nils-herrmann/clean_scirepeval huggingface dataset:
The effect of combined antihypertensive treatment (felodipine with either irbesartan or metoprolol) on erectile function: a randomized controlled trial.

This study aimed to determine whether combining a calcium channel blocker with either an angiotensin II receptor blocker or a β-blocker would have similar effects on sexual function in men with hypertension.



This prospective, randomized study ( 218 male participants with untreated hypertension. Patients were randomized to treatment with felodipine combined with irbesartan or metoprolol for 48 weeks. Sexual function was evaluated at baseline and after 48 weeks of therapy. The levels of serum sex hormones and markers of oxidative stress were measured at the same time.



There was no significant difference in the prevalence of erectile dysfunction before and after treatment in either group (p > 0.05). There were also no differences in the levels of serum testosterone, sex hormone-binding globulin or 4-hydroxynonenal before and after treatment in either group (p > 0.05). In the felodipine-irbesartan group, sexual desire scores rose after treatment (p = 0.022) and the concentrations of serum 8-hydroxy-2'-deoxyguanosine and malondialdehyde declined (p < 0.001 and p = 0.002, respectively). The between-group differences for 8-hydroxy-2'-deoxyguanosine and malondialdehyde were not significant (p > 0.05, respectively).



The results suggest that felodipine-irbesartan may be more beneficial to the sexual desire of hypertensive male patients than felodipine-metoprolol. This effect was possibly relevant to irbesartan, which prevents oxidative stress to some extent.
How accurate is the diagnosis of diabetic retinopathy on telescreening? The Indian scenario.

Diabetes mellitus is a healthcare burden in India. Seventy-four percent of India's population lives in rural areas with limited access to healthcare resources. Telemedicine can play a big role in screening people with diabetes at grassroots level. In the telescreening model, single field 45-degree photographs are used for detecting diabetic retinopathy. The American Academy of Ophthalmology does not recommends single-field fundus photography as an adequate substitute for a comprehensive ophthalmic examination because it may lead to a higher rate of underdiagnosis. We conducted a telescreening project using single-field fundus photography to determine its accuracy compared to the traditional camp-based screenings.



In this project we compared the prevalence of diabetic retinopathy between an ophthalmologist-based and an ophthalmologist-led model on two different samples of people self-reporting with diabetes in rural South India. Between 2004 and 2005 in rural South India, 3522 people with diabetes mellitus underwent ophthalmologist-based diabetic retinopathy screening and 4456 people with diabetes underwent ophthalmologist-led (telescreening) diabetic retinopathy screening. The two population groups were randomly separated. In the ophthalmologist-based program, a trained retina specialist travels along with the camp team and screens patients at the camp site for diabetic retinopathy. In the ophthalmologist-led program (telescreening), fundus photographs are transmitted to the base hospital for further evaluation and grading. A total of 519 people (14.7%) were diagnosed to have diabetic retinopathy in the ophthalmologist-based model, and 853 people (19.1%) in the ophthalmologist-led model p < 0.0001). More sight-threatening retinopathies were found in the ophthalmologist-led model than in the ophthalmologist-based model (6.3% vs. 5%).



The ophthalmologist-led (telescreening) model did not underestimate the prevalence of diabetic retinopathy. Therefore, because it obviates the need for travel by an ophthalmologist, it is a good method for diabetic retinopathy screening in rural areas of India.
Stapled transanal rectal resection and sacral nerve stimulation - impact on faecal incontinence and quality of life.

The aim of the study was to assess the impact of stapled transanal rectal resection (STARR) on pre-existing faecal incontinence and quality of life in patients suffering from obstructive defaecation syndrome (ODS) and to evaluate the efficiency of sequential sacral nerve stimulation (SNS) for improvement of persistent incontinence after STARR.



Thirty-one patients with ODS and major faecal incontinence prior to STARR were prospectively enrolled. The outcome was measured using the Cleveland Clinic Constipation and Incontinence score (CCS, CCIS), Faecal Incontinence Qualities-of-Life Index (FIQL), Patient Assessment of Constipation Quality-of-Life (PAC-QOL) and EuroQol visual analogue scale (EQ-VAS).



