Modling

Endometriosis is a condition affecting at least 1 in 10 women worldwide, with diagnosis often delayed by 5 to 10 years. Currently, a definitive diagnosis requires invasive laparoscopy, which can be costly and burdensome for patients. This multicenter diagnostic validation study evaluates a new non-invasive laboratory test that analyzes biomarkers from menstrual blood samples to diagnose endometriosis. The study involves self-collection of menstrual blood samples by participants. It is a prospective multicenter study conducted at gynecological centers in Austria and Germany, with plans to expand to other sites. The test's diagnostic accuracy will be assessed by comparing women with confirmed endometriosis to control groups without the condition, using measures such as sensitivity, specificity, and predictive values. Participants will be menstruating women aged 14 to 49 years, divided into groups including those with histologically or imaging-confirmed endometriosis, those with no evidence of endometriosis via laparoscopy, and healthy women without symptoms and negative imaging. The primary outcome is the diagnostic accuracy of the menstrual blood-based biomarker test, assessed from a single self-collected sample within seven months after enrollment. The study is expected to last three years.

Researchers are investigating the effect of high dose Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for preventing cardiac events in patients with Type 2 diabetes mellitus (T2DM) who have no known cardiac disease. The study also aims to explore how levels of amino-terminal pro-B type natriuretic peptide (NT-proBNP), a marker of cardiac risk, might influence treatment effects and the overall economic impact. A special eye sub-study at Viennese sites examines how these treatments affect early signs of diabetic micro-angiopathy and neuropathy, as well as the role of NT-proBNP in diabetic retinopathy progression. The trial is a randomized, open-label, parallel-group, active-controlled phase 4 study involving 2400 patients randomized 1:1 to either high dose RAS-antagonists and beta-blockers plus standard diabetes care or standard diabetes care alone. Patients in the treatment group receive prescriptions and/or up-titration of RAS-antagonists and beta-blockers to maximum tolerated doses within three months. The control group maintains stable or no RAS-antagonist and beta-blocker therapy without dose escalation. The study includes regular visits at screening, 3 months, 12 months, and 24 months, with additional up-titration visits for the treatment group between screening and 3 months. Participants undergo health assessments including vital signs, blood tests for chemistry and NT-proBNP, and drug prescription documentation at each visit. The eye sub-study involves biannual evaluations over two years using retinal imaging to detect changes in retinal layers. Patients keep diaries to record blood pressure, heart rate, and symptoms. The primary outcome is the number of patients experiencing unplanned cardiac hospitalization or death due to cardiac events over two years. Long-term follow-up continues through population registers or phone contact to monitor mortality and hospitalizations until study completion.