nils-herrmann/clean_scirepeval huggingface dataset:
An innovative telemedical support system to measure physical activity in children and adolescents with type 1 diabetes mellitus.

To assess physical activity in patients with type 1 diabetes an innovative telemedical support system has been developed. The aim of the feasibility trial was to prove its use in a clinical setting.



16 children/adolescents with type 1 diabetes mellitus aged 14.5 ± 2.2 years (diabetes duration 6.5 ± 3.6 years, HbA1c 8.8 ± 1.0%) were included in the study. During a period of 1-3 days all the patients received a telemedical assessment system. It consists of a sensor for physical activity integrated into a mobile phone (DiaTrace). Additionally it is combined with a system for continuous blood glucose monitoring (CGM).



The technical system was highly accepted by all the 16 children and adolescents. Physical activity measured was 13.3 ± 5.5 AU/d, mean duration of total physical activity was 204.9 ± 66.5 min/d (walking 102.5 ± 62.5, running 7.4 ± 5.8, cycling 39.2 ± 32.7, driving 36.0 ± 18.6, non-specific physical activity 57.0 ± 29.7 min/d). Periods without activity lasted for 386.5 ± 187.2 min/d. Daily energy expenditure was 1,964.1 ± 185.5 kcal/d. Correlations between physical activity (measured with DiaTrace) and blood glucose profiles (measured with CGM) were calculated. Pearson's correlation coefficients ranged between 0.59 and 0.99 (median 0.91). Hence, these good correlation coefficients show the high and direct association between blood glucose values and activity units. The wide ranges in correlation coefficients demonstrate a huge variability of individualized reactions.



Use of innovative electronic health technology is highly accepted by patients. It reveals an accurate, real-time assessment of an individual's physical activity. These information can use for insulin dose-adjustment.
The clinical and economic value of a short course of omeprazole in patients with noncardiac chest pain.

Evaluation of new patients with noncardiac chest pain (NCCP) may require a variety of costly tests. The aim of this study was to evaluate the efficacy of the omeprazole test (OT) in diagnosing gastroesophageal reflux (GERD) in patients with NCCP and estimate the potential cost savings of this strategy compared with conventional diagnostic evaluations.



Thirty-nine patients referred by cardiologists were enrolled. Baseline symptoms were recorded, and the patients were randomized to either placebo or omeprazole (40 mg AM and 20 mg PM) groups for 7 days. Patients were crossed over to the other arm after a washout period and repeat baseline symptom assessment. All patients underwent 24-hour esophageal pH monitoring and upper endoscopy before randomization.



Thirty-seven patients (94.9%) completed the study. Twenty-three (62.2%) were classified as GERD positive and 14 as GERD negative. Eighteen (78%) GERD-positive patients and 2 (14%) GERD-negative patients had a positive OT (P < 0.01), yielding a sensitivity of 78.3% (95% confidence interval, 61.4-95.1) and specificity of 85.7% (95% confidence interval, 67.4-100). Economic analysis showed that the OT saves $573 per average patient evaluated and results in a 59% reduction in the number of diagnostic procedures.



The OT is sensitive and specific for diagnosing GERD in patients with NCCP. This strategy results in significant cost savings and decreased use of diagnostic tests.
Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test

