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  1. New treatments are needed for people with treatment-resistant depression (TRD), who do not benefit from anti-depressants and many of whom do not recover fully with psychological treatments. The Community Navig...

    Authors: Theodora Stefanidou, Gareth Ambler, Gergely Bartl, Nick Barber, Jo Billings, Tumelo Bogatsu, Richard Carroll, Beverley Chipp, Maev Conneely, Anne-Marie Downey, Gamze Evlat, Rachael Hunter, Marie Le Novere, Glyn Lewis, Tanya Mackay, Steven Marwaha…
    Citation: Trials 2023 24:652
    Content type: Study protocol Published on:

  2. Despite remarkable medical advances in the treatment of rheumatoid arthritis (RA), a subset of patients fails to achieve complete clinical remission, as the Patient Global Assessment (PGA) of disease activity ...

    Authors: Cátia Duarte, Ruben L. F. Spilker, Cláudia Paiva, Ricardo J. O. Ferreira, José A. Pereira da Silva and Ana M. Pinto
    Citation: Trials 2023 24:651
    Content type: Study protocol Published on:

  3. Stroke is a leading cause of disability among adults worldwide. A timely structured follow-up tool to identify patients’ rehabilitation needs and develop patient-tailored rehabilitation regimens to decrease di...

    Authors: Xiaolei Hu, Per Liv, Erik Lundström, Fredrik Norström, Olof Lindahl, Kristian Borg and Katharina S. Sunnerhagen
    Citation: Trials 2023 24:650
    Content type: Study protocol Published on:

  4. Chronic insomnia is the most prevalent sleep disorder among military service members, and it compromises readiness, performance, and physical and mental health. Cognitive behavioral treatment for insomnia (CBT...

    Authors: Anne Germain, Megan Wolfson, Matthew S. Brock, Brian O’Reilly, Hunter Hearn, Shelley Knowles, Vincent Mysliwiec and Meredith L. Wallace
    Citation: Trials 2023 24:648
    Content type: Study protocol Published on:

  5. Health problems in neonates with gestational age (GA) ≥ 32 weeks remain a major medical concern. Respiratory distress (RD) is one of the common reasons for admission of neonates with GA ≥ 32 weeks. Noninvasive...

    Authors: Rong Zhou, Tao Xiong, Jun Tang, Yi Huang, Wenli Liu, Jun Zhu, Chao Chen, Lingyue Gong, Ke Tian, Aoyu Wang and Dezhi Mu
    Citation: Trials 2023 24:647
    Content type: Study protocol Published on:

  6. Depressive episodes are common after first-episode psychosis (FEP), affecting more than 40% of people, adding to individual burden, poor outcomes, and healthcare costs. If the risks of developing depression we...

    Authors: Edward R. Palmer, Siân Lowri Griffiths, Ben Watkins, Tyler Weetman, Ryan Ottridge, Smitaa Patel, Rebecca Woolley, Sarah Tearne, Pui Au, Eleanor Taylor, Zara Sadiq, Hareth Al-Janabi, Barnaby Major, Charlotte Marriott, Nusrat Husain, Mohammad Zia Ul Haq Katshu…
    Citation: Trials 2023 24:646
    Content type: Study protocol Published on:

  7. Patients with acute myocardial infarction are at greater risk for chronic heart failure and mortality. Currently, there is limited evidence supporting the beneficial effects of sodium-glucose cotransporter-2 i...

    Authors: Sajad Khiali, Mohammadreza Taban-Sadeghi, Parvin Sarbakhsh, Naser Khezerlouy-Aghdam, Hossein Namdar, Rezvanieh Salehi, Afra Rezagholizadeh and Taher Entezari-Maleki
    Citation: Trials 2023 24:645
    Content type: Study protocol Published on:

  8. Persecutory delusions are strong threat beliefs about others’ negative intentions. They can have a major impact on patients’ day-to-day life. The Feeling Safe Programme is a new translational cognitive-behavio...

