nils-herrmann/clean_scirepeval huggingface dataset:
A Randomized Controlled Trial Comparing the Effects of Sitagliptin and Glimepiride on Endothelial Function and Metabolic Parameters: Sapporo Athero-Incretin Study 1 (SAIS1)

The DPP-4 inhibitors are incretin-related drugs that improve hyperglycemia in a glucose-dependent manner and have been reported to exert favorable effects on atherosclerosis. However, it has not been fully elucidated whether DPP-4 inhibitors are able to improve endothelial function in patients with type 2 diabetes. Therefore, we investigated the efficacy of sitagliptin, a DPP-4 inhibitor, on endothelial function and glycemic metabolism compared with that of the sulfonylurea glimepiride.



In this multicenter, prospective, randomized parallel-group comparison study, 103 outpatients with type 2 diabetes (aged 59.9 ± 9.9 years with HbA1c levels of 7.5 ± 0.4%) with dietary cure only and/or current metformin treatment were enrolled and randomly assigned to receive sitagliptin or glimepiride therapy once daily for 26 weeks. Flow-mediated dilation (FMD), a comprehensive panel of hemodynamic parameters (Task Force® Monitor), and serum metabolic markers were assessed before and after the treatment.



During the study period, no statistically significant change in %FMD was seen in both groups (sitagliptin, 5.6 to 5.6%; glimepiride, 5.6 to 6.0%). Secretory units of islets in transplantation, TNF-α, adiponectin and biological antioxidant potential significantly improved in the sitagliptin group, and superoxide dismutase also tended to improve in the sitagliptin group, while improvements in HbA1c levels were similar between groups. Cardiac index, blood pressure and most other metabolic parameters were not different.



Regardless of glycemic improvement, early sitagliptin therapy did not affect endothelial function but may provide favorable effects on beta-cell function and on inflammatory and oxidative stress in patients with type 2 diabetes without advanced atherosclerosis.
A multinational, observational study to investigate the efficacy, safety and tolerability of acarbose as add-on or monotherapy in a range of patients: the Gluco VIP study.

The burden of type 2 diabetes mellitus is growing rapidly, particularly in the Asia-Pacific region. The aim of this international, large-scale, observational study was to investigate the efficacy and tolerability of the antidiabetic agent acarbose as add-on or monotherapy in a range of patients with type 2 diabetes, including those with cardiovascular morbidities. The majority of practices were included from high-burden regions (predominantly those in the Asia-Pacific region).



This was an observational study conducted in 15 countries/regions. Adults with pre-treated or untreated type 2 diabetes prescribed acarbose as add-on or monotherapy were eligible. Two-hour postprandial blood glucose (2-h PPG), glycosylated haemoglobin (HbA1c) and fasting blood glucose (FBG) were measured over a 3-month observation period.



A total of 15,034 patients were valid for the efficacy analysis and 15,661 for the safety analysis (mean age was 57.6 years and 92.6 % of patients were Asian). Mean (SD) 2-h PPG decreased by -71.9 (62.3) mg/dL, to 170.2 (46.5) mg/dL at final visit (after 12.8 [4.1] weeks). Mean HbA1c decreased by -1.1 % (1.3) to 7.2 % (1.1) and mean FBG decreased by -33.0 (43.3) mg/dL to 124.8 (30.5) mg/dL. Acarbose was effective regardless of the presence of cardiovascular co-morbidities or diabetic complications. The efficacy of acarbose was rated 'very good' or 'good' in 85.5 % of patients, and tolerability as 'very good' or 'good' in 84.9 % of patients. Drug-related adverse events, mainly gastrointestinal, were reported in 490/15,661 patients (3.13 %).



The results of this observational study support the notion that acarbose is effective, safe and well tolerated in a large cohort of Asian patients with type 2 diabetes.
Prognostic value of hyponatremia in heart failure patients: an analysis of the Clinical Characteristics and Outcomes in the Relation with Serum Sodium Level in Asian Patients Hospitalized for Heart Failure (COAST) study

Hyponatremia is a well-known risk factor for poor outcomes in Western studies of heart failure (HF) patients. We evaluated the predictive value of hyponatremia in hospitalized Asian HF patients.



The Clinical Characteristics and Outcomes in the Relation with Serum Sodium Level in Asian Patients Hospitalized for Heart Failure (the COAST) study enrolled hospitalized patients with systolic HF (ejection fraction < 45%) at eight centers in South Korea, Taiwan, and China. The relationship between admission sodium level and clinical outcomes was analyzed in 1,470 patients.



