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PET imaging of arthritis by specific macrophage targeting in Rheumatoid Arthritis patients - clinical proof of concept studies

Primary aim: Stepwise feasibility study to investigate whether intravenously administered macrophage tracers [11C]DPA-713, [18F]DPA-714 and/or [18F]PEG-folate accumulate in inflamed joints of rheumatoid arthritis patients using PET(-CT).Secondary…

CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group

Primary Objective: Investigate whether early valganciclovir treatment of children with SNHL of * 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at follow-up (age 18 * 22 months…

Cardiac disease in Ankylosing Spondylitis

Primary objective: To investigate left ventricular diastolic function in AS-patients compared with osteoarthritis patients. Secondary objectives: To assess the prevalence of valvular heart diseases and conduction disturbances. To assess left…

Percutaneous access in Endovascular Repair versus Open

The incidence of wound complications in endovascular aneurysm repair (EVAR). VAS scores will be obtained to objectify the advances of a percutaneous approach. Cultures and wound biopsies will be obtained from every patient. Also cost-effectiveness…

Evaluation of 18F-FDHT PET/CT as a predictor of response in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide.

Primary objective: to explore 18F-FDHT PET/CT as a predictor of response in patients with metastasized CRPC to be treated with enzalutamide. Secondary objective: to explore 18F-FDHT PET/CT as a predictor of clinical survival endpoints in patients…

THE EFFECTS OF REAL-TIME CONTINUOUS GLUCOSE MONITORING ON GLYCEMIA AND QUALITY OF LIFE IN PATIENTS WITH TYPE 1 DIABETES MELLITUS AND IMPAIRED HYPOGLYCEMIA AWARENESS

Primary objective: To assess the mean difference in time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), expressed as hours/day, between the two 16-week intervention periods, i.e. RT-CGM versus masked CGM, in…

The Home Sweet Home study: An observational, longitudinal study on the home environment of people with chronic obstructive pulmonary disease (COPD).

Primary objectives:1.1 To investigate the differences between patients* and resident loved ones' perceptions of patients* health status and problematic ADLs.1.2 To study prospectively the effects of an acute COPD exacerbation on resident loved…

Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men

The objective of the current proposal is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and intra-anal high-grade, HPV16 positive AIN, who failed on…

Societal participation with Boston Psychiatric Rehabilitation for
patients with severe mental illness: a cost effectiveness study

The main objective of the study is to gain insight into the cost-effectiveness of BPR compared to care as usual (CAU) for patients withSMI who have a wish for change in their societal participation. Research questions:1. Is BPR (cost-)effective…

Unrelated cord blood transplantation after reduced toxicity conditioning with mesenchymal stromal cell co-infusion in patients with severe epidermolysis bullosa

We propose a phase II study (intervention) in patients with severe generalized recessive dystrophic EB receiving reduced toxicity conditioning chemotherapy followe by cord blood transplantation with co-infusion of mesenchymal stromal cell units.…

Efficacy, safety, and tolerability of oral cebranopadol versus morphine sulfate PR in subjects with chronic moderate to severe pain related to cancer.

The primary objective is to evaluate the efficacy of orally administered cebranopadol in comparison with morphine sulfate PR in subjects suffering from chronic moderate to severe pain related to cancer.The secondary objective is to compare the…

*IBDome; Identification of rare variants in candidate genes and regulatory elements in familiar and sporadic early-onset IBD (inflammatory bowel disease) patients*

Primary Objective: Identification of rare variants in candidate genes and regulatory elements in pediatric IBD patients. Secondary Objective(s): To determine the functional consequences of identified genetic variants in IBD, we will correlate…

The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…

Treatment of the Medial Meniscus with the NUsurface® Meniscus Implant.
A Prospective, Multi-Center, Open Label, Non-randomized Study of the NUsurface® Meniscus Implant

To evaluate the safety, device-related complications, and performance of the NUsurface® meniscus implant as a device for the treatment of patients with degenerative and/or tears of the medial meniscus. .

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients with Primary Hypercholesterolemia Not Treated With a Statin

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen including an alirocumab starting dose of 150 mg Q4W as add-on to non-statin lipid modifying background therapy or as…

Prospective evaluation of bone strength, physical activity, falls, subsequent fractures and mortality in patients presenting with a recent clinical fracture.

The primary objective is to assess bone structure parameters and bone strength by high resolution peripheral quantitative CT evaluation (HRpQCT) and physical activity in relation with subsequent falls, fractures and mortality in patients with a…

Treating cocaine dependence by targeting underlying cognitive processes

The objective of this study is to investigate the effectivity on reducing or cessation of cocaine use of 1) working memory training, 2) N-acetylcysteine, 3) the combination of working memory training and N-acetylcysteine. Clinical measures (cocaine…

Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy
(PHM) in the elderly HER2+ metastatic breast cancer population who may
continue on T-DM1 alone following disease progression while on PH / PHM:
an open-label multicentre randomized phase II selection trial of the EORTC
Elderly Task Force and Breast Cancer Group

The main objectives are to evaluate the efficacy (as measured byprogression free survival at 6 months) of pertuzumab combined withtrastuzumab (PH) or PH plus metronomic chemotherapy (PHM) in anelderly metastatic breast cancer population, and to…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Determine efficiency and safety of two different doses of pregabalin as compared to placebo.

A randomised clinical trial evaluating the effect of remifentanil vs fentanyl
during cardiac surgery on the incidence of chronic thoracic pain.

The primary objective of this study is to determine the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic pain one year after cardiac surgery. The secondary objectives are to…