    Authors: Eva Tolmeijer, Felicity Waite, Louise Isham, Laura Bringmann, Robin Timmers, Arjan van den Berg, Hanneke Schuurmans, Anton B. P. Staring, Paul de Bont, Rob van Grunsven, Gert Stulp, Ben Wijnen, Mark van der Gaag, Daniel Freeman and David van den Berg
    Citation: Trials 2023 24:644
    Content type: Study protocol Published on:

    The Correction to this article has been published in Trials 2023 24:813

  9. Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribe...

    Authors: Julia Truthmann, Julia Freyer Martins Pereira, Adrian Richter, Franziska Schuster, Amelie Witte, Susanne Böhm, Alexandra Greser, Petra Kamin, Sylvia Stracke, Marcus Dörr, Robin Bülow, Stefan Engeli, Ildikó Gágyor, Eva Hummers and Jean-François Chenot
    Citation: Trials 2023 24:643
    Content type: Study protocol Published on:

  10. Despite preventive measures, the number of people with type 2 diabetes and obesity is increasing. Obesity increases morbidity and mortality in people with type 2 diabetes, making weight loss a cornerstone of t...

    Authors: Karlijn A. M. Geurts, Behiye Ozcan, Mandy van Hoek, Roel van de Laar, Jolande van Teeffelen, Joost van Rosmalen, Elisabeth F. C. van Rossum and Kirsten A. Berk
    Citation: Trials 2023 24:642
    Content type: Study protocol Published on:

  11. Colorectal cancer stands as a prevalent cause of cancer-related mortality, necessitating effective treatment strategies. Acute colonic obstruction occurs in approximately 20% of patients and represents a surgi...

    Authors: Mathieu Pecqueux, Marius Distler, Olga Radulova-Mauersberger, Ulrike Neckmann, Sandra Korn, Christian Praetorius, Johannes Fritzmann, Anna Klimova, Jürgen Weitz and Christoph Kahlert
    Citation: Trials 2023 24:641
    Content type: Study protocol Published on:

    The Correction to this article has been published in Trials 2023 24:687

  12. In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals “to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and dev...

    Authors: Martin Law, Dominique-Laurent Couturier, Babak Choodari-Oskooei, Phillip Crout, Carrol Gamble, Peter Jacko, Philip Pallmann, Mark Pilling, David S. Robertson, Michael Robling, Matthew R. Sydes, Sofía S. Villar, James Wason, Graham Wheeler, S. Faye Williamson, Christina Yap…
    Citation: Trials 2023 24:640
    Content type: Commentary Published on:

    The Correction to this article has been published in Trials 2023 24:744

  13. Many infants in low-resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast...

    Authors: Moleen Zunza, Lehana Thabane, Louise Kuhn, Christine Els, Mark F. Cotton and Taryn Young
    Citation: Trials 2023 24:639
    Content type: Study protocol Published on:

  14. The extent of resection of glioma is one of the most important predictors of the survival duration of patients after surgery. The presence of eloquent areas within or near a tumor often limits resection, as re...

    Authors: Melina Engelhardt, Ulrike Grittner, Sandro Krieg and Thomas Picht
    Citation: Trials 2023 24:638
    Content type: Study protocol Published on:

  15. Antibiotics are over-used for patients with respiratory tract infections (RTIs) in primary care, especially in the rural areas of China.

    Authors: Rong Liu, Qun Xue, Xiaoqin Guan, Guocheng Li, Tingting Zhang, Debin Wang, Linhai Zhao and Xingrong Shen
    Citation: Trials 2023 24:637
    Content type: Study protocol Published on:

  16. A large epidemic, such as that observed with SARS-CoV-2, seriously challenges available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Bacillus Calmette-Guérin (BCG) i...

    Authors: Andrew R. DiNardo, Moshe Arditi, Ashish M. Kamat, Kent J. Koster, Santiago Carrero, Tomoki Nishiguchi, Maxim Lebedev, Aaron B. Benjamin, Pablo Avalos, Marisa Lozano, Madeleine G. Moule, Brittany McCune, Baysia Herron, Malik Ladki, Daanish Sheikh, Matthew Spears…
    Citation: Trials 2023 24:636
    Content type: Study protocol Published on:

  17. Repeated COVID-19 waves and corresponding mitigation measures have impacted health systems globally with exceptional challenges. In response to the pandemic, researchers, regulators, and funders rapidly pivote...

