Burnaby

Researchers are evaluating the effect of dalcetrapib on cardiovascular risk in people recently hospitalized for acute coronary syndrome ACS who have a specific genetic profile AA genotype. This phase 3, randomized, double-blind, placebo-controlled study focuses on adults aged 45 years and older, aiming to assess the time to first occurrence of fatal or non-fatal myocardial infarction over an average of 30 months from randomization. The study will continue until around 200 participants experience a primary event, or until stopped at an interim analysis. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily, two 300 mg tablets or matching placebo tablets once daily. Screening includes genetic testing for the AA genotype using a specialized Genotype Assay Test. Enrollment can begin during hospitalization or after discharge, but randomization must occur within 12 weeks of the ACS event. After randomization, follow-up visits will be virtual when possible or in clinic every three months until the study ends. Assessments will continue every three months for participants who stop the study medication early. Participants will undergo medical history review and genetic testing before enrollment. During the study, researchers will monitor cardiovascular events such as heart attacks and strokes through regular assessments every three months. Safety evaluations and collection of study endpoints will continue for the duration of participation, which may last approximately 30 months or until the study stops. This includes ongoing monitoring for adverse effects and overall health status.

Researchers are evaluating the effectiveness and safety of a new oral cladribine formulation in adults with Generalized Myasthenia Gravis gMG. This phase 3 clinical trial compares cladribine to a placebo to understand its sustained benefits, the need for retreatment, and long-term safety. The study also includes a component to analyze how the drug is processed in the body and features interviews to learn about participants experiences with cladribine treatment. The trial is organized into three periods a double-blind placebo-controlled DBPC period where participants receive either placebo or cladribine in two separate oral courses a blinded extension BE period where initial placebo recipients switch to cladribine doses and some receive retreatment if needed and a retreatment RT period where participants may receive additional cladribine or placebo based on clinical need. Doses include low and high oral cladribine, administered as scheduled treatment courses. Participants will undergo various assessments including evaluations of muscle weakness and daily living activities using specific scales like the MG-ADL and QMG. Researchers will monitor safety through tracking adverse events, laboratory tests, and heart monitoring. Pharmacokinetic blood sampling will measure cladribine levels at multiple time points. The study duration extends up to week 144, during which participants responses and safety are closely observed to understand the drugs effects over time.

Researchers are evaluating the effects of QBKPN, a new type of Site-Specific Immunomodulator SSI, on immune function in adults aged 65 and older. This study aims to see if QBKPN can improve the bodys innate immune response, reduce respiratory and other infections, enhance response to COVID-19 vaccines, and support quality of life, activity level, health status, and blood sugar control. The trial involves participants from various living settings including community, independent living, assisted living, and long-term care facilities. Participants will be randomly assigned to receive either QBKPN SSI or a placebo, both given as 0.1 mL subcutaneous injections three times a week Monday, Wednesday, and Friday for four weeks. Treatment can be administered by a nurse, self-injected, or a combination of both. After the four-week treatment period, participants will be monitored for 22 more weeks. Blood and urine samples will be collected at multiple points including baseline, weeks 4, 8, 12, and 26, with an additional phone check at week 20. During the study, researchers will perform various tests to assess immune training, antiviral response, immune cell function, and metabolic changes. Safety will be monitored through lab tests and tracking any side effects. Researchers will also review medical records and participant reports to record infections, treatments, hospitalizations, frailty, quality of life, and survival. The total participation lasts about 26 weeks from the first dose.

Researchers are evaluating novel investigational Eye Movement Biomarkers EMBs to track disease-related changes in Canadian patients with active Relapsing-Remitting Multiple Sclerosis RRMS who are receiving treatment with ofatumumab. This exploratory Phase 4 study aims to assess how well these EMBs can monitor disease progression within a real-world group of patients using a specialized eye tracking software device that has not yet been approved by Health Canada. The study uses an investigational software device called ETNA-ProgMS version 1.0.11 or later to accurately track eye movements. Patients prescribed ofatumumab as part of their routine care will have their eye movements assessed at the start of treatment and again at 3, 6, 12, and 24 months after beginning ofatumumab. This device is used solely for research and is not commercially available. The study focuses on patients with active RRMS starting this specific medication. Participants will attend scheduled visits over a two-year period where eye movement data will be collected alongside clinical assessments such as relapse rates, disability status using EDSS, Timed 25-foot walk, and 9-hole peg tests, and cognitive performance tests. Blood samples will also be taken to measure biomarkers like Neurofilament light Chain. Patient-reported outcomes related to physical, psychological, mobility, and cognitive impacts will be collected. Safety monitoring for adverse events will occur throughout the 24 months of follow-up.

This research aims to evaluate the effectiveness and safety of two artificial tear products, Tears Naturale Free and Tears Naturale II, in adults experiencing symptoms of dry eye disease. The study focuses on assessing symptom relief and the impact of these lubricating eye drops on everyday life for individuals with mild to moderate dry eye. Participants will use one to two drops of either Tears Naturale Free or Tears Naturale II in each eye as needed over a 30-day period. The study involves three scheduled visits an initial screening and baseline clinic visit on Day 1, a telephone follow-up around Day 15, and a final in-office visit on Day 30. Both products are commercially available artificial tears designed to supplement and stabilize the tear film, with one being preservative-free and the other containing a gentle preservative. During the study, participants will be closely monitored through these visits, including assessments of dry eye symptoms using the Impact of Dry Eye on Everyday Life - Symptom Bother Module IDEEL - SB score at baseline and Day 30. Researchers will track safety and effectiveness outcomes, ensuring participants adhere to the study protocol by discontinuing other artificial tear products. The total participation time is approximately 30 days.

