nils-herrmann/clean_scirepeval huggingface dataset:
Randomized double-blind placebo-controlled trial to evaluate the effect of the ACTH4–9 analogue ORG 2766 in IDDM patients with neuropathy

In this study we report a randomized double-blind, placebo-controlled trial to evaluate the effect of ORG 2766 in IDDM patients with peripheral neuropathy. Sixty-two patients were selected based on the following criteria: abnormal vibration perception threshold above the 95th-percentile adjusted for age and/or abnormal warm temperature threshold, both measured in the right hand. The patients were randomized into two treatment groups after baseline studies: Group 1 was treated with placebo and Group 2 was treated with 3 mg of the ACTH4–9 analogue ORG 2766 every 24 h. The total study period was 1 year. After 1 year of treatment there was a significant improvement in vibration threshold in Group 1 compared to Group 2. No other parameters improved in the study period. The number of patients selected may have been too small to detect a more important treatment effect. We conclude from this study that ORG 2766 can improve vibration threshold, indicating large myelinated fibre function, but does not affect any the other neurophysiological function tests.
The development and psychometric properties of a new scale to measure mental
illness related stigma by health care providers: The opening minds scale for
Health Care Providers (OMS-HC)

Research on the attitudes of health care providers towards people with mental illness has repeatedly shown that they may be stigmatizing. Many scales used to measure attitudes towards people with mental illness that exist today are not adequate because they do not have items that relate specifically to the role of the health care provider.



We developed and tested a new scale called the Opening Minds Scale for Health Care Providers (OMS-HC). After item-pool generation, stakeholder consultations and content validation, focus groups were held with 64 health care providers/trainees and six people with lived experience of mental illness to develop the scale. The OMS-HC was then tested with 787 health care providers/trainees across Canada to determine its psychometric properties.



The initial testing OMS-HC scale showed good internal consistency, Cronbach's alpha = 0.82 and satisfactory test-retest reliability, intraclass correlation = 0.66 (95% CI 0.54 to 0.75). The OMC-HC was only weakly correlated with social desirability, indicating that the social desirability bias was not likely to be a major determinant of OMS-HC scores. A factor analysis favoured a two-factor structure which accounted for 45% of the variance using 12 of the 20 items tested.



The OMS-HC provides a good starting point for further validation as well as a tool that could be used in the evaluation of programs aimed at reducing mental illness related stigma by health care providers. The OMS-HC incorporates various dimensions of stigma with a modest number of items that can be used with busy health care providers.
A familial risk enriched cohort as a platform for testing early interventions to prevent severe mental illness

Severe mental illness (SMI), including schizophrenia, bipolar disorder and severe depression, is responsible for a substantial proportion of disability in the population. This article describes the aims and design of a research study that takes a novel approach to targeted prevention of SMI. It is based on the rationale that early developmental antecedents to SMI are likely to be more malleable than fully developed mood or psychotic disorders and that low-risk interventions targeting antecedents may reduce the risk of SMI.



Families Overcoming Risks and Building Opportunities for Well-being (FORBOW) is an accelerated cohort study that includes a large proportion of offspring of parents with SMI and embeds intervention trials in a cohort multiple randomized controlled trial (cmRCT) design. Antecedents are conditions of the individual that are distressing but not severely impairing, predict SMI with moderate-to-large effect sizes and precede the onset of SMI by at least several years. FORBOW focuses on the following antecedents: affective lability, anxiety, psychotic-like experiences, basic symptoms, sleep problems, somatic symptoms, cannabis use and cognitive delay. Enrolment of offspring over a broad age range (0 to 21 years) will allow researchers to draw conclusions on a longer developmental period from a study of shorter duration. Annual assessments cover a full range of psychopathology, cognitive abilities, eligibility criteria for interventions and outcomes. Pre-emptive early interventions (PEI) will include skill training for parents of younger children and courses in emotional well-being skills based on cognitive behavioural therapy for older children and youth. A sample enriched for familial risk of SMI will enhance statistical power for testing the efficacy of PEI.



FORBOW offers a platform for efficient and unbiased testing of interventions selected according to best available evidence. Since few differences exist between familial and 'sporadic' SMI, the same interventions are likely to be effective in the general population. Comparison of short-term efficacy of PEI on antecedents and the long term efficacy for preventing the onset of SMI will provide an experimental test of the etiological role of antecedents in the development of SMI.
Diabetes care in the U.S. and Canada.

