nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy and safety of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia: a randomized controlled trial.

The long half-life of atorvastatin and fenofibrate makes them suitable for alternate day therapy. Hence, we aimed to study the efficacy, safety, and cost-effectiveness of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia.



Eligible patients with mixed dyslipidemia were randomly allotted into 2 equal parallel groups-alternate day therapy group (group 1) and daily therapy group (group 2). Patients in groups 1 and 2 received fixed dose combination of atorvastatin 10 mg and fenofibrate 160 mg on alternate days and daily, respectively, for 12 weeks. Mean percentage change from baseline in triglycerides (TGLs), non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and TC-HDL ratio, incidence of adverse effects, and cost-effectiveness were compared in both the groups.



Among 110 patients randomized, 99 completed the study till 12 weeks treatment duration. The TGLs, non-HDL-C, TC, and LDL-C decreased by 56.4%, 49.7%, 36.5%, and 39.2%, respectively, in alternate day therapy group and by 57.5%, 51.2%, 37.5%, and 39.4%, respectively, in daily therapy group. The HDL-C levels increased by 20.1% in alternate day therapy group compared to 21.8% in daily therapy group. No statistically significant difference was seen between both the groups in mean percentage change in lipid parameters from baseline to end of 12 weeks. Incidence of adverse events was reasonably less in alternate day therapy group.



Alternate day therapy with atorvastatin-fenofibrate combination is an effective and safe alternative to daily therapy in mixed dyslipidemia. Apart from significant cost savings, reasonable reduction in the incidence of adverse events is seen with alternate day regimen. However, larger studies are needed to more reliably confirm our interesting but preliminary results.
[Catheter ablation of paroxysmal atrial fibrillation].

Catheter ablation techniques for atrial fibrillation have undergone an extensive evolution, starting with linear lesions in the right, then the left atria before being superseded by ablation of triggers, mainly from the pulmonary veins. We investigate the feasibility and results of combined pulmonary vein and linear ablation utilizing a specific linear lesion connecting the lateral mitral annulus to the left inferior pulmonary vein (left isthmus).



115 patients (101 M: 54 +/- 9 years) with paroxysmal atrial fibrillation (7 +/- 5 years) resistant to 4 +/- 1.6 anti-arrhythmic drugs were studied. After electrophysiologically guided disconnection of all four pulmonary veins, the left isthmus line was performed with an irrigated tip catheter. Complete linear block was demonstrated during coronary sinus pacing by local mapping looking for widely separated double potentials and confirmed by differential pacing. Mapping and ablation from within the coronary sinus was performed if an epicardial gap was detected after unsuccessful endocardial radiofrequency delivery.



100% of pulmonary veins were successfully disconnected and the left isthmus line was complete with bi-directional block in 88% after a mean of 22 +/- 12 min of endocardial radiofrequency delivery in 44 patients. In 58 patients, additional radiofrequency delivery was required from within the coronary sinus for 5 +/- 5 min. After a follow-up of 6.5 +/- 2.6 months and a mean of 1.4 +/- 0.6 procedures/patient, 79% were in stable sinus rhythm without antiarrhythmic drugs.



the left isthmus line is feasible and safe and when performed in addition to pulmonary veins isolation can contribute to an increased success rate.
Respiratory Filter Reduces the Cardiovascular Effects Associated With Diesel Exhaust Exposure: A Randomized, Prospective, Double-Blind, Controlled Study of Heart Failure: The FILTER-HF Trial.

The goal of this study was to test the effects of a respiratory filter intervention (filter) during controlled pollution exposure.



Air pollution is considered a risk factor for heart failure (HF) decompensation and mortality.



This study was a double-blind, randomized to order, controlled, 3-way crossover, single-center clinical trial. It enrolled 26 patients with HF and 15 control volunteers. Participants were exposed in 3 separate sessions to clean air, unfiltered diesel exhaust exposure (DE), or filtered DE. Endpoints were endothelial function assessed by using the reactive hyperemia index (RHi), arterial stiffness, serum biomarkers, 6-min walking distance, and heart rate variability.



