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A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…

Grip op je dip online (Master your mood online): development and effectiveness

The aim of the project is to further develop and study the effectiveness of the Internet groupcourse Gripop Je Dip Online for young people (16-25 years) with depressive symptoms.Development objective:The eight-session groupcourse will be adapted…

GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe).Workpackage 10: Antibiotic Trial One

The aim is to understand which individuals benefit from antibiotics.

Development of a Test to Measure the Quality of Motor Activities of Daily Living in Children with DCD

The development of a valid and reliable test intended to measure functional motor activities in daily life of children with DCD.

The developmental and implantation potential of aneuploid and mosaic human embryos, as assessed in an in vitro model

To increase our understanding of the developmental significance of chromosomal mosaicism in preimplantation embryos by investigating their implantation potential and the fate of abnormal cells after an in vitro implantation procedure.

A Phase-II, double-blind, randomized, placebo-controlled study on the safety and early efficacy of Alkaline Phosphatase in sepsis patients with Renal Failure.

To establish the safety and and tolerability and early efficacy of Alkaline phosphatase in the treatment of sepsis patients with renal failure.

Evaluation of the potential of Real-Time 3-Dimensional echocardiography in the assessment of right ventricular function in patients with congenital heart disease: comparison of RT-3D echo with MRI.

The aim of this study is assessment of right ventricular function: a comparison between MRI and real-time 3-D echocardiography (RT 3-D echo). We have the following research questions: 1) Is assessment of right ventricular (RV) function with RT 3-D…

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease

The primary objectives of the study are to assess the safety and tolerability of E5555 in subjects with coronary artery disease (CAD) (Revised per Amendment 01).The secondary objectives are to determine the effect of E5555 on (a) the incidence of…

PHARMACOGENOMIC AND PHARMACOKINETIC SAFETY AND COST-SAVING ANALYSIS IN PATIENTS TREATED WITH FLUOROPYRIMIDINES

The primary objective of the study is to prospectively determine whether fluoropyrimidine-induced toxicity is preventable by dose adjustment prior to start of the first administration based on the polymorphic status of the DPYD*2A polymorphism in…

A MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED PHASE 3, EFFICACY AND SAFETY STUDY OF SUNITINIB (SU011248) IN PATIENTS WITH ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER TREATED WITH ERLOTINIB

The purpose of this clinical trial is to test whether treatment of patients with NSCLC with erlotinib plus sunitinib is better than treatment with erlotinib plus placebo. All patients enrolling in this study will receive treatment with erlotinib.

A 12-month open-label, randomized, multicenter sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect®, and corticosteroids in de novo adult renal transplant recipients

CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…

A psychological intervention in COPD patients who are hospitalized with an exacerbation: a RCT to improve health related quality of life outcomes and study mechanisms of change

To test the effects of a short psychological intwervention on quality of life, exercise capacity, self-management and health care utilisation.

An open-label, parallel group study to explore the pharmacokinetics of eribulin (E7389) in patients with advanced solid tumors and normal or reduced hepatic function according to the Child Pugh system.

To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.

A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome

The primary objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of Acute Coronary Syndrome (ACS). This will be assessed for a period of up to 16 weeks (…

A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety
and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill
Medical Subjects During and Following Hospitalization

To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…

PENGUIN-trial: pancreatitis, endoscopic transgastric versus primary necrosectomy in patients with infected necrosis. A randomised controlled multicenter observer-blinded trial

To investigate if endoscopic transgastric necrosectomy will lead to a reduction ofthe per- and postoperative pro-inflammatory response, as compared to necrosectomy by laparotomy, in patients with infected (peri-)pancreatic necrosis.

Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.

Therapeutic exploratory study (Phase II).The purpose of this study the efficacy of a new compound (CPD323) for the treatment of Relapsing Remitting Multiple Sclerose (RRMS).CDP323 is a small chemical molecule. It is taken orally (by mouth) as a…

A randomised placebo-controlled trial of
fixed-dose combination medication in people
at raised risk of cardiovascular disease

To measure the efficacy (change in systolic blood pressure and LDL cholesterol) and tolerability of a polypill in individuals with raised risk of a cardiovascular event.

The effect of pain on task persistence: mood-as-input as a possible predictor.

The aim of the study is to check if the mood-as-input model can give a possible explanation for the persistence behaviour seen in patients with work related upper extremity pain. Because of the fact that the mood-as-input model is only tested in non…

Non-invasive assessment of human ventricular-vascular function

To establish the accuracy and precision of systolic cardiac time intervals and arterial pulse wave velocity as obtained from multiple M-mode carotid artery ultrasonography. And to test whether the non-invasive tonometer pressure waveform is…