Clinical trials

The goal of this study is to learn about potential reversible effects of combined oral contraceptive (COC) use on the serotonergic brain system. The main question it aims to answer is: \- If COC discontinuation results in an increase in serotonin 4 receptor binding in caudate, putamen, and hippocampus measured with Positron Emission Tomography from baseline to follow-up ≥ week 8 after discontinuation. The secondary question it aims to answer is: \- Over what timeframe the serotonin 4 receptor binding is restored after COC discontinuation to the level previously seen in a group of premenopausal women who had not used hormonal contraception before. Researchers will compare discontinuation with continuation of a 2nd generation COC containing 150 ug levonorgestrel and 30 microgram to see if COC discontinuation results in an increased serotonin 4 receptor level in the brain. \- Participants will: * Be randomized to discontinue or continue their COC use for 1-52 weeks. * Undergo an investigational program including brain scans, biological sampling, and neuropsychological testing at baseline and at follow-up. The study uses a group sequential design with two sequential analyses planned, including an interim analysis after 60% of the brain scans have been acquired, which will be used to decide the timing of the last 40% of the scans - this is performed to best determine when the recovery of the serotonin 4 receptor level occurs.

The goal of this randomized questionnaire-based study is to evaluate how different presentations of artificial intelligence (AI) decision support influence clinical judgment among medical doctors working in obstetrics and gynecology when assessing the risk of spontaneous preterm birth using clinical case vignettes with cervical ultrasound images. The study specifically compares two AI presentation formats: a binary classification (preterm vs term birth) and an individualized risk estimate of preterm birth. The main questions it aims to answer are: * Which AI presentation format leads to better alignment between clinicians' confidence and decision accuracy (diagnostic calibration)? * Do different AI presentation formats lead to helpful or harmful changes in clinical decisions? Participants will complete an online questionnaire in which they review clinical cases, make diagnostic and management decisions, rate their diagnostic confidence before and after seeing the AI output, and report their trust in the AI.

This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.

The present project serves to test whether stem cell therapy offers a new treatment option for the scars of burn survivors. In Denmark, 12.000 people seek medical assistance every year for burn injuries leaving thousands of people with the devastating condition of hypertrophic scarring. Affected patients experience pain, itching, numbness, and reduced range of motion, which profoundly impact their quality of life. We hypothesize that adipose-derived stem cells can improve scar quality. To test this, we have conducted an integrated phase I + II trial (the ScarASC trials). ScarASC will be the first randomized controlled trial to use stem cells in burn patients. Two scar areas in each patient will be randomly injected with A) allogeneic adipose-derived stem cells and B) the control medium (placebo). We maintain a patient-centered scope, with our primary endpoint being a patient-reported outcome measure. However, we also obtain objective scar assessments using three-dimensional photographs, the scar elevation index, and gene/protein expression regulation.

Coronary artery disease often necessitates complex interventions like coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) with stents. Hybrid coronary revascularization, a minimally invasive approach, integrates both methods for complete revascularization. This multicenter randomized trial involves 1200 patients, comparing hybrid coronary revascularization to CABG in a 1:1 ratio. Eligible participants have multi-vessel coronary disease and are referred for elective or sub-acute CABG. Inclusion criteria include age 18 or older, significant multi-vessel disease, and potential complete revascularization with both methods. Exclusion criteria include chronic kidney disease, pregnancy, contradiction to dual antiplatelet therapy, recent myocardial infarction, and acute revascularization. The hybrid group undergoes staged revascularization, combining minimally invasive grafting of the left interior mammary artery to the left anterior descending artery with PCI-stenting of remaining lesions. The control group undergoes conventional CABG with sternotomy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, or unplanned hospitalization, while secondary outcomes include periprocedural complications, cardiovascular mortality, hospital-free days within 90 days, angina frequency, and quality of life. Evaluation occurs 12 months after randomization. The trial commences in 2024, with inclusion expected to conclude in 5 years.

