nils-herrmann/clean_scirepeval huggingface dataset:
Probiotics in pregnant women to prevent allergic disease: a randomized, double-blind trial.

Previous reports have suggested that certain probiotics given to mothers and children at risk of atopy halves the incidence of atopic dermatitis (AD) at 2 years of age.



To examine if probiotics given to pregnant women in a nonselected population could prevent atopic sensitization or allergic diseases during the child's first 2 years.



In a randomized, double-blind trial of children from a nonselected maternal population (ClinicalTrials.gov identifier: NCT00159523), women received probiotic milk or placebo from 36 weeks of gestation to 3 months postnatally during breastfeeding. The probiotic milk contained Lactobacillus rhamnosus GG, L. acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12. Children with an itchy rash for more than 4 weeks were assessed for AD. At 2 years of age, all children were assessed for atopic sensitization, AD, asthma and allergic rhinoconjunctivitis. The intention-to-treat (ITT) analysis was enabled by multiple imputations.



Four hundred and fifteen pregnant women were computer randomized. At 2 years, 138 and 140 children in the probiotic and the placebo groups, respectively, were assessed. In the ITT analysis, the odds ratio (OR) for the cumulative incidence of AD was 0·51 in the probiotic group compared with the placebo [95% confidence interval (CI) 0·30-0·87; P=0·013]. There were no significant effects on asthma (OR 0·68, 95% CI 0·26-1·80; P=0·437) or atopic sensitization (OR 1·52, 95% CI 0·74-3·14; P=0·254).



  Probiotics given to nonselected mothers reduced the cumulative incidence of AD, but had no effect on atopic sensitization.
Safety and acceptability of condoms for use by homosexual men as a prophylactic against transmission of HIV during anogenital sexual intercourse.

In the Western world the human immunodeficiency virus (HIV), which causes AIDS and AIDS related conditions, is transmitted mainly by anogenital sexual intercourse between men. Since prevention of transmission is at present the only way of controlling the epidemic, prevention programs should be aimed at homosexual men. Information campaigns have resulted in some change in sexual behavior among homosexual men, but additional measures are required. Condoms may prove to be an acceptable and worthwhile means of preventing transmission of the virus during sexual intercourse since the HIV cannot penetrate the intact membrane of latex condoms. 17 male homosexual couples responded to an advertisement in a gay magazine inviting steady couples to participate in a study on the acceptability of condoms. In general, the stiffest condoms seemed to be safer than the others, but they were also the least liked and therefore unacceptable to the participants. Changes are necessary for the successful introduction of condoms as a prophylactic against transmission of the HIV in male homosexuals.
Cilostazol attenuates the severity of peripheral arterial occlusive disease in patients with type 2 diabetes: the role of plasma soluble receptor for advanced glycation end-products

Recent studies have demonstrated that the plasma soluble receptor for advanced glycation end-products (sRAGE) play a major role in developing macrovascular complications of type 2 diabetes, including peripheral arterial occlusion disease (PAOD). Cilostazol is an antiplatelet, antithrombotic agent, which has been used for the treatment of PAOD. We hypothesized that cilostazol attenuates the severity of PAOD in patients with type 2 diabetes through the augmentation of plasma sRAGE. Ninety type 2 diabetic patients with PAOD defined as intermittent claudication with ankle-brachial index (ABI) ≦0.9 were recruited for an open-labeled, placebo-controlled study for 52 weeks with oral cilostazol 100 mg twice daily (n = 45) or placebo (n = 45). Fasting plasma sRAGE, endothelial variables of E-selectin, soluble vascular cell adhesion molecule-1 (sVCAM-1), and inflammatory markers of high-sensitivity C-reactive protein (hsCRP) and tumor necrosis factor-α (TNF-α) were determined. After completely the 52-week treatment program, the ABI values were elevated in cilostazol group (P < 0.001). The plasma sRAGE was significantly increased (P = 0.007), and hsCRP, sVCAM, and E-selectin concentrations were significantly decreased (P = 0.028, <0.001 and <0.001, respectively) with cilostazol treatment. In a partial correlation analysis with adjustments for sex and age, the net change of sRAGE significantly correlated with the change of ABI in the cilostazol group (P = 0.043). In a stepwise multiple regression model, only the change with regards to sRAGE was significantly associated with the change of ABI (P = 0.046). Our results suggest that cilostazol may effectively attenuate the severity of PAOD in patients with type 2 diabetes. Plasma sRAGE plays a role as an independent predictor for improving the index of PAOD.
Rehabilitation in patients with radically treated respiratory cancer: A randomised controlled trial comparing two training modalities.

