264 results on '"Bispebjerg '
Search Results
2. Oxygen Targets in Acute Heart Failure With Pulmonary Congestion (REDOX-AHF)
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Bispebjerg Hospital and Johannes Grand, Principal Investigator
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- 2025
3. Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD (ExPuRe)
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University Hospital Bispebjerg and Frederiksberg, Copenhagen University Hospital, Herlev-Gentofte, Copenhagen University Hospital, Amager-Hvidovre, Denmark, Nordsjaellands Hospital, and Henrik Hansen, Senior Researcher, PhD
- Published
- 2025
4. Rethinking Pulmonary Rehabilitation - a Three-arm Randomised Multicentre Trial (REPORT)
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University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Herlev and Gentofte Hospital, and Henrik Hansen, Principal Investigator
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- 2025
5. Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
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Bispebjerg Hospital, University of Copenhagen, and Center for General Practice at Aalborg University
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- 2025
6. Selenium Supplementation Versus Placebo in Patients with Graves' Hyperthyroidism (GRASS)
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Odense University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Herlev Hospital, Bispebjerg Hospital, Hvidovre University Hospital, Hillerod Hospital, Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, Danish Council for Independent Research, The Danish Council for Strategic Research, and Per Cramon, Principal Investigator
- Published
- 2025
7. Early Vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery (EATERS)
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Copenhagen University Hospital, Hvidovre, Nordsjaellands Hospital, Slagelse Sygehus, Aarhus University Hospital, Gødstrup Hospital, Aalborg University Hospital, Bispebjerg Hospital, Zealand University Hospital, Holbaek Sygehus, and Jannick Brander Hansen, Principal Investigator
- Published
- 2025
8. Physical Activity and Sedentary Behaviour in Patients With Inflammatory Bowel Disease (PASIBO)
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Bispebjerg Hospital and Tanja Thomsen, Postdoc
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- 2025
9. The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure
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Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Rigshospitalet, Denmark, and Jacob Moller, Professor, MD, PhD
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- 2025
10. The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure
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Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Rigshospitalet, Denmark, and Jacob Moller, Professor, MD, PhD
- Published
- 2025
11. Psilocybin Therapy for Psychological Distress in Palliative Patients (PsyPal)
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HumanKindLabs, University of Copenhagen, CTC Clinical Trial Consultants AB, OPEN Foundation, IESE Business School, Uppsala University, The Champalimaud Centre, Lisbon, Portugal, Stockholm University, University of Groningen, The Netherlands, National Institute of Mental Health (NIMH), Prague, Czech Republic, European Association for Palliative Care (EAPC), Madopa, Bispebjerg Hospital, Copenhagen, Denmark, European Association of Neurological Associations (EFNA), 29k International AB, Lung Alliance Netherlands, European Psychiatric Association, and Norrsken Mind
- Published
- 2025
12. Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture (SENSE)
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Aalborg University Hospital, Regionshospital Nordjylland, Aarhus University Hospital, Odense University Hospital, Slagelse Hospital, Bispebjerg Hospital, Regionshospitalet Viborg, Skive, Randers Regional Hospital, Regionshospitalet Horsens, Hospital of Southern Jutland, Esbjerg Hospital - University Hospital of Southern Denmark, Hvidovre University Hospital, Herlev Hospital, Hillerod Hospital, Denmark, Holbaek Sygehus, Zealand University Hospital, Sygehus Lillebaelt, Nykøbing Falster County Hospital, Regional Hospital West Jutland, and Bornholm Hospital
- Published
- 2025
13. Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System (WARD-SX-RCT-II)
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Bispebjerg Hospital, Hvidovre University Hospital, and Jesper Mølgaard, MD, PhD, Principal investigator
- Published
- 2025
14. Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy (WEAN-HF)
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Nordsjaellands Hospital, University Hospital Bispebjerg and Frederiksberg, Zealand University Hospital, Copenhagen University Hospital, Hvidovre, and Emil Wolsk, Head of Heart Failure, Principal investigator
- Published
- 2025
15. Skeletal Maturation and Endocrine Health in Young Adults (EPIPEAK)
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Aarhus University Hospital, Aalborg University Hospital, University of Southern Denmark, University Hospital Bispebjerg and Frederiksberg, Zealand University Hospital, Odense University Hospital, Rigshospitalet, Denmark, Statens Serum Institut, and Hvidovre University Hospital
- Published
- 2025
16. Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes (Steno1)
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Aarhus University Hospital, Steno Diabetes Center Nordjylland, Steno Diabetes Center Odense, Slagelse Hospital, Nykøbing Falster County Hospital, Zealand University Hospital, Hillerod Hospital, Denmark, Rigshospitalet, Denmark, Hvidovre University Hospital, Regionshospitalet Viborg, Skive, Randers Regional Hospital, Herning Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Regionshospitalet Silkeborg, Bispebjerg Hospital, and Regionshospitalet Horsens
- Published
- 2025
17. Greater Cognitive-Motor Interference Among Patients After Anterior Cruciate Ligament Reconstruction Compared With Controls.
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Strong A, Boraxbekk CJ, and Markström JL
- Abstract
Background: Chaotic sporting environments require the performance of concurrent cognitive and motor tasks. A reduced capacity for either or both of the tasks when performed concurrently is known as cognitive-motor interference (CMi) and is believed to increase the injury risk. A greater susceptibility to CMi after a rupture of the anterior cruciate ligament (ACL) has been suggested to be caused by central nervous system adaptations, thus possibly contributing to high secondary ACL injury rates., Purpose: To investigate whether patients after ACL reconstruction (ACLR) demonstrate greater CMi than noninjured controls when adding secondary cognitive tasks to the drop vertical jump (DVJ) and explore the potential influence of sex on CMi., Study Design: Controlled laboratory study., Methods: A total of 40 (50% male) sports-active patients who had undergone ACLR (mean, 24.9 ± 16.1 months after surgery) and 40 (50% male) sports-active noninjured controls performed DVJs with and without secondary cognitive tasks targeting short-term memory, attention, fast decision-making, and inhibitory control. Outcomes included a letter position recall task and 3 motor variables: (1) correct action (landing or landing with a subsequent vertical jump), (2) relative jump height (relative between DVJs), and (3) relative peak vertical ground-reaction force (relative between DVJs). Participants also completed isolated cognitive tests (CANTAB) included as covariates in multivariate analysis., Results: Multivariate analysis of variance revealed that the ACLR group had greater CMi than the control group ( P < .001), as manifested by more incorrect answers for the cognitive letter recall task (mean difference [MD], -13.3% [95% CI, -20.8% to -5.9%]; P < .001), more incorrect motor actions (MD, -7.5% [95% CI, -12.4% to -2.6%]; P = .003), and a reduced relative jump height (MD, -4.5% [95% CI, -7.9% to -1.2%]; P = .010). No difference in relative peak vertical ground-reaction force was found (MD, 2.8% [95% CI, -7.7% to 13.3%]; P = .59). Isolated cognitive outcomes did not affect these results, and there were no significant differences between male and female participants., Conclusion: Patients after ACLR showed greater CMi than noninjured controls, which was unrelated to isolated cognitive outcomes, thus indicating aberrant neurocognitive function., Clinical Relevance: Clinicians should consider cognitive and dual-task training and screening during ACL rehabilitation to better prepare patients for chaotic and uncontrolled sporting environments in which dual tasking is prevalent. Such interventions may help to reduce the risk of secondary ACL injuries., Competing Interests: The authors have declared that there are no conflicts of interest in the authorship and publication of this contribution. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.
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- 2025
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18. Sex Differences in the Participation in Secondary Prevention Stroke Studies.
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Moelgg K, Karisik A, Buergi L, Carcel C, Christensen H, Silva GS, Dejakum B, Komarek S, Domig L, Rinner H, Granna J, Willeit K, Willeit J, Pechlaner R, Boehme C, Mayer-Suess L, Toell T, Kiechl S, and Knoflach M
- Subjects
- Humans, Female, Aged, Male, Middle Aged, Aged, 80 and over, Austria epidemiology, Sex Factors, Patient Selection, Risk Factors, Sex Distribution, Research Subjects, Stroke prevention & control, Stroke epidemiology, Secondary Prevention methods, Ischemic Stroke prevention & control, Ischemic Stroke epidemiology, Ischemic Stroke mortality
- Abstract
Background: Women show higher age-standardized mortality rates for ischemic stroke. Nevertheless, women are underrepresented in secondary stroke prevention trials. Our analysis investigated contributors to reduced study participation among women in a comprehensive stroke center in Austria., Methods: The population-based Tyrolean Stroke Pathway database was used to describe sex distribution in patients with ischemic stroke in the region and at the study site. Screening logs from 3 secondary stroke prevention studies at the Medical University of Innsbruck were analyzed containing information on age, self-reported sex, and causes for nonparticipation. Binary and multinomial logistic regression were performed to calculate odds ratios (ORs) and 95% CIs., Results: Women constituted 45.6% of all patients with ischemic stroke in the federal region and 43.1% at the study site. Of 4511 patients screened, 68.1% were included in at least 1 stroke trial, 39.5% of whom were female. Screened women were older than screened men, median age (interquartile range) of 76 (66-83) versus 72 (61-80) years. Women showed higher odds than men of receiving comfort terminal care (OR, 1.53 [95% CI, 1.14-2.05]), being unable to provide informed consent (OR, 1.95 [95% CI, 1.54-2.47]) due to aphasia (OR, 2.79 [95% CI, 1.91-4.06]) or cognitive impairment (OR, 1.96 [95% CI, 1.30-2.95]), and being ineligible for study participation based on inclusion and exclusion criteria (OR, 1.28 [95% CI, 1.04-1.58]). When adjusting for age, women were not more likely than men to refuse study participation (OR, 1.09 [95% CI, 0.84-1.43])., Conclusions: Female sex was associated with higher odds of exclusion from studies due to comorbidities and more severe neurological deficits. However, in our analysis women were not more likely to refuse study participation.
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- 2025
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19. Food outlet availability differs according to area socioeconomic status in Denmark.
