nils-herrmann/clean_scirepeval huggingface dataset:
Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF). ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those in the placebo group shall receive an oral placebo tablet. At the end of 1 year of administration of metformin/placebo, colonoscopy will be performed to evaluate the polyp formation. This is the first study proposed to explore the effect of metformin against colorectal polyp formation. Metformin activates AMPK, which inhibits the mammalian target of rapamycin (mTOR) pathway. The mTOR pathway plays an important role in the cellular protein translational machinery and cell proliferation. Patients with type 2 diabetes taking under treatment with metformin have been reported to be at a lower risk of cancer development than those not taking under treatment with metformin. We showed in a previous study that metformin suppressed the formation of human colorectal ACF. We therefore decided to conduct a study to determine whether metformin might suppress the formation of human colorectal polyps. This trial has been registered in the University hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000006254
Antirheumatic activity of fenclofenac.

This study has set out to establish whether fenclofenac has an antirheumatic effect in addition to its anti-inflammatory and analgesic activity. The results show that during the course of a 6-month study the drug improved clinical parameters, including the articular index, early morning stiffness, ring sizes, and grip strength, and produced changes in laboratory measurements such as the levels of C-reactive protein, IgG, and rheumatoid factor.
Patient–staff agreement in the perception of spinal cord lesioned patients' problems, emotional well-being, and coping pattern

Matched patient/staff study.To investigate spinal cord lesion (SCL) rehabilitation staff perceptions of SCL patient problems, coping efforts, and well-being, and to compare these evaluations with patient self-reports of the same aspects.Spinal Unit, Sahlgrenska University Hospital, Göteborg, Sweden.In all, 29 persons with SCL and 24 members of the caring staff participated. Each patient was matched to a staff person actually involved in his or her care. The participants completed a study-specific questionnaire containing 45 SCL-related problems covering six problem areas: somatic symptoms, functional limitations, role problems, family-related problems, psychosocial problems, and emotional problems. Coping activities were assessed by a self-report 47-item questionnaire covering eight aspects of coping: self-trust, problem focusing, acceptance, fatalism, resignation, protest, minimization, and social trust. The patients were instructed to respond to the items included in the questionnaires according to their situation during the last week, while staff members were instructed to reply as ‘they thought that their matched patient would answer’.Moderate but statistically significant correlations were demonstrated between patient and staff ratings of most investigated problem areas. However, the staff systematically overestimated patients' emotional as well as family problems, and tended to underestimate patients' reported coping ability and mental health. Staff were most accurate in assessing patients' physical symptoms, functional limitations, and role problems, but less accurate in their perception of less visible symptoms.Relatively high agreement between patients and staff concerning patients' problems and states is possible to obtain in a caring setting. This may be more related to the quality of caring in the studied unit than to the study methodology used. Small units with high staff density and a long stay and/or prolonged contact with the patients probably facilitate communication with and knowledge about the patients. Interventions aimed at increasing staff awareness of patients' coping efforts may further improve staff ability to understand and support patients in their adaptation process.The Foundation of Rehabilitation Research (FRF), The Vårdal Foundation, Sweden.
Short-term effects of highly-bioavailable curcumin for treating knee osteoarthritis: a randomized, double-blind, placebo-controlled prospective study

We previously developed a surface-controlled water-dispersible form of curcumin and named it Theracurmin(®) (Theracurmin; Theravalues, Tokyo, Japan). The area under the blood concentration-time curve of Theracurmin in humans was 27-fold higher than that of curcumin powder. We determined the clinical effects of orally administered Theracurmin in patients with knee osteoarthritis during 8 weeks of treatment.