The evidence on the effectiveness of rehabilitation in lung cancer patients is limited. Whole body vibration (WBV) has been proposed as an alternative to conventional resistance training (CRT).



We investigated the effect of radical treatment (RT) and of two rehabilitation programmes in lung cancer patients. The primary endpoint was a change in 6-min walking distance (6MWD) after rehabilitation. Patients were randomised after RT to either CRT, WBVT or standard follow-up (CON). Patients were evaluated before, after RT and after 12 weeks of intervention.



Of 121 included patients, 70 were randomised to either CON (24), CRT (24) or WBVT (22). After RT, 6MWD decreased with a mean of 38m (95% CI 22-54) and increased with a mean of 95m (95% CI 58-132) in CRT (p<0.0001), 37m (95% CI -1-76) in WBVT (p=0.06) and 1m (95% CI -34-36) in CON (p=0.95), respectively. Surgical treatment, magnitude of decrease in 6MWD by RT and allocation to either CRT or WBVT were prognostic for reaching the minimally clinically important difference of 54m increase in 6MWD after intervention.



RT of lung cancer significantly impairs patients' exercise capacity. CRT significantly improves and restores functional exercise capacity, whereas WBVT does not fully substitute for CRT.
Comparison of traditional risk factors, angiographic findings, and in-hospital mortality between smoking and nonsmoking Turkish men and women with acute myocardial infarction.

The prevalence of smoking is high in Turkey. However, there are no data available evaluating the differences between smokers and nonsmokers according to their sex in patients with acute myocardial infarction (AMI) in Turkey.



The aim of the study was to determine the prevalence of smoking and its relationship to age, localization, and extension of coronary heart disease (CHD), and other risk factors in Turkish men and women with first AMI.



This study included, 1502 patients with first AMI from 3 different cities in Turkey. The baseline characteristics and traditional risk factors for CHD, Coronary angiographic results, and in-hospital outcome were recorded.



The proportion of male smokers was significantly higher than that of women (68% vs 18%, P < 0.001). Smokers were younger by almost a decade than nonsmokers (P < 0.001). Male nonsmokers were younger than females; however, the mean age of first AMI was similar in male and female smokers. In both genders, prevalence of hypertension and diabetes mellitus was significantly lower in smokers than in nonsmokers (P < 0.001). Smokers had less multivessel disease and less comorbidity as compared to nonsmokers. Although the in-hospital mortality rate was lower in smokers, smoking status was not an independent predictor of mortality.



Smoking, by decreasing the age of first AMI in women, offsets the age difference in first AMI between men and women. The mean age of first AMI is lower in Turkey than most European countries due to a high percentage of smoking.
Prospective analysis of body mass index during and up to 5 years after discharge from inpatient spinal cord injury rehabilitation.

To investigate the prevalence of overweight/obesity and the course of the body mass index (BMI) in persons with spinal cord injury during and after inpatient rehabilitation.



Multi-centre longitudinal study.



A total of 184 persons with spinal cord injury.



BMI was determined at the start of active rehabilitation, 3 months later, at discharge, and 1, 2 and 5 years after discharge.



The percentage of persons who were overweight/obese (BMI ≥ 22 kg/m2) increased over the years from 56% to 75%. The absolute BMI did not significantly increase during rehabilitation, but showed a significant increase the year after discharge from inpatient rehabilitation (p < 0.001). From examining the personal or lesion characteristics, age was the only factor that was related to the absolute BMI. BMI increased by 1 kg/m2 for each 10-year increase in age. Men, persons with paraplegia and older people had more chance of being overweight/obese compared with women, persons with tetraplegia and younger people.



