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Formation pratique pour investigateurs d'essais cliniques

Ce volet s’adresse aux cliniciens et chercheurs qui sont – ou aspirent à devenir – des investigateurs de site ou des contributeurs clés à la conduite et à la supervision d’essais cliniques. Que vous vous prépariez à mener votre première étude en tant qu’investigateur principal de site ou que vous souhaitiez élargir votre rôle au sein d’une équipe de recherche, ce volet propose une formation ciblée et flexible destinée à vous aider à gagner en confiance et à vous perfectionner.

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La formation met l’accent sur les responsabilités réelles des investigateurs cliniques, de la compréhension des exigences du protocole et de la conformité réglementaire à la gestion des opérations du site, des produits expérimentaux et de la sécurité des participants.

Ce volet propose d’abord des contenus fondamentaux destinés aux nouveaux investigateurs de sites, puis s’élargira pour inclure des modules avancés destinés à ceux qui conçoivent ou gèrent des essais cliniques plus complexes.

Il s’appuie sur le programme du tronc commun fondamental de CANTRAIN et s’aligne sur son approche axée sur les compétences, afin de s’assurer que les investigateurs acquièrent non seulement des connaissances, mais aussi les compétences et le jugement nécessaires pour s’épanouir dans l’écosystème des essais cliniques au Canada.

Caractéristiques

Modules en ligne électifs adaptés aux différents rôles des investigateurs

Formation pratique, basée sur des scénarios concrets et ancrée dans les réalités des sites

Apprentissage progressif pour soutenir des niveaux de responsabilité croissants

Format flexible et asynchrone pour répondre aux exigences de la pratique clinique

Nous publions chaque mois de nouveaux modules pour ce programme, alors consultez souvent le système de gestion de l’apprentissage !

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Programme de formation aux essais cliniques pour boursiers et jeunes chercheurs cliniques

Ce programme de formation permet aux boursiers et jeunes chercheurs cliniques qui s’apprêtent à se lancer dans la recherche clinique d’acquérir les connaissances fondamentales et le contexte pratique nécessaires pour contribuer avec assurance et compétence aux équipes d’essais cliniques. Le parcours approfondit la compréhension des rouages et des objectifs des essais cliniques, en abordant leurs grands principes éthiques, réglementaires et opérationnels. Les participants y acquerront les compétences nécessaires pour évaluer de manière critique les données scientifiques, soutenir diverses activités de recherche et saisir les fondements de la conception et de la gestion d’essais cliniques rigoureux.

Ce programme sera bientôt disponible, alors n’oubliez pas de consulter régulièrement la plateforme d’apprentissage en ligne et notre site web!

Formation aux essais cliniques pour les boursiers

Ce programme de formation permet aux boursiers qui s’apprêtent à occuper des fonctions dans le domaine de la recherche clinique d’acquérir les connaissances fondamentales et le contexte pratique nécessaires pour contribuer avec confiance et compétence aux équipes d’essais cliniques. Le programme permet de comprendre comment et pourquoi les essais cliniques sont menés, en couvrant les principes éthiques, réglementaires et opérationnels clés. Les boursiers acquerront les compétences nécessaires pour évaluer de manière critique les preuves, soutenir diverses activités de recherche et apprécier ce qui sous-tend la conception et la gestion d’essais cliniques rigoureux.

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Pour en savoir plus sur les programmes de formation aux essais cliniques au Canada, suivez nos développements et nos avancées trimestriels.

Proposed Clinical Trials-Related Project Description
by Michele Monroy-Valle

The role of milk and yogurt supplementation to a regular diet on bone health in Canadian adults aged 19-30 years: A Randomized clinical trial in Saskatoon, Saskatchewan. Lay language title: How adding milk and yogurt to the diet can improve bone health in young Canadian adults: a study in Saskatoon, Saskatchewan.

Dairy products, like milk and yogurt, are packed with important nutrients that support health. However, we don’t yet know the long-term health effects of regularly consuming these dairy products among young adults. In this study, we will examine the impact of daily milk or yogurt consumption over a two-year period on bone health in young Canadian adults. To explore this, we will recruit participants with low calcium intake and split them into three groups. One group will drink milk, another will eat yogurt, and the third group will continue with their regular diets. Over 24 months, the milk group will drink about 1.5 servings (375 mL) of milk daily and the yogurt group will eat 2 servings (350 g) of yogurt daily. We will measure the effects on bone health and hormone. The results will help us create better dietary recommendations to benefit bone health and prevent osteoporosis in later adulthood.

Proposed Clinical Trials-Related Project Description
by Syamala Buragadda

Roadmap for Developing Tool Kit for Inclusion, Diversity, Equity, and Accessibility (IDEA) in the Canadian Clinical Trials

Our project aims to develop a practical toolkit to promote inclusion, diversity, equality, and accessibility (IDEA) within clinical trials. Historically, clinical trials have lacked diversity, leading to gaps in understanding treatments’ effectiveness across different demographics and perpetuating health disparities. Our toolkit will provide researchers with resources and guidance to address IDEA considerations effectively, ultimately enhancing trial outcomes for diverse populations. The toolkit will: Raise awareness about IDEA’s importance in clinical trials. Provide practical resources for integrating IDEA considerations into trial design, implementation, and reporting. Promote evidence-based strategies for enhancing IDEA. Foster collaboration among researchers, stakeholders, and communities. Empower researchers to prioritize IDEA while maintaining scientific rigor and ethical principles. Topics covered include recruitment strategies, culturally sensitive communication, data collection methods, addressing barriers to participation, patient-centred approaches, accessibility, and demographic data monitoring. Our methodology involves stakeholder engagement, content development, pilot testing, revision, refinement, dissemination, and implementation. This includes surveys, focus group discussions, literature reviews, and pilot tests to ensure the toolkit’s usability, relevance, and effectiveness. By engaging diverse stakeholders with multidisciplinary expertise, our toolkit aims to improve IDEA in clinical trials, ultimately leading to more inclusive clinical trials.

Proposed Clinical Trials-Related Project Description
by Nancy Bedingfield

Assessing the impact of rifamycin-based tuberculosis preventative treatment using mixed methods: A quality of life sub-study in the ASTERoiD clinical trial

Tuberculosis (TB) is the world’s leading infectious killer, responsible for over 1 million deaths each year. Preventing TB-related suffering is a priority for global health organizations; however, this is difficult because many people are unable to complete TB preventative treatment (TPT) which currently takes several months and may have significant toxicity. Although much research has been focused on factors associated with completion of TPT, relatively few scientists have asked patients directly about their experiences. We will address this knowledge gap by asking patients to complete surveys and participate in interviews exploring their quality of life and acceptance of treatment at several stages during TPT. This study will take place within a larger clinical trial which is underway in North America, Austral-Asia, and Africa, testing the safety and effectiveness of a new short TPT treatment. We will compare quality of life between groups taking new and existing treatments, and between groups who may have had poor treatment-experiences.  Our results will help researchers and health providers know which patients have difficulty with TPT and how to support people to finish TPT so they can prevent TB.

Proposed Clinical Trials-Related Project Description
by Thomas Scheier

Impact of azithromycin prophylaxis on antimicrobial resistance in adults with advanced HIV disease: an antimicrobial resistance vanguard study of the multi-country REVIVE trial

People living with advanced HIV disease (AHD) have a severely damaged immune system. Despite enrolling in care and receiving recommended therapies, up to 2 in 10 people die in the first six months. Opportunistic bacterial infections are thought to be the main cause for this high mortality. The prophylactic administration of antibiotics may reduce early mortality by preventing these bacterial infections. REVIVE, a large randomized trial, is conducted across Africa and investigates whether azithromycin, a widely available and inexpensive antibiotic, reduces mortality in people living with AHD. Antimicrobial resistance (AMR) describes the ability of bacteria to resist antimicrobial treatment and is recognized as a major threat to global health. One of the main drivers of AMR is the use of antimicrobial therapies, including antibiotics. It is imperative to evaluate the possible impact of widespread implementation of azithromycin for all people with AHD on antimicrobial resistance. As part of this vanguard project, I am aiming to create a network of committed REVIVE trial centres to collect serially biological samples from REVIVE participants. These samples will be analyzed to get a better insight in antimicrobial resistance in people getting azithromycin and thereby provide information about possible negative effects of the antibiotic prophylaxis.

Proposed Clinical Trials-Related Project Description
by Richard Greendyk

Positive Pressure to Maintain Lung Recruitment during Extracorporeal Membrane Oxygenation for Acute Hypoxemic Respiratory Failure: the PRESSURE Pilot RCT

Extracorporeal membrane oxygenation (ECMO) is used for severe lung failure in ICU patients. During ECMO, blood is continuously drained from the body, oxygen is added to the blood, and the blood is returned to the body. ECMO is critical for patients with such severe lung failure that 5 mechanical ventilation (the ‘breathing machine’) cannot provide sufficient oxygen. However, ECMO can lead to complications, and medical teams aim to wean patients from ECMO promptly. Patients being treated with ECMO are usually also connected to a mechanical ventilator, but the optimal settings for the mechanical ventilator to speed recovery of the lungs and facilitate weaning from ECMO are unknown. To address this, we will assess if different mechanical ventilation settings, specifically positive end-expiratory pressure (called ‘PEEP’), can improve lung function in patients on ECMO. We will compare the effects of high and low PEEP settings on lung function. Additionally, we will evaluate patient tolerance to these variations and assess healthcare workers’ ease in managing patients with different PEEP settings. Our goal is to develop a PEEP strategy that can be tested in larger clinical trials to prove whether it can help patients who need ECMO recover more quickly from lung failure.

Proposed Clinical Trials-Related Project Description
by Jodi Langley

Prehab for Lung and Esophageal Cancer: Optimizing Well-being for Better Outcomes

Cancer is one of the leading causes of death in Canada. Among cancer, lung cancer is one of the most common diagnoses, making up 13% of all cases, and causing 28.2% of all cancer-related deaths. Esophageal cancer, although less common, tends to effect patients eating habits, movement and does tend to spread quickly throughout the body. Research does show that people with lung or esophageal cancer do better if they start treatment at a more functional level (healthy body, good nutrition, more active). If we invest in prehabilitation programs to give patients the rights tools (better nutrition, support to quit smoking, good sleep and movement programs) prior to major surgery and if we support them for continuous health behaviour change we will likely see better long-term outcomes. This study is assessing a prehabilitation health coaching program at the YMCA, meeting with patients before and after surgery to best support 5 them in continued movement and healthy behaviours. Previous research in prehabilitation has shown that these types of programs can help people recover quicker and better after surgery. This can lead to increase quality of life for patients and could save money for healthcare.

Proposed Clinical Trials-Related Project Description
by Raza Malik

Non-invasive spinal cord stimulation for cardiovascular recovery following spinal cord injury: a pilot clinical trial

Paralysis is viewed as the most devastating consequence of spinal cord injury (SCI), yet cardiovascular dysfunction is the leading cause of disease and death in this population and is a top rehabilitation priority. Low resting blood pressure (BP) and drops in BP during postural changes (e.g. sit-to-stand) can drastically decrease quality of life and delay rehabilitation. Spinal cord stimulation is a promising therapy with potential for improving BP control. This non-invasive treatment involves placing electrodes over the skin of the spine and delivering small amounts of electrical current. However, the best location to deliver this therapy, and the physiological mechanisms behind it, remain unclear. We aim to conduct a pilot clinical trial to determine the ideal stimulation location by comparing the immediate (real-time) and long-term effects (3x/week for 8 weeks) of mid-back and low-back spinal cord stimulation for controlling BP and quality of life. We also aim to examine the mechanisms in response to this therapy by exploring vascular health and sympathetic nervous system activity. Results from this pilot clinical trial will provide evidence to conduct a larger, multi-center clinical trial. The ultimate goal is to implement spinal cord stimulation in clinical practice and prescribe this therapy for home use.

