nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy and tolerability of vardenafil for treatment of erectile dysfunction in patient subgroups.

To assess whether vardenafil would improve erectile function irrespective of etiology, baseline severity, or patient age. The consistency of the response over time was also evaluated.



A multicenter, randomized, double-blind, placebo-controlled at-home study of vardenafil treatment (5, 10, and 20 mg) was performed. This secondary analysis compared the mean International Index of Erectile Function (IIEF) erectile function domain scores of various subgroups at 12 weeks of treatment. These populations included organic, psychogenic, or mixed etiologies; mild, moderate, or severe baseline severity; and four age groups (younger than 45, 45 to 55, 56 to 65, and older than 65 years). In addition, all IIEF domains were compared at sequential 4-week periods, before and during treatment.



In the 580 men of the intent-to-treat population, the mean erectile function domain scores were statistically greater than placebo, irrespective of etiology, baseline severity, or age. This was seen at all dosages. Compared with placebo, vardenafil statistically improved the IIEF domain scores of erectile function, orgasmic function, intercourse satisfaction, and overall satisfaction after 4 weeks of treatment, and these improvements were maintained for 12 weeks. The rates of the most common adverse events (headache, flushing, and dyspepsia) were either constant or declined over time; they were generally mild to moderate and transient in nature.



Vardenafil improved erectile function regardless of the general etiology, baseline severity of erectile dysfunction, or patient age. Improvements in erectile function and other key IIEF domains were consistently seen throughout the study.
Comparison of two self-rating scales to detect depression: HADS and PHQ-9.

More than half of patients with depression go undetected. Self-rating scales can be useful in screening for depression, and measuring severity and treatment outcome.



This study compares the Hospital Anxiety and Depression Scale (HADS) and the Patient Health Questionnaire (PHQ-9) with regard to their psychometric properties, and investigates their agreement at different cut-off scores.



Swedish primary care patients and psychiatric outpatients (n = 737) who reported symptoms of depression completed the self-rating scales. Data were collected from 2006 to 2007. Analyses with respect to internal consistency, factor analysis, and agreement (Cohen's kappa) at recommended cut-offs were performed.



Both scales had high internal consistency (alpha = 0.9) and stable factor structures. Using severity cut-offs, the PHQ-9 (> or =5) diagnosed about 30% more patients than the HADS depression subscale (HADS-D; > or =8). They recognised the same prevalence of mild and moderate depression, but differed in relation to severe depression. When comparing recommended screening cut-offs, HADS-D > or =11 (33.5% of participants) and PHQ-9 > or =10 (65.9%) agreement was low (kappa = 0.35). Using the lower recommended cut-off in the HADS-D (> or =8), agreement with PHQ-9 > or =10 was moderate (kappa = 0.52). The highest agreement (kappa = 0.56) was found comparing HADS-D > or =8 with PHQ-9 > or =12. This also equalised the prevalence of depression found by the scales.



The HADS and PHQ-9 are both quick and reliable. The HADS has the advantage of evaluating both depression and anxiety, and the PHQ-9 of being strictly based upon the Diagnostic and Statistical Manual of Mental Disorders. The agreement between the scales at the best suitable cut-off is moderate, although the identified prevalence was similar. This indicates that the scales do not fully identify the same cases. This difference needs to be further explored.
Trends, Predictors, and Outcomes of Stroke After Surgical Aortic Valve Replacement in the United States.

Postoperative stroke is a devastating complication after aortic valve replacement (AVR). Our objective was to use a large national database to identify the incidence of and risk factors for stroke after AVR, as well as to determine incremental mortality, resource use, and cost of stroke.



We identified 360,437 patients who underwent isolated surgical AVR between 1998 and 2011 from the National Inpatient Sample (NIH) database. Mean age was 66 ± 32 years. Multivariable regression and propensity matching were used to identify risk factors and the effect of stroke on outcomes. Patients were stratified according to the Elixhauser comorbidity score (ECS) into low- (0-5), medium- (6-15), and high-risk (16+) categories.



