New Westminster

Researchers are evaluating a new blood test as a biomarker for mental health conditions such as depression and schizophrenia. This observational study aims to determine if characteristics of this blood biomarker can indicate depression or psychotic disorders and whether changes in these markers can help distinguish between patients who respond or do not respond to depression treatment, as well as between individuals experiencing a first psychotic episode and those at risk of developing schizophrenia. The study involves up to 500 participants recruited from the Royal Columbian Hospital Psychiatric Clinics and grouped by diagnosis into depression or psychosis/schizophrenia arms. Participants will have blood samples collected and complete standardized mental health assessments during three study visits over six months. These visits will track biomarker characteristics to explore their relationship with depression and psychotic disorders. There are no specific treatment interventions as this is an observational study focusing on biomarker evaluation and mental health status monitoring. Throughout the study, participants will undergo mental health questionnaires and provide blood samples at each visit to allow researchers to measure changes over time. The main outcomes measured include the relationship between depression or psychotic disorders and biomarker characteristics. This approach helps researchers understand how these biomarkers might support diagnosis and treatment evaluation in mental health. The total study duration for each participant is six months from enrollment.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the safety and effectiveness of a drug called GSK4532990 in adults aged 18 to 70 who have alcohol-related liver disease. This Phase 2 study compares GSK4532990 to a placebo to better understand its impact on this condition, focusing on liver health and related symptoms. Participants will receive either GSK4532990 or a placebo during the study. The treatment is given under double-blind conditions, meaning neither the participants nor the researchers know who receives the drug or placebo. The study aims to find the appropriate dose and assess its effect on liver stiffness and disease severity over a period of up to 52 weeks. During the study, participants will be monitored for any side effects or serious health events for up to 8 weeks. Researchers will also track changes in liver stiffness using FibroScan and measure liver disease severity with a specific score at the start and after 52 weeks. Regular checks of vital signs, lab tests, and heart monitoring will be done to ensure safety throughout the study.

Researchers are conducting a phase 3, randomized controlled trial to evaluate the best dosing and use of intravenous tenecteplase for patients with acute ischemic stroke (AIS). The study aims to compare standard-dose tenecteplase (0.25 mg/kg) versus low-dose tenecteplase (0.18 mg/kg) and to assess whether intravenous thrombolysis should be used in patients who recently took direct oral anticoagulants (DOACs) or are eligible for emergency endovascular thrombectomy (EVT). The study also examines how patient factors like diabetes, prior antiplatelet therapy, renal failure, frailty, age, and brain imaging findings influence treatment effects. Participants will be randomly assigned to receive either standard-dose or low-dose intravenous tenecteplase, or no tenecteplase upfront with rescue intra-arterial tenecteplase if needed in EVT-eligible patients. Those who took DOACs within 48 hours before stroke onset may not receive tenecteplase initially. The treatments involve a single intravenous bolus of tenecteplase. The trial follows patients for 90 days after treatment or until death if earlier. During the study, participants will undergo evaluations including assessments of functional dependence using the modified Rankin Scale at 90 days. Researchers will monitor safety and effectiveness, focusing on reducing disability after stroke. The trial includes blinded outcome assessment and gathers data to guide clinical decisions on thrombolysis dosing and use in various patient groups. Total participation lasts up to 90 days from enrollment.

Researchers are evaluating the effectiveness and safety of an aggressive smoking cessation therapy in adults who smoke at least 10 cigarettes per day and have elevated cardiovascular risk, including those hospitalized with acute coronary syndrome (ACS) or outpatients with cardiovascular conditions. This five-year, multi-center Phase 3 trial compares combination therapy of varenicline and nicotine e-cigarettes plus counseling against varenicline plus counseling alone. The study aims to improve smoking abstinence rates and reduce cigarette consumption in this high-risk population. Participants will be randomly assigned to one of two groups: one receiving varenicline and nicotine e-cigarettes along with counseling, and the other receiving varenicline plus counseling only. Varenicline is given for 12 weeks, starting at baseline with a dose of 1.0 mg twice daily. Those in the combination group will receive funds to purchase specific types of e-cigarettes and nicotine cartridges for up to 12 weeks, with reimbursement provided at scheduled visits. Counseling is also provided throughout. Follow-up includes telephone contacts and clinic visits over 52 weeks to monitor treatment adherence and safety. Participants will undergo assessments at several time points including weeks 1, 2, 4, 8, 12, 18, 24, and 52. These include self-reported smoking status, biochemical validation of abstinence using exhaled carbon monoxide, and evaluation of adverse events. The primary outcome measure is the number of participants achieving 7-day point prevalence smoking abstinence at 24 weeks. Safety and tolerability of the treatments will be monitored through serious and non-serious adverse events and treatment discontinuation. Total study participation lasts up to 52 weeks with ongoing support and evaluation.

Researchers are evaluating two methods for managing severe open tibia fractures that require multiple irrigation and debridement surgeries. This Phase III randomized controlled trial compares an antibiotic cement bead pouch with negative pressure wound therapy (NPWT), also called a Wound VAC, to determine which method better reduces complications. The study focuses on patients 18 years and older who have severe open tibia fractures treated with internal or external fixation. Outcomes will be assessed at 6 weeks, 3 months, and 6 months after surgery, with a primary focus on clinical status at six months using a composite measure including mortality, amputation, reoperation, and fracture healing. Participants will be randomly assigned in equal numbers to receive either the antibiotic cement bead pouch or NPWT following their first irrigation and debridement surgery. The antibiotic bead pouch involves placing antibiotic-laden cement beads in the wound, while NPWT applies negative pressure to the wound site. Both treatments are temporary wound management strategies used between multiple surgeries for open fracture care. The study includes a follow-up period with assessments to monitor wound healing and complications. During the study, participants will have follow-up visits at 6 weeks, 3 months, and 6 months post-fracture to evaluate their clinical status. Researchers will assess mortality, need for amputation, unplanned surgeries for wound problems or delayed healing, and fracture healing using a specialized functional index. An independent committee will review all outcomes and safety events. The total participation time spans from randomization through six months of post-surgery follow-up to capture key clinical results.

Researchers are evaluating two different methods for monitoring pancreatic cysts to determine which approach leads to better outcomes for patients with these cysts. The study compares a lower intensity surveillance schedule with a higher intensity surveillance schedule in patients aged 50 to 75 years. The study also aims to assess differences in surgical complications, pancreatic cancer rates, mortality, costs, healthcare use, patient quality of life, anxiety, financial distress, adherence to surveillance, and the predictive value of biomarkers and radiomic markers for cancer or dysplasia. Participants are randomly assigned to one of two surveillance arms. In the low intensity arm, patients receive MRI or CT scans at the start and one year later, then repeat imaging every two years if no abnormalities are found. If positive features appear, imaging frequency increases. In the high intensity arm, surveillance frequency varies by cyst size, ranging from MRI or CT every six months to combined imaging and endoscopic ultrasound (EUS) every 3-6 months for larger cysts. EUS is used to further evaluate cysts based on size and findings. After imaging procedures, patients are followed for five years from enrollment. During the study, patients undergo procedures including MRI, CT, and EUS, along with quality-of-life and questionnaire assessments. Researchers will monitor clinical outcomes, imaging results, healthcare utilization, costs, patient-reported outcomes, and biomarker performance. Safety and adherence to surveillance schedules will be tracked. The study lasts five years after the initial registration to capture long-term outcomes related to pancreatic cyst monitoring.