatment against suicidal thoughts and future studies need to investigate whether targeted treatment (pharmacological and non-pharmacological) may improve the course of persistent suicidal ideation. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Radioactive Seed Localization Compared to Wire Localization in Breast-Conserving Surgery: Initial 6-Month Experience

    PubMed Central

    Murphy, James O.; Moo, Tracy-Ann; King, Tari A.; Van Zee, Kimberly J.; Villegas, Kristine A.; Stempel, Michelle; Eaton, Anne; St. Germain, Jean M.; Morris, Elizabeth; Morrow, Monica

    2014-01-01

    Introduction Wire localization (WL) of non-palpable breast cancers on the day of surgery is uncomfortable for patients and impacts OR efficiency. Radioactive seed localization (RSL) before the day of surgery avoids these disadvantages. In this study we compare outcomes of our initial 6-month experience with RSL to those with WL in the preceding 6 months. Methods Lumpectomies for invasive or intraductal cancers localized with a single 125iodine seed (January-June 2012) were compared to those using 1 wire (July-December 2011). Surgeons and radiologists did not change. Positive and close margins were defined as tumor on ink and tumor ≤1mm from ink, respectively. Demographic and clinical characteristics and outcomes were compared between RSL and WL patients. Results There were 431 RSL and 256 WL lumpectomies performed. Clinicopathologic characteristics did not differ between groups. Most seeds (90%) were placed before the day of surgery. Positive margins were present in 7.7% of RSL versus 5.5% of WL patients, and 16.9% of RSL versus 19.9% of WL had close margins (p=0.38). The median operative time was longer for lumpectomy and sentinel lymph node biopsy (SLNB) in the RSL group (55 versus 48 minutes, p<0.0001). There was no significant difference in the volume of tissue excised between groups. Conclusions In the first 6 months of RSL, operative scheduling was simplified, while rates of positive and close margins were similar to those seen after many years of experience with WL. Operative time was slightly longer for RSL lumpectomy and SLNB; we anticipate this will decrease with experience. PMID:23943024

  6. Predictors of 6-month and 3-year outcomes after psychological intervention for psychogenic non epileptic seizures.

    PubMed

    Duncan, Roderick; Anderson, James; Cullen, Breda; Meldrum, Steven

    2016-03-01

    To determine outcome and its predictors following psychological intervention in people with Psychogenic Non-Epileptic Seizures (PNES) METHODS: Prospective audit of 89 consecutive patients. PNES were recorded at baseline (initial psychology appointment), at 6 months and 3 years post the initial appointment. Six-month data was obtained by face-to-face interview, while 3-year data was obtained by contacting general practitioners and by postal survey. Eight patients had stopped having PNES at the first appointment and were discharged. At 6-month follow up 43/81 patients (53.1%) were free of seizures. Predictors of cessation of seizures were: patient employed (OR 4.48, p=0.004), short waiting time for intervention (OR 0.94, p=0.018), the patient feeling they had some control over the seizures (OR 3.30, p=0.021), and an internal locus of control ((OR 7.46, p=0.001). Outcomes at 3 years based on patient report were available in 32/81 patients (36%). 11/32 patients reported being free of seizures. 50/65 patients were not accessing any healthcare for seizures. There were no significant predictors of either outcome among the variables collected. Just over half of our patients reported being free of seizures following intervention. Being employed predicted good outcome, but the best predictor of being seizure free at 6 months was having an internal locus of control. This may be useful practically and requires further study. No good predictors of long-term outcome were found, possibly because of loss to follow up. Copyright © 2016 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  7. Infants, mothers, and dyadic contributions to stability and prediction of social stress response at 6 months.

    PubMed

    Provenzi, Livio; Olson, Karen L; Montirosso, Rosario; Tronick, Ed

    2016-01-01

    The study of infants' interactive style and social stress response to repeated stress exposures is of great interest for developmental and clinical psychologists. Stable maternal and dyadic behavior is critical to sustain infants' development of an adaptive social stress response, but the association between infants' interactive style and social stress response has received scant attention in previous literature. In the present article, overtime stability of infant, maternal, and dyadic behaviors was measured across 2 social stress (i.e., Face-to-Face Still-Face, FFSF) exposures, separated by 15 days. Moreover, infant, maternal, and dyadic behaviors were simultaneously assessed as predictors of infants' social stress to both FFSF exposures. Eighty-one mother-infant dyads underwent the FFSF twice, at 6 months (Exposure 1: the first social stress) and at 6 months and 15 days (Exposure 2: repeated social stress). Infant and mother behavior and dyadic synchrony were microanalytically coded. Overall, individual behavioral stability emerged between FFSF exposures. Infants' response to the first stress was predicted by infant behavior during Exposure 1 Play. Infants' response to the repeated social stress was predicted by infants' response to the first exposure to the Still-Face and by infants' behavior and dyadic synchrony during Exposure 2 Play. Findings reveal stability for individual, but not for dyadic, behavior between 2 social stress exposures at 6 months. Infants' response to repeated social stress was predicted by infants' earlier stress response, infants' own behavior in play, and dyadic synchrony. No predictive effects of maternal behavior were found. Insights for research and clinical work are discussed. (c) 2015 APA, all rights reserved).

  8. Strategy training shows promise for addressing disability in the first 6 months after stroke

    PubMed Central

    Skidmore, Elizabeth R.; Dawson, Deirdre R.; Butters, Meryl A.; Grattan, Emily S.; Juengst, Shannon B.; Whyte, Ellen M.; Begley, Amy; Holm, Margo B.; Becker, James T.

    2014-01-01

    Background Cognitive impairments occur frequently after stroke and contribute to significant disability. Strategy training shows promise but has not been examined in the acute phase of recovery. Objective We conducted a single-blind randomized pilot study estimating the effect of strategy training, relative to reflective listening (attention control), for reducing disability and executive cognitive impairments. Methods Thirty participants with acute stroke who were enrolled in inpatient rehabilitation and had cognitive impairments were randomized to receive strategy training (n=15, 10 sessions as adjunct to usual inpatient rehabilitation) or reflective listening (n=15, same dose). The Functional Independence Measure assessed disability at baseline, rehabilitation discharge, 3 and 6 months. The Color Word Interference Test of the Delis-Kaplan Executive Function System assessed selected executive cognitive impairments (inhibition, flexibility) at baseline, 3 and 6 months. Results Changes in Functional Independence Measure scores for the two groups over 6 months showed significant effects of group (F1,27=9.25, p=0.005), time (F3.74=96.00, p<0.001), and group*time interactions (F3,74=4.37, p<0.007) after controlling for baseline differences in stroke severity (F1,27=6.74, p=0.015). Color Word Interference Inhibition scores showed significant effects of group (F1,26=6.50, p=0.017), and time (F2,34=4.74, p=0.015), but the group*time interaction was not significant (F2,34=2.55, p=0.093). Color Word Interference Cognitive Flexibility scores showed significant effects of group (F1,26=23.41, p<0.001), and time (F2,34=12.77, p<0.001), and group*time interactions (F2,34=7.83, p<0.002). Interaction effects suggested greater improvements were associated with strategy training. Conclusions Strategy training shows promise for addressing disability in the first 6 months after stroke. Lessons from this pilot study may inform future clinical trials. PMID:25505221

