nils-herrmann/clean_scirepeval huggingface dataset:
Immediate and two-year outcomes after EVAR in "on-label" and "off-label" neck anatomies using different commercially available devices. analysis of the experience of two Italian vascular centers.

Endovascular aneurysm repair (EVAR) has fast become the therapeutic strategy of choice for abdominal aortic aneurysms (AAAs). Nowadays, the most important limit to the effectiveness of this technique is represented by complex anatomical situations, especially regarding the morphology of the proximal sealing zone. The aim of this study was to evaluate the 2-year outcome of unselected, real-world patients with "off-label" (off-L) proximal necks treated in 2 high-volume Italian vascular centers.



A double-center study was conducted on a prospectively compiled computerized database between January 2010 and December 2011. One hundred and ninety-six consecutive elective surgery patients were analyzed and divided into 2 groups ("on-label" [on-L] and "off-L" necks) on the basis of their aortic neck anatomy. The neck was classified as an "off-L neck" in the presence of: (1) a noncylindrical neck, (2) an angulated neck, (3) a short neck, and (4) an enlarged neck. The end points were 30-day and 2-year technical and clinical success, evaluated in terms of freedom from reintervention and death.



One hundred and thirty-three elective patients were treated by standard EVAR in the presence of an "off-L" proximal neck anatomy. Technical success was achieved in all cases in both groups. Six (9.5%) unplanned adjunctive procedures were necessary in the on-L group and 16 (12%) in the off-L group (P = ns). Perioperative endoleaks, reinterventions, stent-graft migration rates, and AAA-related deaths were null. A multivariate analysis was performed to evaluate the subgroups of patients with 2 or > 2 anatomic factors that indicate a challenging neck. In patients with 2 such factors, a significant difference was observed in terms of intraoperative adjunctive procedures, intraoperative endoleaks, and all-cause mortality: 26.7% vs. 9.9% (P = 0.048), 6.7% vs. 0.5% (P = 0.023), and 13.3% vs. 1.1% (P = 0.0012), respectively. The same differences became increasingly evident when analyzing patients with > 2 criteria: 50% vs. 10% (P = 0.0022), 16.7% vs. 0.5% (P < 0.001), and 16.7% vs. 1.0% (P = 0.01). No AAA-related deaths or AAA ruptures were reported in either group at the end of the 2-year follow-up. High-flow endoleaks, stent-graft migration, and, consequently, reintervention were more frequent in the off-L group, but none of these parameters reached statistical significance.



Our experience seems to show that the off-L use of EVAR could be considered effective for the treatment of patients unfit for open surgery. In patients with more than one anatomical proximal neck feature contraindicating open surgery, the rate of immediate complications and reinterventions was higher, but this did not affect the clinical benefit and success at 2-year follow-up.
Changing core beliefs with trial-based cognitive therapy may improve quality of life in social phobia: a randomized study.

To determine whether there are differences in quality of life (QoL) improvement after treatment with the trial-based thought record (TBTR) versus conventional cognitive therapy (CCT) in patients with social anxiety disorder (SAD).



A randomized trial comparing TBTR with a set of CCT techniques, which included the standard 7-column dysfunctional thought record (DTR) and the positive data log (PDL) in patients with SAD, generalized type.



Repeated measures analysis of variance (ANOVA) revealed a significant time effect in the general health, vitality, social functioning, and mental health domains of the Short Form 36. It also indicated significant treatment effects on the bodily pain, social functioning, role-emotional, and mental health domains, with higher scores in the TBTR group. One-way analysis of covariance (ANCOVA), using pretreatment values as covariates, showed that TBTR was associated with significantly better QoL post-treatment (bodily pain, social functioning and role-emotional) and at follow-up (role-emotional). A significant treatment effect on the role-emotional domain at 12-month follow-up denoted a sustained effect of TBTR relative to CCT.



This study provided preliminary evidence that TBTR is at least as effective as CCT in improving several domains of QoL in SAD, specifically when the standard 7-column DTR and the PDL are used.
A randomized double blind comparison of short-term duodenally administrated whale and seal blubber oils in patients with inflammatory bowel disease and joint pain.

