nils-herrmann/clean_scirepeval huggingface dataset:
A Double-Blind Sham-Controlled Study of the Effect of Radiofrequency Energy on Symptoms and Distensibility of the Gastro-Esophageal Junction in GERD

Several studies have reported symptom relief in gastro-esophageal reflux disease (GERD) patients treated with radiofrequency delivery (Stretta procedure) at the gastro-esophageal junction (GEJ), but the mechanism underlying this improvement is unclear. The objective of this study was to test the hypothesis that Stretta alters GEJ resistance.We conducted a double-blind randomized cross-over study of Stretta and sham treatment. Consecutive GERD patients were included in the study. The study was conducted in a tertiary care center. Patients underwent two upper gastrointestinal endoscopies with 3 months interval, during which active or sham Stretta treatment was performed in a randomized double-blind manner. Symptom assessment, endoscopy, manometry, 24-h esophageal pH monitoring, and a distensibility test of the GEJ were done before the start of the study and after 3 months.Barostat distensibility test of the GEJ before and after administration of sildenafil was the main outcome measure. In all, 22 GERD patients (17 females, mean age 47±12 years) participated in the study; 11 in each group. Initial sham treatment did not affect any of the parameters studied. Three months after initial Stretta procedure, no changes were observed in esophageal acid exposure and lower esophageal sphincter (LES) pressure. In contrast, symptom score was significantly improved and GEJ compliance was significantly decreased. Administration of sildenafil, an esophageal smooth muscle relaxant, normalized GEJ compliance again to pre-Stretta level, arguing against GEJ fibrosis as the underlying mechanism.The limitation of this study was reflux evaluation did not include impedance monitoring. In this sham-controlled study, Stretta improved GERD symptoms and decreased GEJ compliance. Decreased GEJ compliance, which reflects altered LES neuromuscular function, may contribute to symptomatic benefit by decreasing refluxate volume.
Static respiratory pressures in patients with post-traumatic tetraplegia

The purpose of this study was to examine ventilatory muscle strength as represented by static respiratory pressures in 30 tetraplegic patients with a complete lesion between the fifth and the eighth cervical vertebrae. The Inspiratory/Expiratory Pressure Meter was used to obtain maximum static expiratory mouth pressure (PEmax) and maximum static inspiratory mouth pressure (PImax) measurements. The PEmax was measured at vital capacity and the PImax at residual volume. The measurements were effected while the patient was in the supported sitting position. The mean PEmax for the group was 50 cm H2O and the mean PImax was −65 cm H2O. There was a significant difference between the PEmax and PImax values. Unlike normal individuals most tetraplegic subjects in this study showed PImax values to be much higher than their PEmax values.
International telemedicine in pediatric cardiac critical care: a multicenter experience.

To describe our multicenter experience in telemedicine-assisted pediatric cardiac critical care (PCCC) with four hospitals in Latin America from July 2011 to June 2013.



This was a descriptive study based on telemedicine encounters related to quality of communication, assessed information, activities, and recommendations. Comparison among centers was performed. A postimplementation survey was conducted through a 5-point Likert scale questionnaire investigating acceptance among professionals involved with the telemedicine service through the assessment of general satisfaction, perception about the work system, usefulness, and impact on medical practice.



One thousand forty consultations were conducted for 476 patients. Postoperatively, patients were distributed into Risk Adjustment Classification for Congenital Heart Surgery (RACHS-1) categories as follows: 2%, 26%, 36%, 26%, and 10% in categories 1, 2, 3, 4, and 6, respectively. A real-time intervention took place in 23% of encounters. Of the 2,173 recommendations given, 70 were related to extracorporeal membrane oxygenation management. There was a different RACHS-1 distribution and encounter characteristics among centers. From a total of 51 surveys sent, 27 responses were received, and among responders, overall satisfaction was very high (4.27 ± 0.18), as well as work system quality (4.4 ± 0.37). Telemedicine was considered useful in the cardiac intensive care unit (3.86 ± 0.60), for patient outcomes (3.8 ± 0.51), and for education (3.7 ± 0.71). There was a difference in overall satisfaction, perception about telemedicine usefulness in education, and impact on medical practice among centers.



