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 frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is much higher than previously assumed, with approximately 10 % of patients undergoing non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study furthermore showed that patients treated with a high inspiratory oxygen fraction during surgery had a higher 1 year mortality compared with patients treated with a low inspiratory fraction. This was especially significant among patients undergoing cancer surgery. A possible explanation, is that a high oxygen fraction results in oxidative stress and endothelial dysfunction. With this randomized cross-over study we wish to investigate the effect of a high inspiratory oxygen fraction on the endothelial function among healthy male volunteers. The primary outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a measure for the effect of oxygen on the autonomic nervous system.
Type 2 Diabetes (T2D) is one of the most common chronic diseases world vide. Patients with T2D experiences reduced quality of life and have a lower physical activity level. Physical activity is well documented treatment to the patient group. The effect of physical activity is shown to reduce co-morbidity, and better functional level and quality of life. Interval Walking Training (IWT) is a new and effective exercise type. IWT is done by walking in a slow and a fast tempo. InterWalk is an application to a smartphone. By using InterWalk the patient can to IWT independently and when used, the app has, as an exercise tool, the potential to better the individual functional level and to measure the physical activity level with the integrated personalised walking test. Motivation for change of habits and lifestyle is subjectively determined by the individual, his or hers individual resources and environment. It is important to get insight in these individual challenges in order to be better structure possible help. The combination of an exercise log, a measure of physical activity fromInterWalk and insight in motivational aspects on an individual level, is essential for successful individualised training. The primary objective of the study is to investigate if the InterWalk app is more effective in increasing the physical activity level compared to a standard care offer in a sample of newly T2D diabetes patients across 52 weeks. Secondarily, we will investigate if the IW app can reduce sitting time, induce weight loss, improve glycaemic control, increase quality of life, improve cardio-respiratory fitness and reduce the use of diabetes medication. The study is designed to test the hypothesis that replacing a standard exercise program in the normal municipal standard care with the Interval Walking Training delivered by the IW app with and without a motivational support program, can increase the long-term physical activity level in patients with T2D for a period of 52 weeks. From January 2015 to June 2016 all patient's with T2D, who are referred to the promotion centres in the municipality, will be offered to participate in the study. In total 513 patients with T2D from different municipalities in Denmark will be included and randomly allocated into three groups. One group will receive standard care and the two other groups will do IWT with the InterWalk app. All three groups are followed by the promotion centre for 8-14 weeks (according to the rehabilitation in the municipality) and hereafter only one of the IWT groups will receive motivational support up to 52 weeks. All patients, no mater group allocation, will be tested and fulfill questionnaires, three times during the intervention period - at baseline, after 8-14 weeks and after 52 weeks. The interventions take place at the promotion centres in the municipalities two times a week and the patient will be encouraged train by them selves one time a week.
The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.
The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.
This is a prospective observational cohorte study. The aim is to investigate actual pain treatment and outcomes in a large population of total hip arthroplasty patients at 5 different hospitals in Denmark.
The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population. The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.
The purpose of this study is to examine whether non-alcoholic fatty liver disease (NAFLD) is associated with hepatic glucagon resistance and hyperglucagonemia.
Background: Five - 15 % of patients with concussion continue to experience impairing physical, cognitive and emotional symptoms longer than 3 months post-injury. Currently, no standardised treatment is available for patients with persistent post-concussional symptoms (PCS) and systematic treatment studies remain limited. Aim: 1. to develop an early intervention programme based on principles from cognitive-behavioural therapy and graded exercise for young patients with PCS lasting more than 3 months, and 2. to evaluate the efficacy of this intervention on PCS in a randomised, controlled trial. Methods: Patients aged 15 - 30 years diagnosed with concussion at hospitals in Central Denmark Region will be screened for persistent symptoms two months post-injury. Those with impairing symptoms will be invited to participate in a randomised controlled trial comparing the early intervention programme with enhanced usual care. We expect to include 120 patients from 2015-2016. Treatment will be interdisciplinary and will begin approximately 3 - 5 months after concussion. All patients will complete self-report measures at baseline and 3, 6 and 15 months after randomisation. The primary outcome is severity of PCS.
The purpose of this study is to describe changes in vitamin D parameters before, during and after a well-defined elective surgical trauma (knee arthroplasty) and to compare these changes to other steroid hormones (testosterone and oestrogens). The hypothesis is that profound changes in free and total vitamin D will occur as a result of changes between intravascular vs extravascular protein compartments during surgical trauma.