In patients with HF, DE was associated with a worsening in RHi from 2.17 (interquartile range [IQR]: 1.8 to 2.5) to 1.72 (IQR: 1.5 to 2.2; p = 0.002) and an increase in B-type natriuretic peptide (BNP) from 47.0 pg/ml (IQR: 17.3 to 118.0 pg/ml) to 66.5 pg/ml (IQR: 26.5 to 155.5 pg/ml; p = 0.004). Filtration reduced the particulate concentration (325 ± 31 μg/m(3) vs. 25 ± 6 μg/m(3); p < 0.001); in the group with HF, filter was associated with an improvement in RHi from 1.72 (IQR: 1.5 to 2.2) to 2.06 (IQR: 1.5 to 2.6; p = 0.019) and a decrease in BNP from 66.5 pg/ml (IQR: 26.5 to 155.5 pg/ml) to 44.0 pg/ml (IQR: 20.0 to 110.0 pg/ml; p = 0.015) compared with DE. In both groups, DE decreased the 6-min walking distance and arterial stiffness, although filter did not change these responses. DE had no effect on heart rate variability or exercise testing.



To our knowledge, this trial is the first to show that a filter can reduce both endothelial dysfunction and BNP increases in patients with HF during DE. Given these potential benefits, the widespread use of filters in patients with HF exposed to traffic-derived air pollution may have beneficial public health effects and reduce the burden of HF.
Effects of Ramipril and Telmisartan on Plasma Concentrations of Low Molecular Weight and Protein Thiols and Carotid Intima Media Thickness in Patients with Chronic Kidney Disease

Hypertension, a common feature in chronic kidney disease (CKD), is an independent risk factor for CKD progression and cardiovascular disease. Although inhibitors of the renin-angiotensin system (RAS) exert salutary effects on blood pressure control and proteinuria in CKD patients, their activity towards traditional and novel oxidative markers is largely unknown. We studied the effects of 6-month treatment with telmisartan versus a combination of telmisartan and ramipril on plasma concentrations of low molecular mass (LMW, including homocysteine and cysteine) and protein thiols (PSH) plasma concentration and their relationships with carotid intima media thickness (IMT), in 24 hypertensive CKD patients (age 60 ± 12 years, 8 females and 16 males). Pretreatment PSH concentrations were independently associated with IMT (r = -0.42, p = 0.039). Neither treatment affected plasma LMW thiols, in both reduced and total form. By contrast, both treatments increased PSH plasma concentrations and reduced IMT, although significant differences were only observed in the combined treatment group. Our results suggest that the beneficial effects of combined RAS inhibitor treatment on IMT in hypertensive CKD patients may be mediated by a reduction of oxidative stress markers, particularly PSH.
Five-year follow-up after sirolimus-eluting stent implantation results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) Trial.

The aim of this study was to examine the 5-year clinical safety and efficacy outcomes in patients enrolled in the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) trial.



The SIRIUS trial was a double-blinded randomized study that demonstrated that sirolimus-eluting stents (SES) significantly improved angiographic results (at 8 months) and clinical outcomes (at 9 and 12 months) compared with bare-metal stents (BMS).



Patients (n = 1,058) with de novo native coronary artery lesions were randomized to either SES (n = 533) or control BMS (n = 525) and were followed for 5 years.



Between 1 and 5 years, additional clinical events were similarly distributed among the sirolimus and control groups. At 5 years, in sirolimus versus control patients, target lesion revascularization was 9.4% versus 24.2% (p < 0.001) and major adverse cardiovascular events and target vessel failure rates were 20.3% versus 33.5% and 22.5% versus 33.5%, respectively (p < 0.0001 for both). There were no significant differences in death, myocardial infarction, and nontarget lesion revascularization. No significant differences were observed in the cumulative incidence of stent thrombosis for sirolimus versus control patients with either protocol-derived (1.0% vs. 0.8%) or Academic Research Consortium definitions (3.9% vs. 4.2%).



In patients with noncomplex coronary artery disease, clinical outcomes 5 years after implantation of SES continue to demonstrate significant reduction in the need for repeat revascularization, with similar safety (death and myocardial infarction) compared with BMS, without evidence for either disproportionate late restenosis or late stent thrombosis.
Predictors of acupuncture use among children and adolescents with cancer.

Evidence for the application of acupuncture in pediatric oncology is limited. We investigated the acceptance of acupuncture and factors associated with its use among children and adolescents with cancer.



