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  1. Employment is a vital source for experiencing well-being and lowering the risk of long-term social marginalisation and poverty. For persons with alcohol and drug addiction, it may also improve sobriety. Howeve...

    Authors: Ulrika Bejerholm, Anders Håkansson, Marcus Knutagård and Helene Hillborg
    Citation: Trials 2024 25:222
  2. Approximately 85% of women experience an obstetric tear at delivery and up to 25% subsequently experience wound dehiscence and/or infection. Previous publications suggest that intravenous antibiotics administr...

    Authors: Kathrine Perslev, Niels Klarskov, Thomas Bergholt and Hanna Jangö
    Citation: Trials 2024 25:221
  3. Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The ...

    Authors: Serafín Lirola-Palmero, Guillem Salva-Coll, Aina María Yáñez-Juan and Eduardo Sánchez-Iriso
    Citation: Trials 2024 25:220
  4. Acute microcirculatory perfusion disturbances and organ edema are important factors leading to organ dysfunction during cardiac surgery with cardiopulmonary bypass (CPB). Priming of the CPB system with crystal...

    Authors: Anne M. Beukers, Carolien S. E. Bulte, Ruben J. Bosch, Susanne Eberl, Charissa E. van den Brom, Stephan A. Loer and Alexander B. A. Vonk
    Citation: Trials 2024 25:219
  5. The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducin...

    Authors: Eva Visser, Lianne Heuthorst, Shri Pathmakanthan, Willem A. Bemelman, Geert R. D’Haens, Kelly Handley, Apostolos Fakis, Thomas D. Pinkney, Christianne J. Buskens and Marcel G. W. Dijkgraaf
    Citation: Trials 2024 25:218
  6. Depression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after...

    Authors: Peter Fonagy, Rabih El Chammay, Carol Ngunu, Manasi Kumar, Lena Verdeli, Elizabeth Allison, Ghida Anani, Pasco Fearon, Fouad Fouad, Zoe Hoare, Lucina Koyio, Henrietta Moore, Andrew Nyandigisi, Stephen Pilling, Hannah Sender, Jolene Skordis…
    Citation: Trials 2024 25:217
  7. The effectiveness of immunisation with pneumococcal conjugate vaccine (PCV) has been demonstrated in many countries. However, the global impact of PCV is limited by its cost, which has prevented its introducti...

    Authors: Grant A. Mackenzie, Isaac Osei, Rasheed Salaudeen, Paul V. Licciardi, Brian Greenwood, Kim Mulholland and Cattram Nguyen
    Citation: Trials 2024 25:216
  8. Populations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of...

    Authors: Jennifer McAnuff, Tim Rapley, Leigh Rooney and Phillip Whitehead
    Citation: Trials 2024 25:215
  9. Endovascular repair of aortic aneurysmal disease is established due to perceived advantages in patient survival, reduced postoperative complications, and shorter hospital lengths of stay. High spatial and cont...

    Authors: James Budge, Tom Carrell, Medeah Yaqub, Hatem Wafa, Matt Waltham, Izabela Pilecka, Joanna Kelly, Caroline Murphy, Stephen Palmer, Yanzhong Wang and Rachel E Clough
    Citation: Trials 2024 25:214
  10. Chronic active antibody-mediated rejection (caAMR) in kidney transplants is associated with irreversible tissue damage and a leading cause of graft loss in the long-term. However, the treatment for caAMR remai...

    Authors: Lillian Streichart, Marie Felldin, Jana Ekberg, Lars Mjörnstedt, Per Lindnér, Annette Lennerling, Verena Bröcker, Johan Mölne, Jan Holgersson, Kristien Daenen, Lars Wennberg, Tomas Lorant and Seema Baid-Agrawal
    Citation: Trials 2024 25:213
  11. Significant disparities continue to exist in the HIV care continuum, whereby Hispanic and Black people living with HIV (PLWH) are less likely to achieve viral suppression compared to their White counterparts. ...

    Authors: Eileen V. Pitpitan, Keith J. Horvath, Jeannette Aldous, Jamila K. Stockman, Thomas L. Patterson, Megan Liang, Constantino Barrozo, Veronica Moore, Katherine Penninga and Laramie R. Smith
    Citation: Trials 2024 25:212
  12. Dysphagia, with its negative impact on life expectancy and quality of life, is a major side effect of head and neck squamous cell carcinoma (HNSCC). In a typical Head and Neck Cancer Center, more than half of ...

