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 investigators hypothesise that the insulinotropic effect of endogenous GIP is improvable in patients with type 2 diabetes after three weeks of near-normalisation of plasma glucose. To test this hypothesis, a randomised, placebo-controlled, double-blinded, crossover study employing a GIP receptor antagonist, will be carried out. Fifteen overweight (body mass index (BMI) > 25 kg/m2) dysregulated (HbA1c >/= 59 mmol/mol and treatment with metformin or >53 mmol/mol and treatment with metformin + add/on) patients with type 2 diabetes will attend two experimental days followed by a three-week-four-week period of plasma glucose near-normalisation (achieved by standard treatment of type 2-diabetes), followed by another two experimental days. On experimental days, patients will receive an infusion of GIP receptor antagonist or placebo during a 75 g oral glucose tolerance test. The primary endpoint is changes in levels of C-peptide divided by changes in levels of plasma glucose and secondary endpoints include changes in circulating levels of C-peptide, insulin, glucose, GIP, glucagon-like peptide 1 (GLP-1), glucagon and markers of bone turnover as well as indices of beta cell function. Furthermore, gastric emptying rate will be assessed.
The aim of this randomised controlled trial (RCT) is to investigate if prolonged consumption of sweetener and sweetness enhancers (S&SEs) within a healthy diet approach will improve weight loss maintenance and obesity related risk factors, and affect safety markers, compared to sugar. We hypothesize, that: - Prolonged use of S&SEs in beverages and food matrices will result in improved body weight control because S&SEs will increase palatability of the diet and thereby increase compliance to the recommendations for a healthy diet. - There will be no safety concerns using S&SEs in the long term. Overweight/obese adults and families where at least one adult (both gender) and one child (both gender) are overweight/obese will be recruited. The majority of measurements will only be conducted in the adult population and some measurement will only be done in sub-groups. The intervention will be performed in four countries: Denmark, Greece, Spain and the Netherlands. The goal is approximately 370 participants - 330 adults (18-65 years of age) and 40 children (6-12 years of age) - will be recruited for the study. All adult participants are first treated by a low energy diet (LED) for 2 months with the aim to reduce body weight (minimum 5% weight loss (WL)), whereas children are treated separately with a conventional weight maintenance (WM) diet, without a specific aim for absolute WL. The participants - both adults and families - are randomized into two different diet interventions for 10 months with or without inclusion of S&SEs products (foods and drinks). For adults, this period aims at preventing weight re-gain and for children maintaining body mass index (BMI)-for-age. The participants will receive food exchange lists and will be guided by dieticians. The randomization will be stratified by age, sex and BMI. Adults (not participating with children) belonging to the same household and all members of a family will be assigned the same intervention - the randomization will here solely be based on the oldest adult in the family/household. The adult participants are weighed at months 0, 0.5 and 1, and if needed at month 1.5. They are supervised during the WL period at months 0 and 1, and if needed at months 0.5 and 1.5, and throughout the WM period at months 2, 4, 6, 9 and 12. Children will follow a similar, but less strict time schedule (their participation is preferred but not required for all dietician meetings). The main assessment points are the clinical investigation days (CIDs) at month 0 (baseline, start of the WL period), 2 (end of the WL period/start of randomized intervention), 6 (6 months from baseline) and 12 (1 year from baseline).
This study explores whether and how DOW, as a PRO marker, can contribute to triage in the Emergency Departments. The study is designed as a mixed-method study consisting of a survey among acutely ill patients and qualitative semi-structured interviews.
