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Found 3 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 prospective, observational registry includes patients who have undergone percutaneous coronary intervention (PCI) using this stent and are planned for a short dual antiplatelet therapy (DAPT) regimen lasting up to 3 months. The aim is to assess clinical outcomes in a real-world population across multiple countries and centers. Participants receive the Vivo ISAR stent and follow standard care with a short DAPT treatment of no more than 3 months after PCI. The study does not influence the choice of device or treatment beyond routine care. After the procedure, patients who meet eligibility criteria and provide consent are enrolled and observed over time without additional interventions. Participants will be followed up through routine clinical practice and telephone calls at 30 days, 3 months, and 12 months after PCI. These follow-ups collect information on ongoing medications, any lab tests performed, adverse events, and any further interventions. The main outcomes measured at 12 months include ischemic events and bleeding events related to the treatment and stent use.
Actively Recruiting
Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.
Actively Recruiting
Researchers are investigating oral squamous cell carcinoma, particularly cases with advanced nodal disease (N2-N3), to determine the benefit of adding induction chemotherapy before surgery. This phase 3, multicenter, randomized controlled trial focuses on patients with operable oral cancer presenting at an advanced stage, aiming to improve disease-free survival and overall outcomes by better selecting patients likely to respond to treatment. The study addresses limitations of earlier trials that included heterogeneous patient groups and stages, which may have affected results. Participants are randomly assigned to one of two treatment groups: the standard arm receives surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, while the experimental arm receives two cycles of TPF or TPX induction chemotherapy before surgery, then the same adjuvant treatment. The chemotherapy regimens include docetaxel, cisplatin, and 5-fluorouracil or capecitabine, administered in specific dosing schedules over a three-week cycle. Patients showing disease progression but still resectable may proceed to surgery, while others may receive alternative treatments. During the study, participants will be monitored for disease-free survival over two years, with further follow-up extending to five years. Researchers will also evaluate overall survival, treatment response rates, toxicity, compliance, postoperative complications, and quality of life. Tissue samples from oral cancer will be collected for future research. The study aims to enroll 346 patients aged 18 to 75 with adequate organ function and performance status, assessing the impact of induction chemotherapy on long-term outcomes.