Halifax

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are conducting a phase III, randomized, open-label, international trial to compare ruxolitinib with the best available therapy for patients with high-risk polycythemia vera (PV). The best available therapy includes either interferon alpha or hydroxycarbamide, selected by the investigator before randomization. This study aims to evaluate which treatment better prevents major complications like thrombosis, hemorrhage, or progression to more severe blood disorders within approximately three years. Participants will be randomly assigned to receive either ruxolitinib at a dose of 10 mg twice daily or best available therapy consisting of interferon alpha or hydroxycarbamide, administered through standard hospital methods. There will be no crossover between treatment arms during the trial. Interferon formulations, including pegylated-interferon, may be used at the investigator's discretion. During the study, participants will be monitored for event-free survival, defined as the time until the first major thrombosis, hemorrhage, death, or disease transformation. Assessments will include regular clinical evaluations and laboratory tests over the approximately three-year trial period. The trial emphasizes safety and effectiveness by closely observing patient outcomes and treatment tolerability throughout the study.

Researchers are studying patients who have survived a heart attack (myocardial infarction) and are at higher risk for sudden cardiac death caused by dangerous heart rhythms. This study focuses on patients with a severely reduced heart function measured by left ventricular ejection fraction (LVEF) of 35% or less. Previous landmark trials showed that implantable cardioverter-defibrillators (ICDs) improved survival compared to medical therapy alone, but since then, new medications have decreased sudden death rates and the need for ICD therapy. Because ICDs carry risks and costs, this study aims to compare modern optimal medical therapy (OMT) alone versus OMT with ICD implantation to see if medical therapy without ICD is not worse for patient survival. Participants will be divided into two groups: one receiving OMT only and the other receiving OMT plus an ICD device. The ICD options include transvenous ICDs, subcutaneous defibrillators, or a newer extravascular ICD with substernal lead placement. OMT will follow current European guidelines for managing coronary syndromes and heart failure. The study is designed to assess outcomes over time from the point of randomization. During the study, researchers will track survival by measuring the time until death from any cause, expecting about 15 months of follow-up after the last participant joins. Patients must have a history of heart attack at least three months prior, symptomatic heart failure, and have been on OMT for at least three months before enrollment. Safety and effectiveness of treatments will be monitored closely throughout the study period.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant (ASCT). This phase III, open-label, randomized, controlled study aims to evaluate whether adding a proteasome inhibitor to the salvage ASCT conditioning improves the depth of response, and to assess the impact of consolidation and maintenance treatments on the durability of response. The study also looks at overall survival, progression time, quality of life, and treatment safety among participants with measurable disease and good performance status. All participants first receive re-induction therapy consisting of 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone (ITD) over 28-day cycles to achieve maximum disease control. Those who reach stable disease or better are randomized to receive either conventional ASCT using melphalan or augmented ASCT combining melphalan with ixazomib. Following this, participants who maintain minimal response or better undergo a second randomization to either receive consolidation therapy with 2 cycles of ITD followed by ixazomib maintenance until disease progression, or no further treatment. During the study, participants will undergo regular assessments including blood tests, disease response evaluations, and monitoring for adverse effects. The primary outcomes measured are overall response rate 100 days after ASCT and progression-free survival up to 10 years. Secondary evaluations include overall survival, time to disease progression, minimal residual disease status at various stages, engraftment kinetics, and quality of life. Follow-up continues with clinic visits every three months until disease progression is observed, enabling long-term monitoring of treatment effects and safety.

Researchers are evaluating whether stopping enteral feeds around the time of blood transfusions in very premature infants born before 30 weeks of gestation can reduce the risk of Necrotizing Enterocolitis (NEC). NEC is a serious intestinal disease that affects mostly preterm infants and can cause severe complications or death. This international trial compares two common care practices in Canada and the UK to see if either approach leads to better outcomes for these vulnerable infants. The trial includes two groups: one group will have all enteral feeds stopped starting 4 hours before a packed red cell transfusion, continuing during the transfusion, and until 4 hours after it ends. The other group will continue receiving feeds during the transfusion as they were before. Infants will stay on their assigned feeding strategy until they reach 34 weeks and 6 days of gestational age. Throughout the study, researchers will monitor infants for the development of NEC up to 40 weeks postmenstrual age. They will review medical records and track feeding and transfusion details to measure outcomes. This trial aims to provide clear evidence on whether withholding feeds around transfusions can help prevent NEC and improve health in very premature infants.