42 results
The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…
2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…
The proposed study has 2 main aims: 1) Understanding the complex interplay of determinants of parenting and examining how specific parenting styles explain associations between parent characteristics (such as personality or mental and physical (ill…
Aim of the present study is to investigate if a combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the SLNM technique in colon and rectal cancer by utilizing the radioactive component for preoperative…
Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).
Primary objectives- To evaluate the feasibility of leukapheresis and the production of human clinical-grade proinsulin-peptideC19-A3-pulsed TolDCs (PIpepTolDCs) in type 1 Diabetes Mellitus patients.- To evaluate the safety of clinical use of…
To determine the median progression-free survival (PFS) and R0/1 secondary resection rate upon induction systemic treatment in colorectal cancer patients with initially unresectable liver-only metastases, stratified by RAS and BRAF tumor mutation…
Primary Objective: Assess the leakage of FFP2 respirators and surgical masks in human subjects using inhalable aerosols consisting of a solution of fluorescein in water.Secondary Objective(s): (a) Study the variability in total inward leakage of…
The study will help us to determine 1. the necessary type of (combined) examinations and 2. the sample size that is essential to evaluate (future) genetic therapy in Usher syndrome type 2 and USH2A associated nsRP.
The objective of this study is to characterise and validate multidimensional latent risk and resilience mental health trajectories in a trans-syndromal sample of help-seeking young people, including identifying genetic, environmental, biological,…
Investigate the effect of FMT from healthy obese donors on objective response rate (ORR according to RECIST criteria) in patients with metastasized or locally advanced NSCLC receiving standard of care first-line immunotherapy with or without…
The primary objective of this study is to compare the mean binocular DCIVA at 66 cm under photopic conditions 3 months after cataract surgery, in a series of patients, who previously underwent myopic laser surgery, bilaterally implanted with the non…
Primary Objective: To investigate motor developmental outcome at school age of children with CHD compared to typically developing peers.Secondary Objective(s): - To investigate neurodevelopmental outcom eat school age on several developmental…
Primary Objective: • To determine the clinical Progression Free Survival (cPFS) in our study cohort of patients with mCRPC and 68Ga-PSMA-PET/CT selected bone-only disease (PET-bone only group). The cPFS will be compared to the cPFS of patients with…
The objective of the study is to assess the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.
The primary aim of this study is to assess the feasibility of EM-navigation for percutaneous liver ablation.
To enhance our knowledge of the molecular nature, induction and regulation of the autoantibody and B cell response involved in/responsible for the induction of VITT
Gain insight into the health and health-related factors in adults with intellectual disabilities.
Primary objective: Development of a normal tissue complication probability (NTCP) model for hypothalamic dysfunction (for severe hypothalamic dysfunction, named hypothalamic syndrome) in childhood brain tumor survivors, incorporating cranial…
The main objective of this study is to determine the maximum tolerated dose (MTD) of 2-fraction boost MRI-guided radiotherapy (MRgRT) for patients with SCC following CROSS therapy. The secondary objectives are feasibility, non-dose limiting toxicity…