nils-herrmann/clean_scirepeval huggingface dataset:
Randomized clinical trial on enhanced recovery versus standard care following open liver resection.

Enhanced recovery programmes (ERPs) have been shown to reduce length of hospital stay (LOS) and complications in colorectal surgery. Whether ERPs have the same benefits in open liver resection surgery is unclear, and randomized clinical trials are lacking.



Consecutive patients scheduled for open liver resection were randomized to an ERP group or standard care. Primary endpoints were time until medically fit for discharge (MFD) and LOS. Secondary endpoints were postoperative morbidity, pain scores, readmission rate, mortality, quality of life (QoL) and patient satisfaction. ERP elements included greater preoperative education, preoperative oral carbohydrate loading, postoperative goal-directed fluid therapy, early mobilization and physiotherapy. Both groups received standardized anaesthesia with epidural analgesia.



The analysis included 46 patients in the ERP group and 45 in the standard care group. Median MFD time was reduced in the ERP group (3 days versus 6 days with standard care; P < 0·001), as was LOS (4 days versus 7 days; P < 0·001). The ERP significantly reduced the rate of medical complications (7 versus 27 per cent; P = 0·020), but not surgical complications (15 versus 11 per cent; P = 0·612), readmissions (4 versus 0 per cent; P = 0·153) or mortality (both 2 per cent; P = 0·987). QoL over 28 days was significantly better in the ERP group (P = 0·002). There was no difference in patient satisfaction.



ERPs for open liver resection surgery are safe and effective. Patients treated in the ERP recovered faster, were discharged sooner, and had fewer medical-related complications and improved QoL.
Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register.

To study treatment response rates of RA patients undergoing second- and third-line anti-TNF therapy and to identify baseline predictors of response to second-line treatment.



RA patients monitored in a prospective, observational study, having switched anti-TNF therapy once (first-time switchers, n = 337) or twice (second-time switchers, n = 36)--i.e. following failures with one antibody- and one receptor-type agent--between March 1999 and December 2006, were studied. Treatment responses at 3 months were assessed by the ACR and European League Against Rheumatism (EULAR) response criteria. Predictive potentials for response to second-line treatment of demographics, baseline disease activity measures, disease and treatment characteristics were analysed using logistic regression.



ACR20 response was met by 51% of first-time and 35% of second-time switchers. Corresponding ACR50 rates were 27 and 18%; EULAR overall rates (EULAR good or moderate response) 71 and 58%; EULAR good rates 25 and 9% and 28-joint disease activity score (DAS28) remission rates 16 and 6%. Identified baseline predictors of response to second-line treatment were lower age and HAQ scores, elevated DAS28 values and having ceased the former anti-TNF treatment due to adverse events rather than inefficacy. No variable was predictive for all examined response criteria.



Response rates of first-time anti-TNF switchers are somewhat below those of anti-TNF naïve RA patients, while the markedly inferior response rates of second-time switchers suggest other therapeutic options to be considered in this situation. Identified baseline predictors of response may be useful indicators to second-line anti-TNF therapy, but vary depending on the response criteria set studied.
Efficacy of Oral Etoposide in Pretreated Metastatic Breast Cancer: A Multicenter Phase 2 Study: Erratum

A Multicenter Phase 2 Study: Erratum I n the article ‘‘Efficacy of Oral Etoposide in Pretreated Metastatic Breast Cancer: A Multicenter Phase 2 Study’’, 1 which appeared in Volume 94, Issue 17 of Medicine, the legend for Figure 2 was presented incorrectly. The green line should represent Internal organ metastasis, and the blue line should represent No internal organ metastasis. The article has been corrected online.
ODD dimensions, ADHD, and callous-unemotional traits as predictors of treatment response in children with disruptive behavior disorders.