The overall levels of constipation (CCS from 13.1 ± 3.8 to 6.2 ± 5.4; P < 0.001) and incontinence (CCIS from 12.6 ± 3.2 to 9.4 ± 5.1; P = 0.005) were significantly improved after STARR; concordantly, the global and specific quality of life were significantly improved. Following postoperative constipation and incontinence, three different groups of patients were differentially referred to SNS. In group I (n = 16, 52%), both constipation (CCS from 12.6 ± 4.0 to 3.6 ± 1.9; P < 0.001) and incontinence (CCSI from 12.43 ± 3.2 to 5.1 ± 1.9; P < 0.001) were improved. In group II (n = 8, 25%), only constipation was improved (CCS from 12.3 ± 2.3 to 3.3 ± 2.2; P < 0.001), while incontinence persisted (CCIS from 12.8 ± 2.9 to 13.1 ± 3.1; P > 0.05). In group III (n = 7, 23%) there was no improvement at all. Sacral nerve stimulation was successfully carried out in six (85%) of seven patients in group II (post-SNS CCSI 6.1 ± 1.7; P = 0.01) but failed in five of five patients in group III.



Stapled transanal rectal resection improves quality of life in ODS patients with both severe constipation and faecal incontinence. Sacral nerve stimulation may efficiently improve persisting incontinence after STARR in selected patients.
Physicians’ perceived usefulness of and satisfaction with test reports for cystic fibrosis (ΔF508) and factor V Leiden

We sought to determine whether variation in test-report content for cystic fibrosis (CF ΔF508) and factor V Leiden (fVL) would impact physician-perceived usefulness of and satisfaction with test reports. A cross-sectional survey of US physicians from specialties likely to order the tests was performed. Physicians received an introductory letter with a clinical scenario, one randomly assigned mock report, and a one-page survey. The analyses evaluated usefulness of and satisfaction with report elements. For CF and fVL, there were significant differences by mock-report version for most of the survey report items (P < 0.05) and for satisfaction (P < 0.0001); results revealed greater usefulness and satisfaction with more comprehensive reports. The three items in CF and fVL reports where physician-perceived usefulness was most highly correlated (R > 0.70) with satisfaction were (1) clinical decision-making information, (2) genetic counseling information, and (3) implications for family members. Opportunities exist to improve the usefulness of genetic test reports in clinical practice.
Multiparametric Cardiac Magnetic Resonance Survey in Children With Thalassemia Major: A Multicenter Study.

Cardiovascular magnetic resonance (CMR) plays a key role in the management of thalassemia major patients, but few data are available in pediatric population. This study aims at a retrospective multiparametric CMR assessment of myocardial iron overload, function, and fibrosis in a cohort of pediatric thalassemia major patients.



We studied 107 pediatric thalassemia major patients (61 boys, median age 14.4 years). Myocardial and liver iron overload were measured by T2* multiecho technique. Atrial dimensions and biventricular function were quantified by cine images. Late gadolinium enhancement images were acquired to detect myocardial fibrosis. All scans were performed without sedation. The 21.4% of the patients showed a significant myocardial iron overload correlated with lower compliance to chelation therapy (P<0.013). Serum ferritin ≥2000 ng/mL and liver iron concentration ≥14 mg/g/dw were detected as the best threshold for predicting cardiac iron overload (P=0.001 and P<0.0001, respectively). A homogeneous pattern of myocardial iron overload was associated with a negative cardiac remodeling and significant higher liver iron concentration (P<0.0001). Myocardial fibrosis by late gadolinium enhancement was detected in 15.8% of the patients (youngest children 13 years old). It was correlated with significant lower heart T2* values (P=0.022) and negative cardiac remodeling indexes. A pathological magnetic resonance imaging liver iron concentration was found in the 77.6% of the patients.



Cardiac damage detectable by a multiparametric CMR approach can occur early in thalassemia major patients. So, the first T2* CMR assessment should be performed as early as feasible without sedation to tailor the chelation treatment. Conversely, late gadolinium enhancement CMR should be postponed in the teenager age.
Use of a C1 Inhibitor Concentrate in Adults ≥65 Years of Age with Hereditary Angioedema: Findings from the International Berinert® (C1-INH) Registry

Treatment of hereditary angioedema (HAE) in 'older adults' (those aged ≥65 years) has not been well studied. The international Berinert Patient Registry collected data on the use of intravenous plasma-derived, pasteurized, nanofiltered C1-inhibitor concentrate (pnfC1-INH; Berinert®/CSL Behring) in patients of any age, including many older adults.



