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  1. Although many efforts have been made to decrease the incidence of anastomotic leak (AL), it remains one of the most serious complications of rectal cancer surgery. Many previous studies have reported an associ...

    Authors: Soo Young Lee, Sohyun Kim, Gyung Mo Son, Hye Jin Kim, Soo Yeun Park, Jun Seok Park, Chang Hyun Kim, Gi Won Ha, Kyung-Ha Lee, Jin Soo Kim, Ki Beom Bae, Sung Uk Bae and Sung Il Kang
    Citation: Trials 2022 23:920
  2. Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, int...

    Authors: Nandi Louise Siegfried, Sally Hopewell, Lesley-Ann Erasmus-Claassen and Bronwyn Myers
    Citation: Trials 2022 23:918
  3. Infectious complications are the main causes of morbidity after pancreaticoduodenectomy (PD). Early enteral nutrition (EN) is a reasonable form of nutritional support that aims to mitigate the occurrence and s...

    Authors: Yoshinori Takeda, Yoshihiro Mise, Yoji Kishi, Hiroyuki Sugo, Yusuke Kyoden, Kiyoshi Hasegawa, Yu Takahashi and Akio Saiura
    Citation: Trials 2022 23:917
  4. Nonarteritic anterior ischemic optic neuropathy (NAAION) is a major cause of blindness in individuals over 50 years of age, with no available effective treatment. The oral dual endothelin receptor antagonist, ...

    Authors: Christophe Chiquet, Catherine Vignal, Philippe Gohier, Emmanuel Heron, Gilles Thuret, Marie Bénédicte Rougier, Audrey Lehmann, Laurent Flet, Jean-Louis Quesada, Mathieu Roustit, Dan Milea and Jean-Louis Pepin
    Citation: Trials 2022 23:916
  5. Refugees often report high levels of psychological distress due to traumatic experiences before and during flight as well as many post-migration stressors. Refugees with hazardous substance use or existing sub...

    Authors: Ingo Schäfer, Philipp Hiller, Sascha Milin and Annett Lotzin
    Citation: Trials 2022 23:915
  6. Late-life depression (LLD) has a poorer prognosis and higher relapse rate than younger adults, with up to one third of patients with LLD showing suboptimal response to antidepressant therapy. LLD has been asso...

    Authors: Sze Ting Joanna Ngan, Lap Kei Chan, Wai Chi Chan, Linda Chiu Wa Lam, Wan Kei Li, Kelvin Lim, Ego Or, Pui Fai Pang, Ting Keung Poon, Mei Cheung Mimi Wong, Ying King Anna Wu and Pak Wing Calvin Cheng
    Citation: Trials 2022 23:914
  7. Disease recurrence is the main cause of mortality after resection of pancreatic ductal adenocarcinoma (PDAC). In 20–30% of resected patients, isolated local PDAC recurrence occurs. Retrospective studies have s...

    Authors: I. W. J. M. van Goor, L. A. Daamen, M. G. Besselink, A. M. E. Bruynzeel, O. R. Busch, G. A. Cirkel, B. Groot Koerkamp, N. Haj Mohammed, H. D. Heerkens, H. W. M. van Laarhoven, G. J. Meijer, J. Nuyttens, H. C. van Santvoort, G. van Tienhoven, H. M. Verkooijen, J. W. Wilmink…
    Citation: Trials 2022 23:913

    The Correction to this article has been published in Trials 2023 24:55

  8. Bladder symptoms are common in Parkinson’s disease (PD), affecting half of all individuals. These have significant impact on quality of life as well as implications for morbidity, contributing to falls and hos...

    Authors: Matthew D. Smith, Emma Tenison, Marcus J. Drake, Yoav Ben-Shlomo and Emily J. Henderson
    Citation: Trials 2022 23:912
  9. Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and...

    Authors: Russell J. McCulloh, Paul M. Darden, Jessica Snowden, Songthip Ounpraseuth, Jeannette Lee, Martina Clarke, Sophia R. Newcomer, Linda Fu, DeAnn Hubberd, Jaime Baldner, Maryam Garza and Ellen Kerns
    Citation: Trials 2022 23:911

    The Correction to this article has been published in Trials 2024 25:111

  10. Implantable collamer lens implantation (ICL) is a form of ‘foldable’ posterior chamber phakic intraocular lens refractive surgery that generally does not impair cornea and natural accommodation. The potential ...