To answer several questions pertinent to DSM-V, the authors examined the predictive validity of pretreatment oppositional defiant disorder (ODD) dimensions, attention-deficit/hyperactivity disorder (ADHD), and callous-unemotional (CU) traits in relation to several treatment outcomes in 177 children diagnosed with ODD or conduct disorder (CD). Multiple informants completed diagnostic interviews and rating scales at 6 assessment points (pretreatment to 3-year follow-up) to document emotional and behavioral outcomes. After controlling for pretreatment CD, the ODD dimension of hurtfulness was related to treatment-resistant CD, delinquent behaviors, and externalizing problems. In contrast, the ODD dimension tapping irritability was associated with treatment-resistant ODD, internalizing problems, and global functional impairment following treatment. Whereas pretreatment ADHD was associated with posttreatment ODD and social problems, it was unrelated to posttreatment CD symptoms and diagnosis. Contrary to predictions, CU traits were unrelated to any posttreatment outcomes after controlling for other covariates. These findings remained after controlling for measures of pretreatment global functional impairment.
Randomized trial of training and supervision in motivational interviewing with adolescent drug treatment practitioners.

Motivational interviewing is an empirically supported treatment for drug and alcohol problems. Training in this approach is very popular, although previous studies have identified that the acquisition of key skills is challenging and that postworkshop supervision inputs are helpful. This pilot trial investigated the training of adolescent drug treatment practitioners, comparing a group who received immediate training against a delayed training study condition. Training and supervision were found to have no impact upon skill levels as measured by the Motivational Interviewing Treatment Integrity Version 2, with the exception of a very specific effect on motivational interviewing spirit. Motivational interviewing was not easy to learn for these practitioners. Progress made indicates the importance of ongoing supervision, and for high level skill acquisition to occur requires more intensive support of learning from ongoing practice than was used here.
Implications of myocardial reperfusion on survival in women versus men with acute myocardial infarction undergoing primary coronary intervention.

We evaluated the effects of myocardial perfusion after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) on gender-based mortality rates. Research has demonstrated a gender-specific response of cardiomyocytes to ischemia and a potential increase in myocardial salvage in women compared with men. Myocardial blush grade (MBG), an angiographic surrogate of myocardial perfusion, is an independent predictor of early and late survival after AMI. Whether the incidence and prognosis of myocardial perfusion differs according to gender among patients with AMI undergoing PCI is unknown. MBG and short- and long-term mortality were evaluated in 1,301 patients (male = 935; female = 366) with AMI randomized to primary angioplasty ± abciximab versus stent ± abciximab. Following PCI, >96% of patients achieved final Thrombolysis In Myocardial Infarction 3 flow, of which MBG 2/3 was present in 58.3% of women versus 51.1% of men (p = 0.02). Worse MBG was an independent predictor of mortality in women at 30 days (7.4% for MBG 0/1 vs 2.4% for MBG 2/3, p = 0.04) and at 1-year (11.0% for MBG 0/1 vs 3.4% for MBG 2/3, p = 0.01); however, MBG was not associated with differences in mortality for men. In conclusion, impaired myocardial perfusion following PCI for AMI, indicated by worse MBG, is an independent predictor of early and late mortality in women but not in men. These findings imply an enhanced survival benefit from restoring myocardial perfusion for women compared with men during primary angioplasty and may have clinical implications for interventional strategies in women.
Attention-deficit hyperactivity disorder: agreement between clinical impression and the SNAP-IV screening tool.

The CONCOR study aimed to determine the predictive value of the SNAP-IV screening tool for ADHD relative to the pediatricians' clinical global impression of the presence of ADHD in children attending their practice.



In this multicentre, cross-sectional, case-control study participated pediatricians from all over Spain and each pediatrician enrolled at least six children over the age of 6 years who had no previous diagnosis of ADHD, three whom they considered to have symptoms characteristic of ADHD (DSM-IV criteria) and three children who did not. Screening with the SNAP-IV tool was completed by parents in the waiting room prior to a consultation (for any reason) and results were compared with the pediatrician's clinical global impression.



Results for 7263 Spanish children (>6 years of age) showed 'good' concordance between the SNAP-IV screening tool and the pediatricians' clinical impression of ADHD (kappa concordance index 0.6471; 95% confidence intervals: 0.6296-0.6646), with acceptable sensitivity and specificity (82.3% and 82.4%, respectively). Based on an estimated ADHD prevalence of 3-10%, the negative predictive values of SNAP-IV were 97.7%-99.3% and positive predictive values were 12.6-34.2%.



SNAP-IV is a useful screening tool that identifies children who are unlikely to have ADHD, and brings those in whom there is a high possibility of ADHD to the attention of the pediatrician for clinical evaluation.
Aortopathy in patients with bicuspid aortic valve stenosis: role of aortic root functional parameters.

