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.
This study aims to compare the effect of flash glucose monitoring (FGM) with traditional self-monitoring of blood glucose (SMBG) with or without carbohydrate counting and automated bolus calculation, in patients with type 1 diabetes and poor metabolic control. The investigators will include in total 200 patients recruited from 5 clinical sites in the Capital Region of Copenhagen. The patients will be randomized into four groups; A) Standard diabetes training, i.e. group training in in general diabetes health issues, B) Group training in carbohydrate counting and automated bolus calculation, the app MySugr will be taught and downloaded, C) Group training as in group A, and instructed to use FGM, D) Group training as in group B, and besides training in the use of the app MySugr, also instructed to use FGM. All patients are followed for 26 weeks with 6 clinical visits, group training (1 visit) and 2 telephone consultations. The primary outcome is time spent in normoglycemia.
This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. A NIRS-electrode is placed on forehead skin, on the skull, and on dura. Secondly, a small dose of Phenylephrine is given, and the brain oxygenation is measured by a Clark-electrode and a NIRS-electrode, to see how Phenylephrine affects these measurements. In the third substudy, the brain oxygenations' (NIRS and Licox) response to an inspired oxygen fraction of 0.30 vs. 0.80 is investigated.
Globally, an estimated 257 million individuals have chronic hepatitis B-virus infection (CHB). In the absence of treatment 15-40% of these will progress to liver cirrhosis and/or hepatocellular carcinoma. Oral antiviral treatment suppresses the virus and improves prognosis, but less than 0.5% per year achieve a "functional cure" (i.e. HBsAg loss). One remaining controversy, therefore, is whether antiviral treatment must continue life-long. Observational studies have assessed stopping antiviral treatment after years of viral suppression; however, HBsAg loss has rarely been seen. But interestingly, a few small trials that chose watchful waiting instead of re-initiation of treatment when reactivation occurred, achieved 40% HBsAg loss during 6 years follow-up. The present proposal is a randomized controlled trial that will assess the safety, efficacy, and cost-effectiveness of treatment discontinuation - and delayed restart - in HBeAg negative CHB. The study is sufficiently powered to address the hypotheses, and a pilot study that demonstrates feasibility has been performed. Patients will be enrolled at 12 Norwegian hospitals, in addition to our collaborating institution in Ethiopia - the largest CHB treatment center in sub-Saharan Africa. If the study shows that discontinuation is safe and effective, it will directly impact both national and international treatment guidelines. Main objective: -To study whether stopping nucleoside analogue (NA) therapy - and delaying re-start - can trigger an immune response and set off a functional cure (viz HBsAg loss) Secondary objectives: - Assess whether stopping NA therapy - and delaying re-start - leads to a higher chance of HBsAg loss - Assess the safety of stopping NA therapy - and delaying re-start - in terms of hepatic decompensation, fibrosis progression, and/or adverse events - Study whether stopping NA therapy - and delaying re-start - leads to a higher chance of sustained off-therapy immune control (low viral load and normal ALT) - Assess the quality of life and cost-effectiveness of stopping NA therapy - and delaying re-start - Identify predictors of HBsAg loss
The purpose of this cross-sectional study is to collect relevant molecular markers of aging and measures of physiological function. Together these biomarkers are used to develope a new Biological Age model, useful in health promotion interventions in the public health sector .
Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour"). The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
A physically active lifestyle during pregnancy has potential to improve maternal and child health. However, less than four out of ten Danish pregnant women succeed to achieve 30 minutes of daily physical activity at moderate intensity as recommended by the Danish Health Authorities. This project investigates how to implement physical activity in pregnant women´s everyday life by testing the efficacy of two very different exercise programs on physical activity level during pregnancy.