Ninety acupuncture-naïve children receiving cancer treatment at Columbia University Medical Center (CUMC) provided consent/assent for participation. Participants could choose to receive or refuse integrative services offered at CUMC. Symptoms were collected for a 6-month period with the Memorial Symptom Assessment Scale (MSAS). Acute and delayed adverse events among participants who received acupuncture were recorded.



Fifty-four percent of the participants elected to receive acupuncture. In total, 252 acupuncture sessions were administered with a median of four sessions per patient (range 1-13 sessions). Pain (56%), nausea (51%), lack of energy (50%), and irritability (43%) were the most frequently reported symptoms in the whole cohort. Determinants of acupuncture use included older age and ethnicity. Acupuncture was more likely than other integrative modalities to be used for gastrointestinal and constitutional symptoms including drowsiness (odds ratio [OR], 3.34; 95% confidence interval [CI], 1.98-5.66; P < 0.0001), lack of energy (OR, 3.23; 95% CI, 1.78-5.87; P = 0.0001), and pain (OR, 2.63; 95% CI, 1.46-4.72; P = 0.001). Adverse events were reported by 3% of the participants. There was no increased incidence of adverse events in children with thrombocytopenia (P = 0.189) or neutropenia (P = 0.497).



Our results highlight the potential use of acupuncture as a safe, adjunctive therapy for symptom management within existing supportive care regimens in pediatric oncology and potential areas to focus research initiatives.
Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study.

We determine the main outcome effects of a 12-month computer-mediated automated interactive voice response (IVR) intervention designed to assist family caregivers managing persons with disruptive behaviors related to Alzheimer's disease (AD).



We conducted a randomized controlled study of 100 caregivers, 51 in the usual care control group and 49 in the technology intervention group, who received yearlong access to an IVR-mediated system. The system provided caregiver stress monitoring and counseling information, personal voice-mail linkage to AD experts, a voice-mail telephone support group, and a distraction call for care recipients. We conducted analyses by using a repeated measures approach for longitudinal data and an intention-to-treat analytic approach. Outcomes included the caregiver's appraisal of the bothersome nature of caregiving, anxiety, depression, and mastery at baseline, 6, 12, and 18 months.



There was a significant intervention effect as hypothesized for participants with lower mastery at baseline on all three outcomes: bother (p =.04), anxiety (p =.01), and depression (p =.007). Additionally, wives exhibited a significant intervention effect in the reduction of the bothersome nature of caregiving (p =.02).



Wives who exhibited low mastery and high anxiety benefited the most from the automated telecare intervention. Findings suggest that, to optimize outcome effects, similar interventions should be tailored to match the users' characteristics and preferences.
Pedicled and skeletonized single and bilateral internal thoracic artery grafts and the incidence of sternal wound complications: Insights from the Arterial Revascularization Trial.

The question of whether skeletonized internal thoracic artery harvesting reduces the incidence of sternal wound complications in comparison with the pedicled technique, in the context of single or bilateral internal thoracic arteries, remains controversial. We studied the impact of the internal thoracic artery harvesting strategy on sternal wound complication in the Arterial Revascularization Trial.



Patients enrolled in the Arterial Revascularization Trial (n = 3102) were randomized to coronary artery bypass grafting with single or bilateral internal thoracic arteries. Sternal wound complication rates were examined according to the harvesting technique that was documented in 2056 patients. The internal thoracic artery harvesting technique, based on the surgeon's preference, resulted in 4 groups: pedicled single internal thoracic artery (n = 607), pedicled bilateral internal thoracic artery (n = 459), skeletonized single internal thoracic artery (n = 512), and skeletonized bilateral internal thoracic artery (n = 478). Propensity scores weighting was used to estimate the impact of the harvesting technique on sternal wound complications.



A total of 219 of 2056 patients (10.6%) experienced a sternal wound complication within 1 year from the index operation. Of those, only 25 patients (1.2%) required sternal wound reconstruction. Pedicled bilateral internal thoracic artery (odds ratio [OR], 1.80; 95% confidence interval [CI], 1.23-2.63) but not skeletonized bilateral internal thoracic artery (OR, 1.00; 95% CI, 0.65-1.53) or skeletonized single internal thoracic artery (OR, 0.89; 95% CI, 0.57-1.38) was associated with a significantly increased risk of any sternal wound complications compared with pedicled single internal thoracic artery.



