nils-herrmann/clean_scirepeval huggingface dataset:
Observer agreement in the assessment of endovascular aneurysm therapy and aneurysm recurrence.

Assessments of completeness of endovascular cerebral aneurysm therapy are commonly reported in the literature. We studied several aneurysm assessment scales with regard to observer variability, which directly affects validity of these scales.



Initial aneurysm occlusion and occlusion at a follow-up angiogram at 3-6 months were assessed independently by 2 experienced observers. Assessments of each aneurysm were made using 3 different scales: 4-response (complete, dog ear, neck remnant, incomplete), 3-response (complete, near-complete, incomplete), and 2-response (complete or near-complete, incomplete). Assessments were also made of comparisons of initial treatment angiogram with follow-up angiogram using 2 different scales: 3-response (better, same, worse) and 2-point response (not worse, worse).



With assessments of both initial and follow-up angiograms, interobserver and intraobserver agreement was progressively worse with increasing response choices in the scales. Observer agreement on assessments of initial angiograms (kappa values 0.48-0.67) was worse than that for follow-up angiograms (kappa values 0.66-0.97). For the comparisons of the initial angiogram with the follow-up angiogram, there was worse observer agreement with the 3-response scale (kappa values 0.64-0.71) than with the 2-response scale (kappa values 0.78-0.89).



Interobserver and intraobserver variability are inherent to assessment scales of completeness of cerebral aneurysm therapy. Observer variability is substantially better in scales that offer fewer observer responses. However, scales with fewer observer responses may not identify aneurysm subgroups that have differing risks of recurrence and/or rehemorrhage.
Patient knowledge, perceptions, expectations and satisfaction on allergen-specific immunotherapy: a survey.

Assessing patient's perspective provides useful information enabling a customized approach which has been advocated by current guidelines. In this multicentre cross-sectional study we evaluated personal viewpoints on allergen-specific immunotherapy (SIT) in patients treated with subcutaneous (SCIT) or sublingual (SLIT) immunotherapy.



A survey of 28 questions assessing patient's knowledge, perceptions, expectations and satisfaction was developed by an expert panel and was applied by physicians from allergology centres in patients with respiratory allergy treated with SIT. Treating physicians independently reported their satisfaction level regarding SIT for each patient.



Fully completed surveys from 434 patients (55.3% male; 66.7% poly-sensitized, 74% SLIT) were analysed. Mean duration of SIT was 2.5 years with different allergens. Most patients acquired their SIT knowledge from their physician (95%) and consequently, their physicians' opinion in their choice to start with SIT was important. Most patients perceived SIT to be safe and easy to integrate into their daily routine. The main motivations for SIT were its supposed potential to alter the course of the disease (45.7%), less need of (28.2%), or dissatisfaction with current pharmacotherapy (19.3%). Both patients' and physicians' satisfaction was high (VAS-scores 74/100 and 78/100, respectively) and showed a significant correlation (SCIT: r=0.612; SLIT: r=0.608). No major difference was found in patients' answers based on the level of education.



In this real life study evaluating different aspects of patient's perspective on SIT, the majority of patients had an adequate level of knowledge, perceptions, expectations and satisfaction about SIT, which corresponded well with the physician's perceptions and satisfaction. Our data warrant the use of patient's perspectives on chronic SIT treatment.
BCM--body composition monitor: a new tool for the assessment of volume-dependent hypertension in patients on maintenance haemodialysis.

Hypertension is a common finding in end-stage renal disease patients with the prevalence between 20 to 85%. Although the etiology of arterial hypertension (AH) in this patient group is multifactorial, sodium and volume excess leading to extracellular volume overload are one of the most important and potentially adjustable causes. Control of volume status can either normalize the blood pressure (BP) or make the AH easier to control in the great majority of dialysis patients. Heavy reliance is placed on the dialysis procedure to gradually remove fluid over a period of days to weeks until a stable dry weight is achieved. Numerous attempts have been made to utilize alternative methods to more accurately assessment of dry weight, and the newest and most interesting method is multifrequency bioelectrical impedance spectroscopy (BIS). In this prospective study we used BIS in 65 haemodialysis (HD) patients in order to detect those with volume-dependent hypertension and to further investigate the role of dry weight management in BP control. Dry weight was corrected at the beginning, and after 1, and 3 months. Final data were collected after six months. Our data showed that assessment of fluid overload using BIS provides better management of fluid status and BP control in the patients on maintenance HD, and that dry weight correction can lead to significantly better control of volume-dependent hypertension in this patient group.
Molecular Diagnosis of Oligodendroglioma in Paraffin Sections

