All Clinical Trials in Canada

Background: Over 60% of Canadians are overweight or obese and more than half have a history of a mental illness. The COVID-19 pandemic has made it difficult for people living with obesity to manage their weight even after undergoing bariatric surgery. These difficulties in combination with the stress of the pandemic can cause significant declines in mental health and well-being. Psychotherapy ("talk therapy") has been shown to be effective in helping to reduce mental health and disordered eating symptoms in patients managing obesity; however, there is limited data in the context of COVID-19. Objective: This study will examine whether providing a convenient and accessible telephone-based psychotherapy during and potentially after the COVID-19 pandemic will lead to better mental health and disordered eating-related outcomes in patients managing obesity after weight loss surgery. Hypothesis: Relative to the control group, those receiving psychotherapy will have lower mental health distress and eating disorder symptoms. Methods: Participants recruited from 4 weight loss surgery programs across Ontario will be randomly assigned to one of two groups: 1) Control (7 weekly non-structured check-in emails and access to online COVID-19 related mental health resources) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy \[a type of "talk therapy"\] intervention focused on developing coping skills and specifically designed for weight loss surgery patients). Participants will complete measures of mental health distress, eating behaviours and a psychological distress scale prior to and immediately following the intervention. Implications: If Tele-CBT is found to improve post-pandemic mental health distress and eating behaviours, it could be routinely offered to patients with other chronic medical conditions as a resource to help manage psychological distress and mental health concerns emerging during and after the COVID-19 pandemic. Read Less

This study aims to elucidate the impact of SGLT2 inhibition on peripheral vascular function, renal function, fluid volume, neurohormonal activation and inflammatory/fibrotic pathways in patients with T2D at high cardiovascular risk and non-T2D patients. Read Less

This study aims to provide essential mechanistic insights into natriuretic and hemodynamic effects of SGLT2i and GLP-1RA agents in T2D patients. Ultimately, by obtaining physiological data in T2D patients without HF, our aims are to gain insight into how the use of this combined therapy may be used in T2D with HF in future work. Read Less

This randomized controlled trial (RCT) will determine if access to a voucher for healthy foods reduces blood sugar levels among people living on a low income who have type 2 diabetes or elevated blood sugar. Read Less

ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact patient care and outcomes. The study will recruit patients admitted to hospital with an acute coronary syndrome, and research-based genetic testing will be conducted for known FH-causing genetic variants. The results will be returned to the patients' treating physicians. The primary endpoint will be the number of patients with a new diagnosis of FH. The secondary endpoints will be the proportion of patients who undergo intensification of lipid-lowering therapy, the lowest LDL cholesterol level achieved, and the proportion of patients reaching guideline recommended lipid targets in the 12 months after the index acute coronary syndrome. Read Less

This study is designed as a prospective comparative randomized clinical study to determine the diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of pulsed fluoroscopy retrograde urethrogram for urethral stricture disease. The target population includes patients scheduled for retrograde urethrogram either new referral or follow up at Thunder Bay Regional Health Sciences Centre (TBRHSC) for treatment of urethral stricture who meet the specific eligibility criteria. The overall number of participants targeted will be 46. Upon presentation to the urology clinic or ambulatory care unit, the treating urologist/investigator will notify the patient of an opportunity to participate in the study. If the patient is interested, a research team member who is not directly involved in the patient care will be invited to discuss the study to the potential participant. The study team member will obtain a full-informed consent form the potential participant. Following informed consent, participants will be screened to ensure they meet the specific eligibility requirements of this study, through consultation with their medical records and the treating urologist. Randomization will be conducted in a 1:1 allocation ratio to either treatment arm: (1) the Pulsed fluoroscopy retrograde urethrogram, or (2) the Traditional retrograde urethrogram. Using an Excel sheet, the RAND function will give a random code. The random code is a figure ranging from 0.00000000 to 0.9999999999. A 0.5 cut-off code will be used, below which we will use the small blocks of 4 cells (4 rows of excel) and above which we will use the large blocks of 8 cells (8 rows of excel). Participants will undergo procedures according to the order of randomization Participants will undergo either Pulsed fluoroscopy retrograde urethrogram or Traditional retrograde urethrogram, depending on the treatment arm they are randomized to. Clinical data such as stricture location, stricture length and possible adverse effects will be recorded. According to the urologist decision based on data obtained during RUG, participant will be scheduled for urethroplasty or cystoscopy. All participants will undergo these procedures according to standard care procedures at TBRHSC. Data collection at baseline will include demographics, and relevant medical history. All retrograde urethrogram data including the type of urethrogram, the urethrogram date, fluoroscopy time, cumulative radiation dose, stricture location, stricture length and intraprocedural complications. Furthermore, we will record intraoperative data such as operative date, stricture location and stricture length. De-identified research files will be maintained in a secure office of a research team member during the conduct of the study. De-identified research data will be input into an electronic database that is password protected and maintained on research team member's computers or encrypted USB devices. An enrolment log, linking Participant ID to identifiable information will be maintained in hard copy in a locked office, or electronically as a password-protected document on the TBRHSC network. Only delegated research team members and the Principal Investigator will have access to research and patient data. Upon study closure, research records will be kept in secure storage in a research team member's office for a period of 5 years. Following this, the files will be securely shredded, and any electronic documents permanently deleted. Data will be analyzed using the commercially available SPSS software version 26 (SPSS Inc., Chicago, IL, USA). For both techniques, data obtained during baseline and postoperative urethrograms will be compared in terms of stricture location, stricture length, fluoroscopy time, cumulative radiation dose and the occurrence of intraprocedural complications. Categorical data will be compared using Chi-squared or Fisher test. Continuous data will be analyzed using the T test or Mann-Whitney U test Data obtained during urethroplasty will set as a standard of comparison to determine sensitivity, specificity, positive predictive value and negative predictive value of pulsed fluoroscopy and traditional urethrograms. For each comparison, 2 × 2 contingency tables were used to present the results and calculate the diagnostic accuracy estimates with 95% confidence intervals Data analysis will be done blindly regarding the type of performed procedure. One procedure will be coded as "1" and the other will "2". Categorical variables will be presented using number and percentage, and continuous variables will be presented using median and ranges. Two-tailed p-values of less than 0.05 will be set for statistical significance. Read Less

