New Westminster

Researchers are evaluating whether a new blood biomarker can help identify depression and schizophrenia in patients attending psychiatric clinics. The study aims to see if changes in this biomarker can distinguish depressed patients who respond to treatment from those who do not, and differentiate individuals having a first psychotic episode from those at risk of developing schizophrenia. This observational study involves up to 500 participants grouped by diagnosis into Depression DEP and PsychosisSchizophrenia PSY arms. Participants will attend three study visits over six months, during which blood samples and standard mental health assessments will be collected. These visits will help researchers analyze the relationship between the biomarker characteristics and the mental health conditions. The study does not involve any treatments but focuses on monitoring and measuring the biomarker and clinical factors over time. During the study, participants will complete standardized mental health questionnaires at each visit, and researchers will collect blood samples to study the biomarker changes. The main outcomes measured include the relationship between depression or psychotic disorders and biomarker characteristics over the six-month period. Researchers will also explore how clinical and demographic factors relate to these biomarker changes. The total participation time spans about six months with three scheduled visits.

Researchers are evaluating how well once-weekly insulin icodec maintains blood sugar levels compared to daily basal insulin injections in adults with type 2 diabetes. The study focuses on people who need to start basal insulin treatment after using other glucose-lowering medications. This phase 4 trial aims to assess insulin icodecs effectiveness in real-world clinical practice over about 13 months. Participants will be randomly assigned to receive either weekly subcutaneous injections of insulin icodec or daily subcutaneous injections of basal insulin analogues such as insulin glargine, detemir, or degludec. The study compares these two insulin regimens as part of standard type 2 diabetes care. Treatment continues during the 52-week period to monitor blood sugar control and treatment satisfaction. Throughout the study, participants will undergo assessments including measuring changes in glycated hemoglobin HbA1c from baseline to week 52. They will also complete questionnaires on treatment adherence, satisfaction, and burden, and researchers will track severe hypoglycemia episodes and insulin doses. The trial spans about 13 months, providing thorough monitoring of treatment impact and safety in daily clinical use.

Researchers are evaluating the safety and effectiveness of TAK-279 in treating adults with moderately to severely active Crohns disease, a long-lasting condition causing inflammation in any part of the gut. This Phase 2b study aims to see if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. The study also compares medical problems experienced by participants taking TAK-279 or placebo and how well they tolerate these issues. An endoscopy will be used to assess bowel inflammation. Participants will be randomly assigned to one of four groups three groups receiving different doses of TAK-279 capsules and one group receiving placebo capsules. The treatment period lasts 52 weeks one year, followed by a 4-week safety follow-up. TAK-279 and placebo capsules are taken orally, and the study is conducted at multiple global centers. Treatment groups remain undisclosed to participants and doctors unless urgent medical needs arise. During the study, participants will visit the clinic 15 times for assessments, including endoscopies to check for bowel inflammation. Researchers will measure responses such as endoscopic improvement based on the Simple Endoscopic Score for Crohns Disease at week 12 and other clinical remission and response indicators. Quality of life and fatigue levels will also be evaluated. The total study duration is about 60 weeks, including treatment and follow-up.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

This trial evaluates the safety and effectiveness of GSK4532990 in adults aged 18 to 70 who have alcohol-related liver disease, including those with advanced chronic liver disease. The study aims to understand how this drug affects liver health, including changes in liver stiffness and liver disease severity over time, compared to a placebo. It is a phase 2, double-blind, placebo-controlled trial sponsored by GlaxoSmithKline. Participants will be assigned to receive one of four doses of GSK4532990 or a placebo. The study uses a sequential design where dosing and treatment effects are monitored closely. Treatment and safety assessments are conducted up to 8 weeks, with liver measurements taken at baseline and at 52 weeks to evaluate long-term effects. During the trial, participants will undergo regular safety evaluations including monitoring for adverse events, heart and vital sign checks, and laboratory tests. Liver stiffness and disease severity scores will be measured at the start and after one year. Additional blood tests will assess drug levels and liver function. The total study participation includes initial screening, treatment, and follow-up visits lasting up to 52 weeks.