    Authors: Kangjun Li, Zheng Wang and Ming X. Wang
    Citation: Trials 2022 23:910
  11. Chronic health conditions have a big impact on disability, morbidity, and mortality worldwide. Smartphone health applications (apps) can improve the health of patients with chronic conditions and enhance the q...

    Authors: Jürgen Barth, Jiani Wang, Jesus Lopez-Alcalde, Christoph Kramm, Daniel Pach, Noelia Álvarez-Díaz, Eulàlia Grifol-Clar and Claudia M. Witt
    Citation: Trials 2022 23:909
  12. The use of platelet-rich plasma has been increasing in spinal fusion surgery. However, the efficacy of platelet-rich plasma in lateral lumbar interbody fusion is unclear. In Japan, Affinos,® (Kuraray Co., Toky...

    Authors: Kosuke Sato, Toru Funayama, Hiroshi Noguchi, Tomoyuki Asada, Mamoru Kono, Fumihiko Eto, Yosuke Shibao, Kosei Miura, Naoya Kikuchi, Tomokazu Yoshioka, Hiroshi Takahashi, Masao Koda and Masashi Yamazaki
    Citation: Trials 2022 23:908
  13. Surgery and radiotherapy are well-established standards of care for unilateral stage 0 and I early-stage glottic cancer (ESGC). Based on comparative studies and meta-analyses, functional and oncological outcom...

    Authors: Philipp Reinhardt, Roland Giger, Eberhard Seifert, Mohamed Shelan, Elena Riggenbach, Dario Terribilini, Andreas Joosten, Daniel H. Schanne, Daniel M. Aebersold, Peter Manser, Matthias S. Dettmer, Christian Simon, Esat M. Ozsahin, Raphaël Moeckli, Andreas Limacher, Francesca Caparrotti…
    Citation: Trials 2022 23:906
  14. Participant recruitment into clinical trials remains challenging. The global increase in the number of social media users has accelerated the use of social media as a modality of recruitment, particularly duri...

    Authors: Arabella Baker, Eleanor J. Mitchell and Kim S. Thomas
    Citation: Trials 2022 23:905
  15. Although screening for coronary artery disease (CAD) using computed tomography coronary angiography in patients with stable chest pain has been reported to be beneficial, patients with chronic kidney disease (...

    Authors: Teruo Noguchi, Hideki Ota, Naoya Matsumoto, Yoshiaki Morita, Akira Oshita, Eiji Kawasaki, Tomohiro Kawasaki, Kensuke Moriwaki, Shingo Kato, Kazuki Fukui, Tomoya Hoshi, Hiroaki Watabe, Tomoaki Kanaya, Yasuhide Asaumi, Yu Kataoka, Fumiyuki Otsuka…
    Citation: Trials 2022 23:904
  16. Dental implant placement may require a bone graft for vertical and horizontal alveolar ridge augmentation. Due to its osteoconduction, osteoinductive, and osteogenesis, autogenous bone graft characteristics ar...

    Authors: Carolina Mendonça de Almeida Malzoni, Victor Gonçalves, Juliana Possari and Elcio Marcantonio Junior
    Citation: Trials 2022 23:903
  17. The long-standing view that auditory verbal hallucinations (AVH) or hearing voices is a sign of schizophrenia has been challenged by research demonstrating that they lie on a continuum ranging from normal to p...

    Authors: Marialuisa Cavelti, Janko M. Kaeser, Stefan Lerch, Stephanie Bauer, Markus Moessner, Thomas Berger, Mark Hayward and Michael Kaess
    Citation: Trials 2022 23:902
  18. Pediatric patients have increasing rates of hospital-associated venous thromboembolism (HA-VTE), and while several risk-prediction models have been developed, few are designed to assess all general pediatric p...

    Authors: Shannon C. Walker, Benjamin French, Ryan Moore, Henry J. Domenico, Jonathan P. Wanderer, Sreenivasa Balla, C. Buddy Creech, Daniel W. Byrne and Allison P. Wheeler
    Citation: Trials 2022 23:901
  19. Metabolic surgery induces rapid remission of type 2 diabetes mellitus (T2DM). There is a paucity of high level evidence comparing the efficacy of the laparoscopic Roux-en-Y gastric bypass (RYGB) and the laparo...

