203 results
The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…
There are two objectives for this study: first, to find specific serum beta cell damage markers that can serve as a clinical predictive tool for beta cell allograft loss. Second, to compare quality of life and diabetes-related outcomes in patients…
The primary objective is to assess bone structure parameters and bone strength by high resolution peripheral quantitative CT evaluation (HRpQCT) and physical activity in relation with subsequent falls, fractures and mortality in patients with a…
Primary objective is to objectively investigate the therapeutic potential of Ivacaftor in Dutch CF patients carrying a mutation associated with residual CFTR function. A secondary objective is to evaluate the correlations between individual…
Evaluate clinical performances of Cre8 in *all comer* population
Main: To assess the effect of an early extra measles immunization between 6and 12 months of age on the development of humoral and cell-mediatedimmunity against measles following routine MMR immunization at 14months of age.Secundary:Determine effect…
To evaluate the safety and effectiveness of Orsiro for the treatment of subjects with up to 2 de novo atherosclerotic coronary artery lesions.
Primary Objectives:To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95,…
The main objective of this study is to assess whether ICD therapy in dialysis patients reduces sudden (arrhythmogenic) cardiac death. The first secondary end point is to compare total mortality death between the two groups. An other is to evaluate…
In this study we want to determine the erlotinib concentrations in blood after administration of erlotinib with water or whole milk with and without an antacid .
To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus.
The primary objective of the study is to determine the mean prediction error (MPE) and mean absolute prediction error (MAPE) of the area under the plasma concentration-time curve (AUC) of carboplatin after adjusted dosing for high BMI (BMI >…
To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
Primary objective To assess accuracy of GCCGM vs FLFM in 18 subjects with diabetes during a 6 day mountainbike tour in the AlpsSecondary objectives To assess the (differences in ) time in hypo-, normo- ,and hyperglycemia (expressed in minutes per…
The main objective of the study is to develop an optimal and individualized asparaginase treatment protocol. The study consist of four sub-studies. The objective of the population pharmacokinetic study is to get more insight in the pharmacokinetics…
Establish the pharmacokinetic parameters of micafungin in critically ill patients and determine whether pharmacokinetic parameters and plasma concentrations of micafungin correlate with disease severity.
Primary ObjectiveTo assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.Secondary Objectives• To estimate…
Primary Objective:To determine whether the long*term use of methylphenidate (> 3 years) increases the blood pressure and causes left ventricular hypertrophy (LVH) identified by echocardiography in late adolescent (>=15 years) and young…
Primary objective: To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.…