Search results for "Randomized"
showing 10 items of 2323 documents
Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations.
2021
Over the past 2 decades, chronic total occlusion (CTO) percutaneous coronary intervention has developed into its own subspecialty of interventional cardiology. Dedicated terminology, techniques, devices, courses, and training programs have enabled progressive advancements. However, only a few randomized trials have been performed to evaluate the safety and efficacy of CTO percutaneous coronary intervention. Moreover, several published observational studies have shown conflicting data. Part of the paucity of clinical data stems from the fact that prior studies have been suboptimally designed and performed. The absence of standardized end points and the discrepancy in definitions also prevent…
Who makes it all the way? Participants vs. decliners, and completers vs. drop-outs, in a 6-month exercise trial during cancer treatment : Results fro…
2022
Abstract Purpose To compare sociodemographic, health- and exercise-related characteristics of participants vs. decliners, and completers vs. drop-outs, in an exercise intervention trial during cancer treatment. Methods Patients with newly diagnosed breast, prostate, or colorectal cancer were invited to participate in a 6-month exercise intervention. Background data for all respondents (n = 2051) were collected at baseline by questionnaire and medical records. Additional data were collected using an extended questionnaire, physical activity monitors, and fitness testing for trial participants (n = 577). Moreover, a sub-group of decliners (n = 436) consented to additional data collection by a…
Cancer in the older person.
2005
Cancer in the older person is an increasingly common problem, due to the progressive prolongation of the life-expectancy of the Western population. This article reviews the mechanisms associating aging and cancer, age-related changes in cancer biology, assessment of the older person to estimate life-expectancy, treatment tolerance, and medical and social conditions that may interfere with cancer treatment, effectiveness of cancer prevention and cancer treatment in older individuals. A comprehensive geriatric assessment (CGA) is commonly used to predict life-expectancy and functional reserve and to unearth conditions that may jeopardize cancer prevention and treatment. In the interest of cos…
Long-term effect of faecal occult blood screening on incidence and mortality from colorectal cancer
2014
Abstract Background Several randomized trials have shown a reduction of colorectal cancer mortality by screening using guaiac-based faecal occult blood tests. However, little is known on the long-term effect of screening at the population level in everyday practice. Methods Small-sized geographic areas including a total of 91,199 individuals were allocated to either biennal screening using the Hemoccult-II test or no screening. The expected mortality and incidence in the cohort invited to screening was determined using mortality and incidence in the non-screened population. Results Colorectal cancer mortality was significantly lower in the population invited to screening than in the non-scr…
Is rectal disimpact always necessary in children with chronic constipation? Evaluation with pelvic ultrasound
2010
PURPOSE: The aim of study was to evaluate if pelvic ultrasound can be useful in managing children with chronic idiopathic constipation. METHODS: A total of 270 children with idiopathic chronic constipation were enrolled in the study. At baseline and at monthly checkups children were evaluated by clinical score and pelvic ultrasound (US). Patients have been divided in 2 groups, based on pelvic US results: group A with a rectal diameter >3 cm, group B with a rectal diameter <3 cm or rectum not visualized. Both groups were subsequently randomly divided in two subgroups (A1, A2, B1, B2) on the basis of the prescribed treatment (disimpaction for the first week and daily laxative or only daily la…
Effects of Home-Based Physical Exercise on Days at Home, Health Care Utilization, and Functional Independence Among Patients With Hip Fractures: A Ra…
2021
Abstract Objective To evaluate the effects of a physical exercise program on days lived at home, the use and costs of health care and social services, mortality, and functional independence among patients with hip fractures. Design Randomized controlled trial with a parallel 2-group design consisting of a 12-month intervention and 12-month registry follow-up. Setting Home-based intervention. Participants Patients aged ≥60 years (N=121) with operated hip fracture and who were living at home were randomized into physical exercise (n=61) and usual care (n=60) groups. Interventions Supervised physical exercise twice a week. Main Outcome Measures The primary outcome was the number of days lived …
Is Overall Mortality the Right Composite Endpoint in Clinical Trials of Acute Respiratory Distress Syndrome?
2018
Objectives Overall mortality in patients with acute respiratory distress syndrome is a composite endpoint because it includes death from multiple causes. In most acute respiratory distress syndrome trials, it is unknown whether reported deaths are due to acute respiratory distress syndrome or the underlying disease, unrelated to the specific intervention tested. We investigated the causes of death after contracting acute respiratory distress syndrome in a large cohort. Design A secondary analysis from three prospective, multicenter, observational studies. Setting A network of multidisciplinary ICUs. Patients We studied 778 patients with moderate-to-severe acute respiratory distress syndrome…
Serial 2-Point Ultrasonography Plus D-Dimer vs Whole-Leg Color-Coded Doppler Ultrasonography for Diagnosing Suspected Symptomatic Deep Vein Thrombosis
2008
Context Patients with suspected deep vein thrombosis ( DVT) of the lower extremities are usually investigated with ultrasonography either by the proximal veins ( 2-point ultrasonography) or the entire deep vein system ( whole- leg ultrasonography). The latter approach is thought to be better based on its ability to detect isolated calf vein thrombosis; however, it requires skilled operators and is mainly available only during working hours. No randomized comparisons are yet available evaluating the relative values of these 2 strategies. Objective To assess if the 2 diagnostic strategies are equivalent for the management of symptomatic outpatients with suspected DVT of the lower extremities.…
Reduction in the Incidence of Type 2 Diabetes With the Mediterranean Diet
2010
OBJECTIVE To test the effects of two Mediterranean diet (MedDiet) interventions versus a low-fat diet on incidence of diabetes. RESEARCH DESIGN AND METHODS This was a three-arm randomized trial in 418 nondiabetic subjects aged 55–80 years recruited in one center (PREDIMED-Reus, northeastern Spain) of the Prevención con Dieta Mediterránea [PREDIMED] study, a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk. Participants were randomly assigned to education on a low-fat diet (control group) or to one of two MedDiets, supplemented with either free virgin olive oil (1 liter/week) or nuts (30 g/day). Diets were ad libitum, and no…
Treatment of Duchenne muscular dystrophy with ciclosporin A: a randomised, double-blind, placebo-controlled multicentre trial.
2010
Summary Background Duchenne muscular dystrophy is a rare X-linked progressive disease characterised by loss of ambulation at about age 10 years, with death in early adulthood due to respiratory and cardiac insufficiency. Steroids are effective at slowing the progression of muscle weakness; however, their use is limited by side-effects, prompting the search for alternatives. We assessed the effect of ciclosporin A as monotherapy and in combination with intermittent prednisone for the treatment of ambulant patients with this disorder. Methods Our study was a parallel-group, placebo-controlled, double-blind, multicentre trial at trial sites of the German muscular dystrophy network, MD-NET, ove…