nils-herrmann/clean_scirepeval huggingface dataset:
A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts.

We compared a conventional stent (Jostent Flex, Jomed GmbH, Rangendingen, Germany) with a polytetrafluoroethylene (PTFE)-membrane-covered stent (Jostent Stentgraft) in patients undergoing intervention of a stenosis in an obstructed vein graft. The use of stents improved results of percutaneous revascularization of obstructed vein grafts, but did not demonstrate the reduced elevated restenosis rate. In addition, long-term clinical event rate is still high compared with intervention in native vessels. Observational studies suggested that stents covered with a PTFE membrane might be associated with a low complication and restenosis rate in venous bypass grafts. This prospective multicenter study included a total of 211 patients who were randomly assigned to receive either a Flex stent or Stentgraft. The primary end point was binary restenosis rate at six months by core lab quantitative coronary angiography. Acute success and procedural events were comparable between the two groups. Restenosis rate was not significantly different between the Flex (20%) and the Stentgraft (29%) groups (p = 0.15), although there was a nonsignificant trend toward a higher late occlusion rate in the Stentgraft group (7% vs. 16%, p = 0.069) at follow-up. Likewise, after a mean observation period of 14 months, cumulative event rates (death, myocardial infarction, or target lesion revascularization) were comparable in the two groups (31% vs. 31%, p = 0.93). This controlled trial does not indicate a superiority of the PTFE-membrane-covered Stentgraft compared with a conventional stent with respect to acute results, restenosis, or clinical event rates.
European Study of Radical Prostatectomy: time trends in Europe, 1993-2005.

European Study of Radical Prostatectomy: time trends in Europe, 1993–2005 Bob Djavan, Vincent Ravery 1 , Bernardo Rocco 2 , Alexandre Zlotta 3 , Maurizio Brausi 4 , Markus Margreiter, Peter Hammerer 5 , Amir Kaisary 6 , Theodore Anagnostou 7 , Imre Romics 8 , Pitor Dobronski 9 , Ottavio De Cobelli 2 and Michael Marberger Departments of Urology, University of Vienna, Vienna, Austria, 1 University of Paris, Paris, France; 2 European Institute of Oncology, Milan, Italy; and Departments of Urology, 3 University of Brussels, Brussels, Belgium, 4 University of Modena, Modena, Italy, 5 University of Hamburg, Hamburg, Germany, 6 University of London, London, UK, 7 University of Athens, Athens, Greece, 8 University of Budapest, Budapest, Hungary and 9 University of Warsaw, Warsaw, Poland
Effects of Anacardium humile leaf extracts on the development of gastrointestinal nematode larvae of sheep.

The rapid development of nematode resistance to anthelmintics has limited the success of small ruminant gastrointestinal helminthiasis control in several countries, stimulating the search for alternatives. The aim of this work was to evaluate the in vitro anthelmintic activity of Anacardium humile (Anacardiaceae) on gastrointestinal nematodes of sheep. Aqueous and ethanolic extracts of A. humile leaves were evaluated by the larval development inhibition assay at concentrations of: 187.5, 150, 100, 50, and 30 mg ml(-1); and 100, 80, 60, 40, and 20 mg ml(-1), respectively. Phytochemical analysis demonstrated the presence of tannins, flavenoids, and alkaloids in the leaves. The LD(50) was 10.14 mg ml(-1) for the aqueous extract and 23.24 mg ml(-1) for the ethanolic extract, providing evidence for the potential of this plant in the endoparasite control.
Effects of sequential combined transdermal and oral hormone replacement therapies on serum lipid and lipoproteins in postmenopausal women

