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  1. Content type: Correction

    Following publication of the original article [1], the authors requested a correction be made, indicating L. Bates as the first author only. There is no joint first authorship.

    Authors: Laura A. Bates, Joseph P. Hicks, John Walley and Emily Robinson

    Citation: Trials 2018 19:556

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    The original article was published in Trials 2018 19:420

  2. Content type: Study protocol

    Tinnitus is a highly prevalent symptom affecting 10–15% of the adult population. It often affects patient quality of life and frequently causes distress. When subjective tinnitus can be elicited by the somatos...

    Authors: Sarah Michiels, Annemarie Christien van der Wal, Evelien Nieste, Paul Van de Heyning, Marc Braem, Corine Visscher, Vedat Topsakal, Annick Gilles, Laure Jacquemin, Marianne Hesters and Willem De Hertogh

    Citation: Trials 2018 19:554

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  3. Content type: Study protocol

    Recent data suggest that 10–20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decl...

    Authors: Cédric Gil-Jardiné, Samantha Al Joboory, Juliane Tortes Saint Jammes, Guillaume Durand, Régis Ribéreau-Gayon, Michel Galinski, Louis-Rachid Salmi, Philippe Revel, Cyril Alexandre Régis, Guillaume Valdenaire, Emmanuel Poulet, Karim Tazarourte and Emmanuel Lagarde

    Citation: Trials 2018 19:555

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  4. Content type: Study protocol

    Cardiovascular diseases (CVDs) increasingly contribute to morbidity and mortality in Tanzania. Public knowledge about CVD risk factors is important for the primary prevention of CVDs and can be improved throug...

    Authors: Alfa J Muhihi, David P Urassa, Rose N M Mpembeni, Germana H Leyna, Bruno F Sunguya, Deodatus Kakoko, Anna Tengia Kessy and Marina A Njelekela

    Citation: Trials 2018 19:552

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  5. Content type: Research

    In Traditional Chinese Medicine (TCM) theories, the typical clinical manifestations of gout are attributed to the “dampness-heat pouring downward.” Therefore, TCM practitioners always consider prescribing the ...

    Authors: Xiao Ning Yu, Hai Yan Wu, Yuan Ping Deng, Guang Tong Zhuang, Bang Huan Tan, Yan Zhou Huang, Shi Yun Tang, Xiang Tu, James B Jordan and Sen Zhong

    Citation: Trials 2018 19:551

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  6. Content type: Study protocol

    Children and young people of parents with mental illness (COPMI) are at risk of poor mental, physical and emotional health, which can persist into adulthood. They also experience poorer social outcomes and wel...

    Authors: Judith Gellatly, Penny Bee, Lina Gega, Peter Bower, Diane Hunter, Paul Stewart, Nicky Stanley, Rachel Calam, Kim Holt, Miranda Wolpert, Simon Douglas, Jonathan Green, Adekeye Kolade, Craig Callender and Kathryn M Abel

    Citation: Trials 2018 19:550

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  7. Content type: Study protocol

    The World Health Organization recommends rapid (≤ 7 days) or same-day initiation of antiretroviral treatment (ART) for HIV-positive patients. South Africa adopted this recommendation in 2017, but multiple clin...

    Authors: S Rosen, M Maskew, A T Brennan, M P Fox, L Vezi, P D Ehrenkranz and W D F Venter

    Citation: Trials 2018 19:548

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  8. Content type: Study protocol

    Endoscopic ultrasonography (EUS)-guided drainage has become the first-line therapy for late peri-pancreatic fluid collection (PFC). Double pigtail plastic stents (DPPS) and lumen-apposing metal stents (LAMS) a...

    Authors: Hui-Yun Zhu, Pei Xie, Ying-Xiao Song, Zhao-Shen Li, Zhen-Dong Jin and Yi-Qi Du

    Citation: Trials 2018 19:549

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  9. Content type: Study protocol

    Colorectal cancer screening participation is a preference-sensitive choice, in which trade-offs between benefits and harms must be made by individual citizens. Often the decision is made without any contact wi...

    Authors: Pernille Gabel, Mette Bach Larsen, Pia Kirkegaard, Adrian Edwards and Berit Andersen

    Citation: Trials 2018 19:543

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  10. Content type: Research

    A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target difference in the primary outcome between the r...

