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A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms

The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…

Energy expenditure and sleep in response to protein/carbohydrate and fat ratio

To determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.

The impact of habitual dietary protein intake on the anabolic response in elderly men

To gain a more complete scientific understanding, it is necessary to examine whether an adaptation does in fact occur after habitual high or low amounts of protein intake with regard to the anabolic response to subsequent protein intake. In the…

A randomized, double-blind trial comparing the efficacy and safety of a fixed combination of fenofibrate and metformin vs rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia

Primary objective : Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients (no antidiabetic drug treatment in the last 6 months), with type 2 diabetes mellitus and dyslipidemia, to show that : - the efficacy of a…

Activity and heart rate monitor heart rate algorithm validation study

The primary objective of this study is to determine the equivalence accuracy of energy expenditure and resting heart rate measurement of newly developed software in reference to currently approved software. Secondary objective is to asses the…

The effect of postoperative glucose control with a basal bolus versus a sliding scale insulin regimen on the incidence of surgical site infections in people with type 2 diabetes mellitus: A multicentre, matched-pair, cluster-randomised controlled trial

The aim is to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to a widely used reactive sliding scale regimen. It is hypothesised that a proactive basal-bolus insulin regimen targeting glucose levels of 3.9-10…

A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia

This study has been transitioned to CTIS with ID 2024-511331-96-00 check the CTIS register for the current data. Primary Objective• To evaluate the safety and efficacy of long-term treatment with ARO-APOC3 in adults with dyslipidemia.

Timing exercise training as strategy to improve nocturnal glucose levels and substrate metabolism in men and woman with pre-diabetes

The main objective of this study is to determine whether prolonged exercise training in the afternoon (15:00-17:00 PM) differs from exercise training in the morning (07:00-09:00 AM) in improving nocturnal glucose levels in individuals with pre-…

A randomized, open-label, parallel-group, 18-month Phase 3 study to evaluate the effect of venglustat compared with usual standard of care on left ventricular mass index in participants with Fabry disease and left ventricular hypertrophy

This study has been transitioned to CTIS with ID 2023-509715-91-00 check the CTIS register for the current data. Primary:•To compare the effect of venglustat with standard of care Fabry therapies on left ventricular mass index over 18 months in…

Activity and heart rate band validation
Activity and heart rate watch energy expenditure algorithm validation

The purpose of the study is to validate the measurements of an activity and heart rate band. The primary objective of this study is to determine the measurement accuracy of the activity and heart rate band with regards to the measurement of energy…