    Authors: A. van Rijswijk, N. van Olst, A. S. Meijnikman, Y. I. Z. Acherman, S. C. Bruin, A. W. van de Laar, C. C. van Olden, O. Aydin, H. Borger, U. H. W. Beuers, H. Herrema, J. Verheij, J. A. Apers, F. Bäckhed, V. E. A. Gerdes, M. Nieuwdorp…
    Citation: Trials 2022 23:900
  20. The COVID-19 pandemic has had major impacts in many different spheres, including mental health. Children and adolescents are especially vulnerable because their central nervous system is still in development a...

    Authors: Caio Borba Casella, Pedro Fonseca Zuccolo, Luisa Sugaya, Aline Santana de Souza, Luara Otoch, Fernanda Alarcão, Wagner Gurgel, Daniel Fatori and Guilherme V. Polanczyk
    Citation: Trials 2022 23:899
  21. Tic disorders (TD) is a neuropsychiatric disease with twitch as the main manifestation in childhood. Jiu-Wei-Xi-Feng granules has been marketed in China for treating children with TD. As Long Gu (Os Draconis) in ...

    Authors: Sheng-xuan Guo, Rui-ben Li, Si-yuan Hu, Qiu-han Cai, Cheng-liang Zhong and Rui-min Hao
    Citation: Trials 2022 23:898
  22. Chemoradiotherapy is the standard of care for esophageal cancer as a neoadjuvant treatment before surgery, or as a definitive treatment for unresectable disease. Intensity-modulated radiotherapy (IMRT) has bee...

    Authors: Chawalit Lertbutsayanukul, Sarin Kitpanit, Danita Kannarunimit, Chakkapong Chakkabat, Sornjarod Oonsiri, Kullathorn Thephamongkhol, Putipun Puataweepong, Kanyarat Katanyoo, Jirasak Sukhaboon, Chokaew Tovanabut, Sirikanya Chongsathientham, Pornravee Treeratsapanich, Jirarat Soonthornrak and Anussara Prayongrat
    Citation: Trials 2022 23:897
  23. Systematically screening for child anxiety problems, and offering and delivering a brief, evidence-based intervention for children who are identified as likely to benefit would minimise common barriers that fa...

    Authors: Tessa Reardon, Obioha C. Ukoumunne, Mara Violato, Susan Ball, Paul Brown, Tamsin Ford, Alastair Gray, Claire Hill, Bec Jasper, Michael Larkin, Ian Macdonald, Fran Morgan, Jack Pollard, Michelle Sancho, Falko F. Sniehotta, Susan H. Spence…
    Citation: Trials 2022 23:896
  24. Infection is one of the most common causes of death in patients with hematological malignancies during chemotherapy. Due to its special location, local warmth and humidity, repeated pollution with stool and ur...

    Authors: Yuqin Luo, Yingli Wang, Mei Yang, Ting Luo, Fengjiao Chen, Yamei Leng, Li Zhou, Jinbo Fang, Yuan Li and Chen Chen
    Citation: Trials 2022 23:895
  25. Chronic, non-cancer pain affects approximately 20–30% of the population in North America, Europe, and Australia, with surgery and trauma frequently cited as inciting events. Prospective studies of fracture pat...

    Authors:
    Citation: Trials 2022 23:894

    The Correction to this article has been published in Trials 2023 24:142

  26. Chronic radiation-associated dysphagia (C-RAD) is considered to be one of the most severe functional impairments in head and neck cancer survivors treated with radiation (RT) or chemoradiation (CRT). Given the...

    Authors: Hanne Massonet, Ann Goeleven, Leen Van den Steen, Alice Vergauwen, Margot Baudelet, Gilles Van Haesendonck, Olivier Vanderveken, Heleen Bollen, Lisette van der Molen, Fréderic Duprez, Peter Tomassen, Sandra Nuyts and Gwen Van Nuffelen
    Citation: Trials 2022 23:893
  27. Couple relationship distress is common and associated with poor physical, psychological, and relational outcomes for both partners. Emotionally Focused Therapy for couples (EFT) is a short-term structured appr...

    Authors: Martiño Rodríguez-Gonzalez, Shayne Anderson, Alfonso Osorio, Marie-France Lafontaine, Paul S. Greenman, María Calatrava, Dania Andrade, Ragan Lybbert, Pilar Martínez-Diaz, Patrick Steffen, Jokin de Irala and Jonathan Sandberg
    Citation: Trials 2022 23:891
  28. Attention deficit/hyperactivity disorder (ADHD) is the most common chronic mental and behavioral disorder among children. Some studies showed the lower levels of vitamin D in patients with ADHD compared with t...

