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  1. Rheumatoid arthritis (RA) is a common autoimmune disease that severely impacts quality of life. Currently available medications for the treatment of RA have adverse side effects. Emerging evidence suggests tha...

    Authors: Huifang Luo, Jie Peng, Qing Ma, Zhihua Wei, Changsong Lin, Mingying Zhang, Peiwu Li, Yang Song and Xiangwei Yang

    Citation: Trials 2021 22:450

    Content type: Study protocol

    Published on:

    The Correction to this article has been published in Trials 2021 22:533

  2. The PolyPrime intervention is a theory-based intervention aimed at improving appropriate polypharmacy in older people (aged ≥65 years) in primary care. The intervention consists of an online video which demons...

    Authors: Audrey Rankin, Gerard J. Molloy, Cathal A. Cadogan, Heather E. Barry, Ashleigh Gorman, Cristín Ryan, Alan Ferrett, Pat McCarthy, Gerard J. Gormley, Tom Fahey and Carmel M. Hughes

    Citation: Trials 2021 22:449

    Content type: Study protocol

    Published on:

  3. There is scarcity of trials about preventative strategies for low anterior resection syndrome (LARS) in rectal cancer patients. The aim of this study is to evaluate the effectiveness of a pre- and post-surgica...

    Authors: Cinara Sacomori, Luz Alejandra Lorca, Mónica Martinez-Mardones, Roberto Ignacio Salas-Ocaranza, Guillermo Patricio Reyes-Reyes, Marta Natalia Pizarro-Hinojosa and Jorge Plasser-Troncoso

    Citation: Trials 2021 22:448

    Content type: Study protocol

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  4. The Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patie...

    Authors: Maria Burton, Kate J. Lifford, Lynda Wyld, Fiona Armitage, Alistair Ring, Anthony Nettleship, Karen Collins, Jenna Morgan, Malcolm W. R. Reed, Geoffrey R. Holmes, Mike Bradburn, Jacqui Gath, Tracy Green, Deirdre Revell, Kate Brain and Adrian Edwards

    Citation: Trials 2021 22:447

    Content type: Research

    Published on:

  5. Literature shows a high prevalence of psychological distress (PD) as well as common mental disorders (CMD) such as major depressive disorders (MDD), generalized anxiety disorders (GAD), post-traumatic stress d...

    Authors: Dickens Akena, Ronald Kiguba, Wilson W. Muhwezi, Brendan Kwesiga, Gwendolyne Kigozi, Noeline Nakasujja and Hafsa Lukwata

    Citation: Trials 2021 22:446

    Content type: Study protocol

    Published on:

  6. Delays in starting physical therapy after hospital discharge worsen deconditioning in older adults. Intervening quickly can minimize the negative effects of deconditioning. Telerehabilitation is a strategy tha...

    Authors: Pollyana Ruggio Tristão Borges, Renan Alves Resende, Jane Fonseca Dias, Marisa Cotta Mancini and Rosana Ferreira Sampaio

    Citation: Trials 2021 22:445

    Content type: Study protocol

    Published on:

  7. Infants born very preterm (< 32 weeks gestational age (GA)) are at risk for developmental language delays. Poor language outcomes in children born preterm have been linked to neurobiological factors, including...

    Authors: Edith Brignoni-Pérez, Maya Chan Morales, Virginia A. Marchman, Melissa Scala, Heidi M. Feldman, Kristen Yeom and Katherine E. Travis

    Citation: Trials 2021 22:444

    Content type: Study protocol

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  8. Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogenei...

    Authors: Nathan A. Pearson, Elizabeth Tutton, Alexander Joeris, Stephen Gwilym, Richard Grant, David J. Keene and Kirstie L. Haywood

    Citation: Trials 2021 22:443

    Content type: Study protocol

    Published on:

  9. Minimal change nephropathy (MCN) is a common cause of nephrotic syndrome in both adults and children. International guidelines recommend treatment with prednisolone 1 mg/kg/day to adults. This dose is derived ...

    Authors: Tilde Kristensen, Henrik Birn and Per Ivarsen

    Citation: Trials 2021 22:442

    Content type: Study protocol

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  10. The COVID-19 pandemic has posed challenges to the conduct of clinical trials. Strategies for overcoming common challenges to non-COVID-19 trial continuation have been reported, but this literature is limited t...