Proposed Clinical Trials-Related Project Description
by Mona Ghannad

An educational intervention to improve prospective study registration and result reporting of trials in Canadian academic institutions

Best research practices and honest reporting are cornerstones of science. Society assumes that research is performed carefully and reported openly. But there are unseen threats to science— 85% of the investment in biomedical research is avoidably wasted due to poor conduct and reporting of research results. When we rely on science to inform decisions about patient care and health policy, society must strive for reliability in science. Only 3 out of every 100 clinical trials conducted in Canada between 2009 and 2019 provided enough information for researchers, clinicians, patients and policymakers to decide whether the research is meaningful and worth implementing in practice. I will lead a project to develop and evaluate an online training programme that aims to teach researchers how to maintain an accurate public record of their research—from its beginning all the way through to sharing the results with the scientific community and the public. The training program will roll out across at least 12 universities (out of 16) in British Columbia and culminate in testing how well researchers and institutions in British Columbia register and report the results of their research.

Proposed Clinical Trials-Related Project Description
by Marie-Pier St-Laurent

Active surveillance versus definitive local therapy for patients showing clinical complete response following neoadjuvant treatment for muscle invasive bladder cancer, a pilot-RCT

Invasive bladder cancer is usually treated with chemotherapy (CT) followed by surgical removal of the bladder or a combination of radiation plus chemotherapy (chemo-RT). Sadly, these treatments can have significant side effects. Studies have found that about one third of patients who receive CT before surgical removal of their bladder have no detectable cancer remaining in their bladder. These patients could theoretically avoid surgery or radiation, significantly improving their quality of life. However, we currently lack the tools to identify these patients before performing bladder removal surgery. We believe that combining state-of-the-art imaging (magnetic resonance imaging), repeat bladder biopsy, and novel biomarkers (liquid biopsy finding tumor DNA in blood and urine) will enhance detection of residual cancer and make active surveillance without bladder removal safer after CT. We propose a feasibility trial (pilot study) to assess the success of enrolling and randomizing patients with bladder cancer found to have no remaining cancer with our tests and following CT, to active surveillance or conventional treatment (surgery or chemo-RT). If successful, this would represent a paradigm shift in the management of patients with invasive bladder cancer, transitioning towards personalized treatment with improved quality of life.

Proposed Clinical Trials-Related Project Description
by Mahsa Khalili

Multi-Modal Wearables with Machine Learning Algorithms for Continuous Cardiac Monitoring: Implications for Timely Detection of Sudden Cardiac Arrest

Sudden cardiac arrest (SCA), defined as the unexpected cessation of cardiac activity and blood circulation, is a major 6 public health issue, with an annual incidence rate of 4.4 million events worldwide and 60,000 cases in Canada. Rapid initiation of cardiopulmonary resuscitation (CPR) is critical, as the likelihood of survival decreases with each minute of delay.4 For SCAs that occur in private locations, where there is no one to start CPR or call 911 (75% of all cases),5 survival is nearly 0%. Therefore, the main barrier to improving SCA outcomes is the timely recognition of the event. Consumer wearable technologies have great potential to continuously monitor cardiac function and automatically recognize signs of disruption or loss of blood circulation at any time. These systems could subsequently activate Emergency Medical Services (EMS) to provide the necessary life-saving interventions.6–8 In this study, we aim to retrain previously developed SCA detection algorithms and validate their performance among those experiencing cardiac arrest. Additionally, we seek to optimize these models for practical applications in realworld settings (e.g., minimizing false positive SCA alerts).

Proposed Clinical Trials-Related Project Description
by Kyle Missen

Nerve transfer surgery to restore upper-limb function after cervical spinal cord injury

People with cervical spinal cord injuries (cSCI) consistently rank regaining hand function as their most important goal. A promising technique called nerve transfer surgery (NTS) is now offered in Canada to help those with cSCI restore movements, like opening and closing the hand. However, some major challenges remain to make NTS more effective and impactful. This project is part of the first large-scale study of NTS in people with cSCI, which aims to see how well NTS works for restoring hand function. Forty-one adults with cSCI (at C5-7 levels) who are planning to have NTS will be compared to a control group from a database. They will have hand function tests shortly after surgery and every three months for two years. Interviews with patients who have had NTS will help us understand their lived experiences. The results will help us develop optimal rehabilitation strategies and predict patient outcomes after surgery. This project is a significant step forward in neurorehabilitation for cSCI and will have important and immediate impacts on clinical care and research.

Proposed Clinical Trials-Related Project Description
by Ryann Tansey

Neuroimaging correlates of psilocybin-assisted psychotherapy in alcohol use disorder

Alcohol use disorder (AUD) is a common mental health burden in Canada. Unfortunately, there are not many effective treatments, and the ones that do exist are demanding, leading to only a small fraction of AUD patients seeking pharmacology-based therapies. There is a clear and urgent need for the development of novel pharmacotherapeutics in AUD. Recently, there has been growing interest in the use of psychedelic drugs, such as psilocybin (the active component in magic mushrooms), to treat psychiatric conditions. Research has shown an increase in cognitive flexibility in depressive patients following a single psychoactive dose of psilocybin. AUD patients with lower cognitive flexibility are at higher risk of poor treatment response. Therefore, we hypothesize that psilocybin will enhance the response to therapy in individuals with AUD, compared to placebo, by increasing their cognitive flexibility. We will also use MRI to explore how psilocybin changes functional connectivity and concentrations of neurometabolites in the brain, in order to get a better understanding of its mechanisms of action. This study will address the need for more effective, alternative treatments for AUD, and expand our understanding of the 5 neurobiological mechanisms underlying both the disorder and psychedelic drugs.

Proposed Clinical Trials-Related Project Description
by Béatrice Bérubé

Différences liées au sexe biologique dans l’insuffisance cardiaque : comparaison des effets de l’exercice physique sur la cognition et l’autorégulation cérébrale chez les hommes et les femmes

Les déficits cognitifs, comme des troubles de mémoire ou d’attention, affectent jusqu’à 50 % des patients atteints d’insuffisance cardiaque (IC) et sont associés à des complications importantes dans la maladie. Un contrôle moins optimal du sang qui se rend au cerveau pourrait expliquer les difficultés cognitives dans l’IC. De plus, l’exercice physique est recommandé comme méthode pouvant améliorer la cognition chez les patients atteints d’IC. Bien que des différences de sexes biologiques notables existent dans l’IC, peu d’études ont documenté les effets de l’exercice sur la santé cognitive et cérébrale en fonction des sexes. L’objectif principal est de mesurer les effets de l’exercice physique sur la santé du cerveau chez les hommes et les femmes atteints d’IC. 128 participants (50 % de femmes) avec de l’IC seront classés aléatoirement dans l’un des deux groupes suivants : 1) Exercice physique ou 2) traitements usuels. La santé du cerveau sera mesurée via des tests cognitifs et l’autorégulation du sang dans le cerveau par le biais de l’imagerie cérébrale. Cette étude permettra de documenter les effets de l’exercice sur la santé cérébrale chez les hommes et les femmes atteints d’IC et permettra de fournir des interventions adaptées au traitement de la maladie.

Proposed Clinical Trials-Related Project Description
by Eric Lortie-Milner

The combination of 0.09% Cyclosporine and Intense Pulsed Light (IPL) Therapy for the Treatment of Dry Eye Disease in Symptomatic Contact Lens Wearers: a Sham-Controlled Randomized Clinical Trial

In this study, two treatments typically used for dry eye disease will be tried for contact lens users to see if their symptoms when they use their contact lenses get better. Cyclosporine is a drop that is used for longterm management of the inflammation and Intense pulsed light (IPL) is a treatment done in a clinic to improve the health of the eyelid glands. The main question in this study is: Does the combined treatment of cyclosporine and IPL improve the symptoms and the dry eye signs of contact lens wearers? All the participants will receive the cyclosporine drops for 4 months twice a day. The research team will split the group of participants in two, half receiving the real IPL treatment and half receiving a sham IPL treatment during the last two months of the study. This will allow to compare the two groups to see how IPL helped. The dry eye tests will be done at the start of the study, after two months and after 4 months. The tests will include a dry eye symptoms questionnaire, measures on the tears, the structures of the front of the eye and the eyelids.

Proposed Clinical Trials-Related Project Description
by Kriti Agarwal

Virtual Physical Rehabilitation in long COVID: participants’ perspectives, long-term follow-up, and adverse events

Recent research on the lasting impacts of COVID-19 indicates that many individuals are experiencing ongoing symptoms, yet there is limited evidence on effectiveness of physical rehabilitation in long COVID. Our research aims to investigate whether an 8-week online homebased physical rehabilitation program for individuals with long COVID improves mobility, physical function, quality of life, and mental health compared to usual care. We will also explore the sustainability of any observed changes at 6-months after the 8-week program, gather participant’s perspectives towards rehabilitation program, and characterize postexertional malaise (worsening of symptoms with even mild exertion). We recruited 132 individuals from Quebec and Ontario, randomly assigning them to either the exercise group (receiving 8-weeks of virtual rehabilitation including educational sessions along with usual care) or control group(receiving only usual care, a document instructing on how to manage symptoms and engage in physical activity). Interviews with exercise group participants and long-term evaluations will provide valuable insights. Listening to participants’ feedback will enhance the program and determine if 8-week is sufficient. Understanding post-exertional malaise will guide us in recommending effective exercises for real-world use. This study will provide clear, practical guidelines for using virtual rehabilitation for people with long COVID in real-world healthcare settings.

Proposed Clinical Trials-Related Project Description
by Caroline Rajda

The use of enhanced intrinsic feedback for upper limb rehabilitation in stroke survivors: a randomized clinical trial.

Stroke diminishes people’s ability to move their arm and learn new skills. People with stroke often have lasting problems using their arm, especially to extend their elbow while reaching, limiting their participation in everyday activities. Our goal is to use a novel intervention, error augmentation (EA) feedback, to improve reaching movement in people with chronic stroke. EA feedback makes it seem like the elbow is more bent than it actually is during reaching training, ‘tricking’ the person into using a greater range of elbow movement during reaching than they typically would. People are randomly assigned to either an EA training group or control (no-EA feedback) training group. We predict that people receiving EA feedback will improve and retain reaching movements more than controls. We will also determine the relationship between poststroke cognitive deficits and learning using EA feedback. Each training group practices 30 minutes of reaching in a virtual reality environment, 3x/week for 9 weeks. Reaching ability and arm motor impairment is assessed before and after 3, 6, 9 weeks of training. Follow-up assessments are done 6 weeks after training finishes. Results will inform therapists on how to design the most effective rehabilitation tools for arm movement recovery.

Proposed Clinical Trials-Related Project Description
by Audrey Moyen

Effects of a novel multimodal intervention for surgical prehabilitation on functional recovery and muscle characteristics of patients with lung cancer

Lung cancer is the top cause of cancer deaths worldwide. Many persons with lung cancer lose muscle, are fatigued, and have more difficulties performing their activities. Those who undergo surgery in these conditions suffer from more complications, longer recovery times and have more risk of mortality. These negative outcomes may be due to lower muscle mass and quality. An exercise and nutrition intervention can improve functional status, not only during recovery but even before surgery. We will take advantage of the 4-week waiting period for surgery to engage patients in this intervention, which will continue for 6 weeks after surgery. Patients scheduled for lung cancer surgery will be assigned by chance to one of three groups: 1) receiving the usual care, 2) receiving a novel nutritional supplement combining important nutrients for muscle health, or 3) taking the supplement and following an exercise program. All groups will attend anxiety management sessions and nutritional counselling. Tests will include walking endurance, muscle strength, and body composition. Hospital length of stay and complications due to surgery will be recorded. This work could help persons with lung cancer regain their normal functions and quality of life faster and with lesser complications after surgery.