The aim of this study was to compare the effects of sequential combined transdermal and oral postmenopausal hormone replacement therapies on serum lipid-lipoprotein profiles risk markers for cardiovascular disease. A prospective randomize study was designed: Ninety-six healthy nonhysterectomised postmenopausal women were randomized to receive either transdermal continuous 17β-estradiol, 0.05 mg/d (Estraderm TTS, Novartis, Basel, Switzerland), with transdermal sequential norethisterone acetate, 0.25 mg/d (Estragest TTS, Novartis, Basel, Switzerland), or oral continuous conjugated equine estrogens, 0.625 mg/d (Premarin 0.625 mg, Wyeth, Philadelphia, U.S.A.), with oral sequential medroxyprogesterone acetate, 10 mg/d (Farlutal 5 mg, Deva, Istanbul, Turkey). 84 women completed the trial, 42 in oral and 42 in the transdermal group. The serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoproteins AI and apolipoproteins B at 6 months after starting treatment were compared with baseline values for both therapies. Both oral and transdermal therapies significantly reduced serum levels of total cholesterol (208– 190 mg/dL and 216–199 mg/dL, respectively, p=0.0001) and LDL-cholesterol (128–112 mg/dL and 140– 127 mg/dL, respectively, p=0.001). The serum levels of triglycerides did not show any significant change with oral therapy, whereas this lipid fell (128–101 mg/dL, p=0.0001) significantly with transdermal therapy. We found significant decrease in HDL-cholesterol with transdermal therapy while there was no significant change with oral therapy. Apolipoproteins AI, the major protein component of HDL2 subfraction, was increased by oral therapy and lowered by transdermal therapy. As a conclusion, we have found that serum total cholesterol and LDL-cholesterol were lowered by both therapies, with no significant differences between treatments, whereas there were significant differences between treatments according to effects on serum triglycerides and apolipoproteins AI.
Anaplastic large cell lymphoma Hodgkin's-like: a randomized trial of ABVD versus MACOP-B with and without radiation therapy.

During the last few years, morphological, immunohistochemical, and genetic findings have placed anaplastic large cell lymphoma (ALCL) as a distinct clinicopathologic entity, and several reports have focused on the existence of different subtypes of the tumor. Particular attention has been paid to the ALCL-Hodgkin's-like (HL) subtype, which seems to be on the border between Hodgkin's disease (HD) and high-grade non-Hodgkin's lymphoma (HG-NHL). From September 1994 to July 1997, during the course of an Italian multicentric trial, 40 ALCL-HLs were randomized to receive as front-line chemotherapy MACOP-B (methotrexate with leucovorin, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin-a third-generation HG-NHL regimen) or ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine-a scheme specific for HD). All patients with bulky disease in the mediastinum at diagnosis underwent local radiotherapy after the chemotherapeutic program. Complete response (CR) was achieved in 17 of the 19 (90%) patients who were treated with MACOP-B, and in 19 of the 21 (91%) patients who were administered ABVD. The probability of relapse-free survival, projected at 32 months, was 94% for the MACOP-B subset and 91% for the ABVD subset. The majority of patients with mediastinal bulky disease obtained CR (evaluated with 67Ga single photon emission computed tomography [SPECT]) after their radiotherapy. The present study suggests that ALCL-HL, in line with its borderline status, responds in an equivalent way to third-generation chemotherapy for HG-NHL and to conventional HD treatment in terms of both CR and relapse-free survival rates. However, as to the latter, a longer follow-up period may be needed before stating the absolute equivalence of the two regimens used.
Circadian profiles of blood glucose and plasma free insulin during treatment with Semisynthetic and Biosynthetic human insulin, and comparison with conventional monocomponent preparations

Sixteen hospitalized insulin requiring diabetics treated with a single daily subcutaneous injection were randomly allocated either to a mixture of porcine Actrapid+Lente MC or a mixture of Regular+NPH—Biosynthetic human insulin (Study 1). In Study 2, 10 patients receiving two daily insulin injections were treated at random with either porcine Actrapid+Monotard, or Actrapid+Monotard—Semisynthetic human insulin or Regular+NPH—Biosynthetic human insulin. Once an optimal insulin regimen was obtained, circadian blood glucose and plasma free insulin profiles (7–9 time points) were determined with the two (Study 1) or three (Study 2) insulin preparations, keeping the doses of insulin constant. In Study 1 no significant difference in blood glucose (BG) or plasma free insulin (FIRI) profiles was observed. The mean daily blood glucose, the mean amplitude of glycaemic excursions (MAGE), the index of blood glucose control (M-value of Schlichtkrull), as well as the post-breakfast increases in blood glucose and mean free IRI, were similar with both types of insulin. In Study 2, BG and FIRI profiles were also similar, except for a significantly lower (p<0.02) BG at 8.30 p.m. with both human insulins. No significant differences were found in free IRI at that time. Mean BG, M index, MAGE and mean FIRI were similar but the postbreakfast increase was significantly smaller with SHI. In conclusion, the pharmacokinetics of animal monocomponent, semisynthetic and biosynthetic human insulin appear similar, but evening BG control was better with both types of human insulins given twice daily.
Does 'peer coaching' increase GP capacity to promote informed decision making about PSA screening? A cluster randomised trial.

Very little effort has been directed to enable GPs to better informed decisions about PSA screening among their male patients.



