nils-herrmann/clean_scirepeval huggingface dataset:
Clinical relapses and disease activity on magnetic resonance imaging associated with viral upper respiratory tract infections in multiple sclerosis.

Although the risk of clinical attacks of multiple sclerosis seems to be significantly increased with viral upper respiratory tract infections (URTI), serological evidence for the reported association remains controversial. In addition, although MRI is six to 10 times more sensitive than clinical exacerbations in indexing disease activity, any possible association between URTI and MRI activity has yet to be investigated.



To examine the relation between URTI and disease activity, in multiple sclerosis patients participating in a placebo controlled trial of interferon beta-1a, as indexed both by clinical exacerbation rate and by the number and volume of gadolinium-diethylenetriaminepentaacetic acid (Gd-DTPA) enhancing lesions on MRI. "At risk" periods were defined around symptomatic URTI, with or without serological confirmation.



The relative risk of clinical relapse for serologically unconfirmed symptomatic URTI was 2.1 (p=0.004). Raised antiviral antibody titres conferred a relative risk of multiple sclerosis exacerbations that was 3.4 times higher than the "not at risk" periods (annual attack rates of 5.7 v 1.6, respectively, p=0.006). There was no definite relation between the number or the volume of active lesions on MRI and either symptomatic or serologically defined at risk periods.



These results confirm the previously reported association between viral infections and multiple sclerosis exacerbations and indicate that the relative risk may be even higher when viral infection is serologically confirmed. However, the results, perhaps because of the confounding effects of interferon beta-1a, do not provide convincing evidence of increased blood-brain barrier breakdown or inflammation during periods of virally induced immune stimulation.
Intraoperative Gamma Detection Of125I-Lanreotide in Women With Primary Breast Cancer

Somatostatin receptors are present in most human breast cancers. We performed a pilot trial of intraoperative tumor-gamma detection using the radiolabeled somatostatin analog 125I-lanreotide in 13 women with 14 primary breast carcinomas.  All patients were given125I-lanreotide intravenously before surgery. Patients underwent lumpectomy, and postresection margins were evaluated with the gamma probe. Axillary dissection specimens were evaluated ex vivo.  Seven of 13 women had gamma probe-positive or clinically suspicious margins reexcised at the time of lumpectomy. Four of six probe-positive margins were histologically positive, and two of six probe-positive margins were histologically negative; a single clinically suspicious margin was histologically positive. A total of 270 axillary lymph nodes were evaluated ex vivo by gamma probe and histology. McNemar’s contingency tests demonstrated a highly statistical correlation between histology and gamma probe counts (P < .0001).  The overall accuracy of nodal evaluation with125I-lanreotide/intraoperative gamma detection was 77%; the negative predictive value of this technique was 97%, however. This technique predicted the presence of tumor in 20% of axillary lymph nodes that were negative by routine histology. This technique appears safe and is able to detect positive tumor resection margins and accurately predict axillary lymph node negativity. Further trials of this technique are required to validate its utility.
Understanding barriers to optimal medication management for those requiring long-term dialysis: rationale and design for an observational study, and a quantitative description of study variables and data

Rates of medication non-adherence in dialysis patients are high, and improving adherence is likely to improve outcomes. Few data are available regarding factors associated with medication adherence in dialysis patients, and these data are needed to inform effective intervention strategies.



This is an observational cross-sectional study of a multi-ethnic dialysis cohort from New Zealand, with the main data collection tool being an interviewer-assisted survey. A total of 100 participants were randomly sampled from a single centre, with selection stratified by ethnicity and dialysis modality (facility versus home). The main outcome measure is self-reported medication adherence using the Morisky 8-Item Medication Adherence Scale (MMAS-8). Study data include demographic, clinical, social and psychometric characteristics, the latter being constructs of health literacy, medication knowledge, beliefs about medications, and illness perceptions. Psychometric constructs were assessed through the following survey instruments; health literacy screening questions, the Medication Knowledge Evaluation Tool (Okuyan et al.), the Beliefs about Medication Questionnaire (Horne et al.), the Brief Illness Perception Questionnaire (Broadbent et al.). Using the study data, reliability analysis for internal consistency is satisfactory for the scales evaluating health literacy, medication knowledge, and beliefs about medications, with Chronbach's α > 0.7 for all. Reliability analysis indicated poor internal consistency for scales relating to illness perceptions. MMAS-8 and all psychometric scores are normally distributed in the study data.



