nils-herrmann/clean_scirepeval huggingface dataset:
The role of fondaparinux as an adjunct to thrombolytic therapy in acute myocardial infarction: a subgroup analysis of the OASIS-6 trial.

No antithrombotic therapy has been shown to reduce mortality when used with thrombolytics in acute myocardial infarction (AMI). In the OASIS-6 trial, fondaparinux significantly reduced mortality and reinfarction without increasing bleeding in 12 092 patients with acute ST elevation MI.



We report the results of a subgroup analysis in the 5436 patients (45%) receiving thrombolytics. According to local practice, 4415 patients did not have an indication for unfractionated heparin (stratum 1) and 1021 did (stratum 2). Fondaparinux reduced the primary study outcome of death or MI at 30 days [Hazard ratio (HR) 0.79, 95% confidence interval (CI) 0.68-0.92] with consistent reductions in both mortality (HR and CI) and reinfarction (HR and CI). There was a non-significantly lower rate of stroke (HR 0.77, CI 0.48-1.25). The risk of severe bleeding was significantly reduced (HR 0.62, CI 0.40-0.94), and thus the balance of benefit and risk (death, MI and severe haemorrhage) was clearly reduced by fondaparinux (HR 0.77, 95% CI 0.67-0.90). Results were consistent in the two strata, by the different types of thrombolytics and across various time intervals from symptom onset to treatment.



In STEMI patients treated with thrombolytic agents (predominantly streptokinase), fondaparinux significantly reduced the risk of death, re-MI and severe bleeds.
Improving quality improvement using achievable benchmarks for physician feedback: a randomized controlled trial.

Performance feedback and benchmarking, common tools for health care improvement, are rarely studied in randomized trials. Achievable Benchmarks of Care (ABCs) are standards of excellence attained by top performers in a peer group and are easily and reproducibly calculated from existing performance data.



To evaluate the effectiveness of using achievable benchmarks to enhance typical physician performance feedback and improve care.



Group-randomized controlled trial conducted in December 1996, with follow-up through 1998.



Seventy community physicians and 2978 fee-for-service Medicare patients with diabetes mellitus who were part of the Ambulatory Care Quality Improvement Project in Alabama.



Physicians were randomly assigned to receive a multimodal improvement intervention, including chart review and physician-specific feedback (comparison group; n = 35) or an identical intervention plus achievable benchmark feedback (experimental group; n = 35).



Preintervention (1994-1995) to postintervention (1997-1998) changes in the proportion of patients receiving influenza vaccination; foot examination; and each of 3 blood tests measuring glucose control, cholesterol level, and triglyceride level, compared between the 2 groups.



The proportion of patients who received influenza vaccine improved from 40% to 58% in the experimental group (P<.001) vs from 40% to 46% in the comparison group (P =.02). Odds ratios (ORs) for patients of achievable benchmark physicians vs comparison physicians who received appropriate care after the intervention, adjusted for preintervention care and nesting of patients within physicians, were 1.57 (95% confidence interval [CI], 1.26-1.96) for influenza vaccination, 1.33 (95% CI, 1.05-1.69) for foot examination, and 1.33 (95% CI, 1.04-1.69) for long-term glucose control measurement. For serum cholesterol and triglycerides, the achievable benchmark effect was statistically significant only after additional adjustment for physician characteristics (OR, 1.40 [95% CI, 1.08-1.82] and OR, 1.40 [95% CI, 1.09-1.79], respectively).



Use of achievable benchmarks significantly enhances the effectiveness of physician performance feedback in the setting of a multimodal quality improvement intervention.
Impact of soluble fms-like tyrosine kinase-1 and placental growth factor serum levels for risk stratification and early diagnosis in patients with suspected acute myocardial infarction.

Angiogenic factors play an important role in the development of atherosclerosis and show pronounced changes during acute myocardial infarction (AMI). We analysed the impact of placental growth factor (PlGF) and its endogen opponent, soluble fms-like tyrosine kinase-1 (sFlt-1), on clinical outcome and the early diagnosis of AMI.