    Authors: Bronwyn Myers, Claire van der Westhuizen, Megan Pool, Nancy Hornsby and Katherine R. Sorsdahl

    Citation: Trials 2021 22:440

    Content type: Commentary

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  11. Many therapeutic interventions are performed by physiotherapists to improve upper extremity function and/or activities of daily living (ADL) in stroke patients. Mirror therapy (MT) is a simple technique that c...

    Authors: Venkadesan Rajendran, Deepa Jeevanantham, Céline Larivière, Ravinder-Jeet Singh, Lisa Zeman and Padma Papuri

    Citation: Trials 2021 22:439

    Content type: Study protocol

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  12. High blood pressure is an independent risk factor of cardiovascular disease (CVD) and is a major cause of disability and death. Managing a healthy lifestyle has been shown to reduce blood pressure and improve ...

    Authors: Fakir M Amirul Islam, Elisabeth A. Lambert, Sheikh Mohammed Shariful Islam, M. Ariful Islam, Dip Biswas, Rachael McDonald, Ralph Maddison, Bruce Thompson and Gavin W. Lambert

    Citation: Trials 2021 22:438

    Content type: Study protocol

    Published on:

  13. Extensive-stage small-cell lung cancer (ES-SCLC) is characterized by extensive metastases, aggressive progression, and poor prognosis. Chemotherapy is applied as a preferred first-line regimen for ES-SCLC, but...

    Authors: Yuyi Chen, Mingwei Yu, Zishen Liu, Yi Zhang, Qiwei Li and Guowang Yang

    Citation: Trials 2021 22:437

    Content type: Study protocol

    Published on:

  14. Dental pulp necrosis, a common health problem, is traditionally treated with root canal therapy; however, it fails in restoring the vitality of damaged pulp. Most studies regarding regenerative endodontic ther...

    Authors: Yuee Liang, Rongyang Ma, Lijuan Chen, Xingzhu Dai, Shiya Zuo, Weiyi Jiang, Naiming Hu, Zilong Deng and Wanghong Zhao

    Citation: Trials 2021 22:436

    Content type: Study protocol

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  15. To evaluate the effect of recombinant erythropoietin on hospitalised COVID-19 patients.

    Authors: Hamid Reza Samimagham, Mehdi Hassani Azad, Dariush Hooshyar, Maryam Haddad, Mohsen Arabi and Mitra KazemiJahromi

    Citation: Trials 2021 22:435

    Content type: Letter

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  16. This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the in...

    Authors: Gholamreza Askari, Babak Alikiaii, Davood Soleimani, Amirhossein Sahebkar, Mahdiye Mirjalili, Awat Feizi, Bijan Iraj and Mohammad Bagherniya

    Citation: Trials 2021 22:434

    Content type: Letter

    Published on:

  17. Adaptive model-based dose-finding designs have demonstrated advantages over traditional rule-based designs but have increased statistical complexity but uptake has been slow especially outside of cancer trials...

    Authors: M. Cole, C. Yap, C. Buckley, W. F. Ng, I. McInnes, A. Filer, S. Siebert, A. Pratt, J. D. Isaacs and D. D. Stocken

    Citation: Trials 2021 22:433

    Content type: Study protocol

    Published on:

  18. Authors: Olga A. Klein, Melanie Boekholt, Dilshad Afrin, Christina Dornquast, Adina Dreier-Wolfgramm, Armin Keller, Bernhard Michalowsky, Ina Zwingmann, Stefan Teipel, Jochen René Thyrian, Ingo Kilimann and Wolfgang Hoffmann

    Citation: Trials 2021 22:432

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:401

  19. Therapeutic targeting of host-cell factors required for SARS-CoV-2 entry is an alternative strategy to ameliorate COVID-19 severity. SARS-CoV-2 entry into lung epithelium requires the TMPRSS2 cell surface prot...

    Authors: Nicholas G. Nickols, Matthew B. Goetz, Christopher J. Graber, Debika Bhattacharya, Guy Soo Hoo, Matthew Might, David B. Goldstein, Xinchen Wang, Rachel Ramoni, Kenute Myrie, Samantha Tran, Leila Ghayouri, Sonny Tsai, Michelle Geelhoed, Danil Makarov, Daniel J. Becker…

    Citation: Trials 2021 22:431

    Content type: Study protocol

    Published on:

  20. Sensorimotor impairments of upper limb (UL) are common after stroke, leading to difficulty to use the UL in daily life. Even though many have sensory impairments in the UL, specific sensory training is often l...

