Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.
Actively Recruiting
Researchers are conducting a national, prospective, multicenter pilot project in the Czech Republic to establish a standardized combined first trimester screening for pregnant women. This screening aims to predict and detect serious obstetric complications such as preeclampsia, fetal growth restriction, preterm labor, intrauterine fetal demise, and structural congenital defects, including chromosomal abnormalities. The study seeks to create a unified method for performing and evaluating this screening linked with the National Health Information System to improve care quality and accessibility. The screening process includes collecting maternal, ultrasound, biochemical, and biophysical parameters during the first trimester of pregnancy 11th-13th week. Certified software from the Fetal Medicine Foundation will be used to assess individual risks for preeclampsia, fetal growth restriction, and fetal chromosomal aneuploidies like trisomies 21, 18, and 13. The project plans to test this methodology on a sample of 2000 women and aims to support the development of reimbursement mechanisms from public health insurance. Participants will be involved during the first trimester, providing data for analysis and risk assessment. The study will measure the proportion of women identified with increased risk for the targeted conditions from June 2025 to October 2026. Women must consent to participate and allow processing of personal data. This observational study is supported by national and European funds and strives to enhance pregnancy care outcomes for all population groups, including socially excluded communities.