nils-herrmann/clean_scirepeval huggingface dataset:
Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial.

The superiority of the combination therapy of methotrexate (MTX) and anti-tumor necrosis factor (TNF) biological agents over anti-TNF monotherapy in MTX-naïve patients with rheumatoid arthritis (RA) has been demonstrated. We investigated the efficacy and safety of continuation versus discontinuation of MTX at the commencement of etanercept (ETN) in patients with active RA despite MTX therapy. In total, 151 patients with active RA despite treatment with MTX were randomized to either ETN 25 mg twice a week and MTX 6-8 mg/week (the E + M group) or ETN alone (the E group). Co-primary endpoints included the European League Against Rheumatism (EULAR) good response rate and the American College of Rheumatology (ACR) 50 response rate at week 24. Demographic and clinical features between groups at baseline were similar. The EULAR good response rates were significantly higher in the E + M group (52%) than in the E group (33%) at week 24 (p = 0.0001). Although the ACR50 response rate, one of the co-primary endpoints, and the ACR70 response rate at week 24 were not significantly greater in the E + M group (64 and 38%, respectively) than in the E group (48 and 26%, respectively), the ACR20 response rate was significantly greater in the E + M group (90%) than in the E group (64%; p = 0.0002). Safety profiles were similar for the groups. Thus, MTX should be continued at the commencement of ETN therapy, even in RA patients who show an inappropriate response to MTX.
Verapamil 240 SR versus verapamil 120 SR in arterial hypertension. A randomized double-blind, placebo-controlled study with 24-hour ambulatory blood pressure monitoring

Fifteen patients (6 males, 9 females), age range 36–70 years, were enrolled in a randomized, double-blind, placebo-controlled study according to a Latin-square design, with the aim of comparing 24-hour blood pressure profiles after three 15-day treatment periods with placebo, verapamil SR 120 mg (V120 SR) given twice daily (bid), and verapamil SR 240 mg (V240 SR) given once daily (od.) All of the patients were diagnosed as mild or moderate essential hypertensives on the basis of standard casual recordings. Noninvasive 24-hour ambulatory blood pressure (BP) monitoring was performed with an ICR Spacelab 5200 automatic device. In comparison with placebo, a clinically and statistically significant reduction in both systolic and diastolic BP over 24 hours was obtained with both active treatments. Comparison of the two active treatments shows that V240 SR led to a greater reduction in systolic and diastolic BP than V120 SR. No changes in heart rate were observed. Both treatments were well tolerated. In conclusion, both verapamil regimens proved to be effective and safe in treating essential hypertensives, with V240 SR giving better 24-hour BP control.
Relationship between blood pressure and outdoor temperature in a large sample of elderly individuals: the Three-City study.

Seasonal variations of blood pressure-related diseases have been described in several populations. However, few studies have examined the seasonal variations of blood pressure in the elderly, a segment of the population particularly exposed to vascular diseases. The association of blood pressure with season and outdoor temperature was examined in 8801 subjects 65 years or older from the Three-City study, a population-based longitudinal study.



Blood pressure was measured at baseline and 2-year follow-up examinations. Daily outdoor temperature measured at 11 am was provided by the local meteorological offices.



Both systolic and diastolic blood pressure values differed significantly across the 4 seasons and across the quintiles of the distribution of outdoor temperature. Systolic blood pressure decreased with increasing temperature, with an 8.0-mm Hg decrease between the lowest (< 7.9 degrees C) and the highest (> or = 21.2 degrees C) temperature quintile. Intraindividual differences in blood pressure between follow-up and baseline examinations were strongly correlated with differences in outdoor temperature. The higher the temperature at follow-up compared with baseline, the greater the decrease in blood pressure. Longitudinal changes in blood pressure according to difference in outdoor temperature were larger in subjects 80 years or older than in younger participants.



Outdoor temperature and blood pressure are strongly correlated in the elderly, especially in those 80 years or older. During periods of extreme temperatures, a careful monitoring of blood pressure and antihypertensive treatment could contribute to reducing the consequences of blood pressure variations in the elderly.
T-SPOT.TB in the diagnosis of active tuberculosis among HIV-infected patients with advanced immunodeficiency.

