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  1. Although approximately 50% of Chinese with type 2 diabetes mellitus (T2DM) patients have vitamin D deficiency, studies regarding vitamin D supplementation on insulin resistance (IR) have mainly focused on non-...

    Authors: Mi Xiang, Xiaomin Sun, Junxiang Wei and Zhen-Bo Cao

    Citation: Trials 2021 22:888

    Content type: Study protocol

    Published on:

  2. Regular exercise is an effective method for reducing pain and disability in patients with knee osteoarthritis (OA), as well as improving body composition. Thus, a combination of both resistance and aerobic tra...

    Authors: Jéssica Bianca Aily, Aline Castilho de Almeida, Marcos de Noronha and Stela Marcia Mattiello

    Citation: Trials 2021 22:887

    Content type: Study protocol

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  3. The range of motion (RoM) of dorsiflexion (DF) plays an important role in human mobility, such as absorption of body weight during gait deceleration, jump landings, balance, and eccentric movements. This limit...

    Authors: Matheus de Castro Silva, Rodrigo de Marche Baldon, Carolina Lins, Gustavo Martins de Andrade, Gustavo Barros Braga de Castro and Lilian Ramiro Felicio

    Citation: Trials 2021 22:886

    Content type: Study protocol

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  4. Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion tr...

    Authors: Lili Song, Chen Chen, Xiaoying Chen, Yijia Guo, Feifeng Liu, Yapeng Lin, Laurent Billot, Qiang Li, Hueiming Liu, Lei Si, Menglu Ouyang, Hisatomi Arima, Philip M. Bath, Gary A. Ford, Thompson Robinson, Else Charlotte Sandset…

    Citation: Trials 2021 22:885

    Content type: Study protocol

    Published on:

  5. One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessm...

    Authors: Fiona A. Forth, Florian Hammerle, Jochem König, Michael S. Urschitz, Philipp Neuweiler, Eva Mildenberger and André Kidszun

    Citation: Trials 2021 22:884

    Content type: Study protocol

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  6. Concerted effort to control malaria has had a substantial impact on the transmission of the disease in the past two decades. In areas where reduced malaria transmission is being sustained through insecticide-b...

    Authors: Onyango P. Sangoro, Ulrike Fillinger, Kochelani Saili, Theresia Estomih Nkya, Rose Marubu, Freddie Masaninga, Sonia Casimiro Trigo, Casper Tarumbwa, Busiku Hamainza, Candrinho Baltazar, Joseph Mberikunashe, Brian Chisanga, Kassie Menale, Emmanuel Chanda and Clifford Maina Mutero

    Citation: Trials 2021 22:883

    Content type: Study protocol

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  7. Addressing the global burden of multidrug-resistant tuberculosis (MDR-TB) requires identification of shorter, less toxic treatment regimens. Médecins Sans Frontières (MSF) is currently conducting a phase II/II...

    Authors: Alexandra Wharton-Smith, Shona Horter, Emma Douch, Nell Gray, Nicola James, Bern-Thomas Nyang’wa, Jatinder Singh, Parpieva Nargiza Nusratovna, Zinaida Tigay, Emil Kazounis, Gulayim Allanazarova and Beverley Stringer

    Citation: Trials 2021 22:881

    Content type: Research

    Published on:

  8. Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in...

    Authors: Danielle H. Bodicoat, Ash C. Routen, Andrew Willis, Winifred Ekezie, Clare Gillies, Claire Lawson, Thomas Yates, Francesco Zaccardi, Melanie J. Davies and Kamlesh Khunti

    Citation: Trials 2021 22:880

    Content type: Methodology

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  9. There are more than 300,000 hip fractures yearly in the USA with mortality rates of 20% within 1 year. The treatment of osteoporotic fractures is a major challenge as bone quality is poor, and healing is expec...

    Authors: Ronald Man Yeung Wong, Simon Kwoon Ho Chow, Ning Tang, Yik Lok Chung, James Griffith, Wing Hong Liu, Raymond Wai Kit Ng, Chi Yin Tso and Wing Hoi Cheung

    Citation: Trials 2021 22:878

    Content type: Study protocol

    Published on:

  10. Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, hormone replacement therapy for POI has some limitations,...

