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 is a Phase 1/2 study of EPI-7386 orally administered in combination with enzalutamide in subjects with mCRPC. Phase 1 of the study will be a single-arm dose escalation study of EPI-7386 in combination with a fixed dose of enzalutamide. This portion of the study will primarily evaluate the safety and tolerability of the drug combination and establish the RP2CDs for EPI-7386 and enzalutamide when dosed in combination. In addition, blood sampling will be conducted for PK evaluation to assess the potential DDI between the two drugs. Once the RP2CD for each drug has been established, Phase 2 of the study will commence. Phase 2 is a two-arm, randomized (2:1), open-label study. Approximately 120 subjects will be randomized 2:1 to: - Group 1: EPI-7386 at the RP2CD + enzalutamide(depending on the results of the Phase 1) (n=80) - Group 2: Enzalutamide single agent (n=40) The planned dose of enzalutamide and EPI-7386 for the combination arm will be those determined in the Phase 1 of this study based on safety and exposure data. Subjects may remain on study treatment as long as they are tolerating treatment without disease progression based on RECIST v1.1 and/or PCWG3.
Foot involvement is a major concern in psoriatic arthritis (PsA). The patients could experience severe levels of foot pain and disability and reduced mobility and quality of life. Previous studies showed that the use of Custom foot orthoses (CFO) was effective to improve foot pain and perceived disability in patients with foot disease associated with rheumatoid arthritis. However, there are no records in the literature on the effectiveness of CFO in PsA patients. Therefore, our objective was o explore the effects of CFO on foot pain, foot function, gait spatiotemporal parameters (STP), and ambulatory physical activity (APA) in PsA patients with foot involvement. In this pre-experimental exploratory study, 22 PsA patients having stable medication in the last 3 months preceding the recruitment were recruited. All the patients wore functional CFO designed by an experimented podiatrist during a 7-week period. Foot and lower limb pain and foot function were measured at baseline (T0) and after the 7-week period using the numerical rating scale (NRS) and the foot function index (FFI), respectively. Gait function was assessed by recording spatiotemporal parameters (STPs) during a 10-meter walk test using an instrumented gait analysis system (Mobility Lab) at T0 and T7. Freeliving walking activities (step count, freeliving cadence, time spent in different ambulatory physical activity (APA) intensities) at T0 and T7 were recorded over 7 days using accelerometer data collected from an instrumented sock worn by the participants during waking hours.
This study will use a form of intermittent fasting called time-restricted eating (TRE) where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE could be an effective addition to cardiac rehabilitation as it has demonstrated cardiovascular health benefits and potential for synergy when combined with exercise training. This study will determine if TRE is a feasible and safe nutrition intervention during cardiac rehabilitation and if TRE improves the health benefits of cardiac rehabilitation compared to cardiac rehabilitation alone.
Glaucoma is a progressive optic neuropathy that results in a loss of contrast sensitivity and visual field if not detected and treated. When glaucoma patients undergo cataract surgery, they are often not ideal candidates for many existing presbyopia correcting IOLs as they reduce contrast sensitivity because of the splitting of light and are more likely to have visual disturbances secondary to diffractive steps in the IOL design. This is largely because of a higher rate of ocular surface disease and meibomian gland dysfunction in this patient population due to the chronic utilization of topical drops. As a result of this, patients with glaucoma currently receive aspheric monofocal IOLs during cataract surgery, which are lenses with minimal loss of contrast sensitivity but only one point of focus (typically targeted for distance). This necessitates the use of glasses for near and intermediate vision and has an impact on quality of life for these patients. The Vivity Extended Depth of Focus (EDOF) IOL is a new technology that maintains uncompromised distance vision and provides improved intermediate vision correction, reducing the need for glasses. This lens uses a new optical system with no diffractive steps in the IOL; trials in non-glaucomatous patients have shown the rate of visual aberrations to be comparable to an aspheric monofocal IOL which are currently the standard of care in patients with glaucoma. There is no published data on outcomes of this IOL in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT). Studies are required to evaluate the clinical success of this new lens technology in glaucomatous patients. This will be the first study in Canada to report clinical outcomes of the Vivity IOL in this patient cohort.
Over 1.7 million hip and knee replacements are performed every year worldwide. These surgeries are associated with high blood loss and transfusion rates. In older patients, the high blood loss can result in postoperative anemia. Anemia is a condition where there is a lack of healthy red blood cells to carry oxygen around the body. This means, the patient may need a blood transfusion. This can result in different immune responses such as lung injury, fluid overload, and sepsis. The purpose of this study is to find an optimal dose of tranexamic acid (TXA) to be given during a hip or knee replacement surgery. TXA is one of the drugs given during surgery because it lowers the amount of bleeding and the risk of a blood transfusion. Individuals who are chosen to participate in the study will be split into two separate groups. After anesthesia is administered, study participant will be given the hospitals standard dose of TXA which is 20mg/kg. However, in patients with kidney problems and lower kidney functions, the dose will be lowered because TXA is filtered out of the body through the kidneys. Throughout the surgery and after it, patients will have about 30-50mL (3-5 tablespoons) of blood samples drawn at specific time points. This will be done through IV line which will stay in place during the surgery and post operation to minimize the amount of needle puncturing's. This study will help to development a new dosing guideline for TXA in patients who are undergoing joint replacement surgery.
The purpose of this research study is to look at how safe and useful a drug called azacitidine in combination with a drug called venetoclax, is in people with accelerated or blast phase BRC-ABL negative myeloproliferative neoplasms.
Early detection through regular diabetic retinopathy screening (DRS) is an effective method of preventing vision loss by enabling earlier intervention and timely treatment. It is recommended that all people with diabetes receive regular DRS, either annually or bi-annually. Current DRS practice in Canada, however, falls remarkably short of recommended DRS rates resulting in preventable vision loss. In this project the investigators use population health-based approach to diabetes care. Linked provincial administrative data will be leveraged to consistently identify all those that have not had DRS in 425 days with the goal to improve outcomes, equity and potentially reduce the cost of care delivery.
The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),
Licensed early learning and childcare centres (ELCCs) can provide children with rich opportunities for outdoor play that they may not otherwise experience in their home or community. However, many ELCCs struggle to provide high quality and stimulating outdoor play time. The primary aim of our study is to develop, implement and test a comprehensive multi-component intervention, the PROmoting Early Childhood Outside (PRO-ECO), to build capacity for, and address the complexities of building support for outdoor play in early childcare centre settings. This is to ultimately increase children's access to engaging outdoor spaces for play. Our overarching goal is to develop and evaluate a comprehensive multi-component intervention, called the PROmoting Early Childhood Outside (PRO-ECO). This intervention is to increase children's outdoor play and the diversity of outdoor play behaviour in Canadian ELCC settings providing full-day licensed care for preschoolers. The PRO-ECO integrates development of policies and procedure, early childhood educator (ECE) training and mentorship, outdoor space modifications and, parent/caregiver engagement. The PRO-ECO intervention will be co-developed, implemented and evaluated in partnership with the YMCA of Greater Vancouver (YMCAGV). A wait-list control cluster randomised trial design (RCT) will evaluate the effectiveness of the intervention and how it can be modified to tackle barriers in diverse settings.
Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.