All Clinical Trials in Canada

This trial will provide evidence for the effective management of pain and pain-related domains among those who experience provoked vestibulodynia (PVD) using photobiomodulation (PBM) and multimodal physiotherapy (mPT) in a randomized controlled trial (RCT). PVD is the most common subcategory of vulvovaginal pain experienced during sexual and non-sexual activities, affects the psychological and sexual health of an astounding one in five Canadian women, yet access to evidence-informed management approaches is limited. We will employ four intervention groups: PBM, sham PBM (control), PBM combined with mPT, and mPT with sham PBM to evaluate the effectiveness of each approach on its own and the two approaches in combination. Among those who experience PVD, we seek to answer: 1. Relative to baseline and to sham PBM, does a 14-week intervention involving PBM, mPT, or a combination of mPT and PMB reduce vulvar pain severity reported on the Vulvar Pain Assessment Questionnaire (VPAQ)? 2. Is a combined mPT and PBM intervention more effective than mPT or PMB alone when considering vulvar pain severity and/or related domains as measured through VPAQ? 3. Are positive changes in vulvar pain severity and related domains observed following a 14-week intervention involving PBM, mPT or a combination of PBM and mPT retained at 6 months and at 1 year? Secondary objectives include determining the effectiveness of PBM, mPT, and mPT combined with PBM relative to sham PBM on: Patient Global Impression of Change (PGIC), pain sensitivity measured using provocative tests, the other domains of the VPAQ, sexual function, as well as investigating mediating effects of psychosocial variables (central sensitization index, chronic pain acceptance), gender identity, and the presence of vaginismus on patient response to mPT, PBM and mPT combined with PBM. Lastly we will monitor patient satisfaction with the interventions, adherence to the interventions, and any adverse events. Read Less

The goal of this observational study is to learn about the amount and types of anesthesia wastes generated for each surgical case at the Toronto Western Hospital (TWH). The main questions it aims to answer are: * The amount of anesthesia waste generated per surgical case at TWH * The amount of wastes that are inappropriately discarded * The percentage of discarded waste that can be reused or recycled * The percentage of recyclable waste that is actually recycled * The percentage of discarded waste that is appropriately sent to landfill * The financial cost of waste disposal * The impact of a staff education program on waste reduction and proper waste disposal The research team will conduct the audit by inspecting the contents of the waste bins and bags following completion of a surgery. Read Less

To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition. Read Less

Chemotherapy induced peripheral neuropathy (CIPN) or nerve pain, is a painful and debilitating complication which can chronically affect up to 70% of patients who receive chemotherapy. It causes "glove-and-stocking" distribution of nerve-pain, weakness, and other debilitating symptoms. This can affect patient's quality of life, function, ability to tolerate chemotherapy, and return to work. Duloxetine is the only recommended medication to reduce the painful symptoms and consequences of CIPN by national and international groups such as the American Society of Clinical Oncology. However, studies indicate it only has modest effect; for example, the largest study shows it only reduces pain by 0.73/10 points compared to placebo. Another promising medication in theory and practice is methadone. It is a commonly used and well-studied opioid with unique attributes which allows it to treat non-cancer and cancer associated nerve-pain with better efficacy when compared to other opioids. Furthermore, patients appear to develop less tolerance to methadone over time when compared to other opioids; this is helpful as many develop long-term CIPN and may greatly benefit from long-term pain medication. Therefore, if a patient requires chronic opioids to reduce the painful symptoms of CIPN, one that develops less tolerance is invaluable. Despite the promising role for methadone to treat CIPN, it has not been studied to treat this condition. Therefore, methadone may never be considered by prescribers to reduce the painful symptoms of CIPN. This study is a randomized controlled trial to assess the efficacy of methadone compared to duloxetine to treat painful CIPN. Participants will be randomized to receive either methadone or duloxetine regularly for 5 weeks. Methadone and duloxetine will be placed in indistinguishable capsules, so the participant and assessor are not aware of their treatment. They will be followed virtually or in-person weekly for 5 weeks where they will answer brief questionnaires detailing the effect of their treatment on their pain and their dose will increase weekly as tolerated until their pain is controlled or its the end of the study. This study would be critical in assessing the efficacy of a very promising medication to reduce the painful symptoms of CIPN: a debilitating disorder with otherwise few treatment options. Read Less

