nils-herrmann/clean_scirepeval huggingface dataset:
Effect of coumarins started before coronary angioplasty on acute complications and long-term follow-up: a randomized trial.

Coronary angioplasty frequently creates a thrombogenic surface, with subsequent mural thrombosis that may lead to acute complications and possibly stimulates the development of restenosis. Whether coumarins can prevent these complications is unclear. The objective of this open, randomized trial was to assess the clinical effect of coumarins started before coronary angioplasty and continued for 6 months.



Before coronary angioplasty, 530 patients were randomly assigned to aspirin plus coumarins and 528 patients to aspirin alone. At the start of the angioplasty, the mean international normalized ratio was 2.7+/-1.1; during follow-up, it was 3.0+/-1.1. At 30 days, the composite end point of death, myocardial infarction, target-lesion revascularization, and stroke was observed in 18 patients (3.4%) treated with aspirin plus coumarin compared with 34 patients (6.4%) treated with aspirin alone (relative risk, 0.53; 95% CI, 0.30 to 0.92). At 1 year, these figures were 14.3% and 20.3%, respectively (relative risk, 0.71; 95% CI, 0.54 to 0.93). The incidence of major bleeding and false aneurysm during hospitalization was 3.2% and 1.0%, respectively (relative risk, 3.39; 95% CI, 1.26 to 9.11). The benefit of coumarins was observed in both stented and nonstented patients.



Coumarins in addition to aspirin started before PTCA and continued for 6 months was more effective than aspirin alone in the prevention of acute and late complications after coronary angioplasty. This benefit was accompanied by a small but significant increase in bleeding complications.
Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors.

To evaluate the efficacy and safety of tabalumab, a monoclonal antibody that neutralises membrane-bound and soluble B-cell activating factor (BAFF), in patients with active rheumatoid arthritis (RA) who showed inadequate response to tumour necrosis factor (TNF) inhibitors.



Patients on stable methotrexate and with inadequate response to one or more TNF inhibitors were randomised to placebo (n=35), 30 mg tabalumab (n=35) or 80 mg tabalumab (n=30) given intravenously at 0, 3 and 6 weeks. The primary outcome was the proportion of patients achieving an American College of Rheumatology 50% response (ACR50) at week 16 (all tabalumab-treated patients vs placebo).



At week 16, no significant differences were observed in the combined tabalumab group versus placebo in ACR50 (12.7% vs 2.9%, p=0.101) or ACR20 response rates (27.0% vs 17.1%, p=0.198). However, significant differences between the combined tabalumab group and placebo were observed at earlier time points for ACR20, ACR50 and Disease Activity Score in 28 joints (DAS28)-C-reactive protein (CRP) reduction. Treatment-emergent adverse events (AEs) were similar with 30 mg tabalumab (65.7%), 80 mg tabalumab (76.7%) and placebo (71.4%), although certain events occurred more often with tabalumab than placebo (eg, infection, anaemia and gastrointestinal events). Serious AEs occurred in two (6.7%) patients receiving 80 mg tabalumab and three (8.6%) receiving placebo, with one serious infection in the placebo group. Initial increases in total and mature B cells were followed by progressive decreases, despite declines in serum tabalumab.



At week 16, the primary end point was not achieved, but an indication of efficacy was observed at earlier time points. Safety findings for tabalumab were consistent with other biological RA therapies.
Fish oil supplementation improves large arterial elasticity in overweight hypertensive patients