Distinction of oligodendrogliomas from other gliomas is clinically important, but the histologic diagnosis of oligodendroglioma has been a difficult and notoriously subjective task. Testing for loss of heterozygosity (LOH) on chromosomal arms 1p and 19q, the genetic signature of oligodendroglioma, has emerged as a useful, objective adjunct to the traditional histologic evaluation. However, LOH testing of glioma specimens has not yet been widely implemented, presumably because of a lack of a practical LOH assay. We describe a 1p and 19q LOH assay suitable for routine diagnostics. In contrast to traditional microsatellite-based LOH analysis, we show that detection of LOH is usually possible even without normal tissue or blood from the same patient. A small area of tumor on a single paraffin section is sufficient for the assay. The assay protocol consists of a one-step DNA extraction, multiplex PCR for microsatellites on 1p and 19q, and capillary electrophoresis of the PCR products. LOH is detected by analysis of the allelic patterns and by integration of data from multiple highly polymorphic microsatellites. In a validation study on 19 gliomas, the results were concordant with results obtained by established methods and correlated well with histologic diagnoses. Because only a paraffin section is required, the pathologist can perform both the traditional histopathologic evaluation and this supporting molecular assay from the material at hand.
The effects of n-3 long-chain polyunsaturated fatty acids on bone formation and growth factors in adolescent boys

Animal studies indicate that n-3 long-chain polyunsaturated fatty acids (LCPUFAs) increase bone formation. To our knowledge, no studies have examined this in growing humans. This study investigated whether bone mass and markers of bone formation and growth were (i) associated with docosahexaenoic acid (DHA) status and (ii) affected by fish oil supplementation, in adolescent boys.Seventy-eight healthy, slightly overweight 13- to 15-y-old boys were randomly assigned to breads with DHA-rich fish oil (1.1 g/d n-3 LCPUFA) or control for 16 wk. Whole-body bone mineral content (BMC), bone area (BA), bone mineral density (BMD), plasma osteocalcin, and growth factors were measured at wk 0 and wk 16, as well as diet, physical activity, and n-3 LCPUFA status in erythrocytes.Fish oil strongly increased DHA status (P = 0.0001). No associations were found between DHA status and BMC, BA, BMD, or the markers of bone formation and growth at baseline. Furthermore, the fish oil intervention did not affect any of the outcomes as compared with control. However, dose–response analyses revealed a positive association between changes in DHA status and plasma insulin-like growth factor-1 (IGF-1) during intervention (β = 0.24, P = 0.03, n = 78).Discussion:DHA status and fish oil supplementation were not associated with bone mass or markers of bone formation in adolescent boys, but IGF-1 increased with increasing DHA status.
Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial

HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients.



Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948). Inclusion criteria were a CD4 count above 300 cells/μl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisolone per day or placebo for 2 years. Primary endpoint was time to progression to an AIDS-defining condition or to a CD4-count below 200 cells/μl.



No significant change in progression towards the primary endpoint was observed in the intent-to-treat (ITT) analysis (19 cases with prednisolone versus 28 cases with placebo, p = 0.1407). In a per-protocol (PP)-analysis, 13 versus 24 study participants progressed to the primary study endpoint (p = 0.0741). Secondary endpoints: Prednisolone-treatment decreased immune activation (sCD14, suPAR, CD38/HLA-DR/CD8+) and increased CD4-counts (+77.42 ± 5.70 cells/μl compared to -37.42 ± 10.77 cells/μl under placebo, p < 0.0001). Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001). In a post-hoc analysis stratifying for sex, females treated with prednisolone progressed significantly slower to the primary study endpoint than females treated with placebo (ITT-analysis: 11 versus 21 cases, p = 0.0567; PP-analysis: 5 versus 18 cases, p = 0.0051): No changes in disease progression were observed in men.



