nils-herrmann/clean_scirepeval huggingface dataset:
Clinical profile and significance of delayed enhancement in hypertrophic cardiomyopathy.

Contrast-enhanced cardiovascular magnetic resonance with delayed enhancement (DE) can provide in vivo assessment of myocardial fibrosis. However, the clinical significance of DE in hypertrophic cardiomyopathy (HCM) remains unresolved.



Cine and cardiovascular magnetic resonance with DE were performed in 202 HCM patients (mean age, 42+/-17 years; 71% male), DE was compared with clinical and demographic variables, and patients were followed up for 681+/-249 days for adverse disease events. DE was identified in 111 (55%) HCM patients, occupying 9%+/-11% of left ventricular myocardial volume, including >25% DE in 10% of patients. The presence of DE was related to occurrence of heart failure symptoms (P=0.05) and left ventricular systolic dysfunction (P=0.001). DE was present in all patients with ejection fraction < or =50% but also in 53% (102/192) of patients with preserved ejection fraction (P<0.001); %DE was both inversely related to (r=-0.3; P<0.001) and an independent predictor of ejection fraction (r=-0.4; P<0.001). DE (7%+/-7% of left ventricle) was present in 54 patients who were asymptomatic (and with normal ejection fraction). Over the follow-up period, the annualized adverse cardiovascular event rate in patients with DE exceeded that in patients without DE but did not achieve statistical significance (5.5% versus 3.3%; ).



In a large HCM cohort, DE was an independent predictor of systolic dysfunction but with only a modest relationship to heart failure symptoms. These data suggest an important role for myocardial fibrosis in the clinical course of HCM patients but are not sufficient at this time to consider DE as an independent risk factor for adverse prognosis.
Non-invasive vagus nerve stimulation for acute treatment of high-frequency and chronic migraine: an open-label study

The treatment of migraine headache is challenging given the lack of a standardized approach to care, unsatisfactory response rates, and medication overuse. Neuromodulation therapy has gained interest as an alternative to pharmacologic therapy for primary headache disorders. This study investigated the effects of non-invasive vagus nerve stimulation (nVNS) in patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM). In this open-label, single-arm, multicenter study, patients with HFEM or CM self-treated up to 3 consecutive mild or moderate migraine attacks that occurred during a 2-week period by delivering two 120-s doses of nVNS at 3-min intervals to the right cervical branch of the vagus nerve. Of the 50 migraineurs enrolled (CM/HFEM: 36/14), 48 treated 131 attacks. The proportion of patients reporting pain relief, defined as a ≥50 % reduction in visual analog scale (VAS) score, was 56.3 % at 1 h and 64.6 % at 2 h. Of these patients, 35.4 % and 39.6 % achieved pain-free status (VAS = 0) at 1 and 2 h, respectively. When all attacks (N = 131) were considered, the pain-relief rate was 38.2 % at 1 h and 51.1 % at 2 h, whereas the pain-free rate was 17.6 % at 1 h and 22.9 % at 2 h. Treatment with nVNS was safe and well tolerated. Non-invasive vagus nerve stimulation may be effective as acute treatment for HFEM or CM and may help to reduce medication overuse and medication-associated adverse events.
Randomized, Double-Blind, Dose-Finding, Phase II Study of Prasugrel in Japanese Patients Undergoing Elective Percutaneous Coronary Intervention.

Prasugrel is a novel platelet P2Y12 receptor blocker with a faster onset of action and greater platelet inhibition with less response variability than clopidogrel. Our objective was to determine the optimal prasugrel dose in Japanese patients undergoing elective percutaneous coronary intervention (PCI) with respect to the incidence of bleeding and platelet inhibition.



A total of 422 patients were randomly assigned to receive clopidogrel or prasugrel in two strata (standard group: ＜75 years of age and body weight ＞50 kg, n=312; high-risk group: ≥75 years of age and/or body weight ≤50 kg, n=110). The standard group received 20/3.75 or 20/5mg (loading/maintenance doses for three months) of prasugrel or 300/75mg of clopidogrel, while the high-risk group received 20/2.5 or 20/3.75mg of prasugrel or 300/75mg of clopidogrel.



