6657 results
The aim of this study is to demonstrate which is the most effective operation for neonates with necrotizing enterocolitis (NEC): intestinal resection with stoma formation or intestinal resection with primary anastomosis.
To establish the pharmacokinetic profiles of saliva and plasma concentration of 10 mg MPH-IR and 18 mg MPH-OROS in healthy volunteers; to investigate whether there is a correlation between saliva- and plasma levels of MPH-IR and MPH-OROS, and if…
Primary objectiveThe objective of this pilot study is to test the hypothesis that the use of individual head supports will result in an actual given dose to both the target volumes as well as organs at risk that corresponds better to the planned…
Primary:To investigate the safety and tolerability of ascending doses of AZD3514 in patients with metastatic castration resistant prostate cancerSecondary: To assess the pharmacokinetics and preliminary anti-tumour activity of ascending doses of…
The objective of the study is to observe the effect of olanzapineat a dose of 10 mg daily for 14 days when given with/without topiramaat at a dose of 25 and 50 mg twice daily on bodyweight in healthy male subjects. In addition the effect of…
Primary:- to evaluate the safety and tolerability of the compound in different multiple dosing regimens in healthy subjects in different dosing regimensSecondary:- to characterize the pharmacokinetics of multiple oral doses of LY2878735 administered…
Primary:Part I:- to determine the effects of gabapentin and remifentanil on the evoked area of hyperalgesia, area of allodynia, pinprick hyperalgesia and background pain using a newly developed HCW sensitization modelPart II: - to determine…
Primary Objective: To determine the effect of breakfast replacement by a low-glycemic index liquid meal on fasting and postprandial glucose and insulin concentrationsSecondary Objective(s): To determine the effect of breakfast replacement by a low-…
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
Primary objective: To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patientsSecondary objectives:• To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett*s correction), and QTcN (population…
Part A:To evaluate the safety and tolerability of increasing doses of VX-770 up to 450 mg (q12h) in healthy male subjects.Part B:To determine if therapeutic or supratherapeutic systemic exposure to multiple doses of VX 770 prolongs the mean…
Evaluate the effect of tedalinab on ECG parameters, CNS Function and Pain Perception in Healthy Subjects.
Primary Objective* Investigate the feasibility, applicability, safety, tolerability, and reproducibility of nociceptive tests in healthy volunteers.Secondary Objectives* Investigation of confounding factors including fear of pain, mood, age and…
The present study will investigate whether implementation of the Hemostasis Management System (HMS) in cardiothoracic surgery will result in higher doses of heparin and lower doses of protamine, thereby leading to a less impaired postoperative…
Objectives: A prospective, open label, randomized trial, in which we aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy,…
In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vascular health. To achive this benefit, the study product contains extra vitamin K2 (selected for its protective role in vascular calcification) and…
The primary endpoint of this feasibility study is the technical success of positioning the SLIDE device to verify the speed and ease of use without unexpected device related adverse events. A technical success is defined that the SLIDE device was…
Observational part on respiratory parametersThe primary objective of this study is to study the effect of hypothermia and rewarming on P/F ratio as a measure of oxygenation and on end tidal CO2 as a measure of ventilation during mechanical…
The objective of this study is to evaluate the safety and efficacy of A-002 when added to atorvastatin plus standard-of-care in subjects with an ACS. Specifically this study will examine the effect of treatment on morbidity and mortality as defined…
to offer continuation of BIBF 1020 treatment for patients with IPF who have completed a prior clinical trial with that drug.establish the long term tolerability and safety profile of BIBF 1120 in IPF.