13 results
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Long-term efficacy.Exploratory: Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (SF-12), Treatment Satisfaction Questionnaire for…
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.
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.
The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…
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…
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 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…
Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…
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.
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…
Primary objectives- To evaluate the effects of buprenorphine on fentanyl induced analgesia using the PainCart test battery in OT patients, when compared to placebo.Secondary objectives- To evaluate the effects of buprenorphine on fentanyl induced…
The purpose of this study is to seek regulatory approval for use of fingolimod in a pediatric population with MS aged 10 to less than 18 years old. This study is conducted in line with the Pediatric Investigational Plan agreed with the EMA (under EU…