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Probing the role of sodium channels in painful neuropathies (PROPANE Study)

To investigate whether sodium and potassium mutations are found in a cohort of patients with small fiber neuropathy, painful diabetic neuropathy (versus diabetes patients with no or only minor symptoms) and in patients with breast, ovarium or…

Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…

A phase Ib, open-label, multi-center, dose escalation and expansion study of an orally administered combination of BKM120 plus MEK162 in adult patients with selected advanced solid tumors

Primary:To determine the MTD and/or RP2D of BKM120 and MEK162 in combination when administered orally to adult patients with selected advanced solid tumors. Secondary:• To characterize the safety and tolerability of the oral combination of BKM120…

Influence of early goal-directed therapy using arterial waveform cardiac output measurement in high-risk surgery

To determine whether early goal-directed therapy, aimed at optimizing cardiac output measured by arterial waveform analysis, improves outcome in high-risk, abdominal surgery.

Neurocognitive effects of low-grade glioma resection in eloquent areas

1) Evaluating the effect and recovery of glioma surgery in eloquent areas on cognitive functioning.2) Examining the effec tof glioma surgery in eloquent areas on quality of life.3) Examining the effect of gliomas in eloquent areas on the…

PreCARA: Preconception Counselling in Active Rheumatoid Artritis and other chronic inflammatory arthritides;
Preconception counselling for women with rheumatoid arthritis (RA) or another chronic inflammatory arthritis and a pregnancy wish, which is evaluated in a prospective observational study monitoring pregnancy, delivery, postpartum period of the mother, and (growth) parameters of the child.

In the present study we will evaluate the standardized care protocol developed in our outpatient clinic, intended to guide counselling for medication use prior to pregnancy. This protocol guides treatment decisions based on disease activity,…

A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 (N8-GP) when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A

Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…

APC & Behaviour

The above anounced studies suggest that some abnormalities in the Wnt pathway can be expected to affect development and function of the brain, potentially leading to recognizable behavioural phenotypes. Given the key role of APC in the Wnt pathway,…

Randomized, open label, multicenter phase III study of Efficacy and Safety in POlycythemia vera subjects who are resistant to or intolerant of hydroxyurea: JAK iNhibitor INC424 tablets verSus bEst available care

Earlier research nas shown the emerging efficacy and safety profile for INC424, which supports further studies in PV subjects who demonstrate resistance or intolerance to HU therapy [Barosi et al.2009]. This pivotal phase III trial (CINC424B2301) is…

An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy

The main aim of this study is to find out if the continuation of bevacizumab, in addition to standard 2nd & 3rd -line treatment, can help patients with NSCLC that has progressed to live longer. The study also aims to find out if continued…

Optimisation of cost effectiveness through Individualised FSH Stimulation dosages for IVF Treatment: The OPTIMIST trial.

To evaluate whether in an IVF program routine application of an ORT and a subsequent individualised FSH regimen is cost-effective compared to a standard dose regimen.

Pressure-Flow Measurements Directly after Primary PCI to Predict Late Occurrence of Microvascular Obstruction

In the present study we aim to determine the value of microvascular resistance measurements in the acute setting to predict the occurrence of MVO in the following days, using the combined pressure-flow wire. Therefore patients with an acute MI will…

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…

A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with retroperitoneal sarcoma (RPS)

To assess whether preoperative radiotherapy, as an adjunct to curative-intent surgery, improves the abdominal local recurrence-free survival.

A prospective, multicenter, randomized, open-label, active-controlled, phase III study to compare efficacy and safety of masitinib to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment

Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.

Phenotyping and genotyping of retinal dystrophies in the Netherlands.

The goal of this study is to collect and clinically characterize a large cohort of patients with hereditary retinal dystrophies in the Netherlands. The study cohort will be used to identify the genetic causes underlying these diseases, and to…

Risk factors for colorectal cancer in patients with inflammatory bowel disease undergoing surveillance: a prospective cohort study

1. To confirm established and identify new risk factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome.2. To provide evidence that mucosal…

MEtoclopramide, DExamethasone or Aloxi (palonosetron) for the prevention of delayed chemotherapy-induced nausea and vomiting in moderately emetogenic non-AC-based chemotherapy: the MEDEA trial

In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…

Left Ventricular Thrombus Formation after Acute Myocardial Infarction - a randomized multi-center trial comparing 2 different anti-thrombotic regimens

The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation

Development of fMRI tasks and scan protocols

Development of (f)MRI tasks and scan protocols and to define the optimal parameters in preparation of a (f)MRI study