To observe the effect of fish oil supplementation on arterial elasticity and blood pressure (BP) in overweight hypertensive patients.This was a double-blind, randomized and placebo-controlled clinical study, in which 52 overweight hypertensive patients from a community were selected and randomly allocated to two groups (26 in the fish oil group (3 g day−1, fish oil capsules) and 26 in the placebo group (only capsules). All the subjects were follow-up for 8 weeks. The arterial elasticity was determined by CVProfilor DO-2020 and expressed as elasticity indexes (C1-large artery and C2-small artery). During the follow-up, totally nine cases were dropped out (three cases from the fish oil group and six cases from the placebo group).Results:After 8 weeks follow-up, the large artery elasticity in the fish oil group, compared with its baseline, was significantly improved (C1: 15.5±1.5 vs 12.8±3.7 ml mm Hg−1 × 10), whereas no effects were found in the placebo group (C1: 13.0±3.4 vs 13.4±3.8 ml mm Hg−1 × 10), P=0.027, RM-ANOVA across the two groups. The small artery elasticity (C2), BP and pulse pressure were not found any changes, either in the fish oil group or in the placebo group. At same time, the serum soluble vascular cell adhesion molecule-1(sVCAM-1) and leptin levels, the lipid profile and insulin sensitivity index (ISI) as well, did not show significant differences between two groups.Fish oil supplementation certainly would improve large arterial elasticity but no effect on BP in overweight hypertensive patients. Further study is needed to confirm the benefits of fish oil supplementation on age-related increases in arterial stiffness.
Analgetic effect of synthetic human calcitonin in patients with primary osteoporosis

Examinations were performed in 20 adult male and female patients (pts) suffering from acute back pain due to vertebral compression fracture secondary to osteoporosis proved by lateral X-rays of the dorso-lumbar spine (Th3-L5), and bone mineral density with the method of dual energy X-ray absorptiometry. The synthetic human calcitonin (SUC) (0.5 mg) was injected I.M. every day during 28 days. Analgesic effect was evaluated on 0, 3, 7, 14, 21 and 28th day by patient's assessment of functional capacity, and physician's assessment of pain and mobility. On the same days biochemical variables of Ca-P homeostasis were determined. Treatment with calcitonin resulted in a positive analgesic effect. The functional capacity and mobility of pts increased with diminution of pain. No significant alterations of Ca-P homeostasis was observed. Mild and transient side effects as nausea and tachycardia were negligible. SHC appears to have a significant analgesic effect in treatment of primary osteoporosis.
Bronchodilator effects of clemastine, ipratropium, bromide, and salbutamol in preschool children with asthma.

The bronchodilator activity in nebulised salbutamol, ipratropium bromide, clemastine, and a placebo was studied in 14 asthmatic children aged between 3 and 5 years. Changes in lung function were monitored by measuring peak expiratory flow rate and total respiratory resistance using a modification of the forced oscillation technique. Ipratropium bromide produced a degree of bronchodilation similar to that of salbutamol, but the bronchodilatory activity of clemastine was not appreciably better than for the placebo.
Functional restoration of elbow extension after spinal-cord injury using a neural network-based synergistic FES controller

Individuals with a C5/C6 spinal-cord injury (SCI) have paralyzed elbow extensors, yet retain weak to strong voluntary control of elbow flexion and some shoulder movements. They lack elbow extension, which is critical during activities of daily living. This research focuses on the functional evaluation of a developed synergistic controller employing remaining voluntary elbow flexor and shoulder electromyography (EMG) to control elbow extension with functional electrical stimulation (FES). Remaining voluntarily controlled upper extremity muscles were used to train an artificial neural network (ANN) to control stimulation of the paralyzed triceps. Surface EMG was collected from SCI subjects while they produced isometric endpoint force vectors of varying magnitude and direction using triceps stimulation levels predicted by a biomechanical model. ANNs were trained with the collected EMG and stimulation levels. We hypothesized that once trained and implemented in real-time, the synergistic controller would provide several functional benefits. We anticipated the synergistic controller would provide a larger range of endpoint force vectors, the ability to grade and maintain forces, the ability to complete a functional overhead reach task, and use less overall stimulation than a constant stimulation scheme.
Unique histological changes in lung metastases of osteosarcoma patients following therapy with liposomal muramyl tripeptide (CGP 19835A lipid)

We have recently begun a phase II trial in patients with osteosarcoma who developed pulmonary metastases during adjuvant chemotherapy or who presented with pulmonary metastases that persisted despite chemotherapy. Eligible patients were rendered free of visible disease by surgery. Liposome-encapsulated muramyl tripeptide phosphatidylethanolamine (MTP-PE, CGP 19835A lipid) (2 mg/m2) was infused twice weekly for 3 months. In five patients, a single tumor nodule recurred within 6 weeks after completion of therapy. These lesions were resected and submitted for pathological examination. Tissue specimens obtained after therapy were compared to those obtained before therapy. All the patients showed a histological change in the characteristics of the pulmonary tumors. In three patients, peripheral fibrosis surrounded the tumor and inflammatory cell infiltration and neovascularization were present. This is in contrast to central necrosis, with viable peripheral tumor cells and no inflammatory response observed in lesions resected following chemotherapy. In a fourth case, evidence of early fibrotic changes was found. This and the fifth case showed a change in malignant characteristics, from high grade before liposomal therapy to low grade after therapy. The present study provides evidence for a biological effect of liposomal MTP-PE.
Tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with an optimized allergen to adjuvant ratio under routine practice conditions: a noninterventional observational study.

