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 goal of this clinical trial is to determine if transitioning to automated insulin delivery (AID) systems, can improve objectively measured sleep quality and quantity and alleviate cardiovascular risk factors in both children and adults diagnosed with type 1 diabetes. The main questions it aims to answer are: - Does the intervention improve sleep efficiency as measured by the HomeSleepTest, EEG based device, 4 months after initiation? - Can the use of AID treatment alleviate cardiovascular risk measured by heart rate variability (HRV), blood pressure and inflammatory markers? - Researchers will compare AID systems to usual treatment, including both multiple daily injections and sensor augmented pumps to see if the above benefits can be achieved with AID in comparison. Participants will be randomized 1:1 to either start AID treatment or to continue their usual care. The study will be open label. Participants will, at baseline and after 4 months: - Have taken blood and urine samples to measure metabolic and inflammatory parameters - Perform digital cognitive testing using the CANTAB software - Fill out questionnaires related to quality of life, fear of hypoglycemia, hypoglycemia awareness, eating habits and sleep quality - Wear a blinded CGM for 10 days - Monitor sleep at home using the HomeSleepTest for 3 consecutive nights - Wear a Holter monitor for 24 hours to determine HRV parameters - Measure blood pressure for 24 hours at 30 min intervals - Wear an ActiGraph for 7 days to assess sleep and activity, supported by daily electronic sleep diaries Participants randomized to AID treatment will receive education in the use of the systems. Virtual follow-up visits are scheduled at week 1, 5 and 9 for both control and intervention groups during the study, following baseline examinations.
The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence. Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin and/or mirabegron and ready for withdrawal will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving.
This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026. The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).
The overall aim is to evaluate the patient-reported outcome and efficiency of replacing posterior teeth with implant-supported crowns compared to RDPs and no treatment. Sub-aims are to evaluate a new 3D-methods for registration of occlusion and to test two crown designs. Thus, the study design has three aims: - To analyze patient perception including OHRQoL, when missing posterior teeth are replaced with implant-supported crowns compared to removable dental prostheses (RDPs) or no replacement. - To develop and validate new 3D digital methods for assessing occlusal contacts between upper and lower jaw and to analyze the methods relation to masticatory ability and efficiency. - To compare the difference in biological technical outcomes between splinted and non-splinted implant-supported crowns over time.
The purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (IGABT) in patients with locally advanced cervical cancer (LACC). The over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.
Peripheral nerve blocks are often used in anaesthesia. They can be used as the only method of anaesthesia during surgery or in combination with other methods, e.g., general anaesthesia and sedation. Moreover, peripheral nerve blocks are used to treat postoperative pain, alleviate pain in trauma patients, and for painful procedures. For a method to be clinically useful, it is essential to understand the factors contributing to high success rates. It is equally important to know the complications related to the method. Finally, it is essential to establish a robust learning system where the anesthesiologists can track their nerve block performance over time and compare it to high performers and general performance. Therefore, we aim to establish a prospective and ongoing database to gain insight into 1) Factors contributing to block quality, e.g., success rate and nerve block duration; 2) Frequencies and types of nerve injuries and bleeding complications associated with the block procedure; 3) Tracking of block performance by anaesthesiologists.
Today, surgery in an ambulatory setting is preferred for many reasons. Total hip and knee arthroplasty (THA and TKA) are now procedures where patients can be sent home on the same day of the surgical procedure. However, this requires substantial knowledge of factors affecting the length of hospital stay. In this prospective, observational cohort study, we will investigate factors that affect the duration of spinal anaesthesia which is often used in THA and TKA. The aim is to gather enough data to be able to determine how local anaesthetic volume and dose affect the duration of spinal anaesthesia. This will enable us to decide whether spinal anaesthesia is a good option when performing TKA and THA in an ambulatory setting.
We have developed an exercise protocol that we plan to evaluate in a future randomized controlled trial in combination with a corticosteroid injection. In accordance with the MRC Framework of Complex Interventions, which reccomends stepwise development of interventions and testing of feasibility before applying them to a trial, we aim to evaluate the feasibility of our intervention before initiating further trials. The purpose of this non-randomized feasibility study is to test the feasibility and acceptability of this exercise protocol with addition of a corticosteroid injection with no aim of evaluating effects. All participants in this study will receive the following interventions: - An ultrasound-guided corticosteroid injection superficial to the insertion of the gluteus medius and minimus tendons on the greater trochanter of the hip. - A home exercise program including 3 exercises, scalable to 3 different difficulty levels. - A patient information leaflet containing relevant information on managing lateral hip pain.
Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few. This observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.
Hypothesis: Treatment with the hydrophilic coated valved intraurethral catheter up to 16 hours per day is effective, well tolerated and seemingly safe for treatment of women with stress incontinence. Test persons: Ten to twenty stress incontinent women. Treatment time: Up to two weeks