  9. Power and limitations of daily prognostications of death in the medical ICU for outcomes in the following 6 months.

    PubMed

    Meadow, William; Pohlman, Anne; Reynolds, Dan; Rand, Leah; Correia, Camil; Christoph, Ella; Hall, Jesse

    2014-11-01

    We tested the power of clinicians' predictions that a medical ICU patient would "die before hospital discharge" for both survival to discharge and for outcomes at 6 months. We restricted our analyses to patients who had been in the medical ICU at least 72 hours and for whom we had follow-up at 6 months after medical ICU admission. For 350 medical ICU patients, on each medical ICU day, we asked their attending physician, fellow, resident, and primary nurse one question-"do you think this patient will die in hospital or survive to be discharged"? We correlated these responses with 6-month outcomes (death and/or Barthel score for survivors). We obtained over 6,000 predictions on 2,271 medical ICU patient-days. Of 350 medical ICU patients who stayed more than 72 hours, 143 patients (41%) had discordant predictions-that is, on the same medical ICU day, at least one provider predicted survival, whereas another predicted death before discharge. As we have shown previously, predictions of "death before discharge" were imperfect-only 104 of 187 of patients with a prediction of death (56%) actually died in hospital. However, this is the central finding of our study, and predictions of death before discharge were much more accurate for 6-month outcomes. Of 120 patients with a corroborated prediction of death before discharge (93%), 112 patients had died within 6 months of medical ICU discharge, and only 4% were functioning with a Barthel score more than 70. In contrast, 67 of 163 patients who did not have any prediction of death before discharge (41%) were alive with Barthel score more than 70 at 6 months. Fewer than 4% of medical ICU patients who required 72 hours of medical ICU care and had a corroborated prediction of death before discharge were alive at 6 months and functioning with a Barthel score more than 70.

  10. Evaluation of occupational physical load during 6-month international crisis management operation.

    PubMed

    Pihlainen, Kai; Santtila, Matti; Vasankari, Tommi; Häkkinen, Keijo; Kyröläinen, Heikki

    2017-10-02

    Generally, operational military duties are associated with a variety of stressors, such as prolonged physical activity (PA). However, limited information is available on the occupational workload or changes in PA during international military operations. Thus, the aim of the study was to investigate the changes in body composition, stress biomarkers, PA, and heart rate (HR) responses of 79 male soldiers during a 6-month international crisis management operation. Measurements were conducted 3 times in South-Lebanon during the operation. Body composition was assessed by the bioelectrical impedance method. Blood samples were analyzed for serum testosterone, sex-hormone binding globulin (SHBG), cortisol and insulin-like growth factor. Saliva sampling was used for analyzing stress biomarkers, cortisol and α-amylase. Heart rate and physical activity were monitored by a recordable belt and tri-axial accelerometer, respectively. Increases in muscle mass (39.2±4.1 vs. 39.5±4.2 kg, p < 0.05) and testosterone (15.9±4.6 vs. 17.2±4 nmol/l, p < 0.01), and reductions in PA variables (e.g., daily step count 9472±2547 vs. 8321±2720, p < 0.05) were observed during the first half (i.e., PRE-MID) of the study. The increase in muscle mass remained significant during the latter half (PRE-POST, 39.2±4.1 vs. 39.6±4.4 kg, p < 0.05), but also fat mass increased (MID-POST, 10.6±4.6 vs. 11.0±4.7 kg, p < 0.05) while SHBG (MID-POST, 31.8±12.1 vs. 26.6±13.2 nmol/l, p < 0.01) and cortisol (MID-POST, 445±116 vs. 400±123 nmol/l, p < 0.05) decreased. With the exception of increased concentration of salivary α-amylase (PRE-POST, 36.5±33.7 vs. 55.1±39.7 U/ml), the acute stress biomarkers and HR responses remained unchanged. Furthermore, the low quantity of PA, low HR values and subjective ratings of exertion refer to rather light physical workload. Due to the operatively calm nature of the working environment, the present soldiers did not express any significant signs of physical

  11. Neuropsychological Functioning Predicts Community Outcomes in Affective and Non-Affective Psychoses: A 6-month follow-up

    PubMed Central

    Lewandowski, Kathryn E.; Cohen, Bruce M.; Keshavan, Matcheri S.; Sperry, Sarah H.; Öngür, Dost

    2013-01-01

    Introduction Neurocognitive dysfunction is a major symptom feature of schizophrenia and bipolar disorder. A prognostic relationship between cognition and community outcomes is well-documented in schizophrenia and increasingly recognized in bipolar disorder. However, specific associations amongst neurocognition, diagnosis, state symptomatology, and community functioning are unclear, and few studies have compared these relationships amongst patients with affective and non-affective psychoses in the same study. We examined neurocognitive, clinical, and community functioning in a cross-diagnostic sample of patients with psychotic disorders over a 6-month follow-up interval. Method Neurocognitive, clinical and community functioning were assessed in participants with schizophrenia (n=13), schizoaffective disorder (n=17), or bipolar disorder with psychosis (n=18), and healthy controls (n=18) at baseline and 6 months later. Results Neurocognitive functioning was impaired in all diagnostic groups and, despite reductions in primary symptoms, did not recover on most measures over the follow-up period. Neurocognitive impairment was not associated with diagnosis or clinical improvement. Several neurocognitive scores at baseline (but not diagnosis or clinical baseline or follow-up scores) predicted community functioning at follow-up. Discussion In one of the few studies to longitudinally examine neurocognition in association with clinical and outcomes variables in a cross diagnostic sample of psychotic disorders patients, neurocognitive deficits were pronounced across diagnoses and did not recover on most measures despite significant reductions in clinical symptoms. Baseline neurocognitive functioning was the only significant predictor of patients’ community functioning six months later. Efforts to recognize and address cognitive deficits, an approach that has shown promise in schizophrenia, should be extended to all patients with psychosis. PMID:23791391

  12. Sleep and physical growth in infants during the first 6 months.

    PubMed

    Tikotzky, Liat; DE Marcas, Gali; Har-Toov, Joseph; Dollberg, Shaul; Bar-Haim, Yair; Sadeh, Avi

    2010-03-01

    The aim of this study was to explore the relationships between infant sleep patterns and infant physical growth (weight for length ratio) using both objective and subjective sleep measures. Ninety-six first-born, healthy 6-month-old infants and their parents participated in the study. Infant sleep was assessed by actigraphy for four consecutive nights and by the Brief Infant Sleep Questionnaire (BISQ). In addition, parents were asked to complete background and developmental questionnaires. Questions about feeding methods were included in the developmental questionnaire. Infants' weight and length were assessed during a standard checkup at the infant-care clinic when the infants were 6 months old. Significant correlations were found between infant sleep and growth after controlling for potential infant and family confounding factors. Actigraphic sleep percentage and reported sleep duration were correlated negatively with the weight-to-length ratio measures. Sex-related differences in the associations between sleep and physical growth were found. Breast feeding at night was correlated with a more fragmented sleep, but not with physical growth. These findings suggest that sleep is related significantly to physical growth as early as in the first months of life. The study supports increasing evidence from recent studies demonstrating a link between short sleep duration and weight gain and obesity in young children.

