nils-herrmann/clean_scirepeval huggingface dataset:
Effect of ramipril on walking times and quality of life among patients with peripheral artery disease and intermittent claudication: a randomized controlled trial.

Approximately one-third of patients with peripheral artery disease experience intermittent claudication, with consequent loss of quality of life.



To determine the efficacy of ramipril for improving walking ability, patient-perceived walking performance, and quality of life in patients with claudication.



Randomized, double-blind, placebo-controlled trial conducted among 212 patients with peripheral artery disease (mean age, 65.5 [SD, 6.2] years), initiated in May 2008 and completed in August 2011 and conducted at 3 hospitals in Australia.



Patients were randomized to receive 10 mg/d of ramipril (n = 106) or matching placebo (n = 106) for 24 weeks.



Maximum and pain-free walking times were recorded during a standard treadmill test. The Walking Impairment Questionnaire (WIQ) and Short-Form 36 Health Survey (SF-36) were used to assess walking ability and quality of life, respectively.



At 6 months, relative to placebo, ramipril was associated with a 75-second (95% CI, 60-89 seconds) increase in mean pain-free walking time (P < .001) and a 255-second (95% CI, 215-295 seconds) increase in maximum walking time (P < .001). Relative to placebo, ramipril improved the WIQ median distance score by 13.8 (Hodges-Lehmann 95% CI, 12.2-15.5), speed score by 13.3 (95% CI, 11.9-15.2), and stair climbing score by 25.2 (95% CI, 25.1-29.4) (P < .001 for all). The overall SF-36 median Physical Component Summary score improved by 8.2 (Hodges-Lehmann 95% CI, 3.6-11.4; P = .02) in the ramipril group relative to placebo. Ramipril did not affect the overall SF-36 median Mental Component 
Among patients with intermittent claudication, 24-week treatment with ramipril resulted in significant increases in pain-free and maximum treadmill walking times compared with placebo. This was associated with a significant increase in the physical functioning component of the SF-36 score.
Using wireless technology in clinical practice: does feedback of daily walking activity improve walking outcomes of individuals receiving rehabilitation post-stroke? Study protocol for a randomized controlled trial

Regaining independent ambulation is the top priority for individuals recovering from stroke. Thus, physical rehabilitation post-stroke should focus on improving walking function and endurance. However, the amount of walking completed by individuals with stroke attending rehabilitation is far below that required for independent community ambulation. There has been increased interest in accelerometer-based monitoring of walking post-stroke. Walking monitoring could be integrated within the goal-setting process for those with ambulation goals in rehabilitation. The feedback from these devices can be downloaded to a computer to produce reports. The purpose of this study is to determine the effect of accelerometer-based feedback of daily walking activity during rehabilitation on the frequency and duration of walking post-stroke.



Participants will be randomly assigned to one of two groups: feedback or no feedback. Participants will wear accelerometers daily during in- and out-patient rehabilitation and, for participants in the feedback group, the participants' treating physiotherapist will receive regular reports of walking activity. The primary outcome measures are the amount of daily walking completed, as measured using the accelerometers, and spatio-temporal characteristics of walking (e.g. walking speed). We will also examine goal attainment, satisfaction with progress towards goals, stroke self-efficacy, and community-integration.



Increased walking activity during rehabilitation is expected to improve walking function and community re-integration following discharge. In addition, a focus on altering walking behaviour within the rehabilitation setting may lead to altered behaviour and increased activity patterns after discharge.
Use of Isokinetic Muscle Strength as a Measure of Severity of Rheumatoid Arthritis: A Comparison of this Assessment Method for RA with other Assessment Methods for the Disease