    Authors: William Sones, Steven A. Julious, Joanne C. Rothwell, Craig Robert Ramsay, Lisa V. Hampson, Richard Emsley, Stephen J. Walters, Catherine Hewitt, Martin Bland, Dean A. Fergusson, Jesse A. Berlin, Doug Altman, Luke David Vale and Jonathan Alistair Cook

    Citation: Trials 2018 19:542

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  11. Content type: Study protocol

    There is a growing need for an evidence-based approach to home support for people with dementia and their carers following diagnosis but research on the effectiveness and cost-effectiveness of different approa...

    Authors: Helen Chester, Paul Clarkson, Linda Davies, Jane Hughes, Muhammad Saiful Islam, Narinder Kapur, Martin Orrell, Julie Peconi, Rosa Pitts, Fiona Poland, Ian Russell and David Challis

    Citation: Trials 2018 19:546

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  12. Content type: Study protocol

    Patients with major depression disorder presents increased rates of cognitive decline, reduced hippocampal volume, poor sleep quality, hypertension, obesity, suicidal ideation and behavior, and decreased funct...

    Authors: Lucas Melo Neves, Carla Silva-Batista, Raquel Marquesini, Telma Fátima da Cunha, Elisa Dimateo, Luciana Nascimento, Acácio Moreira-Neto, Angelo Corrêa de Lima Miliatto, Sheila das Chagas Mendes, Flavia Saad, Jamile Sanches Codogno, Renato Hoffmann Nunes, Raphael Mendes Ritti-Dias, Valeria Juday, Beny Lafer and Carlos Ugrinowitsch

    Citation: Trials 2018 19:545

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  13. Content type: Research

    When designing a randomised controlled trial (RCT), an important consideration is the sample size required. This is calculated from several components; one of which is the target difference. This study aims to...

    Authors: Joanne C. Rothwell, Steven A. Julious and Cindy L. Cooper

    Citation: Trials 2018 19:544

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  14. Content type: Study protocol

    Previous research has demonstrated the clinical effectiveness of long-term psychological treatment for people with some types of personality disorder. However, the high intensity and cost of these intervention...

    Authors: Mike J Crawford, Lavanya Thana, Jennie Parker, Oliver Turner, Kwek Pei Xing, Mary McMurran, Paul Moran, Timothy Weaver, Barbara Barrett, Amy Claringbold, Paul Bassett and Rahil Sanatinia

    Citation: Trials 2018 19:547

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  15. Content type: Review

    Clinical significance in a randomized controlled trial (RCT) can be determined using the minimal clinically important difference (MCID), which should inform the delta value used to determine sample size. The p...

    Authors: A. Fuchsia Howard, Karen Goddard, Shahrad Rod Rassekh, Osama A Samargandi and Haroon Hasan

    Citation: Trials 2018 19:539

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  16. Content type: Study protocol

    An increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of non-valvular atrial fibrillation (NVAF) in China. However, the heterogeneity of outcomes and outc...

    Authors: Ruijin Qiu, Min Li, Xiaoyu Zhang, Shiqi Chen, Chengyu Li and Hongcai Shang

    Citation: Trials 2018 19:541

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  17. Content type: Study protocol

    Mobile Technology and Incentives (MOTIVES) is a randomized pilot study of a mobile technology-based and behavioral economics-supported HIV prevention intervention. Behavioral economics (BE) uses financial ince...

    Authors: Sebastian Linnemayr, Sarah MacCarthy, Alice Kim, Rebecca Giguere, Alex Carballo-Dieguez and Joanna L. Barreras

    Citation: Trials 2018 19:540

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  18. Content type: Study protocol

    Coronary heart disease (CHD) represents approximately 13% of deaths worldwide and is the leading cause of death in the UK with considerable associated health care costs. After a CHD event, timely cardiac rehab...

    Authors: Louisa Y Herring, Helen Dallosso, Sudesna Chatterjee, Danielle Bodicoat, Sally Schreder, Kamlesh Khunti, Tom Yates, Sam Seidu, Ian Hudson and Melanie J Davies

    Citation: Trials 2018 19:537

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  19. Content type: Study protocol

    Weight gain frequently occurs after smoking cessation (SC); the risk of new-onset diabetes mellitus increases for several years after SC. However, no large-scale, randomized controlled trials have examined the...

    Authors: Maki Komiyama, Yuka Ozaki, Hiromichi Wada, Hajime Yamakage, Noriko Satoh-Asahara, Tatsuya Morimoto, Akira Shimatsu, Yuko Takahashi and Koji Hasegawa

    Citation: Trials 2018 19:538

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  20. Content type: Study protocol

    Team-based care has been identified as a key component in transforming primary care. An important factor in implementing team-based care is the requirement for teams to have daily huddles. During huddles, the ...

