All Clinical Trials in Canada

COVID-19 has placed unprecedented strains on parents impacted by toxic stressors (depression, addiction, family violence, and poverty) and reluctant to see mental health-service providers in home/clinic due to fears of infection. Due to the pandemic, PI Letourneau ceased/delayed recruitment in ATTACH™, a CIHR-funded randomized controlled trials (RCT) of in-person (home or clinic) program designed to improve children's mental, emotional and behavioral (MEB) health and development via parent-child relationship intervention. Recognizing the heightened need for already vulnerable families to obtain safe parenting support to manage depressive symptoms/other stressors. The team's primary knowledge user (D. McNeil, Scientific Director, Maternal Newborn Child and Youth Strategic Clinical Network, Alberta Health Services) advocated for online delivery of the ATTACH™ parent training program. In response, an interdisciplinary team from nursing and software engineering rapidly pivoted to an online delivery format. Critical barriers to using existing commercial technologies emerged, making it essential to develop and implement tailored, user-informed virtual care delivery platforms and tools safe, secure, user-friendly for families already stressed. Innovative user interface design and integrated knowledge transfer approaches will be used to: (a) adapt ATTACH™ for virtual delivery; (b) develop virtual platforms (web-based applications) and tools (mobile apps) for flexible delivery of mental health supports for parents and training for professional facilitators; (c) integrate virtual mental health services into the primary care system promoting program uptake; and (d) design/test streamlined and intuitive virtual systems for nimble spread/scaleup. The project catalyzes and enriches the PIs' research program by crossing disciplines (nursing \& engineering) in cutting edge research that is responsive to trends in both mental health intervention and web-interface design. The aim is to adapt, develop, design and pilot test virtual (web-based) intervention program to improve children's mental, emotional and behavioral (MEB) health and development. This will be done by building on successful CIHR funded in-person (home or clinic) programs and pivoting to user-engaged program development, adaptation and pilot testing for virtual delivery in the face of COVID19. Read Less

Compression Garments are a commonly prescribed treatment in Postural Orthostatic Tachycardia Syndrome (POTS). The effectiveness of a proof-of-concept compression garment has been demonstrated in an acute laboratory setting. It is not known if commercially available compression garments that participants wear in their every day lives are effective at improving heart rate and reducing symptoms in POTS. This trial will evaluate the use of commercially available waist-high and abdominal compression garments in adults diagnosed with POTS in a community setting. Read Less