The aim of this study was to study the association between isokinetic muscle strength (IMS) and other clinical indicators of disability and disease activity in patients with rheumatoid arthritis (RA). A cohort of 36 RA patients was followed over a 1-year period with five measurements of disease activity at regular intervals during this time. IMS was measured at seven angular velocities in both knees, on five separate occasions. The measurement was expressed by the level of the fitted line of the seven peak torque values – IMS30. The association between IMS30 and clinical indicators was stated. As an indicator of disability the score from the Stanford Health Assessment Questionnaire (HAQ) was used. As indicators of disease activity morning stiffness, an index of swelling and pain in the joint, erythrocyte sedimentation rate (ESR) and haemoglobin (Hb) were chosen. Larsen’s X-ray score was used as an indicator of bone destruction due to longer-lasting disease activity. IMS was significantly associated with the HAQ score, but not with indicators of disease activity or radiological findings. IMS was significantly associated with changes in indicators of disease activity, but not with the changes in the HAQ score, or in the X-ray-score. IMS showed the strongest association with changes in the degree of arthritis of the knee. In conclusion, IMS was associated with the HAQ score and can therefore be used when measuring outcome in a specific group of RA patients. Changes in IMS were associated with indicators of changes in disease activity, and are therefore usable as a measure of patient outcome. Of particular importance is that IMS decreased if a patient developed active arthritis in the knee, and normalised again when the inflammation decreased.
Patient satisfaction with postmastectomy breast reconstruction: a comparison of saline and silicone implants.

At a time when the safety and effectiveness of breast implants remains under close scrutiny, it is important to provide reliable and valid evidence regarding patient outcomes. In the setting of postmastectomy reconstruction, patient satisfaction and quality of life may be the most significant outcome variables when evaluating surgical success. The objective of the current study was to identify predictors of patient satisfaction with breast appearance, including implant type, in a large sample of women who underwent breast reconstruction surgery using implants.



A multicenter, cross-sectional study design was used. A total of 672 women who had completed postmastectomy, implant-based reconstruction at 1 of 3 centers in North America were asked to complete the BREAST-Q (Reconstruction Module). Multivariate linear regression modeling was performed.



Completed questionnaire data were available for 482 of the 672 patients. In 176 women, silicone implants were placed and in 306, saline implants were used. The multivariate model confirmed that patients' satisfaction with their breasts was significantly higher in patients with silicone implants (P = .016). The receipt of postmastectomy radiotherapy was found to have a significant, negative effect on breast satisfaction (P<.000) in both silicone and saline implant recipients. In addition, for women who received either silicone or saline implants, satisfaction diminished over time (P = .017).



In the setting of postmastectomy reconstruction, patients who received silicone breast implants reported significantly higher satisfaction with the results of reconstruction than those who received saline implants. This information can be used to optimize shared medical decision-making by providing patients with realistic postoperative expectations.
Minimal difference between aerobic and progressive resistance exercise on metabolic profile and fitness in older adults with diabetes mellitus: a randomised trial.

Is progressive resistance training as effective as aerobic training of similar duration in sedentary older adults with diabetes mellitus?



A randomised trial with concealed allocation, assessor blinding and intention-to-treat analysis.



Sixty people with Type 2 diabetes mellitus with glycosylated haemoglobin (HbA1c) between 8% and 10% in the past month.



One group undertook progressive resistance exercise and the other group undertook aerobic exercise. Both groups completed 18 sessions over 8 weeks. In each session, the progressive resistance exercise group did nine resistive exercises while the aerobic exercise group did 50 minutes of aerobic exercise.



HbA1c, blood glucose, lipid profile (total, high- and low-density cholesterol and triglycerides), weight, body mass index, body fat, waist circumference, waist:hip ratio, blood pressure, and peak oxygen consumption.



Forty-nine (82%) participants completed the intervention. HbA1c reduced by a similar amount in both groups (MD 0.1%, 95% CI -0.3 to 0.5). However, significant between-group differences occurred in change in waist circumference in favour of progressive resistance exercise (MD -1.8 cm, 95% CI -0.5 to -3.1), and in change in peak oxygen consumption in favour of aerobic exercise (MD 5.2 ml/kg, 95% CI 0.0 to 10.4).