Fifty patients with knee osteoarthritis of Kellgren-Lawrence grade II or III and who were aged more than 40 years were enrolled in this randomized, double-blind, placebo-controlled, prospective clinical study. Placebo or Theracurmin containing 180 mg/day of curcumin was administered orally every day for 8 weeks. To monitor adverse events, blood biochemistry analyses were performed before and after 8 weeks of each intervention. The patients' knee symptoms were evaluated at 0, 2, 4, 6, and 8 weeks by the Japanese Knee Osteoarthritis Measure, the knee pain visual analog scale (VAS), the knee scoring system of the Japanese Orthopedic Association, and the need for nonsteroidal anti-inflammatory drugs.



At 8 weeks after treatment initiation, knee pain VAS scores were significantly lower in the Theracurmin group than in the placebo group, except in the patients with initial VAS scores of 0.15 or less. Theracurmin lowered the celecoxib dependence significantly more than placebo. No major side effects were observed with Theracurmin treatment.



Theracurmin shows modest potential for the treatment of human knee osteoarthritis.
Adiposity and insulin resistance in nondiabetic hemodialysis patients: effects of high energy supplementation.

In contrast to the general population, a higher body mass index is associated with better survival among hemodialysis patients. Theoretically, high energy supplementation in these patients ought to lead to weight gain over time, but the benefits of this strategy are unclear.



The objective was to assess whether high energy supplementation in nondiabetic hemodialysis patients might adversely affect insulin resistance -- a known risk factor for cardiovascular disease.



We first investigated the association between body fat mass and insulin resistance (homeostasis model assessment of insulin resistance; HOMA-IR) in nondiabetic hemodialysis patients in a cross-sectional analysis (study 1). Of the 106 individuals studied, 55 were randomly assigned to either high energy supplementation (an extra 475 kcal/d; n = 28) or not (n = 27) for 12 wk to assess prospective changes in body fat mass and insulin resistance (study 2).



In study 1, body fat mass (P < 0.05) and C-reactive protein (CRP) (P < 0.05) each contributed independently to HOMA-IR. In study 2, 41 patients completed the study. The 20 patients who received high energy supplementation had a significantly greater increase in body fat mass (P < 0.05), CRP (P < 0.05), and HOMA-IR (P < 0.001) than did the 21 controls.



Body fat mass and CRP are primary determinants of insulin resistance in nondiabetic hemodialysis patients. High energy supplementation, because it increases adiposity and inflammation, exacerbates insulin resistance. A long-term study is needed to clarify the metabolic effects of high energy supplementation on cardiovascular disease outcomes in hemodialysis patients.
Obesity and thyroid cancer risk among U.S. men and women: a pooled analysis of five prospective studies.

Thyroid cancer incidence has risen dramatically in the United States since the early 1980s. Although the prevalence of obesity has doubled during this time period, the relationship between obesity and thyroid cancer is uncertain.



We examined the association between body mass index (BMI) and thyroid cancer risk in a pooled analysis of five prospective U.S. studies, including 413,979 women and 434,953 men. Proportional hazards models with attained age as the time metric were adjusted for education, race, marital status, smoking, alcohol intake, and (where appropriate) cohort and sex.



Over follow-up (mean=10.3 years), 768 women and 388 men were diagnosed with thyroid cancer. The risk of thyroid cancer was greater with increasing BMI [per 5 kg/m2: HR in women, 1.16 (95% CI, 1.08-1.24); HR in men, 1.21 (95% CI, 0.97-1.49)]. There was no significant heterogeneity between studies (both P>0.05). For women and men combined, the HRs for overweight (25.0-29.9 kg/m2) and obesity (≥30 kg/m2) compared with normal-weight (18.5-24.9 kg/m2) were 1.20 (95% CI, 1.04-1.38) and 1.53 (95% CI, 1.31-1.79), respectively. We found no significant effect modification by other factors, and the results did not differ significantly by histologic type. A significant positive association for BMI in young adulthood (ages 18-20) with thyroid cancer risk was also observed [per 5-kg/m2 increase: HR, 1.18 (95% CI, 1.03-1.35)].



BMI was positively associated with thyroid cancer risk in both men and women.