Project rationale: Vasovagal syncope (VVS) affects up to 50% of people, and recurrent syncope markedly reduces quality of life. We recently reported that it is frequently associated with injury and not surprisingly with clinical anxiety. Although conservative measures help many patients there remain many who require more care. CIHR-funded studies have shown that fludrocortisone and midodrine are effective but cannot be used in patients with contraindications such as hypertension and heart failure. Pacemakers are partially effective in older patients, but this is established only in the small minority with proven asystole. There remains a need for a simple, once-daily medication with few contraindications that can be used as first-line therapy for most patients with recurrent vasovagal syncope. Preliminary Studies: Norepinephrine transport (NET) inhibitors show promise as a novel treatment. Three (reboxetine, sibutramine, and atomoxetine) all prevent vasovagal syncope in healthy subjects and vasovagal syncope patients on tilt tests. Atomoxetine, approved to treat attention deficit disorder, is a highly selective NET inhibitor. We reported a proof-of-principle, randomized, placebo-controlled trial of the efficacy of atomoxetine to prevent vasovagal syncope on tilt table tests. Patients underwent tilt testing after receiving either atomoxetine 40 mg or placebo. Fewer VVS patients fainted with atomoxetine than placebo (10/29 vs. 19/27; odds ratio 0.22, p \< 0.01). Our meta-analysis of the effects of NET inhibition on the vasovagal reflex induced by tilt tests was highly positive. A pre-post study showed that sibutramine reduced syncope frequency in highly symptomatic and drug-refractory patients. A similar pre-post study showed that atomoxetine also reduces syncope frequency about 85% in patients with frequent and drug-intolerant or drug-resistant vasovagal syncope. Therefore,NET inhibition by atomoxetine merits assessment based on positive proof-of-principle studies, an apparent class effect, and two open-label pre-post studies. These results provide the rationale for a formal randomized, placebo-controlled, crossover trial of atomoxetine in moderate-to-high risk patients with VVS. Hypothesis: We will test the hypothesis that oral atomoxetine prevents syncope in patients with recurrent VVS. The Study: Patients will be included based on a positive Calgary Syncope Symptom Score and a history of at least 2 faints in the previous year. Eligible patients will be randomized to atomoxetine 40 mg po twice daily or matching placebo in a randomized, placebo-controlled, parallel design, double-blind, crossover trial. Each arm will last 6 months with a 1-week washout period. The primary outcome measure will be the proportion of patients with at least 1 syncope recurrence. The study will be powered to detect a beneficial odds ratio of 0.5, selected on the basis of the control outcome rates in 2 similarly designed, previous studies and international expert requirements for effect size. A sample size of 180 subjects will provide 85% power of detecting a difference between the arms at p\<0.05. We will assess the effects of atomoxetine on quality of life, anxiety, injury, and the cost-effectiveness of atomoxetine treatment, and the effects of genetic factors on outcomes. Substudies : The quality of life scales will be the SF-36 and the Euroqol EQ5D, which will also be used as the health utility index for the economic studies. The depression and anxiety scales will be the Hospital and Anxiety Depression Score (HADS) and the General Anxiety Disorder - 7 Score (GAD-7). Clinical anxiety is highly prevalent in patients with recurrent syncope. Injury will be self-reported using our published definitions. The health economic substudy will be from the health system perspective and will use Alberta administrative data. DNA will be collected from spit acquired in the Oragene saliva self-collection kits, and an initial candidate gene study might include alleles of CYP2D6, COMT, the serotonin (SLC6A4) and norepinephrine (SLC6A2) reuptake transporters, and the 5HT1A and 5HT3 receptors. Summary: Adults who faint recurrently are highly symptomatic. There are no therapies suitable for most patients have withstood the test of randomized clinical trials. If successful, atomoxetine will reduce syncope and improve quality of life. Read Less

About 65,000 Canadians develop acute respiratory failure requiring breathing machines (ventilators) to give oxygen to their lungs. Unfortunately, up to 50% of these individuals will not survive their illness. Mechanical ventilation through breathing machines, though potentially lifesaving, may further injure the lungs and the respiratory muscles. In the patients with the most severe and life threatening forms of respiratory failure a breathing machine alone may not be able to provide enough oxygen to the lungs and vital organs. In these critical situations, patients may require an artificial lung machine, which is referred to as extracorporeal membrane oxygenation (ECMO) to temporarily replace the function of the patient's own lung and supply critical oxygen to the body, while protecting the damaged lungs. How to use the breathing machine safely while a patient is on ECMO is still unknown. Using conventional breathing machine settings while on ECMO can lead to large portions of the lungs or airway to remain collapsed, which can contribute to further lung damage. The investigators have recently discovered a way of detecting if patients on a breathing machine suffer from collapsed airways. Knowing if the most severe patients on ECMO have airway collapse is a pivotal question that the investigators plan to answer in our study. The investigators will use our technique to determine how many patients on ECMO have airway closure and determine if this contributes to a longer time on ECMO and a longer time on a breathing machine, and if this impacts a patient's survival in the intensive care unit. Read Less