    Authors: Nomathemba Chandiwana, Chelsea Kruger, Naomi Richardson, Sibongiseni Nxumalo, Nkoleleng Mashilo, Yengiwe Dineka, Ntanganedzeni Mudau, Hilary Johnstone, Wookyung Kim, Chung Ju, Sarah Arbe-Barnes, Anne Claire Marrast, Julia Flynn and Willem D. Francois Venter
    Citation: Trials 2023 24:635
    Content type: Commentary Published on:

  18. Delirium is a complex neuropsychiatric syndrome which consists of acute and varying changes in cognition and consciousness. Patients who develop delirium are at increased risk for a constellation of physical, ...

    Authors: Sanjay Mohanty, Emma Holler, Damaris Ortiz, Ashley Meagher, Anthony Perkins, Peggy Bylund, Babar Khan, Frederick Unverzagt, Hupuing Xu, Angela Ingraham, Malaz Boustani and Ben Zarzaur
    Citation: Trials 2023 24:634
    Content type: Study protocol Published on:

  19. Neurogenic bowel dysfunction (NBD) is a prevalent complication among stroke patients, significantly affecting their quality of life, duration of hospitalization, medical expenses, and even mortality. Although ...

    Authors: Sumin Ma, Xiaoyan Fan, Ying He, Chengjuan Li, Dandan Qu and Yanli Man
    Citation: Trials 2023 24:633
    Content type: Study protocol Published on:

  21. Authors: Tina Haugen, Joar Øveraas Halvorsen, Oddgeir Friborg, Melanie Rae Simpson, Paul Jarle Mork, Gustav Mikkelsen, Ask Elklit, Barbara O. Rothbaum, Berit Schei and Cecilie Hagemann
    Citation: Trials 2023 24:631
    Content type: Correction Published on:

    The original article was published in Trials 2023 24:126

  22. Authors: Judit Bassols, Francis de Zegher, Marta Diaz, Gemma Carreras‑Badosa, Cristina Garcia‑Beltran, Elsa Puerto‑Carranza, Cora Oliver‑Vila, Paula Casano, Celine Alicia Franco, Rita Malpique, Abel Lopez‑Bermejo and Lourdes Ibanez
    Citation: Trials 2023 24:630
    Content type: Correction Published on:

    The original article was published in Trials 2023 24:56

  23. Authors: Francesco Zaraca, Andreas Kirschbaum, Marco Damiano Pipitone and Luca Bertolaccini
    Citation: Trials 2023 24:629
    Content type: Correction Published on:

    The original article was published in Trials 2023 24:594

  24. Post-traumatic wrist osteoarthritis (OA) can eventually lead to pain, muscular weakness, and stiffness of the wrist, which can affect the function of the entire upper limb and reduce the quality of life. Altho...

    Authors: Sara L. Larsson, Elisabeth Ekstrand, Lars B. Dahlin, Anders Björkman and Elisabeth Brogren
    Citation: Trials 2023 24:628
    Content type: Study protocol Published on:

  25. Intermittent theta burst stimulation (iTBS) when applied over the left dorsolateral prefrontal cortex (DLPFC) has been shown to be equally effective and safe to treat depression compared to traditional repetit...

    Authors: Marte Christine Ørbo, Ole K. Grønli, Camilla Larsen, Torgil R. Vangberg, Oddgeir Friborg, Zsolt Turi, Matthias Mittner, Gabor Csifcsak and Per M. Aslaksen
    Citation: Trials 2023 24:627
    Content type: Study protocol Published on:

  26. This update summarizes key changes made to the protocol for the Frequency of Screening and Spontaneous Breathing Trial (SBT) Technique Trial—North American Weaning Collaborative (FAST-NAWC) trial since the pub...

