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Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are studying an experimental drug called fianlimab combined with cemiplimab, comparing it to cemiplimab combined with a placebo, in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC that has not been previously treated. The study also explores side effects, drug levels in the blood, and whether the body produces antibodies against the study drugs, which could affect their action or cause side effects. Participants are divided into two groups based on HPV status and randomized to receive either the fixed-dose combination of fianlimab and cemiplimab or cemiplimab plus placebo. Approximately 60 participants each with HPV-positive and HPV-negative HNSCC will be enrolled. The drugs are administered according to the study protocol, and participants receive treatment as part of this randomized, phase II trial. During the study, participants will be monitored for treatment response, side effects, and drug levels in their blood. Researchers will assess overall response rates and various adverse events up to 90 days after the last treatment and for approximately 58 months total. Safety, disease control, progression, and immune responses will be closely evaluated throughout the study period.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

This research aims to collect long-term safety and disease progression data on patients diagnosed with atypical hemolytic-uremic syndrome aHUS, including those treated or untreated with the drugs eculizumab or ravulizumab. The study is observational and involves multiple centers and countries, focusing on real-world information after these treatments have been marketed. Participants include patients of any age diagnosed with aHUS, regardless of whether they have identified complement genetic variants or antibodies. The study gathers data without administering new treatments, monitoring patients who may or may not have received eculizumab or ravulizumab. The registry collects information over extended periods to understand safety events and disease course. During the study, researchers track safety-related events over 10 years and the timing of these events within 5 years. Data collection involves reviewing patient health status and disease progression without altering their usual care. The study relies on informed consent and may include minors with appropriate assent. Participation duration varies, with continuous observation to gather comprehensive post-marketing safety data.

Researchers are evaluating several treatments for adults with kidney failure who have recently been diagnosed with calciphylaxis, a rare disease affecting about 1 to 2 people in 10,000. This phase 3 global platform trial aims to provide high-quality evidence on the effects of different therapies across various care areas. The study uses an adaptive design to add or remove treatment options based on ongoing results, improving how patients with this condition are treated. The trial begins with two main treatment areas the Dialysis Membrane Domain and the Pharmacotherapy Domain. In the Pharmacotherapy Domain, participants receive either Vitamin K1 capsules, Magnesium Citrate tablets, Sodium Thiosulfate injections, or placebos, with dosing schedules matched to their dialysis sessions. The Dialysis Membrane Domain compares two types of dialysis filters, high flux and medium cut-off dialysers, in an open-label design. Treatments are given according to these schedules, and new interventions may be added as the trial progresses. Participants will be monitored and assessed using the BEAT-Calci Wound Assessment Scale over 12 weeks as the primary outcome, with additional evaluations up to 26 weeks and beyond. Assessments include wound measurements, pain levels, analgesic use, quality of life, infection rates, hospital days, mortality, kidney transplantation status, and calciphylaxis recurrence. The study uses a Bayesian adaptive approach to adjust sample size and study arms based on collected data, continuing until clear results on treatment effects are reached.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are studying patients with metastatic melanoma to compare two ways of giving PD-1 inhibitor therapy, a type of immunotherapy that helps the immune system fight cancer. The study aims to find out if taking PD-1 inhibitors intermittently with breaks works as well as continuous non-stop treatment in extending patients lives. This is a Phase III randomized trial led by the Canadian Cancer Trials Group. Participants receive PD-1 inhibitors that are government approved and publicly funded, with doses recommended by the manufacturer. One group takes the treatment continuously for up to two years, while the other takes it intermittently, with breaks when the melanoma improves. The trial compares these two treatment schedules to see if intermittent therapy can provide similar benefits with potentially fewer clinic visits, side effects, and costs. During the study, participants will be monitored over seven years to assess overall survival as the main outcome. Researchers will also measure progression-free survival, response rates, duration of response, side effects, quality of life, and economic impact using questionnaires and clinical evaluations. Participants must complete quality of life questionnaires in English or French and be available for treatment and follow-up visits throughout the study period.

Researchers are evaluating epoetin alfa, a medication related to erythropoiesis stimulating agents, in critically ill trauma patients who require mechanical ventilation in intensive care units ICUs. This phase III, randomized, double-blind trial aims to see if epoetin alfa can reduce death rates and severe disability six months after injury. The study involves 2500 patients admitted to ICUs with primary trauma diagnoses from centers in Australia, New Zealand, Europe, and Saudi Arabia. Participants will receive either epoetin alfa 40,000 IU or a placebo sodium chloride 0.9% by subcutaneous injection on Study Days 1 and 8 while in the ICU. Treatment is administered during their ICU stay, and patients are randomly assigned to one of these two groups. The study is designed to compare the effects of epoetin alfa against placebo in this critically ill population. During the study, patients will be monitored for survival and disability outcomes using tools like the World Health Organization Disability Assessment Schedule WHODAS 2.0 at six months. Other outcomes include mortality at different time points and thrombotic vascular events. Data on clinical status, adverse events, and safety will also be collected. The total participation length includes ICU stay and follow-up assessments up to six months after injury.

Researchers are evaluating ways to improve hepatitis C virus HCV care in drug treatment clinics and needle and syringe programs in New South Wales and across Australia. The ETHOS II Project aims to develop a framework to establish HCV screening and treatment programs in these settings nationally. This collaborative research involves several health organizations and focuses on people with a history of injecting drug use or those receiving opioid substitution therapy. The study includes an intervention called campaign days where participants receive hepatitis C screening, liver fibrosis assessments using fibroscans, and clinical assessments. Participants also complete surveys and may consent to link their data with population databases. A sub-study involves collecting blood samples from some participants to evaluate new diagnostic tests for chronic HCV infection. Additionally, interviews with policymakers, clinicians, and patients will explore barriers to HCV care, and an education program will be developed to improve workforce knowledge and care quality. Participants will be recruited from drug treatment clinics, general practitioners with high case loads, and needle and syringe programs. They will undergo hepatitis C testing, fibroscans, clinical assessments, and complete questionnaires during the campaign days. Researchers will track how many participants start anti-HCV treatment each year for up to three years. The study also includes follow-up through medical record reviews to monitor outcomes and improve treatment access and delivery.