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  1. Randomised controlled trials (RCTs) are considered the ‘gold standard’ of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addres...

    Authors: Clare McDermott, Jane Vennik, Carl Philpott, Steffi le Conte, Mike Thomas, Caroline Eyles, Paul Little, Helen Blackshaw, Anne Schilder and Claire Hopkins
    Citation: Trials 2021 22:54
  2. Upper limb and hand motor dysfunction is one of the challenges in rehabilitation after cerebral ischemic stroke (CIS), and the clinical efficacy of rehabilitation needs to be improved. This study aims to combi...

    Authors: Mingzhu Xu, Run Lin, Jing Luo, Chunzhi Tang, Shuhui Wang, John Wong, Meng Wu, Jianting Huang, Peng Shi, Ang Gao, Yuqian Bai, Ying Xie, Jun Luo, Yunqiu Yang and Shaoyang Cui
    Citation: Trials 2021 22:53
  3. Following the World Health Organization’s (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-S...

    Authors: Mohammed Limbada, Chiti Bwalya, David Macleod, Sian Floyd, Ab Schaap, Vasty Situmbeko, Richard Hayes, Sarah Fidler and Helen Ayles
    Citation: Trials 2021 22:52
  4. Through the process of normal aging, cognitive decline would cause a lower level of functioning in real life. This flow might interfere with health-related quality of life (QoL). The purpose of this study is t...

    Authors: Leila kazazi, Mohsen Shati, Seyede Salehe Mortazavi, Vahid Nejati and Mahshid Foroughan
    Citation: Trials 2021 22:51
  5. Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We ...

    Authors: Penelope Schofield, Karla Gough, Amelia Hyatt, Alan White, Mark Frydenberg, Suzanne Chambers, Louisa G. Gordon, Robert Gardiner, Declan G. Murphy, Lawrence Cavedon, Natalie Richards, Barbara Murphy, Stephen Quinn and Ilona Juraskova
    Citation: Trials 2021 22:49

    The Correction to this article has been published in Trials 2021 22:97

  6. Immunosuppression including high-dose calcineurin inhibitors (CNI) is essential after lung transplantation. Dosing is usually guided by therapeutic drug monitoring adjusted to target trough levels of CNIs to k...

    Authors: Jens Gottlieb, Alexander Reuss, Konstantin Mayer, Karin Weide, Carmen Schade-Brittinger, Susanne Hoyer and Peter Jaksch
    Citation: Trials 2021 22:48
  7. This trial evaluates interventions that utilize data entered at point-of-care in the Palestinian maternal and child eRegistry to generate Quality Improvement Dashboards (QID) for healthcare providers and Targe...

    Authors: Kjersti Mørkrid, Binyam Bogale, Eatimad Abbas, Khadija Abu Khader, Itimad Abu Ward, Amjad Attalh, Tamara Awwad, Mohammad Baniode, Kimberly Suzanne Frost, Michael James Frost, Buthaina Ghanem, Taghreed Hijaz, Mervett Isbeih, Sally Issawi, Zaher A. S. Nazzal, Brian O’Donnell…
    Citation: Trials 2021 22:47
  8. Insomnia affects almost one in four military service members and veterans. The first-line recommended treatment for insomnia is cognitive-behavioral therapy for insomnia (CBTI). CBTI is typically delivered in-...

    Authors: Anne Germain, Rachel R. Markwald, Erika King, Adam D. Bramoweth, Megan Wolfson, Gilbert Seda, Tony Han, Erin Miggantz, Brian O’Reilly, Lars Hungerford, Traci Sitzer, Vincent Mysliwiec, Joseph J. Hout and Meredith L. Wallace
    Citation: Trials 2021 22:46
  9. Oral anticoagulant drugs represent an essential tool in the prevention of thromboembolic events. The ones in widespread use are vitamin K antagonists, whose plasma level is monitored by measuring prothrombin t...