    Authors: Karen E. A. Burns, Myriam Lafrienier-Roula, Nicholas S. Hill, Deborah J. Cook, Andrew J. E. Seely, Bram Rochwerg, Michael Mayette, Frederick D’Aragon, John W. Devlin, Peter Dodek, Maged Tanios, Audrey Gouskos, Alexis F. Turgeon, Pierre Aslanian, Ying Tung Sia, Jeremy R. Beitler…
    Citation: Trials 2023 24:626
    Content type: Update Published on:

    The Study protocol to this article has been published in Trials 2019 20:587

  27. The global aging population is expanding rapidly and many individuals have a particularly higher risk of malnutrition. Malnutrition can lead to impaired body function, morbidity, and mortality. Meeting nutriti...

    Authors: Ranil Jayawardena, Prasani Wickramawardhane, Chamila Dalpatadu, Andrew P. Hills and Priyanga Ranasinghe
    Citation: Trials 2023 24:625
    Content type: Study protocol Published on:

  28. Lymph node (LN) metastasis is the most common metastasis route in gastric cancer. Extensive dissection of LNs can significantly improve the prognosis of patients with gastric cancer. Recently, multiple clinica...

    Authors: Yanjun Lu, Shichao Ai, Peng Song, Yan Sun, Xiaofei Shen, Feng Sun, Qiongyuan Hu, Zhiyan Li, Meng Wang, Xiaofeng Lu, Wenxian Guan and Song Liu
    Citation: Trials 2023 24:624
    Content type: Study protocol Published on:

  29. Atrial fibrillation (AF) is a common arrhythmia that requires anticoagulation therapy to prevent stroke. However, there is still a significant under-/over-treatment in stroke prevention for patients with AF. T...

    Authors: Mang-Mang Pan, Chi Zhang, Long Shen, Jing-Jing Sha, Hui Shen, Yi-Dan Yan, Jia Wang, Xin Wang, Hou-Wen Lin and Zhi-Chun Gu
    Citation: Trials 2023 24:623
    Content type: Study protocol Published on:

  30. Authors: Yaping Shi, Qingyu Sun, Yue Wang, Chunting Chen, Jianfei Jin, Wei Wang, Yuting Lu, Yi Hua, Jianming Liu, Jinjun Bian and Yi Zhou
    Citation: Trials 2023 24:622
    Content type: Correction Published on:

    The original article was published in Trials 2023 24:505

  31. Well-organised and managed workplaces can be a source of wellbeing. The construction, healthcare and information and communication technology sectors are characterised by work-related stressors (e.g. high work...

    Authors: Ella Arensman, Mallorie Leduc, Cliodhna O’Brien, Paul Corcoran, Eve Griffin, Caleb Leduc, Evelien Coppens, Fotini Tsantila, Victoria Ross, Kahar Abdulla, Pia Hauck, Benedikt L. Amann, Birgit Aust, Arlinda Cerga Pashoja, Johanna Cresswell-Smith, Luigia D’Alessandro…
    Citation: Trials 2023 24:621
    Content type: Study protocol Published on:

  32. Sepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement develo...

    Authors: Hannah E. Frank, Laura Evans, Gary Phillips, RPhillip Dellinger, Jessyca Goldstein, Lori Harmon, David Portelli, Nima Sarani, Christa Schorr, Kathleen M. Terry, Sean R. Townsend and Mitchell M. Levy
    Citation: Trials 2023 24:620
    Content type: Study protocol Published on:

  33. Radiation-associated dysphagia is defined as impaired swallowing efficiency/safety following (chemo)radiotherapy in head and neck cancer patients. In a dysphagia framework, impaired coughing may lead to lung a...

    Authors: Sofiana Mootassim-Billah, Gwen Van Nuffelen, Jean Schoentgen, Marc De Bodt and Dirk Van Gestel
    Citation: Trials 2023 24:619
    Content type: Methodology Published on:

  34. Authors: Angela T. Hetrick, April M. Young, Miriam R. Elman, Sarann Bielavitz, Rhonda L. Alexander, Morgan Brown, Elizabeth Needham Waddell, P. Todd Korthuis and Kathryn E. Lancaster
    Citation: Trials 2023 24:618
    Content type: Correction Published on:

    The original article was published in Trials 2021 22:948

  35. In contrast to evidence for interventions supporting victim/survivors of domestic violence and abuse (DVA), the effectiveness of perpetrator programmes for reduction of abuse is uncertain. This study aims to e...