    Authors: Julian Kuenzel, Stephan Duerr, Sarah Vester, Florian Zeman, Gunnar Huppertz, Michael Koller, Gerda Pfleger, Annika Woertgen, Hazem Salloum, Monika Klinkhammer-Schalke, Tobias Pukrop and Peter Kummer
    Citation: Trials 2024 25:211
  13. A therapeutic effect of sacral neuromodulation (SNM) on fecal incontinence (FI) and quality of life has been proven in adults. SNM is, however, rarely used in pediatric cases. The aim of the study is to invest...

    Authors: Manuel Besendörfer, Annemarie Kirchgatter, Roman Carbon, Christel Weiss, Hanna Müller, Klaus E. Matzel and Sonja Diez
    Citation: Trials 2024 25:210
  14. Despite a number of recommended strategies, effective treatment of migraine remains elusive. Given the role of oxidative stress in the pathogenesis of migraine, selenium, as an antioxidant nutrient, may have a...

    Authors: Arghavan Balali, Omid Sadeghi, Javad Anjom-Shoae, Mohammad Hossein Rouhani, Fariborz Khorvash and Gholamreza Askari
    Citation: Trials 2024 25:209
  15. Authors: Catharina F. van der Boor, Dalili Taban, Wietse A. Tol, Josephine Akellot, Melissa Neuman, Helen A. Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni, Eugene Kinyanda, Bayard Roberts and Daniela C. Fuhr
    Citation: Trials 2024 25:208

    The original article was published in Trials 2024 25:148

  16. Diabetes distress (DD) affects at least 36% of T2DM patients and is often associated with insufficient support and care. This study examines an intervention that targets DD through enhanced cross-sectoral coll...

    Authors: Steffan Holst Hansen, Troels Mygind Jensen, Gitte Stentebjerg Petersen, Francois Pouwer, Anders L. Sønderlund and Jens Søndergaard
    Citation: Trials 2024 25:207
  17. There is little evidence on how to support ultra-poor people with disabilities to adopt sustainable livelihoods. The Disability-Inclusive Graduation (DIG) programme targets ultra-poor people with disabilities ...

    Authors: Elijah Kipchumba, Calum Davey, Sarah Marks, Anthony Mugeere, Shanquan Chen, Lena Morgon Banks, Kazi Eliza Islam, Tom Shakespeare, Hannah Kuper and Munshi Sulaiman
    Citation: Trials 2024 25:206
  18. With one in five individuals aged 65 or older living with type 2 diabetes worldwide, it is crucial to acknowledge and address the challenges faced by this population. In this context, our study aims to evaluat...

    Authors: Frederico Ludwig da Costa, Lucas Strassburger Matzenbacher, Vicenzo Gheno, Maria Antônia Bertuzzo Brum, Laura Gomes Boabaid de Barros, Isabela Semmelmann Maia, Luiza Machado Blank, Lucas Friedrich Fontoura, Janine Alessi and Gabriela Heiden Telo
    Citation: Trials 2024 25:205
  19. Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Pr...

    Authors: Madhavi Gidh-Jain, Tom Parke, Franz König, Cecile Spiertz and Peter Mesenbrink
    Citation: Trials 2024 25:204
  20. Proteinuria is a modifiable risk factor for chronic kidney disease (CKD) progression in children. Finerenone, a selective, non-steroidal, mineralocorticoid receptor antagonist (MRA) has been approved to treat ...

    Authors: Franz Schaefer, Giovanni Montini, Hee Gyung Kang, Johan Vande Walle, Joshua Zaritsky, Michiel F. Schreuder, Mieczyslaw Litwin, Andrea Scalise, Helen Scott, James Potts, Pablo Iveli, Stefanie Breitenstein and Bradley A. Warady
    Citation: Trials 2024 25:203
  21. Chronic diseases, such as chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes, and heart failure, often coexist and contribute to a significant burden on individuals and health systems. The A...