We prospectively examined functional characteristics of the aortic root and transvalvular haemodynamic flow in order to define factors associated with the severity of aortopathy in patients undergoing surgery for bicuspid aortic valve (BAV) stenosis.



A total of 103 consecutive patients with BAV stenosis (mean age 61 ± 9 years, 66% male) underwent aortic valve replacement ± concomitant aortic surgery from January 2012 through March 2014. All patients underwent preoperative cardiac magnetic resonance imaging (MRI) in order to evaluate the systolic transvalvular flow and the following functional parameters: (i) angulation between the left ventricular outflow axis and the aortic root, (ii) geometrical orientation of residual aortic valve orifice and (iii) BAV cusp fusion pattern. MRI data were used to guide sampling of the ascending aorta during surgery [i.e. jet-sample from the area where the flow-jet impacts on the aortic wall and control sample from the opposite aortic wall (obtained from the aortotomy site)]. Aortopathy was quantified by means of a histological sum-score (0 to 21+) in each sample.



A significant correlation was found between histological sum-score in the jet-sample and the angle between the LV outflow axis and the aortic root (r = 0.6, P = 0.007). Moreover, there was a linear correlation between proximal aortic diameter and the angle between systolic flow-jet and ascending aortic wall (r = 0.5, P = 0.006). Logistic regression identified the angle between the LV outflow axis and the aortic root (OR 1.1, P = 0.04) and the angle between the flow-jet and the aortic wall (OR 1.2, P = 0.001) as independent predictors of an indexed proximal aortic diameter ≥22 mm/m(2).



Functional parameters of the aortic root may be used to predict the severity of aortopathy in patients with BAV stenosis, and may be useful in predicting future risk of aortic disease in such patients.
External validation of urinary PCA3-based nomograms to individually predict prostate biopsy outcome.

Prior to safely adopting risk stratification tools, their performance must be tested in an external patient cohort.



To assess accuracy and generalizability of previously reported, internally validated, prebiopsy prostate cancer antigen 3 (PCA3) gene-based nomograms when applied to a large, external, European cohort of men at risk of prostate cancer (PCa).



Biopsy data, including urinary PCA3 score, were available for 621 men at risk of PCa who were participating in a European multi-institutional study.



All patients underwent a ≥10-core prostate biopsy. Biopsy indication was based on suspicious digital rectal examination, persistently elevated prostate-specific antigen level (2.5-10 ng/ml) and/or suspicious histology (atypical small acinar proliferation of the prostate, >/= two cores affected by high-grade prostatic intraepithelial neoplasia in first set of biopsies).



PCA3 scores were assessed using the Progensa assay (Gen-Probe Inc, San Diego, CA, USA). According to the previously reported nomograms, different PCA3 score codings were used. The probability of a positive biopsy was calculated using previously published logistic regression coefficients. Predicted outcomes were compared to the actual biopsy results. Accuracy was calculated using the area under the curve as a measure of discrimination; calibration was explored graphically.



Biopsy-confirmed PCa was detected in 255 (41.1%) men. Median PCA3 score of biopsy-negative versus biopsy-positive men was 20 versus 48 in the total cohort, 17 versus 47 at initial biopsy, and 37 versus 53 at repeat biopsy (all p≤0.002). External validation of all four previously reported PCA3-based nomograms demonstrated equally high accuracy (0.73-0.75) and excellent calibration. The main limitations of the study reside in its early detection setting, referral scenario, and participation of only tertiary-care centers.



In accordance with the original publication, previously developed PCA3-based nomograms achieved high accuracy and sufficient calibration. These novel nomograms represent robust tools and are thus generalizable to European men at risk of harboring PCa. Consequently, in presence of a PCA3 score, these nomograms may be safely used to assist clinicians when prostate biopsy is contemplated.
Intravascular cooling for rapid induction of moderate hypothermia in severely head-injured patients: results of a multicenter study (IntraCool)

