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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…

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…

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…

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…

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)

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?

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.

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…

Gag Therapy for Recurrent urine tract infection Assessing Comparability to International Nitrofurantoin Gold standard study.

The main objective of the study is to compare efficacy between GAG therapy and gold standard treatment (AB prophylaxis) in the prevention of rUTI. Primary questionIs GAG therapy as efficacy as antibiotic prophylaxis in the prevention of rUTI?…

REDUCER-I: An Observational Study of the Neovasc Reducer* System

To collect long term outcomes on the use of the Neovasc Reducer

*A prospective randomized multicenter study to demonstrate the superiority of the Barricaid® to discectomy for primary lumbar disc herniation*: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction with Other Risk Factors

The purpose of this post-approval protocol amendment is to extend the follow-up of subjects who were originally enrolled in theRCT, EUBARD-CP_001 protocol. This study extension will examine the long-term survivorship of the Barricaid® ACD when…