    Authors: Christian J. Wiedermann, Pasqualina Marino, Angelika Mahlknecht, Verena Barbieri, Giuliano Piccoliori, Adolf Engl and Annerika H. M. Gidding-Slok
    Citation: Trials 2024 25:202
  22. Invasive mechanical ventilation contributes to bronchopulmonary dysplasia (BPD), the most common complication of prematurity and the leading respiratory cause of childhood morbidity. Non-invasive ventilation (...

    Authors: David N. Matlock, Sarah J. Ratcliffe, Sherry E. Courtney, Haresh Kirpalani, Kimberly Firestone, Howard Stein, Kevin Dysart, Karen Warren, Mitchell R. Goldstein, Kelli C. Lund, Aruna Natarajan, Ejigayehu Demissie and Elizabeth E. Foglia
    Citation: Trials 2024 25:201
  23. The neural cells in the brains of patients with Parkinson’s disease (PWP) display aberrant synchronized oscillatory activity within the beta frequency range. Additionally, enhanced gamma oscillations may serve...

    Authors: Hong-yu Zhang, Ting-ting Hou, Zhao-hui Jin, Tian Zhang, Yi-heng Wang, Zi-hao Cheng, Yong-hong Liu, Jin-ping Fang, Hong-jiao Yan, Yi Zhen, Xia An, Jia Du, Ke-ke Chen, Zhen-zhen Li, Qing Li, Qi-ping Wen…
    Citation: Trials 2024 25:200
  24. There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with t...

    Authors: Cydney L. Bruce, Mais Iflaifel, Alan Montgomery, Reuben Ogollah, Kirsty Sprange and Christopher Partlett
    Citation: Trials 2024 25:199
  25. Infants born with congenital diaphragmatic hernia (CDH) are at high risk of respiratory insufficiency and pulmonary hypertension. Routine practice includes immediate clamping of the umbilical cord and endotrac...

    Authors: Emily J. J. Horn-Oudshoorn, Marijn J. Vermeulen, Ronny Knol, Rebekka Bout-Rebel, Arjan B. te Pas, Stuart B. Hooper, Suzan C. M. Cochius-den Otter, Rene M. H. Wijnen, Kelly J. Crossley, Neysan Rafat, Thomas Schaible, Willem P. de Boode, Anne Debeer, Berndt Urlesberger, Calum T. Roberts, Florian Kipfmueller…
    Citation: Trials 2024 25:198
  26. Acute viral bronchiolitis is the most common reason for hospitalization of infants in the USA. Infants hospitalized for bronchiolitis are at high risk for recurrent respiratory symptoms and wheeze in the subse...

    Authors: Kelly Cowan, Erin O. Semmens, Jeannette Y. Lee, Ethan S. Walker, Paul G. Smith, Linda Fu, Rosalyn Singleton, Sara McClure Cox, Jennifer Faiella, Laurie Chassereau, Lora Lawrence, Jun Ying, Jaime Baldner, Maryam Garza, Robert Annett, Sheva K. Chervinskiy…
    Citation: Trials 2024 25:197
  27. The increasing prevalence of childhood obesity has become an urgent public health problem, evidence showed that intervention for childhood obesity bring enormous health benefits. However, an effective individu...

    Authors: Ping-ping Zhang, You-xin Wang, Fang-jing Shen, Yun-fei Xing, Jia-ying Gu, Xue-ying Li, Han Jin, Shi-feng Jin, Miao Xu, Hai-jun Wang, Hui Wang and Li Li
    Citation: Trials 2024 25:196
  28. Patellofemoral pain syndrome (PFPS) is a common musculoskeletal condition in young and active adults. Exercise therapy is an essential part of rehabilitation in people with PFPS (PwPFPS). Telerehabilitation is...

    Authors: Negar Amirabadi, Masumeh Hessam, Saeideh Monjezi, Farshad Molhemi, Mohammad Mehravar and Pardis Hosseinpour
    Citation: Trials 2024 25:195
  29. Pulmonary rehabilitation (PR) is a programme of exercise and education and the most effective treatment for the symptoms and disability associated with chronic obstructive pulmonary disease. However, the benef...

    Authors: Gill Gilworth, Katherine Harris, Toby L. Morgan, Salma Ayis, Julia Fox-Rushby, Emma Godfrey, Nicholas S. Hopkinson, Simon Lewin, Ka Keat Lim, Arietta Spinou, Stephanie J. C. Taylor and Patrick White
    Citation: Trials 2024 25:194
  30. Without surgical repair, flexor tendon injuries do not heal and patients’ ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There...

