10 results
Primary objectiveTo evaluate the efficacy of low dose intravenously lidocaine in comparison with placebo in terms of pain relief after the first oxaliplatin administration measured by a numeric rating scale (NRS 0-10).Secondary objectives1.…
This study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone treatment (study treatments) in patients with advanced idiopathic pulmonary fibrosis (IPF) and intermediate or high probability of Group 3…
We want to answer the following research questions using a peri-operative infusion of lidocaine (PIL) protocol:1. Does low dose peri-operative intravenously administered lidocaine attenuate systemic inflammatory response measured by plasma cytokine…
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
The primary objective of this study is to evaluate whether lidocaine reduces the need of alfentanyl during colonoscopy in patients with IBD.The secondary objective of this study is to evaluate whether lidocaine reduces the incidence of respiratory…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
Our objective is to investigate the value of a HVIGI in chronic midportion Achilles tendinopathy, using a dubbel-blind, placebo-controlled, randomised clinical trial. We expect that this study design gives us the opportunity to provide solid advise…
to investigate the safety and tolerability of pirfenidone in asbestosis patients
To demonstrate the bioequivalence of sorafenib with probenecid relative to sorafenib without probenecid based on the AUC in patients with unresectable hepatocellular cancer, advanced clear-cell renal cell carcinoma, locally recurrent or metastatic,…
Part 1In Part 1 of the study, no study compound will be administered, but a bone marrow aspiration and a blood sample will be taken to evaluate an assay that will be used for Part 2 and Part 3 of the study. Because no nirogacestat is given, we can…