nils-herrmann/clean_scirepeval huggingface dataset:
Continuous interferon-α2b infusion in combination with ribavirin for chronic hepatitis C in treatment-experienced patients.

Sustained virological response (SVR) rates in previous non-responders to pegylated interferon (PEG-IFN)-α and ribavirin for chronic HCV remain low (~10%). We hypothesize that continuous subcutaneous delivery of fully potent interferon (IFN)-α2b via an external pump will lead to stable blood concentrations and thereby prevent subtherapeutic trough levels associated with viral breakthrough. The aims of the study were to assess safety, tolerability and virological response in patients who were previous PEG-IFN-α/ribavirin non-responders.



We randomized 30 HCV genotype 1 (n=24) and genotype 4 (n=6) patients to receive 6, 9 or 12 million units (MU) IFN-α2b daily by continuous subcutaneous administration using an insulin pump (MiniMed(®) 508; Medtronic Inc., Minneapolis, MN, USA) in combination with ribavirin (1,000-1,600 mg) for 48 weeks.



The magnitude of viral decline in the 12 MU group after 4 weeks of treatment was 2.67 log HCV RNA compared with 1.21 and 1.27 log HCV RNA in the 9 and 6 MU groups, respectively (P=0.001). In the intention-to-treat analysis, the SVR rate was 20% (6/30). The per-protocol SVR rate was 25% (6/24), of which four out of six patients in the high-dose arm achieved SVR. Adverse events appeared dose-dependent, were mostly mild-to-moderate and were typical of IFN therapy. Five patients developed irritation and/or abscesses at the injection site. Six serious adverse events were reported in five patients.



Continuous delivery of IFN-α2b can induce a strong dose-dependent viral suppression. This could be an effective approach in conjunction with, or as lead-in therapy prior to, treatment with a direct antiviral agent.
Comparison of the Ventral Epidural Spreading in Modified Interlaminar Approach and Transforaminal Approach: A Randomized, Double-Blind Study.

To evaluate the effectiveness of a modified interlaminar (MIL) approach for accessing ventral epidural space compared with the transforaminal (TF) approach.



Randomized double blinded control trial



Eighty-four patients with lumbar radicular pain were randomly assigned into two groups in which drug delivery to the ventral epidural space was performed through either the MIL (n = 42) or the TF approach (n = 42). Within each group, subgroups were classified according to the dominant pathology as assessed by magnetic resonance imaging (MRI): bulging disc, herniated nucleus pulposus (HNP), and foraminal stenosis. Degenerative changes such as scoliosis and facet hypertrophy was also evaluated.



The overall accessibility to the ventral epidural space was similar between the two groups. In cases with foraminal stenosis, the success rate of ventral epidural spreading was significantly higher in the MIL group compared with the TF group (TF approach = 50.00% vs MIL approach = 100.00%, P = 0.013). Medial spread of contrast was more dominant in the MIL group (P < 0.001). There was no significant difference between the two groups in overall clinical outcome. The total success rate of accessing the ventral epidural space in degenerative bony changes was higher in the MIL group than in the TF group (TF approach = 57.1% vs MIL approach = 84.6%), but the difference was not statistically significant.



In cases where access to the ventral epidural space by conventional approach is limited, our MIL approach can be considered a suitable alternative, especially in the case of foraminal stenosis.
Exercise increases serum brain-derived neurotrophic factor in patients with major depressive disorder.

Brain derived neurotrophic factor (BDNF) has been implicated in the pathogenesis of major depressive disorder (MDD). Existing data on exercise treatment in people with MDD are inconsistent concerning the effect of exercise on BDNF pointing either to increased or unaltered BDNF concentrations. However, studies in non-depressed persons demonstrated a significant effect on resting peripheral BDNF concentrations in aerobic training interventions. Given the lack of clarity mentioned above, the current study aimed at examining the effect of adjunctive exercise on serum BDNF levels in guideline based treated patients with MDD.



42 depressed inpatients were included, and randomized either to a 6 week structured and supervised exercise intervention plus treatment as usual (EXERCISE, n=22), or to treatment as usual (TAU, n=20). BDNF serum concentrations were assessed before and after the intervention in both study groups with established immunoassays.



Serum BDNF slightly decreased in the TAU group, whilst there was an increase in BDNF levels in the exercise group. There was a significant time x group effect concerning sBDNF (p=0.030) with repeated ANOVA measures with age and BMI as covariates, suggesting an increase in BDNF concentrations in the EXERCISE group compared to TAU.



Though there was no statistic difference in the antidepressant medication between EXERCISE and TAU potential interactions between exercise and medication on the effects of exercise in BDNF cannot be excluded. Gender was not considered as a covariate in ANOVA due to the small number of objects.