The mean admission sodium level was 138 ± 4.7 mmol/L, and 247 patients (16.8%) had hyponatremia defined as Na(+) < 135 mmol/L. The 12-month mortality was higher in hyponatremic patients (27.9% vs. 14.6%, p < 0.001), and hyponatremia was an independent predictor of 12-month mortality (hazard ratio, 1.72; 95% confidence interval, 1.12 to 2.65). During hospital admission, 57% of hyponatremic patients showed improvement without improvement in their clinical outcomes (p = 0.620). The proportion of patients with optimal medical treatment was only 26.5% and 44.2% at admission and discharge, respectively, defined as the combined use of angiotensin-converting-enzyme inhibitor/angiotensin receptor blocker and β-blocker. Underuse of optimal medical treatment was more pronounced in hyponatremic patients.



In hospitalized Asian HF patients, hyponatremia at admission is common and is an independent predictor of poor clinical outcome. Furthermore, hyponatremic patients receive less optimal medical treatment than their counterparts.
Mortality in healthcare-associated pneumonia in a low resistance setting: a prospective observational study

The classification of pneumonia as community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) has implications for selection of initial antimicrobial therapy. HCAP has been associated with an increased prevalence of multidrug-resistant (MDR) pathogens and with high mortality leading to recommendations for broad empiric therapy.



We performed a prospective, population-based study on consecutive adults (≥ 18 years) admitted for pneumonia over 1 calendar year. Patients were classified by pneumonia type and severity. Microbial etiologic testing was performed on all patients. Treatment, length of stay, and mortality rates were compared.



A total of 373 admissions were included, 94% of all eligible patients. They were classified as CAP (n = 236, 63%) or HCAP (n = 137, 37%). Chronic underlying disease was more commonly found among patients with HCAP compared with CAP (74% vs 51%, p < 0.001). Mycoplasma pneumoniae was more common among CAP patients (p < 0.01), while gram-negative bacteria were more often found among HCAP patients (p = 0.02). No MDR pathogens were detected, and rates of Staphylococcus aureus were similar in the two groups. HCAP patients were not more likely to receive ineffective initial antimicrobial therapy. HCAP patients had worse prognostic scores on admission and higher in-house mortality than CAP patients (10% vs 1%, respectively, p < 0.01).



Even in a low resistance setting, patients with HCAP have increased mortality compared with patients with CAP. This is most likely explained by a higher prevalence of co-morbidities. Our data do not support broad-spectrum empiric antibiotic therapy for HCAP.
Is balance exercise training as effective as aerobic exercise training in fibromyalgia syndrome?

The aim was to compare the effect of aerobic and balance exercises on pain severity, myalgic score, quality of life, exercise capacity and balance in fibromyalgia syndrome (FMS). A total of 33 females diagnosed with FMS by the American College of Rheumatology criteria were recruited in this randomised controlled study and allocated to aerobic exercise (AE) or balance exercise (BE) groups. Exercises were performed three times a week, for 6 weeks on a treadmill or with a Tetrax interactive balance system (TIBS). Outcome measures were characterised by myalgic score, visual analogue scale, Fibromyalgia Impact Questionnaire (FIQ), exercise testing, Timed Up-Go (TUG) and TIBS measurements. Comparisons from baseline to 6 weeks were evaluated using Wilcoxon test. Mann–Whitney U test was used to compare differences between groups. Effect sizes were also calculated. Improvements in pain, myalgic score and FIQ were found in both groups (p < 0.05). While comparing groups, myalgic score was significant (p = 0.02, d = −1.77), the value was higher in AE. Exercise duration, Borg scale, resting blood pressures (RBP) and maximal heart rate were significant in AE. In BE, Borg scale, exercise duration was significant (p < 0.05). While comparing groups, diastolic RBP (p = 0.04, d = −0.92), exercise duration (p = 0.00, d = −1.64) were significant, with higher values in AE. TUG significantly changed in groups (p < 0.05, d ≥ −1.22). Stability scores, eyes open while standing on elastic pads (p = 0.00, d = −0.98) and head back (p = 0.03, d = −0.74), were significant, with higher values in BE. This study showed that BE provided some improvements in FMS, but AE training led to greater gains. BE training should be included in comprehensive programs.
Health Literacy Mediates the Relationship Between Age and Health Outcomes in Patients With Heart Failure.

