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.
The aim of this study is to perform the first RCT investigating the possible effect of superficial dry-needling (SDN) - a special kind of acupuncture used for PHN. The participants will be divided into two groups. Group A, the intervention group will receive SDN in the area of pain. Group B, the control group will receive a sham procedure.
An exploratory open-label study of PPTH patients to study the efficacy and tolerability of erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic injury to the head. Approximately 100 subjects will be included to erenumab 140 mg. Patients who have participated in study with prior provocation (Ethics Committee of the Capital Region of Denmark (H-1801147 and H-18050498) and who have consented to be contacted will primarily be included. The study will begin February 2019 and is expected to last one year. Patients responding to advertisement (see add) will be contacted by phone.
The objective of this study is to investigate potential early alterations in the DNA methylation profile after severe trauma and to investigate if the early marks persist.
Social Anxiety Disorder (SAD) is classified as a phobic (anxious) disorder in which the patient experiences anxiety in social interactions, during which he or she might be judged or socially evaluated by others. SAD has an estimated lifetime prevalence of 3-13%, but remains under-treated. The recommended psychological treatment for SAD is is the exposure technique imbedded in Cognitive Behavioral Therapy (CBT). Traditionally exposure has taken place either in vivo or through imaginary exposure. In vivo has shown to be most effective, but it is costly and time-consuming and situational elements, such as the reaction of others, are difficult to control. Recently, researchers and clinicians have started to use Virtual Reality (VR) to overcome such difficulties. Compared to traditional methods VR-based Exposure has several advantages mainly based on increased control. Meta-analyzes have found superior effect of CBT with VR-based Exposure compared to imaginary exposure, and similar effects when compared to in vivo exposure, with a recent study finding superior effect of VR-based Exposure compared to in vivo. The current evidence thus supports the clinical efficacy of CBT with VR-based Exposure. However, the meta-analyzes include a total of only six randomized controlled trials (RCTs) and only four of these compare CBT with VR-based Exposure to both an in vivo and a control group. The aims of the current study are to develop a complete program of CBT with VR exposure based on 360° videos for adults suffering from SAD, and to evaluate the treatment effect on SAD symptoms. The study is designed as a three arm RCT comparing 1) a group receiving CBT with VR-based Exposure, 2) a group receiving CBT with in vivo exposure and 3) a group receiving VR relaxation. CBT with VR-based Exposure, will include 360° videos with three different scenarios In Vivo Exposure Therapy consists of role-playing and guided exposure either inside or outside the therapist's office. VR Relaxation Therapy consists of a VR scenario of swimming with dolphins. Treatment will last 10 weeks and there will be a 6 months follow-up. . It is hypothesized that - CBT with VR-based Exposure will reduce symptoms of SAD - CBT with VR-based Exposure will be more effective than both CBT with in vivo exposure and VR relaxation therapy at the end of treatment - An effect on symptom reduction will sustain at the 6 months follow-up
Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.
The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).
In a study from 2003 the investigators showed that adult patients with very low skeletal muscle mass (spinal muscular atrophy (SMA) type II, Duchenne muscular dystrophy, congenital muscular dystrophy) are prone to develop hypoglycemia during prolonged fasting. Since then case reports have described the same phenomenon with hypoglycemia and metabolic crises in children with low skeletal muscle mass provoked by infection, fasting and surgery. Pathophysiological mechanisms of metabolism have never been investigated in adults or children with SMA II. Thus the investigators studied fat and glucose metabolism during prolonged fasting in patients with SMA II and LAMA 2 and compared results to those found in healthy controls.
The aim of the study is to investigate the effects of blocking IL-6 signaling with tocilizumab on lipid, glucose and protein metabolism during rest and exercise in healthy and obese humans. Interleukin-6 is a molecule produced by a variety of cells and impacts on energy metabolism during fasting and fed conditions. Systemic IL-6 levels are low but increase acutely in response to fasting, exercise and infection, and also chronically in response to obesity and other conditions of lowgrade inflammation.Our recent human intervention study showed that IL-6 receptor blockade prevents exercise training from reducing visceral fat mass. Whether IL-6 receptor blockade directly regulates lipolysis and/or lipid oxidation in humans is however unclear. Therefore, this study will be performed to investigate the physiological role of IL-6 on lipid, glucose and protein metabolism in humans.
The concept of normality is a cornerstone in medical practice and research. As an example, in clinical chemistry, a laboratory value based on a plasma sample exceeding the +/- 1.96 x standard deviation (SD) range, referenced from normative material, is, per definition, outside the normal range (the reference interval). Obviously, a number of reasons for this deviation may exist. The sample value could reflect a "true" pathological condition but could also be caused by error, e.g., technical measurement error, drug-interaction error, random error, or reflect a value occurring in 5% of the healthy population. Conversely, a sample value in the normal range evidently does not exclude a pathological condition. The reference interval is calculated from a large number of healthy subjects sampled across age, anthropometrics, ethnicity, and gender. Normative reference intervals are certainly of help, particularly in the screening of subjects, but may be of limited value in the detailed assessment of pathophysiological processes. Also, increasing the number of analyses in a subject expands the risk of making a type I error (acquiring "false" positive results). The likelihood of one or more type I errors in the analysis of 10 different laboratory values in one subject is impressive 46% ([1 - 0.95^10] =0.46). It is well-known that multiple measurements are commonly performed in medical practice and research, but corrected significance levels are not always used.
In Denmark an estimated 200.000 patients suffer from obstructive sleep apnoea (OSA). The breathing pauses during sleep result in varying degrees of symptoms ranging from none over disturbed sleep to severe daytime sleepiness and cognitive deficits such as reduced short-term memory and difficulty concentrating. In addition, it increases the risk of hypertension, cardiovascular thromboembolic disease and type-2 diabetes as well as causing a 3-6 times increased risk of being involved in traffic accidents. Recent studies suggest that measurement of fractioned exhaled nitrogen oxide (FeNO) from the upper airway may be used as marker for airway inflammation. Studies have demonstrated that inflammation of the airway is present in OSA. In this study the investigators want to see whether FeNO measurements from the upper airway can be used to screen severe snorers for OSA. OSA is rarely diagnosed in patients with chronic rhinosinusitis (CRSwNP) or asthma. The connection between these three inflammatory conditions and the level of FeNO has not previously been investigated but might be clarified in our study. Patients suffering from severe snoring will be offered inclusion. The patients will undergo an ENT examination as well as FeNO testing and testing of lung function. A sleep study will be made as well as they will be asked to fill out questionnaires on sleep quality, nasal symptoms, lung function and their health in general.