19 results
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…
Compare Progression Free Survival (PFS) for brivanib versus placebo in subjects with advanced solid tumors with FGF-2 over-expression and who have obtained stable disease after 12 weeks of treatment with brivanib separately for each tumor.
Dividing the study population in four categories (oncological patients, critically ill patients admitted to intensive care, neonates and other children) answers to the following questions are sought:- which initial dosage regimen for vancomycin…
With this study we will investiagate the superiority of fecal clysma therapy (n=34 patients) above conventional therapy with the antibiotic vancomycin (n=34 patients) or bowellavage with conventional antibiotic therapy (n=34 patients).
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 (…
PrimaryPhase 1-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory cHL, DLBCL or PTCL, and to confirm the recommended Phase 2 dose (RP2D).Phase 2- Cohort A1 (anti-…
Primary objective: To study the pharmacokinetics of gentamicin, tobramycin, vancomycin and ciprofloxacin in morbidly obese patients and compare with normal weight patients. Secondary objectives: To assess the influence of covariates (such as TBW,…
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet…
The primary objectives are to determine the inhibitory effect of intravenously administered C1-inhibitor as well as the influence of depletion of the human microbiota on allergic lung inflammation induced by house dust mite (HDM) plus…
The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).The secondary objectives of the study are:• To characterize the…
Primary ObjectivesIn the Dose Escalation Phase:• To assess the safety and pharmacokinetics (PK) in order to determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimabIn…
From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab 1600 mg + cemiplimab and/or fianlimab 400 mg+ cemiplimab compared to pembrolizumab, as measured by progression-…
The primary objective:To determine the safety and tolerability of 89Zr*DFO*REGN5054 alone and in combination with cemiplimab.Secondary ObjectivesFor Part A:• To characterize the radioactivity pharmacokinetic (PK) profile of 89Zr DFO REGN5054• To…
Primary Efficacy Objective:Primary objective: To evaluate if the addition of ISA101b to cemiplimab results in improved overall response rate (ORR) compared to cemiplimab alone, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1…
Primary• Evaluate the efficacy of 8 weeks of treatment with VE202 in terms of endoscopic response at Day 56 • Evaluate the safety of VE202 in Part 1 and Part 2 of the study Secondary objectiveSecondary objective1. Evaluate the safety of VE202 in…
To determine whether 4 weeks of total antibiotic treatment duration is non-inferior to 6 weeks in patients with complicated SAB who have responded well to the initial treatment.
To assess the influence of dosing guided by AutoK on achieving PK targets and clinical endpoints in intensive care patients with sepsis.
Primary objective: 1) To evaluate the overall response rate (ORR) after 24 weeks of cemiplimab in secondary angiosarcomas, according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 or daylight photography as per WHO Offset Publication…
Primary Objectives: Dose Escalation (SAR441000 Monotherapy): -To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the overall safety and tolerability profile of SAR441000 when administered intratumorally as…