All Clinical Trials in Canada

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 study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will measure self-reports of emotion regulation, affect, distress and well-being, as well as a psychophysiological reactivity paradigm pre-post treatment. Read Less

The goal of this clinical trial is to effectively implement virtually-delivered interventions in mental health institutions nationwide to improve the cognitive health of individuals living with schizophrenia. The main objectives are: * To determine the clinical effectiveness of two virtual cognitive health interventions (i.e., Action-Based Cognitive Remediation or MetaCognitive Training). * To evaluate our implementation strategy involving the virtual delivery of cognitive health interventions combined with a digital learning platform to train mental health practitioners. Participants will be assessed for the severity of symptoms, cognitive performance, and overall functioning before and after receiving the intervention. Qualitative interviews will also be conducted with participants and therapists to evaluate the implementation strategies. Read Less

The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale. Read Less

The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week. The first 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus rifabutin (Rb) (BMZRB) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) (2 BMZRb/2 BMRb, Arm 1) The Second 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus delamanid (D or DLM); (BMZD) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) (2 BMZD/2 BMD, Arm 2) The standard 26-week treatment control regimen which is two months of isoniazid, rifampin, ethambutol, and pyrazinamide (2HRZE) followed by four months of isoniazid and rifampin (4HR); (2HRZE/4HR, Arm 3) Target enrollment is 288 male and female participants (96/arm). participants. Participants will be followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first. 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