    Authors: Karen Morgan, Mei-See Man, Rachael Bloomer, Madeleine Cochrane, Melissa Cole, Sandi Dheensa, Nathan Eisenstadt, Gene Feder, Daisy M. Gaunt, Rwth Leach, Rebecca Kandiyali, Sian Noble, Tim J. Peters, Beverly A. Shirkey and Helen Cramer
    Citation: Trials 2023 24:617
    Content type: Study protocol Published on:

  36. Neck pain is the fourth worldwide leading cause of disability and represents 22% of musculoskeletal disorders. Conservative intervention has been strongly recommended to treat chronic neck pain and Telerehabil...

    Authors: Juliene Corrêa Barbosa, Josielli Comachio, Amelia Pasqual Marques, Bruno Tirotti Saragiotto and Mauricio Oliveira Magalhaes
    Citation: Trials 2023 24:616
    Content type: Study protocol Published on:

  37. Many people experience withdrawal symptoms when they attempt to stop antidepressants. Withdrawal symptoms are readily misconstrued for relapse or ongoing need for medication, contributing to long-term use (> 1...

    Authors: Katharine A. Wallis, Maria Donald, Mark Horowitz, Joanna Moncrieff, Robert S. Ware, Joshua Byrnes, Karen Thrift, MaryAnne Cleetus, Idin Panahi, Nicholas Zwar, Mark Morgan, Chris Freeman and Ian Scott
    Citation: Trials 2023 24:615
    Content type: Study protocol Published on:

  38. Authors: M. Masiá, S. Padilla, G. Estañ, J. Portu, A. Silva, A. Rivero, A. González-Cordón, L. García-Fraile, O. Martínez, E. Bernal, C. Galera, V. Boix Martínez, J. Macias, M. Montero, D. García-Rosado, M. J. Vivancos-Gallego…
    Citation: Trials 2023 24:614
    Content type: Correction Published on:

    The original article was published in Trials 2021 22:851

  39. Two characteristics of commonly used outcomes in medical research are zero inflation and non-negative integers; examples include the number of hospital admissions or emergency department visits, where the majo...

    Authors: Kyung Hyun Lee, Claudia Pedroza, Elenir B. C. Avritscher, Ricardo A. Mosquera and Jon E. Tyson
    Citation: Trials 2023 24:613
    Content type: Research Published on:

  40. Respiratory distress syndrome is the main cause of mortality and morbidity in preterm infants. “Less invasive surfactant administration” (LISA), which describes intratracheal surfactant administration to spont...

    Authors: Wolfgang Göpel, Tanja K. Rausch, Barbara Mitschdörfer, Silke Mader, Egbert Herting, Inke R. König and Guido Stichtenoth
    Citation: Trials 2023 24:612
    Content type: Study protocol Published on:

  41. Effectiveness of actions to reduce sugar-sweetened beverage (SB) consumption in children still needs to be improved. Furthermore, the growing concern about sustainable food systems encourages to develop sustai...

    Authors: Katia Castetbon, Wassila Assakali, Isabelle Thiébaut and Lucille Desbouys
    Citation: Trials 2023 24:611
    Content type: Study protocol Published on:

  42. Parkinson’s disease (PD) is a neurodegenerative disorder with debilitating motor and non-motor symptoms which affect participation in meaningful occupations. Occupation-based interventions can improve particip...

