nils-herrmann/clean_scirepeval huggingface dataset:
Exercise videogames for physical activity and fitness: Design and rationale of the Wii Heart Fitness trial.

Despite numerous health benefits, less than half of American adults engage in regular physical activity. Exercise videogames (EVG) may be a practical and attractive alternative to traditional forms of exercise. However there is insufficient research to determine whether EVG play alone is sufficient to produce prolonged engagement in physical activity or improvements in cardiovascular fitness and overall health risk. The goal of the present study is to test the efficacy of exercise videogames to increase time spent in moderate to vigorous physical activity (MVPA) and to improve cardiovascular risk indices among adults.



Wii Heart Fitness is a rigorous 3-arm randomized controlled trial with adults comparing three 12-week programs: (1) supervised EVGs, (2) supervised standard exercise, and (3) a control condition. Heart rate is monitored continuously throughout all exercise sessions. Assessments are conducted at baseline, end of intervention (week 12), 6 and 9 months. The primary outcome is time spent in MVPA physical activity. Secondary outcomes include changes in cardiovascular fitness, body composition, blood lipid profiles and maintenance of physical activity through six months post-treatment. Changes in cognitive and affective constructs derived from Self Determination and Social Cognitive Theories will be examined to explain the differential outcomes between the two active treatment conditions.



The Wii Heart Fitness study is designed to test whether regular participation in EVGs can be an adequate source of physical activity for adults. This study will produce new data on the effect of EVGs on cardiovascular fitness indices and prolonged engagement with physical activity.
Effect of high-frequency, low-magnitude vibration on bone and muscle in children with cerebral palsy.

Children with cerebral palsy (CP) have decreased strength, low bone mass, and an increased propensity to fracture. High-frequency, low-magnitude vibration might provide a noninvasive, nonpharmacologic, home-based treatment for these musculoskeletal deficits. The purpose of this study was to examine the effects of this intervention on bone and muscle in children with CP.



Thirty-one children with CP ages 6 to 12 years (mean 9.4, SD 1.4) stood on a vibrating platform (30 Hz, 0.3 g peak acceleration) at home for 10 min/d for 6 months and on the floor without the platform for another 6 months. The order of vibration and standing was randomized, and outcomes were measured at 0, 6, and 12 months. The outcome measures included computed tomography measurements of vertebral cancellous bone density (CBD) and cross-sectional area, CBD of the proximal tibia, geometric properties of the tibial diaphysis, and dynamometer measurements of plantarflexor strength. They were assessed using mixed model linear regression and Pearson correlation.



The main difference between vibration and standing was that there was a greater increase in the cortical bone properties (cortical bone area and moments of inertia) during the vibration period (all P's ≤ 0.03). There was no difference in cancellous bone or muscle between vibration and standing (all P's > 0.10) and no correlation between compliance and outcome (all r's < 0.27; all P's > 0.15). The results did not depend on the order of treatment (P > 0.43) and were similar for children in gross motor function classification system (GMFCS) 1 to 2 and GMFCS 3 to 4.



The primary benefit of the vibration intervention in children with CP was to the cortical bone in the appendicular skeleton. Increased cortical bone area and the structural (strength) properties could translate into a decreased risk of long bone fractures in some patients. More research is needed to corroborate these findings, to elucidate the mechanisms of the intervention, and to determine the most effective age and duration of the treatment.
Origin of P16 median nerve SEP component identified by dipole source analysis — subthalamic or within the thalamo-cortical radiation?

Following median nerve stimulation, several monophasic peaks were recorded at the scalp in the 15–18 ms time range. Source analysis, using three different methods, modelled a source near the centre of the head with an orientation towards the activated hemisphere and a peak activity at 16 ms post stimulus. Magnetic recordings detected no signal in this time range, which confirmed a subcortical location of the source. From dipole localization it was not possible to assign the exact origin of the P16 source to either the subthalamic level or the thalamo-cortical radiation, because of the limited spatial resolution at the centre of the spherical head model. An estimate of the conduction velocity of the medial lemniscus pointed towards a subthalamic origin. The P16 source was preserved in two patients with a lesion of the thalamo-cortical radiation and the ventral thalamus. Further evidence for a subthalamic location of P16 was derived from the physical mechanisms generating far-field potentials.
Impacts of education level and employment status on health-related quality of life in multiple sclerosis patients.

To evaluate the impacts of education level and employment status on health-related quality of life (HRQoL) in multiple sclerosis patients.



This study included 100 multiple sclerosis patients treated at the Department of Neurology, Clinical Center of the University of Sarajevo. Inclusion criteria were the Expanded Disability Status Scale (EDSS) score between 1.0 and 6.5, age between 18 and 65 years, stable disease on enrollment. Quality of life (QoL) was evaluated by the Multiple Sclerosis Quality of Life-54 questionnaire (MSQoL-54). Mann-Whitney and Kruskal-Wallis test were used for comparisons. Linear regression analyses were performed to evaluate prediction value of educational level and employment status in predicting MSQOL-54 physical and mental composite scores.