EndoPredict (EP) is a clinically validated multianalyte gene expression test to predict distant metastasis in ER-positive, HER2-negative breast cancer treated with endocrine therapy alone. The test is based on the combined analysis of 12 genes in formalin-fixed, paraffin-embedded (FFPE) tissue by reverse transcription-quantitative real-time PCR (RT-qPCR). Recently, it was shown that EP is feasible for reliable decentralized assessment of gene expression. The aim of this study was the analytical validation of the performance characteristics of the assay and its verification in a molecular-pathological routine laboratory. Gene expression values to calculate the EP score were assayed by one-step RT-qPCR using RNA from FFPE tumor tissue. Limit of blank, limit of detection, linear range, and PCR efficiency were assessed for each of the 12 PCR assays using serial samples dilutions. Different breast cancer samples were used to evaluate RNA input range, precision and inter-laboratory variability. PCR assays were linear up to Cq values between 35.1 and 37.2. Amplification efficiencies ranged from 75% to 101%. The RNA input range without considerable change of the EP score was between 0.16 and 18.5 ng/μl. Analysis of precision (variation of day, day time, instrument, operator, reagent lots) resulted in a total noise (standard deviation) of 0.16 EP score units on a scale from 0 to 15. The major part of the total noise (SD 0.14) was caused by the replicate-to-replicate noise of the PCR assays (repeatability) and was not associated with different operating conditions (reproducibility). Performance characteristics established in the manufacturer’s laboratory were verified in a routine molecular pathology laboratory. Comparison of 10 tumor samples analyzed in two different laboratories showed a Pearson coefficient of 0.995 and a mean deviation of 0.15 score units. The EP test showed reproducible performance characteristics with good precision and negligible laboratory-to-laboratory variation. This study provides further evidence that the EP test is suitable for decentralized testing in specialized molecular pathological laboratories instead of a reference laboratory. This is a unique feature and a technical advance in comparison with existing RNA-based prognostic multigene expression tests.
Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry

To collect information on the use of the Reveal implantable loop recorder (ILR) in the patient care pathway and to investigate its effectiveness in the diagnosis of unexplained recurrent syncope in everyday clinical practice.



Prospective, multicentre, observational study conducted in 2006-2009 in 10 European countries and Israel. Eligible patients had recurrent unexplained syncope or pre-syncope. Subjects received a Reveal Plus, DX or XT. Follow up was until the first recurrence of a syncopal event leading to a diagnosis or for ≥1 year. In the course of the study, patients were evaluated by an average of three different specialists for management of their syncope and underwent a median of 13 tests (range 9-20). Significant physical trauma had been experienced in association with a syncopal episode by 36% of patients. Average follow-up time after ILR implant was 10±6 months. Follow-up visit data were available for 570 subjects. The percentages of patients with recurrence of syncope were 19, 26, and 36% after 3, 6, and 12 months, respectively. Of 218 events within the study, ILR-guided diagnosis was obtained in 170 cases (78%), of which 128 (75%) were cardiac.



A large number of diagnostic tests were undertaken in patients with unexplained syncope without providing conclusive data. In contrast, the ILR revealed or contributed to establishing the mechanism of syncope in the vast majority of patients. The findings support the recommendation in current guidelines that an ILR should be implanted early rather than late in the evaluation of unexplained syncope.
Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: design of and rationale for the ABSORB III randomized trial.

Randomized trials have demonstrated progressive improvements in clinical and angiographic measures of restenosis with technologic iterations from balloon angioplasty to bare-metal stents and subsequently to drug-eluting stents (DES). However, the permanent presence of a metal stent prevents coronary vasomotion, autoregulation, and adaptive coronary remodeling. The limitations imposed by a permanent metal implant may be overcome with a bioresorbable scaffold. ABSORB III is a large-scale, multicenter, randomized trial designed to support US premarket approval of the ABSORB BVS platform and is the first study with sufficient size to allow valid examination of the relative clinical outcomes between metallic DES and bioresorbable scaffold.



ABSORB III (ClincalTrials.gov NCT01751906) will register approximately 2,262 patients and includes a lead-in phase (n = 50), the primary randomized analysis group (n = 2,000), an imaging cohort (n = 200), and a pharmacokinetic substudy (n = 12). In the primary analysis group, approximately 2,000 patients with up to 2 de novo native coronary artery lesions in separate epicardial vessels will be prospectively assigned in a 2:1 ratio to ABSORB BVS versus XIENCE everolimus-eluting stents (EES). The primary end point is target lesion failure (the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year, powered for noninferiority of ABSORB BVS compared to XIENCE EES. Clinical follow-up will continue for 5 years. Enrollment has been completed, and the principal results will be available in the fall of 2015.