Our study provides strong evidence that obesity is an independent risk factor for thyroid cancer.
Knowledge, Attitudes, and Beliefs Regarding Cardiovascular Disease in Women: The Women's Heart Alliance.

Cardiovascular disease (CVD) is the number 1 killer of women in the United States, yet few younger women are aware of this fact. CVD campaigns focus little attention on physicians and their roles in assessing risk.



In 2014, the Women's Heart Alliance (WHA) conducted a nationwide survey to determine barriers and opportunities for women and physicians with regard to CVD.



From September 18 to 26, 2014, a total of 1,011 U.S. women (age 25 to 60 years) were interviewed using the GfK ("Gesellschaft für Konsumforschung" Knowledge Panel). From May 6 to 12, 2014, the e-Rewards Inc. Physician and Healthcare Professional Panel surveyed 200 primary care physicians (PCPs) and 100 cardiologists.



Overall, 45% of women were unaware that CVD is the number 1 killer of women; only 11% knew a woman who died from CVD. Overall, 45% of women reported it was common to cancel or postpone a physician appointment until losing weight. CVD was rated as the top concern by only 39% of PCPs, after weight and breast health. Only 22% of PCPs and 42% of cardiologists (p = 0.0477) felt extremely well prepared to assess CVD risk in women, while 42% and 40% felt well-prepared (p = NS), respectively. Few comprehensively implemented guidelines.



CVD was rated as the top concern less frequently than weight issues by both women and physicians. Social stigma particularly regarding body weight appeared to be a barrier. Physicians reported limited training and use of guideline assessment, whereas most supported a campaign and improved physician education. Campaigns should make CVD "real" to U.S. women, countering stereotypes with facts and validated assessments. Both community women and physicians endorsed investment in women's CVD research and physician education.
Unsedated peroral wireless pH capsule placement vs. standard pH testing: A randomized study and cost analysis

Wireless capsule pH-metry (WC) is better tolerated than standard nasal pH catheter (SC), but endoscopic placement is expensive.



to confirm that non-endoscopic peroral manometric placement of WC is as effective and better tolerated than SC and to perform a cost analysis of the available esophageal pH-metry methods.



Randomized trial at 2 centers. Patients referred for esophageal pH testing were randomly assigned to WC with unsedated peroral placement or SC after esophageal manometry (ESM). Primary outcome was overall discomfort with pH-metry. Costs of 3 different pH-metry strategies were analyzed: 1) ESM + SC, 2) ESM + WC and 3) endoscopically placed WC (EGD + WC) using publicly funded health care system perspective.



86 patients (mean age 51 ± 2 years, 71% female) were enrolled. Overall discomfort score was less in WC than in SC patients (26 ± 4 mm vs 39 ± 4 mm VAS, respectively, p = 0.012) but there were no significant group differences in throat, chest, or overall discomfort during placement. Overall failure rate was 7% in the SC group vs 12% in the WC group (p = 0.71). Per patient costs ($Canadian) were $1475 for EGD + WC, $1014 for ESM + WC, and $906 for ESM + SC. Decreasing the failure rate of ESM + WC from 12% to 5% decreased the cost of ESM + WC to $991. The ESM + SC and ESM + WC strategies became equivalent when the cost of the WC device was dropped from $292 to $193.



Unsedated peroral WC insertion is better tolerated than SC pH-metry both overall and during placement. Although WC is more costly, the extra expense is partially offset when the higher patient and caregiver time costs of SC are considered.
Household Costs for Treatment of Severe Pneumonia in Pakistan

Current World Health Organization (WHO) guidelines for severe pneumonia treatment of under-5 children recommend hospital referral. However, high treatment cost is a major barrier for communities. We compared household costs for referred cases with management by lady health workers (LHWs) using oral antibiotics. This study was nested within a cluster randomized trial in Haripur, Pakistan. Data on direct and indirect costs were collected through interviews and record reviews in the 14 intervention and 14 control clusters. The average household cost/case for a LHW managed case was $1.46 compared with $7.60 for referred cases. When the cost of antibiotics provided by the LHW program was excluded from the estimates, the cost/case came to $0.25 and $7.51 for the community managed and referred cases, respectively, a 30-fold difference. Expanding severe pneumonia treatment with oral amoxicillin to community level could significantly reduce household costs and improve access to the underprivileged population, preventing many child deaths.
Drug cue induced overshadowing: selective disruption of natural reward processing by cigarette cues amongst abstinent but not satiated smokers.