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Bernsdorf KA, Bøggild H, Aadahl M, and Toft U
- Subjects
- Humans, Denmark, Female, Male, Adult, Middle Aged, Social Class, Residence Characteristics statistics & numerical data, Supermarkets, Young Adult, Aged, Adolescent, Restaurants statistics & numerical data, Fast Foods statistics & numerical data, Fast Foods supply & distribution, Food Supply statistics & numerical data
- Abstract
Background: Disparities in access to specific foods may contribute to inequalities in diet-related diseases seen at a global and National level., Methods: Based on aggregated population data on income, education, and employment, area-level socioeconomic differences in food outlet availability were analyzed for 53,368 study participants residing across parishes in the Capital Region of Denmark. Validated data on fast-food outlets, convenience stores, supermarkets, and restaurants were used. Information on individual characteristics, home address and corresponding parishes were linked to the participants through the Danish Civil Registration System. Three multilevel hurdle models were applied for each food outlet type to analyze food outlet density (count/km²) within an 800-meter network buffer around participants' homes across four levels of parish socioeconomic status (SES). Model 1 provided a basic examination of the association between density and area SES. Model 2 adjusted for individual characteristics while Model 3 further included urbanity at the area level. The structure of the chosen hurdle models included was Part (1) a logistic multilevel regression modelling the probability of food outlet presence by using the entire dataset and, Part (2) a standard linear multilevel regression modelling the 10 base logarithmic transformation of only positive food outlet densities with a lognormal distribution., Results: No statistically significant spatial patterning of food outlets across area SES was found in Model 1 and 2, however positive and strong significant odds were seen in part 1 of Model 3 for supermarkets, convenience stores and fast-food outlets. Thus, residents in more disadvantaged SES areas had higher odds of having a supermarket, convenience store, or fast-food outlet near their homes compared to those living in the most advantaged areas. No differences were seen in the density across area SES., Conclusion: Area SES influenced the presence of supermarkets, convenience stores, and fast-food outlets, but not the density of these establishments., Competing Interests: Declarations. Ethics approval and consent to participate: This study was in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. It has been approved by the Center for Clinical Research and Prevention in the Capital Region of Denmark. The health survey has been approved by the Department of Research Ethics the Capital Region of Denmark and documented written informed consent was obtained from all participants prior to participation. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)
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- 2025
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20. Real-world Drug Survival of Biosimilar SB5 vs GP2017 Following a Mandatory Non-medical Switch from Adalimumab Originator for Psoriasis: A Nationwide Cohort Study.
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Sieborg J, Maul JT, Wu JJ, Loft NN, Skov L, Bryld LE, Rasmussen MK, Dam TN, Bertelsen T, Ajgeiy KK, Thomsen SF, Thyssen JP, Egeberg A, and Thein D
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- Humans, Male, Female, Middle Aged, Adult, Treatment Outcome, Time Factors, Databases, Factual, Dermatologic Agents therapeutic use, Dermatologic Agents adverse effects, Retrospective Studies, Psoriasis drug therapy, Biosimilar Pharmaceuticals therapeutic use, Biosimilar Pharmaceuticals adverse effects, Adalimumab therapeutic use, Adalimumab adverse effects, Drug Substitution
- Abstract
Biosimilars are designed to be analogous to the biologic originators. However, comprehensive comparisons between biosimilars are limited and lacking for patients with psoriasis. This study's objective was to compare 1-year drug survival of the 2 adalimumab biosimilars, GP2017 with SB5, following a non-medical mandatory switch from the adalimumab originator. Based on the national clinical database DERMBIO, this nationwide cohort study included all patients with psoriasis treated with the adalimumab originator who underwent a non-medical mandatory switch to GP2017 or SB5. The study included 525 patients switching from adalimumab originator to 1 of 2 biosimilars: GP2017 (n=267 patients) or SB5 (n=258 patients). When comparing the drug survival of the biosimilars, the hazard ratio was 1.11 (95% confidence interval, 0.58-2.12) for SB5 with GP2017 as reference. In the sensitivity analysis investigating changes in PASI, no differences were found when comparing the GP2017 group and the SB5 group at 120 days of follow-up (1.9% vs 1.6% improved, 1.9% vs 2.0% worsened, and 43.1% vs 40.9% remained unchanged). When comparing GP2017 and SB5, no discernible differences were found in drug survival or effectiveness based on PASI. Determining drug survival and effectiveness could benefit patients and clinicians in treatment decisions.
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- 2025
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21. Long-term Effectiveness and Safety of Mesenchymal Stromal Cell Therapy for Radiation-Induced Hyposalivation in Head and Neck Cancer Survivors: A Randomized Phase II Trial.
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Fenger Carlander AL, Jakobsen KK, Todsen T, Paaske N, Østergaard Madsen AK, Bendtsen SK, Kastrup J, Friborg J, Duch Lynggaard C, Hauge AW, Christensen R, Grønhøj C, and von Buchwald C
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- Humans, Male, Female, Middle Aged, Aged, Cancer Survivors, Treatment Outcome, Adult, Radiation Injuries therapy, Radiation Injuries etiology, Follow-Up Studies, Mesenchymal Stem Cells, Saliva metabolism, Xerostomia etiology, Xerostomia therapy, Head and Neck Neoplasms therapy, Head and Neck Neoplasms radiotherapy, Mesenchymal Stem Cell Transplantation methods, Mesenchymal Stem Cell Transplantation adverse effects, Quality of Life
- Abstract
Purpose: The long-term effect of adipose-derived mesenchymal stromal cells (ASC) on restoring radiation-induced salivary gland hypofunction in patients with previous head and neck cancer has not been validated in larger settings., Patients and Methods: The study was a 12-month follow-up of a randomized trial, including patients with hyposalivation. Patients were randomized to receive allogeneic ASC or placebo in the submandibular glands. The primary endpoint was unstimulated whole saliva (UWS) followed by stimulated whole saliva, patient-reported outcomes (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Head and Neck Module, and the xerostomia questionnaire), and safety., Results: Of the 120 enrolled patients, 117 (97.5%) were assessed at 12 months. Treatment with ASC did not increase UWS compared with placebo: Increase in UWS was 0.02 mL/minute [95% confidence interval (CI), 0.01-0.04] in the ASC group and 0.02 mL/minute (95% CI, 0-0.03) in the placebo group (P = 0.56). ASC reduced the symptom burden for dry mouth with -10.07 units (95% CI, -13.39 to -6.75) compared with -4.15 units (95% CI, -7.46 to -0.84) in the placebo group (P = 0.01). Compared with placebo, ASC did not improve sticky saliva (-9.27 vs. -4.55 units; P = 0.13), swallowing (-4.50 vs. 3.49 units; P = 0.5), or xerostomia (-3.12 vs. -2.74 units; P = 0.82). Treatment was safe and associated with a transient immune response., Conclusions: Intraglandular ACS therapy in the submandibular glands significantly relieved subjective dry mouth symptoms. Both ASC and placebo increased UWS, but ASC did not prove superior to placebo in restoring salivary gland function, based on the salivary flow rate., (©2025 American Association for Cancer Research.)
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- 2025
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22. Longitudinal study of family formation in 892 women and 193 men 8 years after visiting the Fertility Assessment and (FAC) clinic.
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Sylvest R, Vittrup I, Vassard D, Saupstad M, Ziebe S, Larsen E, Hvidman HW, Birch Petersen K, Nielsen HS, Schmidt L, and Pinborg A
- Abstract
Introduction: Globally, in high-income countries, couples have been delaying family building. However, postponed childbearing implies a higher risk of declining fertility, not achieving desired family size and ultimately involuntary childlessness. The Fertility Assessment and Counseling (FAC) clinic was established to provide information about individuals' current fertility status, aiming to prevent infertility and support the realization of desired family sizes. The aim is to explore the reproductive outcomes and health behaviors 8 years after attending fertility assessment and counseling in the FAC clinic., Material and Methods: Cohort study including women and men who attended the FAC clinic in Copenhagen, Denmark, from 2011 to 2017. From June 2011 until July 2017 2635 women and 1073 men attended fertility counseling at the FAC clinic. Eight years later, an electronic questionnaire was distributed to collect information on subsequent pregnancies and deliveries., Results: The follow-up questionnaire had a response rate of 34% (n = 892) for women and 18% for men (n = 193). The mean age for the subgroup of 892 women who responded at 8 years follow-up was 32.6 (±SD 4.4) years at baseline which was equal to the total cohort of 2635 women at baseline (32.7 (±SD 4.7) years). Most of the women (75%) and men (96%) were in a heterosexual relationship at follow-up. A total of 85% of the 892 women had conceived after the baseline FAC visit. Among those having conceived, the mean number of pregnancies was 2.10 per woman (±SD 1.1). In total, 703 (79%) of the 892 women had delivered at least one child. Among women having delivered, the average number of children was 2.0 (±SD 0.6). Among the men, 91% had conceived with their partner. Women and men were smoking less and drinking less alcohol at the follow-up compared to the baseline visit., Conclusions: This follow-up study emphasizes the importance of fertility assessment and counseling for women and couples during reproductive age, a critical period when decisions about family building are made., (© 2025 The Author(s). Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)
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- 2025
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23. Apolipoprotein A-IV is induced by high-fat diets and mediates positive effects on glucose and lipid metabolism.
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Lundsgaard AM, Del Giudice R, Kanta JM, Larance M, Armour SL, London A, Richter MM, Andersen NR, Nicolaisen TS, Carl CS, Sjøberg KA, Bojsen-Møller KN, Knudsen JG, Lagerstedt JO, Fritzen AM, and Kiens B
- Abstract
Background: Low-carbohydrate, high-fat diets under eucaloric conditions are associated with several health-beneficial metabolic effects in humans, particularly in the liver. We recently observed that apolipoprotein A-IV (apoA-IV), a highly abundant apolipoprotein, was among the most upregulated proteins in circulation after six weeks of consuming a high-fat diet in humans. However, the impact of dietary changes in regulating apoA-IV, and the potential effects of apoA-IV on regulation of glucose- and lipid metabolism remain to be fully established., Results: We demonstrate that in healthy human individuals high-fat intake increased fasting plasma apoA-IV concentrations by up to 54%, while high-carbohydrate intake suppressed plasma apoA-IV concentrations. In mice, administration of apoA-IV acutely lowered blood glucose levels both in lean and obese mice. Interestingly, this was related to a dual mechanism, involving both inhibition of hepatic glucose production and increased glucose uptake into white and brown adipose tissues. In addition to an effect on hepatic glucose production, the apoA-IV-induced liver proteome revealed increased capacity for lipoprotein clearance. The effects of apoA-IV in the liver and adipose tissues were concomitant with increased whole-body fatty acid oxidation. Upon glucose stimulation, an improvement in glucose tolerance by apoA-IV administration was related to potentiation of glucose-induced insulin secretion, while apoA-IV inhibited glucagon secretion ex vivo in islets., Conclusion: We find that apoA-IV is potently increased by intake of fat in humans, and that several beneficial metabolic effects, previously associated with high fat intake in humans, are mimicked by administration of apoA-IV protein to mice., (Copyright © 2025 The Author(s). Published by Elsevier GmbH.. All rights reserved.)
