nils-herrmann/clean_scirepeval huggingface dataset:
Quality of life on randomized treatment for isolated systolic hypertension: results from the Syst-Eur Trial.

To compare quality of life in elderly patients with isolated systolic hypertension allocated randomly to groups to receive placebo or active treatment in the Systolic Hypertension in the Elderly Trial.



Double-blind randomized controlled trial.



Patients aged 60 years were allocated randomly to groups to receive first-line treatment with nitrendipine (with second- and third-line enalapril and hydrochlorothiazide) or placebo. Trained interviewers administered trail-making tests (Trail A and B), Brief Assessment Index (a measure of depressed mood) and four subscales from the Sickness Impact Profile (Ambulation, Social Interaction, Sleep and Rest, and Home work).



Six hundred and ten patients completed a baseline and at least one follow-up questionnaire. Trail-making scores were slower in actively treated patients, especially in the first 6 months of follow-up when the between-group effect sizes were 0.25 [95% confidence interval (CI) 0.07 to 0.43] for Trail-making A and 0.13 (95% CI -0.05 to 0.31) for Trail-making B. Across the 4 years of follow-up, patients receiving active treatment were more likely to report problems on the Social Interaction scale than were placebo-treated patients (odds ratio 1.32, 95% CI 1.02 to 1.69), equivalent to a 7% difference. There were no significant differences between active and placebo treatment in the other Sickness Impact Profile dimensions or in the measure of depression.



Active treatment in the Systolic Hypertension in Europe trial was associated with some small adverse impacts on quality of life.
Prepregnancy BMI influences maternal and fetal outcomes in women with isolated gestational hyperglycaemia: a multicentre study.

This multicentre study analyzed the maternal and fetal outcomes of women who had one elevated 3-h oral glucose tolerance test (isolated gestational hyperglycaemia [IGH]).



From 1999 to 2003, data were collected for 606 IGH women from 31 Italian obstetric or diabetic centres, including time and mode of delivery, gestational hypertension, preeclampsia, eclampsia, congenital malformations, and neonatal mortality and morbidity, to compare them with the general pregnant Italian population. A prognostic model for the outcome of pregnancy was constructed, and the concurrence of certain specified conditions was considered a positive outcome, whereas pregnancies that failed to meet one or more of the stated conditions were classified as "complicated".



Macrosomia was significantly more frequent in women with IGH than in the normal pregnant population (10.7 vs 7.4%, respectively; P=0.003). Stillbirth and neonatal mortality rates did not differ from those in normal pregnancies, while a slight rise in the frequency of major malformations was not statistically significant (1.48 vs 0.89%, respectively; P<0.11). Multivariate logistic analyses confirmed that the prepregnancy body mass index (BMI) was an independent predictor of a complicated pregnancy. As for fetal growth, multivariate logistic analyses according to BMI showed that being overweight or obese were strong predictors of macrosomia.



These findings in a large cohort of Italian women with IGH confirm the detrimental effect of even minimally altered glucose tolerance on fetal outcome. Also, prepregnancy obesity plays an important role in raising the risk of adverse perinatal outcomes in such patients.
Development, validity and responsiveness of the Clinical COPD Questionnaire

The new Global Obstructive Lung Disease (GOLD) guidelines advice to focus treatment in Chronic Obstructive Pulmonary Disease (COPD) on improvement of functional state, prevention of disease progression and minimization of symptoms. So far no validated questionnaires are available to measure symptom and functional state in daily clinical practice. The aim of this study was to develop and validate the Clinical COPD Questionnaire (CCQ).



Qualitative research with patients and clinicians was performed to generate possible items to evaluate clinical COPD control. Thereafter, an item reduction questionnaire was sent to 77 international experts. Sixty-seven experts responded and the 10 most important items, divided into 3 domains (symptoms, functional and mental state) were included in the CCQ (scale: 0 = best, 6 = worst).



Cross-sectional data were collected from 119 subjects (57 COPD, GOLD stage I-III; 18 GOLD stage 0 and 44 (ex)smokers). Cronbach's alpha was high (0.91). The CCQ scores in patients (GOLD 0-III) were significantly higher than in healthy (ex)smokers. Furthermore, significant correlations were found between the CCQ total score and domains of the SF-36 (rho = 0.48 to rho = 0.69) and the SGRQ (rho = 0.67 to rho = 0.72). In patients with COPD, the correlation between the CCQ and FEV1%pred was rho =-0.49. Test-retest reliability was determined in 20 subjects in a 2-week interval (Intra Class Coefficient = 0.94). Thirty-six smokers with and without COPD showed significant improvement in the CCQ after 2 months smoking cessation, indicating the responsiveness of the CCQ.



