nils-herrmann/clean_scirepeval huggingface dataset:
Validierung der deutschen Version des Oxford Elbow Score

Ellenbogenbeschwerden sind ein komplexes Problem mit gravierenden Konsequenzen für die Betroffenen und das Gesundheitssystem. Die deutsche Version des Oxford Elbow Score (OES) ist das erste deutschsprachige Instrument, welches spezifisch Ellenbogenbeschwerden aus der Patientenperspektive darstellen und Veränderungen des Gesundheitszustands aufzeigen kann. Das Ziel dieser Studie ist die Validierung des deutschen OES. In diesem Kontext werden dessen interne Konsistenz und Konstruktvalidität untersucht. 59 Probanden mit Ellenbogenbeschwerden füllten die deutsche Version des OES, des DASH und des SF-36 im Rahmen einer Querschnittsstudie aus. Die interne Konsistenz wurde mit Cronbachs Alpha berechnet. Zur Untersuchung der Konstruktvalidität wurden Korrelationen nach Spearman bestimmt.  Cronbachs Alpha für die Schmerz-, Funktions- und psychosoziale Subskala liegt bei 0,88, 0,81 und 0,90. Der gesamte Fragebogen verfügt über ein Cronbachs Alpha von 0,93. Die konvergente Konstruktvalidität zeigte Korrelationen der OES-Subskalen mit dem DASH von −0,84, −0,77 und −0,82 und von 0,41–0,80 mit den körperlichen Domänen des SF-36. Die divergente Konstruktvalidität zeigte Korrelationen von 0,07–0,20 zu den SF-36-Domänen „allgemeines Gesundheitsbefinden“ und „psychisches Wohlbefinden“. Der deutsche OES ist ein intern konsistentes Instrument mit guter konvergenter und divergenter Konstruktvalidität. Andere Aspekte der Validität wie Reliabilität und Änderungssensitivität sollten durch weitere Studien abgesichert werden. Elbow complaints are complex problems leading to severe consequences for affected people and the healthcare system. The German version of the Oxford Elbow Score (OES) is the first German-speaking instrument that specifically measures elbow complaints from the patient’s perspective and changes of their health status. The aim of this study is the validation of the German version of the OES. In this context the internal consistency and the construct validity were investigated. 59 patients with elbow complaints completed the German version of the OES, the DASH and the SF-36 in a cross-sectional study. The internal consistency was calculated with Cronbach’s alpha coefficients. Spearman’s correlation coefficients were used to confirm construct validity. Cronbach’s alpha for pain, function and psychological subscales was 0.88, 0.81 and 0.90, respectively. The whole questionnaire presents a Cronbach’s alpha value of 0.93. Convergent construct validity was confirmed with correlation coefficients containing values of −0.84, −0.77 and −0.82 compared to DASH and values ranging from 0.41 to 0.80 compared with the physical domains of the SF-36. The divergent construct validity presented values ranging from 0.07 to 0.20 with the SF-36 domains of “general health perception” and “mental health”. The German OES is an internal consistent instrument with good convergent and divergent construct validity. Other aspects of the validity, the reliability and the responsiveness should be confirmed through further studies.
The Effect of Order of Testing in Functional Performance in Persons with and Without Chronic Back Pain

Batteries of individually standardized physical and functional tests are commonly used to assess persons with chronic back pain disability. The order of testing may affect performance on later tests. One hundred and fifty patients with>3 months of back pain disability underwent a multidisciplinary Spine Team Assessment involving Physical Therapy, Occupational Therapy, Pain Psychology, and Vocational Rehabilitation Counselor assessments at a university spine clinic. Seventeen back healthy volunteers performed the physical component of the assessment. For the volunteers the order of testing was randomized to OT tests first or PT test first, with 0.5 h rest between the tests. For patients the order of testing was arbitrarily set by an alternating schedule, with 1 h psychological testing between the two components. For both the patients and volunteers, among the 14 test components, there was no significant difference (p > 0.05) in performance with order of testing. This held true for the subgroup of patients who put out good cardiac effort. Volunteers performed better than patients on all individual tests (p < 0.001). Results suggest that the order of physical testing during a Spine Team Assessment does not affect test performance either in chronic low back disabled patients or in volunteers.
New-onset heart failure due to heart muscle disease in childhood: a prospective study in the United kingdom and Ireland.

