nils-herrmann/clean_scirepeval huggingface dataset:
Selecting constant work rates for endurance testing in COPD: the role of the power-duration relationship.

Constant work rate (CWR) exercise testing is highly responsive to therapeutic interventions and reveals physiological and functional benefits. No consensus exists, however, regarding optimal methods for selecting the pre-intervention work rate. We postulate that a CWR whose tolerated duration (tlim) is 6 minutes (WR6) may provide a useful interventional study baseline. WR6 can be extracted from the power-duration relationship, but requires 4 CWR tests. We sought to develop prediction algorithms for easier WR6 identification using backward stepwise linear regression, one in 69 COPD patients (FEV1 45 ± 15% pred) and another in 30 healthy subjects (HLTH), in whom cycle ergometer ramp incremental (RI) and CWR tests with tlim of ∼6 minutes had been performed. Demographics, pulmonary function, and RI responses were used as predictors. We validated these algorithms against power-duration measurements in 27 COPD and 30 HLTH (critical power 43 ± 18W and 231 ± 43W; curvature constant 5.1 ± 2.7 kJ and 18.5 ± 3.1 kJ, respectively). This analysis revealed that, on average, only corrected peak work rate ( = WRpeak-1 min × WRslope) in RI was required to predict WR6 (COPD SEE = 5.0W; HLTH SEE = 5.6W; R(2) > 0.96; p < 0.001). In the validation set, predicted and actual WR6 were strongly correlated (COPD R(2) = 0.937; HLTH 0.978; p < 0.001). However, in COPD, unlike in HLTH, there was a wide range of tlim values at predicted WR6: COPD 8.3 ± 4.1 min (range 3.6 to 22.2 min), and HLTH 5.5 ± 0.7 min (range 3.9 to 7.0 min). This analysis indicates that corrected WRpeak in an incremental test can yield an acceptable basis for calculating endurance testing work rate in HLTH, but not in COPD patients.
rhGM-CSF vs placebo following rhGM-CSF-mobilized PBPC transplantation: a phase III double-blind randomized trial

In this placebo-controlled randomized trial we evaluated the hematological and clinical effects of r-Hu GM-CSF after high-dose chemotherapy (HDC) followed by GM-CSF-mobilized PBPC transplantation. Fifty patients with poor prognosis malignancies were randomized in a double-blind study to receive either GM-CSF or placebo after HDC followed by PBPC rescue. For all patients, PBPCs were recruited using a combination of VP-16 (300 mg/m2 on days 1 and 2), cytoxan (3 g/m2 on days 3 and 4) and GM-CSF (5 μ g/kg from day 5). No differences were demonstrated between the two groups in median time to neutrophil or platelet recoveries. There was no significant difference between the GM-CSF group and the placebo group in the median duration of post-transplant hospitalization, in the number of days of antibiotic treatment, in the number of infections and in red blood cell or platelet transfusion requirements. There was a significant difference with an advantage for the placebo group in the mean duration of febrile days (P = 0.01). We conclude that the administration of GM-CSF in patients transplanted with GM-CSF-mobilized PBPC is not associated with a clinical benefit in term of tempo of engraftment, numbers of documented infections, transfusion requirements and mucositis grading.
Evaluation of an occupational therapy program for patients with spinal cord injury

Clinical controlled trial.To evaluate the effectiveness of an occupational therapy (OT) program combined with neuromotor rehabilitation, by assessing the degree of functional independence reached by patients with spinal cord injuries at first hospitalization.Subjects selected from the Spinal Cord Unit of the Rehabilitation Institute of Montecatone (Imola, Thirty-six male patients below age 60, with complete paraplegia (ASIA-A) in thoracic-lumbar level, at first hospitalization.Patients were divided into experimental and control groups. Subjects in the experimental group underwent neuromotor rehabilitation coupled with an OT program, whereas those in the control group followed neuromotor rehabilitation only. Increase in functional independence at discharge was evaluated by the Valutazione Funzionale Mielolesi (VFM) assessment scale.Patients in the experimental group showed a significant increase in the total VFM score, and in domains concerning transfers and wheelchair use. A significant improvement was observed in unmarried patients as compared to married ones.An OT service within a Spinal Cord Unit allows us to achieve a higher level of functional independence.
Population pharmacokinetics of melphalan in patients with multiple myeloma undergoing high dose therapy.

To i) investigate the pharmacokinetics of total and unbound plasma melphalan using a population approach, ii) identify clinical factors that affect melphalan disposition and iii) evaluate the role of melphalan exposure in melphalan-related toxicity and disease response.



