Clinical trials

DAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.

The purpose of this clinical trial is to investigate whether the drug verteporfin can reduce the formation of scars in adult patients undergoing a tummy tuck procedure (abdominoplasty). The main questions the study aims to answer are: * Whether treatment with verteporfin can reduce scar formation in surgical wounds that are closed with sutures, compared with placebo (saline). This will be assessed based on how the scars look after 3 months using a standardized scar assessment questionnaire (Patient and Observer Scar Assessment Scale). * Whether treatment with verteporfin can reduce scar formation in small open wounds created after taking small tissue samples (4 mm), compared with placebo. This will also be assessed after 3 months using the same questionnaire. The researchers will compare three different doses of verteporfin (0.5 mg/mL, 1.0 mg/mL, and 2.0 mg/mL) with placebo. Each participant will receive all three doses as well as placebo, but in different areas of the surgical wound and in different small wounds, allowing comparisons to be made within the same person. Participants will: * Undergo a planned abdominoplasty procedure * During surgery, receive small injections in the skin with either verteporfin or placebo in different parts of the surgical wound. * Have four small wounds (4 mm) created from tissue samples, which will also be treated with verteporfin or placebo. * Attend follow-up visits after 1 week, 1 month, and 3 months, where the scars will be examined. * Have photographs and ultrasound measurements taken of the scars. * Complete questionnaires about their own assessment of the appearance of the scars.

The goal of this cluster randomized controlled trial is to evaluate if a web-based thoracic ultrasound (TUS) training program can effectively educate users non-inferiorly to traditional classroom teaching in physicians and selected healthcare professionals attending scheduled TUS courses. The main questions it aims to answer are: * Will participants in the web-based learning group achieve non-inferior theoretical test scores compared to the class-based group? * Will participants in the web-based learning group achieve non-inferior practical test scores on an ultrasound simulator compared to the class-based group? Researchers will compare a traditional class-based learning group (receiving preparational material, oral presentation, and class-based cases) to a web-based learning group (receiving interactive web-based reading, tasks, videos, and quizzes) to see if the web-based approach yields non-inferior educational outcomes and skills retention. Participants will: * Complete pre-course preparation (90 minutes) and a theoretical pre-test (30 MCQs). * Undertake either class-based or web-based theory and clinical integration training (3.5 hours total). * Perform hands-on ultrasound training on healthy volunteers and a simulator (2 hours 30 minutes). * Take a practical post-test using an objective structured assessment on a simulator. * Potentially return for a voluntary retention test (theoretical and practical) to achieve certification.

The goal of this clinical trial is to investigate whether care in a specialised Cardio-Renal Clinic can improve the health of people living with both cardiovascular disease and chronic kidney disease. The clinic brings together expertise in heart and kidney disease and provides structured treatment based on current clinical guidelines. The main research questions are: * After one year, does care in the Cardio-Renal Clinic improve measures of heart and kidney function, quality of life, symptoms, and physical ability compared with usual care? * After five years, does care in the Cardio-Renal Clinic reduce the risk of death, hospitalisation for heart failure, heart attack, stroke, worsening kidney function, or kidney failure compared with usual care? At the beginning of the study, all participants will undergo a detailed assessment of their heart and kidney health. This will include blood and urine tests, an ultrasound examination of the heart, questionnaires, and tests of physical ability. Participants will then be randomly assigned to either optimised care in the Cardio-Renal Clinic or usual care. Participants assigned to the Cardio-Renal Clinic will have their treatment reviewed and adjusted by a multidisciplinary team. The clinic may recommend or prescribe approved medications that are already used in routine care for heart and kidney disease. No experimental medications will be used. Participants assigned to usual care will continue to receive care from their general practitioner and any hospital departments involved in their treatment.

The aim of this study is to evaluate the effects of coronary thrombus modification on preventing the microvascular damage associated with primary percutaneous coronary intervention (PCI), and to limit the associated myocardial damage assessed by myocardial salvage index after 3 months. Furthermore, the project will evaluate coronary microvascular damage assessed invasively using both continuous and bolus thermodilution before and after stent implantation. In addition, the project will evaluate the diagnostic ability and associations of pre-stenting invasive physiological measurement to cardiac magnetic resonance imaging measurements.