Infective endocarditis (IE) is a bacterial infection of the heart valves, inserted material or surrounding struc-tures and is associated with a high morbidity and mortality. In patients with IE, anemia is considered to result from the underlying infection, prolonged sustained inflammatory response due to the often slow natural course of the disease, and coexisting comorbidities. Previous studies have found that moderate to severe anemia is associated with a markedly higher risk of mortality in the 6-months recovery phase following treatment for IE. In many cardiac patients and patients with chronic inflammation, randomized trials have shown benefit of treatment of anemia with adjunctive therapy i.e., vitamins (vitamin B12/folic acid), intravenous iron, and erythropoiesis stimulating agents in alleviating anemia, without increased risk of infection. Despite these findings, anemia screening and management are not addressed in current endocarditis guidelines. Thus, in patients with IE and anemia, adjunctive treatment of the anemia might be beneficial for recovery and improve outcomes. The aim of POET-IRON is to assess the efficacy of adjunctive anemia treatment in patients with IE, using intravenous iron supplementation, erythropoietin-stimulated erythropoiesis, and dietary optimization including vitamins if necessary, and its effect on hemoglobin levels compared to standard care. The investigators hypothesize that this intervention is safe and will increase hemoglobin concentration, thereby alleviating symptoms of anemia and improving clinical outcomes through enhanced oxygen-carrying capacity, tissue oxygenation, and functional status.

This study prospectively evaluates whether the performance of an already-developed artificial intelligence (AI) model for predicting spontaneous preterm birth changes when cervical ultrasound images are obtained using different ultrasound image settings. The primary research question is whether the AI model performs differently across images acquired with different imaging settings.

Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings. Despite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care. The PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a "caregiver compass" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway. PIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care. The study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention. The primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures. In addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.

Aims * To identify patients that should remain admitted in hospital for more intense surveillance because of high risk for development of clinical complications * Expand the understanding of the interactions between physiology and immunology for the design of future projects and general knowledge Hypothesis Development of a risk model based on a combination of physiological and immunological parameters can contribute to early detection of patients at risk for clinical complications after anti-cancer treatment.

The primary objective of this trial is to compare the effects of 18 weeks structured exercise training versus on control on healt-related quality of life in patients with mCRC undergoing first-line chemotherapy.

Peritonsillar abscess (PTA) is a collection of pus between the palatine tonsil and the constrictor muscle. PTA is detected by recognizing characteristics during clinical examination: redness, pain, malaise, trismus, and unilateral peritonsillar swelling. Clinical assessment, including inspection and palpation, is the traditional diagnostic method for patients suspected of having PTA. If PTA is suspected, aspiration with a large-gauge needle or incision is performed to drain the abscess . It can be challenging to distinguish PTA and peritonsillar cellulitis (PTC) based on clinical examination alone. Due to the increased availability of point-of-care ultrasound, it is a part of the diagnostic workup of PTA. Several studies have shown that transoral US can improve the diagnostic accuracy of patients with a suspected PTA. However, no large multicenter study has evaluated whether one of these methods is superior to the other. It is therefore very clinician-dependent whether the patient will have a transoral US performed or not. The investigators hypothesize that transoral US will increase the diagnostic accuracy of PTA compared to solely clinical examination, which is a visual and palpatory assessment. This will result in fewer unnecessary aspiration attempts and overlooked PTAs. Additionally, the investigators wish to investigate the number of aspirations of transoral US-guided needle aspirations compared to aspirations without ultrasound. Methods This is a cluster randomized study. Patients with suspected PTA will be randomized 1:1 to groups A and B. The cluster randomization will happen weekly using an online randomization tool. Participants are patients refeered to the outpatient clinic on suspicion of a peritonsillar absces. The primary outcome is the diagnostic accuracy The investigators aim to determine whether transoral US is a standard part of the clinical examination by comparing clinical examinations with and without US.