An international, multicenter telemedicine program in PCCC is technologically and logistically feasible. Prospective interventions in our international multicenter telemedicine program should consider differences in staff composition, perception of needs, and patient population among centers.
Signs of subclinical coronary atherosclerosis in relation to risk factor distribution in the Multi-Ethnic Study of Atherosclerosis (MESA) and the Heinz Nixdorf Recall Study (HNR)

Modern imaging technology allows us the visualization of coronary artery calcification (CAC), a marker of subclinical coronary atherosclerosis. The prevalence, quantity, and risk factors for CAC were compared between two studies with similar imaging protocols but different source populations: the Multi-Ethnic Study of Atherosclerosis (MESA) and the Heinz Nixdorf Recall Study (HNR).



The measured CAC in 2220 MESA participants were compared with those in 3,126 HNR participants with the inclusion criteria such as age 45-75 years, Caucasian race, and free of baseline cardiovascular disease. Despite similar mean levels of CAC of 244.6 among participants in MESA and of 240.3 in HNR (P = 0.91), the prevalence of CAC > 0 was lower in MESA (52.6%) compared with HNR (67.0%) with a prevalence rate ratio of CAC > 0 of 0.78 [95% confidence interval (CI): 0.72-0.85] after adjustment for known risk factors. Consequently, among participants with CAC > 0, the participants in MESA tended to have higher levels of CAC than those in HNR (ratio of CAC levels: 1.39; 95% CI: 1.19-1.63), since many HNR participants have small (near zero) CAC values.



The CAC prevalence was lower in the United States (MESA) cohort than in the German (HNR) cohort, which may be explained by more favourable risk factor levels among the MESA participants. The predictors for increased levels of CAC were, however, similar in both cohorts with the exception that male gender, blood pressure, and body mass index were more strongly associated in the HNR cohort.
Mosapride, a 5HT-4 receptor agonist, improves insulin sensitivity and glycaemic control in patients with Type II diabetes mellitus

We investigated the potential role of mosapride, a 5HT-4 receptor agonist, in glycaemic control in Type II (non-insulin-dependent) diabetic mellitus patients without autonomic neuropathy.  Thirty-four inpatients with Type II diabetes mellitus were randomly assigned to receive either mosapride (5 mg orally three times a day, n=17) or a placebo (n=17) for 1 week (first study). Changes in blood glucose and insulin were determined basally as well as after intravenous glucose loading. Insulin sensitivity was evaluated during hyperinsulinaemic-normoglycaemic-clamp studies and by measuring the number of and the autophosphorylation of insulin receptors on the erythrocytes of patients (n=9). Sixty-nine outpatients with Type II diabetes were similarly treated with mosapride or a placebo for 8 weeks (second study). Finally, tissue- specific expression of 5HT-4 receptors was examined by reverse transcriptase-polymerase chain reaction (RT-PCR).  Mosapride lowered fasting blood glucose and fructosamine concentrations (p<0.05) (first study). It significantly increased the number of (Mosapride 3323±518 vs 4481±786 [p<0.05], Control 4227±761 vs 3275±554 per 300 µl erythrocytes) and the tyrosine autophosphorylation (Mosapride 3178±444 vs 4043±651 [p<0.05], Control 3721±729 vs 3013±511 insulin receptor unit) of insulin receptors, as well as glucose utilisation (Mosapride 4.92±0.53 vs 5.88±0.72 [p<0.05], Control 4.74±0.65 vs 4.70±0.31 mg/kg·min). Mosapride treatment for 8 weeks significantly reduced fasting glucose (9.91±0.34 vs 8.51±0.34 mmol/l, p<0.05), insulin (53.2±4.62 vs 40.8±5.52 pmol/l, p<0.05) and HbA1c (8.61±0.20 vs 7.67±0.19%, p<0.01) concentrations (second study). The RT-PCR analysis demonstrated specific expression of 5HT-4 receptors in the muscle, but not in the liver or fat tissues.  Mosapride could improve insulin action at muscle and glycaemic control in Type II diabetic patients.
Understanding the impact of colorectal cancer education: a randomized trial of health fairs

