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NCT ID: NCT03527914 Completed - Mental Health Clinical Trials

Patient Generated Goals in Mental Health: Better Outcomes?

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

Researchers believe that clinical care can be improved by engaging patients and families directly in planning the care process. Engagement efforts have included asking patients/families to provide information about whether they are getting better. But what does "getting better" mean? The merits of surveys, questionnaires, or rating scales have been widely discussed. Should they be disorder-specific or global? What should the investigators do if patients have difficulty reading or understanding these instruments? Investigators in the United Kingdom have proposed a simple solution: ask the patients and families what their primary goal treatment goal is and track progress together on that goal (Goal-Based Outcomes or GBO). Although there has been some work to suggest that this is helpful, it has never been tested in a controlled way. This study will do a randomized controlled trial to test whether GBO improves clinical care in child and youth mental health. Although the study will use this in child and youth mental health care, if it is successful, it can be tested and applied in any care setting with any type of medical problem. This could change practice at the Children's Hospital of Eastern Ontario (CHEO) and throughout Canada.

NCT ID: NCT03527446 Completed - Obesity Clinical Trials

Acute and Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study

i-FLEX
Start date: July 3, 2018
Phase: N/A
Study type: Interventional

Regular exercise is a cornerstone in the prevention and the management of cardio-metabolic risk factors. Some of the beneficial effect of exercise training occurs through metabolic flexibility' enhancement. Metabolic flexibility is the ability to respond or adapt to conditional changes in metabolic demand, and previous literature has shown that individuals living with obesity have an impaired metabolic flexibility compared to lean individuals. However, there is a lack of empirical evidence on the impact of sprint interval training on metabolic flexibility and whether this translates into clinically meaningful outcomes. This study will evaluate the impact of 4-week sprint interval training in normal weight individuals as well as individuals living with obesity on acute and chronic metabolic flexibility, irisin secretion and insulin sensitivity.

NCT ID: NCT03527394 Completed - Pediatric Obesity Clinical Trials

Motivation to Change Lifestyle Habits in Youth With Obesity

RMI-Family
Start date: November 6, 2017
Phase:
Study type: Observational

Approximately one-third of Canadian children have excess weight, putting them at increased risk of type 2 diabetes, cardiovascular disease, bone and joint problems, and some forms of cancer. Because current therapies for managing obesity have modest success, there is a need to develop and test innovative strategies to enhance pediatric weight management. Using a novel interview designed to measure motivation to change lifestyle habits, interviewers will conduct separate and structured 1-on-1 interviews with youth with obesity and parents. By applying principles of motivational interviewing, trained interviewers will ask youth and their parents about their motivation to change lifestyle habits related to diet and physical activity. Subsequently, interview data will be used to examine predictors of clinically-meaningful outcomes over time, including changes in weight status, lifestyle habits, health care utilization, and attrition. The investigators will also measure a number of variables related to weight management, including dietary intake, physical activity, anthropometry, and psychosocial health.

NCT ID: NCT03526861 Completed - Atopic Dermatitis Clinical Trials

Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

Start date: June 19, 2018
Phase: Phase 3
Study type: Interventional

Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

NCT ID: NCT03526523 Completed - Depressive Symptoms Clinical Trials

Testing the Efficacy of Mindfulness-based Stress Reduction in the Prevention of Perimenopausal Depression

Start date: July 5, 2018
Phase: N/A
Study type: Interventional

Depression is the leading cause of disability worldwide and a risk factor for other diseases. While women are at elevated risk for depression in general, the menopause transition is a particularly vulnerable time for many women, with the risk for depression increasing 2-4 fold. The objective of this research study is to determine whether mindfulness-based stress reduction (MBSR), an 8-week structured intervention involving meditation and yoga, has any beneficial mood effects for women undergoing this vulnerable time.

NCT ID: NCT03525613 Completed - Geographic Atrophy Clinical Trials

A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration

Start date: August 31, 2018
Phase: Phase 3
Study type: Interventional

This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

NCT ID: NCT03525600 Completed - Geographic Atrophy Clinical Trials

Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration

Start date: August 31, 2018
Phase: Phase 3
Study type: Interventional

This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

NCT ID: NCT03525574 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

NCT ID: NCT03525444 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

NCT ID: NCT03525379 Completed - Clinical trials for Congestive Heart Failure Chronic

Evaluating the Clinical Efficacy of Resveratrol in Improving Metabolic and Skeletal Muscle Function in Patients With Heart Failure

REV-HF
Start date: October 26, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled trial evaluating the effect of resveratrol on metabolic and skeletal muscle function. Patients will be randomized and allocated to either resveratrol or placebo, for 8 weeks with a 2-week run-in period before the intervention period (to ensure they are not on any nutritional supplement that contains resveratrol).