nils-herrmann/clean_scirepeval huggingface dataset:
Insulin-sensitizing effects on muscle and adipose tissue after dietary fiber intake in men and women with metabolic syndrome.

Dietary fibers have been associated with a reduced incidence of type 2 diabetes mellitus in epidemiological studies; however, the precise mechanisms are unknown.



The objective of the study was to evaluate the efficacy and site of action of an insoluble dietary fiber derived from maize (HAM-RS2) in improving insulin resistance in subjects at increased risk of type 2 diabetes mellitus.



This study was a randomized, controlled crossover, dietary intervention study.



The study was conducted at the Centre for Diabetes, Endocrinology, and Research, Royal Surrey County Hospital, Guildford, United Kingdom.



Fifteen men and women with insulin resistance participated in the study.



The intervention included 40 g/d HAM-RS2 compared with a matched placebo for 8 wk.



After each supplement, participants underwent a two-step hyperinsulinemic-euglycemic clamp study with the addition of glucose tracers; a meal tolerance test; arteriovenous sampling across forearm muscle tissue; and a sc adipose tissue biopsy for assessment of gene expression.



There was enhanced uptake of glucose into the forearm muscle measured by arteriovenous sampling (65 ± 15% increase after resistant starch; P < 0.001). Adipose tissue function was also affected, with enhanced fatty acid suppression after HAM-RS2 treatment and an increase in gene expression for hormone sensitive lipase (P = 0.005), perilipin (P = 0.011), lipoprotein lipase (P = 0.014), and adipose triglyceride lipase (P = 0.03) in biopsy samples. There was no effect on the insulin sensitivity of hepatic glucose production or plasma lipids after HAM-RS2.



HAM-RS2 improved peripheral but not hepatic insulin resistance and requires further study as an intervention in patients with or at risk for type 2 diabetes.
Early Intervention Options for Acute Low Back Pain Patients: A Randomized Clinical Trial with One-Year Follow-Up Outcomes

In an earlier study, Gatchel et al. (J Occup Rehabil 13:1–9, 2003) demonstrated that participants at high risk for developing chronic low back pain disability (CLBPD), who received a biopsychosocial early intervention treatment program, displayed significantly more symptom improvement, as well as cost savings, relative to participants receiving standard care. The purpose of the present study was to expand on these results by examining whether the addition of a work-transition component would further strengthen the effectiveness of this early intervention treatment.  Using an existing algorithm, participants were identified as being high-risk (HR) or low-risk (LR) for developing CLBPD. HR participants were then randomly assigned to one of three groups: early intervention (EI); early intervention with work transition (EI/WT); or standard care (SC). Participants provided information regarding pain, disability, work status, and psychosocial functioning at baseline, periodically during treatment, and again 1 year following completion of treatment.  At 1-year follow-up, no significant differences were found between the EI and EI/WT groups in terms of occupational status, self-reports of pain and disability, coping ability or psychosocial functioning. However, significant differences in all these outcomes were found comparing these groups to standard care.  The addition of a work transition component to an early intervention program for the treatment of ALBP did not significantly contribute to improved work outcomes. However, results further support the effectiveness of early intervention for high-risk ALBP patients.
Demographic, Medical, and Psychosocial Predictors of Pregnancy Anxiety.

Pregnancy anxiety is associated with risk of preterm birth and an array of other birth, infant, and childhood outcomes. However, previous research has not helped identify those pregnant women at greatest risk of experiencing this specific, contextually-based affective condition.



We examined associations between demographic, medical, and psychosocial factors and pregnancy anxiety at 24-26 weeks of gestation in a prospective, multicentre cohort study of 5271 pregnant women in Montreal, Canada.



Multivariate analyses indicated that higher pregnancy anxiety was independently related to having an unintended pregnancy, first birth, higher medical risk, and higher perceived risk of complications. Among psychosocial variables, higher pregnancy anxiety was associated with lower perceived control of pregnancy, lower commitment to the pregnancy, more stressful life events, higher perceived stress, presence of job stress, lower self-esteem and more social support. Pregnancy anxiety was also higher in women who had experienced early income adversity and those who did not speak French as their primary language. Psychosocial variables explained a significant amount of the variance in pregnancy anxiety independently of demographic and medical variables.



