nils-herrmann/clean_scirepeval huggingface dataset:
Short-term efficacy of topical capsaicin therapy in severely affected fibromyalgia patients

The purpose of this study was to evaluate the short-term efficacy of topical capsaicin treatment in patients severely affected by fibromyalgia. One hundred and thirty fibromyalgia patients were randomly divided into two groups. The control group, 56 women and 4 men who continued their medical treatment, and the capsaicin group, 70 women who apart from continuing their medical treatment, also underwent topical capsaicin 0.075 % 3 times daily for 6 weeks. At the beginning of the program, there were no significant differences between the two groups in any of the analyzed parameters. At the end of the treatment, there were significant improvements in the capsaicin group in the myalgic score (5.21 vs 3.8, p = 0.02) and global subjective improvement (22.8 vs 5 %, p = 0.001). Six weeks after the end of the treatment, the experimental group showed significant differences in Visual Analogue Scale of depression (5.63 vs 7.35, p = 0.02), Fibromyalgia Impact Questionnaire (67.89 vs 77.7, p = 0.02), role limitations due to emotional problems (36.17 vs 17.2, p = 0.05), Fatigue Severity Scale (6.2 vs 6.6, p = 0.04), myalgic score (3.94 vs 2.66, p = 0.02) and pressure pain threshold (79.25 vs 56.71, p = 0.004). In conclusion, patients severely affected by fibromyalgia can obtain short-term improvements following topical capsaicin 0.075 % treatment three times daily for 6 weeks.
Acetogenic fibers reduce fasting glucose turnover but not peripheral insulin resistance in metabolic syndrome patients.

The acute ingestion of an acetogenic indigestible carbohydrate (lactulose) increased acetate turnover associated with decreased lipolysis (glycerol turnover) in insulin-resistant patients. It is not known whether a decreased lipolysis by chronic ingestion of acetogenic indigestible carbohydrates or fibers improves glucose turnover and insulin sensitivity.



Twenty-one men with metabolic syndrome ingested daily standardized drinks, with or without 28 g acetogenic fibers (acacia gum and pectin), for 5 weeks in a randomized double-blind crossover controlled study design. Euglycaemic-hyperinsulinaemic (EH) clamps coupled with kinetic studies were performed in the fasting state after treatments.



Flatulence was more frequent with fiber treatment. Body weight, lipids as well as acetate and glycerol turnovers were unchanged. Fasting endogenous glucose turnover was improved after fiber treatment (7.9 ± 1.3 μmol kg(-1) min(-1)) compared with control (8.6 ± 1.6 μmol kg(-1) min(-1), P < 0.05). But insulin sensitivity (glucose infusion rate) during the EH clamp was not different at the end of fiber and control treatments, 3.7 ± 1.8 and 3.8 ± 1.5 mg kg(-1) min(-1), respectively, nor fasting plasma glucose and insulin.



The chronic ingestion of acacia gum and pectin fibers did not decrease lipolysis but improved fasting endogenous glucose turnover with no effect on peripheral insulin resistance in metabolic syndrome patients.
Foot Placement and Arm Position Affect the Five Times Sit-to-Stand Test Time of Individuals with Chronic Stroke

To investigate the effect of two foot placements (normal or posterior placement) and three arm positions (hands on the thighs, arms crossed over chest, and augmented arm position with elbow extended) on the five times sit-to-stand (FTSTS) test times of individuals with chronic stroke.



Cross-sectional study.  University-based rehabilitation clinic.



A convenience sample of community-dwelling individuals with chronic stroke (N = 45).



The times in completing the FTSTS with two foot placements and the three arm positions were recorded by stopwatch.



Posterior foot placement led to significantly shorter FTSTS times when compared with normal foot placement in all the 3 arm positions (P ≤ 0.001). In addition, hands on thigh position led to significantly longer FTSTS times than the augmented arm position (P = 0.014).