Previous studies have linked frequent rehospitalizations for heart failure (HF) and increased mortality with older age, higher severity of HF, lack of an evidence-based medication regimen, and inadequate health literacy. However, the pathway between age and health outcomes in patients with HF remains unknown. Therefore, the purpose of this study was to test whether the association between age and health outcomes can be explained by severity of HF, evidence-based medication use, and health literacy in patients with HF.



This was a longitudinal study of 575 rural patients with HF recruited from outpatient clinics and hospitals. Demographics, clinical data, and health literacy were collected at baseline. HF readmissions and cardiac mortality were followed for 2 years; 57% of patients were ≥ 65 years of age. Older patients with HF were more likely to have low health literacy and less likely to be prescribed angiotensin-converting enzyme inhibitors or β-blockers. Using Kaplan-Meier survival curves with log-rank tests, health outcomes were significantly worse in patients who were ≥ 65 years and in those with low health literacy. Separate Cox regressions revealed that age and health literacy predicted worse health outcomes (P = 0.006 and < 0.001, respectively). When health literacy was entered into the model, the hazard ratio for age changed from 1.49 to 1.29 (a 41% reduction); age was no longer a significant predictor of health outcomes, but health literacy remained significant (P < 0.001), demonstrating mediation.



Health literacy mediates the relationship between age and health outcomes in adults with HF.
Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial

Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider.  To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes.  A 421-bed district hospital in Nantou City, Taiwan.  We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P < 0.05.  The change in the mean HbA1c level from the baseline to the next level within 6 months after recruiting.  Nonparametric data (Mann–Whitney test) showed that the mean HbA1c level significantly decreased (0.83 %) after 6 months for the intervention group compared with an increase of 0.43 % for the control group (P ≤ 0.001). Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups.  The pharmacist intervention program provided pharmaceutical services that improved long-term, safe control of blood sugar levels for ambulatory elderly patients with diabetes and did not increase medical expenses.
P300 and symptom improvement in schizophrenia

A reduced amplitude of the auditory evoked P300 was interpreted as a trait marker of schizophrenia but reports about correlations between schizophrenic psychopathology and P300 amplitude indicate also a state character.  To shed light upon these trait and state aspects a longitudinal study was performed to investigate the influence of symptom improvement and atypical neuroleptics on the amplitudes of the P300 and their subcomponents.  P300 was recorded in 17 schizophrenic patients before and after 4 weeks under either clozapine or olanzapine in a double-blind controlled design. For comparison, 17 age- and sex-matched healthy subjects were investigated. Parietal and frontal P300 subcomponents were investigated separately using dipole source analysis.  Schizophrenic patients had smaller parietal (temporo-basal dipole) but not frontal subcomponent amplitudes (temporo-superior dipole) than controls. For the whole sample subcomponent amplitudes did not change over 4 weeks despite clinical improvement but patients with a pronounced improvement of the PANSS positive score showed a slight enhancement of both subcomponents. This was not significant when the P300 amplitude was measured at a single electrode (Pz). No significant difference between clozapine and olanzapine concerning effects on P300 amplitudes were observed.  The results indicate that P300 subcomponents are modulated by changes of positive but not by changes of negative symptoms or different neuroleptics. This result was obvious for P300 subcomponents but not for Pz electrode measurement, which may be due to a higher reliability of the dipole source activity. The results can be integrated into a hypothetical model containing two pathophysiological subgroups of schizophrenia.
Application of transmission scan-based attenuation compensation to scatter-corrected thallium-201 myocardial single-photon emission tomographic images

A practical method for scatter and attenuation compensation was employed in thallium-201 myocardial single-photon emission tomography (SPET or ECT) with the triple-energy-window (TEW) technique and an iterative attenuation correction method by using a measured attenuation map. The map was reconstructed from technetium-99m transmission CT (TCT) data. A dual-headed SPET gamma camera system equipped with parallel-hole collimators was used for ECT/TCT data acquisition and a new type of external source named ”sheet line source” was designed for TCT data acquisition. This sheet line source was composed of a narrow long fluoroplastic tube embedded in a rectangular acrylic board. After injection of 99mTc solution into the tube by an automatic injector, the board was attached in front of the collimator surface of one of the two detectors. After acquiring emission and transmission data separately or simultaneously, we eliminated scattered photons in the transmission and emission data with the TEW method, and reconstructed both images. Then, the effect of attenuation in the scatter-corrected ECT images was compensated with Chang’s iterative method by using measured attenuation maps. Our method was validated by several phantom studies and clinical cardiac studies. The method offered improved homogeneity in distribution of myocardial activity and accurate measurements of myocardial tracer uptake. We conclude that the above correction method is feasible because a new type of 99mTc external source may not produce truncation in TCT images and is cost-effective and easy to prepare in clinical situations.
Effects of ginger on serum glucose, advanced glycation end products, and inflammation in peritoneal dialysis patients.