We undertook the first prospective, national, multicenter study to describe the incidence and outcome of heart muscle disease-induced heart failure in children.



Data were collected on patients admitted to a hospital through 2003 with a first episode of heart failure in the absence of congenital heart disease. All 17 pediatric cardiac centers in the United Kingdom and Ireland participated. Follow-up data were obtained to a minimum of 1 year. The incidence was 0.87/100,000 population <16 years (n=104; 53 girls; 95% confidence interval 0.71 to 1.05 per 100,000). Median age at presentation was 1 year, with 82% in New York Heart Association class III to IV. Causes of heart failure included dilated cardiomyopathy (50 idiopathic, 8 familial), probable myocarditis (23), occult arrhythmia (7), anthracycline toxicity (5), metabolic disease (4), left ventricular noncompaction (3), and other (4). Overall 1-year survival was 82%, and event (death or transplantation)-free survival was 66%. Regression analysis showed older age and reduced systolic function on admission echocardiogram increased the event risk. Only 8% of event-free survivors (n=69) remained in New York Heart Association class III to IV, but 35 required readmission during the study period, and all but 8 remained on medication.



This first national prospective study of new-onset heart failure in children has shown an incidence of 0.87/100,000. Multivariable analysis of survival data indicates a better outcome for younger children and for those with better systolic function at presentation, but overall, one third of children die or require transplantation within 1 year of presentation.
Stroke units and general wards in seven Italian regions: the PROSIT Study

PROSIT (research PROject on Stroke services in ITaly) is a study performed to evaluate number and work organisation of acute in-hospital services (stroke units, SU) and general wards (GW), in seven Italian regions (Liguria, Lombardia, Lazio, Veneto, Friuli-Venezia-Giulia, Emilia Romagna, Toscana), which have a population of 29 169 811 inhabitants and a relative ratio of 225/100 000 hospitalisations for acute stroke. The registers of hospital discharges from January to December 1999 were looked at identify to services recording at least 50 acute stroke discharges (DRG14) per year. A structured questionnaire investigating stroke service characteristics was submitted to the doctors in charge of the identified units and completed in the presence of an external observer between October 2000 and February 2001. SUs were identified as units with dedicated beds (at least 80%) and team (at least 1 physician and 1 nurse) for acute stroke patients. SUs are still uncommon in many Italian regions because only, as 7% of the wards evaluated were found to be a SU and less than 10% of acute stroke patients resulted to be admitted to a SU. Great heterogeneity was found between the different regions surveyed. The most striking differences between SUs and GW were related to the staffing and care organisation, with higher number/patients ratio in SUs as far as physicians and nurses, speech therapists and social workers were concerned.
Prognostic impact of WT1 mutations in cytogenetically normal acute myeloid leukemia: a study of the German-Austrian AML Study Group.

To evaluate the incidence and clinical impact of WT1 gene mutations in younger adult patients with cytogenetically normal acute myeloid leukemia (CN-AML), sequencing of the complete coding region was performed in diagnostic samples from 617 patients who were treated on 3 German-Austrian AML Study Group protocols. WT1 mutations were identified in 78 (12.6%) of the 617 patients; mutations clustered in exon 7 (54 of 78) and exon 9 (13 of 78), but also occurred in exons 1, 2, 3, and 8. WT1 mutations were significantly associated with younger age, higher serum lactate dehydrogenase levels, higher blood blast counts, and the additional presence of FLT3-ITD (P < .001) and CEBPA mutations (P = .004). There was no difference in relapse-free survival and overall survival between patients with (WT1(mut)) or without WT1 mutations. Subset analysis showed that patients with the genotype WT1(mut)/FLT3-ITD(pos) had a lower complete remission rate (P = .003) and an inferior relapse-free survival (P = .006) and overall survival (P < .001) compared with those with the genotype WT1(mut)/FLT3-ITD(neg). In conclusion, in our large cohort of younger adults with CN-AML, WT1 mutation as a single molecular marker did not impact on outcome. However, our data suggest a negative impact of the genotype WT1(mut)/FLT3-ITD(pos).
Prospective comparative study of efficacy and toxicity of netilmicin and amikacin.