  13. Bone Formation in Maxillary Sinus Lift Using Autogenous Bone Graft at 2 and 6 Months

    PubMed Central

    Netto, Henrique Duque; Miranda Chaves, Maria das Graças Alfonso; Aatrstrup, Beatriz; Guerra, Renata; Olate, Sergio

    2016-01-01

    SUMMARY The aim of this study is to compare the bone formation in maxillary sinus lift with an autogenous bone graft in histological evaluation at 2 or 6 months. A comparative study was designed where 10 patients with missing teeth bilaterally in the posterior zone of the maxilla were selected. Patients received a particulate autogenous bone graft under the same surgical conditions, selecting a site to collect a biopsy and histological study at two months and another at six months postoperatively. Histomorphometry was performed and were used Kolmogorov-Smirnov test, student’s t-test and Spearman’s correlation coefficient, considering a value of p<0.05. Differences were observed in inflammatory infiltrate and vascularization characteristics; however, the group analyzed at two months presented 38.12% ± 6.64 % of mineralized tissue, whereas the group studied at 6 months presented an average of 38.45 ± 9.27 %. There were no statistical differences between the groups. It is concluded that the bone formation may be similar in intrasinus particulate autogenous bone grafts in evaluations at two or six months; under these conditions, early installation of implants is viable. PMID:27867255

  14. Bone Formation in Maxillary Sinus Lift Using Autogenous Bone Graft at 2 and 6 Months.

    PubMed

    Netto, Henrique Duque; Miranda Chaves, Maria das Graças Alfonso; Aatrstrup, Beatriz; Guerra, Renata; Olate, Sergio

    2016-09-01

    The aim of this study is to compare the bone formation in maxillary sinus lift with an autogenous bone graft in histological evaluation at 2 or 6 months. A comparative study was designed where 10 patients with missing teeth bilaterally in the posterior zone of the maxilla were selected. Patients received a particulate autogenous bone graft under the same surgical conditions, selecting a site to collect a biopsy and histological study at two months and another at six months postoperatively. Histomorphometry was performed and were used Kolmogorov-Smirnov test, student's t-test and Spearman's correlation coefficient, considering a value of p<0.05. Differences were observed in inflammatory infiltrate and vascularization characteristics; however, the group analyzed at two months presented 38.12% ± 6.64 % of mineralized tissue, whereas the group studied at 6 months presented an average of 38.45 ± 9.27 %. There were no statistical differences between the groups. It is concluded that the bone formation may be similar in intrasinus particulate autogenous bone grafts in evaluations at two or six months; under these conditions, early installation of implants is viable.

  15. [Comparative Effectiveness of Remote Monitoring of People with Cardiac Pacemaker versus Conventional: quality of Life at the 6 Months].

    PubMed

    López-Villegas, Antonio; Catalán-Matamoros, Daniel; Robles-Musso, Emilio; Peiró, Salvador

    2015-04-01

    The use of remote follow-up (RF) of people with pacemakers (PM) is limited in comparison to the hospital modality (HS), being still poor the scientific evidence that shows their comparative effectiveness. The aim of this study was to compare the quality of life in individuals with different modalities of follow-up. Controlled, not randomized nor masked clinical trial, with data collection at pre and post-implantation of pacemakers during the 6 months follow-up. All patients over 18 years-old who were implanted a PM during the study period were selected (n = 83), and they were assigned to RF (n = 30) or HF (n = 53) groups according to their personal characteristics and patient's preferences. Baseline characteristics and number of visits to the hospital were analysed, the EuroQol-5D (EQ5D) questionnaire was administered to evaluate the health-related quality of life, and Duke Activity Status Index (DASI) to assess the functional capacity. There were no significant differences between both groups in relation to the baseline analysis, EQ5D (RF:0.7299; HF:0.6769) and DASI (RF:21.41; HF:19.99). At 6 months the quality of life was improved in both groups (EQ5D RF:0.8613; HF:0.8175; p = 0,439) still without significant differences between them. DASI score was similar to baseline (20.51 vs 21.80). RF group performed less transmissions/visits per patient (1.57) than hospital group (1.96; relative reduction 31%; p = 0.015). Remote follow-up of people with pacemakers might be considered as an equivalent option to the hospital follow-up in relation to the quality of life and it reduces the number of hospital visits.

  16. A Cornea Substitute Derived from Fish Scale: 6-Month Followup on Rabbit Model

    PubMed Central

    Yuan, Fei; Wang, Liyan; Lin, Chien-Chen; Chou, Cheng-Hung; Li, Lei

    2014-01-01

    A fish scale-derived cornea substitute (Biocornea) is proposed as an alternative for human donor corneal tissue. We adopt a regenerative medicine approach to design a primary alternative to the use of fish scale for restoring sight by corneal replacement. Biocornea with corneal multilayer arrangement collagen was implanted to rabbits by pocket implantation. Our study demonstrated the safety and detailed morphologic and physiologic results from the 6 months of followup of rabbit model. In the peripheral Biocornea, the collagen fibrils were arranged in reticular fashion. Slit lamp examination showed that haze and an ulcer were not observed in all groups at 3 months postoperatively while all corneas with Biocornea were clear at both 3 months and 6 months postoperatively. The interface of Biocornea and stromal tissue were filled successfully and without observable immune cells at postoperative day 180. Moreover, the Biocornea was not dissolved and degenerated but remained transparent and showed no apparent fragmentation. Our study demonstrated that the Biocornea derived from fish scale as a good substitute had high biocompatibility and support function after a long-term evaluation. This revealed that the new approach of using Biocornea may yield an ideal artificial cornea substitute for long-term inlay placement. PMID:25089206

  17. Ultrasonographic features of vascular closure devices: initial and 6-month follow-up results

    PubMed Central

    2014-01-01

    Purpose: This study aimed to evaluate the ultrasonographic findings for various types of vascular closure devices (VCDs) immediately after the angiographic procedure and at 6-month follow-up. Methods: We included 18 VCDs including Angio-Seal (n=4), FemoSeal (n=8), ExoSeal (n=3), Perclose (n=2), and StarClose (n=1) in this study. Four patients were implanted with 2 VCDs at the each side of bilateral femoral arteries, while the remaining 8 patients were inserted 1 VCD at the right femoral artery. Ultrasonography was performed within 10 days and at approximately 6 months after the angiographic procedure. Ultrasonographic morphology of the attached VCD and its relationship with the arterial wall were analyzed. Results: Initial ultrasonography revealed the attached VCD as the relevant unique structure with successful deployment and hemostasis. Follow-up ultrasonography demonstrated partial absorption of hemostatic materials in cases of Angio-Seal (n=3), FemoSeal (n=5), and ExoSeal (n=3), changes in the soft tissue surrounding the femoral artery in case of Angio-Seal (n=1), arterial intimal hyperplasia in cases of FemoSeal (n=3), and no gross changes as compared with the initial ultrasonographic findings in cases of Perclose (n=2) and StarClose (n=1). Conclusion: Initial ultrasonographic evaluation reflected the unique structure of each VCD, with most of them being easily distinguishable. Follow-up ultrasonography revealed various changes in the affected vessels. PMID:25145584

  18. Efficacy and safety of leuprorelin acetate 6-month depot, TAP-144-SR (6M), in combination with tamoxifen in postoperative, premenopausal patients with hormone receptor-positive breast cancer: a phase III, randomized, open-label, parallel-group comparative study.