    Authors: Ying Cao, Peijuan-Wang, Yan Lu, Yue Chen, Si Chen and Weibo-Zhao

    Citation: Trials 2021 22:877

    Content type: Study protocol

    Published on:

  11. The suspected or actual effects on health of endocrine-disrupting chemicals (EDC) and their ubiquitous presence in everyday life justify the implementation of health promotion interventions. These intervention...

    Authors: Houria El. Ouazzani, Steeve Rouillon, Nicolas Venisse, Lynda Sifer-Rivière, Antoine Dupuis, Guillaume Cambien, Sarah Ayraud-Thevenot, Anne-Sophie Gourgues, Pascale Pierre-Eugène, Fabrice Pierre, Sylvie Rabouan, Virginie Migeot and Marion Albouy-Llaty

    Citation: Trials 2021 22:876

    Content type: Study protocol

    Published on:

    The Correction to this article has been published in Trials 2021 22:968

  12. Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, p...

    Authors: Stefan Schoisswohl, Berthold Langguth, Martin Schecklmann, Alberto Bernal-Robledano, Benjamin Boecking, Christopher R. Cederroth, Dimitra Chalanouli, Rilana Cima, Sam Denys, Juliane Dettling-Papargyris, Alba Escalera-Balsera, Juan Manuel Espinosa-Sanchez, Alvaro Gallego-Martinez, Efi Giannopoulou, Leyre Hidalgo-Lopez, Michael Hummel…

    Citation: Trials 2021 22:875

    Content type: Study protocol

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  13. Traumatic brain injury (TBI) is a major cause of death and disability across all ages. After the primary impact, the pathophysiologic process of secondary brain injury consists of a neuroinflammation response ...

    Authors: Inge A. M. van Erp, Thomas A. van Essen, Kees Fluiter, Erik van Zwet, Peter van Vliet, Frank Baas, Iain Haitsma, Dagmar Verbaan, Bert Coert, Godard C. W. de Ruiter, Wouter A. Moojen, Mathieu van der Jagt and Wilco C. Peul

    Citation: Trials 2021 22:874

    Content type: Study protocol

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  14. The best way of comparing healthcare treatments is through a randomised trial. In a randomised trial, we compare something (a treatment or intervention) to something else, often another treatment. Who gets wha...

    Authors: Elaine Finucane, Ann O’Brien, Shaun Treweek, John Newell, Kishor Das, Sarah Chapman, Paul Wicks, Sandra Galvin, Patricia Healy, Linda Biesty, Katie Gillies, Anna Noel-Storr, Heidi Gardner, Mary Frances O’Reilly and Declan Devane

    Citation: Trials 2021 22:873

    Content type: Research

    Published on:

  15. Lower than expected recruitment and retention rates are common challenges in parenting trials—particularly for community-based trials targeting parents of young children that rely on face-to-face recruitment b...

    Authors: Maiken Pontoppidan, Sarah Blower, Julie Nygaard Solvang and Tracey Bywater

    Citation: Trials 2021 22:872

    Content type: Research

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  16. Xylitol use is reported to be able to reduce dental plaque amount and cariogenic bacteria and, as a consequence, the caries increment. Only few data on the oral health of Ladakh’s population are available. The...

    Authors: Maria Grazia Cagetti, Fabio Cocco, Ezio Calzavara, Davide Augello, Phunchok Zangpoo and Guglielmo Campus

    Citation: Trials 2021 22:871

    Content type: Study protocol

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  17. Although the provision of performance feedback to healthcare professionals based on data from quality registries is common practice in many fields of medicine, observational studies of its effect on the qualit...

    Authors: Marzyeh Amini, Sanne J. den Hartog, Nikki van Leeuwen, Frank Eijkenaar, Laurien S. Kuhrij, Lotte J. Stolze, Paul J. Nederkoorn, Hester F. Lingsma, Adriaan C. G. M. van Es, Ido R. van den Wijngaard, Aad van der Lugt, Diederik W. J. Dippel and Bob Roozenbeek

    Citation: Trials 2021 22:870

    Content type: Study protocol

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  18. The coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first identified in Wuhan, Hubei, China, in December 2019. It was recognized as a ...

    Authors: A. Abayomi, A. Osibogun, O. Ezechi, K. Wright, B. Ola, O. Ojo, Y. Kuyinu, E. Zamba, H. Abdur-Razzaq, O. A. Erinoso and S. E. Anya

    Citation: Trials 2021 22:869

    Content type: Study protocol

    Published on:

  19. The effectiveness of erythropoiesis-stimulating agents, which are the main stay of managing anaemia of chronic kidney disease (CKD), is largely dependent on adequate body iron stores. The iron stores are deter...

