All Clinical Trials in Canada

Early childhood is a critical period for developmental outcomes, and the parent-child relationship plays a vital role in shaping cognitive and social development. However, elevated parental distress (e.g., depression, anxiety, anger) can disrupt healthy relationships, increasing the risk of negative child outcomes such as difficult temperaments, altered cognitive development, and socio-emotional challenges. Despite the well-documented effects of untreated parental distress, Canadian families face significant barriers to accessing timely and effective mental health support. To address this gap, our team developed BEAM, an app-based program that provides parenting and mental health resources. BEAM includes expert-led videos, online forums, progress monitoring, and peer-coaching sessions. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. Building on BEAM's success, we have developed the LightBEAM program, which aims to expand these supports into a scalable, accessible, massive online open intervention (MOOI) to reach a larger number of families across Canada, particularly in underserved areas or those on waitlists for individualized services. LightBEAM has the potential to support parental mental health, fostering healthier child and family development while addressing barriers to traditional mental health care. This trial involves a pre-post randomized trial design with primary aims of (1) assessing feasibility and acceptability metrics of LightBEAM including recruitment/retention, sustainability, satisfaction, and unmet needs, (2) examining the efficacy of LightBEAM versus waitlist control at improving family and mental health outcomes, and (3) determine for whom LightBEAM is more or less effective at engaging with and addressing mental health needs. This trial will evaluate the feasibility and effectiveness of LightBEAM with a sample of up to 300 parent participants with a child aged 18-107 months. Co-parents of parent participants are permitted to participate in the study as well but are not included in this sample of 300 parent participants. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app. The LightBEAM program will consist of four different components; weekly parenting and mental health videos, weekly progress tracking, a group forum, and exercises designed to reinforce skills learned through the video content. Assessments of parent and child symptoms will occur at pre-test before LightBEAM begins (T1), immediately after the last week of the LightBEAM intervention (post-test, T2), and 6-month follow-up (T3). The LightBEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related metrics of child well-being. By adapting BEAM, an evidence-based parenting and mental health app, into LightBEAM, a large-scale online intervention, the present trial aims to provide accessible mental health support for Canadian families. LightBEAM could reach families in remote areas with limited services, offer interim support during waitlists, or function as a self-referral program. Read Less

The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada. Read Less

Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized Trial To evaluate the effectiveness of deep brain stimulation (DBS) of the nucleus accumbens for the treatment of severe refractory, repetitive self-injurious behavior (SIB) in children with Autism Spectrum Disorder. Secondary objectives are to examine the effects of DBS on subtypes of SIB through functional analysis. Read Less

The purpose of this study is to find out what effects of using adaptive radiotherapy to deliver chest radiation has on the ability to control lung cancer and side effects. Read Less

Currently, the optimal treatment regimen for elderly Glioblastoma (GBM) patients with poor performance status (PS) is unknown. Based on data for elderly GBM patients and the limited data for patients with poor PS, hypofractionated RT or a short course of Temozolomide (TMZ) may provide survival benefit without the added toxicity and inconvenience of a more protracted treatment regimen. In particular, treatment with RT or TMZ monotherapy on the basis of methylated O6 - methyl guanine - DNA methyltransferase (MGMT) promoter methylation status, followed by the alternative therapy at progression, may provide a safe and effective treatment regimen for patients with poor PS. The hypothesis of this trial is that in elderly GBM patients with poor performance status (age ≥ 65 years and KPS 50-70), a biomarker-guided approach to therapy results in non-inferior overall survival compared to combined TMZ/RT. Specifically, biomarker-guided therapy will consist of TMZ monotherapy for patients with a methylated MGMT promoter, and hypofractionated RT (40 Gy in 15 fractions) for patients with a non-methylated MGMT promoter. It is hypothesized that biomarker-guided therapy will result in non-inferior progression-free survival, reduced toxicity and increased cost-effectiveness compared to combined chemoradiotherapy. Primary objective: • To compare overall survival of standard vs biomarker-guided therapy in elderly and frail patients with newly diagnosed GBM. Secondary objective: * To evaluate progression-free survival following treatment in both arms. * To evaluate adverse events according to CTCAE criteria in both arms. * To evaluate health-related quality-of-life as assessed by MoCA and EORTC QLQ-C30/QLQ-BN20 questionnaires in both arms. * To evaluate cost-effectiveness of standard vs biomarker-guided therapy Methods: Patients will be randomized to two treatment groups in a 1:1 ratio. Standard Arm: TMZ with concurrent RT (combined modality arm) Patients will receive 15 days of TMZ daily with concurrent RT. TMZ will be delivered at a dose of 75 mg/m2, given daily with RT. TMZ will be administered 1 hour before each session of RT. After a 4-week break, patients will receive six cycles of adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated by the patient. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue. Investigational Arm: Biomarker based treatment MGMT (+): TMZ monotherapy Patients will receive TMZ at a dose of 75 mg/m2 daily for 15 days on weekdays (Monday through Friday). This will be followed by six cycles of TMZ according to the standard 5-day schedule (days 1-5) every 28 days. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events. Dose will be determined using the body surface area (BSA) calculation. MGMT methylation (-): No TMZ will be given. Participants will receive radiation treatment with 40Gy / 15 fractions over a period of 21 days (3 weeks). Upon treatment completion, participants will be followed by every 3 months for 2 years and every 6 months for years 3-5. Response and progression will be evaluated using the new international criteria proposed by the Response Assessment in Neuro-Oncology working group (RANO). Read Less

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors. Read Less

This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy. Read Less

I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects. I238B: The purpose of this study is to allow patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab) Read Less

CCI-001 is a novel colchicine derivative that is being developed by PharmaMatrix Holdings Ltd. (PharmaMatrix). The drug binds to tubulin, a component of the microtubule polymers which are required for a wide range of cellular processes, perhaps most importantly, cell division and mitosis. CCI-001 has been shown to bind more strongly to β-III tubulin, a tubulin subtype which is overexpressed in many cancers. This trial is being undertaken as a first-in-human, Phase I trial in patients with recurrent and/or metastatic solid tumours. Primary Objectives are to examine the compound's safety profile, and to determine the recommended dose. Secondary Objectives are to determine the compound's pharmacokinetic parameters and to evaluate the clinical response rate and survival. Expansion cohorts in in tumour types known to be sensitive to other approved agents with similar mechanism of action will be treated at the recommended dose: transitional cell bladder cancer, pancreaticobiliary adenocarcinomas, gynecologic cancers (ovarian, cervical, endometrial), and lung adenocarcinoma. Read Less

The radial forearm free flap (RFFF) is widely used in head and neck reconstruction. Its thinness, pliability, pedicle length, and vessel size are particularly suited for oropharyngeal and oral cavity reconstruction. Concerns about aesthetic and functional morbidity at the donor site have given rise to various techniques of closing the donor site, two of which are the split-thickness skin graft (STSG), taken from the thigh, and the hatchet flap, which uses a local flap within the radial forearm. This RCT will determine whether retrospectively reported improvements to aesthetic and functional outcomes for STSG patients are greater compared to hatchet flap patients. Read Less

ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older. Study details include: * The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks. * The intervention duration will be 24 weeks. * The number of visits will be 7 site visits and 8 phone/remote visits. Read Less

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I. Read Less