The rates of TIMI major and minor bleeding (primary endpoint) were similar among the three treatment arms in the standard group (20/5mg of prasugrel: 0%; 20/3.75mg of prasugrel: 3.8%; 300/75mg of clopidogrel: 2.9%) and the high-risk group (20/3.75mg of prasugrel: 2.7%; 20/2.5mg of prasugrel: 0%; 300/75mg of clopidogrel: 2.8%). VerifyNow assays revealed sufficient levels of platelet inhibition at Weeks 4 and 12 in both the prasugrel arms of the standard group and the 20/3.75mg of prasugrel arm in the high-risk group. Platelet inhibition was not affected by the CYP2C19 phenotype in the prasugrel groups.



The prasugrel dosing regimen of 20/3.75mg has strong antiplatelet effects and the risk of bleeding events is low in Japanese patients undergoing PCI.
Ambulatory blood pressure monitoring predicts cardiovascular events in treated hypertensive patients--an Anglo-Scandinavian cardiac outcomes trial substudy.

Results of the Anglo-Scandinavian cardiac outcomes trial-blood pressure lowering arm (ASCOT-BPLA) showed significantly lower rates of coronary and stroke events in individuals allocated an amlodipine-perindopril combination drug regimen than in those allocated an atenolol-thiazide combination drug regimen. The aims of the ambulatory blood pressure (ABP) substudy of ASCOT were to examine the impact of the two blood pressure (BP)- lowering regimens on ambulatory pressures, test to what extent the between-treatment differences in cardiovascular outcome could be attributed to differences in ABP and assess whether ABP provides predictive information additional to that of clinic blood pressure (CBP) in treated hypertensive patients.



One thousand, nine hundred and five patients from four ASCOT centres had repeated ABPs performed over a median follow-up period of 5.5 years. As in the whole ASCOT population, CBP values were lower in amlodipine-perindopril-treated patients compared with those treated with atenolol-thiazide [between-regimen difference [95% confidence intervals (CIs)]]: [-1.5 (-2.4 to -0.5)/-1.2 (-1.8 to +0.5) mmHg]. Daytime BP during follow-up was higher in patients treated with amlodipine-perindopril therapy [+1.1 (0.1-2.1)/+1.6 (0.8-2.3) mmHg]; night-time systolic, but not diastolic BP, was lower in patients treated with amlodipine-perindopril therapy [-2.2 (-3.4 to +0.9)/+0.8 (0.0-1.6) mmHg]. The relative risk of a cardiovascular event associated with a 1 SD increment in accumulated mean BP was 1.35 (1.18-1.53) for clinic systolic BP, 1.30 (1.14-1.49) for daytime systolic BP and 1.42 (1.24-1.62) for night-time systolic BP. With adjustment for baseline variables, treatment regimen and clinic systolic BP, the hazard ratios were 1.17 (1.00-1.36) and 1.25 (1.08-1.47) for daytime and night-time systolic BP, respectively. The between-regimen adjusted hazard ratio for cardiovascular events (amlodipine-perindopril therapy versus atenolol-thiazide therapy) was 0.74 (0.55-1.01) and increased to 0.81 (0.60-1.10) after further adjustment for clinic systolic BP. Further, adjustment for night-time systolic BP increased the hazard ratio to 0.85 (0.62-1.16).



The amlodipine-perindopril and atenolol-thiazide regimens had different effects on daytime and night-time ABP, which may have contributed to the lower rates of events in patients treated with amlodipine-perindopril therapy. Both CBP and ABP were significantly associated with rates of cardiovascular events. ABP nocturnal pressures provided complimentary and incremental utility over CBP in the prediction of cardiovascular risk in treated hypertensive patients. These data support the use of ABP to assess the effect of antihypertensive treatment in clinical practice.
A prospective longitudinal multicentre study of health related quality of life in ICU survivors with COPD

Mortality amongst COPD patients treated on the ICU is high. Health-related quality of life (HRQL) after intensive care is a relevant concern for COPD patients, their families and providers of health care. Still, there are few HRQL studies after intensive care of this patient group. Our hypothesis was that HRQL of COPD patients treated on the ICU declines rapidly with time.



Fifty-one COPD patients (COPD-ICU group) with an ICU stay longer than 24 hours received a questionnaire at 6, 12 and 24 months after discharge from ICU. HRQL was measured using two generic instruments: the EuroQoL instrument (EQ-5D and EQ-VAS) and the Short Form 36 Health Survey (SF-36). The results were compared to HRQL of two reference groups from the general population; an age- and sex-adjusted reference population (Non-COPD reference) and a reference group with COPD (COPD reference).



