6 results
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
The purpose of the study is to investigate how quickly and to what extent 2 different production batches of alpelisib (FMI and FMIopt) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
To study the potential of the daily use of a mini-trampoline or metformin added to the NHG -guided lifestyle to cure early type 2 diabetes in overweight and obese patients. PICO research question. What is the effect of the mini-trampoline or…
The central aim of the POEM Study: to investigate whether the early start of metformin on top of standard care may improve the treatment of GDM for mother and child. Metformin is used as a tool to reduce insulin resistance, the underlying cause of…