Wangaratta

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.

This research aims to compare the effects of oral anticoagulation versus no anticoagulation in patients aged 55 and older who have had recent episodes of transient atrial fibrillation triggered by stress and have additional factors that increase their risk of stroke. The study is a multinational, investigator-initiated, prospective, randomized, open-label trial evaluating the impact of non-vitamin K oral anticoagulants NOACs on preventing stroke and other serious cardiovascular events. Participants will be randomly assigned to either receive one of several NOACs, such as edoxaban, apixaban, dabigatran, or rivaroxaban, prescribed by their physician for the duration of the follow-up, or to a control group that will not receive anticoagulants unless medically indicated during the study. The choice of specific NOAC and dose adjustments are determined by the prescribing doctor. The study excludes patients with certain conditions like chronic atrial fibrillation, severe kidney or liver disease, recent cardiac surgery, or bleeding risks. During the study, participants will be monitored for up to 24 months to assess the occurrence of non-hemorrhagic stroke, systemic embolism, vascular mortality, myocardial infarction, peripheral arterial thrombosis, amputation, and venous thromboembolism. Regular follow-up will include evaluation of these outcomes to measure the effectiveness and safety of anticoagulation compared to no anticoagulation. Participants will provide informed consent and remain under medical supervision throughout the trial.

Researchers are evaluating the use of cyclical testosterone and darolutamide in adults with non-metastatic castration-resistant prostate cancer nmCRPC. The study aims to see if this combination can delay the time it takes for the cancer to spread to other parts of the body or lead to death. This research involves patients who have rising prostate-specific antigen PSA levels despite treatment with darolutamide but show no metastatic disease on conventional imaging. Participants will continue to receive androgen deprivation therapy using LHRH agonists or antagonists. They will also receive intramuscular injections of testosterone enanthate on day 1 of each 56-day cycle, with darolutamide taken orally at 600 mg twice daily from days 29 to 56 of each cycle. These treatments will continue until disease progression, unacceptable side effects, death, withdrawal, or study termination. Standard care medications like LHRH agonistsantagonists and darolutamide are provided through usual healthcare channels. Throughout the study, participants will undergo blood tests, scans including whole body bone scans and CT scans, and complete quality of life questionnaires. The main outcome measured is metastasis-free survival, tracked every 8 weeks for approximately four years. Safety and tolerability, PSA response, quality of life, hormone levels, and bone health markers will also be monitored regularly during the study, which may last around two years for some assessments.