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A randomized, multicenter Study to evaluate the Effect of secukinumab 300 mg s.c. administered during 52 Weeks to patients suffering from new-onset moderate to severe plaque Psoriasis as early Intervention compared to standard treatment with narrow band UVB (STEPin study)

The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old…

Clinical assessment of a new adhesive and HME for night-time use in laryngectomized patients: Provox Luna

The objective of this clinical investigation is to evaluate the clinical performance of Provox Luna in comparison to the usual care of the patient.

A Phase 4 Safety and Efficacy Study of Bosutinib (Bosulif®) in Patients with Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated with One or More Tyrosine Kinase Inhibitors

The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the EMA in providing additional safety and efficacy data in approximately 150 patients with Ph+ CML whose disease had failed or who are otherwise not…

A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)

Primary:The primary objective of this study is to determine whether DMF taken over 12 months is effective in reducing MS-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in subjects with…

Therapeutic drug monitoring in tocilizumab-treated rheumatoid arthritis patients: Pilot study of a double-blind randomised controlled trial

To evaluate the feasibility of the study after 20 weeks of follow-up, which includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA.

A randomized controlled trial evaluating the additional effect of topical coal tar to a topical corticosteroid regimen in patients aged >16 years of age with moderate-severe atopic dermatitis

To evaluate the additional effect of coal tar treatment to a corticosteroid regimen in adults (aged >16 years of age) with moderate to severe atopic dermatitis, based on the percentage change in Eczema Area and Severity Index (EASI) at week 2…

Cryotherapy in the recovery of bursectomy for subacromial pain syndrome. A pragmatic randomized controlled trial.

The purpose of this study is to investigate the value of postoperative cryotherapy on subjective patients-reported pain; shoulder function and quality of life in patients operated for SAPS .

Investigating the role of rTMS in the treatment of chronic depression

(1) To investigate the effect of rTMS in a treatment set-up of 4 weeks including sham-rTMSas a control in 2 x 50 patients who have had at least two prior antidepressant therapies and psychotherapy according to the Dutch guideline of depression.(2)…

Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years

This study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer…

Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

Primary Objective To compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice over 6 months following de novo renal transplantation in a real-life setting in different European Countries.…

INTENT: immunogenicity in patients failing response on anti-TNF
- phase 1: immunogenicity and pharmacokinetics in patients failing to respond to TNF inhibitors.
- phase 2: clinical effectiveness of subsequent TNF inhibitor treatment and predictive value of pharmacokinetics and immunogenicity.

1. To determine the proportion of patients developing anti-drug antibodies (ADA) detectable with an antigen binding test (ABT, radioimmunoassay) in patients experiencing inefficacy of their first TNF inhibitor treatment (phase 1).2. To study…

A twenty-six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of transition to Toujeo compared to standard of care insulin, in basal insulin treated patients with uncontrolled type 2 diabetes mellitus, with six month extension.

To demonstrate non-inferiority of Toujeo versus *standard of care* basal insulin therapy asmeasured by HbA1c change from baseline to Month 6.

Effects of VERApamil versus metoprolol to prevent progression from Paroxysmal to persistent Atrial Fibrillation

We hypothesize that verapamil reduces progression from paroxysmal to persistent AF, improves rate control, exercise tolerance and quality of life and reduces costs compared to metoprolol.

Treatment of port wine stains using Pulsed Dye Laser, Erbium Yag Laser and topical sirolimus in an open label pilot study (POLAR).

Primary: to evaluate and compare the efficacy of:1) PDL treatment followed by topical sirolimus application after Er:Yag laser ablation of the stratum corneum in PWS 2) PDL treatment followed by topical sirolimus application without Er:Yag laser…

Intraarticular treatment of osteoarthrits of the hip: A randomized trial of hyaluronic acid (Fermathron S) vs corticosteroids (Depomedrol).

Will the hyaluronic acid injections have impact on pain reduction and functional improvement in patients with osteoarthritis of the hip ?

*Omega-3 fatty acids in bariatric gastric bypass surgery: effects on liver volume, immune response and erythrocyte function*

Our primary objective is to compare pre-treatment with the standard low calorie diet with pre-treatment with supplemental omega-3 fatty acids on liver volume. Secondary objectives are patient satisfaction about different dietary pre-treatments, the…

Effects of thyroid hormone treatment on mitochondrial function, ectopic fat accumulation, insulin sensitivity and brown adipose tissue in type 2 diabetes mellitus

The purpose of this study is to evaluate whether thyroid hormone replacement therapy in type 2 diabetic patients suffering from overt hypothyroidism will improve muscular mitochondrial function, lower ectopic fat accumulation in muscle and liver,…

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…

Randomized trial of Legflow® Paclitaxel eluting balloon (LPEB) with stentplacement vs. standard PTA with stentplacement for the treatment of intermediate (>5 cm and < 15 cm) and long (>15 cm) lesions of the superficial femoral artery (SFA). The RAPID trial.

The primary objective is to assess the difference in absence of binary restenosis rate of endovascular treatment of intermediate and long lesions of the superficial femoral artery with the Legflow® PEB and nitinol stent, when compared to uncoated…

Wear analysis of cross-linked versus standard polyethylene F.A.L. acetabular cups in patiënts with symptomatic coxarthrosis: a randomized controlled trial

Primary goal: mean linear wear of the cross-linked polyethylene F.A.L. cup compared to the mean linear wear of the standard polyethylene F.A.L. cup at 5 years postoperatively. Secondary goals:1. mean linear wear (millimeters/year) at 1 year, 3 years…