nils-herrmann/clean_scirepeval huggingface dataset:
Multicenter experience on eversion versus conventional carotid endarterectomy in symptomatic carotid artery stenosis: observations from the Stent-Protected Angioplasty Versus Carotid Endarterectomy (SPACE-1) trial.

Carotid endarterectomy (CEA) is beneficial in patients with symptomatic carotid artery stenosis. However, randomized trials have not provided evidence concerning the optimal CEA technique, conventional or eversion.



The outcome of 563 patients within the surgical randomization arm of the Stent-Protected Angioplasty versus Carotid Endarterectomy in Symptomatic Patients (SPACE-1) trial was analyzed by surgical technique subgroups: eversion endarterectomy versus conventional endarterectomy with patch angioplasty. The primary end point was ipsilateral stroke or death within 30 days after surgery. Secondary outcome events included perioperative adverse events and the 2-year risk of restenosis, stroke, and death.



Both groups were similar in terms of demographic and other baseline clinical variables. Shunt frequency was higher in the conventional CEA group (65% versus 17%; P<0.0001). The risk of ipsilateral stroke or death within 30 days after surgery was significantly greater with eversion CEA (9% versus 3%; P=0.005). There were no statistically significant differences in the rate of perioperative secondary outcome events with the exception of a significantly higher risk of intraoperative ipsilateral stroke rate in the eversion CEA group (4% versus 0.3%; P=0.0035). The 2-year risk of ipsilateral stroke occurring after 30 days was significantly higher in the conventional CEA group (2.9% versus 0%; P=0.017).



In patients with symptomatic carotid artery stenosis, conventional CEA appears to be associated with better periprocedural neurological outcome than eversion CEA. Eversion CEA, however, may be more effective for long-term prevention of ipsilateral stroke. These findings should be interpreted with caution noting the limitations of the post hoc, nonrandomized nature of the analysis.
Heart failure during cardiac pacing.

Right ventricular apical (RVA) pacing creates abnormal left ventricular contraction, hypertrophy, and reduced pump function. The adverse effects of ventricular desynchronization may explain the association of RVA pacing with an increased risk of heart failure hospitalization (HFH) in clinical trials.



Baseline and postimplantation variables were used to predict HFH in the Mode Selection Trial, a 2010-patient, 6-year trial of dual-chamber (DDDR) versus ventricular (VVIR) pacing in sinus node dysfunction. A Cox model showed that New York Heart Association (NYHA) class at baseline and follow-up predicted HFH (hazard ratio [HR], 3.99; 95% confidence interval [CI], 2.74-5.79 for NYHA class III/IV and HR, 2.17; 95% CI, 1.54-3.04 for NYHA class II versus class I); other predictors were heart failure (HR, 2.30; 95% CI, 1.70-3.11), atrioventricular (AV) block (HR, 1.48; 95% CI, 1.11-1.97), and myocardial infarction (MI)(HR, 1.37; 95% CI, 1.00-1.86). Postimplantation predictors were VVIR cumulative percent ventricular pacing (Cum%VP) >80 (HR, 3.58; 95% CI, 1.72-7.45), DDDR Cum%VP >40 or VVIR Cum%VP < or =80 (HR, 1.81; 95% CI, 0.94-3.50) versus DDDR Cum%VP < or =40; whether QRS duration (QRSd) was paced or spontaneous (HR, 2.21; 95% CI, 1.39-3.54; spontaneous versus paced); and drugs for atrial fibrillation (HR, 1.60; 95% CI, 1.19-2.15). Low baseline ejection fraction (EF) and postimplantation RVA-paced or spontaneous QRSd predicted HFH; the increased risk with QRSd was steeper for normal versus low EF (HR, 1.18; 95% CI, 1.11-1.27; versus HR, 1.08; 95% CI, 1.01-1.15; for a 10-ms increase); at a QRSd of approximately 200 ms, normal- and low-EF patients had equivalent risk. HFH risk nearly doubled when VVIR Cum%VP was < or =80 or DDDR Cum%VP was >40 versus DDDR Cum%VP < or =40 and was additive with other risk factors.



