8 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…
Primary Objective: the primary objective of this study is to determine the feasibility of [18F]FDHT PET/CT for in vivo evaluation of bone metastases in prostate cancer. Active locations will be compared with those seen on conventional imaging (bone…
The objective of this study is to determine user perception of the 2-piece flat skin barrier compared to the current Dansac flat 2-piece barrier, specifically as it relates to barrier adhesion, barrier tack, comfort, leakage, and ease of barrier…
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 (…
Primary Objective: To assess the detection rate of 18 F-FDHT PET/CT in men with recurrent prostate cancer after radiotherapy who are candidates for local salvage treatment.Secondary Objective(s): To assess the detection rate and accuracy of 18 F-…
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 (…
1. Primary Objectives• To evaluate the safety and tolerability of VX 440 monotherapy and VX 440 in dual and triple combination with VX-661 and IVA• To evaluate the efficacy of VX 440 monotherapy and VX 440 in dual and triple combination with VX 661…