nils-herrmann/clean_scirepeval huggingface dataset:
Brief cognitive-behavioral depression prevention program for high-risk adolescents outperforms two alternative interventions: a randomized efficacy trial.

In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater reductions in depressive symptoms than did supportive-expressive, bibliotherapy, and assessment-only participants at posttest, though only the difference compared with assessment controls was significant at 6-month follow-up. CB participants showed significantly greater improvements in social adjustment and reductions in substance use at posttest and 6-month follow-up than did participants in all 3 other conditions. Supportive-expressive and bibliotherapy participants showed greater reductions in depressive symptoms than did assessment-only controls at certain follow-up assessments but produced no effects for social adjustment and substance use. CB, supportive-expressive, and bibliotherapy participants showed a significantly lower risk for major depression onset over the 6-month follow-up than did assessment-only controls. The evidence that this brief CB intervention reduced risk for future depression onset and outperformed alternative interventions for certain ecologically important outcomes suggests that this intervention may have clinical utility.
Limited sampling models for simultaneous estimation of the pharmacokinetics of irinotecan and its active metabolite SN-38

Irinotecan (CPT-11) is a novel topoisomerase I inhibitor with clinical activity in human malignancies. The objective of this study was to develop efficient limited sampling models (LSMs) to estimate simultaneously the area under the plasma concentration versus time curves (AUC) for both CPT-11 and its active metabolite SN-38. A total of 64 pharmacokinetic sets (≥24-h sampling) were obtained in phase I studies at doses ranging from 50 to 750 mg/m2 (0.5-h i.v. infusion). The patients were randomly assigned to a training data set (n=32) and a test set (n=32). Multiple linear regression analyses were used to determine the optimal LSMs based on the correlation coefficient (r), bias (MPE%, percentage of mean prediction error), and precision (RMSE%, percentage of root mean squared prediction error). Of these LSMs, the ones including maximal concentrations of CPT-11 (0.5 h, the end of the i.v. infusion) and metabolite SN-38 (≈ 1 h) were favored along with predictive precision and clinical constraints. Several bivariate models including a 6-h time point as the last sampling time (or 7 h) were found to be highly predictive of either the CPT-11 AUC or the SN-38 AUC. The chosen sampling time points were the ones that allowed the best compromise between the accurate determination of either compound alone with the same sampling times. The simultaneously best prediction of both CPT-11 and SN-38 AUCs was obtained with sampling time points harvested at 0.5, 1, and 6 h (or 7 h). With these sampling time points a trivariate model was selected for the determination of CPT-11 AUC namely, CPT-11 AUC (ng h ml−1)=0.820×C0.5h+0.402×C1h+15.47 ×C6h+928, and a corresponding model was selected for the determination of metabolite AUC, i.e., SN-38 AUC (ng h ml−1)=4.05×C0.5h−0.81×C1h+23.01×C6h−69.78, whereC(t) is the concentration in nanograms per milliliter of either compound at a given timet. These models performed well with the test data sets for CPT-11 AUC (r=0.98, MPE%=−1.4, RMSE%=13.9) and for SN-38 AUC (r=0.95, MPE%=−6.5, RMSE%=37.7). In addition to the determination of AUCs (and hence clearance), these models also allow the determination of the maximal concentrations of both compounds, which might be needed for pharmacodynamics studies. Other bi- and trivariate models including other time points are also presented. These LSMs not only will facilitate ongoing and future clinical trials by significantly reducing the number of blood samples needed for pharmacokinetics studies but will hopefully contribute to a better knowledge of pharmacokinetic-pharmacodynamic relationships for both CPT-11 and its active metabolite SN-38.
Predictors of adherence to a skill-building intervention in dementia caregivers.

Treatment adherence is a widely recognized problem in health services but understudied in caregiver intervention research. This study examines caregiver sociodemographic and psychological characteristics, patient illness severity, and treatment implementation factors as predictors of caregiver adherence to a skills training intervention to help families manage dementia care problems at home.