The BMI of people with spinal cord injuries gradually increases during and after inpatient rehabilitation, with significant increases in the first year after discharge. It is recommended that emphasis is placed on weight-management protocols (diet and exercise) to encourage a healthy lifestyle.
Leptin levels are reduced by intravenous ghrelin administration and correlated with cue-induced alcohol craving

Increasing evidence supports the role of appetite-regulating pathways, including ghrelin and leptin, in alcoholism. This study tested the hypothesis that intravenous exogenous ghrelin administration acutely decreases endogenous serum leptin levels, and that changes in leptin levels negatively correlate with alcohol craving. This was a double-blind, placebo-controlled human laboratory study. Non-treatment-seeking, alcohol-dependent, heavy drinkers (n=45) were randomized to receive intravenous ghrelin or placebo, followed by a cue-reactivity procedure, during which participants were exposed to neutral (juice) and alcohol trial cues. There was a main effect for intravenous ghrelin administration, compared with placebo, in reducing serum leptin levels (P<0.01). Post hoc analysis showed significant differences in serum leptin levels at the alcohol trial (P<0.05) that persisted at the end of the experiment (P<0.05). By contrast, there were no significant differences in serum leptin levels at the juice trial (P=not significant (NS)). The change of serum leptin level at the alcohol trial correlated with the increase in alcohol urge (P<0.05), whereas urge to drink juice was not correlated with the leptin change at the juice trial (P=NS). These findings provide preliminary evidence of ghrelin–leptin cross-talk in alcoholic individuals and suggest that their relationship may have a role in alcohol craving.
Sex Differences in the Performance of Cardiac Computed Tomography Compared With Functional Testing in Evaluating Stable Chest Pain: Subanalysis of the Multicenter, Randomized CRESCENT Trial (Calcium Imaging and Selective CT Angiography in Comparison to Functional Testing for Suspected Coronary Arter

Cardiac computed tomography (CT) represents an alternative diagnostic strategy for women with suspected coronary artery disease, with potential benefits in terms of effectiveness and cost-efficiency.



The CRESCENT trial (Calcium Imaging and Selective CT Angiography in Comparison to Functional Testing for Suspected Coronary Artery Disease) prospectively randomized 350 patients with stable angina (55% women; aged 55±10 years), mostly with an intermediate coronary artery disease probability, between cardiac CT and functional testing. The tiered cardiac CT protocol included a calcium scan followed by CT angiography if the Agatston calcium score was between 1 and 400. Patients with test-specific contraindications were not excluded from study participation. Sex differences were studied as a prespecified subanalysis. Enrolled women presented more frequently with atypical chest pain and had a lower pretest probability of coronary artery disease compared with men. Independently of these differences, cardiac CT led in both sexes to a fast final diagnosis when compared with functional testing, although the effect was larger in women (P interaction=0.01). The reduced need for further testing after CT, compared with functional testing, was most evident in women (P interaction=0.009). However, no sex interaction was observed with respect to changes in angina and quality of life, cumulative diagnostic costs, and applied radiation dose (all P interactions≥0.097).



Cardiac CT is more efficient in women than in men in terms of time to reach the final diagnosis and downstream testing. However, overall clinical outcome showed no significant difference between women and men after 1 year.
Effects of varespladib methyl on biomarkers and major cardiovascular events in acute coronary syndrome patients.

The purpose of this study was to investigate the effects of varespladib on cardiovascular biomarkers in acute coronary syndrome patients.



Secretory phospholipase A(2) (sPLA(2)) represents a family of proatherogenic enzymes that hydrolyze lipoprotein phospholipids, increasing their affinity for intimal proteoglycans; contribute to cholesterol loading of macrophages by nonscavenger receptor mediated pathways; and activate inflammatory pathways. In prospective studies, high sPLA(2)-IIA levels predicted major adverse cardiovascular events in acute coronary syndrome (ACS) and stable coronary heart disease patients.



This randomized, double-blind, prospective controlled clinical trial (phase 2B) was designed to investigate the effects of sPLA(2) inhibition with varespladib 500 mg daily versus placebo as adjunctive therapy to atorvastatin 80 mg daily on biomarkers (low-density lipoprotein cholesterol [LDL-C], high-sensitivity C-reactive protein [hsCRP], and sPLA(2)-IIA levels), major adverse cardiovascular events (unstable angina, myocardial infarction, death), and safety. In all, 625 ACS subjects were randomized within 96 h of the index event and treated for a minimum of 6 months.



