20 results
In the current study we will measure ventilatory response, as assessed by ventilatory carbon dioxide responses to the administration of oxycodone during three conditions: a *low alcohol condition*, a *high alcohol condition* and a *no alcohol…
To estimate the onset of analgesia of the oxycodone IR formulation OxyNorm Instant using an acute pain model in healthy volunteers.
The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.
Primary objective: to compare the effect two immunosupressive therapy regimens on GFR estimated by iohexol clearance at week 52 post kidney transplantationSecundary objective: to compare the safety and efficacy profiles of the two immunosupressive…
To decrease the cumulative incidence of (hematological) relapse
The primary objective of this study is to compare the prevalence of delirium between oxycodone and morphine, administered by CSCI, for the treatment of pain in dying patients with a diminished renal function.The secondary objective is to compare the…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
* To assess the safety and tolerability of Ampligen administered intranasally in a dosing schedule for 13 days (7 doses) in healthy subjects.* To characterize the mucosal immune response following Ampligen administration over time.
In this study we will measure the effect of Bedrocan which contains primarily *9-tetrahydrocannabinol (THC) and a minute quantity cannabidiol (CBD), on ventilation at 55 mmHg end-tidal PCO2 in 20 healthy volunteers and the combination of THC and 20…
To investigate the effect of enzalutamide on the pharmacokinetics (PK) of oxycodone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer.
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…
Objective(s)* To investigate the pharmacokinetic behaviour of a single dose of MMF;o Plasma concentrationso Cellular concentrationso Relationship between plasma and cellular concentrations* To investigate the pharmacodynamic effects of a single dose…
To determine the optimal treatment strategy in early dcSSc: the effect of HSCT as upfront therapy compared with that of immunosuppressive medication in early dcSSc, with respect to survival and prevention of major organ failure (referred to as *…
The objective of the study is to quantify the effect of pregabaline and lacosamide on oxycodone-induced respiratory depression.
To assess the efficacy and safety of mycophenolate mofetil as induction therapy in patients with treatment naive autoimmune hepatitis.
• To characterize the systemic response to mucosal immunization with an oral cholera vaccination challenge.• To characterize the local response to intranasal rechallenge after cholera vaccination as outcome measure for nasal mucosal immunity.• To…
Primary objective:To evaluate the efficacy of each active treatment combination (hydroxychloroquine + leflunomide and hydroxychloroquine + mycophenolate mofetil) based on proportion of responder patients according to preliminary STAR at week 24.…
Safety: To assess the safety and tolerability of BMS-986165 in LNEfficacy: Efficacy: To evaluate the efficacy of BMS 986165 compared with placebo with regard to proteinuria SecondaryEfficacy - To evaluate the efficacy of BMS-986165 with regard to…
Investigate the effect of hilotherapy on the severity of CIPN and nail toxicity, and its influence on treatment management and quality of life in patients with breast cancer during, and three and six months after treatment with Paclitaxel.
The primary objective of the safety run-in (phase Ib) is to determine the safety of combination therapy with durvalumab and rintatolimod. The primary objective of the phase II trial is to determine the clinical benefit rate of combination therapy…