To compare the glycemic control of patients with type 1 diabetes treated in the U.S. and Canada.



A large multicenter randomized clinical trial conducted in the U.S. and Canada was analyzed. Patients with type 1 diabetes, screened from 1983 to 1989 for enrollment in the Diabetes Control and Complications Trial (DCCT), were categorized as treated in the U.S. (n = 2,604) or Canada (n = 245). HbA(1c) levels were compared between U.S. and Canadian patients, both before and after adjustment for predictors of HbA(1c).



In general, volunteers screened for the DCCT were highly educated and following healthy lifestyles. Canadians were somewhat younger (25 vs. 27 years of age, P = 0.002), less likely to be college educated (62 vs. 71%, P = 0.002), more likely to receive care through a family doctor (41 vs. 28%, P = 0.001), and had a higher frequency of out-patient visits (4 vs. 3 per year, P = 0.004). Despite these differences in health care delivery, the mean HbA(1c) at baseline was identical in the two countries (8.9 vs. 9.0, P = 0.40). Adjustment for demographic, lifestyle, and clinical predictors of HbA(1c) yielded similar findings (9.0 vs. 9.2, P = 0.15). Equal percentages of American and Canadian patients who were screened ultimately entered the trial (21 vs. 19%, P = 0.20), and those randomized to conventional care achieved similar mean HbA(1c) levels (9.1 vs. 9.2, P = 0.50).



Differences in care delivery patterns do not yield large differences in glycemic control for patients with type 1 diabetes who were recruited in the U.S. and Canada for a large randomized trial.
Cross-cultural adaptation and validation of Korean Western Ontario and McMaster Universities (WOMAC) and Lequesne osteoarthritis indices for clinical research.

Our aims were to translate WOMAC and Lequesne osteoarthritis (OA) indices into Korean (KWOMAC, KLequesne) and confirm their reliability, validity, and responsiveness.



The WOMAC and Lequesne indices were translated into Korean by three translators and translated back into English by three different translators. Fifty consecutive patients with OA were asked to rate the comprehensibility of the questions on a 4-point scale. The comprehensibility (responding with 'good' and 'very good') ranged from 78% to 99%. Test-retest was performed in another 47 patients with knee OA. The final 53 patients with knee OA, within the context of a clinical trial of two non-steroidal antiinflammatory drugs for 4 weeks, were studied to assess the internal consistency, construct validity, and responsiveness of the Korean versions.



The test-retest reliability of the KWOMAC 3 subscales and the KLequesne yielded intraclass correlation coefficients of 0.79-0.89 and 0.87. The Cronbach standardized alphas were 0.81-0.96 and 0.75, respectively. For the construct validity, the correlation coefficients of both the KWOMAC subscales and the KLequesne with patient pain assessment and patient global assessment were between 0.30 and 0.70 and the KWOMAC subscales correlated with the KLequesne (0.41-0.55). For responsiveness, the KWOMAC and KLequesne scores significantly improved by 4-week post-treatment compared with pre-treatment; effect size values were between 0.41 and 0.69 for the KWOMAC subscales and 0.70 for the KLequesne; and the relative efficiency values of the KWOMAC subscales vs the KLequesne were between 0.87 and 0.90.



The reliability, validity, and responsiveness of the KWOMAC and the KLequesne are confirmed.
Common carotid artery intima-media thickness: the Cardiovascular Risk Factor Multiple Evaluation in Latin America (CARMELA) study results.

Measurement of far wall common carotid artery intima-media thickness (CCAIMT) has emerged as a predictor of incident cardiovascular events. The Cardiovascular Risk Factor Multiple Evaluation in Latin America (CARMELA) study was the first large-scale population-based assessment of both CCAIMT and cardiovascular risk factor prevalence in 7 Latin American cities; the relationship between CCAIMT and cardiovascular risk markers was assessed in these urban Latin American centers.