    Authors: Megan E. Branda, Aravind Chandrasekaran, Marc D. Tumerman, Nilay D. Shah, Peter Ward, Bradley R. Staats, Theresa M. Lewis, Diane K. Olson, Rachel Giblon, Michelle A. Lampman and David R. Rushlow

    Citation: Trials 2018 19:536

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  21. Content type: Research

    There are more than a quarter of a million individuals aged ≥ 65 years who are resident in care homes in England and Wales. Care home residents have high levels of cognitive impairment, physical disability, mu...

    Authors: Alison Ellwood, Jennifer Airlie, Robert Cicero, Bonnie Cundill, David R Ellard, Amanda Farrin, Mary Godfrey, Liz Graham, John Green, Vicki McLellan, Najma Siddiqi and Anne Forster

    Citation: Trials 2018 19:535

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  22. Content type: Update

    Palmoplantar pustulosis (PPP) is a rare, chronic inflammatory skin disease. It is known to affect quality of life at a level comparable to that from major medical and psychiatric illness, yet current treatment...

    Authors: Suzie Cro, Catherine Smith, Rosemary Wilson and Victoria Cornelius

    Citation: Trials 2018 19:534

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    The Study protocol to this article has been published in Trials 2018 19:465

  23. Content type: Study protocol

    Forty percent of babies who are stillborn born die after 36 weeks gestation and have no lethal structural abnormality. Maternal perception of reduced fetal movement (RFM) is associated with stillbirth and is r...

    Authors: Lindsay Armstrong-Buisseret, Eleanor Mitchell, Trish Hepburn, Lelia Duley, Jim G. Thornton, Tracy E. Roberts, Claire Storey, Rebecca Smyth and Alexander E. P. Heazell

    Citation: Trials 2018 19:531

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  24. Content type: Research

    Following up released prisoners is demanding, particularly for those prisoners with mental health problems, for whom stigma and chaotic lifestyles are problematic. Measurement of mental health outcomes after r...

    Authors: Cath Quinn, Richard Byng, Deborah Shenton, Cordet Smart, Susan Michie, Amy Stewart, Rod Taylor, Mike Maguire, Tirril Harris and Jenny Shaw

    Citation: Trials 2018 19:530

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  25. Content type: Commentary

    Acute severe haemorrhage is a common complication of injury, childbirth, surgery, gastrointestinal pathologies and other medical conditions. Bleeding is a major cause of death, but patients also die from non-b...

    Authors: Amy Brenner, Monica Arribas, Jack Cuzick, Vipul Jairath, Simon Stanworth, Katharine Ker, Haleema Shakur-Still and Ian Roberts

    Citation: Trials 2018 19:533

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  26. Content type: Study protocol

    The gap between the supply and demand of organ donors is substantial, causing patients to suffer from long waiting times. Moreover, the lack of registrations places a burden on family members and medical profe...

    Authors: Esther Steenaart, Rik Crutzen, Math J J M Candel and Nanne K de Vries

    Citation: Trials 2018 19:532

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  27. Content type: Study protocol

    Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease. A global perspective given by the World Gastroenterology...

    Authors: Li-xia Pei, Hao Geng, Hao Chen, Xiao-liang Wu, Lu Chen, Jun-ling Zhou, Lu Ju, Gao Lu, Wan-li Xu, Shan Qin, Jing Guo, Eun Mee Yang and Jian-hua Sun

    Citation: Trials 2018 19:529

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  28. Content type: Study protocol

    Acute pain is always the most common complaint in Emergency Department admissions and options for analgesia are limited. Nitrous oxide/oxygen possess many properties showing it may be an ideal analgesic method...

    Authors: Lu-Lu Gao, Li-Shan Yang, Jun-Jun Zhang, Yi-Ling Wang, Ke Feng, Lei Ma, Yuan-Yuan Yu, Qiang Li, Qing-Huan Wang, Jin-Tao Bao, Ya-Liang Dai, Qiang Liu, Yu-Xiang Li and Qiang-Jian Yu

    Citation: Trials 2018 19:527

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  29. Content type: Study protocol

    Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and sometimes irreversible neurotoxic symptom that occurs in 30–40% of chemotherapy-treated cancer patients. CIPN negatively affect...

    Authors: Chang eun Jang, Mi Sook Jung, Eun Hee Sohn, Mijung Kim, Hwa-Seung Yoo, Kyeore Bae, Je Ryong Kim and Jin Sun Lee

    Citation: Trials 2018 19:526

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  30. Content type: Research

    Clinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is equally crucial that patients are given the opportunity to make a well-informed decision about par...

