Lethbridge

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 investigating the safety, tolerability, and effectiveness of XEN1101 as an additional treatment for people with primary generalized tonic-clonic seizures (PGTCS) who have generalized epilepsy and are already taking 1 to 3 anti-seizure medications. This phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants aged 12 years and older and aims to better understand how XEN1101 affects seizure frequency compared to placebo. Participants will be randomly assigned to receive either XEN1101 or a placebo capsule once daily with their evening meal during a 12-week double-blind treatment period. Those aged 18 and older will take a 25 mg dose of XEN1101 or placebo, while those aged 12 to under 18 may receive 15 mg, 25 mg, or placebo. Before this period, participants will have up to 9.5 weeks to record their baseline seizure frequency. After completing the double-blind period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week follow-up phase if they do not enroll in the extension. During the study, participants will keep detailed seizure diaries and maintain stable doses of their anti-seizure medications. Researchers will monitor seizure frequency changes, safety, and tolerability throughout the treatment. The main measurement is the median percent change in monthly primary generalized tonic-clonic seizure frequency from baseline through the 12-week treatment. Safety follow-up and monitoring will continue during the post-treatment follow-up or open-label extension periods, with total participation lasting several months depending on extension enrollment.

Researchers are evaluating collaborative quality improvement (QI) strategies to standardize care for infants born between 32 and 36 weeks gestation in neonatal intensive care units (NICUs) across Alberta. This stepped-wedge cluster randomized trial aims to determine if using validated QI methods and evidence-based care bundles can reduce the length of hospital stay and help babies go home sooner. The study involves 12 NICUs, including Level 2 and Level 3 units, and tracks outcomes until babies reach a corrected age of six months. The intervention group will receive a set of collaborative QI strategies including QI team building, standardized QI education through workshops, implementation of care bundles for respiratory and nutritional support, mentoring by experienced QI members, and collaborative networking with regular virtual and annual meetings. These care bundles involve best practices for respiratory stabilization and nutritional support tailored for moderate and late preterm infants. The control group will continue their current care practices during the first year before transitioning to the intervention. Each NICU will transition to the intervention arm in stages over three years. Participants will be monitored from birth until discharge home or death, with length of hospital stay as the primary outcome. The study collects data on care practices and outcomes, provides ongoing feedback to NICUs through reports and meetings, and includes surveys and interviews with NICU staff. This comprehensive approach aims to improve care consistency and outcomes for preterm infants across the province.

Researchers are evaluating the use of contingency management alongside standard counseling to help people with gambling disorder, especially those living in rural and remote areas. This study aims to improve attendance and retention in counseling by adding incentive-based rewards, delivered through internet video calls, to usual cognitive behavioral therapy (CBT). The trial compares two groups: one receiving CBT alone and the other receiving CBT plus contingency management. Participants receive treatment over 14 weeks, including 12 weeks of therapy and 2 weeks for assessments before and after treatment. Counseling sessions are provided free of charge via video conferencing apps like Skype or Facetime. The contingency management intervention offers small rewards to encourage attendance and abstaining from gambling, while CBT focuses on education, behavioral strategies, and changing thought patterns to support gambling abstinence. During the study, participants complete assessments before and after treatment that take about 30 to 45 minutes, covering clinical, psychological, and behavioral aspects including co-occurring substance use. The principal investigator checks progress with brief 5 to 10-minute calls. Some participants, counselors, and community stakeholders may also join interviews lasting 30 to 60 minutes to share their experiences. The main outcome measured is gambling abstinence after 12 weeks of treatment.

Researchers are evaluating a standardized pathway for delivering acute renal replacement therapy (RRT) in intensive care units (ICUs) across Alberta. The goal is to reduce program and healthcare system costs while improving important patient-reported outcomes for patients with acute renal injury. This effort addresses the current lack of a uniform approach to prescribing and delivering acute dialysis therapy in ICUs. The study involves implementing evidence-based best practices through quarterly key performance indicator (KPI) reports and individualized prescriber reports. These prescriber reports focus on initiation patterns of acute RRT and include targeted education to align treatment with best evidence-based practices. The program covers all patients receiving acute dialysis therapy in 15 adult and 3 pediatric ICUs in Alberta during the intervention period. Participants will receive acute RRT as part of their usual care. Researchers will monitor key performance indicators throughout the intervention period, lasting up to three years, and evaluate health system costs over the same time frame. The study aims to improve the delivery of acute dialysis therapy while ensuring safety and cost-effectiveness in critically ill patients.

The Pompe Registry is a global, multicenter, international program that follows patients with Pompe disease over time. It is an observational and voluntary study designed to track the natural history and outcomes of Pompe disease in both treated and untreated patients. The registry aims to improve understanding of the disease's variability, progression, identification, and natural history, with the goal of guiding and assessing therapeutic interventions. It also supports the Pompe medical community in developing monitoring recommendations and reporting patient outcomes to optimize care. Additionally, the registry helps characterize the Pompe disease population and evaluates the long-term effectiveness of alglucosidase alfa. This study collects data retrospectively and prospectively from patients worldwide diagnosed with Pompe disease. It does not involve any specific interventions or treatments but gathers comprehensive clinical information over time. Data collection includes medical history, diagnosis details, treatment status, and other relevant health information to better understand the disease and patient experiences. Participants contribute data through regular updates that capture their disease progression and treatment outcomes. Researchers use this information to study how Pompe disease manifests and changes over time, with a maximum follow-up period of 30 years. The registry helps fulfill regulatory commitments, supports product development and reimbursement, and provides valuable information for research and patient care improvements.