This multicentre study enrolled patients presenting with symptoms suggestive of AMI. The final diagnosis was adjudicated by two independent physicians. Levels of sFlt-1 and PlGF were compared with results of a standard troponin T and a novel high-sensitive troponin (hsTnT) assay. Of the 763 patients enrolled, 132 were diagnosed with AMI. Multivariable Cox regression analysis demonstrated sFlt-1 >84 ng/L [hazard ratios (HR) 2.6, 95% confidence intervals (CI) 1.2-5.4, P=0.01] and PlGF >20 ng/L (HR 3.6, 95% CI 1.3-10.4, P=0.02) as predictors for mortality during 1-year follow-up, independent from information provided by troponin T and N-terminal pro-B-type natriuretic peptide (NT-proBNP). However, only sFlt-1 persisted as independent predictor for mortality when analysed together with hsTnT and NT-proBNP, and after adjusting for significant clinical parameters. For the diagnosis of AMI, the combination of troponin T and sFlt-1 improved the performance of troponin T alone and led to a negative predictive value of 98.3% already at time of presentation. However, sFlt-1 and PlGF added only limited diagnostic information when used together with hsTnT.



Only sFlt-1 but not PlGF provides overall independent prognostic information in patients presenting with symptoms suggestive of AMI. After the introduction of hsTnT in clinical routine, sFlt-1 and PlGF can only add limited diagnostic information for the detection or exclusion of AMI.
The Impact of Cardiac Diseases during Pregnancy on Severe Maternal Morbidity and Mortality in Brazil.

To evaluate maternal heart disease as a cause or complicating factor for severe morbidity in the setting of the Brazilian Network for Surveillance of Severe Maternal Morbidity.



Secondary data analysis of this multicenter cross-sectional study was implemented in 27 referral obstetric units in Brazil. From July 2009 to June 2010, a prospective surveillance was conducted among all delivery hospitalizations to identify cases of severe maternal morbidity (SMM), including Potentially Life-Threatening Conditions (PLTC) and Maternal Near Miss (MNM), using the new criteria established by the WHO. The variables studied included: sociodemographic characteristics, clinical and obstetric history of the women; perinatal outcome and the occurrence of maternal outcomes (PLTC, MNM, MD) between groups of cardiac and non-cardiac patients. Only heart conditions with hemodynamic impact characterizing severity of maternal morbidity were considered. 9555 women were included in the Network with severe pregnancy-related complications: 770 maternal near miss cases and 140 maternal death cases. A total of 293 (3.6%) cases were related to heart disease and the condition was known before pregnancy in 82.6% of cases. Maternal near miss occurred in 15% of cardiac disease patients (most due to clinical-surgical causes, p<0.001) and 7.7% of non-cardiac patients (hemorrhagic and hypertensive causes, p<0.001). Maternal death occurred in 4.8% of cardiac patients and in 1.2% of non-cardiac patients, respectively.



In this study, heart disease was significantly associated with a higher occurrence of severe maternal outcomes, including maternal death and maternal near miss, among women presenting with any severe maternal morbidity.
Treatment as long-term prevention: sustained reduction in HIV sexual transmission risk with use of antiretroviral therapy in rural Uganda.

Suppressive antiretroviral therapy (ART) substantially decreases HIV transmission in clinical research settings. We sought to measure the frequency and correlates of periods of transmission risk among individuals taking ART during multiple years of observation in rural, southwestern Uganda.



Observational cohort study.



We collected sexual behavior and viral load data in a Ugandan cohort of people living with HIV/AIDS from the time of ART initiation. We defined each 90-day visit as a potential transmission period if HIV-1 RNA was more than 400 copies/ml and the participant reported sexual transmission risk behavior, defined as unprotected sexual contact with at least 1 HIV-uninfected partners or partners of unknown serostatus in the prior 90 days.