Researchers are evaluating the use of intravenous thrombolysis IVT with tenecteplase for patients who have suffered an acute ischemic stroke AIS. This study aims to compare the effectiveness of standard-dose tenecteplase 0.25 mgkg body weight against a lower dose 0.18 mgkg and also to assess scenarios where no tenecteplase is given upfront, particularly in patients recently taking direct oral anticoagulants DOACs or those planned for emergency endovascular thrombectomy EVT. The trial seeks to provide clearer guidance on dosing and treatment choices, especially for specific patient groups like the elderly or those with other health conditions. Participants are randomly assigned to one of three groups receiving standard-dose tenecteplase, low-dose tenecteplase, or no tenecteplase upfront if eligible for EVT or recently taking DOACs. Tenecteplase is administered as a single intravenous bolus shortly after randomization. The study design is open-label with blinded endpoint assessment and follows patients for 90 days after treatment or until death. During the study, patients will have their functional outcomes measured using the modified Rankin Scale at 90 days, with assessments done by telephone. Researchers will also track mortality, quality of life, serious adverse events, intracranial hemorrhages, and imaging outcomes related to brain infarcts and reperfusion success after EVT. Hospital stay length and ambulatory status at discharge will be recorded. Safety monitoring occurs up to 36 hours post-treatment, with imaging reviewed by blinded experts. The total participant involvement lasts up to 90 days from enrollment.

Researchers are evaluating aggressive smoking cessation therapy for adults at elevated cardiovascular risk who currently smoke at least 10 cigarettes daily and are motivated to quit. This 5-year, multi-center randomized controlled trial compares a combination of varenicline and nicotine e-cigarettes plus counseling to varenicline plus counseling alone. The study aims to determine which treatment better helps people stop smoking and reduces cigarette consumption, while assessing safety and side effects. Participants will be randomly assigned to one of two groups one receiving varenicline alongside nicotine e-cigarettes and counseling, and the other receiving varenicline with counseling only for 12 weeks. Varenicline dosing starts low and increases to 1 mg twice daily, with adjustments if side effects occur. Those in the combination group receive funds to buy e-cigarettes and nicotine cartridges, with monitoring of use and receipts. Follow-up includes telephone calls and clinic visits up to 52 weeks. During the study, participants will report smoking habits, treatment adherence, and any adverse effects. Smoking cessation is confirmed with breath tests measuring carbon monoxide levels. Researchers will track smoking abstinence, reduction in cigarettes smoked, and safety outcomes. Clinic visits occur at weeks 4, 12, 24, and 52, with telephone follow-ups at weeks 1, 2, 8, and 18. The primary measure is smoking abstinence at 24 weeks, with continued monitoring through one year.

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.

Researchers are evaluating wound management methods for adults with severe open tibia fractures requiring multiple irrigation and debridement surgeries. This Phase III trial compares an antibiotic cement bead pouch to negative pressure wound therapy NPWT to see which better reduces complications. The study addresses uncertainty about the best temporary wound care between surgeries and aims to fill gaps in knowledge about these two approaches. Participants will be randomly assigned to one of two groups. One group receives an antibiotic bead pouch where antibiotic-laden cement beads are placed in the wound and sealed with a dressing. Beads may be replaced during subsequent surgeries. The other group receives NPWT, a sealed dressing connected to a vacuum pump that removes fluid and promotes healing. NPWT settings and changes are managed by the surgeon, typically every 24-72 hours until final fracture treatment. Participants will be followed for six months with assessments at 6 weeks, 3 months, and 6 months after surgery. Researchers will evaluate a composite outcome including mortality, amputation, unplanned reoperations, and fracture healing using the Functional IndeX for Trauma FIX-IT tool. Safety events and outcomes will be reviewed by committees. The total study duration for each participant spans these follow-up periods to monitor healing and complications.

This research aims to compare two methods of monitoring pancreatic cysts and to identify biomarkers that may help detect the risk of these cysts turning into pancreatic cancer. The study evaluates whether more frequent monitoring or less frequent monitoring leads to better patient outcomes and explores various blood and imaging biomarkers for improved risk prediction. Participants are observed through two different surveillance approaches that were previously randomized but are now closed to new enrollment. One approach involves lower intensity monitoring with MRI, CT, or endoscopic ultrasound EUS scans spaced out over years, while the other involves higher intensity monitoring with more frequent imaging based on cyst size. Throughout the study, patients may also provide blood samples and undergo biopsies, fine needle aspirations, or surgery as needed. Participants are followed up regularly for five years from registration, with imaging and blood tests at intervals depending on their assigned monitoring method. Researchers collect data on clinical features, anxiety, quality of life, financial distress, healthcare costs, and outcomes such as the development of concerning pancreatic cyst features or pancreatic cancer. The study uses these measures to assess the effectiveness of monitoring strategies and the predictive value of biomarkers.