nils-herrmann/clean_scirepeval huggingface dataset:
Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory.



Adults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study.



This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement.
Green or yellow laser treatment for diabetic macular edema: exploratory assessment within the Diabetic Retinopathy Clinical Research Network.

Explore differences in green compared with yellow focal/grid laser treatment on functional and anatomical endpoints in eyes with diabetic macular edema.



Data from two randomized clinical trials were evaluated for differences in visual acuity and optical coherence tomography parameters for eyes assigned to sham injection + prompt laser, ranibizumab + prompt laser, or prompt laser only: among subgroups of eyes treated exclusively and electively with either green or yellow laser.



In the sham injection + prompt laser group, the mean visual acuity letter score change for eyes receiving green and yellow laser treatment, respectively, was +2.4 ± 14 and +5.1 ± 13 at the 52-week visit (P = 0.06) and +2.4 ± 15 and +6.0 ± 13 at the 104-week visit (P = 0.13), with no corresponding evidence of differences in optical coherence tomography thickness. When comparing wavelength groups in the ranibizumab + prompt laser and prompt laser-only groups, meaningful differences in visual acuity and optical coherence tomography thickness were not detected at 1 year or 2 years.



A trend toward improved vision outcome with yellow laser observed in one trial was not corroborated by anatomical outcomes or by the other trial. In this study, without random assignment to different wavelengths controlling for bias and confounding, it is not possible to determine whether one wavelength is better than the other.
An economic analysis of robot-assisted therapy for long-term upper-limb impairment after stroke.

Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness.



We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization.



A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different.



The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation.
Examining initial sleep onset in primary insomnia: a case-control study using 4-second epochs.

To explore the sleep onset process in primary insomnia patients, new rules for scoring 4-second epochs were implemented to score sleep and artifacts during initial sleep onset. Conventional scorings in 20-second and 60-second epochs were also obtained.



The start of the initial 60-second epoch of stage 1 was used to define "time zero" (t0). Sleep onset periods from 11 patients and 11 individually age- and sex-matched controls spanned from 5 minutes before t0 through 29 minutes after t0. Using the new rules, the periods were scored blind to group assignment. This t0 time-referenced the data analysis to one plausible midpoint in the sleep onset process. In parallel, latencies were time-referenced from good night time.



Reliability in scoring sleep and artifacts was adequate (kappa = 0.68 & 0.63, respectively, p <0.001). Group differences in sleep latencies were marginal in 60-second and 20-second scoring but significant with a definition of 4-second sleep latency. Patients had more 4-second epochs scored as awake (Mantel-Haenszel chi2 = 271, d.f. = 1, p <0.001) and containing artifact (M-H chi2 = 143, p <0.001). Patients took longer to achieve 30 continuous 4-second epochs of NREM sleep (Breslow chi2 = 4.03, d.f. = 1, p = 0.045) after t0. Patients accumulated sleep more slowly with all 3 scoring rules after t0. A slower rate of accumulating sleep after t0 was detected only with the 4-second scoring (p = 0.047).



Evidence was present for momentary state-switching instabilities in the patients during the initial sleep onset process. Using rules for scoring small epochs may reveal such instabilities more readily than traditional scoring methods.
Fontolizumab in moderate to severe Crohn's disease: a phase 2, randomized, double-blind, placebo-controlled, multiple-dose study.

The safety and efficacy of fontolizumab, a humanized anti-interferon gamma antibody, was investigated in patients with Crohn's disease (CD). Elevated gut mucosal levels of interferon gamma, a key cytokine involved in the inflammatory process of CD, are associated with disease symptoms.



A total of 201 patients with Crohn's Disease Activity Index (CDAI) scores between 250 and 450 were randomized to receive an initial intravenous dose of 1.0 or 4.0 mg/kg fontolizumab or placebo, followed by up to 3 subcutaneous doses of 0.1 or 1.0 mg/kg fontolizumab or placebo every 4 weeks. Clinical response at day 29, the primary efficacy endpoint, was defined as a decrease in the CDAI of at least 100 points from baseline levels.



Of 201 patients, 135 (67%) completed the study. Day 29 response rates were similar in all treatment groups (31%-38%). At subsequent timepoints a significantly greater proportion of patients in the 1.0 mg/kg intravenous / 1.0 mg/kg subcutaneous fontolizumab group had clinical response and significantly greater improvement in the CDAI score compared with patients who received placebo. All fontolizumab groups had significant improvement in C-reactive protein levels. The overall frequency of adverse events was similar in all groups (58%-75%); most events were related to exacerbation of CD. There was a low frequency (5.2%) of neutralizing antibodies to fontolizumab.