The present Arterial Revascularization Trial substudy suggests that, with a skeletonization technique, the risk of sternal wound complication with bilateral internal thoracic artery grafting is similar to that after standard pedicled single internal thoracic artery harvesting, whereas skeletonized single internal thoracic artery harvesting did not add any further benefit when compared with pedicled single internal thoracic artery harvesting.
Relative importance of risk factors in bladder carcinogenesis: some new results about Mediterranean habits

In the Mediterranean region of France where bladder cancer mortality and incidence are high, a case-control study with 219 male incident cases and 794 randomized, male population-controls was carried out in 1987–89 to investigate bladder cancer risk factors and more specifically, regional factors. A stepwise logistic regression was applied to the data. This investigation confirms the role of tobacco and of certain occupational exposures in bladder carcinogenesis. There was a significant dose-response relationship with lifelong coffee drinking and alcohol consumption; however the risk estimates were only significantly elevated for the heaviest drinkers. The intake of saccharin was not associated with risk of bladder cancer. Infrequent consumption of carrots, spinach, and marrows conferred an increased risk, suggesting a protective effect of vitamin A. Finally, this investigation results in some new hypotheses. The study of residences and birthplaces has revealed a lower risk for those who have lived in a non-Mediterranean area and a higher risk for those born in a Mediterranean area. These features might be explained by some Mediterranean dietary habits, such as a high consumption of spices (odds ratio =3.64, 95 percent confidence interval=2.21–5.98).
FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial

Therapy guidelines recommend speech and language therapy (SLT) as the "gold standard" for aphasia treatment. Treatment intensity (i.e., ≥5 hours of SLT per week) is a key predictor of SLT outcome. The scientific evidence to support the efficacy of SLT is unsatisfactory to date given the lack of randomized controlled trials (RCT), particularly with respect to chronic aphasia (lasting for >6 months after initial stroke). This randomized waiting list-controlled multi-centre trial examines whether intensive integrative language therapy provided in routine in- and outpatient clinical settings is effective in improving everyday communication in chronic post-stroke aphasia.



Participants are men and women aged 18 to 70 years, at least 6 months post an ischemic or haemorrhagic stroke resulting in persisting language impairment (i.e., chronic aphasia); 220 patients will be screened for participation, with the goal of including at least 126 patients during the 26-month recruitment period. Basic language production and comprehension abilities need to be preserved (as assessed by the Aachen Aphasia Test).Therapy consists of language-systematic and communicative-pragmatic exercises for at least 2 hours/day and at least 10 hours/week, plus at least 1 hour self-administered training per day, for at least three weeks. Contents of therapy are adapted to patients' individual impairment profiles.Prior to and immediately following the therapy/waiting period, patients' individual language abilities are assessed via primary and secondary outcome measures. The primary (blinded) outcome measure is the A-scale (informational content, or 'understandability', of the message) of the Amsterdam-Nijmegen Everyday Language Test (ANELT), a standardized measure of functional communication ability. Secondary (unblinded) outcome measures are language-systematic and communicative-pragmatic language screenings and questionnaires assessing life quality as viewed by the patient as well as a relative.The primary analysis tests for differences between the therapy group and an untreated (waiting list) control group with respect to pre- versus post 3-week-therapy (or waiting period, respectively) scores on the ANELT A-scale. Statistical between-group comparisons of primary and secondary outcome measures will be conducted in intention-to-treat analyses.Long-term stability of treatment effects will be assessed six months post intensive SLT (primary and secondary endpoints).
Different HBsAg decline after 3 years of therapy with entecavir in patients affected by chronic hepatitis B HBeAg-negative and genotype A, D and E.