The goal of this interventional trial is to learn about how immersive Virtual Reality (VR) therapy can be used at home by individuals with dementia, with assistance from their informal (e.g., friend/family) caregivers. The main question it aims to answer are: 1. Can caregivers receive quality respite time by using VR-therapy at home with their loved ones with dementia? Does this intervention reduce feelings of burden and improve well-being and resilience for caregivers? 2. Does VR-therapy help to manage behavioural and psychological symptoms (e.g., mood, apathy, agitation) and improve quality of life for individuals with dementia? 3. What types of VR "medium" (passive or cooperative) are most effective for achieving the above objectives? Participant pairs will be asked to: * Take part in an initial at-home VR technology training session and complete a series of brief questionnaires (e.g., health history/technology use, well-being/quality of life, symptoms of dementia) * Use "VR\&R" (VR Rest \& Relaxation Therapy) for a period of 4 weeks (30 minute sessions, desired frequency), and answer a brief set of questions after each VR\&R session * Provide feedback on the VR\&R intervention in semi-structured interview with the researcher and answer additional questionnaires at a 2-week follow-up During VR\&R sessions, participants with dementia will have the opportunity to choose to watch (1) immersive 360-degree videos (e.g., of a live performance, or beach) on their own and (2) experience the same VR videos together with a researcher. Caregivers will be asked to assist their loved one with dementia to use VR\&R by helping to put on the VR headset, selecting a VR experience through a user-friendly application, and remaining nearby to supervise and provide assistance as needed. During VR\&R sessions, caregivers may use this time to take a personal break or complete short tasks (e.g., make a cup of coffee, have an uninterrupted phone call). Read Less

Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial fibrillation, cardiac masses, or atherosclerosis) i.e. cryptogenic stroke, it is recommended to search for a patent foramen ovale (PFO), especially in young patients. It is estimated that cryptogenic stroke accounts for 30% to 40% of ischemic strokes. Transthoracic echocardiography (TTE) with bubble study at rest and during Valsalva maneuver is the reference method for the diagnosis of PFO. The treatment of PFO using a closure device has demonstrated a significant reduction in recurrent stroke events in patients with PFO and cryptogenic stroke. The Valsalva maneuver is currently achieved using self-directed maneuver i.e. patients are instructed to ''bear down'' or ''strain as if attempting to move your bowels.'' These instructions are subjective and depend largely on individuals understanding and effort. A Goal-Directed Valsalva Maneuver using a manometer has been shown to be a more reproducible way to perform the Valsalva achieving more sensitivity in different settings such as hypertrophic cardiomyopathy but its incremental diagnostic value for the detection of PFO has not been yet evaluated. The aim of the present study is to compare the sensibility and specificity of two methods of Valsalva maneuver for the detection of PFO. We hypothesize that Goal-Directed Valsalva Maneuver will significantly increase the detection rate of PFO compared to Self-Directed Valsalva Maneuver. Read Less

Patients with Postural Orthostatic Tachycardia Syndrome (POTS) and Post-Acute Sequelae of COVID (PASC, or "Long COVID") experience cognitive dysfunction. The investigators will test the hypothesis that 999 mL of IV saline will improve cognitive function in patients with POTS and Long COVID compared to placebo (50 mL of saline). Read Less

Sprint interval training improves endurance performance and induces metabolic adaptations in muscle. Most research demonstrating these responses has been conducted in males, with limited studies evaluating changes to endurance performance and skeletal muscle oxidative capacity in females. Moreover, it is currently unknown if training in specific phases of the menstrual cycle influences adaptations to training. Thus, the purpose of the present study is to compare adaptations to 2 weeks of sprint interval training performed in the follicular vs. luteal phase of the menstrual cycle in healthy, eumenorrheic women. Read Less

The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in full-term infants who are born via caesarean section and require supplementation. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups. The infant gut microbiome plays a critical role in the developing immune, neurologic, and endocrine systems. Yet, most infants experience early life disruptions (ELDs) to their microbiome that have potential long-term health and development impacts. A major source of disruption is caesarean section (c-section) delivery because the infant is born surgically and is not exposed to important commensal bacteria required to establish the infant microbiome. Currently in Canada, over 28% of infants are born via c-section. Exclusive breastfeeding can improve gut microbiota composition in infants who are born via c-section. However, approximately 60% of infants born via c-section require formula supplementation in their first week of life. Evidence indicates that even one bottle of formula can further disrupt the gut microbiome. Donor human milk (DHM) is a superior alternative to formula when supplementation is required as its biotic properties minimize perturbations to the infant gut microbiome and may help to repair the microbiome in infants who experience ELDs. Yet, while DHM is well researched in preterm populations, evidence on the impact of DHM as a therapeutic intervention on the full-term infant gut microbiome is lacking. The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and higher breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula. Read Less

Suicide is the leading cause of death due to illness among Canadian youth, claiming more lives than any medical illness, including cancer. Suicide prevention is possible, and early intervention is needed. The investigators will examine the effectiveness of a previously-piloted, ED-based suicide prevention intervention, across Canadian sites, using a randomized clinical trial design. The investigators will determine whether the patient- and family-centered intervention is more effective than enhanced usual care in reducing suicide-related behaviors in 330 youth at high-risk of suicide. Read Less

Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy. Read Less

Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted. To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia. Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide. Read Less