7 results
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
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…
Demonstrate that the remote management system (Carelink, study group) reduces the time from device detected event onset to clinicaldecision for arrhythmias, cardiovascular disease progression,and system issues compared to patients receiving only in-…
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 (…
The aim of the study is to map the changes that occur in breast tissue composition during pregnancy, lactation and post-lactational involution. The secondary aims are to:• validate the performance of diffuse optical spectroscopic imaging (DOSI)…
The aim of this study is to better understand the role of mammary lactation physiology and breast composition in regulating breast milk transfer during milk extraction. The secondary aim is to validate the performance of diffuse optical…