Coppito

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are studying children with severe anterior crowding of the upper front teeth to compare early treatment during mixed dentition with later treatment in permanent dentition. This trial aims to find out if early maxillary expansion reduces crowding after five years, improves oral health-related quality of life, causes lower dental arch adaptation, and is more cost-effective than later treatment. Children aged 6 to 9 with at least 6 millimeters of crowding and lateral incisors not fully erupted are eligible. Children in the experimental group receive a maxillary expansion device attached to specific baby teeth, which parents activate daily or every other day to create space for erupting teeth. The expansion may pause to allow spontaneous adjustment. The device is kept as a retainer until lateral incisors fully erupt. The control group receives no treatment during the observation period. Both groups attend follow-up visits over about five years, including questionnaires on pain, discomfort, and oral health quality of life. Participants undergo measurements using digital models and scans to assess changes in tooth alignment, arch width, and palatal volume. Questionnaires and cost analyses are completed to evaluate treatment impact and cost-effectiveness. Follow-ups occur at 24, 36, and 48 months, and after all permanent premolars erupt. The study measures include long-term tooth alignment, quality of life, morphological changes, complications, and costs over the five-year period.