Exercise training given as adjunct to standard guideline based treatment appears to have additional effects on BDNF serum concentrations in people with MDD. Our results add further evidence to the beneficial effects of exercise in the treatment of MDD.
Suppressive effects of conversion from mycophenolate mofetil to everolimus for the development of cardiac allograft vasculopathy in maintenance of heart transplant recipients.

Whether converting to everolimus (EVL) from mycophenolate mofetil (MMF) during the maintenance period after heart transplantation (HTx) reduces cardiac allograft vasculopathy (CAV) progression remains unclear. We sought to determine the effect of converting from MMF with standard-dose calcineurin inhibitors (CNIs) to EVL with low-dose CNIs on CAV progression.



We retrospectively reviewed the medical records of 63 HTx recipients who survived at least at 1 year after HTx. Twenty-four recipients were converted from MMF to EVL (EVL group, 2.2 ± 2.3 years after HTx), while 39 recipients were maintained on MMF (MMF group, 2.4 ± 2.2 years after HTx). The EVL group underwent three-dimensional intravascular ultrasound (3D-IVUS) analysis before and 1 year after conversion to EVL, and these data were compared with data from 2 consecutive IVUS in the MMF group.



IVUS indices in the EVL group at 1 year after conversion did not show increased CAV development, whereas a significant increase in %plaque volume (p=0.006) and decrease in lumen volume (p<0.001) were observed in the MMF group. EVL conversion was significantly associated with smaller increases in %plaque volume (p=0.004) and smaller decreases in lumen volume (p=0.017). IVUS indices in the late EVL conversion group (≥ 2 years) also did not exhibit increased CAV development, while those in the MMF group did.



Conversion to EVL from MMF in maintenance periods after HTx may decrease the rate of CAV progression based on IVUS indices.
Alcohol abuse-duration dependent decrease in plasma testosterone and antioxidants in males.

Ethanol is a testicular toxin and it causes fertility abnormalities with low sperm count and impaired sperm motility in men. The present study was designed to investigate plasma testosterone level and hypothalamic pituitary gonadal (HPG) axis function in alcoholic men and also effect of ethanol on systemic oxidative stress. Forty six male alcohol abusers in the age group 20-40 years were selected. Fifty five, males in the same age group served as control. Alcohol abusers had significantly low plasma testosterone with low luteinizing hormone and follicle stimulating hormone. In addition they had significantly high thiobarbituric acid reactive substances (TBARS), superoxide dismutase and glutathione S-transferase, and low glutathione, ascorbic acid, catalase, glutathione reductase and glutathione peroxidase. Moreover, serum testosterone level in alcoholics negatively correlated with duration of alcohol abuse, and TBARS. Duration dependent decreased serum testosterone level in alcohol abusers might be due to 1) increased oxidative stress which can damage Leydig and supporting Sertoli cells and 2) impaired HPG axis.
Low levels of 1,5-anhydro-D-glucitol are associated with vascular endothelial dysfunction in type 2 diabetes

Vascular endothelial dysfunction is involved in macrovascular disease progression in type 2 diabetes mellitus (T2DM). We reported previously that blood glucose fluctuations, as evaluated by continuous glucose monitoring (CGM), correlate with vascular endothelial function, serving as a marker of vascular endothelial function. However, the use of CGM is limited, suggesting the need for another marker of vascular endothelial function. Here, we investigated the relationship between vascular endothelial dysfunction and blood levels of 1,5-anhydro-D-glucitol (1,5-AG), a marker of both postprandial hyperglycemia and fluctuations in blood glucose.



In 32 inpatients with T2DM and HbA1c less than 8.0%, the reactive hyperemia index (RHI), an index of vascular endothelial function, was determined by peripheral arterial tonometry. The relationships between RHI and 1,5-AG, blood glucose, lipid metabolism markers, and blood pressure, were examined.



There was a strong correlation between 1,5-AG and natural logarithmic-scaled RHI (L_RHI) (r = 0.55; P = 0.001). However, there was no correlation between L_RHI and HbA1c, fasting blood glucose, IRI, LDL-C, HDL-C, TG, systolic blood pressure, or diastolic blood pressure. Multivariate analysis identified blood 1,5-AG levels to be the only significant and independent determinant of L_RHI.



In T2DM with HbA1c <8.0%, low 1,5-AG levels were associated with vascular endothelial dysfunction, suggesting it is a potentially useful marker for vascular endothelial dysfunction.
A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department.

To determine whether nebulized 3% hypertonic saline with epinephrine is more effective than nebulized 0.9% saline with epinephrine in the treatment of bronchiolitis in the emergency department.



Randomized, double-blind, controlled trial.



Single-center urban pediatric emergency department.



