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Markers for neurocognitive impairment in congenitally CMV infected infants: MARVELYS study

1. To characterize long-term neurologic- and cognitive disorders, audiological and ophthalmological alterations in cCMV-infected children.2. To identify immunological, neurological host factors and virological factors that are predictive of…

Biomarkers of the HIV reservoir

Primary objectivesLongitudinal quantification of the total latent HIV reservoir with determination of the size of the replication competent HIV reservoir and investigate potential biomarkers of the HIV reservoir size and nature.Cross compare the…

The added effect of oral ondansetron to care-as-usual on persisting
vomiting in children aged 6 months to 6 years, presenting at primary care
out of hours service with acute gastro-enteritis and concomitant vomiting

The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…

Quality of life viral and Immunological dynamics in patients with effectively suppressed HIV who switch second or furtherline cART to a Once daily High genetic barrier Antiretroviral regimen of boosted darunavir and dolutegravir

The primary objective is to investigate quality of life after switch to a combination therapy including boosted DRV and DTG. Secondary objectives are to investigate 1) the residual viral replication, 2) level of virus production from infected cells…

A two-stage, controlled, open-label, dose-ascending first-in-man study to assess the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine

To evaluate the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine in healthy adults.

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…

A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection

Primary ObjectivesThe primary objectives are to evaluate in infants who are hospitalized with RSV infection:• the pharmacokinetics of JNJ-53718678 after multiple oral doses;• the safety and tolerability of JNJ-53718678 when administered for 7 days.…

Ledipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis. HepNed-001 study

To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotype 4 patients without cirrhosis.

Exhaustion of T cells in HIV-1 and HIV-2 infection

1. Determine whether different classes of epigenetic modifiers affect HIV-1-specific T cell immunity.a. Investigate whether HIV-specific T cell exhaustion can be reversed by inhibitors of different classes of epigenetic modifiers.b. Examine whether…

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…

Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years

This study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer…

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.

Immunity to varicella-zoster virus in patients before and after lung transplantation

Objective of the study is to evaluate efficacy of VZV vaccination in lung transplantation patients, intended to prevent morbidity by VZV infection. Efficacy of vaccination will be measured by means of determining cellular immunity to VZV. Cellular…

A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.

A Phase 2b, Randomized, Controlled Trial Evaluating GS 5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is as follows:* To evaluate the effect of presatovir (GS-5806) on nasal RSV viral load in RSV positive LT recipients with acute respiratory symptomsThe secondary objectives of this study are as follows: * To…

Identification and characterization of the latent HIV-infected reservoir in long-term anti-retroviral therapy (ART) suppressed patients

To identify and quantify the HIV reservoir in T-cell subsets of patients who have been on ART for almost 20 years.

Pharmacokinetic analysis of sinecathechins ointment 10% (Veregen) by means of Raman micro-spectroscopy in the skin of healthy volunteers

To gain insight in the pharmacokinetics of sinecathechins ointment 10% (Veregen) applied on healthy skin, using Raman micro-spectroscopy and chromatography of tape strips.

A phase 1, randomized, double-blind, placebo-controlled, escalating single- and multiple-dose study to evaluate the safety, tolerability and pharmacokinetics of EYP001a in healthy male subjects.

In Part 1, a single dose of EYP001a or placebo (same formulation but without the active ingredient EYP001a) will be administered and a total of 6 dose levels of EYP001a will be investigated. The purpose of Part 1 is to investigate how safe EYP001a…

High Flow Nasal Cannula therapy for infants with Bronchiolitis: a randomized controlled trial

To evaluate the effect on severity of dyspnoea of administration of oxygen through High Flow Nasal Cannula compared to oxygen delivery through Low Flow Nasal Prongs in children hospitalized for bronchiolitis with moderate to severe dyspnoea.

A phase 1, open-label study to characterize the absorption, metabolism, and excretion of 14C-JNJ-53718678 after a single oral dose in healthy adult male subjects

The purpose of the study is to investigate how quickly and to what extent JNJ-53718678 is absorbed, distributed, metabolized (broken down) and eliminated from the body. JNJ-53718678 to be administered will be labeled with 14-Carbon (14C) and is thus…