To evaluate an innovative programme designed to enhance GPs' capacity to promote informed decision making by male patients about PSA screening.



The study design was a cluster randomised controlled trial set in New South Wales, Australia's most populous state. 277 GPs were recruited through a major pathology laboratory. The interventions were three telephone-administered 'peer coaching' sessions integrated with educational resources for GPs and patients and the main outcome measures were: GP knowledge; perceptions of patient involvement in informed decision making; GPs' own decisional conflict; and perceptions of medicolegal risk.



Compared with GPs allocated to the control group, GPs allocated to our intervention gained significantly greater knowledge about PSA screening and related information [Mean 6.1 out of 7; 95% confidence interval (CI) = 5.9-6.3 versus 4.8; 95% CI = 4.6-5.0; P < 0.001]. They were less likely to agree that patients should remain passive when making decisions about PSA screening [Odds ratio (OR) = 0.11; 95% CI = 0.04-0.31; P < 0.001]. They perceived less medicolegal risk when not acceding to an 'uninformed' patient request for a PSA test (OR = 0.31; 95% CI 0.19-0.51). They also demonstrated lower levels of personal decisional conflict about the PSA screening (Mean 25.4; 95% CI 24.5-26.3 versus 27.8; 95% CI 26.6-29.0; P = 0.0002).



A 'peer coaching' programme, supplemented by education materials, holds promise as a strategy to equip GPs to facilitate informed decision making amongst their patients.
C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus.

Inflammation is hypothesized to play a role in development of type 2 diabetes mellitus (DM); however, clinical data addressing this issue are limited.



To determine whether elevated levels of the inflammatory markers interleukin 6 (IL-6) and C-reactive protein (CRP) are associated with development of type 2 DM in healthy middle-aged women.



Prospective, nested case-control study.



The Women's Health Study, an ongoing US primary prevention, randomized clinical trial initiated in 1992.



From a nationwide cohort of 27 628 women free of diagnosed DM, cardiovascular disease, and cancer at baseline, 188 women who developed diagnosed DM over a 4-year follow-up period were defined as cases and matched by age and fasting status with 362 disease-free controls.



Incidence of confirmed clinically diagnosed type 2 DM by baseline levels of IL-6 and CRP.



Baseline levels of IL-6 (P<.001) and CRP (P<.001) were significantly higher among cases than among controls. The relative risks of future DM for women in the highest vs lowest quartile of these inflammatory markers were 7.5 for IL-6 (95% confidence interval [CI], 3.7-15.4) and 15.7 for CRP (95% CI, 6.5-37.9). Positive associations persisted after adjustment for body mass index, family history of diabetes, smoking, exercise, use of alcohol, and hormone replacement therapy; multivariate relative risks for the highest vs lowest quartiles were 2.3 for IL-6 (95% CI, 0.9-5.6; P for trend =.07) and 4.2 for CRP (95% CI, 1.5-12.0; P for trend =.001). Similar results were observed in analyses limited to women with a baseline hemoglobin A(1c) of 6.0% or less and after adjustment for fasting insulin level.



Elevated levels of CRP and IL-6 predict the development of type 2 DM. These data support a possible role for inflammation in diabetogenesis.
Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial).

The primary objective of this 6-week, parallel-group, open-label, randomized, multicenter trial was to compare rosuvastatin with atorvastatin, pravastatin, and simvastatin across dose ranges for reduction of low-density lipoprotein (LDL) cholesterol. Secondary objectives included comparing rosuvastatin with comparators for other lipid modifications and achievement of National Cholesterol Education Program Adult Treatment Panel III and Joint European Task Force LDL cholesterol goals. After a dietary lead-in period, 2,431 adults with hypercholesterolemia (LDL cholesterol > or =160 and <250 mg/dl; triglycerides <400 mg/dl) were randomized to treatment with rosuvastatin 10, 20, 40, or 80 mg; atorvastatin 10, 20, 40, or 80 mg; simvastatin 10, 20, 40, or 80 mg; or pravastatin 10, 20, or 40 mg. At 6 weeks, across-dose analyses showed that rosuvastatin 10 to 80 mg reduced LDL cholesterol by a mean of 8.2% more than atorvastatin 10 to 80 mg, 26% more than pravastatin 10 to 40 mg, and 12% to 18% more than simvastatin 10 to 80 mg (all p <0.001). Mean percent changes in high-density lipoprotein cholesterol in the rosuvastatin groups were +7.7% to +9.6% compared with +2.1% to +6.8% in all other groups. Across dose ranges, rosuvastatin reduced total cholesterol significantly more (p <0.001) than all comparators and triglycerides significantly more (p <0.001) than simvastatin and pravastatin. Adult Treatment Panel III LDL cholesterol goals were achieved by 82% to 89% of patients treated with rosuvastatin 10 to 40 mg compared with 69% to 85% of patients treated with atorvastatin 10 to 80 mg; the European LDL cholesterol goal of <3.0 mmol/L was achieved by 79% to 92% in rosuvastatin groups compared with 52% to 81% in atorvastatin groups. Drug tolerability was similar across treatments.
4A randomized trial of prolonged prone positioning in children with acute respiratory failure.

