Coswig

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the effectiveness of minimally invasive extracorporeal circulation MiECC compared to conventional cardiopulmonary bypass cCPB in reducing serious complications after cardiac surgery. This large multicenter randomized controlled trial, led by the Aristotle University of Thessaloniki, focuses on patients undergoing coronary artery bypass grafting, aortic valve replacement, or both, aiming to see if MiECC can lower the rate of serious postoperative problems such as death, heart attack, stroke, kidney injury, and respiratory complications within 30 days after surgery. Participants are assigned to receive cardiac surgery using either a MiECC system or a conventional heart-lung machine cCPB. The study includes patients undergoing elective or urgent surgery without circulatory arrest and excludes those needing emergency operations or major aortic surgery. The trial will recruit about 1,300 participants across 10 to 15 centers worldwide to detect meaningful differences in postoperative outcomes. During the study, participants will be monitored for serious adverse events up to 30 days after surgery. Researchers will also track blood transfusions, time spent in the cardiac intensive care unit and hospital, new onset postoperative atrial fibrillation, delirium, and health-related quality of life up to 90 days after surgery. Safety and recovery will be carefully assessed through hospital records and clinical evaluations throughout the initial hospital stay and follow-up periods.

Researchers are collecting real-world data on how the CytoSorb device is used to remove antithrombotic agents in hospital patients. The registry aims to understand clinical use patterns and related outcomes, particularly focusing on reducing bleeding risks linked to these medications. Both past and current patient data will be included to provide comprehensive insights. The study involves gathering clinical information on patients who receive CytoSorb treatment specifically for antithrombotic removal during acute hospital care. CytoSorb is a sorbent hemoperfusion device used to filter out these agents. The registry includes both retrospective and prospective data collection, with safety monitored by tracking any device-related adverse events. Participants clinical outcomes will be followed for up to 30 days after their procedure. Key measurements include bleeding complications and the need for blood transfusions or other blood products, assessed until postoperative day 3, ICU discharge, or death, whichever occurs first. This observational registry does not involve experimental treatments but records standard care outcomes to better understand the devices use and safety.

Researchers are studying inhaled treprostinil to assess its safety and effectiveness in people with progressive pulmonary fibrosis PPF. This Phase 3, multinational, randomized, double-blind, placebo-controlled trial will compare inhaled treprostinil to a placebo over one year. The study focuses on adults diagnosed with PPF who have shown lung fibrosis progression despite standard treatments. Participants will be randomly assigned to receive either inhaled treprostinil or a matching placebo using an ultrasonic nebulizer four times a day. The dose starts at 3 breaths per session and will be gradually increased to a target of 12 breaths per session or the highest tolerated dose. The treatment period includes six visits at weeks 4, 8, 16, 28, 40, and 52. Those completing the 52-week treatment may join an open-label extension study. During the study, participants will undergo lung function tests like forced vital capacity FVC and lung diffusion capacity DLCO, complete questionnaires about their lung disease, and have blood tests to measure biomarkers. Researchers will monitor safety by tracking adverse events, vital signs, lab results, and electrocardiograms. The main measure is the change in lung function from the start to week 52, with additional assessments of clinical worsening, acute lung exacerbations, survival, and oxygen use.