The sample consisted of 105 caregivers randomized to the Home Environmental Skill-Building Program at the Philadelphia site of the National Institutes of Health (NIH) Resources for Enhancing Alzheimer's Caregiver Health (REACH I). The intervention, implemented by occupational therapists, consisted of education, problem solving, communication, environmental and task simplification techniques, and home modifications. Adherence was measured by a proportion score representing the percentage of strategies used by participants compared to the total number of strategies prescribed during intervention (Strategy Use).



Regression analysis with intraclass correlation adjustment for interventionist effects revealed that caregivers with better physical health (p <.001), greater treatment exposure (p <.001), more problem areas addressed (p =.012), and for whom more active therapeutic techniques (role play) were used (p =.004) demonstrated greater adherence. Other caregiver characteristics, patient cognitive impairment, and troublesome behaviors were not significantly related to caregiver adherence.



Modifiable caregiver and treatment implementation factors, including active engagement of caregivers, were associated with adherence, whereas patient characteristics were not. Caregivers with poor health may be at risk for not benefiting from intervention, suggesting that efforts, including instruction in preventive care and allocating time to attend to their own health care needs, be directed towards improving their health.
Early infant feeding patterns and HIV-free survival: findings from the Kesho-Bora trial (Burkina Faso, Kenya, South Africa).

To investigate the association between feeding patterns and HIV-free survival in children born to HIV-infected mothers and to clarify whether antiretroviral (ARV) prophylaxis modifies the association.



From June 2005 to August 2008, HIV-infected pregnant women were counseled regarding infant feeding options, and randomly assigned to triple-ARV prophylaxis (triple ARV) until breastfeeding cessation (BFC) before age 6 months or antenatal zidovudine with single-dose nevirapine (short-course ARV). Eighteen-month HIV-free survival of infants HIV-negative at 2 weeks of age was assessed by feeding patterns (replacement feeding from birth, BFC <3 months, BFC ≥3 months).



Of the 753 infants alive and HIV-negative at 2 weeks, 28 acquired infection and 47 died by 18 months. Overall HIV-free survival at 18 months was 0.91 [95% confidence interval (CI): 0.88-0.93]. In the short-course ARV arm, HIV-free survival (0.88; CI: 0.84-0.91) did not differ by feeding patterns. In the triple ARV arm, overall HIV-free survival was 0.93 (CI: 0.90-0.95) and BFC <3 months was associated with lower HIV-free survival than BFC ≥3 months (adjusted hazard ratio: 0.36; CI: 0.15-0.83) and replacement feeding (adjusted hazard ratio: 0.20; CI: 0.04-0.94). In the triple ARV arm, 4 of 9 transmissions occurred after reported BFC (and 5 of 19 in the short-course arm), indicating that some women continued breastfeeding after interruption of ARV prophylaxis.



In resource-constrained settings, early weaning has previously been associated with higher infant mortality. We show that, even with maternal triple-ARV prophylaxis during breastfeeding, early weaning remains associated with lower HIV-free survival, driven in particular by increased mortality.
Understanding heterogeneity in response to antidiabetes treatment: a post hoc analysis using SIDES, a subgroup identification algorithm.

Treatment response in patients with type 2 diabetes mellitus (T2DM) varies because of different genotypic and phenotypic characteristics. Results of clinical trials are based largely on aggregated estimates of treatment effect rather than individualized outcomes. This research assessed heterogeneity and differential treatment response using the subgroup identification based on differential effect search (SIDES) algorithm with data from a large multinational study.



This was a retrospective analysis of the DURABLE trial, a randomized, open-label, two-arm, parallel study. The trial enrolled 2091 insulin-naïve T2DM patients aged 30 to 80 years. Patients received twice-daily insulin lispro mix 75/25 (LM75/25) or once-daily insulin glargine (insulin glargine). The SIDES methodology was used to find subgroups where the treatment effect was substantially different from what was observed in the full population of the clinical trial. A subgroup identification tool implementing the SIDES algorithm was used to examine data for 1092 patients (584 LM75/25 and 508 insulin glargine), achieving at-goal 12- or 24-week glycated hemoglobin A1c (A1C) (≤7.0%).