The CCQ is a self-administered questionnaire specially developed to measure clinical control in patients with COPD. Data support the validity, reliability and responsiveness of this short and easy to administer questionnaire.
Comparison of Neurologic and Radiographic Outcomes with Solitaire versus Merci/Penumbra Systems for Acute Stroke Intervention

The Solitaire Flow Restoration was approved by the FDA in 2012 for mechanical thrombolysis of proximal occlusion of intracranial arteries. To compare the Solitaire FR device and the Merci/Penumbra (previously FDA approved) systems in terms of safety, clinical outcomes, and efficacy including radiographic brain parenchymal salvage.



Thirty-one consecutive patients treated with the Solitaire and 20 patients with comparable baseline characteristics treated with Merci or Penumbra systems were included in the study. Primary outcome measures included recanalization rate and modified Rankin Scale score at followup. Secondary outcomes included length of procedure, incidence of symptomatic intracranial hemorrhage, 90-day mortality, and radiographic analysis of percentage area salvage.



Compared with the Merci/Penumbra group, the Solitaire group showed a statistically significant improvement in favorable outcomes (mRS ≤ 2) (69% versus 35%, P = 0.03) and symptomatic ICH rate (0 versus 15%, P = 0.05) with a trend towards higher recanalization rates (93.5% versus 75%, P = 0.096) and shorter length of procedure (58.5 min versus 70.8 min, P = 0.08). Radiographic comparison also showed a significantly larger area of salvage in the Solitaire group (81.9% versus 71.9%, P = 0.05).



Our study suggests that the Solitaire system allows faster, safer, and more efficient thrombectomy than Merci or Penumbra systems.
Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older.

Although standard chemotherapy remains associated with a poor outcome in older patients with acute myeloid leukemia (AML), it is unclear which patients can survive long enough to be considered as cured. This study aimed to identify factors influencing the long-term outcome in these patients.



The study included 727 older patients with AML (median age, 67 years) treated in two idarubicin (IDA) versus daunorubicin (DNR) Acute Leukemia French Association trials. Prognostic analysis was based on standard univariate and multivariate models and also included a cure fraction model to focus on long-term outcome.



Age, WBC count, secondary AML, Eastern Cooperative Oncology Group (ECOG) performance status (PS), and adverse-risk and favorable-risk AML subsets (European LeukemiaNet classification) all influenced complete remission (CR) rate and overall survival (OS). IDA random assignment was associated with higher CR rate, but not with longer OS (P = .13). The overall cure rate was 13.3%. Older age and ECOG-PS more than 1 negatively influenced cure rate, which was higher in patients with favorable-risk AML (39.1% v 8.0% in adverse-risk AML; P < .001) and those treated with IDA (16.6% v 9.8% with DNR; P = .018). The long-term impact of IDA was still observed in patients younger than age 65 years, although all of the younger patients in the DNR control arm received high DNR doses (cure rate, 27.4% for IDA v 15.9% for DNR; P = .049). In multivariate analysis, IDA random assignment remained associated with a higher cure rate (P = .04), together with younger age and favorable-risk AML, despite not influencing OS (P = .11).



In older patients with AML, younger age, favorable-risk AML, and IDA treatment predict a better long-term outcome.
Psychosocial Constructs and Postintervention Changes in Physical Activity and Dietary Outcomes in a Lifestyle Intervention, Hub City Steps, 2010

Although modifications to dietary and physical activity (PA) behavior can reduce blood pressure, racial disparities in prevalence and control of hypertension persist. Psychosocial constructs (PSCs) of self-regulation, processes of change, and social support are associated with initiation and maintenance of PA in African Americans; which PSCs best predict lifestyle behavior changes is unclear. This study's objective was to examine relationships among PSC changes and postintervention changes in PA and dietary outcomes in a community-based, multicomponent lifestyle intervention.



This study was a noncontrolled, pre/post experimental intervention conducted in a midsized, Southern US city in 2010. Primarily African American adults (n = 269) participated in a 6-month intervention consisting of motivational enhancement, social support, pedometer diary self-monitoring, and 5 education sessions. Outcome measures included pedometer-determined steps per day, fitness, dietary intake, and PSC measures. Generalized linear mixed models were used to test for postintervention changes in behavioral outcomes, identify predictors of PSC changes, and determine if PSC changes predicted changes in PA and diet.



Postintervention changes were apparent for 10 of 24 PSCs (P < .05). Processes of change components, including helping relationships, reinforcement management, and consciousness raising, were significant predictors of fitness change (P < .05).



This article is among the first to address how measures of several theoretical frameworks of behavior change influence changes in PA and dietary outcomes in a multicomponent, community-based, lifestyle intervention conducted with African American adults. Findings reported identify PSC factors on which health behavior interventions can focus.
Association of vegetable, fruit, and grain intakes with colorectal cancer: the Multiethnic Cohort Study.