Stroke after AVR occurred in 5,092 (1.45%) patients. The incidence of stroke declined from 1.69% in 1999 to 0.94% in 2011 (p < 0.001). Increasing age and higher comorbidities were the main predictors of stroke (each p < 0.001). The highest-volume centers (>200 AVRs/y) had the lowest rate of stroke (1.2%). After multivariable adjustment, high-volume centers had lower odds of stroke in medium-risk (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.37-0.94) and high-risk patients (OR, 0.39; 95% CI, 0.22-0.68) compared with the lowest-volume centers. For low-risk patients, volume was not associated with stroke. Patients who experienced stroke were hospitalized for 4 days longer, had an average of $10,496 higher costs, and had 2.74 (95% CI, 1.97-3.80) times higher odds of in-hospital mortality compared with those who did not experience stroke (all p < 0.001).



The incidence of stroke after AVR has decreased but remains a significant cause of morbidity in medium- and high-risk patients. Superior outcomes can be achieved in medium- to high-risk patients at high-volume centers.
Rauchen vor und nach der Brustkrebsdiagnose

Methode Die Autoren untersuchten die Assoziation von Nikotinabusus, vor und nach einer Brustkrebsdiagnose, mit der Letalität in der Collaborative Breast Cancer and Women’s Longevity Study, einer populationsbasierten prospektiven Beobachtungsstudie, die in Wisconsin, New Hampshire und Massachusetts durchgeführt wurde. Insgesamt 20.691 Frauen im Alter von 20–79 Jahren, und einer zwischen 1988–2008 gestellten Diagnose von lokalem oder regionalem Brustkrebs, nahmen an der Studie teil. Eine Subgruppe von 4562 dieser Frauen konnte 6 Jahre (Median) nach der Diagnose nochmals kontaktiert werden. Hierbei wurden relative Risiken (HR) mit 95%Konfidenzintervallen (95% KI) und auch der Rauchstatus für Tod durch Brustkrebs, durch Krebs der Atemwege (Lunge, Kopf-Hals-Tumoren) und durch andere Tumorerkrankungen ermittelt. Auch die HR für Atemwegsund kardiovaskuläre Erkrankungen wurde ausfindig gemacht.
Radiofrequency denervation of lumbar facet joints in the treatment of chronic low back pain: a randomized, double-blind, sham lesion-controlled trial.

Radiofrequency facet joint denervation procedures have been common practice for 2 decades in treatment of chronic low back pain. We designed this multicenter, randomized, double-blind, sham treatment controlled trial to determine the efficacy of radiofrequency facet joint denervation, as it is routinely performed.



Inclusion criteria were low back pain, duration more than 6 months, and >or=50% Visual Analog Scale (VAS) reduction on diagnostic block. Exclusion criteria were prior radiofrequency treatment, radicular syndrome, coagulopathies, specific allergies, cancer, and pregnancy. A total of 81 out of 462 patients were randomized to undergo radiofrequency facet joint denervation or sham treatment. The first evaluation was carried out 3 months after treatment. Primary outcome was determined with a combined outcome measure comprising VAS, physical activities, and analgesic intake, from a twice-weekly recorded diary. Secondary outcome measures were the separate diary parameters, global perceived effect (complete relief, >50% relief, no effect, pain increase), and SF-36 Quality of Life Questionnaire.



There were no dropouts before the first evaluation. The combined outcome measure showed no differences between radio- frequency facet joint denervation (n=40; success 27.5%) and sham (n=41; success 29.3%) (P=0.86). The VAS in both groups improved (P<0.001). Global perceived effect improved after radiofrequency facet joint denervation (P<0.05). The other secondary outcome parameters showed no significant differences. Relevant costs were evaluated.



