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  1. Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex patho...

    Authors: Charles Ethan Paccione, Lien My Diep, Audun Stubhaug and Henrik Børsting Jacobsen

    Citation: Trials 2020 21:808

    Content type: Study protocol

    Published on:

  2. The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptabi...

    Authors: Deirdre A. Hurley, Isabelle Jeffares, Amanda M. Hall, Alison Keogh, Elaine Toomey, Danielle McArdle, Suzanne M. McDonough, Suzanne Guerin, Ricardo Segurado and James Matthews

    Citation: Trials 2020 21:807

    Content type: Research

    Published on:

  4. Although used extensively worldwide, the effects of general anaesthesia on the human brain remain largely elusive. Moreover, general anaesthesia may contribute to serious conditions or adverse events such as p...

    Authors: Signe Sloth Madsen, Kirsten Møller, Karsten Skovgaard Olsen, Mark Bitsch Vestergaard, Ulrich Lindberg, Henrik Bo Wiberg Larsson, Johan Mårtensson, Mads U. Werner, Sofia Alexandra Gaspar Santos and Mohammad Sohail Asghar

    Citation: Trials 2020 21:805

    Content type: Study protocol

    Published on:

  5. Almost half of people living with HIV (PLWH) in the USA are over 50 years of age; this is expected to increase to 70% by 2020. Yet, few interventions exist for older PLWH that address psychological and physica...

    Authors: Gladys E. Ibañez, Kristopher Fennie, Linda Larkey, Nan Hu, Angel B. Algarin, Chelsea Valdivia and Helen Lavretsky

    Citation: Trials 2020 21:804

    Content type: Study protocol

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  6. Every year, many infants are infected with the respiratory syncytial virus (RSV) or other agents and need hospitalisation due to bronchiolitis. The disease causes much suffering and high costs. Thus, it is imp...

    Authors: Sonja Andersson-Marforio, Annika Lundkvist Josenby, Eva Ekvall Hansson and Christine Hansen

    Citation: Trials 2020 21:803

    Content type: Study protocol

    Published on:

  7. Safety data is required to be collected in all clinical trials and can be separated into two types of data, adverse events and serious adverse events. Often, these types of safety data are collected as two dis...

    Authors: Elizabeth C. James, David Dunn, Adrian D. Cook, Andrew R. Clamp and Matthew R. Sydes

    Citation: Trials 2020 21:802

    Content type: Methodology

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  8. Many asthmatic children suffer from uncontrolled asthma with frequent exacerbations, despite an optimal treatment plan using inhalation medication. Studies have shown that therapy adherence and inhalation tech...

    Authors: Esther T. Sportel, Martijn J. Oude Wolcherink, Job van der Palen, Anke Lenferink, Boony J. Thio, Kris L. L. Movig and Marjolein G. J. Brusse-Keizer

    Citation: Trials 2020 21:801

    Content type: Study protocol

    Published on:

  9. Exercise has been shown to significantly improve pain and function in individuals with fibromyalgia. Research into the effectiveness of exercise is often based on standardised exercise programmes that are chos...

    Authors: T. Rulleau, L. Planche, F. Etcheverrigaray, A. Dorion, N. Kacki, M. Miot, A. Liaigre, Y. Ganem, A. Schmidt, F. Taddéi, S. Acapo, J. Nizard and Y. M. Pluchon

    Citation: Trials 2020 21:800

    Content type: Study protocol

    Published on:

  10. Objectives: The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and morta...

    Authors: Anne Marie Rosendahl Madsen, Frederik Schaltz-Buchholzer, Thomas Benfield, Morten Bjerregaard-Andersen, Lars Skov Dalgaard, Christine Dam, Sisse Bolm Ditlev, Gulia Faizi, Isik Somuncu Johansen, Poul-Erik Kofoed, Gitte Schultz Kristensen, Ellen Christine Leth Loekkegaard, Christian Backer Mogensen, Libin Mohamed, Anne Ostenfeld, Emilie Sundhaugen Oedegaard…

    Citation: Trials 2020 21:799

    Content type: Letter

    Published on:

  11. Randomized controlled trials (RCTs) conducted in the routine care setting provide the opportunity to better understand the effectiveness of new medicines but can present recruitment difficulties. An improved u...

