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Stichting Gezondheidscentra Eindhoven (SGE) Smoking Cessation Innovation.

Our proposed randomized controlled trial is the first making this head-to-head comparison in a *real life* primary care setting in the Netherlands. The primary research question is: does a 12-week combination therapy of open label varenicline and…

Study to investigate the sensitivity and specificity of 3.0 Tesla MRI, MRS and ultrasound imaging for carotid artery plaque dimension and composition assessment.

PrimaryTo investigate sensitivity and specificity of 3.0 Tesla MRI and MRS for dimension and composition assessment of carotid artery plaques, in particularly those plaques with lipid rich necrotic cores (LRNC), with the aim to develop these…

An Efficacy and 2-Year Safety Study of Open-label Rosuvastatin in Children and Adolescents (aged from 6 to less than 18 years) with Familial Hypercholesterolaemia

Primary Objectives * To assess the efficacy of rosuvastatin in paediatric patients with familial hypercholesterolaemia. * To establish long-term safety, tolerability and efficacy of rosuvastatin in paediatric patients with familial…

An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…

A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma

The primary objective of this study is to compare the overall survival (OS) of patients whohave received one prior regimen of dacarbazine or temozolomide-based chemotherapy for metastaticmelanoma when treated with either tasisulam or paclitaxel.The…

Urethral suspension using vas deferens for prevention of urine incontinence after robot-assisted laparoscopic prostatectomy (RALP)

Improve postoperative urine continence after prostatectomy for prostate cancer.

The level of physical activity and participation in society of adolescents with chronic musculoskeletal pain.

1. Is there a difference between the level of activities and participation among adolescents with chronic musculoskeletal pain as compared with the activity and participation level of adolescents not suffering from chronic pain?2. What is the impact…

A new diagnostic development in MRI screening for breast cancer

Primary objective:To compare the specificity of multiple voxel MR spectroscopy with MRI.Secondary objective: To decrease the number of false positive diagnostic outcomes by using multiple-voxel MR-spectroscopy and therefore to reduce benign biopsies…

The effects of dopamine depletion on endogenous glucose production in healthy subjects

We would like to eludicate the role of dopamine on glucose metabolism.

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…

Intervention effects of Multidimensional Treatment Foster Care Program for Preschoolers (MTFC-P) compared to Therapeutic Foster Care (TFC) for young children with psychological problems.

Main goal of the present research is to study the surplus value of MTFC-P compared to the regular TFC for young foster children with psychological problems.

Sleep State Misperception Mispercieved?

We aim to establish whether our judgment of *misperception* is really doing justice to the condition paradoxical insomniacs suffer from. We should keep in mind that our present definition of sleep, based on the standardized polysomnographic scoring…

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…

Preventing preterm birth: Costs and effects of screening of healthy women with a singleton pregnancy for a short cervical length.

To evaluate whether progesterone treatment for women with a short cervical length is effective in reducing the risk of preterm delivery. In addition to assess whether it is cost-effective to do so.

Chemoradiation combined with panitumumab followed by surgery for patients with operable esophageal cancer

A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Confirming the Efficacy and Safety of Genz-112638 in Patients with Gaucher
Disease Type 1

The primary objective of this study is to confirm the efficacy and safety of Genz 112638 after 39 weeks of treatment in patients with Gaucher disease type 1.The secondary objective of this study is to determine the long term efficacy, safety, and…

A randomized, double-blind, multi-center phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapy

To compare overall survival between RAD001+BSC and placebo+BSC in patients with advanced gastric cancer after progression on prior systemic chemotherapy.

The CHIPS Trial (Control of Hypertension In Pregnancy Study)

For pregnant women with non-severe non-proteinuric maternal hypertension at 14-33 weeks, will *less tight* control (target dBP of 100mmHg) vs. *tight* control (target dBP of 85mmHg) increase or decrease the likelihood of pregnancy loss or neonatal…

Antecolic versus retrocolic route of the gastroenteric anastomosis after pancreatoduodenectomy: ARCO-trial

Primary objective:To determine the relationship of route of gastroenteric anastomosis after PD and postoperative incidence of DGE.Secondary objectives:To determine the relationship of route of gastroenteric anastomosis after PD and gastric emptying…