Giant cell arteritis (GCA) is an inflammation of the blood vessels. A dangerous complication is sudden vision loss due to insufficient blood supply to the optic nerve. However, it is often difficult to distinguish acute vision loss due to GCA from a similar condition of insufficient blood supply to the optic nerve, called NAION. Quick treatment with anti-inflammatory medication is needed in case of GCA to prevent vision loss on the eye and other serious complications. Patients with NAION have no benefit of the medication, but can have serious side effects, why it is very important to differentiate between these conditions. In this project, the investigators will use FDG PET/MRI with Black Blood (BB) sequences and OCT-imaging to study patients with GCA and/or ischemic optic nerve disease. The investigators will look for signs of inflammation in and around the small vessels of the orbit using PET/MRI and study subtle retinal changes using OCT images. The investigators want to answer the following research questions: Do patients with ischemic optic nerve disease and GCA show signs of inflammation in the orbital vessel wall on PET/MRI-scans, that are not present in patients with NAION? Do GCA patients without vision loss, but with signs of orbital vessel wall inflammation on PET/MRI-scans, have a higher risk of later vision loss than GCA patients without? Can subtle changes in the retina, detectable through OCT, help distinguish between GCA-related vision loss and NAION? This will, to our knowledge, be the first study to systematically use FDG PET/MRI BB-scans to illuminate vascular changes in the orbit of patients with GCA and/or ischemic optic nerve disease. The results may improve diagnosis and treatment of GCA and NAION in the future. The investigators hope that this will help prevent blindness and other serious complications in patients with GCA, while also avoiding unnecessary treatments for patients with NAION.

This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 44 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.

The objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation, and amount of high-level mobilisation during the neuro-ICU stay.

The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis. The main questions it aims to answer are: • Does acute TAVI increase survival compared with standard treatment? Participants will: * Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission * Visit an outpatient clinic and be evaluated for quality of life and heart function

Background: Intravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting. This clinical equipoise will be tested in a trial including patients with pulmonary congestion immediately at hospital admission. Primary objective: To determine the superior strategy of loop-diuretics (furosemide), vasodilation (nitrates) or the combination during emergency treatment. Design: Investigator-initiated, randomized, double-blinded, placebo-controlled trial with 1:1:1 allocation. Intervention: Intervention-phase will last 6 hours from study-inclusion, and patients will be allocated to one of three groups: * Boluses of 40 mg IV furosemide + nitrate-placebo as soon as possible and repeated up to 10 times. * Boluses of 3 mg IV isosorbide dinitrate + furosemide-placebo as soon as possible. * Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg as soon as possible.

The aim of this study is to describe national trends over the past 10 years in patients receiving invasive home mechanical ventilation (HMV) in Denmark. This includes indications for invasive HMV, diagnostic groups, and one-year mortality.

Atrial fibrillation (AF) is the most common arrhythmia, diagnosed in approximately 50 million people worldwide. Its prevalence is expected to increase, eventually affecting every third person, which will result in significant healthcare costs. AF symptoms include palpitations, shortness of breath, and fatigue. The condition may lead to discomfort from symptoms and medical treatment, reduced quality of life, and an increased risk of heart failure, stroke, and death. High alcohol intake can cause AF, trigger new episodes and worsen the condition. The aim of this project is to determine the effect of six months of alcohol abstinence after atrial fibrillation ablation, as modifiable risk factors have gained more attention in the prevention and treatment of AF. Secondly, this study will provide new insights into utilizing a technology platform that enables wearable devices to collect health data remotely. This approach makes ready-to-wear devices a simple and effective solution for monitoring patients' health from home. The study is designed as an open-label, pragmatic, prospective, 1:1 Randomized Controlled Trial (RCT) that will be preceded by a feasibility study (n=40) that will test the feasibility of the proposed inter-vention for the RCT study. The intervention consists of six months of alcohol abstinence after the ablation procedure. To ensure the best possible chance to succeed with complete alcohol absti-nence, the patients will be offered guidance and support from nurses at the hospital based on the techniques of motivational interviewing. After evaluating the outcomes of the feasibility study, appropriate adjustments will be made. All participants from the feasibility study will be included in the RCT study. The study will include a total of 414 participants. The feasibility will be evaluated in five main objec-tives according to the Medical Research Council guidance for designing and evaluating complex in-terventions: Recruitment, data collection, acceptability, resources spent and participant responses. The primary outcome of the RCT study is AF recurrence after 6 months measured with Withings Scanwatch 2. Secondary outcomes are Number of days with AF, change in AUDIT score, change in symptom burden (AFSS score), change in health-related quality of life (EQ-5D-5L), change in alcohol consumption (self-reported and Peth analysis), change in antiarrhythmic medicine and sick leave days. Part two of the study will investigate the long-term effect of alcohol abstinence after atrial fibrilla-tion ablation. Primary outcome is time to AF and secondary outcome is re-ablations, hospital admis-sions and antiarrhythmic therapy. Lastly, a cost-utility analysis will be performed.

