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A single-center, randomized, open-label, two-arm study to evaluate the ovarian function inhibition of a monophasic combined oral contraceptive (COC) containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP) and a monophasic COC containing 20 mcg ethinylestradiol (E4)/3 mg drospirenone (Yaz®), administered orally once daily in a 24/4 day regimen for three consecutive cycles

Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…

Renal Nerve Stimulation and Renal Denervation in Patients with Sympathetic Ventricular Arrhythmias

This study will investigate the effects of renal nerve stimulation before and after percutaneous transluminal renal denervation on cardiac excitable properties including induction of ventricular tachy-arrhythmias before and after renal denervation…

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…

Characterisation of ovulation inhibition and effects on metabolic parameters and haemostatic system of multiple administrations of a fixed-dose combination product containing 0.02 mg ethinylestradiol and 2 mg dienogest (24+4) in a multiple administration, comparative parallel-group trial vs. a marketed product containing 0.02 mg ethinylestradiol and 0.10 mg levonorgestrel with healthy females of childbearing potential

descriptive characterisation of the influence of Test or Reference on ovarian activity determined by means of maximum follicular diameter and Hoogland scoredescriptive characterisation of the effect of Test or Reference on endometrial thickness,…

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…

A Phase 1/2 Combined Dose Ranging and Randomised, Open-label, Comparative Study of the Efficacy and Safety of Plerixafor in Addition to Standard Regimens for Mobilisation of Haematopoietic Stem Cells into Peripheral Blood, and Subsequent Collection by Apheresis, Versus Standard Mobilisation Regimens Alone in Paediatric Patients, Aged 1 to <18 Years, with Solid Tumours Eligible for Autologous Transplants

In this study, plerixafor, the study drug, will be given in addition to GCSF to see if it works the same way in children as in adults.

A phase 2 multicentre randomized controlled comparative efficacy and safety study of Tiscover and AS210 in chronic (arterio-)venous ulcers

Determine the safety and efficacy of Tiscover compared to AS210 (acellular donor dermis, construct Tiscover is cultured on) for the treatment of chronic, therapy resistant (arterio-) veneus leg/foot ulcers in an out patient setting.

A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.

The primary objective of this study is to investigate equivalence of weight gain from randomisation until the age of 17 weeks in infants receiving the test product compared to infants receiving the control product. Secondary objectives of this study…

A pilot randomized controlled trial on the feasibility and efficacy of an exercise intervention to improve cognitive functioning in patients with glioma

The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility and to determine the effect size of a physical activity/exercise program in improving objective cognitive functioning and reducing self-reported cognitive…

Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma

The primary endpoint is overall survival (OS) in patients with low hENT1 expression. Ifthe hENT1 expression data are available for analysis prior to randomizing 250 patientsthen an interim analysis for sample size re-estimation may be performed.

The safety, tolerability, and analgesic efficacy of &Delta;9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain

Primary Objective: - To investigate the efficacy of Namisol® after a single dose of Δ9-THC on the experienced pain intensity (measured by the VASpain in rest and on movement) in patients with chronic pancreatitis.Secondary Objectives:- To…

A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients (CAEB071A2214)

Primary objectivesThe primary objective of the study is demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of…

The effect of positivity training on treatment result in an outpatient population.

The main objective of the present study is to investigate whether addition of CBM to regular CBT treatment aimed at retraining a positive action bias has a positive influence of the affect of the participants, and on treatment result in terms of…

The impact of the macronutrient composition of a nutritional supplement on postprandial skeletal muscle protein synthesis in elderly

Obtain more insight in the preferred macronutrient composition of an oral nutritional supplement.

A multicenter, randomized, partially-blinded, Phase IIb dose-finding study on ovarian function, vaginal bleeding pattern, and pharmacokinetics associated with the use of combined vaginal rings releasing 17*-estradiol plus three different doses of either nomegestrol acetate or etonogestrel in healthy women aged 18-35 years;

The main objective of the trial is to identify at least one NGR that will demonstrate all of the following:1. Inhibition of ovulation2. Cycle control that is non-inferior to NuvaRing®, as judged by the incidence ofBTB-S during Treatment Cycle 3. The…

An extension to a 12-month, open-label, randomised, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect® and corticosteroids in de novo adult renal transplant recipients

The purpose of this extension is to provide continued treatment and to assess the long term safety, efficacy and tolerability of oral AEB071 plus Certican® vs. Neoral® plus Certican® in de novo renal transplant recipients. The study is a…

Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a pilot study

The primary objective of the study is to determine the effect of tVNS on the innate immune response elicited by endotoxin (LPS) administration in healthy volunteers up to 24 hours after stimulation.Secondary objectives are to:- Determine effects of…

A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…

A 12-month open-label, randomized, multicenter sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect®, and corticosteroids in de novo adult renal transplant recipients

CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…

A randomized, multicenter, explorative trial to explore the safety, acceptability and vaginal bleeding pattern of three doses of an etonogestrel-releasing medicated intrauterine system (ENG-MIUS) versus a copper-releasing intrauterine device (IUD)

To explore saftey and acceptability of three doses of an etonogestrel-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.