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Background: Current management of mesenteric ischemia is primarily endovascular stent treatment. Typical CMI symptoms are postprandial abdominal pain, food fear, weight loss, and diarrhea. Revascularization is often necessary, as mesenteric ischemia may progress to bowel necrosis and death if left untreated. This study aims to compare the outcome using bare metal stent (BMS) or covered stent (CS) in the endovascular treatment of chronic and acute on chronic mesenteric ischemia. Methods: This is an investigator-driven, prospective, randomized, single-blinded, and single-center, national cohort study at the Copenhagen University Hospital, Denmark. A total of 98 patients with chronic mesenteric ischemia (CMI) and acute-on-chronic mesenteric ischemia (AoCMI) will be randomized to treatment with either BeSmooth BMS (Bentley Innomed GmbH) or BeGraft CS (Bentley Innomed GmbH). Randomization occurs intraoperatively after lesion crossing. Discussion: There is currently no published data from prospective controlled trials regarding the preferred type of stent used for the treatment of chronic and acute-on-chronic mesenteric ischemia. This trial will evaluate the short- and long-term outcome of BMS versus CS when treating CMI and AoCMI, as well as the benefit of a more intense postoperative surveillance program. Trial registration: ClinicalTrials.gov NCT05244629. Registered on February 8, 2022. [ABSTRACT FROM AUTHOR]

Background: The 15-method is a targeted screening and treatment approach for alcohol problems in primary care. The 15-method used in primary care has proven as effective as specialized treatment for mild to moderate alcohol dependence in Sweden. A feasibility study of the 15-method in Danish primary care found the method acceptable and feasible. Aims: To evaluate the effectiveness of the 15-method in a Danish primary care setting in (1) lowering the proportion of patients exceeding the Danish low-risk alcohol consumption limit of ten standard units per week and a maximum of four standard units on a single day for men and women, and (2) increasing the likelihood of alcohol use being addressed during a consultation in general practice. Further, the rate of prescribed pharmacological treatment for alcohol problems (Disulfiram, Naltrexone, Acamprosate, and Nalmefene) will be measured along with the use of the biomarkers Alanine Transaminase and Gamma-Glutamyl Transferase. Methods: Stepped wedge cluster randomized controlled trial in sixteen general practices in the Region of Southern Denmark. Following a three-month baseline, the practices are randomly assigned to launch dates in one of four clusters. General practitioners and nurses receive three hours of training in the 15-method before launch. Patient questionnaires will collect data on alcohol consumption levels among patients affiliated with the practices. The healthcare professionals will register consultations in which alcohol is addressed in their patient filing system. Pharmacological treatment rates and the use of biomarkers will be collected through Danish national registries. The study follows the Medical Research Council's guidelines for developing and evaluating complex interventions. Discussion: From the patient's perspective, the 15-method may help identify alcohol-related problems at an earlier stage with flexible treatment offers in a familiar setting. For healthcare professionals, it addresses a traditionally challenging topic by equipping them with concrete tools, communication training, and clear treatment directives. From a societal perspective, primary care holds a unique position to identify hazardous and harmful alcohol use across different age groups, with potential public health and economic benefits through early identification and intervention. Trial registration: Clinicaltrials.gov NCT05916027. Retrospectively registered 22 June 2023. [ABSTRACT FROM AUTHOR]

Background: Most young children (0–3 years) attend formal childcare in Denmark, many of them fulltime. Yet recent reports of the quality of Danish childcare centers have shown that in more than one-third of nurseries, the interactions between caregivers and young children (0–3 years) are of "insufficient" quality, which constitutes a risk for affected children's well-being and development. Effective interventions to improve childcare providers' interactive skills are necessary. Methods: In this randomized controlled trial, we test the effectiveness of the Caregiver Interaction Profile training, which focuses on improving six core interactive skills: sensitive responsiveness, respecting children's autonomy, structuring and limit setting, verbal communication, developmental stimulation, and fostering positive peer interactions. We will recruit N = 200 childcare providers from nursery groups in Copenhagen (n = 100 training group, n = 100 waiting-list control group). Our primary outcomes are childcare providers' six interactive skills named above, observed from video-recorded interactions in the nursery groups. The secondary goal of our study is to test whether the training boosts children's social-emotional and linguistic development. To this end we aim to recruit N ≈ 500 children from participating childcare providers' nursery groups (n ≈ 250 training group, n ≈ 250 waiting-list control group). We measure