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  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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  11. 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

  12. 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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  13. 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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  14. 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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  15. 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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  16. Content type: Research

    Intervention fidelity is the degree to which interventions have been implemented as intended by their developers. Assessing fidelity is crucial for accurate interpretation of intervention effectiveness, but fi...

    Authors: Daragh McGee, Fabiana Lorencatto, Karen Matvienko-Sikar and Elaine Toomey

    Citation: Trials 2018 19:504

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  17. Content type: Study protocol

    Generalised anxiety disorder (GAD) is a chronic and debilitating condition characterised by high co-morbidity. Alongside pharmacological treatment, cognitive behavioural therapy (CBT) is an established psychol...

    Authors: Ladislav Timulak, Daragh Keogh, Craig Chigwedere, Charlotte Wilson, Fiona Ward, David Hevey, Patrick Griffin, Louise Jacobs and Brenda Irwin

    Citation: Trials 2018 19:506

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  18. Content type: Research

    The Endovascular Acute Stroke Intervention (EASI) trial was conceived as a pragmatic care trial, designed to integrate trial methods with clinical practice. Reporting the EASI experience was met with objection...

    Authors: Robert Fahed, Stefanos Finitsis, Naim Khoury, Yan Deschaintre, Nicole Daneault, Laura Gioia, Gregory Jacquin, Céline Odier, Alexande Y. Poppe, Alain Weill, Daniel Roy, Tim E. Darsaut, Thanh N. Nguyen and Jean Raymond

    Citation: Trials 2018 19:508

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  19. 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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  20. 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

  21. Content type: Research

    Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequ...

    Authors: Adwoa Parker, Peter Knapp, Shaun Treweek, Vichithranie Madhurasinghe, Roberta Littleford, Stephanie Gallant, Frank Sullivan, Stuart Schembri, Jo Rick, Jonathan Graffy, David J. Collier, Sandra Eldridge, Anne Kennedy and Peter Bower

    Citation: Trials 2018 19:503

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  22. Content type: Study protocol

    Whilst current guidelines highlight the importance of pain management for children with acute otitis media (AOM), there is evidence to suggest that this is not implemented in everyday practice. We have develop...

    Authors: Rick T. van Uum, Roderick P. Venekamp, Alies Sjoukes, Alma C. van de Pol, G. Ardine de Wit, Anne G. M. Schilder and Roger A. M. J. Damoiseaux

    Citation: Trials 2018 19:501

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  23. Content type: Study protocol

    Throughout sub-Saharan Africa HIV-testing rates remain low. Barriers to testing, such as inconvenient service hours and long wait times, lack of privacy, and fear of unwanted disclosure, continue to impede ser...

    Authors: Kathryn Dovel, Frackson Shaba, Mike Nyirenda, O. Agatha Offorjebe, Kelvin Balakasi, Khumbo Phiri, Brooke Nichols, Chi-Hong Tseng, Ashley Bardon, Khumbo Ngona and Risa Hoffman

    Citation: Trials 2018 19:498

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  24. Content type: Study protocol

    Hospitalized older persons with Alzheimer’s disease and related dementias are at greater risk for functional decline and increased care dependency after discharge due to a combination of intrinsic factors, env...

    Authors: Marie Boltz, Ashley Kuzmik, Barbara Resnick, Rebecca Trotta, Jacqueline Mogle, Rhonda BeLue, Douglas Leslie and James E. Galvin

    Citation: Trials 2018 19:496

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  25. Content type: Study protocol

    Anxiety is among the most prevalent and disabling mental health problems in older adults. Few older adults with mild to moderately severe anxiety symptoms receive adequate interventions, putting them at risk f...

    Authors: Maartje Witlox, Vivivan Kraaij, Nadia Garnefski, Margot W. M. de Waal, Filip Smit, Erik Hoencamp, Jacobijn Gussekloo, Ernst T. Bohlmeijer and Philip Spinhoven

    Citation: Trials 2018 19:502

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  26. Content type: Commentary

    The classification of phase 3 trials as superiority or non-inferiority has become routine, and it is widely accepted that there are important differences between the two types of trial in their design, analysi...

    Authors: David T. Dunn, Andrew J. Copas and Peter Brocklehurst

    Citation: Trials 2018 19:499

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  27. Content type: Study protocol

    In China, cervical cancer is the fifth most commonly diagnosed cancer, and the outcomes for patients with advanced or recurrent disease are poor. Apatinib, a small molecule inhibitor of vascular endothelial gr...

    Authors: Jian-Guo Zhou, Nan-Jing Zhou, Qiong Zhang, Yao-yao Feng and Hang Zhou

    Citation: Trials 2018 19:500

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  28. Content type: Study protocol

    Graves’ disease (GD) is characterized by thyrotoxicosis and goiter and arises through circulating autoantibodies that bind to, and stimulate, the thyroid hormone receptor (TSHR). A temporal relation between th...

