16 results
Primary:* To assess the efficacy of a 48-week treatment with 2 x 0.5 mg/d or 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis (EoE).Secondary…
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 primary objective of this study is to evaluate whether adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation reduces…
* To demonstrate efficacy of budesonide (9 mg budesonide/d) vs. placebo for induction of remission in active incomplete microscopic colitis after 8 weeks of treatment* To study the maintenance of remission after end of treatment* To study safety and…
To evaluate the safety and efficacy in terms of progression-free survival (PFS) and overall survival (OS) of nintedanib + pemetrexed / cisplatin followed by nintedanib versus placebo + pemetrexed / cisplatin followed by placebo as first line…
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.
Primary:* To assess the efficacy of 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis (EoE).Secondary:* To study safety and tolerability…
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
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…
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.
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…
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.
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…
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 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…