19 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.
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…
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 Objective:To evaluate the efficacy of selinexor 60 mg in comparison to a minimally effective lower threshold level of ORR of 15% in patients with R/R DLBCL Secondary Objectives:* To determine DOR* To determine the disease control rate (DCR…
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 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.
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…
Primary Objective:To determine overall survival (OS) of Selinexor as compared to physician choice (PC) in patients * 60 years old with relapsed/refractory AML that requires treatment and are ineligible for intensive chemotherapy and/or…
Primary objective is to evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection.Secondary objective is to evaluate the (hypothetical) dose of…
Primary objective:• To determine the efficacy of selinexor in adults with recurrent GBM asdetermined by the 6-months progression-free survival (6mPFS) rateSecondary objectives:• To determine the efficacy of selinexor in adults with recurrent GBM…
To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) -with standard pressure pneumoperitoneum- and the early quality of recovery.
Part I: Evaluate the safety and tolerability of selinexor at 3 different dose levels in combination with bortezomib/dexamethasone & determine recommended dose level (RDL) of selinexor for Part IIPart II: Evaluate the efficacy of the…
To study the time needed for full recovery of carotid body response to hypoxia (ie. hypoxic ventilatory response, HVR) after full recovery of neuromuscular block with and without reversal with sugammadex
The main objective of this study is to assess the potential effect of deep neuromuscular blockade on the quality of recovery after total hip replacement surgery under general anesthesia. Secondary aims are to establish the relationship between the…
The primary objective of the study is to compare the PFS of SPd versus EloPd in patients with MM who have received 1 to 4 prior anti-MM lines of therapy and never received pomalidomide, selinexor, or elotuzumab. Patients must have had prior…
Primary objective: To evaluate the comparative long-term safety of TAK-503 treatment (formerly known as SPD503) in children and adolescentsaged 6 to 17 years diagnosed with ADHD for whom stimulants are not suitable, not tolerated, or shown to…