    Authors: Lindsay Brammen, Philipp Riss, Julius Lukas, Alois Gessl, Daniela Dunkler, Shuren Li, Asha Leisser, Sandra Rezar-Dreindl, Katharina Eibenberger, Andreas Selberherr, Christian Scheuba and Andrea Papp

    Citation: Trials 2018 19:495

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  29. Content type: Research

    Recruitment of pregnant women into trials is a challenge exacerbated by a number of factors, including strict eligibility criteria. There has been little in-depth examination of the recruitment process to tria...

    Authors: Mahalakshmi Ekambareshwar, Seema Mihrshahi, Li Ming Wen, Sarah Taki, Greer Bennett, Louise A. Baur and Chris Rissel

    Citation: Trials 2018 19:494

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  30. Content type: Study protocol

    Electroacupuncture has been used for treatment in patients with overactive bladder. This study was conducted to evaluate the efficacy and safety of electroacupuncture for treating overactive bladder of postmen...

    Authors: Eun-Young Nam, Ju-Yeon Park, Junyoung Jo, Seung-Hyun Jung, Chi-Yeon Lim and Dong-Il Kim

    Citation: Trials 2018 19:493

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  31. Content type: Study protocol

    Parkinson’s disease is a degenerative neurological condition causing multiple motor and non-motor symptoms that have a serious adverse effect on quality of life. Management is problematic due to the variable a...

    Authors: Angelo Antonini, Giovanni Gentile, Manuela Giglio, Andrea Marcante, Heather Gage, Morro M. L. Touray, Dimitrios I. Fotiadis, Dimitris Gatsios, Spyridon Konitsiotis, Lada Timotijevic, Bernadette Egan, Charo Hodgkins, Roberta Biundo and Clelia Pellicano

    Citation: Trials 2018 19:492

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  32. Content type: Study protocol

    Coronary heart disease (CHD) is a common cardiovascular disease accounting for 10–20% mortality by heart disease worldwide. The gold standard treatment to manage CHD is aspirin, which may prevent myocardial in...

    Authors: Wantong Zhang, Baochen Zhu, Weiyi Cao, Rui Li, Shuge Wang and Rui Gao

    Citation: Trials 2018 19:491

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  33. Content type: Study protocol

    Management of trauma involves long-term bed rest even when muscle strength in the lower extremities is preserved. Prolonged bed rest reduces muscle mass and causes muscle atrophy. A recent study reported the e...

    Authors: Makiko Yamamoto, Akio Kimura, Kento Takii, Naruaki Otake, Wataru Matsuda, Tatsuki Uemura, Takunori Sato, Kentaro Kobayashi, Ryo Sasaki, Akiyoshi Hagiwara and Junko Fujitani

    Citation: Trials 2018 19:490

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  34. Content type: Study protocol

    Implant placement in the posterior maxilla is often complicated by the insufficient bone volume. While transalveolar sinus floor elevation (TSFE) has been proven as a predictable surgical procedure to increase...

    Authors: Xu Zhao, Wei Gao and Feng Liu

    Citation: Trials 2018 19:489

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  35. Content type: Correction

    Following publication of the original article [1], the authors reported that the figure legend for Figure 3 was absent. In addition, they have requested additional funding information to be added. In this Corr...

    Authors: Lucia Macken, Louise Mason, Catherine Evans, Heather Gage, Jake Jordan, Mark Austin, Nick Parnell, Max Cooper, Shani Steer, Justine Boles, Stephen Bremner, Debbie Lambert, David Crook, Gemma Earl, Jean Timeyin and Sumita Verma

    Citation: Trials 2018 19:488

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    The original article was published in Trials 2018 19:401

  36. Content type: Study protocol

    Cognitive impairment is present in bipolar disorder (BD) during the acute and remitted phases and hampers functional recovery. However, there is currently no clinically available treatment with direct and last...

    Authors: Caroline V. Ott, Maj Vinberg, Christopher R. Bowie, Ellen Margrethe Christensen, Gitte M. Knudsen, Lars V. Kessing and Kamilla W. Miskowiak

    Citation: Trials 2018 19:487

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  37. Content type: Study protocol

    There is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need ...

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

    Citation: Trials 2018 19:479

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    The Correction to this article has been published in Trials 2018 19:516

  38. Content type: Study protocol

    A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embed...

    Authors: Bonhyuk Goo, Dek-Woo Ryoo, Eun-Jung Kim, Dongwoo Nam, Hyun-Jong Lee, Jae-Soo Kim, Yeon-Cheol Park, Yong-Hyeon Baek and Byung-Kwan Seo

    Citation: Trials 2018 19:484

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  39. Content type: Study protocol

    Adolescent idiopathic scoliosis (AIS) is one of the most prevalent spinal deformities that may progress sharply during growth. The aim of this study will be to evaluate the efficacy of three-dimensionally inte...

