11 results
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…
Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…
In this double-blind randomized controlled trial, we would like to show that a five-day treatment course with 16mg/day oral dexamethason is effective in inducing recovery from an exacerbation of MS. The advantages of oral dexamethason over…
To assess if short antibiotic treatment (3x24 hours) with an anti-pseudomonal carbapenem (imipenem-cilastatin or meropenem) is safe (NON-INFERIOR) with regard to treatment failure in comparison with extended treatment (at least 9x24hours) of high-…
The purpose of the study is to compare LA-EP2006 and Neulasta®US and Neulasta®EU with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called…
The purpose of the study is research. The study investigates to what extent ANF Rho is tolerated in comparison to Neulasta® (representing standard of care treatment) and placebo. A placebo is the same formulation as the study medication without the…
Primary Objective: - To confirm the effect of dexamethasone on clinical outcome in patients admitted with CAP.Secondary Objectives: - To study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis…
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…
Primary objectives- Evaluate the efficacy, defined as PFS, of pomalidomide maintenance plus dexamethasone versus pomalidomide maintenance in patients who responded (>= PR) to the combination of pomalidomide (POM), carfilzomib (CAR) and low…
To assess the influence of dosing guided by AutoK on achieving PK targets and clinical endpoints in intensive care patients with sepsis.
The purpose of this study is to compare the efficacy of teclistamab and talquetamab both in combination with daratumumab and lenalidomide (Tec-DR and Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).