We evaluated the performance of T-SPOT.TB (a commercial interferon gamma release assay) and its accuracy for the diagnosis of active tuberculosis (TB) among HIV-infected subjects with advanced immunodeficiency. In a clinical prospective study, we assessed the performance of T-SPOT.TB for the diagnosis of active TB in HIV-infected patients with CD4 cell counts below 350 cells/mm(3) who were naive to antiretroviral and anti-TB therapies. Results were available from 147 patients, of whom 38 (25.9%) had active TB. The majority (85%) of the participants were male, with a median age of 40 years and a median CD4 cell count of 77 cells/mm(3). T-SPOT.TB yielded 15 (10.2%) indeterminate results. The indeterminate results were not associated with CD4 cell counts. However, younger patients were more likely to have an indeterminate result (OR = 0.91 per unit increase in age, p = 0.007). After excluding the indeterminate results, the sensitivity of T-SPOT.TB for the diagnosis of active TB was 37.1% and the specificity was 88.7%. The sensitivity of the T-SPOT.TB was independent of the CD4 cell count. However, its specificity was higher when used for patients with CD4 cell counts <100 cells/mm(3) when compared to patients with CD4 cell counts ≥100 cells/mm(3) (97.9% vs. 79.6%, p = 0.008). T-SPOT.TB could not be used as a routine tool to screen for active TB among HIV-infected patients with advanced immunodeficiency because of its poor performance and low sensitivity. However, it may be used as an adjunctive tool to diagnose active TB in this population due to its high specificity.
Can the pre-operative Western Ontario and McMaster score predict patient satisfaction following total hip arthroplasty?

In this study we evaluated whether pre-operative Western Ontario and McMaster Universities (WOMAC) osteoarthritis scores can predict satisfaction following total hip arthroplasty (THA). Prospective data for a cohort of patients undergoing THA from two large academic centres were collected, and pre-operative and one-year post-operative WOMAC scores and a 25-point satisfaction questionnaire were obtained for 446 patients. Satisfaction scores were dichotomised into either improvement or deterioration. Scatter plots and Spearman's rank correlation coefficient were used to describe the association between pre-operative WOMAC and one-year post-operative WOMAC scores and patient satisfaction. Satisfaction was compared using receiver operating characteristic (ROC) analysis against pre-operative, post-operative and δ WOMAC scores. We found no relationship between pre-operative WOMAC scores and one-year post-operative WOMAC or satisfaction scores, with Spearman's rank correlation coefficients of 0.16 and -0.05, respectively. The ROC analysis showed areas under the curve (AUC) of 0.54 (pre-operative WOMAC), 0.67 (post-operative WOMAC) and 0.43 (δ WOMAC), respectively, for an improvement in satisfaction. We conclude that the pre-operative WOMAC score does not predict the post-operative WOMAC score or patient satisfaction after THA, and that WOMAC scores can therefore not be used to prioritise patient care.
Vitamin K1 to slow vascular calcification in haemodialysis patients (VitaVasK trial): a rationale and study protocol.

Patients on haemodialysis (HD) exhibit increased cardiovascular mortality associated with accelerated vascular calcification (VC). VC is influenced by inhibitors such as matrix Gla protein (MGP), a protein activated in the presence of vitamin K. HD patients exhibit marked vitamin K deficiency, and supplementation with vitamin K reduces inactive MGP levels in these patients. The VitaVasK trial analyses whether vitamin K1 supplementation affects the progression of coronary and aortic calcification in HD patients.



VitaVasK is a prospective, randomized, parallel group, multicentre trial (EudraCT No. that will include 348 HD patients in an open-label, two-arm design. After baseline multi-slice computed tomography (MSCT) of the heart and thoracic aorta, patients with a coronary calcification volume score of at least 100 will be randomized to continue on standard care or to receive additional supplementation with 5 mg vitamin K1 orally thrice weekly. Treatment duration will be 18 months, and MSCT scans will be repeated after 12 and 18 months. Primary end points are the progression of thoracic aortic and coronary artery calcification (calculated as absolute changes in the volume scores at the 18-month MSCT versus the baseline MSCT). Secondary end points comprise changes in Agatston score, mitral and aortic valve calcification as well as major adverse cardiovascular events (MACE) and all-cause mortality. VitaVask also aims to record MACE and all-cause mortality in the follow-up period at 3 and 5 years after treatment initiation. This trial may lead to the identification of an inexpensive and safe treatment or prophylaxis of VC in HD patients.
[Long-term Development of Acute Tinnitus].