It is uncertain whether or not vegetables, fruit, or grains protect against colorectal cancer.



In a large prospective study, we investigated the association of vegetable, fruit, and grain intakes with colorectal cancer risk.



Between 1993 and 1996, 85 903 men and 105 108 women completed a quantitative food-frequency questionnaire that included approximately 180 foods and beverages in the Multiethnic Cohort Study. A diagnosis of colorectal cancer was made in 1138 men and 972 women after an average follow-up of 7.3 y. Cox proportional hazards models were used to calculate multivariate-adjusted relative risks and 95% CIs for colorectal cancer.



In men, multivariate adjustment for energy intake, dietary, and nondietary variables resulted in relative risks in the highest quintile group of 0.74 (95% CI: 0.59, 0.93; P for trend = 0.02) for vegetables and fruit combined, 0.80 (95% CI: 0.64, 0.99; P for trend = 0.09) for fruit alone, and 0.85 (95% CI: 0.69, 1.05; P for trend = 0.05) for vegetables alone. When colon and rectal cases were separated among men, the inverse associations were stronger for colon than for rectal cancer. In women, none of the associations with vegetables, fruit, or vegetables and fruit combined were significant. Grain intake was not associated with colorectal cancer for either men or women.



The intake of vegetables and fruit was inversely related to colorectal cancer risk among men but not among women. The association appears stronger for colon than for rectal cancer.
Phase II study of ABVd therapy for newly diagnosed clinical stage II-IV Hodgkin lymphoma: Japan Clinical Oncology Group study (JCOG 9305).

Although ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) therapy has been regarded as a standard of care for advanced-stage Hodgkin lymphoma (HL) since 1992, there has been no prospective data of ABVD therapy in Japan. To investigate the efficacy and safety of ABVd therapy with the lower dose of dacarbazine (250 mg/m(2)) in patients with newly diagnosed stage II-IV HL, Lymphoma Study Group of Japan Clinical Oncology Group conducted a phase II study. The primary endpoints were complete response rate (%CR) and progression-free survival (PFS). A total of 128 patients with age less than 70 years were enrolled and received 6-8 cycles of ABVd followed by radiation to initial bulky mass. The %CR in 118 eligible patients was 81.4% [95% confidence interval (CI) 73.1-87.9%]. Major toxicity was grade 4 neutropenia (45.3%). Grade 3 nausea/vomiting was the most frequent non-hematological toxicity (10.9%). Transient grade 4 constipation, infection (abscess), hypoxemia and hyperbilirubinemia were observed in 4 patients. No treatment-related death was observed. PFS and overall survival at 5 years were 78.4% (95% CI 70.9-85.9%) and 91.3% (95% CI 86.1-96.5%), respectively. In conclusion, ABVd is effective in Japanese patients with stage II-IV HL with acceptable toxicities (UMIN-CTR Number: C000000092).
Neither heavy nor light load resistance exercise acutely exacerbates lymphedema in breast cancer survivor.

Resistance exercise has great potential to aid in the management of breast cancer-related lymphedema (BCRL), but little is known regarding the acute response of performing resistance exercises with the affected limb.



To examine the acute impact of upper body resistance exercise on the amount of swelling and severity of symptoms in women with BCRL and to compare these effects between resistance exercise involving high and low loads (heavier vs lighter weights).



Seventeen women aged 61 ± 9 years with mild to severe BCRL participated in this study. Participants completed a high load (6-8 repetition maximum) and low load (15-20 repetition maximum) exercise session consisting of 2 sets of 5 upper body resistance exercises in a randomized order separated by a 10- to 12-day wash-out period. The extent of swelling was assessed using bioimpedance spectroscopy, dual-energy x-ray absorptiometry, and arm circumference measurements. The severity symptoms were assessed using the visual analogue scale (pain, heaviness, and tightness) and a modified Brief Pain Inventory. Measurements were taken pre-exercise, immediately post-exercise, 24 hours post-exercise, and 72 hours post-exercise.



No changes in the extent of swelling or the severity of symptoms were observed between pre-exercise and immediately post-exercise, 24 hours post-exercise, or 72 hours post-exercise. No differences in the response to the high or low load exercise were observed.



