All Clinical Trials in Canada

As musculoskeletal disorders (MSKDs) reach epidemic proportions in Canada, access to the public health system for those who suffer from them is increasingly difficult. One of the main barriers is the delays to see a publicly funded health professional. New models of care must therefore be developed to ensure better access. We have previously shown that not all patients with a MSKD need to be closely followed by a health professional as for a large proportion of patients simply educating them is enough to resolve their MSKD. A stepped care model where education would be given first before deciding if patients need a more extensive follow-up should be explored. This project will compare the effectiveness of a Stepped Care Model to that of the two most widely used models of care: Usual Medical Care and Usual Rehabilitation Care. We think that a Stepped Care Model will be as effective to reduce functional limitations, but will lead to lower healthcare costs. Adults (n=369) with a MSKD will be randomly assigned to one of the intervention groups: Stepped Care, Usual Medical Care (physician-led intervention: e.g., advice/education, pharmacological pain management), or Usual Rehabilitation Care (physiotherapist-led intervention: e.g., advice/education, exercises). Participants in the Stepped Care Group will take part in two education sessions during the first 6 weeks. After 6 weeks, those who still have clinically important symptoms will receive follow-up rehabilitation interventions, while those who don't will be considered recovered and will have no further intervention. Primary (functional limitations) and secondary (e.g., pain, quality of life) outcomes will be assessed at baseline, and at 6, 12 and 24 weeks, and costs estimate will be established for each model of care. Knowing the urgent need for an overhaul of services to reduce wait times, the Stepped Care Model proposed could be a solution to improve access to health services without compromising quality of care. Read Less

Diuretic therapy is the cornerstone of the management of fluid overload in heart failure. Resistance to diuretic therapy is the most common reason for treatment failure in patients affected by the combination of heart failure and kidney disease. Currently, there is no way of predicting whether heart failure patients will develop resistance to diuretic therapy and what dose of diuretic is necessary to overcome diuretic resistance. Answering these questions would allow doctors to be able to prescribe an accurate dose of diuretic therapy to prevent diuretic resistance and potential side effects of an excessive diuretic dose. With magnetic resonance imaging, it is possible to measure the kidney sodium (salt) content and observe the diuretic response in patients with heart failure and kidney disease. The investigators speculate that measuring kidney sodium content will allow to predict diuretic response in these patients. The aim of this study is to compare the kidney sodium content in patients with chronic cardiorenal syndrome with and without diuretic resistance. Secondly, in a sample of patients with diagnosed diuretic resistance,the aim will be to observe the changes in kidney sodium content induced by an additional dose of diuretic therapy and to observe whether these changes are associated with a response to diuretic therapy. Read Less

The corticomedullary gradient is largely responsible for developing the gradients that are needed to concentrate urine (more solutes and less water). The ability of the kidneys to produce concentrated urine is a major determinant of the ability to survive the warm weather. When temperatures are high, we lose water through sweat, and so the kidneys retain water to maintain fluidity in the blood. The maintenance of a sodium (salt) gradient is required for urine concentration because increased medullary sodium concentration increases the reabsorption of water into the kidney, to be redistributed in the blood. The purpose of this study is to know if the corticomedullary gradient is altered in patients across a wide spectrum of kidney disease using sodium Magnetic Resonance Imaging (MRI), a machine that takes pictures and measures the salt content in the kidneys. 23Na kidney MRI, will provide functional MR of the kidney as a non-invasive tool to describe medullary function to improve management of chronic and kidney disease. Read Less

The purpose of this clinical investigation is to assess the safety and performance of Compedica's OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU's) versus the standard of care (SOC). OptiPulse™ is designed to enhance blood circulation in the venules and arterioles. Fibracol Plus (or equivalent) is a collagen alginate dressing that is used as the primary dressing. Both products are 510(k) FDA cleared and will be used within the cleared intended use. Read Less

This study will evaluate efficacy and tolerability of iberdomide, bortezomib, dexamethasone and isatuximab on demand administered in combination. Read Less

