7 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Primary objectives:To characterize the pharmacokinetics of the 300 mg trientine capsule with a fast dissolution profile.To assess the effect of dissolution rate on the pharmacokinetics of trientine.To assess the effect of food on the…
The primary objective of this study is to evaluate and compare the plasma PK parameters of TETA and its two metabolites (MAT and DAT) after two dose levels of Syprine® capsules and TETA 4HCL tablets in adult healthy male and female volunteers.The…
The main objectives of this study are to determine the accuracy of the device (1) to determine functional oxygen saturation (SpO2) compared to a reference device, and (2) to determine respiratory rate compared to visual observations. As a secondary…
The main objective of this study is to validate the accuracy of the device to monitor the physical activity of a subject by comparing the measured values to the golden standard (video recording).
Primary Objective: To study whether the pulse oximeter functionality of the wearable ear sensor is able to reliably measure oxygen saturation, pulse rate, and respiratory rate in a clinical (postoperative) setting.Secondary Objective(s): To evaluate…
To assess the concurrent validity of the FastFocus* Vital Sign Monitoring System classification algorithm that discriminates between lying, sitting/standing, and walking activities, and detects number of walking steps in hospitalised patients under…