nils-herrmann/clean_scirepeval huggingface dataset:
Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation.

A substantial proportion of patients receiving fibrinolytic therapy for myocardial infarction with ST-segment elevation have inadequate reperfusion or reocclusion of the infarct-related artery, leading to an increased risk of complications and death.



We enrolled 3491 patients, 18 to 75 years of age, who presented within 12 hours after the onset of an ST-elevation myocardial infarction and randomly assigned them to receive clopidogrel (300-mg loading dose, followed by 75 mg once daily) or placebo. Patients received a fibrinolytic agent, aspirin, and when appropriate, heparin (dispensed according to body weight) and were scheduled to undergo angiography 48 to 192 hours after the start of study medication. The primary efficacy end point was a composite of an occluded infarct-related artery (defined by a Thrombolysis in Myocardial Infarction flow grade of 0 or 1) on angiography or death or recurrent myocardial infarction before angiography.



The rates of the primary efficacy end point were 21.7 percent in the placebo group and 15.0 percent in the clopidogrel group, representing an absolute reduction of 6.7 percentage points in the rate and a 36 percent reduction in the odds of the end point with clopidogrel therapy (95 percent confidence interval, 24 to 47 percent; P<0.001). By 30 days, clopidogrel therapy reduced the odds of the composite end point of death from cardiovascular causes, recurrent myocardial infarction, or recurrent ischemia leading to the need for urgent revascularization by 20 percent (from 14.1 to 11.6 percent, P=0.03). The rates of major bleeding and intracranial hemorrhage were similar in the two groups.



In patients 75 years of age or younger who have myocardial infarction with ST-segment elevation and who receive aspirin and a standard fibrinolytic regimen, the addition of clopidogrel improves the patency rate of the infarct-related artery and reduces ischemic complications.
Factors Contributing to the Preference of Korean Patients with Crohn's Disease When Selecting an Anti-Tumor Necrosis Factor Agent (CHOICE Study).

Two comparable anti-tumor necrosis factor (TNF) agents with different routes of administration (intravenous [iv] infliximab [IFX] vs subcutaneous [sc] adalimumab [ADA]) are available for patients with Crohn's disease (CD) in Korea. This study aimed to identify the preferences of Korean CD patients for a specific anti-TNF agent and the factors contributing to the decision.



A prospective survey was performed among anti-TNF-naive CD patients in 10 tertiary referral hospitals. A 16-item questionnaire addressed patient preferences and the factors contributing to the decision in favor of a particular anti-TNF agent. A logistic regression was conducted to assess predictive factors for ADA preference.



Overall, 189 patients (139 males; mean age, 32.47±11.71 years) completed the questionnaire. IFX and ADA were preferred by 63.5% (120/189) and 36.5% (69/189) of patients, respectively. The most influential reason for choosing IFX was 'doctor's presence' (68.3%, 82/120), and ADA was "easy to use" (34.8%, 24/69). Amid various clinicodemographic data, having a >60-minute travel time to the hospital was a significant independent predictive factor for ADA preference.



A large number of anti-TNF-naive Korean patients with CD preferred anti-TNFs with an iv route of administration. The reassuring effect of a doctor's presence might be the main contributing factor for this decision.
Markers of inappropriate placement in acute psychiatric inpatient care: a five hospital study

Previous researchers in the UK have measured the prevalence of the `inappropriateness' of acute adult psychiatric inpatient placements by eliciting the judgements of health professionals. We extended the methodology by identifying inpatient sub-groups with stable characteristics that were associated with elevated risk of inappropriate placement, and by calculating the level of that risk.  A 1-day census was taken in five hospitals. Using a structured instrument, consultant psychiatrists recorded judgements on current placements, recommended alternative placements and stated why alternatives had not been used. Judgements were obtained for 100% of the 261 inpatients. Risk ratios and adjusted odds ratios were calculated to identify sub-groups that were at high risk.  Eighty-eight inpatients were inappropriately placed, a point prevalence of 34% (95% CI 28–40%). Consultants recorded that services outside hospital, if available, could have supported most of these inpatients as an alternative to at least part of their hospital stay. Diagnostic rather than socio-demographic or administrative characteristics, in particular primary diagnoses of substance-related disorder, personality disorder, anxiety/stress, and schizophrenia with co-morbid substance misuse, were the strongest markers of elevated risk.  The point prevalence of inappropriate placement within the British mental health-care system is considerable. Diagnostic categories are reasonable pragmatic markers. Further research should aim to identify a strong marker of risk within the numerically large sub-group of schizophrenia without substance misuse.
Amelioration of osteopenia and hypovitaminosis D by 1alpha-hydroxyvitamin D3 in elderly patients with Parkinson's disease.

