Modling

Endometriosis is a condition affecting at least 1 in 10 women worldwide, often diagnosed late due to the need for invasive laparoscopy. Researchers are studying a new non-invasive laboratory test that analyzes biomarkers from menstrual blood samples to diagnose endometriosis more easily. This multicenter diagnostic validation study aims to assess how well this blood-based test can identify endometriosis compared to confirmed cases and controls. Participants include menstruating women aged 14 to 49 years who are divided into groups based on their endometriosis status those with confirmed endometriosis through laparoscopy, histology, or imaging, and control groups without evidence of the disease confirmed by laparoscopy or imaging. Women self-collect menstrual blood samples, which are then analyzed for biomarkers to evaluate the tests diagnostic accuracy. Women involved in the study will provide a single menstrual blood sample within seven months after enrollment. The primary outcome measured is the diagnostic accuracy of this biomarker test, including several performance metrics such as sensitivity, specificity, and predictive values. The study is observational and conducted at multiple centers in Austria and Germany, with a planned duration of three years, including follow-up and data analysis.

Researchers are evaluating the effect of high dose Renin-Angiotensin System RAS-antagonists and beta-blocker treatments for preventing cardiac events in patients with Type 2 diabetes mellitus T2DM who have no signs of existing heart disease. The study aims to show if these treatments reduce unplanned hospitalizations or death from cardiac events compared to standard therapy, especially in patients with higher levels of the biomarker NT-proBNP. There is also a related eye sub-study to assess the impact of these treatments on early diabetic eye complications and how NT-proBNP levels may affect diabetic retinopathy progression. Participants are randomly assigned to two groups. One group receives high doses of RAS-antagonists and beta-blockers up to maximum tolerated levels, added to their usual diabetes treatment. The other group receives standard diabetes care and may continue stable doses of these drugs but without dose increases during the study. The study involves up-titration visits for the treatment group to safely adjust medication doses. The eye sub-study enrolls a subset of patients for specialized eye exams every six months over two years. Participants attend scheduled visits at screening, 3 months, 12 months, and 24 months after starting treatment. Assessments include blood tests for safety and biomarkers, vital signs, and documentation of medications. The treatment group uses diaries to record blood pressure, heart rate, and symptoms during dose adjustments. Long-term follow-up through registries or phone calls monitors mortality and hospitalizations. The main outcome measured is the number of patients experiencing unplanned cardiac hospitalizations or cardiac-related death over two years.