    Authors: Kim Gemzoe, Rebecca Crawford, Ann Caress, Sheila McCorkindale, Rebecca Conroy, Susan Collier, Lynda Doward, Renu M. Vekaria, Sally Worsley, David A. Leather and Elaine Irving

    Citation: Trials 2020 21:798

    Content type: Research

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  12. Fatigue is a well-known common clinical feature of numerous chronic diseases including various forms of cancer, neurological disorders such as multiple sclerosis, and psychiatric disorders. A significant propo...

    Authors: Stéphane Raffard, Nicolas Rainteau, Sophie Bayard, Yasmine Laraki, Joanna Norton and Delphine Capdevielle

    Citation: Trials 2020 21:797

    Content type: Study protocol

    Published on:

  13. Alcohol dependence is a significant issue contributing to disease burden. Changes in cortisol concentrations during alcohol withdrawal are associated with cognitive deficits and symptoms of depression. Current...

    Authors: Kim Donoghue, Abigail Rose, Simon Coulton, Rachel Coleman, Joanna Milward, Thomas Philips, Colin Drummond and Hilary Little

    Citation: Trials 2020 21:796

    Content type: Research

    Published on:

  14. Osteoarthritis (OA) is a common chronic disease in older adults. Currently, there are no effective therapies to reduce disease severity and progression of knee OA (KOA), particularly in mid- to late-stages. Th...

    Authors: Zhaohua Zhu, Qinghong Yu, Xiaomei Leng, Weiyu Han, Zhanguo Li, Cibo Huang, Jieruo Gu, Yi Zhao, Kang Wang, Tianwang Li, Yifang Mei, Jianhua Xu, Zhiyi Zhang, David Hunter, Flavia Cicuttini, Xiaofeng Zeng…

    Citation: Trials 2020 21:795

    Content type: Study protocol

    Published on:

  15. In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release. Elevated levels of blood IL-6...

    Authors: Antonio F. Caballero Bermejo, Belén Ruiz-Antorán, Ana Fernández Cruz, Elena Diago Sempere, Alejandro Callejas Díaz, Elena Múñez Rubio, Cristina Avendaño-Solá, Antonio Ramos Martínez and Aránzazu Sancho López

    Citation: Trials 2020 21:794

    Content type: Letter

    Published on:

  16. Physical activity (PA) can be used to prevent and treat diseases. In Sweden, licensed healthcare professionals use PA on prescription (PAP) to support patients to increase their PA level. The aim of this rando...

    Authors: Stefan Lundqvist, Mats Börjesson, Åsa Cider, Lars Hagberg, Camilla Bylin Ottehall, Johan Sjöström and Maria E. H. Larsson

    Citation: Trials 2020 21:793

    Content type: Research

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  17. Cancer survivors experience compromised quality of life due to impaired cognitive function as a result of cancer diagnosis and treatment. Although exercise has proven to be effective in improving cognitive fun...

    Authors: Neha P. Gothe, Emily E. Erlenbach, Samuel L. Streeter and Linda Lehovec

    Citation: Trials 2020 21:792

    Content type: Study protocol

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  18. Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgica...

    Authors: Heidi Tegner, Bente Appel Esbensen, Marius Henriksen, Rachid Bech-Azeddine, Mari Lundberg, Louise Nielsen and Nanna Rolving

    Citation: Trials 2020 21:791

    Content type: Study protocol

    Published on:

  19. We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients ...

    Authors: Omid Safa, Mehdi Hassani-Azad, Mehdi Farashahinejad, Parivash Davoodian, Habib Dadvand, Soheil Hassanipour and Mohammad Fathalipour

    Citation: Trials 2020 21:790

    Content type: Letter

    Published on:

  20. Engagement in activities meaningful to the individual may support the process of recovery in those with mental illness. Persons with psychiatric disabilities may reduce their engagement in meaningful activitie...

    Authors: Siv Therese Bogevik Bjørkedal, Ulrika Bejerholm, Lene Falgaard Eplov and Tom Møller

    Citation: Trials 2020 21:789

    Content type: Study protocol

    Published on:

  21. Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture ...

