nils-herrmann/clean_scirepeval huggingface dataset:
Comparison of training methods to improve walking in persons with chronic spinal cord injury: a randomized clinical trial.

To compare two forms of device-specific training - body-weight-supported (BWS) ambulation on a fixed track (TRK) and BWS ambulation on a treadmill (TM) - to comprehensive physical therapy (PT) for improving walking speed in persons with chronic, motor-incomplete spinal cord injury (SCI).



Thirty-five adult subjects with a history of chronic SCI (>1 year; AIS 'C' or 'D') participated in a 13-week (1 hour/day; 3 days per week) training program. Subjects were randomized into one of the three training groups. Subjects in the two BWS groups trained without the benefit of additional input from a physical therapist or gait expert. For each training session, performance values and heart rate were monitored. Pre- and post-training maximal 10-m walking speed, balance, muscle strength, fitness, and quality of life were assessed in each subject.



All three training groups showed significant improvement in maximal walking speed, muscle strength, and psychological well-being. A significant improvement in balance was seen for PT and TRK groups but not for subjects in the TM group. In all groups, post-training measures of fitness, functional independence, and perceived health and vitality were unchanged.



Our results demonstrate that persons with chronic, motor-incomplete SCI can improve walking ability and psychological well-being following a concentrated period of ambulation therapy, regardless of training method. Improvement in walking speed was associated with improved balance and muscle strength. In spite of the fact that we withheld any formal input of a physical therapist or gait expert from subjects in the device-specific training groups, these subjects did just as well as subjects receiving comprehensive PT for improving walking speed and strength. It is likely that further modest benefits would accrue to those subjects receiving a combination of device-specific training with input from a physical therapist or gait expert to guide that training.
The Role of Contextual Threat in Predicting Self-Reported Distress among Siblings of Children with Cancer

Each year, 14,000 children are diagnosed with cancer in the United States. Prolonged, intensive treatment regimens disrupt the entire family system, but effects on siblings are poorly understood. In this preliminary investigation, we employed a risk and resistance framework to study adjustment among 30 siblings (aged 10–17) of children undergoing cancer treatment. We examined whether or not objective stress associated with the cancer experience (contextual threat) predicted sibling distress and explored demographic and disease-related predictors of sibling adjustment. Contextual threat was positively associated with sibling-reported distress, independent of sibling age, gender, birth order relative to the child with cancer, and cancer treatment intensity. From among the demographic and disease-related factors, only younger birth order relative to the child with cancer was independently associated with sibling distress. These results suggest that a subset of siblings may be at increased risk for elevated distress in the face of their brother’s or sister’s illness.
Predictive value and utility of oral steroid testing for treatment of COPD in primary care: the COOPT study

The oral prednisolone test is widely used to distinguish chronic obstructive pulmonary disease (COPD) patients who might benefit from inhaled steroid treatment. Previous studies used selected patient groups that did not represent the large COPD population in primary care.



The study included smokers and exsmokers with chronic bronchitis or COPD from primary care, who underwent prednisolone testing (30 mg for 14 days) before randomization in a three-year follow-up randomized controlled trial (COOPT Study). Spirometry was performed before and after the test. Responders and nonresponders were classified according to international criteria. Effectiveness of inhaled fluticasone relative to placebo was compared in terms of health status (Chronic Respiratory Disease Questionnaire), exacerbations, and postbronchodilator forced expiratory volume in one second (FEV(1)), using repeated measurement analysis.



Two hundred eighty-six patients recruited from 44 primary care practices were randomized. Nine percent to 16% of the COPD population was classified as responder, depending on the international guideline criteria used. On average, responders did not reach the minimum clinically important difference in health status (0.29 points/year, P = 0.05), although a borderline significant effect of inhaled fluticasone was noted. Possible clinically relevant reductions in exacerbation rate (rate ratio 0.67) and FEV(1) decline (39 mL/year) occurred in responders, but did not reach statistical significance.



Oral steroid testing identifies a limited proportion of COPD patients, but does not reveal any clinically relevant benefit from inhaled steroid treatment on health status. No significant effects on exacerbation rate and lung function decline occurred.
Did a quality improvement collaborative make stroke care better? A cluster randomized trial

Stroke can result in death and long-term disability. Fast and high-quality care can reduce the impact of stroke, but UK national audit data has demonstrated variability in compliance with recommended processes of care. Though quality improvement collaboratives (QICs) are widely used, whether a QIC could improve reliability of stroke care was unknown.



Twenty-four NHS hospitals in the Northwest of England were randomly allocated to participate either in Stroke 90:10, a QIC based on the Breakthrough Series (BTS) model, or to a control group giving normal care. The QIC focused on nine processes of quality care for stroke already used in the national stroke audit. The nine processes were grouped into two distinct care bundles: one relating to early hours care and one relating to rehabilitation following stroke. Using an interrupted time series design and difference-in-difference analysis, we aimed to determine whether hospitals participating in the QIC improved more than the control group on bundle compliance.