Proposed Clinical Trials-Related Project Description
by Javad Raeesi

Enhancing Shoulder Joint Replacement Recovery: A Patient-Centered, Technology-Enabled Rehabilitation Program

Shoulder joint replacement surgery can improve the quality of life for individuals suffering from shoulder arthritis. However, recovery can be difficult.  A rehabilitation program after surgery helps patients manage pain and gain function. This project aims to develop and test a new, personalized rehabilitation program that combines education and exercise with options to use technology supports. We are working closely with patients and healthcare professionals to create a program that is both effective and easy to use. The program will include instructional videos and a special «  »motion shirt » » that tracks movement, allowing patients to exercise correctly at home. We will then conduct a study to test the program’s effectiveness in reducing pain, improving function, and enhancing overall quality of life for those recovering from shoulder joint replacement surgery. Our goal is to create a program that helps patients recover faster and empowers them to take an active role in their rehabilitation. By combining the latest technology with evidence-based practices, we hope to set a new standard for shoulder joint replacement recovery and improve the lives of countless individuals.

Proposed Clinical Trials-Related Project Description
by Christopher Pople

Interleaved transcranial magnetic stimulation-functional magnetic resonance imaging (TMS-fMRI) for prediction of response to connectivity-guided accelerated intermittent theta-burst stimulation

In this study, individuals with treatment-resistant depression will undergo an MRI to measure functional brain activity prior to treatment with transcranial magnetic stimulation (TMS), an approved treatment for depression. Connectivity between brain regions within an individual will be used to identify a personalized brain target for TMS. Prior to treatment, patients will return to receive TMS at this personalized brain target, to brain responses to stimulation in real time. Thereafter, patients will receive a form of TMS called intermittent theta burst stimulation (iTBS), a common pattern of TMS used in depression, on accelerated timeline that condenses 4-6 weeks of treatments into a single week. The relationship between brain activity in the MRI during TMS delivery and subsequent clinical response will be investigated to identify predictors of antidepressant effects and better understand the therapeutic mechanisms of TMS in depression and other brain disorders.

Proposed Clinical Trials-Related Project Description
by Spencer Skaper

Impact of Moderate-Intensity Aerobic Exercise on Cerebral Blood Flow in Individuals with Down Syndrome

Individuals with Down syndrome (DS) have lower blood flow to their brain. This causes faster aging and a higher risk of early Alzheimer’s disease. As blood flows, it imposes a dynamic force on arterial walls, known as hemodynamic force. Unless reduced, hemodynamic forces damage cerebral arteries. This 4 damage may cause cognitive impairments and advanced aging. Yet, limited studies show how exercise impacts hemodynamic force. We aim to determine how moderate exercise affects hemodynamic force in DS. This randomized control trial requires 34 DS and 34 non-DS participants, aged between 19 and 40. Participants will be randomly placed into a resting group (RG) or an exercise group (EG). An ultrasound will measure all participants’ internal carotid and middle cerebral arteries. RG participants will visit the lab once for resting supine ultrasound measures. The EG participants will visit once to perform a 1-mile walk to estimate their maximal aerobic capacity (V̇O2max). During EG participants’ second visit, they will perform supine cycling between 40 and 50% of their V̇OV̇ 2max for 30 minutes. Ultrasound measures will occur before, during, and after exercise. We hypothesize that aerobic exercise will reduce cerebral arterial hemodynamic forces.

Proposed Clinical Trials-Related Project Description
by Carolina Hernandorena

Safety and efficacy of psilocybin-assisted psychotherapy for demoralization syndrome in patients diagnosed with advanced stage cancer: a pilot study.

This is a research study investigating the potential role of psilocybin, a controlled psychedelic compound that is found in certain mushrooms (sometimes called “magic mushrooms”), as a potential treatment for demoralization syndrome in advanced cancer. Demoralization syndrome has been described as a psychiatric condition in which patients experience hopelessness, pessimism, loss of purpose in life, isolation, and other symptoms as a result of a life-threatening illness. We’ll be using psilocybin to enhance psychotherapy, in particular a type of therapy designed for patients with advanced cancer. Our aim is to test if there is an improvement in the feelings of demoralization through this treatment, and to register any adverse effects related to the treatment to assess its’ safety. The patients included in this study will be 18 to 70 years old, with a diagnosis of advanced cancer and demoralization syndrome.

Proposed Clinical Trials-Related Project Description
by Abigail McGrory

Optimizing Bayesian Dynamic Borrowing in Adaptive Platform Trials: A Standardized Elicitation Framework for Prior Distributions

Adaptive platform trials (APTs) are clinical trials designed to test multiple treatments for a single disease. They use real-time data to continuously adjust the trial design, making the process more efficient. A key feature of APTs is Bayesian dynamic borrowing, a statistical method that accounts for variations in treatment effects among different patient subgroups. This method improves outcome accuracy and reduces the number of patients needed for the trial by sharing information across patient subgroups. Bayesian dynamic borrowing helps manage these differences, using statistical techniques to ensure that the treatment effects are appropriately compared. This project aims to enhance the use of Bayesian dynamic borrowing by developing a standardized process to create accurate prior distributions, which are crucial for this method. The project has three main goals: creating an elicitation framework, generating robust prior distributions, and testing the 5 framework on an existing clinical trial. The project will use the CALM trial, which investigates the effectiveness of the antidepressant sertraline for anxiety in children with various neurodevelopmental disorders, as a case study. By improving prior distribution methods, this project will ensure more accurate and efficient clinical trials, particularly in oncology and rare disease research, where patient recruitment is often challenging.

Proposed Clinical Trials-Related Project Description
by Olivia Ferguson

The effects of dietary nitrate supplementation on exercise tolerance in patients with fibrotic interstitial lung disease

Interstitial lung disease (ILD) is a progressive lung disease with a mean survival of only three years. Breathlessness and severely low oxygen levels are the hallmark features of ILD, which worsen with exercise. They are a source of severe distress and negative behaviour change in these individuals, causing avoidance of physical activities that trigger these symptoms further degrading overall health. Unfortunately, very few effective and safe pharmacological therapies that target the lungs are available for ILD. Thus, preserving or enhancing muscle and heart function is essential to offset the progressive decline in lung health to maintain quality of life and independence. Using nitrate in the form of concentrated beetroot juice, a safe and commercially available dietary supplement, may improve the delivery and efficiency of oxygen use at the site of exercising muscles. Oral ingestion may improve the use of diminished oxygen availability rather than relying on external sources of supplemental oxygen, a common practice in ILD, which lacks real-world practicality. This novel therapeutic may allow patients with ILD to reach greater exercise intensities to improve their overall exercise tolerance. If successful, it would enable them to sustain their functional abilities, promoting independence and improved quality of life.

Proposed Clinical Trials-Related Project Description
by Simran Gill

Active Steps: Feasibility of a virtual intervention to promote active lifestyles in children with type 1 diabetes living in rural and remote communities

Type 1 diabetes (T1D) is one of the most common chronic conditions in children, affecting about 30,000 children in Canada. Regular physical activity is important for better blood sugar control. Children with T1D face challenges being active due to fear of hypoglycemia (alarmingly low blood sugar levels). We propose to run a 12-week virtual physical activity program to increase activity in children with T1D. The children will interact with a counsellor via Zoom, who will provide useful information like how to manage blood sugar levels during exercise. To see if the program works, children will wear a special activity tracker for 7 days before and after the program, plus a Fitbit for the whole 12 weeks to measure their physical activity.

Proposed Clinical Trials-Related Project Description
by Mahtab Matin

Comparing the Impact of Infant Feeding on Resultant Sleep Behaviors and Microbiome Outcomes of Full-term Infants Exposed to Antibiotics in Labour: A Mixed-Method Trial

Sleep is essential for human health, particularly babies. Research on the impact of gut bacteria on baby’s brain is limited, especially in relation to sleep. Baby’s feeding type affects gut bacteria, and no study evaluated the effects of donor human milk (DHM), which is highly similar to mother’s own milk, on sleep. The project aims to examine the effects of DHM, formula, and exclusive breastfeeding on baby sleep habits, assess parental perception of infant sleeping patterns, and if gut bacteria mediate the relationship between infant feeding type and sleep. The study will recruit participants from postpartum units and study three groups of babies with antibiotics exposure during birth. For babies who require extra supplementation, one group will receive standard care, which is formula (n=75), and the other will receive DHM (n=75) for their first seven days of life. Infants who do not require any supplementation and receive EBF (~n=60-90) will be only observed during the study. Parents will provide data on demographic characteristics, breastfeeding self-efficacy, mood, and baby’s sleep and baby’s stool will be collected at different time points. We hypothesize that DHM and EBF, containing probiotics, prebiotics, and melatonin, will improve sleep and influence gut bacteria type and quantity.

Proposed Clinical Trials-Related Project Description
by Karina Thiessen

Effects of Cannabis on Stress Response: A Double-Blind Randomized Placebo-Controlled Crossover Trial

Approximately 50% of Canadians have used cannabis. The vast majority of cannabis users report using cannabis to reduce stress. There remains limited high-quality evidence on if cannabis reduces stress and how it might do so. The current Phase I randomized control trial examines the effects of cannabis on acute stress response in humans by assessing both neurobiological and subjective markers of stress. 30 adult occasional cannabis users will be recruited for this study. Each participant will ingest oral cannabis oil containing tetrahydrocannabinol (THC) with cannabidiol (CBD), THC alone, or placebo. At the time of peak drug effects, participants will complete a stress induction task while undergoing functional Magnetic Resonance Imaging (fMRI). In addition to fMRI data, we will also evaluate salivary stress biomarker levels, cardiovascular response, and subjective stress to comprehensively evaluate biological and psychological stress response. We expect that the cannabis oils will cause reduced stress response compared to placebo. Canada’s legalization of cannabis, the high prevalence of cannabis use–especially for stress reduction—and the high interest in cannabis as a potential medical treatment has significant public health implications and studies such as this are needed to better understand the effects of cannabis.

Proposed Clinical Trials-Related Project Description
by Ho Jung Yoon

The effects of diesel exhaust air pollution exposure on inhaled corticosteroid treatment in late-onset asthmatic patients

With increasing global industrialization, traffic-related air pollution (TRAP) in the form of diesel exhaust (DE) has become of increasing concern for individuals predisposed to harm in highly polluted areas. DE exposure is associated with negative health effects including breathing difficulties, decreased pulmonary function, inflammation, and the development of respiratory diseases. In particular, asthmatic children and adults are at greater risk of hospitalization as harmful substances such as air pollutant lead to irritation, inflammation and changes in the airways, causing difficulty breathing. To address this issue, medical practitioners often prescribe inhaled corticosteroids (ICS) to alleviate symptoms. However, recent data suggest that air pollution may decrease ICS effectiveness, but the exact biological reasons for this phenomenon remain unclear. This discrepancy can lead to overprescription of ICS as doctors are unable to control patient symptoms, which can lead to reduced disease control despite the higher doses and increased side effects. These factors can cause a burden on healthcare services and will continue to be a problem in developing countries worldwide. Therefore, it is vital to investigate the underlying biological 5 pathways and immunology associated with ICS treatment as we may be able to improve ICS effectiveness by promptly addressing these issues prior to administration.

Proposed Clinical Trials-Related Project Description
by Denghuang Zhan

Investigation of innovative clinical trial designs through plasmode simulation – a research proposal

This project aims to enhance the design of clinical trials for treatment-resistant depression by using innovative Bayesian adaptive methods. Traditional trials often use fixed sample sizes, which can be inefficient or impractical. In contrast, Bayesian adaptive designs allow for ongoing adjustments based on accumulating data, making the trial process more flexible and efficient. By analyzing data from a major depression study, we seek to identify key considerations for these adaptive trials. Our goal is to demonstrate how these methods can improve statistical power and reduce sample sizes, ultimately leading to faster and more personalized treatments for patients. The findings from this research could revolutionize how clinical trials are conducted, making them more responsive to patient needs and more resource-effective. This advancement has the potential to significantly impact the field of clinical research, improving treatment outcomes and accelerating the approval of new therapies.

