nils-herrmann/clean_scirepeval huggingface dataset:
Associations between physical activity , sedentary behavior , and glycemic control in a large cohort of adolescents with type 1 diabetes : the Hvidoere Study Group on Childhood Diabetes

The Hvidoere Study Group on Childhood Diabetes has demonstrated persistent differences in metabolic outcomes between pediatric diabetes centers. These differences cannot be accounted for by differences in demographic, medical, or treatment variables. Therefore, we sought to explore whether differences in physical activity or sedentary behavior could explain the variation in metabolic outcomes between centers.  An observational cross-sectional international study in 21 centers, with demographic and clinical data obtained by questionnaire from participants. Hemoglobin A1c (HbA1c) levels were assayed in one central laboratory. All individuals with diabetes aged 11–18 yr (49.4% female), with duration of diabetes of at least 1 yr, were invited to participate. Individuals completed a self-reported measure of quality of life (Diabetes Quality of Life Short Form [DQOL-SF]), with well-being and leisure time activity assessed using measures developed by Health Behaviour in School Children WHO Project.  Older participants (p , 0.001) and females (p , 0.001) reported less physical activity. Physical activity was associated with positive health perception (p , 0.001) but not with glycemic control, body mass index, frequency of hypoglycemia, or diabetic ketoacidosis. The more time spent on the computer (r 1⁄4 0.06; p , 0.05) and less time spent doing school homework (r 1⁄4 20.09; p , 0.001) were associated with higher HbA1c. Between centers, there were significant differences in reported physical activity (p , 0.001) and sedentary behavior (p , 0.001), but these differences did not account for center differences in metabolic control.  Physical activity is strongly associated with psychological well-being but has weak associations with metabolic control. Leisure time activity is associated with individual differences in HbA1c but not with intercenter differences. J Åman, TC Skinner, CE de Beaufort, PGF Swift, H-J Aanstoot and F Cameron, for and on behalf of Hvidoere Study Group on Childhood Diabetes Department of Paediatrics, Örebro University Hospital, Örebro, Sweden; Department of Psychology, University of Wollongong, Wollongong, Australia; Clinique Pédiatrique, Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg; Children’s Hospital, Leicester Royal Infirmary, Leicester, UK; Diabetes Center for Pediatric and Adolescent Diabetes, Rotterdam, The Netherlands; and Department of Endocrinology and Diabetes, Royal Children’s Hospital, Parkville, Victoria,
Deleterious effect of right ventricular apical pacing on left ventricular diastolic function and the impact of pre-existing diastolic disease.

Right ventricular apex (RVA) pacing may have deleterious effects on left ventricular (LV) systolic function, but its impact on LV diastolic function has not been explored.



Ninety-seven patients with sinus node dysfunction and ejection fraction (EF) ≥ 50% with permanent RVA pacing were randomly programmed to V-sense and V-pace modes and examined by echocardiography. Tissue Doppler imaging was employed to assess myocardial systolic velocity (S') and early diastolic velocity (E') at the mitral annulus. Systolic dyssynchrony was assessed using 12 LV segmental model (Ts-SD). Switching from V-sense to V-pace resulted in the worsening of both diastolic and systolic functions as shown by the decreased EF, reduced mean E' and S' velocities, as well as increase in LV volume and Ts-SD (all P< 0.001). Reduction of mean E' and S' of ≥ 1 cm/s occurred in 35 (36%) and 45 (46%) patients, respectively. In pre-defined subgroup analysis, only patients with pre-existing LV diastolic dysfunction had a significant reduction of mean E' and S' (both P< 0.001) even after age adjustment. Multivariate logistic regression analysis showed that independent factors for the reduction of mean E' ≥ 1 cm/s or mean S' ≥ 1 cm/s at V-pace were pre-existing LV diastolic dysfunction [odds ratio (OR): 4.735, P= 0.007 for E'; OR: 3.307, P= 0.022 for S'] and systolic dyssynchrony at V-pace (OR: 5.459, P= 0.007 for E'; OR: 2.725, P= 0.035 for S').