The role of measurement of hepatitis B "s" antigen (HBsAg) during the therapy with oral nucleos(t)ide analogues is still debatable. The HBsAg declines after 3 years of therapy with entecavir (ETV) was investigated among patients affected by hepatitis B virus (HBV), e antigen (HBeAg)-negative and genotypes A, D and E. A prospective cohort of 123 patients was enrolled consecutively from April 2007 to May 2010 with at least 3 years of treatment with ETV. Patients with chronic HBV infection, HBeAg-negative, naive for previous treatment and with virological response to ETV were included in the study. HBsAg level and HBV-DNA were tested every 3 months during the first year of treatment, then every 6 months for a time of at least 3 years. After 3 years, HBsAg decline was 0.77 log IU/ml, 0.65 log IU/ml, 0.45 respectively; A versus D (P = 0.012), A versus E (P < 0.001), D versus E (P < 0.001). In the multivariate linear regression analysis only the HBV genotype was predictive of HBsAg decline after 3 years of treatment (P < 0.001). The expected time to HBsAg loss was 15.6 years for the A genotype, 17 years for D, 24.6 years for E (P < 0.001). The treatment with ETV leads the different kinetics in HBsAg decline among genotypes A, D and E; the expected time of HBsAg loss was significantly higher in E genotype compared to A and D genotype.
Bead-based ELISA for validation of ovarian cancer early detection markers.

Efforts to validate ovarian cancer early detection biomarkers with immunoassays are challenged by the limited specimen volumes available. We sought to develop a specimen-efficient assay to measure CA125 in serum, assess its reproducibility, validity, and performance, and test its potential for multiplexing and combining with human epididymis protein 4 (HE4), a promising novel ovarian cancer marker.



Four pairs of commercially available anti-CA125 antibodies and one pair of anti-HE4 antibodies were evaluated for accuracy in measuring known concentrations of antigen on a bead-based platform. The two best pairs were further assessed for reproducibility, validity, and the ability to discriminate between blinded serum samples obtained from ovarian cancer cases (n = 66) and women without ovarian cancer (n = 125).



Suitability for use in a bead-based assay varied across CA125 antibody pairs. Two CA125 bead-based assays were highly reproducible (overall correlations between replicates >/= 0.95; coefficients of variation < 0.2) and strongly correlated with the research standard CA125II RIA (correlations >/= 0.9). Their ability to distinguish ovarian cancer cases from non-cases based on receiver operating characteristic analyses (area under the curve, AUC, of 0.85 and 0.84) was close to that of the CA125II RIA (AUC, 0.87). The HE4 bead-based assay showed lower reproducibility but yielded an AUC of 0.89 in receiver operating characteristics analysis. Multiplexing was not possible but a composite marker including CA125 and HE4 achieved an AUC of 0.91.



Optimization procedures yielded two bead-based assays for CA125 that perform comparably to the standard CA125II RIA, which could be combined with an HE4 bead-based assay to improve diagnostic performance, and requires only 15 muL of sample each.
Change in patients’ body weight after 12 months of treatment with glimepiride or glibenclamide in Type 2 diabetes: a multicentre retrolective cohort study

Our study compared the effects of glimepiride or glibenclamide treatment on body weight over 12 months of treatment in patients with Type 2 diabetes in routine outpatient practice. This new retrospective study design used data from physicians in a restricted manner (retrolective). Data from case report forms from 520 patients from 91 randomly selected centres were assessed and covariance analysis performed. The influence of practice and patient characteristics on treatment assignment was low, reflecting the design of randomised controlled trials. Mean weight loss and reduction in body mass index from baseline to study endpoint were greater with glimepiride than with glibenclamide (−2.04±3.99 kg vs −0.58±3.65 kg, p<0.001; −0.71±1.38 kg/m2 vs −0.20±1.28 kg/m2, p<0.001). Duration of treatment at baseline influenced treatment outcome, but propensity score, sex, age and fasting blood glucose at baseline did not. Both glimepiride and glibenclamide led to decreases in fasting blood glucose (−2.43±0.24 mmol/l vs −3.03±0.24 mmol/l; p<0.001 vs baseline) and HbA1c (−1.23±0.09% vs −1.26±0.09%; p<0.001 vs baseline). Both treatments were associated with a decrease in serum total cholesterol and low density lipoprotein cholesterol. Triglycerides were lower in the glibenclamide group and high density lipoprotein cholesterol was higher in the glimepiride group only. Initial treatment of Type 2 diabetes with glimepiride was associated with a significantly greater decrease in body weight and body mass index than treatment with glibenclamide, while providing equivalent glycaemic control.