A high prevalence of hip and other fractures in elderly patients with Parkinson's disease has been linked to reduced bone mass arising from a defect of renal synthesis of 1, 25-dihydroxyvitamin D (1, 25-[OH]2D). Treatment with 1alpha-hydroxyvitamin D3 (1alpha(OH)D3; an active form of vitamin D) was evaluated for maintaining bone mass and reducing the incidence of hip and other nonvertebral fractures in patients with Parkinson's disease.



In a double blind, randomised trial, 86 elderly patients with Parkinson's disease (mean Hoehn and Yahr stage, 3; mean age 70.6 years) were randomised to receive either 1 microg 1alpha(OH)D3 daily (treatment group, n=43) or a placebo (n=43) for 18 months. Bone mineral densities in the second metacarpals were determined by computed radiographic densitometry. Serum bone turnover indices were measured serially, and incidence of nonvertebral fractures was recorded.



Bone mineral densities decreased 1.2% in the treatment group compared with 6.7% in the placebo group during 18 months (p<0.0001). At baseline in both groups, the serum concentration of 1, 25-[OH]2D was reduced. Parathyroid hormone was abnormally increased in 15 patients (17%) and correlated negatively with serum 25-hydroxyvitamin D, indicating compensatory hyperparathyroidism. Eight patients sustained fractures (six at the hip and two at other sites) in the placebo group, and one hip fracture occurred among treated patients (odds ratio 9.8; p=0.0028).



By increasing serum 1, 25-[OH]2D concentrations, treatment with 1alpha(OH)D3 can reduce the risk of hip and other non-vertebral fractures in osteoporotic elderly patients with Parkinson's disease by slowing the loss of bone mineral densities.
Sofosbuvir plus simeprevir treatment of recurrent genotype 1 hepatitis C after liver transplant.

Patients with recurrent hepatitis C (HCV) infection post-liver transplant can be difficult to treat safely and effectively. A prior (COSMOS) study in patients with non-transplant HCV, using sofosbuvir plus simeprevir, had high efficacy and tolerability in treating patients with HCV genotype 1, even prior non-responders to interferon therapy and those with cirrhosis. Our aim was to evaluate the efficacy of sofosbuvir and simeprevir in patients with genotype 1 HCV post-liver transplant.



In this prospective, observational study, patients received sofosbuvir 400 mg plus simeprevir 150 mg daily for 12 wk without ribavirin. The primary end point was a sustained virologic response 12 wk after the end of therapy.



Forty-two patients completed the treatment. Twenty-six percent started the treatment ≤ 6 months post-liver transplant. Nineteen percent of the included patients had cirrhosis, 14% with decompensation. At week 4 on the treatment, 21% of patients had detectable virus but at the end of the treatment, 100% were undetectable. Twelve weeks after the end of the treatment, 95% of the patients had undetectable hepatitis C. The regimen was generally well tolerated.



The oral regimen of sofosbuvir plus simeprevir without ribavirin is efficacious and well tolerated in the treatment of patients with genotype 1 hepatitis C post-liver transplant.
Anaemia treatment in chronically dialysed children: a multicentre nationwide observational study.

Erythropoiesis-stimulating agents (ESAs) are applied as a standard therapy in children with anaemia in chronic kidney disease. The aim of this study was to describe the efficacy and details of ESA treatment in a population of dialysed children in Poland.