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- 2025
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24. Addressing the obesity epidemic through safe and effective endoscopic bariatric therapies.
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Adamsen S
- Abstract
Competing Interests: Disclosure S. Adamsen is a medical advisor to Ambu A/S.
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- 2025
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25. Enabling six- to ten-year-old children to self-report their wellbeing and quality of life: development and psychometric investigation of an age-adapted and video-assisted version of the KIDSCREEN-27.
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Kurtzhals M, Melby PS, Elsborg P, Bentsen P, Eckert C, Larsen MN, and Nielsen G
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Purpose: Identifying the underlying factors that contribute to poor wellbeing and developing strategies for early intervention are essential for promoting overall wellbeing. Many important aspects of wellbeing and quality of life are subjective experiences and therefore require self-report. The KIDSCREEN-27 questionnaire is widely used for this purpose. However, the self-report versions have mainly been validated for children aged 12 to 18 years. This study aims to develop a video-assisted format the KIDSCREEN-27 that enable self-report of wellbeing by children aged six to ten years and to test its psychometric properties., Methods: The Danish-translated version KIDSCREEN-27 was slightly adapted in wording and items (N=12) and a video-format, including audio, illustrations, and smiley-supported scales, was developed, and tested. Next, a psychometric investigation of this version (KIDSCREEN-VIDEO) was conducted on 788 Danish children aged six to ten years (49.8% girls)., Results: Confirmatory factor analysis showed an acceptable to good model-fit: X
2 = 727.053; df = 242; P <0.001; root mean squared error of approximation=0.05; the comparative fit index = 0.98; and the Tucker-Lewis index = 0.98, and factor loadings ranged from 0.40 to 0.88. Cronbach's alpha values ranged from 0.65 to 0.89, suggesting acceptable to good internal reliability of the scales. Linear mixed model analyses, and Pearson's r correlation coefficients showed positive associations with the global and physical self-worth scales, indicating convergent validity. The test for measurement invariance indicated the model fit for the five-factor model was consistent across sex and age groups., Conclusion: Based on our results, the KIDSCREEN-VIDEO provides a promising self-reported measure for wellbeing among children aged six to ten., Competing Interests: Declarations. Ethics approval and consent to participate: Please, see the section on “Ethical considerations” for this information. Competing interests: The authors declare that they have no competing financial interests or personal relationships that could have influenced the work reported in this paper., (© 2025. The Author(s).)- Published
- 2025
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26. Intraoperative opioid administrations, rescue doses in the post-anaesthesia care unit and clinician-perceived factors for dose adjustments in adults: A Danish nationwide survey.
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Tran TXM, Wetterslev M, Nørskov AK, Meyhoff CS, Olsen MH, Itenov TS, Mathiesen O, and Karlsen APH
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- Humans, Denmark, Cross-Sectional Studies, Adult, Male, Female, Middle Aged, Surveys and Questionnaires, Intraoperative Care methods, Aged, Pain Management methods, Fentanyl administration & dosage, Analgesics, Opioid administration & dosage, Analgesics, Opioid therapeutic use, Pain, Postoperative drug therapy
- Abstract
Background: The impact of demographic- and surgical factors on individual perioperative opioid requirements is not fully understood. Anaesthesia personnel adjust opioid administrations based on their own clinical experience, expert opinions and local guidelines. This survey aimed to assess the current practice of anaesthesia personnel regarding intraoperative opioid treatment for postoperative analgesia and rescue opioid dosing strategies in the post-anaesthesia care unit in Denmark., Methods: We conducted a cross-sectional online survey with 37 questions addressing pain management and opioid-dosing strategies. Local site investigators from 46 of 47 public Danish anaesthesia departments distributed the survey. Data collection took place from 5 February to 30 April 2024., Results: Of the 4187 survey participants, 2025 (48%) answered. Intra- and postoperative opioid doses were adjusted based on chronic pain, age, preoperative opioid use, body weight and type of surgery. Between 84% and 89% of respondents adhered to and had perioperative pain management guidelines available. Respondents preferred intraoperative fentanyl (44%) and morphine (36%) to prevent postoperative pain. Median intraoperative intravenous morphine equivalents ranged from 0.12 to 0.38 mg/kg in clinical scenarios. In these cases, the following variables were assembled in different combinations to assess their impact on dosing: age (30 vs. 65 years), sex (female vs. male), ASA score (1 vs. 3) and type of surgery (anterior cruciate ligament vs. laparoscopic cholecystectomy surgery). Respondents preferred intravenous morphine and fentanyl for moderate and severe postoperative pain, respectively. Median postoperative rescue doses were 0.06-0.12 mg/kg in clinical scenarios based on shifting combinations of the variables: age (30 vs. 65 years), ASA score (1 vs. 3) and degree of expected pain (moderate vs. severe)., Conclusion: Respondents preferred fentanyl and morphine for postoperative pain control with considerable variation in choice of opioid and morphine equivalent dose. Respondents expressed that guidelines were highly available and strongly adhered to. Opioid dosing was predominantly guided by chronic pain, age, preoperative opioid use, body weight and type of surgery., (© 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)
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- 2025
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27. Predictive Biomarkers and Personalized Therapy: Use of Pharmacogenetic Testing in a Scandinavian Perspective.
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Westergaard N, Lund TM, and Vermehren C
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- Humans, Scandinavian and Nordic Countries, Cytochrome P-450 Enzyme System genetics, Cytochrome P-450 Enzyme System metabolism, Biomarkers metabolism, Pharmacogenetics, Clinical Decision-Making, Drug-Related Side Effects and Adverse Reactions prevention & control, Pharmacogenomic Variants, Precision Medicine methods, Pharmacogenomic Testing methods, Liver-Specific Organic Anion Transporter 1 genetics, Liver-Specific Organic Anion Transporter 1 metabolism
- Abstract
Precision medicine has significantly advanced through the development of predictive biomarkers based on pharmacogenetic (PGx) testing. These tests identify interactions between drugs and genetic variants that influence patient responses to treatments. Understanding genetic variations in drug-metabolizing enzymes, receptors and transporters and their impact on pharmacokinetics and pharmacodynamics allows for the prediction of drug effects and side effects, enabling tailored treatments for different patient groups. This review focuses on drugs metabolized by cytochrome P450 (CYP450) enzymes, for example, citalopram and clopidogrel or transported by the solute carrier organic anion transporter family member 1B1 (SLCO1B1), for example, atorvastatin and simvastatin, with PGx dosing guidelines, in the context of consumption in Scandinavian countries. A major barrier to the widespread adoption of PGx tests in clinical practice has been healthcare professionals' uncertainty about their efficacy, complexity in result interpretation and questions regarding the evidence base. However, recent studies have demonstrated PGx testing has the potential to improve treatment outcomes, reduce adverse drug reactions and achieve cost savings. These findings underscore the potential of PGx testing as a valuable tool in clinical decision making, promoting its use in a pre-emptive manner to enhance patient care., (© 2025 The Author(s). Basic & Clinical Pharmacology & Toxicology published by John Wiley & Sons Ltd on behalf of Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).)
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- 2025
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28. Tactical Emergency Medical Services in Copenhagen, Denmark: A mixed methods design study introducing a new concept.
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Glahn JEE, Heltø KMM, Alstrøm H, Petersen MC, and Gärtner R
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- Denmark, Humans, Terrorism, Male, Police, Female, Adult, Emergency Medical Services
- Abstract
Aims and Objectives: The purpose of this study was to introduce the concept of Tactical Emergency Medical Services (TEMS) in Denmark and to explore the TEMS providers' and the Danish Police Forces' confidence in the TEMS concept in case of a terrorist attack within the Capital Region of Denmark., Background: Terrorist attacks pose a major challenge to prehospital emergency medical services when it comes to reaching trapped victims. The threat to healthcare professionals limits access and creates a so-called therapeutic vacuum, leading to delayed treatment and evacuation of victims and ultimately increases mortality., Methods: This study used a mixed methods triangulation approach, integrating qualitative data from an interview study and quantitative data from a register study. The interview study consisted of 18 semistructured interviews conducted across three interview groups (Copenhagen TEMS physicians/paramedics, senior on-site commanders, and tactical and medical officers from the Copenhagen Police Department) with six participants in each group. Data from the interview study were analyzed using thematic framework analysis. The register study used data from the TEMS database, including 61 assignments from 2019 to 2020, that were analyzed using descriptive statistics., Results: The interview study found three core themes in each interview group. The main findings included insights on the advantages of having healthcare professionals in the warm zone, the prerequisites for the concept's success, TEMS's cooperation with the Danish Police Force, and challenges concerning healthcare providers inside tactical zones. The participants expected TEMS' presence inside the warm zone could improve triage and medical treatment, free police resources, increase police safety, optimize preparedness of the health sector, and significantly reduce the therapeutic vacuum. Data from the register study demonstrated that TEMS have had prior assignments in the warm and hot zones., Conclusion: All participating groups have high confidence in TEMS to close the gap of the therapeutic vacuum and deliver advanced physician and paramedic-based tactical medicine inside the warm zone in case of a terrorist attack in Copenhagen, Denmark., Editorial Comment: This study includes both provider interviews and registry data to support insight into processes of Tactical Emergency Medicine. The authors discuss possible advantages of having emergency medical personnel in the major incident area early to support a coordinated response., (© 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)
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- 2025
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29. The Physical Activity Health Paradox in Type 2 Diabetes.
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Stage A, Wibaek R, Rønn PF, Bjørnsbo KS, Brøns C, Allesøe K, Holtermann A, Vaag AA, Linneberg A, and Aadahl M
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- Humans, Middle Aged, Male, Female, Denmark epidemiology, Adult, Exercise, Risk Factors, Cohort Studies, Age Factors, Incidence, Sedentary Behavior, Poisson Distribution, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 2 prevention & control, Leisure Activities
- Abstract
Introduction: The physical activity health paradox refers to the contrasting associations of leisure-time physical activity and occupational physical activity with cardiovascular disease, but whether this applies to Type 2 diabetes risk is unknown. This study aimed to investigate the physical activity health paradox and age-specific Type 2 diabetes., Methods: Working adults (N=5,866) in Denmark aged 30-60 years enrolled in the Inter99 cohort at baseline in 1999 were followed in a Diabetes Register. Incidence rates of Type 2 diabetes as a function of age, sex, and separate and combined levels of self-reported occupational physical activity and leisure-time physical activity were modeled using Poisson regression, adjusting for relevant covariates in separate analyses (2024)., Results: Moderate/vigorous leisure-time physical activity was associated with lower risk of Type 2 diabetes than light (rate ratio=0.63, 95% CI=0.46, 0.85). Strenuous occupational physical activity was associated with a slightly higher risk of Type 2 diabetes than moderate occupational physical activity, but the association diminished adjusted for covariates (rate ratio=1.12, 95% CI=0.79, 1.58). Sedentary leisure-time physical activity combined with any level of occupational physical activity was associated with higher risk of Type 2 diabetes than light leisure-time physical activity/moderate occupational physical activity combined (e.g., sedentary leisure-time physical activity and demanding occupational physical activity) (rate ratio=1.68, 95% CI=1.14, 2.48). Moderate/vigorous leisure-time physical activity combined with any level of occupational physical activity was associated with lower risk of Type 2 diabetes (e.g., moderate/vigorous leisure-time physical activity and moderate occupational physical activity) (rate ratio=0.6, 95% CI=0.39, 0.92)., Conclusions: Leisure-time physical activity lowered the risk of Type 2 diabetes regardless of the level of occupational physical activity, whereas no similar beneficial effects were found for occupational physical activity level. The differential effects of occupational physical activity and leisure-time physical activity on Type 2 diabetes suggest that the paradox may also exist in Type 2 diabetes., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2025
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30. Therapeutic drug monitoring in acute lymphoblastic leukemia-a deep dive into pharmacokinetics, -dynamics, and -genetics of antileukemic drugs.
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Toksvang LN, Brigitha LJ, van der Sluis IM, Brivio E, Raja R, Pontoppidan P, Buhl Rasmussen AS, Andres-Jensen L, Uhlving HH, Kielsen K, Als-Nielsen B, Elitzur S, Dalhoff K, Schmiegelow K, and Rank CU
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- Humans, Precision Medicine, Adolescent, Age Factors, Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Drug Monitoring methods, Antineoplastic Agents administration & dosage, Antineoplastic Agents adverse effects, Antineoplastic Agents pharmacokinetics, Antineoplastic Agents pharmacology
- Abstract
Introduction: Therapeutic drug monitoring (TDM) is important to optimize drug exposure and minimize toxicity for the individual patient., Areas Covered: This narrative review covers the pharmacokinetics (PK), -dynamics (PD) and -genetics of classic chemotherapeutic drugs used in frontline therapy for acute lymphoblastic leukemia (ALL), including anthracyclines, asparaginase, busulfan, cyclophosphamide, cytarabine, glucocorticoids, methotrexate, nelarabine, thiopurines, tyrosine kinase inhibitors, and vincristine. Furthermore, novel immunotherapies including blinatumomab, inotuzumab ozogamicin, and chimeric antigen receptor T-cells that are rapidly moving into frontline therapy are addressed. This review focuses on TDM already used in clinical practice as well as the unused potential and feasibility of TDM. Finally, important factors affecting PK/PD such as obesity and transition to adolescence and young adulthood are discussed., Expert Opinion: Investigation of TDM as standard of care for antileukemic agents is highly warranted to personalize curative yet toxic anticancer regimens within frontline ALL treatment. Some of the drugs have been used in ALL treatment regimens for decades, but a wide range of new compounds are being introduced, some like blinatumomab reaching standard-of-care designation. Not least, optimized drug efficacy and reduction of the risk of serious toxicities may render TDM implementation cost-effective.
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- 2025
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31. Trends in utilization of tramadol and other opioids in Denmark 2017-2023: A nationwide drug utilization study.
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Rasmussen L, Ernst MT, Forberg S, Pottegård A, Søndergaard J, and Sørensen AMS
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- Humans, Denmark, Male, Female, Adult, Middle Aged, Aged, Young Adult, Adolescent, Drug Prescriptions statistics & numerical data, Oxycodone therapeutic use, Oxycodone administration & dosage, Pain drug therapy, Morphine supply & distribution, Morphine therapeutic use, Child, Pain Management trends, Pain Management statistics & numerical data, Pain Management methods, Infant, Analgesics, Opioid therapeutic use, Tramadol therapeutic use, Drug Utilization trends, Drug Utilization statistics & numerical data, Practice Patterns, Physicians' trends, Practice Patterns, Physicians' statistics & numerical data, Registries statistics & numerical data
- Abstract
The use of tramadol and other opioids for pain management has been accompanied by a multitude of challenges and concerns worldwide. The use of tramadol saw a decline in Denmark during 2017-2019 accompanied by a slight increase in the use of morphine and oxycodone. Using the Danish National Prescription Registry and utilizing data until and including 2023, we aimed to provide updated data on the utilization patterns of tramadol and other opioids in Denmark. We found a 35% decline in the use of tramadol from 2017 to 2023 most likely due to media attention, regulatory actions, health campaigns and targeted education of physicians and patients by the Danish health authorities. This decline was accompanied by an increase in the number of new (+90%) and current users of morphine (+57%), which surpassed those of tramadol, oxycodone and other opioids in 2023., (© 2025 British Pharmacological Society.)
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- 2025
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32. No association between acne treatment with retinoids and suicide attempts in adolescents: A case-control study.
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Heerfordt IM, Tulstrup M, and Horwitz H
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Competing Interests: Conflicts of interest None disclosed.
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- 2025
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33. Gut decontamination in the poisoned patient.
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Gosselin S, Hoegberg LCG, and Hoffman RS
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- Humans, Gastric Lavage methods, Gastrointestinal Tract drug effects, Therapeutic Irrigation methods, Antidotes administration & dosage, Antidotes therapeutic use, Charcoal administration & dosage, Charcoal therapeutic use, Poisoning therapy, Decontamination methods
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Poisoning management includes gastrointestinal decontamination strategies to decrease the burden of poison entering the body and change the expected severe toxicity expected to a less toxic, more favourable outcome. Common modalities are orogastric lavage, oral-activated charcoal and whole-bowel irrigation. Endoscopic retrieval and laparotomy are rare options reserved for severe ingestions and body packers. Although supporting data are generally of low quality, gastrointestinal decontamination is likely to improve patient outcome in many situations. Unfortunately, technical limitations and contraindications can explain their infrequent use. Orogastric lavage can be useful for early lethal ingestions, albeit with significant complications such as aspiration and perforation. Activated charcoal cannot adsorb every substance. Usual dosing is 1 g/kg per dose. Whole-bowel irrigation is reserved for charged molecules or substances not adsorbed to activated charcoal but requires intact gut motility. Indications depend on several factors inherent to the ingestion (dose, time, poison) and patient's characteristics. During recent decades, studies of newer pharmaceuticals or modified-release formulations showed that significant amounts of poison, especially pharmacobezoars, persist in the gut hours postingestion, thus are amenable to gastrointestinal decontamination. Improved understanding of gut motility in volunteer studies and overdose showed clinically significant reduction in drug exposure with activated charcoal. The 1-h dogma for gastrointestinal decontamination, especially activated charcoal, is now obsolete. Clinicians must perform a risk assessment for each ingestion to determine the expected benefit at the time of decision-making, choosing the modality to achieve reduction in the toxicity burden while planning for complications or contraindications., (© 2025 British Pharmacological Society.)
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- 2025
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34. Psychosocial and mental impact of alopecia areata: Analysis of the Danish Skin Cohort.
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Clemmesen MER, Gren ST, Frøstrup AG, Thomsen SF, Egeberg A, and Thein D
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- Humans, Female, Male, Denmark, Middle Aged, Adult, Anxiety psychology, Depression psychology, Cohort Studies, Absenteeism, Social Isolation psychology, Aged, Surveys and Questionnaires, Social Stigma, Alopecia Areata psychology, Severity of Illness Index, Quality of Life
- Abstract
Importance: Alopecia areata (AA) carries a psychological burden for patients beyond hair loss. However, quality-of-life measurement tools such as EQ-5D used in clinical trials may not adequately capture the burden of AA, the perceived stigmatization or the psychosocial impact of AA., Objective: To investigate the potential association between disease severity and the degree of social isolation, perceived stigmatization, anxiety and depression, alcohol consumption and work absenteeism using multiple PRO measures in patients with AA., Design, Setting and Participants: Using the Danish Skin Cohort, the study included adult patients diagnosed with AA. The study included multiple PRO measures, including Skindex-16, EQ-5D-5L, Work Productivity and Activity Impairment (WPAI), Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and the Alopecia Areata Symptom Impact Scale (AASIS). The questionnaires were dispatched to the patients in January 2023. The severity of AA was determined based on scalp involvement using a modified Alopecia Areata Scale. Multiple multivariate linear regressions were conducted using Skindex-16, AASIS and WPAI, while multivariate logistic regressions were applied to HADS, AUDIT-C and EQ-5D-5L., Results: A total of 376 patients were included, of which 177 (47%) had severe disease, 41 (11%) had moderate disease, 94 (25%) had mild disease, and 64 (17%) were in remission. The median age of patients was 55 (IQR, 47-66 years) and most were female (70%). Skindex-16 and AASIS were the only PRO measures able to distinguish between severity. For these scores, moderate and severe diseases, female sex, and involvement of eyebrows increased the score and negatively impacted patient quality of life., Conclusion and Relevance: The results indicate the importance of using the proper tool for the intended measurement of quality of life and that factors such as the severity of AA, as well as female sex and involvement of the eyebrows, may potentially increase the psychosocial burden of AA., (© 2024 The Author(s). Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)
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- 2025
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35. Patient-reported lymphedema after sentinel lymph node mapping in women with low-grade endometrial cancer.
