15 results
1. Primary objective: to investigate changes in BMD of the lumbar spine (LS) one year after treatment discontinuation in denosumab-treated women and in denosumab-treated women who received a single infusion of zoledronic acid after treatment…
Objective: To test feasibility and safety of alpha beta T-/CD19 B-cell depleted allo-SCT in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI)
Although these products have been used extensively in patients, the effect of these medications on experimental pain sensation has never been investigated. There is little knowledge about any direct effect of these medications on pain perception. In…
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in men with hormone-refractory prostate cancer and bone metastases.
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in subjects with advanced breast cancer and bone metastases.
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancers and bone metastases (or lytic bone lesions from multiple myeloma).SRE is…
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab compared with placebo as adjunct treatment for the prevention of vaso-occlusive episodes (VOEs) in patients with sickle cell disease (SCD).
This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of crovalimab compared with placebo for the management of acute uncomplicated vaso-occlusive episodes (VOE) in patients with sickle cell disease (SCD).
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
To study the effectiveness and safety of semi-annual zoledronic acid treatment for reducing articular cartilage and pain loss in knee osteoarthritis.
The primary objective will be to investigate if a two-year course of TPTD followed by antiresorptive treatment with a single infusion of ZA in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care…