Search results for "Standard"
showing 10 items of 3299 documents
Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum
2019
Abstract: Lifestyle modification is the foundation of treatment recommendations for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The design of clinical trials in NASH may be impeded by the lack of a systematic approach to identify and evaluate how lifestyle changes and/or modifications influence clinical trial outcomes and associated endpoints. Furthermore, there are additional uncertainties regarding the methods that can be utilised to better characterise and quantify lifestyle variables - which can influence disease activity and alter trial endpoints - to allow for comparisons of trial outcomes across different phases of research and/or within drug-c…
A new principle to normalize plasma concentrations allowing single-sample clearance determinations in both children and adults.
1992
A sufficiently accurate quantification of renal function requiring only one plasma sample without an additional gamma-camera study has, until now, only been possible in adults. A new principle will be presented here allowing the universal application of known algorithms, regardless of the clearance substance used, by normalizing the plasma concentrations with respect to the individual body dimensions of the patients - for infants as well as for adults. In this respect, algorithms are developed for clearance determinations using technetium-99m mercaptoacetyltriglycine (99mTc-MAG3), which are based on steady-state studies as the reference. They allow the calculation of quantitative clearance …
Within subject variability of HDL-cholesterol in HIV-infected patients
2019
Background and objective: Within-subject variability of cardiovascular risk factors may influence the development of cardiovascular disease. We aimed to improve knowledge on HDL-cholesterol variability and its clinical significance in HIV-infected patients, a population at high risk of cardiovascular disease.Methods: This was a cohort study to quantify the variability of HDL-cholesterol between two consecutive visits and to determine factors associated with such variability, in a group of HIV-infected patients.Results: A total of 307 patients were included, mean ± standard deviation of their age was 45.1 ± 8.5 years, and 225 of them (73.3%) were male. The absolute difference (after squaring…
United States and European Multicenter Prospective Study for the Analytical Performance and Clinical Validation of a Novel Sensitive Fully Automated …
2016
Abstract BACKGROUND The objective of this study is the validation and proof of clinical relevance of a novel electrochemiluminescence immunoassay (ECLIA) for the determination of serum calcitonin (CT) in patients with medullary thyroid carcinoma (MTC) and in different diseases of the thyroid and of calcium homeostasis. METHODS This was a multicenter prospective study on basal serum CT concentrations performed in 9 US and European referral institutions. In addition, stimulated CT concentrations were measured in 50 healthy volunteers after intravenous calcium administration (2.5 mg/kg bodyweight). RESULTS In total, 1929 patients and healthy controls were included. Limits of blank, detection, …
Participation in adjuvant clinical breast cancer trials: does study participation improve survival compared to guideline adherent adjuvant treatment?…
2012
Abstract Adjuvant clinical trials (CTs) usually compare a standard treatment regime versus an innovative new substance or regimen. Participation in CT however, is available for only few patients and exclusion criteria are usually very strict. Therefore we used an unselected patient cohort to investigate the following questions: (1) Is participation in adjuvant CT associated with improved survival in breast cancer (BC)? (2) What is the impact of guideline conform therapy on survival in BC compared to that of participants in CT? Does guideline-conform adjuvant treatment provide an equal impact? Material and methods This German retrospective multi-centre cohort study included 9433 patients wit…
Possible misclassification of cardiovascular risk by SCORE in antisynthetase syndrome: results of the pilot multicenter study RI.CAR.D.A
2020
Abstract Objectives To test the ability of an established traditional cardiovascular (CV) risk prediction score [Systematic COronary Risk Evaluation (SCORE)] and its EULAR modified version (mSCORE) to identify antisynthetase syndrome (ASyS) patients at high CV risk and to examine for the first time associations of CV and cerebrovascular surrogate markers with clinical and immunological ASyS parameters. Methods SCORE/mSCORE and the gold standard marker of aortic stiffness [carotid-femoral pulse wave velocity (cfPWV)] were examined in ASyS patients and healthy controls. Moreover, sonography of the common- (CCA) and internal- (ICA) carotid arteries was performed in subsets of both groups, eval…
New spectrophotometric procedure for determining cefotaxime based on derivatization with 1,2-naphthoquinone-4-sulphonate into solid-phase extraction …
1998
Cefotaxime was derivatised with 1,2-naphthoquinone-4-sulphonate (NQS), extracted into solid-phase cartridges (C18) and detected using a UV-visible detection system. Optimum conditions for this new procedure were: hydrogencarbonate-carbonate buffer, pH 10.5, 5-min reaction time at 25 degrees C and an NQS concentration of 7.1x10(-3) mol l(-1). The accuracy and the precision of the liquid-solid procedure were tested. The procedure was used to measure cefotaxime in pharmaceutical and urine samples. The results obtained were contrasted with those reported for a HPLC method for urine samples. The generalized H-point standard additions method was used to measure cefotaxime in urine samples.
Prevalence of Atrophic Gastritis in Kazakhstan and the Accuracy of Pepsinogen Tests to Detect Gastric Mucosal Atrophy
2019
Background Atrophic gastritis is considered precursor condition for gastric cancer. There is so far limited evidence on the performance of pepsinogens for atrophy detection in Central Asia. The aim of our study was to detect the prevalence of atrophic gastritis in the asymptomatic adult population in Kazakhstan as well as address the accuracy of pepsinogen testing in atrophy detection. Methods Healthy individuals aged 40-64 were included. Upper endoscopy and pepsinogens (PG) evaluation were performed. PG were analysed in plasma by latex agglutination. Cut off values were used to define decreased PG values (PGR ≤ 3 and PG I ≤ 70 ng/mL); severely decreased PG values (PGR ≤ 2 and PG I ≤ 30 ng/…
Prevention of ischemic-type biliary lesions by arterial back-table pressure perfusion
2003
Abstract Ischemic-type biliary lesions (ITBLs) lead to considerable morbidity after orthotopic liver transplantation (OLT). The exact pathogenesis is unknown. We tested the hypothesis that insufficient perfusion of biliary arterial vessels might be responsible for ITBLs. This could be prevented by improved perfusion techniques. Since February 2000, we performed a controlled study using arterial back-table pressure perfusion (AP) to achieve reliable perfusion of the biliary-tract capillary system, which may be impaired by the high viscosity of University of Wisconsin solution. We retrospectively analyzed 190 OLTs performed between September 1997 and July 2002 with regard to ITBLs. One hundre…
Intra‐ and interreader reproducibility of PI‐RADSv2: A multireader study
2018
Background The Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) has been in use since 2015; while interreader reproducibility has been studied, there has been a paucity of studies investigating the intrareader reproducibility of PI-RADSv2. Purpose To evaluate both intra- and interreader reproducibility of PI-RADSv2 in the assessment of intraprostatic lesions using multiparametric magnetic resonance imaging (mpMRI). Study type Retrospective. Population/subjects In all, 102 consecutive biopsy-naive patients who underwent prostate MRI and subsequent MR/transrectal ultrasonography (MR/TRUS)-guided biopsy. Field strength/sequences Prostate mpMRI at 3T using endorectal with phased…