After 8 weeks (primary efficacy end point), varespladib/atorvastatin reduced mean LDL-C levels from baseline by 49.6% compared with 43.4% with placebo/atorvastatin (p = 0.002). Respective 8-week median reductions in sPLA(2)-IIA levels were 82.4% and 15.6% (p < 0.0001), and hsCRP levels were lowered by 75.0% and 71.0% (p = 0.097). At 24 weeks, respective reductions with varespladib and placebo were as follows: LDL-C 43.5% versus 37.6% (p < 0.05), hsCRP 79.8% versus 77.0% (p = 0.02), and sPLA(2)-IIA 78.5% versus 6.4% (p < 0.0001). Major adverse cardiovascular events were not different from placebo 6 months post-randomization (7.3% varespladib vs. 7.7% placebo). No treatment differences in elevated liver function studies on >1 occasion were observed.



Varespladib therapy effectively reduced LDL-C and inflammatory biomarkers in ACS patients treated with conventional therapy including atorvastatin 80 mg daily. There were no treatment differences in clinical cardiovascular events. (FRANCIS [Fewer Recurrent Acute Coronary Events With Near-Term Cardiovascular  A Study of the Safety and Efficacy of A 002
Detection of residual wall motion after myocardial infarction by gated technetium-99m tetrofosmin SPET: a comparison with contrast ventriculography

The differentiation of residual viability from necrotic myocardium in patients with a prior myocardial infarction is important when deciding whether revascularization is indicated. Myocardial viability can be assessed by studying perfusion and regional wall motion. Gated single-photon emission tomography (SPET) imaging allows the simultaneous assessment of perfusion and function through a single study. The aim of this study was to analyse the concordance between wall motion score derived by gated SPET and by contrast ventriculography. Furthermore, the agreement between myocardial perfusion and regional myocardial wall motion was analysed for both techniques. We studied a homogeneous group of 26 consecutive patients with a prior myocardial infarction, using both gated technetium-99m tetrofosmin SPET and contrast ventriculography. A seven-segment model of the left ventricle was employed to score regional myocardial wall motion on images obtained with gated SPET and contrast ventriculography using a four-point scale. Contrast ventriculography was performed within 2 weeks of the gated SPET study. Prevalence of abnormal wall motion (akinetic or dyskinetic) was 24/182 (13%) for gated SPET and 25/182 (14%) for contrast ventriculography (P=NS). There was a high agreement (80%) in wall motion score between gated SPET and contrast ventriculography (κ =0.67, P<0.001). The agreement was better in segments with normal or mild to moderate hypoperfusion (82%, κ=0.69) than in those with severe hypoperfusion (67%, κ=0.56). The agreement between myocardial perfusion and myocardial wall motion was 89% (162/182), κ=0.57, for gated SPET and 80% (145/182), κ=0.21, for contrast ventriculography. The relation between the summed wall motion scores per patient on gated SPET and contrast ventriculography was excellent (y=0.81x+2.9, r=0.82, P<0.01). Thirteen (43%) out of 30 segments with severely diminished or no myocardial perfusion showed normal or hypokinetic wall motion on gated SPET, suggesting residual myocardial viability in malperfused regions. Our results suggest that gated SPET imaging is a reliable tool for the assessment of regional wall motion in post-myocardial infarction patients. Furthermore, in patients with a previous myocardial infarction, gated SPET imaging has the potential to detect preserved wall motion in regions with fixed perfusion defects, which might be indicative of residual myocardial viability.
A randomised controlled trial evaluating the effects of two workstation interventions on upper body pain and incident musculoskeletal disorders among computer operators.

Call centre work with computers is associated with increased rates of upper body pain and musculoskeletal disorders.



This one year, randomised controlled intervention trial evaluated the effects of a wide forearm support surface and a trackball on upper body pain severity and incident musculoskeletal disorders among 182 call centre operators at a large healthcare company. Participants were randomised to receive (1) ergonomics training only, (2) training plus a trackball, (3) training plus a forearm support, or (4) training plus a trackball and forearm support. Outcome measures were weekly pain severity scores and diagnosis of incident musculoskeletal disorder in the upper extremities or the neck/shoulder region based on physical examination performed by a physician blinded to intervention. Analyses using Cox proportional hazard models and linear regression models adjusted for demographic factors, baseline pain levels, and psychosocial job factors.