The overall at-goal population treatment difference (A1C reduction) was not clinically meaningful, but a clinically meaningful difference was observed (A1C reduction 2.31% ± 0.06% LM75/25 versus 2.01% ± 0.07% insulin glargine; p = .001) in patients with a baseline fasting insulin level >11.4 μIU/ml and age ≤56 years.



The observation that younger patients with higher levels of fasting insulin may benefit from a regimen that includes short-acting insulin targeting postprandial glycemia helps explain the heterogeneity in response and warrants further investigation.
Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials

We assessed the safety and efficacy of 10-day twice-daily triple therapy for Helicobacter pylori (H. pylori) in three double-blind, controlled trials in patients with duodenal ulcer disease.H. pylori-infected patients with one or more duodenal ulcer(s) at endoscopy (studies 1, 2) or with a documented duodenal ulcer history and no duodenal ulcer or erosions at endoscopy (study 3) were randomly assigned to 10-day courses of omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. plus clarithromycin 500 mg b.i.d. (OAC) or placebo plus amoxicillin 1 g b.i.d. plus clarithromycin 500 mg b.i.d. (AC). In studies 1 and 2, patients received an additional 18 days of omeprazole 20 mg q.d. (OAC group) or placebo (AC group). Endoscopy was repeated 4 wk after therapy in studies 1 and 2 and 4–6 wk after therapy in study 3. At baseline, H. pylori was diagnosed by CLOtest plus histology, or by culture. Eradication was defined as no positive biopsy test and two or more negative tests. Patients were defined as compliant if they took 75% or more of each study drug and missed ≤ 3 consecutive days of the 10-day therapy.Intent-to-treat populations of the three studies combined were 241 patients for OAC and 266 for AC. Of all OAC patients combined, 2% stopped study medications due to adverse events, and 93% were compliant. Per-protocol cure rates were 78% to 90% (all studies combined, 84%) for OAC vs 33% to 45% (combined, 39%) for AC (p < 0.001, OAC vs AC); intent-to-treat eradication rates were 69% to 83% (combined, 75%) for OAC vs 32% to 37% (combined, 35%) for AC; (p < 0.001, OAC vs AC).Conclusion:Rigorously designed studies indicate that 10 days of twice-daily triple therapy with omeprazole, amoxicillin, and clarithromycin achieves per-protocol eradication rates of approximately 80% to 90% in the U.S.
To tweet or not to tweet about schizophrenia systematic reviews (TweetSz): study protocol for a randomised controlled trial

The Cochrane Schizophrenia Group (CSzG) has produced and maintained systematic reviews of effects of interventions for schizophrenia and related illness. Each review has a Plain Language Summary (PLS), for those without specialised knowledge, and an abstract, which are freely available from The Cochrane Library (https://summaries.cochrane.org). Increasingly, evidence is being distributed using social media such as Twitter and Weibo (in China) alongside traditional publications.



In a prospective two-arm, parallel, open randomised controlled trial with a 1:1 allocation ratio, we will allocate 170 published systematic reviews into the intervention group (tweeting arm/Weibo arm) versus the control group (non-tweeting arm). Reviews will be stratified by baseline access activity, defined as high (≥19 views per week, n=14), medium (4.3 to 18.99 views per week, n=72) or low (<4.3 views per week, n=84), based on Google Analytics, which will also be used for evaluating outcomes. The intervention group will have three tweets daily using Hootsuite with a slightly different accompanying text (written by CEA and AB) and a shortened Uniform Resource Locator (URL) to the PLS: a) The review title as it appears in summaries.cochrane.org, b) A pertinent extract from results or discussion sections of the abstract and c) An intriguing question or pithy statement related to the evidence in the abstract. The primary outcome will be: total number of visits to a PLS in 7 days following the tweet. Secondary outcomes will include % new visits, bounce rate, pages per visit, visit duration, page views, unique page views, time on page, entrances, exiting behaviour and country distribution.


ETHICS AND DISSEMINATION
This study does not involve living participants, and uses information available in the public domain. Participants are published systematic reviews, hence, no ethical approval is required. Dissemination will be via Twitter, Weibo and traditional academic means.
Dofetilide is safe and effective in preventing atrial fibrillation recurrences in patients accepted for catheter ablation.