social-emotional and linguistic development with various standardized questionnaires, filled out by parents and childcare providers. Discussion: If the training is effective at improving childcare providers' interactive skills, then this will be an important foundation for implementation efforts, such as offering the training as part of the educational program of childcare providers. Future research should also evaluate whether the Caregiver Interaction Profile training is effective for childcare providers of older children (3–5 years) in Danish kindergartens. Trial registration: This trial is registered at clinicaltrials.gov as "Testing the Effects of the Caregiver Interaction Profile Training on the Interactive Skills of Daycare Providers (CDP)" with registry ID NCT05654116. Registration date: 12/01/2022. [ABSTRACT FROM AUTHOR]

Multisystem functional somatic disorder is characterized by specific patterns of persistent physical symptoms with a complex biopsychosocial etiology. The disorder can lead to disability and personal suffering. Current treatment options require specialized settings, therefore patients often wait a long time to receive specific treatment. Patient education is considered important in most treatment programs, but has only been investigated sparsely as a stand-alone treatment. Pharmacological treatment is limited to tricyclic antidepressants in low doses with no antidepressant properties. Duloxetine has been found effective in single organ functional disorders. As a treatment for multisystem functional somatic disorder, duloxetine could reduce symptoms and treat comorbid anxiety and depression. It may furthermore enhance the effect of patient education through a hypothesized effect on cognitive functioning. The purpose of the EDULOX trial is to study psycho-EDUcation and duLOXetine alone and in combination. This is a nested study design. The parent trial "EDULOX1" (n = 424) will compare a patient education program with enhanced usual care in an open-labelled, randomized controlled trial. In addition to this, eligible participants will furthermore receive either duloxetine or active placebo in the nested, double-blinded, randomized controlled trial, "EDULOX2" (n = 212). Patient and clinician reported outcomes will be collected through questionnaires. The EDULOX trial may establish evidence for treatments applicable for the majority of patients with multisystem functional somatic disorder. If effective, duloxetine would be a more tolerable pharmacological treatment option that can target comorbid depression and anxiety, and potentially boost the effect of patient education. Trial registration number The study is registered at www.clinicaltrials.gov (NCT06232473) and the internal list of research projects at the Region of Central Denmark (Case number 1-16-02-305-23). Approval from the Danish Medical Research Ethics Committees (Case number: 2212291) and the Danish Medicines Agency was obtained under EudraCT Number: 2022-002780-30 and Sponsor's Protocol Code Number: 9515. [ABSTRACT FROM AUTHOR]

Background: Limited evidence exists regarding the effectiveness of pain relief and functional improvement in patients undergoing revision total hip replacement (THR). Furthermore, there are no clinical guidelines or consensus on optimal rehabilitation after revision THR., Purpose: The primary aim of this study was to compare the effectiveness of an exercise intervention targeting hip strengthening with standard community-based rehabilitation in patients undergoing revision THR., Methods: This multicenter randomized controlled assessor-blinded trial will be conducted at eight hospitals and multiple municipality rehabilitation centers in Denmark. A total of 84 patients undergoing revision THR are estimated to be allocated to either an exercise intervention targeting hip strengthening (NEMEX-STR) or standard community-based rehabilitation (Usual care). Recruitment was initiated in November 2022 and is expected to be completed by June 2024. The primary outcome is change in functional performance measured by the 30 s chair stand test, from baseline to 4 months after the start of intervention. Secondary outcomes include hip disability and osteoarthritis outcome score; 40 m fast-paced walk test; 9-step timed stair climb test; leg extensor muscle power; global perceived effect; and adverse events. Other outcomes include The International Physical Activity Questionnaires, pain intensity, and European quality of life-5 dimensions. An intention-to-treat approach will be used for analyzing changes in primary and secondary outcome measures. The trial was approved by the Central Denmark Region Committees on Health Research Ethics (Journal No 1-10-72-134-22) and registered on the Central Denmark Regions' internal list of research projects (Journal No 1-16-02-285-22)., Discussion: To our knowledge, this study is the first to explore different rehabilitation programs after revision THR through a randomized controlled trial. The results will provide clinically relevant evidence for optimal rehabilitation after revision THR for improving functional performance, physical function, and quality of life, with great importance for patients, relatives, physiotherapists, and decision-makers., Clinicaltrial: GOV: NCT05657054., (© 2024 The Author(s). Physiotherapy Research International published by John Wiley & Sons Ltd.)