HRQL of the COPD-ICU group at 6 months after discharge from ICU was lower compared to the COPD reference group: Median EQ-5D was 0.66 vs. 0.73, P = 0.08 and median EQ-VAS was 50 vs.55, P < 0.05. There were no significant differences in the SF-36 dimensions between the COPD-ICU and COPD-reference groups, although the difference in physical functioning (PF) approached statistical significance (P = 0.059). Patients in the COPD-ICU group who were lost to follow-up after 6 months had low HRQL scores at 6 months. Scores for patients who died were generally lower compared to patients who failed to respond to the questionnaire. The PF and social functioning (SF) scores in those who died were significantly lower compared to patients with a complete follow up. HRQL of patients in the COPD-ICU group that survived a complete 24 months follow up was low but stable with no statistically significant decline from 6 to 24 months after ICU discharge. Their HRQL at 24 months was not significantly different from HRQL in the COPD reference group.



HRQL in COPD survivors after intensive care was low but did not decline from 6 to 24 months after discharge from ICU. Furthermore, HRQL at 24 months was similar to patients with COPD who had not received ICU treatment.
Predictive markers in elderly patients with estrogen receptor-positive breast cancer treated with aromatase inhibitors: an array-based pharmacogenetic study

So far, no reliable predictive clinicopathological markers of response to aromatase inhibitors (AIs) have been identified, and little is known regarding the role played by host genetics. To identify constitutive predictive markers, an array-based association study was performed in a cohort of 55 elderly hormone-dependent breast cancer (BC) patients treated with third-generation AIs. The array used in this study interrogates variants in 225 drug metabolism and disposition genes with documented functional significance. Six variants emerged as associated with response to AIs: three located in ABCG1, UGT2A1, SLCO3A1 with a good response, two in SLCO3A1 and one in ABCC4 with a poor response. Variants in the AI target CYP19A1 resulted associated with a favourable response only as haplotype; haplotypes with increased response association were also detected for ABCG1 and SLCO3A1. These results highlight the relevance of host genetics in the response to AIs and represent a first step toward precision medicine for elderly BC patients.
Impact on prognosis of periprocedural bleeding after TAVI: mid-term follow-up of a multicenter prospective study.

Impact of periprocedural bleeding after transcatheter aortic valve implantation (TAVI) over mid-term prognosis remains still unclear.



Consecutive patients who underwent TAVI from May 2008 to July 2012 were prospectively included and stratified according to life-threatening (LT) and major bleeding (MB). Mid-term all-cause death was the primary end-point, and 30-day death, vascular complications, stroke, and acute kidney injury the secondary ones. All end-points were adjudicated according to VARC.



Seven hundred fourteen patients with an average age of 81.9 ± 5.8 years were included. 130 (18%) patients suffered a LT, 112 (16%) a MB. A preprocedural GFR <30 ml/min and increasing diameter of sheaths were independent predictors of LT or MB, while transfemoral approach showed a protective effect (OR 0.42; CI: 0.26-0.68; P = 0.035). At 30 days LT (OR 3.3; CI: 1.1-9.7; P = 0.0026) and MB (OR 3.5; CI: 1.4-8.6; P = 0.007) bleeding along with GFR < 30 ml/min (OR 2.3; CI: 1.1-5.5; P = 0.04) were independent predictors of death, while bleeding did not impact survival on mid term (OR 0.9; CI: 0.47-1.7; P = 0.78; all CI 95%).



Periprocedural bleeding after TAVI was frequent and associated with an increased mortality after 30 days but not after mid-term follow-up. A preprocedural GFR < 30 ml/min was the most important predictor of bleeding, enabling risk stratification and choice of approach for these patients.
Validating and updating a risk model for pneumonia – a case study

The development of risk prediction models is of increasing importance in medical research - their use in practice, however, is rare. Among other reasons this might be due to the fact that thorough validation is often lacking. This study focuses on two Bayesian approaches of how to validate a prediction rule for the diagnosis of pneumonia, and compares them with established validation methods.