A fast updosed immunologically enhanced subcutaneous immunotherapy (SCIT) formulation with an optimized allergen to aluminium hydroxide ratio was first introduced in September 2009 in Germany. A large randomized controlled trial showed that the formulation had considerable immunologic effects and good tolerability. In this open-label, uncontrolled, noninterventional study, tolerability was investigated during routine application.



Patients with allergic rhinoconjunctivitis and/or asthma were treated with pollen and mite allergens using a 5-injection updosing schedule (AVANZ: 300, 600, 3000, 6000 and 15 000 SQ+ units) with weekly intervals, followed by a maintenance schedule with injections of 15,000 SQ+ units.Adverse events (AEs) were recorded by physicians, and symptoms and use of symptomatic medication were analyzed before the start of therapy and after an average 8-month treatment period.



SCIT was documented by 362 allergists in 1036 patients between September 2009 and February 2011. AEs mainly consisted of local reactions during updosing (in 24.5% of patients). Systemic reactions were observed during updosing (8.4%) and maintenance therapy (1.7%), the most frequent of which was dyspnea. Overall, tolerability and the effect of treatment were rated as good or very good by 94.9% and 86.6% of patients and by 96.2% and 89.6% of physicians, respectively.



In this open-label, noninterventional study, fast updosed immunologically enhanced SCIT (AVANZ) was well tolerated in a large group of patients.
Combination Therapy with Metolazone and Loop Diuretics in Outpatients with Refractory Heart Failure: An Observational Study and Review of the Literature

Metolazone is a potent thiazide-like diuretic. It is recommended in severe congestive heart failure (HF). We conducted a review of the existing literature and found that the available information on the use of metolazone in HF is based on studies containing less than 250 patients in total. Nevertheless, metolazone is widely used, often in combination with a loop diuretic. Absorption of metolazone seems to be reduced in HF. Metolazone produces a diuretic response despite a low glomerular filtration rate. A wide dose range of metolazone has been investigated (≤2.5 to 200 mg), leaving no clear dosing recommendation. However, in most studies a low starting dose (≤5 mg) was used. We further report an observational study on 21 patients with refractory systolic HF from our specialized outpatient HF clinic. The aim was to evaluate the effects of metolazone in combination with a loop diuretic in contemporary HF patients.  We registered 42 episodes of treatment with metolazone. The maximal dose of metolazone was 5 mg. NYHA functional class improved. A significant reduction during treatment in weight, blood pressure, plasma-sodium and –potassium was seen whereas plasma-BUN and –creatinine increased significantly. Clinically important hypokalemia (<2.5 mM) or hyponatremia (<125 mM) were observed during 10% of the treatment episodes.  The literature review and the observational study support the use of low-dose metolazone (≤5 mg) on top of oral loop diuretics, as an effective and relatively safe treatment in contemporary outpatients with refractory HF.
Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer

The primary end point of this study was to determine the safety and feasibility of intraprostatic administration of PSA-TRICOM vaccine [encoding transgenes for prostate-specific antigen (PSA) and 3 costimulatory molecules] in patients with locally recurrent or progressive prostate cancer. This trial was a standard 3 + 3 dose escalation with 6 patients each in cohorts 4 and 5 to gather more immunologic data. Nineteen of 21 patients enrolled had locally recurrent prostate cancer after definitive radiation therapy, and 2 had no local therapy. All cohorts received initial subcutaneous vaccination with recombinant vaccinia (rV)-PSA-TRICOM and intraprostatic booster vaccinations with recombinant fowlpox (rF)-PSA-TRICOM. Cohorts 3–5 also received intraprostatic rF-GM-CSF. Cohort 5 received additional subcutaneous boosters with rF-PSA-TRICOM and rF-GM-CSF. Patients had pre- and post-treatment prostate biopsies, and analyses of peripheral and intraprostatic immune cells were performed. There were no dose-limiting toxicities, and the maximum tolerated dose was not reached. The most common grade 2 adverse events were fever (38 %) and subcutaneous injection site reactions (33 %); the single grade 3 toxicity was transient fever. Overall, 19 of 21 patients on trial had stable (10) or improved (9) PSA values. There was a marked increase in CD4+ (p = 0.0002) and CD8+ (p = 0.0002) tumor infiltrates in post- versus pre-treatment tumor biopsies. Four of 9 patients evaluated had peripheral immune responses to PSA or NGEP. Intraprostatic administration of PSA-TRICOM is safe and feasible and can generate a significant immunologic response. Improved serum PSA kinetics and intense post-vaccination inflammatory infiltrates were seen in the majority of patients. Clinical trials examining clinical end points are warranted.
Insulin sensitivity and metabolic flexibility following exercise training among different obese insulin-resistant phenotypes.

Impaired fasting glucose (IFG) blunts the reversal of impaired glucose tolerance (IGT) after exercise training. Metabolic inflexibility has been implicated in the etiology of insulin resistance; however, the efficacy of exercise on peripheral and hepatic insulin sensitivity or substrate utilization in adults with IFG, IGT, or IFG + IGT is unknown. Twenty-four older (66.7 ± 0.8 yr) obese (34.2 ± 0.9 kg/m(2)) adults were categorized as IFG (n = 8), IGT (n = 8), or IFG + IGT (n = 8) according to a 75-g oral glucose tolerance test (OGTT). Subjects underwent 12-wk of exercise (60 min/day for 5 days/wk at ∼85% HRmax) and were instructed to maintain a eucaloric diet. A euglycemic hyperinsulinemic clamp (40 mU·m(2)·min(-1)) with [6,6-(2)H]glucose was used to determine peripheral and hepatic insulin sensitivity. Nonoxidative glucose disposal and metabolic flexibility [insulin-stimulated respiratory quotient (RQ) minus fasting RQ] were also assessed. Glucose incremental area under the curve (iAUCOGTT) was calculated from the OGTT. Exercise increased clamp-derived peripheral and hepatic insulin sensitivity more in adults with IFG or IGT alone than with IFG + IGT (P < 0.05). Exercise reduced glucose iAUCOGTT in IGT only (P < 0.05), and the decrease in glucose iAUCOGTT was inversely correlated with the increase in peripheral but not hepatic insulin sensitivity (P < 0.01). Increased clamp-derived peripheral insulin sensitivity was also correlated with enhanced metabolic flexibility, reduced fasting RQ, and higher nonoxidative glucose disposal (P < 0.05). Adults with IFG + IGT had smaller gains in clamp-derived peripheral insulin sensitivity and metabolic flexibility, which was related to blunted improvements in postprandial glucose. Additional work is required to assess the molecular mechanism(s) by which chronic hyperglycemia modifies insulin sensitivity following exercise training.
Zoledronic acid for the treatment of osteoporosis in patients with beta-thalassemia: results from a single-center, randomized, placebo-controlled trial.

The aim of this study was to evaluate the effect of zoledronic acid (ZA) on thalassemia-induced osteoporosis.



We studied 66 thalassemia patients with osteoporosis, who were randomized to receive 4 mg ZA iv, every 6 months (23 patients; group A) or every 3 months (21 patients; group B), or to receive placebo every 3 months (22 patients; group C), for a period of 1 year. Bone mineral density (BMD) of the lumbar spine, femoral neck and wrist was determined before and 12 months after treatment. Pain scores and markers of bone resorption [C-telopeptide of collagen type-I (CTX), 5b-isoform of TRAP], bone formation [bone-alkaline phosphatase (bALP), osteocalcin (OC), C-telopeptide of procollagen type-I (CICP)], and osteoclast stimulators [sRANKL, osteoprotegerin (OPG), osteopontin] were also measured at baseline and before each treatment administration.