    Authors: Hongyu Yue, Shuang Zhou, Huangan Wu, Xuan Yin, Shanshan Li, Tingting Liang, Yan Li, Zhihong Fang, Xufeng Zhang, Linglin Wang, Min Han, Xiaolei Chen, Ming Zhang, Wei Zhang, Zhangjin Zhang and Shifen Xu

    Citation: Trials 2020 21:788

    Content type: Study protocol

    Published on:

  22. To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC.

    Authors: Nicole C. Gavin, Tricia M. Kleidon, Emily Larsen, Catherine O’Brien, Amanda Ullman, Sarah Northfield, Gabor Mihala, Naomi Runnegar, Nicole Marsh and Claire M. Rickard

    Citation: Trials 2020 21:787

    Content type: Research

    Published on:

  23. Despite the enormous investment governments allocate to fight obesity, its worldwide prevalence is still on the rise. Moreover, the majority of the programs implemented are still targeting adults struggling wi...

    Authors: Paula Magalhães, Cátia Silva, Beatriz Pereira, Gabriela Figueiredo, Ana Guimarães, Armanda Pereira and Pedro Rosário

    Citation: Trials 2020 21:786

    Content type: Study protocol

    Published on:

  24. 1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive p...

    Authors: Farhan Raza Khan, Syed Murtaza Raza Kazmi, Najeeha Talat Iqbal, Junaid Iqbal, Syed Tariq Ali and Syed Akbar Abbas

    Citation: Trials 2020 21:785

    Content type: Letter

    Published on:

  25. The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporari...

    Authors: Eleanor J. Mitchell, Khaled Ahmed, Suzanne Breeman, Seonaidh Cotton, Lynda Constable, Gillian Ferry, Kirsteen Goodman, Helen Hickey, Garry Meakin, Katy Mironov, Niamh Quann, Natalie Wakefield and Alison McDonald

    Citation: Trials 2020 21:784

    Content type: Commentary

    Published on:

  26. Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and o...

    Authors: Kathrin Wode, Johanna Hök Nordberg, Gunver S. Kienle, Nils O. Elander, Britt-Marie Bernhardson, Berit Sunde, Lena Sharp, Roger Henriksson and Per Fransson

    Citation: Trials 2020 21:783

    Content type: Study protocol

    Published on:

  27. Vessel-sparing anastomotic repair (vsAR) has been developed as a less traumatic alternative to transecting anastomotic repair (tAR) to treat isolated short bulbar urethral strictures. This vessel-sparing techn...

    Authors: Wesley Verla, Marjan Waterloos, Mieke Waterschoot, Benjamin Van Parys, Anne-Françoise Spinoit and Nicolaas Lumen

    Citation: Trials 2020 21:782

    Content type: Study protocol

    Published on:

  28. This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (...

    Authors: Stefan Roehrig, Ali Ait Hssain, Nabil Al Hamid Shallik, Ingi Mohamed A. Elsaid, Salma Faisal Mustafa, Osama A. M. Smain, Ashraf Abdulla Molokhia and Marcus D. Lance

    Citation: Trials 2020 21:781

    Content type: Letter

    Published on:

  29. The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant a...

    Authors: Heshen Tian, Yumin Zhou, Longhui Tang, Fan Wu, Zhishan Deng, Bijia Lin, Peiyu Huang, Shaodan Wei, Dongxing Zhao, Jingping Zheng, Nanshan Zhong and Pixin Ran

    Citation: Trials 2020 21:780

    Content type: Study protocol

    Published on:

  30. Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high resea...

    Authors: Elizabeth M. Burnette, Wave-Ananda Baskerville, Erica N. Grodin and Lara A. Ray

    Citation: Trials 2020 21:779

    Content type: Study protocol

    Published on:

  32. Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone a...

    Authors: Pablo Rodríguez-Sánchez-Laulhé, Luis Gabriel Luque-Romero, Jesús Blanquero, Alejandro Suero-Pineda, Ángela Biscarri-Carbonero, Francisco José Barrero-García and Alberto Marcos Heredia-Rizo

    Citation: Trials 2020 21:777

    Content type: Study protocol

    Published on:

  33. Robotic-arm assisted surgery aims to reduce manual errors and improve the accuracy of implant positioning during total hip arthroplasty. The objective of this study is to compare the accuracy of implant positi...