Eighty patients were treated with either amikacin or netilmicin in a prospective randomized study of serious gram-negative bacillary infections, including 11 due to gentamicin-resistant pathogens. Thirty-six treated with netilmicin and 35 treated with amikacin were evaluable for efficacy or toxicity, or both. The overall groups differed significantly only in age. There were no significant differences in efficacy of the two drugs. There were no statistically significant differences at the 95% level between the netilmicin group and the amikacin group with respect to nephrotoxic reactions (38 versus 28%, respectively) or ototoxic reactions (9 versus 25%, respectively). Further comparative trials of netilmicin and other aminoglycosides appear warranted before it is widely used.
Insulin, Hyperglycemia, and Severe Retinopathy of Prematurity in Extremely Low-Birth-Weight Infants.

This study aims to determine the association between hyperglycemia, insulin therapy, and severe retinopathy of prematurity (ROP) in extremely low-birth-weight (ELBW) infants.



In this retrospective database study, we included all ELBW infants who were ≤ 32 weeks gestational age (GA). We excluded infants without any ophthalmology evaluation and infants who died before 28 days of life. A multivariable model was constructed to determine the association between hyperglycemia, insulin use, and severe ROP. We defined hyperglycemia as blood glucose (BG) > 180 mg/dL. Covariates were GA, small for GA status, discharge year, sex, Apgar score at 5 minutes, mechanical ventilation, oxygen use, bacteremia, and postnatal steroid exposure. We defined severe ROP as ROP requiring bevacizumab, cryotherapy, laser therapy, or vitrectomy. Sensitivity analysis using BG > 150 mg/dL and > 200 mg/dL was performed.



A total of 24,548 infants were included; 2,547 (10%) had severe ROP. Hyperglycemia alone was not associated with severe ROP (odds ratio [OR], 0.88; 95% confidence interval [CI], 0.66-1.17). Hyperglycemia and insulin use were not associated with severe ROP (OR, 1.43; 95% CI, 0.91-2.23). BG > 150 mg/dL and insulin use were associated with severe ROP (OR, 1.34; 95% CI, 1.02-1.76).



Hyperglycemia alone was not associated with severe ROP in ELBW infants. However, we did observe a possible trend between the use of insulin and severe ROP.
Cervical conization for cervical intraepithelial neoplasia (CIN) 2 and 3 in HIV-positive women: a case-control study.

The purposes of the study were to investigate the outcomes of cervical conization for cervical intraepithelial neoplasia (CIN) 2 and 3 in HIV-positive women and age-matched HIV-negative controls and to determine whether positive margin, positive endocervical curettage, CD4 count, or viral load was associated with the persistence of CIN 2,3 or residual CIN 2,3 on the specimen from repeat excision procedure or hysterectomy.



HIV-positive women and HIV-negative controls with CIN 2,3 on cervical conization were enrolled in the study. Patients who underwent repeat conization or hysterectomy were identified, and the specimens were evaluated for residual CIN 2,3. CD4 count and viral load within 8 weeks of procedure were analyzed.



A total of 44 patients and 44 age-matched controls were identified. Persistent CIN 2,3 was diagnosed in 28 HIV-positive (63.6%) and 14 HIV-negative patients (31.8%; odds ratio [OR] = 4.7, 95% confidence interval [CI] = 1.9-11.5, p < .001). In HIV-positive women, a positive margin was associated with a higher persistence rate after cervical conization (OR = 5.3, 95% CI = 1.17-24.14, p = .03). In HIV-negative patients, positive endocervical curettage was associated with a higher persistence rate after conization (OR = 12, 95% CI = 2.24-64.23, p = .004). Of HIV-positive women, 75% had residual CIN 2,3 on the specimen from repeat procedure compared to 45.2% of controls (OR = 3.6, 95% CI = 1.3-10.6, p = .018). CD4 count or viral load was not associated with the rate of residual disease or persistence rate after cervical conization, but the lowest OR that the sample size allowed to assess with 90% power was 5.02.



