40 results
Objective is to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.
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…
The aim of the study is to assess if a dose reduction of craniospinal irradiation in children with a medulloblastoma does not reduce event free survival (EFS) or overall survival (OS). Furthermore it will be assessed if a field reduction (only tumor…
Primary Trial Objective:To assess the effect of reversal of neuromuscular blockade with sugammadex 4 mg.kg-1 compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of adjudicated postsurgical events of…
The primary objective is to study whether treatment with the mTOR inhibitor Everolimus results in an objectable change in phosphorylation of the selected downstream effectors 4eBP1 and p70S6K in human prostate cancer biopsies. A secondary objective…
To investigate the potential of an interaction between 4 mg/kg and 16 mg/kg sugammadex and enoxaparin or UFH on anticoagulant activity in young healthy male volunteers.
The main aim of the present study is i)To assess whether sugammadex has a positive effect on the post-operative alertness of the patients, and ii) to assess the nature, magnitude and the time of onset of this effect (if any).
Primary objectives-Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years.-Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an out…
The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…
To assess (i) the effect of partial neuromuscular blockade (NMB; TOF ratio 0.7) induced by low-dose rocuronium on the ventilatory response to isocapnic hypoxia and (ii) the effect of the reversal by sugammadex, neostigmine or placebo in healthy…
The aim of the trial is to individualize treatment for each patient by adapting it to early response and thus to continue intensive treatment only with those patients wo show an inadequate treatment response.For patients who show a good initial…
Primary Objective: * To evaluate the ability to concentrate the radiotracer within the prostate gland improving the evaluation of the primary prostate tumor. Secondary Objective(s): * To evaluate the PET/CT imaging characteristics of transcatheter,…
The current trial aims to demonstrate that sugammadex is generally safe and effective for reversing both moderate and deep block after rocuronium or vecuronium induced NMB in term neonates and young children.
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.
primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP, each followed by radiotherapy on PET-positive residual lesions, in terms of progression free survival (…
Main objectiveThe primary objective of this study is to assess whether a higher HRQoL, in terms of impact of the disease and its treatment on physical and role functioning, is achieved with metronomic schedules of doxorubicin or cyclophosphamide…
The primary objectives for the study are: Cohort 1, to characterize cardiac safety of different Daratumumab, cyclophosphamide, bortezomib, and dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B:…
The overall objective of this study is to investigate the potential immunomodulatory effect of sugammadex as seen in previous ex vivo experiments. Specified, the main objective is to investigate the effect of administration of sugammadex without…
The effect of deep muscle relaxation on the abdominal working space during laparosopy, measured by MRI.
- To establish the relationship between the use of deep neuromuscular blockade (NMB) with low pressure pneumoperitoneum (PNP) and the quality of recovery after RARP.- To establish the relationship between the use of deep neuromuscular blockade (NMB…