    PubMed

    Kurebayashi, Junichi; Toyama, Tatsuya; Sumino, Shuuji; Miyajima, Eri; Fujimoto, Tsukasa

    2017-01-01

    Leuprorelin acetate, a luteinizing hormone-releasing hormone agonist, is used worldwide in premenopausal women with hormone receptor-positive breast cancer. This study was conducted to assess the non-inferiority of the 6-month depot formulation, TAP-144-SR (6M) 22.5 mg to the 3-month depot formulation, TAP-144-SR (3M) 11.25 mg in postoperative, premenopausal patients with hormone receptor-positive breast cancer. This was a 96-week phase III, randomized, open-label, parallel-group comparative study. All patients concomitantly received oral tamoxifen (20 mg daily). The primary endpoint was the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 48. In total, 167 patients were randomized to receive TAP-144-SR (6M) (n = 83) or TAP-144-SR (3M) (n = 84) and the E2 suppression rate was 97.6 and 96.4 %, respectively. The estimated between-group difference was 1.2 % (95 % confidence interval -5.2 to 7.8). The non-inferiority of TAP-144-SR (6M) to TAP-144-SR (3M) for E2 suppression was confirmed. As for safety, common adverse events were hot flush and injection site reactions including induration, pain, and erythema in both treatment groups, which were of ≤Grade 2 in severity and not serious. No significant between-group differences in safety profiles and tolerability were observed. TAP-144-SR (6M) was not inferior to TAP-144-SR (3M) for its suppressive effect on serum E2. TAP-144-SR (6M) was also as well tolerated as TAP-144-SR (3M).

  19. Dynamic relation between working memory capacity and speech recognition in noise during the first 6 months of hearing aid use.

    PubMed

    Ng, Elaine H N; Classon, Elisabet; Larsby, Birgitta; Arlinger, Stig; Lunner, Thomas; Rudner, Mary; Rönnberg, Jerker

    2014-11-23

    The present study aimed to investigate the changing relationship between aided speech recognition and cognitive function during the first 6 months of hearing aid use. Twenty-seven first-time hearing aid users with symmetrical mild to moderate sensorineural hearing loss were recruited. Aided speech recognition thresholds in noise were obtained in the hearing aid fitting session as well as at 3 and 6 months postfitting. Cognitive abilities were assessed using a reading span test, which is a measure of working memory capacity, and a cognitive test battery. Results showed a significant correlation between reading span and speech reception threshold during the hearing aid fitting session. This relation was significantly weakened over the first 6 months of hearing aid use. Multiple regression analysis showed that reading span was the main predictor of speech recognition thresholds in noise when hearing aids were first fitted, but that the pure-tone average hearing threshold was the main predictor 6 months later. One way of explaining the results is that working memory capacity plays a more important role in speech recognition in noise initially rather than after 6 months of use. We propose that new hearing aid users engage working memory capacity to recognize unfamiliar processed speech signals because the phonological form of these signals cannot be automatically matched to phonological representations in long-term memory. As familiarization proceeds, the mismatch effect is alleviated, and the engagement of working memory capacity is reduced. © The Author(s) 2014.

  20. Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial.

    PubMed

    Dutra, Bernardo Carvalho; Oliveira, Alcione Maria Soares Dutra; Oliveira, Peterson Antônio Dutra; Manzi, Flavio Ricardo; Cortelli, Sheila Cavalca; Cota, Luís Otávio de Miranda; Costa, Fernando Oliveira

    2017-01-01

    Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy.

  1. Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial

    PubMed Central

    DUTRA, Bernardo Carvalho; OLIVEIRA, Alcione Maria Soares Dutra; OLIVEIRA, Peterson Antônio Dutra; MANZI, Flavio Ricardo; CORTELLI, Sheila Cavalca; COTA, Luís Otávio de Miranda; COSTA, Fernando Oliveira

    2017-01-01

    Abstract Background and objectives Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Material and Methods Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Results Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Conclusions Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy. PMID:28678950

  2. Long-term effects on bone mineral density and bone metabolism of 6 months' treatment with gonadotropin-releasing hormone analogues in Japanese women: comparison of buserelin acetate with leuprolide acetate.

    PubMed

    Makita, Kazuya; Ishitani, Ken; Ohta, Hiroaki; Horiguchi, Fumi; Nozawa, Shiro

    2005-01-01

    Our objective was to assess the effects of 6 months' treatment with two types of gonadotropin-releasing hormone (GnRH) analogues on lumbar bone mineral density (BMD) and bone metabolism. We studied 27 women who had been given a diagnosis of endometriosis or uterine myoma. The subjects received drug therapy for 6 months and were subsequently followed up for 1 year. The BMD of the lumbar spine (L2, L3, L4) was measured by dual energy X-ray absorptiometry four times: at baseline, after 6 months, after 12 months, and after 18 months. The serum concentrations of sex steroids and bone metabolic markers were measured at the same times as BMD. Compared with the baseline value, the mean decrease in the buserelin group L2-4 BMD was 3.7% at 6 months, 1.7% at 12 months, and 0.4% at 18 months. In the leuprolide group, L2-4 BMD decreased respectively by 5.1%, 6.2%, and 4.3%. Serum concentrations of calcium increased significantly after 6 months of treatment (P < 0.05) and returned to the baseline level at 12 months in both groups. In the leuprolide group, the intact osteocalcin concentration after 6 months was significantly higher than the baseline value, and after 12 months, it decreased to the baseline level. Our results indicate that the effect on BMD of 6 months' treatment with GnRH analogues virtually resolves by 1 year after treatment, provided that drugs affecting bone metabolism are not given during this period.

  3. Body composition at 6 months of life: comparison of air displacement plethysmography and dual-energy X-ray absorptiometry.

    PubMed

    Fields, David A; Demerath, Ellen W; Pietrobelli, Angelo; Chandler-Laney, Paula C

    2012-11-01

    Body composition assessment during infancy is important because it is a critical period for obesity risk development, thus valid tools are needed to accurately, precisely, and quickly determine both fat and fat-free mass. The purpose of this study was to compare body composition estimates using dual-energy x-ray absorptiometry (DXA) and air displacement plethysmography (ADP) at 6 months old. We assessed the agreement between whole body composition using DXA and ADP in 84 full-term average-for-gestational-age boys and girls using DXA (Lunar iDXA v11-30.062; Infant whole body analysis enCore 2007 software, GE, Fairfield, CT) and ADP (Infant Body Composition System v3.1.0, COSMED USA, Concord, CA). Although the correlations between DXA and ADP for %fat (r = 0.925), absolute fat mass (r = 0.969), and absolute fat-free mass (r = 0.945) were all significant, body composition estimates by DXA were greater for both %fat (31.1 ± 3.6% vs. 26.7 ± 4.7%; P < 0.001) and absolute fat mass (2,284 ± 449 vs. 1,921 ± 492 g; P < 0.001), and lower for fat-free mass (5,022 ± 532 vs. 5,188 ± 508 g; P < 0.001) vs. ADP. Inter-method differences in %fat decreased with increasing adiposity and differences in fat-free mass decreased with increasing infant age. Estimates of body composition determined by DXA and ADP at 6 months of age were highly correlated, but did differ significantly. Additional work is required to identify the technical basis for these rather large inter-method differences in infant body composition.

