Burnaby

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

Researchers are evaluating the potential of QBKPN Site-Specific Immunomodulator (SSI) to improve immune function in adults aged 65 years and older. The study focuses on whether QBKPN can help protect against respiratory and other infections, enhance the immune response to COVID-19 vaccines, improve quality of life, activity level, health status, and glycemic control. This is a Phase 2 randomized, double-blind, placebo-controlled study involving participants living in community settings, independent-living, assisted-living, and long-term care facilities. Participants will receive either QBKPN SSI or a normal saline placebo for 4 weeks. Study staff or the participants themselves will administer the treatment, with options for nurse-administration, self-administration, or a combination. After the treatment period, participants will be monitored for an additional 22 weeks. Blood and urine samples will be collected at baseline, week 4 (end of treatment), week 8, week 12, and week 26, along with a phone visit at week 20. The study will assess trained innate immunity, antiviral immune response, immune augmentation, adaptive immune response duration to SARS-CoV-2 vaccination or infection, metabolome changes, and Natural Killer cell function. During the study, participants will have regular assessments including clinical laboratory tests, safety monitoring for adverse events, and evaluations of health outcomes through medical records and patient-reported information. Researchers will track infections, hospitalizations, antibiotic or antiviral use, frailty, quality of life, end-of-life prediction scores, and all-cause mortality. The total participation duration is approximately 26 weeks with ongoing monitoring to evaluate the effects and safety of QBKPN SSI compared to placebo.

Researchers are evaluating new investigational Eye Movement Biomarkers (EMBs) to monitor disease changes in Canadian adults with active Relapsing-Remitting Multiple Sclerosis (RRMS) who are receiving the disease-modifying treatment ofatumumab. This phase 4 exploratory study aims to understand how these novel EMBs can track treatment response and disease progression using a patented eye-tracking software medical device (ETNA-ProgMS), which is not yet approved by Health Canada and is used only for research purposes. Participants will have their eye movements tracked using the investigational ETNA-ProgMS software device version 1.0.11 or later. The study focuses on patients prescribed ofatumumab as part of routine care, who have not yet received their first dose. The device precisely measures eye movements to assess neurological changes associated with RRMS. The device is investigational and will not be commercialized. There are no additional treatment groups, as all participants are receiving ofatumumab. Throughout the study, participants will undergo assessments to monitor eye movement biomarkers and other evaluations at baseline and over six months to detect changes. Researchers will collect blood samples and assess patient disability scores. Participants must have sufficient corrected vision to complete visual tasks on-screen. The primary outcome is the change in eye movement biomarkers from baseline to six months. Safety and compliance with the device and treatment will be closely monitored during this period.

Researchers are studying how the body's cardiovascular system reacts to emotional triggers related to blood-injection-injury phobia (needle phobia) during an upright posture challenge. This phobia can cause low blood pressure and fainting reactions during medical procedures like blood draws or vaccinations, affecting up to a quarter of adults and leading to avoidance of care. The study aims to better understand these reactions and how the body responds during these emotional and physical stressors. Participants will undergo a "tilt test" on two separate days in a randomized order. On one day, they will view blood-injection-injury phobia-related images and videos starting two minutes before being tilted upright, and on the other day, they will view neutral images and videos. Cardiovascular responses will be closely monitored throughout the tests to assess autonomic function and orthostatic tolerance. During the study, participants will be assessed for cardiovascular reflex control and their time to near fainting (presyncope) will be measured. Researchers will collect data on how the heart and blood pressure respond to the emotional stimuli during the upright tilt. The total participation involves two test sessions with detailed monitoring of cardiovascular function, aiming to capture a comprehensive profile of these responses.