Regular screening for colorectal cancer (CRC) reduces morbidity and mortality from this disease. A number of factors play a role in the underutilization of CRC screening; populations with the lowest CRC screening rates are least likely to be aware of the need for screening or have knowledge about screening options. The overall purpose of this project was to assess two methods for increasing knowledge about CRC in a health fair context: one, by using a health educator to provide CRC information at a table, or two, to provide a tour through a giant inflatable, walk-through colon model with physical depictions of healthy tissue, polyps, and CRC.



We participated in six community health fair events, three were randomized to incorporate the use of the inflatable colon, and three used a standard display table method. We used a pre/post-design to look for changes in knowledge about CRC before and after participating in a health fair. We examined descriptive statistics of participants using frequencies and proportions. 's test for paired binary data was used to test whether there were significant differences in the distribution of correct answer percentage from pre to post and from pre to follow up. Linear regression (GEE) was used to investigate whether there was a significant difference in the change from pre- to post-intervention in the percentage of correct answers on knowledge of tests available to detect CRC and awareness of risk factors for CRC between participants at sites with the inflatable colon compared to participants at sites without the inflatable colon.



Participants (n = 273) were recruited at the six health fairs. Participants in health fairs with the inflatable colon had higher knowledge at post-test than participants in health fairs with tabling activities, that is, without the inflatable colon; however, the difference was not significant. One month follow-up after each health fair showed virtually no recollection of information learned at the health fairs.



The use of an inflatable colon may be an innovative way to help people learn about CRC and CRC screening; however, it is not significantly more effective than conventional table display methods. Further research is needed to associate intention to obtain screening after touring the inflatable colon with actual screening. Future research could explore ways to better retain knowledge at long-term follow-up.
Effects of structured heart failure disease management on mortality and morbidity depend on patients' mood: results from the Interdisciplinary Network for Heart Failure Study.

Depression is common in heart failure (HF) and associated with adverse outcomes. Randomized comparisons of the effectiveness of HF care strategies by patients' mood are scarce. We therefore investigated in a randomized trial a structured collaborative disease management programme (HeartNetCare-HF™; HNC) recording mortality, morbidity, and symptoms in patients enrolled after hospitalization for decompensated systolic HF according to their responses to the 9-item Patient Health Questionnaire (PHQ-9) during an observation period of 180 days.



Subjects scoring <12/≥12 were categorized as non-depressed/depressed, and those ignoring the questionnaire as PHQ-deniers. Amongst 715 participants (69 ± 12 years, 29% female), 141 (20%) were depressed, 466 (65%) non-depressed, and 108 (15%) PHQ-deniers. The composite endpoint of mortality and re-hospitalization was neutral overall and in all subgroups. However, HNC reduced mortality risk in both depressed and non-depressed patients [adjusted hazard ratios (HRs) 0.12, 95% confidence interval (CI) 0.03-0.56, P = 0.006, and 0.49, 95% CI 0.25-0.93, P = 0.03, respectively], but not in PHQ-deniers (HR 1.74, 95% CI 0.77-3.96, P = 0.19; P = 0.006 for homogeneity of HRs). Average frequencies of patient contacts in the HNC arm were 12.8 ± 7.9 in non-depressed patients, 12.4 ± 7.1 in depressed patients, and 5.5 ± 7.2 in PHQ-deniers (P < 0.001).



Early after decompensation, HNC reduced mortality risk in non-depressed and even more in depressed subjects, but not in PHQ-deniers. This suggests that differential acceptability and chance of success of care strategies such as HNC might be predicted by appropriate assessment of patients' baseline characteristics including psychological disposition. These post-hoc results should be reassessed by prospective evaluation of HNC in larger HF populations.
Biomarker validation of reports of recent sexual activity: results of a randomized controlled study in Zimbabwe.