In patients with preserved EF, RVA pacing is associated with the deterioration of both LV diastolic and systolic functions, which is particularly obvious in those with pre-existing LV diastolic dysfunction and V-pace-induced systolic dyssynchrony.
High prevalence of masked uncontrolled hypertension in people with treated hypertension.

There are limited data on the quality of treated blood pressure (BP) control during normal daily life, and in particular, the prevalence of 'masked uncontrolled hypertension' (MUCH) in people with treated and seemingly well-controlled BP is unknown. This is important because masked hypertension in 'treatment naïve' patients is associated with a high risk of cardiovascular events. We therefore conducted the first study to define the prevalence and characteristics of MUCH among a large sample of hypertensive patients in routine clinical practice in whom BP was treated and controlled to recommended clinic BP goals.



We analysed data from the Spanish Society of Hypertension ambulatory blood pressure monitoring (ABPM) Registry and identified patients with treated and controlled BP according to current international guidelines (clinic BP <140/90 mmHg). Masked uncontrolled hypertension was diagnosed in these patients if despite controlled clinic BP, the mean 24-h ABPM average remained elevated (24-h systolic BP ≥130 mmHg and/or 24-h diastolic BP ≥80 mmHg). From 62 788 patients with treated BP in the Spanish registry, we identified 14 840 with treated and controlled clinic BP, of whom 4608 patients (31.1%) had MUCH according to 24-h ABPM criteria (mean age 59.4 years, 59.7% men). The prevalence of MUCH was significantly higher in males, patients with borderline clinic BP (130-9/80-9 mmHg), and patients at high cardiovascular risk (smokers, diabetes, obesity). Masked uncontrolled hypertension was most often because of poor control of nocturnal BP, with the proportion of patients in whom MUCH was solely attributable to an elevated nocturnal BP almost double that solely attributable to daytime BP elevation (24.3 vs. 12.9%, P < 0.001).



The prevalence of masked suboptimal BP control in patients with treated and well-controlled clinic BP is high. Clinic BP monitoring alone is thus inadequate to optimize BP control because many patients have an elevated nocturnal BP. These findings suggest that ABPM should become more routine to confirm BP control, especially in higher risk groups and/or those with borderline control of clinic BP.
Characteristics of Sodium Sensitivity in Korean Populations

Sodium sensitivity (SS) is a variable response of blood pressure (BP) to changes in sodium intake. The present study evaluated the existence and the characteristics of subjects with SS in Koreans. One hundred one subjects with (n = 31, 57.7 ± 9.8 yr) or without hypertension (n = 70, 40.8 ± 16.5 yr) were given a low-sodium dietary approache to stop hypertension (DASH) diet (LSD) for 7 days and a high-sodium DASH diet (HSD) for the following 7 days. The prevalence of SS in the present study population was 27.7% (17.6% in the non-hypertensive subjects and 51.6% in the hypertensive subjects). Analysis of the non-hypertensive subjects showed that systolic BP, diastolic BP, and mean arterial pressure at baseline and after HSD were higher in the subjects with SS than the subjects without SS, and there were no differences after LSD. In the hypertensive subjects, there was no difference in the BP at baseline and after HSD whether or not the subjects had SS. However, the systolic BP of hypertensive subjects with SS was lower than hypertensive subjects without SS after LSD. In the present study population, subjects with SS have distinctive BP features unlike to subjects without SS.
Evaluation of CSF neurotransmitters and folate in 25 patients with Rett disorder and effects of treatment

Rett disorder (RD) is a progressive neurodevelopmental entity caused by mutations in the MECP2 gene. It has been postulated that there are alterations in the levels of certain neurotransmitters and folate in the pathogenesis of this disease. Here we re-evaluated this hypothesis.



We evaluated CSF folate, biogenic amines and pterines in 25 RD patients. Treatment with oral folinic acid was started in those cases with low folate. Patients were clinically evaluated and videotaped up to 6 months after therapy.



