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  1. Content type: Methodology

    Patient-reported outcome measures (PROMs) are now frequently used in randomised controlled trials (RCTs) as primary endpoints. RCTs are longitudinal, and many have a baseline (PRE) assessment of the outcome an...

    Authors: Stephen J. Walters, Richard M. Jacques, Inês Bonacho dos Anjos Henriques-Cadby, Jane Candlish, Nikki Totton and Mica Teo Shu Xian

    Citation: Trials 2019 20:566

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  2. Content type: Study protocol

    There are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fract...

    Authors: Thomas H. Carter, William M. Oliver, Catriona Graham, Andrew D. Duckworth and Timothy O. White

    Citation: Trials 2019 20:565

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  3. Content type: Study protocol

    Polycystic ovary syndrome (PCOS) is one of the most common endocrine diseases for women. Acupuncture is widely used for the infertile female because of it is non-invasive and has fewer side effects, but the po...

    Authors: Qiao Wang, Haiping Deng, Ke Cheng, Zouqin Huang, Xiuqi Yin, Yichen Zhou, Yiqin Yang, Weidong Shen, Ling Zhao and Xueyong Shen

    Citation: Trials 2019 20:564

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  4. Content type: Study protocol

    The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac ...

    Authors: Christian Jons, Peter Sogaard, Steffen Behrens, Jürgen Schrader, Sascha Mrosk and Poul Erik Bloch Thomsen

    Citation: Trials 2019 20:563

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  5. Content type: Study protocol

    Interval training in deep water running (DWR-IT) is a training method to improve cardiovascular fitness, functional health, and quality of life and to help control body weight. Its main advantages are the redu...

    Authors: Bruna Pianna, Bianca Christianini Moreno, Caroline Aquino de Souza, Thais Fernanda Bôscoa, Guilherme Eleutério Alcalde, Silvia Regina Barrile, Camila Gimenes, Bruno Martinelli, Antonio Roberto Zamunér, Bruna Varanda Pessoa-Santos and Eduardo Aguilar Arca

    Citation: Trials 2019 20:562

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  6. Content type: Research

    Critically ill patients lose up to 2% of muscle mass per day. We assessed the feasibility of administering a leucine-enriched essential amino acid (L-EAA) supplement to mechanically ventilated trauma patients ...

    Authors: L. Wandrag, S. J. Brett, G. S. Frost, M. To, E. Alves Loubo, N. C. Jackson, A. M. Umpleby, V. Bountziouka and M. Hickson

    Citation: Trials 2019 20:561

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  7. Content type: Study protocol

    Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing with either preconditioning or postconditioning or assessing a single as...

    Authors: Pascal Chiari, Michel Durand, Olivier Desebbe, Marc-Olivier Fischer, Diane Lena-Quintard, Jean-Charles Palao, Catherine Mercier, Géraldine Samson, Yvonne Varillon, Matteo Pozzi, Nathan Mewton, Delphine Maucort-Boulch, Michel Ovize and Jean-Luc Fellahi

    Citation: Trials 2019 20:560

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  8. Content type: Study protocol

    Keeping a certain level of physical activity has beneficial effects on the body itself but also, surprisingly, on cognition: specifically, physical high-intensity intermittent aerobic exercise (HIE) can show i...

    Authors: Dalila Burin, Noriki Yamaya, Rie Ogitsu and Ryuta Kawashima

    Citation: Trials 2019 20:559

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  9. Content type: Study protocol

    Within the field of plastic surgery, free tissue transfer is common practice for knee and lower leg defects. Usually, after such free flap reconstruction, patients undergo a dangling protocol in the postoperat...

    Authors: David D. Krijgh, Teun Teunis, Pascal P. A. Schellekens, Marc A. M. Mureau, Antonius J. M. Luijsterburg, Tallechien M. T. Tempelman, Eva S. J. van der Beek, Wiesje Maarse and J. Henk Coert

    Citation: Trials 2019 20:558

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  10. Content type: Correction

    Following publication of the original article [1], it has been brought to our attention that an error was slipped into the article’s title.

    Authors: Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee and Daniel Wight

    Citation: Trials 2019 20:557

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    The original article was published in Trials 2019 20:499

  11. Content type: Study protocol

    Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effec...

    Authors: Lauren Arancini, Chiara C. Bortolasci, Seetal Dodd, Olivia M. Dean and Michael Berk

    Citation: Trials 2019 20:555

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  12. Content type: Study protocol

    Hypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral netwo...

    Authors: Tim Mercer, Benson Njuguna, Gerald S. Bloomfield, Jonathan Dick, Eric Finkelstein, Jemima Kamano, Ann Mwangi, Violet Naanyu, Sonak D. Pastakia, Thomas W. Valente, Rajesh Vedanthan and Constantine Akwanalo

    Citation: Trials 2019 20:554

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  13. Content type: Research

    Adverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent informati...

    Authors: Evan Mayo-Wilson, Nicole Fusco, Hwanhee Hong, Tianjing Li, Joseph K. Canner and Kay Dickersin

    Citation: Trials 2019 20:553

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  14. Content type: Study protocol

    Mild cognitive impairment (MCI) is an intermediate state between normal aging and Alzheimer’s disease, which is the world’s most common form of dementia. It is important to identify early and easily available ...

    Authors: Jae-Hong Kim, Myoung-Rae Cho, Gwang-Cheon Park and Jeong-Soon Lee

    Citation: Trials 2019 20:551

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  15. Content type: Study protocol

    Cigarette smoking negatively impacts on maternal and fetal health. Smoking cessation is one of the few interventions capable of improving pregnancy outcomes. Despite the risks, the most effective antenatal mod...