Progressive resistance exercise has similar effects to aerobic exercise and therefore offers a useful alternative for patients unable to participate in aerobic exercise.
Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB)

Current therapies often have limited efficacy and untenable side effects when used to treat persistent incisional pain following cancer-related surgery. Lidocaine patches reduce neuropathic pain from herpes zoster but their benefits for persistent cancer-related postsurgical incisional pain remain unclear. Multicenter, double-blind, randomized, two-period crossover trial. Twenty-eight cancer patients with postsurgical incisional pain were randomly assigned to receive either lidocaine patches followed by placebo patches or the reverse. Each study period lasted 4 weeks. Patches were applied daily upon waking and left in place for a maximum of 18 h. The primary outcome measure, an 11-point pain intensity rating scale, was administered weekly. Secondary outcomes were administered weekly (Brief Pain Inventory-Short Form(BPI-SF), Subject Global Impression of Change) and at the end of each study period (Short Form-Magill Pain Questionnaire, Linear Analogue Self Assessment Scale, Neuropathy Pain Scale, Pain Catastrophizing Scale, Profile of Mood States Short Form). Twenty-one patients completed the first period and 18 completed their crossover second phase. No significant intergroup differences were detected in pain intensity ratings. Few secondary end points were significantly different when subjects used the lidocaine versus placebo patches. BPI-SF interference scores were lower in patients using the lidocaine patch during the first study period, including several scores that achieved statistical significance, general activity (p = 0.02), work (p = 0.04), and relations with others (p = 0.02). Lidocaine patch use did not significantly reduce pain intensity ratings or the majority of related secondary end points in cancer patients with persistent incisional pain.
Lifestyle and cardiovascular disease in middle-aged British men: the effect of adjusting for within-person variation.

To examine the effect that within-person variation has on the estimated risk associations between cigarette smoking, physical inactivity, and increased body mass index (BMI) and the development of cardiovascular disease (CVD) in middle-aged British men.



In total, 6452 men aged 40-59 with no prior evidence of CVD were followed for major CVD events (fatal/non-fatal myocardial infarction or stroke) and all-cause mortality over 20 years; lifestyle characteristics were ascertained at regular points throughout the study. A major CVD event within the first 20 years was observed in 1194 men (18.5%). Use of baseline assessments of cigarette smoking and physical activity in analyses resulted in underestimation of the associations between average cumulative exposure to these factors and major CVD risk. After correction for within-person variation, major CVD rates were over four times higher for heavy smokers (> or =40 cigarettes/day) compared with never smokers and three times higher for physically inactive men compared with moderately active men. Major CVD risk increased by 6% for each 1 kg/m(2) increase in usual BMI. If all men had experienced the risk levels of the men who had never regularly smoked cigarettes, were moderately active, and had a BMI of < or =25 kg/m(2) (6% of the population), 66% of the observed major CVD events would have been prevented or postponed (63% before adjustment for within-person variation). Adjustment for a range of other risk factors had little effect on the results. Similar results were obtained for all-cause mortality.



Failure to take account of within-person variation can lead to underestimation of the importance of lifestyle characteristics in determining CVD risk. Primary prevention through lifestyle modification has a great preventive potential.
Comparing different calcification scores to detect outcomes in chronic kidney disease patients with vascular calcification.

There is no consensus on the most appropriate technique to diagnose vascular calcification in chronic kidney disease. This is primarily because of the absence of direct comparisons of predictive values of the various calcification scores, especially outside the coronary vascular beds, to detect clinical outcomes.



We included 93 haemodialysis patients and performed 6 vascular calcification scores: two scores utilised simple X-rays of abdominal aorta and peripheral vessels. CT scans of the thoracic, upper abdominal and lower abdominal aorta were performed to calculate the aortic calcification index and CT of the pelvis for calcification of iliac vessels. Patients were followed for 63months (mean 46.8months) for first major cardiovascular events and mortality.



Nineteen cardiovascular events and 28 deaths occurred. Calcification was detected more sensitively in central and peripheral beds using CT scans compared to X-rays (p<0.001). CT scans detected calcification more frequently in distal than proximal vascular beds (p<0.001). Calcification of the pelvic vessels and lower abdominal aorta were most predictive of events including pre-existing cardiovascular disease O.R. 6.5 (95% C.I. 2-22; p=0.001) and O.R. 3 (95% C.I. 1.1-9; p=0.035); new major cardiovascular events H.R. 4.2 (95% C.I. 1.5-11; p=0.006) and H.R. 2 (95% C.I. 0.8-5.3; p=0.1) as well as mortality H.R. 2.8 (95% C.I. 1.3-6; p=0.01) and H.R. 2.2 (95% C.I. 1.04-5; p=0.04) respectively.



