21 results
The primary objective of this study is to evaluate the efficacy (clinical and MRI) of switching tonatalizumab compared to receiving interferon β1-a or glatiramer acetate.
This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and Patent Blue) in detecting…
Ergonomics and function of the imaging system - the NIRF imaging system should not interfere with the standard Sentinel Lymph Node mapping procedure and used safely by the surgeon while detection of ICG takes place. Duration: 1,5 hour clinical…
To test an intra-operative fluorescent camera system with a fluorescent optical agent in detection of the sentinel lymph node. This will be compared to the standard method with radiocolloid and patent blue.
Primary Objective:-Evaluate tumour detection sensitivity and specificity with the following image enhancement modalities:1 *narrow-band imaging*, (NBI)2 *near-infrared indocyanin green imaging*, (ICG)3 *5-aminolevulinic acid fluorescent imaging*, (5…
The purpose of this study is to investigate the safety and tolerability of the new compound PB006 (natalizumab) when it is administered to healthy volunteers. PB006 has not been administered to humans before. It has been previously tested in the…
Natalizumab (Tysabri®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes
The primary objective of the study is the functional improvement with one point or more on the modified Rankin scale after the 12th week of natalizumab (compared to baseline).
Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…
Primary objectiveThe primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe HS.Secondary objectiveThe secondary objective of this study is to assess the safety, tolerability, immunogenicity,…
To determine which advanced image enhanced modality is the most feasible for the detection of endometriosis lesions, with respect to the specificity and sensitivity of the investigated modalities. To determine which imaging modality reveals more…
Aim of the study is to develop an intraoperative technique for SLN mapping in colon cancer which is suitably in daily practice in colon surgery in an average hospital setting.
Our main objective is to prove that extending dose intervals guided by serum concentrations of natalizumab, will not result in radiological or clinical disease activity.
Aim of the present study is to investigate if a combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the SLNM technique in colon and rectal cancer by utilizing the radioactive component for preoperative…
The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…
In this open-label extension study, we look at how safe and effective the new medicinal product called bimekizumab (hereafter called the *study drug*) is for long-term treatment of hidradenitis suppurativa. Open label means that both you and your…
Primary Objective: Our objective is to validate the safety, measured by radiological disease activity, of personalized extended interval dosing of natalizumab to >=6 weeks (with an aim natalizumab trough concentration of 5 µg/ml) in a large…
The primary objective of this open-label extension (OLE) study is to assess the long-term safety and tolerability of bimekizumab administered over a period of up to 112 weeks.
The purpose of this study is to find out how safe and effective a new drug called bimekizumab is for long-term use in treating hidradenitis suppurativa. Bimekizumab (hereafter referred to as *the study drug*) has been approved by the health…
Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously (sc) every 4 weeks (Q4W) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).…
Primary Objective:The primary objective of this study is to compare the efficacy of bimekizumab administered scfor 16 weeks versus secukinumab at achieving complete clearance (PASI100) in subjects withmoderate to severe chronic plaque PSO.The…