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NCT ID: NCT05670405 Completed - Clinical trials for Psychological Trauma

The Trauma PORTAL Project: a Virtual Asynchronous Treatment for Interpersonal Trauma

Start date: January 16, 2023
Phase: N/A
Study type: Interventional

Virtual delivery of mental health care is an emerging strategy for increasing access and enhancing the delivery of mental health services; however, evidence that virtual interventions are an efficacious form of therapy is limited. An asynchronous virtual treatment program that allows patients to access program material at any time could be a widely accessible, cost-effective alternative to in-person or synchronous virtual group therapy. The Trauma Therapy Program (TTP) at Women's College Hospital (WCH) follows clinical guidelines for the treatment of complex post-traumatic stress disorder that recommend a staged approach to treatment for adults suffering from the sequelae of childhood interpersonal trauma (CIT). The initial stage is safety and stabilization; in TTP, this begins with the Resourced and Resilient (R&R) group, a stage 1 trauma-focused psychoeducational psychotherapy group. Psychoeducational psychotherapy is a widely used approach to help patients understand the impact of trauma, challenge maladaptive behaviour patterns, learn safer coping skills and reduce trauma-related symptoms as part of a comprehensive approach to the treatment of PTSD. To address gaps in equitable access to trauma-focused care, the investigators developed the Trauma PORTAL: Providing Online tRauma Therapy using an Asynchronous Learning platform. The investigators developed an asynchronous virtual multimedia version of R&R consisting of 8 modules, called the Trauma PORTAL; previously called electronic Resourced and Resilient or e-R&R. The investigators then conducted an open-label pilot study where the Trauma PORTAL intervention was offered that included access to the asynchronous virtual modules, along with an optional weekly 1-hour synchronous virtual group that offers patients an opportunity to ask questions about content from the modules. Preliminary data from the investigators' open-label eR&R pilot study demonstrates feasibility, usability, and acceptability, as well as a significant improvement in PTSD symptoms from pre- to post-group. This phase of the Trauma PORTAL project seeks to test the efficacy and further assess the intervention processes, including recruitment, retention, acceptability, and adherence to the Trauma PORTAL intervention through a randomized controlled trial.

NCT ID: NCT05669755 Recruiting - Clinical trials for Cardiovascular Disease

REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

REDEFINE 3
Start date: March 1, 2023
Phase: Phase 3
Study type: Interventional

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

NCT ID: NCT05669599 Active, not recruiting - Obesity Clinical Trials

Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

Start date: January 18, 2023
Phase: Phase 2
Study type: Interventional

The study aims to compare and assess the dose response of 3 selected doses of AMG 133 compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).

NCT ID: NCT05669495 Recruiting - Alzheimer Disease Clinical Trials

ANNE Vital Sign System Remote Sleep Assessment

Start date: November 10, 2022
Phase:
Study type: Observational

Sleep apnea is characterized by temporary pauses or stops to participant's breathing. Currently, sleep apnea is diagnosed using an in-lab sleep study, which involves spending a night in a sleep laboratory hooked up to wires on the head, chest, and legs. However, this is not feasible for many older adults. To overcome this barrier, the investigators will utilize an investigational vital signs monitor - the Advanced NeoNatal Epidermal (ANNE) Vital Sign System (Sibel Health, Evanston, IL,USA). The primary objective of this study is to test the hypothesis that sleep apnea is associated with accelerated cognitive decline in older adults at risk for dementia. The investigators will measure sleep apnea at baseline and 12 months later and relate this to cognitive function at the same time points. Sex-stratification will be used in analyses as appropriate. Qualitative feedback forms will be used to collect information about participant ease of use and experience with the ANNE Vital Sign System.

NCT ID: NCT05669378 Recruiting - Physical Inactivity Clinical Trials

A Good Start Matters Intervention Study

Start date: January 20, 2023
Phase: N/A
Study type: Interventional

The BC government and partners developed Active Play Standards and a capacity-building strategy to help childcare centers implement the Standards. We have developed an intervention to supplement the governmental capacity-building strategies. The intervention is comprised of implementation support strategies targeted at childcare providers in BC that will aid with the sustainment of Active Play best practices at their facilities. The impact of the intervention will be assessed by measuring its impact on a) change in practices with respect to Active Play; and b) improving child-level outcomes (children's physical activity, sedentary behavior, and motor skill competencies). The findings will inform future policies and enhance our understanding of how policy action supported by communication, capacity-building, and sustainment strategies influence the environment of childcare centres.

NCT ID: NCT05668988 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

NCT ID: NCT05668741 Recruiting - Cystic Fibrosis Clinical Trials

A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)

Start date: February 27, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.

NCT ID: NCT05668507 Not yet recruiting - Type1diabetes Clinical Trials

REACHOUT Mental Health Support Mobile App

Start date: May 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effectiveness of participation in a 6-month peer-led mental health support program, delivered via a mobile app (REACHOUT), to adults with type 1 diabetes compared to a wait-list control condition. Participants will connect with a Peer-Supporter (an adult with type 1 diabetes trained in providing mental health support), and have access to the app features including a 24/7 chat room and face-to-face support delivered via virtual happy hours.

NCT ID: NCT05667675 Recruiting - Behavior Problem Clinical Trials

Targeting Child Mental Health and Household Poverty

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Living in poverty has long-lasting negative effects on children's mental health and on their mental health in adulthood. Child poverty is very common, affecting 17% of Canadian children. Many low income families may not be getting all the social benefits they are entitled to receive. Increasingly, there are calls for primary care providers to ask all patients about poverty and to intervene if poverty is identified. However, it is not known if an intervention can improve children's health. This study will test the effect of having a Community Support Worker work with families of children age 2-5 years during a primary care visit to identify unmet financially related social needs (like food, housing or energy insecurity) and help families navigate the social service system. The Community Support Worker will help families complete income tax, apply for benefits and community supports to which they are entitled. The investigators will study the effect on child emotional and behavioural health, parent stress and depression and family income. Results from this study will help health care providers and policy makers understand whether this is an effective way to integrate the health and social service systems to improve child and parent health.

NCT ID: NCT05667493 Recruiting - Clinical trials for Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Start date: November 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.