Karlsburg

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are studying baricitinib to see if it can help preserve beta-cell function in children and adults aged 1 to 35 years who have been newly diagnosed with type 1 diabetes. This Phase 3 study aims to evaluate the treatments impact on preserving insulin production shortly after diagnosis. Participants will be followed for about 60 weeks to assess changes in key diabetes-related measures. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study compares these two groups to evaluate the effects of baricitinib on beta-cell function. The main measurement is the change in C-peptide area under the curve over 52 weeks, which indicates insulin production. Additional outcomes include changes in blood sugar control, insulin use, hypoglycemia events, and other health indicators. During the study, participants will attend visits for assessments and monitoring over approximately 60 weeks. Tests will include blood measurements like C-peptide and hemoglobin A1c, insulin dose tracking, and health surveys. Safety and drug levels will be monitored. Researchers will use these data to understand if baricitinib can help maintain beta-cell function in people newly diagnosed with type 1 diabetes.

Researchers are evaluating cardiac performance by comparing stroke-volume-index measurements taken by three different methods in patients undergoing and recovering from cardiac surgery. The study focuses on patients after cardiac surgery who have a pulmonary artery catheter and involves monitoring during surgery and in the intensive care unit, including both ventilated and spontaneously breathing patients. The study assesses cardiac performance using three diagnostic tools the pulmonary artery catheter, FloTrac, and the Argos Monitor. These devices measure cardiac output and stroke-volume-index by different mechanisms. Investigations are conducted in the operating theater and intensive care unit to observe measurements under various patient conditions. Participants will be monitored for stroke volume index over a 24-hour period following surgery. The study collects data using these devices without altering patient treatment. Researchers will evaluate and compare the measurements to understand differences among the methods. This observational study does not include treatments or interventions beyond standard care, and participation duration depends on the postoperative monitoring period.

This trial focuses on patients who have undergone implantation of a durable left ventricular assist device LVAD and are being monitored using a pulmonary artery catheter. The study aims to compare the effects of two different ventilation methods on heart function, particularly the right ventricle. Researchers are evaluating hemodynamic changes between extra thoracic negative pressure ventilation and traditional intrathoracic positive pressure ventilation in this patient group. Participants will first receive ventilation using negative pressure ventilation for 15 minutes, followed by ventilation with positive pressure ventilation. Both ventilation modes are applied sequentially to each participant while hemodynamic parameters are measured. The study does not include a placebo or control group but compares the two ventilation techniques within the same individuals. During the study, participants will be closely monitored using a pulmonary artery catheter to assess right ventricular function and other hemodynamic changes. The main outcome measure is the right ventricular stroke work index RVSWI recorded during one minute of ventilation. The total duration of the study participation is dependent on the ventilation period and monitoring immediately after LVAD implantation. Safety and stability of participants are carefully observed throughout the procedure.