This study will provide important information on the factors involved in medication non-adherence in New Zealand dialysis patients. The resulting knowledge will inform long-term initiatives to reduce medication non-adherence in dialysis patients, and help ensure that they are addressing appropriate and evidence based targets for intervention.
Children’s Feedback Preferences in Response to an Experimentally Manipulated Peer Evaluation Outcome: The Role of Depressive Symptoms

The present study examined the linkage between pre-adolescent children's depressive symptoms and their preferences for receiving positive vs. negative feedback subsequent to being faced with an experimentally manipulated peer evaluation outcome in real time. Participants (n = 142) ages 10 to 13, played a computer contest based on the television show Survivor and were randomized to either a peer rejection (i.e., receiving the lowest total 'likeability' score from a group of peer-judges), a peer success (i.e., receiving the highest score), or a control peer evaluation condition. Children's self-reported feedback preferences were then assessed. Results revealed that participants assigned to the negative evaluation outcome, relative to either the success or the control outcome, showed a significantly higher subsequent preference for negatively tuned feedback. Contrary to previous work and predictions derived from self-verification theory, children higher in depressive symptoms were only more likely to prefer negative feedback in response to the negative peer evaluation outcome. These effects for depression were not accounted for by either state mood at baseline or mood change in response to the feedback manipulation.
A case-control study on the effect of hormone replacement therapy on ischaemic heart disease.

Many clinicians believe that hormone replacement therapy (HRT) protects against coronary heart disease (CHD) in women. However, recent reports have cast some doubt on this because of lack of dose-response or duration-response effects. Since CHD is common in women--about half of all postmenopausal women will get it and about a third of these will die from it--the effect of HRT on CHD is of great public health importance.



To determine the degree of cardioprotection conferred by HRT, including the effect of duration, time since last issue, the addition of progestogens, route of administration, and dose.



Population-based case-control study.



Nine general practices recruited from the Trent Focus Collaborative Research Network.



A total of 417 female cases with CHD matched by age and practice to 2435 controls with a case-control ratio of 1:5.8 were studied. The main outcome measure was the odds ratio for CHD calculated by conditional logistic regression adjusted for diabetes, hypertension, body mass index, and smoking.



No evidence was found, either from univariate analysis or multivariate analysis, that use of HRT was associated with reduced risk of CHD (odds ratio = 1.32; 95% confidence interval = 0.93 to 1.87). Indeed, the trend was in the opposite direction. There was no association for different types of HRT (opposed or unopposed) or routes of administration. Similarly, there was no association for current or past use and no effect for dose or duration.



This study adds to growing evidence that HRT does not confer cardioprotection. Until there is robust evidence to the contrary, general physicians need to assess risks and benefits of HRT independently of any possible reduction in risk of CHD.
Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma

Monitoring free serum IgE in severe asthma patients treated with omalizumab. 2 Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. 2 Effects of adding omalizumab, an anti-immunoglobulin E antibody, on airway wall thickening in asthma. 3 A genome-wide association study of plasma total IgE concentrations in the Framingham Heart Study. 4 Reduction of total IgE by targeted coengagement of IgE B-cell receptor and FcγRIIb with Fc-engineered antibody.
Light fractionation significantly improves the response of superficial basal cell carcinoma to aminolaevulinic acid photodynamic therapy: five-year follow-up of a randomized, prospective trial.

