45 results
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…
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…
The aim of the trial is to individualize treatment for each patient by adapting it to early response and thus to continue intensive treatment only with those patients wo show an inadequate treatment response.For patients who show a good initial…
The aim of this trial is to individualize and thus to optimize treatment for each patient by adapting it to the individual response. The treatment response is determined by means of FDG-PET after 2 cycles of escalated BEACOPP + 2 cycles of ABVD.The…
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…
1. To explore the pharmacokinetics (PK) of intra-vaginal delivery of gonadorelin and oxybutynin. 2. To assess the safety and tolerability of gonadorelin and oxybutynin delivery with a prototype intra-vaginal ring.
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 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…
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…
(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-…
Primary objectives-Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years.-Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an out…
The primary objective of this study is to compare, in a randomized phase III trial, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (*3+7*) on OS in older AML patients.
The objectives of the Phase 1 dose escalation are:Primary Objectives:* To establish the Maximum Tolerated Dose (MTD) and to establish the Recommended Phase 2 Dose (RPTD) for veliparib in combination withcarboplatin and etoposide.* To evaluate the…
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…
It is expected that LF111 will offer benefits to adults in the form of efficacy similar to COCPs, absence of estrogen-related risks, reduced tendency to weight gain and extended dosing window. It is likely that adolescents will share these benefits…
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…
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).
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.