The study had a prospective observational design and was performed in 12 dialysis centres. The study group comprised 117 dialysed children with a mean age at enrolment of 165.33 (97.18-196.45) months.



Dialysed children were treated mostly with epoietin beta and darbepoietin. The mean dose of ESA was 99 (68-147) U/kg/week with a significant difference between patients on peritoneal dialysis [83 (54-115)] and haemodialysis [134 (103-186)] (p < 0.0001). The mean haemoglobin of all the time-point tests during 6 months was 10.91 ± 1.18 g/dl. The efficacy of anaemia treatment was unsatisfactory in 52% of subjects. In multivariate analysis, initial haemoglobin level <10 g/l, any infection, younger age at first dialysis, malnutrition and inadequate ESA dosage remained significant predictors of anaemia.



The study revealed that anaemia treatment in Polish children is unsatisfactory. Late commencement of the treatment, inadequate dosing, malnutrition and infections could constitute risk factors for therapy failure.
Deep Venous Thrombosis Short-and Long-Term Results After Thrombolytic Treatment of Deep Venous Thrombosis

The goal of this study was to assess the shortand long-term efficacy of different thrombolytic therapy regimens in patients with leg or pelvic deep venous thrombosis (DVT).  It is unclear whether locoregional or systemic thrombolysis is superior in treating acute leg DVT or even whether lysis is more effective than anticoagulation therapy in preventing postthrombotic syndrome.  A total of 250 patients averaging 40 years of age with acute DVT were randomized into five groups to receive full heparinization (1,000 IU/h) and compression treatment, with four groups also administered locoregional tissue plasminogen activator (20 mg/day) or urokinase (100,000 IU/day) or systemic streptokinase (3,000,000 IU daily) or urokinase (5,000,000 IU daily). All groups then received anticoagulation and compression treatment for one year. Primary efficacy criteria included the change after one year in the number of closed vein segments and the occurrence of postthrombotic syndrome.  Systemic thrombolytic therapy significantly reduced the number of closed vein segments after 12 months in patients with acute DVT compared with conventional treatment (p , 0.05). Postthrombotic syndrome also occurred with less frequency in systemically treated patients versus controls (p , 0.001). High-dose thrombolysis led to better rates of complete recanalization after seven days (p , 0.01) than locoregional lysis. However, 12 patients receiving thrombolysis (9 systemic, 3 local) suffered major bleeding complications; 9 patients on systemic treatment developed pulmonary emboli.  Systemic thrombolytic treatment for acute DVT achieved a significantly better shortand long-term clinical outcome than conventional heparin/anticoagulation therapy but at the expense of a serious increase in major bleeding and pulmonary emboli. Given the inherent risks for such serious complications, systemic thrombolysis, although effective, should be used selectively in limb-threatening thrombotic situations. (
Effect of a platelet activating factor antagonist, WEB 2086, on allergen induced asthmatic responses.

Platelet activating factor (PAF) has been implicated in the pathogenesis of airway hyperresponsiveness in asthma. The purpose of this study was to evaluate the effects of a selective PAF antagonist (WEB 2086), given in doses known to antagonise the effects of inhaled PAF in human subjects, on allergen induced early and late asthmatic responses and on airway hyperresponsiveness.



Eight atopic, mildly asthmatic subjects were studied during a screening period and two treatment periods. During the screening period subjects inhaled an allergen to which they were known to be sensitised and the response was measured as the fall in the forced expired volume in one second (FEV1) to show the presence of early (0-1 h) and late (3-7 h) asthmatic responses. On another day the subjects inhaled allergen diluent. During the treatment periods subjects inhaled allergen after one week's pretreatment with WEB 2086 (100 mg three times a day) or placebo administered in a randomised, double blind, crossover fashion. Histamine airway responsiveness was measured 24 hours before and 24 hours after allergen and the results were expressed as the provocative concentration causing a 20% fall in FEV1 (PC20).