    Authors: Emma Bamford, Hannah Berntsson, Suzanne Beale, Lauren Desoysa, Joseph Dias, Sienna Hamer-Kiwacz, Daniel Hind, Nick Johnson, Amanda Loban, Kaye Molloy, Emma Morvan, Ines Rombach, Anna Selby, Praveen Thokala, Chris Turtle, Stephen Walters…
    Citation: Trials 2024 25:193
  31. Authors: Corinna Engel, Mario Rüdiger, Manon J. N. L. Benders, Frank van Bel, Karel Allegaert, Gunnar Naulaers, Dirk Bassler, Katrin Klebermaß-Schrehof, Maximo Vento, Ana Vilan, Mari Falck, Isabella Mauro, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Metsvaht…
    Citation: Trials 2024 25:192

    The original article was published in Trials 2024 25:81

  32. One of the main goals of cardiopulmonary bypass (CPB) is targeting an adequate mean arterial pressure (MAP) during heart surgery, in order to maintain appropriate perfusion pressures in all end-organs. As inhe...

    Authors: Alessandra Francica, Gina Mazzeo, Antonella Galeone, Daniele Linardi, Livio San Biagio, Giovanni Battista Luciani and Francesco Onorati
    Citation: Trials 2024 25:191
  33. In healthy people, the “fight-or-flight” sympathetic system is counterbalanced by the “rest-and-digest” parasympathetic system. As we grow older, the parasympathetic system declines as the sympathetic system b...

    Authors: Kaoru Nashiro, Hyun Joo Yoo, Christine Cho, Andy Jeesu Kim, Padideh Nasseri, Jungwon Min, Martin J. Dahl, Noah Mercer, Jeiran Choupan, Paul Choi, Hye Rynn J. Lee, David Choi, Kalekirstos Alemu, Alexandra Ycaza Herrera, Nicole F. Ng, Julian F. Thayer…
    Citation: Trials 2024 25:190
  34. Prospective registration of clinical trials is mandated by various regulations. However, clinical trial registries like ClinicalTrials.gov allow registry entries to be updated at any time, and key study elemen...

    Authors: Martin Holst and Benjamin Gregory Carlisle
    Citation: Trials 2024 25:189
  35. Persistent depressive disorder (PDD) is prevalent and debilitating. For patients with PDD, psychiatric rehabilitation using self-management interventions is advised as the next therapeutic step after multiple ...

    Authors: Ericka C. Solis, Ingrid V. E. Carlier, Noëlle G. A. Kamminga, Erik J. Giltay and Albert M. van Hemert
    Citation: Trials 2024 25:187
  36. Traumatic brain injury (TBI) is a leading cause of disability in children. Cognitive rehabilitation for this population is critical for their long-term health outcomes. This trial aims to evaluate the efficacy...

    Authors: Jiabin Shen, Yan Wang, Susan Quinn, Stacy J. Suskauer, Julia Birch, Tyler Busch, Adrian Svingos, Roger Crawfis, Keith Owen Yeates and H. Gerry Taylor
    Citation: Trials 2024 25:185
  37. Occupational Therapists use craft-making activities as therapeutic interventions to improve physical and psychological functioning of injured people. Despite the therapeutic effects, craft-making is not routin...

    Authors: Rui Fen Teoh, Siaw Chui Chai, Nor Afifi Razaob Razab, Mohd Iskandar Mohd Amin and Julianne W. Howell
    Citation: Trials 2024 25:184
  38. Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evid...

    Authors: C. E. Arundel, L. K. Clark, A. Parker, D. Beard, E. Coleman, C. Cooper, D. Devane, S. Eldridge, S. Galvin, K. Gillies, C. E. Hewitt, C. Sutton, D. J. Torgerson and S. Treweek
    Citation: Trials 2024 25:183
  39. Data to support the use of specific vasopressors in septic shock are limited. Since angiotensin II (AT2) was approved by the Food and Drug Administration in 2017, multiple mechanistically distinct vasopressors...