Despite high success rates of hip and knee arthroplasty, up to 20% of patients report moderate-to-severe pain (NRS \> 3) persisting beyond the expected healing period. This investigator-initiated, descriptive cohort study will re-invite approximately 100 consenting patients with persistent postoperative pain-identified from a pool of \~7 000 respondents-to complete standardized assessments of neuropathic (DN4), nociplastic (IASP criteria + Fibromyalgia Survey Questionnaire) and nociceptive (KOOS/HOOS pain domains) pain. Primary outcomes are the prevalence of potential nociplastic pain and the proportion experiencing significant pain in two or more mechanistic categories. Secondary analyses will compare baseline vs. re-evaluated DN4 scores, FSQ and KOOS/HOOS distributions, and examine differences between patients with and without possible neuropathic pain. Findings will inform targeted pre- and postoperative pain management strategies.

Radiotherapy of head-neck cancer is associated with significant side effects. Using daily online adaptive radiotherapy to account for the changing anatomy, radiation to organs at risk can be lowered. We will investigate whether this is feasible and associated with a reduction in the risk of toxicity.

The goal of this parallel-group, two-arm, assessor-blinded, randomised clinical trial is to investigate the effects of reducing physical activity on food intake and satiety in physically active and healthy males, 40-55 years of age. The main questions it aims to answer are: * Does physical inactivity affect GLP-1 stimulated food intake? * Does physical inactivity affect food preferences, satiety and other mechanisms supporting appetite regulation? Participants will be randomised (1:1) to two weeks of either no intervention (control group) or inactivity. Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day. Researchers will compare the inactivity group to the control group to see if physical inactivity impairs appetite regulation.

This study wishes to investigate the effects of strength exercise in patients with either HypoPP or HyperPP. The investigators wishes to include participants already diagnosed with either HypoPP or HyperPP in af 24 week prospective study where the patients will be tested and asked to fill out questionnaires three times. These appointments will be schedueled at week 0, week 12 and week 24. In the time period between week 12 and week 24, the patients will have a personalized strength exercise program, which they will have to follow these 3 months. The exercise will be supervised by one or more of the investigators. We will also assess the muscle structure and function cross sectionally.

In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic postconditioning reduces reperfusion injury and this will translate into improved clinical outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing primary PCI

The NORDIC-CSP trial is an investigator-initiated, blinded, nordic RCT aimed at evaluating whether using direct pacing of the HIS bundle (HIS)-pacing or left bundle branch (LBB) pacing is superior to conventional biventricular pacing in reducing the incidence of the composite endpoint of death and non-planned HF hospitalization. The study will be conducted in the 4 CRT-centres in Denmark and 6-8 centres from countries Sweden, Norway and Finland.

Advances in pediatric cancer treatment have led to significant improvements in survival rates, where 5-year survival now exceeds 85%. Despite improved survival, children and adolescents who survive cancer often face significant short- and long-term psychosocial and physical late effects. Children undergoing cancer treatment often experience prolonged school absence, which disrupts their academic development and impedes critical socio-emotional growth during formative school years, with lasting consequences into adulthood. Together, these challenges underscore the need for targeted interventions that support educational continuity, promote school activity, and foster psychosocial well-being. The SchoolCare Intervention aims to reduce school absence experienced by children diagnosed with cancer during their treatment trajectory. The intervention introduces school navigation support in combination with the use of telepresence robots (TPRs) and a teleteaching program. TPRs enable the children to attend school remotely, when they are not able to attend physically. The study is designed to investigate the effectiveness of the intervention throughout a period of eight months for school-aged children (i.e., 5-17 years) who are diagnosed with cancer. The investigators hypothesize that telepresence robots will increase school attendance among children and adolescents diagnosed with cancer, representing our primary outcome (H1). Additionally, the investigators explore secondary outcomes by hypothesizing that the intervention will improve the social well-being of these children and adolescents (H2) and enhance their academic level (H3). By focusing on both school attendance and broader psychosocial and academic effects, this study will provide a comprehensive evaluation of the telepresence robot intervention and its potential to support educational continuity and well-being for children with cancer.