Data were available from nine interventions (3,533 patients) and nine control hospitals (3,059 patients). Hospitals in the QIC showed a modest improvement from baseline in the odds of average compliance equivalent to a relative improvement of 10.9% (95% CI 1.3%, 20.6%) in the Early Hours Bundle and 11.2% (95% CI 1.4%, 21.5%) in the Rehabilitation Bundle. Secondary analysis suggested that some specific processes were more sensitive to an intervention effect.



Some aspects of stroke care improved during the QIC, but the effects of the QIC were modest and further improvement is needed. The extent to which a BTS QIC can improve quality of stroke care remains uncertain. Some aspects of care may respond better to collaboratives than others.
Determination of imatinib plasma levels in patients with chronic myeloid leukemia by high performance liquid chromatography-ultraviolet detection and liquid chromatography-tandem mass spectrometry: methods' comparison.

The aims of this study were to validate and compare HPLC and LCMSMS analytical methods and their applicability for the quantitation of imatinib in human plasma. A total of 50 patients with chronic myeloid leukemia (CML) in chronic phase (CP) receiving 400 mg/day imatinib were enrolled in the study. Drug levels were determined by HPLC-UV and LCMSMS. HPLC intra-day accuracy ranged from 100.51 to 103.19%. LCMSMS accuracy ranged from 89.72 to 106.29%. The correlation coefficient between both methods was r(2)=0.96. HPLC can be used for imatinib levels' determinations in patients accurately and precisely.
Overview and Perspectives of Antihypertensive Treatment

An overview of antihypertensive trials shows that, when absolute rather than relative measures of benefit are considered, a large benefit is derived from treating severe hypertension, whereas in mild hypertension the rate of prevented morbid events is relatively small. However, a greater benefit is observed when a mildly elevated diastolic blood pressure is associated with other risk factors. Thus, antihypertensive therapy in the 1990s needs to be regarded as a component, albeit an important one, in a multiple-strategy approach to prevention and reversal of cardiovascular diseases. At a time when many different classes of antihypertensive agents are available, it is reasonable to ask whether some classes are more suitable than others for the treatment of patients with hypertension and concomitant risk factors such as dyslipidaemias and reduced glucose tolerance. It is well known that thiazide diuretics and β-blockers have potentially adverse effects on lipid and glucose metabolism, that calcium antagonists and ACE-inhibitors are lipid neutral and that α-blockers have potentially favourable effects. Although the real impact of some of these changes is unproven, it is possible that one or more of the metabolic side effects of drugs such as diuretics and β-blockers may offset some of the benefits of reduced blood pressure. Extensive testing of antihypertensive drugs with a favourable profile can be foreseen in the 1990s.
Vitamin D 3 Supplementation and Upper Respiratory Tract Infections in a Randomized , Controlled Trial

Judy R. Rees, Kristy Hendricks, Elizabeth L. Barry, Janet L. Peacock, Leila A. Mott, Robert S. Sandler, Robert S. Bresalier, Michael Goodman, Roberd M. Bostick, and John A. Baron Department of Community and Family Medicine, Section of Biostatistics and Epidemiology, and Department of Pediatrics, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; Division of Health and Social Care Research, King’s College London, and NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, United Kingdom; Department of Medicine, University of North Carolina School of Medicine, Chapel Hill; Department of Gastroenterology, Hepatology and Nutrition, The University of Texas MD Anderson Cancer Center, Houston; and Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, Georgia
The relationship between change in apathy and changes in cognition and functional outcomes in currently non-depressed SSRI-treated patients with major depressive disorder.

Apathy in the context of treated major depressive disorder (MDD) is a frequently observed phenomenon in clinical practice. This study aimed to assess the validity of the Rothschild Scale for Antidepressant Tachyphylaxis® (RSAT) and the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) for measuring apathy, and to assess the relationship between apathy and possible contributing factors, in patients with MDD and residual apathy in the absence of depressed mood.



The underlying structure and validity of the RSAT and CPFQ were assessed via factor analysis and correlation with the Apathy Evaluation Scale-Clinician rated version (AES-C) in 483 patients who had previously responded to treatment with a selective serotonin reuptake inhibitor. The relationship between apathy and contributing variables was investigated via structural equation modeling. Correlation and regression analyses were conducted to examine the relationship between the Sheehan Disability Scale (SDS) and the RSAT, CPFQ, and AES-C.



The RSAT and CPFQ were validated with the AES-C with respect to energy and motivation. The latent variable "Energy and Interest", based on the energy, motivation, and interest items (RSAT and CPFQ), was a major contributing factor to apathy. Improvements in function (SDS) were significantly correlated with, and predicted by, improvements in apathy and cognitive and physical functioning (assessed by the RSAT, CPFQ, and AES-C).