Obsessive-Compulsive Disorder (OCD) is a common neuropsychiatric illness beginning in childhood. Effective OCD treatments include cognitive-behaviour therapy (CBT) and medications but access to treatment is difficult and does not systematically include parents. The investigators will evaluate clinical and neural effects of Group-based Family CBT (GF-CBT), via a case-control study including: Group 1 - OCD cases receiving GF-CBT (N=90); Group 2 - OCD waitlist cases (N=90). Effects will be measured between baseline and completion of 12 GF-CBT sessions: comparing OCD severity and functioning changes between Groups 1 and 2. Read Less

Background: In nearly all people with human immunodeficiency virus (HIV) infection, immunity cannot either control or eradicate the infection. There are good medicinal treatments, collectively called "ART" (antiretroviral therapy) which control HIV infection by suppressing the virus in the bloodstream. ART is needed for life, and if a person stops taking ART the HIV infection returns in the bloodstream. So, there is good treatment, but no cure. The researchers want to test whether a period of treatment with vedolizumab can be used to control HIV infection in the bloodstream in persons with HIV on ART, after stopping ART. Objective: To determine whether vedolizumab is safe and tolerable in people with HIV, to assess the safety of an analytical treatment interruption (ATI), and to determine whether vedolizumab can control HIV infection in the bloodstream without the use of ART. Eligibility: Adults 18-65 with HIV who are being treated with ART Design: Participants will be screened with: Physical exam, medical history, blood and urine tests Participants will have a baseline visit which will include repeat of the screening testing. Participants will then present for their first study visit which will include: receiving vedolizumab infusions through an arm vein, repeats of the baseline testing. Participants will then have serial visits on a pre-specific schedule to receive ongoing vedolizumab doses every 2-4 weeks until week 20. Each visit will also include repeat of the baseline tests. After week 6 and before week 7 patients will discontinue ART. After the final infusion of vedolizumab at week 20 patients will continue to be assessed with physical exam, medical history, and repeat of the baseline testing every 4 weeks up to 1 year. ART will be re-started for participants if the level of HIV in the blood becomes too high, persists for too long, or if the CD4 count decreases by too much. Read Less

Total Knee Arthroplasty (TKA) is also known as a knee replacement. It is one of the most common orthopaedic (bone) surgeries performed and is usually very successful, but some people who have had a knee replacement feel pain that lasts for at least 3 months after surgery and thus continue to take pain control/ analgesic (opioids) medication. Opiates are medications like morphine. Pain post-surgery can make it difficult to recover and return to daily activities. A better control of pain before the surgery, can help people feel less pain, recover faster, and use less opioids after surgery. Cryoneurolysis means freezing the nerves that can cause pain. It uses very low temperatures in a specific body part (e.g., nerves to the knee) to freeze the pain nerves and therefore reduce the pain. When applied before the surgery it might help with postoperative pain after knee replacement. This study will evaluate Iovera, a cryoneurolysis handheld device commercially available in Canada that delivers freezing cold to a target nerve by using nitrous oxide. Cryoneurolysis can relieve pain and symptoms associated with osteoarthritis of the knee for up to 90 days. Read Less

Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue, nausea-vomiting, and sleep problems that can significantly affect patients' quality of life. Fatigue is the most common, lasting and bothersome of these, which prevents people from working and carrying out daily activities. Mindfulness-Based Cancer Recovery (MBCR) is an evidence-based group training program which has shown to help treat negative physical and psychosocial symptoms in cancer patients. The investigators propose to evaluate a pilot-tested online-MBCR program for patients undergoing CT who may be low on energy, time or have compromised immunity. Objectives: To evaluate the impact of participation in online MBCR during CT on fatigue (primary outcome), sleep, pain, nausea/vomiting, mood disturbance, stress symptoms and quality of life (secondary outcomes) as well as cognitive function and return to work (exploratory outcomes) over the course of treatment. Methods: The study design is a randomized wait-list controlled trial, conducted during CT for patients with breast or colorectal cancer. Participants will take the 12-week online MBCR program at home within 2 weeks of randomization (immediate group) or after CT completion (waitlist group). Outcomes will be assessed online at, 1) Baseline, 2) Post-MBCR, 3) Post-CT (primary outcome) and 4) 12 months post-baseline. Anticipated Findings: MBCR is a promising adjuvant program that could help patients prevent, delay or diminish aversive symptoms and side-effects associated with CT, particularly fatigue. If helpful, online-MBCR could be made easily available at cancer centers worldwide and significantly lessen the burden of cancer treatments. Read Less

Hepatopulmonary syndrome (HPS) is a rare condition that presents in about a quarter of patients with liver cirrhosis. In addition, a small subset of these HPS patients also have orthodeoxia, defined as a drop in oxygen levels when they are sitting up (upright), as opposed to lying flat (supine). At present, there is little known about this condition. Patients diagnosed with HPS and orthodeoxia experience reduced ability to exercise, especially when upright. While standard cardiopulmonary exercise is routinely performed in the sitting position, there are machines that enable candidates to exercise in the supine position. This is especially relevant in patients with severe HPS, with clinically significant orthodeoxia, where conventional upright exercise is difficult. Currently there is a gap in the literature regarding the efficacy of supine exercise compared to upright exercise in these patients. Due to their improvement in dyspnea when lying supine, it is predicted that these patients will be able to exercise for a greater length of time and have increased exercise capacity, which can be projected to improve outcomes pre- and post-transplant. Overall, HPS patients tend to experience hypoxemia and exercise limitation. Exercise limitation impacts quality of life, incidence and severity of comorbid conditions, and in those who are liver transplant candidates, low exercise tolerance deleteriously impacts transplant outcomes. Accordingly, a strategy that enables patients to exercise more often and/or for longer periods would offer direct benefits to patients with HPS, and if employed as part of an exercise program, could also improve exercise capacity, and thus, liver transplant outcomes. The purpose of this study is to investigate the effect of supine, compared to upright position on exercise in patients with HPS and orthodeoxia. We hypothesize that these patients will be able to exercise for longer in the supine compared to the upright position, given improved oxygen levels when supine. Read Less

Intravitreal injection (IVI) is an ophthalmological procedure used worldwide to treat ocular conditions. Its use has been steadily increasing for several years, because this method of drug delivery minimizes systemic exposure and allows for intraocular drug levels not achievable through systemic or topical drug administration. IVI of agents such as anti-vascular endothelial growth factor (anti-VEGF) or corticosteroids are efficacious for several retinal diseases, including age-related macular degeneration, macular edema due to retinal vein occlusion or diabetic macular edema, and uveitis, among others. But IVIs are not without their risk of complications and the most feared of which is infectious endophthalmitis, which can occur following intravitreal injections and has potentially devastating visual consequences, including loss of vision and/or the eye itself. Although endophthalmitis´s incidence ranges from 0-0.2% per infection, the cumulative risk for patients under sequential treatment may equate to more than 1% after 2 years of treatment. Endophthalmitis management following IVIs generally consists of a vitreous tap and inject (TAI) and/or a pars plana vitrectomy (PPV) with intravitreal injection of antibiotics. However, there is no consensus on the optimal treatment of IVI-related endophthalmitis. Thus, an established treatment protocol for IVI-related endophthalmitis is warranted to optimize patient outcomes. The aim of this study is to determine whether PPV or TAI is superior for the treatment of IVI-related endophthalmitis. Read Less