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A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus.

The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…

Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial.

To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm,
Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab
(MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in
Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…

Evaluation of the Accu-Chek® Combo System by subjects treated with CSII (Continuous Subcutaneous Insulin Infusion).

The primary objective is to measure the frequency of unexpected critical errors* of the Accu-Chek Combo® encountered during everyday normal use. (*Unexpected critical errors are device related events that may result in an adverse or serious adverse…

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, 2-PERIOD, CROSSOVER STUDY TO COMPARE THE EFFECTS OF EZETIMIBE/SIMVASTATIN (10 MG/10 MG) COMBINATION TABLET VERSUS SIMVASTATIN 80 MG TABLET ON POSTPRANDIAL ARTERIAL ENDOTHELIAL FUNCTION IN PATIENTS WITH METABOLIC SYNDROME

The combination of simvastatin 10 mg/ezetimibe 10 mg has a beneficial effect on post prandial endothelial function in comparison to monotherapy with simvastatin 80 mg.

A Phase I, Single-Centre, Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARA 290 Administered Intravenously to Healthy Subjects, and extension in renal patients

The present study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARA 290 administered intravenously to healthy subjects, and of intravenously and subcutaneously administered ARA 290 to renally impaired subjects.

A RANDOMISED, MULTI-CENTRE, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED, 5-WAY, PARALLEL GROUP STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ONO-8539 IN PATIENTS WITH OVERACTIVE BLADDER

The primary objective of this trial is to compare the effect of three different doses of ONO-8539 with placebo in the mean change of the number of micturitions per 24 hrs from baseline to 12 weeks.The secondary objectives of this trial will be:*To…

An Open-Label, Non-Randomized, Single-Center Study to Determine the Metabolism and Elimination of 14C-E7080 in Patients with Advanced Solid Tumors or Lymphomas, who are Unsuitable For, or Have Failed, Existing Therapies

Primary objective:To determine the pharmacokinetics of E7080 and its excretion balance in order to elucidate its metabolic profile in plasma, urine, and feces following a single oral dose of radiolabeled 14C-E7080 in patients with advanced tumors or…

A PHASE I, SINGLE-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE ASCENDING-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GRC 10693 IN HEALTHY MALE SUBJECTS

The study has three objectives. Firstly, we will study the safety and tolerability of the drug after the administration of both single and multiple doses of the drug. Secondly, we will study the speed at which the drug is absorbed in the body, as…

A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…

A RANDOMIZED PHASE II STUDY OF CONCOMITANT TRASTUZUMAB, BEVACIZUMAB WITH PACLITAXEL VERSUS TRASTUZUMAB AND BEVACIZUMAB FOLLOWED BY THE COMBINATION OF TRASTUZUMAB, BEVACIZUMAB AND PACLITAXEL AT PROGRESSION AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER WITH HER2-NEU OVEREXPRESSION

Primary objective: To establish whether concomitant therapy of trastuzumab, bevacizumab with paclitaxel (regimen A) and/or trastuzumab and bevacizumab followed by the combination of trastuzumab, bevacizumab, and paclitaxel at progression (regimen B…

A MULTI-CENTRE, PROSPECTIVE, POST MARKETING SURVEILLANCE STUDY INVESTIGATING THE PERFORMANCE OF CERVICAL ARTHROPLASTY FOR THE TREATMENT OF CERVICAL DEGENERATIVE DISC DISEASE (DDD)

The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial Cervical Disc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index (NDI) and neurological…

Clinical feasibility of a MRI guided robotic system for implantation of position verification markers in the prostate prior to radiotherapy.

The goal of this project is to investigate the clinical feasibility of the robotic MRI-guided implant system for the implementation of fiducial gold markers for position verification for external beam radiation (or Intensity Modulated Radiotherapy (…

The effect of azithromycin in patients with COPD and chronic productive cough.

To determin the effect of low dose azithromycin ( 3 times a week 250 mg) on the cough related health status in patients with COPD and chronic productive cough.In a randomized controlled study.

Effects of the norepinephrine reuptake inhibitor reboxetine on the exploitation-exploration trade-off

The objective of this study is to assess the effects of an increased NE level on the trade-off between exploitation and exploration. More specifically, this study will compare the exploitative/explorative behavior of participants who received either…

Endoluminal fundoplication with the Esophyx*-device versus proton-pump-inhibition in treatment of Gastro-esophageal reflux disease (GERD).

The purpose of this prospective randomized controlled trial is to demonstrate that the EsophyX-TIF procedure will be more effective than PPI therapy as a short and long-term treatment of GERD.

Effects of a structured progressive task-oriented circuit training program to enhance walking competency after stroke

The primary aim of this study is to evaluate the effects of a structured, progressive task-oriented fitness training program applied in a group of 8 to 10 patients on perceived outcome of mobility after stroke when compared to individually-tailored…

The effect of the Meniett in patients with unstable Meniere's disease

Evaluation of the effect of treatment with the Meniett in patients with unstable Menière*s disease.

The effect of inhaled heparin on pulmonary coagulation activation and vascular permeability in mechanically ventilated patients with acute lung injury / acute respiratory disress syndrome

Objectives1. to determine whether nebulization of heparin decreases coagulation activation in the pulmonary compartment (i.e. BAL fluid)2. to determine whether nebulization of heparin decreases pulmonary vascular permeability

Metamemory intervention in stroke patients: long-term effects on social participation and quality of life

The aim of this study is to investigate the effect of a MSE intervention on social participation and quality of life in chronic stroke patients. This MSE intervention will be compared to a controlgroup in order to measure the additional effect of…