17 results
The objectives of this exploratory trial are:1. To measure the pharmacodynamic (PD) effect on parameters derived from 24-hpH/impedance (MII) monitoring,2. To explore the effect on symptoms,3. To evaluate the safety and tolerabilityof treatment with…
The goal of this study is to determine whether a short course of amoxicillin/clavulanic acid reduces the number of urinary tract infections in children that have been catheterized during a short period.
The primary objective of the study is to reject the Null hypothesis: A 7 to 21 day therapy with moxifloxacin, 400 mg once daily is more than 10 % less effective than a 7 to 21 day therapy with piperacillin/tazobactam three times daily possibly…
The primary objective of this study is:• To evaluate whether selonsertib (SEL, previously known as GS 4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH. The secondary objective of this…
This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.
Investigation of the impact of a treatment consisting of inhalation antibiotics and prolonged oral antibiotic course during a bacterial exacerbation on the prevention of further exacerbations.
This will be the first study with JNJ-63733657 in humans to investigate the safety, tolerability and pharmacokinetics of JNJ-63733657 and to explore potential pharmacodynamic (PD) effects in healthy subjects following single dose administration and…
The primary objective is to establish the non-inferiority of treating a symptomatic urinary tract infection in patients with a long-term indwelling catheter for 5 days, as compared to the standard duration of 10 days of therapy. Secondary objectives…
- To assess the effectiveness of rectal culture-guided antimicrobial prophylaxis for transrectal prostate biopsy (random ultrasound-guided, targeted MRI-guided or targeted MRI-ultrasound fusion guided) on infectious complications. - To compare the…
To observe a decrease in number of definite and/or suspected pneumonia after prophylactic treatment with antibiotics during CRT in patients with LAHNC.To observe a decrease in the number of admissions in the hospital To observe a decrease in the…
Primary Objectives•To assess and compare the efficacy of five doses of HM11260C (once weekly subcutaneous injections) over the 12 weeks from baseline in comparison with placebo (once weekly subcutaneous injections) on glycaemic control, as assessed…
This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…
To assess the safety and tolerability profile of escalating dose levels of ESB1609 when administered as once daily (qd) oral doses for up to 25 days in healthy volunteers.
This study is an extension of the European Multicenter Tics in Children Studies (EMTICS) Course study for which a separate study protocol exists; its aim is to verify the efficacy of GAS colonization treatment on tic symptoms in term of severity.…
The primary objectives for this study are:To evaluate the preventive effect of GYM329 on disuse muscle atrophy in healthy male volunteers through changes in muscle strength following a single subcutaneous administration prior to unilateral thigh and…
To evaluate the clinical outcomes, antiviral activity, safety, tolerability, PK, and PK/PD of JNJ 53718678 in adult (ie, adult cohort) and adolescent (ie, adolescent cohort) HSCT recipients with an RSV upper respiratory tract infection (URT)I.The…
To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk NM-CRPC treated with apalutamide versus placeboSecondary Objective:To compare the overall survival (OS) of men with high risk NM-CRPC treated with apalutamide…