    Authors: J. Pedro Teixeira, David Perez Ingles, Jordan B. Barton, James T. Dean, Pablo Garcia, Susan J. Kunkel, Preeyaporn Sarangarm, Natalie K. Weiss, Christopher L. Schaich, Laurence W. Busse and Nathan D. Nielsen
    Citation: Trials 2024 25:182
  40. Vulvar lichen planus (VLP) is a chronic vulvar dermatosis that is difficult to treat and can severely impair quality of life in the absence of adequate treatment. There is a lack of high-quality evidence to di...

    Authors: Marlene Wijaya, Gayle Fischer and Rebecca Bronwyn Saunderson
    Citation: Trials 2024 25:181
  41. Randomized trials for the treatment of tuberculosis (TB) rely on a composite primary outcome to capture unfavorable treatment responses. However, variability between trials in the outcome definition and estima...

    Authors: Isabelle R. Weir, Suzanne M. Dufault and Patrick P. J. Phillips
    Citation: Trials 2024 25:180
  42. Referrals to specialised mental health care (such as community mental health centres; CMHC) have increased over the last two decades. Patients often have multifaceted problems, which cannot only be solved by s...

    Authors: Camilla Angelsen Kvestad, Ingvild Rønneberg Holte, Solveig Klæbo Reitan, Charlotte S. Chiappa, Gunn Karin Helle, Anne E. Skjervold, Anne Marit A. Rosenlund, Øyvind Watne, Heidi Brattland, Jon Helle, Turid Follestad, Karen Walseth Hara and Katrine Høyer Holgersen
    Citation: Trials 2024 25:179
  43. Authors: Samyra R. Cox, Abhay Kadam, Sachin Atre, Akshay N. Gupte, Hojoon Sohn, Nikhil Gupte, Trupti Sawant, Vishal Mhadeshwar, Ryan Thompson, Emily Kendall, Christopher Hofmann, Nishi Suryavanshi, Deanna Kerrigan, Srikanth Tripathy, Arjunlal Kakrani, Madhusudan S. Barthwal…
    Citation: Trials 2024 25:178

    The original article was published in Trials 2022 23:635

  44. Multimorbid and frail elderly patients often carry a high burden of treatment. Hospitalization due to the onset of an acute illness can disrupt the fragile balance, resulting in further readmissions after hosp...

    Authors: Christoph Heinrich Lindemann, Volker Burst, Linus Alexander Völker, Sebastian Brähler, Dusan Simic, Ingrid Becker, Martin Hellmich, Clarissa Kurscheid, Nadine Scholten, Ruben Krauspe, Kerstin Leibel, Stephanie Stock and Paul Thomas Brinkkoetter
    Citation: Trials 2024 25:177
  45. Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfac...

    Authors: Rabea Vogt, Julia Haas, Lukas Baumann, Anja Sander, Christina Klose, Jenny Riecke, Winfried Rief, Ulrike Bingel, Dustin Maser, Michael Witthöft, Jens Keßler, Marco Richard Zugaj, Beate Ditzen and Julia Anna Glombiewski
    Citation: Trials 2024 25:176
  46. The demand for plasma products is growing, necessitating an increase in plasma collection by plasmapheresis. While the 20th edition of the European Guidelines permits plasma donors in Europe to donate with 96-...

    Authors: Morten Haugen, Karin Magnussen, Tonje Eiane Aarsland, Lise Sofie Haug Nissen-Meyer and Tor A. Strand
    Citation: Trials 2024 25:175
  47. While research on substance using youth experiencing homelessness (YEH) is increasing, there is a dearth of information regarding effective prevention interventions for these youth. Suicide is the leading caus...

    Authors: Natasha Slesnick, Brittany Brakenhoff, Laura J. Chavez, Caleb L. Cuthbertson, Ruri Famelia, Xin Feng, Jodi Ford, Eugene Holowacz, Soren Jaderlund, Kelly Kelleher, Ellison Luthy, Allen M. Mallory, Alexis Pizzulo, Tatiana D. Slesnick and Tansel Yilmazer
    Citation: Trials 2024 25:174
  48. Emerging adults (EAs) who are not 4-year college students nor graduates are at elevated risk for lifetime alcohol use disorder, comorbid drug use, and mental health symptoms, compared to college graduates. The...

    Authors: James G. Murphy, Ashley A. Dennhardt, Jacob Tempchin, Hannah E. Colgonis, Meghan E. McDevitt-Murphy, Brian Borsari and Kristoffer S. Berlin
    Citation: Trials 2024 25:173

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