nils-herrmann/clean_scirepeval huggingface dataset:
Hemispatial neglect and rehabilitation in acute stroke.

To compare 2 methods for determining neglect in patients within 2 days of stroke, and to investigate whether early neglect was related to rehabilitation practice, and whether this relationship was affected by an early, intensive mobilization intervention.



Data were collected from patients participating in a phase II randomized controlled trial of early rehabilitation after stroke.



Acute hospital stroke unit.



Stroke patients (N=71).



The 2 arms of the trial were very early mobilization (VEM) and standard care (SC).



Neglect was assessed using the Star Cancellation Test and the National Institutes of Health Stroke Scale (NIHSS) inattention item within 48 hours of stroke onset, and therapy details were recorded during the hospital stay.



Assessing neglect so acutely after stroke was difficult: 29 of the 71 patients were unable to complete the Star Cancellation Test, and agreement between this test and the NIHSS measure was only .42. Presence of neglect did not preclude early mobilization. SC group patients with neglect had longer hospital stays (median, 11d) than those without neglect (median, 4d); there was no difference in length of stay between patients with and without neglect in the VEM group (median, 6d in both).



Early mobilization of patients with neglect was feasible and may contribute to a shorter acute hospital stay.
A comparison of 16 weeks of continuous vs intermittent exercise training in chronic heart failure patients.

The authors compared the effects of continuous (CON) and intermittent (INT) exercise training programs on functional capacity, quality of life (QOL), and cardiac function in 23 congestive heart failure patients. Patients were randomized to CON exercise training (n=13; aged 66±7 years; peak oxygen consumption [VO(2)], 12.4±2.5 mL/kg/min; weight, 83±12 kg; left ventricular ejection fraction [LVEF], 29.5%±7.2%) or INT exercise training (n=10; aged 59±11 years; VO(2), 12.2±6.5 mL/kg/min; weight, 87±24 kg; LVEF 27%±7.9%). These groups completed 16 weeks of stationary cycling at 70% VO(2) thrice weekly for 30 minutes continuously or 60 minutes (60 seconds work:60 seconds rest) intermittently; both groups completed the same absolute volume of work. Three QOL questionnaire responses, VO(2), LVEF, and regional tissue Doppler were quantified. After exercise training, VO(2) increased by 13% in the CON group (P=.12) and significantly by 21% in the INT group (P=.03), although not significantly between the groups (P=.72). In the CON group, Minnesota Living With Heart Failure score improved at 16 weeks (P=.02), while in the INT group, Hare-Davis scores improved (P=.02). Cardiac volumes, resting and peak LVEF, contractile reserve, and tissue velocities were all unchanged from baseline. Intermittent exercise may improve functional capacity to a greater extent than continuous exercise. QOL changes were variable between groups.
Dexmedetomidine impairs success of patient-controlled sedation in alcoholics during ERCP: a randomized, double-blind, placebo-controlled study

There is a lack of studies about procedural sedation of alcoholics. Dexmedetomidine is recommended for procedural sedation and reported effective for alcohol withdrawal. We evaluated the suitability of dexmedetomidine for sedation of alcoholics during endoscopic retrograde cholangiopancreatography (ERCP). Fifty patients with chronic alcoholism scheduled for elective ERCP were randomized 1:1 to receive dexmedetomidine (Dex group) (loading dose 1 μg kg−1 over 10 min, followed by constant intravenous infusion 0.7 μg kg−1 h−1) or saline placebo (P group). Patient-controlled sedation with propofol–alfentanil was used by patients as a rescue method. Sedation was considered as successful if no intervention of an anesthesiologist was needed. Consumption of sedatives was registered, and sedation levels and vital signs were monitored. Dexmedetomidine alone was insufficient in all patients. The mean ± SD consumption of propofol was 159 ± 72 mg in the P group, and 116 ± 61 mg in the Dex group (p = 0.028). Sedation was successful in 19 of 25 (76 %) patients in the Dex group and in all patients in the P group (p = 0.022). The incidence of sedation adverse events did not differ between the groups. Dexmedetomidine was associated with delayed recovery. Patient-controlled sedation with propofol and alfentanil but not dexmedetomidine can be recommended for sedation of alcoholics during ERCP.
Telephone interpersonal counseling with women with breast cancer: symptom management and quality of life.

To examine the effectiveness of a telephone interpersonal counseling (TIP-C) intervention compared to a usual care attentional control for symptom management (depression and fatigue) and quality of life (positive and negative affect, stress) for women with breast cancer.