Our results showed that foot placement and arm position could influence the FTSTS times of individuals with chronic stroke. Standardizing the foot placement and arm position in the test procedure is essential, if FTSTS test is intended to be used repeatedly on the same subject.
An open-label, two-stage, phase II study of bevacizumab and lapatinib in children with recurrent or refractory ependymoma: a collaborative ependymoma research network study (CERN)

Co-expression of ERBB2 and ERBB4, reported in 75 % of pediatric ependymomas, correlates with worse overall survival. Lapatinib, a selective ERBB1 and ERBB2 inhibitor has produced prolonged disease stabilization in patients with ependymoma in a phase I study. Bevacizumab exposure in ependymoma xenografts leads to ablation of tumor self-renewing cells, arresting growth. Thus, we conducted an open-label, phase II study of bevacizumab and lapatinib in children with recurrent ependymomas. Patients ≤21 years of age with recurrent ependymoma received lapatinib orally twice daily (900 mg/m2/dose to the first 10 patients, and then 700 mg/m2/dose) and bevacizumab 10 mg/kg intravenously on days 1 and 15 of a 28-day course. Lapatinib serum trough levels were analyzed prior to each course. Total and phosphorylated VEGFR2 expression was measured in peripheral blood mononuclear cells (PBMCs) before doses 1 and 2 of bevacizumab and 24–48 h following dose 2 of bevacizumab. Twenty-four patients with a median age of 10 years (range 2–21 years) were enrolled; 22 were eligible and 20 evaluable for response. Thirteen had anaplastic ependymoma. There were no objective responses; 4 patients had stable disease for ≥4 courses (range 4–14). Grade 3 toxicities included rash, elevated ALT, and diarrhea. Grade 4 toxicities included peri-tracheostomy hemorrhage (n = 1) and elevated creatinine phosphokinase (n = 1). The median lapatinib pre-dose trough concentration was 3.72 µM. Although the combination of bevacizumab and lapatinib was well tolerated in children with recurrent ependymoma, it proved ineffective.
Compliance with osteoporosis treatment guidelines in postmenopausal women.

Osteoporosis continues to be poorly managed despite compelling statistics indicating increased morbidity and mortality associated with fractures. Guideline compliance in individual practices must be evaluated to implement improvements in the care of patients with this disease state.



To evaluate compliance with osteoporosis treatment guidelines by physicians and patients at 2 family medicine clinics affiliated with a large university teaching hospital.



Postmenopausal women 65 years of age or older with the ICD-9 diagnosis code 733.0 for osteoporosis during the study period between July 2006 and July 2007 were identified through the family medicine electronic medical record (EMR). Of 133 patients, 113 were eligible for inclusion. A retrospective chart review was conducted and prospective voluntary telephone surveys were administered. The EMR of each eligible patient was examined for presence of a baseline dual-energy X-ray absorptiometry (DXA) scan as well as appropriate follow-up DXA monitoring, appropriateness of osteoporosis pharmacotherapy, calcium and vitamin D supplementation, and fracture history. The telephone survey was used to assess the patients' calcium use, nonpharmacologic recommendations received, and fracture incidence after diagnosis of osteoporosis.



Of 113 patients diagnosed with osteoporosis, 68 of 82 (82.9%) had appropriate baseline DXA scans; however, only 9 (13.2%) of these 68 patients had appropriate follow-up scans every 2 years thereafter. Sixty-five (57.5%) patients were on Food and Drug Administration-approved, guideline-endorsed pharmacotherapy for osteoporosis. Thirty-five (70%) of the 50 participants in the telephone survey reported taking calcium regularly, and 41 (82%) patients recalled receiving some nonpharmacologic advice. Thirteen (26%) patients reported a fracture after diagnosis.



Osteoporosis care can be measurably improved at these clinics with use of baseline and appropriate follow-up DXA scans, increasing the number of patients who receive pharmacotherapy, and providing ongoing reinforcement of nonpharmacologic measures whereby bone health may be maintained.
Diagnostic blood loss from phlebotomy and hospital-acquired anemia during acute myocardial infarction.

Hospital-acquired anemia (HAA) during acute myocardial infarction (AMI) is associated with higher mortality and worse health status and often develops in the absence of recognized bleeding. The extent to which diagnostic phlebotomy, a modifiable process of care, contributes to HAA is unknown.



We studied 17,676 patients with AMI from 57 US hospitals included in a contemporary AMI database from January 1, 2000, through December 31, 2008, who were not anemic at admission but developed moderate to severe HAA (in which the hemoglobin level declined from normal to <11 g/dL), a degree of HAA that has been shown to be prognostically important. Patients' total diagnostic blood loss was calculated by multiplying the number and types of blood tubes drawn by the standard volume for each tube type. Hierarchical modified Poisson regression was used to test the association between phlebotomy and moderate to severe HAA, after adjusting for site and potential confounders.



