17 results
The aim of the present study is to investigate the differences in patient and endoscopist satisfaction and experiences and patient*s safety with different sedation protocols.
Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…
Here we will perform a proof of concept study on the ability of the antidepressant tianeptine to prevent respiratory depression from the opioid alfentanil in humans.
Primary objectives:*To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of EPZ-5676 when administered as a 21-day or 28 day CIV infusion to patients with refractory hematologic malignancies.*To assess the safety and…
PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…
The purpose of this study is testing a respiratory stimulant, doxapram. Painkillers such as morphine and alfentanil mute breathing. This is often undesirable, especially in patients. To counteract this attenuation is often used drugs also take away…
The aim of this study is to determine the patients* and endoscopists experiences and patients* safety with different sedation protocols.
Primary Objective: To evaluate whether a single intravenous alfentanil bolus (7.5 mcg/kg) has a clinically significant analgesic effect in clinical patients who undergo an elective CT-colonography compared to placebo. We have defined a clinically…
The primary objective is to select one of two platinum strategies to be used in this regimen for use as experimental arm in Phase III. This is a screening feasibility study addressing purely investigational approaches.
The aim of this study is to demonstrate that procedural sedation with propofol and esketamine is more effective and will result in less cardiopulmonary depression than sedation with propofol and the opioid alfentanil. Less side effects should also…
The objectives of the study are to: -To evaluate the safety and tolerability of MOTREM in patients with septic shock. -To evaluate the effects of MOTREM exposure over up to 5 days in patients with septic shock -To evaluate the PK/PD and dose/PD…
The objectives of this study are to:- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 21 days per dosing cycle.- Evaluate the pharmacokinetics of gemcitabine and 2', 2'-difluorodeoxyuridine (dFdU, a…
The objectives of this study are to:• Evaluate the safety, tolerability, and immunogenicity of long-term treatment with intravenous (IV) ATYR1940 in adult patients with facioscapulohumeral muscular dystrophy (FSHD) previously enrolled in clinical…
Primary objective:Evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of multiple doses of intravenous (IV) ATYR1940 in adults 18 to 65 years of age, inclusive, with FSHDSecondary objective:Explore pharmacodynamic (PD)…
The primary objective is to assess the effects on amyloid plaque burden of administration of VX-745 for 12-weeks, as assessed by Dynamic 11C-PiB (Carbon-11 labeled Pittsburgh Compound B) PET Amyloid Scanning in patients with Mild Cogntitive…
- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…
Part I (dose-escalation): to evaluate the safety of SYD985 and to determine the Maximum Tolerated Dose and Recommended Phase 2 DosePart II (expanded cohorts): to evaluate the Objective tumour Response Rate