Aim was to assess correlations between hearing threshold and mental health measures at tinnitus onset and tinnitus severity after 6 months. Short self-report questionnaires were used to permit later use in ENT-practices.



28 patients with tinnitus of no longer than 4 weeks filled out questionnaires at inclusion (T1), and at 6 weeks (T2), 3 (T3) and 6 months (T4) after tinnitus onset. An audiogram was recorded at T1. Tinnitus loudness and sound sensitivity were assessed by numeric rating scales, tinnitus-distress was recorded with the short form of the tinnitus questionnaire. Mental health and personality factors were measured by the depressivity, anxiety and somatic severity scales of the Patient Health Questionnaire, and the resilience scale.



Tinnitus loudness and distress were stable throughout the investigation period whereas sound sensitivity decreased. Resilience did not represent a predictor for tinnitus severity after 6 months. Depressivity and hearing loss at T1 had an effect on later tinnitus loudness, while depressivity and age at T1 showed an effect on sound sensitivity and tinnitus-related distress at T4.



Stability of tinnitus severity during the 6 months after onset supports the hypothesis of early manifestation. RESULTS also support the hypothesis that later tinnitus severity is related to psychological distress and hearing impairment at onset. RESULTS suggest to use hearing aids to alleviate tinnitus loudness, and to include tools for the identification of depressive disorders at an early stage to identify patients that might benefit from psychotherapeutic interventions.
The effects of age and emotional acceptance on distress among breast cancer patients

This study examined whether emotional acceptance moderates the relationship between age and distress among breast cancer patients near the end of the first year after diagnosis. The Emotional acceptance scale and the Profile of Mood States scale were completed by 79 women with Stage II or III breast cancer. Results showed that younger women reported greater distress than older women. Those who were less accepting of their emotions also reported greater distress than those who were more accepting, regardless of age. These results suggest that emotional acceptance may be beneficial for both younger and older women facing breast cancer. Additional implications of these findings are discussed.
Hematopoietic SCT in Europe 2013: recent trends in the use of alternative donors showing more haploidentical donors but fewer cord blood transplants

A record number of 39 209 HSCT in 34 809 patients (14 950 allogeneic (43%) and 19 859 autologous (57%)) were reported by 658 centers in 48 countries to the 2013 survey. Trends include: more growth in allogeneic than in autologous HSCT, increasing use of sibling and unrelated donors and a pronounced increase in haploidentical family donors when compared with cord blood donors for those patients without a matched related or unrelated donor. Main indications were leukemias, 11 190 (32%; 96% allogeneic); lymphoid neoplasias, 19 958 (57%; 11% allogeneic); solid tumors, 1543 (4%; 4% allogeneic); and nonmalignant disorders, 1975 (6%; 91% allogeneic). In patients without a matched sibling or unrelated donor, alternative donors are used. Since 2010 there has been a marked increase of 96% in the number of transplants performed from haploidentical relatives (802 in 2010 to 1571 in 2013), whereas the number of unrelated cord blood transplants has slightly decreased (789 in 2010 to 666 in 2013). The use of donor type varies greatly throughout Europe.
Comparison of the efficacy and systemic effects of 4 mg and 8 mg formulations of salbutamol controlled release in patients with asthma