Proposed Clinical Trials-Related Project Description
by Curtis Leclerc

Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET.

This project is an international randomized clinical trial being implemented across 12 Canadian and 5 International centers exploring the effectiveness of Stereotactic Ablative Radiotherapy (SABR) in the treatment of oligometastatic cancer. SABR is a modern radiotherapy technique for cancer treatment that delivers high doses of radiation to small tumor targets, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose and avoidance of nearby normal tissue. The purpose of this study is to compare different doses of SABR regarding toxicity, progression-free survival, quality of life, and costeffectiveness. The outcomes of this project will contribute valuable insights to shape cancer treatment approaches, policies, and decision-making processes, considering their impact on healthcare resources and the burden on patients.

Proposed Clinical Trials-Related Project Description
by Jane Fletcher

The ACCESS Trial: Secondary analyses from a large randomized trial of copayment elimination to alleviate financial barriers and improve medication adherence in low-income seniors with chronic diseases.

Chronic diseases are a leading cause of death for Canadian adults. These conditions can be managed by medications and making health behaviour changes. Despite these treatments, many Canadians experience complications from the long-term effects of chronic diseases, particularly those who can’t afford their medications. In addition to its impact on patients, this costs the healthcare system, since these individuals then need specialized care in the hospital system. While many aspects of healthcare are covered by public insurance for Canadians, 4 medications are not universally covered by governments, and there is variation across the country. A patchwork of employer, private, and public insurance provides medication coverage for around 80% of Canadians, but many more are underinsured. Understanding how providing an intervention like free medications impacts patients, their financial barriers and their likelihood to take medications can inform future policies for medication insurance coverage in Canada. We will use data collected in the ACCESS trial information from a recent large randomized clinical trial in 4761 low-income seniors to analyze multiple factors that may connect to adherence to better understand the underlying causes.

Proposed Clinical Trials-Related Project Description
by Lauren Lindsey

Trials for optimizing treatment to eliminate Helicobacter pylori infection in northern Canadian Indigenous communities

The Canadian North Helicobacter pylori (CANHelp) Working Group conducts community-driven projects to address concerns of Indigenous communities in the Northwest Territories and Yukon, Canada about Helicobacter pylori (Hp) infection and its link to stomach cancer. A key concern is poor effectiveness of treatment to eliminate Hp infection, as is common in populations where Hp occurs frequently. Major risk factors for Hp treatment failure include antibiotic-resistant Hp infection, prescribing of suboptimal regimens, and suboptimal adherence to regimens, which occurs commonly due to bothersome side effects. During 2008-2018, CANHelp projects included a series of community-specific treatment trials designed with community input to identify effective treatment regimens. These community trials engaged underrepresented Indigenous populations in clinical trial research. Of 340 Hp-positive trial participants assigned treatment at random across 9 communities, 231 received a post-treatment test for Hp 8 or more weeks after completing treatment. My project aims to estimate the effectiveness of of treatment regimens using statistical methods to control for diverse participant characteristics, thereby addressing a question of key concern to communities that seek to reduce health risks from Hp infection.

Proposed Clinical Trials-Related Project Description
by Anna Shologan

Perioperative Rehabilitation for Individuals Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial

Despite how common inguinal hernia repair (IHR) surgery is, there is little research how to prepare people for this operation. Surgeon’s advice to patients about exercise and physical activity are inconsistent and usually based on their clinical opinion. Some surgeons say to exercise to help prepare for the operation while others say to rest. Research is needed to help know whether exercise is helpful before and after IHR surgery. We will conduct a study to test the effectiveness of education and exercise before and immediately after IHR surgery. We will randomize some participants to an education and exercise group and the other to a non-exercise, care as usual group. We will measure participant outcomes up to 3 months after their surgery. We expect the education and exercise group will have less pain, better hernia-related outcomes, and return to activity and work quicker. Our project will help people who need IHR better prepare for their surgeries. 

Proposed Clinical Trials-Related Project Description
by Yabo Chen

Feasibility of Multimodal Prehabilitation to Enhance Glycemic Control Before Surgery in Patients with Colorectal Cancer and HbA1C ≥ 5.7%

Colorectal surgery is a common practice in Canada for treating cancers and other intestinal diseases. One in three individuals awaiting colorectal surgery, without a diabetes diagnosis, has a high blood sugar level that categorizes them as having prediabetes or diabetes. Numerous studies have shown that these patients face more challenges in recovering after surgery, including an increased risk of infections. Since the waiting time for this type of surgery is generally around 44-45 days in Canada, we would like to capitalize on this waiting period to help these individuals improve their blood sugar levels before the operation. 6 We will measure blood sugar levels during the first meeting with the surgeon to identify individuals with elevated levels. Subsequently, we will offer these individuals a daily nutrition and exercise plan to lower their blood sugar levels before their surgery. We believe that this program will be appreciated by the participants and will improve their blood sugar levels so that they can achieve a better recovery after surgery.

Proposed Clinical Trials-Related Project Description
by Nicholas Rozza

Investigating the interaction between the immune system and bone and its effect on cancer immunotherapy in melanoma patients.

Melanoma is the deadliest form of skin cancer. A serious and frequent progression of melanoma is bone metastasis. This is when cancer cells spread and form tumors within the bones of an affected individual. Recent research has shown that the bone marrow microenvironment plays a crucial role in cancer progression and metastasis. Additionally, the immune system’s response to cancer is a major determinant of disease outcome. Immune checkpoint inhibitors are new treatments that allow a patient’s own immune system to fight cancer cells. This has allowed the dismal rate of survival in metastatic melanoma to be greatly improved with the potential for curability. However, clinical data shows that patients with bone metastasis have worse outcomes and respond poorly to immunotherapy. During periods of high bone activity, such as in bone metastasis, bone cells are released into the circulation where they may interact with immune cells and/or cancer cells. The interactions between circulating bone and immune cells appear to be crucial in mounting an effective anti-cancer immune response following treatment with immune checkpoint inhibitors. This research aims to investigate the unexplored interplay between circulating bone cells and immune cells in patients with metastatic melanoma treated with immune checkpoint inhibitors.

Proposed Clinical Trials-Related Project Description
by Elias John Elenjickal

Canagliflozin in patients with advanced renal disease with magnetic resonance imaging endpoints (the CARe-MRI trial)

Chronic kidney disease is a condition characterized by irreversible and progressive loss of kidney function leading to accumulation of harmful substances in blood. As kidney function declines to very low levels, patients will require regular cleaning of the blood by a procedure called dialysis to sustain life. Patients with chronic kidney disease are at a high risk of developing heart disease 10 . In fact, nearly half of patients with chronic kidney disease on dialysis will succumb to heart disease within 4 years of diagnosis. A promising new group of drugs, called SGLT-2 inhibitors , seems to reduce the number of deaths due to heart disease. However, these drugs are not currently approved in advanced kidney disease. In our study, we will use one of these drugs, called canagliflozin, to see if it will reduce excessive growth of the heart muscle. Excessive growth of heart muscle is bad for health as it may lead to serious heart conditions including sudden death. If we demonstrate that canagliflozin can reduce this growth, then this medication will be considered in patients with advanced kidney disease. This may help in saving lives of many patients with kidney disease who currently do not have access to this medicine.

Proposed Clinical Trials-Related Project Description
by Dan Nguyen

Urolithin A supplementation during pulmonary rehabilitation participation in patients with chronic obstructive pulmonary disease: A randomized pilot and feasibility study

Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung disease that is a leading cause of morbidity and death. Patients with COPD often have persistent breathlessness and low exercise tolerance which affect their ability to do everyday tasks. COPD treatment includes medications/inhalers, and participation in pulmonary rehabilitation (PR). PR is a multidisciplinary program consisting of exercise, education, and nutritional counseling led by a diverse team of healthcare experts and has consistently been found to improve breathlessness and exercise tolerance in patients with COPD. It is possible nutritional supplementation of Urolithin A, a compound which been found to be safe, well-tolerated, and improve exercise capacity in healthy adults may further enhance benefits from PR participation in patients with COPD. This study will recruit ten participants clinically diagnosed with COPD to participate in an 8-week PR program in which they will be randomly assigned to either take Urolithin A or an indistinguishable placebo during PR participation. Participants will be assessed on their exercise capacity, body composition, muscle strength, quality of life, and on an opt-in basis, their muscle tissue. This study will test the feasibility of recruiting patients, completing the whole study, and completing the tests.

Proposed Clinical Trials-Related Project Description
by Samantha Dunlop-Bassett

The STRIVE Before Surgery Trial: a vanguard pragmatic multicenter randomized trial of Structured TRaining to Improve fitness in a Virtual Environment (STRIVE) before surgery

Over a million Canadians undergo surgery annually, with about one-fifth experiencing complications or post-operative difficulties. To address this, many believe that ‘prehabilitation’ which involves doing exercises and eating healthy food before surgery could lead to better recovery outcomes. Research suggests that prehabilitation may: 1) lead to fewer complications, 2) help patients have better recovery, and 3) lead to shorter stays in hospital. Unfortunately, existing studies don’t reflect real world implementation of prehabilitation; therefore, we don’t know if prehabilitation will work for most surgical patients, despite the promise shown in specialized studies. With the experience of COVID-19, we’ve learned that programs like prehabilitation need to be provided in a way that they can be done at home with technological support. Virtually-supported prehabilitation has not been widely studied, but needs to be. The next step is to test whether at home, virtually supported prehabilitation, provided in a way that looks like a real world approach, will help patients to have better outcomes after surgery. Our study will help to find out if doing a test like this is practical. If it is, we will do a large study across Canadian hospitals to find out if this approach to prehabilitation can help patients.

Proposed Clinical Trials-Related Project Description
by Sabrina Lai

Cow’s Milk Obesity pRevention Trial (CoMFORT) Internal Pilot Randomized Trial

Childhood obesity is a major public health issue in Canada. To lower the risk of obesity, the Canadian Paediatric Society advises parents to switch their children from whole milk (3.25% fat) to reduced-fat milk (1% fat) at 2 years old. However, recent research suggests that whole milk might be associated with lower body fat in children instead. To investigate, the Cow’s Milk Fat Obesity Prevention Trial (CoMFORT) will compare the effects of whole milk versus reduced-fat milk on child obesity. Before launching the main trial, we will conduct an internal 5 pilot study to test the feasibility of this research. We will focus on recruitment, adherence, retention, and assessing the proper age range of participants involved. The pilot study will include 30 children aged 1.5 to 2.99 years, who will be randomly assigned to either the whole milk (3.25% fat) or reduced-fat milk (1% fat) group. Over six months, we will track how well we can recruit, retain participants and whether they consume their assigned milk. This pilot study is crucial for refining the trial design and ensuring the success of the main CoMFORT trial, which aims to provide guidance on milk fat consumption and childhood obesity.

Proposed Clinical Trials-Related Project Description
by Marisa Deodat

Polymorphisms in GSTA1 and UGT2B17 genotypes, estrogen levels and menopause-related side effects in post-menopausal women in the MAP.3 trial: A nested cohort study

This study explores how genetic differences in two specific genes, GSTA1 and UGT2B17, impact estrogen levels and menopause-related side effects in postmenopausal women taking exemestane (EXE) for breast cancer prevention. EXE is an effective medication for reducing the risk of breast cancer, but it can cause side effects such as fatigue, hot flashes, and joint pain. These side effects can lead some women to stop treatment early, reducing the medication’s effectiveness. By examining genetic variations in these two genes, we aim to understand why some women experience more severe side effects than others. This research is conducted within the MAP.3 trial, a large international study involving over 4,500 women, making our findings robust and widely applicable. Our goal is to identify genetic markers that predict who is more likely to experience side effects from EXE. This knowledge could enable doctors to personalize treatment plans, improving adherence to breast cancer prevention therapies and enhancing the quality of life for women undergoing EXE treatment. Ultimately, this study strives to support more effective breast cancer prevention strategies and contribute to personalized medicine, ensuring that each woman receives the most suitable care based on her genetic makeup.