Timely access to family-centred services for children with disability and their families is important to support their development and well-being. Currently, many children face long wait times and barriers to services. Lack of access can lead to negative impacts for children and stress for their families. With the COVID-19 pandemic, these issues have been made more challenging with the loss of rehabilitation support for children, increasing stress on families. During this time, therapists moved to telehealth service delivery to support children and families. We know that telehealth can improve access to services, children's outcomes, and family satisfaction, and that telehealth a key element of Family Centred Services (FCS) in pediatric rehabilitation. FCC include practices that promote flexibility, respect and dignity for families' views, knowledge and strengths, effective information sharing, partnership and collaboration in decision making, and coordinated and comprehensive care. FCC focuses on developing collaborative family-provider relationships, where parents are active participants in collaborative goal-setting, therapy planning, implementation, and evaluation, and where activities are integrated within daily routines and contexts (e.g., home and community). Compared to traditional service delivery methods, telehealth offers opportunities to enhance FCC practices. FCC provides alternate, convenient, and flexible ways to partner with families, respecting their characteristics and barriers, allows knowledge and information sharing about the child within their contexts, supports family decision making and parents' well-being, and has been recognized as an important addition to comprehensive care coordination and service delivery. Telehealth is an important and effective alternative for families living in both urban and remote or underserved areas and can be more convenient than in-person visits (e.g., less travel time, schedule flexibility). However, the use of telehealth prior to the pandemic was low in pediatric rehabilitation. In addition, many therapists report delivering telehealth without prior experience, and lack confidence, knowledge, and training in effective intervention strategies. Although therapists' knowledge, skills and attitudes toward telehealth can improve with time and experience, training and support are required for behavioural changes to occur. Following the pandemic, there has been continued support for the use of FCT and for its ongoing use to support families of children with disability. Pediatric rehabilitation therapists, service managers, professional associations, policy makers, and families are all making the case for not "returning to normal", and are asking for help to keep telehealth as part of FCS care. The goal of the current study is to evaluate the use and effectiveness of a Training Intervention and Program of Support (TIPS) to increase the uptake of FCT in pediatric rehabilitation centres across Canada. The main research question is: Can TIPS be adapted to increase the use of FCT interventions by therapists working in different contexts? The primary objectives are to: 1. Evaluate the use of FCT regarding: 1. Therapists' desire to use vs actual use of FCT practices 2. Use of FCT practices as they were intended to be used Secondary objectives are to: 2. Describe the variations required to adapt the TIPS to meet each site's needs 3. Identify factors that influence FCT use and adherence 4. Evaluate the effectiveness with regards to: 1. Service wait-times 2. Family-centredness of services 3. Changes in service delivery 5. Evaluate the costs (and possible cost savings) related to increased use of FCT The primary hypotheses are that therapists' desire to adopt FCT and deliver FCT practices as intended will (i) improve slightly in the short term (i.e., one-month post-TIPS), yet (ii) will improve significantly post-TIPS, (iii) while actual use will vary over time, across sites and therapists, and will depend on therapist-, client-, organizational- and system-factors. For the secondary hypotheses, the investigators expect that, for sites with the largest changes in desire to use and use of FCT practices as intended, (iv) wait times will significantly decrease and (v) families' perceptions of service quality will significantly improve post-TIPS. Read Less

The overall goals of our project is to understand the effects of participating in park visits and nature-based activities for people living with dementia and their caregivers. Nature-based activities such as park visits can have beneficial effects on quality of life, psychological symptoms and physical health. However, there may be barriers for people with dementia and their caregivers that may prevent them from engaging in park visits. The Nature Connections park visit program will provide education sessions for 10 persons living with dementia and 10 caregivers highlighting the beneficial effects of park visits and address common barriers to participating in park visits. Following the education session participants will be provided with weekly telephone/internet support meetings for participants to share their experiences with park visits and to address any challenges individuals encountered when trying to complete their visits. The impact of park visits on quality of life, behaviours, and measures of stress for people with dementia and their caregivers will be assessed over 8 weeks. Following completion of the program participants will provide an evaluation of the program to understand their experience and satisfaction with the program. This project will provide new information about the effects of park visits as a practical strategy to improve the quality of life, psychological symptoms and measures of stress for both people with dementia and caregivers. Read Less

This randomized controlled trial will investigate the hypothesis that since balance and executive functions (EFs) require a similar neural circuit and EFs are recruited when trying to maintain balance, that training balance might improve EFs as well as balance. There will be an active control condition (watching music videos) and a no-treatment condition. Children (18-12 years old) will be randomly assigned to one of these conditions for 12 weeks (36 per condition). The balance and music conditions will involve 15-min sessions 3x/week and a weekly check-in session with an investigator. Participants will be assessed pre-intervention, immediately post and 3-months post. Read Less