Infants younger than 12 months with mild to moderate bronchiolitis.



Patients were randomized to receive nebulized racemic epinephrine in either hypertonic or normal saline.



The primary outcome measure was the change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS) from baseline to 120 minutes. The change in oxygen saturation was also determined. Secondary outcome measures included the rates of hospital admission and return to the emergency department.



Forty-six patients were enrolled and evaluated. The 2 study groups had similar baseline characteristics. The RACS from baseline to 120 minutes demonstrated no improvement in respiratory distress in the hypertonic saline group compared with the normal saline control group. The change in oxygen saturation in the hypertonic saline group was not significant when compared with the control group. Rates of admission and return to the emergency department were not different between the 2 groups.



In the treatment of acute bronchiolitis, hypertonic saline and epinephrine did not improve clinical outcome any more than normal saline and epinephrine in the emergency setting. This differs from previously published results of outpatient and inpatient populations and merits further evaluation.
Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients

Health-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus, there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version.



The EPIC questionnaire measures urinary, bowel, sexual and hormonal domains. The first step, corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step, comprising the validation of the psychometric properties of the EPIC questionnaire, was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed, i.e., before and at the end of treatment for the Treatment group, to assess sensitivity to change; and at 2 weeks' interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory.



The first step showed overall good acceptability and understanding of the questionnaire. In the second step, 215 patients were included from January 2012 to June 2014: 125 in the Treatment group, and 90 in the Cured group. All domains exhibited good internal consistency, except the bowel domain (Cronbach's α = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable, expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment.



The French EPIC questionnaire seems to have adequate psychometric properties, comparable to those exhibited by the original English-language version, except for the construct validity, which was not available in original version.
Changes in anti-citrullinated protein antibody titers following treatment with infliximab for rheumatoid arthritis.

The presence of anti-citrullinated peptide/ protein antibody (ACPA) has a high specificity and predictive value for the development of rheumatoid arthritis (RA). Some studies have shown decreased titers of this antibody after treatment with infliximab.



To assess the changes in ACPA titers in patients with RA after treatment with infliximab as a first biological agent, and to correlate these variations with non-infusion-related adverse effects.



In a prospective multicenter observational study involving 48 research centers, we assessed 139 patients with established moderate-to-severe RA diagnosed according to American College of Rheumatology criteria. Samples were collected before and 6-12 months after treatment.



The mean age of the study patients was 50.6 years and 118 were female (84.9%). Statistically significant variations in ACPA titers were noted in 47 patients (before and after treatment) (P = 0.012). Overall, ACPA titers were decreased in 32 (65.3%) and increased in 15 (34.7%). No correlation was found between severe or mild adverse effects in patients presenting variations in ACPA titers.



The present study showed that infliximab affected ACPA titers, promoting mainly a decrease; however, this was not related to the occurrence of non-infusion-related adverse effects.
The effect of tranexamic acid on blood loss during orthognathic surgery: a randomized controlled trial.

Tranexamic acid has been used to reduce blood loss and the subsequent need for transfusion in orthopedic, spinal, and cardiac surgery. Orthognathic surgery can be associated with significant bleeding yet its efficacy in this setting is not clear. The purpose of this study was to investigate the effect of tranexamic acid on blood loss during bimaxillary osteotomy.



Seventy-three consecutive patients, scheduled for elective bimaxillary osteotomy, were included in this double blind, randomized, controlled trial. They received either a bolus of tranexamic acid (20 mg/kg) or placebo (normal saline) intravenously just before surgery. All patients received induced mild hypotension and had surgery according to a standard protocol. Intraoperative blood loss, operation time, transfusion of blood products, perioperative hemoglobin, and hematocrit were recorded.



The total blood loss and blood loss during maxillary surgery was reduced significantly in the tranexamic acid group compared with the control group (878.6 +/- 577.7 mL vs 1,257.2 +/- 817.8 mL and 428.0 +/- 233.3 mL vs 643.8 +/- 430.0 mL, respectively; P < .05). Considering the duration of operation and the treatment groups only, the mean total blood loss in the control group was 422 mL more than that in the tranexamic acid group (P < .001). There was no significant difference in blood transfusion or the length of hospital stay between the 2 groups.



Preoperative intravenous bolus administration of tranexamic acid at 20 mg/kg reduces blood loss compared with placebo during bimaxillary osteotomy.
Relative abuse liability of indiplon and triazolam in humans: a comparison of psychomotor, subjective, and cognitive effects.

