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The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.

In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects with Uncomplicated Influenza.

Primary ObjectiveTo evaluate the clinical efficacy of favipiravir compared with placebo in treating adult subjects who have confirmed influenza.Secondary Objectives- To further evaluate the clinical and anti-viral effects of favipiravir.- To…

The effect of Staphefekt on the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis.

To retrieve (in vivo) data about the effect of Staphefekt on the microbiome, including Staphylococcus aureus, and on disease severity in patients with atopic dermatitis.

Identification of pre-erythrocytic target antigens induced by Plasmodium falciparum sporozoite immunization under chemoprophylaxis.

Primary objective: To delineate the antibody repertoire directed against the pre-erythrocytic stages of Plasmodium falciparum induced by CPS-immunization.Secondary objectives: • To assess the functionality of CPS-immunization induced antibodies.• To…

Effect of donor human milk on severe infections and mortality in VLBW infants, a double blind randomized controlled trial

To determine whether (supplemental) human donor milk has beneficial effects (in terms of reduction of infectious episodes and mortality) when compared to (supplemental) preterm formula during the first 10 days of life in VLBW infants. Amendement ESS…

POETIC: Point Of carE Testing for urinary tract Infection in primary Care:
Study Stages 3 & 4: Randomised controlled trial and post-RCT observational study

The overall aim of our study is to evaluate the management of suspected uncomplicated UTI in women presenting in primary care through use of a novel point of care test (POCT, Flexicult). This study is being carried out in 4 European networks: Wales…

Effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur or pelvic fracture.

A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…

A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon α-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

The primary objective of this study is to evaluate the efficacy of TDF plus Peginterferon *-2a (PEG) combination therapy for 48 weeks versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined…

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)

The primary objective of the study is to evaluate the safety and efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of autologous hemotopoietic cell transplants (HCTs).

A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old men.

This study is designed to evaluate the immunogenicity and tolerability of V503 in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men, 16 to 26 years of age. The safety and immunogenicity data will be used to bridge GARDASIL®…

MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV;Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…

Augmenting response to entecavir using a temporary peginterferon alpha-2a add-on strategy for the treatment of HBeAg-positive chronic hepatitis B (ARES study)
- Long-term follow-up of a peginterferon alpha-2a add-on strategy in chronic hepatitis B patients treated with entecavir

To investigate the use of a temporary peginterferon alpha-2a add-on strategy during entecavir therapy in patients with HBeAg-positive chronic hepatitis B by comparing the efficacy of this regimen versus entecavir monotherapy.To evaluate the long-…

Clinical and microbiological evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a randomized controlled study

The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surfaceduring the surgical treatment of peri-implantitis using a 35% phosphoric acid gel or saline.The secondary objective…

Tick Test and Prophylaxis Proof

To determine the efficacy of antibiotic prophylaxis after a tick bite in the Dutch setting, in relation to tick infection, tick engorgement and attachment time.

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in
Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-…

A study of more time-efficient and cost-effective pre-exposure rabies vaccination schedules to secure timely adequate protection prior to military deployment

1. To reduce the time required for pre-exposure rabies vaccination of military personnel2. To reduce costs of pre-exposure rabies vaccination of military personnel 3. To obtain a non-inferior immune response to a shortened, low-dosed scheme compared…

A Phase 3, Open Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically Suppressed, HIV 1 Positive Subjects

The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…

Effectiveness of routine nebulisation of mucolytic agents and bronchodilating drugs in intubated and ventilated intensive care unit patients.

To determine the efficiency, safety and health care costs of a strategy using routine nebulisation of mucolytics and bronchodilators four times daily, with a strategy of nebulisation on a strict clinical indication only, in mechanical ventilated…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 4282 in Healthy Adult Human Subjects

To evaluate the safety and tolerability of multiple escalating doses of intravenous WCK 4282 in healthy, adult, human subjects.To evaluate the pharmacokinetics (PK) of multiple escalating doses of 1g:1g (1 vial) of intravenous (IV) WCK 4282 every 8…

Local gentamicin in Redon treated post-sternotomy mediastinitis

The aim of our study is to evaluate clinical outcomes of patients primarily closed over Redon catheters for the treatment of PSM, comparing the application of local gentamicin with a control group.