The values of CTX, bALP, CICP, sRANKL, and OPG were higher in the all patients than in the controls. Patients in group A showed no differences in BMD of all sites at 12 months, while they had reductions in bone pain, bALP, OC and OPG. Conversely patients in group B had a significant increase in their lumbar spine BMD, which was accompanied by dramatic reductions in bone pain, CTX, bALP, CICP, and OC. Patients in group C showed no alteration in BMD of any studied site or in bone pain, while they had an aggravation in bone resorption.



ZA, at a dose of 4 mg, iv, every 3 months is an effective treatment for increasing BMD and reducing bone resorption in thalassemia-induced osteoporosis.
From Seed Discovery to Deep Reconstruction: Predicting Saliency in Crowd via Deep Networks

Although saliency prediction in crowd has been recently recognized as an essential task for video analysis, it is not comprehensively explored yet. The challenges lie in that eye fixations in crowded scenes are inherently "distinct" and "multi-modal", which differs from those in regular scenes. To this end, the existing saliency prediction schemes typically rely on hand designed features with shallow learning paradigm, which neglect the underlying characteristics of crowded scenes. In this paper, we propose a saliency prediction model dedicated for crowd videos with two novelties: 1) Distinct units are discovered using deep representation learned by a Stacked Denoising Auto-Encoder (SDAE), considering perceptual properties of crowd saliency; 2) Contrast-based saliency is measured through deep reconstruction errors in the second SDAE trained on all units excluding distinct units. A unified model is integrated for online processing crowd saliency. Extensive evaluations on two crowd video benchmark datasets demonstrate that our approach can effectively explore crowd saliency mechanism in two-stage SDAEs and achieve significantly better results than state-of-the-art methods, with robustness to parameters.
Aminophylline inhibits adaptation to ischaemia during angioplasty. Role of adenosine in ischaemic preconditioning.

The ability of brief periods of ischaemia to protect the heart from subsequent ischaemia has been termed "ischaemic preconditioning'. In order to assess the role of adenosine receptor stimulation in this phenomenon we studied the ischaemic preconditioning effect during angioplasty in 10 control patients and in 10 patients pre-treated with 5 mg.kg-1 aminophylline, an adenosine receptor antagonist. The ischaemic response was assessed by analysis of the intracoronary electrocardiogram every 10 s during three consecutive inflations of 90 s with a reperfusion time of 180 s. The severity of transmural local ischaemia was expressed as the magnitude of the ST segment shift in relation to the time during each inflation. The control patients showed an improved tolerance to myocardial ischaemia: ST segment shift decreased from 1.42 +/- 0.49 mV at the end of the first inflation to 1.03 +/- 0.44 mV at the end of the third inflation (P < 0.001). However, in patients pre-treated with aminophylline, the ischaemic response was not significantly different during three inflations.



Aminophylline inhibits ischaemic preconditioning, as assessed by analysis of the intracoronary. ST segment changes during angioplasty. This suggests that ischaemic preconditioning is mediated by adenosine receptor stimulation in humans.
A genetic analysis of the validity of the Hypomanic Personality Scale.

Studies of mania risk have increasingly relied on measures of subsyndromal tendencies to experience manic symptoms. The measures of mania risk employed in those studies have been shown to predict manic onset, to show familial associations, and to demonstrate expected correlations with psychosocial variables related to bipolar disorder. However, little work has been conducted to validate such measures against biologically relevant indices, or to consider whether early adversity, which has been shown to be highly elevated among those with bipolar disorder, is related to higher scores on mania risk measures. This study tested whether a well-used, self-report measure of vulnerability to mania is associated with several candidate genes that have previously been linked with bipolar disorder or with early adversity. Interactions of genes with early adversity in the prediction of mania vulnerability were also tested.



Undergraduate students from the University of Miami (Coral Gables, FL, USA) (N = 305) completed the Hypomanic Personality Scale and the Risky Families Scale, and provided blood for genotyping.



Findings indicated that the Hypomanic Personality Scale was related to a number of dopamine-relevant polymorphisms and with early adversity. A polymorphism of ANKK1 appeared to specifically increase mania risk in the context of early adversity.



These results provide additional support for the validity of the Hypomanic Personality Scale.