Congenital hyperinsulinism (HI) causes persistent neonatal hypoglycemia that, if untreated, can lead to neurodevelopmental impairments (NDI) such as cognitive delays, cerebral palsy, epilepsy, and blindness. Despite being preventable with early diagnosis and treatment, 30-50% of affected infants still suffer NDI. Transient HI occurs in about 1 in 1,200 births, while persistent forms are rarer. Current screening focuses on high-risk groups but misses many infants with HI, resulting in delayed diagnosis and brain injury. Our pilot research suggests that measuring umbilical cord blood glucose (UCBG), already routinely collected for other purposes, can serve as a timely, non-invasive screening test for HI. Arterial UCBG below 3.5 mmol/L showed excellent accuracy in predicting pathological HI. This project aims to validate UCBG screening for neonatal HI, implement a national screening program, and assess the neurological outcomes of screen-positive infants. Planned studies: 1. A review will analyze current screening strategies and the impact of delayed diagnosis on brain outcomes 2. A nationwide, prospective study in Denmark will implement UCBG screening in all newborns. Infants with arterial UCBG below 3.5 mmol/L will undergo hypoglycemia monitoring and diagnostic testing. Diagnostic accuracy and optimal thresholds will be evaluated. 3. Neurological follow-up at 6 months will assess development using standardized cognitive and motor tests, EEG, and MRI. 4. A retrospective observational study to investigate whether UCBG can provide improved risk stratification for hypoglycaemia in infants born to mothers with diabetes.

BACKGROUND Brain tumor surgery requires balancing two competing priorities: maximizing the extent of tumor resection to improve survival while preserving neurological function. This is particularly challenging in eloquent brain tumor surgery, where even minor injury may result in permanent loss of functions such as muscle paralysis, language impairment, or visual loss, substantially affecting patients' independence and quality of life. Intraoperative neurophysiological monitoring (IOM) combines functional mapping to identify eloquent structures with continuous monitoring of the integrity of eloquent structures during tumor resection. IOM with motor evoked potentials (MEP) is widely used to map and monitor motor-eloquent structurse but still lack high-quality evidence demonstrating patient-related benefit. Other modalities, including cortico-cortical evoked potentials (CCEP) for language monitoring and visual evoked potentials (VEP) for visual pathway monitoring, are promising but lack standardization and further clinical validation. AIM To strenghten the evidence base and clinical application of IOM in eloquent brain tumor surgery, enabling safer and more effective surgical treatment. HYPOTHESES The project is based on the following hypotheses: 1. CCEP monitoring lacks standardization and clinical validation, and its use varies considerably across clinical practice. 2. Intraoperative CCEP signal changes are associated with postoperative language impairment and can be used to establish clinically relevant warning thresholds. 3. IOM with MEP improves motor function preservation and/or increases the extent of safe tumor resection compared with surgery without IOM. 4. Intraoperative VEP signal changes are associated with postoperative visual impairment and can be used to establish clinically relevant warning thresholds. PROJECT DESIGN The project comprises four unprecedented studies. Part 1 is a scoping review on CCEP monitoring to evaluate current clinical practice and evidence gaps. Part 2 is a prospective observational cohort study including adult patients undergoing resection of language-eloquent brain tumors in either general anesthesia or asleep-awake-asleep setting which evaluates the association between intraoperative CCEP signal changes and postoperative language impairment, and explores clinically relevant warning thresholds. Part 3 is a randomized controlled trial in adult patients undergoing resection of motor-eloquent brain tumors which compares surgery performed using IOM with MEP versus no IOM to evaluate its effect on postoperative motor function and extent of tumor resection. Part 4 is a prospective observational cohort study including adult patients undergoing visual-eloquent transsphenoidal or transcranial surgery for tumors involving the visual pathways. It evaluates the association between intraoperative VEP signal changes and postoperative visual impairment, and explores clinically relevant warning thresholds. Standardized clinical assessments, advanced neuroimaging, and appropriate statistical analyses will be used for this purpose. LIMITATIONS Variability between patients, tumor characteristics, and surgical procedures may complicate interpretation of intraoperative signals. In particular, VEP recordings may be affected by physiological and technical variability. Furthermore, ethical and safety considerations mean that not all patients will be eligible for every part of the project. EXPECTED OUTCOME AND IMPACT Brain tumors are associated with substantial morbidity, permanent loss of function, and mortality. Even modest improvements in functional preservation and the extent of safe tumor resection may significantly improve survival, independence, quality of life, and return to daily activities. The project is expected to generate unprecedented clinical evidence on IOM in eloquent brain tumor surgery through the first randomized controlled trial evaluating the patient-related benefits of IOM with MEP, and the first prospective studies on CCEP monitoring in awake and general anesthesia setting and VEP monitoring of the entire visual pathway. By addressing major evidence gaps, the project will strengthen the evidence base for IOM, improve interpretation of IOM signals and surgical decision-making, and support rapid implementation into clinical practice locally as well as impacting the use of IOM world wide. Ultimately, the project is expected to enable safer and more effective brain tumor surgery with a lower risk of permanent motor, language, and visual impairment, improved survival and quality of life, and reduced need for rehabilitation and supportive care, thereby improving patient safety and enabling more precise and effective surgical treatment. Furthermore, the project is related to the 3rd United Nations sustainable development goal: "Ensure healthy lives and promote well-being for all at all ages."