Compared with soy oil, 10 days treatment with seal oil (SO), 10mLx3 daily, self-administrated through a nasoduodenal feeding tube, relieves joint pain in patients with inflammatory bowel disease (IBD). This randomized, controlled, double blind pilot trial compares SO and whale oil (WO) administered similarly by duodenal tube, for 10 days in 18 patients with IBD-related joint pain (n=9 per group). Other long chain n-3 polyunsaturated fatty acids were prohibited 7-days prior to and during study. Significant changes from baseline to study end were observed in both groups: reduced plasma arachidonic acid to eicosapentaenoic acid ratio and prostaglandin E(2) (PGE(2)) levels (tendency in WO group), decreased IBD-related joint pain and IBD-disease activity, and improved quality of life. These changes were not significantly different between SO and WO groups. Inhibition of cyclooxygenase is consistent with amelioration of IBD-related joint pain, but, as active control was used, effects need confirmation.
Cost-effectiveness of internet and telephone treatment for smoking cessation: an economic evaluation of The iQUITT Study.

Internet and telephone treatments for smoking cessation can reach large numbers of smokers. There is little research on their costs and the impact of adherence on costs and effects.



To conduct an economic evaluation of The iQUITT Study, a randomised trial comparing Basic Internet, Enhanced Internet and Enhanced Internet plus telephone counselling ('Phone') at 3, 6, 12 and 18 months.



We used a payer perspective to evaluate the average and incremental cost per quitter of the three interventions using intention-to-treat analysis of 30-day single-point prevalence and multiple-point prevalence (MPP) abstinence rates. We also examined results based on adherence. Costs included commercial charges for each intervention. Discounting was not included given the short time horizon.



Basic Internet had the lowest cost per quitter at all time points. In the analysis of incremental costs per additional quitter, Enhanced Internet+Phone was the most cost-effective using both single and MPP abstinence metrics. As adherence increased, the cost per quitter dropped across all arms. Costs per quitter were lowest among participants who used the 'optimal' level of each intervention, with an average cost per quitter at 3 months of US$7 for Basic Internet, US$164 for Enhanced Internet and US$346 for Enhanced Internet+Phone.



'Optimal' adherence to internet and combined internet and telephone interventions yields the highest number of quitters at the lowest cost. Cost-effective means of ensuring adherence to such evidence-based programmes could maximise their population-level impact on smoking prevalence.
18F-FDG versus 11C-choline PET/CT for the imaging of advanced head and neck cancer after combined intra-arterial chemotherapy and radiotherapy: the time period during which PET/CT can reliably detect non-recurrence

The purpose of this prospective study was to evaluate the usefulness of 18F-fluorodeoxyglucose (FDG) and 11C-choline positron emission tomography (PET)/computed tomography (CT) for detecting recurrences of advanced head and neck cancer after combined intra-arterial chemotherapy and radiotherapy. Additionally, we surveyed the time period during which an effective negative predictive value could be maintained after the first follow-up PET/CT examination and estimated the optimal timing of a second PET/CT examination for detecting late recurrences. Fifty-three subjects (36 men and 17 women; mean age: 59.4 ± 11.5 years) with advanced head and neck squamous cell carcinoma were recruited. Post-treatment 18F-FDG PET/CT and 11C-choline examinations were performed in all patients between 8 and 12 weeks after combined intra-arterial chemotherapy and radiotherapy. The PET/CT images were evaluated using a patient-based analysis and a lesion-based analysis. All of the patients were prospectively followed for at least 9 months after the post-treatment PET/CT examination, with surveillance using conventional images (including CT and/or MRI) and a physical examination performed every 3 months. Recurrences, as determined using the patient-based analysis, were eventually confirmed in 18, 6 and 5 patients at 3, 4–6 and 7–9 months after the post-treatment PET/CT examination, respectively. The sensitivity and specificity of the 18F-FDG PET/CT and the 11C-choline PET/CT examinations to predict recurrence within 3 months were higher (FDG: 89 and 91%; choline: 83 and 80%, respectively) than for recurrence detection 6 months (FDG: 67 and 90%; choline: 62 and 76%, respectively) and 9 months later (FDG: 59 and 92%; choline: 55 and 75%, respectively). The lesion-based analysis showed that the maximum standardized uptake value of 18F-FDG and 11C-choline in the recurrent lesions were correlated with each other, compared with their relation in scar tissues (R 2 = 0.492 and 0.197, respectively). 11C-choline was not superior to 18F-FDG for the detection of recurrent head and neck cancer. Both modalities had difficulty identifying recurrences at 4–9 months after the post-treatment PET/CT examination. In patients with advanced head and neck cancer who have received combined therapy, a second post-treatment PET/CT examination to check for late recurrences should be performed within 4–6 months after the first post-treatment PET/CT examination.
Signal functions for measuring the ability of health facilities to provide abortion services: an illustrative analysis using a health facility census in Zambia

