There are about 11304 clinical studies being (or have been) conducted in Denmark. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Aim The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma. The present investigation aims at testing how well the new Athena base plate adhere to perspiring skin both with and without mechanical exposure (cycling) since the ability to adhere under normal daily activity is an important quality for Coloplast products. Success criteria: The investigation is an explorative investigation where the adherence of Athena on perspiring skin is evaluated. Due to the explorative nature of the study it has not been possible to define specific success criteria up front. However, the adherence qualities of Athena may not be significantly reduced compared to SenSura. Design: Two groups of men, one group with a colostomy and one group without a colostomy, are included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate intensity and with Athena and SenSura base plates applied on the back and stomach. The adhesion of the base plates are tested before and after the physical activities. Population: The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate intensity on an exercise bike. The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat custom cut base plate, a closed bag size midi or maxi with the intended use of collecting faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy product with a closed bag. SenSura is CE-marked and launched on the market.
Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with alcoholic hepatitis. The liver might play an important role in this stress-catabolism by increasing the production of urea during the inflammatory process. The purpose of this study is to examine the regulation of urea synthesis in patients with alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and pentoxifylline on this regulation.
The aim of the current project is to use a model of painful stimulation of skin, muscles and internal organs, where it is possible to measure activity in the brain centers that process pain simultaneously. Magnetic resonance imaging and electroencephalography are combined to optimize the anatomical and physiological description of brain activation. During administration of morphine we will identify how different brain areas are affected. This knowledge will be used to: 1. Understand the mechanisms of morphine to a greater extent than is possible today, including: 1. to investigate the mechanisms of morphine versus placebo on pain signals in the spinal cord and brain. This is done by a combination of experimental pain models, neurophysiological and imaging techniques (EEG and fMRI). This can be achieved as both subjective and objective measures of the analgesic effect. 2. to examine morphines effect on communication between the centers of the brain that are involved in painprocessing . 3. modeling of morphine pharmacokinetics (the understanding of what the body does to the drug, such as. concentration in the blood and the brain), since this is central to understand the pharmacodynamics (the description of what the drug does to the body and thus the effect it has). 4. to identify biomarkers that can predict whether healthy subjects respond to morphine by experiencing an analgesic effect.
This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36). After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to <15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered. Approximately 300 subjects will be enrolled.
The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain. The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
At Bispebjerg Hospital we have introduced an Early Warning Score based triage system , called Bispebjerg Early Warning Score (BEWS), in order to identify critically ill patient on arrival at the emergency department. The purpose of this study is to validate our triage system.
The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.
This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer. Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated.
Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder dysfunction. Recently, the concept of a surgically created somat-sensory reflex arch for bladder dysfunction in SCI has been introduced. The concept is promising, not just for bladder but also for bowel dysfunction. However, well designed studies need to be performed before recommending the procedure to a large number of patients worldwide. In this study we perform multidisciplinary studies providing necessary information about the clinical outcome of the somato-sensory reflex arch in adult SCI patients. The hypothesis is as follows: 1. In a "western setting" the somato-sensory reflex arch can be created in adult SCI patients with only minor morbidity and complications. 2. Somato-sensory reflex arch reduces bladder and bowel symptoms in SCI patients.