Proposed Clinical Trials-Related Project Description
by Una Spasovski

PRophylactic Indomethacin in MicropreemiEs (PRIME) – a retrospective cohort study

Infants born extremely prematurely, especially before 26 weeks, are very vulnerable and often face significant short and long-term health issues. One of the most critical complications is severe intraventricular hemorrhage (IVH), a type of brain bleed, that continues to be the leading cause of death in extremely premature infants. Severe IVH can lead to other significant long-term problems such as cerebral palsy, reduced IQ, and overall neurodevelopmental disabilities. Clinical trials have shown that preventative indomethacin, a type of drug, can prevent IVH and death. Between 2018-2022 in Canada, extremely premature babies who received indomethacin had a 5% lower death rate and were 4% more likely to survive without severe IVH in comparison to those who did not receive the drug. However, there are no recent studies on the effect of this drug on short- and long-term neurodevelopmental outcomes in the extremely premature population. Therefore, we propose a study linking data from the Canadian Neonatal Network and the Canadian Neonatal Follow Up Network to investigate the relationship between preventative indomethacin and death and disability in extremely premature infants. This study will lay the groundwork for a future clinical trial on the use of indomethacin specifically in the most vulnerable population

Proposed Clinical Trials-Related Project Description
by Michael Diaz-Stewart

Circulating Tumor DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colorectal Cancer: A Randomized Phase III Trial (DYNAMIC-III/CO.29)

Colorectal cancer is the second most deadly cancer in Canada. Treatment typically involves surgery and chemotherapy, which can be effective but also cause significant side effects and not always prevent the cancer from returning. The DYNAMIC-III/CO.29 study is a major international clinical trial involving 1000 patients who have had surgery for stage III colorectal cancer. This trial is trying a new approach that identifies fragments of tumor DNA in the blood, called circulating tumor DNA (ctDNA), to tailor chemotherapy more closely to each patient’s needs. By checking for ctDNA shortly after surgery, doctors can adjust the intensity of chemotherapy—either increasing it if ctDNA is detected, suggesting remaining cancer, or reducing it if no ctDNA is found, to spare unnecessary side effects. The study aims to see if this personalized strategy can improve patient outcomes, decrease side effects, and reduce healthcare costs. This could revolutionize how stage III colorectal cancer is treated and pave the way for more personalized cancer treatments.

Proposed Clinical Trials-Related Project Description
by Dana Lao

Harmonized biomarkers to measure response to ustekinumab in type 1 diabetes

In type 1 diabetes (T1D), immune cells called T cells destroy insulin-producing beta cells, causing lifelong insulin dependence. Blood glucose control remains imperfect despite insulin injections, leading to an increased risk of complications from chronic hyperglycemia and a shortened lifespan. An antibody known as ustekinumab has been found to inhibit inflammation and can be safely administered to young adults 5 with recent-onset T1D. Our clinical trial, UST1D2, aims to test ustekinumab’s ability to halt progression of recent-onset T1D in young adults. This drug was previously demonstrated to decrease inflammatory proteins thought to damage islets, IFN-γ and IL-17. Changes in inflammatory proteins and in the balance of immunoregulatory versus inflammatory cells may elucidate ustekinumab’s mechanism of action and biomarkers of response to therapy. To comprehensively evaluate mechanism and response biomarkers, the mechanistic studies carried out are harmonized between UST1D2 and another study called USTEKID that tests ustekinumab in children. This increases sample size, allowing for faster determination of treatment effectiveness. Our project contributes toward evaluating ustekinumab as a T1D treatment and represents a new collaborative model to evaluate outcomes from international, multi-centre clinical trials.

Proposed Clinical Trials-Related Project Description
by Tucker Reed

Assessing the impact of the Diabetes Mobile Clinic (DMC) on access to diabetes screening and subsequent management of preventable complications among socially disadvantaged populations in Calgary

Access to regular screening for the retina, feet, and kidneys, along with timely diabetes education, is crucial for managing diabetes effectively. However, many individuals from underserved populations face barriers to accessing these services, leading to poorer health outcomes. These barriers include competing needs and priorities, scheduling difficulties, transportation costs, inadequate public transportation, and perceived judgment and stigma. Our previous work showed that individuals from disadvantaged neighbourhoods in Calgary are 30-40% less likely to attend diabetes specialty appointments. To address this, we developed a pilot study, to provide accessible screenings for diabetes complications to adults experiencing homelessness in Calgary. Although promising, the pilot study was not randomized and didn’t assess long-term outcomes. Building on its success, we launched the Diabetes Mobile Clinic 5 (DMC) in collaboration with The Alex Community Health Centre. The DMC is a comprehensive clinic, aimed to aid in the accessibility of diabetes specialty care, such as diabetes specialists and screening for eye, kidney, and neurovascular complications. This study will test both the implementation/feasibility of the program and the effectiveness of the DMC in adults aged 18-85 years with diabetes mellitus who are being discharged from acute care facilities within Calgary, Alberta through a hybrid-type 2 randomized controlled trial.

Proposed Clinical Trials-Related Project Description
by Jana Radosavljevic

Identification of Sex- and Gender-Based Immune Subtypes in Depression

Women are understudied in health research, despite significant sex (biological) and gender (sociocultural) differences influencing the risk of developing disorders. Women are twice as likely to experience major depressive disorder (MDD) and have higher rates of autoimmune disorders. Interestingly, having an autoimmune disorder increases MDD risk, and individuals with MDD often have inflammation. Women are also more likely to have physical MDD symptoms like fatigue, which has been linked to inflammation, and gender inequality can worsen MDD symptoms in women, mainly for those who are non-white, less educated, unmarried, or have lower income. Moreover, research has shown that some individuals with inflammation do not respond to antidepressants, which has led to new anti-inflammatory medications that can relieve depression symptoms for all men but only women with high inflammation. Thus, research on sex and gender differences are needed to reveal health inequities for everyone. We will analyze 883 immune samples from clinical trials, including those at high-risk for MDD, current MDD, and healthy controls. Using clustering analysis, we will identify protein-clusters associated with inflammation and examine how sex and gender-related sociodemographic factors intersect to 11 influence these immune subtypes. This will advance our understanding of MDD risk, biology, and treatment.

Proposed Clinical Trials-Related Project Description
by Julia Downey

Using preferences and best existing evidence to inform the design of future clinical trials in rheumatoid arthritis

This MSc project will explore, through simulation and modelling studies, the expected results and impact of different novel trial designs for second-line biologic therapy in rheumatoid arthritis (RA). It will specifically look at the feasibility and expected impact of a trial that allows patients to be randomized between several treatment option of choice.

Proposed Clinical Trials-Related Project Description
by Claire Hopkins

Comparison of Knee Gait Parameters on Varying Walking Terrains Before and After Total Knee Arthroplasty: Secondary Analysis of Randomized Clinical Trial Data

Osteoarthritis (OA) is a prevalent form of arthritis and commonly affects the knee. The aim of a total knee arthroplasty (TKA) is to improve knee mechanics, decrease knee pain, increase function of the knee, and thus improve patients’ quality of life. TKA is effective for correcting end stage OA of the knee. One of the main patient goals of receiving a TKA is improvements in the ability to walk without knee pain. The purpose of this project is to perform a secondary analysis of clinical trial data to compare differences between pre-operative and post-operative walking. This will inform how TKAs impact knee pain, movements, forces, and walking patterns. These walking parameters will be evaluated with different walking conditions. These conditions include level treadmill walking, uphill/downhill walking, and crossslopes (similar to walking on the side of the road). Different walking terrains may detect subtle changes in how the knee moves. We will also examine if males and females demonstrate different walking patterns after TKA. This information may inform walking retraining and rehabilitation after TKA to improve patients’ function and quality of life.

Description du projet proposé lié aux essais cliniques
par Vrinda Dimri

Sex Matters: Does biological sex moderate the effect of different types of exercise on cognitive function in older adults with mild cognitive impairment?

Individuals with mild deficits in their thinking abilities are at risk for dementia, and more than half of all dementia cases are among females. Exercise, such as running (aerobic training) and lifting weights (resistance training) can improve thinking abilities and reduce risk factors for dementia. Research suggests females benefit more from aerobic training than males in improving thinking abilities; however, the quality of evidence is low. Notably, no study has been specifically designed compare the effects of different exercises on thinking abilities between females and males living with impaired thinking abilities. To address this important knowledge gap, we recruited and trained 228 older adults living with impaired thinking abilities to determine whether the benefits of different types of exercise training for thinking abilities (cognitive function) and the brain differ between males and females. The participants were divided into four training groups: aerobic, resistance, combination, and balance (as the control group). Participants were asked to attend instructor-led exercise training classes 4x/week for six months. Before and after the intervention, we measured their thinking abilities and scanned their brains to study brain structure and function. Our findings will allow more precise exercise recommendations for individuals to promote their brain health.

Description du projet proposé lié aux essais cliniques
par Jessica Barron

Determining optimal timing of clinical intervention and efficacy of huntingtin-lowering therapeutics in a Huntington’s disease mouse model

Huntington’s disease (HD) is a fatal hereditary brain disorder caused by a mutation in the huntingtin (HTT) gene. HD symptoms include issues with movement and cognition, which typically begin in mid-adulthood and progress rapidly. There is no cure for HD, only treatments that help manage symptoms. However, many drugs that target the root cause of HD by lowering levels of HTT have entered clinical trials in recent years. Two promising therapeutic approaches include antisense oligonucleotides (ASOs), which are injected through the spinal cord, and small molecule drugs that are taken orally. While both have shown promise as treatments for HD, they have not been directly compared to each other in a living system, and the optimal time point for drug delivery has not yet been determined. Our study will use a mouse model of HD that closely mimics human disease. Here, we will test both HD therapeutics in these mice before and after symptoms appear, then examine the brain and bodily fluids to measure how effective these drugs are at stopping disease progression. Results from this project will help determine which treatment is more effective and when it should be administered, which will provide valuable insights for HD clinical trials.

Description du projet proposé lié aux essais cliniques
par Junbum Im

A phase 2 trial of gilteritinib in combination with azacitidine and venetoclax to overcome venetoclax resistance in patients with FLT3-wt acute myeloid leukemia

Acute myeloid leukemia (AML) is a rapidly growing blood cancer that originates in the bone marrow. Patients with AML have poor survival rates and limited treatment availability. The treatment combination of venetoclax and azacitidine has shown high response rates and improved overall survival in patients who cannot tolerate intense chemotherapy. However, a third of patients don’t respond and nearly all patients relapse. These patients are then left with no treatment options and diminished chances of survival. Here, we propose a clinical trial for this non-responding and relapsed patient cohort that combines the treatment gilteritinib with venetoclax and azacitidine. While gilteritinib is typically used for AML patients carrying a mutation in a protein called FLT3, recent studies show that this treatment can also benefit patients without this mutation. The trial focuses on this patient group and involves an initial treatment phase, followed by additional treatment phases if the patient responds, and the monitoring phase. This combination aims to improve patient survival rates and offer a novel treatment approach for patients who otherwise have no options. 

