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An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy (TASCO1 study)

This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…

The influence of high frequency 10Hz repetitive transcranial magnetic stimulation (rTMS) on experimental pain measured through quantitative sensory testing in healthy subjects.

to investigate the analgesic effect of high frequency 10 Hz rTMS on experimental pain measured through quantitative sensory testing (QST) in healthy subjects.

The effect of transcranial direct current stimulation on processing speed in patients after ischemic stroke

To evaluate the effects of tDCS on information processing speed in comparison to sham tDCS in patients after stroke with ascertained reduced processing speed. A proof of principle study.

A single-center, randomized, open-label, two-arm study to evaluate the ovarian function inhibition of a monophasic combined oral contraceptive (COC) containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP) and a monophasic COC containing 20 mcg ethinylestradiol (E4)/3 mg drospirenone (Yaz®), administered orally once daily in a 24/4 day regimen for three consecutive cycles

Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…

Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model for the evaluation of transmission-blocking interventions

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…

Bumetanide in Autism Medication and Biomarker study

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,…

Hypofractionated Focal Lesion Ablative Microboost in prostatE cancer (Hypo-FLAME)

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…

A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS

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…

An international phase II trial assessing tolerability and efficacy of sequential Methotrexate-Aracytin-based combination and R-ICE combination, followed by high-dose chemotherapy supported by autologous stem cell transplant, in patients with systemic B-cell lymphoma with central nervous system involvement at diagnosis or relapse (MARIETTA regimen)

This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and feasibility of a newsequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and byhigh-dose chemotherapy supported by ASCT.

A Phase II, global, randomized study to evaluate the efficacy and safety of Danirixin (GSK1325756) co-administered with a standard-of-care antiviral (oseltamivir), in the treatment of adults hospitalized with influenza (study 201023, DAHLIA)

Primary:To assess the efficacy of treatment with IV danirixin twice daily given with oral oseltamivir compared to oral oseltamivir twice daily on time to clinical response (TTCR)Secondary:Time to respiratory response (TTRR), clinical measures of…

Proof-of-concept study on treating cognitive side-effects of Tamoxifen with guanfacine in postmenopausal women with E2/Pg receptor-positive breast cancer.

Provide proof-of-concept for the hypothesis that guanfacine diminishes cognitive side-effects in ER+ BC patients treated with adjuvant hormonal therapy. Secondary, provide data for power calculations in later studies.

Safety and protective efficacy of BCG vaccination against controlled human malaria infection

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.

Proof-of-pharmacology clinical trial on a vaccine that elicits a protective humoral immune response against oxidized low density lipoprotein

The aim of the present study is to determine the effect of vaccination on anti-oxLDL antibodies in man.

A MULTINATIONAL, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED
STUDY TO ASSESS THE SAFETY AND EFFICACY OF LUCINACTANT FOR
INHALATION IN PRETERM NEONATES 26 TO 32 WEEKS GESTATIONAL AGE
WITH RESPIRATORY DISTRESS SYNDROME.

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…

A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection

The primary objective of this Registry is:*To evaluate the long term effects of Hepatitis B Virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144 The secondary objective of this Registry is :*To evaluate the long…

Human intestinal ischemia and reperfusion

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…

Mindfulness training for youth with ADHD: Improving self-control and ADHD symptoms

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)…

A randomised, double-blind, placebo-controlled, single-centre phase IIb trial as part of the EU-funded UNISEC project to assess the immunogenicity and safety of different formulations and dosing regimens of FLU-v vaccine administered subcutaneously in healthy adults aged 18-60 years.

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.

The effectiveness of Pivotal Response Treatment in children and adolescents with autism spectrum disorder: a randomized clinical trail

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…

Topical treatment of perianal dermatitis with potato protease inhibitor cream in children after colorectal surgery.

To address the hypothesis that a potato derived protease inhibitor cream significantly limits perianal dermatitis in patients after colorectal surgery.