Coswig

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the effectiveness of minimally invasive extracorporeal circulation (MiECC) compared to conventional cardiopulmonary bypass (cCPB) during cardiac surgery. The trial focuses on patients undergoing coronary artery bypass grafting, aortic valve replacement, or both, aiming to reduce serious postoperative complications such as death, myocardial infarction, stroke, acute kidney injury, and other critical events within 30 days after surgery. This large multicenter randomized controlled trial is conducted under the guidance of the Minimal Invasive Extracorporeal Technologies International Society and led by experts from Aristotle University of Thessaloniki School of Medicine. Participants will be randomly assigned to receive cardiac surgery using either MiECC or the standard cCPB technique. MiECC uses a miniaturized heart-lung machine designed to potentially reduce complications associated with conventional methods. The study plans to recruit about 1,300 patients from 10 to 15 cardiac surgery centers worldwide. Both techniques involve extracorporeal circulation without circulatory arrest during the procedures. During the study, researchers will monitor patients for serious adverse events occurring within 30 days after surgery, including complications related to heart and lung function and other major health issues. They will also assess the use of blood transfusions, time spent in intensive care and hospital, and overall healthcare resource use. Patient safety, recovery progress, and hospital stay durations will be carefully tracked to determine the benefits and risks of MiECC compared to cCPB.

Researchers are collecting real-world data on how the CytoSorb device is used to remove antithrombotic agents in patients at risk of bleeding during and after surgery. This registry aims to better understand clinical use patterns and outcomes related to antithrombotic removal in acute hospital settings. Both past and current patients treated with CytoSorb are included to provide a comprehensive view of its application and safety. The study involves using the CytoSorb device, a sorbent hemoperfusion system, to remove antithrombotic agents from patients. This intervention is chosen to reduce the risk of bleeding complications associated with these agents. The registry collects data from patients who have undergone this treatment as part of their clinical care. No additional treatment groups or placebo controls are involved since this is an observational registry. Participants will have their clinical data collected up to 30 days after surgery, including monitoring for bleeding complications such as the need for blood transfusions. Safety is assessed by tracking any device-related adverse events. Data collection includes retrospective and prospective patients, and outcomes are evaluated until postoperative day 3, ICU discharge, or death, whichever occurs first, with an average follow-up of three days for bleeding complications.

Researchers are evaluating the safety and effectiveness of inhaled treprostinil in adults with progressive pulmonary fibrosis (PPF) over a period of 52 weeks. This Phase 3, multinational, randomized, double-blind, placebo-controlled study focuses on adults aged 18 and older who have PPF other than idiopathic pulmonary fibrosis (IPF) confirmed by lung imaging. Participants must show evidence of disease progression despite standard treatment for interstitial lung disease (ILD). Participants will be randomly assigned to receive either inhaled treprostinil or a placebo. Both are administered using an ultrasonic nebulizer delivering doses four times daily, starting at 3 breaths per dose and titrated up to a target of 12 breaths per dose as tolerated. The study includes six clinic visits during the treatment period at Weeks 4, 8, 16, 28, 40, and 52. After completing the 52-week visit, participants may have the option to join an open-label extension study. During the study, researchers will assess lung function through spirometry, measuring forced vital capacity (FVC), and monitor clinical worsening, acute exacerbations, survival, respiratory symptoms, and quality of life using questionnaires. Blood tests will measure biomarkers like NT-proBNP, and oxygen use and lung diffusion capacity will be tracked. Safety evaluations include monitoring adverse events, vital signs, lab tests, and heart function via ECG. The main outcome measured is the change in absolute FVC from baseline to Week 52.