    Authors: Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob and Fares S. Haddad

    Citation: Trials 2020 21:776

    Content type: Study protocol

    Published on:

  34. Poor ovarian response (POR), a manifestation of low ovarian reserve and ovarian aging, leads to a significant reduction in the pregnancy rate after in vitro fertilization-embryo transfer. Acupuncture has incre...

    Authors: Huanfang Xu, Chensi Zheng, Liyun He, Tongsheng Su, Huidan Wang, Yu Li, Cui Zhao, Cuilian Zhang, Yang Bai, Guoqing Tong, Li Chen, Fang Zhao, Huisheng Yang, Mingzhao Hao, Yaqian Yin, Li Yang…

    Citation: Trials 2020 21:775

    Content type: Study protocol

    Published on:

  35. This study reports on qualitative research conducted within a randomised controlled trial to explore possible intervention mechanisms. It focuses on the ‘Learning Together’ whole-school intervention delivered ...

    Authors: Emily Warren, G. J. Melendez-Torres, Russell Viner and Chris Bonell

    Citation: Trials 2020 21:774

    Content type: Research

    Published on:

    The Correction to this article has been published in Trials 2020 21:806

  36. Evidence synthesis of clinical trials requires consistent outcome assessment. For pain management after surgery, inconsistency of effectiveness assessment is still observed. A subproject of IMI-PainCare (Innov...

    Authors: Ulrike Kaiser, Hiltrud Liedgens, Winfried Meissner, Claudia Weinmann, Peter Zahn and Esther Pogatzki-Zahn

    Citation: Trials 2020 21:773

    Content type: Study protocol

    Published on:

  37. The main aim of the study is to evaluate the efficacy of a single dose of sarilumab, in subcutaneous administration, in hospitalised patients with moderate to early severe COVID-19 infection compared to the cu...

    Authors: Rosario Garcia-Vicuña, Francisco Abad-Santos, Isidoro González-Alvaro, Francisco Ramos-Lima and Jesús Sanz Sanz

    Citation: Trials 2020 21:772

    Content type: Letter

    Published on:

  38. Undifferentiated connective tissue disease (UCTD) is known to induce adverse pregnancy outcomes and even recurrent spontaneous abortion (RSA) by placental vascular damage and inflammation activation. Anticoagu...

    Authors: Shaoying Yang, Ruoning Ni, Yikang Lu, Suli Wang, Feng Xie, Chunyan Zhang and Liangjing Lu

    Citation: Trials 2020 21:771

    Content type: Study protocol

    Published on:

  39. The OVID study will demonstrate whether prophylactic-dose enoxaparin improves survival and reduces hospitalizations in symptomatic ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral di...

    Authors: Stefano Barco, Roland Bingisser, Giuseppe Colucci, André Frenk, Bernhard Gerber, Ulrike Held, Francois Mach, Lucia Mazzolai, Marc Righini, Thomas Rosemann, Tim Sebastian, Rebecca Spescha, Stefan Stortecky, Stephan Windecker and Nils Kucher

    Citation: Trials 2020 21:770

    Content type: Letter

    Published on:

  40. To assess the effect of anticoagulation with bivalirudin administered intravenously on gas-exchange in patients with COVID-19 and respiratory failure using invasive mechanical ventilation.

    Authors: Nadir Kharma, Stefan Roehrig, Ahmed Atef Shible, Moustafa Sayed Elshafei, Dema Osman, Ingi Mohamed Elsaid, Salma Faisal Mustafa, Asjad Aldabi, Osamah A.M. Smain and Marcus D. Lance

    Citation: Trials 2020 21:769

    Content type: Letter

    Published on:

  41. Carotid atherosclerosis disease (CAD) is generally associated with the occurrence of cardiovascular and cerebrovascular accidents. However, CAD has not been taken seriously enough in the clinic, which, coupled...