Photodynamic therapy (PDT) using topical porphyrin-precursors is a promising treatment for superficial basal cell carcinoma (sBCC), but it needs further optimization. The aim of this study was to compare 5-year lesion (complete) response rates of sBCC treated with topical aminolaevulinic acid (ALA)-PDT using a single illumination vs. ALA-PDT using a 2-fold illumination scheme. A prospective, randomized study was performed, in which 91 patients with 299 lesions were treated with a 2-fold illumination scheme with 2 light fractions of 20 and 80 J/cm2 delivered 4 and 6 h after a single application of 20% ALA, and 106 patients with 274 lesions were treated with a single illumination of 75 J/cm2 4 h after a single application of 20% ALA. All lesions were treated at a fluence rate of 50 mW/cm2. An interim time to event analysis of complete response (CR) rates at 12 months showed encouraging results, and therefore lesions were followed for 5 years post-therapy. A third group of 50 patients with 172 lesions treated with 2-fold illumination were included after the initial period and analysed separately. The CR rate was significantly greater following the 2-fold illumination than the single illumination (p = 0.0002, log-rank test). Five years after therapy the CR rate after 2-fold illumination was 88%, whereas the CR rate after single illumination was 75%. The CR rate in the third group of lesions, treated with 2-fold illumination was 97% and 88% at 12 months and 5 years after therapy, respectively. Long-term follow-up indicates superior efficacy in sBCC of ALA-PDT with 2-fold illumination compared with ALA-PDT with single illumination.
Incidence of central nervous system metastases in patients with HER2-positive metastatic breast cancer treated with pertuzumab, trastuzumab, and docetaxel: results from the randomized phase III study CLEOPATRA

Results from the phase III trial CLEOPATRA in human epidermal growth factor receptor 2-positive first-line metastatic breast cancer demonstrated significant improvements in progression-free and overall survival with pertuzumab, trastuzumab, and docetaxel over placebo, trastuzumab, and docetaxel. We carried out exploratory analyses of the incidence and time to development of central nervous system (CNS) metastases in patients from CLEOPATRA.



Patients received pertuzumab/placebo: 840 mg in cycle 1, then 420 mg; trastuzumab: 8 mg/kg in cycle 1, then 6 mg/kg; docetaxel: initiated at 75 mg/m(2). Study drugs were administered i.v. every 3 weeks. The log-rank test was used for between-arm comparisons of time to CNS metastases as first site of disease progression and overall survival in patients with CNS metastases as first site of disease progression. The Kaplan-Meier approach was used to estimate median time to CNS metastases as first site of disease progression and median overall survival.



The incidence of CNS metastases as first site of disease progression was similar between arms; placebo arm: 51 of 406 (12.6%), pertuzumab arm: 55 of 402 (13.7%). Median time to development of CNS metastases as first site of disease progression was 11.9 months in the placebo arm and 15.0 months in the pertuzumab arm; hazard ratio (HR) = 0.58, 95% confidence interval (CI) 0.39-0.85, P = 0.0049. Overall survival in patients who developed CNS metastases as first site of disease progression showed a trend in favor of pertuzumab, trastuzumab, and docetaxel; HR = 0.66, 95% CI 0.39-1.11. Median overall survival was 26.3 versus 34.4 months in the placebo and pertuzumab arms, respectively. Treatment comparison of the survival curves was not statistically significant for the log-rank test (P = 0.1139), but significant for the Wilcoxon test (P = 0.0449).



While the incidence of CNS metastases was similar between arms, our results suggest that pertuzumab, trastuzumab, and docetaxel delays the onset of CNS disease compared with placebo, trastuzumab, and docetaxel.
Comparison between cardiac output values measured by thermodilution and partial carbon dioxide rebreathing in patients with acute lung injury.

Thermodilution, which is considered to be a standard technique for measuring the cardiac output in critically ill patients, is not free from relevant risks. There is a need to find alternative, noninvasive, automatic, simple and accurate methods for monitoring cardiac output at the bedside.



To compare cardiac output measurements by thermodilution and partial carbon dioxide rebreathing in patients with acute lung injury at two levels of severity (lung injury score, LIS: below 2.5, group A; and above 2.5, group B).



Comparative, prospective and controlled study.



Intensive Care Units of two university hospitals.



Cardiac output was measured by thermodilution and partial carbon dioxide rebreathing. Twenty patients with acute lung failure (PaO2/FiO2 < 300) who were under mechanical ventilation and from whom 294 measurements were taken: 164 measurements in group A (n = 11) and 130 in group B (n = 9), ranging from 14 to 15 determinations per patient.



