Laval

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating various treatment strategies for Gram-negative bloodstream infections GN BSIs in a large, ongoing platform trial called BALANCE. This trial aims to improve treatment methods, patient outcomes, and reduce antimicrobial resistance. It builds on previous research and uses an adaptive design to answer critical questions about managing these serious infections in hospitalized patients. The trial studies different treatment approaches including antibiotic de-escalation, oral beta-lactam versus non-beta-lactam antibiotics, whether to replace or retain central vascular catheters, selecting cephalosporins or carbapenems for specific bacteria, and the use of routine follow-up blood cultures. Participants are randomly assigned to one of these treatment strategies within each domain, with ongoing adjustments based on interim analyses. The initial pilot study has completed, and all patients from that phase are included in the main trial. Participants will be monitored over 90 days for outcomes including death, reinfection, hospital readmission, and development of new antimicrobial resistance. Evaluations include laboratory tests, clinical assessments, and tracking of antibiotic use and patient health status. The trial uses a ranking scale combining these outcomes to determine the desirability of each treatment strategy. This adaptive platform design allows continuous learning and refinement of treatments to improve care for people with GN BSIs.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are evaluating the use of intravenous hyperoncotic albumin compared to normal saline boluses in critically ill patients suffering from Acute Kidney Injury requiring renal replacement therapy AKI-RRT. This trial aims to determine whether albumin administration during renal replacement therapy sessions increases organ support-free days and renal replacement therapy-free days within 28 days after randomization. The study addresses the challenge that renal replacement therapy, while life-saving, may cause complications like hypotension and organ ischemia in these patients. Participants will be randomly assigned to receive either 20-25% albumin fluid or normal saline boluses during their renal replacement therapy sessions in the intensive care unit. Each treatment involves two 100 mL boluses one at the start and one halfway through each session. The renal replacement therapies include continuous renal replacement therapy CRRT, prolonged intermittent renal replacement therapy PIRRT, or intermittent hemodialysis IHD. Treatments will continue for up to 14 days in the ICU, with dosing schedules tailored to the type of renal replacement therapy. During the study, participants will be closely monitored for organ support-free days, renal replacement therapy-free days, and other health outcomes through 28 days, with extended follow-up for mortality and kidney function up to 365 days. Researchers will collect data on fluid balance, hypotension episodes during therapy, organ function scores, healthcare costs, and quality of life measures. The trial involves multiple intensive care units and includes comprehensive assessments to evaluate the impact and safety of albumin use in this critical condition.

Researchers are investigating whether adding ertapenem to cefazolin improves treatment outcomes in adults with methicillin-susceptible Staphylococcus aureus MSSA bacteremia. This phase 2 randomized controlled trial builds on previous laboratory and animal studies, as well as small human case series, suggesting potential benefits of this drug combination. The study is a sub-study of the larger Staphylococcus aureus Network Adaptive Platform SNAP trial and aims to explore clinical success rates by day 5 of treatment. Participants receive either ertapenem 1 gram intravenously once daily infused over 2 hours for 5 days alongside cefazolin or a saline placebo infused daily over 2 hours for 5 days with cefazolin as standard therapy. The study uses quadruple masking to compare the effects of ertapenem plus cefazolin against cefazolin with placebo. The trial will monitor a variety of secondary outcomes including blood culture clearance at 30 days, clinical improvement, length of hospital stay, mortality, and infection complications over periods up to 90 days. Throughout the study, participants will have blood cultures and clinical assessments to evaluate infection clearance and treatment response. Researchers will also monitor for adverse events such as acute kidney injury or seizures within the first week. The total participation timeframe includes outcome assessments up to 90 days after treatment starts. This comprehensive monitoring will help determine if the combination therapy reduces bacteremia duration and improves patient outcomes without increasing risks.

Atrial Fibrillation AF affects around 200,000 Canadians and increases the risk of stroke, illness, and death. A stroke can severely impact a persons ability to speak, eat, walk, work, care for themselves, and socialize, and it can be fatal. In AF, blood flow slows in the hearts upper chambers, causing blood clots that can travel to the brain and cause a stroke. Blood thinners, or anticoagulants, reduce clot formation and stroke risk. This research compares two newer blood thinners, apixaban and rivaroxaban, to assess their safety in preventing bleeding in patients with non-valvular AF. The study randomly assigns participants to take either apixaban twice daily or rivaroxaban once daily for 12 months. Dose adjustments are made based on age, weight, kidney function, and creatinine clearance. Both treatments are taken by mouth, and kidney function is checked at the start and at least annually during treatment. The trial focuses on comparing bleeding rates between these two approved anticoagulants. Participants will be monitored over 12 months for bleeding events classified as major or clinically relevant non-major bleeding. Researchers will also track strokes, deaths from any cause, medication adherence, and cost-effectiveness. The primary measure is the rate of clinically relevant bleeding during the study, helping to guide first-line therapy choices for stroke prevention in AF.

This research is focused on individuals who have experienced a stroke and suffer from lasting muscle weakness in their affected upper limb, which greatly reduces their daily functioning and independence. The study aims to evaluate whether combining a personalized upper limb strength training program with a novel brain stimulation technique called cranial nerve non-invasive neuromodulation CN-NINM can improve arm motor function and promote brain plasticity in people at the chronic stage of stroke recovery. Participants will take part in a 4-week upper limb strength training program conducted three times per week, lasting 60 minutes each session. During the first 20 minutes of each session, participants will receive either real or sham CN-NINM via a device placed on the tongue that stimulates cranial nerves linked to motor control. The strength training intensity will be tailored according to each participants baseline motor evoked potential MEP amplitude, with training loads adjusted weekly to maximize recovery potential. Throughout the study, participants will undergo clinical and neurophysiological assessments before and after the intervention, including tests of upper limb motor function and measurement of brain excitability using transcranial magnetic stimulation. Researchers will monitor changes in motor ability, functional performance, range of motion, and neuroplasticity indicators to determine the effects of CN-NINM combined with tailored training. The total involvement includes a 4-week training period with detailed evaluations at baseline and post-training to measure progress and brain changes.