    Authors: Håkan Carlsson, Birgitta Rosén, Anders Björkman, Hélène Pessah-Rasmussen and Christina Brogårdh

    Citation: Trials 2021 22:430

    Content type: Methodology

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  21. Routinely recorded data held in electronic health records can be used to inform the conduct of randomised controlled trials (RCTs). However, limitations with access and accuracy have been identified. Objective: U...

    Authors: G. A. Powell, L. J. Bonnett, C. T. Smith, D. A. Hughes, P. R. Williamson and A. G. Marson

    Citation: Trials 2021 22:429

    Content type: Research

    Published on:

  22. Sodium valproate (VPA) has been associated with a reduced risk of head and neck cancer development. The potential protective mechanism of action is believed to be via inhibition of histone deacetylase and subs...

    Authors: Caroline McCarthy, Joseph Sacco, Stefano Fedele, Michael Ho, Stephen Porter, Triantafillos Liloglou, Bill Greenhalf, Max Robinson, Bridget Young, Silvia Cicconi, Seema Chauhan, Binyam Tesfaye, Richard Jackson, Frances Sherratt and Richard Shaw

    Citation: Trials 2021 22:428

    Content type: Study protocol

    Published on:

  23. Intravenous fluid therapy represents the most common intervention critically ill patients are exposed to. Hyperchloremia and metabolic acidosis associated with 0.9% sodium chloride have been observed to lead t...

    Authors: Sainath Raman, Andreas Schibler, Renate Le Marsney, Peter Trnka, Melanie Kennedy, Adrian Mattke, Kristen Gibbons and Luregn J. Schlapbach

    Citation: Trials 2021 22:427

    Content type: Study protocol

    Published on:

  24. Bacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death. Antibiotic abuse and resistance are widespread problems...

    Authors: Chao-ran Bi, Wei Jing, Xiao-fei Xie and Yan-jing Liu

    Citation: Trials 2021 22:426

    Content type: Study protocol

    Published on:

  25. In this report, we aim to describe the design for the randomised controlled trial of Stereotactic electroencephalogram (EEG)-guided Radiofrequency Thermocoagulation versus Anterior Temporal Lobectomy for Mesia...

    Authors: Yi-He Wang, Si-Chang Chen, Peng-Hu Wei, Kun Yang, Xiao-Tong Fan, Fei Meng, Jia-Lin Du, Lian-Kun Ren, Yong-Zhi Shan and Guo-Guang Zhao

    Citation: Trials 2021 22:425

    Content type: Study protocol

    Published on:

  26. There has been increasing focus to improve the quality of recovery following anterior cervical spine surgery (ACSS). Postoperative pain and nausea are the most common reasons for prolonged hospital stay and re...

    Authors: Michael J. Mulcahy, Thananchayan Elalingam, Kevin Jang, Mario D’Souza and Matthew Tait

    Citation: Trials 2021 22:424

    Content type: Study protocol

    Published on:

  27. Tracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the contr...

    Authors: José M. Añón, María Soledad Arellano, Manuel Pérez-Márquez, Claudia Díaz-Alvariño, José A. Márquez-Alonso, Jorge Rodríguez-Peláez, Kapil Nanwani-Nanwani, Ana Martín-Pellicer, Belén Civantos, Alba López-Fernández, Irene Seises, Jorge García-Nerín, Juan C. Figueira, Henar Casero, Javier Vejo, Alexander Agrifoglio…

    Citation: Trials 2021 22:423

    Content type: Study protocol

    Published on:

  28. Costs of care are important to patients making cancer treatment decisions, but clinicians often do not feel prepared to discuss treatment costs. We aim to (1) assess the impact of a conversation-based decision...

    Authors: Mary C. Politi, Rachel C. Forcino, Katelyn Parrish, Marie-Anne Durand, A. James O’Malley and Glyn Elwyn

    Citation: Trials 2021 22:422

    Content type: Study protocol

    Published on:

  29. The expeditious surgical evacuation of acute epidural hematoma (AEDH) is an attainable gold standard and is often expected to have a good clinical outcome for patients with surgical indications. However, contr...

