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Browse 8,272 clinical trials for ulcerative colitis. Find studies that match your criteria and connect with research centers.
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NCT07223749
Under-diagnosis of Chronic Obstructive Pulmonary Disease (COPD) is prevalent, with an estimated 75% of adults suffering from COPD in the US, without clinical recognition. Often, the first diagnosis of COPD comes with a flare or exacerbation. In one study, 34% of patients were first diagnosed during hospitalization for an exacerbation, an event associated with a 1-year mortality rate of 26%. When COPD is finally diagnosed, it is often in the late stages, with an average lung function of 50% of normal. Conversely, COPD can be over-diagnosed, defined as symptoms in an individual without airflow obstruction. Over-diagnosed people have significantly higher rates of hospitalization, ER visits, and ambulatory care visits because individuals are treated for a disorder they don't have and are not being treated for the disorder they do have. Lack of diagnostic clarity places patients at risk of medication complications without potential benefit. Conversely, failure to diagnose preempts the benefits of therapy. To date, no reliable solution has been found to address this problem.
NCT04428476
This Phase 2, multi-center, open-label extension trial will provide deramiocel (CAP-1002) to subjects that were enrolled in the HOPE-2 trial and completed 12 months of follow-up. The trial will explore the safety and efficacy of twenty intravenous administrations of deramiocel, each separated by three months, over a period of approximately 60 months. Following completion of the initial open-label phase (Month 60), subjects who have completed all Month 60 assessments will be eligible to continue into a long-term open label extension (LT-OLE) period and can continue to receive deramiocel once every 3 months until deramiocel is commercially available or the sponsor terminates the study, or the subject withdraws consent or study participation is terminated by the sponsor. Subjects will undergo a targeted screening during a 30-day screening period, eligible subjects will then undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of deramiocel. Subjects will complete trial assessments at Screening; Day 1; Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, and all LT-OLE visits. Safety and efficacy assessments will be conducted prior to deramiocel administration at the Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, and at all LT-OLE trial visits, unless otherwise indicated. All deramiocel infusions will be conducted in an outpatient setting at the investigative site on Day 1 and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, with continued dosing in the LT-OLE visits. Subjects will be observed in the outpatient setting for at least two hours post infusion and then discharged the same day, if medically cleared by the site Investigator.