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Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.

PRIMARY OBJECTIVESthe assessment if survival in grade III glioma without combined 1p/19q loss is improved by - daily temozolomide chemotherapy during radiotherapy - the administration of temozolomide after the end of radiotherapy SECONDARY…

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…

Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex covered stent-graft versus endoscopic treatment for acute bleeding of esophageal varices.

The aim of this study is to compare the new (covered) TIPS stent with the standard treatment, local band ligation and/or sclerosing of the bleeding vessel under endoscopic guidance, in patients with acute bleeding of esophageal varices, with regard…

Comparative roentgen stereophotogrammetry analysis (RSA) between the conventional Mallory- Head stem in primary uncemented total hip replacement compared to two shorter variations

Objective: To perform a comparative assessment between the clinical, bone remodelling, and radiographic outcomes (as measured with RSA) of the conventional Mallory-Head stem compared two shorter versions of Mallory-Head stems in patients undergoing…

Primary Baerveldt glaucoma implant versus trabeculectomy study.

Demonstrate that compared to trabeculectomy, at 12 months follow-up:- a Baerveldt implant is not inferior with respect to IOP and- a Baerveldt implant is superior with respect to failure.

Application of cultured autologous keratinocytes in combination with a meshed split skin autograft for burn wound healing

ObjectiveEvaluation of the application of cultured autologous keratinocytes in combination with a meshed split skin autograft to improve burn wound healing

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.

A randomized European Study Comparing Endoluminal Stent grafting and best medical Therapy (BMT) to BMT Alone in the Traetment of Acute Uncomplicated Type B Aortic Dissection

Objective of the study: The primary objective of this study is to assess the efficacy See primary endpoints, section 7.1 of endoluminal stent grafting and BMT compared to BMT alone in the treatment of uncomplicated acute type B aortic dissections.

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.

Dutch Arthoscopy Association Rotator Cuff Study

The objective is to evaluate and compare the outcome of conventional open or arthroscopic rotator cuff surgery, by means of clinical scores and biomechanical studies (range of motion, scapulohumeral rhythm, muscle activation patterns).

Group training for Hepatitis C patients to improve quality of life

The objective of the study is to improve quality of life of patients with Hepatitis C, by teaching patients psychological skills that aid in coping with the consequences of the disease.

A randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in completely resected non-small-cell lung cancer patients with high-risk for recurrence: NVALT- 8B.

The primary aim of the study is to investigate whether adding Nadroparin to adjuvant chemotherapy in patients in the poor prognostic group (i.e. high SUV) prolongs recurrence-free survival.

The efficacy of radioguided occult lesion localisation (ROLL) versus wire guided lesion localisation (WGL) in breast conserving surgery for non palpable breast cancer: a randomised controlled trial

To evaluate the efficacy of ROLL versus WGL in breast conserving surgery for non-palpable breast cancer.

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…

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…

COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.

Are there differences is efficacy, side effects, tolerance en costs in patients with early RA in treatment with COBRA-light compared with COBRA according to BeSt?

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…

A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in Combination with Bevacizumab and Paclitaxel or AMG386 plus Paclitaxel as First-Line Therapy in Subjects with Her2-Negative, Metastatic or Locally Recurrent Breast Cancer.

To estimate the treatment effect as measured by progression free survival(PFS) of subjects receiving AMG 386 (at 2 doses) in combination with paclitaxel + bevacizumabrelative to paclitaxel + bevacizumab + placebo.