    Authors: Junhe Zhou, Lin Zhao, Lingcui Meng, Huitao Liang, Ting Zhou, Siting Ye, Zhiqi Qi, Xichang Huang, Peng Zhou and Wenbin Fu

    Citation: Trials 2020 21:768

    Content type: Study protocol

    Published on:

  42. The Getting it Right: Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without cort...

    Authors: Ioana R. Marian, Sally Hopewell, David J. Keene, Lucy Cureton, Sarah E. Lamb and Susan J. Dutton

    Citation: Trials 2020 21:767

    Content type: Update

    Published on:

  43. To investigate the potential efficacy of Acacia Senegal extract Gum Arabic (GA) supplementation as immunomodulatory and anti-inflammatory dietary intervention among newly diagnosed COVID 19 Sudanese patients. ...

    Authors: Lamis Kaddam, Rasha Babiker, Sara Ali, Shahinaz Satti, Nour Ali, Maha Elamin, Mowaia Mukhtar, Mustafa Elnimeiri and Amal Saeed

    Citation: Trials 2020 21:766

    Content type: Letter

    Published on:

  44. Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequent...

    Authors: Lynda Constable, Tracey Davidson, Suzanne Breeman, Seonaidh Cotton, Alison McDonald, Samantha Wileman and John Norrie

    Citation: Trials 2020 21:765

    Content type: Commentary

    Published on:

  45. Lynch syndrome (LS) is the most common cause of inherited colorectal cancer (CRC) and confers a high lifetime risk of CRC estimated to be up to 60%. Colonoscopy is recommended every 2 years in LS patients abov...

    Authors: Adil Soualy, David Deutsch, Mourad Benallaoua, Amal Ait-Omar, Florence Mary, Sabine Helfen, Marouane Boubaya, Vincent Levy and Robert Benamouzig

    Citation: Trials 2020 21:764

    Content type: Study protocol

    Published on:

  46. Community-based interventions have shown promise in addressing the childhood obesity epidemic. Such efforts rely on the knowledge of key community members and their engagement with the drivers of obesity in th...

    Authors: Jillian Whelan, Claudia Strugnell, Steven Allender, Ariella R. Korn, Andrew D. Brown, Liliana Orellana, Josh Hayward, Vicki Brown, Colin Bell, Marj Moodie, Anna Peeters and Melanie Nichols

    Citation: Trials 2020 21:763

    Content type: Study protocol

    Published on:

  47. Bronchopulmonary dysplasia (BPD) is still a common complication in very premature infants. At present, there is no effective treatment for BPD. Glucocorticoids are drugs commonly used to prevent or treat BPD b...

    Authors: Yuan He, Yong Zhang, Shuqiang Gao, Xiaoling Wang, Na He, Deshuang Zhang, Wenbin Dong, Christian Wieg and Xiaoping Lei

    Citation: Trials 2020 21:762

    Content type: Study protocol

    Published on:

  48. As the USA grapples with an opioid epidemic, medical emergency departments (EDs) have become a critical setting for intervening with opioid-dependent patients. Brief interventions designed to bridge the gap fr...

    Authors: Amber Regis, Sarah E. Meyers-Ohki, Sarah E. Mennenga, Peter P. Greco, Richard Glisker, Rhonda Kolaric, Ryan P. McCormack, Richard C. Rapp and Michael P. Bogenschutz

    Citation: Trials 2020 21:761

    Content type: Methodology

    Published on:

  49. Pediatric musculoskeletal injuries cause moderate to severe pain, which should ideally be addressed upon arrival to the emergency department (ED). Despite extensive research in ED-based pediatric pain treatmen...

    Authors: Anna Heath, Maryna Yaskina, Gareth Hopkin, Terry P. Klassen, Christopher McCabe, Martin Offringa, Petros Pechlivanoglou, Juan David Rios, Naveen Poonai and Samina Ali

    Citation: Trials 2020 21:759

    Content type: Update

    Published on:

  50. Tocilizumab is a humanized monoclonal antibody which targets and inhibits interleukin-6 (IL-6) and has demonstrated efficacy in treating diseases associated with hyper-inflammation. Data are suggestive of toci...

    Authors: Aoife Cotter, Deborah Wallace, Cormac McCarthy, Eoin Feeney, Lorraine O’Neill, John Stack, Geraldine McCarthy, Rabia Hussain, Elena Alvarez Barco, Peter Doran and Patrick Mallon

    Citation: Trials 2020 21:758

    Content type: Letter

    Published on:

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