Annually, around 44 million abortions are induced worldwide. Safe termination of pregnancy (TOP) services can reduce maternal mortality, but induced abortion is illegal or severely restricted in many countries. All abortions, particularly unsafe induced abortions, may require post-abortion care (PAC) services to treat complications and prevent future unwanted pregnancy. We used a signal-function approach to look at abortion care services and illustrated its utility with secondary data from Zambia.



We refined signal functions for basic and comprehensive TOP and PAC services, including family planning (FP), and assessed functions currently being collected via multi-country facility surveys. We then used the 2005 Zambian Health Facility Census to estimate the proportion of 1369 health facilities that could provide TOP and PAC services under three scenarios. We linked facility and population data, and calculated the proportion of the Zambian population within reach of such services.



Relevant signal functions are already collected in five facility assessment tools. In Zambia, 30 % of facilities could potentially offer basic TOP services, 3.7 % comprehensive TOP services, 2.6 % basic PAC services, and 0.3 % comprehensive PAC services (four facilities). Capability was highest in hospitals, except for FP functions. Nearly two-thirds of Zambians lived within 15 km of a facility theoretically capable of providing basic TOP, and one-third within 15 km of comprehensive TOP services. However, requiring three doctors for non-emergency TOP, as per Zambian law, reduced potential access to TOP services to 30 % of the population. One-quarter lived within 15 km of basic PAC and 13 % of comprehensive PAC services. In a scenario not requiring FP functions, one-half and one-third of the population were within reach of basic and comprehensive PAC respectively. There were huge urban-rural disparities in access to abortion care services. Comprehensive PAC services were virtually unavailable to the rural population.



Secondary data from facility assessments can highlight gaps in abortion service provision and coverage, but it is necessary to consider TOP and PAC separately. This approach, especially when combined with population data using geographic coordinates, can also be used to model the impact of various policy scenarios on access, such as requiring three medical doctors for non-emergency TOP. Data collection instruments could be improved with minor modifications and used for multi-country comparisons.
Feasibility study of alternate-day S-1 as adjuvant chemotherapy for gastric cancer: a randomized controlled trial

The Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer established oral S-1 administration for 1 year as the standard postoperative adjuvant chemotherapy for gastric cancer in Japan. We conducted a multicenter cooperative prospective study comparing daily and alternate-day S-1 administration as postoperative adjuvant therapy for gastric cancer. Patients with Stage II or III gastric cancer who underwent curative surgery were randomly assigned to receive standard daily S-1 administration [group A: 80–120 mg/day S-1 depending on body surface area (BSA); days 1–28 every 6 weeks for 1 year] or alternate-day administration (group B: 80–120 mg/day S-1 depending on BSA; alternate days for 15 months). Treatment completion rate was the primary endpoint, and relative dose intensity and safety, overall survival, and relapse-free survival (RFS) were secondary endpoints. Seventy-three patients were enrolled. The treatment completion rate was 72.2 % in group A and 91.8 % in group B; the relative dose intensity was 67.5 % in group A and 81.2 % in group B; and compliance was better in group B. Digestive system adverse effects were less frequent in group B than in group A. Median follow-up time was 2.8 years; 3-year survival rate was 69.6 % in group A and 87.3 % in group B; and 3-year RFS rate was 76.4 % in group A and 73.1 % in group B. Our data show improved compliance and fewer adverse effects with alternate-day S-1 administration, which appears to be a more sustainable option for adjuvant chemotherapy for Stage II or III gastric cancer.
Consumption of an oil composed of medium chain triacyglycerols, phytosterols, and N-3 fatty acids improves cardiovascular risk profile in overweight women.