About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, can be injured, and have poor quality of life. There are few therapies that have withstood the test of randomized clinical trials. the investigators will conduct a prospective, randomized, parallel, double-blind, proof-of-concept study that tests the hypothesis that serotonin 5HT3 receptor inhibition with ondansetron prevents tilt-induced vasovagal syncope (VVS) and pre-syncope in patients with clinical VVS. A total of 70 patients with quantitative clinical diagnostic criteria for VVS and at least 1 syncopal spell in the preceding year will be randomized in a double-blind acute phase 2 study to ondansetron 8 mg PO BID x 2 doses or matching placebo. The endpoint will be presyncope or syncope associated with diagnostic hemodynamic changes. These data should provide useful preliminary data as a foundation on which to conduct a subsequent randomized clinical trial. Read Less

Human rhinovirus is also called the "common cold virus" because it causes at least half of all of the common colds experienced each year. In patients with asthma, getting a rhinovirus infection can cause worsening of asthma symptoms. Although these symptoms are well known, researchers do not fully understand how the virus worsens these asthma symptoms, nor do they really know whether virus infection causes longer term structural changes (often referred to as airway remodeling) in the airways. This study plans to address and answer these questions. Doing so will provide the researchers with a better understanding of how to treat the worsening of asthma that are caused by human rhinovirus infections. The epithelial cell is the cell that lines the surface of your airways from your nose down to your lungs, and is also the cell type that gets infected by rhinovirus. At present, it is thought that the virus causes symptoms by changing epithelial cell biology in a way that causes airway inflammation. Some of these inflammatory molecules are also thought to cause scarring (remodeling) of the airways, which over time, may lead to a loss of lung function. In order to examine how the virus causes inflammation, many earlier studies have used experimental infection with the virus and have measured various markers of inflammation. The purpose of this study is to compare the levels of inflammatory and remodeling products in the airways of study participants with mild to moderate asthma and healthy, non-asthmatic subjects after infection with rhinovirus (the common cold virus). Read Less

Many patients with postural orthostatic tachycardia syndrome (POTS) have decreased plasma volume. Current POTS guidelines recommend \~10 g of salt and 2-3 L of fluid per day. Despite this recommendation, there is no long term data evaluating the use of salt in POTS. This randomized, placebo-controlled cross-over trial will evaluate a high salt diet, compared to a normal salt diet over a period of 3 months. Participants will complete 3 in lab evaluations including autonomic function testing, tilt table testing, blood volume and urine sodium evaluation, plasma catecholamine measurements and and cytokine measurements. Read Less

The placement of external ventricular drainage (EVD) is a life-saving procedure used to relieve high pressures in the brain. Often performed at the bedside, a small tube (catheter) is inserted into one ventricle of the brain to drain cerebrospinal fluid and release the pressure build up. In standard practice, EVDs are placed freehand and initial catheter malpositioning occurs in up to \~60% of procedures. Currently, there are no adequate means to verify the position of the catheter before insertion which is a significant impediment to ensure accurate positioning. This non-interventional study aims to validate a novel technology, Bullseye EVD, for verifying the position of the EVD catheter during these emergency procedures. Read Less

By 2040, 25% of Canadians will have osteoarthritis, a disabling joint condition. Most people think osteoarthritis only affects older adults, but 50% of the 700,000 Canadian youth who hurt their knee playing sports annually will develop osteoarthritis by 40 years of age. These young people with old knees face knee pain and disability for much of their adult lives, interfering with parenting, work, and recreation. Yet, most do not know about osteoarthritis or how to reduce their risk. In this clinical trial, people who have torn the Anterior Cruciate ligament in their knee and had reconstruction surgery 9-36 months previously will be randomized to receive either a 6-month virtual education and exercise therapy program called Stop OsteoARthritis (SOAR) or a minimal intervention control program. Researchers will test if those who received the SOAR program have larger gains in knee health, including pain, symptoms, function, and quality of life at 6, 12, and 24 months. Researchers will also use MRIs (baseline and 24 months) to assess how the SOAR program influences knee cartilage degeneration and its cost-effectiveness. Read Less