CSF folate was below the reference values in 32% of the patients. Six months after treatment no clinical improvement was observed. Three of the four patients with the R294X mutation had increased levels of a dopamine metabolite associated to a particular phenotype. Three patients had low levels of a serotonin metabolite. Two of them were treated with fluoxetine and one showed clinical improvement. No association was observed between CSF folate and these metabolites, after adjusting for the patients age and neopterin levels.



Our results support that folinic acid supplementation has no significant effects on the course of the disease. We report discrete and novel neurotransmitter abnormalities that may contribute to the pathogenesis of RD highlighting the need for further studies on CSF neurotransmitters in clinically and genetically well characterized patients.
Procedures for an instrument development study: the Botswana experience.

Health protective sexual communication (HPSC) between sexual partners can contribute to human immunodeficiency virus (HIV) prevention, but women face difficulties with HPSC because of cultural and gender issues.



To present the procedures for an instrument development study conducted in Botswana between 2006 and 2008 on different aspects of HPSC. The study was guided by the theory of planned behaviour constructs.



A literature review and a qualitative pilot study among young women aged 18-35 years in Gaborone city clinics generated items for the measures. Eleven measures were developed and evaluated for content validity. The measures were translated and evaluated by three typical participants for cultural relevance and acceptance. A quantitative pilot among ten women and a larger quantitative study among 280 other young women followed in 13 Gaborone city clinics for internal consistency reliability, and construct validity based on principal components analysis. All women who met selection criteria consented and responded to all questions. Research protocols were strictly adhered to.



Eight measures were reliable, with Cronbach's alphas between 0.69 and 0.95. Underlying factors were extracted for these. Two measures were unreliable, one with spuriously low reliability due to its brevity. Some significant relationships were identified between measures.  The results highlighted the importance of HPSC, the significant influence of the male sexual partners and other relatives, and the need to integrate HPSC at all levels of HIV/acquired immunodeficiency syndrome prevention and research, focusing on the effectiveness of HPSC.
Activating Mutations of Nand Kras in Multiple Myeloma Show Different Clinical Associations : Analysis of the Eastern Cooperative Oncology Group Phase I 11 Trial

Mutations of members of the rasfamily are among the most common oncogene mutations found in multiple myeloma (MM). We have examined the mutational status of the Nand K-res genes at codons 12,13, and 61 in 160 newly diagnosed MM patients enrolled on the Eastern Cooperative Oncology Group (ECOG) phase 111 clinical trial E9486. The total incidence of ras mutations was found to be 39% of the samples analyzed. Five patients showed evidence of more than one mutation. We obtained 22 marrow samples from patients at the time of disease progression or relapse, for whom a res mutation was identified at diagnosis. In all cases, the ras mutation of the disease progression sample was identical t o that found at diagnosis. In contrast, three of 25 patients who did not show any ras mutation at diagnosis acquired a ras mutation at the time of disease progression. No significant association was observed between any ras mutation and stage of disease, &-microglobulin levels, labeling index, or protein type. The mean tumor burden and median survival for patients with mutations of N-ras was
Breast Cancer Surgery Trend Changes Since the Introduction of BRCA1/2 Mutation Screening: A Retrospective Cohort Analysis of 158 Mutation Carriers Treated at a Single Institution

Bilateral mastectomy in women diagnosed with unilateral breast cancer is on the rise in the USA. One contributing factor is increased awareness of contralateral breast cancer risk. Positive testing for deleterious mutation in BRCA1/2 is a concrete measure of this contributing factor. We hypothesize that breast cancer surgery trend change is temporally associated with the introduction of BRCA1/2 genetic testing around 1996. Our study cohort included 158 BRCA1 or BRCA2 mutation carriers diagnosed with unilateral breast cancer between 1963 and 2009. Mutation carriers with ovarian cancer or bilateral breast cancer were excluded. Breast surgery and breast reconstruction surgery trends were analyzed according to year of breast cancer diagnosis or when bilateral mastectomy was performed, respectively. Surgery trends changed significantly over time. We observed a significant drop in the rate of unilateral mastectomy (P < 0.001) after the period 1996–2000, and the rate of bilateral mastectomy appears to be on the rise, up to 30.3% between 2006 and 2009. Breast reconstruction trends also changed significantly over time, with a significant rise in the rate of free flap reconstruction to 58.8% between 2006 and 2009. Our results demonstrated a significant decrease in unilateral mastectomy with a rise in bilateral mastectomy after the period 1996–2000, a period which encompassed the year when genetic testing of the two BRCA1/2 genes became commercially available, hence supporting our hypothesis.
Efficacy and safety of memantine in patients with moderate-to-severe Alzheimer’s disease: results of a pooled analysis of two randomized, double-blind, placebo-controlled trials in Japan