The aim of this study was to assess the safety and efficacy of dofetilide among patients refractory to other anti-arrhythmic drugs (AADs) and accepted for atrial fibrillation (AF) ablation.



One hundred and twenty-seven of 454 patients (69% male, 58% paroxysmal, age 60 +/- 10 years, AF duration 8 +/- 7 years) scheduled for AF ablation between February 2004 and May 2008 were treated with dofetilide. Patients had failed 1.9 +/- 1.1 AADs. Anti-arrhythmic drugs were stopped five half-lives before ablation and 3 months for amiodarone. Patients were followed for 15 +/- 7 months with routine and symptom-driven monitoring. Success was defined as no further AF and partial success as a 50% reduction in frequency/duration of AF episodes. Thirty-six patients started dofetilide 158 +/- 167 days before ablation: 9 had no improvement, 16 experienced partial success, 8 had no further AF, and 2 improved enough to forgo ablation. Seventy-one patients started dofetilide immediately following ablation, of which 14 had no improvement, 22 experienced partial success, and 32 had no further AF. Twenty patients started dofetilide 119 +/- 153 days post-ablation, of which four had no improvement, seven experienced partial success, and nine had no further AF. Six patients discontinued dofetilide during initiation for QT prolongation.



Dofetilide appears safe and effective in preventing AF in patients refractory to other AADs undergoing catheter ablation.
Soy consumption alters endogenous estrogen metabolism in postmenopausal women.

Isoflavones are soy phytoestrogens that have been suggested to be anticarcinogenic. Our previous study in premenopausal women suggested that the mechanisms by which isoflavones exert cancer-preventive effects may involve modulation of estrogen metabolism away from production of potentially carcinogenic metabolites [16alpha-(OH) estrone, 4-(OH) estrone, and 4-(OH) estradiol] (X. Xu et al., Cancer Epidemiol. Biomark. Prev. 1998). To further evaluate this hypothesis, a randomized, cross-over soy isoflavone feeding study was performed in 18 healthy postmenopausal women. The study consisted of three diet periods, each separated by a washout of approximately 3 weeks. Each diet period lasted for 93 days, during which subjects consumed their habitual diets supplemented with soy protein isolate providing 0.1 (control), 1, or 2 mg isoflavones/kg body weight/day (7.1 +/- 1.1, 65 +/- 11, or 132 +/- 22 mg/day). A 72-h urine sample was collected 3 days before the study (baseline) and days 91-93 of each diet period. Urine samples were analyzed for 10 phytoestrogens and 15 endogenous estrogens and their metabolites by a capillary gas chromatography-mass spectrometry method. Compared with the soy-free baseline and very low isoflavone control diet, consumption of 65 mg isoflavones increased the urinary 2/16alpha-(OH) estrone ratio, and consumption of 65 or 132 mg isoflavones decreased excretion of 4-(OH) estrone. When compared with baseline values, consumption of all three soy diets increased the ratio of 2/4-(OH) estrogens and decreased the ratio of genotoxic: total estrogens. These data suggest that both isoflavones and other soy constituents may exert cancer-preventive effects in postmenopausal women by altering estrogen metabolism away from genotoxic metabolites toward inactive metabolites.
Effects of a physical therapy program combined with manual lymphatic drainage on shoulder function, quality of life, lymphedema incidence, and pain in breast cancer patients with axillary web syndrome following axillary dissection

