Burlington, Canada

To Evaluate Safety and Immunogenicity of a Prophylactic Plasmid DNA

Phase 1 is the randomized, observer-blinded, multi-center, dose-finding part of the study, followed by an adaptive Phase 2 in which the optimal dose, determined from Phase 1, will be evaluated for safety and efficacy. In Phase 1 up to 50 participants are planned to be randomized 1:1 into one of two groups: either 100 μg intramuscular (IM) injection or 250 μg IM injection. Participants are to receive a single 0.5 mL IM injection of VAX-002 100 μg or 250 μg on Day 0. Follow-up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180. An interim analysis is planned once all participants in Phase 1 have completed their Day 28 visit to evaluate dose-response and safety to support optimal dose selection for Phase 2. In Phase 2 approximately 250 participants will be enrolled and will receive a single 0.5 mL IM injection of the optimal VAX-002 dose (determined in the Phase 1 interim analysis) on Day 0. Follow- up visits will occur on Days 7, 14, 17 (phone call visit), 21, 28, 42, and 180.

The IMPACT Implementation-Effectiveness Trial

Rationale: The burden of cancer in Canada is growing. More individuals are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during active treatment. Institution-based PA services to support wellbeing and minimize burden during treatment are not available across Ontario. Novel implementation strategies are needed within the institution to close the gap between the evidence and clinical practice. Implementation research allows us to understand how to deliver interventions effectively in diverse settings. Aim & Objectives: The overall aim of this project is to conduct a fully powered, multi-centred randomized controlled trial (RCT) to evaluate the effectiveness of a novel implementation strategy including exercise and SM versus usual care for individuals with cancer during treatment. To do this, there are two main objectives: 1) Determine the feasibility and effectiveness of a novel implementation strategy using exercise and SM during treatment Methods: Study Design: Effectiveness-Implementation RCT Participants: Adults (>18 years) with a cancer diagnosis of any stage, currently receiving treatment, and cleared for exercise by their oncology care team will be included in this study. Procedure: Participants will be randomized to three groups. Group 1: Exercise & SM: Eight sessions of supervised, in-person institution-based exercise and SM education. This group will also receive 4 booster sessions by telephone post intervention. Group 2: SM Only: Eight virtual sessions of SM education using video conferencing with a qualified exercise professional. This group will also receive 4 booster sessions by phone post intervention. Group 3: Usual care: No intervention. Significance: Implementation research is crucial to improving our understanding of real-world factors that impact successful application of research in healthcare settings. This novel implementation strategy builds off previous work and incorporates institution-based exercise and SM during treatment. Findings from this trial will build off our previous work and inform the way PA services are provided within cancer institutions across Ontario. Our goal is to make these services available to all individuals with cancer during treatment.

A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis

SUBLOCADE Long-term Outcomes

This is a Phase IV, prospective, multicentre, multinational, open-label, real-world observational study in participants with current or a history of OUD/opioid dependence.

The Fourth Left Atrial Appendage Occlusion Study

LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

This is a phase-3 multicentre, double-blind, parallel-group placebo-controlled, randomised study. The study will comprise of: 1. Screening/Run-in period of 4 to 6 weeks, 2. 52-week double-blind Treatment period, 3. Post-treatment Follow-up period of 12 weeks. Participants will be randomised 2:1 to receive either tezepelumab or placebo administered by (SC) Subcutaneous injections for 52 weeks (double-blind Treatment period). There will then be a 12-week off-treatment Follow-up period for participants who do not continue in the optional open-label Active Treatment Extension period. An optional open-label Active Treatment Extension will allow all eligible participants the opportunity to receive active treatment with tezepelumab. The Active Treatment Extension period of the study will start following the 52-week double-blind Treatment period and will consist of a 24-week open-label Treatment period prior to the 12-week post-treatment Follow-up period.

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

This is a multicenter, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of dexpramipexole in adults and adolescents with severe, inadequately controlled asthma with eosinophilic phenotype on medium to high-dose inhaled corticosteroids (ICS )and at least one additional asthma controller medication with or without oral corticosteroids (OCS). Approximately 1400 participants will be randomized globally. Participants will receive dexpramipexole, or placebo, administered orally, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 4 weeks.

A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 12 weeks.

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

The primary objective of the study is to assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in composite measure of motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA- exposed control group. The secondary objectives comprise the assessment of the following endpoints in GBCA-exposed participants as compared to controls a) changes from baseline in composite measure of motor and cognitive function post-baseline on yearly basis (Years 1 to 4); b) changes from baseline in each individual test of motor and cognitive function on yearly basis (Years 1 to 5). Total Gd concentrations in blood and urine samples on yearly basis (Years 1 to 5) and adverse events will be collected as secondary objectives. Of note : The study is considered interventional because of the addition of UE-MRI scans for all participants, as well as blood sampling and the administration of the motor and cognitive tests. The GBCA administered as part of the contrast-enhanced MR imaging in the experimental arms is not the intervention in this study. Neither the protocol nor the investigators assign patients to a specific GBCA as part of the study, making this part of the study observational rather than interventional. The participants were already scheduled, prior to study screening, to undergo CE-MRI as part of their clinical care. The choice of GBCA for the CE-MRI will be based on medical need and institutional usage of GBCA, independent of study participation.

Evaluating the Impact of the Eating Matters Program on the Nutritional Status of Medical Rehab Patients at Joseph Brant Hospital

We will be conducting a prospective open-label non-randomized controlled trial to evaluate patients' nutritional outcomes in units that have the Eating Matters Program available (Study Group A) vs. similar units that do not have this program (Control Group B), as this can provide useful data on the effectiveness of such programs in developing innovative prevention strategies to address hospital malnutrition. A total sample size of eighty participants (40 in each group) will be included in this study from Medical and Rehabilitation units at Joseph Brant Hospital. Study group A will include patients from the medical unit on 6S100 in addition to the Rehab units on 6N400/500. Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200. Baseline food intake data (including breakfast, lunch and dinner) will be gathered during a 2-day period for both Study Group A and Control Group B. Following the collection of baseline data, feeding assistance will then be provided to participants in the units that have the EMP program available (6S100 and 6N400/500). In addition, food intake will be recorded for a total of 6 days for both Study Group A, and Control Group B. Outcome measures including C-reactive protein and weight will be measured weekly. Following, a Subjective Global Assessment (SGA) will be completed and Hand Grip Strength will be recorded on days 1 and 18 as the literature shows that this is an appropriate timeframe to reassess these measures (Flood et al., 2014; Canadian Malnutrition Task Force, 2019). Energy and protein intake will then be calculated using visual estimation by completion of the My Meal Intake Tool, and the hospital's CBORD software. Further, to evaluate the success of the feeding assistance program, volunteers will distribute the feedback survey to patients, staff, family members or friends of participants. To prevent contamination from staff working on both sides, members of the research team will have a discussion with staff to explain that the study and potential benefits should not be discussed, as this may impact the research findings.