nils-herrmann/clean_scirepeval huggingface dataset:
Computed tomographic colonography (virtual colonoscopy): a multicenter comparison with standard colonoscopy for detection of colorectal neoplasia.

Conventional colonoscopy is the best available method for detection of colorectal cancer; however, it is invasive and not without risk. Computed tomographic colonography (CTC), also known as virtual colonoscopy, has been reported to be reasonably accurate in the diagnosis of colorectal neoplasia in studies performed at expert centers.



To assess the accuracy of CTC in a large number of participants across multiple centers.



A nonrandomized, evaluator-blinded, noninferiority study design of 615 participants aged 50 years or older who were referred for routine, clinically indicated colonoscopy in 9 major hospital centers between April 17, 2000, and October 3, 2001. The CTC was performed by using multislice scanners immediately before standard colonoscopy; findings at colonoscopy were reported before and after segmental unblinding to the CTC results.



The sensitivity and specificity of CTC and conventional colonoscopy in detecting participants with lesions sized at least 6 mm. Secondary outcomes included detection of all lesions, detection of advanced lesions, possible technical confounders, participant preferences, and evidence for increasing accuracy with experience.



A total of 827 lesions were detected in 308 of 600 participants who underwent both procedures; 104 participants had lesions sized at least 6 mm. The sensitivity of CTC for detecting participants with 1 or more lesions sized at least 6 mm was 39.0% (95% confidence interval [CI], 29.6%-48.4%) and for lesions sized at least 10 mm, it was 55.0% (95% CI, 39.9%-70.0%). These results were significantly lower than those for conventional colonoscopy, with sensitivities of 99.0% (95% CI, 97.1%->99.9%) and 100%, respectively. A total of 496 participants were without any lesion sized at least 6 mm. The specificity of CTC and conventional colonoscopy for detecting participants without any lesion sized at least 6 mm was 90.5% (95% CI, 87.9%-93.1%) and 100%, respectively, and without lesions sized at least 10 mm, 96.0% (95% CI, 94.3%-97.6%) and 100%, respectively. Computed tomographic colonography missed 2 of 8 cancers. The accuracy of CTC varied considerably between centers and did not improve as the study progressed. Participants expressed no clear preference for either technique.



Computed tomographic colonography by these methods is not yet ready for widespread clinical application. Techniques and training need to be improved.
Technological profile assessment of voluntary HIV counseling and testing centers in Brazil.

To characterize and analyze technological profiles of voluntary HIV counseling and testing centers in Brazil.



A structured self-completion questionnaire with 78 questions was used. This questionnaire was answered by 320 (83.6%) of the 383 Brazilian centers, in 2006. Responses that characterized the services' technological profile were analyzed using K-means clustering technique. Associations between the profiles described and the municipal contexts were analyzed using the chi-square and residue analysis for proportions, and ANOVA and Bonferroni for means.



Centers showed significant deficiencies to guarantee adequate services. A total of four technological profiles were identified. The 'care' profile (21.6%) predominated among the services instituted before 1993, in areas with high AIDS incidence and in large cities. The 'prevention' profile (30.0%), prevalent between 1994 and 1998, was the type that best complies with the Ministry of Health's norms, with better readiness and productivity indicators. The 'care and prevention' profile (26.9%), included in the AIDS services, predominated between 1999 and 2002, and developed the most comprehensive set of activities, including STD treatment. The 'testing' profile (21.6%) was the most precarious, found where the epidemic is most recent and with a lower number of people tested.



Counseling and testing centers constitute a set of heterogeneous services. In addition, service implementation guidelines have not been completely incorporated in Brazil, thus having and influence on low resolution and productivity indicators and also the inadequate development of prevention activities.
Effective recruitment strategies and community-based participatory research: community networks program centers' recruitment in cancer prevention studies.

Community-based participatory research (CBPR) approaches that involve community and academic partners in activities ranging from protocol design through dissemination of study findings can increase recruitment of medically underserved and underrepresented racial/ethnic minority populations into biomedical research.



Five cancer screening and prevention trials in three National Cancer Institute (Bethesda, MD)-funded Community Networks Program Centers (CNPC), in Florida, Kansas, and South Carolina, were conducted across diverse populations. Data were collected on total time period of recruitment, ratios of participants enrolled over potential participants approached, selected CBPR strategies, capacity-building development, and systematic procedures for community stakeholder involvement.



