9 results
To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of progression-free survival (PFS) by independent review
To provide high level of evidence that omitting perioperative antibiotic prophylaxis does not increase the postoperative infection rate, in patients with acute calculous cholecystitis undergoing laparoscopic cholecystectomy.
Primary: To compare the pharmacokinetics (PK) of the once daily (QD) and once weekly (QW) formulations of setmelanotideSecondary Objectives:To assess the safety of the QW formulation of setmelanotide with up to 6 months (26 weeks) of drug…
The purpose of the study is to test whether a centre-wide policy of incremental antibiotic therapy will reduce arrhythmia device infection in patients undergoing arrhythmia device procedures compared to a policy of conventional antibiotic…
EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
In light of the above, our objective is to study the (cost-) effectiveness of a single intravenous gift of antibiotic prophylaxis with a firstgeneration cephalosporin prior to implant removal following surgical fixation of foot, ankle and/or lower…
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 (…
Primary objective:- To compare efficacy of induction vemurafenib + cobimetinib followed by ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).Secondary Objectives- To describe duration of response and overall…