Moderate to severe HAA developed in 3551 patients (20%). The mean (SD) phlebotomy volume was higher in patients with HAA (173.8 [139.3] mL) vs those without HAA (83.5 [52.0 mL]; P < .001). There was significant variation in the mean diagnostic blood loss across hospitals (moderate to severe HAA: range, 119.1-246.0 mL; mild HAA or no HAA: 53.0-110.1 mL). For every 50 mL of blood drawn, the risk of moderate to severe HAA increased by 18% (relative risk [RR], 1.18; 95% confidence interval [CI], 1.13-1.22), which was only modestly attenuated after multivariable adjustment (RR, 1.15; 95% CI, 1.12-1.18).



Blood loss from greater use of phlebotomy is independently associated with the development of HAA. These findings suggest that HAA may be preventable by implementing strategies to limit blood loss from laboratory testing.
Correlation between plasma clozapine concentration and heart rate variability in schizophrenic patients

Forty schizophrenic patients treated with 50–600 mg/day of clozapine as monotherapy and 40 normal control subjects were tested for heart rate variability (HRV) which is mediated by the vagus nerve using acetylcholine as neurotransmitter. As compared to the control subjects, the patients showed essentially reduced HRV parameters which were negatively correlated with the plasma clozapine levels. Therefore, clozapine’s anticholinergic effect is correlated to the plasma clozapine level when measured by the decrease of HRV. We suggest that HRV data might be useful as a predictor for plasma clozapine levels.
Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine.

An observational safety study of the quadrivalent human papillomavirus vaccine (HPV4) in women was conducted. This report presents findings from autoimmune surveillance. Subjects were followed for 180days after each HPV4 dose for new diagnoses of 16 prespecified autoimmune conditions.



Two managed care organizations in California. Number of 189,629 women who received ≥1 dose of HPV4 between 08/2006 and 03/2008.



Potential new-onset autoimmune condition cases amongst HPV4 recipients were identified by electronic medical records. Medical records of those with ≥12-month health plan membership prior to vaccination were reviewed by clinicians to confirm the diagnosis and determine the date of disease onset. The incidence of each autoimmune condition was estimated for unvaccinated women at one study site using multiple imputations and compared with that observed in vaccinated women. Incidence rate ratios (IRR) were calculated. Findings were reviewed by an independent Safety Review Committee (SRC).



Overall, 1014 potential new-onset cases were electronically identified; 719 were eligible for case review; 31-40% were confirmed as new onset. Of these, no cluster of disease onset in relation to vaccination timing, dose sequence or age was found for any autoimmune condition. None of the estimated IRR was significantly elevated except Hashimoto's disease [IRR=1.29, 95% confidence interval: 1.08-1.56]. Further investigation of temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions. The SRC and the investigators identified no autoimmune safety concerns in this study.



No autoimmune safety signal was found in women vaccinated with HPV4.
Comparison of haemodynamic responses to dobutamine and salbutamol in cardiogenic shock after acute myocardial infarction.

Nine patients with critically reduced cardiac output after acute myocardial infarction underwent a single cross-over comparison of dobutamine and salbutamol to compare the haemodynamic effects of these drugs, which have, respectively, predominantly beta 1-adrenergic and beta 2-adrenergic agonist activity. The responses were used to select the more appropriate treatment for individual patients. Only relatively small responses were obtained: those with poorest baseline measurements tended to show the least effect. When the results from the series were averaged, dobutamine (250-750 microgram/min) caused a small but progressive increase in cardiac index (1.8 to 2.2 1/min/m2) throughout the dose range. Systemic blood pressure was not increased, and calculated systemic vascular resistance fell from 25 to 19 units. Heart rate rose from 107 to 118 beats/min and stroke index from 17 to 19 ml/beat/m2. Pulmonary artery end-diastolic pressure fell from 18 to 15 mm Hg. Salbutamol (10-40 microgram/min) produced a similar progressive increase in cardiac index, from 1.6 to 2.21/min/m2. Systemic blood pressure was not altered, and systemic vascular resistance fell from 25 to 20 units. Heart rate rose from 105 to 119 beats/min and stroke index from 16 to 19 ml/beat/m2. Pulmonary artery end-diastolic pressure did not fall. Dobutamine and salbutamol have closely similar haemodynamic effects when used in cardiogenic shock after acute myocardial infarction. Both drugs increase cardiac index but heart rate also rises, and the increase in stroke index is relatively small. Mean arterial pressure is altered little by either agent, but dobutamine (in contrast with dopamine) tends to reduce pulmonary artery end-diastolic pressure, which may be beneficial.
A phase I dose-escalation study of aflibercept administered in combination with pemetrexed and cisplatin in patients with advanced solid tumours