Challenges in the accurate measurement of sexual behavior in human immunodeficiency virus (HIV) prevention research are well documented and have prompted discussion about whether valid assessments are possible. Audio computer-assisted self-interviewing (ACASI) may increase the validity of self-reported behavioral data. In 2006-2007, Zimbabwean women participated in a randomized, cross-sectional study that compared self-reports of recent vaginal sex and condom use collected through ACASI or face-to-face interviewing (FTFI) with a validated objective biomarker of recent semen exposure (prostate-specific antigen (PSA) levels). Of 910 study participants, 196 (21.5%) tested positive for PSA, an indication of semen exposure during the previous 2 days. Of these 196 participants, 23 (11.7%) reported no sex in the previous 2 days, with no difference in reported sexual activity between interview modes (12.5% ACASI vs. 10.9% FTFI; Fisher's exact test: P = 0.72). In addition, 71 PSA-positive participants (36.2%) reported condom-protected vaginal sex only; their reports also indicated no difference between interview modes (33.7% ACASI vs. 39.1% FTFI; P = 0.26). Only 52% of PSA-positive participants reported unprotected sex during the previous 2 days. Self-report was a poor predictor of recent sexual activity and condom use in this study, regardless of interview mode, providing evidence that such data should be interpreted cautiously.
Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients

Previously, we had identified gene expression patterns that predicted response to neoadjuvant docetaxel. Other studies have validated that a high Recurrence Score (RS) by the 21-gene RT-PCR assay is predictive of worse prognosis but better response to chemotherapy. We investigated whether tumor expression of these 21 genes and other candidate genes can predict response to docetaxel. Core biopsies from 97 patients were obtained before treatment with neoadjuvant docetaxel (4 cycles, 100 mg/m2 q3 weeks). Three 10-μm FFPE sections were submitted for quantitative RT-PCR assays of 192 genes that were selected from our previous work and the literature. Of the 97 patients, 81 (84%) had sufficient invasive cancer, 80 (82%) had sufficient RNA for QRTPCR assay, and 72 (74%) had clinical response data. Mean age was 48.5 years, and the median tumor size was 6 cm. Clinical complete responses (CR) were observed in 12 (17%), partial responses in 41 (57%), stable disease in 17 (24%), and progressive disease in 2 patients (3%). A significant relationship (P < 0.05) between gene expression and CR was observed for 14 genes, including CYBA. CR was associated with lower expression of the ER gene group and higher expression of the proliferation gene group from the 21 gene assay. Of note, CR was more likely with a high RS (P = 0.008). We have established molecular profiles of sensitivity to docetaxel. RT-PCR technology provides a potential platform for a predictive test of docetaxel chemosensitivity using small amounts of routinely processed material.
Novel modeling of reference values of cardiovascular risk factors in children aged 7 to 20 years.

Most of the cardiovascular risk factors strongly associated with obesity and overweight vary with age and gender. However, few reference values are available for healthy European children. Our objective was to establish pediatric reference ranges for waist circumference, systolic and diastolic blood pressures, fasting lipid levels (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides), glucose, and insulin.



A representative sample of 1976 healthy French individuals (1004 female participants and 972 male participants) aged 7 to 20 years was used to obtain age- and gender-specific normal ranges for each of the above-listed cardiovascular risk factors, based on the Royston and Wright method.



Mean waist circumference increased with age in both genders and was slightly higher in males than in females. Whereas systolic blood pressure increased gradually with age, with the increase being steeper in males than in females, no gender effect was found for diastolic blood pressure, which was therefore modeled after pooling males and females. Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride values varied little with age and gender. Glucose and insulin levels revealed pubertal peaks, which were sharper in females than in males, reflecting the normal insulin resistance during puberty.



