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Development of Tools (and prediction rules) to time and select therapy in treatment of pre-clinical, early and established Rheumatoid Arthritis: Creating Enhanced Remedy (TRACER): established reumatoid arthritis

to combine and validate diagnostic tests for the prediction of clinical response to therapy with biologics in patients with reumatoid artritis.

Vitamin D and non-specific musculoskeletal complaints in non-Western immigrants

We aim to assess the effect of high-dose vitamin D supplementation on non-specific musculoskeletal complaints in non-Western vitamin D-deficient immigrants and to determine whether improvement of mood is associated with this effect.

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild Alzheimer*s Disease

1. To demonstrate the clinical efficacy of leuco-methylthioninium bis(hydromethanesulfonate) (also known as LMTM,TRx0237) in mild Alzheimer*s disease as assessed by change from baseline on:• Alzheimer*s Disease Assessment Scale - Cognitive Subscale…

A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy

This study has two parts. The main purpose of Part 2 of this study is to see how safe and effective different doses of BI 655064 are as well as to look at the pharmacokinetics (the amount of medication in your blood) and the pharmacodynamics (the…

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV).

To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation-positive, locally advanced or…

Capillaroscopy in patients with early Raynaud

zie Nederlandse samenvatting

A Two-part, Randomised, Open-label, Multicentre, Phase I Study to
Determine the Effect of Food on the Pharmacokinetics of Olaparib Following Single
400 mg Doses of the Capsule Formulation in Patients with Advanced Solid Tumours

The primary objective of this study is to investigate the effect of food on the pharmacokinetics (PK) of olaparib following oral dosing of the capsule formulation in patients with advanced solid tumours.The secondary objective is to further…

Influence of Late Diagnosis on the Burden of disease in Adult Patients with Coeliac Disease.

The purpose of this study is to determine how diagnostic delay of CD affects the burden of CD to patients and society in terms of healthcare and mental healthcare utilisation and socioeconomic costs.

A 52 WEEK, PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF PF-04950615 IN SUBJECTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

A complete list of the study objectives is presented in the Objectives section of the protocol. In summary, the primary objective of this study is to demonstrate a superior LDL-C lowering effect of PF-04950615 150 mg administered by the SC route…

Clinical Evaluation of Safety and Performance of the BackBeat Moderato System

To evaluate the safety and performance of the BackBeat Moderato system.

Effects of ivabradine on vascular function in individuals at increased risk of developing cardiovascular disease and with impaired endothelial function;An international, multicentre, randomised, double-blind, placebo-controlled study over 12 weeks.

The purpose of this study is to demonstrate the beneficial effect of ivabradine on endothelial function in individuals with risk factors for cardiovascular disease and a resting HR * 75 bpm.

What is the effectiveness of a tailor-made social fitness program for community dwelling older people with dementia and their caregivers?

The main objective of this study is to evaluate the effectiveness of a newly developed interdisciplinary tailor-made social fitness programme on the participation in meaningful social activities of community-dwelling older people with dementia and…

Joint distraction in the treatment of knee osteoarthritis; long-term efficacy (pilot)

To analyse survival and long-term effects of knee distraction in the treatment of knee osteoarthritis, based on physical examination, daily functioning and pain, and based on joint space width and subchondral sclerosis on the radiographs and…

Comparison of the effects of atropine on haemodynamics and tissue oxygenation in anaesthesia with propofol and sufentanil versus propofol and remifentanil.

To investigate if there is a clinically important different effect of atropine on haemodynamic variables, tissue oxygenation or microcirculation during anaesthesia with either sufentanil and propofol or with remifentanil and propofol.

Feasibility of Diffusion Tensor Imaging MRI in post-polio syndrome

The main objective of this study is to compare DTI findings of PPS patients with those of healthy controls. Secondary objective of this study is to correlate DTI findings with clinical data such as isometric muscle strength. Third objective is to…

Assessment of normal values of Esophagogastric Junction (EGJ) distensibility in healthy volunteers

Aim of the present study is to assess normal values of EGJ distensibility in healthy volunteers.

A prospective, single arm, open label study assessing the
performance and safety of the Birmingham Hip Resurfacing
system in relatively young males with primary arthritis of the
hip requiring hip replacement.

The primary objectives of this study are to assess the performance of the Birmingham Hip Resurfacing in young active men with large femoral heads as measured with the Oxford Hip Score (OHS) and to evaluate the safety of this device as assessed by…

MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS

To evaluate the safety and tolerability of SC TCZ monotherapy and/or in combination with MTX or other non-biologic DMARDs comprising AEs, physical examination, vital signs, and clinical laboratory assessments, including immunogenicity, in patients…

European Multicenter Registry using Hybrid Staged Operating Room and Interventional Catheter Ablation Techniques to treat Chonic Atrial Fibrilation "HISTORIC-AF Registry"

The objective of the study is to demonstrate that the creation of cardiac lesions with epicardially applied RF ablation through a minimally invasive surgical (MIS) approach plus EP ablation performed when needed at least 3 months later enhances the…

Gene expression analysis elucidating pathogenic mechanisms and predicting vespid venom anaphylaxis

Primary Objective: Difference in gene expression profiles in peripheral blood cells between reactors and non-reactors on a sting challenge with corresponding functional annotation and a naïve Bayes prediction model for patients at risk of a re-…