    Authors: Chun Yang, Xianjian Huang, Junfeng Feng, Li Xie, Jiyuan Hui, Weiping Li and Jiyao Jiang

    Citation: Trials 2021 22:421

    Content type: Study protocol

    Published on:

  30. The SAVVY project aims to improve the analyses of adverse events (AEs), whether prespecified or emerging, in clinical trials through the use of survival techniques appropriately dealing with varying follow-up ...

    Authors: Regina Stegherr, Claudia Schmoor, Jan Beyersmann, Kaspar Rufibach, Valentine Jehl, Andreas Brückner, Lewin Eisele, Thomas Künzel, Katrin Kupas, Frank Langer, Friedhelm Leverkus, Anja Loos, Christiane Norenberg, Florian Voss and Tim Friede

    Citation: Trials 2021 22:420

    Content type: Methodology

    Published on:

  31. Randomised controlled trials (RCTs) provide valuable information for developing harm profiles but current analysis practices to detect between-group differences are suboptimal. Drug trials routinely screen con...

    Authors: Anca Chis Ster, Rachel Phillips, Odile Sauzet and Victoria Cornelius

    Citation: Trials 2021 22:419

    Content type: Methodology

    Published on:

  32. Stroke can lead to varying degrees of oropharyngeal dysphagia, respiratory muscle dysfunction and even increase medical complications such as aspiration, malnutrition and death. Recent studies suggest that ins...

    Authors: A. Guillen-Sola, M. Messaggi-Sartor, C. Ramírez-Fuentes, E. Marco and E. Duarte

    Citation: Trials 2021 22:416

    Content type: Study protocol

    Published on:

  33. AO Spine REsearch objectives and Common Data Elements for Degenerative Cervical Myelopathy [RECODE-DCM] is a multi-stakeholder consensus process aiming to promote research efficiency in DCM. It aims to establi...

    Authors: Benjamin M. Davies, Oliver D. Mowforth, Danyal Z. Khan, Xiaoyu Yang, Sybil R. L. Stacpoole, Olesja Hazenbiller, Toto Gronlund, Lindsay Tetreault, Sukhvinder Kalsi-Ryan, Michelle L. Starkey, Iwan Sadler, Ellen Sarewitz, Delphine Houlton, Julia Carter, Evangeline Howard, Vafa Rahimi-Movaghar…

    Citation: Trials 2021 22:415

    Content type: Methodology

    Published on:

  34. Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-ba...

    Authors: Aziza Ajlan, Hassan Aleid, Tariq Zulfiquar Ali, Hala Joharji, Khalid Almeshari, Ahmed Mohammed Nazmi, Yaser Shah, Edward Devol, Dalal Alkortas, Zinah Alabdulkarim, Dieter Broering, Ibrahim Alahmadi, Asad Ullah, Anwar Alotaibi and Ahmed Aljedai

    Citation: Trials 2021 22:414

    Content type: Study protocol

    Published on:

  35. Self-management of hypertension is of great significance given its increasing incidence and its associated disabilities. In view of the increased use of mobile health in medicine, the present study evaluated t...

    Authors: Ali Bozorgi, Hamed Hosseini, Hassan Eftekhar, Reza Majdzadeh, Ali Yoonessi, Ali Ramezankhani, Mehdi Mansouri and Mahnaz Ashoorkhani

    Citation: Trials 2021 22:413

    Content type: Research

    Published on:

  36. It is currently thought that most—but not all—individuals infected with SARS-CoV-2 develop symptoms, but that the infectious period starts on average two days before the first overt symptoms appear. It is esti...

    Authors: Timo B. Brakenhoff, Billy Franks, Brianna Mae Goodale, Janneke van de Wijgert, Santiago Montes, Duco Veen, Eskild K. Fredslund, Theo Rispens, Lorenz Risch, Ariel V. Dowling, Amos A. Folarin, Patricia Bruijning, Richard Dobson, Tessa Heikamp, Paul Klaver, Maureen Cronin…

    Citation: Trials 2021 22:412

    Content type: Letter

    Published on:

  37. Small umbilical hernia repair is one of the most common surgical performances in general surgery. Yet, a gold standard procedure for the repair is still lacking today. There is an increasing evidence that mesh...

    Authors: M. Melkemichel, S. Bringman, G. Granåsen and B. Widhe

    Citation: Trials 2021 22:411

    Content type: Study protocol

    Published on:

  38. Core outcome sets (COS) should be relevant to key stakeholders and widely applicable and usable. Ideally, they are developed for international use to allow optimal data synthesis from trials. Electronic Delphi...