CARMELA was a cross-sectional, population-based, observational study using stratified, multistage sampling. The participants completed a questionnaire, were evaluated in a clinical visit and underwent carotid ultrasonography. Clinical measurements were obtained by health personnel trained, certified and supervised by CARMELA investigators. Mannheim intima-media thickness consensus guidelines were followed for measurement of CCAIMT.



In all cities and for both sexes, CCAIMT increased with higher age. CCAIMT was greater in the presence of cardiovascular risk factors than in their absence. In all cities, there was a statistically significant linear trend between increasing CCAIMT and a growing number of cardiovascular risk factors (p < 0.001). After adjustment for age and sex, metabolic syndrome was strongly associated with increased CCAIMT (p < 0.001 in all cities), as were hypercholesterolemia, obesity and diabetes (p < 0.001 in most cities). By multivariate analysis, hypertension was independently associated with an increase in CCAIMT in all cities (p < 0.01).



CARMELA was the first large-scale population study to provide normal CCAIMT values according to age and sex in urban Latin American populations and to show CCAIMT increases in the presence of cardiovascular risk factors and metabolic syndrome.
Association of intrahepatic cccDNA reduction with the improvement of liver histology in chronic hepatitis B patients receiving oral antiviral agents.

Covalently closed circular DNA (cccDNA) of hepatitis B virus (HBV) is difficult to eradicate using current antiviral therapy. This study compares cccDNA reduction with relation to liver histology in nucleoside/nucleotide-naïve chronic hepatitis B patients receiving oral antiviral monotherapy (n=35), including entecavir (ETV, n=13), adefovir dipivoxil (ADV, n=22) or placebo (n=14). Serum HBV DNA, intrahepatic total HBV DNA and cccDNA are quantified. Histological hepatic examination is performed at baseline and at 48 weeks of treatment. Treatment with ETV or ADV shows significant median reduction in serum HBV DNA (-6.21 and -4.27 log(10) copies/mL) and intrahepatic total HBV DNA (-1.69 and -1.23 log(10) copies/cell). Intrahepatic cccDNA levels are reduced slightly in the ETV and the ADV groups, but do not differ statistically from the placebo group (-0.17 vs. -0.01 vs. 0.02 copies/cell). Only the level of intrahepatic cccDNA correlates with Knodell necroinflammation activity (r=0.527, P<0.001) and Ishak fibrosis severity (r=0.348, P=0.015) before treatment. Multivariate logistic regression analysis indicates that treatment-induced cccDNA reduction is associated with improved necroinflammation (P=0.041) and fibrosis (P=0.026). In conclusion, baseline intrahepatic cccDNA loads correlate with histologic activity. Although one-year ETV or ADV treatment is insufficient for cccDNA eradication, oral antiviral therapies may improve liver histology, probably by suppressing intrahepatic cccDNA.
Regional differences in the coverage and uptake of bariatric-metabolic surgery: A focus on type 2 diabetes.

There is high-quality evidence that bariatric-metabolic surgery (BMS) generates positive health outcomes in patients with obesity and type 2 diabetes (T2D).



To understand the regional variations in the coverage and uptake of BMS, with a focus on T2D.



An Australian diabetes research institute.



A survey was conducted via a questionnaires sent to national leaders in BMS. The respondents provide their nations' BMS annual numbers, general and any T2D-specific indications for surgery, and source of surgical funding. The total population and adult diabetes prevalence (age 20-70 yr) of the countries were used to model the uptake of BMS for those with T2D.



Data were provided from 22 countries, representing approximately 75% of BMS procedures performed in 2014. BMS uptake varied from 885 per million total population per year in Belgium to 2 per million per year in Japan. The estimated proportion of eligible individuals with diabetes treated annually varied from 1.9% in The Netherlands to<.01% in China and Japan. Few countries treat>1% of estimated eligible patients annually. Of 22 countries, 19 have national guidelines for BMS, and all incorporate BMI in the selection criteria. Several countries have specific criteria for patients with T2D.