Although a strong clinical response to fontolizumab was not observed, significant decreases in C-reactive protein levels suggest a biological effect. Fontolizumab was well tolerated, and further studies to assess its efficacy are warranted.
Risk Reduction Counseling for Alcohol Using Sexually Transmitted Infections Clinic Patients in Cape Town , South Africa

Overall, the experimental intervention demonstrated more than a 25% increase in condom use and a 65% reduction in unprotected intercourse over the 6-month follow-up period, with risk reduction significantly greater for the experimental condition than for the control condition at both follow-ups. Alcohol use in sexual contexts [F(1,94) = 6.2; P , 0.05] and expectancies that alcohol enhances sexual experiences [F(1,94) = 8.3; P , 0.01] were also significantly lower for the experimental condition at the 3-month follow-up.
Prise en charge des hypertendus dans la ville de Cotonou (Bénin) en 2011: connaissances attitudes et pratiques des médecins généralistes

We aimed to assess the management of hypertensive patients by general practitioners in Cotonou city.



This was a cross-sectional study based on a multicentre survey conducted from 1 May to 31 July 2011. We recruited all consenting general practitioners who worked in public and private centres in Cotonou city. We used the 7th report of the Joint National Committee to assess the management of hypertension by general practitioners. A tested and validated self-questionnaire was used to collect the data on hypertension management by general practitioners.



In eight centres that approved the study, 41 general practitioners were included. The definition of hypertension was known by 20 (48.8%) practitioners. Only 25 (61.0%) could describe the conditions for blood pressure measurement. Ten of them were unable to list half of the minimum recommended tests for hypertension, and the majority (92.7%) did not have any idea of global cardiovascular risk. The blood pressure goal was known by only 18 (43.9%) practitioners. Lifestyle (82.9%) and monotherapy (70.7%) were the therapeutic modalities most prescribed. Antihypertensive agents commonly used by practitioners were calcium channel blockers (82.9%), angiotensin converting enzyme inhibitors (53.7%) and diuretics (36.6%). The general practitioners referred their patients to cardiologists mainly for uncontrolled hypertension (63.4%) and the onset of acute complications (56.1%).



The general practitioners' knowledge of hypertension was insufficient and their management did not reflect international guidelines.
Improved detection of hepatitis B virus surface antigen by a new rapid automated assay.

The performance of hepatitis B virus (HBV) surface antigen (HBsAg) screening assays is continuously improved in order to reduce the residual risk of transfusion-associated hepatitis B. In a multicenter study, a new automated rapid screening assay, Elecsys HBsAg (Roche Diagnostics), was compared to well-established tests (Auszyme Monoclonal [overnight incubation] version B and IMx HBsAg [Abbott]). Included in the evaluation were 23 seroconversion panels; sera from the acute and chronic phases of infection; dilution series of various HBsAg standards, HBV subtypes, and S gene mutants; and isolated anti-HBV core antigen-positive samples. To challenge the specificity of the new assay, sera from HBsAg-negative blood donors, pregnant women, and dialysis and hospitalized patients and potentially cross-reactive samples were investigated. Elecsys HBsAg showed a higher sensitivity for HBsAg subtypes ad, ay, adw2, adw4, ayw1, ayw2, ayw4, and adr detection in dilution series of different standards or sera than Auszyme Monoclonal version B and/or IMx HBsAg. Acute hepatitis B was detected in 11 to 16 of 23 seroconversion panels between 2 and 16 days earlier with Elecsys HBsAg than with the alternative assays. Elecsys HBsAg and Auszyme Monoclonal version B detected HBsAg surface mutants with equal sensitivity. The sensitivity and specificity of Elecsys HBsAg were 100%.  B had a 99.9% specificity, and its sensitivity was 96.6%. IMx HBsAg showed a poorer sensitivity and specificity than the other assays. In conclusion, Elecsys HBsAg permits earlier detection of acute hepatitis B and different HBV subtypes than the alternative assays. By using highly sensitive HBsAg screening assays, low-level HBsAg carriers among isolated anti-HBV core antigen-positive individuals can be detected.
MR Angiography at 3 T of Peripheral Arterial Disease: A Randomized Prospective Comparison of Gadoterate Meglumine and Gadobutrol.

