180 results
Primary objectives:1) To evaluate the safety of four different CHMI-trans protocols in healthy malaria-naïve volunteers challenged with Plasmodium falciparum by sporozoite challenge. 2) To determine the best CHMI-trans protocol for induction of…
The primary objective of the proposed study is to investigate whether bumetanide therapy indeed reduces autistic symptomatology. Important secondary goals of this project are to determine whether bumetanide will improve specific behavioral,…
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The main goal of this phase II study is to investigate whether a focal ablative SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT. Based on the present study, a phase III…
Safety (Primary) ObjectiveThe primary objective for this study is as follows:- To evaluate the safety and tolerability of cobimetinib in children and young adults, including estimation of the maximum-tolerated dose (MTD) or the maximum administered…
Although DC vaccinations have been used in allo-HCT settings, no previous studies have been performed using a CBDC vaccine after CBT. This study will therefore be subdivided into 2 parts:- Part A: to determine a safe dose of the vaccination, and -…
This study aims at (further) revealing the pathophysiology of intestinal IR in man, with a specific interest for the role of proteases and protease-activated receptor-2 (PAR-2), cellular and inflammatory changes, barrier function and intestinal…
Our primary objective is to evaluate the effectiveness of mindfulness training in improving self-control of youth with ADHD. As secondary objectives, we aim to quantify the effectiveness in reducing ADHD symptoms, reducing comorbid (e.g. ASD)…
To investigate the safety of the vaccination and the immune responses generated by the different formulations and dosing regimens of FLU-v in healthy adults.
Primary Objective: The main objective is to investigate the effectiveness of PRT compared to CAU in school-aged children and adolescents with ASD.The primary research question is:1) Directly after treatment and at follow-up, what is the…
To address the hypothesis that a potato derived protease inhibitor cream significantly limits perianal dermatitis in patients after colorectal surgery.
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
The primary objective is to determine the safety and tolerability BCG vaccination followed by controlled human malaria infection; and to determine the protective efficacy BCG vaccination against a controlled human malaria infection.
The aim of the present study is to determine the effect of vaccination on anti-oxLDL antibodies in man.
To evaluate the safety and efficacy of lucinactant for inhalation, in comparison to nasal continuous positive airway pressure (nCPAP) alone, inpreterm neonates with RDS, as assessed by the time to, and incidence of, respiratory failure and/or death…
Primary Objective:To compare the efficacy of BMS-986142 versus placebo on a background of MTX as assessed by ACR20 and ACR70 response rates at week 12.Secondary Objectives:1) Assess additional efficacy outcomes of BMS-986142 at week 12 and over 12…
The main objective of this phase II observational study is to investigate the early and early-delayed toxicity in 100 patients with localized prostate cancer (cT1c-T3bN0M0) that is observed in the first year following after stereotactic MRI-guided…
Primary objective:To evaluate the effect of each of 2 doses of AK001 separately in combination with an INS versus the INS alone on the reduction in size of nasal polyps as evaluated by the change from Baseline to Week 12 after the start of treatment…
Efficacy and safety trial with S 44819 after recent ischemic cerebral Event
To explore the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms.