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A 4-Year Open-Label Extension (OLE) Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 as an Adjunctive Therapy in Patients With Refractory Partial Seizures

To evaluate the safety of E2007 given as adjunctive, long-term treatment in patients with refractory partial onset seizures with or without secondary generalization that completed the E2007-A001-206 or the E2007-G000-208 studies (revised per…

Amendment on the CYPTAM documentation study: effect of CYP2D6 genotype on pharmacokinetics and clinical outcome in tamoxifen treated breast cancer patients:;(P07.234 CYPTAM study)
Validation and optimization of 13C-dextrometorphan breath test (DM-BT) for CYP2D6 phenotyping

-To optimize DM-BT by addition of multiple breath sampling and improve it for use in clinical practice-To create a population based pharmacokinetic model based on DM-BT predicting endoxifen serum levels-To identify ideal single or two time points…

Comparison of celite activated clotting time with kaolin activated clotting time during cardiac surgery.

We want to compare duplicate measurements of celite ACT and kaolin ACT in patients undergoing cardiac surgery. In addition we want to measure heparin use during surgery in patients monitored with celite ACT and with kaolin ACT.In addition,…

Lenalidomide maintenance combined with Bortezomib following tandem autologous stem cell and non myeloablative allogeneic transplantation for patients with multiple myeloma <= 66 years.

To study the efficacy of low dose Lenalidomide maintenance combined with bortezomib treatment following non myeloablative Allo-SCT on Event Free Survival.

First-in-Man Study on the Stentys

Procedural success, comprising insertion of the Stentys SDS, deployment of the Stentys Sent in the main branch, withdrawal of the Stentys SDS and creation of the Stentys Sent opening for the sidebranch, without major adverse cardiac events during…

Determination of the toxicity of standard dose cetuximab together with concurrent individualised, isotoxic accelerated radiotherapy and cisplatin - vinorelbine for patients with stage III non-small cell lung cancer (NSCLC): a phase I study.

To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine.

Predicited 3D-SAR coverage: a prognostic indicator for treament outcome in superficial hyperthermia for breast cancer recurrences at the chest wall?

The prime objective of the proposed study is to apply treatment modeling for superficial hyperthermia in a well-defined group of patients to investigate the potential of predicted 3-dimensional energy as source for a dose parameter that is…

Comparison of the everolimus eluting XIENCE-V* stent with the paclitaxel eluting TAXUS* stent in all-comers: a randomized open label study.

The main objective of the study is a head tot head comparison of the everolimus coated XIENCE-V* stent with the paclitaxel coated TAXUS* stent in order to observe whether there is a difference in clinical outcome between both stents. Efficacy of…

Pharmacodynamic assessment and exploration of cerebral changes in relation to fatigue of antiangiogenic treatment in cancer patients

The study is divided in two parts. In the first part, we will study our hypothesis that the biological activity of antiangiogenic therapy is partly mediated by inhibition of platelets. We will study whether antiangiogenic agents inhibit the…

Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasie (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial)

This is a phase I/II trial of the EORTC Leukemia Group and the italian GIMEMA Acute Leukemia Working Party. In a phase I setting we will investigate the optimal dosage and route of administration (one hour infusion or intravenous injection) of…

Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age with an extension of the LCS16 treatment arm up to five years

The objective of this study is to assess the safety, efficacy and pharmacokinetics of 2 doses of LNG, delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 35 years of age during 3 years and with an extension…

Shockwave treatment for advanced angina in Maastricht (SWAAM). A double blind randomised study.

Goal of the project is to implement the shockwave therapy for no-option CAD patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality 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…

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.

Phase II study of PHA-739358 administered by a 24-hour IV infusion every 14 days in advanced/metastatic breast, ovarian, colorectal, pancreatic, small cell lung and non small cell lung cancers.

To determine if PHA-739358 has an antitumor activity against breast, ovaria, pancreatic, colerectal, small and non small cell squamous lung cancer.

A phase II study of docetaxel/carboplatin as secondline treatment in patients with refractory or relapsed SCLC

To evaluate the anti-tumor activity of a docetaxel/carboplatin regimen in patients with refractory or relapsed SCLC. Furthermore to asses the safety profile of the docetaxel/carboplatin combination.In patients who have experienced FN, the efficacy…

Optimal Stimulation Rates in Sacral Neuromodulation Therapy

To determine whether rate change is feasible and has a positive influence on the effect of SNS on the symptoms measured with voiding diaries.To investigate whether there are differences between optimal stimulation settings between patients with SNS…

A Study of the Efficacy of MORAb-003 in Subjects with Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

The objective of this study is to determine the efficacy of multiple intravenous infusions of MORAb-003 in platinum-sensitive subjects with a first relapse of epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) within…

Combined clinical and home rehabiliation for stroke patients: a pilotstudy into the implementation of a new treatment protocol.

The objective of the pilotstudy is to develop and evaluate a new combined clinical and home rehabiliation research protocol for stroke patients. This pilotstudy will focus on the (re)learning of ADL and mobility skills. Important questions are:-Is…

The Split Dose Study: Split dose Rhenium-188-HEDP regimen in hormone refractory prostate cancer patients with bone metastases; a phase I toxicity study and phase II efficacy study.

The primary aim of the phase I part of this trial is to establish the safety of a split dose regimen of Re-188-HEDP . The primary aim of the phase II part of this trial is to obtain insight in the efficacy of a split dose regimen of Re-188-HEDP , as…