This Phase II, open-label, multicenter study will evaluate teclistamab in combination with pomalidomide administered using an alternative dosing approach in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy, including lenalidomide and anti-CD38 therapy. Teclistamab is a bispecific antibody that targets BCMA on myeloma cells and CD3 on T cells, bringing these cells into close proximity and activating T cells to induce targeted killing of BCMA-expressing myeloma cells. The study will assess the safety and efficacy of this treatment combination in participants with relapsed or refractory multiple myeloma.

The purpose of this feasibility study is to investigate whether NIPEC with carboplatin after surgery is safe for the elderly and frail women with advanced ovarian cancer. To achieve this, women with advanced ovarian cancer who receive surgery followed by NIPEC will be closely monitored in the period after treatment. We will assess complications, side effects, recovery after surgery and NIPEC, and whether standard chemotherapy can be started on time and completed as planned. In addition, participants will be followed for six months using questionnaires and interviews to evaluate patient-reported outcomes, including quality of life. In the more technical assessment of NIPEC, carboplatin tissue pharmacokinetics and inflammatory responses during and after NIPEC will be analysed using microdialysis and histology.

A multi-center double-blinded placebo-controlled randomized clinical trial. The patients will be randomized into two groups. To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD). After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF. Period of randomization: four months. Number anticipated to be included: 60 patients

Multiple myeloma (MM) is a severe plasma cell cancer caused by proliferation and accumulation of malignant plasma cells in the bone marrow. Novel therapies have improved responses and survival considerably. Recently, it was shown that achieved and sustained minimal residual disease (MRD) negativity is the best predictor for long-term disease-free and overall survival. Achieving and maintaining MRD negativity will therefore be the new treatment goal for patients with MM. Two methods are established for MRD analysis; next-generation flowcytometry (NGF), e.g., the Euro-MRD flow assay, and next-generation sequencing (NGS), e.g., the ClonoSeq assay. Both methods are highly sensitive, with 10\^-5 as the standard goal, and currently reaching for 10\^-6. Both methods are based on bone marrow sampling, which is inconvenient and painful for the patients, particularly for serial analyses. Blood-based MRD analyses of high sensitivity would allow more frequent sampling and monitoring. Methods based on circulating free tumor DNA are found to have rather low sensitivity. Mass spectrometry (MS) based analysis of patient-specific M-protein is another potential candidate for sensitive and specific monitoring of patients in deep remission. This method is under development, e.g., at the Mayo Clinic, USA, but is not fully standardized. No commercial assays have been approved. The investigators will assess and validate the sensitivity of MS-based MRD analyses in monitoring patients with MM in remission. Reproducibility and quality controls will be performed in collaboration with an international partner. The investigators will compare the sensitivity of MS-based analysis with Euro-flow MRD assay and NGS LymphoTrack assay, both performed on bone marrow aspirates. Prospectively, the investigators will monitor a cohort of 40 patients in stringent, complete remission. Imaging by FDG-PET/CT (fluoro-deoxyglucose (FDG) positron-emission tomography (PET) combined with computerized tomography (CT)) is part of MRD assessment according to the International Myeloma Working Group (IMWG) and will be included in our studies. Establishing a blood based MRD analysis will potentially not only be more convenient, it may, in some patients, be more sensitive. The blood reflects disease status in the whole body, whereas bone marrow sampling only allows examining what is present at this particular site. MRD in MM may be patchily located in the skeleton, highlighting the relevance of including FDG PET/CT in the assessment.

