Comuna 2

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating an organ dysfunction score adapted specifically for pregnant and early postpartum patients up to 3 days after birth admitted to intensive care units ICU. This observational study aims to determine if this adjusted score, called SOFA-OBS, better predicts ICU mortality compared to the general SOFA score. The study also assesses whether a non-invasive pulse oximeter can effectively evaluate respiratory function instead of the standard arterial blood gas test, which is more painful and invasive. The study involves following pregnant and postpartum patients admitted to the ICU for at least 24 hours. Researchers will collect routine clinical data and laboratory results already used in ICU care, without requiring extra interventions. The SOFA-OBS score adjusts kidney function and blood pressure measurements to reflect the physiological changes during pregnancy and postpartum. It also replaces arterial blood gas oxygen measurements with pulse oximetry when blood gas analysis is unavailable. Data will be recorded daily during the ICU stay. Participants will be monitored for organ dysfunction and mortality outcomes during their ICU stay or up to 28 days after enrollment. Researchers will evaluate and compare the predictive ability of the SOFA-OBS and general SOFA scores for ICU mortality and sepsis-related death. Data quality will be carefully checked, and privacy will be protected by anonymizing patient information. The study is approved by ethical boards and requires informed consent from participants, with a planned enrollment of 130 patients.

This research aims to evaluate the effects of Seladelpar on clinical outcomes in adults with Primary Biliary Cholangitis PBC who also have compensated cirrhosis. The study is a Phase 3 randomized, double-blind, placebo-controlled trial focusing on treatment outcomes for this liver condition. It is sponsored by Gilead Sciences and seeks to understand how Seladelpar may impact disease progression and survival in this specific patient group. Participants will be randomly assigned to receive either Seladelpar or a placebo daily for up to 36 months. Those with CP-A cirrhosis will take 10 mg capsules of Seladelpar, while those with CP-B cirrhosis will take 5 mg capsules. The placebo group will take one capsule daily as well. This long-term treatment period allows researchers to compare outcomes between the two groups effectively. During the study, participants will follow a schedule of assessments to monitor their health and response to the study drug. Researchers will measure outcomes such as event-free survival, overall survival, liver transplant-free survival, and time to hospitalization over 36 months. Safety and laboratory parameters will be regularly evaluated to ensure participant well-being throughout the trial.