All Clinical Trials in Canada

Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Although there are best treatment practices to improve survival, some women have other conditions that limit treatment options. One such condition seen in as many as 50% of women with advanced ovarian cancer is frailty (an age-related decline in function and health). This is a major concern as doctors will often have to change how the cancer is treated based on the patient being frail. For example, patients living with frailty are less likely to have their full tumor removed during surgery. They are also more likely to have complications with surgery, stay in the hospital longer, and recover less well from surgery overall. Patients living with frailty also are more likely to experience delays in their chemotherapy starting, receive lower doses of chemotherapy and/or receive fewer cycles of chemotherapy. These changes in treatment may decrease how long a patient survives after diagnosis. Thus, research is needed to explore strategies to decrease frailty in patients who require treatment for advanced ovarian cancer. An option gaining more attention is physical exercise (e.g. walking, repeatedly rising from a chair). Exercise performed before surgery, which is called prehabilitation, can improve how well a patient recovers after surgery and increase how long they survive. Research has shown that prehabilitation is very beneficial for patients undergoing surgery for heart disease. However, it is not clear whether prehabilitation works for those with advanced ovarian cancer that are going to have surgery. Therefore, the investigators want to explore how a 4+ week exercise program performed while waiting for surgery for advanced ovarian cancer changes frailty and how a patient recovers after surgery. The investigators will specifically look whether the exercise program: 1) reduces how frail a patient is before surgery; 2) improves how well the patient recovers after surgery; and 3) affects the patient's chemotherapy treatment plan. This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ovarian cancer. Overall, it is believed that exercise has the potential to improve the survival of advanced ovarian cancer patients. Read Less

Pain control after surgery is a crucial component of postoperative recovery. Thus, in open abdominal surgery, the use of TEA (Thoracic epidural analgesia) has become a gold standard. However, analgesia may still remain a challenge, especially in patients with large incision abdominal incisions. To address this problem, the use of the PIEB (Programmed intermittent epidural bolus) mode has been proposed, because it offers a better spread of the epidural medication. Only a few studies have evaluated the superiority of this PIEB mode in open abdominal surgery, yielding conflicting results. However, PIEB showed to be at least as effective in controlling pain as CEI, and clinical experience shows that it can be a valuable tool, especially in patients with a large laparotomy incision. However, the optimal dosage of the PIEB mode has never been determined, Furthermore, it is known whether men and women have the same dosage needs to achieve adequate analgesia since most studies have failed to account for sex-based differences in postoperative analgesia. Hence, the main objective of this study will be to determine the optimal volume dose of the PIEB delivered at a fixed interval of 60 min in patients undergoing surgery using a large midline laparotomy incision. The optimal dose for male and female patients will be determined separately by evaluating men and women in two independent groups. We hypothesize that the optimal dose of the PIEB that will provide effective analgesia in 90% of patients on the first postoperative day will range between 5 and 10 mL, for both groups. The primary outcome in both groups is successful analgesia. It is defined as a requirement of 5 or less patient-controlled epidural boluses between 8 AM and 8 PM on the first postoperative day. Secondary outcomes will be the incidence of motor block and hypotension, comparison of the level of sensory block according to group, comparison of patient satisfaction according to group and comparison of Quality of Recovery-15 score at 48h post-op according to group. Read Less

There are currently no validated tools to specifically measure family engagement in the intensive care unit (ICU). To address this gap, an interdisciplinary team developed a novel instrument to measure family engagement in the ICU. This will be a prospective observational cohort with an embedded qualitative study to validate the FAMily Engagement (FAME) instrument in the ICU setting. This study will also evaluate the association between family activation, engagement, and family-centred outcomes, and exploring factors (age, relationship, sex, gender, race/ethnicity) that may influence family engagement in the ICU. Read Less

Background/rationale While multiple disorders feature a Type 2 (T2) inflammation, triggers for T2 remains unknown. In Chronic Rhinosinusitis with Nasal Polyposis CRSwNP), a classic Type 2 disorder, dysfunction of the epithelial barrier is suggested by loss of epithelial cell differentiation, impaired response to wounding, and impairment of innate defense mechanisms. After unsuccessful attempts to describe T2 disorders solely by host genetic or environmental factors, the role of epigenetics in the modification of innate immune response and epithelial integrity appears an important unexplored mechanism for a novel appreciation of T2 disease. In addition, the investigators explore the possibility that these changes may be induced by viral pathogens. This concept has been supported by the recent observation that SARS-CoV-2 viral reduction measures resulted in a reduction of the frequency of respiratory viruses and a concomitant reduction in chronic airway disease, suggesting a role for viruses in T2 disease. Hypothesis The investigators believe T2 chronic rhinosinusitis (CRSwNP) involves epigenetic mechanisms where external factors, possibly viruses, contribute to disease via epigenetic manipulation and/or chronic viral infection. Objectives The investigators aim to identify epigenetic signatures associated with T2 CRS and explore the contribution of viruses. Method A robust methylation profiling with extensive coverage will be used for epigenome-wide association studies in T2 CRS patients assessing healthy subjects, CRS patients in remission, and diseased patients undergoing surgery. Moreover, advanced transcriptomic and metagenomic methods will identify gene expression profiles and viruses. This proposal also includes a cross-sectional study of patients undergoing surgery to assess transcriptomic patterns and epigenetics at the single-cell level. Expected outcome The investigators expect to identify epigenetic biomarkers and implicate several pathogenic viruses to open new targets for novel therapies. Read Less

The goal of this preference-based pilot study will be to assess the feasibility and acceptability, and impact of a 12-week exercise intervention on oncology care provider burnout. Participants self-select to participate into one of two exercise groups. Group assignment will be based on participant preference. Group 1: Supervised circuit-based resistance exercise Group 2: Nature-based walking Read Less

The GYVE study aims at testing an online program (eModule) to help people who have had breast or gynecologic cancer and are experiencing pelvic health issues like urinary incontinence and pain during sex. These cancers and their treatments can cause significant pelvic health problems, affecting daily life and quality of life. Physiotherapy can help, but access is often limited due to costs and other barriers. The study will involve 20 participants from Quebec and Edmonton, who will take part in a 12-week program with weekly online group sessions led by a physiotherapist. Topics include pelvic floor muscle training, use of vaginal moisturizers, hydration, diet, and pain management. Led by experts in cancer rehabilitation and pelvic health, the study aims to provide valuable information on the feasibility and effectiveness of the eModule, potentially leading to broader implementation to help more people with lived experience of cancer. Read Less

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

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 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