28 results
With this study we will investiagate the superiority of fecal clysma therapy (n=34 patients) above conventional therapy with the antibiotic vancomycin (n=34 patients) or bowellavage with conventional antibiotic therapy (n=34 patients).
Dividing the study population in four categories (oncological patients, critically ill patients admitted to intensive care, neonates and other children) answers to the following questions are sought:- which initial dosage regimen for vancomycin…
To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.
* To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and…
Primary efficacy objective:To compare descriptively the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and MajorBleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) in the…
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…
Primary objective: To study the pharmacokinetics of gentamicin, tobramycin, vancomycin and ciprofloxacin in morbidly obese patients and compare with normal weight patients. Secondary objectives: To assess the influence of covariates (such as TBW,…
The primary objective is to compare a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist against a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12…
The primary objectives are to determine the inhibitory effect of intravenously administered C1-inhibitor as well as the influence of depletion of the human microbiota on allergic lung inflammation induced by house dust mite (HDM) plus…
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
Primary Objective: To assess the ex-vivo anticoagulant potency of Edoxaban in patients with Child Pugh A/B cirrhosis, by means of percentual changes in ex-vivo thrombin generation from baseline compared to steady state. These results will be…
The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH compared with dalteparin for theprevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects…
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 (…
The purpose of the study is to test whether a centre-wide policy of incremental antibiotic therapy will reduce arrhythmia device infection in patients undergoing arrhythmia device procedures compared to a policy of conventional antibiotic…
The primary efficacy objective of this study is to:* Compare the incidences of the composite endpoints of stroke, systemic embolic event (SEE), myocardial infarction (MI) and cardiovascular (CV) mortality between the edoxaban group and the…
Primary• Evaluate the efficacy of 8 weeks of treatment with VE202 in terms of endoscopic response at Day 56 • Evaluate the safety of VE202 in Part 1 and Part 2 of the study Secondary objectiveSecondary objective1. Evaluate the safety of VE202 in…
Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…
primary objectives:* Part 1 (dose escalation): To determine therecommended Phase 2 dose(s) (RP2D[s]) forTAR-210* Part 2 (dose expansion): To determine thesafety of TAR-210 administered at theRP2D(s)for up to 12 monthsSecondary objectives (Parts 1…
To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) and lung injury…
To assess the influence of dosing guided by AutoK on achieving PK targets and clinical endpoints in intensive care patients with sepsis.