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Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet

To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific >= grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period…

Does the application of cryolijm SQ fibrin sealant, for abdominal closure after secondary DIEP flap surgery, leads to a quicker recovery with less complications? A randomized controlled study.

The aim of this study is to assess the efficacy of Cryolijm SQ (Sanquin blood supply foundation, Groningen, The Netherlands) fibrin sealant in reducing postoperative drainage at the abdominal donor site which could result in earlier drain removal,…

A randomized controlled trial on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth

In the proposed study, two main issues will be addressed: first, it will be studied whether a high dose (4.0 mg) of FA supplementation periconceptional has an added value over the now recommended low dose of 0.4 mg in the prevention of congenital…

The effect of vitamin D-supplementation on insulin sensitivity in non-western immigrants in the Netherlands

To assess whether supplemention of vitamin D3 (1200 IU/day) in vitamin-D deficient non-western immigrants at risk for type 2 diabetes mellitus can improve the insulin resistance and betacell function as well.

Understanding gut feelings: Probiotics and cognition

Translating these animal findings to humans is one of the aims of the current study. The proposed project aims to replicate the aforementioned preliminary findings (Evrensel & Ceylan, 2015; Steenbergen et al., 2015; de Noos et al., 2015;…

PRODEO: PROfylactic Haloperidol in patients defined as high risk for DElirium with delirium risk mOdel

Research questionWill prophylactic administration of haloperidol to patients with a high risk of developing a delirium according to DEMO, reduce the incidence of a delirium? HypothesesProphylactic administration of haloperidol in post-operative…

Safety and preliminary protective efficacy of genetically attenuated Pf*mei2 (GA2) malaria parasites in healthy Dutch volunteers

Phase 1 • Primary objective: to determine the safety and tolerability, including the attenuation phenotype of a novel late-arresting GAP, named GA2 parasite, administered by sequentially increasing numbers of mosquito bites.• Secondary objective: to…

Peri-Operative ISchemic Evaluation-3 Trial

Perioperative bleeding in the setting of noncardiac surgery is strongly associated with 30-day cardiovascular complications and mortality. Trial evidence suggests that intravenous TXA reduces perioperative bleeding and transfusion in orthopedic…

The effect of a single gift antibiotics before ERCP to prevent post-ERCP pancreatitis.
A study protocol for a single centre, double blinded randomized controlled study.

This study aims to further reduce the incidence of a post-ERCP pancreatitis by administrating a single gift antibiotics after the procedure.

BACILLUS CALMETTE-GUÉRIN VACCINATION TO PREVENT SERIOUS RESPIRATORY TRACT INFECTION AND COVID-19 IN VULNERABLE ELDERLY -* AN ADAPTIVE RANDOMIZED CONTROLLED TRIAL

To determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerablel older adults.

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine given as a series of 2 infant doses and 1 toddler dose in healthy infants

Primary Safety Objective: To describe the safety profile of 20vPnC

A multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema

The primary objective of this study is to evaluate the efficacy of SC administration of CSL312 as prophylaxis to prevent HAE attacks in subjects with HAE.The secondary objectives of the study are:1. To characterize the clinical efficacy of SC CSL312…

A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

The sites of the Netherlands will only participate in cohort 2. Primary objectives - cohort 2: - To evaluate the safety and reactogenicity of the selected dose of ExPEC10V in participants >=60 years of age with a history of UTI in the past 5…

PROtective ventilation with high versus low PEEP during one-lung ventilation for THORacic surgery - PROTHOR: A randomized controlled trial

To compare a strategy using high PEEP (10 cmH2O) with recruitment maneuvers versus low PEEP (5 cmH2O) without recruitment maneuvers, during thoracic surgery under standardized one lung ventilation with low VT (5 mL/kg predicted body weight - PBW) in…

A phase 3 study to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus (RSV) prefusion F subunit vaccine in adults

ObjectivesPrimary Efficacy:To demonstrate the efficacy of RSVpreF in preventing LRTI-RSV in the first RSV season following vaccination.Primary Safety:To describe the safety profile of RSVpreF as measured by the percentage of participants reporting…

Evaluating the effect of different daily plant stanol ester intakes on the vaccination response to an influenza vaccine

The primary objective of this study is to demonstrate the effect of consuming different daily amounts of plant stanols (2.0, 3.0, or 4.0 gr stanols; delivered via products enriched with plant stanol esters) on the vaccination response to an…

Combined effect of Pregabaline and Oxycodone, and Lacosamide and Oxycodone, on breathing: an exploratory study in healthy volunteers
the POLO study

The objective of the study is to quantify the effect of pregabaline and lacosamide on oxycodone-induced respiratory depression.

A pilot study assessing the feasibility of a randomized controlled trial evaluating aspirin in postpartum women at risk of developing venous thromboembolism

The purpose of this pilot trial is to determine whether it is feasible to conduct a full multicentre randomized controlled trial (RCT) to determine whether low-dose aspirin (ASA) is efficacious and safe at preventing postpartum venous…

A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of
Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55
Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive

The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and…

Stimulation of the beta-2 adrenergic receptor for activating human brown adipose tissue

1. To investigate the acute effect of ADRB2 activation, via intravenous administration of salbutamol (250 µg), on 18F-FDG uptake by BAT.2. To assess the acute effect of ADRB2 activation via intravenous administration of salbutamol (250 µg) on…