Upper body resistance exercise does not acutely increase swelling or feelings of discomfort/pain, heaviness tightness in the affected limb of BCRL patients when performed at either high or low loads.
Modal Reasoning and Rough Set Theory

In this paper, we would like to present some modal logics with semantics based on rough set theory and related notions. In addition to surveying some well-known results about the links between modal logics and rough set theory, we also develop some new applied logics inspired I)y generalized rough set theory.  Rough set, modal logic, cpistcmic logic. 1 I n t r o d u c t i o n Tile rough set theory is invented by Pawlak[15, 16] to account for the definability of a concept in terms of some elementary ones in an approximation space. Pawlak claims that knowledge is deep-seated in the classificatory abilities of human beings and other species, so rough set theory is a framework for discussions about knowledge, ill particular when imprecise knowledge is of primary concern([16], p.2). Thus the theory is in particular effective in extracting knowledge from data tables and it has been successfully and widely applied to domains such as intelligent data analysis (data mining and knowledge discovery in database), decision making, machine learning, pattern recognition and conflict analysis[13]. An important common feature of these applications is the classification of objects and the representation of the classificatory knowledge in rough set notions. The most well-known relationship between rough set theory and logics is the connection of approximation space with possible world semantics for the modal epistemic logic $5. Recently, the relationship between more general rough set model and modal logics have been examined in [28, 27, 29]. The common semantic intuition behind them is to view the set of possible worlds as an approximation space. These results all show the cross fertilization between rough set theory and logics, so it is worthwhile to investigate the further relationship between different generalizations of rough set models and logic systems. Based on this background, the purpose of this paper is twofold. The first is to survey and present the current results in a uniform way. The second is to fill some missing links between the existing general rough set models and logical formalisms and develop further some applied logics inspired by rough set theory. In what follows, we will first review the rough set theory and some of its main generalizatious. Then different modal logics and their relationship with rough set notions are discussed. Finally, some concluding remarks are given.
Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II

Sodium reduction is efficacious for primary prevention of hypertension, but the feasibility of achieving this effect is unclear. The objective of the paper is detailed analyses of adherence to and effects of the sodium reduction intervention among overweight adults in the Trials of Hypertension Prevention, Phase II. Sodium reduction (comprehensive education and counselling about how to reduce sodium intake) was tested vs no dietary intervention (usual care) for 36–48 months. A total of 956 white and 203 black adults, ages 30–54 years, with diastolic blood pressure 83–89 mmHg, systolic blood pressure (SBP) <140 mmHg, and body weight 110–165% of gender-specific standard weight were included in the study. At 36 months, urinary sodium excretion was 40.4 mmol/24 h (24.4%) lower in sodium reduction compared to usual care participants (P<0.0001), but only 21% of sodium reduction participants achieved the targeted level of sodium excretion below 80 mmol/24 h. Adherence was positively related to attendance at face-to-face contacts. Net decreases in SBP at 6, 18, and 36 months of 2.9 (P<0.001), 2.0 (P<0.001), and 1.3 (P=0.02) mmHg in sodium reduction vs usual care were associated with an overall 18% lower incidence of hypertension (P=0.048); were relatively unchanged by adjustment for ethnicity, gender, age, and baseline blood pressure, BMI, and sodium excretion; and were observed in both black and white men and women. From these beneficial but modest results with highly motivated and extensively counselled individuals, sodium reduction sufficient to favourably influence the population blood pressure distribution will be difficult to achieve without food supply changes.
Psychological distress in parents of children with advanced cancer.

Parent psychological distress can impact the well-being of childhood cancer patients and other children in the home. Recognizing and alleviating factors of parent distress may improve overall family survivorship experiences following childhood cancer.



To describe the prevalence and factors of psychological distress (PD) among parents of children with advanced cancer.



Cohort study embedded within a randomized clinical trial (Pediatric Quality of Life and Evaluation of Symptoms Technology [PediQUEST] study).



Multicenter study conducted at 3 children's hospitals (Boston Children's Hospital, Children's Hospital of Philadelphia, and Seattle Children's Hospital).



Parents of children with advanced (progressive, recurrent, or refractory) cancer.



Parental PD, as measured by the Kessler-6 Psychological Distress Scale.



Eighty-six of 104 parents completed the Survey About Caring for Children With Cancer (83% participation); 81 parents had complete Kessler-6 Psychological Distress Scale data. More than 50% of parents reported high PD and 16% met criteria for serious PD (compared with US prevalence of 2%-3%). Parent perceptions of prognosis, goals of therapy, child symptoms/suffering, and financial hardship were associated with PD. In multivariate analyses, average parent Kessler-6 Psychological Distress Scale scores were higher among parents who believed their child was suffering highly and who reported great economic hardship. Conversely, PD was significantly lower among parents whose prognostic understanding was aligned with concrete goals of care.



Parenting a child with advanced cancer is strongly associated with high to severe levels of PD. Interventions aimed at aligning prognostic understanding with concrete care goals and easing child suffering and financial hardship may mitigate parental PD.
Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.



Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466.



Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported.



In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost.



ZonMw; COOK Medical.