Karlsburg

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

A comparison of cardiac performance determined by stroke-volume-index measured by different mechanisms in patients during and after cardiac surgery: 1. Pulmonary artery catheter 2. Flo Trac 3. Argos Monitor Investigations will be done in theater and on ICU in ventilated and spontaneously breathing patients.

This research evaluates how different ventilation methods affect heart function, specifically focusing on the right ventricle, in patients who have received a durable left ventricular assist device (LVAD). The study includes patients with heart failure or critical illness who have undergone LVAD implantation and had stable postoperative conditions without complications. It aims to compare the impact of two ventilation techniques on hemodynamics using pulmonary artery catheter measurements. Participants first receive negative pressure ventilation through a specialized device, followed by the usual positive pressure ventilation. Each ventilation method is applied for 15 minutes, and changes in heart performance between the two modes are carefully monitored. The study focuses on measuring right ventricular function and overall cardiovascular response during these ventilation periods. Throughout the study, patients are closely monitored using pulmonary artery catheters to assess hemodynamic changes. Researchers focus on right ventricular stroke work index (RVSWI) as the primary outcome measure. The study includes careful observation for any adverse events after surgery before starting ventilation tests. Patient participation involves a single session of ventilation testing and monitoring to understand the physiological effects of these ventilation methods after LVAD implantation.