Community-engaged approaches used included establishing colearning opportunities, participatory procedures for community-academic involvement, and community and clinical capacity building. A relatively large proportion of individuals identified for recruitment was actually approached (between 50% and 100%). The proportion of subjects who were eligible among all those approached ranged from 25% to more than 70% (in the community setting). Recruitment rates were very high (78%-100% of eligible individuals approached) and the proportion who refused or who were not interested among those approached was very low (5%-11%).



Recruitment strategies used by the CNPCs were associated with low refusal and high enrollment ratios of potential subjects. Adherence to CBPR principles in the spectrum of research activities, from strategic planning to project implementation, has significant potential to increase involvement in biomedical research and improve our ability to make appropriate recommendations for cancer prevention and control programming in underrepresented diverse populations.



CBPR strategies should be more widely implemented to enhance study recruitment.
Feasibility and safety of 7F sheathless guiding catheter during transradial coronary intervention.

The aim of our study is to assess the feasibility, safety, and rate of radial artery occlusion (RAO) using 7F sheathless guiding catheter in a large population undergoing transradial intervention (TRI).



There is a frequent need for large bore guiding catheter to perform complex coronary interventions. Hydrophilic sheathless guiding catheters are not available in the US, therefore, we present the results of a multicenter study using the modified sheathless technique and readily available catheters.



Between December 2010 and February 2011, 116 consecutive patients from four tertiary US centers who underwent TRI using 7F sheathless guiding catheter were included in this study.



In our study of 116 patients with 123 coronary lesions, 57 stenoses (49%) were complex interventions, which included patients with acute coronary syndromes, chronic total occlusion (CTO), bifurcation stenting, calcified lesions, left main artery, and saphenous venous graft interventions. Overall procedural success rate was 95%. At 7-day, there were six patients (5%) with RAO, of which two of the six had severe radial artery spasm during the procedure. At 30-day, the overall persistent RAO was only detected in three patients (2.5%), as three patients had return of antegrade radial artery flow.



In our multicenter study of 116 consecutive patients, using 7F sheathless guiding catheter to perform TRI is associated with a high procedural success (95%) and a low 30-day RAO rate (2.5%).
UVA irradiation of human skin vasodilates arterial vasculature and lowers blood pressure independently of nitric oxide synthase.

The incidence of hypertension and cardiovascular disease (CVD) correlates with latitude and rises in winter. The molecular basis for this remains obscure. As nitric oxide (NO) metabolites are abundant in human skin, we hypothesized that exposure to UVA may mobilize NO bioactivity into the circulation to exert beneficial cardiovascular effects independently of vitamin D. In 24 healthy volunteers, irradiation of the skin with two standard erythemal doses of UVA lowered blood pressure (BP), with concomitant decreases in circulating nitrate and rises in nitrite concentrations. Unexpectedly, acute dietary intervention aimed at modulating systemic nitrate availability had no effect on UV-induced hemodynamic changes, indicating that cardiovascular effects were not mediated via direct utilization of circulating nitrate. UVA irradiation of the forearm caused increased blood flow independently of NO synthase (NOS) activity, suggesting involvement of pre-formed cutaneous NO stores. Confocal fluorescence microscopy studies of human skin pre-labeled with the NO-imaging probe diaminofluorescein 2 diacetate revealed that UVA-induced NO release occurs in a NOS-independent, dose-dependent manner, with the majority of the light-sensitive NO pool in the upper epidermis. Collectively, our data provide mechanistic insights into an important function of the skin in modulating systemic NO bioavailability, which may account for the latitudinal and seasonal variations of BP and CVD.
Antibody-response to three recombinant hepatitis B vaccines: comparative evaluation of multicenter travel-clinic based experience.