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Bjørnholt SM, Groenvold M, Petersen MA, Mogensen O, Bouchelouche K, Sponholtz SE, Neumann G, Bjørn SF, Hamid BH, Dahl K, and Jensen PT
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- Humans, Female, Middle Aged, Aged, Prospective Studies, Risk Factors, Neoplasm Staging, Neoplasm Grading, Lymphatic Metastasis, Sentinel Lymph Node pathology, Postoperative Complications epidemiology, Lymph Node Excision adverse effects, Adult, Endometrial Neoplasms surgery, Endometrial Neoplasms pathology, Lymphedema etiology, Quality of Life, Sentinel Lymph Node Biopsy adverse effects, Patient Reported Outcome Measures
- Abstract
Background: Sentinel lymph node mapping is a minimally invasive surgical staging procedure that allows identification of macro- and micrometastases. The implementation of sentinel lymph node mapping to women with low-grade endometrial cancer allows detection of lymph node metastases and avoids the morbidity of radical pelvic lymphadenectomy. The extent of myometrial invasion is highly predictive of lymph node metastases but is hard to determine precisely preoperatively. The exact rate of lymph node metastases in the large group of women with <50% myometrial invasion is low but unknown. The benefit of detecting metastases in this group should balance the risk of lymphedema. There is limited knowledge of early and late lymphedema and its impact on the quality of life in women with low-grade endometrial cancer following sentinel lymph node mapping., Objective: The primary objective was to investigate the risk of patient-reported lymphedema after sentinel lymph node mapping in women with low-grade endometrial cancer. In addition, we aimed to evaluate risk factors for lymphedema and the condition-specific quality of life (QoL) among women who reported lymphedema 12 months after surgery., Study Design: Women with presumed stage I low-grade endometrial cancer were included in a national prospective cohort study on sentinel lymph node mapping from March 2017 to February 2022. Women completed a package of validated patient-reported outcome measures before surgery, 3 and 12 months after surgery. The primary outcome was the leg lymphedema domain score from the European Organisation for Research and Treatment of Cancer-Endometrial Cancer Module (EORTC QLQ-EN24). The lymphedema assessment was further supplemented by 7 validated single items from the European Organisation for Research and Treatment of Cancer item library addressing lymphedema of legs, genitals, and groin. The disease-specific quality of life was assessed using the validated Lymphedema Quality of Life Tool. Scores were linearly transformed to 0 to 100. A change from baseline of 8 points in leg lymphedema sum-score was considered clinically important. Mean difference scores over time with 95% confidence interval were estimated. Multiple linear regression models evaluated baseline predictors associated with the 12 months postoperative lymphedema score, and if early lymphedema predicted lymphedema at 12 months after surgery. Lymphedema condition-specific quality of life was evaluated for women with lymphedema., Results: Seventy-nine % (486/617) completed patient-reported outcome measures at baseline and 12 months. The mean difference score of leg lymphedema from baseline to 12 months was 5.0, confidence interval [3.3, 6.8], that is, below the threshold for clinical importance. Baseline leg lymphedema score and body mass index were positively associated with the leg lymphedema score at 12 months. The leg lymphedema score at 3 months was associated with a higher 12-month score. High scores of lymphedema at 12 months were negatively associated with the women's daily activities, appearance, emotional functioning, and global quality of life and increased their subjective symptom burden., Conclusion: Women with low-grade endometrial cancer have a low risk of lymphedema after sentinel lymph node mapping. Leg swelling at baseline and body mass index predicted more lymphedema at 12 months after surgery. Early lymphedema at 3 months predicted persistent lymphedema. A high leg lymphedema score at 12 months is associated with impairment in several aspects of quality of life., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2025
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36. A Peptide Motif Covering Splice Site B in Neuroligin-1 Binds to Aβ and Acts as a Neprilysin Inhibitor.
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Dietz LT, Põld K, Györffy BA, Zharkovsky A, Sørensen JB, Pankratova S, and Dmytriyeva O
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- Animals, Humans, Amino Acid Motifs, Mice, Transgenic, Plaque, Amyloid metabolism, Plaque, Amyloid pathology, Mice, Amino Acid Sequence, Peptide Fragments metabolism, Peptide Fragments pharmacology, Alzheimer Disease metabolism, Alzheimer Disease drug therapy, Alzheimer Disease pathology, Binding Sites, Peptides pharmacology, Peptides metabolism, Peptides chemistry, Neuroligins, Amyloid beta-Peptides metabolism, Neprilysin metabolism, Neprilysin antagonists & inhibitors, Cell Adhesion Molecules, Neuronal metabolism, Protein Binding drug effects
- Abstract
The most common cause of dementia among elderly people is Alzheimer's disease (AD). The typical symptom of AD is the decline of cognitive abilities, which is caused by loss of synaptic function. Amyloid-β (Aβ) oligomers play a significant role in the development of this synaptic dysfunction. Neuroligin-(NL)1 is a postsynaptic cell-adhesion molecule located in excitatory synapses and involved in the maintenance and modulation of synaptic contacts. A recent study has found that Aβ interacts with the soluble N-terminal fragment of NL1. The present study aimed to elucidate the role of NL1 in Aβ-induced neuropathology. Employing surface plasmon resonance and competitive ELISA, we confirmed the high-affinity binding of NL1 to the Aβ peptide. We also identified a sequence motif representing the NL1-binding site for the Aβ peptide and showed that a synthetic peptide modeled after this motif, termed neurolide, binds to the Aβ peptide with high affinity, comparable to the NL1-Aβ interaction. To assess the effect of neurolide in vivo, wild-type and 5XFAD mice were subcutaneously treated with this peptide for 10 weeks. We observed an increase in Aβ plaque formation in the cortex of neurolide-treated 5XFAD mice. Furthermore, we showed that neurolide reduces the activity of neprilysin, the predominant Aβ-degrading enzyme in the brain. Accordingly, we suggest that neurolide is the NL1-binding site for Aβ peptide, and acts as an inhibitor of neprilysin activity. Based on these data, we confirm the involvement of NL1 in the development of AD and suggest a mechanism for NL1-induced Aβ plaque formation., Competing Interests: Declarations. Ethics Approval: All animal experiments were performed in accordance to European Union law with licenses from the Danish Animal Experiments Inspectorate and from the Ethical Committee of the Estonian Ministry of Agriculture. Consent to Participate: Not applicable. Consent for Publication: Not applicable. Competing Interests: The authors declare no competing interests., (© 2024. The Author(s).)
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- 2025
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37. The SAM-Krom biomonitoring study shows occupational exposure to hexavalent chromium and increased genotoxicity in Denmark.
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Saber AT, Levin M, Kines P, Aimonen K, Givelet L, Andersen C, Huusom AJ, Carøe T, Ebbehøj NE, Christensen FM, Jiang Z, Lundh T, Tinnerberg H, Albin M, Engfeldt M, Broberg K, Catalan J, Loeschner K, Fuglsang K, and Vogel U
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- Humans, Denmark, Adult, Male, Cross-Sectional Studies, Female, Middle Aged, Young Adult, Micronucleus Tests, Erythrocytes, Chromium urine, Occupational Exposure analysis, Biological Monitoring, Air Pollutants, Occupational analysis, Air Pollutants, Occupational urine
- Abstract
Background: Hexavalent chromium (Cr(VI)) is a carcinogen. Exposure to Cr(VI) may occur in different industrial processes such as chrome plating and stainless steel welding. The aim of this study was to assess occupational exposure to Cr(VI) in Denmark., Methods: This cross-sectional study included 28 workers and 8 apprentices with potential Cr(VI) exposure and 24 within company controls, all recruited from six companies and one vocational school. Use of occupational safety and health (OSH) risk prevention measures were assessed through triangulation of interviews, a questionnaire and systematic observations. Inhalable Cr(VI) and Cr-total were assessed by personal air exposure measurements on Cr(VI) exposed participants and stationary measurements. Cr concentrations were measured in urine and in red blood cells (RBC) (the latter reflecting Cr(VI)). Genotoxicity was assessed by measurement of micronuclei in peripheral blood reticulocytes (MNRET)., Results: At announced visits, a consistent high degree of compliance to OSH risk prevention measures were seen in 'chromium bath plating' for both technical devices (e.g. ventilation, plastic balls, sheet coverings) and in the use of personal protective equipment (e.g. gloves, respirators), yet a lesser degree of compliance was observed in 'stainless steel welding'. The geometric mean of the air concentration of Cr(VI) was 0.26 μg/m
3 (95% confidence interval (CI): 0.12-0.57) for the Cr(VI)-exposed workers and 3.69 μg/m3 (95% CI: 1.47-9.25) for the Cr(VI)-exposed apprentices. Subdivided by company type, the exposure levels were 0.13 μg/m3 (95% CI: 0.04-0.41) for companies manufacturing and processing metal products, and 0.81 μg/m3 (95% CI: 0.46-1.40) for bath plating companies. Workers with occupational exposure to Cr(VI) had significantly higher median levels of urinary Cr (2.42 μg/L, 5th-95th percentile 0.28-58.39), Cr in RBC (0.89 μg/L, 0.54-4.92) and MNRET (1.59 ‰, 0.78-10.92) compared to the within company controls (urinary: 0.40 μg/L, 0.16-21.3, RBC: 0.60 μg/L, 0.50-0.93,MNRET: 1.06 ‰, 0.71-2.06). When sub-dividing by company type, urinary Cr (4.61 μg/L, 1.72-69.5), Cr in RBC (1.33 μg/L, 0.95-4.98) and MNRET (1.89 μg/L, 0.78-12.92) levels were increased for workers with potential Cr(VI) exposure in bath-plating companies, and when subdividing by work task, workers engaged in process operation had increased levels of urinary Cr (8.51 μg/L, 1.71-69.5), Cr in RBC (1.33 μg/L, 0.95-4.98) and MNRET (1.89 μg/L, 0.82-12.92) levels., Conclusion: This biomonitoring study shows that bath platers were highly exposed to Cr(VI), as suggested by relatively high levels of urinary Cr, Cr in RBC and increased levels of micronuclei. The urinary Cr concentrations were high when compared to the French biological limit value of 2.5 μg Cr/L, corresponding to the Danish occupational exposure limit of 1 μg/m3 . This, in turn, indirectly suggests that additional exposure routes than via air may contribute to the exposure. For welders, no statistically significant increases compared to within company controls were observed, however, the observed urinary Cr levels were similar to the levels observed in a European study (HBM4EU), and were higher than the levels observed for welders in Sweden (SafeChrom). In spite of a high degree of self-reported and observed compliance to OSH risk prevention measures during announced visits, the biomarkers of exposure reflecting recent exposure (urinary Cr) or exposure during the last four months (Cr in RBC) may point to variation in compliance to OSH risk prevention measures in general. Reduced occupational exposure to Cr(VI) may be achieved by applying the hierarchy of controls in eliminating or substituting Cr(VI), and the use of more effective technical solutions (e.g. automation)., (Copyright © 2024 The Authors. Published by Elsevier GmbH.. All rights reserved.)- Published
- 2025
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38. Cardiac power and the association with heart failure and cardiovascular death in the general population.