    Authors: Leovigildo Ginel-Mendoza, Alfonso Hidalgo-Natera, Rocío Reina-Gonzalez, Rafael Poyato-Ramos, Juana Morales-Naranjo, Inmaculada Lupiañez-Pérez, Antonio Baca-Osorio, Miguel Gutiérrez-Jansen, María Paz Fernández-Lara, Diego Lozano-Noriega, Ulises Salgado-Carvallo, Cristina Bandera-García and Francisco Javier Navarro-Moya
    Citation: Trials 2021 22:45
  10. The primary objective of this study is to evaluate the therapeutic potential of hydroxychloroquine (HCQ) in the treatment of adult patients with PCR-confirmed Covid-19 infection in a primary open-care setting,...

    Authors: Petri J. Vainio, Pauliina Hietasalo, Anna-Liisa Koivisto, Susanna Kääriäinen, Jari Turunen, Mika Virtala, Jouni Vuorinen and Mika Scheinin
    Citation: Trials 2021 22:44
  11. The aim of this study is to assess the effectiveness and safety of glucocorticoid infusion pulse therapy to improve the clinical outcomes of patients with COVID-19 pneumonia with elevated inflammatory biomarkers.

    Authors: Iñigo Les Bujanda, Jose Loureiro-Amigo, Ferran Capdevila Bastons, Iñaki Elejalde Guerra, Javier Anniccherico Sánchez, Anna Murgadella-Sancho, Ruth García Rey, Julián Librero López and Julio Sánchez Álvarez
    Citation: Trials 2021 22:43
  12. As of December, 1st, 2020, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, resulted in more than 1 472 917 deaths worldwide and death toll is still increasing exponentially. Many COVID-19 infected peopl...

    Authors: W. Dioh, M. Chabane, C. Tourette, A. Azbekyan, C. Morelot-Panzini, L. A. Hajjar, M. Lins, G. B. Nair, T. Whitehouse, J. Mariani, M. Latil, S. Camelo, R. Lafont, P. J. Dilda, S. Veillet and S. Agus
    Citation: Trials 2021 22:42
  13. The only curative treatment for most esophageal cancers is radical esophagectomy. Minimally invasive esophagectomy (MIE) aims to reduce postoperative morbidity, but is not yet widely established. Linear staple...

    Authors: Felix Nickel, Pascal Probst, Alexander Studier-Fischer, Henrik Nienhüser, Jana Pauly, Karl-Friedrich Kowalewski, Sebastian Weiterer, Philipp Knebel, Markus K. Diener, Markus A. Weigand, Markus W. Büchler, Thomas Schmidt and Beat P. Müller-Stich
    Citation: Trials 2021 22:41
  14. Partial pancreatoduodenectomy (PD) is the indicated surgical procedure for a wide range of benign and malignant diseases of the pancreatic head and distal bile duct and offers the only potential cure for pancr...

    Authors: Rosa Klotz, Colette Dörr-Harim, Thomas Bruckner, Philipp Knebel, Markus K. Diener, Thilo Hackert and André L. Mihaljevic
    Citation: Trials 2021 22:40
  15. In this cluster-randomised controlled study (CoV-Surv Study), four different “active” SARS-CoV-2 testing strategies for general population surveillance are evaluated for their effectiveness in determining and ...

    Authors: Andreas Deckert, Simon Anders, Manuela de Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Kathleen Boerner, Matthias Meurer, Konrad Herbst, Matthias Sand, Lisa Koeppel, Tobias Siems, Lucia Brugnara, Stephan Brenner, Robin Burk, Dan Lou…
    Citation: Trials 2021 22:39

    The Study protocol to this article has been published in Trials 2021 22:656

  16. The FLAIR trial in chronic lymphocytic leukaemia has a randomised, controlled, open-label, confirmatory, platform design. FLAIR was successfully amended to include an emerging promising experimental therapy to...

