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NCT ID: NCT05125809 Active, not recruiting - Clinical trials for Osteogenesis Imperfecta

Study to Assess Dose, Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta

Orbit
Start date: February 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.

NCT ID: NCT05125510 Active, not recruiting - Covid19 Clinical Trials

The Canadian COVID-19 Prospective Cohort Study

CANCOV
Start date: June 17, 2020
Phase:
Study type: Observational

The CANCOV study will be the first Canadian study to provide a comprehensive evaluation of early, and 1-year, outcomes of outpatient and hospitalized COVID-19 survivors and their family caregivers, their varied trajectories and associated clinical risk factors. The overall objectives are to determine short- (in hospital) and longer-term (1, 3, 6 and 12 months post-acute hospital discharge) outcomes COVID-19+ patients across the spectrum of symptom severity, including outpatients and inpatients from GIM and ICU wards and their caregivers, and the clinical, sociodemographic, multi-omic predictors of these outcomes. By leveraging expertise from investigators across disciplines and divisions, this study presents a suite of complementary projects that explore the genetic, transcriptomic, epigenomic and immunologic evaluation of COVID-19 infection across the illness and recovery trajectory during the acute illness and in the context of multidimensional long-term outcomes. As there continues to be need for longer term follow up and research on Long-COVID, this study has added an optional extension to include 2-year, 3-year, 4-year and 5 year outcomes.

NCT ID: NCT05124639 Active, not recruiting - Clinical trials for Generalized Anxiety Disorder

Clinical Trial of a Group Self-management Support Program for Anxiety Disorders

Start date: October 6, 2022
Phase: N/A
Study type: Interventional

Background. Self-management support is a complementary approach to treatment that aims to educate participants on the nature of anxiety and to improve their strategies to manage symptoms and well-being, thus presenting the potential to enhance recovery, improve outcomes, reduce recurrence rates and lower health care costs. There is limited evidence to support the effectiveness of group self-management support for anxiety disorders in community-based care. Objectives. This study aims at examining the effectiveness of a virtual group self-management support program (SMS) for anxiety disorders as an add-on to treatment-as-usual (TAU) in community-based care settings. We will also assess the incremental cost/effectiveness ratio and the implementability of the intervention. Methods. The trial is a pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. Intervention. The experimental condition will consist of a 10-week SMS program for anxiety disorders in addition to TAU. The control condition will receive TAU without restrictions for anxiety disorders. Inclusion criteria will comprise being 18 years old or older, French-speaking, and presenting symptoms of anxiety disorders based on self-reported validated assessment scales. Patients will be recruited in the province of Quebec (Canada). Outcome measures: The primary outcome measure is the Beck Anxiety Inventory (BAI). The secondary outcome measures include self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation. Statistical analysis: Intention-to-treat analysis. A mixed effects regression model will be used to account for between and within-subject variations in the analysis of the longitudinal effects of the intervention. Expected outcomes. The rigorous evaluation of the SMS intervention in the real world will provide information to decision makers, health care managers, clinicians and patients regarding the added value of group SMS for patients with anxiety disorders. Widespread implementation of this intervention could lead to more efficient mental health care services, to better long-term outcomes and to a significant reduction in the extensive social and economic burden of anxiety disorders.

NCT ID: NCT05121194 Active, not recruiting - Clinical trials for Cognitive Behaviour Therapy