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Bøgh-Sørensen S, Dons M, Shabib A, Olsen FJ, Vesterlev D, Espersen C, Duus LS, Højbjerg Lassen MC, Skaarup KG, Johansen ND, Schnohr P, Jensen GB, Møgelvang R, and Biering-Sørensen T
- Subjects
- Humans, Male, Female, Prospective Studies, Middle Aged, Aged, Follow-Up Studies, Stroke Volume physiology, Echocardiography, Cohort Studies, Ventricular Function, Left physiology, Population Surveillance methods, Adult, Heart Failure mortality, Heart Failure physiopathology, Heart Failure epidemiology
- Abstract
Background: Cardiac power (CP) integrates echocardiographic and clinical parameters of hemodynamics, yet its prognostic value within the general population remains unexplored. This study investigated the association between CP and incident heart failure (HF) and cardiovascular (CV) death in the general population., Methods: In this prospective cohort study, we measured CP in a total of 4022 individuals from the general population without prior HF. CP was expressed in W/100 g of left ventricular (LV) myocardium. The outcome was a composite of incident HF and CV death and the association between CP and the composite outcome was explored in Cox regression models., Results: During a median follow-up of 3.5 years (IQR 2.6;4.4 years), 134 (3.3 %) individuals experienced the composite outcome. Left ventricular (LV) ejection fraction (LVEF) significantly modified the association between CP and outcome (p
interaction < 0.001). Stratifying the population according to LVEF, CP had no prognostic value in LVEF ≥50 % (p = 0.81). In individuals with LVEF <50 %, CP remained significantly associated with the composite outcome after multivariable adjustment (HR 1.22 per 0.1 W decrease, 95 % CI: 1.06-1.41, p = 0.005). Individuals with reduced LVEF and CP <0.84 W had the highest risk of the composite outcome (SHR 7.45 per 0.1 W decrease, CI: 4.63-12.00, p < 0.001.) CONCLUSION: CP was associated with incident HF and CV death in the general population, however, LVEF significantly modified this relationship. CP was independently associated with incident HF and CV death in individuals with LVEF <50 % but not individuals with LVEF ≥50 %., Competing Interests: Declaration of competing interest TBS: TBS: Research grants from Novartis, Pfizer, Sanofi Pasteur, GSK, Novo Nordisk, AstraZeneca, Boston Scientific and GE Healthcare, consulting fees from Novo Nordisk, IQVIA, Parexel, Amgen, CSL Seqirus, GSK and Sanofi Pasteur, and lecture fees from AstraZeneca, Bayer, Novartis, Sanofi Pasteur, GE healthcare and GSK., (Copyright © 2024. Published by Elsevier B.V.)- Published
- 2025
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39. The adverse effects with ibuprofen after major orthopedic surgeries: A protocol for the PERISAFE randomized clinical trial.
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Laursen CCW, Lunn TH, Hägi-Pedersen D, Therkelsen ASN, Varnum C, Lange KHW, Yilmaz M, Pedersen NA, Kappel A, Jakobsen T, Eljaja SB, Thougaard T, Graungaard BK, Bjerno T, Beck J, Runge C, Steiness J, Gasbjerg KS, Thybo KH, Brorson S, Lindberg-Larsen M, Overgaard S, Jakobsen JC, and Mathiesen O
- Subjects
- Humans, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Postoperative Complications epidemiology, Double-Blind Method, Randomized Controlled Trials as Topic, Ibuprofen therapeutic use, Ibuprofen adverse effects, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Pain, Postoperative drug therapy
- Abstract
Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for pain treatment after elective hip and knee arthroplasties. However, evidence regarding the incidence of adverse effects with short-term NSAID treatment following surgery is limited. We, therefore, aim to assess the adverse effects with an eight-day postoperative treatment with ibuprofen after elective hip and knee arthroplasties., Methods and Analysis: PERISAFE is a randomized, placebo-controlled, blinded multicenter trial with 90-day and one-year follow-up. Eligible patients undergoing elective hip or knee arthroplasty are allocated 1:1 to either ibuprofen 400 mg ×3/day or identical placebo ×3/day for eight days after surgery. The primary outcome is a composite of either death, acute myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, renal failure, major bleeding, re-operation, gastrointestinal ulcer, or readmission within 90 days postoperatively. Secondary outcomes are hospital-free days within 90 days postoperatively, a composite of ibuprofen and opioid-related adverse reactions based on eight-day postoperative diary, and health related quality of life after 90 days postoperatively. A total of 2904 patients are needed to demonstrate a relative risk reduction of 33% in the placebo group, accepting a risk of type I error of 5% and type II error of 20% and a proportion of serious adverse events in the ibuprofen group of 8%. The primary analysis will be in the modified intention-to-treat population., Ethics and Dissemination: The trial is approved by the Danish Medicine Agency and the Research Ethics Committee (EU CT no. 2022-502, 502-32-00). We plan to submit for publication in a major international peer-reviewed journal and present results at scientific meetings., (© 2025 Acta Anaesthesiologica Scandinavica Foundation.)
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- 2025
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40. Muscle spindle receptors and their impact on Parkinson´s disease and Cerebral Palsy subjects.
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Bartels EM and Harrison A
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- Humans, Proprioception physiology, Muscle, Skeletal metabolism, Parkinson Disease metabolism, Parkinson Disease physiopathology, Parkinson Disease pathology, Muscle Spindles metabolism, Cerebral Palsy metabolism, Cerebral Palsy physiopathology, Cerebral Palsy pathology
- Abstract
In some neurological conditions, like Parkinson's disease (PD) and Cerebral Palsy (CP), as well as with ageing, muscle spindles have been mentioned as participating in the pathological response of observed muscles. The aim of this review has therefore been to examine what is known about muscle spindle receptors, their function and how they are involved in regulating precise muscle movement in relation to these two conditions. Data from acoustic myography (AMG) studies with healthy controls (HC), CP and PD subjects have been re-examined with a view to identifying possible effects of changes in muscle movement which could be related to muscle spindle receptor function. Studies of muscle spindles have shown that during shortening and lengthening contractions the fusimotor system is activated differently with different discharge frequencies and sensitivities. With increasing age comes a loss of precise proprioception, something that coincides with a change in the AMG E-score towards lower values, indicating a reduced level of coordination and efficiency of muscle use. With PD and CP there is likewise a documented decrease in proprioception, also showing lower E-values than age-matched HC subjects. We conclude that the decrease in proprioception observed in these subjects must be partly due to a change in the muscle spindle / C-centre feedback system., Competing Interests: Declarations. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)
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- 2025
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41. Effectiveness, safety and drug survival of oral roflumilast for hidradenitis suppurativa.
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Holgersen N, Nielsen VW, Ring HC, Egeberg A, Thyssen JP, Gyldenløve M, and Thomsen SF
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- 2025
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42. Development and evaluation of a new semi-quantitative and morphometric scoring system for magnetic resonance imaging in adolescents with Osgood Schlatter Disease (The OSIS Score).
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Sørensen LB, Hever M, Wielopolski P, Magnusson SP, Dean BJF, Holden S, Rathleff MS, Olesen JL, and Oei EHG
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- Humans, Adolescent, Female, Reproducibility of Results, Male, Knee Joint diagnostic imaging, Knee Joint pathology, Magnetic Resonance Imaging methods, Osteochondrosis diagnostic imaging
- Abstract
Background: Osgood Schlatter Disease (OSD) is a common injury in adolescents. A recent systematic review identified multiple tissue characteristics evaluated in imaging studies, but the studies used different imaging modalities, used varying MRI protocols and were of poor study quality, which led to conflicting findings and hamper the clinical utility of MRI scans. This study aimed to develop and evaluate the reliability of a semi-quantitative MRI scoring system for use in adolescents with OSD., Materials and Methods: Based on a systematic review, we used an expert-led process to develop a scoring list to describe soft tissues, cartilage, bone, and morphometric characteristics in adolescents with OSD. 1.5 T MRI was performed on the most symptomatic knee in adolescents with OSD. A trained radiologist and a research trainee each assessed 10 cases twice to assess the intra- and inter-rater reliability of the scoring list., Results: The final 18 item scoring list included an assessment of the patellar tendon, infrapatellar bursa, cartilage, and the tibial epiphysis, metaphysis, and tibial tuberosity, which were scored by signal intensity, degree, and signal homogeneity. Patellar height, patella morphology, patellar tendon attachment, and tendon thickness and width were quantified. Ten adolescents with OSD (13.2 ± 1.1, 30 % female) were included for reliability. Most features showed good to very good (κ and ICC > 0.6) reliability. The exceptions were intra-rater reliability for superficial bursa homogeneity (κ = 0.51) and inter-rater reliability for signal degree in the patellar tendon (κ = 0.55), tibial epiphysis (κ = 0.53) and tibial tuberosity (κ = 0.52) and patella morphology ratio (ICC: -0.16, p = 0.67. Reliability for patella height and patellar tendon width had the highest reliability (intra-rater ICC (0.75-0.98); inter-rater ICC (0.48-0.93))., Conclusion: This semi-quantitative scoring system for MRI allows the comprehensive and reliable assessment of features relevant for evaluating affected tissues in adolescent patients with OSD., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Benjamin Dean reports was provided by University of Oxford. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Edwin H.G. Oei reports a relationship with GE Healthcare that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Michael Skovdal Rathleff reports financial support was provided by Independant Research Foundation Denmark. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper]., (Copyright © 2025 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2025
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43. Dynamics of troponins and 30-day mortality in hospitalized patients with pulmonary embolism.
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Sonne-Holm E, Kjærgaard J, Bang LE, Køber L, Fosbøl E, Hassager C, Beske RP, Carlsen J, and Winther-Jensen M
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Hospitalization, Troponin I blood, Troponin T blood, Denmark epidemiology, Troponin blood, Aged, 80 and over, Pulmonary Embolism mortality, Pulmonary Embolism blood, Pulmonary Embolism diagnosis
- Abstract
Background: In patients with pulmonary embolism (PE), the impact of repeated troponin I or T (TnI/TnT) measurements remains unclear., Methods: Using Danish national registries, we identified PE patients (≥18 years) hospitalized between 2013 and 2018 with initial TnI or TnT measurement within -1/+1 day from admission and >1 repeated measurement within three days. Trajectories of TnI and TnT were identified using latent class trajectory modeling. Hazard ratios for 30-day mortality were compared across trajectories via multivariable Cox regression., Results: Among 1539 patients with TnI measurements and 1323 with TnT measurements, three distinct trajectories were identified. Trajectory I (n
TnI = 286, nTnT = 472) exhibited consistently low TnI/TnT concentrations, trajectory II (nTnI = 1076, nTnT = 724) demonstrated initial elevated TnI/TnT decreasing within 24 h, and trajectory III (nTnI = 177, nTnT = 127) was characterized by elevated index TnI/TnT increasing within 10 h. 30-day mortality rates were higher in trajectory II and III compared to I in both the TnI (3 %, 7 % and 18 % across trajectory I to III) and the TnT (1 %, 9 % and 20 % across trajectory I to III) cohort. After adjustment hazard ratio of 30-day mortality for trajectory II vs. I was 7.42 (95 % CI 1.00-54.84, p = 0.04, TnI) and 2.93 (95 % CI 1.17-7.33, p = 0.02 TnT); and for trajectory III vs. I, 16.42 (95 % CI 2.42-127.29, p = 0.007, TnI) and 8.21 (95 % CI 2.78-24.19, p < 0.001, TnT)., Conclusion: A steep increase in TnI or TnT concentration within 10 h of PE diagnosis significantly escalates 30-day mortality risk indicating that early serial sampling may enhance risk stratification of PE patients., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2025 Elsevier Ltd. All rights reserved.)- Published
- 2025
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44. Complicating Objectification in the Medical Encounter: Embodied Experiences in the ICU during COVID-19.
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Køster A, Fernandez AV, and Andersen LPK
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- Humans, Female, SARS-CoV-2, Male, Adult, Middle Aged, Pandemics, COVID-19 psychology, Intensive Care Units, Qualitative Research
- Abstract
Illness and injury are often accompanied by experiences of bodily objectification. Medical treatments intended to restore the structure or function of the body may amplify these experiences of objectification by recasting the patient's body as a biomedical object-something to be examined, measured, and manipulated. In this article, we contribute to the phenomenology of embodiment in illness and medicine by reexamining the results of a qualitative study of the experiences of nurses and patients isolated in an intensive care unit during the first wave of COVID-19. Drawing upon the phenomenological concept of embodiment-as developed in the work of Edmund Husserl, Maurice Merleau-Ponty, Jean-Paul Sartre, and Emmanuel Levinas-we reconsider how bodily objectification manifests in complex clinical encounters. We show that, in these settings, objectification is not simply the unilateral act of a clinician objectifying a patient. Rather, both clinicians and patients reported a variety of objectifying experiences influenced by their interactions, the immediate context of the intensive care milieu, and the broader atmosphere of a global pandemic. In light of these findings, we argue that bodily objectification in illness and medicine can often be more complicated than typically presented in the phenomenological literature., Competing Interests: Declarations. Ethics approval: Ethics approval was not needed according to Danish law. Participation was voluntary, and participants provided written and verbal informed consent before inclusion. All interviews were anonymized. Conflict of interest: There are no conflicts of interest., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2025
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45. Combining Paracentral Acute Middle Maculopathy and Peripapillary Fluid as Biomarkers in Anterior Ischemic Optic Neuropathy.
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Klefter ON, Hansen MS, Lykkebirk L, Subhi Y, Brittain JM, Jensen MR, Døhn UM, Fana V, Wiencke AK, Heegaard S, Terslev L, and Hamann S
- Subjects
- Humans, Prospective Studies, Male, Female, Cross-Sectional Studies, Aged, Middle Aged, Acute Disease, Optic Disk pathology, Visual Acuity physiology, Fluorescein Angiography methods, Retinal Diseases diagnosis, Optic Neuropathy, Ischemic diagnosis, Optic Neuropathy, Ischemic metabolism, Tomography, Optical Coherence methods, Subretinal Fluid metabolism, Biomarkers metabolism
- Abstract
Purpose: To determine if paracentral acute middle maculopathy (PAMM) and peripapillary intraretinal and subretinal fluid (IRF/SRF) could help distinguish between arteritic anterior ischemic optic neuropathy (A-AION) and nonarteritic AION (NA-AION) at an early stage., Design: Nested prospective cross-sectional diagnostic accuracy study., Methods: This study used single-center optical coherence tomography (OCT) data from 8 patients with A-AION and 24 patients with NA-AION from two prospective cross-sectional studies with consecutive sampling (ClinicalTrials.gov: NCT05248906 and NCT05305079). The diagnosis of A-AION was based on expert interpretation of biochemical markers of inflammation, temporal artery biopsy and positron emission tomography/computed tomography. The diagnosis of NA-AION was made in cases without suspicion or clinical evidence of A-AION and with confirmed neuroophthalmological expert diagnosis. For this substudy patients were also required to have an OCT scan in relation to the diagnosis of AION. Macular OCT scans were graded by two independent, masked graders for the presence of PAMM and for IRF/SRF. The extension of IRF/SRF was assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) grid., Results: PAMM was found in 50% of patients with A-AION and in 0% of patients with NA-AION (P = .0019). In the setting of AION, the sensitivity of PAMM for the diagnosis of A-AION was 50% (95% CI: 16%-84%) while the specificity was 100% (95% CI: 86%-100%). Conversely, peripapillary IRF/SRF with extension into the ETDRS grid was observed in 83% of patients with NA-AION but in 0% of patients with A-AION (P = .000047). The sensitivity of central macula-involving IRF/SRF for the diagnosis of NA-AION was 83% (95% CI: 63%-95%), while the specificity was 100% (95% CI: 63%-100%). Combining the two biomarkers, 75% of patients with AION could be classified based on OCT alone., Conclusion: PAMM appears to be a biomarker of A-AION while extensive peripapillary fluid appears to be a biomarker of NA-AION. Combining OCT biomarkers might allow for early classification of AION and warrants further prospective studies., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2025
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46. The effect of stretching intensity on pain sensitivity: A randomized crossover study on healthy adults.
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Støve MP, Hansen LØ, Elmbæk KK, Magnusson SP, Thomsen JL, and Riis A
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- Humans, Female, Male, Adult, Young Adult, Pain Measurement, Pain physiopathology, Healthy Volunteers, Cross-Over Studies, Pain Threshold physiology, Muscle Stretching Exercises
- Abstract
Background: Stretching exercises have effects on local and widespread pain sensitivity. A dose-response relationship may exist between the analgesic effect and the intensity of stretching, such that a higher intensity of stretching may generate a larger reduction in analgesic response, but this remains to be studied. This study aimed to examine the dose-response relationship between stretching intensity and the analgesic effect., Methods: A randomized, repeated-measures crossover study was performed to examine the effect of stretching to the first point of pain onset and stretching to the point of a sensation of stretching (discomfort). The primary outcome was regional and distant pressure pain thresholds., Results: Thirty-one participants (n = 24 female) were available for analysis. We observed a 22.2% increase in regional pressure pain thresholds (93.2 kPa, p = 0.001) and a 15.0% increase in distant pressure pain thresholds (50.9 kPa, p = 0.012) following stretching to the point of stretch. We observed a 20.0% increase in regional pressure pain thresholds (90.3 kPa, p = 0.001) and a 15.1% increase in distant pressure pain thresholds (52.1 kPa, p = 0.004) following stretching to the point of pain., Conclusions: The results showed that local and widespread pain sensitivity decreased following acute stretching, regardless of stretching intensity. No differences in pain sensitivity were found between stretching to the point of stretch or stretching to the first onset of pain. Thus, the results showed no evidence of a dose-response relationship between stretching intensity and the analgesic effect., Significance: The study showed a significant acute hypoalgesic effect of stretching exercises regardless of stretching intensity. This may have appropriate clinical implications for patients with musculoskeletal and nociplastic pain., (© 2024 The Author(s). European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation ‐ EFIC ®.)
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- 2025
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47. Intubating conditions during rapid sequence induction with either rocuronium or suxamethonium in elderly patients. A randomised study.
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Vested M, Creutzburg A, Meyhoff CS, Rovsing ML, Nielsen T, Rosa F, Aasvang EK, Mollerup H, Fuchs-Buder T, and Rasmussen LS
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- Humans, Male, Female, Aged, 80 and over, Androstanols administration & dosage, Neuromuscular Depolarizing Agents, Rocuronium administration & dosage, Succinylcholine administration & dosage, Neuromuscular Nondepolarizing Agents administration & dosage, Intubation, Intratracheal methods, Rapid Sequence Induction and Intubation methods
- Abstract
Background: During rapid sequence induction, either rocuronium 1.0 mg kg
-1 or suxamethonium 1.0 mg kg-1 can be administered to facilitate endotracheal intubation. We hypothezised that rocuronium provided a larger proportion of excellent intubating conditions compared to suxamethonium in elderly patients., Methods: A total of 90 patients 80 years or above with American Society of Anesthesiologists physical health Classes I-IV, and a body mass index < 35 kg m-1-2 were randomised to either rocuronium 1.0 mg kg-1 or suxamethonium 1.0 mg kg-1 during rapid sequence induction with intubation using a video laryngoscope. After 60 s, tracheal intubating conditions were evaluated using the Fuchs-Buder scale by a blinded investigator, and the primary outcome was the proportion of patients with excellent intubating conditions. Further outcomes included first pass success rate, intubating conditions according to the intubating difficulty scale (IDS), onset time and postoperative occurrence of muscle soreness, hoarseness and sore throat., Results: All patients were evaluated for the primary outcome. Excellent intubating conditions occurred in 36 patients (73%) versus 31 (75%) in the rocuronium group and suxamethonium group, respectively (95% confidence interval [CI]: -16 to 20) (p = .82). The first pass success rate was 48 (98%) versus 40 (98%) comparing the rocuronium group with the suxamethonium group, respectively (p = .90). No difference in IDS score was found; median 0 (interquartile ranges [IQR]: 0-1) versus median 0 (IQR: 0-1) (p = .48). Onset time was significantly shorter in the suxamethonium group 99 versus 131 s (p = .01) (95% CI: 7 to 57). Finally, no difference was found in the occurrence of muscle soreness, hoarseness or sore throat postoperatively., Conclusion: No important difference in intubating conditions was found during rapid sequence induction after the administration of either rocuronium 1.0 mg kg-1 or suxamethonium 1.0 mg kg-1 in patients 80 years or above., Editorial Comment: This reports a superiority trial comparing standardised doses of rocuronium and suxamethonium at 60 s for quality of intubating conditions in the rapid sequence context, and this in an elderly cohort. The findings showed no difference between the drugs concerning intubation outcomes, though the onset or time to peak effect was shorter for suxamethonium, again demonstrated in a cohort 80 years old or older., (© 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)- Published
- 2025
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48. Efficacy of a home-based stretching programme on fibromyalgia symptoms: study protocol for a randomised controlled trial.