There was a poor positive correlation between the methods studied for the patients from groups A (r = 0.52, p < 0.001) and B (r = 0.47, p < 0.001). The application of the Bland-Altman test made it possible to expose the lack of agreement between the methods (group A: -0.9 +/- 2.71 l/min; 95% CI = -1.14 to -0.48; and group B: -1.75 +/- 2.05 l/min; 95% CI = -2.11 to -1.4). The comparison of the results (Student t and Mann-Whitney tests) within each group and between the groups showed significant difference (p = 0.000, p < 0.05).



Errors in estimating CaCO2 (arterial CO2 content) from ETCO2 (end-tidal CO2) and situations of hyperdynamic circulation associated with dead space and/or increased shunt possibly explain our results.



Under the conditions of this study, the results obtained allow us to conclude that, in patients with acute lung injury, the cardiac output determined by partial rebreathing of CO2 differs from the measurements obtained by thermodilution. This difference becomes greater, the more critical the lung injury is.
Can multimodality imaging using 18F-FDG/18F-FLT PET/CT benefit the diagnosis and management of patients with pulmonary lesions?

Dual-tracer, 18F-fluorodeoxyglucose and 18F-fluorodeoxythymidine (18F-FDG/18F-FLT), dual-modality (positron emission tomography and computed tomography, PET/CT) imaging was used in a clinical trial on differentiation of pulmonary nodules. The aims of this trial were to investigate if multimodality imaging is of advantage and to what extent it could benefit the patients in real clinical settings. Seventy-three subjects in whom it was difficult to establish the diagnosis and determine management of their pulmonary lesions were prospectively enrolled in this clinical trial. All subjects underwent 18F-FDG and 18F-FLT PET/CT imaging sequentially. The images were interpreted with different strategies as either individual or combined modalities. The pathological or clinical evidence during a follow-up period of more than 22 months served as the standard of truth. The diagnostic performance of each interpretation and their impact on clinical decision making was investigated. 18F-FLT/18F-FDG PET/CT was proven to be of clinical value in improving the diagnostic confidence in 28 lung tumours, 18 tuberculoses and 27 other benign lesions. The ratio between maximum standardized uptake values of 18F-FLT and 18F-FDG was found to be of great potential in separating the three subgroups of patients. The advantage could only be obtained with the full use of the multimodality interpretation. Multimodality imaging induced substantial change in clinical management in 31.5% of the study subjects and partial change in another 12.3%. Multimodality imaging using 18F-FDG/18F-FLT PET/CT provided the best diagnostic efficacy and the opportunity for better management in this group of clinically challenging patients with pulmonary lesions.
Effects of different types of exercise training followed by detraining on endothelium-dependent dilation in patients with recent myocardial infarction.

In coronary artery disease, exercise training (ET) is associated with an improvement in endothelial function, but little is known about the relative effect of different types of training. The purpose of this study was to prospectively evaluate the effect of different types of ET on endothelial function in 209 patients after a first recent acute myocardial infarction.



Endothelial function was evaluated before and after 4 weeks of different types of ET and after 1 month of detraining by measuring flow-mediated dilation and von Willebrand factor levels at baseline and after ET. Patients were randomized into 4 groups: group 1, aerobic ET (n=52); group 2, resistance training (n=54); group 3, resistance plus aerobic training (n=53); and group 4, no training (n=50). At baseline, flow-mediated dilation was 4.5+/-2.6% in group 1, 4.01+/-1.6% in group 2, 4.4+/-4% in group 3, and 4.3+/-2.3% in group 4 (P=NS). After ET, flow-mediated dilation increased to 9.9+/-2.5% in group 1, 10.1+/-2.6% in group 2, and 10.8+/-3% in group 3 (P<0.01 versus baseline for all groups); it also increased in group 4 but to a much lesser extent (to 5.1+/-2.5%; P<0.01 versus trained groups). The von Willebrand factor level after ET decreased by 16% (P<0.01) similarly in groups 1, 2, and 3 but remained unchanged in group 4. Detraining returned flow-mediated dilation to baseline levels (P<0.01 versus posttraining).



In patients with recent acute myocardial infarction, ET was associated with improved endothelial function independently of the type of training, but this effect disappeared after 1 month of detraining.
Improvement of insulin sensitivity by a novel drug, BGP-15, in insulin-resistant patients: a proof of concept randomized double-blind clinical trial.