This study could not detect any significant effects of prednisolone on disease progression in antiretroviral-untreated HIV infection within the intent-to-treat population. However, significant effects were observed on CD4 counts, immune activation and HIV viral load. This study contributes to a better understanding of the role of immune activation in the pathogenesis of HIV infection.
Low-Dose Glucose-Insulin-Potassium Is Ineffective in Acute Myocardial Infarction: Results of a Randomized Multicenter Pol-GIK Trial

We aimed to assess the clinical efficacy of glucose-insulin-potassium (GIK) in acute myocardial infarction. Experimental data provided evidence of the beneficial effects of GIK on ischemic myocardium. The clinical trials, mostly uncontroled and conducted mainly before the thrombolytic era, were inconclusive due to the small number of patients and discrepancies in protocols. In order to evaluate the efficacy of this intervention, we have performed a prospective multicenter randomized study. The study consisted of 954 patients with acute myocardial infarction (MI) randomized within 24 hours from the onset of symptoms to low-dose GIK (n = 494), which consisted of 1000 mL 10% dextrose, 32–20 U insulin, and 80 mEq K+, or to the control group (n = 460), which was given 1000 mL 0.09% sodium chloride, by intravenous 24-hour infusion at a rate of 42 mL/h. Cardiac mortality and the occurrence of cardiac events at 35 days did not differ between GIK and control-allocated patients (32 (6.5%) vs. 21 (4.6%), respectively; OR 1.45, 95% CI 0.79–2.68, P = 0.20; and 214 (43.3%) vs. 192 (41.7%), OR 1.07, 95% CI 0.82–1.38, P = 0.62). Total mortality at 35 days was significantly higher in the GIK than in the control group (44 (8.9%) vs. 22 (4.8%), respectively, OR 1.95, 95% CI 1.12–3.47, P = 0.01). The excess of noncardiac deaths in the GIK group may have occurred by chance. Low-dose GIK treatment does not improve the survival and clinical course in acute MI.
Drug combination therapy of systemic lupus erythematosus

This long-term study on 73 patients with severe SLE has shown that drug combination therapy with steroids, CsA, MTX and Cy permits a control of disease activity and maintenance of kidney function with very few side effects and, to a large extent, allows patients a good quality of life in both professional and personal terms. In particular, it has been possible to drastically reduce steroid medication (Table 5). The mortality rate is now well under 1% per year, but is still three to four times higher than in an ageand sex-matched control population. Further efforts are necessary to improve the management of SLE. The investigation of the cytokine network might lead to the introduction of new agents . There is also hope that CsA analogues, devoid of or with less toxicity, will be developed.
Impact of Individual and Environmental Socioeconomic Status on Peritoneal Dialysis Outcomes: A Retrospective Multicenter Cohort Study

We aimed to explore the impacts of individual and environmental socioeconomic status (SES) on the outcome of peritoneal dialysis (PD) in regions with significant SES disparity, through a retrospective multicenter cohort in China.



Overall, 2,171 incident patients from seven PD centers were included. Individual SES was evaluated from yearly household income per person and education level. Environmental SES was represented by regional gross domestic product (GDP) per capita and medical resources. Undeveloped regions were defined as those with regional GDP lower than the median. All-cause and cardiovascular death and initial peritonitis were recorded as outcome events.



Poorer PD patients or those who lived in undeveloped areas were younger and less-educated and bore a heavier burden of medical expenses. They had lower hemoglobin and serum albumin at baseline. Low income independently predicted the highest risks for all-cause or cardiovascular death and initial peritonitis compared with medium and high income. The interaction effect between individual education and regional GDP was determined. In undeveloped regions, patients with an elementary school education or lower were at significantly higher risk for all-cause death but not cardiovascular death or initial peritonitis compared with those who attended high school or had a higher diploma. Regional GDP was not associated with any outcome events.



