7 results
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
To define the optimum laparoscopic hiatus hernia repair, ensuring long-term effect with minimal postoperative side effects.
Primary:To assess the efficacy of DS-1062a, as measured by the ORR, as a treatment for subjects with NSCLC with actionable genomic alterations that has progressed on or after 1platinum-containing therapy and 1 platinum-containing therapy and 1 or…
MAIN OBJECTIVES:- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone, as measured by progression-free survival (PFS) by blinded independent central review (BICR).- To compare the efficacy of Dato-DXd in…