Experimental with repeated measures.



Academic cancer center and urban, private oncology offices.


SAMPLE
48 women with breast cancer who were in their mid-50s, married, and employed at the time of the study.



Women were assigned to either the six-week TIP-C or attentional usual care groups. Women were matched on stage and treatment. Data were collected at baseline, after the six interventions, and one month postintervention. Measures included the Center for Epidemiologic Studies Depression Scale, Positive and Negative Affect Schedule, Multidimensional Fatigue Inventory, and Index of Clinical Stress.



Depression, positive and negative affect, fatigue, and stress.



Women in the intervention group experienced decreases in depression, fatigue, and stress over time and increases in positive affect.



The preliminary results partially supported the effectiveness of TIP-C for symptom management and quality of life. The authors hypothesized that decreased depression, reduced negative affect, decreased stress, decreased fatigue, and increased positive affect over time would be the resulting psychosocial effects, given the theoretical underpinnings of the intervention.



Nurses need to assess the quantity and quality of the social support network early in treatment; women with less social support need to be referred to counseling and support services. Because these women have limited participation in face-to-face interventions, they should be encouraged to participate in telephone or online support programs or in other programs or organizations (e.g., churches, social clubs) that would provide support.
Lack of short-term effect of the thromboxane synthetase inhibitor UK-38,485 on airway reactivity to methacholine in asthmatic subjects.

Previous open studies have suggested that thromboxane receptor antagonists or synthesis inhibitors lower airway hyperresponsiveness in human subjects. This would indicate a role of thromboxane A2 in the development or maintenance of hyperresponsiveness in asthma. Ten nonsmoking asthmatics (aged 23-64 yrs, 9 male) were included in a randomized, double-blind, placebo-controlled, cross-over study of the effect of one week of treatment with a potent selective thromboxane synthetase inhibitor (UK-38,485, 600 mg daily) on airway responsiveness. The study was preceded by a two week run-in period, and two weeks were used for wash-out between the two trial periods. Adequacy of dosage and patient compliance was confirmed by a reduction in the ex vivo formation of thromboxane B2 (median concentration 3.22 micrograms.ml-1 after placebo, 0.10 microgram.ml-1 after UK-38,485, p < 0.05). The mean forced expiratory volume in one second (FEV1) after UK-38,485 was 2.55 l, compared to 2.56 l after treatment with placebo (p = 0.74). The geometric mean provocative dose of methacholine producing a 20% fall in FEV1 (PD20) before and after UK-38,485 was 23.9 and 32.2 micrograms, respectively, compared to 25.1 and 26.3 micrograms respectively, before and after placebo (p = 0.31). The results of this study suggest that thromboxane A2 does not play an important role in the maintenance of increased airway responsiveness in moderately severe asthmatics treated with low doses of inhaled steroids.
Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease).

The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested.



Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory.



In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.



Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months.



This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244).
Establishing reference values for central blood pressure and its amplification in a general healthy population and according to cardiovascular risk factors.

Estimated central systolic blood pressure (cSBP) and amplification (Brachial SBP-cSBP) are non-invasive measures potentially prognostic of cardiovascular (CV) disease. No worldwide, multiple-device reference values are available. We aimed to establish reference values for a worldwide general population standardizing between the different available methods of measurement. How these values were significantly altered by cardiovascular risk factors (CVRFs) was then investigated.



Existing data from population surveys and clinical trials were combined, whether published or not. Reference values of cSBP and amplification were calculated as percentiles for 'Normal' (no CVRFs) and 'Reference' (any CVRFs) populations. We included 45,436 subjects out of 82,930 that were gathered from 77 studies of 53 centres. Included subjects were apparently healthy, not treated for hypertension or dyslipidaemia, and free from overt CV disease and diabetes. Values of cSBP and amplification were stratified by brachial blood pressure categories and age decade in turn, both being stratified by sex. Amplification decreased with age and more so in males than in females. Sex was the most powerful factor associated with amplification with 6.6 mmHg (5.8-7.4) higher amplification in males than in females. Amplification was marginally but significantly influenced by CVRFs, with smoking and dyslipidaemia decreasing amplification, but increased with increasing levels of blood glucose.