Researchers are studying how the bodys cardiovascular autonomic system responds to emotional triggers, specifically blood-injection-injury needle phobia, during an upright posture challenge. This study compares individuals with and without needle phobia to better understand why some people have low blood pressure reactions that can lead to fainting. Such reactions are common in medical settings and can cause avoidance of important health care, which impacts public health and healthcare systems. Participants will undergo a tilt test on two separate days in a randomized order. On one day, they will view images and videos related to blood-injection-injury phobia, and on the other day, they will see neutral content. Each exposure lasts about 498 seconds and begins two minutes before the upright tilt test. Cardiovascular responses will be closely monitored throughout the tests. During the study, volunteers will be assessed for cardiovascular control and tolerance to standing upright, measured by the time until near fainting occurs. Researchers will record heart and blood pressure changes while participants watch the videos and images. The main outcome is orthostatic tolerance, observed over a period of up to 50 minutes. The study aims to provide detailed insights into fainting susceptibility related to needle phobia and will run until December 2026.

Researchers are investigating whether specific muscle movements in the lower body, called discrete counterpressure maneuvers CPM, can improve blood pressure and heart function in children aged 6 to 18 years who experience fainting. The study focuses on children with recurrent fainting due to vasovagal syncope or postural orthostatic tachycardia syndrome POTS. Researchers will compare cardiovascular responses to different maneuvers and analyze factors like sex, puberty stage, body size, and autonomic nervous system control. Participants will perform a series of movements including leg crossing with muscle tensing, crouching, exaggerated forward-backward swaying, and rhythmic gluteal muscle clenching. These maneuvers will be tested alongside a baseline standing period, with volunteers acting as their own controls. The study involves one 1.5-hour session where participants will undergo cardiovascular monitoring using non-invasive devices measuring heart rate, blood pressure, cerebral blood flow, and stroke volume. Tests include the Valsalva maneuver and sit-stand transitions. During the session, participants will complete questionnaires on fainting history, physical activity, and quality of life. Measurements of height, weight, muscle mass, and pubertal development will be taken. Urine samples will be collected briefly for sodium testing. Continuous cardiovascular data will be recorded during rest, standing, and maneuver performance. The main outcome is how stroke volume relates to postural movements. Safety will be monitored closely, and testing will pause if participants feel unwell. The total participation time is about 1.5 hours in a controlled clinical setting.

Researchers are conducting a long-term, multinational observational registry to collect information on patients with AQP4 Neuromyelitis Optica Spectrum Disorder NMOSD who are treated with Alexion Complement Component 5 Inhibitor Therapies C5IT. This registry aims to gather real-world data on clinical outcomes, safety, patient-reported outcomes, and quality of life to better understand the impact of these therapies on patients living with AQP4 NMOSD. Participants enrolled in the registry must already be receiving treatment with either eculizumab or ravulizumab, which are C5 inhibitor therapies used for chronic relapse prevention. The registry will collect retrospective data on medical history and treatment from one year before starting the therapy through enrollment, as well as ongoing data for up to five years following the last participants enrollment. During the study, participants clinical outcomes such as relapse rates will be monitored along with safety and quality-of-life assessments. Data collection will include treatment dosing history and relapse types, with annualized relapse rate as a primary measure. The overall participation period extends up to approximately five years, providing a comprehensive view of long-term treatment effects and patient experiences.

Researchers are evaluating whether carbonated water can improve orthostatic tolerance in healthy volunteers. Orthostatic tolerance is the ability to maintain stable blood pressure when standing, which can prevent dizziness or fainting. Drinking water is known to help raise blood pressure and reduce fainting, but it is unclear if carbonation adds any extra effect. The study aims to clarify if carbonated water increases sympathetic nervous activity and blood pressure more than non-carbonated water, which could benefit people with syncope. Participants will undergo a tilt test on three separate days to measure their cardiovascular reflexes and orthostatic tolerance, defined as the time until near fainting. On each test day, participants will drink one of three types of water 50mL still water control, 500mL still water, or 500mL carbonated water. The order of water types is randomized and single-blinded, meaning the investigator stopping the test does not know which water was consumed, though participants can tell if the water is carbonated. During the study, participants will be monitored for their blood pressure response and time to presyncope during the tilt test. Researchers will assess whether carbonated water improves orthostatic tolerance more than still water. The trial includes multiple visits spaced on separate days, and participants will be asked to drink the assigned water immediately before each test. The primary outcome is the duration of orthostatic tolerance measured in minutes up to 50 minutes.

Researchers are studying metastatic castration-resistant prostate cancer in men who have progressed after treatment with androgen receptor pathway inhibitors. The study aims to compare the length of time patients live without their cancer worsening on imaging when treated with 177Lu-TLX591 plus standard care versus standard care alone. This is a Phase 3 trial with a focus on both efficacy and safety of the new treatment in this patient group. Participants are divided into three parts a safety and dosimetry lead-in with 30 patients, a randomized treatment expansion with approximately 490 patients, and a long-term follow-up period lasting at least 5 years. In the randomized phase, patients receive either 177Lu-TLX591 plus standard of care, which may include enzalutamide, abiraterone, or docetaxel, or standard of care alone. The 177Lu-TLX591 is given as two doses about 14 days apart. Standard care treatments involve oral medications or chemotherapy as specified. During the study, participants will be regularly monitored through scans and other assessments to evaluate cancer progression and safety. Imaging includes PETCT or PETMRI scans to confirm PSMA positivity and detect disease spread. Researchers will track radiographic progression-free survival as the main outcome, along with overall survival and response rates. The long-term follow-up helps assess lasting effects and safety over several years. Participants are expected to adhere to study protocols and radiation safety precautions throughout their involvement.