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Støve MP, Magnusson SP, Thomsen JL, and Riis A
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- Humans, Female, Middle Aged, Treatment Outcome, Male, Adult, Time Factors, Surveys and Questionnaires, Home Care Services, Telemedicine, Pain Measurement, Mobile Applications, Range of Motion, Articular, Fibromyalgia therapy, Fibromyalgia diagnosis, Fibromyalgia physiopathology, Muscle Stretching Exercises, Randomized Controlled Trials as Topic, Quality of Life
- Abstract
Background: This protocol was developed to describe the design of a randomised controlled trial that will examine the clinical efficacy of a 6-week, novel, home-based stretching programme compared with usual care on the effect of symptoms experienced by patients with fibromyalgia. The hypothesis is that the total score of the Fibromyalgia Impact Questionnaire (FIQ-R) and other fibromyalgia symptoms will improve 6 weeks following the stretching intervention compared with usual care., Methods: Fifty-eight adults under 65 years of age diagnosed with fibromyalgia will be recruited for this study. Participants will be randomised into an intervention group and a control group (waitlist). Randomisation will be stratified by sex. The intervention group will perform 6 weeks of daily stretching exercises for 6 min-a day. The control group will maintain usual care. A mHealth app will support stretching adherence. The primary outcome will be the total score of the Revised Fibromyalgia Impact Questionnaire (FIQ-R). The secondary outcomes include regional and widespread pain sensitivity, range of motion, quality of life (SF-36), mental and physical functioning and adherence. Evaluations will be performed at baseline, following 6 weeks of daily stretches (primary endpoint) and 6 months after the termination of the intervention period (secondary endpoint)., Discussion: By investigating the clinical efficacy of a 6-week, novel, home-based stretching programme, we hope to provide applicable and generalisable knowledge about the efficacy of stretching exercises that can potentially help ease the burden of symptoms experienced by patients with fibromyalgia., Trial Registration: NTC, NCT06487741. Registered on 24 June 2024., Competing Interests: Declarations. Ethics approval and consent to participate: The trial is approved by The North Denmark Region Committee on Health Research Ethics (N-20240035), reported to the Danish Data Protection Agency, and registered at ClinicalTrials.gov (Trial registration number NCT06487741). The participants will provide written informed consent before allocation. Consent for publication: Not applicable. Competing interests: The authors declare that they have no competing interests., (© 2025. The Author(s).)
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- 2025
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49. Serious Neurologic Adverse Events in Tofersen Clinical Trials for Amyotrophic Lateral Sclerosis.
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Lovett A, Chary S, Babu S, Bruneteau G, Glass JD, Karlsborg M, Ladha S, Mayl K, McDermott C, Bucelli RC, Chiò A, Ferguson TA, Cochrane T, Fradette S, Smirnakis K, Inra J, Malek S, and Fanning L
- Abstract
Introduction/aims: Tofersen is approved for the treatment of amyotrophic lateral sclerosis (ALS) due to superoxide dismutase 1 mutations (SOD1-ALS). Here we report serious neurologic adverse events (AEs) that occurred in the tofersen clinical trials in people with SOD1-ALS., Methods: Serious neurologic AEs of myelitis, radiculitis, aseptic meningitis, and papilledema reported in the tofersen clinical trials are described. Serious AEs were defined according to International Conference for Harmonization guidelines, and neurologic AEs in clinical trials were diagnosed by investigators based on symptoms, clinical examination findings, and diagnostic workup., Results: Ten participants (approximately 7% of tofersen 100-mg-treated trial participants) experienced a total of 12 serious neurologic AEs-4 of myelitis, 2 of radiculitis, 2 of aseptic meningitis, and 4 of intracranial hypertension (ICH) and/or papilledema. All events but one resolved either spontaneously, with dosing interruption/modification, or with concomitant therapies. One event was ongoing but improved as of December 2022. While 3 events led to tofersen treatment discontinuation, all other participants were able to remain on treatment. No event was life-threatening or fatal., Discussion: Some antisense oligonucleotides (ASOs) have been described as having pro-inflammatory properties. Aseptic meningitis has been reported with nusinersen; however, myelitis, radiculitis, increased intracranial pressure, and papilledema have not been reported with ASO treatment. These neurologic AEs should be considered when assessing the overall benefit/risk of tofersen treatment for SOD1-ALS. Safety data from the open-label extension and expanded access program will continue to characterize these events and further inform the safety profile of tofersen in SOD1-ALS., (© 2025 The Author(s). Muscle & Nerve published by Wiley Periodicals LLC.)
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- 2025
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50. Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials.
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Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Würtzen PA, Ngantcha M, Holzkämper T, and Smolen J
- Abstract
Introduction: Synovitis and enthesitis are key manifestations in psoriatic arthritis (PsA). This descriptive analysis investigated the association between improvement in synovitis and enthesitis, individually and combined, and improvement in patient-reported outcomes (PROs) including health-related quality of life (HRQoL) for patients with PsA from the SPIRIT-P1, SPIRIT-P2, and SPIRIT-H2H trials who presented with synovitis and enthesitis at baseline and received ixekizumab (IXE) treatment., Methods: In this post hoc analysis, data are presented from patients with PsA treated with IXE every 4 weeks from two phase III studies (SPIRIT-P1 and SPIRIT-P2) and one phase IIIb/IV study (SPIRIT-H2H) who had both synovitis and enthesitis at baseline. Associations between improvements in synovitis and improvements in enthesitis were explored using Pearson analyses through week 52. Associations between improvements in both, either, and neither condition with improvements in PROs (36-item Short Form Health Survey Physical Component Score [SF-36 PCS], the European Quality-of-Life 5 Dimensions 5 Levels [EQ-5D-5L] including the EQ-5D Visual Analogue Score [VAS] and the EQ-health index, Patient's Global Assessment [PtGA], and pain VAS) were assessed descriptively through week 52., Results: Results demonstrated the synergistic improvements in synovitis and enthesitis, individually or combined, and improvements in PROs including HRQoL, for patients treated with IXE through week 52. An association between improvements in synovitis and enthesitis symptoms was observed through week 52. Patients who achieved resolution of both synovitis and enthesitis reported highest improvements in SF-36 PCS, EQ-5D-5L, pain VAS, and PtGA., Conclusion: Synergistic improvements in two key PsA domains, namely synovitis and enthesitis, and improvements in PROs including HRQoL, were observed for patients with PsA treated with IXE through week 52. These findings support PsA treatment goal aiming to achieve the lowest possible level of disease activity in all disease domains., Trial Registration Numbers: SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295), and SPIRIT-H2H (NCT03151551)., Competing Interests: Declarations. Conflict of Interest: Lars-Erik Kristensen received grants or contracts from Pfizer, AbbVie, Amgen, Galapagos, UCB, Celgene, BMS, MSD, Novartis, Eli Lilly, and Janssen Pharmaceuticals, consulting fees from Pfizer, AbbVie, Amgen, Galapagos, UCB, Celgene, BMS, MSD, Novartis, Eli Lilly, and Janssen Pharmaceuticals, and honoraria from Pfizer, AbbVie, Amgen, Galapagos, UCB, Celgene, BMS, MSD, Novartis, Eli Lilly, and Janssen Pharmaceuticals. Dennis McGonagle received grant funding, support for attending meetings or travel, and support for attending advisory board from Eli Lilly and Company. Martin Rudwaleit received consulting fees from Eli Lilly and Company, Novartis, and UCB, honoraria from AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Novartis, and UCB, and support for attending meetings or travel from Janssen, Novartis, Galapagos, AbbVie, and UCB. Hideto Kameda received grants or contracts from Asahi Kasei, Taisho, Mitsubishi-Tanabe, Eisai, Chugai, Pfizer, and AbbVie, consulting fees from Sanofi, Novartis, and AbbVie, honoraria from AbbVie, Asahi Kasei, Bristol Myers, Boehringer Ingelheim, Chugai, Eisai, Mitsubichi-Tanabe, Janssen, Eli Lilly and Company, Novartis, Pfizer, and UCB, support for participation in data safety monitoring board or advisory board from AbbVie, Astellas, Amgen, Eli Lilly and Company, Sanofi, and UCB, and holds a leadership or fiduciary role in the Japan Spondyloarthritis Society. Josef Smolen received grants or contracts from AbbVie, AstraZeneca, Eli Lilly and Company, Novartis, Galapagos, and Roche, consulting fees from AbbVie, Amgen, Ananda, Astro, BMS, Celltrion, Chugai, Eli Lilly and Company, Gilead, Immunovant, MSD, Novartis, Pfizer, Roche, R-Pharma, Samsung, Sanofi, and UCB, and support for attending meetings or travel from Eli Lilly and Company. Thorsten Holzkaemper, Marcu Ngantcha and Peter Adler are employees and shareholders at Eli Lilly and Company. Joanna Burke was a contract statistician for Eli Lilly and Company via Agile who contributed to the manuscript during development. Joanna Burke was not affiliated to Eli Lilly and Company after the completion of this manuscript. Ethical Approval: The studies were compliant with ethical guidelines including the Declaration of Helsinki and other relevant laws and regulations. The three trials were approved by each site’s ethical review committee/institution review board; names of all principal investigators and participating study sites have been previously published [18, 20, 21]. All patients provided written informed consent., (© 2025. The Author(s).)
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- 2025
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