The combined outcome measure and VAS showed no difference between radiofrequency and sham, though in both groups, significant VAS improvement occurred. The global perceived effect was in favor of radiofrequency. In selected patients, radiofrequency facet joint denervation appears to be more effective than sham treatment.
Gastric emptying following brain injury: Effects of choice of sedation and intracranial pressure

To compare the effects of opioid and nonopioid sedation on gastric emptying. Prospective, randomized trial. University teaching hospital ICU. 21 brain injured patients requiring sedation, mechanical ventilation and intracranial pressure (ICP) monitoring for >24h. Patients were randomized to receive infusions of either morphine plus midazolam (M), or propofol (P). Gastric emptying was assessed by the paracetamol absorption technique and by residual volumes following a 200 ml test feed. Pre-sedation Glasgow Coma Score, mean ICP and the presence of bowel sounds were noted. Plasma concentrations of paracetamol were measured over 3 h following a 1 g gastric dose. There were no differencese in median peak paracetamol concentration (M, 18.5 versus P, 20.8 mg/l), median time to peak concentration (M, 20 versus P, 25 min), median area under the concentration-time curve (AUC), or in the median residual volumes at 1 h (M, 14 versus P, 10.5 ml) and 2 h (M, 5 versus P, 3 ml). In patients with ICP>20 mmHg, paracetamol concentrations were lower (p<0.05), and AUC after 30 min was lower (165 mg·min/l versus 411 mg·min/l,p=0.023). Mean ICP was correlated with AUC (Kendall rankp=0.027). Gastric emptying did not correlate with initial Glasgow Coma Score or presence of bowel sounds. Gastric emptying is not improved in patients with brain injury by avoiding morphine (1–8 mg/h) in the sedative regimen. Intracranial hypertension is associated with reduced gastric emptying.
Feedback and education improve physician compliance in use of lung-protective mechanical ventilation

Use of lung-protective mechanical ventilation (MV) by applying lower tidal volumes is recommended in patients suffering from acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). Recent data suggest that lung-protective MV may benefit non-ALI/ARDS patients as well. This study analyzed tidal volume settings in three ICUs in The Netherlands to determine the effect of feedback and education concerning use of lung-protective MV. Observational study in one academic and two nonacademic “closed format” ICUs. Intubated mechanically ventilated subjects. Feedback and education concerning lung-protective MV with special attention to the importance of closely adjusting tidal volumes to predicted body weight (PBW). Tidal volumes declined significantly within 6 months after intervention (from 9.8±2.0 at baseline to 8.1±1.7 ml/kg PBW) as the percentage of undesirable ventilation data points, defined as tidal volumes greater than 8 ml/kg PBW (84% vs. 48%). There were no differences between patients meeting the international definition criteria for ALI/ARDS and those not. Only four patients received tidal volumes less than 6 ml/kg PBW. Lower tidal volumes were still used after 12 months. Tidal volumes in patients on mandatory MV and patients breathing on spontaneous modes were similar. Feedback and education improve physician compliance in use of lung-protective MV.
Randomised phase II study comparing dose-escalated weekly paclitaxel vs standard-dose weekly paclitaxel for patients with previously treated advanced gastric cancer

This randomised phase II trial compared dose-escalated weekly paclitaxel (wPTX) vs standard-dose wPTX for patients with previously treated advanced gastric cancer (Ninety patients were randomised to a standard dose of wPTX (80 mg m−2) or an escalated dose of wPTX (80–120 mg m−2) to assess the superiority of overall survival (OS) with a one-sided alpha error of 0.3 and a power of 0.8.Results:The median OS showed a trend towards longer survival in the dose-escalated arm (11.8 vs 9.6 months; hazard ratio (HR), 0.75; one-sided P=0.12), although it was statistically not significant. The median progression-free survival (PFS) was significantly longer in the dose-escalated arm (4.3 vs 2.5 months, HR, 0.55; P=0.017). Objective response rate was 30.3% with dose escalation and 17.1% with standard dose (P=0.2). The frequency of all grades of neutropenia was significantly higher with dose escalation (88.7% vs 60.0%, P=0.002); however, no significant difference was observed in the proportion of patients experiencing grade 3 or more (40.9% vs 31.1%, Dose-escalated wPTX in patients with pretreated AGC met our predefined threshold of primary end point, OS (P<0.3); however, it did not show a significantly longer OS. Progression-free survival was significantly better with dose escalation.
Catecholamine pathway polymorphisms and antidepressant response.

Genes that regulate the catecholamine metabolism pathways are potential targets for research in the antidepressant treatment response. This study was intended to determine whether antidepressant responses to selective serotonin reuptake inhibitors (SSRIs) are associated with genetic polymorphisms of the tyrosine or tryptophan gene in Chinese major depressive disorder (MDD) patients.