Expert knowledge was used to derive a risk prediction model for pneumonia. Data on more than 600 patients presenting with cough and fever at a general practitioner's practice in Switzerland were collected in order to validate the expert model and to examine the predictive performance of it. Additionally, four modifications of the original model including shrinkage of the regression coefficients, and two Bayesian approaches with the expert model used as prior mean and different weights for the prior covariance matrix were fitted. We quantify the predictive performance of the different methods with respect to calibration and discrimination, using cross-validation.



The predictive performance of the unshrinked regression coefficients was poor when applied to the Swiss cohort. Shrinkage improved the results, but a Bayesian model formulation with unspecified weight of the informative prior lead to large AUC and small Brier score, naïve and after cross-validation. The advantage of this approach is the flexibility in case of a prior-data conflict.



Published risk prediction rules in clinical research need to be validated externally before they can be used in new settings. We propose to use a Bayesian model formulation with the original risk prediction rule as prior. The posterior means of the coefficients, given the validation data showed best predictive performance with respect to cross-validated calibration and discriminative ability.
Factors associated with the development of motor fluctuations and dyskinesias in Parkinson disease.

Motor fluctuations and dyskinesias can cause disability and reduce quality of life for patients with Parkinson disease (PD).



To evaluate factors associated with the development of motor fluctuations and dyskinesias and to assess the sequence in which they occur in individual patients.



We performed a retrospective analysis of data from a randomized clinical trial comparing pramipexole dihydrochloride and levodopa as initial treatment for PD. Subjects were followed up for 48 to 58 months and evaluated at 3-month intervals for the presence of motor fluctuations and dyskinesias.



Academic and private practices.  Three hundred one patients with early Parkinson disease were enrolled in this study between October 2, 1996, and August 21, 1997, and were observed through August 24, 2001, when the last patient enrolled completed 4 years of follow-up.



Order of appearance of motor fluctuations and dyskinesias, time to the first occurrence of motor fluctuations, and time to the first occurrence of dyskinesias.



One hundred eighty-nine subjects (62.8%) developed motor complications. Of these, 71 (37.6%) developed fluctuations but not dyskinesias, 23 (12.2%) developed dyskinesias but not fluctuations, 48 (25.4%) developed fluctuations before dyskinesias, 33 (17.5%) developed dyskinesias before fluctuations, and 14 (7.4%) developed both at the same time. Factors significantly associated with earlier occurrence of dyskinesia were Hoehn and Yahr stage of 2 or higher, cumulative levodopa dose, cumulative levodopa equivalent dose (levodopa plus pramipexole), and occurrence of motor fluctuations. Pramipexole treatment was associated with later occurrence of dyskinesias. Factors associated with earlier occurrence of motor fluctuations were cumulative levodopa dose, cumulative levodopa equivalent dose, and occurrence of dyskinesias. Factors associated with later occurrence of motor fluctuations were age at onset of 65 years or older and pramipexole treatment.



Higher cumulative levodopa doses and higher cumulative levodopa equivalent doses (levodopa plus pramipexole) were associated with the earlier occurrence of motor complications. Motor fluctuations and dyskinesias appear to be interrelated because the presence of one is associated with the earlier development of the other.
Absence of effects of prolonged simvastatin therapy on nocturnal sleep in a large randomized placebo-controlled study. Oxford Cholesterol Study Group.

1. It has been suggested that lipophilic HMG CoA reductase inhibitors, like lovastatin and simvastatin, may cause sleep disturbance. 2. Six hundred and twenty-one patients at increased risk of coronary heart disease were randomized in a single centre to receive 40 mg daily simvastatin, 20 mg daily simvastatin or matching placebo. To assess the effects of prolonged use of simvastatin on nocturnal sleep quality and duration, a sleep questionnaire was administered to 567 patients (95% of 595 survivors) at an average of 88 weeks (range: 44-129 weeks) after randomization. 3. The main outcome measures were sleep-related problems and use of sleep-enhancing medications reported during routine study follow-up visits, and responses to the sleep questionnaire about changes in sleep duration and about various sleep events during the preceding month. 4. No differences were observed between the treatment groups in the frequency of sleep-related problems reported, in the proportion of follow-up visits at which such problems were reported, or in the use of sleep-enhancing medications. The numbers who stopped study treatment were similar in the different treatment groups, and no patient stopped principally because of insomnia. In response to the sleep questionnaire, there were no significant differences between the treatment groups in reports of various sleep events during the preceding month, except that slightly fewer patients allocated simvastatin reported waking often. No differences in sleep duration were observed. 5. This placebo-controlled trial does not indicate any adverse effects of prolonged treatment with simvastatin on systematically sought measures of sleep disturbance.
Prognostic impact of meningeal dissemination in primary CNS lymphoma (PCNSL): experience from the G-PCNSL-SG1 trial.

