2232 results
Primary objectives Phase Ib: To estimate the MTD and/or RP2D of LGX818 in combination with cetuximab ± BYL719. Incidence of dose-limiting toxicities (DLTs). Phase II: To compare the efficacy of the dual (LGX818, cetuximab) and triple (LGX818, BYL719…
Primary objectives are:To assess the diagnostic accuracy of DWI in the evaluation of disease activity in JIA as compared to contrast-enhanced MRI as the reference standard.To assess the accuracy of DWI in detecting joint inflammation as compared to…
1. To improve the overall outcome as compared to the previous protocols of the DCOG, especially ALL-9 and ALL-10.This is aimed for by decreasing therapy for part of the patients (TEL/AML1, Down syndrome, PPR only), increasing therapy for IKZF1…
Primary Objective: To show that an integrated chronic care program in a specialized AF clinic reduces cardiovascular hospitalizations and mortality.Secondary Objective(s): 1) To demonstrate the benefits of an integrated chronic care program in terms…
* To establish the safety profile of daratumumab when given in combination with lenalidomide and dexamethasone in subjects with relapsed or relapsed and refractory MM
Primary Objective: Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone (LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM.Secondary Objectives:- Analyze the population…
Primary objective To determine the relation between age and pharmacokinetics of docetaxel, paclitaxel, doxorubicin, gemcitabine, vinorelbine and capecitabine, respectively. Secondary objectives All here cited secondary endpoints will be separately…
To assess toxicity of MRI guided high-dose-rate focal brachytherapy as monotherapy for favourable risk prostate cancer. As secondary objectives, technical feasibility, quality of life and biochemical free survival will be determined.
1- To estimate the prevalence of cardiac abnormalities, defined as systolic dysfunction, cardiovascular risk factors in CCS who have received anthracyclines, mitoxantrone and / or radiotherapy to the heart region compared with sibling controls and…
Primary Objective: Investigate whether early valganciclovir treatment of children with SNHL of >= 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at 1 year follow-up.…
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
Evaluation the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score >= 2 points, with no individual subscore > 1 point.
Primary: to determine whether an early psychological intervention poststroke in order to reduce symptoms of anxiety and depression, is feasible.Secondary: To evaluate if an early individual psychological intervention in patients independent in…
Primary objective: Are changes in stress-induced autonomic and hormonal parameters associated with (epi)genetic vulnerability for schizophrenia and bipolar disorder?Secondary objectives: 1. Are changes in autonomic and hormonal parameters after…
The PRELHUDE study investigates the reversal of the ZAHARA3 study; whether subclinical congenital heart disease occurs in women who deliver prematurely for unknown reason. The biosamples taken during and after delivery will be used to determine…
The aims of the present study are: 1. to create a tracer kinetic model for quantification of [18F]FCH and simultaneously validate a simplified quantitative method, and 2. to assess the repeatability of the latter method.
The first aim is to test the effect of the surgical intervention for fear of blushing in a randomized controlled trail consisting of a robot-assisted highly selective dorsal sympathectomy and a waiting list control group. There are several outcome…
Primary objectiveThe primary objective of this study is to assess the feasibility and safety of omitting prophylactic postoperative drainage after pancreatic surgery. This study was designed in order to gather conclusive information regarding the…
The goal of this investigation is to show that Hemospray is effective in achieving initial hemostasis rates equivalent to standard of care treatment and a decreased rate of further bleed when compared to standard of care up to 72 hours after…
We want to describe in detail the MTH-induced changes in pro- and anti-inflammatory markers in patients after CA. We further aim to evaluate the relation between neurological outcome and levels of pro- and anti-inflammatory markers.