Background: Duloxetine provides an analgesic effect of patients with OA. The mode of action of duloxetine is partly believed to act through modulating the descending inhibitory pain pathways from the brainstem towards the spinal cord thereby dampening pain by gating the afferent pain signals from the periphery during their passage to the brain. This study aims to investigate if the analgesic effect of duloxetine is due to modulation of pain mechanisms. Study Rationale: The present study will utilize a set of quantitative pain biomarkers developed to assess peripheral and central manifestations in OA and the influence of duloxetine on those manifestations. Treatment: Patients will be randomized to one of two treatment sequences: 1. Sequence 1: 20 mg duloxetine QD for 1 week, 40 mg Duloxetine QD for 1 week, 60 mg duloxetine QD for 10 weeks, 40 mg duloxetine QD for 1 week, 20 mg duloxetine QD for 1 week, followed by 14 weeks of corresponding placebo 2. Sequence 2: 14 weeks of placebo followed by 20 mg Duloxetine QD for 1 week, 40 mg duloxetine QD for 1 week, 60 mg duloxetine QD for 10 weeks, 40 mg duloxetine QD for 1 week and 20 mg duloxetine QD for 1 week. The two treatment periods of 14 weeks each are separated by a washout period of two weeks and include a two-week titration period. Primary Objective: To assess the effect of 60 mg daily maintenance dose administration of Duloxetine for 10 weeks compared with placebo on pain mechanisms. Sample Size Justification/Statistics: The sample size was calculated to 32 patients providing a power of 85% with a significant level of 0.05 to detect a group difference of 1 point in the change from baseline of the week 12 mean of 24-hour worst pain between duloxetine and placebo treatment. Patient Selection: Up to 40 patients with osteoarthritic knee pain will be enrolled in this study in order to complete 32 patients. Study sites: Mech-Sense Aalborg University Hospital, DK-9000 Aalborg, Denmark Study Assessments: As the primary objective of this study is the assessment of which pain mechanisms are modulated by administration of the study drug, the primary endpoints will be Experimental Mechanism Based Pain Measures (EPMs) including 1) Pressure Pain Thresholds (PPTs), Temporal Summation, Conditioned Pain Modulation (CPM) and Offset Analgesia. In addition, efficacy will be evaluated using 1) pain severity (worst daily pain and night pain), 2) Pittsburgh Sleep Quality Index (PSQI), 3) Brief Pain Inventory (BPI), 4) Investigator and Patient Global Assessment of Changes (IGIC and PGAC), 5) Western Ontario and MacMaster (WOMAC) OA physical function, 6) PainDetect, and 7) Central Sensitization Index (CSI). Safety: Discontinuation rates and Treatment Emergent Adverse Events (TEAEs). Key Inclusion/Exclusion Criteria: Males or females between 40 and 75 years of age, who are postmenopausal or using allowed contraception methods, and have a Body Mass Index (BMI) between 20-35 kg/m2 inclusive Patient with unilateral or bilateral OA of knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence with pain severity equal to or higher than 5 on a Visual Analogue Scale (VAS) assessed as the worst pain within the last 24 hours.
The purpose of this study is to validate and standardize bioelectrical impedance analysis (BIA, Maltron BioScan touch i8) for estimating body composition in hospitalized elderly patients with pneumonia. Body composition assessments with BIA and dual-energy x-ray absorptiometry (DXA,
This study investigates a relatively new device TMFI and incubation of ALA in a cream-vehicle and a gel-vehicle.
Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache. The aim of the study is to identify factors that protect against headache by studying multiomics in people who never have had a headache (headache resistant) versus non-resistant controls. The investigators will measure multiomic changes (transcriptomics and metabolomics) after pain induction by Cold Pressor Test. 3 blood samples, two for RNA and one for metabolites are taken 5 minutes before a Cold Pressor Test and again 1 hour after the Cold Pressor Test. The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.
Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier for treatment success. There is a need for improved patient support for psoriasis patients, which is suggested to improve long-term use of topical drugs. The project aims to test whether a patient-supporting intervention delivered by healthcare professionals can improve the use of topical drugs. The intervention design is based on experiences with previous adherence-improving studies consisting of digital support by conducting a systematic literature search and holding focus groups with patients as well as healthcare professionals. The intervention consists of shared decision-making with patients, nurses and doctors, frequent consultations, easy access to healthcare professionals through video or in-office consultations and holding patients accountable for taking the medication. The intervention will be tested in a randomized controlled trial: during a 48 week period, a group of patients (18-85 years of age) diagnosed with mild-to-moderate psoriasis and treated with topical drugs will be randomized to an intervention (n=40) or non-intervention group (n=40). The primary outcome will be severity of psoriasis and secondary outcomes primary adherence (i.e., rate of filled prescriptions) and quality of life. If the intervention can reduce the severity of psoriasis in a significant manner, there is a potential for a national implementation of the intervention.
Emergency medical Services Copenhagen has developed a machine learning model that analyzes the calls to 1-1-2 (9-1-1) in real time. The model are able to recognize calls where a cardiac arrest is suspected. The aim of the study is to investigate the effect of a computer generated alert in calls where cardiac arrest is suspected. The study will investigate 1. whether a potential increase in recognitions is due to machine alerts or the increased focus of the medical dispatcher on recognizing Out-of-Hospital cardiac Arrest (OHCA) when implementing the machine 2. if a machine learning model based on neural networks, when alerting medical dispatchers will increase overall recognition of OHCA and increase dispatch of citizen responders. 3. increased use of automated external defibrillators (AED), cardiopulmonary resuscitation (CPR) or dispatch of citizen responders in cases of OHCA on machine recognised OHCA vs. medical dispatcher recognised OHCA.
Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache. The aim of the study is to identify factors that protect against headache by studying multiomics in people who never have had a headache (headache resistant) versus non-resistant controls. The investigators will measure multiomic changes (transcriptomics and metabolomics) after headache provocation with isosorbide mononitrate. 3 blood samples, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate. The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.