15 results
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
To assess the efficacy of octreotide LAR in decreasing the need for transfusions and endoscopic intervention in patients ROW with refractory anaemia due to gastrointestinal bleeding telangiectasias.
The primary endopoint is to determine whether ketoconazole/octreotide combination therapy, followed by octreotide monotherapy, is an effective treatment for Cushing's disease. Secundary endpoints address the effects of this therapy on bone…
- To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.- To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
With this trial we want to compare both somatostatin analogues, octreotide and lanreotide, in one trial, so we can see whether there is a difference in effect on liver volume in patients with polycystic livers. Furthermore, we want to find the…
Reduction of polycystic liver volume by treating with octreotide, whether or not combined with everolimus. Assessing whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide…
To assess the efficacy of octreotide in decreasing the need for iron infusions or blood transfusions in patients with refractory gastrointestinal bleedings due to small bowel angiodysplasias despite endoscopic intervention.
To determine if SSA are effective in decreasing transfusion requirements and improving quality of life while being cost-effective.
To evaluate the treatment effect of CAM2029 compared to placebo on liver volume in patients with polycystic liver disease (PLD)
To evaluate the effect of Avelle negative pressure wound therapy in reducing postoperative wound complications after mastectomy with flap fixation and closed suction drainage.
Co-primary (tested in parallel for non-inferiority):- To compare daprodustat to rhEPO for CV safety (non-inferiority)- To compare daprodustat to rhEPO for Hgb efficacy(non-inferiority)
Primary objectives: - Describe the safety of daprodustat, overall (all ages) and in each age group.Secondary objectives:- Describe changes in other parameters relevant to safety, overall and in each age group.- Describe the effect of daprodustat on…
Co-primary (tested in parallel for non-inferiority):-To compare daprodustat to darbepoetin alfa for CV safety (non-inferiority)-To compare daprodustat to darbepoetin alfa for Hgb efficacy(non-inferiority)
Therefore, we propose conducting this pilot study to compare time to complete wound healing and experienced QoL between NPWT and a capillary dressing and with SWC. We aim to establish the feasibility of conducting a definitive randomised controlled…