Women with pregnancy-related risk factors, stress of various kinds, and other psychosocial factors experienced higher pregnancy anxiety in this large Canadian sample. Some of the unique predictors of pregnancy anxiety match those of earlier US studies, while others point in new directions. Screening for high pregnancy anxiety may be warranted, particularly among women giving birth for the first time and those with high-risk pregnancies.
A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer.

Neoadjuvant systemic therapy (NST) before surgery is a standard option for patients with early breast cancer (EBC) that allows in vivo chemosensitivity testing. Given the promising activity of pemetrexed plus doxorubicin in metastatic breast cancer, it was reasonable to evaluate the utility of this combination as part of an NST regimen in EBC.



Patients with untreated operable T2-T4a-c N0-2 M0 breast cancer were randomly assigned to receive either four cycles of pemetrexed 500 mg/m(2) plus doxorubicin 60 mg/m(2) every 3 weeks (q3w) followed by four cycles of docetaxel 100 mg/m(2) q3w (AP-D) or four cycles of doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) q3w followed by four cycles of docetaxel 100 mg/m(2) q3w (AC-D). Surgery was carried out within 2 months after last chemotherapy. Primary end point was pathological complete response (pCR) rate in the breast. Secondary end points included clinical response rate, rate of histologically negative axillary lymph nodes, toxicity, and disease-free survival.



From September 2005 to August 2007, 257 patients were randomly allocated to 17 sites. Median age was 48 and 49 years for AP-D and AC-D, respectively. Overall pCR rates were 16.5% for AP-D and 20.2% for AC-D. With AP-D, pCR rate was 17.8% for hormone receptor (HR)-negative patients and 15.9% for HR-positive patients. With AC-D, pCR rates were 42.9% and 7.8% for HR-negative and HR-positive patients, respectively. Clinical response rates were 59.5% in the AP-D group and 68.1% in the AC-D group. The rate of histologically negative axillary lymph nodes was 53% in both groups. Both treatments were well tolerated. Median disease-free survival is currently not mature.



AP-D and AC-D are well tolerated and active as NST in EBC. Of note, AC-D had a higher pCR rate in HR-negative tumors, whereas AP-D had more activity if HRs were expressed.
A randomized double-blind crossover trial of triventricular versus biventricular pacing in heart failure.

A significant proportion of patients implanted with biventricular (BiV) devices fail to respond. Clinical response may be improved by additional ventricular stimulation sites. This single-centre, double-blinded randomized crossover trial aimed to determine whether long-term multisite ventricular pacing is superior to conventional BiV pacing in heart failure patients.



A total of 43 patients referred for cardiac resynchronization therapy (CRT) underwent transvenous implantation of a triventricular (TriV) device. Pacing leads were positioned in the right ventricular (RV) apex and a lateral coronary sinus (CS) branch, with a third ventricular lead implanted in a further lateral CS branch in 23 patients (group A) and on the high RV septum in 20 patients (group B). Devices were programmed in a randomized order to four pre-determined pacing configurations: conventional BiV, TriV, and dual-site and single-site left bentricular (LV) or RV pacing for 3-month periods with clinical and echo assessment at the end of each period. The primary endpoint was the comparison of 6 min walk distance (6MW) after 3 months of BiV vs. TriV pacing; secondary endpoints were Minnesota Living With Heart Failure (MLWHF) scores, and LV dimensions and function. The 12-month follow-up period was completed by 37 patients. Compared with BiV pacing, TriV pacing resulted in significant improvements in 6MW (451 ± 112 m vs. 425 ± 119 m, P = 0.008), MLWHF (32 ± 19 vs. 38 ± 24, P = 0.036), LV end-systolic volume (158 ± 79mL vs. 168 ± 76 mL, P < 0.05), and ejection fraction (30 ± 8% vs. 27 ± 8%, P < 0.05).



TriV pacing was associated with significant improvements in clinical and echocardiographic parameters compared with BiV pacing.
Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial.

Bleeding limits anticoagulant treatment in patients with acute coronary syndromes (ACS).



We investigated whether background concomitant antiplatelet therapy influences the effects of apixaban after ACS.