Population pharmacokinetic modelling (using NONMEM) was performed with total and unbound concentration-time data from 100 patients (36-73 years) who had received a median 192 mg m(-2) melphalan dose. Model derived estimates of total and unbound melphalan exposure (AUC) in patients with serious melphalan toxicity and those who had a good disease response (>or=90% decrease in paraprotein concentrations) were compared using the Mann-Whitney test.



A two compartment model generated population mean estimates for total and unbound melphalan clearance (CL) of 27.8 and 128 l h(-1), respectively. Estimated creatinine clearance, fat free mass and haematocrit were important determinants of total and unbound CL, reducing the inter-individual variability in total CL from 34% to 27% and in unbound CL from 42% to 30%. Total AUC (range 4.9-24.4 mg l(-1) h) and unbound AUC (range 1.0-6.5 mg l(-1) h) were significantly higher in patients who had oral mucositis (>or=grade 3) and long hospital admissions (P < 0.01). Patients who responded well had significantly higher unbound AUC (median 3.2 vs. 2.8 mg l(-1) h, P < 0.05) when assessed from diagnosis to post-melphalan and higher total AUC (median 21.3 vs. 13.4 mg l(-1) h, P= 0.06), when assessed from pre- to post-melphalan.



Creatinine clearance, fat free mass and haematocrit influence total and unbound melphalan plasma clearance. Melphalan exposure is related to melphalan toxicity while the association with efficacy shows promising trends that will be studied further.
Improving stroke rehabilitation. A controlled study.

Assessment of stroke rehabilitation is complicated by the heterogeneity of patients and settings and by difficulties in disentangling effects of organization from effects of types and amounts of treatment input.



A prospective controlled study was undertaken in 245 stroke patients stratified into three groups according to prognosis and managed on a stroke rehabilitation unit (n = 124) or general medical wards (n = 121). Patients were randomly allocated to either setting 2 weeks after stroke and were comparable for baseline characteristics.



Patients on general medical wards received more physiotherapy on average (16.2 +/- 7.2 versus 14.3 +/- 3.2 hours; P < .05) but similar amounts of occupational therapy (9.3 +/- 2.8 versus 9.5 +/- 3.2 hours) compared with stroke unit patients. More time was spent on individual rehabilitation on the stroke unit compared with general wards (P < .001). Functional abilities at discharge, destination of discharge, and length of hospital stay in patients with good prognosis were comparable in both settings. Patients with poor prognosis managed on general wards showed higher mortality (P < .05) and longer hospital stay (123.2 +/- 48.2 versus 52.3 +/- 19.8 days; P < .001), but functional abilities at discharge in survivors were comparable with those of stroke unit patients. Patients with intermediate prognosis had significantly better outcome on the stroke unit, with more patients being discharged home (75% versus 52%; P < .001), shorter average length of hospital stay (48.7 +/- 17.2 versus 104.6 +/- 28.6 days; P < .001), and better functional abilities at discharge (P < .05).



Stroke units improve outcome and reduce hospital stay without increasing therapy time. Their effectiveness may be enhanced by patient selection.
Communication style and exercise compliance in physiotherapy (CONNECT). A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods

Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist's recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients' autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists' recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists' autonomy-supportive communication on low back pain patients' adherence to physical activity and exercise therapy recommendations.



This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12) in Dublin, Ireland (population = 1.25 million) will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics) will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics) will not receive this training. Participants (N = 292) with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as they will not be told if their physiotherapist has received the communication skills training. Outcome assessors will also be blinded.We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects.



This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients' adherence to rehabilitation recommendations.
Genetic influences on mechanically-assessed activity level in children.

Activity level is an important component of children's temperament, as well as being part of the core symptom domain of hyperactivity-impulsivity within attention deficit hyperactivity disorder (ADHD). Yet it is poorly understood, due partly to limitations on parent and teacher ratings, which are typically used as measurements of these symptoms.



We aimed to study the etiology of objectively-measured activity level across two situations, using actigraphs. A population-based sample of 463 7-9-year-old twin pairs were assessed individually both when apart undergoing laboratory-based cognitive testing and when together during a break in testing.



Heritability of activity level was estimated as 24% during the test session and at 30% during the break in testing. Shared environmental influences accounted for 27% of the variance in activity level during the test session and 42% of activity level measured during the break. A genetic correlation of 1.0 indicated that the same genes influenced activity level across the two situations, justifying the use of a composite measure of the two situations. This produced a heritability estimate of 36%.



Objectively-measured activity level shows a moderate degree of genetic influence, with a common set of genes influencing activity level across situations. This supports the use of actigraphs as an additional source of information in studies that aim to improve phenotype definition for molecular genetic studies of activity level and ADHD.
Estimated GFR Before and After Bariatric Surgery in CKD.