Innovative treatments are urgently needed for severe behavioural problems (SBPs) in adults with intellectual and developmental disabilities (IDD). Although a synthetic cannabinoid, nabilone may be a plausible and safe alternative to treat SBP, safety and efficacy of nabilone in people with IDD has never been evaluated. The investigators propose to conduct this first-ever Phase I pre-pilot open-label clinical trial to collect data on the tolerability and safety profile of nabilone in adults with IDD, and explore changes in SBP pre- and post-treatment. The results will inform a next-stage pilot randomized controlled trial, followed by a fully powered trial eventually. Read Less

Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, \< 27+0 weeks). Ibuprofen and acetaminophen, which act by reducing prostaglandin synthesis, are the most commonly used first and second line agents for PDA treatment across Canada. However, initial treatment failure with monotherapy is a major problem, occurring in \>60% ELGANs. Treatment failure is associated with worsening rates of mortality and bronchopulmonary dysplasia (BPD), while early treatment success can achieve rates comparable to neonates without PDA. Treatment failure resulting in prolonged disease exposure is thought to be a major contributor. Recently, combination therapy with acetaminophen and ibuprofen has emerged as a new treatment regime. Acetaminophen exerts anti-prostaglandin effect through a different receptor site than ibuprofen, providing a biological rationale for their synergistic action. The objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment). Read Less

The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy. Read Less

The goal of this study is to learn if Multispectral Optoacoustic Tomographs (MSOT) works to diagnose and follow the course of neuromuscular diseases (NMDs) in children. MSOT scans will be obtained from muscle region to measure hemo/myoglobin, collagen and lipid content/signal and oxygenation in patients with neuromuscular diseases. No additional research activities -other than MSOT - will be done during this study. Existing clinical, laboratory and imaging data from standard-of-care procedures will be correlated with the MSOT data. The expected total duration of the study is approximately 36 months. Repeated measurements will be done to evaluate disease progression and the value of MSOT in NMD. Read Less

The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute SCI (time since injury 3-6 months) and the impact on quality of life. The study will be conducted at two sites; site 1 in Canada and site 2 in the Ukraine. Up to 60 subjects will be enrolled; 10 adults at the ICORD, University of British Columbia (UBC), Vancouver, Canada site and 50 adults at the Rivne Regional War Veterans Hospital, Rivne, Ukraine. Eligible participants will be randomized (1:1 ratio) either to Group 1 (G1) or Group 2 (G2). G1 will receive therapeutic TSCS for 8 weeks (3 times per week; 1 hour per session) in conjunction with conventional rehabilitation (3-4 hours per day; 5 days per week). G2 will receive 8 weeks of sham stimulation in conjunction with conventional rehabilitation. After 8 weeks, G2 will cross over and receive therapeutic TSCS for 8 weeks, whereas G1 will continue to receive TSCS therapy for another 8 weeks, for a total of 16 weeks. Eligible participants enrolled into the study will attend fifty eight (58) visits for assessments, therapy, and follow-up. The expected duration of study participation for each participant will be 33 weeks. Read Less

