Intestinal Microbiota: Immunity, Recovery and Metabolic Health
Conditions: Healthy Interventions: Dietary Supplement: Placebo Comparator; Dietary Supplement: Whey protein hydrolysate milk product; Dietary Supplement: Postbiotic and whey protein hydrolysate milk product Sponsors: University of Turku; Government Body Funding Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 9, 2024 Category: Research Source Type: clinical trials

Navigating uncharted territory with a borrowed map: lessons from setting up the BATH-OUT-2 randomised controlled trial in adult social care and housing services in English local authorities
AbstractPopulations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of health and social care. Health research funders are now also prioritising research in adult social care and wider local authority settings, e.g. housing services.Developing the evidence base for adult social care should include implementing randomised controlled trials, where appropriate. Within the UK, the clinical trial is the established road map for evaluating interventions in the National Health Service ...
Source: Trials - March 25, 2024 Category: Research Source Type: clinical trials

Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review
DiscussionWhen deciding the content of a usual care arm, researchers need to understand the context in which a trial will be implemented and what the trial needs to achieve to address its aim and remain ethical. This is a complex decision-making process and trade-offs might need to be made. It also requires research and engagement with stakeholders, and therefore time and funding during the trial ’s design phase.Trial registrationPROSPERO CRD42022307324. (Source: Trials)
Source: Trials - February 12, 2024 Category: Research Source Type: clinical trials

Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9 —Pragmatic Research and Innovation through Multinational Experimentation
AbstractIn an era focused on value-based healthcare, the quality of healthcare and resource allocation should be underpinned by empirical evidence. Pragmatic clinical trials (pRCTs) are essential in this endeavor, providing randomized controlled trial (RCT) insights that encapsulate real-world effects of interventions. The rising popularity of pRCTs can be attributed to their ability to mirror real-world practices, accommodate larger sample sizes, and provide cost advantages over traditional RCTs. By harmonizing efficacy with effectiveness, pRCTs assist decision-makers in prioritizing interventions that have a substantial ...
Source: Trials - January 23, 2024 Category: Research Source Type: clinical trials

Prophylactic Radiotherapy Of MInimally Symptomatic Spinal Disease (PROMISSeD): study protocol for a randomized controlled trial
DiscussionThe results of this RCT will demonstrate the value, if any, of early radiotherapy for high-risk spine metastases. The trial has received IRB approval, funding, and prospective registration (NCT05534321) and has been open to accrual since August 19, 2022. If positive, the trial will expand the scope and utility of spine radiotherapy.Trial registrationClinicalTrials.GovNCT05534321. Registered September 9, 2022.Trial statusVersion 2.0 of the protocol (2021-KOT-002), revised last on September 2, 2022, was approved by the WCG institutional review board (Study Number 1337188, IRB tracking number 20223735). The trial wa...
Source: Trials - January 12, 2024 Category: Research Source Type: clinical trials

A prevention program for binge drinking among students based on mindfulness and implementation intention (ALCOMEDIIT): a randomized controlled trial
This study will include 170 healthy subjects who will be students at the university, alcohol users, with a BD score> 1 in the month preceding the inclusion but not presenting any specific disorder. The trial will be proposed by e-mail and students who meet the inclusion criteria will join either a control group which will benefit from a MI or an experimental group which will additionally benefit from an initiation to MBM with II (initial visit T0). In order to measure the effectiveness of the prevention program in terms of BD decrease, a follow-up at 1 month (T1) as well as a follow-up at 6 months (T6; exploratory) will...
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials

Efficacy of an Online-Based Self-Help Intervention for Auditory Hallucinations in Persons With Psychotic Disorders
Conditions: Psychotic Disorders Interventions: Behavioral: Online-Based Self-Help Intervention Sponsors: Charite University, Berlin, Germany; Elsa-Neumann scholarship of the federal state of Berlin, Doctoral funding.; Charit é - University Medicine Berlin, Medical scientist program. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 1, 2024 Category: Research Source Type: clinical trials

Effects of Rehabilitation Combined With a Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19
Conditions: Post-COVID-19 Syndrome Interventions: Procedure: Rehabilitation + maintenance program; Procedure: Rehabilitation only Sponsors: Sch ön Klinik Berchtesgadener Land; Bavarian State Ministry of Health and Care (Funding); Deutsche Rentenversicherung Bund (German pension insurance) (Design); Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 9, 2023 Category: Research Source Type: clinical trials

Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study
Conditions: Emotional Regulation Interventions: Other: REThink Game; Other: MoodWheel; Other: PsyPills Sponsors: Babes-Bolyai University; The Executive Agency for Higher Education, Research, Development and Innovation Funding Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 17, 2023 Category: Research Source Type: clinical trials

Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in College Students.
Conditions: Emotion Regulation; Stress Interventions: Behavioral: REThink Life Game; Behavioral: PsyPills; Behavioral: MoodWheel Sponsors: Babes-Bolyai University; The Executive Agency for Higher Education, Research, Development and Innovation Funding Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 17, 2023 Category: Research Source Type: clinical trials

Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)
Conditions:   Delirium;   Delirium in Old Age;   Critical Illness;   Intensive Care Unit Delirium Interventions:   Device: EyeControl-Pro;   Other: Control Sponsors:   Beth Israel Deaconess Medical Center;   BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency;   Rabin Medical Center;   Assuta Medical Center;   Eyefree Assisting Communication Ltd Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 8, 2023 Category: Research Source Type: clinical trials

Magnetic Stimulation as a Treatment for Stress Urinary Incontinence
Condition:   Stress Urinary Incontinence Interventions:   Device: Magnetic stimulation;   Device: Sham Magnetic stimulation Sponsors:   Sunnybrook Health Sciences Centre;   Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 19, 2023 Category: Research Source Type: clinical trials