    Authors: Dena R. Howard, Anna Hockaday, Julia M. Brown, Walter M. Gregory, Susan Todd, Tahla Munir, Jamie B. Oughton, Claire Dimbleby and Peter Hillmen
    Citation: Trials 2021 22:38
  17. Cardiovascular disease (CVD) is the most common complication and the leading cause of death in patients with chronic kidney disease (CKD). Accelerated atherosclerosis is a pathophysiological process that is vi...

    Authors: Jiachuan Xiong, Ting He, Zhikai Yu, Ke Yang, Feng Chen, Jingbo Cheng, Yu Shi, Yinghui Huang, Yu Qiao, Haiyang Li, Yunzhu Shen and Jinghong Zhao
    Citation: Trials 2021 22:37
  18. Acute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion. Goal-directed fluid therapy (GDFT) is an individualized fluid...

    Authors: Zheng Guan, Yanfeng Gao, Qiao Qiao, Qiang Wang and Jingjie Liu
    Citation: Trials 2021 22:36
  19. Atrial fibrillation (AF) is a common arrhythmia, which is closely related to cardiovascular morbidity and mortality. Although acupuncture is used in the treatment of AF, the evidence is insufficient. The objec...

    Authors: Ying Lin, Xian Wang, Xue-Bin Li, Bang-Qi Wu, Zhao-Hui Zhang, Wei-Hua Guo, Cun-Cao Wu, Xin Chen, Ming-Long Chen, Zhong Dai, Fu-Yan Chen, Rui Zhu, Chu-Xi Liang, Yun-Peng Tian, Gang Yang, Chao-Qun Yan…
    Citation: Trials 2021 22:35
  20. Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strateg...

    Authors: Fang-Ting Yu, Guang-Xia Ni, Guo-Wei Cai, Wen-Jun Wan, Xiao-Qing Zhou, Xiu-Li Meng, Jin-Ling Li, Jian-Feng Tu, Li-Qiong Wang, Jing-Wen Yang, Hai-Yang Fu, Xin-Chang Zhang, Jing Li, Yan-Fu Wang, Beng Zhang, Xiao-Hui Zhang…
    Citation: Trials 2021 22:34
  21. Endoscopic removal of colorectal adenoma is considered an effective treatment for reducing the mortality rates associated with colorectal cancer. Warfarin, a type of anticoagulant, is widely used for the treat...

    Authors: Yasuaki Nagami, Taishi Sakai, Masafumi Yamamura, Masami Nakatani, Takayuki Katsuno, Takehisa Suekane, Hironori Uno, Hiroaki Minamino, Masatsugu Okuyama, Junichi Okamoto, Mitsutaka Kumamoto, Atsushi Noguchi, Kazuki Yamamori, Osamu Takaishi, Masahiro Ochi, Takako Miyazaki…
    Citation: Trials 2021 22:33
  22. People with hereditary spastic paraplegia (HSP) experience difficulties adapting their gait to meet environmental demands, a skill required for safe and independent ambulation. Gait adaptability training is po...

    Authors: Lotte van de Venis, Bart P. C. van de Warrenburg, Vivian Weerdesteyn, Bas J. H. van Lith, Alexander C. H. Geurts and Jorik Nonnekes
    Citation: Trials 2021 22:32
  23. After the US Surgeon General declared youth electronic cigarette (e-cigarette) use an epidemic in 2018, the number of youth e-cigarette users continued to surge, growing from 3.8 million in 2018 to over 5 mill...

    Authors: Kar-Hai Chu, Sara Matheny, Alexa Furek, Jaime Sidani, Susan Radio, Elizabeth Miller, Thomas Valente and Linda Robertson
    Citation: Trials 2021 22:31
  24. Post-extubation stridor (PES) is one of the most common complications of invasive respiratory support, with severe cases leading to possible extubation failure (reintubation within 48 h) and increased mortalit...