This observational registry, conducted from 2010 to 2014 at 30 US and seven European sites, gathered prospective (post-enrollment) and retrospective (pre-enrollment) usage and adverse event (AE) data on subjects treated with pnfC1-INH.



The registry documented 1701 pnfC1-INH infusions in 27 older adults. A total of 1511 HAE attacks treated with pnfC1-INH administration were reported among 25 of the 27 (92.6 %) older adults. Among the older adults, mean (standard deviation [SD]) (8.8 [4.1] IU/kg) and median (6.4 IU/kg) pnfC1-INH doses were lower than those reported for 252 'younger adults' (those aged <65 years: 12.9 [6.2], 12.5 IU/kg, respectively). A total of 19 AEs occurred in 8 of 23 (34.8 %) older adults with prospective data, for rates of 0.83 events per subject and 0.02 events per infusion, similar to corresponding rates in younger adults (0.91 and 0.03, respectively). None of the AEs were considered related to pnfC1-INH, and all but two events (prostatectomy, gastrointestinal bleeding) were mild or moderate in severity. Administration of pnfC1-INH outside of a healthcare setting was reported for 1609 infusions in 16 older adults, representing 94.6 % of all pnfC1-INH infusions in this age group. There were no recorded instances of difficulty with self-administration of intravenous pnfC1-INH.



These findings suggest a high degree of safety with intravenous pnfC1-INH use in older adults with HAE, regardless of administration setting.
Genome-wide association analysis of circulating vitamin D levels in children with asthma

Vitamin D deficiency is becoming more apparent in many populations. Genetic factors may play a role in the maintenance of vitamin D levels. The objective of this study was to perform a genome-wide analysis (GWAS) of vitamin D levels, including replication of prior GWAS results. We measured 25-hydroxyvitamin D (25(OH)D) levels in serum collected at the time of enrollment and at year 4 in 572 Caucasian children with asthma, who were part of a multi-center clinical trial, the Childhood Asthma Management Program. Replication was performed in a second cohort of 592 asthmatics from Costa Rica and a third cohort of 516 Puerto Rican asthmatics. In addition, we attempted replication of three SNPs that were previously identified in a large GWAS of Caucasian individuals. The setting included data from a clinical trial of childhood asthmatics and two cohorts of asthmatics recruited for genetic studies of asthma. The main outcome measure was circulating 25(OH)D levels. The 25(OH)D levels at the two time-points were only modestly correlated with each other (intraclass correlation coefficient = 0.33) in the CAMP population. We identified SNPs that were nominally associated with 25(OH)D levels at two time-points in CAMP, and replicated four SNPs in the Costa Rican cohort: rs11002969, rs163221, rs1678849, and rs4864976. However, these SNPs were not significantly associated with 25(OH)D levels in a third population of Puerto Rican asthmatics. We were able to replicate the SNP with the strongest effect, previously reported in a large GWAS: rs2282679 (GC), and we were able to replicate another SNP, rs10741657 (CYP2R1), to a lesser degree. We were able to replicate two of three prior significant findings in a GWAS of 25(OH)D levels. Other SNPs may be additionally associated with 25(OH)D levels in certain populations.
A brief behavioural treatment of chronic post-traumatic stress disorder in earthquake survivors: results from an open clinical trial.

Natural disasters such as earthquakes affect large numbers of people. Given the extent of the mental health problem following earthquakes, brief, effective and cost-effective treatment interventions are urgently needed. The present study examined whether cognitive-behavioural treatment could be shortened to a minimum number of sessions without undermining its effectiveness in post-traumatic stress disorder (PTSD).