Addicts show both reward processing deficits and increased salience attribution to drug cues. However, no study to date has demonstrated that salience attribution to drug cues can directly modulate inferences of reward value to non-drug cues. Associative learning depends on salience: a more salient predictor of an outcome will 'overshadow' a less salient predictor of the same outcome. Similarly, blocking, a demonstration that learning depends on prediction error, can be influenced by the salience of the cues employed.



This study investigated whether salient drug cues might interact with neutral cues predicting financial reward in an associative learning task indexing blocking and overshadowing in satiated smokers (n=24), abstaining smokers (n=24) and non-smoking controls (n=24). Attentional bias towards drug cues, craving and expired CO were also indexed.



Abstaining smokers showed drug cue induced overshadowing, attributing higher reward value to drug cues than to neutral cues that were equally predictive of reward. Overshadowing was positively correlated with expired CO levels, which, in turn, were correlated with craving in abstainers. An automatic attentional bias towards cigarette cues was found in abstainers only.



These findings provide the first evidence that drug cues interact with reward processing in a drug dependent population.
Prognostic value of pulmonary hemodynamic parameters in cardiac transplant candidates.

Pulmonary hypertension is a contradiction for heart transplantation (HTx). The aim of the study was to examine prognostic significance of pulmonary hemodynamic variables in patients with severe chronic heart failure (HF) considered for HTx.



Patients with HF were qualified to HTx in Poland. We measured pulmonary artery systolic pressure (PASP), pulmonary capillary wedge pressure (PCWP), transpulmonary gradient (TPG), cardiac output (CO), pulmonary vascular resistance (PVR) and systemic vascular resistance (SVR). We performed biochemical evaluation, 6-min walking test, VO2max. Death or emergency HTx were assumed as the endpoints in the follow-up. Death or any kind of HTx were considered an end of observation. Survival analysis was conducted using Kaplan-Meier curves (long rank test with strait defined by terciles of analyzed hemodynamic parameters).



Six hundred and fifty-eight patients were qualified to HTx between 2003 and 2007. The mean follow-up: 601 days. 87.8% male. Mean age was under 50, III and IV NYHA class. Mean PASP was 44.3 ± 16.9 mm Hg, TPG 10.0 ± 6.6 mm Hg and PVR 2.9 mm Hg, PCWP20.9 ± 9.3 mm Hg. PASP and PCWP had influence on survival or emergency HTx. There was a significant difference in survival between patients with PCWP > 25 mm Hg and PCWP < 25 mm Hg. The worst prognosis was with PASP higher than 50 mm Hg. One-, two-, and three-year survival was 75%, 58% and 48% compared to patients with PASP < 35 mm Hg (80%, 70%, and 68%, respectively).



In patients qualified to HTx, pathological values of pulmonary hemodynamic parameters have a significant influence on survival. The worst prognosis have patients with PASP > 50 mm Hg, and PCWP > 25 mm Hg. Pulmonary hemodynamic parameters are important during allocation process to HTx.
Assessment of Fatigue in Patients with Chronic Hepatitis C Using the Fatigue Impact Scale

The aim of this study was to assess the impact of fatigue on the quality of life of patients with chronic hepatitis C (CHC) and to examine its relationship with various parameters of the disease, including viral load. The Fatigue Impact Scale (FIS), a self-report questionnaire, was applied to 92 patients with CHC, and the results were compared to those of an age-matched cohort of 213 healthy blood donors. Fatigue was frequent and disabling, being present in 67% of CHC patients, and the FIS was significantly increased in CHC patients compared to the healthy controls. Fatigue severity was not correlated with the activity of the disease or with the level of viremia. The FIS proved to be a valuable tool to assess this symptom. It should be of help for better evaluation of the clinical spectrum of the disease and should be included in trials assessing the efficacy of therapeutic interventions.
Initial clinical validation of an embedded performance validity measure within the automated neuropsychological metrics (ANAM).