Medium chain triacylglycerols (MCT) have been suggested as efficacious in weight management because they possess greater thermogenic qualities relative to long chain triacylglycerols; however, MCT may also increase circulating lipid concentrations, possibly increasing risk of cardiovascular disease (CVD). The present objective was to examine the effect of a diet supplemented with a functional oil (FctO) composed of energy expenditure-enhancing MCT (50% of fat), cholesterol-lowering phytosterols (22 mg/kg body weight), and triacylglycerol-suppressing n-3 fatty acids (5% of fat), versus a beef tallow-based diet (BT), on plasma lipid and aminothiol concentrations. In a randomized, single-blind, crossover design, partially-inpatient trial, 17 overweight women consumed each oil as part of a controlled, supervised, targeted energy balance diet for 27 days, with 4 or 8 weeks of washout between phases. Mean plasma total cholesterol concentration was lower (P <.0001), by 9.1%, on FctO (4.37 +/- 0.20 mmol/L) versus BT (4.80 +/- 0.20 mmol/L). Mean plasma low-density lipoprotein (LDL) cholesterol was also lower (P <.0001) following FctO (2.39 +/- 0.15 mmol/L) versus BT (2.86 +/- 0.16 mmol/L), representing a 16.0% difference between diets. High-density lipoprotein (HDL) cholesterol and circulating triacylglycerol concentrations remained unaffected by treatment. Ratios of HDL:LDL and HDL:total cholesterol were higher (P <.01) by 22.0% and 11.0%, respectively, on FctO versus BT. Plasma total homocysteine remained unchanged with FctO, but decreased (P <.05) with control, hence higher (P <.05) end points were observed with FctO (6.95 +/- 0.33 micromol/L) versus BT (6.27 +/- 0.28 micromol/L). Plasma glutathione increased (P <.05) by 0.44 micromol/L with FctO supplementation. In conclusion, despite equivocal effects on homocysteine levels, consumption of a functional oil composed of MCT, phytosterols, and n-3 fatty acids for 27 days improves the overall cardiovascular risk profile of overweight women.
Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856]

Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now.



900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial.



A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.
Bioavailability of a Novel, Water-Soluble Vitamin E Formulation in Malabsorbing Patients

In cystic fibrosis (CF), pancreatic insufficiency and a diminished bile acid pool cause malabsorption of important nutrients and dietary components leading to deficiency, poor nutritional status, and oxidative stress. Of particular significance is the malabsorption of fat-soluble nutrients and antioxidants, which are important for normal immune and neurologic function. Patients with CF often are deficient in these compounds despite supplementation with the current standard of care therapy. The objective was to compare the pharmacokinetic profile of this water-soluble vitamin E formulation (Aqua-E) with an oil-based softgel formulation in a malabsorbing patient population. Patients with CF who had documented malabsorption were recruited for participation in this pharmacokinetic study. Patients who met inclusion and exclusion criteria discontinued vitamin E supplementation, except for that in a multivitamin, for 7 to 21 days before the day of dosing. Patients were randomized to a single dose of 20 ml of Aqua-E or three oil-based softgels, which contained equivalent amounts of tocopherols. Blood was drawn from patients at time 0, 2, 4, 8, 24, 48, and 168 hr and analyzed for tocopherols. Eight patients were enrolled in the study and randomized to Aqua-E or softgels. The primary outcome, the absorption of γ-tocopherol in Aqua-E (AUC=115 μg/ml*hr), was significantly greater than that of oil-based softgels (AUC=25.3 μg/ml*hr; P=0.013). Total-tocopherols (α+γ+δ) in Aqua-E (AUC=294 μg/ml*hr) showed a strong trend toward increased absorption compared with that of oil-based softgels (AUC=117 μg/ml*hr; P=0.09). In conclusion, this novel, water-soluble formulation showed a marked and statistically significant increase in absorption of γ-tocopherol in malabsorbing patients with CF compared with an oil-based formulation.
Effect of Bariatric Surgery vs Medical Treatment on Type 2 Diabetes in Patients With Body Mass Index Lower Than 35: Five-Year Outcomes.

