20 results
The study primary goal is to determine the effectiveness of a single infusion of 1 x 10E13 DRP MYDICAR® in the coronary arteries in addition to an optimal HF regimen in patients with ischemic or non-ischemic cardiomyopathy and moderate to advanced…
The study is divided in Stage A and BGA1 stage A1. To determine the safety and tolerability of direct venous inoculation of PfSPZ-GA1 in healthy volunteers.GA1 stage B Primary objective:1. To determine the safety, and tolerability of PfSPZ-…
The aim of this study is to test the hypothesis that a gentamicin-collagen sponge reduces the incidence of surgical site infection (SSI) in patients undergoing inguinal dissection for vascular disease
Objective: The main objective is to demonstrate superiority of the intravesical overnight instillation of gentamicin versus oral antibiotic prophylaxis in reducing the number of recurrences of UTI and extending the time-interval to a next UTI, in…
Primary objectiveSafety assessment of the MVA-H5-sfMR vaccine in humans. Study subjects will undergo physical examinations performed before and on fixed time points during the study. Clinical chemistry is performed on the blood samples that are…
The objective of the trial is to compare the efficacy and safety of treatment with Allovectin 7® versus treatment with DTIC or TMZ in subjects with recurrent metastatic melanoma. The results of the trial will be used to support registration of…
The objective of this study is to evaluate the safety, tolerability and pharmacokinetics of AIN457 and to compare the efficacy of AIN457 with placebo, in patients with active RA when administered in combination with a stable dose of methotrexate.…
Primary objective:-To compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCTSecondary objectives:- To compare…
The aim of our study is to evaluate clinical outcomes of patients primarily closed over Redon catheters for the treatment of PSM, comparing the application of local gentamicin with a control group.
Primary Efficacy Objectives:To ascertain whether the overall survival of subjects randomized to Arm V+G (PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior to that from subjects randomized to Arm P (placebo control).Secondary Efficacy…
To assess the safety and reactogenicity of HB-101.To assess the immunogenicity of HB-101.
Primary objective:- Disease free survival (DFS)Secondary objective:- Safety & tolerability- Overall survival (OS)Exploratory objective:- Association between HPV subtypes and efficacy- Patient reported outcomes (PRO)Please refer to section 1…
- To assess the safety and tolerability of live-attenuated RSV vaccine in healthy adults.- To assess the immunogenicity of the live-attenuated RSV vaccine (systemic and mucosal immunity) - To assess the viral load/shedding of the live-attenuated RSV…
Primary objectivesTo determine the bacterial eradication capacity of ertapenem, fosfomycine and gentamicine compared to the reference treatment (ceftriaxone) in uncomplicated anogenital gonococcal infections (at one included infection site) by…
• To investigate the safety and tolerability of two ascending dose levels and two different dosing intervals of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects.• To investigate safety and tolerability of three intramuscular dose…
Phase 1 • Primary objective: to determine the safety and tolerability, including the attenuation phenotype of a novel late-arresting GAP, named GA2 parasite, administered by sequentially increasing numbers of mosquito bites.• Secondary objective: to…
Primary objective: To compare the efficacy of JNJ-68284528 with standard therapy, either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
The primary objective is to investigate if a very short-course of antibiotics for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics.
To compare the efficacy of VRd followed by cilta-cel therapy versus VRd followed by Rd therapy in terms of progression free survival (PFS)
The primary objective is to compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy, in terms of progression-free survival (PFS) and sustained minimal…