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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…

Effectiveness of lipofilling in patients with impaired speech and/or swallowing function after treatment for head and neck cancer

The primary objective of this study is to evaluate the effectiveness of lipofilling in treatment of speech and swallowing impairment after treatment for head and neck cancer. The secondary objective is to evaluate the effect of lipofilling on tongue…

COLDFIRE-2 study: Colorectal metastatic liver disease: efficacy of irreversible electroporation (IRE) - a phase II clinical trial

The primary objective of this project is to evaluate the primary and secondary technique effectiveness of IRE for centrally located colorectal liver metastases that are neither amenable for resection nor for other local ablation methods due to the…

A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS

Safety (Primary) ObjectiveThe primary objective for this study is as follows:- To evaluate the safety and tolerability of cobimetinib in children and young adults, including estimation of the maximum-tolerated dose (MTD) or the maximum administered…

A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER

For the primary and secondary efficacy objectives, analyses will be performed in patients in different patient subpopulations according to programmed death*ligand 1 (PD-L1) expression in tumor tissue as evaluated by immunohistochemistry (IHC). The…

Pharmacokinetics of two high dose regimes of intravenous vitamin C in critically ill patients

To determine the pharmacokinetics of two high dose regimens of intravenous vitamin C in critically ill patients, in particular the attained plasma concentration and the fraction retained in the body and excreted in urine.

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…

Adjuvant hepatic Holmium-166-radioembolization in patients with unresectable liver metastases of neuroendocrine origin, who have been treated with Lutetium-177-dotatate; a single center, interventional, non-randomized, non-comparative, open label, phase II study

Primary objectives:* To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study Secondary objectives:* To establish the safety and toxicity profile of adjuvant 166Ho-RE after…

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 Phase I/II study to determine the safety and efficacy of a combination of anti-CD3 & anti-CD7
ricin A immunotoxins (T-Guard) for treating steroid-resistant acute graft-versus-host disease.

PRIMARY* To determine the efficacy on study Day 28 of T-Guard in inducing a clinical response in patients with severe acute GVHD refractory to first line steroid therapy.SECONDARY* To evaluate the overall safety and efficacy during the first 6…

A Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole

To determine the tacrolimus bioavailability after tacrolimus administration via a rectiole.

Non invasive imaging of tumor hypoxia with [18F]HX4 Positron-Emission-Tomography (PET): A phase II trial

Primary Objective: Visualization and quantification of tumor hypoxia with [18F] HX4 PET imagingSecondary Objectives: - Correlation of [18F] HX4 with local tumor recurrence and survival- Correlation of hypoxia imaging with blood hypoxia markers -…

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 Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505® Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception

To Evaluate the Safety and Effectiveness of the Essure® ESS505 Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception (*Study*)

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, open label, placebo controlled exploratory study in healthy volunteers, to characterise the acid neutralisation activity of sodium alginate oral suspension in the fasted state, using a custom-designed intragastric and oesophageal pH catheter

The objective of this exploratory study is to investigate the acid neutralisation action of sodium alginate oral suspension versus placebo liquid, within the stomach and to assess suitability and robustness of the pH monitoring methodology.

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…

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.