Full employment status had positive impact on physical health (54.85 vs. 37.90; p les than 0.001) and mental health (59.55 vs. 45.90; p les than 0.001) composite scores. Employment status retained its independent predictability for both physical (r(2)=0.105) and mental (r(2)=0.076) composite scores in linear regression analysis. Patients with college degree had slightly higher median value of physical (49.36 vs. 45.30) and mental health composite score (66.74 vs. 55.62) comparing to others, without statistically significant difference.



Employment proved to be an important factor in predicting quality of life in multiple sclerosis patients. Higher education level may determine better QOL but without significant predictive value. Sustained employment and development of vocational rehabilitation programs for MS patients living in the country with high unemployment level is an important factor in improving both physical and mental health outcomes in MS patients.
Particulate matter air pollution components and risk for lung cancer.

Particulate matter (PM) air pollution is a human lung carcinogen; however, the components responsible have not been identified. We assessed the associations between PM components and lung cancer incidence.



We used data from 14 cohort studies in eight European countries. We geocoded baseline addresses and assessed air pollution with land-use regression models for eight elements (Cu, Fe, K, Ni, S, Si, V and Zn) in size fractions of PM2.5 and PM10. We used Cox regression models with adjustment for potential confounders for cohort-specific analyses and random effect models for meta-analysis.



The 245,782 cohort members contributed 3,229,220 person-years at risk. During follow-up (mean, 13.1 years), 1878 incident cases of lung cancer were diagnosed. In the meta-analyses, elevated hazard ratios (HRs) for lung cancer were associated with all elements except V; none was statistically significant. In analyses restricted to participants who did not change residence during follow-up, statistically significant associations were found for PM2.5 Cu (HR, 1.25; 95% CI, 1.01-1.53 per 5 ng/m(3)), PM10 Zn (1.28; 1.02-1.59 per 20 ng/m(3)), PM10 S (1.58; 1.03-2.44 per 200 ng/m(3)), PM10 Ni (1.59; 1.12-2.26 per 2 ng/m(3)) and PM10 K (1.17; 1.02-1.33 per 100 ng/m(3)). In two-pollutant models, associations between PM10 and PM2.5 and lung cancer were largely explained by PM2.5 S.



This study indicates that the association between PM in air pollution and lung cancer can be attributed to various PM components and sources. PM containing S and Ni might be particularly important.
The reliability and validity of radiographic measurements for determining the three-dimensional position of the talus in varus and valgus osteoarthritic ankles

To assess the most accurate radiographic method to determine talar three-dimensional position in varus and valgus osteoarthritic ankles, we evaluated the reliability and validity of different radiographic measurements. Nine radiographic measurements were performed blindly on weight-bearing mortise, sagittal, and horizontal radiographs of 33 varus and 33 valgus feet (63 patients). Intra- and interobserver reliability was determined with the intraclass coefficient (ICC). Discriminant validity of measurements between varus and valgus feet was assessed with effect size (ES). Convergent validity (Pearson’s r) was evaluated by correlating measurements to the dichotomized varus and valgus groups. Obtained measurements in both groups were finally compared with each other and with 30 control feet. Reliability was excellent (ICC > 0.80) in all but two measurements. Whereas frontal plane validity was excellent (ES and r > 0.80), horizontal and sagittal measurements showed poor to moderate validity (ES and r between 0.00 and 0.60). Four measurements were significantly different among all groups (p < 0.05). Talar positional tendency was found towards dorsiflexion or endorotation in the varus group and towards plantarflexion or exorotation in the valgus group. The frontal tibiotalar surface angle, sagittal talocalcaneal inclination angle, and horizontal talometatarsal I angle showed the best reliability, validity, and difference among the groups. The frontal tibiotalar surface angle, sagittal talocalcaneal inclination angle, and horizontal talometatarsal I angle accurately determine talar three-dimensional radiographic position in weight-bearing varus and valgus osteoarthritic ankles. Careful radiographic evaluation is important, as these deformities affect talar position in all three planes.
Intensified chemotherapy and dose-reduced involved-field radiotherapy in patients with early unfavorable Hodgkin's lymphoma: final analysis of the German Hodgkin Study Group HD11 trial.

Combined-modality treatment consisting of four to six cycles of chemotherapy followed by involved-field radiotherapy (IFRT) is the standard of care for patients with early unfavorable Hodgkin's lymphoma (HL). It is unclear whether treatment results can be improved with more intensive chemotherapy and which radiation dose needs to be applied.



