5 results
Objective: The primary objective of the study is to determine whether the intracervical installation of vasopressin reduces the incidence and severity of gas embolism as detected by trans oesophageal echocardiography (TOE).The secondary objective is…
The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…
The primary objective is to investigate whether the rebreathing apparatus or the steady-state apparatus should be used as a diagnostic tool in the MST. The primary objective is answer by means of sub questions, which involve; the repeatability of…
Primary Objective * To evaluate the effect of a 6-week treatment with elafibranor versus placebo on hepatic lipid composition in subjects with a fatty liver.Secondary objectives * To evaluate the between treatment difference (elafibranor 120 mg/d vs…
Primary objectives * surrogate endpoint (at interim analysis)To evaluate the efficacy of elafibranor QD for 72 weeks versus placebo on resolution of NASH without worsening of fibrosis.* Resolution of NASH is defined as the disappearance of…