This study examined high-risk ACS patients who were treated with aspirin or aspirin plus clopidogrel and who were randomized to apixaban 5 mg twice daily or placebo. In a post-hoc analysis, we assessed whether the effect of apixaban on efficacy and safety outcomes varied by the concomitant antiplatelet regimen by using simple Cox modeling and marginal structural models with propensity scores and antiplatelet therapy as a time-dependent covariate.



At baseline, of 7,364 patients, 16.3% (n = 1,202) were on aspirin alone, and 79.0% (n = 5,814) were on aspirin plus clopidogrel. A total of 19.2% (n = 1,415) switched antiplatelet therapy during follow-up. No differential effect of apixaban versus placebo was observed for the composite endpoint of cardiovascular death, myocardial infarction, and ischemic stroke in patients taking aspirin (12.21 per 100 patient-years vs. 13.21 per 100 patient-years; adjusted hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.62 to 1.32) or aspirin plus clopidogrel (13.22 vs. 14.24; adjusted HR: 0.95; 95% CI: 0.78 to 1.14; p(interaction)= 0.84). Compared with placebo, apixaban increased Thrombolysis In Myocardial Infarction major bleeding in patients taking aspirin (1.48 vs. 0.25; adjusted HR: 6.62; 95% CI: 0.75 to 51.73) and in patients taking aspirin plus clopidogrel (2.58 vs. 1.02; adjusted HR: 2.44; 95% CI: 1.34 to 4.45; p(interaction)= 0.41). Similar results were obtained with marginal structural models and in patients treated with and without percutaneous coronary intervention.



Post-ACS treatment with apixaban versus placebo showed no efficacy, but it increased bleeding regardless of concomitant therapy with aspirin alone or aspirin plus clopidogrel. (Apixaban for Prevention of Acute Ischemic Events 2 [APPRAISE-2]; NCT00831441).
Effect of Salt Intake and Potassium Supplementation on Serum Renalase Levels in Chinese Adults

Renalase, a recently discovered enzyme released by the kidneys, breaks down blood-borne catecholamines and may thus regulate blood pressure (BP). Animal studies have suggested that high levels of dietary salt might reduce blood and kidney renalase levels. We conducted a randomized trial to assess the effects of altered salt and potassium intake on serum renalase levels and the relationship between serum renalase levels and BP in humans.Forty-two subjects (28-65 years of age) were selected from a rural community of northern China. All subjects were sequentially maintained on a low-salt diet for 7 days (3.0 g/day of NaCl), a high-salt diet for additional 7 days (18.0 g/day of NaCl), and a high-salt diet with potassium supplementation for final 7 days (18.0 g/day of NaCl + 4.5 g/day of KCl).Serum renalase levels were significantly higher than baseline levels during the low-salt diet intervention period. Renalase levels decreased with the change from the low-salt to high-salt diet, whereas dietary potassium prevented the decrease in serum renalase induced by the high-salt diet. There was a significant inverse correlation between the serum renalase level and 24-h urinary sodium excretion. No significant correlation was found between the renalase level and BP among the different dietary interventions.The present study indicates that variations in dietary salt intake and potassium supplementation affect the serum renalase concentration in Chinese subjects.
Anaemia management with subcutaneous epoetin delta in patients with chronic kidney disease (predialysis, haemodialysis, peritoneal dialysis): results of an open-label, 1-year study

Anaemia is common in patients with chronic kidney disease (CKD) and can be managed by therapy with erythropoiesis-stimulating agents (ESAs). Epoetin delta (DYNEPO, Shire plc) is the only epoetin produced in a human cell line. The aim of this study was to demonstrate the safety and efficacy of subcutaneously administered epoetin delta for the management of anaemia in CKD patients (predialysis, peritoneal dialysis or haemodialysis)



This was a 1-year, multicentre, open-label study. Patients had previously received epoetin subcutaneously and were switched to epoetin delta at an identical dose to their previous therapy. Dose was titrated to maintain haemoglobin at 10.0-12.0 g/dL. The primary endpoint was mean haemoglobin over Weeks 12-24. Secondary analyses included long-term haemoglobin, haematocrit and dosing levels. Safety was assessed by monitoring adverse events, laboratory parameters and physical examinations.