The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can reduce the risk of developing post-transplant diabetes in kidney transplant recipients who do not have diabetes at the time of transplantation. The main questions it aims to answer are: * Does Forxiga reduce the risk of developing post-transplant diabetes and prediabetes compared with placebo? * Does Forxiga help preserve the function of the transplanted kidney compared with placebo? * Is Forxiga safe for kidney transplant recipients who do not have diabetes? * Does Forxiga affect the occurrence of urinary tract infections, the amount of protein in the urine, and other kidney- and heart-related health measures compared with placebo? Researchers will compare Forxiga with a placebo (a look-alike tablet containing no active medicine) to see whether it can reduce the risk of post-transplant diabetes while maintaining kidney function and remaining safe to use. Adults who have recently received a kidney transplant and do not have diabetes may take part if they meet the study requirements. Participants will be randomly assigned to receive either Forxiga or placebo once daily for 12 months. They will attend study visits 3, 6, and 12 months after joining the study. These visits will include health checks, blood tests, and urine tests. Neither the participants nor the study doctors will know which treatment each participant is receiving.

Objective To investigate validity of the hysteroscopy assessment tool (HYSAT) for assessment of competence in a clinical environment. Methods Novices and experienced gynecologists are recruited from three hospitals and observed and assessed while performing hysteroscopy. Performances are assessed using the HYSAT tool by two independent raters. Validity evidence is gathered in accordance with Messick's framework: validity evidence for content was ensured in previously published Delphi study, response process is ensured by standardization of written rater instructions. Internal structure is explored using Cronbach's alpha for internal consistency reliability; inter-rater reliability and test-retest reliability are calculated as Pearson's r independently across all ratings. Relationship to other variables is investigated by comparing performances of the participants in each group. Consequences evidence is explored by calculating a pass/fail standard using the contrasting groups' standard setting method.

Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking. The researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit/hyperactivity disorder (ADHD). If methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.

The goal of this observational study is to explore early cognitive changes in patients aged 70 years or older undergoing same-day discharge after hip or knee replacement surgery. The main question it aims to answer is: Does patients experience cognitive changes in cognitive test performance from before surgery to the first day after surgery? Participants will: * Complete a cognitive test battery virtually about 14 days before surgery, and on the first and seventh day after their operation. * Record pain levels and pain medicine use during the first week after surgery

This single-arm phase 2 trial investigates whether a single high-dose radiotherapy treatment can safely treat men whose prostate cancer has come back in a small number of lymph nodes in the pelvis or abdomen after curative treatment. Participants receive one fraction of 24 Gy delivered with MR-guided stereotactic body radiotherapy (SBRT), which uses MRI to visualise the tumour and surrounding organs during treatment. The main goal is to assess safety (severe side effects). The trial also evaluates local tumour control, longer-term side effects, time until hormone (androgen deprivation) therapy is needed, survival, and quality of life. The trial aims to enrol 48 patients.

Treatment for blood cancers has improved significantly, and more patients are now living longer. However, these treatments are often intensive and long-lasting, and many patients experience serious side effects and symptoms. As more patients require ongoing treatment and long-term care, the demand for haematology services is increasing. Home-based treatment is expected to play an increasingly important role in the future. It can support more patient-centred care, help patients maintain their everyday lives, improve quality of life, and reduce pressure on hospitals. Despite these benefits, some patients are either not eligible for home-based treatment or choose to decline it. The reasons for this are not yet well understood. This study combines quantitative data-such as medical information, sociodemographic characteristics, and questionnaire responses about quality of life and health literacy-with qualitative interviews involving patients, relatives, and healthcare professionals. The aim is to identify barriers and differences between patients, and to better understand why some patients opt out of or are unable to participate in home-based treatment. The findings will help support the development of more inclusive and patient-centred care models, ensure more equal access to home-based treatment, and improve support for socially vulnerable patients. The results will be shared with patients and families through patient organisations, with hospitals through the Treat@Home programme, and at national and international conferences.