    Authors: Sandawana William Majoni, Jane Nelson, Darren Germaine, Libby Hoppo, Stephanie Long, Shilpa Divakaran, Brandon Turner, Jessica Graham, Sajiv Cherian, Basant Pawar, Geetha Rathnayake, Bianca Heron, Louise Maple-Brown, Robert Batey, Peter Morris, Jane Davies…

    Citation: Trials 2021 22:868

    Content type: Study protocol

    Published on:

  20. Coronavirus disease 2019 (COVID-19) results in debilitating long-term symptoms, often referred to as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), in a substantial subgroup of patients. One of the most p...

    Authors: T. A. Kuut, F. Müller, A. Aldenkamp, E. Assmann-Schuilwerve, A. Braamse, S. E. Geerlings, K. B. Gibney, R. A. A. Kanaan, P. Nieuwkerk, T. C. Olde Hartman, D. Pauëlsen, M. Prins, K. Slieker, M. Van Vugt, C. P. Bleeker-Rovers, S. P. Keijmel…

    Citation: Trials 2021 22:867

    Content type: Study protocol

    Published on:

  21. The majority of breast cancer patients suffer from persistent impairments after completion of their primary oncological therapy. Cancer-related fatigue (CRF) in particular is a multidimensional syndrome having...

    Authors: Shiao Li Oei, Thomas Rieser, Sarah Becker, Jessica Groß, Harald Matthes, Friedemann Schad and Anja Thronicke

    Citation: Trials 2021 22:866

    Content type: Study protocol

    Published on:

  22. Most people living with dementia want to remain living in their own homes and are supported to do so by family carers. No interventions have consistently demonstrated improvements to people with dementia’s lif...

    Authors: Alexandra Burton, Penny Rapaport, Marina Palomo, Kathryn Lord, Jessica Budgett, Julie Barber, Rachael Hunter, Laurie Butler, Jessica Vickerstaff, Kenneth Rockwood, Margaret Ogden, Debs Smith, Iain Lang, Gill Livingston, Briony Dow, Helen Kales…

    Citation: Trials 2021 22:865

    Content type: Study protocol

    Published on:

  23. The prevalence of myopia is increasing worldwide and is presently recognized as a major public health issue. Researchers and clinicians have been devoted in exploring appropriate clinical interventions to slow...

    Authors: Ying Yuan, Chengcheng Zhu, Mingming Liu, Yali Zhou, Xiao Yang, Bingru Zheng, Zhouyue Li, Xinjie Mao and Bilian Ke

    Citation: Trials 2021 22:863

    Content type: Study protocol

    Published on:

  24. Authors: Natalie Durbeej, Serena McDiarmid, Anna Sarkadi, Inna Feldman, Raija-Leena Punamäki, Reeta Kankaanpää, Arnfinn Andersen, Per Kristian Hilden, An Verelst, Ilse Derluyn and Fatumo Osman

    Citation: Trials 2021 22:861

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:98

  25. Leg cramps are painful sensations of tightening in the muscles of the legs that commonly appear during the night and are often associated with secondary insomnia. They are common especially in older age. There...

    Authors: Jenni Joensuu, Pertti P. Mustajoki, Pekka K. Mustonen, Minna Kaila and Tuomas Koskela

    Citation: Trials 2021 22:860

    Content type: Study protocol

    Published on:

  26. Neonatal sepsis is a global public health problem. There is no consensus regarding the optimum duration of antibiotics for culture-proven neonatal sepsis. Published randomized controlled trials (RCTs) comparin...

    Authors: Sourabh Dutta, Sushma Nangia, Mamta Jajoo, Geeta Gathwala, Saudamini Nesargi, Mangalabharathi Sundaram, Praveen Kumar, Arvind Saili, Dipti Kumar, Poonam Dalal, P. N. Suman Rao, Ramya Shanmugam, Pallab Ray, Valinderjeet Singh Randhawa, Karnika Saigal, Madhu Sharma…

    Citation: Trials 2021 22:859

    Content type: Study protocol

    Published on:

  27. Orthopedic trauma patients face complex pain management needs and are frequently prescribed opioids, leaving them at-risk for prolonged opioid use. To date, post-trauma pain management research has placed litt...