We evaluated data from 463 individuals on ART over a median 3.5 years of observation and 5293 total study visits. During that time, over half (259, 56%) had detectable viremia or reported sexual transmission risk behavior at least once. However, only 23 (5%) had both simultaneously, at 28 (<1%) of all visits. Transmission sexual behavior was reported at 6% of visits with detectable viremia. In multivariable regression modeling, correlates of transmission risk periods included younger age, lower CD4 cell count, low household asset ownership and increased internalized stigma.



Although detectable viremia and/or sexual transmission risk behavior occurred in over half of individuals, ART reduced periods of HIV transmission risk by over 90% during up to 6 years of observation time. These findings provide further support for provision of ART, along with interventions to promote long-term adherence, to reduce HIV transmission in HIV-endemic settings.
Facilitation of motor and balance recovery by thermal intervention for the paretic lower limb of acute stroke: a single-blind randomized clinical trial.

To evaluate the effectiveness of thermal stimulation accompanied by either active or passive movement added to standard rehabilitation in facilitating motor and balance function of the paretic leg of acute stroke.



Pilot, observer-blinded, randomized clinical trial.



Department of rehabilitation medicine in a general hospital.



Thirty-six patients were enrolled within four weeks of the onset of a stroke causing moderate to severe leg paresis (Brunnstrom stage ≤III).



Patients were randomly assigned to thermal (standard rehabilitation plus approximately 30-40 minutes of thermal stimulation therapy daily for six weeks) and control (standard rehabilitation only) groups.



Fugl-Meyer lower extremity score, Medical Research Council scale for lower extremity, Modified Motor Assessment Scale, Postural Assessment Scale for Stroke Patients Trunk Control, Berg Balance Scale, Functional Ambulation Classification and Modified Ashworth Scale.



Patients in the thermal group experienced significantly better median scores for Fugl-Meyer lower extremity (14.0; interquartile range, 10.5-15.5), Medical Research Council scale for lower extremity (6.0; 4.0-7.0), Modified Motor Assessment Scale (16.0; 12.5-18.5), Berg Balance Scale (28.0; 20.5-33.5), and Functional Ambulation Classification (2.0; 2.0-2.0) (all P < 0.05). The thermal group also had more independent walkers (15/17; 88.2%) than the control group (9/16; 56.3%) after six weeks (P = 0.06). No adverse effect occurred.



Thermal stimulation accompanied by either manual facilitation or encouragement for active participation of the paretic lower limb may be an effective promising supplementary treatment for the early-phase rehabilitation of moderate to severe stroke that warrants additional study.
Longitudinal validation of the Test for Respiratory and Asthma Control in Kids in pediatric practices.

The 5-item, caregiver-completed Test for Respiratory and Asthma Control in Kids (TRACK) was developed and validated primarily in asthma-specialist practices to monitor respiratory control in preschool-aged children. This longitudinal study in children treated by pediatricians evaluated the responsiveness of TRACK to changes in respiratory- and asthma-control status over time and further assessed TRACK's reliability and validity.



Caregivers of children younger than 5 years with symptoms consistent with asthma within the past year (N = 438) completed TRACK at 2 clinic visits separated by 4 to 6 weeks. Physicians were blinded to caregiver assessment, completed a guidelines-based respiratory-control survey at both visits, and were asked whether the visit resulted in a change in therapy. Responsiveness of TRACK to change in respiratory-control status over time was evaluated; reliability and discriminant validity were assessed.



Mean changes in TRACK scores from the initial to follow-up visits differed in the expected direction in subsets of children whose clinical status improved, remained unchanged, or worsened based on physicians' and caregivers' assessments (P < .001). Mean TRACK scores also differed significantly (P < .001) across patient subsets, with lower scores (indicating poorer control) in children classified as very poorly controlled, in those who required a step-up in therapy, and in those who had 4 or more episodes or attacks of wheezing, coughing, or shortness of breath per week in the past 3 months.



The present study extends the validity and reliability of TRACK by demonstrating its responsiveness to change in respiratory-control status over time in preschool-aged children with symptoms consistent with asthma.
Group sequential testing of the predictive accuracy of a continuous biomarker with unknown prevalence.