To compare the effect of the prone position (PP) vs supine position (SP) on oxygenation in children with acute respiratory failure (ARF).



Prospective, randomized controlled trial.



A 36-bed pediatric critical-care unit in a tertiary-care, university-based children's hospital.



Ten children (mean [SD] age, 5 +/- 3.6 years) with ARF with a baseline oxygenation index (OI) of 22 +/- 8.5.



Following a period of stabilization in the SP, baseline data were collected and patients were randomized to one of two groups in a two-crossover study design: group 1, supine/prone sequence; group 2, prone/supine sequence. Each position was maintained for 12 h. Lung mechanics and acute response to inhaled nitric oxide were examined in each position.



OI was significantly better in the PP compared to the SP over the 12-h period (analysis of variance, p = 0.0016). When patients were prone, a significant improvement in OI was detected (7.9 +/- 5.3; p = 0.002); this improvement occurred early (within 2 h in 9 of 10 patients) and was sustained over the 12-h study period. Static respiratory system compliance and resistance were not significantly affected by the position change. Inhaled nitric oxide had no effect on oxygenation in either position. Urine output increased while prone, resulting in a significantly improved fluid balance (+ 6.6 +/- 15.2 mL/kg/12 h in PP vs + 18.9 +/- 13.6 mL/kg/12 h in SP; p = 0.041). No serious adverse effects were detected in the PP.



In children with ARF, oxygenation is significantly superior in the PP than in the SP. This improvement occurs early, remains sustained for a 12-h period, and is independent of changes in lung mechanics.
LycoRed as an alternative to hormone replacement therapy in lowering serum lipids and oxidative stress markers: a randomized controlled clinical trial.

Menopause is a pro-atherogenic state with a sharp rise in the incidence of coronary artery disease. This pilot study was designed as an equivalence randomized clinical trial to explore the potential of LycoRed (containing 2000 microg lycopene) as an alternative to hormone replacement therapy (HRT) for the prevention of coronary artery disease in postmenopausal women.



Forty-one healthy postmenopausal women were randomly allocated to receive either continuous combined HRT (n = 21) or LycoRed (n = 20) for six months. Serum lipid profile, marker of lipid peroxidation (malondialdehyde), and the level of endogenous antioxidant (glutathione) were measured at the baseline, and 3 and 6 months after the intervention in both groups.



At 6 months, HRT resulted in a significant decrease in total cholesterol (TC) level by 23.5%, low-density lipoproteins (LDL) by 19.6%, and an increase in high-density lipoproteins (HDL) by 38.9%. The LycoRed group showed similar changes in TC (-24.2%), LDL (-14.9%) and HDL (+26.1%). Triglyceride levels showed a smaller though significant increase at 6 months, but not at 3 months, in both groups. There was no significant change in the very LDL (VLDL) level in either group. Malondialdehyde levels decreased significantly by 16.3% and 13.3%, whereas glutathione levels increased significantly by 5.9% and 12.5% in HRT and LycoRed groups, respectively.



Both HRT and LycoRed had a favorable effect on serum lipids and oxidative stress markers which were comparable. LycoRed can be used as an alternative to HRT to reduce the risk of atherosclerosis in postmenopausal women.
"The Fly": a new clinical assessment and treatment method for deficits of movement control in the cervical spine: reliability and validity.

Test-retest and case-control study designed to detect accuracy of cervical spine movements by comparing 3 incrementally difficult movement patterns. An asymptomatic group, a nontrauma neck pain group, and a group with whiplash-associated disorders, Grade II, were tested (n = 18 in each group).



To determine the test-retest reliability and the discriminative validity of the new Fly method.



A lack of reliable and valid measures for grading the deficits of movement control in the cervical spine makes it impossible to prescribe treatment appropriate to each patient's respective impairment level.