    Authors: Bilal Alkhaffaf, Jane M. Blazeby, Aleksandra Metryka, Anne-Marie Glenny, Ademola Adeyeye, Paulo Matos Costa, Ismael Diez del Val, Suzanne S. Gisbertz, Ali Guner, Simon Law, Hyuk-Joon Lee, Ziyu Li, Koji Nakada, Rafael Mauricio Restrepo Nuñez, Daniel Reim, John V. Reynolds…

    Citation: Trials 2021 22:410

    Content type: Methodology

    Published on:

  39. Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectivenes...

    Authors: Lena Violetta Krämer, Nadine Eschrig, Lena Keinhorst, Luisa Schöchlin, Lisa Stephan, Malin Stiene and Jürgen Bengel

    Citation: Trials 2021 22:409

    Content type: Study protocol

    Published on:

  40. Diarrhoeal disease remains a leading cause of mortality and morbidity worldwide. Cholera alone is estimated to cause 95,000 deaths per year, most of which occur in endemic settings with inadequate water access...

    Authors: Karin Gallandat, Aurélie Jeandron, Ian Ross, Jaime Mufitini Saidi, Baron Bashige Rumedeka, Vercus Lumami Kapepula, Simon Cousens, Elizabeth Allen, Amy MacDougall and Oliver Cumming

    Citation: Trials 2021 22:408

    Content type: Study protocol

    Published on:

  41. A substantial proportion of rheumatoid arthritis (RA) patients discontinues treatment with tumour necrosis factor inhibitors (TNFi) due to inefficacy or intolerance. After the failure of treatment with a TNFi,...

    Authors: Maike H. M. Wientjes, Sadaf Atiqi, Gerrit Jan Wolbink, Michael T. Nurmohamed, Maarten Boers, Theo Rispens, Annick de Vries, Ronald F. van Vollenhoven, Bart J. F. van den Bemt and Alfons A. den Broeder

    Citation: Trials 2021 22:406

    Content type: Study protocol

    Published on:

  42. More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer....

    Authors: Xiao-Lin Wei, Ru-Zhen Yuan, Yong-Mei Jin, Shu Li, Ming-Yue Wang, Jie-Ting Jiang, Cai-Qin Wu and Kun-Peng Li

    Citation: Trials 2021 22:405

    Content type: Study protocol

    Published on:

  43. IMI2-PainCare-BioPain-RCT3 is one of four similarly designed clinical studies aiming at profiling a set of functional biomarkers of drug effects on the nociceptive system that could serve to accelerate the fut...

    Authors: André Mouraux, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Giulia Di Stefano, Nanna Brix Finnerup, Luis Garcia-Larrea, Marcus Goetz, Anna Kostenko, Bernhard Pelz, Esther Pogatzki-Zahn, Karin Schubart, Alexandre Stouffs, Andrea Truini, Irene Tracey…

    Citation: Trials 2021 22:404

    Content type: Study protocol

    Published on:

  44. Almost all Aboriginal children in remote communities have persistent bilateral otitis media affecting hearing and learning throughout early childhood and school years, with consequences for social and educatio...

    Authors: Kelvin Kong, Alan Cass, Amanda Jane Leach, Peter Stanley Morris, Amy Kimber, Jiunn-Yih Su and Victor Maduabuchi Oguoma

    Citation: Trials 2021 22:403

    Content type: Study protocol

    Published on:

  45. Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we ...

    Authors: Alice MacLachlan, Karen Crawford, Shona Shinwell, Catherine Nixon and Marion Henderson

    Citation: Trials 2021 22:402

    Content type: Research

    Published on:

  46. Up to two-thirds of dementia care is provided by family caregivers who often experience high burden, little support and adverse health outcomes. Enabling and supporting family caregivers to provide care at hom...

    Authors: Olga A. Klein, Melanie Boekholt, Dilshad Afrin, Christina Dornquast, Adina Dreier-Wolfgramm, Armin Keller, Bernhard Michalowsky, Ina Zwingmann, Stefan Teipel, Jochen René Thyrian, Ingo Kilimann and Wolfgang Hoffmann

    Citation: Trials 2021 22:401

    Content type: Study protocol

    Published on:

    The Correction to this article has been published in Trials 2021 22:432

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