    Authors: Jingyi Wang, Joseph Harold Walline, Lu Yin, Yili Dai, Jiayuan Dai, Huadong Zhu, Xuezhong Yu and Jun Xu
    Citation: Trials 2021 22:30
  25. The pain management of postherpetic neuralgia (PHN) remains a major challenge, with no immediate relief. Nitrous oxide/oxygen mixture has the advantages of quick analgesic effect and well-tolerated. The purpos...

    Authors: Hai-Xiang Gao, Jun-Jun Zhang, Ning Liu, Yi Wang, Chun-Xiang Ma, Lu-Lu Gao, Qiang Liu, Ting-Ting Zhang, Yi-Ling Wang, Wen-Qiang Bao and Yu-Xiang Li
    Citation: Trials 2021 22:29
  26. Heavy cannabis use is associated with adverse physical and mental health effects. Despite available effective treatments, the majority of heavy cannabis users does not seek professional help. Web-based interve...

    Authors: Marleen I. A. Olthof, Matthijs Blankers, Margriet W. van Laar and Anna E. Goudriaan
    Citation: Trials 2021 22:28
  27. Cognitive impairment is a common dysfunction after stroke that seriously affects the overall recovery of patients. Cognitive rehabilitation training is currently the main treatment to improve cognitive functio...

    Authors: Kai-Qi Su, Su-Tong Liu, Jie-Ying Li, Rui-Qing Li, Hui-Li Feng, Yang Xue and Xiao-Dong Feng
    Citation: Trials 2021 22:27
  28. The aim of this paper is to share the methodological problems of an unsuccessful prospective single-arm feasibility trial conducted to evaluate the safety and feasibility of a 12-week progressive exercise inte...

    Authors: Jennifer Brunet, Jenson Price and Céline Delluc
    Citation: Trials 2021 22:26
  29. Recent experimental evidence shows that sevoflurane can reduce the inflammatory response during cardiac surgery with cardiopulmonary bypass. However, this observation so far has not been assessed in an adequat...

    Authors: Thiago Augusto Azevedo Maranhão Cardoso, Gudrun Kunst, Caetano Nigro Neto, José de Ribamar Costa Júnior, Carlos Gustavo Santos Silva, Gisele Medeiros Bastos, Jéssica Bassani Borges and Mario Hiroyuki Hirata
    Citation: Trials 2021 22:25
  30. Left hemispatial neglect (LHN) is a neuropsychological syndrome often associated with right hemispheric stroke. Patients with LHN have difficulties in attending, responding, and consciously representing the ri...

    Authors: Francesco Di Gregorio, Fabio La Porta, Emanuela Casanova, Elisabetta Magni, Roberta Bonora, Maria Grazia Ercolino, Valeria Petrone, Maria Rosaria Leo and Roberto Piperno
    Citation: Trials 2021 22:24
  31. We aimed to test our hypothesis that traditional Japanese (Kampo) medicine, hochuekkito (Hochu-ekki-to: HET) has a preventive effect for the symptoms on COVID-19.

    Authors: Takao Namiki, Shin Takayama, Ryutaro Arita, Tadashi Ishii, Mosaburo Kainuma, Toshiaki Makino, Masaru Mimura, Tetsuhiro Yoshino, Tatsuya Nogami, Makoto Arai, Juichi Sato, Koichiro Tanaka, Hajime Nakae, Hidetoshi Igari, Yoshihito Ozawa, Yuki Shiko…
    Citation: Trials 2021 22:23
  32. Recently, a large group of patients with persistent dyspnea, poor physical capacity, and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under...

    Authors: Stacey Haukeland-Parker, Øyvind Jervan, Hege Hølmo Johannessen, Jostein Gleditsch, Knut Stavem, Kjetil Steine, Martijn A. Spruit, René Holst, Mazdak Tavoly, Frederikus A. Klok and Waleed Ghanima
    Citation: Trials 2021 22:22
  33. Globally, methamphetamine use has increased in prevalence in recent years. In Australia, there has been a dramatic increase in numbers of people seeking treatment, including residential rehabilitation, for met...

