Search for a trial

An open label, randomized, single inhaled dose, three-way cross over pilot study to compare the pharmacokinetic profiles of different dry powder inhalers with tiotropium bromide in healthy volunteers.

Primary objective:* To compare the bioavailability of different dry powder formulations of tiotropium bromide in healthy volunteersSecondary objectives:* To compare the safety and tolerability of different dry powder formulations of tiotropium…

A randomized, double-blind, repeat dose cross-over study
to assess the bronchodilator effects of once daily QVM149
following morning or evening dosing for 14 days compared
to placebo in patients with asthma

To investigate the potential influence of time of dosing (morning or evening)on the bronchodilator effect of once daily orally inhaled QVM149 compared toplacebo.

A COMPARATIVE, OPEN-LABEL, RANDOMIZED, 2 PERIODS, 2 SEQUENCES CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUSPENSION (FT218) FORMULATION (SINGLE DOSE ADMINISTERED AT THE DOSE OF 6 G) VERSUS THE MARKETED REFERENCE XYREM® (AT THE DOSE OF 2*3 G) IN HEALTHY VOLUNTEERS

FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy. The purpose of…

Long-term StaphyloCoccus aureus decolonizAtion in patients on home parentRal nutRition: a randomized multicEnter tRial.

To identify the most effective and safe long-term S. aureus carriage decolonization strategy in HPN patients. Ultimately this willlead to less antimicrobial resistance, less catheter removals and lower mortality rates. Also, other chronic…

Stimulating physical activity in children with asthma

The SIMBA project is a research collaboration in which children with asthma, their parents and healthcare professionals play an important role. The SIMBA study is a two year program that aims to develop and finally (pilot) test an exercise game that…

A phase 1 study to evaluate the absorption, metabolism and excretion of BCX7353 following administration of a single, oral dose of [14C]-radiolabeled BCX7353 to healthy male subjects.

The purpose of this study is to investigate how quickly and to what extent BCX7353 is absorbed, metabolized (changed or broken down by the body) and eliminated from the body (this is called pharmacokinetics). For this study BCX7353 will be labelled…

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 CHMI-trans protocols in healthy malaria-naïve volunteers challenged with Plasmodium falciparum by sporozoite challenge and blood stage challenge. 2) To assess gametocyte infectiousness for Anopheles…

A first-in-human, single-centre, placebo-controlled, randomized, double-blind study in healthy subjects to evaluate safety, tolerability, pharmacokinetics and food effect after oral single and multiple ascending dosing of KAND567

The primary objective is to determine the safety and tolerability of KAND567 following oral single ascending dose (SAD) and multiple ascending doses (MAD) administration in healthy young and elderly subjects.

Validation of the Philips EmoGraphy technology to measure sympathetic nervous system activity in an ambulatory setting

The primary aim of this study is threefold. The first objective is to determine whether the SCL and the frequency of non-specific skin conductance response (nsSCRs) measured by the Philips GTEP Emography Bracelet are accurate measures of sympathetic…

Phase 1b study of safety and tolerability in patients treated with stereotactic radiotherapy combined with durvalumab and tremelimumab in stage 4 NSCLC

To assess safety and tolerability of the combination of SBRT and combined CTLA-4/PD-L1 inhibition. In addition immune modulatory effect of the combination of an ablative dose of radiotherapy to the primary tumor and response to durvalumab/…

Target attainment of ciprofloxacin in patients admitted to a general ward: a prospective observational study.

To investigate whether the current dosing regimen of ciprofloxacin, recommended by the Dutch *Stichting Werkgroep Antibioticabeleid* (SWAB) and applied at the Academic Medical Center for patients with various degrees of renal function admitted at…

68Ga-PSMA-PET/CT imaging for locally advanced, recurrent and metastatic adenoid cystic carcinoma or salivary duct carcinoma

Primary objective- To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC or SDC by performing 68Ga-PSMA-PET/CT scans.Secondary objectives- To calculate the SUV tumor-to-background ratio and tumor-to-*healthy salivary…

Novel mass spectrometric monitoring (steroid metabolomics) to detect treatment success and chronic over- or under-treatment in children with CAH (CAH metabolomics).

The aim of this study is to determine novel (bio)markers that show a stronger correlation with signs of over- and under-treatment than the conventional adrenal steroid profile in children with CAH.

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…

The effect of forward arm extension on gait initiation in patients with Parkinson*s disease

To assess whether forward extension of both arms improves gait initiation in patients with PD, measured by faster coverage of the initial two meters of walking. Secondary objectives are to determine whether this change in performance can be measured…

Validity and Reliability of the Northwestern Ego Integrity Scale in patients with amyotrophic lateral sclerosis

To evaluate measurement properties and feasibility of the self-report Northwestern Ego-Integrity Scale in patients with ALS (or its variants PMA and PLS)

Smoking Topography Study 2018

Is there a difference in natural smoking topography between Marlboro, Marlboro Prime and Marlboro Prime taped leading to a different exposure for the smoker? Is it possible to map personal smoking profiles with only 4 random cigarettes, as showed in…

Head to head comparison between Rubidium-82 myocardial perfusing imaging with a digital and analog PET system

To compare the image quality, visibility of perfusion deficits and myocardial blood flow of a conventional analog PET system with a digital PET system in 30 patient referred for PET myocardial perfusion imaging (MPI).

Observation of oral health and oral microbiome during a 4-month naval mission

The primary objective of this study is to monitor changes in oral health during a 3.5-month naval mission and once one month thereafter.

An open-label, randomized, crossover, phase 1 study to evaluate bioequivalence and relative bioavailability between JZP-507 commercial scale and pilot oral solutions in healthy subjects

During the study, an oral solution of JZP-507 produced on a commercial scale will be compared with a JZP-507 oral solution produced on a pilot scale (an oral solution of JZP-507 which is manufactured locally at PRA). The purpose of the study is to…