  4. Association of fewer hours of sleep at 6 months postpartum with substantial weight retention at 1 year postpartum.

    PubMed

    Gunderson, Erica P; Rifas-Shiman, Sheryl L; Oken, Emily; Rich-Edwards, Janet W; Kleinman, Ken P; Taveras, Elsie M; Gillman, Matthew W

    2008-01-15

    Shorter sleep duration is linked to obesity, coronary artery disease, and diabetes. Whether sleep deprivation during the postpartum period affects maternal postpartum weight retention remains unknown. This study examined the association of sleep at 6 months postpartum with substantial postpartum weight retention (SPPWR), defined as 5 kg or more above pregravid weight at 1 year postpartum. The authors selected 940 participants in Project Viva who enrolled during early pregnancy from 1999 to 2002. Logistic regression models estimated odds ratios of SPPWR for sleep categories, controlling for sociodemographic, prenatal, and behavioral attributes. Of the 940 women, 124 (13%) developed SPPWR. Sleep distributions were as follows: 114 (12%) women slept < or =5 hours/day, 280 (30%) slept 6 hours/day, 321 (34%) slept 7 hours/day, and 225 (24%) slept > or =8 hours/day. Adjusted odds ratios of SPPWR were 3.13 (95% confidence interval (CI): 1.42, 6.94) for < or =5 hours/day, 0.99 (95% CI: 0.50, 1.97) for 6 hours/day, and 0.94 (95% CI: 0.50, 1.78) for > or =8 hours/day versus 7 hours/day (p = 0.012). The adjusted odds ratio for SPPWR of 2.05 (95% CI: 1.11, 3.78) was twofold greater (p = 0.02) for a decrease in versus no change in sleep at 1 year postpartum. Sleeping < or =5 hours/day at 6 months postpartum was strongly associated with retaining > or =5 kg at 1 year postpartum. Interventions to prevent postpartum obesity should consider strategies to attain optimal maternal sleep duration.

  5. Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg, Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study

    PubMed Central

    Krystal, Andrew D.; Erman, Milton; Zammit, Gary K.; Soubrane, C.; Roth, Thomas

    2008-01-01

    the efficacy of 3 to 7 nights per week dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness. Citation: Krystal AD; Erman M; Zammit GK; Soubrane C; Roth T. Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg, Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study. SLEEP 2008;31(1):79-90. PMID:18220081

  6. Vaporization of the Prostate with 150-W Thulium Laser: Complications with 6-Month Follow-Up

    PubMed Central

    García-Larrosa, Alejandro; Capdevila, Santiago; Laborda, Ainhoa

    2014-01-01

    Abstract Purpose: To analyze the efficacy and safety of vaporization of the prostate (VP) with the 150-W thulium:yttrium-aluminum-garnet (Tm:YAG) laser. Patients and Methods: In a prospective series of 55 patients with small- and medium-size prostates undergoing major outpatient surgery (MOS), the primary objectives were to analyze changes in maximum flow (Qmax) and International Prostate Symptom Score (IPSS) after 6 months. Immediate (<30 days) and late (>30 days) complications were subsequently recorded. Results: An increase in mean Qmax of 9.33 mL/s (95% confidence interval [CI] of the mean difference 6.73–11.93; P<0.001) was recorded, and mean IPSS was reduced by 16.88 points (95% CI 14.22–19.54; P<0.001). The immediate complications recorded were acute urinary retention (one patient), urinary tract infection without fever (two patients), and macroscopic hematuria (two patients). The only late complication observed was bladder neck sclerosis (one patient). Conclusion: After 6 months, VP with 150-W Tm:YAG presents promising results in the clinical improvement of patients with small- and medium-size prostates. Its complication rate is low and it offers excellent hemostasis. The data from our study provide the basis for the design of clinical trials to compare this technique with other procedures. PMID:24521152

  7. Vaporization of the prostate with 150-w thulium laser: complications with 6-month follow-up.

    PubMed

    Vargas, César; García-Larrosa, Alejandro; Capdevila, Santiago; Laborda, Ainhoa

    2014-07-01

    Purpose: To analyze the efficacy and safety of vaporization of the prostate (VP) with the 150-W thulium:yttrium-aluminum-garnet (Tm:YAG) laser. In a prospective series of 55 patients with small- and medium-size prostates undergoing major outpatient surgery (MOS), the primary objectives were to analyze changes in maximum flow (Qmax) and International Prostate Symptom Score (IPSS) after 6 months. Immediate (<30 days) and late (>30 days) complications were subsequently recorded. An increase in mean Qmax of 9.33 mL/s (95% confidence interval [CI] of the mean difference 6.73-11.93; P<0.001) was recorded, and mean IPSS was reduced by 16.88 points (95% CI 14.22-19.54; P<0.001). The immediate complications recorded were acute urinary retention (one patient), urinary tract infection without fever (two patients), and macroscopic hematuria (two patients). The only late complication observed was bladder neck sclerosis (one patient). After 6 months, VP with 150-W Tm:YAG presents promising results in the clinical improvement of patients with small- and medium-size prostates. Its complication rate is low and it offers excellent hemostasis. The data from our study provide the basis for the design of clinical trials to compare this technique with other procedures.

  8. Replicating ¡Cuídate!: 6-Month Impact Findings of a Randomized Controlled Trial.

    PubMed

    Kelsey, Meredith; Layzer, Carolyn; Layzer, Jean; Price, Cristofer; Juras, Randall; Blocklin, Michelle; Mendez, Jacqueline

    2016-09-01

    To test whether ¡Cuídate!, a program culturally adapted for Hispanic youths, affects sexual risk behavior. We evaluated 3 replications of ¡Cuídate! in California, Arizona, and Massachusetts in a randomized controlled trial (registry no. NCT02540304) in which 2169 primarily Hispanic participants were randomly assigned to an intervention (n = 1326) or a control (n = 870) group. Youths were surveyed at baseline (September 2012-April 2014) and 6 months postbaseline (March 2013-October 2014). We estimated pooled and subgroup impacts using a regression framework with baseline covariates to increase statistical precision (1216 youths analyzed in the treatment group, 806 analyzed in the control group). We found no impacts on the study's primary outcomes of recent sexual activity or recent unprotected sexual activity. However, ¡Cuídate! improved knowledge (10%-20% increase; P < .001), attitudes (effect size = .24; P < .001), and skills (effect size = .14; P = .002). Exploratory subgroup analyses suggest potentially problematic effects for some groups. Findings suggest that ¡Cuídate! was effective in improving youths' knowledge and attitudes. However, after 6 months, these changes did not translate to improvements in reported sexual risk behaviors.

  9. Effect of 6 Months of Balance Training During Pulmonary Rehabilitation in Patients With COPD.

    PubMed

    Mkacher, Wajdi; Mekki, Marwa; Tabka, Zouhair; Trabelsi, Yassine

    2015-01-01

    Balance impairment is recognized as an important issue for patients with chronic obstructive pulmonary disease (COPD). The aim of this study was to examine the effect of balance training as part of pulmonary rehabilitation (PR) on balance in COPD patients. Patients were randomly assigned to an intervention or usual care group. The intervention group underwent balance training 3 times a week for 6 months in addition to the standard PR. The control group received 6 months of the standard PR program only. Balance was assessed by the Timed Up and Go (TUG), Tinetti, Berg Balance Scale (BBS), and the Unipodal Stance (UST) tests. Balance confidence was rated using the ABC scale. Exercise tolerance was determined using a 6-Minute Walk Test. Following the completion of PR, the intervention group showed improvement in all balance measures. Only TUG, ABC, and UST scores were improved in the usual care group (P < .05). Results demonstrated significant between-group differences in TUG, Tinetti, BBS, and ABC scores (P < .01) and UST score (P < .05). Balance training incorporated into a standard PR program significantly improves scores on balance tests in COPD patients.