The study participants (N=231) were consecutive referrals to five project sites in the earthquake region in Turkey a mean of 13 months after the disaster. A modified behavioural treatment (BT) was used, which involved self-exposure instructions based on an enhancement of 'sense of control' rather than a habituation rationale and minimal cognitive interventions. The duration of treatment was variable, involving as many sessions as required for clinical improvement. Survival analysis was used to explore the minimum number of sessions required for clinical improvement, and multiple regression analysis to examine the predictors of outcome.



The survivors received a mean of 4-3 sessions. Significant treatment effects and clinically meaningful effect sizes were noted on all measures. The treatment improved all PTSD and depression symptoms. The cumulative proportion of improved cases was 76% after one session and 88% after two sessions. No baseline variable predicted treatment outcome.



The modified BT appears to be promising as an effective one- or two-session intervention for earthquake survivors. It may be particularly useful in large-scale disasters as a cost-effective treatment that can be relatively easily disseminated to mass populations. Further research is needed to clarify the possible role of a treatment focus on sense of control in rapid recovery from traumatic stress.
Addition of salmeterol versus doubling the dose of beclomethasone in children with asthma. The Dutch Asthma Study Group.

Studies in adults revealed that addition of salmeterol to a moderate dose of inhaled corticosteroid resulted in better symptom control and higher PEF compared with doubling the dose of inhaled corticosteroid. The aim of this three group study was to compare the effects of a moderate dose of beclomethasone, the same dose of beclomethasone with salmeterol, and a doubling dose of beclomethasone on lung function and symptoms in children with moderate asthma. A total of 177 children already treated with inhaled corticosteroids, were randomized in a double-blind parallel study either to salmeterol 50 microg twice daily (BDP400+salm), beclomethasone 200 microg twice daily (BDP800), or placebo (BDP400) in addition to beclomethasone 200 microg twice daily. No significant differences between groups were found in FEV1, PD20 methacholine, symptom scores, and exacerbation rates after 1 yr. Salmeterol resulted in slightly better PEF in the first months of treatment. FEV1, and PD20 methacholine significantly improved in all groups. After 1 yr mean changes in FEV1, percent predicted were 4.3% (95% CI 1.3; 7.2), 5.8% (95% CI 2.9; 8.7), and 4.3% (95% CI 2.1; 6.5) for BDP400+salm, BDP800, and BDP400, respectively. Changes in airway responsiveness were 0.60 (95% CI 0.05; 1.14), 1.30 (95% CI 0.73; 1. 87), and 0.80 (95% CI 0.33; 1.27) doubling doses. Growth was significantly slower in the BDP800 group. We conclude that no additional benefit was found of adding either salmeterol or more beclomethasone to a daily dose of 400 microg beclomethasone in this group of children with excellent compliance of medication.
Outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention in the current era: a report from the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial.

Diabetes portends an adverse prognosis in patients undergoing percutaneous coronary intervention (PCI). Whether improvements in current clinical practice (stents, IIb/IIIa antagonists) have resulted in substantial improvement of these outcomes remains an issue. The aim of this study was to determine the influence of diabetes on 9-month outcomes of patients undergoing PCI in the current era.



The 11 482 patients enrolled in the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial were stratified according to the presence (n=2694) or absence (n=8798) of diabetes. Diabetic patients were older; were more likely to be female; had a higher proportion of congestive failure, hypertension, prior CABG, and unstable angina; and had higher body mass index and lower ejection fraction than nondiabetic patients (P<0.01 for all comparisons). The degree of multivessel disease was similar between the two groups. American College of Cardiology/American Heart Association type C lesions were more common in diabetic patients (17% versus 15%, P<0.01). Angiographic and procedural success rates and in-hospital events were similar between the two groups. The primary end point of death, myocardial infarction, or target vessel revascularization (TVR) was analyzed as time-to-first event within 9 months of the index PCI. After adjusting for certain baseline characteristics, diabetes was independently associated with death at 9 months (relative risk [RR], 1.87; 95% CI, 1.31 to 2.68, P<0.01) and with an increased likelihood of TVR (RR, 1.27; 95% CI, 1.14 to 1.42, P<0.01), as well as the composite end point of death/myocardial infarction/TVR (RR, 1.26; 95% CI, 1.13 to 1.40, P<0.01).