The aim of this study was to investigate the effects of ginger supplementation on serum glucose, advanced glycation end products, oxidative stress, and systemic and vascular inflammatory markers in patients on peritoneal dialysis (PD).



In this randomized, double-blind, placebo-controlled trial, 36 patients on PD were randomly assigned to either the ginger or the placebo group. The patients in the ginger group received 1000 mg/d ginger for 10 wk, whereas the placebo group received corresponding placebos. At baseline and the end of week 10, serum concentrations of glucose, carboxymethyl lysine, pentosidine, malondialdehyde (MDA), high-sensitivity C-reactive protein (hs-CRP), soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), and sE-selectin were measured after a 12- to 14-h fast.



Serum fasting glucose decreased significantly up to 20% in the ginger group at the end of week 10 compared with baseline (P < 0.05), and the reduction was significant in comparison with the placebo group (P < 0.05). There were no significant differences between the two groups in mean changes of serum carboxymethyl lysine, pentosidine, MDA, hs-CRP, sICAM-1, sVCAM-1, and sE-selectin.



This study indicated that daily administration of 1000 mg ginger reduces serum fasting glucose, which is a risk factor for hyperinsulinemia, dyslipidemia, peritoneal membrane fibrosis, and cardiovascular disease, in patients on PD.
Back Pain and Body Posture Evaluation Instrument (BackPEI): development, content validation and reproducibility

Following a search conducted in several databases, no instrument was found that jointly evaluates the prevalence of back pain and its associated demographic, social–economic, hereditary, behavioral and postural risk factors. Thus, the present study aims to develop the Back Pain and Body Posture Evaluation Instrument (BackPEI) for school-age children and verify its validity and reproducibility. Twenty-one questions were elaborated to compose the BackPEI instrument, eight experts checked the content validity, and its reproducibility was tested by applying the questionnaire to 260 primary schoolchildren, at two different times with a 7-day interval. The reproducibility data for the first 20 questions, analyzed using the kappa (k) coefficient, were classified as “very good” (k > 0.8) or “good” (0.6 < k ≤ 0.8). The reproducibility data for the pain intensity question, analyzed using the Wilcoxon test and the intraclass correlation coefficients (ICC), demonstrated that there was no difference between the averages (p = 0.251) and the responses were highly correlated (ICC = 0.937) for these two tests. The BackPEI constitutes a valid and reproducible instrument which is relevant for the evaluation of back pain and its associated risk factors.
Evaluation of a fatigue initiative: information on exercise for patients receiving cancer treatment.

An observational cohort study in patients undergoing treatment at a single cancer centre to evaluate the usefulness of providing written information on exercise and fatigue to patients at the start of their treatment, to assess whether patients exercised during treatment and their level of fatigue before and after treatment.



Participants were 205 patients of mean age 63.4 years (115 men and 90 women), starting a course of radical radiotherapy, postoperative radiotherapy and palliative radiotherapy or chemotherapy between October 2004 and June 2005 for genitourinary, gynaecological or breast cancer. A patient-held folder was provided, containing written information on cancer or treatment-related fatigue and the use of exercise to manage this, together with flyers for workshops on fatigue management held at local palliative care centres. Study evaluation questionnaires were used for patients to rate the information's usefulness and provide information regarding fatigue. Fatigue level was documented using Brief Fatigue Inventory score sheets. The main research variables were patient rating of the usefulness of the written information provided, whether patients reported being able to exercise during their cancer treatment and self-completed fatigue scores.



The information provided was rated as helpful or very helpful by 70-78% of patients. Overall, 144/163 patients (88.3%) reported exercising during treatment (70.2% of all patients in the fatigue initiative). Patients receiving radical or postoperative radiotherapy as compared with chemotherapy, and those using the information supplied were more likely to exercise during treatment. There was a significant overall increase in mean fatigue from the start to the end of cancer treatment (P<0.001). Patients who did not exercise, younger patients, those with breast cancer and those receiving chemotherapy (compared with radical or postoperative radiotherapy) all had higher fatigue scores.



Provision of written information on exercise to manage fatigue was rated as helpful by most patients receiving cancer therapies; patients who were able to exercise during treatment had lower fatigue levels.