CT based techniques are more sensitive than plain X-rays at detecting peripheral and aortic vascular calcifications. Distal CT scans of the aorta and pelvic vessels have the highest predictive value for cardiovascular events and mortality.
The association of chronic kidney disease and waist circumference and waist-to-height ratio in Chinese urban adults

This study aims to investigate the association of body mass index (BMI), waist circumference (WC), and waist-to-height ratio (WHtR) with chronic kidney disease (CKD).A cross-sectional survey was conducted in a nationally representative sample of 123,629 Chinese urban adults who participated in health examinations between 2008 and 2009. BMI, WC, and WHtR were measured, as well as serum and urine biochemical tests. CKD was defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m or urine protein positivity (proteinuria)≥1+ with dipstick testing.WHtR had the largest areas under ROC curve for CKD in men and women, followed by WC and BMI. Higher levels of BMI, WC, and WHtR were each associated with an increased odds for CKD among men. For per unit size change, the multivariable-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) of CKD were 1.19 (95% CI, 1.13-1.25) for BMI, 1.12 (95% CI, 1.08-1.16) for WC, and 1.13 (95% CI, 1.10-1.17) for WHtR. The corresponding values were significant in multivariable models among women aged 40 years and above. Using Chinese-recommended cutoffs for BMI (≥24 kg/m), WC (≥85 cm for men, and ≥80 cm for women), and WHtR (≥0.05), WHtR was superior in the association with CKD than BMI for men, whereas WC was superior for women.Increased obesity indices were positively associated with the odds of CKD. Central obesity, defined by WC and WHtR, may be more closely correlated with CKD for Chinese urban adults.
The comparison and validity of troponin I assay systems in diagnosing myocardial ischemic injury after surgical coronary revascularization.

A prospective observational study was conducted to test the agreement between 2 commercially available automated cardiac troponin-I immunoassay systems (Opus Plus, Behring Diagnostics UK Ltd, Hounslow, UK; AxSYM, Abbott Laboratories, Abbott Park, IL) and to determine a normal reference range and threshold value indicative of perioperative myocardial infarction (PMI) after elective coronary artery bypass graft (CABG) surgery for the Opus Plus system.



Prospective, observational study.  Single institution, cardiothoracic specialty hospital.



Seventy patients undergoing elective CABG surgery.



After institutional review board approval, patients received standardized anesthetic, surgical, and myocardial preservation techniques. Serial electrocardiographs, creatine kinase-MB, troponin-I, and perioperative outcome data were collected. Correlation between the immunoassay systems was tested using 124 duplicate samples from the first 18 patients. The normal reference range and threshold value indicative of PMI were tested for the Opus Plus system using duplicate samples from all 70 patients.



Peak troponin-I concentrations (median [interquartile range]) differed significantly when measured by the Opus Plus and AxSYM immunoassay systems (5.61 [3.20-22.35] microg/L v 46.50 [14.55-70.95] microg/L, respectively; p < 0.001). There was clear proportional bias that was corrected with log transformation of the raw data. By using confidence interval and receiver operating characteristic curve analysis, the authors showed that a value > or =15 mug/L was indicative of PMI (Opus Plus system) and accordingly report a 35.7% (2.9% Q-wave) overall incidence of PMI in this study population (n = 70).



These data highlight differences between commercially available troponin-I assay systems. The authors recommend that each institution establish a local reference range and threshold indicative of perioperative myocardial infarction for its specific patient population and assay system and provide sample methodology.
Effects of complementary whole-body vibration training in patients after lung transplantation: A randomized, controlled trial.

In recent years, some studies have shown that whole-body vibration training (WBVT) may be a beneficial training mode in patients with chronic obstructive pulmonary disease (COPD). However, the effects of WBVT in patients after lung transplantation (LTx) have not yet been investigated.