    Authors: Abbas Ali Sangouni, Hamid Mirhosseini and Mahdieh Hosseinzadeh
    Citation: Trials 2022 23:890
  29. Randomised clinical trials with a factorial design may assess the effects of multiple interventions in the same population. Factorial trials are carried out under the assumption that the trial interventions ha...

    Authors: Markus Harboe Olsen, Aksel Karl Georg Jensen, Josef Dankiewicz, Markus B. Skrifvars, Matti Reinikainen, Marjaana Tiainen, Manoj Saxena, Anders Aneman, Christian Gluud, Susann Ullén, Niklas Nielsen and Janus Christian Jakobsen
    Citation: Trials 2022 23:889
  30. Patients with chronic idiopathic axonal polyneuropathy (CIAP) can have neuropathic pain that significantly impacts quality of life. Oral neuropathic pain medication often has insufficient pain relief and side ...

    Authors: David J. Kopsky, Ruben P. A. van Eijk, Janna K. Warendorf, Jan M. Keppel Hesselink, Nicolette C. Notermans and Alexander F. J. E. Vrancken
    Citation: Trials 2022 23:888
  31. The study will compare the efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative analgesia in tumor ablation and the differences between the two group...

    Authors: Youhua Xue, Zhengli Huang, Bingwei Cheng, Jie Sun, Haidong Zhu, Yuting Tang and Xiaoyan Wang
    Citation: Trials 2022 23:887
  32. Aboriginal Australians are known to suffer high levels of acquired brain injury (stroke and traumatic brain injury) yet experience significant barriers in accessing rehabilitation services. The aim of the Heal...

    Authors: Elizabeth Armstrong, Tapan Rai, Deborah Hersh, Sandra Thompson, Juli Coffin, Natalie Ciccone, Leon Flicker, Dominique Cadilhac, Erin Godecke, Deborah Woods, Colleen Hayward, Graeme J. Hankey, Meaghan McAllister and Judith Katzenellenbogen
    Citation: Trials 2022 23:886
  33. Xanthohumol (XN), a bioactive flavonoid from Humulus lupulus with anti-inflammatory properties, has potential benefits for patients with Crohn’s disease (CD), a type of inflammatory bowel disease. We recently com...

    Authors: Blake O. Langley, Jennifer Joan Ryan, John Phipps, Lita Buttolph, Brenna Bray, Joseph E. Aslan, Thomas O. Metz, Jan F. Stevens and Ryan Bradley
    Citation: Trials 2022 23:885
  34. As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here to inform post-pandemic trial methodology.

    Authors: Laura A. Magee, Sue Tohill, Katie Kirkham, Ruth Evans, Eleni Gkini, Catherine A. Moakes, Clive Stubbs, Jim Thornton and Peter von Dadelszen
    Citation: Trials 2022 23:884
  35. Recruiting patients to randomised controlled trials (RCTs) is often reported to be challenging, and the evidence base for effective interventions that could be used by staff (recruiters) undertaking recruitmen...

    Authors: Nicola Farrar, Daisy Elliott, Catherine Houghton, Marcus Jepson, Nicola Mills, Sangeetha Paramasivan, Lucy Plumb, Julia Wade, Bridget Young, Jenny L. Donovan and Leila Rooshenas
    Citation: Trials 2022 23:883
  36. Enteral nutrition is a major pathway of nutrition for patients requiring critical care. However, it remains unclear whether intermittent or continuous feeding is the better approach, especially after nasogastr...

    Authors: Guang Yang, Aijing Deng, Bojun Zheng, Jian Li, Yi Yu, Honglian Ouyang, Xin Huang and Hong Chen
    Citation: Trials 2022 23:882
  37. To inform the oversight of future clinical trials during a pandemic, we summarise the experiences of the Data Monitoring Committee (DMC) for the Randomised Evaluation of COVID therapy trial (RECOVERY), a large...

    Authors: Peter A. G. Sandercock, Janet Darbyshire, David DeMets, Robert Fowler, David G. Lalloo, Mohammed Munavvar, Natalie Staplin, Adilia Warris, Janet Wittes and Jonathan R. Emberson
    Citation: Trials 2022 23:881
  38. Treatment of opiate addiction with opiate substitution treatment (e.g. methadone) is beneficial. However, some individuals desire or would benefit from abstinence but there are limited options to attenuate pro...