Description du projet proposé lié aux essais cliniques
par Luxcia Kugathasan

INcretin And TReatment with Inhibition of sodiUm-glucose cotRansportEr-2 combinaTion Insights into mechanisms implicated in Congestive heart failure: “NATRIURETIC” trial

Type 2 diabetes (T2D) is a widespread condition affecting over 350 million people globally. Despite current treatments, T2D still causes significant health problems and financial strain, particularly in Canada. New medications, like sodium-glucose co-transporter-2 inhibitors (SGLT2i), have been developed to better control blood sugar and have been seen to reduce the risk of death and heart failure in T2D patients. Another promising drug, glucagon-like peptide-1 receptor agonist (GLP-1RA), helps manage blood sugar and reduces risks of heart disease, although it doesn’t directly reduce heart failure risk.T2D patients are often at risk for heart failure and cardiovascular disease. Since SGLT2i and GLP-1RAs work in different ways to improve heart and kidney health, combining these two treatments may offer better outcomes.This study will test how two diabetes treatments, empagliflozin (SGLT2i) and liraglutide (GLP-1RA), work alone and together in 36 patients with T2D not yet with heart failure. Participants will be randomly assigned to start with one treatment for 6 weeks, then switch to the other for another 6 weeks. The study will primarily focus on measuring change in kidney function, blood pressure, and blood vessel health, to see how these treatments impact overall health when used alone and in combination. By comparing single drug with the combined approach, the study aims to determine if using both drugs together provides greater benefits. This trial aims to provide valuable preliminary data to guide future larger-scale studies and could help guide future treatments for T2D patients, particularly those with heart failure.

Description du projet proposé lié aux essais cliniques
par Yao Sun

Lower limb sensory modulation for managing urinary dysfunction after spinal cord injury – a pilot clinical trial

People with spinal cord injury (SCI) often experience problems with their bladder function, resulting in symptoms like urine leakage. The bladder and its associated structures are controlled by neural circuits located in the lower part of the spinal cord. This area also contains neural circuits that help control leg movements and sensation. Studies in animals showed that sensory input from the legs can affect muscles controlling urinary function. There is also evidence for such connections between these two systems in humans. For example, walking exercise or electrical stimulation of nerves in the lower leg may help with bladder symptoms in people with neural injury. The reasons for these effects are unclear. However, our recent studies indicate that the pelvic floor muscles, which are crucial for maintaining continence, are activated when people with SCI walk with the help of an exoskeleton. To better understand these phenomena, this proposal will examine the potential of using this neural connection to develop rehabilitation-based approaches to manage urinary dysfunction after SCI.

Description du projet proposé lié aux essais cliniques
par Glauco Plens

Partial Paralysis to Achieve Lung and Diaphragm Protection during Mechanical Ventilation: the PARADIGM Pilot Trial

Mechanical ventilation (support from a ‘breathing machine’) can be lifesaving for patients with severe acute respiratory failure. However, delivery of adequate mechanical ventilation can be challenging in very sick patients, because their respiratory muscles can generate very strong efforts which can overstretch and further damage the lungs. A strategy to protect the lungs from this damage is to use deep sedation and medications that paralyze the respiratory muscles (paralytics), allowing the clinical team to control exactly the amount of pressure in the lungs. On the other hand, if the respiratory muscles are completely paralyzed, they can atrophy and become weak, impairing the ability of the patient to breathe without the help of a mechanical ventilator. A new strategy to address this problem is to give light sedation and small doses of paralytics to keep the lungs protected from overstretch, while also preventing atrophy of the respiratory muscles by maintaining moderate effort. This strategy, termed partial paralysis, has been used in previous studies for only a few hours, but its feasibility and safety still need to be tested for longer periods. We will investigate if partial paralysis is effective to maintain the lungs and the respiratory muscles protected.

Description du projet proposé lié aux essais cliniques
par Romaniya Zayats

Allogeneic regulatory T cell therapy to prevent graft versus host disease.

Immune tolerance is a crucial process that protects our body from harmful foreign substances while preserving our own tissues. In the setting of transplantation, when immune tolerance fails the rejection process can lead to significant morbidity and mortality. Currently, there are no medications to promote immune tolerance so transplant recipients must take immunosuppressants for the rest of their lives. These drugs are often ineffective and cause many side effects. The goal of our clinical trial is to harness the natural properties of regulatory T cells (Tregs), a specialized type of white blood cell, to suppress unwanted immune responses and promote tissue healing. Tregs are rare in the bloodstream, but we have discovered that the thymus, typically discarded during heart surgery, is rich in easily isolated, pure Tregs. We have developed methods to isolate and expand thymus Tregs for clinical application and demonstrated their potential to enhance immune tolerance in mouse models of transplantation. This clinical trial aims to evaluate the safety and effectiveness of thymus Tregs in preventing chronic inflammation following bone marrow transplantation. We hope that the successful completion of this trial will expand the off-the-shelf thymus Treg therapies to various inflammatory diseases.

Description du projet proposé lié aux essais cliniques
par Mai Wageh

Exercise, Diet, and Muscle Health: Investigating Menopause’s Impact on Muscle Stem Cells and Lipid Metabolism

In Canada, physical inactivity contributes significantly to chronic diseases like cardiovascular disease and diabetes, which are responsible for over 50% of adult deaths. Women, especially post-menopause, are particularly vulnerable to these conditions. Skeletal muscle plays a crucial role in managing metabolic health, regulating blood sugar and storing fats for energy. However, excess muscle fat can impair mitochondria, muscle regenerative capacity, and blood sugar control. While exercise and diet can improve metabolic health, Health Canada’s guidelines rely largely on male data, leaving gaps in understanding female-specific responses – especially after menopause, where declines in estrogen place post-menopausal women at even greater risk of cardiometabolic disease.This project examines how exercise and improved diet quality affect muscle metabolism in pre- and post-menopausal women. Using advanced muscle imaging and metabolic analysis techniques, we will assess muscle regeneration, fat and sugar metabolism. We hypothesize that exercise will improve muscle fat size/distribution and stem cell activity, but post-menopausal women will require dietary changes for optimal metabolic benefits, demonstrating a blunted adaptive response compared to pre-menopausal women. Our findings will generate evidence-based knowledge on the effects of exercise and diet among women, supporting better strategies for preventing chronic disease and improving women’s health outcomes in Canada.

Description du projet proposé lié aux essais cliniques
par Brenda Valdes Sustaita

Urinary PROTeomic analyses in high-risk pregnancies complicated by preeclampsia (U-PROT Study)

Preeclampsia is a serious pregnancy complication and be devastating for both mother and baby. Preeclampsia is characterized by high blood pressure, organ damage, and protein in the urine. It affects 1 out of 12 pregnancies. Yet, no accurate clinical tools exist to predict preeclampsia, and its underlying causes remain unclear. Kidney damage is central to preeclampsia development. Urine is easy to collect, rich in information, and presents a valuable source of proteins for studying preeclampsia. Our study aims to: 1) investigate proteins in the urine that show different levels in preeclampsia, 2) develop a new predictive tool for preeclampsia, and 3) better understand the origins of this disease. We recruited pregnant individuals at high risk for preeclampsia. Urine samples were collected in the first and second trimesters and will be analyzed using specialized protein analysis techniques to identify and measure each protein’s quantity. Using artificial intelligence, we will determine its predictive ability for preeclampsia. Finally, we will investigate the biological processes that are related to the protein levels in samples from healthy subjects and individuals with preeclampsia. Effective preeclampsia prediction would enable preventive measures and optimal use of healthcare resources, ultimately accelerating the development of new treatments for preeclampsia.

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par Dihogo de Matos

Autonomic and Inflammatory Dysfunction in Postural Orthostatic Tachycardia Syndrome (POTS): A Randomized Trial of Auricular Vagal Neuromodulation Therapy

Postural Orthostatic Tachycardia Syndrome (POTS) is a disabling condition that mainly affects young women, causing a rapid increase in heart rate, lightheadedness, and brain fog when standing. These symptoms severely impact daily activities, education, and work. Current treatments focus on managing heart rate and blood volume but often leave patients with persistent symptoms. There is an urgent need for new, safe, and effective therapies that address a range of symptoms and underlying causes. This project will evaluate auricular vagal neuromodulation therapy (aVNT), a safe, non-invasive therapy that stimulates the vagus nerve through the ear. Research in other conditions shows that aVNT can balance the nervous system, reduce inflammation, and improve cognitive function. However, its effects on POTS remain unknown.In this Canadian clinical trial, we will test whether using aVNT daily for three months can improve the body’s regulation of blood pressure, reduce inflammation, enhance brain blood flow, improve cognitive abilities, and lessen the symptom burden in people with POTS. The study will combine advanced measures of nervous system activity, brain blood flow, and cognitive function, along with patient-reported outcomes. This research will provide critical evidence to support new, patient-centered treatment approaches for POTS and related autonomic and immune disorders.

Description du projet proposé lié aux essais cliniques
par Lauren Lindsay

Retrospective process evaluation of participation hesitancy and nonadherence in community-driven treatment trials in Arctic Indigenous communities

The Canadian North Helicobacter pylori (CANHelp) Working Group conducts community-driven projects to address concerns of Indigenous communities in the Northwest Territories and Yukon, Canada, about Helicobacter pylori (Hp) infection and its link to stomach cancer. During 2008 to 2018, nine communities launched a CANHelp project that screened participants for Hp infection and offered treatment to those who tested positive. Each community project included a randomized controlled treatment trial designed with community input to identify effective treatment regimens. These community trials engaged underrepresented Indigenous populations in clinical trial research. Of the 1422 participants screened for Hp across the nine communities, 682 tested positive. Of the 682 who tested positive, 504 received treatment; 340 of whom enrolled in a treatment trial. Of the 340 trial participants, 231 returned for a post-treatment breath test to assess treatment success. My project aims to assess nonparticipation and loss-to-follow-up in community-driven treatment trials using process evaluation methods that incorporate input from community members. The findings will inform clinical trial best practices recommendations, public health initiatives, and future stomach cancer prevention activities.

Description du projet proposé lié aux essais cliniques
par Kylie Arsenault

Feasibility and Effectiveness of an Adapted Virtual Group Cystic Fibrosis-Specific Cognitive Behavioural Therapy (CF-CBT) for Adults with CF on Highly Effective Modulator Therapies: A Pilot Randomized Clinical Trial

Cystic fibrosis (CF) is a genetic disease that affects multiple organs, shortens lifespan, and is linked to worse mental health. New highly effective modulator therapies (HEMTs) have improved life expectancy and fertility for people with CF. As a result, family planning and parenthood have become important, yet stressful topics for adults with CF. Research shows people with CF desire more support to navigate reproductive health decisions. CF-Specific Cognitive Behavioural Therapy (CF-CBT) is an online group program that addresses the emotional challenges of living with CF, but does not yet include support for family planning and pregnancy. This study will test the addition of a fertility-specific module to CF-CBT. Adults with CF taking a HEMT, considering starting a family, and experiencing anxiety or depression will be recruited from Canadian CF clinics. Participants will be randomly assigned to one of three groups: 1) CF-CBT with the new module built in; (2) CF-CBT with the module delivered asynchronously; or (3) existing CF-CBT. This study will explore whether adapted CF-CBT is acceptable and effective for improving fertility-related distress, anxiety, depression, stress, coping skills, and quality of life. Adapted CF-CBT could provide CF clinics a valuable program to better support reproductive and mental health needs.

Description du projet proposé lié aux essais cliniques
par Maha El-shimy

Association of Acute Postoperative NSAIDs Use and Chronic Postsurgical Pain: A Target Trial Emulation in the POISE-2 RCT

Long-lasting pain after surgery is a significant issue; in some patients, it can contribute to addition to pain medications. While common non-addictive medications called NSAIDs (like ibuprofen) are effective for immediate post-surgery pain, concerns about kidney damage often limit their use, especially in patients with pre-existing kidney problems.This research will analyze data from a large international study of over 10,000 patients who had non-heart surgery. Using advanced statistical methods that carefully mimic a new clinical trial, we aim to determine if short-term NSAID use immediately after surgery is associated with lower risk of developing persistent pain one year later without harming the kidneys. The findings could lead to safer pain management strategies, potentially reducing chronic pain and reliance on opioids. This work will also provide crucial evidence for designing future studies to directly test the best ways to use NSAIDs for pain relief in surgical patients, including those with kidney concerns, ensuring more people can recover from surgery without long-term pain.