Eighty-three LTx patients (56 ± 7 years of age, 51% male, 10 ± 12 weeks post-LTx, forced expiratory volume in 1 second [FEV1] 68 ± 20 percent predicted [% pred], baseline 6-minute walk distance [6MWD] 350 ± 120 meters) admitted to a 4-week inpatient multidisciplinary program of pulmonary rehabilitation (PR) performed supervised endurance and strength training on 5 days per week. In addition, patients were randomly assigned to 1 of 2 supervised intervention groups on 3 days/week: (1) 4 × 2 minutes of bilateral dynamic squat exercises on a side-alternating vibration platform at 24 to 26 Hz (WBVT); and (2) a control group (CON) with the same amount of exercise time on the floor.



Seventy patients completed the study (WBVT: n = 34; CON: n = 36). Improvement in 6MWD was significantly (p = 0.029) higher in the WBVT group (83.5 meters [95% CI 65.4 to 101.7]) compared with the CON group (55.2 m [95% CI 37.5 to 72.8]). Also, peak work rate increased significantly (p = 0.042) more in the WBVT group (16.8 W [95% CI 13.5 to 20.5]) than in the CON group (12.6 W [95% CI 9.0 to 16.1]). No adverse events related to the intervention occurred during the study.



A complementary WBVT on top of conventional endurance and strength training seems to be a feasible and safe exercise modality in patients after LTx. Furthermore, it may even enhance the benefits of a comprehensive PR on exercise capacity.
Reduced mismatch negativity and increased variability of brain activity in schizophrenia

Schizophrenia patients commonly exhibit smaller amplitudes of mismatch negativity (MMN) than in controls. It remains unclear whether this results from deficient processes indexed by MMN or 'normally' though more variable processing. The present magnetoencephalographic study addressed this question by analyzing intra-individual trial-by-trial variability and MMN amplitude.



Twenty inpatients meeting ICD criteria for schizophrenia and 18 healthy controls participated in an auditory oddball experiment. The neuromagnetic mismatch field (MMNm) was defined as the difference waveform deviant minus standard tone response. Variability index (VI) in different frequency bands was quantified as trial-by-trial variation of stimulus-evoked responses and epoch-by-epoch variation of signal amplitude during a resting condition.



Patients displayed a smaller MMNm amplitude and higher VI during the oddball experiment and during the resting condition than in controls. VI and MMNm amplitude were correlated in controls, but not in patients.



Reduced MMN in schizophrenia cannot be explained by augmented variability of brain activity; deficient auditory sensory memory and stimulus related phase-locking may characterize the disorder.



Understanding the contribution of diminished temporal stability of neuronal network dynamics to schizophrenia is crucial in modeling the impact of such instability on performance and thus for understanding deviant attention and memory functions.
Intradetrusor versus suburothelial onabotulinumtoxinA injections for neurogenic detrusor overactivity: a pilot study

This was a multicentre, prospective, randomised study.To compare the outcomes of intradetrusor and suburothelial onabotulinumtoxinA injections in patients with spinal cord injury and refractory neurogenic detrusor overactivity (Urology departments of two tertiary hospitals in the Czech Republic.A total of 32 spinal cord injury patients with severe NDO refractory to the standard anticholinergic treatment were randomised to receive either intradetrusor or suburothelial 300 IU onabotulinumtoxinA injections. Subjective satisfaction, bladder diary data and urodynamic data were compared in both groups before treatment and at 3 months post treatment.In all, 64.3% patients in the intradetrusor group and 88.8% patients in the suburothelial group were subjectively satisfied with the treatment. There was a significant post-treatment improvement in both groups regarding the number of catheterisations over 24 h, number of incontinence episodes over 24 h, catheterised volume, cystometric capacity, volume at first involuntary detrusor contraction, maximal detrusor pressure during filling and detrusor compliance. No significant differences between the groups were observed, with the exception of improvement of detrusor compliance, which was better in the intradetrusor group. There was one adverse effect comprising transient muscle weakness that was reported by one patient in the intradetrusor group.Results in both groups were comparable. The authors favour suburothelial onabotulinumtoxinA injection because this method allows more precise toxin localisation.