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A multi center, prospective, randomized controlled trial comparing cervical arthroplasty to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease.

The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial CervicalDisc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index(NDI) and neurological function…

Pharmacologic optimization of voriconazole; a prospective cluster randomized controlled trial of therapeutic drug monitoring

The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to…

Immune response after Human Papillomavirus vaccination in patients with automimmune disease

Objective: The primary goal of the current study is to study the immunogenicity and safety of HPV vaccination in patients with an autoimmune disease. Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune…

Augmenting response to entecavir using a temporary peginterferon alpha-2a add-on strategy for the treatment of HBeAg-positive chronic hepatitis B (ARES study)
- Long-term follow-up of a peginterferon alpha-2a add-on strategy in chronic hepatitis B patients treated with entecavir

To investigate the use of a temporary peginterferon alpha-2a add-on strategy during entecavir therapy in patients with HBeAg-positive chronic hepatitis B by comparing the efficacy of this regimen versus entecavir monotherapy.To evaluate the long-…

The effect of the addition of dronedarone to, versus increase of, existing conventional rate control medication on ventricular rate during persistent atrial fibrillation (AFRODITE study)

Primary:To assess whether the addition of dronedarone (Multaq®) to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high HR at rest during AF in comparison to an increase of conventional…

Better Accepance of a Singe injection Apidra (insulin glulisine) Added to once daily Lantus (insulin glargine) versus twice daily Premixed insulin in a real Life Use Setting.

The objective of this observational, randomized study is to examine the efficacy, safety and patient acceptance of the basal plus insulin regimen (i.e. one injection rapid acting insulin glulisine at the main meal added to once daily basal insulin…

A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study

Primary objectives1. What is the effect of stopping mesalazine in the maintenance setting of patients with quiescent CD?2. Can subgroups of CD patients, for example based on prior treatment (medical vs. surgical), localization of disease, disease…

Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study)

The primary objective of the study is to assess the effect of missed doses of atomoxetine and OROS methylphenidate in ADHD patients who are stable on pharmacotherapy based on the patient*s daily behavior as assessed by the Daily Parent Report of…

EFFECTS OF ANGIOTENSIN-RECEPTOR BLOCKADE WITH OLMESARTAN ON CAROTID ATHEROSCLEROSIS IN PATIENTS WITH HYPERTENSION: THE CONFIRMATORY OLMESARTAN PLAQUE REGRESSION STUDY (CONFIRM)

The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…

Two-arm, randomized, open-label, phase IIIb study investigating the safety of a 3 hour i.p. infusion of catumaxomab with and without prednisolone premedication in patients with malignant ascites due to epithelial cancer

Primary objective:The primary objective of the study is to compare the 3 hour i.p. infusion of catumaxomab with prednisolone to catumaxomab without prednisolone by demonstrating superiority for safety and non inferiority for efficacy.Secondary…

A prospective, open, randomized, single center study comparing the effects of duo therapy with Everolimus and steroids versus triple treatment of low dose calcineurin inhibitor, low-dose MMF and steroids at least one year after renal transplantation.
Effects on renal function, tolerability, chronic allograft damage, cardiovascular parameters and malignancies.

Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute…

Does vitamin D deficiency contribute to fatigue in patients in remission after treatment of gynaecological malignancy.

-To answer the main question *Can we demonstrate a decreased prevalence of fatigue (i.e. a lower score on the fatigue assessment) in patients in complete remission after successful treatment of a gynaecological malignancy, after treatment of a…

An independent prospective randomised controlled trial comparing the efficacy and cost effectiveness of infliximab and etanercept in 'high need' patients with moderate to severe chronic plaque type psoriasis

What is the incremental cost effectiveness ratio of the use of etanercept versus infliximab?Are there subgroups of which infliximab or etanercept is more or less cost-effective in daily practice?Primary objectives: 1. To compare clinical efficacy of…

Women*s Hormonal Intervention Study in early Postmenopause of Estradiol-progesterone Replacement therapy - effects on quality of life

The primary objective is to evaluate health related QoL under an oral sequential treatment with natural steroid hormones: Duogestan®. The secondary objective is to evaluate the bleeding patterns over a one-year period.

A randomized, controlled, open-label, parallel-group, multi-center study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy®) versus Best Medical Treatment (BMT) on spasticity in post-stroke patients after 6 months active treatment

The objective is to determine whether ITB Therapy is more effective than oral anti-spasticity agents in reducing the spasticity.

Cost-effectiveness of subcutaneous immunotherapy in adults with allergic rhinitis

First, to estimate the cost-effectiveness of SCIT with tree pollen (TP), grass pollen (GP), and house dust mites (HDM) - the most prevalent allergies treated with SCIT - or combinations compared with UC. Second, to estimate the clinical efficacy of…

External Cephalic Version with uterine-relaxation: atosiban versus fenoterol; a multi centre trial.

For women with a singleton fetus in breech presentation at term, this study answers the question if atosiban is more effective compared to fenoterol as a tocolyticum in external cephalic version

Women*s Hormonal Intervention Study in early Postmenopause of Estradiol-progesterone Replacement therapy - effects on quality of life

To evaluate health related QoL under an oral cyclic treatment with physiological steroid hormones: Duogestan®.

Parva II Trial: Randomized unicentre trial of re-crossectomy vs (repeated) ultrasound guided foam sclerotherapy of recurrence after crossectomy of the small saphenous vein

To compare the success rate and the occurrence of complications of re-crossectomy and (repeated) UGFS for the treatment of recurrence of the SSV for a period of 5 years.

Effects of morning versus evening dose of hydroxyzine 50 mg on cognition in healthy subjects

Primary: To explore the effect of the H1-antagonist hydroxyzine 50 mg on motor response, attention and impulsivity, using a test battery and task manipulations. Secondary: To explore the effect of the H1-antagonist hydroxyzine 50 mg on…