The purpose of the present study was to compare the efficacy and systemic effects of 4 mg and 8 mg doses of salbutamol controlled release (SCR) after single dosing and at steady state in patients with asthma. Fifteen asthmatic patients (Age 36 y, FEV1 85% predicted) were given SCR 4 mg and 8 mg twice daily for 7 days in a randomised double-blind cross-over design, with at least 7 days washout between treatments. There were no differences between the bronchodilator effects of 4 mg and 8 mg doses. There was no evidence of tolerance to the bronchodilator effects after chronic dosing. Morning and evening PEFR measurements also showed improvements during treatment with SCR 4 mg and SCR 8 mg, although there were no differences between the two formulations. Both doses of SCR caused significant objective tremor responses which were maintained after chronic dosing. The 8 mg dose produced a larger tremor response after single dosing, but not at steady-state. Subjective tremor occurred in 7 patients with SCR 8 mg, and in 2 patients with SCR 4 mg. There were no cardiac arrhythmias on Holter ECG monitoring. These results suggest that the 8 mg dose of SCR was no more effective than the 4 mg formulation, and was associated with more systemic adverse effects.
Motivation and patch treatment for HIV+ smokers: a randomized controlled trial.

To test the efficacy of two smoking cessation interventions in a HIV positive (HIV+) sample: standard care (SC) treatment plus nicotine replacement therapy (NRT) versus more intensive motivationally enhanced (ME) treatment plus NRT.



Randomized controlled trial.



HIV+ smoker referrals from eight immunology clinics in the northeastern United States.



A total of 444 participants enrolled in the study (mean age = 42.07 years; 63.28% male; 51.80% European American; mean cigarettes/day = 18.27).



SC participants received two brief sessions with a health educator. Those setting a quit date received self-help quitting materials and NRT. ME participants received four sessions of motivational counseling and a quit-day counseling call. All ME intervention materials were tailored to the needs of HIV+ individuals.



Biochemically verified 7-day abstinence rates at 2-month, 4-month and 6-month follow-ups.



Intent-to-treat (ITT) abstinence rates at 2-month, 4-month and 6-month follow-ups were 12%, 9% and 9%, respectively, in the ME condition, and 13%, 10% and 10%, respectively, in the SC condition, indicating no between-group differences. Among 412 participants with treatment utilization data, 6-month ITT abstinence rates were associated positively with low nicotine dependence (P = 0.02), high motivation to quit (P = 0.04) and Hispanic American race/ethnicity (P = 0.02). Adjusting for these variables, each additional NRT contact improved the odds of smoking abstinence by a third (odds ratio = 1.32, 95% confidence interval = 0.99-1.75).



Motivationally enhanced treatment plus NRT did not improve cessation rates over and above standard care treatment plus NRT in this HIV+ sample of smokers. Providers offering brief support and encouraging use of nicotine replacement may be able to help HIV+ patients to quit smoking.
Changes in implicit and explicit self-esteem following cognitive and psychodynamic therapy in social anxiety disorder.

The present investigation is the first to analyse changes in implicit and explicit self-esteem following cognitive therapy (CT) and psychodynamic therapy (PDT) in social anxiety disorder (SAD). We assessed a sub-sample of patients with SAD (n=27 per treatment group, n=12 waitlist condition) in the course of a randomized controlled trial prior to and following individual treatment or wait assessment with an Implicit Association Test and the Rosenberg Self-Esteem Scale. Both CT and PDT consisted of 25 sessions. Treatments were effective in enhancing implicit and explicit self-esteem. In CT and PDT, changes in explicit self-esteem were associated with SAD symptom change. No such relationships were found in implicit self-esteem. The results seem to indicate that both CT and PDT are effective in establishing a positive implicit and explicit self-esteem in SAD. The differential relationships of changes in implicit and explicit self-esteem to treatment effects on social phobic symptoms are discussed.
Four-hour versus 24-hour intravenous infusion of FK 506 in liver transplantation.

I N AN earlier study, intravenous (IV) FK 506 appeared to be less well tolerated than the oral drug for two reasons. 1 One was the selection of a starting IV dose that was too high. The other may have been the use of pulse infusion therapy (over 2 to 4 hours) with consequent high peak plasma concentrations. In patients with unsatisfactory liver graft function, these peak values were sustained for long periods. In the present study, we compared the perioperative use of constant IV infusion of FK 506 to 4-hour pulse infusion in a total of 238 consecutive primary liver recipients. The therapeutic efficacy and adverse effects of the drug were compared.
Neurocognition across the spectrum of mucopolysaccharidosis type I: Age, severity, and treatment.