This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography (MRA) using digital subtraction angiography (DSA) as the reference standard in patients with peripheral arterial occlusive disease (PAOD).



In this prospective international randomized double-blind phase IV trial, 189 patients were enrolled. Of them, 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings. Subjects underwent peripheral MRA, after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol, and DSA within 30 days. The diagnostic accuracy was evaluated and compared using a noninferiority analysis. Secondary endpoints included sensitivity, specificity, diagnostic confidence, contrast-to-noise ratio, and signal-to-noise ratio evaluations.



The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups (mean ± SD, 80.6% ± 16.1% with gadoterate meglumine vs 77.1% ± 19.6% with gadobutrol; 3.5% difference), and the same was true for off-site readings (73.9% ± 16.9% with gadoterate meglumine vs 75.1% ± 13.8% with gadobutrol; 1.1% difference). The noninferiority of gadoterate meglumine to gadobutrol was shown for both on- and off-site readings. Sensitivity in detecting significant stenosis (> 50%) was 72.3% for gadoterate meglumine versus 70.6% for gadobutrol, whereas specificity (92.6% vs 92.3%), diagnostic confidence (87.0% vs 86.0%), signal-to-noise ratio (165.5 vs 161.0), and contrast-to-noise ratio (159.5 vs 155.3) did not differ statistically significantly between the two groups.



Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA. No statistically significant differences were detected between the two MRA groups.
Bisphenol A is associated with insulin resistance and modulates adiponectin and resistin gene expression in obese children.

Bisphenol A (BPA) exposure has been associated with increased incidence of diabetes and obesity in adults.



To evaluate whether an association between BPA urinary levels and insulin resistance as well as adiponectin and resistin production and serum concentrations may occur in obese children.



Clinical and biochemical features of 141 obese children were collected. Serum resistin and adiponectin were evaluated. Insulin resistance and urinary BPA levels were assessed. Moreover, the effect of BPA on adiponectin and resistin gene expression in adipocytes from eight normal weight prepubertal children was investigated by quantitative real-time RT-PCR (qPCR).



Direct association between BPA and homeostasis model assessment (r = 0.23; p: 0.0069) and a strong inverse association between BPA and adiponectin have been found (r = -0.48; p < 0.0001). In adipocytes, resistin expression was detected only after BPA treatment, while adiponectin expression resulted down-regulated after BPA exposure (p < 0.05 at both 10 and 100 nM BPA concentrations).



We suggest the involvement of BPA in the development of insulin resistance in childhood obesity highlighting that urinary BPA levels are directly associated with insulin resistance regardless of BMI. This association may be explained, at least partly, by the findings that BPA affects resistin and adiponectin production in adipose tissue cultures.
A controlled study of community-based exercise training in patients with moderate COPD

The effectiveness of clinic-based pulmonary rehabilitation in advanced COPD is well established, but few data exist for less severe patients treated in alternative settings. The purpose of this study was to investigate whether a novel, community-based exercise program (CBE) was feasible and effective for patients with moderate COPD.



Nineteen patients with moderate COPD (mean FEV1 62%) and self-reported exercise impairment were randomized to 12-weeks of progressive endurance and strength training at a local health club under the guidance of a certified personal trainer, or to continuation of unsupervised habitual physical activity. Outcomes assessed at baseline and 12 weeks included session compliance, intensity adherence, treadmill endurance time, muscle strength, dyspnea, and health status.



Compliance was 94% and adherence was 83%. Comparisons between CBE and control groups yielded the following mean (SEM) differences in favor of CBE: endurance time 134 (74) seconds versus -59 (49) seconds (P=0.041) and TDI 5.1 (0.8) versus -0.2 (0.5) (P<0.001). The CBE group increased muscle strength (weight lifted) by 11.8 kilograms per subject per week of training (P<0.001). SGRQ was not significantly changed.