Several reviews have recently detailed the beneficial effects of weight loss surgery for kidney function. However, these studies have a number of limitations, including small sample size, few done in chronic kidney disease (CKD) stages 3 and 4, and many not including the main bariatric surgery procedures used in the United States today.



This was an observational retrospective cohort study comparing propensity score-matched bariatric surgery patients and nonsurgery control patients who were referred for, but did not have, surgery. Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy were also compared using propensity matching.



Patients (714 surgery patients; 714 controls) were from a large integrated health care system, a mean of 58±8 (SD) years old, and mostly women (77%) and non-Hispanic whites (56%) and had diabetes mellitus (66%) and/or hypertension (91%).



Predictors at the time of surgery or referral to surgery were age, sex, race/ethnicity, weight, and presence of diabetes and/or hypertension.



The primary outcome for this study was change in estimated glomerular filtration rate (eGFR) from serum creatinine level over a median 3-year follow-up period.



Serum creatinine was used to calculate eGFR using the CKD-EPI (CKD Epidemiology Collaboration) creatinine equation.



Surgery patients had 9.84 (95% CI, 8.05-11.62) mL/min/1.73m2 greater eGFRs than controls at a median 3 years' follow-up and RYGB patients had 6.60 (95% CI, 3.42-9.78) mL/min/1.73m2 greater eGFRs than sleeve gastrectomy patients during the same period.



This study is limited by its nonrandomized observational study design, estimation of GFR, and large changes in muscle mass, which may affect serum creatinine level independent of changes in kidney function.



Bariatric surgery, especially the RYGB procedure, results in significant improvements for up to 3 years in eGFRs for patients with CKD stages 3 and 4.
Non-invasive 16-row multislice CT coronary angiography: usefulness of saline chaser

The aim of this study was to investigate the usefulness of saline chaser in 16-row multislice CT (16-MSCT) coronary angiography. Forty-two patients were divided into two groups for contrast material (CM) administration: group 1 (140 ml at 4 ml/s) and group 2 (100 ml at 4 ml/s followed by 40 ml of saline chaser at 4 ml/s). All patients underwent retrospectively ECG-gated 16-MSCT coronary angiography. The attenuation at the origin coronary vessels was assessed. Three regions of interest (ROIs) were drawn throughout the data set: (a) ascending aorta (ROI 1); (b) descending aorta (ROI 2); and (c) pulmonary artery (ROI 3). The attenuation in the superior vena cava was recorded (ROI 4). The average attenuation and the slope were calculated in each ROI and differences were assessed with a Student’s t test. The average attenuation in the coronary vessels was not significantly different in the two groups. The average attenuations in ROI 1 were 325 and 327 HU, in ROI 2 were 328 and 329 HU and in ROI 3 were 357 and 320 HU, for groups 1 and 2, respectively (p>0.05). The slopes in ROI 1 were −0.2 and 1.1, in ROI 2 were 2.8 and 2.1 (p>0.05) and in ROI3 were 3.9 and −9.0 (p<0.05), for groups 1 and 2, respectively. The average attenuations in ROI 4 were 927 and 643 HU (p<0.05), for groups 1 and 2, respectively. One hundred milliliters of CM with 40 ml of saline chaser provides the same attenuation as 140 ml of CM (35% less) with decreased hyper-attenuation in the superior vena cava.
Feasibility and acceptability of web-based enhanced relapse prevention for bipolar disorder (ERPonline): trial protocol.

Relapse prevention interventions for Bipolar Disorder are effective but implementation in routine clinical services is poor. Web-based approaches offer a way to offer easily accessible access to evidence based interventions at low cost, and have been shown to be effective for other mood disorders.



This protocol describes the development and feasibility testing of the ERPonline web-based intervention using a single blind randomised controlled trial. Data will include the extent to which the site was used, detailed feedback from users about their experiences of the site, reported benefits and costs to mental health and wellbeing of users, and costs and savings to health services. We will gain an estimate of the likely effect size of ERPonline on a range of important outcomes including mood, functioning, quality of life and recovery. We will explore potential mechanisms of change, giving us a greater understanding of the underlying processes of change, and consequently how the site could be made more effective. We will be able to determine rates of recruitment and retention, and identify what factors could improve these rates.



The findings will be used to improve the site in accordance with user needs, and inform the design of a large scale evaluation of the clinical and cost effectiveness of ERPonline. They will further contribute to the growing evidence base for web-based interventions designed to support people with mental health problems.
Effects of behavioral and pharmacological therapies on peer reinforcement of deviancy in children with ADHD-only, ADHD and conduct problems, and controls.