    Authors: Mahsa Meimandi, Akram Azad, Jafar Haj Ghani, Fatemeh HojabriFard, Philip von Rosen, Naeeme Haji Alizadeh and Ghorban Taghizadeh
    Citation: Trials 2023 24:610
    Content type: Study protocol Published on:

  43. People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of subst...

    Authors: Jemima A. Frimpong, Carrigan L. Parish, Daniel J. Feaster, Lauren K. Gooden, Mindy C. Nelson, Tim Matheson, Karolynn Siegel, Louise Haynes, Benjamin P. Linas, Sabrina A. Assoumou, Susan Tross, Tiffany Kyle, Terri K. Liguori, Oliene Toussaint, Debra Annane and Lisa R. Metsch
    Citation: Trials 2023 24:609
    Content type: Study protocol Published on:

  44. Malignant gastric outlet obstruction (GOO) is a debilitating condition that frequently occurs in patients with malignancies of the distal stomach and (peri)ampullary region. The standard palliative treatment f...

    Authors: Janine B. Kastelijn, Yorick L. van de Pavert, Marc G. Besselink, Paul Fockens, Rogier P. Voermans, Roy L. J. van Wanrooij, Thomas R. de Wijkerslooth, Wouter L. Curvers, Ignace H. J. T. de Hingh, Marco J. Bruno, Bas Groot Koerkamp, Gijs A. Patijn, Alexander C. Poen, Jeanin E. van Hooft, Akin Inderson, J. Sven D. Mieog…
    Citation: Trials 2023 24:608
    Content type: Study protocol Published on:

  45. Postoperative delirium (POD) is a common complication, and it has a high incidence in neurosurgery patients. Awake craniotomy (AC) has been widely performed in patients with glioma in eloquent and motor areas....

    Authors: Muhan Li, Minying Liu, Qianyu Cui, Min Zeng, Shu Li, Liyong Zhang and Yuming Peng
    Citation: Trials 2023 24:607
    Content type: Study protocol Published on:

  46. Limited access to specialized palliative care exposes persons with late-stage Alzheimer’s disease and related dementias (ADRD) to burdensome treatment and unnecessary hospitalization and their caregivers to av...

    Authors: M. Toles, C. Kistler, F. C. Lin, M. Lynch, K. Wessell, S. L. Mitchell and L. C. Hanson
    Citation: Trials 2023 24:606
    Content type: Study protocol Published on:

    The Correction to this article has been published in Trials 2024 25:407

  47. During the cochlear implantation procedure, the receiver/stimulator (R/S) part of the implant is fixated to prevent postoperative device migration, which could have an adverse effect on the position of the ele...

    Authors: Laura M. Markodimitraki, Timen C. ten Harkel, Edwin Bennink, Inge Stegeman and Hans G. X. M. Thomeer
    Citation: Trials 2023 24:605
    Content type: Study protocol Published on:

  48. Spinal cord stimulation (SCS) is one of the neuromodulation therapies for chronic neuropathic pain. The conventional paresthesia-based SCS involves the application of tonic stimulation that induces a sense of ...

    Authors: Takafumi Tanei, Satoshi Maesawa, Yusuke Nishimura, Yoshitaka Nagashima, Tomotaka Ishizaki, Masahiko Ando, Yachiyo Kuwatsuka, Atsushi Hashizume, Shimon Kurasawa and Ryuta Saito
    Citation: Trials 2023 24:604
    Content type: Study protocol Published on:

  49. Haemoglobin SC (HbSC) is a common form of sickle cell disease (SCD), especially among individuals of West African ancestry. Persons with HbSC disease suffer from the same clinical complications and reduced qua...

    Authors: Luke R. Smart, Catherine I. Segbefia, Teresa S. Latham, Susan E. Stuber, Kwesi N. Amissah-Arthur, Klenam Dzefi-Tettey, Adam C. Lane, Yvonne A. Dei-Adomakoh and Russell E. Ware
    Citation: Trials 2023 24:603
    Content type: Study protocol Published on:

  50. Due to the growing gap between the demand and supply of therapeutic services for people suffering from depression, with this study, we are investigating the effectiveness and factors of influence of new approa...

    Authors: Leona Kind, Katharina Luttenberger, Vivien Leßmann, Lisa Dorscht, Christiane Mühle, Christian P. Müller, Eva-Maria Siegmann, Sophia Schneider and Johannes Kornhuber
    Citation: Trials 2023 24:602
    Content type: Study protocol Published on:
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