These analyses provide further information on apathy and its assessment in the context of treated MDD. A better understanding of apathy will aid further investigation of this phenomenon and, ultimately, determination of the most appropriate approach for its clinical management.
Cholecystoenterostomy or Choledochoenterostomy for Distal Bile Duct Obstruction?

A prospective evaluation of computerized estimates of risk in the management of obstructive jaundice. Surgery, 473-6 10. A prospective, randomized clinical trial was conducted to assess the efficacy of bilioenteric bypass in noncalculous distal biliary obstruction. Thirty-one patients required bypass for either malignant obstruction or chronic pancreatitis and were randomized into two groups: cholecystoenterostomy or choledochoenterostomy with cholecystectomy [15,16]. Nine bypasses failed after cholecystoenterostomy and two after choledochoenterostomy (p <0.04). Eight of the 9 failures occurred in the subgroup of 22 patients with malignant biliary obstruction. In this subgroup, five bypasses failed within 90 days of operation, all after cholecystoenterostomy (p 0.03 compared with choledochoenterostomy). The results indicate that choledochoenterostomy is the superior operation for malignant distal biliary obstruction. Additional studies will be necessary to identify the procedure ofchoice for benign noncalculous obstructions.  The authors are to be congratulated for conceiving and carrying out a prospective, randomized investigation of the values and defects of cholecystoenterostomy and choledochoenterostomy as alternative bypass conduits for patients with obstructive jaundice. All too often, opinions are given about the value of a method of treatment which are not based on good statistical evidence. Futhermore, surgeons are commonly criticized for not using prospective, randomized trials. Thirty-one patients have been included in their trial, 15 undergoing cholecystenterostomy (CCE) and 16 choledochoenterostomy (CDE). Twenty-two of the patients had malignant jaundice, the remaining nine jaundice secondary to chronic pancreatitis. In the malignant group, 19 patients suffered from pancreatic carcinoma. A variety of other procedures, including gastroenterostomy, pancreaticoduodenectomy, colonic resection and gastrectomy were performed as necessary on selected patients. Patients were randomized according to whether the last digit of their social security number was odd or even. To be included in the trial, the patient needed to have evidence of a dilated common bile duct, a gallbladder and
Efficacy and tolerability of moexipril and nitrendipine in postmenopausal women with hypertension

The aim of this study was to compare the efficacy and tolerability of the new angiotensin-converting enzyme (ACE) inhibitor moexipril and the calcium antagonist nitrendipine in postmenopausal women with mild to moderate hypertension.  After a 4-week placebo run-in period, 93 postmenopausal women (age range 44–70 years) with primary hypertension were randomized to receive moexipril 15 mg once daily or nitrendipine 20 mg once daily for 8 weeks. The mean sitting systolic (SSBP) and sitting diastolic blood pressures (SDBP) at baseline were 161.3/103.0 mmHg in the moexipril group, and 162.2/102.3 mmHg in the nitrendipine group.  After the 8 weeks of treatment, the SSBP/SDBP reductions were −21.2/−15.2 mmHg in the moexipril group and −18.2/−13.6 mmHg in the nitrendipine group. Blood pressure responses were adequate in 82.2% of the moexipril-treated patients and in 80.9% in the nitrendipine-treated group. Adverse events were more frequent with nitrendipine than with moexipril. The most common adverse events in the nitrendipine group were headache (23.4%), flushing (21.3%) and ankle oedema (14.9%). In the moexipril group the most common adverse event was cough (8.9%).  The results of the study suggest that moexipril and nitrendipine are equieffective in the given dosages. In the patient population of postmenopausal women, the ACE inhibitor moexipril appears to have an advantage over the calcium antagonist nitrendipine with regard to tolerability.
Evidence into practice: evaluating a child-centred intervention for diabetes medicine management The EPIC Project

There is a lack of high quality, child-centred and effective health information to support development of self-care practices and expertise in children with acute and long-term conditions. In type 1 diabetes, clinical guidelines indicate that high-quality, child-centred information underpins achievement of optimal glycaemic control with the aim of minimising acute readmissions and reducing the risk of complications in later life. This paper describes the development of a range of child-centred diabetes information resources and outlines the study design and protocol for a randomized controlled trial to evaluate the information resources in routine practice. The aim of the diabetes information intervention is to improve children and young people's quality of life by increasing self-efficacy in managing their type 1 diabetes.