The large-scale ABSORB III randomized trial will evaluate the safety and effectiveness of ABSORB BVS compared to XIENCE EES in the treatment of patients with coronary artery disease.
Constant Space Self-Stabilizing Center Finding in Anonymous Tree Networks

It is known that there is no self-stabilizing silent distributed algorithm for finding the center (or centers) of an anonymous tree network that uses less than O(log diam) space per process, where diam is the diameter of the tree. In this paper, a self-stabilizing, but non-silent, distributed algorithm, STC, for this problem is given, which takes O(diam) rounds under the unfair daemon and uses O(1) space per process. The method is to first construct a silent O(1)-space algorithm for the problem that works under the synchronous daemon, provided it has a clean start. A transformer is then constructed, which transforms any tree algorithm which is silent under the synchronous algorithm given a clean start into an equivalent non-silent self-stabilizing algorithm with the same asymptotic space complexity. The desired center finding algorithm, CSTC, is then obtained by applying the transformer to STC.
Effects of prenatal exposure to atypical antipsychotics on postnatal development and growth of infants: a case-controlled, prospective study

This study aims to investigate the developmental effects of atypical antipsychotics on infants who were born to mothers taking an atypical antipsychotic throughout pregnancy. The developmental progress of 76 infants who experienced fetal exposure to atypical antipsychotics was compared to that of 76 matched control infants who had no fetal exposure to any antipsychotics. Planned assessment included Apgar score, body weight, height, and the cognitive, language, motor, social–emotional, and adaptive behavior composite scores of the Bayley Scales of Infant and Toddler Development, third edition (BSID-III). Student’s t test and Chi-square analysis were used as appropriate. Repeated measurements were evaluated by analysis of covariance. At 2 months of age, the mean composite scores of cognitive, motor, social–emotional, and adaptive behavior of BSID-III were significantly lower in atypical antipsychotic-exposed infants than the controls. More atypical antipsychotic-exposed infants had delayed development in cognitive, motor, social–emotional, and adaptive behavior domains as defined by the composite score of <85 in these subscales of BSID-III. At 12 months of age, there were no significant differences between the two groups in all mean composite scores of BSID-III. More atypical antipsychotic-exposed infants had low birth weight than the controls (13.2 vs. 2.6 %, P = 0.031), although there were no significant difference in mean birth weight and height between the two groups. Fetal exposure to atypical antipsychotics may cause short-term delayed development in cognitive, motor, social–emotional, and adaptive behavior, but not in language, body weight, or height.
Serotonergic mechanisms responsible for levodopa-induced dyskinesias in Parkinson's disease patients.

Levodopa-induced dyskinesias (LIDs) are the most common and disabling adverse motor effect of therapy in Parkinson's disease (PD) patients. In this study, we investigated serotonergic mechanisms in LIDs development in PD patients using 11C-DASB PET to evaluate serotonin terminal function and 11C-raclopride PET to evaluate dopamine release. PD patients with LIDs showed relative preservation of serotonergic terminals throughout their disease. Identical levodopa doses induced markedly higher striatal synaptic dopamine concentrations in PD patients with LIDs compared with PD patients with stable responses to levodopa. Oral administration of the serotonin receptor type 1A agonist buspirone prior to levodopa reduced levodopa-evoked striatal synaptic dopamine increases and attenuated LIDs. PD patients with LIDs that exhibited greater decreases in synaptic dopamine after buspirone pretreatment had higher levels of serotonergic terminal functional integrity. Buspirone-associated modulation of dopamine levels was greater in PD patients with mild LIDs compared with those with more severe LIDs. These findings indicate that striatal serotonergic terminals contribute to LIDs pathophysiology via aberrant processing of exogenous levodopa and release of dopamine as false neurotransmitter in the denervated striatum of PD patients with LIDs. Our results also support the development of selective serotonin receptor type 1A agonists for use as antidyskinetic agents in PD.
C-Peptide replacement therapy and sensory nerve function in type 1 diabetic neuropathy.

C-peptide replacement in animals results in amelioration of diabetes-induced functional and structural abnormalities in peripheral nerves. The present study was undertaken to examine whether C-peptide administration to patients with type 1 diabetes and peripheral neuropathy improves sensory nerve function.



This was an exploratory, double-blinded, randomized, and placebo-controlled study with three study groups that was carried out at five centers in Sweden. C-peptide was given as a replacement dose (1.5 mg/day, divided into four subcutaneous doses) or a dose three times higher (4.5 mg/day) during 6 months. Neurological examination and neurophysiological measurements were performed before and after 6 months of treatment with C-peptide or placebo.