The maximal early asthmatic response after allergen with placebo treatment was 18.4% (SE 4.4%) and with WEB 2086 18.9% (4.4%). The maximal late response with placebo treatment was 21.7% (5.3%) and with WEB 2086 21.2% (3.0%). The log difference (before and after allergen) in histamine PC20 was 0.35 (0.06) after placebo treatment and 0.30 (0.1) after WEB 2086.



These results indicate that one week of treatment with an orally administered PAF antagonist (WEB 2086) does not attenuate allergen induced early or late responses or airway hyperresponsiveness.
Changes in microcirculation of the trapezius muscle during a prolonged computer task

The aim of this study is to investigate if there is a change in oxygen saturation and blood flow in the different parts of the trapezius muscle in office workers with and without trapezius myalgia during a standardized computer task. Twenty right-handed office workers participated; ten were recruited based on pain in the trapezius and ten as matching controls. Subjects performed a combination of typing and mousing tasks for 60 min at a standardized workstation. Muscle tissue oxygenation and blood flow data were collected from the upper trapezius (UT), the middle trapezius (MT) and the lower trapezius (LT), both on the left and right side at seven moments (at baseline and every tenth minute during the 1-h typing task) by use of the oxygen to see device. In all three parts of the trapezius muscle, the oxygen saturation and blood flow decreased significantly over time in a similar pattern (p < 0.001). Oxygenation of the left and right UT was significantly higher compared to the other muscle parts (p < 0.001). Oxygen saturation for the MT was significantly lower in the cases compared to the control group (p = 0.027). Blood flow of the UT on the right side was significantly lower than the blood flow on the left side (p = 0.026). The main finding of this study was that 1 h of combined workstation tasks resulted in decreased oxygen saturation and blood flow in all three parts of the trapezius muscle. Future research should focus on the influence of intervention strategies on these parameters.
Increased cardiac electrical instability concomitant with pacing induced repolarisation abnormalities.

The relation between the occurrence of repolarisation abnormalities after right ventricular pacing and spontaneous arrhythmias was investigated in 16 patients in whom the sick sinus syndrome was suspected. All patients had normal QRS complexes and T waves in the electrocardiogram before pacing and required atrial stimulation and His bundle recording for diagnostic purposes. Patients were randomised into a study group or a control group. In the eight patients in the study group right ventricular pacing was performed for 12 hours, and was followed by inversion of the T wave in surface leads II, III, aVF, and V2-V5 and lengthening of the QTc interval. The frequency and complexity of ventricular arrhythmias increased after pacing in six patients who had ventricular extrasystoles in the baseline Holter recording. As the configuration of the T wave became normal the frequency of ventricular extrasystoles returned to baseline values. In the control group of eight patients ventricular pacing was not performed after the electrophysiological study and no changes were seen in T wave configuration and in the frequency of spontaneous arrhythmias. These results suggest that the post-pacing repolarisation abnormalities reflect abnormal electrical properties of the ventricle and that in some cases they lead to increased electrical instability.
Positive effect of removal of subchondral bone plate for cemented acetabular component fixation in total hip arthroplasty: a randomised RSA study with ten-year follow-up.

We hypothesised that the removal of the subchondral bone plate (SCBP) for cemented acetabular component fixation in total hip arthroplasty (THA) offers advantages over retention by improving the cement-bone interface, without jeopardising implant stability. We have previously published two-year follow-up data of a randomised controlled trial (RCT), in which 50 patients with primary osteoarthritis were randomised to either retention or removal of the SCBP. The mean age of the retention group (n = 25, 13 males) was 70.0 years (sd 6.8). The mean age in the removal group (n = 25, 16 males) was 70.3 years (sd 7.9). Now we have followed up the patients at six (retention group, n = 21; removal group, n = 20) and ten years (retention group: n = 17, removal group: n = 18), administering clinical outcome questionnaires and radiostereometric analysis (RSA), and determining the presence of radiolucent lines (RLLs) on conventional radiographs. RSA demonstrated similar translation and rotation patterns up to six years. Between six and ten years, proximal acetabular component migration and changes of inclination were larger in the retention group, although the mean differences did not reach statistical significance. Differences in migration were driven by two patients in the SCBP retention group with extensive migration versus none in the SCBP removal group. The significant difference (p < 0.001) in the development of radiolucent lines in the retention group, previously observed at two years, increased even further during the course of follow-up (p < 0.001). While recognising SCBP removal is a more demanding technique, we conclude that, wherever possible, the SCBP should be removed to improve the cement-bone interface in order to maximise acetabular component stability and longevity.
Circulating Kidney Injury Molecule-1 Levels in Acute Heart Failure: Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure).

