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Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens

The primary purpose of the study is to determine the efficacy of AZD2281 compared to placebo in serous ovariancancer platinum sensitive patients and in a defined HRD subset.

Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year

A novel class of regulators: the potential of IL-10 producing B cells in decreasing allergic inflammation in asthmatic patients.

Conditions that promote IL-10 producing B cells in humans are still ill defined. In this project our aim is to investigate the frequnecy of IL-10 producing B cells in healthy volunteers. Next, we aim to compare this to the frequency of IL-10…

Randomized study with a run-in feasibility phase to assess the added value of Clofarabine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or myelodysplasia (MDS) (RAEB with IPSS â*¥ 1.5)

Primary objectivesFor part A of the study: -To determine the feasibility of Clofarabine when given at three possible dose levels together with standard induction cycles I and II in patients with AML/ RAEB with IPSS>=1.5 in a prospective…

Learning, Memory and Networks in the Human Brain: Single Neuron Recordings in Depth-electrode Candidates for Epilepsy Surgery

The first goal of the present study is to elucidate the network topology of the MTL on both large-scale and micro-scale levels with the aim of further understanding epilepsy related changes to the network structure. Additionally we will also use the…

Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.

Primary objectives:1.The fesibility of clofarabine when given together with standard prephase chemotehrapy in a prospective comparison to standard prephase chemotherapy (prednison). 2.To evaluate the effect of clofarabin when combined with prephase…

Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer

- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.- Secondary study objectives: Establish and compare…

Costs and effects of a structured lifestyle program in overweight and obese subfertile couples to prevent unnecessary treatment and improve reproductive outcome.;Titel follow-up:
- WOMB women - Preconception lifestyle intervention: does it affect long term female health?
- WOMB kids - Preconception lifestyle intervention: does it affect offspring*s health?

In view of this lack of evidence and strong practice variation we propose a randomized clinical trial in overweight and obese subfertile women, in which we compare the costs and effects of a six months structured lifestyle program, aimed at weight…

String of Pearls - Diabetes Cohort: Generation of a Dutch academic Bio-Databank for the study of the etiology of type 2 diabetes mellitus and related diseases and complications

The goal of the *String-of-Pearls national academic biobank - the diabetes cohort* is to create a nation diabetes bio-databank, with DNA, urine and blood samples of 12.000 diabetespatients in combination with clinical data from the diabetes care in…

Minitub: Prospective registry of Sentinel Node (SN) positive melanoma patients with minimal SN tumor burden who undergo Completion Lymph Node Dissection (CLND) or Nodal Observation

With this prospective registry we aim to evaluate the outcome of patients with a T2-T3 primary melanoma and minimal SN tumor burden, treated by CLND or nodal observation:* The main objective is to determine if T2-T3 melanoma patients with minimal SN…

Medical Nutrition in prodromal Alzheimer's Disease, a double-blind controlled 24-month study, with four times a 12 month extension study.

To evaluate the effect of Souvenaid® on cognition in patïents with mild cognitive impairment after 24 months.

A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis

To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in…

Personality factors in the prediction of anxiety and depression during pregnancy and the postnatal period.

Developing a risk score based on established risk factors and personality traits, to predict possible postnatal anxiety/depression with or without problems in bonding between mother and child at the first consult at the midwives practice or…

Treatment of bulimia nervosa and eating disorders not otherwise specified: Cognitive Behaviour Therapy versus Cognitive Therapy

The goal of this study is to learn whether:The above described CBT according to protocol is more effective than CT according to protocol without behavioral interventions (binge cue exposure with respons prevention and body exposure including…

Rituximab in Primary Central Nervous system Lymphoma.
A randomized HOVON / ALLG intergroup study

Primary objectiveTo assess the effect of the addition of rituximab in a standard chemotherapy regime on EFS in newly diagnosed PCNSL.Secondary objectiveTo evaluate the effect of the addition of rituximab to a standard chemotherapy regimen with…

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn's Disease

Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…

A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.

Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…

The assessment of the Plaque At RISK by non-invasive (molecular) imaging and modelling (ParisK): Prospective clinical study for diagnosis efficacy for high risk plaque and stroke.

The main objective is to show whether imaging characteristics assessed at baseline can predict clinical events in patients with a 30-69 % symptomatic carotid stenosis.

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…

A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Objective: The principal objective is To evaluate the long-term safety and maintenance of efficacy of BOTOX® (200 U) injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have…