Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating a structured multidisciplinary approach called iABC to improve the management of elderly patients with atrial fibrillation (AF) who have multiple other health conditions. This study aims to provide clear evidence that this integrated approach can improve clinical outcomes and quality of life compared to usual care. The research is conducted in Bulgaria, Denmark, Italy, Romania, Serbia, and Spain and focuses on patients aged 65 years and older with AF and multimorbidity. The iABC approach follows the ABC pathway focused on three key areas: preventing stroke with anticoagulation (using optimized vitamin K antagonists or direct oral anticoagulants), better management of AF symptoms, and optimized care for related cardiovascular and non-cardiovascular conditions. The study uses a novel platform incorporating education, a healthy or functional diet and physical activity, guideline-based drug treatments, and regular reassessments. Clinical centers in each country are randomized to either implement the iABC approach or continue with usual care. Participants will be outpatients with confirmed AF and at least one additional long-term health condition such as hypertension, coronary artery disease, or diabetes. Researchers will monitor outcomes including the impact of iABC on all-cause unplanned hospitalizations over 12 months. Assessments include guideline-based diagnosis confirmation, regular follow-up, and monitoring of treatments and lifestyle changes. Safety and adherence will be evaluated throughout the study, which aims to provide holistic care improvements for this high-risk population.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating ways to prevent incisional hernia, a common complication after laparoscopic surgery, which can occur in up to 30% of patients. This study compares the use of an onlay mesh versus a standard fascial closure device at the umbilical trocar site during laparoscopic cholecystectomy, with or without exploration of the common bile duct. The trial is a randomized controlled study conducted at two centers, aiming to find a better closure technique through accurate diagnosis using ultrasound imaging at 12 months after surgery. Participants will be randomly assigned to one of two groups. In the prosthesis group, after suturing the aponeurosis, a lightweight mesh made of polyvinylidene fluoride (PVDF) will be placed over the closure site and fixed with cyanoacrylate glue. In the control group, closure will occur with sutures alone under direct vision. Both groups undergo laparoscopic cholecystectomy using the Hasson technique for pneumoperitoneum. Follow-up includes a 12-month period during which the abdominal wall is assessed by ultrasound to detect hernia development. During the study, participants will have an abdominal ultrasound focused on the trocar site 12 months post-surgery to identify any defects or hernias. Researchers will record any adverse events and classify them by severity. The study will analyze differences between groups statistically, evaluating the presence of hernias to determine the preventive effect of the mesh. Participation lasts at least 12 months after the surgery, with safety and efficacy monitored throughout.