The age of the 139 patients who completed the protocol was 44.2 +/- 0.6 (mean +/- SE) years and their duration of diabetes was 30.6 +/- 0.8 years. Clinical neurological impairment (NIA) (score >7 points) of the lower extremities was present in 86% of the patients at baseline. Sensory nerve conduction velocity (SCV) was 2.6 +/- 0.08 SD below body height-corrected normal values at baseline and improved similarly within the two C-peptide groups (P < 0.007). The number of patients responding with a SCV peak potential improvement >1.0 m/s was greater in C-peptide-treated patients than in those receiving placebo (P < 0.03). In the least severely affected patients (SCV < 2.5 SD below normal at baseline, n = 70) SCV improved by 1.0 m/s (P < 0.014 vs. placebo). NIA score and vibration perception both improved within the C-peptide-treated groups (P < 0.011 and P < 0.002). A1C levels (7.6 +/- 0.1% at baseline) decreased slightly but similarly in C-peptide-and placebo-treated patients during the study.



C-peptide treatment for 6 months improves sensory nerve function in early-stage type 1 diabetic neuropathy.
Validation of a clinical decision rule: chest X-ray in patients with chest pain and possible acute coronary syndrome

Current literature suggests that a large proportion of chest X-rays (CXRs) performed in emergency department (ED) patients with chest pain and suspected acute coronary syndrome (ACS) are unnecessary. The Canadian ACS Guidelines aim to guide clinicians in the appropriate use of CXR within this patient population. This study determined the prevalence of clinically significant CXR abnormalities and assessed the utility of the guidelines in a population of ED patients with chest pain and suspected ACS. Included in the study were participants over the age of 18 who presented to an Australian metropolitan ED, over a 1-year period, with a primary complaint of chest pain and who had a CXR and troponin level ordered in the ED (N = 760). We retrospectively compared their radiographic findings with their recommendations for CXR according to the ACS Guidelines. We found that 12 % of the participants had a clinically significant chest X-ray. The guidelines had a sensitivity of 80 % (95 % CI 0.70–0.87) and specificity of 50 % (95 % CI 0.47–0.54). The positive predictive value was 18 % (95 % CI 0.15–0.22) with a 95 % negative predictive value (95 % CI 0.92–0.97). Had the ACS guidelines been applied to our patient population, the number of CXR performed would have been reduced by 47 %. This study suggests that the ACS Guidelines has the potential to reduce the numbers of unnecessary CXR performed in ED patients. However, this would come at the expense of missing a minority of significant CXR abnormalities.
Syndemic conditions associated with increased HIV risk in a global sample of men who have sex with men.

We evaluated the relationship among syndemic conditions (defined as a cluster of interconnected psychosocial health conditions), sexual behaviours and self-reported HIV infection in a global sample of men who have sex with men (MSM).



We used generalised estimating equations logistic regression models with robust SEs to assess the relationships among cumulative number of syndemic conditions--including depression, substance use, violence, sexual stigma and homelessness--and unprotected anal intercourse (UAI) and HIV infection, while accounting for clustering within-country in a global cross-sectional survey of 3934 MSM across 151 countries.



We observed parallel, significant dose-response associations between the number of syndemic conditions and UAI, as well as number of syndemic conditions and HIV infection. Compared with participants without syndemics, the adjusted OR (aOR) for UAI among those with 1, 2 and 3 or more syndemic conditions were 1.44 (Bonferroni-adjusted 95% CI 1.23 to 1.68), 1.89 (1.51 to 2.36) and 2.03 (1.43 to 2.89), respectively. Compared with participants without syndemics, the aOR for HIV infection among those with 1, 2 and 3 or more syndemic conditions were 1.67 (1.24 to 2.26), 2.02 (1.44 to 2.85) and 2.35 (1.31 to 4.21), respectively.



This analysis provides evidence of intertwining syndemics that may operate synergistically to increase HIV risk among MSM globally. To curb HIV effectively and advance the health of MSM, multiple conditions must be addressed concurrently using multi-level approaches that target both individual and structural risk factors.
Beneficial effects of viscous dietary fiber from Konjac-mannan in subjects with the insulin resistance syndrome: results of a controlled metabolic trial.