The measurement of effort and performance validity is essential for computerized testing where less direct supervision is needed. The clinical validation of an Automated Neuropsychological Metrics-Performance Validity Index (ANAM-PVI) was examined by converting ANAM test scores into a common metric based on their relative infrequency in an outpatient clinic sample with presumed good effort. Optimal ANAM-PVI cut-points were determined using receiver operator characteristic (ROC) curve analyses and an a priori specificity of 90%. Sensitivity/specificity was examined in available validation samples (controls, simulators, and neurorehabilitation patients). ANAM-PVI scores differed between groups with simulators scoring the highest. ROC curve analysis indicated excellent discriminability of ANAM-PVI scores ≥5 to detect simulators versus controls (area under the curve = 0.858; odds ratio for detecting suboptimal performance = 15.6), but resulted in a 27% false-positive rate in the clinical sample. When specificity in the clinical sample was set at 90%, sensitivity decreased (68%), but was consistent with other embedded effort measures. Results support the ANAM-PVI as an embedded effort measure and demonstrate the value of sample-specific cut-points in groups with cognitive impairment. Examination of different cut-points indicates that clinicians should choose sample-specific cut-points based on sensitivity and specificity rates that are most appropriate for their patient population with higher cut-points for those expected to have severe cognitive impairment (e.g., dementia or severe acquired brain injury).
Vitamin D supplementation and endothelial function in vitamin D deficient HIV-infected patients: a randomized placebo-controlled trial.

Studies suggest that vitamin D deficiency is a risk factor for cardiovascular disease and diabetes. Vitamin D deficiency is prevalent in HIV patients but the effect of vitamin D supplementation on cardiovascular risk in this population is unknown.



We conducted a randomized, double-blind, placebo-controlled trial among 45 HIV-infected adults in Cleveland (OH, USA) on stable antiretroviral therapy with durable virological suppression and a baseline serum 25-hydroxyvitamin D level of ≤20 ng/ml. Participants were randomized 2:1 to vitamin D3 4,000 IU daily or placebo for 12 weeks. The primary outcome was a change in flow-mediated brachial artery dilation (FMD).



Baseline demographics were similar except for age (vitamin D versus placebo, mean ±sd 47 ±8 versus 40 ±10 years; P=0.009). Both groups had reduced FMD at baseline (median values 2.9% [IQR 1.6-4.8] for vitamin D versus 2.5% [IQR 1.7-6.4] for placebo; P=0.819). Despite an increase in the concentration of serum 25-hydroxyvitamin D from baseline to 12 weeks (5.0 ng/ml [IQR -0.9-7.4] versus -1.9 ng/ml [IQR -4.0-0.1] for vitamin D versus placebo, respectively; P=0.003), there was no difference in FMD change (0.55% [IQR -1.05-2.13] versus 0.29% [IQR -1.61-1.77]; P=0.748). Vitamin D supplementation was associated with a decrease in total and non-high-density lipoprotein cholesterol, and an increase in indices of insulin resistance.



Among HIV-infected individuals with vitamin D deficiency, supplementation with 4,000 IU vitamin D3 daily for 12 weeks modestly improved vitamin D status and cholesterol but worsened insulin resistance without change in endothelial function. The mechanisms of resistance to standard doses of vitamin D and the complex role of vitamin D in glucose metabolism in this population require further investigation.