8 results
Please refer to protocol, section 1.2 "Rationale"
Aim of this study is to see if the use of an anti-adhesive medical device, the FlexiSurge, is safe to use against adhesions that arise after open abdominal surgery.
• The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (defined as GG >= 2) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the…
The primary objective of the study is to determine the proportion of patients with elevated TGs, without Familial ChylomicronemiaSyndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of…
The primary objective of this trial is to test the safety and efficacy of Perceval valve versus standard sutured stented bioprosthetic aortic valves among the intended trial population. The secondary objective is to compare all relevant device and…
The primary objective of the study is:* To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab 15 mg/kg intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial…
PrimaryThe primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).The primary objective for Part B of the study is to demonstrate a…
The primary objectives of the study are- To evaluate the long-term safety and tolerability of evinacumab 15 mg/kg intravenous (IV) administered every 4 weeks (Q4W) in patients with homozygous familial hypercholesterolemia (HoFH).- To evaluate the…