    Authors: Pia Dellson, Kerstin Nilsson, Helena Jernström and Christina Carlsson

    Citation: Trials 2018 19:528

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  31. Content type: Study protocol

    Congenital diaphragmatic hernia is an orphan disease with high neonatal mortality and significant morbidity. An important cause for this is pulmonary hypertension, for which no effective postnatal therapy is a...

    Authors: Francesca Maria Russo, Alexandra Benachi, Tim Van Mieghem, Jan De Hoon, Kristel Van Calsteren, Pieter Annaert, Jean-Marc Tréluyer, Karel Allegaert and Jan Deprest

    Citation: Trials 2018 19:524

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  32. Content type: Study protocol

    There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availabili...

    Authors: Monica Taljaard, Charles Weijer, Jeremy M. Grimshaw, Adnan Ali, Jamie C. Brehaut, Marion K. Campbell, Kelly Carroll, Sarah Edwards, Sandra Eldridge, Christopher B. Forrest, Bruno Giraudeau, Cory E. Goldstein, Ian D. Graham, Karla Hemming, Spencer Phillips Hey, Austin R. Horn…

    Citation: Trials 2018 19:525

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  33. Content type: Study protocol

    Dental caries is the most prominent childhood disease in the world. In the United States, more than 50% of children have experienced caries. Untreated caries can have negative impacts on quality of life, acade...

    Authors: Ryan Richard Ruff and Richard Niederman

    Citation: Trials 2018 19:523

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  34. Content type: Study protocol

    Mild cognitive impairment (MCI) is a syndrome characterised by a decline in cognition but relatively intact activities of daily living. People with MCI have an increased risk of developing dementia, and MCI is...

    Authors: Genevieve Z. Steiner, Alan Bensoussan, Jianxun Liu, Mark I. Hohenberg and Dennis H. Chang

    Citation: Trials 2018 19:522

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  35. Content type: Study protocol

    Compared to whites, blacks are at increased risk for obstructive sleep apnea (OSA) yet less likely to adhere to physician-recommended sleep assessment and treatment. Poor OSA health literacy and lack of social...

    Authors: Azizi A. Seixas, Chau Trinh-Shevrin, Joseph Ravenell, Gbenga Ogedegbe, Ferdinand Zizi and Girardin Jean-Louis

    Citation: Trials 2018 19:519

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  36. Content type: Study protocol

    Residents of care homes have high levels of disability and poor mobility, but the promotion of health and wellbeing within care homes is poorly realised. Residents spend the majority of their time sedentary wh...

    Authors: Liz Graham, Robert Cicero, David Clarke, Bonnie Cundill, Alison Ellwood, Amanda Farrin, Jill Fisher, Madeline Goodwin, Rebecca Hawkins, Karen Hull, Claire Hulme, Dominic Trépel, Rachel Williams and Anne Forster

    Citation: Trials 2018 19:521

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  37. Content type: Study protocol

    Home monitoring of foot temperatures in high-risk diabetes patients proves to be a promising approach for early recognition and treatment of pre-signs of ulceration, and thereby ulcer prevention. Despite previ...

    Authors: Wouter B. aan de Stegge, Nora Mejaiti, Jaap J. van Netten, Marcel G. W. Dijkgraaf, Jeff G. van Baal, Tessa E. Busch-Westbroek and Sicco A. Bus

    Citation: Trials 2018 19:520

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  38. Content type: Study protocol

    In recent years, the number of arthroscopic shoulder surgeries has increased given that the intervention is minimally invasive. However, postoperative pain is one of the most common symptoms of patients who un...

    Authors: Sun-Young Moon, Jung-Eun Kim, O-Jin Kwon, Ae-Ran Kim, Da-Heui Kim, Jae-Hong Kim, Hwa Soo Hwang and Changsop Yang

    Citation: Trials 2018 19:518

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  39. Content type: Study protocol

    Greater trochanteric pain syndrome (GTPS) is a painful condition characterised by pain around the greater trochanter usually affecting middle-aged women. The majority of patients will improve with conservative...

    Authors: Eshan Oderuth, Mohammed Ali, Ismael Atchia and Ajay Malviya

    Citation: Trials 2018 19:517

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  40. Content type: Study protocol

    Prior evidence shows that behaviours closely related to the intervention delivered for autism are amenable to change, but it is more difficult to generalise treatment effects beyond the intervention context. W...