Differences in HFH risk can be explained by interactions between substrate (atrial fibrillation, AV conduction, heart failure, MI, EF) and pacing promoters (ventricular desynchronization-paced QRSd and Cum%VP, and AV desynchronization-pacing mode). Management of RVA pacing is important for reducing the risk of HFH, particularly among patients with low EF and heart failure.
Efficacy and tolerability of pregabalin as preventive treatment for migraine: a 3-month follow-up study

Migraine is a common neurological disorder and epidemiological studies have documented its high social and economic impact. Unfortunately, preventive treatment is often insufficient to substantially reduce migraine frequency or it is not well tolerated. Antiepileptic drugs are increasingly used in migraine prevention. However, data on efficacy and tolerability of pregabalin in patients with migraine are still lacking. Our aim was to evaluate efficacy and tolerability of pregabalin in patients with migraine. We recruited 47 patients who started pregabalin at 75 mg/day, which was titrated to 300 mg/day as tolerated. A total of six patients (13%) reported one or more side effects during the intake of pregabalin; however, three of them discontinued pregabalin, because side effects were intolerable and persistent. Statistically significant reduction in migraine frequency compared to baseline (p < 0.001) was evident after 1 and 3 months of treatment. A greater frequency reduction was observed in those patients who increased the dosage within the first month of therapy. Our data suggest that pregabalin may be well tolerated and may represent an alternative preventive treatment in migraneurs. Limitations of the present study were a small sample size and an uncontrolled, open-label design; further randomized case–control studies are warranted to confirm our findings.
Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study.

This 13-week, double-blind study evaluated the efficacy and safety of the atypical antipsychotic paliperidone palmitate (recently approved in the United States) versus placebo administered as monthly gluteal injections (after two initial doses given 1 week apart) in acutely symptomatic patients with schizophrenia. Patients (N=388) were randomly assigned (1 : 1 : 1 : 1) to paliperidone palmitate 50, 100, or 150 mg eq. or placebo. As the 150 mg eq. dose was administered to fewer patients (n=30) than planned, meaningful and definitive conclusions cannot be drawn from the results of this group. The change from baseline in Positive and Negative Syndrome Scale total score at endpoint showed improvement in both paliperidone palmitate 50 and 100 mg eq. groups but was significant only in the 100 mg eq. group (P=0.019). The paliperidone palmitate 50 (P=0.004) and 100 mg eq. (P<0.001) groups showed significant improvement in the Personal and Social Performance score from baseline to endpoint versus placebo. Common adverse events (in >or=2% of patients in any group) more frequent with paliperidone palmitate 50 or 100 mg eq. than placebo (>or=5% difference) were headache, vomiting, extremity pain, and injection site pain. Treatment with paliperidone palmitate (100 mg eq.) was efficacious and all doses tested were tolerable.
Sodium Intake and All-Cause Mortality Over 20 Years in the Trials of Hypertension Prevention.

The relationship between lower sodium intake and total mortality remains controversial.



This study examined the relationship between well-characterized measures of sodium intake estimated from urinary sodium excretion and long-term mortality.



Two trials, phase I (1987 to 1990), over 18 months, and phase II (1990 to 1995), over 36 months, were undertaken in TOHP (Trials of Hypertension Prevention), which implemented sodium reduction interventions. The studies included multiple 24-h urine samples collected from pre-hypertensive adults 30 to 54 years of age during the trials. Post-trial deaths were ascertained over a median 24 years, using the National Death Index. The associations between mortality and the randomized interventions as well as with average sodium intake were examined.



Among 744 phase I and 2,382 phase II participants randomized to sodium reduction or control, 251 deaths occurred, representing a nonsignificant 15% lower risk in the active intervention (hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.66 to 1.09; p = 0.19). Among 2,974 participants not assigned to an active sodium intervention, 272 deaths occurred. There was a direct linear association between average sodium intake and mortality, with an HR of 0.75, 0.95, and 1.00 (references) and 1.07 (p trend = 0.30) for <2,300, 2,300 to <3,600, 3,600 to <4,800, and ≥4,800 mg/24 h, respectively; and with an HR of 1.12 per 1,000 mg/24 h (95% CI: 1.00 to 1.26; p = 0.05). There was no evidence of a J-shaped or nonlinear relationship. The HR per unit increase in sodium/potassium ratio was 1.13 (95% CI: 1.01 to 1.27; p = 0.04).