Results indicated that BMS has a negligible impact on the global burden of T2D. The low uptake indicates that BMS has not become an established treatment for T2D and emphasizes the need to define when it should be recommended as a standard of care. BMS needs to be integrated into the clinical pathways for managing T2D.
A model for the implementation of cervical cancer screening and human papillomavirus vaccination in the ED: a pilot study.

ume is associated with aortic arterial stiffness in patients with Behçet’s disease without significant cardiovascular involvement.  2014; 28(10):1388–93.  Ekiz O, Balta I, Sen BB, Rifaioglu EN, Ergin C, Balta S, et al. Mean platelet volume in recurrent aphthous stomatitis and Behçet disease. Angiology 2014;65(2):161–5.  Balta I, Balta S, Demir M, Ozturk C, Demirkol S. Thrombotic events in Behçet’s disease.
A phase 2 study of intravenous panobinostat in patients with castration-resistant prostate cancer

Panobinostat, a pan-deacetylase inhibitor, increases acetylation of proteins associated with growth and survival of malignant cells. This phase 2 study evaluated the efficacy of intravenous (IV) panobinostat in patients with castration-resistant prostate cancer (CRPC) who had previously received chemotherapy. The primary end point was 24-week progression-free survival. Secondary end points included safety, tolerability, and the proportion of patients with a prostate-specific antigen (PSA) decline. IV panobinostat (20 mg/m2) was administered to patients on days 1 and 8 of a 21-day cycle. Tumor response was assessed by imaging every 12 weeks (4 cycles) according to modified response evaluation criteria in solid tumors (Scher et al. , and PSA response was defined as a 50 % decrease from baseline maintained for ≥4 weeks. Safety monitoring was routinely performed and included electrocardiogram monitoring. Of 35 enrolled patients, four (11.4 %) were alive without progression of disease at 24 weeks. PSA was evaluated in 34 (97.1 %) patients: five (14.3 %) patients demonstrated a decrease in PSA but none ≥50 %; one patient (2.9 %) had carcinoembryonic antigen as a marker of his prostate cancer, which declined by 43 %. Toxicities regardless of relationship to panobinostat included fatigue (62.9 %), thrombocytopenia (45.7 %), nausea (51.4 %), and decreased appetite (37.1 %). Despite promising preclinical data and scientific rationale, treatment with IV panobinostat did not show a sufficient level of clinical activity to pursue further investigation as a single agent in CRPC.
Structural connectivity in schizophrenia and its impact on the dynamics of spontaneous functional networks.

The neuropathology of schizophrenia remains unclear. Some insight has come from modern neuroimaging techniques, which offer an unparalleled opportunity to explore in vivo the structure and function of the brain. Using functional magnetic resonance imaging, it has been found that the large-scale resting-state functional connectivity (rsFC) in schizophrenia--measured as the temporal correlations of the blood-oxygen-level-dependent (BOLD) signal--exhibit altered network topology, with lower small-world index. The origin of these rsFC alterations and link with the underlying structural connectivity remain unclear. In this work, we used a computational model of spontaneous large-scale brain activity to explore the role of the structural connectivity in the large-scale dynamics of the brain in health and schizophrenia. The structural connectomes from 15 adolescent patients with early-onset schizophrenia and 15 age- and gender-matched controls were built from diffusion tensor imaging data to detect the white matter tracts between 90 brain areas. Brain areas, simulated using a reduced dynamic mean-field model, receive excitatory input from other areas in proportion to the number of fibre tracts between them. The simulated mean field activity was transformed into BOLD signal, and the properties of the simulated functional networks were analyzed. Our results suggest that the functional alterations observed in schizophrenia are not directly linked to alterations in the structural topology. Instead, subtly randomized and less small-world functional networks appear when the brain operates with lower global coupling, which shifts the dynamics from the optimal healthy regime.
C-terminal provasopressin (copeptin) as a prognostic marker after acute non-ST elevation myocardial infarction: Leicester Acute Myocardial Infarction Peptide II (LAMP II) study.