We evaluated the frequency and prognostic impact of meningeal dissemination (MD) in immunocompetent adult patients with primary central nervous system lymphoma treated in a randomized phase III trial.



MD was evaluated at study entry and defined by lymphoma proof in the meningeal compartment detected by at least one of the following methods: cerebrospinal fluid (CSF) cytomorphology, detection of clonal B cells by IgH PCR in CSF or contrast enhancement of the leptomeninges on magnetic resonance imaging (MRI).



Data on MD were available in 415 patients, of those, MD was detected in 65 (15.7%): in 44/361 (12.2%) by CSF cytomorphology, in 16/152 (10.5%) by PCR and in 17/415 (4.1%) by MRI. Major patients' characteristics and therapy did not significantly differ between patients with MD (MD+) versus those without MD (MD-). There was a significant correlation of MD with CSF pleocytosis (>5/μl; P < 0.0001), but no correlation with CSF protein elevation (>45 mg/dl). Median progression-free survival was 6.7 months [95% confidence interval (CI) 0-14.5] in MD+ and 8.3 months (5.7-10.8) in MD- patients (P = 0.95); median overall survival was 21.5 months (95% CI 16.8-26.1) and 24.9 months (17.5-32.3), respectively (P = 0.98).



MD was detected infrequently and had no impact on outcome in this trial.
Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment

The management of unruptured intracranial aneurysms is controversial. Investigators from the International Study of Unruptured Intracranial Aneurysms aimed to assess the natural history of unruptured intracranial aneurysms and to measure the risk associated with their repair.



Centres in the USA, Canada, and Europe enrolled patients for prospective assessment of unruptured aneurysms. Investigators recorded the natural history in patients who did not have surgery, and assessed morbidity and mortality associated with repair of unruptured aneurysms by either open surgery or endovascular procedures.



4060 patients were assessed-1692 did not have aneurysmal repair, 1917 had open surgery, and 451 had endovascular procedures. 5-year cumulative rupture rates for patients who did not have a history of subarachnoid haemorrhage with aneurysms located in internal carotid artery, anterior communicating or anterior cerebral artery, or middle cerebral artery were 0%, 2. 6%, 14 5%, and 40% for aneurysms less than 7 mm, 7-12 mm, 13-24 mm, and 25 mm or greater, respectively, compared with rates of 2 5%, 14 5%, 18 4%, and 50%, respectively, for the same size categories involving posterior circulation and posterior communicating artery aneurysms. These rates were often equalled or exceeded by the risks associated with surgical or endovascular repair of comparable lesions. Patients' age was a strong predictor of surgical outcome, and the size and location of an aneurysm predict both surgical and endovascular outcomes.



Many factors are involved in management of patients with unruptured intracranial aneurysms. Site, size, and group specific risks of the natural history should be compared with site, size, and age-specific risks of repair for each patient.
Liraglutide decreases carotid intima-media thickness in patients with type 2 diabetes: 8-month prospective pilot study

Liraglutide, a long-acting glucagon-like peptide-1 (GLP-1) analog, has several non- glycemic properties, but its effect on carotid intima-media thickness (IMT), a recognized marker of subclinical atherosclerosis, is still unknown.



A prospective study of 8 months duration in 64 patients with type-2 diabetes and no prior history of coronary artery disease evaluated whether adding liraglutide to metformin affects carotid IMT, measured by color doppler ultrasound.



After 8 months, fasting glucose decreased by 2.1 mmol/l and HbA1c by 1.9% (p < 0.01 for all). Liraglutide reduced total-cholesterol and triglycerides by 10%, and LDL-cholesterol by 19%, whereas HDL-cholesterol increased by 18% (p < 0.01 for all lipid changes). Carotid IMT decreased from 1.19 ± 0.47 to 0.94 ± 0.21 mm (p < 0.01). Yet, changes in carotid IMT did not correlate with changes in any other variable studied.



Liraglutide decreases carotid IMT after 8 months treatment independently of its effect on plasma glucose and lipids concentrations.