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Psychological interventions for familymember and partners of murdered persons

This study aims to determine to which degree the offered help - according to our treatment program - for familymembers and partners of murdered persons helps to treat complicated grief and PTSD (Murphy, 2006, Shear et al 2006) and to gain insight…

Memantine Add-On Therapy to Clozapine

This proposal entails a proof-of-concept study into the neuropsychological effects of memantine augmentation in a random cross-over comparison to placebo, as add-on treatment to ongoing clozapine in severely mentally ill (SMI) patients with…

Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format, APPEL 4

The main objective is to assess the efficacy of the closed loop system at the home of the patient. Secondary objectives are to assess the safety of the new prototype while the telemonitoring intensity is being reduced during the trial; to…

A Randomized, Multicenter, Phase II study to Investigate Efficacy and Safety of ITF2984 in Acromegalic patients.

- To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.- To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l…

DD-study: diet or diuretics for salt-sensitivity in chronic kidney disease

Primary objective: To compare the anti-hypertensive response to dietary salt restriction with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in patients with CKD stages 3 or 4. Secondary objectives: * To analyze the…

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination with Anastrozole to those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy with Abemaciclib in Combination with Anastrozole in Postmenopausal Women with Hormone Receptor Positive, HER2 Negative Breast Cancer

The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…

A randomized, open-label, vehicle-controlled, parallel-cohort, dose-ranging study to explore the pharmacodynamics of topically applied imiquimod in healthy volunteers

Primary objective- To explore the pharmacodynamic effects of topically applied IMQ (in combination with or without TS) - To identify dose-response relationship of topically applied IMQ Secondary objective- To assess safety and tolerability of…

A comparative, open-label, randomized, 2-stage sequential design, 2 periods, crossover study to demonstrate the bioequivalence of 2 FT218 batches (single dose of 4.5 gram) in healthy volunteers

The purpose of the study is to investigate how quickly and to what extent 2 different production batches of FT218 (batch A and batch B) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…

A Phase I, open-label, randomized, two-way crossover study to investigate the effects of morning versus evening repeated dosing on the pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in healthy female subjects.

- To evaluate the pharmacokinetic (PK) profile of the combination of GLPG3067, GLPG2222, and GLPG2737 following repeated morning versus evening doses given to healthy female subjects - To evaluate the safety and tolerability of the combination of…

Open label, randomized, cross-over study to explore the pharmacokinetics of BAY 1834845 after oral and intravenous dosing, including food effect and absolute bioavailability (Part A), and to investigate the effect of BAY 1834845 on the pharmacokinetics of orally administered methotrexate (Part B) in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent BAY 1834845 is absorbed and eliminated from the body (this is called pharmacokinetics). In both study parts it will also be investigated to what extent BAY 1834845 is…

Sensorimotor Incongruence and Distorted Visual Feedback in Patients with Low Back Pain: an Experimental Study

The objective of this study is to investigate the effect of incongruent and congruent visual feedback on pain reports and Pressure Pain Thresholds (PPTs).

Role of different phosphate binders on absorption of vitamin K, metabolism of matrix *-carboxy-glutamaat (Gla) proteïne (MGP).

This research will have as aim to look at progression or decrease of vascular calcification in dialysis population with use of different phosphate binders. There is a possibility that differect phosphate binders bind vitamin K in a different way in…

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…

A single-center, randomized, open-label, four-period, four-treatment, cross-over study to investigate the comparative bioavailability of dispersible tablet and capsule formulations of RO5285119 in healthy volunteers

The purpose of the study is to investigate how quickly and to what extent RO5285119 is absorbed from the gut and then eliminated from the body (this is called pharmacokinetics).It will also be investigated to what extent RO5285119 is tolerated.

The acute effects of the nutrition method "Breinspijs" (Brainfood) on cognitive functioning - a pilot intervention study

The primary objective of this study is to investigate the acute effects of a Breinspijs meal on the cognitive domains attention, processing speed, working memory and episodic memory. Secondary objectives are the effects of a Breinspijs meal on…

An open label study in two parallel groups, each receiving in a randomized, two period, cross-over design two single doses of Risperdal® Consta®, to explore the comparative bioavailability of two different batches of Risperdal® Consta® and the intra subject variability of one Risperdal® Consta® batch after intramuscular administration in healthy volunteers

Primary objectives:* To explore the comparative bioavailability between 12.5 mg of Risperdal® Consta® prepared from a 25 mg dose strength of Risperdal® Consta® EU-sourced, and 12.5 mg of Risperdal® Consta® prepared from a 12.5 mg dose strength…

A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)

Primary: superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma.Secondary: overall survival, best overall response, duration of response, non-melanoma skin lesions,…

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 single dose, randomized, four-way cross-over, bioavailability and food interaction study of PedPRM (Pediatric Prolonged Release Melatonin, Neurim Pharmaceuticals Ltd) and Circadin® tablets in healthy male and female volunteers.

Primary Objective- To demonstrate dose proportionality between 1 mg and 5 mg of PedPRM (Neurim Pharmaceuticals Ltd.) following a single oral dose in healthy male and female volunteers (treatment A and C), under fed conditions.Secondary Objectives-…

Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma (CTCL)

The main purpose of this study is to determine if KW-0761, an investigational drug will work against cutaneous T-cell lymphoma (CTCL) that has failed to respond to other treatments, and to evaluate its side effects. An investigational drug is one…