Researchers are investigating whether specific lower body muscle movements, called discrete counterpressure maneuvers, can improve blood pressure and heart function in children aged 6 to 18 who experience fainting due to vasovagal syncope or postural orthostatic tachycardia syndrome. The study evaluates these maneuvers compared to commonly recommended movements like leg crossing and crouching, aiming to better understand cardiovascular responses in pediatric patients. The study also considers factors such as sex, pubertal stage, muscularity, height, and autonomic control. Participants will attend one 1.5-hour testing session where they perform movements including exaggerated sway, leg crossing with muscle tensing, crouching, and rhythmic gluteal clenching while standing on a force platform. Cardiovascular monitoring is done noninvasively using ECG, blood pressure cuffs, nasal cannulas for gases, and ultrasound probes to measure blood flow. Participants will also perform Valsalva maneuvers lying down and sitting upright to test nervous system control of circulation. During the session, participants undergo assessments of height, weight, muscle mass, pubertal stage, and complete questionnaires about fainting episodes, physical activity, and quality of life. Urine samples will be collected for sodium testing. Researchers continuously monitor cardiovascular responses during the maneuvers and standing tests, stopping if symptoms appear. The main outcome measured is the relationship between body movements and the volume of blood pumped by the heart during the maneuvers.

Researchers are collecting long-term data on patients diagnosed with anti-Aquaporin 4 antibody-positive neuromyelitis optica spectrum disorder (AQP4+ NMOSD) who are treated with Alexion complement component 5 inhibitor therapies (ALXN-C5IT). This observational registry study involves multiple centers and countries to gather information on clinical outcomes, safety, patient-reported outcomes, quality of life, and the use of targeted AQP4+ NMOSD treatments in real-world settings. Participants in this registry will have their medical and treatment histories reviewed retrospectively, starting one year before they began ALXN-C5IT treatment and continuing through their enrollment in the study. The registry will then collect prospective data for about five years following the enrollment of the last participant. Patients must have received at least one dose of eculizumab or ravulizumab recently and be treated according to local guidelines for chronic relapse prevention. During the study, researchers will monitor the annualized relapse rate of NMOSD and assess safety outcomes. Data collection includes detailed dosing information and relapse history, as well as patient-reported quality of life measures. This long-term monitoring aims to provide comprehensive real-world evidence on the impact of ALXN-C5IT therapies in managing AQP4+ NMOSD over several years.

Researchers are evaluating whether carbonated water can improve orthostatic tolerance, which is the ability to maintain stable blood pressure when standing. This study focuses on healthy volunteers and aims to see if the carbonation in water has any additional effect on blood pressure beyond that of plain water. This question is important because carbonated water might expand the stomach and increase activity in the nervous system that raises blood pressure, potentially helping people who experience fainting due to low blood pressure when standing. Participants will undergo a "tilt test" on three separate days to measure how long they can tolerate standing before nearly fainting. Before each test, they will drink one of three water types: a small 50mL amount of still water, 500mL of still water, or 500mL of carbonated water. The order of these drinks will be randomized, and the study staff deciding when to stop the test will not know which type of water was given, making the study single-blind. Participants themselves will know if the water is carbonated but won't be told what effect the water is expected to have. During each test, researchers will monitor participants' cardiovascular responses and measure orthostatic tolerance by timing how long they maintain adequate blood pressure before symptoms occur. The study will assess if carbonated water changes blood pressure responses differently than still water. In total, each participant will attend three test sessions, allowing comparison of the effects of different water types on blood pressure control when standing.

The primary objective of the study is to compare radiographic progression-free survival (rPFS) in participants who receive 177Lu-TLX591 with SOC to rPFS in participants who receive SOC only. This study consists of three Parts: * Part 1: Safety and Dosimetry Lead-in, * Part 2: Randomized Treatment Expansion, and * Part 3: Long-term Follow-up The study will commence with a 30-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment expansion in approximately 490 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either 177Lu-TLX591 + Standard of Care SoC (Group A), or SoC alone (Arm B). SoC in this trial is either: ARPI (enzalutamide or abiraterone) or docetaxel. All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3). Only patients that meet PSMA-positivity criteria per Blinded Independent Central Review (BICR) will be eligible for this study.