To evaluate the feasibility, safety and effectiveness of a new method of intravascular temperature management for inducing moderate hypothermia (MHT). Prospective, international-multicenter clinical trial conducted in four university hospitals. In a 2-year period 24 patients with severe head injury and refractory high ICP were treated with MHT (32.5°C) by intravascular methods. Seventeen were males and seven females, with a median age of 25 years (range 15–60). The median Glasgow Coma Scale upon admission was 7 (range 3–13) and the median Injury Severity Score was 22 (range 13–43). A total of 75% of patients presented a diffuse lesion in the pre-enrollment computed tomography. Median time from injury until reaching refractory high ICP was 71.5 h after injury (minimum 14 h, maximum 251 h). Twelve patients (50%) reached this situation within the first 72 h after injury. MHT was attained in a median time of 3 h. Pre-enrollment median ICP was 23.8 mmHg and was reduced to 16.8 mmHg upon reaching target temperature. At 6 months after injury, nine patients had died (37.5%), six were severely disabled (25%), two moderately disabled (8.3%) and seven had a good recovery (29.2%). Of the nine patients who died, in four the cause was rebound ICP during rewarming, one death was attributed to accidental potassium overload, two to septic shock, one to cardiac arrest of unknown origin and the ninth to a pulmonary embolism. Intravascular methods to induce MHT combined with precooling with cold saline at 4°C appear to be feasible and effective in reducing ICP in patients with high ICP refractory to first-line therapeutic measures.
Hyperglycaemic Preterm Babies Have Sex Differences in Insulin Secretion.

Hyperglycaemia is a common complication of prematurity and is associated with neonatal mortality and morbidity, yet the aetiology is incompletely understood. C-peptide has been used in adults to estimate endogenous insulin secretion due to its simple clearance kinetics.



To determine insulin secretion calculated from plasma C-peptide concentrations in hyperglycaemic preterm babies.



This is a retrospective analysis of a cohort of 41 very preterm babies with a median gestational age of 27.2 weeks (26.2-28.7) enrolled in a randomised controlled trial of tight glycaemic control when they developed hyperglycaemia (2 consecutive blood glucose concentrations, BGC, > 8.5 mmol·l(-1)). Insulin secretion was determined using a steady state analysis of a 2-compartment C-peptide kinetic model.



BGC, plasma insulin concentration, plasma C-peptide concentrations, and insulin secretion were higher at randomisation than 1-2 weeks following randomisation (p ≤ 0.02). Insulin secretion was higher in girls at 11.7 mU·l(-1)·kg(-1)·min(-1) (5.3-18.7) vs. 4.7 mU·l(-1)·kg(-1)·min(-1) (2.1-8.3; p < 0.005), with no difference in clinical characteristics, BGC, plasma insulin concentration, or nutrition between the sexes (p > 0.25). Insulin secretion was lower in samples taken during exogenous insulin delivery at 3.7 mU·l(-1)·kg(-1)·min(-1) (1.8-6.9) vs. 9.8 mU·l(-1)·kg(-1)·min(-1) (4.7-17.8; p = 0.02).



Insulin secretion was higher when babies had higher BGC, indicating that endogenous insulin secretion is sensitive to BGC. Girls had higher insulin secretion, at similar blood glucose and plasma insulin concentrations, than boys.
S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for first-line treatment of patients with metastatic colorectal cancer: a randomised, non-inferiority phase 3 trial.

Capecitabine plus oxaliplatin (CapeOX) is one of the reference doublet cytotoxic chemotherapy treatments for patients with metastatic colorectal cancer. We aimed to compare the efficacy and safety of CapeOX with that of S-1 plus oxaliplatin (SOX), a promising alternative treatment for patients with metastatic colorectal cancer.