A total of 290 MDD patients were recruited and received a 6-week SSRIs randomized double-blinded treatment. Allele, genotype, and haplotype frequencies were compared between responders and nonresponders in catecholamine genes.



Genotype frequency of the rs1800544 polymorphism in the DRD4 gene was significantly different between responders and nonresponders after false discovery rate correction (P = 0.042). The frequency of the DRD4 rs1800544 CG genotype was significantly higher (P = 0.003) in responders (51.4%) than in nonresponders (35.8%), and patients with the CG genotype showed an 81.7% response rate. In comparison, the response rates were 73.9% and 52.2% in patients with the GG genotype and the CC genotype, respectively. The frequencies of the DRD4 rs1800544 CC and GG genotypes were significantly lower (P = 0.003) in responders (7.7%, 40.9%) than in the nonresponders (19.4%, 44.8%). No significant difference was found between two groups either in genotype or allele frequencies of single nucleotide polymorphisms in the TPH, SLC6A2, SLC6A3, or DRD2 genes. No significant difference was found between two groups in TPH, SLC6A2, SLC6A3, DRD2, orDRD4 gene haplotypes.



Polymorphisms of the DRD4 gene appear to be associated with SSRI treatment response in Chinese MDD patients.
Pilot Study using Gabapentin for Tamoxifen-induced Hot Flashes in Women with Breast Cancer

In this pilot study, 22 women with breast cancer on tamoxifen therapy with at least two hot flashes a day took oral gabapentin at 300 mg three times a day for 4 weeks. The 16 women who completed the study had a mean decrease in hot flash duration of 73.6% (P = 0.027), frequency of 44.2% (P < 0.001), and severity of 52.6% (P < 0.001), with a complete response in 8/16 women. Side effects reported by four women who did not complete 4 weeks of the study were nausea (1/4), rash (1/4) and excessive sleepiness (3/4). Two additional patients did not provide complete data. Gabapentin is a promising new agent in the treatment of tamoxifen induced hot flashes, and should be studied further.
Microsomal epoxide hydroxylase genotypes/diplotypes, traffic air pollution, and childhood asthma.

Epidemiologic studies indicate that exposure to air pollution caused by traffic may have an association with an increased risk of childhood asthma. Some studies report an association between the polymorphisms of the microsomal epoxide hydroxylase (EPHX1) gene and enzyme activity. We investigated the associations of EPHX1 Tyr113His and His139Arg polymorphisms with asthma and wheezing outcomes, and focused on the functional genetic change in different ambient nitrogen dioxide (NO₂) levels on glutathione S-transferase p1 (GSTP1) and glutathione S-transferase m1 (GSTM1) genotypes.



A total of 3,741 children were enrolled in the Taiwan Children Health Study from 14 communities. We examined the associations of EPHX1 Tyr113His and His139Arg genotypes and diplotypes with asthma and wheezing outcomes under different ambient NO₂ exposures.



Children with the EPHX1 Arg/His or Arg/Arg genotypes at codon 139 were significantly associated with increased risks of lifetime asthma (adjusted OR [aOR] = 1.3; 95% CI, 1.1-1.7; and aOR = 1.5; 95% CI, 1.1-2.1, respectively). The EPHX1 diplotypes showed significant associations with lifetime asthma (global P value = .01) and early-onset asthma (global P value = .01). The risk of EPHX1 139Arg allele and 113Tyr-139Arg diplotype were of greater magnitude in higher compared with lower NO₂ communities. The increase of the effect from the EPHX1 139Arg allele with higher NO₂ exposure was most marked in the GSTP1 Val allele and GSTM1 present genotype.