The main goal in this open label, phase four, prospective, non-randomized, sponsor-initiated multicenter feasibility study is to evaluate the feasibility and safety of self-administration of subcutaneously (SC) daratumumab in the patients with multiple myeloma in their own home. The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. To reduce potential bias, patients will function as their own controls by receiving alternating treatments at home and in the outpatient clinic. To participate, patients must be scheduled for SC daratumumab alone or in combination with other drugs not necessitating outpatient visits on days of planned SC daratumumab self-administration. Patients can be included and trained during cycle 1 and 2, but only treatments administered in cycle 3-6 are considered protocol treatments. Here, patients will receive SC daratumumab once every second week with treatments at day 1 administered in the outpatient clinic and treatments at day 15 administered at home. From cycle 7 onwards, patients continues SC daratumumab outside protocol according to local standards. At inclusion, baseline demographic and clinical data should be registered for included patients. For each SC daratumumab administration in the protocol, planned treatment location (home/hospital) should be registered together with information on whether the dose was administered as planned. For each protocol treatment, regardless of treatment location, patients, caregivers, and healthcare professionals should register their time spent. In addition, patients should complete the Health Literacy Questionnaire (HLQ) and caregivers are to complete the Caregiver Roles and Responsibilities Scale (CRRS). Throughout the study, patient will also register all unplanned contacts to the healthcare system. Patient will also be asked to complete an evaluation form. Lastly, qualitative evaluations of the experience of self-administration will be conducted through semi-structured interviews with patients and caregivers, as well as focus group interviews with involved healthcare professionals.

Lung cancer is the leading course of cancer related deaths world-wide. Lung cancer screening will increase the number of small lung lesion in need of biopsy to confirm the diagnosis. Obtaining lung biopsies with a bronchoscopy has the lowest risk of complications (1-2%) compared to other modalities such as transthoracic needle biopsy (20%), however diagnostic yield needs improvement. Currently a diagnosis is established in 50- 70% of the bronchoscopic procedures depending on the step-up. One way to improve the yield would be by using a cryo probe through the bronchoscope which freezes a small part of the lung for extraction, and thereby provides larger biopsies for examination. This will increase the chances of obtaining sufficient material from a small lesion to determine the diagnosis. The DR CRYO study will compare cryo biopsies to forceps biopsies for the diagnosis of peripheral lung lesions. We hope that the cryo biopsies can improve the diagnostic capabilities of bronchoscopy and provide better biopsies for tumor marker analyses. The project is relevant both for patients undergoing diagnostic work-up for lung cancer in early stages .

Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority remains limited and inconclusive. Thus, the aim is assess if an ankle stirrup is non-inferior to a standard walker in reducing pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The hypothesis is that ankel stirrups align better with patients preferenes for less immobilising braces and offer sufficient stability while the fracture heals. Secondarily it may lead to faster recovery of function, return to work and reduced cost. The sample size of a maximum of 1400 patients allow us to assess non-inferiority in age and sex specific subgroups and treatment (surgical or non-sugical). Non-inferiority will be assessed in a pragmatic, multicenter, randomised controlled trial involving Scandinavian orthopedic departments.

The goal of this quasi-experimental single-arm trial is to evaluate whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people with physical disabilities. The study includes participants aged 8-18 years with cerebral palsy or other conditions causing physical disabilities. The aim of the study is to investigate changes in the primary outcome measure; functional ability using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT), and a series of secondary outcome measures on mobility capacity, physical endurance, performance of everyday activities, and health-related quality of life in children and young people with physical disabilities. Participants will complete a 24-week training program carried out in community athletics clubs: 12-week low-intensity control period with one supervised weekly Frame Running session focused on familiarization. 12-week moderate-to-high intensity intervention period with two weekly training sessions, including warm-up, technique training, endurance and speed intervals, and participation-focused activities. Data collection comprises four standardized questionnaires, four physical performance tests conducted at multiple time points, an electronic training diary, and Rating of Perceived Exertion-Pediatric Scale (RPE-P) obtained before and after selected endurance tests.

Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold viruses, or bacteria, experience difficulty breathing, rapid breathing, increased heart rate, low oxygen levels in the blood, and reduced appetite. If left untreated, a child can become exhausted, lose consciousness, and ultimately die from the condition. Children with severe acute respiratory insufficiency occupy most of the acute care beds in the pediatric wards of hospitals during the winter months. Some children are treated simply with saline inhalations, nasal saline drops, and suctioning of the nose, but many require respiratory support in the form of Continuous Positive Airway Pressure (CPAP) or high-flow oxygen therapy. In adults, it has been observed that prone positioning can improve blood oxygenation compared to supine positioning in cases of acute respiratory insufficiency. The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position. The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen. The study will last a total of 2 hours and will not involve any uncomfortable procedures or pose any risks to the child. The Study Itself: Once the child has CPAP or high-flow oxygen administered via the nose, the child will be positioned for 1 hour in the prone position and 1 hour in the supine position. The order will be random and determined by lottery. A nurse will record the child's breathing in both the prone and supine positions. After the two hours, the child will be placed in the supine position, which is standard practice in the department. The child will have a pulse oximeter on both during the study and afterwards.

This study aims to evaluate the clinical utility of \[68Ga\]Ga-FAP-2268 PET/CT for disease staging and assessment in patients with high-risk primary breast cancer. By targeting fibroblast activation protein (FAP), this novel imaging approach may offer improved tumor visualization compared to conventional imaging, which may help improve treatment planning.

The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress. The expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes. The intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care. The main research questions are: * Does a group-based psychological intervention reduce diabetes distress? * Does a group-based psychological intervention improve psychological well-being and glycemic outcomes? Researchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2). Participants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.

Ankle fractures are among the most common fractures and represent the second most frequent fracture type requiring surgery. Many patients experience long-term pain, stiffness, and reduced ankle function, which substantially limits their physical activity. Even five years after injury, more than a third of patients have not regained their pre-injury activity levels. Standard treatment typically involves immobilisation using a rigid foot-ankle brace (walker). Although effective in protecting fracture healing, these braces may be overly restrictive, contributing to ankle stiffness, swelling, delayed physical recovery and return to daily activities, and reduced quality of life. Patients increasingly express a preference for lighter, movement-permitting ankle supports, such as minimal ankle stirrups. Recent evidence suggests that braces and elastic bands that allow more ankle movement than walkers may enhance faster recovery without increasing complications. However, high quality evidence is necessary for more robust conclusions. The Scandinavian Bracing after Ankle Fracture (BAF) multicentre randomised controlled trial (NCT07163091) therefore investigates whether an ankle stirrup is non-inferior to a standard walker with respect to patient-reported ankle pain and function, measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The primary hypothesis is that ankle stirrups better align with patients' preferences for less restrictive bracing while providing sufficient stability during fracture healing. Secondarily, ankle stirrups may promote faster recovery and physical activity. The Re-BAF trial is nested within a larger multicentre non-inferiority trial (Bracing after Ankle Fracture \[BAF\], ClinicalTrials.gov ID: NCT07163091), aiming to investigate whether an ankle stirrup is non-inferior to a standard foot-ankle brace in improving patient-reported foot and ankle function, as measured by the Manchester-Oxford Foot Questionnaire (\[MOXFQ\], primary BAF outcome) after ankle fracture. The aim of the Re-BAF trial is to investigate whether ankle stirrups are superior to standard foot-ankle braces in improving physical activity, assessed using objectively measured thigh-worn accelerometry from baseline (i.e. randomisation) to 12-week follow-up. We hypothesize that early and continuous movement during rehabilitation, enabled by an ankle stirrup, is superior in improving physical activity compared with a foot-ankle brace, without compromising fracture healing.