It has been well recognized that metabolic surgery has short-term benefits for mildly obese patients with type 2 diabetes mellitus (T2DM), but how long these effects can be sustained is uncertain.



To compare the 5-year efficacy between gastrointestinal metabolic surgery and medical treatment on glycemic control and diabetes remission in patients with T2DM and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) lower than 35.



This retrospective cohort study compares long-term outcomes for mildly obese patients with T2DM receiving metabolic surgery (n = 52) vs medical treatment (n = 299). The surgical group, enrolled from August 20, 2007, to June 25, 2008, and followed up through December 31, 2013, received standard sleeve gastrectomy (n = 19) or bypass (n = 33) procedures in a regional hospital. The medical group, selected from a nationwide community cohort that was recruited from August 27, 2003, to December 31, 2005, and followed up through December 31, 2012, was matched with the surgical group by age, BMI, and diabetes duration.



Glycated hemoglobin (HbA1c) reduction and prolonged complete and partial diabetes remission (defined as HbA1c <6.0% and 6.0%-6.5% of total hemoglobin [Hb; to convert to proportion of total Hb, multiply by 0.01], respectively, for those who were exempted from any antidiabetic drugs for 5 years).



At the end of the fifth year, the surgical group had a mean weight loss of 21.0% (from a mean [SD] BMI of 31.0 [2.4] to 24.5 [2.7]), their mean (SD) HbA1c decreased from 9.1% (2.1%) to 6.3% (1.1%) of total Hb, 18 participants (36.0%) had complete remission, 14 (28.0%) had partial remission, 1 (1.9%) died, and 1 (1.9%) had end-stage renal disease. In the same follow-up period in the medical group, 3 (1.2%) had complete remission, 4 (1.6%) had partial remission, 9 (3.0%) died, and 2 (0.7%) had end-stage renal disease; their mean HbA1c remained around 8% of total Hb (mean [SD], 8.1% [1.8%] of total Hb at baseline and 8.0% [1.6%] of total Hb at 5 years), and BMI also stayed similar (mean [SD], 29.1 [2.4] at baseline and 28.8 [2.6] at 5 years). The HbA1c reduction and complete and partial remission rates were all significantly larger in the surgical group as compared with the medical group (all P < .001). However, the mortality rate and end-stage renal disease incidence were not significantly different in these 2 comparison groups (P = .66 and .37, respectively).



For mildly obese patients with T2DM, the improvement in glycemic control from metabolic surgery lasts at least 5 years. However, the survival benefit and lifelong adverse outcomes require more than 5 years to be established.
Design of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST).

Carotid endarterectomy (CEA) and medical therapy were shown superior to medical therapy alone for symptomatic (> or =50%) and asymptomatic (> or =60%) stenosis. Carotid angioplasty stenting (CAS) offers a less invasive alternative. Establishing safety, efficacy, and durability of CAS requires rigorous comparison with CEA in symptomatic and asymptomatic patients.



The objective is to compare the efficacy of CAS versus CEA in patients with symptomatic (> or =50%) or asymptomatic (> or =60%) extracranial carotid stenosis.



The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) is a prospective, randomized, parallel, two-arm, multi-center trial with blinded endpoint adjudication. Primary endpoints are analyzed using standard time-to-event statistical modeling with adjustment for major baseline covariates. Primary analysis is on an intent-to-treat basis.



The primary outcome is the occurrence of any stroke, myocardial infarction, or death during a 30-day peri-procedural period, and ipsilateral stroke during follow-up of up to four years. Secondary outcomes include restenosis and health-related quality of life.