We found an increased risk of mortality for high-sodium intake and a direct relationship with total mortality, even at the lowest levels of sodium intake. These results are consistent with a benefit of reduced sodium and sodium/potassium intake on total mortality over a 20-year period.
Population-based prevalence and age distribution of human papillomavirus among women in Santiago, Chile.

More than 18 types of human papillomavirus (HPV) are associated with cervical cancer, the relative importance of the HPV types may vary in different populations.



To investigate the types of HPV, age distribution, and risk factors for HPV infection in women from Santiago, Chile.



We interviewed and obtained two cervical specimens from a population-based random sample of 1,038 sexually active women (age range, 15-69 years). Specimens were tested for the presence of HPV DNA using a GP5+/6+ primer-mediated PCR and for cervical cytologic abnormalities by Papanicolaou smears.



122 women tested positive for HPV DNA, 87 with high risk types (HR), and 35 with low risks (LR) only. Standardized prevalence of HPV DNA was 14.0% [95% confidence interval (95% CI), 11.5-16.4]. HR HPV by age showed a J reverse curve, whereas LR HPV showed a U curve, both statistically significant in comparison with no effect or with a linear effect. We found 34 HPV types (13 HR and 21 LR); HPV 16, 56, 31, 58, 59, 18, and 52 accounted for 75.4% of HR infections. Thirty-four (3.6%) women had cytologic lesions. Main risk factor for HPV and for cytologic abnormalities was number of lifetime sexual partners, odds ratios for > or =3 versus 1 were 2.8 (95% CI, 1.6-5.0) and 3.8 (95% CI, 1.3-11.4), respectively.



LR HPV presented a clear bimodal age pattern; HR HPV presented a J reverse curve. HPV prevalence was similar to that described in most Latin American countries.
Increased expression of inducible nitric oxide synthase and cyclo-oxygenase-2 in the airway epithelium of asthmatic subjects and regulation by corticosteroid treatment.

Nitric oxide (NO) and prostanoids are mediators of vascular and bronchial tone that are postulated to be involved in asthma. Increased levels of both are found in asthmatic subjects and are synthesised by enzymes that have cytokine inducible forms: inducible NO synthase (iNOS) and cyclo-oxygenase-2 (COX-2), respectively. We hypothesised that the in vivo expression of iNOS and COX-2 in the airways would be increased in asthma, and that these cytokine inducible enzymes may represent targets for regulation by corticosteroid treatment.



Bronchial biopsy specimens were obtained from three groups of subjects: atopic asthmatics treated with beta(2) agonists alone (n=7), atopic asthmatics additionally receiving regular treatment with corticosteroids (n=8), and non-asthmatic control subjects (n=10). Expression of iNOS and COX-2 mRNA and immunoreactive protein was studied using in situ hybridisation and quantitative immunohistochemistry.



Immunoreactivity and the hybridisation signal for iNOS and COX-2 were mainly localised in the airway epithelium. The proportion of epithelium immunostained was significantly greater in the non-steroid treated asthmatic subjects (iNOS 8.6 (1.8)%; COX-2 26.3 (4.6)%) than either the steroid treated asthmatics (iNOS 3.4 (1.0)%, p=0.009; COX-2 13.0 (0.6)%, p=0.0015) or the non-asthmatic controls (iNOS 4.2 (0.9)%, p=0.018; COX-2 11.6 (0.6)%, p=0.0003). Similarly, the hybridisation signal was stronger in the non-steroid treated group of asthmatic subjects than in the other two groups.



These findings highlight the potential role of the airway epithelium both as a contributor to the inflammatory process in asthma and as a target for inhaled corticosteroid treatment in this disease.
An Algorithm for Subgraph Isomorphism

Subgraph isomorphism can be determined by means of a brute-force tree-search enumeration procedure. In this paper a new algorithm is introduced that attains efficiency by inferentially eliminating successor nodes in the tree search. To assess the time actually taken by the new algorithm, subgraph isomorphism, clique detection, graph isomorphism, and directed graph isomorphism experiments have been carried out with random and with various nonrandom graphs.
A parallel asynchronous logic-in-memory implementation of a vital part of the algorithm is also described, although this hardware has not actually been built. The hardware implementation would allow very rapid determination of isomorphism.
Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial.