Introduction: Colposcopy is the most important diagnostic tool to detect cervical precancerous lesions and thereby prevention of cervical cancer. Due to age-dependent changes of the cervix, colposcopy is challenging in postmenopausal women, as the majority will have a non-visible transformation zone, resulting in increased risk of missing disease, a diagnostic cone biopsy and prolonged follow-up with repeated colposcopies. This study will be among the first to investigate, if treatment with vaginal oestrogen prior to colposcopy will improve the colposcopy performance, to ensure accurate and timely diagnosis of precancerous cervical lesions among postmenopausal women., Methods and Analysis: A randomised blinded controlled multicentre study. Enrolment will be performed at gynaecology departments in Central Denmark Region and Region of Southern Denmark. A total of 150 postmenopausal women aged ≥50 years referred for colposcopy due to abnormal cervical screening results will be randomised 1:1 to either pretreatment with vaginal application of Vagifem 30 µg or placebo once a day for 14 days prior to colposcopy. The primary outcome will be to compare the percentage of women in the two groups with a visible transformation zone at colposcopy, and biopsies representative of the transformation zone. Secondary outcomes will be the proportion of detected cervical intraepithelial neoplasia grade 2 or higher in the cervical biopsies; the proportion of diagnostics cone biopsies; the patients' report on possible side effects and compliance to the pretreatment., Ethics and Dissemination: The study has been approved by the Central Denmark Region Committee on Biomedical Research Ethics (1-10-72-34-22), the Central Denmark Regions' Research Unit (1-16-02-72-22) and The Danish Health Authority (Danish Medicine Agency; 2022015030). The study's EudraCT number is (1-23-456; 2022-000269-42) and it is registered on www., Clinicaltrials: gov. The local Good Clinical Practice (GCP) unit will supervise and monitor the study closely before, during and after the study period. Findings will be disseminated in peer-reviewed scientific journals and presented in relevant conferences., Trial Registration Number: NCT05283421., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: To support the implementation of advance care planning and serious illness conversations in haematology, a previously developed conversation intervention titled 'Advance Consultations Concerning your Life and Treatment' (ACT) was found feasible. This study aims to investigate the effect of ACT on the quality of end-of-life care in patients with haematological malignancy and their informal caregivers., Methods and Analysis: The study is a nationwide 2-arm cluster randomised trial randomising 40 physician-nurse clusters across seven haematological departments in Denmark to provide standard care or ACT intervention. A total of 400 patients with haematological malignancies and their informal caregivers will be included. The ACT intervention includes an ACT conversation that centres on discussing the patient's prognosis, worries, hopes and preferences for future treatment. The intervention is supported by clinician training and supervision, preparatory materials for patients and informal caregivers, and system changes including dedicated ACT-conversation timeslots and templates for documentation in medical records.This study includes two primary outcomes: (1) the proportion of patients receiving chemotherapy within the last 30 days of death and (2) patients' and informal caregivers' symptoms of anxiety (General Anxiety Disorder-7) at 3 6, 9, 12 and 18 months follow-up. Mixed effects models accounting for clusters will be used., Ethics and Dissemination: The Declaration of Helsinki and the European GDPR regulations as practised in Denmark are followed through all aspects of the study. Findings will be made available to the participants, patient organisations, funding bodies, healthcare professionals and researchers at national and international conferences and through publication in peer-reviewed international journals., Registration Details: The study is registered at ClinicalTrials.gov (NCT05444348). The Regional Ethics Committee of the Capital Region of Denmark (record no: 21067634) has decided that approval is not necessary as per Danish legislation. Study approval has been obtained from The Capital Region of Denmark Data Protection Agency (record no: P-2022-93)., Trial Registration Number: NCT05444348., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Aims: The evidence for beta-blocker therapy after myocardial infarction (MI) is randomized trials conducted more than 30 years ago, and the continued efficacy has been questioned., Design and Methods: The ongoing Danish (DANBLOCK) and Norwegian (BETAMI) randomized beta-blocker trials are joined to evaluate the effectiveness and risks of long-term beta-blocker therapy after MI. Patients with normal or mildly reduced left ventricular ejection fraction (LVEF ≥ 40%) will be randomized to open-label treatment with beta-blockers or no such therapy. The event-driven trial will randomize ∼5700 patients and continue until 950 primary endpoints have occurred. As of July 2023, 5228 patients have been randomized. Of the first 4000 patients randomized, median age was 62 years, 79% were men, 48% had a ST-segment elevation myocardial infarction (STEMI), and 84% had a normal LVEF. The