Musculoskeletal (MSK) pain in adolescents is much more persistent than commonly appreciated. It has previously been described as a self-limiting condition, but several studies indicate otherwise. In a cohort study of 564 11-year olds with weekly MSK pain, 50% of the participants still reported pain after one year. Prospective cohort studies of adults in general practice show that 16-32% of patients with knee pain still have pain after a year. In accordance with this, Kastelein et al. found that 21% of 12 to 35-year-old patients had knee pain six years after initial general practitioner (GP) contact. Collectively, these studies highlight that a significant proportion of adolescents will continue to report pain even years after the initial onset of pain. Can the adolescents with a high risk of MSK pain at follow-up be investigated? Our recent systematic review on children and adolescents with MSK pain indicates that female sex, depression, anxiety, and parental pain are associated with a higher risk of MSK pain at follow-up. However, the validity of these prognostic factors may be questioned as they have been tested in single cohorts and not validated in new external cohorts. Moreover, in accordance with our results, other studies identify emotional problems, psychological symptoms, and frequent exercise associated to a higher risk of MSK pain at follow-up. Given the paucity of high-quality evidence for prognostic factors in childhood and adolescent MSK pain, robust studies are needed to further explore prognostic factors in this population. The investigators want to follow up on this need and conduct a cohort study with a similar aim as in their review; to investigate prognosis in youth MSK pain. In this cohort study, the investigators will limit their participant group to those who are 8-19 years old, because the participants have to be able to provide self-reported data on a questionnaire. Participants aged 0-7 years will not be included as they will have difficulties in doing so and because they i) only represent 2% of all patients consulting GPs in Denmark, with a musculoskeletal complaint and ii) were sparsely represented in our systematic review which included a total of 23.933 patients. At present we lack age-specific prognostic factors in adolescents with MSK pain, although multiple prognostic factors have been identified in adult MSK pain. One systematic review found that higher pain severity upon presentation to the GP, longer pain duration, multiple-site pain, anxiety and/or depression, higher somatic perceptions and/or distress, low social support, higher baseline disability, and greater movement restriction were all associated with a poor prognosis. Systematic reviews on adult knee pain suggest an association between low/middle education level, non-skeletal comorbidity, duration of knee symptoms of > 3 months, bilateral knee symptoms, self-reported warm knee, history of non-traumatic knee symptoms, valgus alignment and an unfavorable prognosis. Similar to findings in patients with adult low back pain, there was high evidence that fear-avoidance beliefs and meagre social support at work were associated with an poor prognosis. If future studies are to tailor and target treatment for the adolescents with the highest risk of long-standing MSK pain, there is a need to identify prognostic factors for an unfavorable prognosis. The aim of this prospective cohort study is to identify the most important prognostic factors for adolescents with MSK pain in general practice.
Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. New evidence indicates that NAFLD is associated with development of heart failure, abnormal ventricular glucose and fatty acid (FA) utilisation and cardiosteatosis. The mechanisms behind cardiac involvement and the progression from NAFL to NASH are poorly understood but must include altered cardiac and intrahepatic lipid handling. In collaboration with renowned research groups from Oxford, Mayo Clinic and Copenhagen we plan comprehensive kinetic studies of heart and liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with NAFL and NASH and the relationship with heart function. In addition, we will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in these subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. We will address these questions using innovative tracer techniques (11Cpalmitate, 11C acetate, 18FDG glucose PET tracers and TG tracers) in combination with hepatic vein catherisation to study cardiac and liver substrate trafficking, as well as NMR spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. Effects of acute exercise as well as GLP-1 agonist and SGLT-2 inhibitor treatment (alone and in combination) will be assessed. The overarching goals are to define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism and to assess hepatic, adipose and skeletal muscle lipid and substrate utilisation.
The purpose of this study is to investigate how expectations induced by information given prior to exercise influence the magnitude of exercise-induced hypoalgesia after a 3 min wallsquat exercise in healthy subjects. The study is a double blinded (participant, investigator) randomized controlled trial The results from the study may be of great importance to the understanding of exercise-induced hypoalgesia, and whether the information related to exercise as pain relief can be used in practice for patients with pain. The subjects are randomized to 1 in 3 groups. Hypoalgesia expectation, hyperalgesia expectation, neutral expectation. Each group (besides the neutral group) is given different information of what to expect on pain ratings after a 3 minutes wallsquat.