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par Sarah Remedios

From Injury to Intervention: A Randomized Surgical Trial and Biomechanical Comparison in Rotator Cuff Tear Patients and Asymptomatic Adults

Shoulder disease and disability place a growing burden on the healthcare system. Rotator cuff (RC) tears are common, affecting 25% of adults over the age of 60, and disrupt normal shoulder movement by altering muscle activation which can lead to joint overload and loss of function. Although surgical repair is common, the impact of RC tears on shoulder function compared to individuals with asymptomatic shoulders remains unclear, and the role of surgery in restoring muscle coordination is not well understood.This study will examine how RC tears affect shoulder movement and muscle activity. Adults with and without a rotator cuff tear will complete a lab-based shoulder assessment, performing arm elevation tasks with and without added load. During these tasks, muscle activity and three-dimensional shoulder movement will be measured. Participants with a diagnosed tear will be randomly assigned to one of two surgical procedures. One year after surgery, these participants will repeat the same assessment to evaluate how well shoulder function has been restored.Expected outcomes include a better understanding of how RC tears impair movement, how surgical repair affects recovery, and which surgical approach leads to better functional outcomes. This information may improve treatment strategies and long-term results.

Description du projet proposé lié aux essais cliniques
par Callie Stirling

The effects of Zoledronic acid on longitudinal local subchondral bone changes and the presence of bone marrow lesions following an ACL injury.

Anterior cruciate ligament tears are common knee injuries, especially in young, active people. These injuries often lead to long-term problems like post-traumatic osteoarthritis (PTOA), a painful joint disease with no cure. One of the first changes after injury happens deep in the bone near the knee joint, where bruises and swelling cause the bone to weaken. We want to understand how this bone damage leads to long-term joint breakdown—and whether we can stop it. This study follows people with recent ACL injuries for 18 months to see how their bone and joint change using advanced imaging like MRI and CT scans. In one part of the study, participants are randomly given either Zoledronic Acid (Zol), a drug that slows bone loss, or a placebo. We will look at whether this one-time treatment helps protect their knee bones and slows or stops the changes that cause PTOA. If successful, this could become a quick, simple treatment that prevents life-long problems after knee injury. Since Zol is already approved for other bone diseases, we hope this research will speed up how quickly it can help people with knee injuries.

Description du projet proposé lié aux essais cliniques
par Tina Kabir

Coordinating smoking cessation treatment with menstrual cycle phase to improve quit outcomes (MC-NRT Study): a randomized controlled trial and mixed methods process evaluation.

Women find quitting smoking more difficult than men. Research suggests that hormonal changes during the menstrual cycle (monthly hormonal cycle that results in periods) might affect a person’s ability to quit. This study’s goal is to find out whether quitting smoking during a specific phase of the menstrual cycle can improve quit success compared to quitting without considering menstrual cycle. This online quit-smoking study aims to enroll 1,200 people who will receive six weeks of nicotine replacement therapy (NRT). Participants are randomly assigned to start their quit attempt either shortly after their period; a few days before they are supposed to get a period; or regardless of their period. One week, six weeks, and six months after their quit date, participants are asked to report if they have been smoke-free. The number of successful quitters at each time point will be compared between groups. Researchers will also interview participants to understand whether the study has been helpful, and if the fully virtual study procedures were acceptable. If effective, the menstrual cycle timing strategy could make quitting easier by aligning treatment with natural hormonal cycles. Combining this approach with accessible tools like NRT could help more people successfully quit smoking.

Description du projet proposé lié aux essais cliniques
par Emma Finch

Targeted Urine Metabolomics for Enhanced Diagnosis of Hypoxic-Ischemic Encephalopathy in Newborns

Infants are at risk of a lack of oxygen to the brain when being born and this can cause brain damage (called hypoxic-ischemic encephalopathy (HIE)). The condition can have long-term adverse effects on infants including cerebral palsy (CP). Cooling therapy of infants can prevent CP if it is recognized early. Current diagnosis of HIE is based on clinical features of the child and measuring lactate levels. These predictors are not able to identify all affected infants and can be influenced by the experience of the healthcare practitioner. Thus, a better objective test based on metabolite levels would be a significant improvement to available diagnostic tests. Liquid Chromatography- Mass Spectrometry (LC-MS) is a method of analyzing small molecules, such as metabolites, which are directly affected by disease state. The analysis of a non-invasively collected fluid, namely urine, using LC-MS holds promise as a novel diagnostic tool. An initial pilot study showed that 15 quantifiable metabolites were differentially expressed between healthy and HIE infants. A clinical study to refine the diagnostic model is of value as it can contribute to the development of an objective diagnostic tool, which can be used to prevent brain injury.

Description du projet proposé lié aux essais cliniques
par Michael Ibekaku

Dementia Moves: Testing a Rehabilitation Program for Long-Term Care Residents with Moderate to Severe Dementia

« People living with dementia often experience a decline in their ability to do everyday activities like walking, dressing, or eating. While research shows that structured exercise can help slow this decline, residents in LTC homes are often left out of exercise programs or research studies. When they are included, the programs are rarely tailored to their individual needs especially for those with more advanced stages of dementia. To address this gap, we developed Dementia Moves, a new group-based exercise program designed specifically for LTC residents with moderate to severe dementia. The program was co-created with input from people living with dementia, family caregivers, long-term care staff, and researchers to make sure it reflects the real needs and abilities of those in care. Each session includes aerobic activity, strength training, balance exercises, and mindfulness, all adapted to the residents’ preferences and capacities. In this study, we will test whether it’s possible to successfully run the Dementia Moves program in two LTC homes in Halifax. We want to see how many residents we can recruit, how many complete the program, and if they will finish the study. This research will help us prepare for a larger study in the future. »

Description du projet proposé lié aux essais cliniques
par Silar Gardy

High-intensity impact training with nutrition supplementation to improve bone health in female endurance athletes: A pilot feasibility study.

Endurance athletes may be at risk for poor bone health due to intense training and elevated nutritional needs. While high-impact exercise and adequate nutrition are can help support strong bones, there are few bone-targeted interventions in athletes, especially females who are at greater risk for impaired bone health. This study will evaluate whether it is feasible to recruit and retain female endurance athletes in an 18-week trial comparing high-intensity impact training, combined with protein and carbohydrate supplementation, to a standard care approach. The results will inform the design of a future, larger trial.

Description du projet proposé lié aux essais cliniques
par Makan Pourmasoumi

Evaluating the Effect of a Relaxing Virtual Reality Environment on Glucose Response Following Consumption of High-Glycemic Instant Rice

Virtual reality (VR) is a technology that creates computer-generated environments that feel real. While a stress-inducing environment, like a horror game, can increase stress, a calming VR environment can help reduce it. Since stress can also affect blood sugar, this is especially important for people at risk of diabetes or other chronic conditions.As VR has the potential to influence stress, we designed a randomized crossover clinical trial to explore whether relaxing VR environments can improve the body’s response to food. In this study, each participant will experience four different conditions in a specific order: a relaxing VR environment, a stress-inducing VR environment, a neutral VR environment (similar to a basic lab setting), and a standard clinical lab setting without VR. Participants will either wear a VR headset or sit in a lab for 15 minutes, then eat a ready-made instant rice meal over 10 minutes. They will continue the same activity for one more hour. During this time, we will measure blood sugar at several points, along with stress levels, skin conductance, and heart rate. This study will help us understand whether changing the environment, such as using relaxing VR, can help manage blood glucose levels.

Description du projet proposé lié aux essais cliniques
par Sabrina Shafi Zinia

Anti-fibrotic therapies as modulators of Particulate Matter <2.5-associated harms in patients with fibrotic interstitial lung disease (fILD)

Fibrotic interstitial lung disease (fILD) reflects a group of conditions that cause lung scarring and breathing difficulty. Air pollution particles are dangerous to everyone, but especially threaten people with fILD, where this exposure increases the risk of disease worsening, hospital visits, and death. These particles are produced by human activities like vehicle traffic and factory exhaust, but also from natural sources like wildfire smoke. We do not understand how current treatments of fILD impact pollution risk in this population. This study will determine whether a common anti-fibrotic medication used to treat patients with fILD, nintedanib, protects against air pollution. This research will involve international nintedanib clinical trials data involving over 2,400 people with fILD. Satellite data will estimate pollution exposures at patients’ home locations. This study will also evaluate markers in the blood that determine how biologically young or old a person is, including telomere length and epigenetic aging, to understand if treatment with nintedanib changes molecular responses to pollution. We expect this research to show that people treated with nintedanib are more protected from the harmful effects of air pollution. This will help to design future treatments and to protect people with lung disease from harmful environmental exposures. 

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par Sam Pedro Galilee Ayivi

Évaluation de l’hématopoïèse clonale de potentiel indéterminé (CHIP) pour prédire la réponse à la metformine et à la dapagliflozine chez les personnes atteintes de diabète de type 2, en tenant compte des différences attribuables à l’origine de populations.

Le diabète de type 2 est une maladie fréquente qui augmente les risques de complications graves, comme les maladies cardiovasculaires, les cancers ou les maladies des reins. De plus, avec l’âge, nos cellules souches sanguines peuvent accumuler des mutations dans des gènes associés aux cancers du sang. Ces mutations confèrent à ces cellules un avantage prolifératif, leur permettant d’augmenter leur proportion dans le sang au fil du temps. Chez les personnes présentant ces mutations, appelées hématopoïèse clonale de potentiel indéterminé (CHIP), il n’y a pas de cancer du sang diagnostiqué ni d’autres anomalies hématologiques évidentes. Les mutations CHIP sont désormais reconnues comme un facteur de risque indépendant des maladies cardiovasculaires et métaboliques. Des études montrent que les mutations CHIP dans les gènes TET2 et DNMT3A sont associées à une inflammation systémique accrue et à une réponse aux traitements anti-inflammatoires altérée. Nos études préliminaires montrent également qu’il existe une interaction entre CHIP et la metformine, médicament utilisé pour le traitement du diabète de type 2. Dans ce projet, nous allons analyser des données provenant de grandes études cliniques internationales pour évaluer si les personnes atteintes de diabète de type 2 et porteuses de CHIP répondent différemment à la metformine ou à la dapagliflozine. Ces recherches pourraient ouvrir la voie à une médecine personnalisée, en adaptant les traitements selon le profil génétique de chaque patient, et ainsi mieux prévenir les complications du diabète.

Description du projet proposé lié aux essais cliniques
par Alvin Kimbowa

Developing Methods for Quantitative Assessment of Cartilage and Synovitis in Knee Osteoarthritis Using Point-of-Care Ultrasound Devices

Knee osteoarthritis (OA) is a common condition that causes pain, stiffness, and reduced mobility, especially in older adults. It affects over 650 million people worldwide and is a leading cause of disability. Despite its impact, there is currently no cure, and the disease is not fully understood. Medical imaging plays an important role in studying OA and guiding its management. The current gold standard is Magnetic Resonance Imaging (MRI), but MRI is expensive, has long wait times, and is often unavailable in rural and remote areas. Recent advances in portable ultrasound devices offer a promising alternative for imaging the knee. However, ultrasound results depend heavily on the skill of the operator, are prone to inconsistencies, and currently lack the ability to detect mild inflammation typical in knee OA. This project aims to enhance portable ultrasound using artificial intelligence (AI) to automatically analyze knee images and detect mild inflammation. The study will collect ultrasound data from both healthy volunteers and OA patients to train and test the AI algorithms, and the results will be compared with standard clinical assessments. When successful, these tools will enable more accurate, consistent, and accessible evaluation of knee OA, especially in clinical research and trials.