The immunogenicity of three currently used hepatitis B vaccines was compared in an unselected study population in an every day travel clinical setting. Five hundred and eighteen vaccinees received Engerix-B (EB), 990 received Twinrix (TWX), and 366 were immunised with Gen-HB-Vax (GHB). Overall, 88.6% of the vaccinees, tested within the first 6 months after completion of the vaccination series, developed protective levels of anti-HBs (> or = 10 mIU/ml). However, GHB recipients showed significantly lower seroprotection rates (SPR) than EB and TWX recipients (79.3% vs. 87.7% vs. 92.3%, P < 0.000001). GMTs for anti-HBs, tested within 6 months after the third vaccination, showed the lowest results in the GHB group, followed by EB and TWX (142 vs. 523 vs. 1008 mIU/ml, P < 0.000001). TWX vaccinees, however, showing a higher antibody decline rate than EB recipients within the first years after completion of the full immunisation course (30% vs. 25%; P = 0.0538). This study confirms an overall good immune response to the 20 microg-dose vaccine, in the course of a regular clinical setting. The significant difference in SPRs and GMTs to the 10 microg-dose vaccine, however, may influence future immunisation practices for the elderly.
Changes in Lp(a) lipoprotein levels during the treatment of hypercholesterolaemia with simvastatin

Thirty-six patients with total serum cholesterol levels above 6.5 mmol/l and Lipoprotein(a) levels above 100 mg · 1−1 were evaluated in a 24 week double-blind, placebo controlled, cross-over study to assess the possible changes in Lp(a) during treatment with the HMG CoA reductase inhibitor simvastatin. The median plasma Lp(a) increased from 359 to 464 mg·l−1 during simvastin treatment as compared to placebo (not significant). Individual changes in Lp(a) varied. In a multivariate linear regression analysis the individual change in Lp(a) was correlated with the baseline Lp(a) (r = 0.64), the change in serum triglycerides (r = 0.48) and the baseline apolipoprotein B (r = 0.36). Differences between the Lp(a) phenotypes may explain some of the varied Lp(a) responses. It appears that the effect of simvastatin on the Lp(a) level in individuals is usually insignificant, but in patients with a high Lp(a) simvastatin may further increase it.
Sifalimumab, a Human Anti–Interferon-α Monoclonal Antibody, in Systemic Lupus Erythematosus: A Phase I Randomized, Controlled, Dose-Escalation Study

To evaluate the safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adults with moderate-to-severe systemic lupus erythematosus (SLE).



In this multicenter, double-blind, placebo-controlled, sequential dose-escalation study, patients were randomized 3:1 to receive IV sifalimumab (0.3, 1.0, 3.0, or 10.0 mg/kg) or placebo every 2 weeks to week 26, then followed up for 24 weeks. Safety assessment included recording of treatment-emergent adverse events (AEs) and serious AEs. Pharmacokinetics, immunogenicity, and pharmacodynamics were evaluated, and disease activity was assessed.



Of 161 patients, 121 received sifalimumab (26 received 0.3 mg/kg; 25, 1.0 mg/kg; 27, 3.0 mg/kg; and 43, 10 mg/kg) and 40 received placebo. Patients were predominantly female (95.7%). At baseline, patients had moderate-to-severe disease activity (mean SLE Disease Activity Index score 11.0), and most (75.2%) had a high type I interferon (IFN) gene signature. In the sifalimumab group versus the placebo group, the incidence of ≥1 treatment-emergent AE was 92.6% versus 95.0%, ≥1 serious AE was 22.3% versus 27.5%, and ≥1 infection was 67.8% versus 62.5%; discontinuations due to AEs occurred in 9.1% versus 7.5%, and death occurred in 3.3% (n=4) versus 2.5% (n=1). Serum sifalimumab concentrations increased in a linear and dose-proportional manner. Inhibition of the type I IFN gene signature was sustained during treatment in patients with a high baseline signature. No statistically significant differences in clinical activity (SLEDAI and British Isles Lupus Assessment Group score) between sifalimumab and placebo were observed. However, when adjusted for excess burst steroids, SLEDAI change from baseline showed a positive trend over time. A trend toward normal complement C3 or C4 level at week 26 was seen in the sifalimumab groups compared with baseline.



The observed safety/tolerability and clinical activity profile of sifalimumab support its continued clinical development for SLE.
Longevity of implantable cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer

Device replacement at the time of battery depletion of implantable cardioverter-defibrillators (ICDs) may carry a considerable risk of complications and engenders costs for healthcare systems. Therefore, ICD device longevity is extremely important both from a clinical and economic standpoint. Cardiac resynchronization therapy defibrillators (CRT-D) battery longevity is shorter than ICDs. We determined the rate of replacements for battery depletion and we identified possible determinants of early depletion in a series of patients who had undergone implantation of CRT-D devices.



