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Assessing and predicting functional and quality of life-related outcomes of islet and pancreatic transplantation in patients with type 1 diabetes mellitus

There are two objectives for this study: first, to find specific serum beta cell damage markers that can serve as a clinical predictive tool for beta cell allograft loss. Second, to compare quality of life and diabetes-related outcomes in patients…

Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma (CTCL)

The main purpose of this study is to determine if KW-0761, an investigational drug will work against cutaneous T-cell lymphoma (CTCL) that has failed to respond to other treatments, and to evaluate its side effects. An investigational drug is one…

A randomised phase III trial comparing a strategy based on molecular analysis to the empiric strategy in patients with carcinoma of an unknown primary;A la carte CUP treatment using the CancerTYPE ID test

Determine wether or not a strategy based on molecular analysis is effective in improving the PFS

Registry of the treatment of primary insufficiency of the great saphenous vein with a diameter >/= 12 mm, antero-lateral branches, or great saphenous vein insufficiency below the knee with mechano-chemical endovenous ablation (MOCA)

The goal of this registry study is to provide insight in the safety and efficacy of treatment with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient antero-lateral branches (<12 mm) and insifficincy of the…

Effects of bosentan in a homogeneous population of SSc subjects with a predefined restriction of blood flow in the hands

The primary objectives are:- To demonstrate the relationship of blood flow in the hands and the extent of digital ulcera in patients with systemic scleroderma;- Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks…

A randomized, controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective (CACZ885H2357)

Primary: To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient*s assessment of gout pain intensity in the target joint at 72 hours post-dose (on a 0-100mm VAS). To confirm that canakinumab…

European Health Economic Trial on home monitoring in ICD and CRT-D patients

This amendment (extension to CRT-D subjects) aims to assess the economic effects of HM technology vs. classical follow-up of CRT-D patients from two perspectives: 1) the cost-effectiveness for the payer of health care, and 2) the economic impact on…

Allopurinol TreatmenT And oxypurinol Concentrations in gouty patients: Knowing the therapeutic window.

- Demonstrating an association between oxypurinol concentration and the chance of succesfull lowering of urate concentration in gouty patients (defined as reaching urate concentrations < 0,30 mmol/l)

The use of Prevena Incision Management System on clean closed sternal midline incisions in subjects at high risk for surgical site occurrences.

The objective of the study is to assess the performance of topical negative pressure therapy application with Prevena* Incision Management System (IMS) versus standard conventional wound therapy (SCWT) on closed median sternal incisions in patients…

A randomized, double-blind, placebo-controlled phase III study to evaluate active immunization in adjuvant therapy of patients with stage IIIB and IIIC melanoma with natural dendritic cells pulsed with synthetic peptides

The primary objective is to determine whether adjuvant treatment with natural dendritic cell (nDC) vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves recurrence-…

A randomised controlled trial of oral S-ketamine as add-on medication for patients with treatment-resistant major depressive disorder

The proposed study aims to examine the antidepressant efficacy of oral S-ketamine augmentation in patients with TRD treated with regular antidepressants in a double-blind randomised controlled trial. Secondary questions involve the effects of oral S…

Study on half-dose Photodynamic therapy versus Eplerenone in chronic CenTRAl serous chorioretinopathy (SPECTRA trial)

Primary Objective: to investigate whether half-dose PDT treatment leads to a higher percentage of cCSC patients with SRF on OCT at baseline, achieving an absence of this SRF on OCT as compared to eplerenone treatment.Secondary Objectives: to…

A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.

The objective of the study is to compare conventional therapy with biological therapy in patients with early rheumatoid arthritis.

A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.
The APOLLO Study

The purpose of this study is to evaluate the effects of the addition of daratumumab to pomalidomide and dexamethasone in subjects with relapsed or refractory MM.1. Primary objectiveThe primary objective of this study is to compare PFS between…

A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus

The primary objective is to assess whether combination treatment BLM+RTX will lead to reduced treatment failure and the improvement of pivotal, SLE-specific autoimmune phenomena compared SLE patients treated with standard of care.

Platelet Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): A multi-center, stratified, block-randomized, double-blind, placebo-controlled trial

The goal of this study is to determine the efficacy of PRP injections in the management of ankle osteoarthritis by comparing 2 groups: One receiving a PRP injection and the other a saline solution.

Ciprofloxacin pharmacokinetics after IV and oral administration in cachectic elderly patients

Primary Objective: - To study the pharmacokinetics (CL, Vd, and F) of ciprofloxacin in cachectic elderly patients and compare with normal weight participants.Secondary Objective(s): - To assess the influence of covariates (such as TBW, LBW, serum…

Multiple doses versus single dose of cefazolin to prevent periprosthetic joint infection after revision arthroplasty: a multicenter open-label, randomized clinical trial

The aim of this multicenter open-label, randomized controlled trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee.

Exercise Enhances: A randomized controlled trial on aerobic exercise as depression treatment augmentation strategy

Is care as usual (CAU) with adjunct evidence-based prescription of exercise more effective than CAU alone in reducingdepressive symptoms in patients with major depressive disorder in the specialised mental health service setting?

COvid-19 vaccination and Biomarkers in cirrhosis And post-Liver Transplantation

The primary objective of this observational study is:- to determine if patients with Chronic Liver Disease (CLD) mount comparable humoral immune responses to healthy controls at 8-months following SARS-CoV-2 vaccination.Secondary objectives of this…