Typical values of cSBP and amplification in a healthy population and a population free of traditional CVRFs are now available according to age, sex, and brachial BP, providing values included from different devices with a wide geographical representation. Amplification is significantly influenced by CVRFs, but differently in men and women.
Rationale and design of a randomized trial on the impact of aldosterone antagonism on cardiac structure and function in diabetic cardiomyopathy

Development of a cardiomyopathy in diabetes mellitus is independent of traditional risk factors, with no clinical trials targeting specific therapeutic interventions. Myocardial fibrosis is one of the key mechanisms and aldosterone is a key mediator of myocardial fibrosis. We propose that aldosterone antagonism will improve cardiac function. We aim to evaluate the efficacy of selective aldosterone receptor antagonism with eplerenone added to optimal medical treatment in improving cardiac structure and function in diabetic cardiomyopathy. We will randomize 130 patients with type 2 diabetes mellitus, stable metabolic control and impaired left ventricular (LV) systolic or diastolic function, to either eplerenone (target dose 50mg) or matching placebo, in addition to optimal medical therapy for 12 months. The primary endpoints are changes in LV systolic and diastolic function, measured by echocardiographic 2-dimensional speckle tracking strain and strain rate and tissue Doppler imaging. The secondary endpoints include changes in echocardiographic markers and plasma biomarkers of collagen turnover; left atrial dimensions and function, incidence of atrial fibrillation and changes in exercise capacity and dyspnea score. The present study will assess whether specific aldosterone antagonism with eplerenone in addition to standard therapy will prevent progression or reverse cardiac dysfunction in diabetic cardiomyopathy using sensitive, robust and quantifiable echocardiographic measures that allow early detection of change. The study may offer a new direction in the management of this condition.
Comparison of Zotarolimus-Eluting stent versus Sirolimus-Eluting stent for de novo coronary artery disease in patients with diabetes mellitus from the ESSENCE-DIABETES II trial.

Angiographic and clinical outcomes remain relatively unfavorable for diabetic patients even after the use of drug-eluting stent. This prospective, multicenter, randomized study compared the relative efficacy and safety of resolute zotarolimus-eluting stent (R-ZES) and sirolimus-eluting stent (SES) implantation in diabetic patients with coronary artery disease. The primary end point was noninferiority of angiographic in-segment late loss at 9 months. Clinical events were also monitored for at least 12 months. Patient recruitment was prematurely stopped after enrollment of 256 patients (127 in R-ZES group and 129 in SES) because of discontinuing production of SES. The R-ZES was noninferior to the SES for 9-month in-segment late loss (0.34 ± 0.30 vs 0.39 ± 0.43 mm; difference -0.048; 95% confidence interval -0.157 to 0.061; upper 1-sided 95% confidence interval 0.044; p <0.001 for noninferiority). In addition, in-stent late loss (0.22 ± 0.29 vs 0.21 ± 0.40 mm, p = 0.849) and the rates of in-segment (1.2% vs 6.7%, p = 0.119) and in-stent (1.2% vs 3.3%, p = 0.621) binary restenoses were similar between the 2 groups. At 12 months, there were no statistical differences between the 2 groups in the incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, ischemia-driven target lesion revascularization, ischemia-driven target vessel revascularization, and composite outcomes). In conclusion, despite having reduced power because of early study termination, our study suggests that the R-ZES has noninferior angiographic outcomes at 9 months to the SES in diabetic patients with coronary artery disease.
The Effects of Armillarisin A on Serum IL-1β and IL-4 and in Treating Ulcerative Colitis

To study the therapeutic effect of Armillarisin A on patients with ulcerative colitis (UC) and on serum IL-1β and IL-4, sixty patients with UC were randomly divided into three groups: Armillarisin A treatment group (Group I), Armillarisin-combined hormone therapy group (Group II), and hormones treatment as the control group (Group III). Patients in Group I received Armillarisin A 10 mg enema in 100 ml saline. Patients in Group II received Armillarisin A 10 mg and dexamethasone 5 mg enema in 100 ml saline. Patients in Group III received only dexamethasone 5 mg enema in 100 ml saline. The therapeutic efficacy and serum levels of IL-4 and IL-1β were observed. After 4 week treatment, the total effective rates were 90.0 % in Group I and 95.0 % in Group II. Both are higher than it in control group, which was 70.0 %. The serum levels of IL-4 in Groups I and II were significantly higher than it in control group. Compared to IL-4 levels before treatment, the levels of IL-4 after treatment were significantly higher in both Groups I and II. The serum levels of IL-11β were significantly decreased in Groups I and II in comparison to it in control group. Compared to the levels of IL-1β before treatment, the levels of IL-1β were significantly decreased. Armillarisin A shows a significant effect in treating UC. It helps increase IL-4 and lower IL-1β and the mechanism may be related to the body’s immunity regulation.
Obesity and blood pressure in the elderly free-living population