  10. Refractive and visual outcomes after Keraring intrastromal corneal ring segment implantation for keratoconus assisted by femtosecond laser at 6 months follow-up

    PubMed Central

    Heikal, Mohamed A; Abdelshafy, Marwa; Soliman, Tarek T; Hamed, Abdelmonem M

    2017-01-01

    Purpose We attempted to evaluate the efficacy of femtosecond laser-assisted intrastromal corneal ring segment implantation in patients with keratoconus (KC). Patients and methods A retrospective interventional consecutive clinical study was conducted on patients with KC who were treated with femtosecond laser Keraring implantation. All procedures were performed at Ebsar Eye Center in the period from January 5, 2015, to February 28, 2016. Results Thirty eyes of 20 patients were included in this study. The mean age of patients was 27.43±3.57 years. Eleven patients (55%) were female and nine patients (45%) were male. Keraring segments were successfully implanted in all eyes. There were no complications or need for ring repositioning. The follow-up period was 6 months postoperatively. There was a significant improvement in the mean logarithm of the minimum angle of resolution (LogMAR) of uncorrected visual acuity (UCVA) after Keraring segment implantation from 1.5±0.23 preoperatively to 0.54±0.16 at 6 months postoperatively (P=0.001). The preoperative mean LogMAR of best-corrected visual acuity (BCVA) was 0.85±0.17. At 1 month postoperatively, it was 0.35±0.15; at 3 months postoperatively, it was 0.26±0.11, and at 6 months postoperatively, it was 0.14±0.07 (P=0.001). The mean preoperative maximum keratometric value for 3 mm pupil in diopters (K max) significantly decreased from 55.85±5.44 preoperatively (N=30) to 44.05±1.64 D at 6 months postoperatively (P=0.001). There was a statistically significant reduction in the mean preoperative spherical equivalent from −5.43±1.76 D preoperatively to −2.43±0.95 D at 6 months postoperatively. No statistically significant differences were detected between 1 and 3 months of follow-up regarding the visual and refractive outcomes. Conclusion Analysis of the outcomes after Keraring ICRS implantation showed a significant postoperative corneal flattening with a subsequent increase in UCVA and BCVA. Using the femtosecond

  11. Derivation and Validation of a Prognostic Model to Predict 6-Month Mortality in an Intensive Care Unit Population.

    PubMed

    Hadique, Sarah; Culp, Stacey; Sangani, Rahul G; Chapman, Kyle D; Khan, Saad; Parker, John E; Moss, Alvin H

    2017-10-01

    Identification of terminally ill patients in the intensive care unit (ICU) would facilitate decision making and timely palliative care. To develop and validate a patient-specific integrated prognostic model to predict 6-month mortality in medical ICU patients. A longitudinal prospective cohort study of temporally split samples of 1,049 consecutive medical ICU patients in a tertiary care hospital was performed. For each patient, we collected demographic data, Acute Physiology and Chronic Health Evaluation III score, Charlson comorbidity index, intensivist response to a surprise question (SQ; "Would I be surprised if this patient died in the next 6 months?") on admission, and vital status at 6 months. Between November 2013 and May 2015, derivation and validation cohorts of 500 and 549 consecutive patients were studied to develop a multivariate logistic regression model. In the multivariate logistic regression model, Charlson comorbidity index (P = 0.033), Acute Physiology and Chronic Health Evaluation III score (P < 0.001), and SQ response (P < 0.001) were predictors of vital status at 6 months. The odds of dying within 6 months were significantly higher when the SQ was answered "no" than when it was answered "yes" (odds ratio, 7.29; P < 0.001). The c-statistic for the derivation and validation cohorts were 0.832 (95% confidence interval, 0.795-0.870) and 0.84 (95% confidence interval, 0.806-0.875), respectively. Our integrated prognostic model, which includes the SQ, has strong discrimination and calibration to predict 6-month mortality in medical ICU patients. This model can aid clinicians in identifying ICU patients who may benefit from the integration of palliative care into their treatment.

  12. Comparative investigation of a dentifrice containing triclosan/copolymer/sodium fluoride and specially-designed silica and a dentifrice containing 0.243% sodium fluoride in a silica base for the control of established supra-gingival plaque and gingivitis: a 6-month clinical study.

    PubMed

    Mankodi, Suru; Chaknis, Patricia; Panagakos, Fotinos S; DeVizio, William; Proskin, Howard M

    2011-07-01

    To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica in controlling established dental plaque and gingivitis. Qualifying adult male and female subjects from the West Palm Beach, Florida area were randomly assigned into one of two treatment groups: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica (Test Dentifrice); and (2) a dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). All subjects received an oral soft and hard tissue examination, baseline plaque and gingivitis were assessed, and subjects were dispensed their assigned dentifrice product along with a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for plaque and gingivitis, and oral soft and hard tissue assessments were repeated after 3 and 6 months of product use. 115 subjects complied with the protocol, and completed the 6-month examination. After 6 months of product use, subjects assigned to the Test Dentifrice group exhibited statistically significant reductions from baseline with respect to Plaque Index, Plaque Severity Index, Gingival Index, and Gingivitis Severity Index scores; and subjects assigned to the Negative Control Dentifrice group exhibited statistically significant reductions from baseline with respect to Gingival Index scores only. Relative to the Negative Control Dentifrice group, the Test Dentifrice group exhibited an 18.8% reduction in Plaque Index; a 50% reduction in Plaque Severity Index; a 19.6% reduction in Gingival Index; and a 60% reduction in Gingivitis Severity Index after 6 months, all of which were statistically significant.

  13. Cognitive-Behaviorally-Oriented Group Rehabilitation of Adults with ADHD: Results of a 6-Month Follow-Up

    ERIC Educational Resources Information Center

    Salakari, Anita; Virta, Maarit; Gronroos, Nina; Chydenius, Esa; Partinen, Markku; Vataja, Risto; Kaski, Markus; Iivanainen, Matti

    2010-01-01

    Objective: Recently, novel psychological treatments for adult ADHD have been reported with promising results. However, studies about long-term treatment effects are scanty. The authors study effects of cognitive-behaviorally-oriented group rehabilitation during a 6-month follow-up. Method: Participating in the rehabilitation were 29 adults, of…

  14. Cognitive-Behaviorally-Oriented Group Rehabilitation of Adults with ADHD: Results of a 6-Month Follow-Up

    ERIC Educational Resources Information Center

    Salakari, Anita; Virta, Maarit; Gronroos, Nina; Chydenius, Esa; Partinen, Markku; Vataja, Risto; Kaski, Markus; Iivanainen, Matti

    2010-01-01

    Objective: Recently, novel psychological treatments for adult ADHD have been reported with promising results. However, studies about long-term treatment effects are scanty. The authors study effects of cognitive-behaviorally-oriented group rehabilitation during a 6-month follow-up. Method: Participating in the rehabilitation were 29 adults, of…