    Authors: Joshua B. B. Garfield, Hugh Piercy, Shalini Arunogiri, Dan I. Lubman, Samuel C. Campbell, Paul G. Sanfilippo, Jeff Gavin, Malcolm Hopwood, Eli Kotler, Suzanne George, Goke Okedara, Lara R. Piccoli and Victoria Manning
    Citation: Trials 2021 22:21
  34. HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant wo...

    Authors: Zachary Kwena, Liza Kimbo, Lynae A. Darbes, Abigail M. Hatcher, Anna Helova, George Owino, Harsha Thirumurthy, Elizabeth A. Bukusi, Thomas Braun, Meredith Kilgore, Maria Pisu, Ashutosh Tamhane, Van T. Nghiem, Kawango Agot, Torsten B. Neilands and Janet M. Turan
    Citation: Trials 2021 22:19
  35. Knee osteoarthritis (OA) is a highly prevalent musculoskeletal condition causing pain, physical disability, and reduced quality of life. Exercise and patient education are non-pharmacological interventions for...

    Authors: Elisabeth Bandak, Anders F. Overgaard, Lars Erik Kristensen, Karen Ellegaard, Jørgen Guldberg-Møller, Cecilie Bartholdy, David J. Hunter, Roy D. Altman, Robin Christensen, Henning Bliddal and Marius Henriksen
    Citation: Trials 2021 22:18
  36. Acupuncture is effective in symptom and quality of life improvement of chronic asthma, but the efficacy differences between different acupoints are uncertain. In terms of the theory of Meridian-viscera Associa...

    Authors: Shirui Cheng, Xiaohui Dong, Lei Lan, Zhaoxuan He, Siyi Yu, Yi Yang, Chuantao Zhang, Mei Chen, Jun Yang, Haoran Chu, Yalan Liu, Menglin Wang, Qingsong Huang and Fang Zeng
    Citation: Trials 2021 22:17
  37. Due to advancements in treatment, the survival of breast cancer (BC) patients has significantly improved. Improving the postoperative quality of life has become a widespread concern for patients and doctors. A...

    Authors: Yu-Wei Shao, Qing Shu, Dan Xu, Hui Teng, Gao-Song Wu, Jin-Xuan Hou and Jun Tian
    Citation: Trials 2021 22:16
  38. Procedural sedation and analgesia (PSA) is frequently required to perform closed reductions for fractures and dislocations in children. Intravenous (IV) ketamine is the most commonly used sedative agent for cl...

    Authors: Anna Heath, Juan David Rios, Eleanor Pullenayegum, Petros Pechlivanoglou, Martin Offringa, Maryna Yaskina, Rick Watts, Shana Rimmer, Terry P. Klassen, Kamary Coriolano and Naveen Poonai
    Citation: Trials 2021 22:15
  39. Subjective cognitive decline (SCD) is an early manifestation of Alzheimer’s disease (AD) and offers a therapeutic window where interventions have strong potential to prevent or delay the progression of AD. Aer...

    Authors: Dereck Salisbury, Tom Plocher and Fang Yu
    Citation: Trials 2021 22:14
  40. Adaptations to the gold standard randomised controlled trial (RCT) have been introduced to decrease trial costs and avoid high sample sizes. To facilitate development of precision medicine algorithms that aim ...

    Authors: Nils Kappelmann, Bertram Müller-Myhsok and Johannes Kopf-Beck
    Citation: Trials 2021 22:13
  41. Survival rates for lymphoma are highest amongst hematological malignancies. In 2019, it was estimated that over 6400 Australians were diagnosed with lymphoma, a group of hematological malignancies with a high ...