Post-intervention, 63 participants were diagnosed with one or more incident musculoskeletal disorders. Hazard rate ratios showed a protective effect of the armboard for neck/shoulder disorders (HR = 0.49, 95% CI 0.24 to 0.97) after adjusting for baseline pain levels and demographic and psychosocial factors. The armboard also significantly reduced neck/shoulder pain (p = 0.01) and right upper extremity pain (p = 0.002) in comparison to the control group. A return-on-investment model predicted a full return of armboard and installation costs within 10.6 months.



Providing a large forearm support combined with ergonomic training is an effective intervention to prevent upper body musculoskeletal disorders and reduce upper body pain associated with computer work among call centre employees.
Comparing the effectiveness of efavirenz and nevirapine for first-line antiretroviral therapy in a South African multicentre cohort.

Current WHO guidelines for developing countries recommend efavirenz (EFV) and nevirapine (NVP) for first-line antiretroviral treatment (ART). This paper compares the effectiveness of EFV and NVP among ART-naive patients initiating treatment at 56 public health facilities in South Africa between January 2004 and December 2007.



Participants were assigned to the EFV or NVP cohorts depending on their baseline ART regimen. Mortality, viral load suppression after 6 months and ART regimen change were compared between the cohorts using Cox proportional hazards models and logistic regression.



At initiation, 19 441 (71.1%) patients started EFV and 7909 (28.9%) started NVP treatment. The median follow-up period was 9.5 months (IQR 4.6-17.7). After adjustment, mortality was similar in the two cohorts, (adjusted HR = 1.07, 95% CI 0.89-1.28). Viral load suppression at 6 months was higher in the EFV cohort overall (adjusted odds ratio [AOR] = 1.29, 95% CI 1.05-1.59) and in women aged 16-40 years (AOR = 1.35, 95% CI 1.11-1.63) and women with CD4 counts <25 cells/µL (AOR = 1.95, 95% CI 1.01-3.76). Patients starting on EFV were 47% less likely to change regimen (AOR = 0.53, 95% CI 0.48-0.59).



These findings suggest the superior effectiveness of EFV for first-line ART compared with NVP and should be considered during development of future ART guidelines for high-burden regions.
Height, weight and body mass index of children with congenital cataracts before surgical treatment

To investigate the distribution of the height, weight and body mass index (BMI) of children with congenital cataracts (CC) before surgical treatment.



This prospective study included children with CC ≤14 years of age presenting at the Zhongshan Ophthalmic Center from Jan. 2013 to Aug. 2016. The height, weight, and BMI measurements of all participating children were obtained and compared with the World Health Organization Child Growth Reference  The presence of a family history of CC or complicated systemic diseases as well as parental education levels and family income were also recorded.



In total, 595 children with CC were included. The mean age was 52.75 ± 33.99 months, and 34.29% (204/595) of them were unilateral cases. Among all of the children, 6.72% (40/595) of cases were complicated by systemic diseases. More than 1/5 (21.01%, 125/595) of the children had a family history of CC and exhibited bilateral involvement. Less than 1/4 (23.2) of the mothers were highly educated, and more than half of the families had a family income below the city average. Height, weight, and BMI measurements of most children with CC were within the normal ranges (±95% CI of the WHO Reference). Compared to the WHO Reference, both girls and boys aged 2-5 years revealed shorter heights, and the girls aged 5-14 years exhibited a shorter height, lower body weight and lower BMI. The heights of the children with CC and systemic diseases were also shorter than the WHO Reference. The children with CC who had a family history of disease had shorter heights and lower BMIs than children with CC but no family history, and the measurements of both groups were lower than the WHO Reference values.



The height, weight and BMI of most of the children with CC in this study were within the normal ranges of the WHO Reference. However, the children with CC and concomitant systemic diseases and those with a family history of CC had shorter heights and lower BMIs. This information aids in our understanding of the physical development of children with CC.