Precise characterization of cognitive outcomes and factors that contribute to cognitive variability will enable better understanding of disease progression and treatment effects in mucopolysaccharidosis type I (MPS I). We examined the effects on cognition of phenotype, genotype, age at evaluation and first treatment, and somatic disease burden.



Sixty patients with severe MPS IH (Hurler syndrome treated with hematopoietic cell transplant and 29 with attenuated MPS I treated with enzyme replacement therapy), were studied with IQ measures, medical history, genotypes. Sixty-seven patients had volumetric MRI. Subjects were grouped by age and phenotype and MRI and compared to 96 normal controls.



Prior to hematopoietic cell transplant, MPS IH patients were all cognitively average, but post-transplant, 59% were below average, but stable. Genotype and age at HCT were associated with cognitive ability. In attenuated MPS I, 40% were below average with genotype and somatic disease burden predicting their cognitive ability. White matter volumes were associated with IQ for controls, but not for MPS I. Gray matter volumes were positively associated with IQ in controls and attenuated MPS I patients, but negatively associated in MPS IH.



Cognitive impairment, a major difficulty for many MPS I patients, is associated with genotype, age at treatment and somatic disease burden. IQ association with white matter differed from controls. Many attenuated MPS patients have significant physical and/or cognitive problems and receive insufficient support services. Results provide direction for future clinical trials and better disease management.
A Field-based Approach to Support Improved Diabetes Care in Rural States

Diabetes care is a challenge in rural areas where primary care practices are faced with limited resources, few clinical information systems, and relative isolation from education programs and diabetes centers with multispecialty teams. This report describes an effective field-based approach to support improved care for patients with diabetes in primary care practices in rural states.



A collaborative effort between diabetes prevention and control programs in Montana and Wyoming and the University of North Dakota was established to provide support to rural primary care practices for improvement in diabetes care. Field teams from each state diabetes program approached primary care practices. After assessment and orientation of office staff, a computer-based registry was established in each practice. Baseline data were collected in 1997 in Montana and in 1998 in Wyoming; follow-up occurred on July 31, 2004. Health department staff provided ongoing technical support for implementing and evaluating quality-improvement interventions.



Forty primary care practices, providing care to more than 7000 patients with diabetes, participated in this quality-improvement effort at follow-up. Of the 37 primary care practices participating in the quality-improvement program for 6 or more months at follow-up, there were significant improvements in Montana in rates of hemoglobin A1c testing, blood glucose control, low-density lipoprotein cholesterol testing, foot and dilated retinal examinations, and pneumococcal vaccinations, and there were significant improvements in pneumococcal vaccinations in Wyoming.



A field-based approach in which individual practices maintain and use their own registries for both clinical care and quality improvement with ongoing support is a sustainable and an effective strategy for improving diabetes care for rural populations.
The effects of interleukin-1 therapy on peripheral blood granulocyte function in humans

During a phase I trial of interleukin-1α (IL-1α) in patients with ovarian carcinomas, the effects of this treatment on blood granulocyte respiratory burst and locomotive responses were examined. Differences in baseline granulocyte function in patients as well as dose-related effects of IL-1α treatment were observed. Patients enrolled early in the trial (low-dose patients) had significantly lower locomotive responses before treatment than their paired controls; these low responses normalized after 5 days of continuous-infusion IL-1α treatment. Patients enrolled later (high-dose patients) had normal locomotive responses before treatment and IL-1α treatment was associated with suppression of responses to selected stimuli at the end of treatment. Pretreatment respiratory burst responses in both low-and high-dose patient groups were essentially normal, but the rates of granulocyte H2O2 production following phorbol myristate acetate stimulation became significantly less than control values at the end of treatment. In vitro exposure of either patient or control cells to 150 U/ml IL-1α did not alter their locomotive or respiratory burst responses, suggesting the observed in vivo effects were not mediated directly by IL-1α. Treatment with IL-1α is associated with changes in ex vivo granulocyte function that are related to the IL-1α dose. Treatment with low doses of IL-1α may provide a means of normalizing abnormal polymorphonuclear leukocyte function in some patients with ovarian malignancies.