    Authors: L. M. Paterson, D. Barker, S. Cro, P. Mozgunov, R. Phillips, C. Smith, L. Nahar, S. Paterson and A. R. Lingford-Hughes
    Citation: Trials 2022 23:880
  39. Non-erosive reflux disease (NERD) is characterized by typical gastroesophageal reflux symptoms, such as heartburn and regurgitation but an absence of esophageal mucosal damage during upper gastrointestinal end...

    Authors: Xia Li, Haomeng Wu, Beihua Zhang, Ting Chen, Xiaoshuang Shi, Jinxin Ma, Jiaqi Zhang, Xudong Tang and Fengyun Wang
    Citation: Trials 2022 23:879
  40. Surgical care, which is performed by intensely interacting multidisciplinary teams of surgeons, anesthetists, and nurses, remains associated with significant morbidity and mortality. Intraoperative communicati...

    Authors: Sandra Keller, Franziska Tschan, Norbert K. Semmer, Sven Trelle, Tanja Manser and Guido Beldi
    Citation: Trials 2022 23:878
  41. Menière’s disease is an idiopathic disorder characterized by recurrent episodes of vertigo lasting more than 20 min, unilateral sensorineural hearing loss, and tinnitus. If vertigo attacks occur frequently, th...

    Authors: Casper Grønlund Larsen, Mikael Karlberg, Frank Guldfred, Louise Devantier, Mathias Maagaard, Preben Homøe and Bjarki Ditlev Djurhuus
    Citation: Trials 2022 23:877
  42. This study is in regard to the comparison of whole brain radiation therapy for synchronous brain metastases with irradiation protecting the hippocampus versus whole brain radiotherapy for sequential brain meta...

    Authors: Xiaofang Zhang, Tianlu Wang, Chen Yu Wang, Peng Zhao, Bo Huang, Lei He and Ying Qiu Song
    Citation: Trials 2022 23:876
  43. Since early 2022, patients with 2019 novel coronavirus (COVID-19) infection have increased rapidly in Shanghai, China. Nevertheless, there is no widely used unified rehabilitation treatment available for disch...

    Authors: Guangxin Guo, Xiruo Xu, Wong Yu Yin, Kunyu Zhang, Jacelyn Pang Min Hui, Janice Hiew Yuen Yee, Bryan Chung Qi Heng, Yuan Qin, Fei Yao and Min Fang
    Citation: Trials 2022 23:875
  44. The value of pulsed electromagnetic field (PEMF) in postoperative pain management, due to the inconsistent findings so far, remains unclear. We extended the evaluation of PEMF on postoperative pain and intrave...

    Authors: Muralitharan Perumal, Aizatul Isla Abdul Latib, Malarvilee Paul Samy, Mohd Rohisham bin Zainal Abidin, Elanngovan Nagandran, Tham Sim Wan, Pamela Francis and Chee Yoong Foo
    Citation: Trials 2022 23:874
  45. Neuromuscular electrical stimulation (NMES) is an established therapy that has been widely used for many decades to improve circulation in the legs. However, studies using NMES devices in an elderly, ambulant,...

    Authors: Binoy Kumaran, Darren Targett and Tim Watson
    Citation: Trials 2022 23:873
  46. Stroke, the incidence of which increases with age, has a negative impact on motor and cognitive performance, quality of life, and the independence of the person and his or her family, leading to a number of di...

    Authors: Silvia Giovannini, Chiara Iacovelli, Fabrizio Brau, Claudia Loreti, Augusto Fusco, Pietro Caliandro, Lorenzo Biscotti, Luca Padua, Roberto Bernabei and Letizia Castelli
    Citation: Trials 2022 23:872
  47. Intracerebral hemorrhage (ICH) is a devastating disease, its mortality and disability rate are high. In China, hypertensive intracerebral hemorrhage (HICH) is responsible for 75% of all the cases of primary IC...

    Authors: Min Jia, Yan Lu, Xiao Liang, Chenguang Tong, Jian Wang, Jun Tang, Jian Yang, Min Wang, Weiwei Jiao, Wanqing Du, Jingjing Wei, Zixiu Zeng, Zhenmin Xu, Qian Chen, Lin Lei, Xing Liao…
    Citation: Trials 2022 23:871
  48. The evidence on what strategies can improve recruitment to clinical trials in maternity care is lacking. As trial recruiters, maternity healthcare professionals (MHCPs) perform behaviours (e.g. talking about t...

    Authors: Vivienne Hanrahan, Louisa Lawrie, Eilidh Duncan, Linda Biesty and Katie Gillies
    Citation: Trials 2022 23:870

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