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.
Despite the promising data emanating from trials investigating the effectiveness of advanced hybrid closed loop (AHCL) insulin delivery systems in managing glycaemia in those with type 1 diabetes (T1D), we currently know little about their efficacy in optimising glycaemia when physical activity is factored into the equation. With the introduction of new AHCL systems that have novel technological features, we are left with important questions of how to optimise their use around physical exercise to not only minimise dysglycaemia, but also encourage individuals with T1D to lead a physically active lifestyle for the associated wider health benefits. This will be a three-period, randomised, cross-over study with a single-hormone (insulin) AHCL system that compares the efficacy of three insulin management strategies: (i) unannounced exercise and a full dose of meal-time insulin 90-minutes prior to commencement, (ii) a 25% reduced dose of meal-time insulin with exercise announcement 90-minutes prior to commencement and (iii) a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement, in optimising TIR around dynamic physical exercise in adults with T1D.
Despite the established health benefits conveyed by physical activity for people with type 1 diabetes (T1D), participation rates remain low, with fear of hypoglycaemia, lack of freedom to engage in unplanned activities, and uncertainty in making appropriate adjustments to insulin and nutritional therapy reported as the leading barriers to regular exercise engagement. Indeed, the synergistic glucose lowering effects of peripheral hyperinsulinaemia and exercising muscle tissue accentuate the risk of exercise-related hypoglycaemia for individuals with T1D, particularly if performed post-prandially. Hence, the introduction of commercially available artificial pancreas systems, also known as ''advanced hybrid-closed-loop'' (AHCL) systems, that regulate insulin rates with minimal user interaction constitute compelling therapeutic aids with clinically relevant potential. Nevertheless, we know little about their safe and efficacious integration around dynamic physical exercise. Nor do we know how alterations in carbohydrate fueling strategies around exercise effect subsequent glucose trends. This study aims to 1) compare the efficacy of an AHCL system versus usual care insulin pump therapy, with carbohydrates taken before or during exercise, in optimising TIR around dynamic physical exercise and 2) explore the influence of carbohydrate intake before versus during exercise on the metabolomic, hormonal and physiological responses to exercise.
Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines. People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them. When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).
Each participant would complete four test days and each test day is separated by 7-10 days. At each test day the participants would complete a graded maximal exercise test (VO2max-test), a chair rise (Linear encoder) as well as measuring of basic demographic outcomes (weight, fat%,blood pressure etc.). The first test day would further include a motor (MDS-UPDRS III) and cognitive examination (MoCA), a questionnaire about quality of life (PDQ-39) and one about depression (BDI-II). Furthermore, the first test day would include two test of walking performance (6 minutes walk test and Time Up and Go). Two of the test days would be completed while the participants are off their Parkinson disease medication for at least 12 hours, while the other two test days would be completed while on their Parkinson medication. The order of the tests would be randomized. It is hypothesized that the VO2max test would be reliable and valid when participants are on medication, while off-medication would affect the reliability and validity.
A Feasibility Study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO).
We need to identify the essential factors that are linked to readmission among older medical patients as approximately 20% of all medical patients above the age of 65 are readmitted within 30 days after discharge. The objective of this cross-sectional survey study is to to identify factors and aspects that contribute to unplanned hospital readmissions of older medical patients. This will be done through a survey where readmitted patients and their relatives and healthcare professionals answer questions about the patients readmission. The survey questions cover following themes: 1) disease, 2) diagnostics, treatment and care, 3) social network, 4) organisation, 5) communication, 6) competences and knowledge, 7) resources and 8) practical aspects. The hypothesis is that the more knowledge we gain on factors that contribute to readmission, the more targeted actions and interventions and thus preventing readmissions.
Long-term approaches are challenging to implement within the current care system, which rewards clinicians for attempting to quick-fix a long-term condition. This results in increased inappropriate imaging, opioid prescriptions, surgery, and visits/rehabilitation in secondary care, leading to higher societal costs and the continuing increase of LBP-related disability that is currently observed. The investigators argue that LBP management can be optimized by providing patients with self-management strategies supported by a multidisciplinary team and providing simple, safe, and low-cost interventions that adhere to clinical guidelines. This has the potential to change patient behaviors and facilitate empowerment to self-manage LBP leading to lower societal costs of LBP. Research objectives The investigators will develop and test a long-term supportive multidisciplinary team-based management strategy with a specific focus on communicating a structured and unchanging message about individualized diagnosis, treatment, and prognosis, focusing on conducting a large randomized controlled trial as the next phase. This feasibility trial will be completed in a secondary care settings, where relevant patients with poor management skills and insufficient effects of usual (primary) care management can be identified. The specific objectives are: (I) To develop a long-term supportive multidisciplinary team-based management strategy for secondary-care low back pain patients (II) To test the feasibility by assessing: - Changes in relevant outcomes - Utilization of Primary care - Patients and clinicians experience with the intervention - Practical challenges of the setting The management strategy development follows the principles provided by the Medical Research Council for developing complex interventions. Development of the framework Step 1: Framework setup The investigators constructed a basic framework for the intervention by reviewing relevant systematic reviews and clinical guidelines. The research group determined the initial management intervention. Afterward, the investigators conducted a small survey on 191 participants (11% of the total sample of patients between February and May 2021), about their interest in participating. The majority would find such an approach of interest (147(77%)). In parallel, the investigators conducted short semi-structured interviews concerning the intervention with a convenient sample of 20 patients. Seventeen provided usable data. Step 2 - Development Using the participants' information, the investigators re-framed the management strategy. Subsequent semi-structured focus-group interviews with a clinical panel for further modifications before testing was conducted. Step 3 - Feasibility The multidisciplinary team for the feasibility trial consists of two coordinators (chiropractors), two therapists (physical therapists), one medical doctor, and one nurse. The feasibility trial aims to identify and develop the appropriate framework by: I) Investigating the patients' experiences of the current management strategy II) Ensuring satisfactory work-relations between clinicians III) Determining the primary outcome IV) Mapping the multiple interacting components of the management strategy V) Investigating how to measure parallel use of primary care and how this could be applied in the trial evaluation VI) Estimating the workload (number of hours) of the clinicians VII) Quantifying any out-of-protocol behaviors by clinicians and patients alike VIII) Quantifying the different aspects of the intervention using the clinical records The feasibility trial will include 25 LBP patients from the Spine Centre willing to participate in a limited three-month follow-up. The intervention procedure is: 1) A team meeting will be held each morning where the coordinator and the feasibility team will go through the patients. This will start the initial sparring process to ensure a structured and unchanging message for the patient. The coordinator will first assess each patient face-to-face according to ICD-10 principles and enroll eligible patients in the trial. Afterward, the therapist will evaluate the patient's current functional status and management strategy. During the three months, patients will have multiple encounters with the coordinator, the therapist, and the nurse, if needed. The therapist will provide further interventions (e.g., exercise and cognitive/behavioral therapy) to encourage self-management. The investigators will assess the following outcomes at three months: Disability (primary), pain, self-efficacy, quality of life, LBP trajectory, workability, and work retention.
The primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.
The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.