    Authors: Nicholas A. Giordano, Jesse Seilern und Aspang, J‘Lynn Baker, Cammie Wolf Rice, Bailey Barrell, Lauren Kirk, Erika Ortega, Michelle Wallace, Alaina Steck and Mara L. Schenker

    Citation: Trials 2021 22:858

    Content type: Study protocol

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  28. Some pain, fatigue, and gastrointestinal adverse events were observed in potential association with injection of COVID-19 vaccines, while there was no preventive intervention for it. We aim to investigate the ...

    Authors: Qinwei Fu, Hui Xie, Li Zhou, Xinrong Li, Yang Liu, Min Liu, Chaoyu Wang, Xiaocen Wang, Zhiqiao Wang, Jinfan Tang, Huan Xiao, Zhiyong Xiao, Jing Zhou, Chengzhi Feng, Li Wang, Zhimin Ao…

    Citation: Trials 2021 22:857

    Content type: Update

    Published on:

    The Letter to this article has been published in Trials 2021 22:162

  29. Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Interv...

    Authors: Julia Nordlund, Richard S. Henry, Linda Kwakkenbos, Marie-Eve Carrier, Brooke Levis, Warren R. Nielson, Susan J. Bartlett, Laura Dyas, Lydia Tao, Claire Fedoruk, Karen Nielsen, Marie Hudson, Janet Pope, Tracy Frech, Shadi Gholizadeh, Sindhu R. Johnson…

    Citation: Trials 2021 22:856

    Content type: Study protocol

    Published on:

  30. Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term op...

    Authors: Maxime Léger, Solène Pessiot-Royer, Tristan Perrault, Elsa Parot-Schinkel, Fabienne Costerousse, Emmanuel Rineau and Sigismond Lasocki

    Citation: Trials 2021 22:855

    Content type: Study protocol

    Published on:

  31. Common mental disorders such as depression and anxiety are major contributors to the global burden of disease. Affected individuals suffer reduced quality of life, impaired functioning and reduced capacity to ...

    Authors: Kenneth Sandin, Ragne G. H. Gjengedal, Kåre Osnes, Marit Hannisdal, Torkil Berge, Jonas S. R. Leversen, Lars G. Røv, Silje Endresen Reme, Suzanne Lagerveld, Roland Blonk, Hans M. Nordahl, Gemma Shields, Adrian Wells and Odin Hjemdal

    Citation: Trials 2021 22:854

    Content type: Study protocol

    Published on:

    The Correction to this article has been published in Trials 2021 22:941

  32. Fibromyalgia is a chronic multidimensional pain disease with no curative treatment currently available. Its management relies on a multimodal approach involving pharmacologic and non-pharmacologic elements. Be...

    Authors: Zuzana Javorcikova, Michel Dangoisse, Stéphane Nikis, Jean-Paul Lechat, Aline Gillain, Jean-François Fils and Philippe Van der Linden

    Citation: Trials 2021 22:853

    Content type: Study protocol

    Published on:

  33. The incidence of non-AIDS defining cancer (NADC) is higher in people living with HIV (PLWH) than in the general population, and it is already one of the leading causes of death in the HIV-infected population. ...

    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 2021 22:851

    Content type: Study protocol

    Published on:

  34. A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is “usual care.” The main challenge is to ensure that the control group receives genuine usual care as...

    Authors: Margrete Mangset, Gabriele Kitzmüller, Anne S. Evju, Sanne Angel, Lena Aadal, Randi Martinsen, Berit Arnesveen Bronken, Kari J. Kvigne, Line K. Bragstad, Ellen Gabrielsen Hjelle, Unni Sveen and Marit Kirkevold

    Citation: Trials 2021 22:850

    Content type: Research

    Published on:

  35. As the population of Korea ages, interest in healthcare has increased. In particular, there is an increasing demand for immune-function improvement to prevent infectious diseases. Phellinus linteus (PL) has previ...

    Authors: Yong Ho Ku, Hyun Lee, Hwa Yeon Ryu and Jae Hui Kang

    Citation: Trials 2021 22:849

    Content type: Study protocol

    Published on:

  36. Trauma-focused treatments for posttraumatic stress disorder (PTSD) are commonly delivered either once or twice a week. Initial evidence suggests that session frequency affects treatment response, but very few ...