  15. Association between depression in carers and malnutrition in children aged 6 months to 5 years.

    PubMed

    Motlhatlhedi, Keneilwe; Setlhare, Vincent; Ganiyu, Adewale; Firth, Jacqueline

    2017-01-30

     Childhood malnutrition is an important risk factor for child mortality and underlies close to 50% of child deaths worldwide. Previous studies have found an association between maternal depression and child malnutrition, but it is not known whether this association exists in Botswana. In addition, previous studies excluded non-maternal primary caregivers (PCGs). It is unclear whether the association between primary caregiver depression and child malnutrition remains when non-maternal PCGs are included. The aim of this study was to determine if there is an association between PCG depression and malnutrition in children aged between 6 months and 5 years in Mahalapye, Botswana. The study was conducted in the child welfare clinics of Xhosa and Airstrip clinics, two primary health care facilities in Mahalapye, Botswana. This was a case control study. Cases were malnourished children aged between 6 months and 5 years, and controls were non-malnourished children matched for age and gender. The outcome of interest was depression in the PCGs of the cases and controls, which was assessed using the Patient Health Questionnaire 9 (PHQ 9), a depression screening tool. From a sample of 171 children, 84 of whom were malnourished, we found that the malnourished children were significantly more likely to have depressed PCGs (odds ratio = 4.33; 95% CI: 1.89, 9.89) than non-malnourished children in the 6-month to 5-year age group; the PCGs of malnourished children also had lower educational status. This study found a significant association between PCG depression and child malnutrition.

  16. Effects of growth hormone administration for 6 months on bone turnover and bone marrow fat in obese premenopausal women.

    PubMed

    Bredella, Miriam A; Gerweck, Anu V; Barber, Lauren A; Breggia, Anne; Rosen, Clifford J; Torriani, Martin; Miller, Karen K

    2014-05-01

    Abdominal adiposity is associated with low BMD and decreased growth hormone (GH) secretion, an important regulator of bone homeostasis. The purpose of our study was to determine the effects of a short course of GH on markers of bone turnover and bone marrow fat in premenopausal women with abdominal adiposity. In a 6-month, randomized, double-blind, placebo-controlled trial we studied 79 abdominally obese premenopausal women (21-45 y) who underwent daily sc injections of GH vs. placebo. Main outcome measures were body composition by DXA and CT, bone marrow fat by proton MR spectroscopy, P1NP, CTX, 25(OH)D, hsCRP, undercarboxylated osteocalcin (ucOC), preadipocyte factor 1 (Pref 1), apolipoprotein B (ApoB), and IGF-1. GH increased IGF-1, P1NP, 25(OH)D, ucOC, bone marrow fat and lean mass, and decreased abdominal fat, hsCRP, and ApoB compared with placebo (p<0.05). There was a trend toward an increase in CTX and Pref-1. Among all participants, a 6-month increase in IGF-1 correlated with 6-month increase in P1NP (p=0.0005), suggesting that subjects with the greatest increases in IGF-1 experienced the greatest increases in bone formation. A six-month decrease in abdominal fat, hsCRP, and ApoB inversely predicted 6-month change in P1NP, and 6-month increase in lean mass and 25(OH)D positively predicted 6-month change in P1NP (p≤0.05), suggesting that subjects with greatest decreases in abdominal fat, inflammation and ApoB, and the greatest increases in lean mass and 25(OH)D experienced the greatest increases in bone formation. A six-month increase in bone marrow fat correlated with 6-month increase in P1NP (trend), suggesting that subjects with the greatest increases in bone formation experienced the greatest increases in bone marrow fat. Forward stepwise regression analysis indicated that increase in lean mass and decrease in abdominal fat were positive predictors of P1NP. When IGF-1 was added to the model, it became the only predictor of P1NP. GH replacement in

  17. Effects of growth hormone administration for 6 months on bone turnover and bone marrow fat in obese premenopausal women

    PubMed Central

    Bredella, Miriam A.; Gerweck, Anu V.; Barber, Lauren A.; Breggia, Anne; Rosen, Clifford J.; Torriani, Martin; Miller, Karen K.

    2014-01-01

    Purpose Abdominal adiposity is associated with low BMD and decreased growth hormone (GH) secretion, an important regulator of bone homeostasis. The purpose of our study was to determine the effects of a short course of GH on markers of bone turnover and bone marrow fat in premenopausal women with abdominal adiposity. Materials and Methods In a 6-month, randomized, double-blind, placebo-controlled trial we studied 79 abdominally obese premenopausal women (21–45y) who underwent daily sc injections of GH vs. placebo. Main outcome measures were body composition by DXA and CT, bone marrow fat by proton MR spectroscopy, P1NP, CTX, 25(OH)D, hsCRP, undercarboxylated osteocalcin (ucOC), preadipocyte factor 1 (Pref 1), apolipoprotein B (ApoB), and IGF-1. Results GH increased IGF-1, P1NP, 25(OH)D, ucOC, bone marrow fat and lean mass, and decreased abdominal fat, hsCRP, and ApoB compared with placebo (p<0.05). There was a trend toward an increase in CTX and Pref-1. Among all participants, 6-month increase in IGF-1 correlated with 6-month increase in P1NP (p=0.0005), suggesting that subjects with the greatest increases in IGF-1 experienced the greatest increases in bone formation. Six-month decrease in abdominal fat, hsCRP, and ApoB inversely predicted 6-month change in P1NP, and 6-month increase in lean mass and 25(OH)D positively predicted 6-month change in P1NP (p≤0.05), suggesting that subjects with greatest decreases in abdominal fat, inflammation and ApoB, and the greatest increases in lean mass and 25(OH)D experienced the greatest increases in bone formation. Six-month increase in bone marrow fat correlated with 6-month increase in P1NP (trend), suggesting that subjects with the greatest increases in bone formation experienced the greatest increases in bone marrow fat. Forward stepwise regression analysis indicated that increase in lean mass and decrease in abdominal fat were positive predictors of P1NP. When IGF-1 was added to the model, it became the only predictor

  18. Effect of Admission Hyperglycemia on 6-Month Functional Outcome in Patients with Spontaneous Cerebellar Hemorrhage.

    PubMed

    Tao, Chuanyuan; Hu, Xin; Wang, Jiajing; You, Chao

    2017-03-08

    BACKGROUND Cerebellar hemorrhage (CH) has a quite different treatment strategy and prognostic factors compared with supratentorial intracerebral hemorrhage (ICH). The prognostic role of hyperglycemia has been discussed mainly in cases of supratentorial hemorrhage; it remains to be elucidated following CH. We aimed to determine the association of hyperglycemia on admission with 6-month functional outcome in CH patients. MATERIAL AND METHODS We retrospectively analyzed 77 patients with acute CH between September 2010 and April 2015 in West China Hospital. Blood glucose level was measured when the patients were admitted. Primary outcome was 6-month functional outcome, which could comprehensively reflect the patient's recovery of physical and social ability after stroke and was assessed by the modified Rankin scale (mRS). Association of hyperglycemia with functional outcome was identified in logistic regression models. RESULTS There were 50 (64.9%) patients with poor functional outcomes. Patients with poor outcome were much older (P<0.001) and had a significantly higher glucose level on admission (P<0.001), a lower Glasgow Coma Scale score (P<0.001), a larger hematoma (P=0.003), and a higher incidence of intraventricular extension (P=0.002), brainstem compression (P=0.013), and hydrocephalus (P=0.023). Multivariate analysis showed that hyperglycemia (OR 1.50, 95% CI 1.07-2.08, P=0.017 when glucose level was analyzed as a continuous variable; OR 7.46, 95% CI 1.41-39.51, P=0.018 when glucose level was dichotomized by the critical threshold of 6.78 mmol/L) emerged as an independent predictor for adverse functional outcome at 6 months. CONCLUSIONS To the best of our knowledge, this is the first study focusing on the relationship between hyperglycemia and long-term functional outcome after CH. The study combined with previous pertinent reports definitely indicates the poor effect of hyperglycemia on both supra- and infratentorial ICH independent of hemorrhage site