The efficacy and safety of the new drug, BGP-15, were compared with placebo in insulin-resistant patients in a 28-day dose-ranging study. Forty-seven nondiabetic patients with impaired glucose tolerance were randomly assigned to 4 weeks of treatment with 200 or 400 mg of BGP-15 or placebo. Insulin resistance was determined by hyperinsulinemic euglycemic clamp technique and homeostasis model assessment method, and beta-cell function was measured by intravenous glucose tolerance test. Each BGP-15 dose significantly increased whole body insulin sensitivity (M-1, p=0.032), total body glucose utilization (M-2, p=0.035), muscle tissue glucose utilization (M-3, p=0.040), and fat-free body mass glucose utilization (M-4, p=0.038) compared to baseline and placebo. No adverse drug effects were observed during treatment. BGP-15 at 200 or 400 mg significantly improved insulin sensitivity in insulin-resistant, nondiabetic patients during treatment compared to placebo and was safe and well-tolerated. This was the first clinical study demonstrating the insulin-sensitizing effect of a molecule, which is considered as a co-inducer of heat shock proteins.
The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder.

Developmental coordination disorder (DCD) affects approximately 5% of school-aged children. In addition to the core deficits in motor function, this condition is associated commonly with difficulties in learning, behavior, and psychosocial adjustment that persist into adulthood. Mounting evidence suggests that a relative lack of certain polyunsaturated fatty acids may contribute to related neurodevelopmental and psychiatric disorders such as dyslexia and attention-deficit/hyperactivity disorder. Given the current lack of effective, evidence-based treatment options for DCD, the use of fatty acid supplements merits investigation.



A randomized, controlled trial of dietary supplementation with omega-3 and omega-6 fatty acids, compared with placebo, was conducted with 117 children with DCD (5-12 years of age). Treatment for 3 months in parallel groups was followed by a 1-way crossover from placebo to active treatment for an additional 3 months.



No effect of treatment on motor skills was apparent, but significant improvements for active treatment versus placebo were found in reading, spelling, and behavior over 3 months of treatment in parallel groups. After the crossover, similar changes were seen in the placebo-active group, whereas children continuing with active treatment maintained or improved their progress.



Fatty acid supplementation may offer a safe efficacious treatment option for educational and behavioral problems among children with DCD. Additional work is needed to investigate whether our inability to detect any improvement in motor skills reflects the measures used and to assess the durability of treatment effects on behavior and academic progress.
Antithrombotic therapy influences location, enlargement, and mortality from intracerebral hemorrhage. The Bleeding with Antithrombotic Therapy (BAT) Retrospective Study.

To determine whether the use of oral antithrombotic agents before the onset of intracerebral hemorrhage (ICH) affects hematoma features and early patient outcome.



A retrospective, multicenter study involving 1,006 consecutive Japanese patients (607 men, 67 +/- 12 years of age) hospitalized within 24 h after the onset of nontraumatic ICH was conducted.



One hundred and eighty patients were taking oral antiplatelet agents (17.9%, AP group), 67 were taking warfarin (6.7%, W group), and 21 were taking both (2.1%, W + AP group). After adjustment for age, sex, and known confounders, the taking of each kind of antithrombotic therapy was independently related to cerebellar hemorrhage; the odds ratios (OR) and 95% CI, with patients taking no antithrombotic agents as the reference group, were 2.31 (1.23-4.32) for the AP group, 2.90 (1.26-6.63) for the W group, and 3.43 (1.02-11.59) for the W + AP group. Similarly, the taking of each kind of antithrombotic therapy was independently related to hematoma enlargement within the initial 24 h (OR and 95% CI: AP group, 1.92, 1.10-3.34; W group, 4.80, 2.12-10.87; W + AP group, 4.94, 1.31-18.61) and mortality at 3 weeks post-ICH (OR and 95% CI: AP group, 2.70, 1.56-4.68; W group, 2.50, 1.05-5.96; W + AP group, 9.41, 2.78-31.88).



Prior medication with antiplatelet agents, warfarin, or both was predictive of cerebellar hemorrhage, hematoma enlargement, and early death in Japanese ICH patients.