11 results
The purpose of this prospective, pivotal, multi-center, single-arm cohort, pre-market, investigational clinical study is to assess the safety and performance of Deternia* Self-Gripping Resorbable Mesh when used for suture line reinforcement after…
To investigate the effects of a 5-day diet with 30% caloric and 70% protein restriction on cardiotoxicity induced by anthracycline treatment in women with triple negative or hormone receptor-positive breast cancer. The biomarker high-sensitivity…
The main objectives of this project are:- To start a prospective observational cohort study of patients who have been diagnosed with CRC, small bowel and anal cancer and follow them from time of diagnosis until death.- To prospectively collect data…
Primary objective Primary objective is to create a prediction model based on early clinical screening of motor, cognitive, and emotional disturbances to predict restrictions in participation at one year after cardiac arrest in patients that have…
Our objective is to compare the efficacy of early chest tube removal combined with single-shot PVB versus standard treatment (chest tube for at least 3 days and thoracic epidural analgesia (TEA)) after surgery for PSP. Efficacy is defined as…
The aim of this study is to investigate the safety and efficacy of CAL-WR as primary and curative colon-preserving treatment for T1 colon cancer. Our primary endpoint is reduction of oncologic resections for low-risk T1 colon cancer. As secondary…
This strategy will result in a reduction reduce the incidence of major adverse cardiovascular events (MACE) defined as death or non-fatal myocardial infarction and appear more efficient than care as usual.
Primary objective: determine whether HAPTOS intervention results in earlier attainment (postnatal days) of full enteral feeding and/or full oral feeding (postmenstrual age) compared to standard care. Secondary objectives: To determine whether…
The objective of the SEAL Early Feasibility Study (STUDY) is to provide proof of concept and initialclinical safety data for the Aortoseal Endostapling System for the fixation and seal of abdominal aorticaneurysms (AAA) endovascular grafts to the…
Main objective is to assess the effectiveness of SP+ in an almost real-life setting of a randomised controlled trial (RCT) in 930 women with obesity, using CVMD-score as primary outcome measurement. Secondary aim is to assess the cost-effectiveness…
This study aims to determine the effect of real-time symptom monitoring on HRQoL in patients with mBC who start first-line chemo(immune)therapy. Further objectives include analyzing the effect of PRS monitoring on physical functioning, the severity…