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NCT ID: NCT05263934 Recruiting - Clinical trials for Eosinophilic Granulomatosis With Polyangiitis

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)

OCEAN
Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.

NCT ID: NCT05263206 Recruiting - Pruritus Clinical Trials

Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)

Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design may be adapted based on the results of Study A. For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale [WI-NRS ≥7) will enter a 4-week run-in period during with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks (Study A) or 12 weeks (Study B) with either dupilumab or matching placebo in addition to their antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.

NCT ID: NCT05262127 Recruiting - PTSD Clinical Trials

Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing

Flash-EMDR
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

To assess the Flash version of EMDR in reductions of the disturbance of upsetting memories at post-intervention, and 1-month follow up within a double-blinded, online 2-arm randomized controlled trial (RCT) with self-report outcomes. We will assess 45 per group, adequate for the detection of a medium effect size. This double-blinded, RCT will assess the comparative efficacy of these two online interventions designed to reduce memory disturbance.

NCT ID: NCT05261906 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

The FreeStyle Libre Enabled Reduction of A1c Through Effective Eating and Exercise Study

LIBERATE
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

This two-year multisite, real-world, before-after prospective six-month pilot study utilizing a single-group cohort design (n=184) which will first occur in London, Ontario (n=92) through the St. Joseph's Primary Care for Diabetes Support (PCDSP) program. To test fidelity, the intervention will be delivered again in Hamilton, Ontario through the Hamilton Health Sciences' Boris Clinic in Diabetes Care and Research Program (n=92). Participants will begin by attending the first class at the PCDSP clinic to complete baseline fitness testing as well as receive/set up their wearable technology (FitBit Inspire 2™ and FreeStyle® Libre sensors). Two weeks of baseline data collection will following (glucose values and step counts). Five bi-weekly, followed by three monthly, one-hour videoconferencing group education classes via Microsoft Teams video platform will be offered. Participants will be given the choice to communicate with the LIBERATE clinical team (exercise specialist, physician, and/or registered) weekly between the group classes using their preferred method of communication i.e., email. Classes will offer FreeStyle® Libre-assisted behavioural coaching (i.e., nutrition and exercise). FreeStyle® Libres will be used during the first three months of the program and optionally in the last three months of the intervention. The FitBit Inspire 2™ monitors will be worn for six months. Participants are provided the option to receive individualized aerobic and resistance training prescriptions. The primary outcome is change in glycated hemoglobin. A main goal of this study is to create a "toolkit" for other Canadian Diabetes Management centres (DMCs) to use in the future.

NCT ID: NCT05261399 Recruiting - Carcinoma Clinical Trials

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

SAFFRON
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.

NCT ID: NCT05261321 Recruiting - Healthy Clinical Trials

Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure

CAPU RISE
Start date: October 15, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this Phase I non-therapeutic trial is to examine the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis users. We expect differences between high ratio CBD:THC cannabis oil, low ratio CBD:THC cannabis oil, and/or placebo on outcome measures.

NCT ID: NCT05259943 Recruiting - Clinical trials for Major Depressive Disorder

Microdosing Psychedelics to Improve Mood

Start date: July 15, 2023
Phase: Phase 2
Study type: Interventional

This trial aims to examine the safety and efficacy of small (2mg) sub-hallucinogenic doses of psilocybin in people with Major Depressive Disorder.

NCT ID: NCT05258578 Recruiting - Obesity Clinical Trials

Tele-BARICARE to Manage COVID-19-Related Distress

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

Background: Over 60% of Canadians are overweight or obese and more than half have a history of a mental illness. The COVID-19 pandemic has made it difficult for people living with obesity to manage their weight even after undergoing bariatric surgery. These difficulties in combination with the stress of the pandemic can cause significant declines in mental health and well-being. Psychotherapy ("talk therapy") has been shown to be effective in helping to reduce mental health and disordered eating symptoms in patients managing obesity; however, there is limited data in the context of COVID-19. Objective: This study will examine whether providing a convenient and accessible telephone-based psychotherapy during and potentially after the COVID-19 pandemic will lead to better mental health and disordered eating-related outcomes in patients managing obesity after weight loss surgery. Hypothesis: Relative to the control group, those receiving psychotherapy will have lower mental health distress and eating disorder symptoms. Methods: Participants recruited from 4 weight loss surgery programs across Ontario will be randomly assigned to one of two groups: 1) Control (7 weekly non-structured check-in emails and access to online COVID-19 related mental health resources) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy [a type of "talk therapy"] intervention focused on developing coping skills and specifically designed for weight loss surgery patients). Participants will complete measures of mental health distress, eating behaviours and a psychological distress scale prior to and immediately following the intervention. Implications: If Tele-CBT is found to improve post-pandemic mental health distress and eating behaviours, it could be routinely offered to patients with other chronic medical conditions as a resource to help manage psychological distress and mental health concerns emerging during and after the COVID-19 pandemic.

NCT ID: NCT05258292 Recruiting - Type1diabetes Clinical Trials

Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes

GLYMETY
Start date: May 2, 2022
Phase:
Study type: Observational

In clinical practice, women living with type 1 diabetes frequently report that insulin requirements change across the menstrual cycle. Consequently, glycemic fluctuations are observed. This phenomenon could be explained by a decrease in insulin sensitivity during the second half of the menstrual cycle (luteal phase). Overall, despite an important proportion of women reporting glycemic and/or insulin variations across the menstrual cycle, studies to date have involved small sample sizes, and have had inconsistent results. The objective of this study will be to study glycemic fluctuations across the menstrual cycle using CGM data, alongside insulin data, in a large sample of women.

NCT ID: NCT05257967 Recruiting - Clinical trials for Non Small Cell Lung Cancer

CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease

Start date: July 18, 2022
Phase: N/A
Study type: Interventional

Leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life. With improvement in treatment options, rates of leptomeningeal disease are increasing and currently found in up to 9% of EGFR mutant NSCLC. Systemic therapy may be more effective if it can target the correct molecular aberration. The molecular characterization of central nervous system disease may differ from disease outside of the central nervous system. The aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) through the use of ddPCR and BC Cancer NGS panel molecular testing.