Head tracking of a moving fly which appeared on a computer screen. Easy, medium, and difficult patterns, each of which was repeated 3 times in random order, were tested. Amplitude accuracy (deviation of movements), directional accuracy (time on target, undershoots vs. overshoots) were compared across patterns and groups on 2 occasions, 1 week apart.



The intraclass correlation coefficient(2,1) ranged from 0.53 to 0.82 for both variables, except for the subvariable "overshoots" (0.14-0.42). The limits of agreement (LOA) were progressively wider across patterns (easy-medium-difficult) and groups (asymptomatic-nontrauma-whiplash-associated disorder). Analysis of variance with repeated measures revealed significant differences between patterns within each group and between groups respectively for both outcome variables (P < 0.001).



The Fly method provides reliable and valid measures for movement control of the cervical spine. Higher means and wider LOA across patterns and subject groups are reasoned to be inherent in the new Fly method and the subject groups tested. The wide LOA in the symptomatic groups supports the development of a normative database. The new Fly method can be used both as an assessment and a treatment method and ensures gradual progression in the treatment for deficits of movement control in patients with neck pain.
Plant sterol-fortified orange juice effectively lowers cholesterol levels in mildly hypercholesterolemic healthy individuals.

Hypercholesterolemia is a major risk factor for coronary artery disease. Therapeutic lifestyle changes include dietary modifications such as inclusion of phytosterols, which effectively lowers low-density lipoprotein (LDL) cholesterol in margarines and other fats. Their effectiveness in nonfat moieties is not yet established. The aim of this study was to examine if phytosterols alter the plasma lipoprotein profile when incorporated into nonfat orange juice.



After a 2-week run-in phase with orange juice, 72 mildly hypercholesterolemic healthy subjects were randomized to receive either placebo orange juice (placebo OJ) or plant sterol-fortified orange juice (sterol OJ) (2g/d) for 8 weeks. Fasting blood was obtained at baseline, after 2 weeks of OJ, and after 8 weeks of placebo/sterol-OJ supplementation. Sterol OJ supplementation significantly decreased total (7.2%), LDL (12.4%), and non-high-density lipoprotein (HDL) cholesterol (7.8%) compared with baseline and compared with placebo OJ (P<0.01). Apolipoprotein B levels were significantly decreased (9.5%) with sterol OJ. There were no significant changes in HDL cholesterol or triglycerides with the sterol OJ. While folate and B12 levels significantly increased, homocysteine levels were unchanged.



Orange juice fortified with plant sterols are effective in reducing LDL cholesterol and could easily be incorporated into the therapeutic lifestyle changes dietary regimen.
Concomitant granulocyte colony-stimulating factor and induction chemoradiotherapy in adult acute lymphoblastic leukemia: a randomized phase III trial.

This prospective multicenter study examined whether simultaneous administration of granulocyte colony-stimulating factor (G-CSF; Filgrastim) and induction chemotherapy for adult acute lymphoblastic leukemia (ALL) could prevent treatment-related neutropenia, infections, and resulting treatment delays. Seventy-six patients were randomly assigned to receive either G-CSF (n = 37) or no growth factor (n = 39) in conjunction with a uniform chemotherapy consisting of cyclophosphamide, cytarabine, mercaptopurine, intrathecal methotrexate, and cranial irradiation. The median duration of neutropenia (absolute neutrophil count < 1 x 10(9)/L) during chemotherapy was 8 days in patients receiving C-CSF, compared with 12.5 days in the control group (P < .002). A similar reduction from 11.5 to 7 days was observed in patients with T-ALL receiving additional mediastinal irradiation (P = .13). Infections occurred in 43% and 56% of patients in the G-CSF and control arm, respectively (P = .25); the incidence of nonviral infections was reduced by 50%, from 32 episodes in the control arm to 16 episodes in the G-CSF arm. Prolonged interruptions of chemotherapy administration were less frequent, with delays of 2 weeks or more occurring in only 24% of patients receiving G-CSF as opposed to 46% in the control arm (P = .01). Accordingly, chemotherapy was completed significantly earlier with the use of G-CSF (39 v 44 days, P = .008). With a median follow-up of 20 months, the probability of disease-free survival was 0.45 in the G-CSF group and 0.43 in the control group (P = .34). In conclusion, adult ALL patients appear to benefit by the simultaneous administration of G-CSF with induction chemotherapy because of a significant reduction in the duration of neutropenia, a trend to fewer infections, and a more rapid completion of chemotherapy.