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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…

Pilot study: Fosfomycin levels in prostate tissue after oral and iv administration

To measure intraprostatic concentrations and serum levels of fosfomycine after a single oral or intravenous dose prior to TURP. This is done to achieve more insight in whether fosfomycin is a suitable antibiotic to use as profylaxis or treatment of…

Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome

Primairy Objective* To test whether 5-ASA reduces the occurrence of colonic benign or malignant neoplasia compared to placebo in Lynch syndrome (LS) patients as detected by any colonoscopy until the end of study.Secondary Objectives* To test wheter…

Bioprofiling response to mineralocorticoid receptor antagonists for the prevention of heart failure. A proof of concept clinical trial within the EU FP 7 *HOMAGE* programme « Heart OMics in AGing

Main objective: To investigate whether spironolactone can favourably alter extra-cellular matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III N-Terminal Peptide (PIIINP), in patients at increased risk of developing…

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.

Effect of Health games on Cognitive Function in Parkinson*s Disease

The main aim of this phase-II-proof-of-principle study is to test whether the health game AquaSnap offers improvement of cognitive impairment in PD patients with mild cognitive impairment, using an RCT. The long-term ambition is to test whether the…

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 effect of orally applied encapsulated lipids in yoghurt on satiety and food intake: a randomized single-blind study with cross-over design

To explore the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms.

Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])

1. The primary objective is to assess the effects of four 250 mg PC-mAB (also referred to as "3G10") once monthly intravenous injections on monocyte function ex vivo. The secondary objectives are to:1. assess the functional effects of 3G10…

A Phase II/III, multicenter, partially randomized, open label trial investigating safety and efficacy of on-demand and prophylactic treatment with BAY 94-9027 in Severe Hemophilia A

PART A: To assess the efficacy of BAY 94-9027 in prevention and treatment of bleeding at different infusion schedules.PART B: To assess the safety and efficacy of BAY 94-9027 in the prevention of bleeding during major surgical procedures.

Stenting of symptomatic vertebral artery stenosis. A randomised safety and feasibility study

The primary aim of the proposed study is to assess whether stenting for symptomatic vertebral artery stenosis >= 50% is feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar…

A phase II, randomized, double-blind, placebo controlled, parallel design, dose ranging, multi-center trial of four levels of exposure of QGE031 s.c. for 16 weeks in subjects aged 18-50 years with peanut allergy (CQGE031A2208)

Primary: To characterize the QGE031 dose response relationship for the increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment.Secondary (only key parameters): The percentage of patients…

Local Infiltration Anaesthesia in Total Hip Arthroplasty by Anterior Supine Intermuscular Approach

Determining the outcome of reversed and antegrade LIA in THA with ASI by analysing postoperative pain with the 100 mm Visual Analogue Scale (NRS), length of hospital stay, the amount of postoperative consumption of opioid pain medication as well as…

Efficacy and Cost Efficacy of Prophylactic treatment with Antibiotics during concomitant chemoradiotherapy in patients with locally advanced head and neck cancer to prevent Aspiration Pneumonia. A randomized phase II-III study

To observe a decrease in number of definite and/or suspected pneumonia after prophylactic treatment with antibiotics during CRT in patients with LAHNC.To observe a decrease in the number of admissions in the hospital To observe a decrease in the…

A prospective, single arm feasibility pilot study to evaluate the safety and performance of the TriGuard*-HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)

To demonstrate the safety and performance of the Embolic Deflection Device (TriGuard*HDH) in patients undergoing Transcatheter Aortic Valve Replacement (TAVI).

A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

Primary Objectives:*Phase 0: To determine the receptor occupancy of OPN-305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN-305 to be used in Part A of the study.*Part A: to…

The potential of do-it-yourself devices for obtaining personal health data

The first objective of this study is to evaluate the potential of do-it-yourself devices for self-measuring health parameters by subjects in obtaining interesting data. The second objective of this study is to evaluate if increased awareness of own…

The effects of BCG-vaccination on the immune response induced by influenza-vaccination in healthy volunteers. A pilot proof-of-principle study.

Primary objective: The primary objective of the study is to determine the effects of BCG-vaccination on the immune response induced by subsequent influenza vaccination in healthy volunteers. This will be determined by measuring the Th1/Th2 response…

Immunogenicity and safety of an adjuvant hepatitis B vaccine (fendrix) compared to Engerix in non-responding HIV-infected patients

To study the immunogenicity and safety of adjuvanrt hepatitis B vaccin (Fendrix) compared to double-dosage of Engerix vaccination in HIV infected patients, previously failing HBV vaccinations.

Preventive Swallowing Exercises to prevent persistent swallowing dysfunction after curative (chemo)-radiation in head and neck cancer

The proposed phase II study will test the hypothesis that preventive swallowing exercises (PSE) during treatment will reduce the incidence of swallowing dysfunction among patients with HNSCC treated with curatively intended (CH)-RT using SWIMRT. As…