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.
Critical illness, severe infection, extensive trauma or tissue damage cause an inflammatory (irritative) reaction in the body. This reaction affects the whole body and causes malaise, circulatory and cardiac changes, fever, increases the number of white blood cells in the blood stream and prompts release of signaling proteins. This reaction contributes to the development of considerable organ damage and possibly organ failure. These are serious complications in critical illness which are associated with a high mortality. This inflammatory reaction is affected by the autonomic nervous system. This is the part of the nervous system, which is beyond the control of the free will, and the part that regulates circulation, breathing and digestive functions. The autonomic nervous system works via so-called sympathetic signals, which set the body in a state of alertness to overcome immediate challenges, and parasympathetic (vagal) signals, which are especially active during restitution and rest. It is known, that the balanced activity in the autonomic nervous system affects the body's inflammatory response in critical illness. A study in mice has shown that if parasympathetic (vagal) signals are blocked mortality in critical illness is increased. Reversely, when the autonomic nervous system is medically stimulated towards parasympathetic signaling, the magnitude of the inflammatory response is decreased. Nicotine exerts this stimulatory effect. Also, we know that individuals in good physical shape have increased parasympathetic tone compared to less trained individuals. However, studies have never addressed whether this shifted balance in the autonomic nervous system affects the inflammatory response related to critical illness. Over the last 30 years an experimental model mimicking the inflammatory response has been used in studies. Inflammation may be simulated by injecting the drug E.Coli LPS, which induces a controlled, fully reversible, harmless reaction the duration of which is a few hours. Influenza-like symptoms occur and changes in circulatory parameters and concentrations of signaling proteins can be measured. Using this experimental model, the investigators wish to study whether this shifted balance in the autonomic nervous system in individuals in good physical shape affects the body's reaction to critical illness. Investigators also want to determine how nicotine (using a nicotine patch) affects this reaction.
This is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers to: - obtain natural history data on many HD mutation carriers and individuals who are part of an HD family - relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers) - expedite identification and recruitment of participants for clinical trials - develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care - plan for future research studies
Background 25,000 infants are born extremely preterm every year in Europe. This group of infants carries a high risk of death and subsequent cerebral impairment for the infant, especially in the first 72 hours of life. Mortality is about 20%, and about 25% of survivors live with either cerebral palsy or low intelligence quotient. Preventative measures are keys to reducing mortality and morbidity in this population. There is evidence that the cerebral oxygenation time spent out of range (time with hypoxia or hyperoxia) is associated with poor outcome in infants. Near-infrared spectroscopy (NIRS) has been used to monitor tissue oxygenation since the mid-1980s, and quantification of oxygenation (rStO2) in a percentage from 0 to 100% has been possible for 10 years. From almost 400 preterm infants normal ranges of rStO2 has been determined to be from 55% to 85%. Still, there are no clinical trials and thus no solid evidence of the clinical utility of NIRS in preterm infants. Thus, research on the benefits and harms of cerebral monitoring using NIRS as a part of clinical management of premature infants is much needed. Objectives The primary objective of the SafeBoosC trial is to examine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral NIRS oximetry and implementation of an rStO2-specific clinical treatment guideline. We hypothesise that by using the specified treatment guideline to respond to cerebral monitoring readings outside the target range, we would reduce the burden of hypo- and hyperoxia and consequently reduce brain injury. Trial design This is an investigator-initiated randomised, blinded, multinational, phase II feasibility clinical trial involving preterm infants from 12 European countries. Inclusion criteria The inclusion criteria are: neonates born more than 12 weeks preterm (gestational age up to 27 weeks and 6 days); decision to conduct full life support; parental informed consent; and cerebral NIRS oximeter placed within 3 hours after birth. Sample size With a 50% reduction of the area outside the normal range of oxygenation in %hours in the experimental group compared to the control group as the minimal clinically significant difference, a standard deviation of the area outside the normal range of 83.2 %hours, a type I error (alpha) of 5%, and a type II error of 0.05 (power of 95%) inclusion of 75 preterm infants in the experimental group and 75 preterm infants in the control group is required. The inclusion of twins are likely to decrease power, so it has been decided to increase sample size to 165 on a pragmatic basis of estimating intracluster correlation, control event rate, and incidence of twin births. Intervention The premature infants will be randomised into one of two groups (experimental or control). Common is that both groups will have a cerebral oximeter monitoring device placed within three hours after birth. In the experimental group, the cerebral oxygenation reading is visible, and the infant will be treated accordingly using a defined treatment guideline. In the control group, the cerebral oxygenation reading is NOT visible, and the infant will be treated as usual. Trial duration Monitoring by cerebral oximeter will be started as soon as possible and within 3 hours after birth and the intervention will last for 72 hours. Thereafter, each neonate will be followed up at term date (approximately three months after birth) and at 24 months after term date. Outcome measures The primary outcome is the burden of hypo- and hyperoxia in %hours during the first 72 hours after birth. The secondary outcomes are brain activity on an amplitude-integrated electroencephalogram (aEEG), blood biomarkers (brain fatty acid binding protein (BFABP), neuroketal, and S100β), serious adverse reactions (SARs), severe brain injury, and all cause mortality at term date (approximately three months after birth). The exploratory outcomes are burden of hypoxia, burden of hyperoxia, neonatal morbidities, brain injury score on magnetic resonance imaging (MRI), number of therapies implemented during the intervention, physiological variables (mean blood pressure (BP), pulse oximeter oxygen saturation (SpO2), and partial pressure of carbon dioxide (pCO2)), and psychomotor impairment according to neurodevelopmental scales at 24 months after term date.
Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore, metatarsalgia can be a sign of excessive load caused by sport activities or at work. The condition is very common at diabetics and patients with rheumatism. The purpose of the study is to examine the load under the front foot at health people and patients with metatarsalgia. Furthermore, the researchers aim at being able to assess the best treatment of the flat foot deformity at each patient.
This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.
The aim of present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair.
Use of risk scoring systems in the assessment of patients presenting with upper gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify the system of choice, but the majority of these are characterized by retrospective designs, small sample sizes, low rate of severe bleeding, or low mortality. The main aim of this study was to identify the optimal scoring system.
It is the primary objective of this study to show safety and tolerability for administration of the cell based immunotherapy ALECSAT to patients with Glioblastoma brain cancer. It is a secondary objective to establish if any indications of positive therapeutic or palliative effects may be observed.
This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable rhEPO to GSK1278863 in approximately 68 hemodialysis-dependent subjects with anemia associated with chronic kidney disease. The study consists of a screening phase of 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study eligibility is 9.5-12.0 g/dL and the subjects must have received the same rhEPO product with total weekly doses that varied by no more than 50% during the 4 weeks prior to the Screening visit (Week -1. This study aims to estimate the relationship between dose of GSK1278863 and Hgb response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease after switching from a stable maintenance dose of recombinant human erythropoetin (rhEPO).
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.