Global warming, progressing at a rapid pace in Canada, is causing severe consequences for ecosystems and human health. Rising temperatures accelerate glacier melting, increase heat waves, and disrupt biodiversity. These environmental changes impact mental health, notably through ecoanxiety, a form of anxiety linked to climate change. Although ecoanxiety is a natural reaction to environmental degradation, it can lead to chronic stress, generalized anxiety, and even depression. Recent studies show that ecoanxiety is increasingly common, especially among young people. In Quebec, 73% of young adults (18-35 years) report experiencing ecoanxiety, with 42% experiencing significant levels. Vulnerable populations, such as Indigenous communities like the Inuit of Nunavik, are particularly affected. To address ecoanxiety, interventions focused on emotional management and reconnecting with nature are essential. Studies show that outdoor activities such as walking or gardening reduce negative emotions and improve well-being by fostering a connection with nature, thereby increasing resilience to climate change. Art, especially pictorial art, is emerging as a promising tool in combating ecoanxiety. The World Health Organization (WHO) recognizes the mental health benefits of art, which is not only beneficial for those suffering from mental illness but also for the general population. The Quebec Interministerial Mental Health Action Plan (PAISM) 2022-2026 highlights the promotion of art as a priority in mental health prevention. Among art forms, the contemplation of Impressionist paintings has shown positive effects, generating emotions of serenity and deeper reflection on our relationship with nature. Music therapy also plays a vital role in anxiety management, promoting relaxation and emotional expression. Music, in particular, has shown promise in reducing ecoanxiety. Listening to music can alleviate anxiety and depression by stimulating the limbic system, which regulates emotions. Music can also modulate physiological stress responses and strengthen personal resilience, enhancing emotional regulation in environmental crises. An innovative approach involves creating music from electrophysiological signals captured from plants, a process known as sonification. This nature-inspired music fosters a deeper connection with the environment, potentially reducing ecoanxiety and increasing resilience. Emotions, both positive and negative, are central to mental health. According to James Russell\&#39;s circumplex theory of emotions, they are classified into two dimensions: valence (pleasant or unpleasant) and arousal (energy level). Positive emotions like joy and relaxation promote well-being, while negative emotions, such as anxiety and sadness, have detrimental effects on mental health. Emotional responses manifest through physiological changes, such as increased heart rate and skin conductance. Modern technologies, like functional MRI, allow researchers to observe the brain\&#39;s activity in areas like the amygdala, responsible for emotional regulation. Digital technologies have revolutionized the use of art in promoting mental health. Immersive digital interventions, such as apps that allow users to experience art online, have shown positive results. One such app currently in development combines the works of Impressionist painters Claude Monet and Helen McNicoll with music created from plant electrophysiological signals. This digital combination of art and nature offers emotional benefits, promoting well-being in the face of climate challenges. It is well-established that positive emotions play a crucial role in improving mental health and protecting against ecoanxiety. Research shows that Impressionist paintings and music can generate positive emotions. This study hypothesizes that (1) observing and listening to musicalized paintings can generate positive emotions, (2) the emotional effect is stronger when both stimuli are combined, and (3) these emotions vary with age. Read Less

By 2050, one in six people in the world will be over 65, leading to an increase in the number of people with neurocognitive disorders (NCD), such as Alzheimer's disease. The number of cases will rise from 57 million to 153 million by 2050. This presents challenges for healthcare systems, as NCDs affect not only mental health but also the physical health, psychological well-being, and social relationships of patients, as well as their caregivers (PCA). In Quebec, primary care is often inadequate for people living with NCDs due to delays in accessing resources, incomplete coverage of needs, and the COVID-19 pandemic, which has exacerbated these challenges. This situation can lead to a deterioration in patients' health, affecting their quality of life as well as that of their PCAs, while also increasing healthcare costs. Many elderly people wish to age at home, but cognitive and functional decline complicates this desire. PCAs, generally family members or close friends, play an essential role in the daily support of these individuals. Their role, as defined in the Act to support caregivers in Quebec, includes non-professional and voluntary assistance to improve the quality of life of the person being cared for. However, the support provided by PCAs can lead to significant stress, especially if public services are insufficient. The exhaustion of PCAs is often correlated with the severity of the care recipient's loss of autonomy. This exhaustion impacts the mental and physical health of PCAs, leading to isolation, depression, and anxiety, as well as reduced productivity and an increase in sick leave. It is therefore urgent to find support solutions to prevent PCA burnout. Telehealth, which involves remote consultations through information and communication technologies (ICT), appears to be a promising solution to improve access to care for people with NCDs, especially in underserved areas. By enabling remote monitoring, telehealth facilitates aging in place while stimulating the remaining capacities of patients, such as responsiveness to sensory stimuli. Artificial intelligence (AI) is also a promising tool for tracking the health of older adults in real-time, detecting early signs of diseases, and providing personalized recommendations. Virtual assistants or avatars, like "Talk-to-Jo," can interact with patients to reduce their sense of loneliness. However, the effectiveness of these technologies depends on their accessibility and adaptability to the needs of patients, particularly in cases of sensory impairments. "Talk-to-Jo" is a digital avatar designed for older adults with NCDs and their PCAs. It asks questions about memory and depression and provides tailored recommendations to prevent or stabilize detected disorders. A first version of this tool is currently available on a tablet. With the growing number of people living with NCDs, it is essential to develop support solutions based on telemedicine and AI. It is important to assess the usability and acceptability of these technologies by patients and their PCAs to ensure their effectiveness. Read Less