To evaluate the safety, pharmacokinetics (PKs), and pharmacodynamics of aflibercept, and to identify the recommended phase II dose (RP2D) of aflibercept in combination with pemetrexed and cisplatin.Aflibercept was administered at escalating doses of 2, 4, or 6 mg kg−1 in combination with fixed doses of pemetrexed (500 mg m−2) plus cisplatin (75 mg m−2) every 3 weeks. Blood samples were collected for PK analyses. Serum antiaflibercept antibodies were quantified to assess their impact on systemic aflibercept concentrations.Eighteen patients were enrolled. One patient dosed at 4 mg kg−1 experienced grade 3 hypophosphatemia (dose-limiting toxicity; DLT), which prompted a cohort expansion. No further DLTs were observed in the 4 mg kg−1 cohort or the 6 mg kg−1 dose cohort. Most common adverse events (AEs) of all grades included (%): fatigue (89), anaemia (89), nausea (83), hyponatremia (78), and neutropenia (72). Grade ⩾3 AEs consistent with anti-vascular endothelial growth factor therapy included (%): hypertension (22), pulmonary embolism (11), and deep vein thrombosis (6). Five patients (28%) experienced mild neurocognitive disturbance. No episodes of reversible posterior leukoencephalopathy syndrome (RPLS) were noted.The results of this phase I study allowed further evaluation of the combination of aflibercept with pemetrexed and cisplatin in a phase II study. The RP2D of aflibercept was 6 mg kg−1, to be administered intravenously every 3 weeks in combination with pemetrexed and cisplatin.
Increased 30-day and 1-year mortality rates and lower coronary revascularisation rates following acute myocardial infarction in patients with autoimmune rheumatic disease

It is now well-recognised that patients with autoimmune rheumatic disease (AIRD) have a predisposition to cardiovascular disease that results in increased morbidity and mortality. Following myocardial infarction (MI), patients with rheumatoid arthritis have been shown to have an increased case fatality rate; however, this has not been demonstrated in other forms of AIRD. The aim of this study was to compare case fatality rates following a first MI in patients with AIRD versus the general population. The secondary aim was to compare revascularisation treatment following MI in patients with AIRD versus the general population.



A retrospective cohort study using two population-based linked databases was undertaken. Cases of first MI from July 2001 to June 2007 were identified based on International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification, codes. Thirty-day and one-year mortality rates were calculated (all-cause and cardiovascular causes of death). Logistic regression models were fitted to calculate the odds of mortality by AIRD status with adjustment for relevant characteristics.



There were 79,390 individuals with a first MI, of whom 1,409 (1.8%) had AIRD. After adjusting for relevant covariates, the odds ratio (OR) for 30-day cardiovascular mortality in patients with AIRD was 1.44 (95% confidence interval (CI): 1.25 to 1.66), and the OR for 12-month cardiovascular mortality was 1.71 (95% CI: 1.51 to 1.94). The 90-day adjusted odds of percutaneous transluminal coronary angioplasty and coronary artery bypass graft were significantly lower in the AIRD group compared with controls (OR: 0.81, 95% CI: 0.70 to 0.94, and OR: 0.52, 95% CI: 0.39 to 0.69, respectively).



We identified a higher risk-adjusted mortality rate for the majority of patients with AIRD at 30 days and 12 months after first MI. We also identified lower post-MI revascularisation rates in the AIRD group, suggesting there may be current gaps in cardiovascular treatment for patients with AIRD.
Intimate partner violence perpetration, standard and gendered STI/HIV risk behaviour, and STI/HIV diagnosis among a clinic-based sample of men

The estimated one in three women worldwide victimized by intimate partner violence (IPV) consistently demonstrate elevated STI/HIV prevalence, with their abusive male partners' risky sexual behaviours and subsequent infection increasingly implicated. To date, little empirical data exist to characterise the nature of men's sexual risk as it relates to both their violence perpetration, and STI/HIV infection.