In total 478 patients received epoetin delta, forming the safety-evaluable population. Efficacy analyses were performed on data from 411 of these patients. Mean +/- SD haemoglobin over Weeks 12-24 was 11.3 +/- 1.1 g/dL. Mean +/- SD weekly dose over Weeks 12-24 was 84.4 +/- 72.7 IU/kg. Haemoglobin levels were maintained for the duration of the study. Epoetin delta was well tolerated, with adverse events occurring at rates expected for a CKD patient population; no patient developed anti-erythropoietin antibodies.



Subcutaneously administered epoetin delta is an effective and well-tolerated agent for the management of anaemia in CKD patients, irrespective of dialysis status.
ENCARA: real-time detection of frontal faces

This paper describes a real-time approach for face detection and selection of frontal views, for further processing. Typically, face detection papers provide results for a set of single images but the problem of face detection in video streams rarely is tackled. Instead of performing an exhaustive search for every video stream frame a set of opportunistic ideas applied in a cascade fashion and based on temporal and spatial coherence provide promising results in real-time.
High serum IL-21 levels after 12 weeks of antiviral therapy predict HBeAg seroconversion in chronic hepatitis B.

Interleukin-21 (IL-21) stimulates T cell and B cell responses and plays a role in control of chronic viral infections. The role of IL-21 in chronic hepatitis B virus (HBV) infection is not understood.



Serum IL-21 levels were measured by enzyme immunoassay in 75 HBeAg-positive chronic hepatitis B (CHB) patients undergoing telbivudine treatment. The findings were validated in 103 patients from a separate clinical trial of telbivudine. A complete response to telbivudine was defined as having both HBeAg seroconversion and serum HBV-DNA level <300 copies/ml by treatment week 52. The proportions of T-cells producing IL-21 and/or expressing programmed death 1 (PD-1) in peripheral blood mononuclear cells were assessed longitudinally during treatment by intracellular cytokine staining and flow cytometry.



Median serum IL-21 levels at treatment week 12 were significantly higher in patients who did achieve vs. patients who did not achieve a complete response in both the initial (128.4 vs. 69.2 pg/ml, p=0.003) and the validation (142.2 vs. 89.9 pg/ml, p=0.004) trials. Serum levels of IL-21 (p=0.005) or HBV-DNA (p=0.003) levels at treatment week 12 independently predicted HBeAg seroconversion in the first year of treatment. The decrease in PD-1 expression on CD4(+) and CD8(+) T cells during the first 12 weeks on telbivudine treatment was not correlated with changes in IL-21 concentrations.



Serum IL-21 levels may be a biomarker for HBeAg seroconversion, and may contribute to individualization of antiviral therapy in HBeAg-positive CHB. IL-21 may also have a role in immunotherapy for CHB.
Effect of ivabradine-induced heart rate reduction on flow-mediated dilation measured with high-sensitivity ultrasound in patients with stable coronary heart disease

Experimental data suggests that exclusive heart rate reduction with ivabradine is associated with the amelioration of the endothelial function. Since it is presently unknown whether this also applies to humans, the aim of this pilot study was to investigate whether heart rate reduction with ivabradine modulates the endothelial function in humans with an established coronary heart disease.



Using high-sensitivity ultrasound, we analysed the flow-mediated (FMD) and nitro-mediated dilation (NMD) of the brachial artery in 25 patients (62.9 ± 8.4 years) with a stable coronary heart disease and a resting heart rate of ≥70 beats per minute (bpm). To assess acute effects, measurements were performed before and 4 hours after the first intake of ivabradine 7.5 mg. Sustained effects of an ivabradine therapy (5 mg to 7.5 mg twice daily) were investigated after 4 weeks.