    Authors: Raymond Javan Chan, Stephanie Buhagiar, Laisa Teleni, Camilla Simonsen, Jane Turner, Courtney Rawson, Nicolas H. Hart, Lee Jones, Louisa Gordon, Ria Joseph, Oluwaseyifunmi Andi Agbejule, Fiona Henderson, Joel Rhee, Marissa Ryan, Christine Carrington and Sally Mapp
    Citation: Trials 2021 22:12
  42. The application of artificial intelligence (AI) in healthcare is an area of immense interest. The high profile of ‘AI in health’ means that there are unusually strong drivers to accelerate the introduction and...

    Authors: Hussein Ibrahim, Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, An-Wen Chan, Matthew R. Sydes, Melanie J. Calvert and Alastair K. Denniston
    Citation: Trials 2021 22:11
  43. Diabetes and its sequelae such as diabetic foot ulcer are rising health hazards not only in western countries but all over the world. Effective, yet safe treatments are desperately sought for by physicians, he...

    Authors: Alfred Gugerell, Ghazaleh Gouya-Lechner, Helmut Hofbauer, Maria Laggner, Franz Trautinger, Gabriele Almer, Anja Peterbauer-Scherb, Marcus Seibold, Wolfram Hoetzenecker, Christiane Dreschl, Michael Mildner and Hendrik Jan Ankersmit
    Citation: Trials 2021 22:10
  44. 1. To assess the efficacy of Mesenchymal Stromal Cells (MSC) versus a control arm as described in the primary endpoint.

    Authors: Concepción Payares-Herrera, María E. Martínez-Muñoz, Inés Lipperheide Vallhonrat, Rosa Malo de Molina, Manuel Pérez Torres, Andrea Trisan, Isabel Salcedo de Diego, Rosalía Alonso, Rocío Zafra, Trinidad Donaire, Rocío Sánchez, Juan José Rubio, Rafael F. Duarte Palomino and Cristina Avendaño Solá
    Citation: Trials 2021 22:9
  45. The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practi...

    Authors: Gordon McGregor, Harbinder Sandhu, Julie Bruce, Bartholomew Sheehan, David McWilliams, Joyce Yeung, Christina Jones, Beatriz Lara, Jessica Smith, Chen Ji, Elaine Fairbrother, Stuart Ennis, Peter Heine, Sharisse Alleyne, Jonathan Guck, Emma Padfield…
    Citation: Trials 2021 22:8

    The Correction to this article has been published in Trials 2021 22:96

  46. Delirium is defined as acute organic brain dysfunction characterised by inattention and disturbance of cognition. It is common in the intensive care unit and is associated with poorer outcomes. Good quality sl...

    Authors: Bradley Wibrow, F. Eduardo Martinez, Andrew Ford, Erin Kelty, Kevin Murray, Kwok M. Ho, Edward Litton, Erina Myers and Matthew Anstey
    Citation: Trials 2021 22:7

    The Study protocol to this article has been published in Trials 2017 18:4

  47. We will evaluate the efficacy and safety of Ivermectin in patients with mild and moderately severe COVID-19.

    Authors: Fatemeh Sadat Hosseini, Alireza Malektojari, Sara Ghazizadeh, Mehdi Hassaniazad, Parivash Davoodian, Habib Dadvand, Amin Reza Nikpoor, Sara Nikoofal-Sahlabadi, Sara Kahoori, Mojtaba Sepandi, Soheil Hassanipour and Mohammad Fathalipour
    Citation: Trials 2021 22:4
  48. Conestat alfa, a recombinant human C1 esterase inhibitor, is a multi-target inhibitor of inflammatory cascades including the complement, the kinin-kallikrein and the contact activation system. The study object...

    Authors: Pascal Urwyler, Panteleimon Charitos, Stephan Moser, Ingmar A. F. M. Heijnen, Marten Trendelenburg, Reto Thoma, Johannes Sumer, Adrián Camacho-Ortiz, Marcelo R. Bacci, Lars C. Huber, Melina Stüssi-Helbling, Werner C. Albrich, Parham Sendi and Michael Osthoff
    Citation: Trials 2021 22:1

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