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Topical Vitamin D3, Diclofenac or a combination of both to treat Basal Cell Carcinoma

Primary Objective: To determine whether topical application of Calcitriol (Silkis) 3 µg/g, Diclofenac 10% or a combination of both can lead to a 40% histological reduction (*)/increase (*) of expression of the following antibodies: Ki67 (*), BCL2…

Exploratory open label study to investigate the effect of teriflunomide on immune cell subsets in the blood of patients with relapsing forms of multiple sclerosis

Primary:- To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary:- To assess…

A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer.

The main purpose of this study is to determine the side effects of trastuzumab when it is given by each of these subcutaneous injection methods. The study will also gather information about whether and when the cancer comes back after taking…

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…

A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Primary: To compare the proportion of patients demonstrating Major Molecular Response (MMR) at 12 months (48 weeks) in the bosutinib arm with that of the imatinib arm in newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP)…

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

Efficacy ObjectivesThe primary efficacy objective of study GO28141 is as follows:* To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive…

Stimulation of the sphenopalatine ganglion with the ATI Neurostimulation system for cluster headache treatment

We investigated the safety and efficacy of on-demand SPG stimulation for chronic CH (CCH).

Advance Care Planning; an Innovative Palliative Care Intervention to Improve Quality of Life in Cancer Patients *a Multi-Centre Cluster Randomized Clinical Trial

We will investigate whether the Respecting Choices program will improve communication between patients and healthcare professionals, will improve the QOL and wellbeing of patients and their relatives, will reduce futile treatments and unnecessary…

A Long-Term, Safety and Maintenance of Efficacy Study of JZP110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea

To evaluate the safety and tolerability of JZP-110 administered once daily for up to 52 weeks in doses of 75, 150, and 300 mg

A randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis combined with standard anticoagulant therapy versus standard anticoagulant therapy alone for acute primary iliofemoral deep vein thrombosis (IFDVT).

Primary Objective: Can catheter directed thrombolytic therapy, for the treatment of primary IFDVT, safely and effectively reduce post thrombotic morbidity after one year?Secondary Objective: Does catheter directed thrombolytic intervention have a…

The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

Effect of N-acetylcysteine on hydrogen sulfide in chronic kidney disease

Primary Objective: Our primary objective is to investigate the effect of NAC on H2S levels in plasma in different patient groups, i.e. healthy volunteers, CKD patients, and dialysis patients. We hypothesize that there is an increase in H2S levels…

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL* as an Adjunct to Sutured Dural Repair

To evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.

A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNF?? Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy

The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by more or equal to 5 joints with active arthritis despite MTX therapy…

Feasibility, meachanism of action and potential side effects of extended release depot naltrexone (XRNT) in opioid dependent patients

The aims are: (1) to explore the feasibility of XRNT treatment in the Netherlands in terms of treatment participation and treatment retention; and (2) to study the mechanism of action of XRNT using pharmacoMRI and SPECT, and (3) to study the…

Cognitive Adaptation Training in the Netherlands: a nursing intervention to improve daily functioning in people with schizophrenia

The goal of this pilot study is to (i) investigate which measurements are suitable best for the evaluation of (cost) effectiveness, (ii) investigate whether CAT can be given as a nursing intervention (feasability).

A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients with Mucopolysaccharidosis IVA (Morquio A Syndrome)

To evaluate the long-term safety and efficacy of BMN 110 administration at 2.0 mg/kg/qw and 2.0 mg/kg/qow in patients with MPS IVA.

A Phase 3b Clinical Study To Assess Whether Regular Administration Of Advate In The Absence Of Immunological Danger Signals Reduces The Incidence Rate Of Inhibitors In Previously Untreated Patients With Hemophilia A

Primary objective:Determine the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A during the first 50 exposure days (EDs) to starting with a once weekly prophylactic regimen together with the minimization…

Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE). A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione (TZD) or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease.

This trial will determine the relative incidence of CV outcomes compared to placebo forthe TZD class as a whole, rosiglitazone (RSG), and pioglitazone (PIO) when added to thetherapeutic regimen of a person with type 2 diabetes who has additional…

Joint distraction as a treatment for end stage knee osteoarthritis: a comparison with presently applied surgical alternatives.

1. Is KJD clinically non-inferior to current surgical techniques (HTO and TKP)?2. Is KJD superior to HTO in actual structural repair of cartilage?3. Is KJD cost-effective in the long-term compared to HTO and TKP?