Low personal income independently influenced all-cause and cardiovascular death, and initial peritonitis in PD patients. Education level predicted all-cause death only for patients in undeveloped regions. For PD patients in these high risk situations, integrated care before dialysis and well-constructed PD training programs might be helpful.
Reduction of Hippocampal Hyperactivity Improves Cognition in Amnestic Mild Cognitive Impairment

Elevated hippocampal activation is observed in conditions that confer risk for Alzheimer's disease, including amnestic mild cognitive impairment (aMCI). Studies in relevant animal models have indicated that overactivity in selective hippocampal circuits contributes to cognitive impairment. Here, we tested the effect of reducing hippocampal activation in aMCI. Under placebo treatment, hippocampal activation in the dentate gyrus/CA3 was elevated in aMCI patients compared to a healthy control group. By using a low dose of the antiepileptic levetiracetam hippocampal activation in aMCI was reduced to a level that did not differ from the control group. Compared to aMCI memory performance under placebo, performance in the scanning task was significantly improved under drug treatment. Contrary to the view that greater hippocampal activation might serve a beneficial function, these results support the view that increased hippocampal activation in aMCI is a dysfunctional condition and that targeting excess hippocampal activity has therapeutic potential.
Promoter but not exon 7 polymorphism of endothelial nitric oxide synthase affects training-induced correction of endothelial dysfunction.

Background- Polymorphisms in the promoter (T-786C) and exon 7 (G894T) of the endothelial nitric oxide synthase (eNOS) gene were shown to be associated with reduced vascular NO production or increased proteolytic cleavage of eNOS. Therefore, we aimed to determine the effects of these polymorphisms on endothelial function and endothelial response to physical exercise in patients with coronary artery disease (CAD).



Sixty-seven patients were randomized to either a training or a control group. At the beginning and after 4 weeks, acetylcholine-induced changes in average peak velocity (APV) of a coronary or mammary artery were invasively assessed by Doppler velocimetry. Polymorphisms were detected by polymerase chain reaction-restriction fragment length polymorphism. At the beginning, in subjects with the wild-type (WT) variant, APV increased by 88+/-7% in response to acetylcholine. This response was significantly blunted in patients who were positive for the promoter (44+/-7%) or the exon 7 (62+/-9%) polymorphism. Four weeks of exercise training resulted in augmentation of an endothelium-dependent increase in APV by +36+/-12% in promoter polymorphism-positive patients but by +81+/-18% and +91+/-15% in WT variant- and exon 7 polymorphism-positive subjects, respectively.



These results suggest that the presence of either one of the polymorphisms attenuates endothelium-dependent vasodilatation in CAD patients. Only the promoter polymorphism might have an adverse effect on training-induced improvement in endothelial function.
Effect of the Frequency of Self-Monitoring Blood Glucose in Patients with Type 2 Diabetes Treated with Oral Antidiabetic Drugs—A Multi-Centre, Randomized Controlled Trial

Recommendations on the frequency of self-monitoring of blood glucose (SMBG) vary widely among physicians treating patients with type 2 diabetes (T2D). Aim of this study was to investigate two testing regimen of SMBG in patients with stable metabolic control.



Patients with T2D treated with oral antidiabetic drugs were randomized to two groups: either one SMBG (low) or four SMBG (high) per week. Subjects were followed up after 3, 6 and 12 months. Primary outcome parameter was the change in HbA1c between baseline and 6 months. Primary outcome criterion was tested by a one-sided t- test for non- inferiority. Secondary outcome parameters were safety, compliance and HbA1c at 3 and 12 months.



There were no differences in the 202 subjects for demographic and sociodemographic parameters and drug treatment. HbA(1)c (%) at baseline was similar in both groups (7.2+/-1.4 vs. 7.2+/-1.0). Non- inferiority was demonstrated for the low group (p = 0.0022) with a difference from baseline to 6 months of 0.24 in the low and of 0.16 in the high group. Compliance with the testing regimen was 82-90% in both groups. There were no statistical significant differences for compliance, HbA(1)c at 3 and 12 months and serious adverse events (SAE).