Dietary fiber has recently received recognition for reducing the risk of developing diabetes and heart disease. The implication is that it may have therapeutic benefit in prediabetic metabolic conditions. To test this hypothesis, we investigated the effect of supplementing a high-carbohydrate diet with fiber from Konjac-mannan (KJM) on metabolic control in subjects with the insulin resistance syndrome.



We screened 278 free-living subjects between the ages of 45 and 65 years from the Canadian-Maltese Diabetes Study. A total of 11 (age 55+/-4 years, BMI 28+/-1.5 kg/m2) were recruited who satisfied the inclusion criteria: impaired glucose tolerance, reduced HDL cholesterol, elevated serum triglycerides, and moderate hypertension. After an 8-week baseline, they were randomly assigned to take either KJM fiber-enriched test biscuits (0.5 g of glucomannan per 100 kcal of dietary intake or 8-13 g/day) or wheat bran fiber (WB) control biscuits for two 3-week treatment periods separated by a 2-week washout. The diets were isoenergetic, metabolically controlled, and conformed to National Cholesterol Education Program Step 2 guidelines. Serum lipids, glycemic control, and blood pressure were the outcome measures.



Decreases in serum cholesterol (total, 12.4+/-3.1%, P<0.004; LDL, 22+/-3.9%, P<0.002; total/HDL ratio, 15.2+/-3.4%, P<0.003; and LDL/HDL ratio, 22.2+/-4.1%, P< 0.002), apolipoprotein (apo) B (15.1+/-4.3%, P<0.0004), apo B/A-1 ratio (13.1+/-3.4%, P< 0.0003), and serum fructosamine (5.2+/-1.4%, P<0.002) were observed during KJM treatment compared with WB-control. Fasting blood glucose, insulin, triglycerides, HDL cholesterol, and body weight remained unchanged.



A diet rich in high-viscosity KJM improves glycemic control and lipid profile, suggesting a therapeutic potential in the treatment of the insulin resistance syndrome.
Reliability of the Brazilian Portuguese version of the Neuropsychiatric Inventory (NPI) for patients with Alzheimer's disease and their caregivers.

Behavioral symptoms and caregivers' responses may differ among various ethnic and cultural groups. Therefore it is important to have a reliable instrument to assess behavioral disturbances of dementia in various cultures. The Neuropsychiatric Inventory (NPI) has been widely used in many countries. To date there has been no reliability study of this instrument in Brazil.



The psychometric properties of the Brazilian Portuguese version of the NPI were studied in a sample of 36 Alzheimer's disease (AD) outpatients from southern Brazil. Test-retest, inter-rater reliability and internal consistency were estimated. The profile of neuropsychiatric symptoms and caregiver distress were also evaluated. The NPI was translated into Portuguese and then back translated to English.



The Brazilian Portuguese version of the NPI showed good inter-rater and test-retest reliability with the coefficients of all scales > 0.85. Internal consistency was also good (Cronbach's alpha 0.70 for total severity and distress). Apathy provided higher NPI scores of total severity and distress.



This NPI version was found to be a reliable instrument for the evaluation of neuropsychiatric symptoms and caregiver distress due to dementia in AD. The profile of behavioral disturbances was similar to that observed in other countries. Severity of dementia may have biased some caregivers' answers.
Intravesical idarubicin — a phase-l study

In the scope of a pharmacokinetic and dosefinding study 33 patients received instillations of idarubicin in 11 different doses 1 h before scheduled transurethral resection of bladder cancer. The dose was increased continuously from 5 to 30 mg and the concentration from 0.25–1.5 mg/ml. Idarubicin uptake into tissue was measured along with the serum level. The results showed a clear correlation of the tissue levels with dose and concentration. A significantly higher concentration of idarubicin was measured in the tumor in comparison with the mucosa. Absorption into the muscle was minimal and serum levels were low. Systemic toxicity was not observed, but there were signs of local toxicity in 50% of the subjects. Cytotoxic concentrations in the mucosa were reached at doses of over 15 mg and concentrations of over 0.5 mg/ml. A phase-II study is in preparation.