This study sought to determine the relationship of KIM-1 levels with adverse clinical outcomes in acute decompensated heart failure (ADHF).



Kidney injury molecule (KIM)-1 is a biomarker expressed by the nephron in acute tubular injury, and is a sensitive and specific marker for early acute kidney injury. Although commonly measured in urine, KIM-1 levels are also detectable in plasma, but its clinical and prognostic utility in ADHF is unknown.



Baseline, 48- to 72-h, and 30-day KIM-1 plasma levels were measured in 874 subjects in the ASCEND-HF ( Multivariable logistic and Cox models were used to assess the relationship between KIM-1 levels and outcomes during and after ADHF.



The median circulating KIM-1 level at baseline was 375.4 pg/ml (interquartile range [IQR]: 237.0 to 633.1 pg/ml), at 48 to 72 h was 373.7 pg/ml (IQR: 220.3 to 640.5 pg/ml), and at 30 days was 382.6 pg/ml (IQR: 236.5 to 638.0 pg/ml). There were no associations between KIM-1 levels and any 30-day outcomes. In univariable analysis, both baseline and follow-up KIM-1 were associated with greater 180-day mortality risk. However, after adjusting for blood urea nitrogen or creatinine in addition to established risk predictors from ASCEND-HF, higher KIM-1 at all time points during hospitalization was not associated with in-hospital or post-discharge outcomes (all p > 0.05), but KIM-1 levels measured at 30 days were associated independently with 180-day mortality (hazard ratio: 1.49; p = 0.04).



In our study cohort, circulating KIM-1 at baseline and during hospitalization was not associated with adverse clinical outcomes in ADHF after adjusting for standard indices of kidney function.
Validation of the revised injury severity classification score in patients with moderate-to-severe traumatic brain injury.

By analysing risk-adjusted mortality ratios, weaknesses in the process of care might be identified. Traumatic brain injury (TBI) is the main cause of death in trauma, and thus it is crucial that trauma prediction models are valid for TBI patients. Accordingly, we assessed the validity of the RISC score in TBI patients by internal and external validation analyses.



Patients with moderate-to-severe TBI admitted to the TraumaRegister DGU® (TR-DGU) and the trauma registry of Helsinki University Hospital (TR-THEL) in 2006-2011 were included in this retrospective open cohort study. Definition of moderate-to-severe TBI was head abbreviated injury scale of 3 or higher. Subgroup analysis for patients with isolated and polytrauma TBI was performed. The performance of the RISC score was evaluated by assessing its discrimination (area under the curve, AUC) and calibration (Hosmer-Lemeshow [H-L] test).



Among the 9106 and 809 patients with moderate-to-severe TBI admitted to TR-DGU and TR-THEL, unadjusted mortality was 26% and 23%, respectively. Internal and external validation of the RISC score showed good discrimination (TR-DGU AUC 0.89, 95% confidence interval [CI] 0.88-0.90 and TR-THEL AUC 0.84, 95% CI 0.81-0.87), but poor calibration (p<0.001) in patients with moderate-to-severe TBI. Subgroup analysis found the discrimination only to be modest in isolated TBI (AUC 0.76) and calibration to be particularly poor in polytrauma TBI (TR-DGU H-L=4356, p<0.001; TR-THEL H-L 112, p<0.001).



The RISC score was found to be of limited predictive value in patients with moderate-to-severe TBI. A new general trauma scoring system that includes TBI specific prognostic factors is warranted.