primary endpoint is a composite of adjudicated recurrent MI, incident heart failure (HF), coronary revascularization, ischaemic stroke, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest. The primary safety endpoint includes a composite of recurrent MI, HF, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest 30 days after randomization. Secondary endpoints include each of the components of the primary endpoint, patient-reported outcomes, and other clinical outcomes linked to beta-blocker therapy. The primary analysis will be conducted according to the intention-to-treat principle using a Cox proportional hazards regression model. End of follow-up is expected in December 2024., Conclusion: The combined BETAMI-DANBLOCK trial will have the potential to affect current clinical practice for beta-blocker therapy in patients with normal or mildly reduced LVEF after MI., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The use of antibiotics is a key driver of antimicrobial resistance and is considered a major threat to global health. In Denmark, approximately 75% of antibiotic prescriptions are issued in general practice, with acute lower respiratory tract infections (LRTIs) being one of the most common indications. Adults who present to general practice with symptoms of acute LRTI often suffer from self-limiting viral infections. However, some patients have bacterial community-acquired pneumonia (CAP), a potential life-threatening infection, that requires immediate antibiotic treatment. Importantly, no single symptom or specific point-of-care test can be used to discriminate the various diagnoses, and diagnostic uncertainty often leads to (over)use of antibiotics. At present, general practitioners (GPs) lack tools to better identify those patients who will benefit from antibiotic treatment. The primary aim of the PLUS-FLUS trial is to determine whether adults who present with symptoms of an acute LRTI in general practice and who have FLUS performed in addition to usual care are treated less frequently with antibiotics than those who only receive usual care., Methods: Adults (≥ 18 years) presenting to general practice with acute cough (< 21 days) and at least one other symptom of acute LRTI, where the GP suspects a bacterial CAP, will be invited to participate in this pragmatic randomized controlled trial. All participants will receive usual care. Subsequently, participants will be randomized to either the control group (usual care) or to an additional focused lung ultrasonography performed by the GP (+ FLUS). The primary outcome is the proportion of participants with antibiotics prescribed at the index consultation (day 0). Secondary outcomes include comparisons of the clinical course for participants in groups., Discussion: We will examine whether adults who present with symptoms of acute LRTI in general practice, who have FLUS performed in addition to usual care, have antibiotics prescribed less frequently than those given usual care alone. It is highly important that a possible reduction in antibiotic prescriptions does not compromise patients' recovery or clinical course, which we will assess closely., Trial Registration: ClinicalTrials.gov NCT06210282. Registered on January 17, 2024., (© 2024. The Author(s).)

Introduction: Inflammation is a hallmark of cancer and is involved in tumour growth and dissemination. However, the hallmarks of cancer are also the hallmarks of wound healing, and modulating the wound inflammatory response and immune contexture in relation to cancer surgery may represent effective targets of therapies.Repurposing anti-inflammatory drugs in a cancer setting has gained increasing interest in recent years. Interestingly, the known and thoroughly tested antifibrinolytic drug tranexamic acid reduces the risk of bleeding, but it is also suggested to play important roles in anti-inflammatory pathways, improving wound healing and affecting anti-carcinogenic mechanisms.As a novel approach, we will conduct a randomised controlled trial using perioperative treatment with tranexamic acid, aiming to prevent early relapses by >10% for patients with melanoma., Methods and Analysis: Design: investigator-initiated parallel, two-arm, randomised, blinded, Danish multicentre superiority trial., Patients: ≥T2 b melanoma and eligible for sentinel lymph node biopsy (n=1204).Project drug: tranexamic acid or placebo., Treatment: before surgery (intravenous 15 mg/kg) and daily (peroral 1000 mg x 3) through postoperative day 4., Primary Outcome: relapse within 2 years after surgery.Primary analysis: risk difference between the treatment arms (χ 2 test)., Secondary Outcomes: postoperative complications, adverse events and survival.Inclusion period: summer 2023 to summer 2026., Ethics and Dissemination: The trial will be initiated during the summer of 2023 and is approved by the National Committee on Health Research Ethics, the Danish Medicine Agency, and registered under the Data Protection Act. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Patients included in the study will adhere to normal Danish treatment protocols and standards of care, and we expect only mild and temporary side effects. Positive and negative results will be published in peer-reviewed journals, with authorships adhering to the Vancouver rules., Trial Registration Number: NCT05899465; ClinicalTrials.gov Identifier., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)