Patients age 16 to 75 years with newly diagnosed early unfavorable HL were randomly assigned in a 2 × 2 factorial design to one of the following treatment arms: four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy of IFRT; four cycles of ABVD + 20 Gy of IFRT; four cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP(baseline)) + 30 Gy of IFRT; or four cycles of BEACOPP(baseline) + 20 Gy of IFRT.



With a total of 1,395 patients included, the freedom from treatment failure (FFTF) at 5 years was 85.0%, overall survival was 94.5%, and progression-free survival was 86.0%. BEACOPP(baseline) was more effective than ABVD when followed by 20 Gy of IFRT (5-year FFTF difference, 5.7%; 95% CI, 0.1% to 11.3%). However, there was no difference between BEACOPP(baseline) and ABVD when followed by 30 Gy of IFRT (5-year FFTF difference, 1.6%; 95% CI, -3.6% to 6.9%). Similar results were observed for the radiotherapy question; after four cycles of BEACOPP(baseline), 20 Gy was not inferior to 30 Gy (5-year FFTF difference, -0.8%; 95% CI, -5.8% to 4.2%), whereas inferiority of 20 Gy cannot be excluded after four cycles of ABVD (5-year FFTF difference, -4.7%; 95% CI, -10.3% to 0.8%). Treatment-related toxicity occurred more often in the arms with more intensive therapy.



Moderate dose escalation using BEACOPP(baseline) did not significantly improve outcome in early unfavorable HL. Four cycles of ABVD should be followed by 30 Gy of IFRT.
A pediatric phase I trial and pharmacokinetic study of thioguanine administered by continuous i.v. infusion.

Although mercaptopurine is the thiopurine antimetabolite predominantly used in the treatment of childhood acute lymphoblastic leukemia (ALL), thioguanine (TG) is more potent than mercaptopurine in in vitro cytotoxicity studies in human leukemic cell lines and leukemic cells from patients with ALL. We conducted a pediatric Phase I trial of TG administered as a continuous i.v. infusion (CIV). A pharmacokinetically guided dose escalation was performed to define the dose rate of TG required to achieve a steady-state plasma concentration (Css) exceeding the target concentration of 1 microM, and then the maximum tolerated duration of infusion of TG at this dose rate was defined. Eighteen patients (median age, 18 years; range, 4-25 years) with refractory malignancies (16 solid tumors and 2 ALL) were enrolled in this study. The starting dose rate of 10 mg/m2/h administered for 24 h achieved an average Css of 0.9 microM (range, 0.7-1.2 microM). Therefore, the dose rate was escalated to 20 mg/m2/h, which achieved an average Css of 4.1 microM (range, 1. 0-8.3 microM). This disproportionate increase in the Css of TG suggested a capacity-limited (saturable) elimination process, and a pharmacokinetic model incorporating two compartments with capacity-limited elimination from the central compartment was developed to describe the disposition of TG. The TG clearances (derived from model parameters) at the 10- and 20-mg/m2/h dose rates were 987 and 608 ml/min/m2, respectively. Dose-limiting myelosuppression (absolute granulocyte count < 500/mm3 and platelet count < 25,000/mm3) was observed in two of three patients treated with a dose rate of 20 mg/m2/h administered for 36 h. Administration of CIV of TG at 20 mg/m2/h for 24 h was well tolerated in nine patients. Nonhematological toxicities included nonneutropenic infections and mild, reversible changes in hepatic function tests. The recommended dose rate and duration for CIV of TG is 20 mg/m2/h for 24 h.
Therapeutic hypothermia after cardiac arrest: outcome
predictors

The determination of coma patient prognosis after cardiac arrest has clinical, ethical and social implications. Neurological examination, imaging and biochemical markers are helpful tools accepted as reliable in predicting recovery. With the advent of therapeutic hypothermia, these data need to be reconfirmed. In this study, we attempted to determine the validity of different markers, which can be used in the detection of patients with poor prognosis under hypothermia.



Data from adult patients admitted to our intensive care unit for a hypothermia protocol after cardiac arrest were recorded prospectively to generate a descriptive and analytical study analyzing the relationship between clinical, neurophysiological, imaging and biochemical parameters with 6-month outcomes defined according to the Cerebral Performance Categories scale (good 1-2, poor 3-5). Neuron-specific enolase was collected at 72 hours. Imaging and neurophysiologic exams were carried out in the 24 hours after the rewarming period.



Sixty-seven patients were included in the study, of which 12 had good neurological outcomes. Ventricular fibrillation and electroencephalographic theta activity were associated with increased likelihood of survival and improved neurological outcomes. Patients who had more rapid cooling (mean time of 163 versus 312 minutes), hypoxic-ischemic brain injury on magnetic resonance imaging or neuron-specific enolase > 58ng/mL had poor neurological outcomes (p < 0.05).