  19. Effect of Admission Hyperglycemia on 6-Month Functional Outcome in Patients with Spontaneous Cerebellar Hemorrhage

    PubMed Central

    Tao, Chuanyuan; Hu, Xin; Wang, Jiajing; You, Chao

    2017-01-01

    Background Cerebellar hemorrhage (CH) has a quite different treatment strategy and prognostic factors compared with supratentorial intracerebral hemorrhage (ICH). The prognostic role of hyperglycemia has been discussed mainly in cases of supratentorial hemorrhage; it remains to be elucidated following CH. We aimed to determine the association of hyperglycemia on admission with 6-month functional outcome in CH patients. Material/Methods We retrospectively analyzed 77 patients with acute CH between September 2010 and April 2015 in West China Hospital. Blood glucose level was measured when the patients were admitted. Primary outcome was 6-month functional outcome, which could comprehensively reflect the patient’s recovery of physical and social ability after stroke and was assessed by the modified Rankin scale (mRS). Association of hyperglycemia with functional outcome was identified in logistic regression models. Results There were 50 (64.9%) patients with poor functional outcomes. Patients with poor outcome were much older (P<0.001) and had a significantly higher glucose level on admission (P<0.001), a lower Glasgow Coma Scale score (P<0.001), a larger hematoma (P=0.003), and a higher incidence of intraventricular extension (P=0.002), brainstem compression (P=0.013), and hydrocephalus (P=0.023). Multivariate analysis showed that hyperglycemia (OR 1.50, 95% CI 1.07–2.08, P=0.017 when glucose level was analyzed as a continuous variable; OR 7.46, 95% CI 1.41–39.51, P=0.018 when glucose level was dichotomized by the critical threshold of 6.78 mmol/L) emerged as an independent predictor for adverse functional outcome at 6 months. Conclusions To the best of our knowledge, this is the first study focusing on the relationship between hyperglycemia and long-term functional outcome after CH. The study combined with previous pertinent reports definitely indicates the poor effect of hyperglycemia on both supra- and infratentorial ICH independent of hemorrhage site

  20. Explosive and maximal strength before and 6 months after total hip arthroplasty.

    PubMed

    Friesenbichler, Bernd; Casartelli, Nicola C; Wellauer, Vanessa; Item-Glatthorn, Julia F; Ferguson, Stephen J; Leunig, Michael; Maffiuletti, Nicola A

    2017-06-02

    Patients with unilateral hip osteoarthritis experience impairments in lower limb muscle function due to pain and disuse of the affected limb. The influence of hip osteoarthritis and subsequent total hip arthroplasty (THA) has mostly been evaluated by maximal strength tests, yet the functionally important explosive strength capabilities of hip and knee muscles are largely unknown. We aimed to evaluate hip and knee explosive and maximal strength in hip osteoarthritis patients before and after THA. Twenty-one patients with unilateral hip osteoarthritis were evaluated before and 6 months after THA. They performed rapid maximal contractions of hip (flexor, extensor, abductor, adductor) and knee (flexor, extensor) muscles, from which explosive and maximal strength asymmetries were evaluated (involved versus uninvolved limb). Before THA, the involved limb showed significantly lower hip flexor, extensor, adductor, and knee extensor explosive and maximal strength compared to the uninvolved limb. Six months after THA surgery, hip flexor, extensor and adductor maximal and explosive strength asymmetries persisted, except for knee extensors. Explosive, but not maximal strength of hip abductors and knee extensors was lower in the involved limb before surgery and the reduced explosive strength capabilities may compromise daily living activities in hip osteoarthritis patients. After hip replacement, explosive strength asymmetries of knee extensors resolved, yet lingering asymmetries in hip flexor muscles should receive focused attention during postoperative rehabilitation. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

  1. A 6 month evaluation of a non-powered hybrid mattress replacement system.

    PubMed

    Newton, Heather

    2015-11-11

    In 2013, the Royal Cornwall Hospitals NHS Trust undertook a 6-week evaluation of the AtmosAir 4000 non-powered reactive pressure redistribution mattress replacement system to determine its suitability in supporting the prevention of pressure ulcers in high-risk patients (phase one). The results demonstrated that the AtmosAir 4000 mattress system, together with skin assessment and repositioning regimes, met the pressure ulcer preventative needs of patients at high and very high risk of developing pressure ulcers. It also resulted in a notable reduction in the use of dynamic air mattresses. Consequently, 50 AtmosAir 4000 mattresses were purchased for two acute medical wards in the evaluation site, where the majority of patients are elderly with an acute medical condition. This article discusses the second phase where an audit compares the number of hospital-acquired pressure ulcers reported over a 6-month period with the equivalent time period in 2014. Results show that the number of pressure ulcers reduced by 65% and 50% in the two wards. The number of dynamic mattresses used on the two wards reduced significantly from 28 to 7, which represents a 75% reduction in usage.

  2. Role of spinal ultrasound in diagnosis of meningitis in infants younger than 6 months.

    PubMed

    Nepal, Pankaj; Sodhi, Kushaljit Singh; Saxena, Akshay Kumar; Bhatia, Anmol; Singhi, Sunit; Khandelwal, Niranjan

    2015-03-01

    Spinal ultrasound (US) can detect changes in CSF echogenicity and decreased cord pulsations which reflect the inflammatory changes in meningitis. Till date, there is no published data about the prospective accuracy of spinal US in meningitis. To assess accuracy of spinal US in diagnosis of meningitis in infants younger than 6 months. This was an institute ethics committee approved prospective study carried out in infants less than 6 months of age with clinical suspicion of meningitis who presented to pediatric emergency unit. 60 infants each in study and control group were enrolled. US of thoraco-lumbar spine were performed prior to lumbar puncture in all cases. We looked for the presence of echogenicity or trabeculations in posterior subarachnoid space and for presence or absence of spinal cord and nerve root pulsations on real time ultrasound. The results of spinal US were evaluated in correlation with cerebrospinal fluid analysis. Follow up ultrasounds were done in infants who showed abnormal findings after the initiation of treatment and findings compared with initial results. The study group comprised of 40 boys and 20 girls with mean age of 47.85 days. The control group comprised of 36 boys and 24 girls with a mean age of 60.53 days. 34/60 cases in study group had CSF findings suggestive of meningitis. Based on imaging parameters, spinal US had sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 67.16%, 92.3%, 93.1% and 74.64%, respectively. Chi-square test showed a statistically significant association between infants with meningitis and positive US findings (p<0.05). Spinal US findings of CSF debris, septations and decreased spinal cord pulsations can be seen in infants with meningitis. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  3. Electronic cigarettes, quit attempts and smoking cessation: a 6-month follow-up.