Indiplon [N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5-alpha]pyrimidin-7-yl]phenyl]acetamide; NBI 34060] is a positive allosteric GABA(A) receptor modulator that is under development for the treatment of insomnia. This study compared the abuse potential of indiplon, a compound with preferential affinity for GABA(A) receptors containing an alpha(1) subunit, with triazolam in 21 volunteers with histories of drug abuse. Placebo, triazolam (0.25, 0.5, and 0.75 mg), and indiplon (30, 50, and 80 mg) were studied in counterbalanced order under double-blind conditions at two different residential research facilities. Both drugs impaired psychomotor and cognitive performance and produced similar dose-related increases in participant and observer ratings of drug strength. The onset of action of both drugs was rapid (30 min); however, the duration of action of indiplon (3-4 h) was shorter than that of triazolam (4-6 h). The profiles of subjective effects of triazolam and indiplon were similar; however, a maximum of 52% of participants identified indiplon as a benzodiazepine or barbiturate, compared with 81% of participants after 0.75 mg of triazolam. On participantrated subjective effects relevant to sedation, the slope of the triazolam dose-effect curve was significantly steeper than that of indiplon. Neither the largest doses of indiplon and triazolam nor the slope of the indiplon and triazolam dose-effect curves were significantly different from each other on any of the same-day or next-day measures of positive drug effects or next-day measures of reinforcing effects. Together, these data suggest that although the abuse potential of indiplon is not different from that of triazolam at these doses, psychomotor and cognitive impairment after large doses of indiplon might be less.
Value of body mass index in the diagnosis of obesity according to DEXA in well-controlled RA patients.

Rheumatoid arthritis (RA) has an indirect effect on body composition. Body mass index (BMI) is not a valid predictor of body fat in RA patients.



To evaluate the accuracy of BMI in identifying obesity diagnosed according to dual energy X-ray absorptiometry (DXA) in well-controlled RA patients.



An observational, cross-sectional, descriptive, analytical study. We used 3 different cutoffs for obesity as determined by DXA: >35% total fat, >40% total fat, and >35% central fat mass (central obesity).



One hundred one patients were included. We found that 35% total fat corresponded to a BMI of 24kg/m2, with a sensitivity of 90% and specificity of 75% (area under the curve [AUC] 0.917); 40% total fat to a BMI of 25kg/m2, with a sensitivity of 86% and specificity of 39% (AUC 0.822); and 35% central fat mass to a BMI of 22kg/m2, with a sensitivity of 97% and specificity of 84% (AUC 0.951).



Obesity according to DXA was underdiagnosed when the classic BMI cutoffs were used in well-controlled RA patients.
A comparison of the effects of anticholinergic and beta 2-agonist and combination therapy on respiratory impedance in COPD.

The effects of three different regimens of inhaled bronchodilators on spirometry and respiratory impedance as measured with the technique of forced oscillations were compared in a double-blind crossover study in 22 patients with stable chronic obstructive pulmonary disease (FEV1 less than 70 percent predicted). On three trial days, patients inhaled, in random order, 40 micrograms ipratropium bromide, 200 micrograms fenoterol hydrobromide, or a combination of 40 micrograms ipratropium and 100 micrograms fenoterol from a powder inhaler, followed by a second dose of the same drug after 60 min. The effects were measured at baseline and 20, 40, 60, and 120 min after the first inhalation. No significant decrease in total respiratory resistance at 8 Hz (Rrs ) was observed after ipratropium, whereas Rrs (8) decreased significantly 20 min after fenoterol and 40 min after the combination regimen (p less than 0.05). All three studied drugs resulted in a significant increase in the reactance (p less than 0.01) and decrease in resonant frequency. Both fenoterol (delta FEV1 34 percent, p less than 0.0001) and the combination regimen (delta FEV1 38 percent, p less than 0.0001) resulted in a significantly larger increase in FEV1 than ipratropium alone (delta FEV1 17 percent, p less than 0.0001). A second dose of fenoterol and of the combination regimen resulted in a further significant increase in FEV1 after 120 min (p less than 0.05). A second dose of ipratropium did not result in a further significant increase in FEV1. The changes in respiratory impedance were qualitatively similar for all three drug regimens, but larger in absolute terms after fenoterol and the combination regimen than after ipratropium. The similar effect of these drugs on the reactance can be explained by an increase in the capacitance of the respiratory system, and in combination with a decrease in frequency dependence of resistance, by assuming a decrease in peripheral airway resistance.
Statin therapy has no significant effect on skin tissue cholesterol: results from a prospective randomized trial.

Statin Therapy Has No Significant Effect on Skin Tissue Cholesterol: Results from a Prospective Randomized Trial, Markus Reiter, Susan Wirth, Ali Pourazim, Mehrdad Baghestanian, Erich Minar, and Robert A. Bucek (Clinic for Internal Medicine II, Department of Angiology, University of Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria; * author for correspondence: fax 43-1-40400-4665, e-mail markus.reiter@akh-wien.ac.at)