We found a significant decrease in heart rate, both 4 hours after the intake of 7.5 mg of ivabradine (median -8 [interquartile range (IQR) -14 to -4] bpm) and after 4 weeks of twice daily intake (median -10 [IQR-17 to -5] bpm) (p < 0.05). However, the FMD did not change significantly: neither after first dose of ivabradine nor after sustained therapy (baseline FMD: median 5.0 [IQR 2.4 to 7.9]%; FMD 4 hours after 7.5 mg of ivabradine: median 4.9 [IQR 2.7 to 9.8]%; FMD after 4 weeks of ivabradine therapy: median 6.1 [IQR 4.3 to 8.2]%). No significant changes of the NMD were observed. In regression analysis, the heart rate and FMD did not correlated, irrespective of the ivabradine intake (r2 = 0.086).



In conclusion, in our study heart rate reduction through ivabradine does not improve the endothelial function in patients with a stable coronary heart disease. Moreover, we found no correlation between the heart rate and the endothelial function.
A within-patient comparison of bethanidine, methyldopa and propranolol in the treatment of hypertension.

1. A within-patient comparison showed that bethanidine, methyldopa and propranolol produced similar control of the blood pressure. 2. Unlike bethanidine, propranolol did not produce postural and exercise hypotension; methyldopa was intermediate in effect. 3. Overall side effects were of a similar incidence though there were differences in incidence of particular side effects.
A phase I and pharmacokinetic study of liposomal vinorelbine in patients with advanced solid tumor

This phase I study was performed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of an untargeted liposomal formulation of vinorelbine (NanoVNB®) and to characterize its plasma pharmacokinetics in patients with advanced solid tumors which were refractory to conventional treatment or without an effective treatment.  The study incorporated an accelerated titration design. Twenty-two patients with various solid tumors were enrolled. NanoVNB® was administered intravenously at doses of 2.2–23 mg/m2 once every 14 days. Pharmacokinetic endpoints were evaluated in the first cycle. The safety profiles and anti-tumor effects of NanoVNB® were also determined.  Skin rash was the DLT and the most common non-hematological toxicity. The MTD was 18.5 mg/m2. Drug-related grade 3–4 hematological toxicities were infrequent. Compared with intravenous free vinorelbine, NanoVNB® showed a high Cmax and low plasma clearance. Of the 11 patients completing at least 1 post-treatment tumor assessment, 5 had stable disease. No responders were noted.  NanoVNB® was well tolerated and exhibited more favorable pharmacokinetic profiles than free vinorelbine. Based on dose-limiting skin toxicity, further evaluation of NanoVNB® starting from 18.5 mg/m2 as a single agent or in combination with other chemotherapeutic agents for vinorelbine-active malignancies is warranted.
False-name bids in combinatorial auctions

In Internet auctions, it is easy for a bidder to submit multiple bids under multiple identifiers (e.g., multiple e-mail addresses). If only one good is sold, a bidder cannot make any additional profit by using multiple bids. However, in combinatorial auctions, where multiple goods are sold simultaneously, submitting multiple bids under fictitious names can be profitable. A bid made under a fictitious name is called a false-name bid. This article gives a brief introducion on false-name bids in combinatorial auctions.
Evaluation of insulin sensitivity in hyperprolactinemic subjects by euglycemic hyperinsulinemic clamp technique

The background and aim of the study is to evaluate insulin sensitivity in hyperprolactinemic subjects via euglycemic hyperinsulinemic clamp technique. Sixteen hyperprolactinemic subjects and 12 healthy subjects were included in the study. B and HOMA-IR values of groups were calculated. Euglycemic hyperinsulinemic clamp technique was performed in both groups, and the M value of the groups was defined. Mann–Whitney U and chi-square tests were used in statistical analysis. Basal insulin level of hyperprolactinemic patients were higher than the control group (6.85 ± 4.68; 3.66 ± 0.88 μU/ml respectively; P < 0.05). Mean HOMA-IR and HOMA-B values of patients were higher than control group (1.49 ± 1.30; 0.78 ± 0.27 respectively; P = 0.02 and 136.28 ± 72.53; 64.77 ± 23.31, respectively, P < 0.001). M values of the patients were statistically lower than the control group (5.64 ± 2.36; 7.05 ± 1.62 kg/mg/min respectively; P < 0.05). (1) Hyperprolactinemic patients were more insulin resistant than control subjects. (2) Insulin resistance in hyperprolactinemic patients is not associated with obesity or anthropometric parameters such as fat content, waist circumference and BMI.