    Authors: Jonathan Green, Catherine Aldred, Tony Charman, Ann Le Couteur, Richard A. Emsley, Victoria Grahame, Patricia Howlin, Neil Humphrey, Kathy Leadbitter, Helen McConachie, Jeremy R. Parr, Andrew Pickles, Vicky Slonims and Carol Taylor

    Citation: Trials 2018 19:514

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  41. Content type: Research

    A shortage of organs available for transplantation is causing loss of life. Increasing the number of individuals on the National Health Service (NHS) Organ Donor Register (ODR) is one way to address the shorta...

    Authors: Anna Sallis, Hugo Harper and Michael Sanders

    Citation: Trials 2018 19:513

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  42. Content type: Study protocol

    Qi stagnation and blood stasis syndrome (QS&BSS) is one of the common Zhengs in traditional Chinese medicine (TCM), which manifests as various symptoms and signs, such as distending pain or a tingling sensation i...

    Authors: Haoqiang He, Guang Chen, Jialiang Gao, Yu Liu, Chenhao Zhang, Chao Liu, Hongzheng Li, Qingyong He, Jun Li and Jie Wang

    Citation: Trials 2018 19:515

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  43. Content type: Correction

    Following publication of the original article [1], the authors reported that Elizabeth Camacho was omitted from the author name list.

    Authors: Anja Wittkowski, Kim Cartwright, Richard Emsley, Penny Bee, Elizabeth Camacho, Rachel Calam, Catherine Cross, Kathryn M. Abel and Holly Reid

    Citation: Trials 2018 19:516

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    The original article was published in Trials 2018 19:479

  44. Content type: Study protocol

    The quality of cardiopulmonary resuscitation (CPR) performed by emergency medical services (EMS) personnel affects patient outcomes after cardiac arrest. A CPR feedback device with an accelerometer mounted on ...

    Authors: Akihiro Hirakawa, Toshihiro Hatakeyama, Daisuke Kobayashi, Chika Nishiyama, Akiko Kada, Takeyuki Kiguchi, Takashi Kawamura and Taku Iwami

    Citation: Trials 2018 19:510

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  45. Content type: Study protocol

    Clinical practice guidelines recommend exercise as the first line of management for hip osteoarthritis, yet high-quality evidence from Cochrane reviews suggest only slight benefits for pain and physical functi...

    Authors: Adam Ivan Semciw, Tania Pizzari, Stephanie Woodley, Anita Zacharias, Michael Kingsley and Rod A. Green

    Citation: Trials 2018 19:511

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  46. Content type: Study protocol

    Tai Chi is a moderately intense exercise that dates back to ancient China. It has been reported that Tai Chi not only has beneficial effects on metabolic disorders, such as diabetes, cardiovascular diseases an...

    Authors: Yan Li, Changle Peng, Guangying Cao, Wei Li and Lihui Hou

    Citation: Trials 2018 19:512

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  47. Content type: Review

    Clinical trial registries have been a priority topic in the past few years in promoting data transparency and accountability. In this context, in 2011, the IRCCS - Istituto di Ricerche Farmacologiche “Mario Ne...

    Authors: Chiara Pandolfini and Maurizio Bonati

    Citation: Trials 2018 19:509

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  48. Content type: Research

    The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FD...

    Authors: Aviv Ladanie, Benjamin Speich, Florian Naudet, Arnav Agarwal, Tiago V. Pereira, Francesco Sclafani, Juan Martin-Liberal, Thomas Schmid, Hannah Ewald, John P. A. Ioannidis, Heiner C. Bucher, Benjamin Kasenda and Lars G. Hemkens

    Citation: Trials 2018 19:505

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  49. Content type: Update

    Several studies evaluating clinical forms of chronic Chagas disease show that about one-third of patients present cardiac involvement. Heart failure, sudden death and cardioembolic stroke are the main mechanis...

    Authors: Marcelo Teixeira Holanda, Mauro Felippe Felix Mediano, Alejandro Marcel Hasslocher-Moreno, Sérgio Salles Xavier, Roberto Magalhães Saraiva, Andrea Silvestre Sousa, Erica Rodrigues Maciel, Fernanda Martins Carneiro, Paula Simplicio da Silva, Luiz Henrique Conde Sangenis, Henrique Horta Veloso, Claudia Santos de Aguiar Cardoso, Maria da Gloria Bonecini-Almeida, Andreia Lamoglia Souza, Eric Henrique Roma, Marcos José Azevedo…

    Citation: Trials 2018 19:507

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    The Study protocol to this article has been published in Trials 2014 15:388

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