Copeptin, the 39-amino-acid C-terminal portion of provasopressin, has been shown to be an independent predictor for adverse events following STEMI (ST elevation myocardial infarction). We hypothesized that plasma copeptin was an independent predictor for adverse outcomes following acute NSTEMI (non-STEMI) and evaluated whether copeptin added prognostic information to the GRACE (Global Registry of Acute Coronary Events) score compared with NT-proBNP (N-terminal pro-B-type natriuretic peptide). Plasma copeptin and NT-proBNP were measured in 754 consecutive patients admitted to the hospital with chest pain and diagnosed as having NSTEMI in this prospective observational study. The end point was all-cause mortality at 6 months. Upper median levels of copeptin were strongly associated with all-cause mortality at 6 months. Copeptin was a significant predictor of time to mortality {HR (hazard ratio), 5.98 [95% CI (confidence interval, 3.75-9.53]; P < 0.0005} in univariate analysis and remained a significant predictor in multivariate analysis [HR, 3.03 (05% CI, 1.32-6.98); P = 0.009]. There were no significant differences between the area under ROC (receiver operating characteristic) curves of copeptin, NT-proBNP and the GRACE score. Copeptin improved accuracy of risk classification when used in combination with the GRACE score as determined by net reclassification improvement, whereas NT-proBNP did not. The relative utility of the GRACE score was increased more by copeptin than by NT-proBNP over a wide range of risks. Plasma copeptin is elevated after NSTEMI, and higher levels are associated with worse outcomes. Copeptin used in conjunction with the GRACE score improves risk stratification enabling more accurate identification of high-risk individuals.
Cranial and non-cranial embolism: incidence in hospitalised patients in Germany

Using the information of the federal statistics, a detailed description of the hospitalisation rate for cranial and non-cranial embolic events in Germany is given for the years 2005–2010. Detailed lists of the ICD codes I63.0 (stroke) and I74 (arterial embolism and thrombosis) as principal diagnosis and of I48.0 (atrial fibrillation) as additional diagnosis for the years 2005–2010 were provided by the Federal Statistical Office. In the 6 years period total number of cases hospitalised for stroke increased by 24 % (from 185.026 to 229.798) and those hospitalised for embolic events by 60 % (from 64,106 to 92,428). The number of atrial fibrillation as a major cause of arterial embolism documented as additional diagnosis increased by 38 % (from 1.06 to 1.48 Mio). Considering the rate per 100,000 inhabitants, intra-cranial embolism showed the most relevant increase with about 56 % since 2005. Cranial embolism is around 2.5 to 4 times more frequent than non-cranial embolism in females aged 70 to 80 years, but only two times in females aged 40–50, 50–60 and 90 years and older. Males showed a similar distribution with a broader peak. From 2005 to 2010 the total number of embolic events increased, with a higher increase in cranial embolism compared to non-cranial embolism.
Change in the fatty acid pattern of erythrocyte membrane phospholipids after oral supplementation of specific fatty acids in patients with gastrointestinal diseases

The fatty acid pattern of membrane phospholipids is suggested to affect membrane fluidity and epithelial barrier function as a result of membrane fatty acid unsaturation. The incorporation of n-3 polyunsaturated fatty acids (PUFAs) into membrane phospholipids may diminish inflammatory potential in patients with gastrointestinal diseases. The aim of this study was to improve the fatty acid profile of erythrocyte membrane phospholipids after oral supplementation of specific fatty acids in patients with maldigestion and/or malabsorption.We conducted a randomized, double-blind, controlled trial. A total of 48 patients with gastrointestinal diseases received either fat-soluble vitamins A,D,E,K (ADEK) or ADEK plus fatty acids α-linolenic acid (ALA), docosahexaenoic acid (DHA) and medium-chain triglycerides (FA-ADEK) for 12 weeks. The fatty acid profile of erythrocyte membrane phospholipids, dietary intake, plasma antioxidant vitamins and serum γ-glutamyl transferase (GGT) were evaluated at baseline, 8 and 12 weeks after supplementation.Supplementation with FA-ADEK increased ALA, DHA and eicosapentaenoic acid (EPA) concentrations of erythrocyte membrane phospholipids by 0.040, 1.419 and 0.159%, respectively, compared with ADEK supplementation (−0.007, 0.151 and 0.002%, respectively) after 12 weeks (all P⩽0.001). Serum GGT activity decreased in patients receiving FA-ADEK compared with those receiving ADEK with a significant difference after 8 weeks.The significant change in erythrocyte membrane fatty acid pattern demonstrates the incorporation of orally administered n-3 PUFA in patients with maldigestion and malabsorption. The increase in ALA and DHA, as well as the conversion of ALA to EPA is attributed to the supplementation of sufficient amounts of ALA and DHA, respectively. Serum GGT activity decreased in response to decreased oxidative stress.