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Found 3 Actively Recruiting clinical trials
Actively Recruiting
This clinical trial investigates the best way to use prone position placing patients on their stomachs for adults with moderate to severe Acute Respiratory Distress Syndrome ARDS who need mechanical ventilation. Researchers want to find out if longer prone sessions lasting more than 48 hours improve survival compared to daily sessions lasting 16 to 24 hours. The study also evaluates the safety of prolonged prone positioning and its impact on medical problems related to this intervention. Participants are randomly assigned to one of two groups one receiving prolonged prone position sessions lasting at least 48 hours and up to 120 hours until their oxygenation improves, and the other receiving intermittent daily prone sessions lasting between 16 and 24 hours. Both groups may have repeated prone sessions during the first 7 days if their oxygen levels fall below a certain threshold after returning to the supine position. This design allows comparison of continuous versus intermittent prone positioning in managing ARDS. During the study, participants will be followed for up to 90 days to monitor their clinical progress. Researchers will assess outcomes including mortality at 28 and 90 days, ventilator-free days, and hospital-free days at 28 days. Safety and adverse events related to prone positioning will also be recorded. The total participation involves receiving the assigned prone sessions during the first week and ongoing clinical follow-up to evaluate the effectiveness and safety of each approach.
Actively Recruiting
Researchers are tracking patients with Fabry disease through an ongoing international observational program called the Fabry Registry. This registry collects routine clinical outcomes for patients regardless of whether they are receiving treatment. The study aims to better understand the diseases variability, progression, and natural history, including in women who carry one copy of the gene, and to help improve patient care by developing monitoring recommendations and reporting outcomes. Additionally, the registry evaluates the long-term safety and effectiveness of Fabrazyme4, a treatment used in Fabry disease. The registry includes a special pregnancy sub-registry for women with Fabry disease who are pregnant or have been pregnant. This sub-registry observes pregnancy outcomes and infant growth up to 36 months after birth, collecting medical and obstetric history and treatment details. No experimental treatments are given participants continue to receive their usual care as determined by their physicians. Data from both registries support regulatory requirements and ongoing research. Participants undergo regular clinical assessments and receive standard care from their doctors throughout the study. The research team collects data on disease progression, treatment effectiveness, pregnancy outcomes, and infant development. The study is observational, meaning no study drugs or procedures are administered. The total participation can last up to 33 years, allowing for long-term monitoring of safety and outcomes related to Fabry disease and pregnancy.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of the drug RO7771950 combined with trastuzumab and capecitabine compared to tucatinib combined with trastuzumab and capecitabine in people with locally advanced or metastatic HER2-positive breast cancer. This study includes patients with or without central nervous system metastases and focuses on those who have previously received anti-HER2 therapies. The trial is a randomized, open-label study sponsored by Hoffmann-La Roche, designed to assess treatment outcomes in this patient population. Participants will be assigned to one of three groups two experimental arms receiving different doses of RO7771950 orally twice daily, or a comparator arm receiving tucatinib orally twice daily. All participants will also receive trastuzumab, administered either intravenously or subcutaneously according to local guidelines, and capecitabine taken orally twice daily. The study evaluates these treatments over an extended period to monitor their effects on disease progression and safety. During the trial, participants will undergo regular assessments including imaging scans to measure disease progression, evaluations of heart function, and monitoring of symptoms and quality of life. Researchers will track progression-free survival as the primary outcome, along with secondary measures such as overall survival, response rates, treatment-related side effects, and patient-reported outcomes. The total study duration may extend up to several years to capture long-term results and safety data.