Group sequential testing procedures have been proposed as an approach to conserving resources in biomarker validation studies. Previously, we derived the asymptotic properties of the sequential empirical positive predictive value (PPV) and negative predictive value (NPV) curves, which summarize the predictive accuracy of a continuous marker, under case-control sampling. A limitation of this approach is that the prevalence cannot be estimated from a case-control study and must be assumed known. In this paper, we consider group sequential testing of the predictive accuracy of a continuous biomarker with unknown prevalence. First, we develop asymptotic theory for the sequential empirical PPV and NPV curves when the prevalence must be estimated, rather than assumed known in a case-control study. We then discuss how our results can be combined with standard group sequential methods to develop group sequential testing procedures and bias-adjusted estimators for the PPV and NPV curve. The small sample properties of the proposed group sequential testing procedures and estimators are evaluated by simulation, and we illustrate our approach in the context of a study to validate a novel biomarker for prostate cancer.
Body Composition Indices and Single and Clustered Cardiovascular Disease Risk Factors in Adolescents: Providing Clinical-Based Cut-Points.

The aims of the present study in adolescents were 1) to examine how various body composition-screening tests relate to single and clustered cardiovascular disease (CVD) risk factors, 2) to examine how lean mass and body fatness (independently of each other) relate to clustered CVD risk factors, and 3) to calculate specific thresholds for body composition indices associated with an unhealthier clustered CVD risk. We measured 1089 European adolescents (46.7% boys, 12.5-17.49years) in 2006-2007. CVD risk factors included: systolic blood pressure, maximum oxygen uptake, homeostasis model assessment, C-reactive protein (n=748), total cholesterol/high density lipoprotein cholesterol and triglycerides. Body composition indices included: height, body mass index (BMI), lean mass, the sum of four skinfolds, central/peripheral skinfolds, waist circumference (WC), waist-to-height ratio (WHtR) and waist-to-hip ratio (WHR). Most body composition indices are associated with single CVD risk factors. The sum of four skinfolds, WHtR, BMI, WC and lean mass are strong and positively associated with clustered CVD risk. Interestingly, lean mass is positively associated with clustered CVD risk independently of body fatness in girls. Moderate and highly accurate thresholds for the sum of four skinfolds, WHtR, BMI, WC and lean mass are associated with an unhealthier clustered CVD risk (all AUC>0.773). In conclusion, our results support an association between most of the assessed body composition indices and single and clustered CVD risk factors. In addition, lean mass (independent of body fatness) is positively associated with clustered CVD risk in girls, which is a novel finding that helps to understand why an index such as BMI is a good index of CVD risk but a bad index of adiposity. Moderate to highly accurate thresholds for body composition indices associated with a healthier clustered CVD risk were found. Further studies with a longitudinal design are needed to confirm these findings.
Examining patients' and other group members' agreement about their alliance to the group as a whole and changes in patient symptoms using response surface analysis.

There is a lack of research examining patients' and other group members' agreement about their therapeutic alliance. In the present study, the person-group (P-G) fit model was adopted to predict that the group member symptom reduction will be greater when the group member's and the other group members' perceptions of their alliance to the group-as-a-whole fit and are high. In addition, the effect of disagreement between the group member and the other group members in their perceptions of the group alliance on the individual's outcome was investigated by using response surface analysis. Thirty-two patients from 5 long-term (> 1 year) psychodynamic group treatments were studied. Participants filled out the California Psychotherapy Alliance Scale-Group (CALPAS-G; Gaston & Marmar, 1993) and the Outcome Questionnaire-45 (OQ-45; Lambert et al., 1996) monthly over the course of group treatment until termination. As hypothesized, patient's symptom reduction was greater when there was agreement between the group member and the other group members that their alliance to the group as a whole was strong. Contrary to the authors' hypothesis, a lack agreement on alliance to the group as a whole between the patient and the other group members was not related to less symptom reduction, as lack of fit increased, symptom reduction decreased. Also contrary to the authors' hypothesis, when other group members saw their alliance to the group as a whole as stronger than did the patient, there was increased symptom reduction. The findings suggest that the P-G fit model may be a useful strategy to examine group process variables in the psychotherapy context.
Multi-institutional experience using the MammoSite radiation therapy system in the treatment of early-stage breast cancer: 2-year results.