Evaluation of Virtual CBTm for Public Safety Personnel

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

The principal aim of this study is to evaluate whether virtual CBTm is effective in improving mental wellness among public safety personnel (PSP). The investigators have adapted the CBTm classes to two virtual formats: 1) a facilitator-led set of virtual CBTm classes, and 2) an online self-guided version of the program. Primary Objective: Can virtual CBTm increase resiliency among PSP? Secondary Objectives: i. Does virtual CBTm improve clinical symptoms of mental and substance use disorders (e.g., depression, anxiety, PTSD, alcohol abuse) among PSP? ii. Does virtual CBTm improve self-perceived health-related quality of life among PSP? iii. Does virtual CBTm reduce burnout among PSP? Evaluation of all primary and secondary objectives will focus on clinically significant improvement in scores on well-validated measures. Steps to evaluate these objectives will include: 1) Recruit a cohort of PSP; 2) Assess baseline levels of resiliency, mental health symptoms, substance use, level of burnout, and current health-related quality of life; 3) Randomize individuals to one of two intervention arms or a waitlist control group; 4) Deliver CBTm in 2 different virtual formats; 5) Evaluate whether scores over time are significantly improved among individuals in each of the virtual CBTm groups compared with the waitlist control group. Comparisons of similarities and differences between the two intervention arms will also be conducted, particularly in terms of feasibility, acceptability, and facilitators/barriers of the virtual format for participants. The investigators will identify the demographic/symptom profiles of those who benefit most from each virtual-based CBTm.

NCT ID: NCT05116189 Active, not recruiting - Ovarian Cancer Clinical Trials

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)

Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

NCT ID: NCT05115903 Active, not recruiting - Clinical trials for Axial Spondyloarthritis

Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

BIOTAPE
Start date: December 1, 2021
Phase: Phase 4
Study type: Interventional

Current evidence on tapering of tumor necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) is still hampered by heterogeneity in tapering regimens, selection and performance biases, and lack of data on optimized treatment dosing strategies especially in real-world clinical settings. This study aims to contribute to the ongoing investigation of disease-activity-guided tapering of TNFi in axSpA in the form of a prospective, randomized controlled trial.

NCT ID: NCT05115422 Active, not recruiting - Cancer Clinical Trials

Feasibility and Acceptability of a Virtual 'Coping With Brain Fog' Intervention for Young Adults With Cancer

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Cancer-related cognitive problems, also known as "brain fog", have a significant impact on patients with cancer and cancer survivors. Previous studies indicate that cancer and cancer treatments can negatively affect memory, attention and thinking abilities. Adolescents and young adults (AYAs) are individuals with a cancer diagnosis, who are currently between 18 to 40 years old. These individuals are especially vulnerable to brain fog symptoms due to the effect these symptoms have on their education, employment, health behaviors, mental health, and social relationships. There is a clear need for programming directed at brain fog symptoms among AYAs with cancer diagnoses. The 'Coping with Brain Fog' program, developed by Maximum Capacity Inc., is an eight-week group program that has been designed to educate patients about their brain fog symptoms and develop strategies to manage these symptoms. In this study the investigators will aim to determine the feasibility of adapting the 'Coping with Brain Fog' program to the virtual setting for AYAs with cancer during the COVID-19 pandemic. The investigators will also aim to explore the efficacy of the program on cognitive functioning and symptoms of anxiety, depression and fatigue. This study is an important step towards finding ways to treat brain fog symptoms in cancer patients, and could help guide future studies and programs.

NCT ID: NCT05115032 Active, not recruiting - Dizziness Clinical Trials

Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

Start date: January 17, 2022
Phase: N/A
Study type: Interventional

People that have difficulty with balance have a higher risk of falling and reduced quality of life. Some individuals can learn to compensate using their vision, their sense of where their limbs are in space, and balance organs that are still intact. Rehabilitation exercises, which typically involve shaking and nodding of the head, are often prescribed for dizzy patients but are not effective for everyone. Our study aims to determine if specific exercises performed on footplate sensors with visual feedback is superior to traditional rehabilitation exercises done at home for improving balance and quality of life.

NCT ID: NCT05113251 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

Start date: October 25, 2021
Phase: Phase 3
Study type: Interventional

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

NCT ID: NCT05110456 Active, not recruiting - Clinical trials for Depression, Postpartum

To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk

Start date: November 9, 2021
Phase: N/A
Study type: Interventional

Women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. To prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in Quebec. The Parents & Babies program, which is a distance learning course, followed during pregnancy and accompanied by telephone follow-up, aims to improve the mental health of future parents.The investigators seek to evaluate the effect of the intervention of the Parents & Babies program offered with telephone support compared to the course offered without telephone follow-up.