This study compared the unique and combined effects of evidence-based treatments for ADHD-stimulant medication and behavior modification-on children's rates of reinforcement for deviant peer behavior (RDPB).



Using a within-subjects design, 222 elementary school-age children attending a summer treatment program, including 151 children with ADHD (127 male), with and without comorbid conduct problems, and 71 control children (57 male), received varying combinations of behavior modification (no, low-intensity, and high-intensity) and methylphenidate (placebo, 0.15 mg/kg, 0.30 mg/kg, and 0.60 mg/kg). RDPB was measured through direct observation and compared across all behavior modification and medication conditions.



Children with ADHD reinforced the deviant behavior of their peers at a significantly higher rate than control children in the absence of either intervention. However, that difference largely disappeared in the presence of both behavior modification and medication. Both low and high-intensity behavior modification, as well as medium (0.30 mg/kg) and high (0.60 mg/kg) doses of methylphenidate, significantly reduced the rate of ADHD children's RDPB to levels similar to the control group.



Results indicate that although untreated children with ADHD do engage in RDPB at a greater rate than their non-ADHD peers, existing evidence-based interventions can substantially decrease the presence of RDPB, thereby limiting potential iatrogenic effects in group-based treatment settings.
The effect of PTH(1–84) or strontium ranelate on bone formation markers in postmenopausal women with primary osteoporosis: results of a randomized, open-label clinical trial

We explored the effects of PTH(1–84) compared with strontium ranelate on bone remodeling as measured by bone remodeling markers in postmenopausal women with osteoporosis. Biochemical markers of bone formation were significantly increased after treatment with PTH(1–84) but not strontium ranelate, indicating a different mechanism of action between these agents. PTH(1–84) and strontium ranelate (SR) are both known to reduce fracture risk in osteoporosis. Measuring changes in biochemical markers of bone turnover induced by these agents can help in characterizing the action of PTH(1–84) and SR on bone remodeling. A 24-week, randomized, open-label, parallel group, phase IV trial was conducted in 81 postmenopausal women with primary osteoporosis (≥50 years of age, lumbar spine, or total hip T-score ≤−2.5 SD) to assess the effect of SR as compared to PTH(1–84) on bone formation markers P1NP and BSAP. The bone resorption marker CTX was also measured. Subjects were randomly assigned to receive daily either 100 μg PTH(1–84) (n = 41) (subcutaneous injection) or oral 2 g SR (n = 40) for 24 weeks with daily supplements of 800 IU vitamin D3 and 1,000 mg calcium. Patient-reported outcomes were collected to investigate the effect of treatment on quality of life (QoL). Percentage changes from baseline in P1NP and BSAP were significantly increased for PTH(1–84) by week 24 compared with SR (p < 0.0001). Significant changes from baseline in P1NP and BSAP were noted for PTH(1–84) from week 4 onwards; no significant changes were noted for SR. A trend towards a positive impact on QoL was seen with PTH(1–84) treatment. Safety profiles concur with previous analyses. PTH(1–84) had a more rapid and higher effect on bone formation markers compared to SR, indicating that SR has a different mode of action on bone remodeling than the bone building agent PTH(1–84) in postmenopausal women with osteoporosis.
The Role of Endogenous Incretin Secretion as Amplifier of Glucose-Stimulated Insulin Secretion in Healthy Subjects and Patients With Type 2 Diabetes

In order to quantify the role of incretins in first- and second-phase insulin secretion (ISR) in type 2 diabetes mellitus (T2DM), a double-blind, randomized study with 12 T2DM subjects and 12 healthy subjects (HS) was conducted using the hyperglycemic clamp technique together with duodenal nutrition perfusion and intravenous infusion of the glucagon-like peptide 1 (GLP-1) receptor antagonist exendin(9-39). Intravenous glucose alone resulted in a significantly greater first- and second-phase ISR in HS compared with T2DM subjects. Duodenal nutrition perfusion augmented both first- and second-phase ISR but first-phase ISR more in T2DM subjects (approximately eight- vs. twofold). Glucose-related stimulation of ISR contributed only 20% to overall ISR. Infusion with exendin(9-39) significantly reduced first- and second-phase ISR in both HS and T2DM subjects. Thus, both GLP-1 and non-GLP-1 incretins contribute to the incretin effect. In conclusion, both phases of ISR are impaired in T2DM. In particular, the responsiveness to glucose in first-phase ISR is blunted. GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) secretions are unaltered. The absolute incretin effect is reduced in T2DM; its relative importance, however, appears to be increased, highlighting its role as an important amplifier of first-phase ISR in T2DM.