We retrieved data on 1726 consecutive CRT-D systems implanted from January 2008 to March 2010 in nine centres. Five years after a successful CRT-D implantation procedure, 46% of devices were replaced due to battery depletion. The time to device replacement for battery depletion differed considerably among currently available CRT-D systems from different manufacturers, with rates of batteries still in service at 5 years ranging from 52 to 88% (log-rank test, P < 0.001). Left ventricular lead output and unipolar pacing configuration were independent determinants of early depletion [hazard ratio (HR): 1.96; 95% 95% confidence interval (CI): 1.57-2.46; P < 0.001 and HR: 1.58, 95% CI: 1.25-2.01; P < 0.001, respectively]. The implantation of a recent-generation device (HR: 0.57; 95% CI: 0.45-0.72; P < 0.001), the battery chemistry and the CRT-D manufacturer (HR: 0.64; 95% CI: 0.47-0.89; P = 0.008) were additional factors associated with replacement for battery depletion.



The device longevity at 5 years was 54%. High left ventricular lead output and unipolar pacing configuration were associated with early battery depletion, while recent-generation CRT-Ds displayed better longevity. Significant differences emerged among currently available CRT-D systems from different manufacturers.
Body size, physical activity, and risk of triple-negative and estrogen receptor-positive breast cancer.

Triple-negative breast cancer, characterized by a lack of hormone receptor and HER2 expression, is associated with a particularly poor prognosis. Focusing on potentially modifiable breast cancer risk factors, we examined the relationship between body size, physical activity, and triple-negative disease risk.



Using data from 155,723 women enrolled in the Women's Health Initiative (median follow-up, 7.9 years), we assessed associations between baseline body mass index (BMI), BMI in earlier adulthood, waist and hip circumference, waist-hip ratio, recreational physical activity, and risk of triple-negative (n=307) and estrogen receptor-positive (ER+, n=2,610) breast cancers.



Women in the highest versus lowest BMI quartile had 1.35-fold (95% CI, 0.92-1.99) and 1.39-fold (95% CI, 1.22-1.58) increased risks of triple-negative and ER+ breast cancers, respectively. Waist and hip circumferences were positively associated with risk of ER+ breast cancer (Ptrend=0.01 for both measures) but were not associated with triple-negative breast cancer. Compared with women who reported no recreational physical activity, women in the highest activity tertile had similarly lower risks of triple-negative and ER+ breast cancers (HR=0.77; 95% CI, 0.51-1.13; and HR=0.85; 95% CI, 0.74-0.98, respectively).



Despite biological and clinical differences, triple-negative and ER+ breast cancers are similarly associated with BMI and recreational physical activity in postmenopausal women. The biological mechanisms underlying these similarities are uncertain and these modest associations require further investigation.



If confirmed, these results suggest potential ways postmenopausal women might modify their risk of both ER+ and triple-negative breast cancers.
A modeling system based on dynamic constraints

We present "dynamic constraints," a physically-based technique for constraint-based control of computer graphics models. Using dynamic constraints, we build objects by specifying geometric constraints; the models assemble themselves as the elements move to satisfy the constraints. The individual elements are rigid bodies which act in accordance with the rules of physics, and can thus exhibit physically realistic behavior. To implement the constraints, a set of "constraint forces" is found, which causes the bodies to act in accordance with the constraints; finding these "constraint forces" is an inverse dynamics problem.
Factors predictive of overall health over the course of the disease in patients with systemic lupus erythematosus from the LUMINA cohort (LXII): use of the SF-6D.

Health related quality of life (HRQOL) over course of the disease was ascertained in SLE patients from LUMINA, a multiethnic US cohort, using the SF-36-derived utility measure, the SF-6D.



All available visits were examined to predict HRQOL using either variables from the baseline or enrollment visits or from the preceding visits. The physical and mental component summary (PCS and MCS, respectively) measures of the SF-36 were also examined. A total of 2662 visits from 588 SLE patients were included; 90% of the patients were women, 19% Hispanic-Texans, 17% Hispanic-Puerto Ricans, 35% African Americans and 29% Caucasians. The patients' mean (SD) SF-6D was 0.6 (0.1).