The aim of this study was to evaluate the effects of physical therapy (PT) combined with manual lymphatic drainage (MLD) on shoulder function, pain, lymphedema, visible cords, and quality of life (QOL) in breast cancer patients with axillary web syndrome (AWS). In this prospective, randomized trial, 41 breast cancer patients with visible and palpable cords on the arm and axilla and a numeric rating scale (NRS) pain score of >3 were randomly assigned to PT (3 times/week for 4 weeks; n = 20) and PT combined with MLD (5 times/week for 4 weeks; PTMLD; n = 21) groups. MLD was performed by a physical therapist and the patients themselves during week 1 and weeks 2–4, respectively. Arm volume, shoulder function (muscular strength; active range of motion; and disabilities of the arm, shoulder, and hand [DASH]); QOL (European Organization for Research and Treatment of Cancer Core and Breast Cancer‐Specific QOL questionnaires), and pain (NRS) were assessed at baseline and after 4 weeks of treatment. QOL including functional and symptom aspects, shoulder flexor strength, DASH, and NRS scores were significantly improved in both groups after the 4-week intervention (P < 0.05). NRS score and arm volume were significantly lower in the PTMLD group than in the PT group (P < 0.05). Lymphedema was observed in the PT (n = 6), but not PTMLD, group (P < 0.05). PT improves shoulder function, pain, and QOL in breast cancer patients with AWS and combined with MLD decreases arm lymphedema.
Effectiveness of computer-generated (virtual reality) graded exposure in the treatment of acrophobia.

The authors' goal was to examine the efficacy of computer-generated (virtual reality) graded exposure in the treatment of acrophobia (fear of heights).



Twenty college students with acrophobia were randomly assigned to virtual reality graded exposure treatment (N = 12) or to a waiting-list comparison group (N = 8). Seventeen students completed the study. Sessions were conducted individually over 8 weeks. Outcome was assessed by using measures of anxiety, avoidance, attitudes, and distress associated with exposure to heights before and after treatment.



Significant differences between the students who completed the virtual reality treatment (N = 10) and those on the waiting list (N = 7) were found on all measures. The treatment group was significantly improved after 8 weeks, but the comparison group was unchanged.



The authors conclude that treatment with virtual reality graded exposure was successful in reducing fear of heights.
A comparative efficacy of oral prednisone with intramuscular triamcinolone in acute exacerbation of asthma.

Corticosteroids are recommended for emergency management of an asthmatic attack. This study was designed to compare the effectiveness of oral and intramuscular steroid on spirometric results in acute asthma. We performed a randomized trial involving 88 adults, aged 15-70 years, with acute exacerbation of asthma requiring treatment with steroids. All had been treated with standard bronchodilator regimens and then received oral prednisone, 40 mg/day for 7 days, or 40 mg/day intramuscular triamcinolone long acting (LA) for 3 days. Spirometric variable and percentage of change to baseline forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) after treatment were calculated. Baseline characteristic were comparable in the oral prednisone group (n=44) and in the intramuscular triamcinolone LA groups (n=44). After 7 days of treatment, the mean (SD) FEV1 and FVC in both groups improved statistically over baseline values (P<0.001). The median percentage change improvement of FEV1 between two treatment groups was statistically significant: 68+/-45.3% vs. 53.4+/-46.5%, P=0.04) respectively, but for FVC although improvement with prednisone was better than intramuscular triamcinolone LA groups, it was not statistically significant (52.6+/-40.1% vs. 45.8+/-39.9%, P=0.43) respectively. We conclude that in adults with acute asthma, oral prednisone is more effective than intramuscular triamcinolone LA in improvement of FEV1, but although efficacy of oral prednisone in improvement of FVC is more than intramuscular triamcinolone LA group, this effect is not significant.
Evaluation of school- and community-based HIV prevention interventions with junior secondary school students in Edo State, Nigeria.

This study examined the impact of two interventions delivered in rural communities and schools in Edo State, Nigeria designed to decrease youth vulnerability to HIV infection. The Ministry of Education approved Family Life and HIV Education (FLHE) programme delivered in Junior Secondary Schools and a community-based initiative to raise AIDS Competency of rural communities were evaluated using a clustered randomized control trial and mixed qualitative-quantitative methods. Ten schools were assigned to each of three research arms: FLHE programme only, FLHE and community programme, and control. Results demonstrated positive effects on rejection of myths, attitudes related to abstinence and use of condoms, and sexual activity. Confidence in these results is supported by both levels of statistical significance and consistency in patterns of results across different levels of schooling. Results support expansion of delivery of the FLHE programme and development of community-based initiatives as effective methods of reducing youth vulnerability to HIV infection.