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Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands

Primary Objective: To determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxisSecondary Objectives:• To determine the dose-dependent protective efficacy of NF135.C10 CPS-immunization against homologous…

European Fans in Training (EuroFIT): A multicentre randomised controlled trial of a gender-sensitised programme to increase physcal activity and reduce sedentary time delivered to men aged 30-65 in elite European football clubs

The main aim of the EuroFIT trial is to assess the effectiveness and cost-effectiveness of the EuroFIT programme in supporting men to achieve an increase of at least 1000 steps per day (about 10 minutes on average per day, or 70 minutes per week)…

The efficacy of night splinting in children with cerebral palsy, a randomised controlled trial

1) To evaluate the efficacy of knee-ankle-foot orthoses (worn by night) in preventing a decrease of range of motion to ankle dorsiflexion in children with cerebral palsy (Clinical part). 2) To evaluate the effect of night-worn knee-ankle-foot…

A study on the influence of dynamic light on sleep and circadian rhythm, in long-stay patients on a haematology ward

To evaluate the influence of dynamic light on the disturbance of the rest-activity rhythm of patients admitted to the haematology ward of the Erasmus MC- Daniel den Hoed Cancer Centre.The results of the study can possibly be used in the future…

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.

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…

Become Active in Beating osteoarthritiS (BABS): A randomized controlled trial on the effectiveness of a promotional campaign in improving the management of osteoarthritis and quality of care

An information campaign was developed targeting early-stage KHOA patients and healthcare professionals (HCPs) to optimise timing of referral to secondary care.

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.

Heart failure and Promotion of Physical Activity before and after Cardiac reHabilitation

To investigate in our defined HF patient population if monitoring in combination with motivation on physical activity leads to an increase in enrollment rate for cardiac rehabilitation and sustained physical activity after cardiac rehabilitation as…

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

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 randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…

A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure

Despite continuous improvements in the medical management of pediatric patients with CHD, the risk of thrombotic events remains an important complication for pediatric patients following the Fontan procedure.The National Heart, Lung and Blood…

A randomized controlled trial comparing venous stenting with conservative treatment in patients with Deep Venous Obstruction

Primary Objective: Measure QoL (VEINES QoL/Sym) change in patients with DVO at one year after PTA and stenting compared to conventional therapy (short class II elastic compressions stockings, exercise, lymph drainage therapy and the use of (pain)…

Virtual reality exposure before elective pediatric day-care surgery: effects on pre- and postoperative anxiety and pain

The objective is:(1) To test the efficacy of VRE versus CAU in 200 children undergoing surgery on the anxiety level of the child during induction of anesthesia (primary outcome), pre- and postoperative child anxiety, pre- and postoperative parental…

Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial.

To determine if SSA are effective in decreasing transfusion requirements and improving quality of life while being cost-effective.

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;…