The aim of presented analysis was to determine the relationship between blood pressure (BP) and different indices of obesity in the elderly free-living population. In 317 inhabitants of the randomly chosen area of Cracow (70 years old and older) who could come to the out-patient clinic for an interview, BP, weight and height were taken. Body mass index (BMI) was used to classify the population into lean (BMI < 25 kg/m2), overweight (25 ⩽ BMI < 30 kg/m2) and obese (BMI ⩾ 30 kg/m2) subjects. In order to separate the effect of adipose tissue and lean body mass, weight of total adipose tissue (AT) and lean body mass (LBM) were calculated according to the anthropometric CT-calibrated equations. Obese patients had a significantly higher systolic BP (SBP) when compared with lean subjects (respectively SBP [mm Hg] 175.7 ± 27.5 vs 161.8 ± 21.8), and higher diastolic BP (DBP) [mm Hg] in comparison with both other groups (obese: 93.7 ± 12.4 vs lean: 85.34 ± 10.6, overweight: 87.15 ± 12.73). The relationship between systolic and diastolic BP, and weight (respectively for SBP: r = 0.256, DBP: r = 0.216), BMI (SBP: r = 0.261, DBP: r = 0.216) and AT (SBP r = 0.269, DBP r = 0.22, P < 0.01) was found only in women but not in men. Our results suggest that in the elderly the importance of obesity in the pathogenesis of hypertension depends partially on gender and it may be essential in women but not in men.
Urinary pyridinoline and deoxypyridinoline as bone metabolic markers in predicting therapeutic effects of estrogen and alfacalcidol in women with osteoporosis

The purpose of the present study was to evaluate the clinical usefulness of urinary pyridinoline (Pyr) and deoxypyridinoline (Dpyr) in predicting therapeutic effects of estrogen and alfacalcidol (1α-D3) in patients with postmenopausal osteoporosis. We measured urinary excretion of Pyr and Dpyr, and determined bone mineral density (BMD) using a dual-energy x-ray absorptiometry in 48 women with osteoporosis (average age, 55.9 ± 8.4 years). Patients were treated with estrogen (HRT, n = 13), 1α-D3 (n = 20), or calcium alone (n = 15). Baseline mean levels of urinary Pyr and Dpyr were significantly higher in the 48 patients compared to those in the age-matched postmenopausal women. The levels of urinary Pyr and Dpyr were inversely correlated with BMD. After treatment with estrogen or 1α-D3, a significant decrease of urinary Pyr and Dpyr was observed, and elevated urinary Pyr and Dpyr were reduced to the level in premenopausal women. A significant inverse correlation was found in Pyr and Dpyr at 6 months and in lumbar BMD after 24 months of treatment (r = −0.43 to −0.52; P < 0.01). We concluded that urinary Pyr and Dpyr have clinical utility for predicting response to estrogen and 1α-D3 therapy of osteoporosis patients.
A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II)

Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases. The TROG 13.01/ALTG 13.001 clinical trial is a multicentre unblinded randomised phase II study. Eligible patients have up to three metastases to the lung from any non-haematological malignancy, each < 5 cm in size, non-central targets, and have all primary and extrathoracic disease controlled with local therapies. Patients are randomised 1:1 to a single fraction of 28Gy versus 48Gy in four fractions of SABR. The primary objective is to assess the safety of each treatment arm, with secondary objectives including assessment of quality of life, local efficacy, resource use and costs, overall and disease free survival and time to distant failure. Outcomes will be stratified by number of metastases and origin of the primary disease (colorectal versus non-colorectal primary). Planned substudies include an assessment of the impact of online e-Learning platforms for lung SABR and assessment of the effect of SABR fractionation on the immune responses. A total of 84 patients are required to complete the study. Fractionation schedules have not yet been investigated in a randomised fashion in the setting of oligometastatic disease. Assuming the likelihood of similar clinical efficacy in both arms, the present study design allows for exploration of the hypothesis that cost implications of managing potentially increased toxicities from single fraction SABR will be outweighed by costs associated with delivering multiple-fraction SABR. ACTRN12613001157763 , registered 17th October 2013