We demonstrated the feasibility and effectiveness of a novel community-based exercise program involving health clubs and personal trainers for patients with moderate COPD.
Effects of high-efficiency postdilution online hemodiafiltration and high-flux hemodialysis on serum phosphorus and cardiac structure and function in patients with end-stage renal disease

Cardiovascular disease is the leading cause of mortality in patients with chronic kidney disease and has a strong association with hyperphosphatemia. Dialysis is the major treatment tool for attaining serum phosphorus control. Phosphorus removal can be increased with hemodiafiltration. We compared the effect of hemodiafiltration and hemodialysis on serum phosphorus and phosphorus removal and changes in cardiovascular variables in a short-term follow-up. Adult patients with end-stage renal disease were randomized to receive hemodialysis or hemodiafiltration for 3 months. Clinical and biochemical variables were recorded monthly. Cardiac resonance was done at randomization and at the end of follow-up. A total of 24 patients were studied (10 in hemodialysis and 14 in hemodiafiltration) with a mean age of 34.7 ± 11.4 years. The two groups did not differ as for age and blood pressure control at baseline. Phosphorus removal was higher (1,099 ± 239 in hemodiafiltration vs. 864 ± 366 mmol/session in hemodialysis, p < 0.05) and serum phosphorus was lower in the hemodiafiltration group at the end of follow-up (3.4 ± 0.8 in hemodiafiltration vs. 4.5 ± 1.6 mg/dl in hemodialysis, p < 0.05). We found a significant increase in ejection fraction only in the hemodiafiltration group. There was a trend to smaller increase in myocardial mass and a decrease in left ventricular end-diastolic volume only in the hemodiafiltration group. The changes in cardiac variables were significantly associated with changes in serum phosphorus levels. Hemodiafiltration was associated with better control of serum phosphorus and improvement in left ventricular ejection fraction, compared with hemodialysis.
Pharmacokinetics, safety, and monotherapy antiviral activity of GSK1265744, an HIV integrase strand transfer inhibitor.

GSK1265744 is an HIV integrase strand transfer inhibitor selected for clinical development.



This first-time-in-human and phase IIa investigation assessed GSK1265744 antiviral activity, pharmacokinetics, safety, and tolerability in healthy and HIV-1-infected subjects.



This double-blind, placebo-controlled study consisted of a dose escalation of single (part A) and multiple (part B) oral doses in 48 healthy subjects and an oral dose (part C) in 11 HIV-1-infected subjects. In part A, 2 cohorts of 9 subjects received either 5 and 25 mg or 10 and 50 mg. In part B, 3 cohorts of 10 subjects received 5, 10, or 25 mg once daily for 14 days. In part C and the phase IIa study, subjects received 5 or 30 mg once daily for 10 days.



Dose-proportional increases in drug exposure were observed in healthy and HIV-1-infected subjects. In healthy subjects, pharmacokinetic variability was low following single or repeat dosing (coefficient of variation, 13%-34% and 15%-23%, respectively). Mean plasma half-life was 31.5 hours. GSK1265744 monotherapy significantly reduced plasma HIV-1 RNA from baseline to day 11 in HIV-1-infected subjects receiving 5 or 30 mg versus placebo (P < .001); mean decrease was 2.2 to 2.3 log10 copies/mL, respectively. Study drug was generally well tolerated with no clinically relevant trends in laboratory values, vital signs, or electrocardiograms.



GSK1265744 was well tolerated in healthy and HIV-1-infected subjects. Results demonstrate once-daily doses of 5 or 30 mg exceeded minimum target therapeutic concentrations and produced a significant reduction in plasma HIV-1 RNA viral load.
Dietary electrolytes are related to mood.

Dietary therapies are routinely recommended to reduce disease risk; however, there is concern they may adversely affect mood. We compared the effect on mood of a low-sodium, high-potassium diet (LNAHK) and a high-calcium diet (HC) with a moderate-sodium, high-potassium, high-calcium Dietary Approaches to Stop Hypertension (DASH)-type diet (OD). We also assessed the relationship between dietary electrolytes and cortisol, a stress hormone and marker of hypothalamic-pituitary-adrenal (HPA) axis activity. In a crossover design, subjects were randomized to two diets for 4 weeks, the OD and either LNAHK or HC, each preceded by a 2-week control diet (CD). Dietary compliance was assessed by 24 h urine collections. Mood was measured weekly by the Profile of Mood States (POMS). Saliva samples were collected to measure cortisol. The change in mood between the preceding CD and the test diet (LNAHK or HC) was compared with the change between the CD and OD. Of the thirty-eight women and fifty-six men (mean age 56.3 (sem 9.8) years) that completed the OD, forty-three completed the LNAHK and forty-eight the HC. There was a greater improvement in depression, tension, vigour and the POMS global score for the LNAHK diet compared to OD (P < 0.05). Higher cortisol levels were weakly associated with greater vigour, lower fatigue, and higher levels of urinary potassium and magnesium (r 0.1-0.2, P < 0.05 for all). In conclusion, a LNAHK diet appeared to have a positive effect on overall mood.