    Authors: Carlijn J. M. Wibbelink, Christopher W. Lee, Nathan Bachrach, Sarah K. Dominguez, Thomas Ehring, Saskia M. van Es, Eva Fassbinder, Sandra Köhne, Magda Mascini, Marie-Louise Meewisse, Simone Menninga, Nexhmedin Morina, Sophie A. Rameckers, Kathleen Thomaes, Carla J. Walton, Ingrid G. Wigard…

    Citation: Trials 2021 22:848

    Content type: Study protocol

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  37. Diabetic cognitive impairment (DCI) is a serious chronic complication caused by diabetes. The pathogenesis of DCI is complex, but brain nerve injury and brain nerve cell apoptosis are important pathological ch...

    Authors: Lin Yao, Mengyuan Li, Shunan Sun, Ming Xu, Shuo Yu, Ziyang Zhang, Liying Zhang, Haizhu Zheng, Zhen Zhong, Shiqi Ma, Haipeng Huang and Hongfeng Wang

    Citation: Trials 2021 22:847

    Content type: Study protocol

    Published on:

  38. Gait difficulties in Parkinson’s disease have been related to problems shifting the center of gravity forward. We previously showed reduced forward stepping latencies for people with Parkinson’s disease after ...

    Authors: Janet H. Bultitude, Dawna M. Pidgeon, Pauline R. LeBlanc, Charlotte A. Jeffreys, Faith P. Alexandre and Stephen L. Lee

    Citation: Trials 2021 22:846

    Content type: Research

    Published on:

  39. Poor participant recruitment is the most frequent reason for premature discontinuation of randomized clinical trials (RCTs), particularly if they are investigator-initiated. The aims of this qualitative study ...

    Authors: Matthias Briel, Bernice S. Elger, Stuart McLennan, Stefan Schandelmaier, Erik von Elm and Priya Satalkar

    Citation: Trials 2021 22:844

    Content type: Research

    Published on:

  40. Perineal tear is a common consequence of vaginal births affecting females globally. Even mild perineal tears could cause short- and long-term complications for females. Though many studies of interventions to ...

    Authors: Lin Xiao, Lei Shi, Suting Liu, Yuanyuan Luo, Jinhui Tian and Lili Zhang

    Citation: Trials 2021 22:843

    Content type: Study protocol

    Published on:

  41. Authors: Sheung-Tak Cheng, Ka Long Chan, Rosanna W. L. Lau, Monique H. T. Mok, Phoon Ping Chen, Yu Fat Chow, Joanne W. Y. Chung, Alexander C. B. Law, Jenny S. W. Lee, Edward M. F. Leung and Cindy W. C. Tam

    Citation: Trials 2021 22:842

    Content type: Correction

    Published on:

    The original article was published in Trials 2017 18:528

  42. The needs of children in care are a government priority, yet the evidence base for effective interventions to support the emotional wellbeing of children in care is lacking. Research suggests that supporting t...

    Authors: Nick Midgley, Karen Irvine, Beth Rider, Sarah Byford, Antonella Cirasola, Poushali Ganguli, Thando Katangwe-Chigamba, Jamie Murdoch, Martin Pond, Benita Pursch, Sheila Redfern, Zena Louise Richards, Lee Shepstone, Erika Sims, Caroline Smith, Eva Sprecher…

    Citation: Trials 2021 22:841

    Content type: Study protocol

    Published on:

  43. Reach Out is a factorial trial studying multicomponent behavioral interventions to reduce blood pressure in hypertensive emergency department patients. The original study protocol was published in June 2020. H...

    Authors: Lesli E. Skolarus, Mackenzie Dinh, Kelley M. Kidwell, Zahera Farhan, Candace Whitfield, Deborah A. Levine and William J. Meurer

    Citation: Trials 2021 22:836

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2020 21:456

  44. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of some chemotherapy regimens. Lithium has been suggested for CIPN in some animal studies. We aimed to study lithium’s preventive ef...

    Authors: S. Najafi, Z. Heidarali, M. Rajabi, Z. Omidi, F. Zayeri, M. Salehi and S. Haghighat

    Citation: Trials 2021 22:835

    Content type: Research

    Published on:

  45. Generalized anxiety disorder (GAD) is common among perimenopausal women. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related ...

    Authors: Xin Liu, Xiaoyan Xie, Yingjia Li, Meichen Li, Yuting Wang, Nanbu Wang, Lixing Zhuang and Muxi Liao

    Citation: Trials 2021 22:833

    Content type: Study protocol

    Published on:

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