26 results
Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…
Primary Efficacy ObjectivesUnless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + paclitaxel + bevacizumab (Arm B) versus carboplatin + paclitaxel + bevacizumab (…
The aim of this study is to investigate whether a physiologically low hydrocortisone (HC) dose is better for cognition as compared to a high hydrocortisone dose. In addition, quality of life, metabolic profile and somatosensation will be described…
The aim of this study is to determine the effects of propranolol on patients* crucial fear-related memories and dental trait anxiety in those undergoing surgical removal of one of their teeth or molars. The hypotheses that are tested are that…
The aim of this study is to determine whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cTnT in patients scheduled for minimally invasive, port access operations (mitral valve…
The primary objective of this study is to evaluate the role of 68Ga-DOTA-NOC PET/CT in the imaging of disease activity in suspected neurological and cardiac sarcoidosis and to assess the sensitivity and specificity of 68Ga-DOTA-NOC PET/CT. We…
The objective of this clinical research study is to evaluate the safety and effectiveness of brodalumab, compared with ustekinumab and placebo, for the treatment of moderate to severe plaque psoriasis.
Estimate the maximum tolerated dose (MTD) of AEB071 (dose escalation) and characterize the safety and tolerability of the MTD or recommended Phase 2 dose of AEB071 in patients with metastatic uveal melanoma (dose expansion).
To evaluate the safety and tolerability of multiple escalating doses of intravenous WCK 4282 in healthy, adult, human subjects.To evaluate the pharmacokinetics (PK) of multiple escalating doses of 1g:1g (1 vial) of intravenous (IV) WCK 4282 every 8…
Phase Ib: Estimate the MTD and the RP2D of the combination of AEB071 and MEK162 in patients with metastatic uveal melanoma. And to assess the preliminary anti-tumor activity of the combination of AEB071 and MEK162. To characterize the PK profiels of…
Phase Ib:Estimate the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of AEB071 and everolimus combination therapy inpatients with DLBCLPhase II:Assess the preliminary evidence for anti-tumor activity at R2PD for AEB071 and…
(1) To assess [11C]phenytoin plasma and brain kinetics in healthy volunteer(s), including assessment of the presence of radioactive metabolites in plasma. (2) To develop a tracer kinetic model for [11C]phenytoin in humans. (3) To determine intra-…
The purpose of the study is to investigate how safe the compound USL260 is and how well the compound USL260 is tolerated under fasting and fed conditions. The study will also investigate how quickly and to what extent the compound USL260 is absorbed…
Primary:to evaluate the safety and tolerability of single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with rheumatoid arthritis (RA)Secondary:- to evaluate the pharmacokinetics (PK) of single escalating IV doses…
The primary objective of this study is to evaluate the effects of two types of AR treatment & placebo in counteracting AR*s effects on Cognition and Driving. Therefore, the effects of nasal provocation in AR patients on cognitive functions…
The purpose of the study is to determine how a single administration of rifampicin influences the uptake and breakdown of clazosentan. Furthermore, the safety and tolerability of clazosentan when administered after administration of rifampicin, will…
Primary Objectives:* To determine the safety and tolerability of ENA-001 in healthy subjects after low and high doses of ENA-001 under hypoxic and hypercapnic conditions in conjunction with low and high doses of propofol.* To determine the…
Lu AF28996 is an orally administered investigational compound of a potent, long-acting dopamine agonist, Lu AA40326, currently under development by H. Lundbeck A/S for the treatment of Parkinson*s disease (PD). Primary Objective:to investigate the…
The main purpose of this study is to investigate the effect of nipocalimab on how quickly and to what extent etanercept or hydroxychloroquine is absorbed, distributed, metabolized and eliminated from the body. The study consists of 2 parts, Part 1…
Primary• To assess the safety and tolerability in healthy volunteers of nizaracianine administered IV in three divided dosesSecondary• To perform pharmacokinetic analyses of blood and urine• To determine if bolus injection of nizaracianine enables…