7 results
The primary objective is to establish the non-inferiority of treating a symptomatic urinary tract infection in patients with a long-term indwelling catheter for 5 days, as compared to the standard duration of 10 days of therapy. Secondary objectives…
In the current phase 2 study we will investigate the efficacy of the combination of fulvestrant and alpelisib directly after progression on 1st or 2nd line therapy with fulvestrant with or without a CDK 4/6 inhibitor in patients with HR+HER2-…
Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with a response at Week 24 in at least one of the following groups:* Group 1 (>= 18 yr-old)* Group 2 (6 - 17 yr…
The purpose of the study is to determine whether treatment with alpelisib in combination with olaparib can delay the time to cancer progression compared to standard-of-care chemotherapy in participants with your type of ovarian cancer known as…
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…
Primary Objective: To determine the safety and efficacy of 6000 IU C1-INH in patients with subarachnoid hemorrhage (SAH)Primary hypothesis: The hypothesis is that random assignment to C1-INH in SAH will lead to a reduction in delayed cerebral…
Primary Objective: To determine the safety and efficacy of 6000 IU Cinryze in patients with moderate and severe TBI (GCS <13 with a clinical indication for ICP measurements).Primary hypothesis: The hypothesis is that random assignment to…