Children with high EPHX1 activity may have increase risk of asthma and wheezing outcomes, and can be mediated through airway oxidative stress generation.
Vagally mediated heart rate variability and heart rate entropy as predictors of treatment outcome in flight phobia

In the present study a computer-assisted exposure-based treatment was applied to 54 flight phobics and the predictive role of vagally mediated heart rate (HR) variability (high frequency, 0.15-0.4 Hz band power) and heart rate entropy (HR time series sample entropy) on treatment outcome was investigated. Both physiological measures were taken under controlled breathing at 0.2 Hz and during exposure to a fearful sequence of audiovisual stimuli. Hierarchical regression analyses were conducted to assess the predictive power of these variables in these conditions on treatment self-report measures at the end of treatment and at 6 months follow-up, as well as on the behavioral treatment outcome (i.e. flying at the end of treatment). Regression models predicting significant amounts of outcome variance could be built only when HR entropy was added to the HR variability measure in a second step of the regression analyses. HR variability alone was not found to be a good predictor of neither self-reported nor behavioral treatment outcomes.
Heparin-coated Wiktor stents in human coronary arteries (MENTOR trial). MENTOR Trial Investigators.

The purpose of this study was to determine the feasibility, safety, and efficacy of elective stenting with heparin-coated Wiktor stents in patients with coronary artery disease. In experimental studies, heparin coating has been shown to prevent subacute thrombosis and restenosis. Recently, a new method of heparin coating was developed, resulting in a more stable and predictable heparin layer on stent devices. This trial constitutes the first in-human use of this coating procedure, applied on the well-known Wiktor stent device. Heparin-coated Wiktor stent implantation was performed in 132 consecutive patients (132 lesions) in a multicenter international trial from September 1996 to February 1997. Forty-three percent of patients had unstable angina, 33% had previous myocardial infarction, and 10% had diabetes mellitus. Patients were followed for 12 months for occurrence of major adverse cardiovascular events, and 96% of the eligible patients underwent quantitative angiographic control at 6 months. Stent deployment was successful in 95.5% of lesions. Minimal lumen diameter increased by 1.67 +/- 0.48 mm (from 1.02 +/- 0.38 mm before to 2.69 +/- 0.37 mm after the stent implantation). Mean percent diameter stenosis decreased from 67.4 +/- 11.3% before to 18.9 +/- 7.7% after the intervention. A successful intervention (<50% diameter stenosis and no major adverse cardiac events within 30 days) occurred in 97% of the patients. The subacute thrombosis rate was 0.8%, which compares favorably with historical controls of this stent, and a low incidence of postprocedural increase in creatine kinase-MB was noted. At 6 months, event-free survival was 85% and angiographic restenosis rate was 22% with late loss of 0.78 +/- 0.69 mm and a loss index of 0.48 +/- 0.44. Heparin-coated Wiktor stents appeared to be an efficacious device to treat Benestent-like lesions, yielding angiographic and clinical results comparable to a heparin-coated Palmaz-Schatz stent. Despite its use in more complex lesions, the incidence of subacute thrombosis appeared to be lower than historical controls with a similar noncoated stent.
Tonic chemoreflex activation contributes to increased sympathetic nerve activity in heart failure-related anemia.

Sympathetic activation contributes to both the initiation and progression of heart failure. The role of anemia in determining sympathetic overactivity in chronic heart failure (CHF) patients is unknown. We tested the hypothesis that, in CHF patients, anemia could lead to increased sympathetic activity through tonic activation of excitatory chemoreceptor afferents. We conducted a double-blind, randomized, vehicle-controlled study to examine the effect of chemoreflex deactivation on muscle sympathetic nerve activity in CHF patients with and without anemia. We compared the effect of breathing 100% oxygen for 15 minutes in 18 stable CHF patients with anemia and 18 control CHF patients matched for age, sex, blood pressure, and body mass index. Baseline muscle sympathetic nerve activity was significantly elevated in CHF patients with anemia compared with patients with CHF alone (56.0+/-3.2 versus 45.5+/-3.1 bursts per minute; P<0.0237). Administration of 100% oxygen led to a significant decrease in muscle sympathetic nerve activity in CHF patients with anemia (from 56.0+/-3.4 to 50.9+/-3.2 bursts per minute; P<0.0019). In contrast, neither room air nor 100% oxygen changed muscle sympathetic nerve activity or hemodynamics in patients with CHF alone. We report for the first time direct evidence of increased sympathetic nerve traffic in patients with CHF-related anemia. Sympathetic hyperactivity in patients with CHF and anemia is partially chemoreflex mediated and could explain how anemia contributes to the progression of CHF and increases morbidity and mortality in these patients.