    Authors: Juping Liang, Xuan Zhou, Nan Chen, Xin Li, Hong Yu, Yuqi Yang, Yuanyuan Song and Qing Du

    Citation: Trials 2018 19:485

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  40. Content type: Study protocol

    This paper describes the study protocol of a hybrid type I randomized controlled trial that evaluates the effectiveness and cost-effectiveness of implementing Empowering African-American Women on the Road to H...

    Authors: Karen Johnson, Louisa Gilbert, Timothy Hunt, Elwin Wu, Lisa Metsch, Dawn Goddard-Eckrich, Stanley Richards, Rick Tibbetts, Jessica C. Rowe, Milton L. Wainberg and Nabila El-Bassel

    Citation: Trials 2018 19:486

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  41. Content type: Study protocol

    Traumatic events like critical illness and intensive care are threats to life and bodily integrity and pose a risk factor for posttraumatic stress disorder (PTSD). PTSD affects the quality of life and morbidit...

    Authors: Jochen Gensichen, Susanne Schultz, Christine Adrion, Konrad Schmidt, Maggie Schauer, Daniela Lindemann, Natalia Unruh, Robert P. Kosilek, Antonius Schneider, Martin Scherer, Antje Bergmann, Christoph Heintze, Stefanie Joos, Josef Briegel, Andre Scherag, Hans-Helmut König…

    Citation: Trials 2018 19:480

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  42. Content type: Research

    Randomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention. All too often the methodologies employed to address these problems are n...

    Authors: Jo Rick, Mike Clarke, Alan A. Montgomery, Paul Brocklehurst, Rachel Evans and Peter Bower

    Citation: Trials 2018 19:481

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  43. Content type: Study protocol

    Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis ha...

    Authors: Yeeun Cho, Seunghoon Lee, Jihye Kim, Jung Won Kang, Yong-Hyeon Baek, Byung-Kwan Seo and Jae-Dong Lee

    Citation: Trials 2018 19:482

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  44. Content type: Study protocol

    As a common complication of diabetes, the incidence of diabetic peripheral neuropathy (DPN) is 60–70% worldwide. DPN is a major risk factor for diabetic foot, which may lead to foot ulceration and even amputat...

    Authors: Guanjie Fan, Haoyue Huang, Yuping Lin, Guoqing Zheng, Xianyu Tang, Yu Fu, Hua Wei, Ling Zhao, Zhenjie Liu, Mei Wang, Shidong Wang, Qingbo Li, Zhaohui Fang, Yuehong Zhou, Fang Dai and Xiaotang Qiu

    Citation: Trials 2018 19:483

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  45. Content type: Research

    Randomised controlled trials (RCTs) are widely recognised to be the most rigorous way to test new and emerging clinical interventions. When the interventions under study are two different surgical procedures, ...

    Authors: Jonathan A. Cook, Marion K. Campbell, Katie Gillies and Zoë Skea

    Citation: Trials 2018 19:478

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  46. Content type: Study protocol

    Many randomized controlled trials have investigated the effects of exercise on the rehabilitation of patients with breast cancer. However, the exercise forms used in most previous studies were monotonous. Ther...

    Authors: Dong Xiaosheng, Yi Xiangren, Huang Shuyuan, Gao Dezong, Chao Mengyao and Ding Meng

    Citation: Trials 2018 19:477

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  47. Content type: Study protocol

    Sciatica is a common condition reported to affect over 3% of the UK population at any time and is often caused by a prolapsed intervertebral disc (PID). Although the duration and severity of symptoms can vary,...

    Authors: Martin J. Wilby, Carolyn Hopkins, Emma Bedson, Sue Howlin, Girvan Burnside, Elizabeth J. Conroy, Dyfrig A. Hughes, Manohar Sharma, Anthony Marson, Simon R. Clark and Paula Williamson

    Citation: Trials 2018 19:475

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  48. Content type: Study protocol

    The treatment of acute promyelocytic leukemia (APL) has been revolutionized in the past two decades by the advent of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO). It suggests that non-high-risk AP...

    Authors: Xinxin Zhang, Huiyun Zhang, Limei Chen, Mengchang Wang, Jieying Xi, Xin Liu, Ming Xie, Dengzhe Li, Ekamjyot Singh Gulati, Sha Gong and Huaiyu Wang

    Citation: Trials 2018 19:476

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  49. Content type: Study protocol

    The time to diagnosis of invasive Candida infection (ICI) is often too long to initiate timely antifungal therapy in patients with sepsis. Elevated serum (1,3)-β-D-glucan (BDG) concentrations have a high diagnost...

    Authors: Frank Bloos, Jürgen Held, Peter Schlattmann, Nicole Brillinger, Oliver Kurzai, Oliver A. Cornely and Daniel Thomas-Rüddel

    Citation: Trials 2018 19:472

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