Search results for "trials"
showing 10 items of 966 documents
Session 2: Are we ready for primary chemotherapy in rectal cancer: who, when, why?
2018
The potential of preoperative chemotherapy in rectal cancer is the subject of investigation in a number of global randomized trials. In this overview and expert discussion, Professor Cervantes summarizes the findings of numerous Phase II trials testing neoadjuvant chemotherapy. The crucial points in the next phase of trials include: patient selection, whether radiotherapy can be omitted altogether and whether chemotherapy can be used to augment the initial response to chemoradiotherapy. Finally, with the emergence of Magnetic Resonance Tumour Regression Grade a reliable method for assessing response after initial chemoradiotherapy, we ask if this can be used to drive the use of further sele…
Polyphenol intake and cardiovascular risk factors in a population with type 2 diabetes: The TOSCA.IT study
2017
Background: The role of polyphenol intake on cardiovascular risk factors is little explored, particularly in people with diabetes. Aim: To evaluate the association between the intake of total polyphenols and polyphenol classes with the major cardiovascular risk factors in a population with type 2 diabetes. Methods: Dietary habits were investigated in 2573 males and females participants of the TOSCA.IT study. The European Prospective Investigation on Cancer and Nutrition (EPIC) questionnaire was used to assess dietary habits. In all participants, among others, we assessed anthropometry, plasma lipids, blood pressure, C-reactive protein and HbA1c following a standard protocol. The USDA and Ph…
Sample size planning of two-arm superiority and noninferiority survival studies with discrete follow-up
2016
In clinical trials using lifetime as primary outcome variable, it is more the rule than the exception that even for patients who are failing in the course of the study, survival time does not become known exactly since follow-up takes place according to a restricted schedule with fixed, possibly long intervals between successive visits. In practice, the discreteness of the data obtained under such circumstances is plainly ignored both in data analysis and in sample size planning of survival time studies. As a framework for analyzing the impact of making no difference between continuous and discrete recording of failure times, we use a scenario in which the partially observed times are assig…
Mediterranean Diet Decreases the Initiation of Use of Vitamin K Epoxide Reductase Inhibitors and Their Associated Cardiovascular Risk: A Randomized C…
2020
Our aim is to assess whether following a Mediterranean Diet (MedDiet) decreases the risk of initiating antithrombotic therapies and the cardiovascular risk associated with its use in older individuals at high cardiovascular risk. We evaluate whether participants of the PREvenció
Influence of lifestyle factors and staple foods from the Mediterranean diet on non-alcoholic fatty liver disease among older individuals with metabol…
2020
Objective: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver morbidity. This condition often is accompanied by obesity, diabetes, and metabolic syndrome (MetS). The aim of this study was to evaluate the connection between lifestyle factors and NAFLD in individuals with MetS. Methods: A cross-sectional study with 328 participants (55-75 y of age) diagnosed with MetS participating in the PREDIMED-Plus trial was conducted. NAFLD status was evaluated using the non-invasive hepatic steatosis index (HSI). Sociodemographic, clinical, and dietary data were collected. Adherence to the Mediterranean diet (mainly assessed by the consumption of olive oil, nuts, legumes…
Improve hip fracture outcome in the elderly patient (iHOPE) : A study protocol for a pragmatic, multicentre randomised controlled trial to test the e…
2018
IntroductionHip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.Methods and analysisThe iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner aft…
Treatment of irritable bowel syndrome with probiotics. An etiopathogenic approach at last?
2009
Irritable bowel syndrome (IBS) is the most common functional digestive disorder, and may affect 11-20% of the adult population in industrialized countries. In accordance with Rome III criteria (2006) IBS involves abdominal pain and bowel habit disturbance, which are not explained by structural or biochemical abnormalities. Several hypotheses attempt to account for the pathophysiology of IBS, but the etiology still remains uncertain or obscure, perhaps multifactorial. Abnormalities in colonic microflora have recently been suggested in such patients, as has abnormal small-intestine bacterial overgrowth (SIBO), or in particular a significant reduction in the amount of intraluminal Bifidobacter…
Use of oral anticoagulant drugs in older patients with atrial fibrillation in internal medicine wards
2018
no abstract available
Treating eating disorders in the real world — MaiStep: A skill-based universal prevention for schools
2019
Eating disorders are difficult to treat and often associated with morbidity and mortality. Universal prevention approaches are increasingly focusing on enhancing skills, but few eating disorder programs are available for under-15-year-olds. This study aimed to develop and examine a school-based universal prevention program ('MaiStep') for adolescent boys and girls. A three-arm randomized controlled trial with baseline, post-intervention and 12-month follow-up was conducted with 1654 adolescents (M = 13.35, SD 0.76). 'MaiStep' was delivered by psychologists in the first intervention group (IG1) and teachers in the second intervention group (IG2), and compared to an active control group (ACG)…
[Macrolides in the treatment of children with Mediterranean spotted fever].
2002
Till now there is not a gold standard therapy for Mediterranean spotted fever (MSF) in children. Standard treatment for MSF is the administration of tetracycline or chloramphenicol, however both these drugs can cause significant adverse effects in children (tetracyclines can cause staining of teeth, chloramphenicol severe hematological adverse events such as aplastic anemia, gray baby syndrome and hemolytic anemia in patients with the Mediterranean form of G6PD deficiency). We conducted two randomized clinical trials; the first compared clarithromycin versus chloramphenicol: mean time to defervescence was 36.7 +/- 18.1 h in the clarithromycin group and 47.1+/- 21.9 h in the chloramphenicol …