We used published evidence, undertook qualitative research and consulted with children, young people and key stakeholders to design and produce a range of child-centred, age-appropriate children's diabetes diaries, carbohydrate recording sheets, and assembled child-centred, age-appropriate diabetes information packs containing published information in a folder that can be personalized by children and young people with pens and stickers. Resources have been designed for children/young people 6-10; 11-15; and 16-18 years.To evaluate the information resources, we designed a pragmatic randomized controlled trial to assess the effectiveness, cost effectiveness, and implementation in routine practice of individually tailored, age-appropriate diabetes diaries and information packs for children and young people age 6-18 years, compared with currently available standard practice.Children and young people will be stratified by gender, length of time since diagnosis (< 2 years and > 2 years) and age (6-10; 11-15; and 16-18 years). The following data will be collected at baseline, 3 and 6 months: PedsQL (generic, diabetes and parent versions), and EQ-5 D (parent and child); NHS resource use and process data (questionnaire and interview). Baseline and subsequent HbA1c measurements, blood glucose meter use, readings and insulin dose will be taken from routine test results and hand-held records when attending routine 3-4 monthly clinic visits.The primary outcome measure is diabetes self-efficacy and quality-of-life (Diabetes PedsQL). Secondary outcomes include: HbA1c, generic quality of life, routinely collected NHS/child-held data, costs, service use, acceptability and utility.
Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08).

Elevated concentrations of doxorubicin are found in eccrine sweat glands of the palms and soles. We therefore evaluated an antiperspirant as preventive treatment for palmar-plantar erythrodysesthesia (hand-foot syndrome) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin.



An antiperspirant containing aluminum chlorohydrate or placebo cream was applied to the left or right hand and foot in a double-blinded manner (intra-patient randomization). The primary endpoint was the rate of grade 2 or 3 palmar-plantar erythrodysesthesia. A secondary endpoint was the patient-reported symptom burden (tingling, numbness, pain, or skin problems). Using McNemar's matched pairs design, 53 patients were needed to detect a 20% difference between the treatment and placebo sides with a significance level of 5% and power of 90%.



Grade 2 or 3 PPE occurred in 30 (58%) of 52 evaluable patients; in six patients adverse effects occurred on the placebo side but not on the treatment side, whereas one patient developed palmar-plantar erythrodysesthesia on the treatment side only (P = 0.07). Four patients developed grade 2 or 3 palmar-plantar erythrodysesthesia on their foot on the placebo side but not on the treatment side (P = 0.05). In the cohort with grade 2 or 3 palmar-plantar erythrodysesthesia there was a trend towards fewer dermatologic symptomatologies with the active treatment (P = 0.05), and no difference for other adverse events.



Using topical aluminum chlorohydrate as an antiperspirant appears to reduce the incidence of grade 2 or 3 palmar-plantar erythrodysesthesia following pegylated liposomal doxorubicin chemotherapy for metastatic breast cancer.
Serum amyloid A-related inflammation is lowered by increased fruit and vegetable intake, while high-sensitive C-reactive protein, IL-6 and E-selectin remain unresponsive.

The present study assessed whether increased fruit and vegetable (F&V) intake reduced the concentrations of the inflammatory marker serum amyloid A (SAA) in serum, HDL2 and HDL3 and whether the latter reduction influenced any of the functional properties of these HDL subfractions. The present study utilised samples from two previous studies: (1) the FAVRIT (Fruit and Vegetable Randomised Intervention Trial) study - hypertensive subjects (systolic blood pressure (BP) range 140-190 mmHg; diastolic BP range 90-110 mmHg) were randomised to receive a 1-, 3- or 6-portion F&V/d intervention for 8 weeks, and (2) the ADIT (Ageing and Dietary Intervention Trial) study - older subjects (65-85 years) were randomised to receive a 2- or 5-portion F&V/d intervention for 16 weeks. HDL2 and HDL3 were isolated by rapid ultracentrifugation. Measurements included the following: serum high-sensitive C-reactive protein (hsCRP) by an immunoturbidimetric assay; serum IL-6 and E-selectin and serum-, HDL2- and HDL3-SAA by ELISA procedures; serum-, HDL2- and HDL3-cholesterol ester transfer protein (CETP) activity by a fluorometric assay. Although the concentrations of hsCRP, IL-6 and E-selectin were unaffected by increasing F&V intake in both studies (P>0·05 for all comparisons), those of SAA in HDL3 decreased in the FAVRIT cohort (P= 0·049) and those in HDL2 and HDL3 decreased in the ADIT cohort (P= 0·035 and 0·032), which was accompanied by a decrease in the activity of CETP in HDL3 in the FAVRIT cohort (P= 0·010) and in HDL2 in the ADIT cohort (P= 0·030). These results indicate that SAA responds to increased F&V intake, while other inflammatory markers remain unresponsive, and this leads to changes in HDL2 and HDL3, which may influence their antiatherogenic potential. Overall, the present study provides tangible evidence of the effectiveness of increased F&V intake, which may be of use to health policy makers and the general public.