With the increase in the aging population, there is a pressing need to provide effective treatment options for individuals with Alzheimer's disease (AD). Memantine is an N-methyl-D-aspartate receptor antagonist used to treat AD in > 80 countries worldwide, and studies in the USA and Europe have shown it to be effective in improving language deficits; however, there are currently no data on language improvements in Japanese patients treated with memantine.



To clarify the efficacy and safety of memantine in Japanese outpatients with moderate to severe AD, using a pooled analysis of two multicenter randomized placebo-controlled trials, a phase 2 dose-finding study and a phase 3 study.



The final analysis comprised 633 patients (318 receiving memantine and 315 placebo). Memantine produced better outcomes in terms of Severe Impairment Battery-Japanese version, Clinician's Interview-Based Impression of Change plus-Japanese version, Behavioral Pathology in AD Rating Scale, and language scores, versus placebo. The overall incidence of adverse events and adverse reactions was similar between groups.



In this pooled analysis of Japanese patients, memantine achieved better outcomes than placebo in terms of cognition, including attention, praxis, visuospatial ability and language, and behavioral and psychological symptoms, including activity disturbances and aggressiveness.
Phase I study of RGB-286638, a novel, multitargeted cyclin-dependent kinase inhibitor in patients with solid tumors.

RGB-286638 is a multitargeted inhibitor with targets comprising the family of cyclin-dependent kinases (CDK) and a range of other cancer-relevant tyrosine and serine/threonine kinases. The objectives of this first in human trial of RGB-286638, given i.v. on days 1 to 5 every 28 days, were to determine the maximum tolerated dose (MTD) and to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of this new drug.



Sequential cohorts of 3 to 6 patients were treated per dose level. Blood, urine samples, and skin biopsies for full PK and/or PD analyses were collected.



Twenty-six patients were enrolled in 6-dose levels from 10 to 160 mg/d. Four dose-limiting toxicities were observed in 2 of the 6 patients enrolled at the highest dose level. These toxicities were AST/ALT elevations in 1 patient, paroxysmal supraventricular tachycardias (SVTs), hypotension, and an increase in troponin T in another patient. The plasma PK of RGB-286638 was shown to be linear over the studied doses. The interpatient variability in clearance was moderate (variation coefficient 7%-36%). The PD analyses in peripheral blood mononuclear cells, serum (apoptosis induction) and skin biopsies (Rb, p-Rb, Ki-67, and p27(KIP1) expression) did not demonstrate a consistent modulation of mechanism-related biomarkers with the exception of lowered Ki-67 levels at the MTD level. The recommended MTD for phase II studies is 120 mg/d.



RGB-286638 is tolerated when administered at 120 mg/d for 5 days every 28 days. Prolonged disease stabilization (range, 2-14 months) was seen across different dose levels.
A 1-h Combination Algorithm Allows Fast Rule-Out and Rule-In of Major Adverse Cardiac Events.

A 1-h algorithm based on high-sensitivity cardiac troponin T (hs-cTnT) testing at presentation and again 1 h thereafter has been shown to accurately rule out acute myocardial infarction.



The goal of the study was to evaluate the diagnostic accuracy of the 1-h algorithm when supplemented with patient history and an electrocardiogram (ECG) (the extended algorithm) for predicting 30-day major adverse cardiac events (MACE) and to compare it with the algorithm using hs-cTnT alone (the troponin algorithm).



