Lethbridge

Researchers are investigating new treatments for adults with moderately to severely active ulcerative colitis or Crohns disease under a master protocol called Study IIBD. This Phase 2 trial evaluates multiple drugs to understand their safety and effectiveness in managing these conditions. Participants will be assigned to specific sub-studies and randomized to treatment groups, with the study lasting at least 62 weeks. The study includes two treatment periods. In the first period, participants may receive mirikizumab intravenously, or a combination of the oral drug LY4395089 with intravenous mirikizumab. Those who respond to treatment will then enter a second period where they receive mirikizumab through subcutaneous injections. These steps allow researchers to assess different dosing methods and combinations of these drugs. Participants will be monitored regularly throughout the study, including screening tests and laboratory evaluations to ensure eligibility and safety. Researchers will track the number of participants allocated to each treatment group up to day 42 as a primary outcome. The study involves randomization without masking and continues until at least 62 weeks, with ongoing assessments to evaluate treatment effects and monitor health outcomes.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

This trial investigates the safety and effectiveness of combining a drug called LY4395089, which is a farnesoid X receptor FXR agonist, with mirikizumab compared to using mirikizumab alone in adults who have moderately to severely active Crohns disease. This Phase 2 study is part of a larger research protocol focused on inflammatory bowel diseases and will last about 62 weeks. Participants are assigned to one of two groups. In the first study period, one group receives mirikizumab via intravenous IV infusion, while the other group receives both LY4395089 orally and mirikizumab IV. In the second study period, participants who respond to treatment will stop LY4395089 and receive mirikizumab subcutaneously SC. This design allows comparison of the combined treatment versus mirikizumab alone. Throughout the study, participants will undergo assessments including endoscopic evaluations to measure Crohns disease response up to Week 12, clinical remission checks, and fecal calprotectin tests to monitor inflammation. The study includes regular visits for treatment administration and monitoring, with the total participation lasting approximately 62 weeks. Safety and efficacy are closely observed during the trial.

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.

Researchers are studying the use of XEN1101 as an additional treatment for people aged 12 years and older who have primary generalized tonic-clonic seizures PGTCS associated with generalized epilepsy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the clinical effectiveness, safety, and tolerability of XEN1101 when added to existing anti-seizure medications. Participants are currently taking 1 to 3 anti-seizure medications and have had probable or possible PGTCS for at least one year. Participants will be randomly assigned to receive either XEN1101 or a placebo. Those aged 18 years and older will receive a 25 mg daily dose of XEN1101 or placebo. Participants aged 12 to under 18 years may receive 15 mg, 25 mg, or placebo daily. The study includes a baseline period lasting up to 9.5 weeks to track seizure frequency, followed by a 12-week double-blind treatment period where participants will take the assigned capsules once daily with an evening meal. After completing this period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week post-treatment follow-up if they do not enroll. During the study, participants will keep accurate seizure diaries and attend scheduled visits to monitor their health and response to treatment. Researchers will evaluate changes in monthly seizure frequency as the main outcome. Additional assessments will track safety, tolerability, and other measures throughout the treatment and follow-up periods. Overall participation may last several months, including baseline assessment, treatment, possible extension, and follow-up phases.

The trial focuses on moderate and late preterm infants born between 32 and 36 weeks gestation who are admitted to Level 2 and 3 Neonatal Intensive Care Units NICUs across Alberta. Researchers aim to find out if applying collaborative quality improvement methods and standardized care bundles can reduce the length of hospital stays and help babies get home faster. This stepped-wedge cluster randomized trial includes 12 NICUs randomized to adopt the intervention at different times, allowing comparison against current standard care. The intervention involves multiple collaborative quality improvement strategies building dedicated QI teams in each NICU, providing standardized QI education, implementing two care bundles focused on respiratory and nutritional support, mentoring by experienced QI members, and facilitating collaborative networking with regular virtual and in-person meetings. Participating NICUs will transition from current practices to this intervention in phases over three years. During the control period, NICUs continue their usual care and any ongoing QI activities without the new intervention strategies. Participants progress will be monitored from birth until discharge or death, with assessments continuing up to six months after their due date. Researchers will track hospital stay length, healthcare costs, respiratory support duration, feeding milestones, growth measurements, rehospitalizations, mortality, and staff perceptions of QI implementation. Data will be collected through clinical records and surveys. The study spans from May 2023 to August 2027, aiming to improve care quality and outcomes for these preterm infants.

Researchers are evaluating the use of contingency management alongside cognitive behavioural therapy CBT as a treatment for people with gambling disorder living in rural and remote areas. This randomized clinical trial aims to see if adding contingency management improves attendance and retention in counselling sessions compared to CBT alone. The study uses internet video-conferencing to make counselling accessible for participants who might otherwise have difficulty receiving care. Participants are randomly assigned to receive either CBT alone or CBT combined with contingency management CM. The CM group earns points for attending sessions and showing evidence of gambling abstinence, which they can redeem for goods from online stores. Both groups will attend online counselling sessions three times per week for 12 weeks. The full participation period lasts 14 weeks, including one week of assessments before treatment and one week after. During the study, participants complete assessments before and after treatment to evaluate clinical, psychological, and behavioral aspects, including substance use. These assessments take about 30 to 45 minutes. The principal investigator conducts brief progress check-ups during treatment. A smaller group of participants, counsellors, and community members will share their experiences in interviews lasting 30 to 60 minutes. Researchers focus on measuring gambling abstinence, session attendance, and study retention throughout the 12-week treatment.

This research aims to collect detailed information about Pompe disease, a rare genetic disorder also known as Glycogen Storage Disease Type II. The study is a global, long-term observational program designed to better understand the diseases progression, variability, and identification in patients who are either treated or untreated. It also supports regulatory requirements, product development, reimbursement, and other research purposes. Participants in the Pompe Registry are tracked over many years, up to 30 years, to observe the natural history of the disease and evaluate long-term outcomes, including the effects of treatments like alglucosidase alfa. This observational study does not involve experimental treatments but gathers data from patients worldwide to improve care strategies and recommendations. During the study, participants health information is collected retrospectively and prospectively, including clinical outcomes and disease manifestations. Researchers analyze these data to understand patient variability, disease progression, and treatment effectiveness. The registry helps develop guidance for monitoring patients and provides valuable insights to optimize Pompe disease care over an extended period.