These ranges can be used as references for European children to monitor cardiovascular risk factors and to plan interventions and education programs.
Estimation of glomerular filtration rate in paediatric cancer patients using 51CR-EDTA population pharmacokinetics

Estimation of glomerular filtration rate (GFR) using the clearance of chromium 51 EDTA (51Cr-EDTA) (or other radiolabelled isotopes) is reliable, but invasive and not always practicable. Mathematical models have been devised for estimating GFR using readily obtainable patient characteristics. Unfortunately, these models were developed using various patient populations and may not provide the optimal prediction of GFR in children with cancer. The current study uses population pharmacokinetics to determine the relationship between 51Cr-EDTA clearance, and patient covariates in 50 paediatric cancer patients. These models were validated using a separate group of 43 children and were compared with previously published models of renal function. Body size was the major determinant of 51Cr-EDTA clearance and inclusion of weight or surface area reduced the residual variability between individuals (coefficient of variation) from 61 to 32%. Serum creatinine was the only other parameter that significantly improved the model. Mean percentage error values of –5.0 and –1.1% were observed for models including weight alone or weight and creatinine, respectively, with precision estimates of 21.7 and 20.0%. These simple additive models provide a more rationale approach than the use of complex formulae, involving additional parameters, to predict renal function.
Trends in pharmacotherapy for neonatal hypotension.

To determine trends in pharmacotherapy for neonatal hypotension in all infants and in extremely low birth weight (ELBW, birth weight 300-1000 g) infants.



We queried the Pediatric Health Information System database for all infants ≤28 days with a diagnosis code for hypotension that were discharged between January 2001 and December 2012. Patients were excluded if they had complex congenital heart disease or cardiac surgery, sepsis or meningitis, or had extracorporeal membrane oxygenation. We determined trends in pharmacotherapy for hypotension in all infants and ELBW infants, an especially vulnerable group.



A total of 8019 hypotensive infants met study criteria. The 2 most prescribed medications were dopamine (65.3%) and dobutamine (19.9%). For 1487 hypotensive ELBW infants, the 2 most prescribed medications were dopamine (83.4%) and hydrocortisone (33%). During the study period, the use of dobutamine decreased, and hydrocortisone and vasopressin use increased for all infants and for ELBW infants.



Treatment of neonatal hypotension varies widely between institutions and individual practitioners, and pharmacotherapy for neonatal hypotension has changed over the past decade. Although dopamine and dobutamine were the most frequently used agents, their use has declined and the uses of hydrocortisone and vasopressin have increased.
Screening for the detection of impaired fasting glucose, impaired glucose tolerance and type 2 diabetes in welfare homes residents from south-eastern region of Poland.

This response (1) confirms that many chiropractors find it impossible to accept the key messages regarding spinal manipulation therapy (SMT), namely that this therapy lacks a plausible rationale (2) and its risks outweigh its benefits (3). The risks are, of course, far greater than the relatively few deaths seem to imply. Several hundred cases of severe but non-fatal adverse events are on record (e.g. 4,5). The benefits of SMT have, so far, not been demonstrated; even the many chiropractors who criticised my review (6–12), have not produced convincing evidence for such benefit. Why? The answer is simple: there is none! In the most recent Cochrane review of SMT for chronic low back pain, the main indication for chiropractors, concluded that ‘there is no clinically relevant difference between SMT and other interventions for reducing pain’ (13). For all other conditions, the evidence is even more squarely negative (14). If we focus on the bigger picture, we are confronted with balancing little benefit with considerable risks. The result of such an evaluation can never be positive – no matter how we turn and twist the complex details of this debate. Prof. E. Ernst Director, Complementary Medicine, Peninsula Medical School, University of Exeter, 25 Victoria Park Road, Exeter, EX2 4NT,
Evaluation of NeuroPage: a new memory aid.

This report describes NeuroPage, a simple and portable paging system, developed in California by the engineer father of a son with head injury working together with a neuropsychologist. Using an ABA single case experimental design, the efficacy of NeuroPage was evaluated with 15 neurologically impaired subjects all of whom had significant everyday memory problems because of organic memory impairment or because of problems with planning and organisation consequent on frontal lobe damage. Data were analysed with an odds ratio test which takes into account different underlying success rates for each target and calculates an average improvement factor. This test showed a significant improvement between the baseline and the treatment phases for each subject (P<0.05).