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A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator*s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Primary:* To determine if alisertib improves overall response rate (ORR; complete response [CR] plus partial response [PR]) versus a selection of single agents in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)* To determine…

Fast-track thyroidectomy and radioiodine ablation therapy in patients with differentiated thyroid cancer.

This study aims to detect differences in sick leave time, associated costs and quality of life between differentiated thyroid cancer patients treated in either a fast-track protocol or a traditional longer time interval between total thyroidectomy…

A multicenter, randomized, double blind, placebo controlled, phase II trial evaluating the safety and efficacy of TKI258 combined with fulvestrant, in postmenopausal patients with HER2- and HR+ breast cancer that have evidence of disease progression on or after prior endocrine therapy

Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…

A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

Primary Objectives:*Phase 0: To determine the receptor occupancy of OPN-305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN-305 to be used in Part A of the study.*Part A: to…

Phase I study of dalteparin, a low molecular weight heparin (LMWH), in combination with Sunitinib (SU11248), an oral, selective multitargeted tyrosine kinase inhibitor, as first line treatment, in patients with metastatic renal cell carcinoma

The proposed study is designed to test the hypothesis that the combination of anticoagulants, in particular Dalteparin plus Sunitinib, can be safely administered in a phase I feasibility trial in patients with renal cell cancer in which Sunitinib…

Dynamic Changes in Bone Marrow Adiposity and the Role of Estrogen

To investigate the dynamic changes in bone marrow adiposity during the menstrual cycle as assessed by Dixon*s Quantitative Chemical Shift Imaging (QCSI) measurements and to determine the role of estrogen in these changes.

Identification and characterization of community-dwelling older people with sarcopenia.

The objective of this study is to obtain insight in the characteristics of sarcopenic versus non-sarcopenic community-dwelling older people.

The role of intestinal fatty acid binding protein (iFABP) in the treatment of small bowel obstruction

usefulness of I-FABP in the surgical managment of small bowel obstruction caused by adhesions.

IMPella versus IABP REduces mortality in STEMI patients treated with primary PCI IN SEVERE and deep cardiogenic SHOCK.
An international multicenter, randomized trial of the Impella cVAD (left ventricular assist) device versus Intra Aortic Balloon Counter Pulsation (IABP) therapy for acute ST-elevation myocardial infarction patients treated with primary PCI in severe and deep cardiogenic shock

The primary objective of this study is to determine whether the Impella cVAD device vs. IABP therapy leads to a higher 30 day survival rate in shock STEMI patients in the setting of primary PCI.

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event

The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…

Enable® Aortic Sutureless bioprosthesis Evaluation (EASE study): A post-market release non-interventional study

The objective is to collect additional data on the clinical outcomes (surgical data, safety and clinical performance) of the Medtronic Enable® Aortic Bioprosthesis in *real world* patients. The collected data will be used to improve aortic valve…

After the Health Check in vulnerable groups: an individually tailored self regulation intervention led by Community Health Workers.

The overall objective of this study is to increase the uptake and maintenance of healthy behaviors among adults from non-Western immigrant populations who are identified as having a high risk of cardiometabolic disease after completing a health…

Protocol I1V-MC-EIAN Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes - the ACCELERATE Study

The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary…

Treatment study for patients with acute promyelocytic leukemia under 21 years of age

The study aims to limit the use of anthracyclines and to reduce the dose of ATRA. Another aim is to stratify treatment by risk group: standard risk - WBC <10 x 109/l : high risk - WBC >=10 x 109/l. Furthermore this study aims to…

Preoperative identification of response to neoadjuvant chemoradiotherapy for esophageal cancer

The objective of this explorative study is to assess the value of anatomical and functional magnetic resonance imaging (MRI) and 18F-fluorodeoxyglucose positron emission tomography and computed tomography (PET-CT) in the evaluation of treatment…

Evaluation of Zirconia stock and customized implant abutments provided with composite resin
crowns: a pilot study

We aim to compare the clinical performance of zirconia stock and CAD-CAM produced implant abutments (experimental group) after one year of function. After one year, the abutments and crowns are removed and subjected to a static bending test in vitro…

IOinated contrast DILution in digital subtraction angiography of the limb:
a randomized controlled trial with three different concentrations of iodine

To compare the confidence of the interventional radiologist in diagnosing and treating arterial stenoses and occlusions by digital subtraction angiography with contrast concentrations of 300, 240 and 140 mg iodine per ml. Also, we will compare the…

Mechanisms of disability in MS patients with long disease duration

*To examine the (longitudinal) association between long term clinical outcomes in MS and pathology occurring in brain grey matter, spinal cord grey matter and brain lesion load.

Open-label follow-up study of the VIPES study to evaluate long-term efficacy and safety of the Viaskin Peanut

The objectives of this follow-up/extension study of the VIPES study are:• To assess the efficacy of Viaskin® Peanut after up to 36 months of Epicutaneous Immunotherapy (EPIT) in peanut-allergic subjects.• To evaluate the safety of long-term…

Physical fitness and physical strain in people after lower limb amputation during rehabilitation .

The aim of the study is to assess physical fitness of people in rehabilitation after lower limb amputation and to assess their physical strain during the regular rehabilitation program and specific (physical therapy) sessions of this program.…