In this open-label, multicentre, randomised phase 3 trial, we randomly assigned patients (1:1) from 11 institutions in South Korea to receive either CapeOX (capecitabine 1000 mg/m(2) twice daily on days 1-14 and oxaliplatin 130 mg/m(2) on day 1) or SOX (S-1 40 mg/m(2) twice daily on days 1-14 and oxaliplatin 130 mg/m(2) on day 1). Treatment was repeated every 3 weeks and continued for as many as nine cycles of oxaliplatin-containing chemotherapy, except in instances of disease progression, unacceptable toxicity, or a patient's refusal. Maintenance chemotherapy with S-1 or capecitabine was allowed after discontinuation of oxaliplatin. Randomisation was done with a computer-generated sequence (stratified by primary sites, previous adjuvant or neoadjuvant treatment, and the presence of measurable lesions). The primary endpoint was to show non-inferiority of SOX relative to CapeOX in terms of progression-free survival (PFS). The primary analysis was by intention to treat. 
Between May 14, 2008, and Sept 23, 2009, we randomly assigned 168 patients to receive SOX and 172 to receive CapeOX. Median PFS was 8·5 months (95% CI 7·6-9·3) in the SOX group and 6·7 months (6·2-7·1) in the CapeOX group (hazard ratio, 0·79 [95% CI 0·60-1·04]; p(non-inferiority)<0·0001, p(log-rank)=0·09). The upper limit of the CI was below the predefined margin of 1·43, showing the non-inferiority of SOX to CapeOX. We recorded a higher incidence of grade 3-4 neutropenia (49 [29%] vs 24 [15%]), thrombocytopenia (37 [22%] vs 11 [7%]), and diarrhoea (16 [10%] vs seven [4%]) in the SOX group than in the CapeOX group. The frequency of any grade of hand-foot syndrome was greater in the CapeOX group than it was in the SOX group (51 [31%] vs 23 [14%]).



The SOX regimen could be an alternative first-line doublet chemotherapy strategy for patients with metastatic colorectal cancer. Further investigation is needed to explore its potential when used together with other targeted agents or as adjuvant chemotherapy.



Korea Healthcare Technology Research and Development Project, Ministry of Health and Welfare, South Korea.
Ventricular tachycardia in ischemic cardiomyopathy; a combined endo-epicardial ablation as the first procedure versus a stepwise approach (EPILOGUE) – study protocol for a randomized controlled trial

The role of epicardial substrate ablation of ventricular tachycardia (VT) as a first-line approach in patients with ischemic heart disease is not clearly defined. Epicardial ablation as a first-line option is standard for patients with nonischemic dilated cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy. Several nonrandomized studies, including studies on patients with ischemic heart disease, have shown that epicardial VT ablation improves outcome but this approach was often used after a failed endocardial approach. The aim of this study is to determine whether a combined endo-epicardial scar homogenization as a first-line approach will improve the outcome of VT ablation.



The EPILOGUE study is a multicenter, two-armed, nonblinded, randomized controlled trial. Patients with ischemic heart disease who are referred for VT ablation will be randomly assigned to combined endo-epicardial scar homogenization or endocardial scar homogenization only (control group). The primary outcome is recurrence of sustained VT during a 2-year follow-up. Secondary outcomes include procedural success and safety.



This study is the first randomized trial that evaluates the role of a combined endo-epicardial scar homogenization versus endocardial scar homogenization for the treatment of ischemic scar-related VT.
The effect of climatic conditions on exercise-induced bronchoconstriction in 10-12 year old students.

Exercise-induced asthma is seen following vigorous or prolonged exercise or physical exertion. It has been suggested that climatic conditions have an influence on exercise-induced asthma. Therefore, the aim of the present study was to examine the effect of two climatic conditions on exercise-induced deterioration of pulmonary function tests in 10-12 year old students. Two hundred and fifty six students were randomly chosen from two cities namely Kerman and Gorgan (128 subjects in each who were equally from both cities) including 62 girls and 66 boys of 10-12 years old. A questionnaire was used to obtain demographic information and to identify the prevalence of asthma symptoms. Each subject performed a seven-minute free run exercise with maximum effort and sufficient motivation until they reached 70-75% heart rate. Pulmonary function tests (PFT) including, forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), and maximum expiratory flow at 50% of vital capacity (MEF50) were measured before, at the beginning, and 7 and 20 min after physical activity. The prevalence of both asthma (28.12%) and exercise-induced asthma (20.31%) in Kerman students was higher than those of Gorgan students (21.09% and 17%, respectively). All PFT values declined 7 and 20 min post-exercise in both groups. Although all baselines PFT in Kerman students were higher than those of Gorgan students, the decline in PFT values in Kerman students was greater than those of Gorgan students. At 20 min post exercise, the decline in FEV1, PEF and MEF50 in Kerman students was significantly higher than those of Gorgan students (p < 0.05 to p < 0.01). The results of the present study showed that prevalence of both asthma and exercise-induced asthma in a city with dry and cool climate such as Kerman was higher than in a city with humid climate such as Gorgan. In addition, the results showed that in a humid climate, post-exercise decline in PFT values was less than in a dry climate.