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Treatment in the Rotterdam Early Arthritis CoHort

5. Study objective(s) and hypothesis:The aim of this study is to assess the value of early, intensive and efficient treatment of patients with recent acquired arthritis, in preventing progression into destructive RA

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…

Autologous bone marrow-derived mononuclear cells for therapeutic arteriogenesis in patients with limb ischemia
A double blind placebo controlled study in diabetic and non-diabetic patients

To validate and extend findings from the TACT sytudy group as well as our own preliminary data in a randomized, placebo controlled study in patients with and without diabetes.

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.

High-dose versus standard-dose weight-based ribavirin in combination with peginterferon alfa-2a for patients infected with hepatitis C virus genotype 1 or 4

To investigate if high-dose ribavirin in combination with peginterferon alfa-2a can improve outcome in treatment naïve hepatitis C patients with genotype 1 or 4 and a high viral load (>400.000 IU/ml).

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…

A randomized, double-blind placebo-controlled, multicenter phase III study in patients with advanced carcinoid tumor receiving Sandostatin LAR and RAD001 10 mg/Day or Sandostatin LAR and Placebo

To determine whether treatment with RAD001 10 mg/d plus Sandostatin LAR® prolongs the progression free survival (PFS) compared to treatment with Sandostatin LAR® alone in patients with advanced carcinoid tumor.

Induction and waning of specific immune mechanisms against Bordetella Pertussis after infection.

I. Evaluation of the nature and maintenance of specific cellular immune mechanisms after infection with Bordetella pertussis in different age groups, to identify critical parameters for pertussis re-emergenceII. To relate individual patient*s…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2*P - TIMI 50)

Objectives:The following objectives are designed to address the effects of SCH 530348 when administered orally in addition to the standard of care for a minimum of 1 year in subjects with documented atherosclerotic disease.Primary Objective: The…

Comparing accuracy, patient experiences and costs of lower gastrointestinal endoscopy between nurse and physician endoscopists; a prospective cohort study.

To compare accuracy, patient experience and costs of lower gastrointestinal endoscopy (sigmoidoscopy and colonoscopy) between nurse and physician endoscopists.

Tracing the origin of psychosis in schizophrenia - A repetitive TMS/neuroimaging study of frontostriatal interaction

The objective of this study is to directly test, in humans, the hypothesis that reduced prefrontral control leads to dysregulation of the striatum.

A 24 month, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo liver transplant recipients.

To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…

A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality

The purpose of this study is to determine whether, in patients with type II diabetes at high risk for cardiovascular and/or renal events, aliskiren at a target dose of 300 mg o.d. compared to placebo, on top of conventional treatment, reduces…

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…

Effect of domperidone and omeprazole in gastro-oesophageal reflux disease in infants between 0 and 2 years.

To measure the effect of domperidone and omeprazole on reflux-time, duration, and symptoms of GERD

Continuation of the Doetinchem Cohort Study

The general objective of the Doetinchem Cohort Study is to contribute to the answering of public health questions, now and in the future, by providing basic data on developments in lifestyle and health problems in the general Dutch population.

Rheos(TM) Pivotal Trial, a Study of Baroreflex Hypertension Therapy in Refractory Hypertension.
Amendment 1: Dynamic cerebral autoregulation and lacol pulsewave velocity.
Amendment 2: Investigational Plan , revision D
Amendment 3: Investigational Plan, revision E
Amendment 4: Investigational Plan, revision F

The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with JNC-7 defined stage II hypertension that is resistant to treatment with at least three anti-hypertension agents, one of which is a…

Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care

The aim of this study is to explore the incidence of MTX related gastro-intestinal in a large cohort of JIA patients. Secondly, we want to investigate the effect of psychological behavioural therapy or switch to parenteral MTX dosing to ameliorate…

An open prospective randomized long-term effectiveness study, comparing best medical practice with or without adjunctive spinal cord stimulation in patients with chronic diabetic neuropathic pain

What is the long-term clinical benefit of best medical practice with and without adjunctive SCS Therapy in patients with chronic diabetic neuropathic pain?

Cervical spine movement, before and after anterior cervical discectomy (ACD).
ACD, pure intervertebral discectomy (1) compared to intervertebral discectomy followed by implantation of an intervertebral disc prosthesis (2) in patients with a radicular syndrome. A randomised study

Objective of the study is to verify whether the movement pattern after anterior cervical discectomy normalises, in case of implantation of a cervical disc prosthesis.