Certolizumab pegol (CZP) is a pegylated-conjugated Fab' against tumor necrosis factor (TNF). Additional data are needed regarding the efficacy of induction therapy with CZP in active Crohn's disease (CD).



A placebo-controlled trial evaluated the efficacy of CZP therapy in 439 adults with moderate to severe CD naive to anti-TNF therapy. Patients were randomized to receive CZP (400 mg subcutaneously) or placebo at weeks 0, 2, and 4. The primary end point was clinical remission at week 6.



Clinical remission rates at week 6 in the CZP and placebo groups were 32% and 25% (P = .174), respectively. Remission rates at weeks 2 and 4 in the CZP and placebo groups were 23% and 16% (P = .033) and 27% and 19% (P = .063), respectively. Clinical response rates at weeks 2, 4, and 6 in the CZP and placebo groups were 33% and 20% (P = .001), 35% and 26% (P = .024), and 41% and 34% (P = .179), respectively. There were significantly greater rates of clinical remission at week 6 for CZP in patients with increased concentrations of C-reactive protein (≥5 mg/L) at entry. Serious adverse events developed in 5% and 4% of patients in the CZP and placebo groups, respectively.



The primary end point did not reach statistical significance. Significant differences between CZP and placebo were observed in patients who had increased concentrations of C-reactive protein when the study began. Future clinical trials should emphasize the treatment of patients who have objective evidence of inflammation in addition to symptoms of active disease.
Digital image analysis of breast epithelial cells collected by random periareolar fine-needle aspirates (RPFNA) from women at high risk for breast cancer taking hormone replacement and the aromatase inhibitor, letrozole, for six months

Aromatase inhibitors are currently being evaluated as preventive agents in post-menopausal women at high risk for breast cancer. A phase II trial of 42 women on hormone replacement therapy (HRT) treated with letrozole for 6 months showed Ki-67 was reduced by 66% but showed no change in cytomorphology or Masood score. Subsequent image analytical procedures (karyometry) conducted on a subset of the samples captured subvisual information that showed reduced cellular abnormality after 6 months of letrozole. In the present study we expanded on the preliminary karyometry study to determine if the change in karyometric measurements corresponded to changes in risk biomarkers quantified in the Phase II trial; and secondly, whether these biomarkers might be used together to serve as markers of response in individual cases. Pap stained slides from the Phase II trial were used. Epithelial cell images were digitized on a CCD video-microphotometer and the nuclei were segmented from the field using a semiautomatic algorithm. Nine out of 37 cases analyzed showed a numerical decrease in all three markers, although only three of these exhibited changes substantial enough to be considered as an improvement. However, 12 cases showed improvement by cytology (a decrease in Masood score of at least 2), an additional 13 cases demonstrated a reduction in Ki-67 expression by 50% of the median baseline value, and an additional five cases exhibited a decrease of at least 10% in abnormal cells by nuclear morphometry. Thus, a total of 30 of 37 cases (81%) showed improvement in at least one marker. There was no correlation between changes in Ki-67%, karyometric abnormality, and Masood score change other than specimens that exhibited an improvement in cytology also displayed greater decreases in nuclear morphometry abnormalities. Given the heterogeneity of mechanisms leading to malignancy, the quantitative analysis of nuclear chromatin patterns may be valuable as a global, or integrating, biomarker of change in chemoprevention studies in conjunction with additional markers. Correlation with long term clinical outcome is needed to validate meaningful combinations of informative biomarkers.
Comparison of contemporaneous responses for EQ-5D-3L and Minnesota Living with Heart Failure; a case for disease specific multiattribute utility instrument in cardiovascular conditions.

The EQ-5D-3L, a generic multi-attribute utility instrument (MAUI), is widely employed to assist in economic evaluations in health care. The EQ-5D-3L lacks sensitivity when used in conditions such as cardiovascular disease (CVD). Although there are number of CVD specific quality of life instruments, currently, there are no CVD specific MAUIs. The aim of this study is to investigate the discriminative ability and responsiveness of the EQ-5D-3L and the Minnesota Living with Heart Failure Questionnaire (MLHF), a CVD specific quality of life instrument in a group of heart failure patients.