This prospective observational study enrolled consecutive patients presenting to the emergency department (ED) with chest pain, for whom hs-cTnT testing was ordered at presentation. Hs-cTnT results at 1 h and the ED physician's assessments of patient history and ECG were collected. The primary outcome was an adjudicated diagnosis of 30-day MACE defined as acute myocardial infarction, unstable angina, cardiogenic shock, ventricular arrhythmia, atrioventricular block, cardiac arrest, or death of a cardiac or unknown cause.



In the final analysis, 1,038 patients were included. The extended algorithm identified 60% of all patients for rule-out and had a higher sensitivity than the troponin algorithm (97.5% vs. 87.6%; p < 0.001). The negative predictive value was 99.5% and the likelihood ratio was 0.04 with the extended algorithm versus 97.8% and 0.17, respectively, with the troponin algorithm. The extended algorithm ruled-in 14% of patients with a higher sensitivity (75.2% vs. 56.2%; p < 0.001) but a slightly lower specificity (94.0% vs. 96.4%; p < 0.001) than the troponin algorithm. The rule-in arms of both algorithms had a likelihood ratio >10.



A 1-h combination algorithm allowed fast rule-out and rule-in of 30-day MACE in a majority of ED patients with chest pain and performed better than the troponin-alone algorithm.
A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health.



This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24-hour urine.


 The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups.



The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide.
Functional polymorphisms in antioxidant genes in Hurthle cell thyroid neoplasm - an association of GPX1 polymorphism and recurrent Hurthle cell thyroid carcinoma

Hurthle cells of the thyroid gland are very rich in mitochondria and oxidative enzymes. As a high level oxidative metabolism may lead to higher level of oxidative stress and can be associated with an increased risk for cancer, we investigated whether common functional polymorphisms in antioxidant genes (SOD2, CAT, GPX, GSTP1, GSTM1 and GSTT1) are associated with the development or clinical course of Hurthle cell thyroid carcinoma (HCTC).



A retrospective study was performed in 139 patients treated by thyroid surgery for a Hurthle cell neoplasm. HCTC, Hurthle cell thyroid adenoma (HCTA) or Hurthle cell thyroid nodule (HCTN) were diagnosed by pathomorphology. DNA was extracted from cores of histologically confirmed normal tissue obtained from formalin-fixed paraffin-embedded specimens and genotyped for investigated polymorphisms. Logistic regression was used to compare genotype distributions between patient groups.



HCTC, HCTA and HCTN were diagnosed in 53, 47 and 21 patients, respectively. Metastatic disease and recurrence of HCTC were diagnosed in 20 and 16 HCTC patients, respectively. Genotypes and allele frequencies of investigated polymorphisms did not deviate from Hardy-Weinberg equilibrium in patients with HCTC, HCTA and HCTN. Under the dominant genetic model we observed no differences in the genotype frequency distribution of the investigated polymorphisms when the HCTA and HCTN group was compared to the HCTC group for diagnosis of HCTC or for the presence of metastatic disease. However, GPX1 polymorphism was associated with the occurrence of recurrent disease (p = 0.040).



GPX1 polymorphism may influence the risk for recurrent disease in HCTC.
Treatment of Incidental Prostate Cancer by Active Surveillance: Results of the HAROW Study.

To report on a cohort of patients with incidental prostate cancer (IPC) that was treated by an active surveillance (AS) protocol in the HAROW study.



The HAROW study is an observational study on the management of localized prostate cancer in Germany. Treating urologists were reporting clinical parameters, information on therapy and clinical course of disease at 6-month intervals.



In total, 3,169 patients were enrolled. In 224 patients were found an IPC and 104 (46%) of them were put on an AS protocol. The mean follow-up was 26.5 months. Tumor progression was noted in 16 patients. In 11 patients, AS was replaced by a definite intervention. In univariate and multivariate analyses, only PSA density correlated with progression.



This is the first prospective description of an IPC patient cohort on AS as part of an outcomes research study. AS was selected as a therapeutic strategy in nearly half of the patients (46%). Only a minor proportion (16%) displayed progression. Of the clinical parameters, only PSA density correlated with progression.