To present a retrospective multi-institutional experience of patients treated with the MammoSite radiation therapy system (RTS).



Nine institutions participated in a pooled analysis of data evaluating the clinical experience of the MammoSite RTS for delivering accelerated partial breast irradiation. Between 2000 and 2004, 483 patients were treated with the MammoSite RTS to 34 Gy delivered in 10 fractions. Treatment parameters were analyzed to identify factors affecting outcome.



Median follow-up was 24 months (minimum of 1 year). Overall, infection was documented in 9% of patients, but the rate was only 4.8% if the catheter was placed after lumpectomy. Six patients (1.2%) experienced an in-breast failure; four failures occurred remote from the lumpectomy site (elsewhere failure). Cosmetic results were good/excellent in 91% of patients. Treatment parameters identified as significant on univariate analysis were tested in multivariate regression analysis. The closed-cavity placement technique significantly reduced the risk of infection (p = 0.0267). A skin spacing of <6 mm increased the risk of severe acute skin reaction (p = 0.0178) and telangiectasia (p = 0.0280). The use of prophylactic antibiotics reduced the risk of severe acute skin reaction (p < 0.0001). The use of multiple dwell positions reduced the risk of severe hyperpigmentation (p = 0.0278). Infection was associated with an increased risk of fair or poor overall cosmesis (p = 0.0009).



In this series of patients, the MammoSite RTS seems to have acceptable toxicity rates and cosmetic outcomes, comparable to those with whole-breast radiotherapy. On the basis of these data, the closed-cavity placement technique, use of prophylactic antibiotics, use of multiple dwell positions, and a minimum skin spacing of 6 mm seem to improve patient outcome.
Use case and task models: An integrated development methodology and its formal foundation

User Interface (UI) development methods are poorly integrated with standard software engineering practice. The differences in terms of artifacts involved, development philosophies, and lifecycles can often result in inconsistent system and UI specifications leading to duplication of effort and increased maintenance costs. To address such shortcomings, we propose an integrated development methodology for use case and task models. Use cases are generally used to capture functional requirements whereas task models specify the detailed user interactions with the UI. Our methodology can assist practitioners in developing software processes which allow these two kinds of artifacts to be developed in a codependent and integrated manner. We present our methodology, describe its semantic foundations along with a set of formal conformance relations, and introduce an automated verification tool.
Specific immunotherapy downregulates peripheral blood CD4 and CD8 T-lymphocyte activation in grass pollen-sensitive asthma.

Several lines of evidence indicate that specific immunotherapy may act by modifying the immune responses of T-lymphocytes to the antigen. To evaluate the effect of specific immunotherapy on the activation of T-lymphocytes by cluster of differentiation cells (CD4+ and CD8+) in peripheral blood, the expression of two surface activation markers, the p55 interleukin-2 receptor (CD25) and human leucocyte antigen (HLA)-DR, was studied prospectively on circulating CD4+ and CD8+ T-cell subsets in subjects with grass-pollen sensitive asthma before and after 1 yr of treatment with specific immunotherapy. Twenty five asthmatic patients with pollen sensitivity other than grass, studied out of their pollen season, served as the control group. Specific immunotherapy improved clinical indices of disease activity including symptom scores and medication use during the pollen season of the treatment year. It had a marked effect in reducing the expression of the two activation markers, CD25 and HLA-DR, in both CD4+ (p=0.002 and p=0.005, respectively) and CD8+ (p=0.01 and p=0.01, respectively) T-cell subsets, in parallel with a significant decrease in CD23 expression on B-cells (p=0.008) and in grass-specific immunoglobulin E levels (p=0.01) in the peripheral blood of subjects with grass pollen-sensitive asthma. The decreased T-lymphocyte activation observed in immunotherapy-treated subjects after the treatment year was significant (p=0.05) in comparison with the control group. These data add to the view that the efficacy of specific immunotherapy may be attributed to the downregulation of T-cell responses.