Search results for "Trial registration"

No long-term effect of a 2-days intervention on how to prepare homemade food, on toddlers’ skepticism for new food and intake of fruits and vegetable…

2017

Objective Optimal nutrition from early age reduces the risk of developing non-communicable diseases later in life. The aim of this study was to examine the long-term effect on toddlers’ fruit and vegetable intake and sweet beverages, and skepticism for new food, of a 2-days’ intervention on how to prepare homemade food for toddlers. Results The effect of the cooking intervention was evaluated by a randomized, controlled trial where 110 parents of 4–6 months old infants were included. Child diet and food skepticism were measured at 6, 15 and 24 months of age. There were no differences between the control and intervention group in the consumption of fruits and vegetables and intake of water o…

Long-term effects of a cluster randomized controlled kindergarten-based intervention trial on vegetable intake among Norwegian 3-5-year-olds: the BRA…

2020

AbstractObjectiveTo report on long-term effects of a cluster randomized controlled kindergarten-based intervention trial, which aimed to increase vegetable intake among Norwegian preschool children (3–5 years at baseline). The effects of the intervention at follow-up 1 (immediately post-intervention) have previously been published. This paper presents the effects of the intervention from baseline to follow-up 2 (12 months post-intervention).ResultsParental consents were obtained for 633 out of 1631 eligible children (response rate 38.8%). The effects of the intervention from baseline to follow-up 2 were assessed by mixed-model analyses taking the clustering effect of kindergartens into acco…

2021

Background Physical activity is beneficial for cardiovascular rehabilitation. Digitalization suggests using technology in the promotion of physical activity and lifestyle changes. The effectiveness of distance technology interventions has previously been found to be similar to that of conventional treatment, but the added value of the technology has not been frequently studied. Objective The aim of this pilot study was to investigate whether additional distance technology intervention is more effective in promoting physical activity than non-technology–based treatment in 12 months of cardiac rehabilitation. Methods The cardiovascular disease rehabilitation intervention consisted of three 5…

Everolimus after hepatic arterial embolisation therapy of metastases from gastrointestinal neuroendocrine tumours: The FFCD 1104-EVACEL-GTE phase II …

2019

Abstract Background Hepatic arterial embolisation therapy (HAET) is a treatment of liver metastases of gastrointestinal neuroendocrine tumours (GI-NETs). HAET increases circulating vascular endothelial growth factor levels. Everolimus is a treatment in NETs that may have antiangiogenic activity. Methods This phase II study was conducted in patients with predominant and progressive liver metastases from GI-NETs. Everolimus was initiated 7–30 days after HAET. The hypothesis was that everolimus after HAET would increase hepatic progression-free survival (hPFS) rate at 24 months from 35% to 50%. Results Among the 74 patients included, 88% had small-bowel primary tumour, 43% had grade I and 57% …

Detection of precancerous gastric lesions and gastric cancer through exhaled breath.

2015

Timely detection of gastric cancer (GC) and the related precancerous lesions could provide a tool for decreasing both cancer mortality and incidence.968 breath samples were collected from 484 patients (including 99 with GC) for two different analyses. The first sample was analysed by gas chromatography linked to mass spectrometry (GCMS) while applying t test with multiple corrections (p value0.017); the second by cross-reactive nanoarrays combined with pattern recognition. For the latter, 70% of the samples were randomly selected and used in the training set while the remaining 30% constituted the validation set. The operative link on gastric intestinal metaplasia (OLGIM) assessment staging…

Bicycling to school improves the cardiometabolic risk factor profile:a randomised controlled trial

2012

Objectives To investigate whether bicycling to school improves cardiometabolic risk factor profile and cardiorespiratory fitness among children. Design Prospective, blinded, randomised controlled trial. Setting Single centre study in Odense, Denmark Participants 43 children previously not bicycling to school were randomly allocated to control group (n=20) (ie, no change in lifestyle) or intervention group (ie, bicycling to school) (n=23). Primary and secondary outcome measures Change in cardiometabolic risk factor score and change in cardiorespiratory fitness. Results All participants measured at baseline returned at follow-up. Based upon intention-to-treat (ITT) analyses, clustering of car…

Protocol of a multicenter international randomized controlled manikin study on different protocols of cardiopulmonary resuscitation for laypeople (MA…

2018

IntroductionOut-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR.Methods and analysisThis is a prospective randomise…

Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial

2023

AimTo investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).MethodsProspective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor’s safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tono…

Use of a real-Time training software (Laerdal QCPR®) compared to instructor-based feedback for high-quality chest compressions acquisition in seconda…

2016

High-quality chest compressions are pivotal to improve survival from cardiac arrest. Basic life support training of school students is an international priority. The aim of this trial was to assess the effectiveness of a real-time training software (Laerdal QCPR®) compared to a standard instructor-based feedback for chest compressions acquisition in secondary school students. After an interactive frontal lesson about basic life support and high quality chest compressions, 144 students were randomized to two types of chest compressions training: 1) using Laerdal QCPR® (QCPR group– 72 students) for real-time feedback during chest compressions with the guide of an instructor who considered sof…

Determinants of CAT (COPD Assessment Test) scores in a population of patients with COPD in central and Eastern Europe: The POPE study

2019

Abstract Background The COPD Assessment Test (CAT) has been proposed to help guide therapy in chronic obstructive pulmonary disease (COPD). It is important to understand the distribution of scores in different COPD populations and their determinants. Methods The POPE study is an international, observational cross-sectional study of COPD subjects in 11 Central and Eastern European countries aimed at characterizing COPD phenotypes. Here we report the analysis of CAT scores with the objective of identifying their determinants, evaluating symptom load and investigating the distribution of scores among the participating countries. Additionally, we investigated the discrepancies between the CAT a…