12 results
Primary Objective: The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose of 600 and 800 mg MFX. Secondary Objectives: * To evaluate limited…
The purpose of part A of the study is to investigate how safe the study drug is and how well the study drug is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body. The…
The purpose of the study is to investigate the maximum effect of ADASUVE on repolarization of the heart. This is the process where the cells of the heart muscle recharge again after contraction. If this process is strongly slowed down, (potentially…
Primary• To determine the safety profile of oral topotecan in subjects with cancer andmildly moderately or severely impaired renal function (Groups C, D and E) compared to subjects with cancerwhose renal function is normal and who have received…
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 is to compare the efficacy of moxifloxacin 400 mg PO OD for five days with the respective efficacy of amoxicillin clavulanic acid 875/125 mg PO BID for seven days in the treatment of subjects with AECB. The primary efficacy…
Primary:- To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide or irinotecan-temozolomide or topotecan-temozolomide) demonstrates activity in children with relapsed or refractory neuroblastoma- To test whether the…
The primary objective is to assess treatment with rovalpituzumab tesirine improves overall survival rate (OS) compared to topotecan in subjects with DLL3high SCLC who have first disease progression during or following front-line platinum based…
There are four main objectives in this research project, belonging to two different parts of the study. Part 1 comprises objectives 1 and 2:1. Determine the electrode discrimination abilities of prelingually deafened adult CI users in order to…
The effect of pulse rate on temporal resolution and speech intelligibility in cochlear implant users
To determine the (in)direct effect of CI pulse rate on speech intelligibility by means of (1) a standard test for temporal resolution: amplitude modulation detection (AMD) at two different modulation frequencies, (2) speech intelligibility tests (…
The purpose of the study is to investigate the effect of CBD on specific ECG parameters. Importantly, it will be evaluated if there is a prolongation of the QT interval. When the QT interval is prolonged, repolarization of the heart is delayed. This…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…