There are about 28871 clinical studies being (or have been) conducted in Canada. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to continue treatment with oral levosimendan. The study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with ALS. This is an open-label study, so that all eligible subjects that complete the double-blind REFALS study (48-weeks of treatment) will have the opportunity to receive oral levosimendan treatment. The primary objective, in addition to continuing treatment for subjects enrolled in the REFALS study, is to evaluate long-term safety of oral levosimendan in ALS patients. Another important objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with ALS. This study is open only to patients taking part in the REFALS study.
Clinical evidence is urgently needed to be able to advise patients on which cannabis-based products to take, or to avoid, in managing cancer-related symptoms. This trial was therefore designed to determine which cannabis extract combination (High THC-Low CBD, Low THC-High CBD, or Equal amounts of THC and CBD) is most effective at treating cancer related symptoms for each patient relative to placebo. Investigators propose a randomized, double-blind, N-of-1 trial to test the effectiveness of each cannabis extract combination using cannabis oils in a minimum of 120 patients on 4 cancer-related symptoms: nausea, pain, anxiety and sleep disturbance. The three active treatments will be the following cannabis oil extract combinations: High THC/Low CBD, Low THC/High CBD, and Equal amounts of THC/CBD. - THC = Tetrahydrocannabinol - CBD = Cannabidiol The placebo treatment will be Medium Chain Triglyceride (MCT) oil. The active oils and the placebo are similar in taste, smell and effectively blind subjects. Primary objective: To identify whether there is an active cannabis extract that is more effective than placebo in managing overall cancer-related symptoms for individual subjects who completed at least 1 treatment cycle for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Secondary objective: To identify whether there is a cannabis extract that is more effective than placebo in managing each of the 4 index symptoms (pain, nausea, anxiety and sleep disturbance) for individual subjects who completed at least 1 treatment cycle, for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Tertiary objectives: To investigate the safety (e.g., serious adverse events) of each of the three cannabis extracts. To identify subject preference of each of the 4 oils (if any).
High blood pressure is a leading risk factor for cardiovascular disease. Traditionally, one of the ways to treat or prevent high blood pressure is to prescribe aerobic exercise training (i.e.brisk walking). Previous studies have shown that stretching is also very effective for reducing blood pressure. This is an exciting possibility because if stretching is more effective, it would change the way exercise is prescribed to people with elevated blood pressure. This study will now assess 20 individuals in a supervised stretching or walking program five days per week for 8 weeks to determine for certain whether stretching is superior for reducing blood pressure. This research will contribute to recommendations about the most effective exercise programs for reducing blood pressure and risk of cardiovascular disease.
Major depressive disorder (MDD) is a leading cause of disability worldwide. Up to 50% of patients experience treatment resistant depression (TRD), which accounts for a vast majority of disease burden. Current medications for TRD have limited efficacy and can be associated with intolerable side effects. Therefore, there is a need for finding new treatment targets. Accumulating evidence suggests some patients with MDD including those with TRD, display brain inflammation. Thus, patients with TRD may benefit from medications that can reduce this inflammation. Minocycline is an antibiotic which can cross the blood-brain barrier and has effects on several systems implicated in depression. The principal investigator led the first pilot study of minocycline as an add-on treatment in TRD demonstrating that it led to a significant reduction in depressive symptoms compared to placebo and these findings require replication in a larger sample to confirm the efficacy and tolerability of this treatment approach. This study is a 12 week, double-blind, placebo-controlled trial of minocycline as add-on treatment for patients suffering from a major depressive episode who have failed to respond to antidepressant treatment, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) and the Antidepressant Treatment History Form (ATHF) at screening. After screening and randomization to the two parallel arms of the trial, 50 patients will receive minocycline added to treatment as usual (TAU) and 50 patients will receive placebo added to TAU. Clinical assessment will include the Hamilton Depression Rating Scale (HRSD-17), Clinical Global Impression scale (CGI), World Health Organization Quality of Life Short Form (WHOQOL-BREF), and Generalized Anxiety Disorder scale (GAD-7), administered at each study visit (baseline, week 2, 6, and 12). Side effects checklists will be undertaken at each visit. Minocycline will be started at 100 mg once daily and will be increased to 100 mg twice daily at two weeks. Secondary outcomes include inflammatory biomarkers measured at baseline, weeks 6 and 12. This trial will provide further evidence of minocycline's efficacy and acceptability as a treatment option for patients with TRD and provide insights into its mechanism of action.
Our proposed study is a 5-d double-blind randomised cross-over trial, seeking to simulate a training identification camp in competitive adolescent soccer players The purpose of the proposed study is to investigate whether increased protein consumption by Greek yogurt, compared to an isoenergetic carbohydrate (CHO) control supplement, consumed immediately following exercise training, prior to sleep and between breakfast and lunch, for a week during an intense training period (high volume, high intensity) will: - Attenuate the pro-inflammatory response (cytokines, acute phase proteins) - Reduced the severity of muscle damage and impairment (creatine kinase) - Maintain performance Secondary outcome measures: - Increase bone turnover (in favour of formation)
Human papillomavirus (HPV) is the most common sexually transmitted infection (STI) worldwide. Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal infection with these HR-HPV strains, and the resultant high-grade anal dysplasia and anal cancer are much higher in men who have sex with men (MSM) than in the general population. Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer prior to the adoption of routine cervical cytology screening. Despite these alarming statistics, there are no established protocols for optimal screening and treatment of anal HPV and cancer precursors, nor has there been any widespread rollout of organized screening programs anywhere in Canada. Further, not only does HPV directly cause significant disease in these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies in care for HIV-positive MSM. The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team was funded by the Canadian Institutes of Health Research (CIHR) via its Boys' and Men's Health Team Grant Competition. It aims to recruit a large group of MSM from various Ontario and Vancouver clinics, in order to carry out a number of different studies. The HPV-SAVE team brings together community and internationally-recognized experts in HPV and HIV disease and mucosal immunology, to better define the optimal approaches for primary and secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor for HIV transmission. This will yield critical information which can lead to improvement in the health of MSM, and will provide a foundation on which to build large-scale screening and treatment trials on a national level. A key part of this research program involves an analysis of the potential role played by the HPV vaccine in the overall management of HIV-positive MSM. Planned vaccine-related projects include: - A mixed-methods analysis of the knowledge, attitudes, and acceptability of HPV vaccination amongst HIV-positive MSM, through quantitative (e.g. cross-sectional survey) and qualitative (e.g. in-depth interviews) means. - A comprehensive assessment of the 9-valent HPV vaccine in HIV-positive MSM, including safety and immunogenicity, as well as its potential role in secondary prevention of high-grade anal dysplasia. This is the study on which the current proposal is based.
The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.
This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study. Crizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity.
This Phase II is a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS) not eligible for Hematopoietic Stem Cell Transplant (HSCT) or intensive chemotherapy.
This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs).