Search for a trial

A phase 1 multicenter, open label, dose-escalation study of oral LEE011 in patients with advanced solid tumors or lymphomas.

Primary To determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLT) of LEE011 when administered orally once daily for 21 consecutive days followed by a 7 day break.Secondary *Safety and tolerability of LEE011.*…

Joint distraction in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: total knee prosthesis

Primary:- To test the hypothesis that the clinical effect of KJD (determined by WOMAC) is not (clinically relevant) different from TKP at 2 years post treatment (equivalence hypothesis). Secondary:- To describe and compare the clinical efficacy over…

Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The objective of this extension study is to find out the potential long-term benefits and safety of tolvaptan. During this study all participants will receive tolvaptan.PRIMARY OBJECTIVE is to demonstrate whether tolvaptan modifies ADPKD progression…

Relevance of Biomarkers and Clinical Predictors of Outcome in Unselected Population with Febrile Urinary Tract Infection at Primary Care and Emergency Department in a Prospective, Randomized Cohort Trial Comparing Short (7 days) Antibiotic Treatment with Conventional Treatment (14 days)

To assess clinical parameters and biomarkers in blood and urine in predicting bacteremia, need for hospital admission, clinical and bacteriologic cure and mortality in patients with fUTI.To determine whether a 7-day duration of antibiotic treatment…

Sensitive Imaging in Ankylosing Spondylitis

* To study the relationship between inflammation on MRI and syndesmophyte formation with very detailedimaging methods: radiography, computed tomography (CT), 3 and 7 Tesla MRI. * To examine the time order of pathologic changes like inflammation,…

Time Resolved Angiography in Cerebrovascular Shunts (TRACS)

The aim of this project is to assess whether 4D-CTA can generate 3D cranial image data sets with sufficient spatial and temporal resolution to enable its use as a diagnostic tool in cerebrovascular pathology and physiology such as arteriovenous…

Systemic manifestation and co-morbidity in COPD are associated with circulating markers of aging

Part I of the study: I) to determine if one or a batch of aging marker(s) is/are associated with the presence of objectively diagnosed COPD related co-morbidity (muscle wasting, osteoporosis, cardiovascular risk, glucose intolerance, renal failure,…

Analysis of expression differences between endometria of women with PCOS and normal cycling women, collection of normal endometrial tissue

1. Evaluation of gene-expression profiles of endometria of PCOS women compared to normal ovulatory women2. Identify genes and pathways which contribute to a high rate of miscarriages of PCOS women3. Identify genes and pathways related to the high…

MINIMAL INVASIVE MONITORING OF VOLUME STATUS IN PATIENTS AFTER MAJOR ABDOMINAL SURGERY.

The primary objectives of this study consist of:1. To assess the accuracy of different pulse contour methods to measure CO compared to thermodilution CO measured with a PAC in major abdominal surgery patients.2. To assess the effect of propofol…

A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction

The current study is being conducted to determine whether long-term dual-antiplatelet therapy with ticagrelor in combination with ASA (recommended daily dose 75-100 mg) is beneficial in patients with history of MI (1-3 years ago) and additional risk…

Development and implementation of a self-report screening instrument for suicidality among adolescents age 12-21 of diverse ethnic / cultural backgrounds. (main study includes adolescents age 18-21 only)

The present research protocol aims at the development and implementation of a valid self-report instrument for suicidality amongadolescents. The instrument needs to be invariant for ethnicity and needs to register fluctuations in suicide risk and…

Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet

To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific >= grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period…

Prophylaxis of venous thromboembolism in patients with a fracture of the lower extremity being treated conservatively with a below-knee plaster cast.

The purpose of this study is to determine the need for thromboprofylaxis in patients being treated in a below-knee plaster cast after trauma of a lower extremity and if there is, to assess if both of the two tested prophylactic treatments are suited…

Prostate Cancer Molecular Medicine

1. To construct a Dutch multicenter prospective biorepository for validation of biomarker and imaging products.2. To provide a Medical Technology Assessment (MTA) of newly developed biomarkers, contrast enhanced ultrasound and multimodality MR Iin…

Treatment transitions in uremia:
A survey on the effects of dialysis on cardiovascular and nutritional state, and physical activity

The main of objectives are to study the effect of the start of dialysis treatment (hemodialysis and peritoneal transplantation), on selected cardiovascular, nutritional parameters as well as physical activity. Secondly, a differentiation will be…

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…

PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

The purpose of this study is to evaluate the efficacy and safety of MDV3100, a novel potent androgen-receptor antagonist without known agonist activity, in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who…

A multicenter, phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis

* To determine the efficacy of bortezomib plus dexamethasone induction therapy followed by HDM and auto-SCT in patients with newly diagnosed AL amyloidosis who are 18-70 years inclusive.* To asses the safety of bortezomib plus dexamethasone as…

GLOBAL STUDY TO ASSESS THE ADDITION OF BEVACIZUMAB TO CARBOPLATIN AND PACLITAXEL AS FRONT-LINE TREATMENT OF EPITHELIAL OVARIAN CANCER, FALLOPIAN TUBE CARCINOMA OR PRIMARY PERITONEAL CARCINOMA

Zie pagina 39-40 van het protocol MO22923 versie 2, 26 Mei 2011

Spinal Muscular Atrophy, SMN protein and Genetics; A population based study on spinal muscular atrophy in the Netherlands to explore the prevalence of SMA type 1-4 and their severity in the Netherlands by registrating all patients in a so called SMA-database, to elucidate the genetic factors determining disease severity and to determine the value of SMN protein concentrations as a surrogate marker for clinical trials.

The main objective of this prospective population-based study of patients with proximal SMA in the Netherlands is to register SMA patients in the Netherlands in a socalled SMA-database to study prevalence and severity of SMA types 1-4, to perform…