One SMBG per week is as sufficient and safe as four SMBG per week to maintain HbA(1)c in non-insulin treated T2D close to metabolic target. The results of this study are in contrast to current international consensus guidelines.
The single and multiple dose pharmacokinetics of pranlukast in healthy volunteers

The pharmacokinetics of pranlukast, a leukotriene LTD4 antagonist, were studied in 48 young, healthy subjects after single and repeated oral doses (given every 12 h) ranging from 112.5 to 675 mg. The doses were administered 30 minutes after a light breakfast.  Maximal drug concentrations generally occurred between 2 and 6 h after dosing, and there was some evidence of an absorption lag-time. Secondary peaks were observed in the plasma concentration vs. time profiles of many of the study subjects after both single and repeated doses, particularly during the period of maximum drug absorption. In general, after both single and repeated doses, there were related increases in the corresponding Cmax and AUC with a rise in dose, although the increase was diminished at doses above 450 mg. With repeated dosing of pranlukast the mean AUC was generally higher (up to 1.6-fold), and the higher plasma concentrations allowed characterisation of a longer mean t1/2 than after single dose administration. The mean steady-state trough plasma concentrations attained after evening doses were considerably higher (up to 14-fold) than those obtained after the morning dose.  The data suggested that the pharmacokinetics of pranlukast are influenced by the time of dosing. Based on analysis of urinary 6β-hydroxycortisol excretion, there was no evidence that pranlukast modified the metabolic activity of cytochrome P-450 3A isoenzymes.
Effects of chiropractic care on pain and function in patients with hip osteoarthritis waiting for arthroplasty: a clinical pilot trial.

The purpose of this study was to explore the short-term effects of chiropractic care on pain and function in patients with hip osteoarthritis.



A convenience sample of 14 patients waiting to undergo unilateral hip arthroplasty at a large university hospital received either chiropractic care (n = 7) or no additional treatment (n = 7) during a 3-week period. The main outcome was the change in self-rated hip pain on a 100 mm Visual Analogue Scale (VAS, 0-100). Secondary outcomes were the change in the five Hip disability and Osteoarthritis Outcome Subscales (HOOS, 0-100), which include pain, other symptoms, function in daily living, function in sport and recreation and hip related quality of life. Nonparametric statistics were used to explore outcome changes from baseline to follow-up after three weeks within and between the groups.



Patients receiving chiropractic care, on average 4.4 (SD +/-1.0) treatments over 3 weeks, showed a clinically and statistically significant improvement in self-rated hip pain, VAS - 26.0 (SD +/-28.4), P = .043. The chiropractic patients also had clinically important, but not statistically significant, improvement scores in HOOS function in daily living 18.6 (SD +/-18.5), pain 15.4 (SD +/-17.2), and hip-related quality of life 12.4 (SD +/-19.6). The waiting list controls had no statistically significant improvements in any outcome measured, but a clinically relevant improvement in HOOS Pain 12.2 (SD +/-18.2), P = .051 was observed. There were no statistically significant differences between the groups due to the small sample size. Approximately 25 patients per arm would be required to adequately power a full scale randomized controlled trial with VAS for hip pain as the main outcome measure.



Chiropractic care may provide a short-term benefit in decreasing hip pain for patients with hip osteoarthritis waiting for hip arthroplasty. The pilot findings warrant larger scale randomized controlled trials with longer-term follow-ups.
Problem-solving skills training for vulnerable families of children with persistent asthma: report of a randomized trial on health-related quality of life outcomes.

To test the efficacy of problem-solving skill training (PST) in improving health-related quality of life (HRQOL) of children with persistent asthma from predominantly lower socioeconomic status (SES) Spanish-speaking Hispanic families.



Randomized controlled trial comparing standard care waitlist (SC) control, home-visiting asthma education/care coordination (CC), and combined intervention (CC + PST) at baseline, after intervention, and 6-month follow-up. The primary outcome was parent proxy-report child HRQOL (PedsQL).



Participants (n = 252) were 83.3% Hispanic and 56.3% monolingual Spanish speakers, and 72.6% of mothers had not graduated high school. We found a significant (P = 0.05) intervention effect for parent proxy-reported child generic (but not asthma-specific) HRQOL, with CC + PST superior to SC [83.8 vs 79.8; adjusted mean difference of 4.05 points (95% confidence interval 0.63-7.4], but no difference between the CC and SC groups.



In this sample of vulnerable families of children with persistent asthma, a CC + PST intervention was efficacious in improving children's generic HRQOL.