Despite advances in interventional techniques, diabetes remains a significant independent predictor of adverse events in the intermediate term after PCI.
EEG abnormalities are associated with increased risk of transplant or poor outcome in children with acute liver failure.

There are limited data on the incidence of seizures and utility of brain imaging and electroencephalogram (EEG) to predict outcome of children with acute liver failure (ALF). We investigated the association between hepatic encephalopathy (HE) scores, abnormal EEG or neuroimaging, and short-term outcome.



Single-center retrospective observational study of infants and children with ALF who underwent continuous EEG monitoring and brain imaging within 24 hours of admission to the intensive care unit (ICU).



A total of 19 patients with ALF with a mean age of 6.8 ± 1.5 years were evaluated. The majority of cases (74%) were indeterminate. Of the total, 10 patients (53%) survived to discharge without liver transplant (LT), 5 (26%) received LT, and 4 (21%) died without LT. Seizures occurred in only 2 cases (19%). Patients who had an abnormal EEG on admission (n = 7) were significantly more likely to die or require LT (P < 0.05, Fisher exact test). Patients with either an admission HE score ≤ 2, or liver injury unit score <222, combined with a normal or mildly abnormal EEG were more likely to survive without LT. Neuroimaging was normal in the majority of cases (87%) and was not associated with outcome.



Children with a moderate or severe abnormality of EEG background on admission were significantly more likely to require LT or to die. Children with an HE score ≤ 2, and a normal or only mildly abnormal EEG, were significantly more likely to survive without needing LT. These findings are an initial step toward distinguishing patients with ALF who may recover spontaneously from those who will require LT.
Safety and efficacy of alinidine in symptom-free asthmatics

Alinidine is a new bradycardic agent which has been shown to be beneficial in the treatment of coronary heart disease. Patients with both coronary heart disease and obstructive lung disease are difficult to treat, because the use of beta-blockers in them is greatly limited by their potential to provoke bronchospasm. Alinidine has no beta-blocking, muscarinic or quinidine-like properties. In a randomized double-blind cross-over study the heart rate reducing effect and safety of alinidine 40 mg p.o. has been examined in 12 symptom-free asthmatics. Alinidine significantly reduced mean heart rate from 81±10.5 beats/min to 65±9.7 beats/min two hours after administration. Forced expiratory volume in one second (FEV1), vital capacity (CV), airway resistance (Raw), functional residual capacity (FRC), and specific airway conductance (SGaw) were not affected. It is concluded that alinidine did not influence respiratory function in patients with bronchial hypersensitivity.
Activation of axonal Kv7 channels in human peripheral nerve by flupirtine but not placebo - therapeutic potential for peripheral neuropathies: results of a randomised controlled trial

Flupirtine is an analgesic with muscle-relaxing properties that activates Kv7 potassium channels. Kv7 channels are expressed along myelinated and unmyelinated peripheral axons where their activation is expected to reduce axonal excitability and potentially contribute to flupirtine’s clinical profile. To investigate the electrical excitability of peripheral myelinated axons following orally administered flupirtine, in-vitro experiments on isolated peripheral nerve segments were combined with a randomised, double-blind, placebo-controlled, phase I clinical trial (RCT). Threshold tracking was used to assess the electrical excitability of myelinated axons in isolated segments of human sural nerve in vitro and motoneurones to abductor pollicis brevis (APB) in situ in healthy subjects. In addition, the effect of flupirtine on ectopic action potential generation in myelinated axons was examined using ischemia of the lower arm. Flupirtine (3-30 μM) shortened the relative refractory period and increased post-conditioned superexcitability in human myelinated axons in vitro. Similarly, in healthy subjects the relative refractory period of motoneurones to APB was reduced 2 hours after oral flupirtine but not following placebo. Whether this effect was due to a direct action of flupirtine on peripheral axons or temperature could not be resolved. Flupirtine (200 mg p.o.) also reduced ectopic axonal activity induced by 10 minutes of lower arm ischemia. In particular, high frequency (ca. 200 Hz) components of EMG were reduced in the post-ischemic period. Finally, visual analogue scale ratings of sensations perceived during the post-ischemic period were reduced following flupirtine (200 mg p.o.). Clinical doses of flupirtine reduce the excitability of peripheral myelinated axons.