Description du projet proposé lié aux essais cliniques
par Sophia Pawelko

Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Randomized Controlled Trial

Stroke is one of the main causes of long-term disability in adults. Improvements in early stroke care have resulted in more people surviving strokes and living longer. However, the first six months after a stroke are especially important for recovery as early walking recovery can help people leave the hospital sooner and reduce the risk of having another stroke. Unfortunately, many survivors become very inactive after leaving the hospital. This physical inactivity can slow their recovery and affect their quality of life. To address this issue, this research project looks to implement a program called BIG STEPS (Behavioral Intervention and Guided Stepping Training Early Post-Stroke). This program is designed to help survivors and their care partners become more active by increasing daily steps and reducing time spent sitting. In this study, 30 stroke survivors will be randomly placed into two groups: one will receive the BIG STEPS program in addition to their regular care, while the other group will continue with usual care and receive the program later. The goal is to see if BIG STEPS helps improve walking, independence, and confidence to keep moving. The results could lead to more personalized and effective stroke recovery programs in the future.

Description du projet proposé lié aux essais cliniques
par Dan Nguyen

Urolithin A Supplementation during Pulmonary Rehabilitation Participation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Pilot & Feasibility Study

Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung disease that is a leading cause of morbidity and death. Patients with COPD often have persistent breathlessness and low exercise tolerance which affect their ability to do everyday tasks. COPD treatments include medications/inhalers, and participation in pulmonary rehabilitation (PR), a multidisciplinary program consisting of exercise, education, and nutritional counseling led by a diverse team of healthcare experts. PR has consistently been found to improve breathlessness and exercise tolerance in patients with COPD. It is possible that supplementation with Urolithin A, a compound which been found to be safe, well-tolerated, and improve exercise capacity in healthy adults, may further enhance clinical benefits from PR participation in patients with COPD. This study will recruit up to 22 participants with COPD who are participating in an 8-week PR program, during which they will be randomly assigned to receive either Urolithin A or an indistinguishable placebo. Participants will be assessed on their exercise capacity, body composition, muscle strength, quality of life, and on a volunteer basis, their muscle tissue characteristics. This study will test the feasibility of recruiting patients and of completing the whole study including all scheduled clinical tests.

Description du projet proposé lié aux essais cliniques
par Wafa Hassan

A 2×2 factorial, randomized, open-label trial to evaluate neuromodulators and cough control therapy in patients with refractory or unexplained chronic cough: the FORTITUDE trial protocol

Chronic cough that doesn’t improve with treatment or has no clear cause can greatly affect a person’s quality of life. Doctors sometimes prescribe medications like low-dose morphine or pregabalin, but there are no direct comparisons to show which works better. Non-drug treatments like breathing and speech therapy are also recommended, but they haven’t been well studied. The FORTITUDE trial will test how well these treatments work—alone or in combination—in adults across Canadian hospitals. Participants will be randomly assigned to receive either low-dose morphine or pregabalin, with or without a virtual cough therapy program led by a physiotherapist and speech-language pathologist. The study will track changes in cough frequency, severity, and impact on daily life over 6 weeks and up to 1 year. This trial will provide much-needed evidence to guide doctors and patients in choosing safe, effective treatments for chronic cough.

Description du projet proposé lié aux essais cliniques
par Yuwei Li

Optimizing cerebellar theta burst stimulation to improve motor performance after stroke: a pilot clinical trial

The ability to accurately perform movements and respond to changing environments is essential for daily life. This is often disrupted after a stroke, leading to motor impairments and a reduced quality of life. The cerebellum is an important brain structure involved in movement coordination and learning, making it a promising target for improving motor performance. Transcranial magnetic stimulation (TMS) is a non-invasive and safe technique used to measure or modulate brain activity. Theta burst stimulation (TBS), a patterned form of TMS, uses short bursts of stimulation to induce lasting changes in brain activity. While TBS has shown therapeutic potential in various clinical populations, its rehabilitative effects and underlying mechanisms in stroke survivors remain poorly understood. This study aims to investigate whether applying TBS over the cerebellum can improve motor performance in individuals with chronic stroke. We will assess participants’ movement accuracy and ability to adapt to a visual rotation after receiving real or sham TBS. Different stimulation doses will be delivered to determine the optimal amount to elicit meaningful changes in behaviour and brain activity. My findings will help inform future rehabilitation interventions aimed at improving movement performance and promoting motor recovery post-stroke.

Description du projet proposé lié aux essais cliniques
par Will Roderick

Evaluating novel MST1 inhibitors as a potential therapeutic strategy for multiple myeloma

Multiple myeloma (MM) is a type of cancer affecting bone marrow, leading to serious health issues including bone damage, kidney problems, and anemia. Although new treatments have improved survival and quality of life, MM remains incurable, with patients experiencing relapses and resistance to existing therapies. Recent research has identified the Hippo signaling pathway, particularly the MST1 protein, as a potential target for new MM treatments. In MM,components of this pathway (like TAZ) may actually suppress tumor growth. Previous studies have shown that increasing TAZ activity can trigger cancer cell death in MM, but the drugs tested so far either lack specificity or require high, potentially unsafe doses. This study aims to evaluate three new MST1 inhibitors that have shown high specificity and effectiveness at very low doses. The study will test these drugs on MM cell lines to determine how well they work alone and in combination with existing treatments.We will measure how the drugs affect proteins and genes in the Hippo pathway, and whether they can induce cancer cell death. Ultimately, this research hopes to identify promising new drugs that could be more effective and safer for MM patients, leading to better treatment options in the future.

Description du projet proposé lié aux essais cliniques
par Sydney MacNinch

Dementia Moves: Testing the Effects of a Rehabilitation Program for Long-Term Care Residents with Moderate to Severe Dementia on Activities of Daily Living, Falls and Adverse Events

Dementia Moves is a physiotherapy-led group rehabilitative exercise intervention designed to provide a research-based approach to group exercise within long-term care (LTC) for individuals living with moderate to severe dementia. The number of LTC residents living with dementia is continually rising in Canada. Physiotherapy, in the form of exercise, is vital for individuals living with dementia to maintain independence, though, LTC residents with dementia often receive less physiotherapy care than their counterparts. This sub-study is intended to provide information on the effects of Dementia Moves on activities of daily living (e.g., grooming, dressing), falls and other adverse events. Using evidence-based practices for exercise adherence and benefits, the program will consist of aerobic, strength, and balance exercise, with mindfulness exercises included, delivered by physiotherapists, physiotherapy assistants and volunteers. We aim to maintain or improve residents’ independence and sense of self, while decreasing stress and burden on nursing and care staff in these settings. This pilot study will inform a future larger study to examine if implementing Dementia Moves in LTC homes is more beneficial to the residents and staff, than the current physiotherapy method most residents living with dementia receive, which is little to no physiotherapy care.

Description du projet proposé lié aux essais cliniques
par Kamrani Doray

Transcranial direct current stimulation (tDCS) in combination with varenicline for tobacco smoking cessation: a randomized controlled trial

Quitting smoking cigarettes is extremely difficult, and most smokers relapse within a few months despite access to medications and various treatment options. This study investigates a new approach to help individuals quit smoking by combining a stop-smoking medication called varenicline with a safe, non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS). Varenicline aids in reducing cravings and withdrawal in smokers, while tDCS targets brain regions involved in addiction and impulse control. Participants in this study will receive varenicline for 12 weeks while attending brief tDCS sessions in which a mild electrical current is applied to the scalp. The purpose of this study is to see whether this combination leads to better quit rates when compared to varenicline on its own. The study will also use computer-based tasks to investigate attention and memory in each participant, which are often affected during nicotine withdrawal. By exploring this new treatment strategy, we hope to improve long-term success rates for those who want to quit smoking. This combined approach, if successful, could offer an effective and accessible option for individuals trying to quit smoking tobacco in Canada and around the world.

Description du projet proposé lié aux essais cliniques
par Naila Bouadi

La réticulation du collagène cornéen afin d’augmenter la résistance des greffons utilisés comme support à la Kératoprothèse de Boston Type I.

La cornée est souvent décrite comme la « fenêtre de la vision » : cette structure transparente à l’avant de l’œil permet à la lumière d’entrer et de se focaliser sur la rétine. Lorsqu’elle est endommagée par une maladie ou un traumatisme, la vision peut être considérablement altérée, voire complètement perdue. Pour restaurer la vision, une des options thérapeutiques est la greffe de cornée, qui consiste à remplacer la cornée malade par un greffon cornéen provenant d’un donneur. Toutefois, certaines greffes échouent, notamment en raison de rejets, d’infections, ou d’une dégradation du tissu greffé. Chez les patients pour qui la greffe conventionnelle échoue, une alternative est la kératoprothèse de Boston type 1 (KPro). Cependant, le succès de cette prothèse dépend de la stabilité du greffon-support dans lequel elle est insérée, et ce greffon demeure vulnérable à la dégradation. Cette étude vise à tester si l’utilisation de greffons cornéens renforcés par une technique appelée réticulation du collagène peut prévenir cette dégradation. L’étude est menée au CHUM, avec un suivi à long terme. Les résultats pourraient améliorer la durabilité de la KPro et, plus largement, les soins offerts aux patients atteints de maladies oculaires graves.

Description du projet proposé lié aux essais cliniques
par Nicole Bushfield

Molecular Signatures of Brain Hypoxia After Cardiac Arrest: A Multi-Omic Analysis of Hypoxic-Ischemic Brain Injury in Humans

Each year, ~60,000 Canadians experience cardiac arrest. Even when circulation is restored many patients suffer lasting brain injury due to inadequate oxygen delivery to the brain, known as hypoxic-ischemic brain injury (HIBI). HIBI is the leading cause of death in post-cardiac arrest patients and contributes to long-term neurological disability in survivors. Yet, there are currently no targeted therapies to treat it.
This research aims to improve our understanding of HIBI by identifying biological markers of brain oxygen deficiency and injury. Using real-time brain monitoring data and biological samples from critically ill patients and healthy controls, the study will apply analysis of thousands of proteins and metabolic markers to identify molecular changes associated with poor brain oxygenation. These findings will clarify how injury develops at the cellular level and uncover potential therapeutic targets.
One key goal is to discover blood-based biomarkers that could serve as simple, non-invasive tools to assess brain injury severity, especially in settings lacking access to advanced neuroimaging. These biomarkers could guide clinical decisions and support personalized treatment strategies. Ultimately, this research will lay the groundwork for future clinical trials aimed at improving outcomes for patients with HIBI and reducing the burden of brain injury after cardiac arrest.

Description du projet proposé lié aux essais cliniques
par Jordyn Burgar

Pharmacist-physiotherapist collaborative management for early knee osteoarthritis

Osteoarthritis (OA) is a progressive chronic condition associated with aging and characterized as joint pain which greatly impacts quality of life. It is known that >25% of people aged 55+ report knee pain of ≥4 weeks duration and that 40% of people being assessed for knee replacement have not had appropriate conservative care. Individuals with early-stage OA usually attempt to treat their joint pain & stiffness with over-the-counter pain medication. Therefore, Alberta pharmacists can be seen as a first point of contact to identify, support, and direct patients with OA to appropriate care by a physiotherapist. Early identification of people in the community will provide self-management skills, pain relief, and help maintain their physical function, productivity, and mental health. The primary objective is to evaluate the effectiveness of a 3-month pharmacist-physiotherapist community collaboration in early knee OA on pain relief and functional improvement. Little research has looked at early knee OA in the community, more often than not, moderate to advanced OA is evaluated when people access the medical system. This study will examine the clinical effectiveness and feasibility of this unique primary care collaboration, where pharmacists and physiotherapists provide education about self-efficacy along with medication management and evidence-based exercise.