Data from a cross-sectional survey of men ages 18-35 recruited from three community-based health clinics in an urban metropolitan area of the northeastern US (n = 1585) were analysed to estimate the prevalence of IPV perpetration and associations of such violent behaviour with both standard (eg, anal sex, injection drug use) and gendered (eg, coercive condom practices, sexual infidelity, transactional sex with a female partner) forms of sexual-risk behaviour, and self-reported STI/HIV diagnosis.



Approximately one-third of participants (32.7%) reported perpetrating physical or sexual violence against a female intimate partner in their lifetime; one in eight (12.4%) participants self-reported a history of STI/HIV diagnosis. Men's IPV perpetration was associated with both standard and gendered STI/HIV risk behaviours, and to STI/HIV diagnosis (OR 4.85, 95% CI 3.54 to 6.66). The association of men's IPV perpetration with STI/HIV diagnosis was partially attenuated (adjusted odds ratio (AOR) 2.55, 95% CI 1.77 to 3.67) in the multivariate model, and a subset of gendered sexual-risk behaviours were found to be independently associated with STI/HIV diagnosis-for example, coercive condom practices (AOR 1.67, 95% CI 1.04 to 2.69), sexual infidelity (AOR 2.46, 95% CI 1.65 to 3.68), and transactional sex with a female partner (AOR 2.03, 95% CI 1.36 to 3.04).



Men's perpetration of physical and sexual violence against intimate partners is common among this population. Abusive men are at increased risk for STI/HIV, with gendered forms of sexual-risk behaviour partially responsible for this association. Thus, such men likely pose an elevated infection risk to their female partners. Findings indicate the need for interwoven sexual health promotion and violence prevention efforts targeted to men; critical to such efforts may be reduction in gendered sexual-risk behaviours and modification of norms of masculinity that likely promote both sexual risk and violence.
Contemplative meditation reduces ambulatory blood pressure and stress-induced hypertension: a randomized pilot trial

A total of 52 pharmacologically untreated subjects with essential hypertension were randomly allocated to either 8 weeks of contemplative meditation combined with breathing techniques (CMBT) or no intervention in this observer-blind controlled pilot trial. CMBT induced clinically relevant and consistent decreases in heart rate, systolic and diastolic blood pressure if measured during office readings, 24-h ambulatory monitoring and mental stress test. Longer-term studies should evaluate CMBT as an antihypertensive strategy.
Serial optical frequency domain imaging in STEMI patients: the follow-up report of TROFI study.

To investigate the incidence of incomplete stent apposition and to explore the impact of the presence of thrombus and protruding plaque after stent implantation on neointima formation at follow-up in ST-segment elevation myocardial infarction (STEMI) patients with serial optical frequency domain imaging (OFDI) investigations.



In a multi-centre study, 141 patients with ST elevation myocardial infarction <12 h from onset were randomized to either PPCI with thrombectomy (TB) using an Eliminate catheter (TB: n = 71) or without TB (non-TB: n = 70). OFDI after drug-eluting stenting was performed using TERUMO OFDI system. Per protocol, at follow-up 49 patients segments were reimaged. At post-procedure and follow-up, there were no differences in stent and lumen areas between the two groups. At follow-up, per strut-level analysis, percentage of incompletely apposed struts was 0.42 ± 0.94 vs. 0.38 ± 0.77% (P = 0.76), and percentage of covered struts was 92.7 ± 7.2 vs. 94.4 ± 9.2% (P = 0.47) in the TB and non-TB groups, respectively. There was a positive correlation between intra-stent structure (ISS) volume at post-procedure and the neointima volume at 6-month follow-up (Pearson's r = 0.409, P = 0.04). Up to 12 months, there have been two and four patients having target vessel failure in the TB and in the non-TB groups, respectively.



In patients with STEMI, there were no significant differences in OFDI parameters between TB and non-TB groups at both post-procedure and 6-month follow-up. However, ISS volume at post-procedure was positively associated with neointimal volume at 6-month follow-up.