HIV-positive women have a higher rate of residual disease and higher persistence rate after conization for CIN 2,3 than age-matched HIV-negative controls.
Performance on the continuous performance test in children with ADHD is associated with sleep efficiency.

To examine whether the level of sleep efficiency of children diagnosed with ADHD moderates their performance on the Continuous Performance Test (CPT) while receiving a placebo and while receiving methylphenidate (MPH).



Nightly sleep actigraphic assessment during a double-blind, placebo-controlled, crossover clinical study (1 week of 0.5 mg/kg MPH; 1 week of placebo) were obtained on 37 children between 6 and 12 years of age with a DSM-IV diagnosis of ADHD. Subjects were divided into 2 groups based on the mean sleep efficiency score during the placebo condition, with subjects above and below the mean placed in the Poor Sleep Group (PSG) and Good Sleep Group (GSG), respectively.



Vigilance testing was conducted in the laboratory; sleep was assessed in the home.



Sleep was monitored using actigraphy for 2 weeks. In addition, parents were asked to complete nightly sleep logs and a sleep questionnaire. The Conners' Continuous Performance Test (CPT) was used to assess vigilance.



Significant interaction of Sleep Group with Medication was found on 1 CPT factor.



The findings of the present study support the hypothesis that sleep moderates performance on CPT in children with ADHD while receiving placebo or MPH.
Short-term efficacy of ultrasonically nebulized hypertonic saline in cystic fibrosis.

Progressive lung disease in patients with cystic fibrosis (CF) is caused by thick secretions, which cause airway obstruction and subsequent colonization and infection by inhaled pathogenic microorganisms. Recently, recombinant human DNase has been shown to reduce the viscoelasticity of sputum in patients with cystic fibrosis and to improve lung function. Ultrasonically nebulized hypertonic saline (HS) has been demonstrated to enhance mucociliary clearance and sputum expectoration by rehydrating airway secretions, and may therefore provide a low cost alternative. We studied the changes in pulmonary function and symptoms in a group of patients with CF who have moderate to severe lung disease. The patients were evaluated following 2 weeks of treatment with HS in an open-label study. Subjects were randomly allocated to receive 10 ml of either 0.9% NaCl (IS) or 6% NaCl (HS). Twice daily, prior to physiotherapy, treatments were delivered by a portable ultrasonic nebulizer. To prevent bronchoconstriction, 600 mg of salbutamol was administered prior to the nebulized solutions. A symptom score was recorded and spirometry was performed on day 0 before therapy was started, on day 14 (the last day of therapy), and on day 28 (14 days after the last treatment with either IS or HS). Fifty-two patients (32 males), with a mean age of 16.2 (range 7-36) years completed the study. There was no difference in baseline characteristics between the two groups. Following 2 weeks of treatment, there was a significant improvement from baseline in FEV1 of 15.0 +/- 16.0% (mean +/- SD) in patients treated with HS, compared with a change of 2.8 +/- 13% in those on IS therapy (P = 0.004). Furthermore, there was a subjective improvement in the effectiveness of chest physiotherapy as reported by those using HS (P = 0.02). The treatment was well tolerated. We conclude that in patients with CF, ultrasonically nebulized hypertonic saline improves lung function in a way similar to that reported for human recombinant DNase when inhaled over a 2 week period. Nebulized saline also enhances the perception of effectiveness of chest physiotherapy.
Comparison of prasugrel and bivalirudin vs clopidogrel and heparin in patients with ST-segment elevation myocardial infarction: Design and rationale of the Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 trial.

Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI). Effective and safe adjunct antithrombotic therapy is a major determinant for short- and long-term outcomes after primary PCI. Two separate studies have shown significant benefits vs conventional therapy for 2 recently approved drugs. In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcome compared with heparin plus glycoprotein IIb/IIIa inhibitors. However, during the first 24 hours after PCI, there was an increase in stent thrombosis rates with bivalirudin. In the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis In Myocardial Infarction (TRITON-TIMI) 38 trial, prasugrel was superior to clopidogrel in patients with acute coronary syndrome with and without ST-segment elevation. The synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for STEMI patients undergoing primary PCI. However, no specifically designed studies have so far compared the combination of prasugrel plus bivalirudin with that of clopidogrel plus unfractionated heparin in these patients. The Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 study is a randomized, open-label, multicenter trial aimed to test the hypothesis that a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus unfractionated heparin in terms of net clinical outcome in STEMI patients with planned primary PCI.
Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

Clinical depression is common, debilitating and treatable; one in four people experience it during their lives. The majority of sufferers are treated in primary care and only half respond well to active treatment. Evidence suggests that folate may be a useful adjunct to antidepressant treatment: 1) patients with depression often have a functional folate deficiency; 2) the severity of such deficiency, indicated by elevated homocysteine, correlates with depression severity, 3) low folate is associated with poor antidepressant response, and 4) folate is required for the synthesis of neurotransmitters implicated in the pathogenesis and treatment of depression.



The primary objective of this trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary and secondary care. Secondary objectives are to evaluate the cost-effectiveness of folate augmentation of antidepressant treatment, investigate how the response to antidepressant treatment depends on genetic polymorphisms relevant to folate metabolism and antidepressant response, and explore whether baseline folate status can predict response to antidepressant treatment. Seven hundred and thirty patients will be recruited from North East Wales, North West Wales and Swansea. Patients with moderate to severe depression will be referred to the trial by their GP or Psychiatrist. If patients consent they will be assessed for eligibility and baseline measures will be undertaken. Blood samples will be taken to exclude patients with folate and B12 deficiency. Some of the blood taken will be used to measure homocysteine levels and for genetic analysis (with additional consent). Eligible participants will be randomised to receive 5 mg of folic acid or placebo. Patients with B12 deficiency or folate deficiency will be given appropriate treatment and will be monitored in the 'comprehensive cohort study'. Assessments will be at screening, randomisation and 3 subsequent follow-ups.



If folic acid is shown to improve the efficacy of antidepressants, then it will provide a safe, simple and cheap way of improving the treatment of depression in primary and secondary care.
Level of adenosine diphosphate receptor P2Y12 blockade during percutaneous coronary intervention predicts the extent of endothelial injury, assessed by circulating endothelial cell measurement.

We aimed to investigate whether clopidogrel-induced inhibition of platelet reactivity could reduce the level of circulating endothelial cells (CEC), reflecting the endothelial injury induced by percutaneous coronary intervention (PCI).



Clopidogrel loading dose before percutaneous coronary angioplasty (PCI) reduces platelet activation through a selective and irreversible blockade of the adenosine diphosphate (ADP) receptor P2Y(12). The impact of clopidogrel on endothelial cells has been scarcely studied.



A total of 149 patients undergoing PCI for stable angina were enrolled. Levels of CEC were measured at baseline (H0) and 6 (H6) and 24 (H24) h after the procedure using a CD146-based immunomagnetic separation assay. The CEC delta-change (CEC at H6 - CEC at H0) was analyzed according to ADP receptor P2Y(12) blockade, assessed by a vasodilator-stimulated phosphoprotein (VASP) assay after a 600-mg loading dose of clopidogrel.



The PCI induced a significant rise in CEC levels 6 h after the procedure. The CEC peak value was significantly higher in patients with high on-treatment platelet reactivity (VASP index ≥50%: 59.6 ± 27.5 cells/ml) as compared with good responders (VASP index <50%: 27 ± 22 cells/ml; p = 0.04). The endothelial injury, assessed by CEC delta-change between H6 and H0, was significantly higher in the high on-treatment platelet reactivity group compared with the good responders group (52.6 ± 25.6 vs. 18.6 ± 23.5, respectively; p < 0.001) and correlated with the VASP index (r = 0.59; p < 0.001). In multivariate analysis, VASP group, the number of diseased vessels, and the number of implanted stents independently predicted the endothelial injury (p < 0.001).



Optimal ADP receptor P2Y(12) blockade reduces the endothelial injury during PCI. This protective effect of clopidogrel on endothelial cells could add to the clinical benefit associated with this drug.