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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease CAD. This observational registry focuses on individuals treated with this specific stent and planned for a short dual antiplatelet therapy DAPT of up to 3 months. The study aims to collect real-world data on clinical outcomes including safety and effectiveness over a 12-month period. Participants in this single-arm registry have undergone percutaneous coronary intervention PCI using the Vivo ISAR stent and will receive standard care short DAPT treatment for no more than 3 months. The study does not affect treatment choices or standard care procedures. After the PCI, eligible patients will be invited to join the registry and followed up at 1 month, 3 months, and 12 months. During the study, researchers will collect baseline medical data and conduct telephonic follow-ups at 30 days, 3 months, and 12 months. These follow-ups will check on medication use, laboratory assessments, adverse events, and any further interventions. The main outcomes measured include ischemic and bleeding events at 12 months, along with secondary outcomes such as mortality, heart attacks, strokes, stent thrombosis, and need for additional vessel treatments. The total participation duration is one year from the PCI procedure.
Actively Recruiting
Researchers are comparing two treatment approaches for patients with diabetes and significant three-vessel coronary artery disease CAD that does not involve the left main artery. This randomized study aims to evaluate outcomes between imaging- and physiology-guided state-of-the-art percutaneous coronary intervention PCI and coronary artery bypass grafting CABG. The trial focuses on how these methods affect major cardiac and cerebrovascular events in this patient group. Participants will receive either PCI guided by advanced imaging and physiological assessments, including intravascular ultrasound IVUS or optical coherence tomography OCT, and tools like fractional flow reserve FFR or instantaneous wave-free ratio iFR, along with modern drug-eluting stents and optimal medical therapy, or they will undergo standard CABG surgery. Both treatments are delivered under careful clinical protocols, and patients will be followed up extensively to assess various health outcomes. During the study, participants will be monitored for major adverse events over two years and other cardiovascular outcomes over five years. Assessments include hospitalization duration, rehospitalization rates, changes in functional class, quality of life questionnaires, medication use, and healthcare costs. The study aims to provide comprehensive data on the effectiveness and safety of these two revascularization strategies, with participants involved in clinical follow-ups and evaluations throughout the study period.
Actively Recruiting
Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.
Actively Recruiting
Researchers are studying oral squamous cell carcinoma, focusing on patients with advanced nodal disease N2-N3 who are operable and present biologically aggressive tumors. The study aims to evaluate whether adding induction chemotherapy before surgery improves 2-year disease-free survival compared to upfront surgery alone. This phase 3, open-label, multi-center randomized controlled trial addresses previous trial limitations by selecting a more homogenous patient group likely to benefit from chemotherapy. Secondary goals include assessing overall survival, treatment response, compliance, toxicity, postoperative complications, quality of life, and tumor biobanking for future research. The study compares two treatment approaches. The standard arm involves surgery wide local excision with comprehensive neck dissection followed by adjuvant radiotherapy with or without concurrent chemotherapy. The experimental arm adds two cycles of induction chemotherapy using TPF or TPX regimens before surgery and similar adjuvant treatment. Patients will receive standard care according to current guidelines, with surgery timed after assessing chemotherapy response. Participants aged 18 to 75 with confirmed operable oral squamous cell carcinoma and advanced nodal involvement will be followed for up to five years. Researchers will monitor disease-free survival at two years as the primary outcome, alongside overall survival, treatment completion, toxicity, quality of life assessments over multiple timepoints, and surgical morbidity. Tumor and blood samples will be collected for biobanking. Safety and quality of life will be tracked regularly, including early and late radiotherapy-related toxicities and financial impact questionnaires.