Hypoxic-ischemic brain injury on magnetic resonance imaging and neuron-specific enolase were strong predictors of poor neurological outcomes. Although there is the belief that early achievement of target temperature improves neurological prognoses, in our study, there were increased mortality and worse neurological outcomes with earlier target-temperature achievement.
Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown.



This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data.
[Analysis of differences between indication and prescription of gastroprotection in patients with risk factors treated with nonsteroidal anti-inflammatory agents: the GAP study].

Preventive measures in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDS) have been reported to be underused. The aim of the present study was to analyze differences between the indication and prescription of gastroprotection with proton pump inhibitors (PPI) in patients treated with NSAIDS and with risk factors for gastrointestinal complications.



We performed an observational, cross-sectional, multicenter study. Data were gathered retrospectively from medical records and from a questionnaire on risk factors and indication for gastroprotection.



A total of 432 physicians gathered data from 2,160 patients treated with NSAIDs. Nearly all (90.4%) of the patients were prescribed gastroprotection with a PPI. Long-term versus short-term (<1 month) NSAID treatment was associated with gastroprotection (OR=2.37; 95% CI 1.779-3.171). The mean number of risk factors per patient was 2+/-0.16 (range 0-7), and a significant association was found between the number of risk factors and the percentage of patients receiving gastroprotection. Nevertheless, the proportion of patients with risk factors not receiving gastroprotection was 3% for those with a prior history of ulcer and/or gastrointestinal bleeding due to NSAIDS and 7-10% for the remaining factors. Differences were found between the indication for gastroprotection and the gastroprotection prescribed among the various specialties. The specialists prescribing gastroprotection the least were radiotherapy specialists.



These results demonstrate that, in daily clinical practice, differences between the indication and prescription of gastroprotection in patients treated with NSAIDS and with risk factors are small in Spain.
Increased urinary IgM excretion in patients with chest pain due to coronary artery disease

Micro-albuminuria is a recognized predictor of cardiovascular morbidity and mortality in patients with coronary artery disease. We have previously reported, in diabetic and non-diabetic patients, that an increased urinary excretion of IgM is associated with higher cardiovascular mortality. The purpose of this study was to investigate the pattern of urinary IgM excretion in patients with acute coronary syndrome (ACS) and its correlation to cardiovascular outcome.



Urine albumin, and IgM to creatinine concentration ratios were determined in 178 consecutive patients presenting with chest pain to the Department of Emergency Medicine (ED) at the University Hospital of Lund. Fifty eight (23 female) patients had ACS, 55 (19 female) patients had stable angina (SA), and 65 (35 female) patients were diagnosed as non-specific chest pain (NS).



Urine albumin and IgM excretions were significantly higher in patients with ACS (p = 0.001, and p = 0.029, respectively) compared to patients with NS-chest pain. During the 2 years follow-up time, 40 (19 female) patients suffered a new major cardiovascular event (ACS, acute heart failure, stroke) and 5 (4 male/1 female) patients died of cardiovascular cause. A high degree of albuminuria and IgM-uria significantly predicted cardiovascular mortality and morbidity (HR = 2.89, 95% CI: 1.48 - 5.66, p = 0.002). Microalbuminuric patients (≥3 mg/mmol) with high IgM-uria (≥0.005 mg/mmol) had a 3-fold higher risk for cardiovascular new events compared to patients with low IgM-uria (RR = 3.3, 95% CI: 1.1 - 9.9, p = 0.001).



In patients with chest pain, an increased urine IgM excretion, is associated with coronary artery disease and long-term cardiovascular complications. Measuring urine IgM concentration could have a clinical value in risk stratification of patients with ACS.
Topiramate in migraine prophylaxis: a randomised double-blind versus placebo study

The objectives of this paper are to evaluate the efficacy and tolerability of topiramate, given at the dose of 100 mg/day, in the prophylactic treatment of migraine. The hypothesis that migraine is the result of a condition of neuronal hyperexcitability and the quest for drugs that are able to limit the number of crises justifies the attempt to utilise the new antiepileptic drugs in the prophylaxis of this pathology, which is so important due to its high prevalence and due to the high disability it causes. The study was randomised double-blind versus placebo, lasting 16 weeks, and was preceded by a run-in period of 4 weeks. One hundred and fifteen patients were randomly allocated to treatment with topiramate (TPM) or placebo: 35 patients completed the study in the TPM group and 37 patients in the placebo group. At the end of the double-blind phase of study, in the TPM group, we recorded a significant reduction in the frequency of migraine crises (from 5.26 at baseline to 2.60 in the last 4 weeks), a significant reduction in the quantity of symptomatic drugs taken as compared to the placebo control group (from 6.17±1.80 SD to 2.57±0.80) and a significant downward trend in the number of days of disability over the 16-week period of therapy. In the TPM group, side effects were transient and well tolerated. TPM has thus proven its efficacy and tolerability in the prophylaxis of migraine.