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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying the real-world effectiveness, safety, and patient experience of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Age: 18Years - 100YearsAll Genders
283 locations
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Actively Recruiting

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction MI specifically ST-segment elevation MI STEMI or non-ST-segment elevation MI NSTEMI who also have multivessel coronary artery disease CAD and have undergone successful treatment of the culprit lesion with Percutaneous Coronary Intervention PCI. The study aims to compare physiology-guided complete revascularization to angiography-guided complete revascularization, focusing on both efficacy and safety outcomes. Participants are randomly assigned to one of two groups. One group receives physiology-guided PCI where the function of non-culprit lesions NCLs is assessed using resting full-cycle ratio RFR or fractional flow reserve FFR, with PCI performed on lesions meeting specific thresholds. The other group undergoes angiography-guided PCI, receiving routine staged PCI on all qualifying NCLs identified before randomization. Both approaches follow local practice standards for PCI. During the study, researchers monitor participants for a minimum of two years to assess the time to first occurrence of major cardiovascular events, including cardiovascular death, new MI, or ischemia-driven revascularization, as well as safety outcomes like significant bleeding, stroke, stent thrombosis, or kidney injury related to contrast use. The trial also includes an observational imaging study using optical coherence tomography in a subset of patients. Follow-up assessments will enable evaluation of both efficacy and safety over the study period.

Age: 18Years +All GendersPhase Not Applicable
113 locations
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Actively Recruiting

Ulcerative colitis UC is a chronic inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. This research evaluates how risankizumab treatment affects disease activity in adults with moderate to severe UC during routine clinical care. The study is observational and aims to understand risankizumabs impact in real-world settings across Germany and Austria. Participants will receive risankizumab prescribed by their doctors following local guidelines and usual practice. The study does not alter the treatment plan and involves no additional medication beyond what is normally prescribed. Participants will be observed and followed for up to 52 weeks as they continue their routine care. During the study, participants will attend regular hospital or clinic visits as part of their usual care schedule. Researchers will measure the percentage of participants achieving symptomatic remission based on the Partial Adapted Mayo Score over approximately 52 weeks. There is no added burden, and safety and effectiveness will be assessed through ongoing clinical monitoring.

Age: 18Years +All Genders
55 locations
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Actively Recruiting

Researchers are evaluating the safety and performance of the Occlutech Atrial Flow Regulator device in patients with heart failure. This international, multicenter follow-up registry aims to identify unknown side effects and determine when this treatment is appropriate. The study focuses on patients with chronic symptomatic heart failure and monitors outcomes over a 36-month period after device implantation. Participants will receive the Occlutech Atrial Flow Regulator, which is an interatrial shunt device delivered through a catheter. Treatments and procedures follow clinical routine and device instructions, performed by experienced physicians at equipped centers. The study tracks device performance and cardiovascular events at 12, 24, and 36 months after implantation. During the study, participants will undergo assessments including vital signs, lab tests, quality of life questionnaires, ECGs, and echocardiograms. Researchers will measure major adverse cardiovascular and neurological events within one year, as well as heart function, exercise capacity, and medication changes over three years. Safety and efficacy will be closely monitored throughout the follow-up period.

Age: 18Years +All Genders
36 locations