The psychometric performance of the EQ-5D-3L and the MLHF was assessed using data from a randomised trial for a heart failure management intervention. The two instruments were compared for discrimination, responsiveness and agreement. The severity groups were defined using New York Heart Association functional classes.



The effect sizes for severe classes were generally similar showing good discrimination. The MLHF recorded better responsiveness between the time points than the EQ-5D-3L which was indicated by higher effect sizes and standardised response means. The change in MLHF summary scores between the time points was significant (p<0.005; paired t-test). The overall agreement between the two measures was low.



The low correlation indicates that the two classification systems cover different aspects of health space. Comparison of CVD specific instruments with other generic MAUIs such as EQ-5D-3L and AQOL-8D is recommended for further research.
Effect of Internet Therapeutic Intervention on A1C Levels in Patients With Type 2 Diabetes Treated With Insulin

To assess the effect of an Internet-based glucose monitoring system (IBGMS) on A1C levels in patients with type 2 diabetes treated with insulin.



This trial involved 50 patients randomly assigned to receive either conventional treatment alone or with additional follow-up through an IBGMS for 6 months. Patients randomized to the intervention group uploaded blood glucose readings every 2 weeks to a secure Web site for review and receipt of feedback from their endocrinologist. A1C and laboratory test results were collected at 0, 3, and 6 months.



The baseline parameters were not significantly different. Over a 6-month follow-up, A1C dropped from 8.8 to 7.6% (P < 0.001) in the intervention group compared with 8.5 to 8.4% (P = 0.51) in the control group.



The use of IBGMS significantly improved A1C levels in patients with type 2 diabetes treated with insulin.
Model of hospital-supported discharge after stroke.

Readmission rate within 6 months after a stroke is 40% to 50%. The purpose of the project was to evaluate whether an interdisciplinary stroke team could reduce length of hospital stay, readmission rate, increase patient satisfaction and reduce dependency of help.



One hundred and ninety-eight patients with acute stroke were randomized into 103 patients whose discharge was supported by an interdisciplinary stroke team and 95 control patients who received standard aftercare. Baseline characteristics were comparable in the 2 groups. The patients were evaluated after 6 and 12 months regarding functional status and need for help.



Length of hospital admission was insignificantly shorter in the intervention compared with the control group (35.2 versus 39.8 days). There was no significant difference in readmission, GP-visits, and primary health care services. Furthermore, there was no significant difference in functional scores or patient satisfaction.



In this setting we could not show benefit of an interdisciplinary stroke team supporting patients at discharge perhaps because standard aftercare was very efficient already.
[Usefulness of the low protein rice on the diet therapy in patients with chronic renal failure].

Diet therapy for patients with chronic renal failure is based on low protein and high energy. To achieve strict diet therapy, it is necessary to use specially formulated low protein foods. Previously, rice with a low content of protein was not available, but recently, a low protein rice (LGC-1: low glutelin content-1) has been developed. LGC-1 was found to have a low content of glutelin in its seed protein compared to other ordinary rice. Glutelin is the major digestive protein in the rice grain. We studied the usefulness of LGC-1 in the diet therapy of patients with chronic renal failure. Twenty-three patients were placed on the low protein diet (0.6-0.9 g/kg/day) during the pre-study period (a mean of 10 months). Subsequently they were followed with the same diet using LGC-1 for the staple foods during the study period (mean of 7 months). Protein intake and the slope of the reciprocal of serum creatinine did not differ between each study period in all patients. Among the 23 patients, 9 consumed rice mainly as the staple food (120-180 g/day as polished rice: rice group), according to the results of a questionnaire. In the rice group, protein intake decreased (from 47 +/- 9 to 42 +/- 9 g/day, p < 0.05), and the slope of the reciprocal of serum creatinine reduced (from -4.59 +/- 4.33 to -1.47 +/- 3.51 x 10(-4) dl/mg/day, p < 0.05) during the study period, compared with the pre-study period. We conclude that LGC-1 is a useful and effective food for a low protein diet in patients with chronic renal failure, especially, for those who consume rice mainly as their staple food.