In multivariable analyses, Hispanic-Texan ethnicity and higher levels of social support were predictors of HRQOL whereas older age, poverty, greater disease activity and damage and higher levels of fatigue, helplessness and abnormal illness-related behaviors were negative predictors. Prior SF-6D was the strongest variable predictive of subsequent HRQOL, when included. The analyses in which the PCS and MCS were examined as end-points were, overall, consistent with the SF-6D results.



We conclude that the SF-6D index provides an adequate measure of self-perceived HRQOL and that patients' self-perception of HRQOL is influenced by disease and non-disease related factors.
Five minutes of extended assisted ventilation with an open umbilical trocar valve significantly reduces postoperative abdominal and shoulder pain in patients undergoing laparoscopic hysterectomy.

Residual carbon dioxide contributes substantially to pain following laparoscopic surgery. We evaluated the effects of extended assisted ventilation (EAV) with an open umbilical trocar valve for five additional minutes following laparoscopic hysterectomy on postoperative abdominal and shoulder pain levels. We also examined whether a combination of EAV and trocar site infiltration (TSI) with lidocaine could further reduce postoperative pain levels.



In this prospective randomized trial, the effectiveness of EAV and EAV/TSI in reducing postoperative abdominal and shoulder pain were compared with that of a standard treatment regime in 283 patients undergoing laparoscopic hysterectomy (total or supracervical). Pain levels were evaluated by self-assessment questionnaire using a numeric rating scale (NRS) and by postoperative piritramid requirement, a surrogate parameter for postoperative analgesic drug requirement. The incidence of nausea and vomiting was also assessed.



Compared with the standard treatment regime, EAV reduced abdominal pain levels significantly at 3h (NRS score, 3.21 ± 1.56 vs. 4.73 ± 1.71) and 24h (3.82 ± 1.49 vs. 4.95 ± 1.68) postoperatively (both p < 0.01). EAV also significantly reduced shoulder pain at 24h (EAV vs. control, 4.28 ± 1.51 vs. 5.14 ± 1.49) and 48 h (3.64 ± 1.66 vs. 4.22 ± 1.43) postoperatively (both p < 0.01). Patients in the EAV group had significantly lower piritramid requirements compared with standard treatment at 3h post-operatively (4.28 ± 2.09 mg vs. 6.31 ± 2.21 mg; p<0.01). EAV/TSI showed no additional benefit in terms of pain reduction compared with EAV alone. Incidences of postoperative nausea and vomiting were not reduced by EAV or EAV/TSI.



EAV was found to be an effective and safe method to reduce postoperative pain levels in patients undergoing laparoscopic hysterectomy.
Direct stenting for stable angina pectoris is associated with reduced periprocedural microcirculatory injury compared with stenting after pre-dilation.

We conducted a randomized study to compare the effect of direct stenting (DS) and conventional stenting (CS) on post-procedural index of microcirculatory resistance (IMR) values.



Direct stenting has been suggested to reduce periprocedural microcirculatory injury compared with stenting that follows pre-dilation (CS). The index of microcirculatory resistance is a sensitive invasive marker of coronary microvascular resistance.



Fifty patients admitted for elective percutaneous coronary intervention (PCI) were included. All patients had stable angina (Canadian Cardiovascular Society class <IV) related to a lesion suitable for DS and were randomized to DS (n = 25) or CS (n = 25). Baseline demographics and clinical and procedural data were comparable in both groups. An intracoronary pressure/temperature sensor-tipped guide wire was used. Thermodilution curves were obtained at baseline and during maximal hyperemia achieved by infusion of intravenous adenosine. The index of microcirculatory resistance was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time.



After otherwise-uneventful PCI, patients treated with CS had significantly greater IMR (DS 13 +/- 3, CS 24 +/- 14; p < 0.01) and tended to have greater post-PCI troponin T values (DS 0.035 +/- 0.04, CS 0.17 +/- 0.02; p = 0.07). In the whole sample, 20% of patients had post-PCI troponin release (troponin T >0.03 ng/ml). Patients with troponin elevation had significantly greater post-PCI IMR values than patients without troponin elevation: 24.7 +/- 13.2 versus 16.9 +/- 10.2; p = 0.04.



In patients undergoing successful coronary stenting for stable angina, DS is associated with reduced microvascular dysfunction induced by PCI as compared with CS.