    Authors: Brendan P. McDonnell, Patrick Dicker, Sheila Keogan, Luke Clancy and Carmen Regan

    Citation: Trials 2019 20:550

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  16. Content type: Study protocol

    There is a global pandemic of type 2 diabetes mellitus (T2DM), especially in Asia. Singapore has a prevalence of T2DM at 10.5%, which is higher than the world average of 8.8%. Multiple studies have shown that ...

    Authors: Eberta Tan, Joan Khoo, Linsey Utami Gani, Roy Debajyoti Malakar, Tunn Lin Tay, Prasanna Sivanath Tirukonda, Jia Wen Kam, Aung Soe Tin and Tjun Yip Tang

    Citation: Trials 2019 20:549

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  17. Content type: Study protocol

    Diabetes is an important health burden in Indonesia. However, diabetes management and treatment remain poor, with most people with diabetes in Indonesia not achieving the recommended blood glucose levels. Peer...

    Authors: Till Seuring, Marthoenis, Sabrina Rhode, Lisa Rogge, Holger Rau, Stéphane Besançon, Hendra Zufry, Hizir Sofyan and Sebastian Vollmer

    Citation: Trials 2019 20:548

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  18. Content type: Research

    Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2...

    Authors: Aleksandra Herbec, Jamie Brown, Lion Shahab, Robert West and Tobias Raupach

    Citation: Trials 2019 20:547

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  19. Content type: Study protocol

    Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men p...

    Authors: Jessica Frost, J. Athene Lane, Nikki Cotterill, Mandy Fader, Lucy Hackshaw-McGeagh, Hashim Hashim, Margaret Macaulay, Stephanie J. MacNeill, Sian Noble, Jonathan Rees, Matthew J. Ridd, Luke Robles, Gordon Taylor, Jodi Taylor, Marcus J Drake and Jo Worthington

    Citation: Trials 2019 20:546

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  20. Content type: Study protocol

    There are significant barriers to providing accessible, quality mental health care for young adolescents affected by adversity. In an attempt to overcome this, the World Health Organization (WHO) has developed...

    Authors: Felicity L. Brown, Frederik Steen, Karine Taha, May Aoun, Richard A. Bryant, Mark J. D. Jordans, Aiysha Malik, Mark van Ommeren, Adnan Abualhaija, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Marit Sijbrandij, Rabih El Chammay, Sarah Watts and Aemal Akhtar

    Citation: Trials 2019 20:545

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  21. Content type: Study protocol

    Large field irradiation had been standard for early-stage follicular lymphoma (FL) for a long time. Although involved field radiotherapy (IF-RT) was recently favored because of the toxicity of large field irra...

    Authors: Laila König, Martin Dreyling, Jan Dürig, Marianne Engelhard, Karin Hohloch, Andreas Viardot, Mathias Witzens-Harig, Meinhard Kieser, Wolfram Klapper, Christiane Pott and Klaus Herfarth

    Citation: Trials 2019 20:544

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  22. Content type: Study protocol

    The sectorization of health-care systems leads to inefficient treatment, especially for elderly people with cognitive impairment. The transition from hospital care to primary care is insufficiently coordinated...

    Authors: Angela Nikelski, Armin Keller, Fanny Schumacher-Schönert, Terese Dehl, Jessica Laufer, Ulf Sauerbrey, Diana Wucherer, Adina Dreier-Wolfgramm, Bernhard Michalowsky, Ina Zwingmann, Horst Christian Vollmar, Wolfgang Hoffmann, Stefan H. Kreisel and Jochen René Thyrian

    Citation: Trials 2019 20:543

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  23. Content type: Study protocol

    The optimal vitamin D intake for nursing mothers with overweight or obesity has not been defined. Vitamin D concentrations are associated with body composition indices, particularly body fat mass. Few studies ...

    Authors: Zohre Gerveieeha, Fereydoun Siassi, Mostafa Qorbani, Farzaneh Ziaeian and Gity Sotoudeh

    Citation: Trials 2019 20:542

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  24. Content type: Study protocol

    Early childhood is a critical period of development. Caregivers, including providers of early care and education (ECE), have a substantial influence on the health of young children. Family child care homes (FC...

    Authors: Susan B. Sisson, Alicia L. Salvatore, Deana Hildebrand, Tiffany Poe, Cady Merchant, Megan Slawinski, Chelsea L. Kracht, Julie A. Stoner, Naneida Alcala Lazarte, Lu Ann Faulkner Schneider, Jennifer Weber, Felecia Jones and Dianne Ward

    Citation: Trials 2019 20:541

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  25. Content type: Study protocol

    In Hong Kong, one of six couples is affected by subfertility problems. Male infertility contributes to half of the infertility cases. In male infertility, there is no effective treatment for patients with idio...

    Authors: Mingpeng Zhao, Carol Pui Shan Chan, Cosy Wing Ching Cheung, Odai Alqawasmeh, Ronald Chi Chiu Wang, Justin Che Yuen Wu, Zhi Xiu Lin, Tin Chiu Li, Jacqueline Pui Wah Chung, Jennifer Sze Man Mak, Tracy Sze Man Law and David Yiu Leung Chan

    Citation: Trials 2019 20:540

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  26. Content type: Study protocol

    Cardiotocography is almost ubiquitous in its use in intrapartum care. Although it has been demonstrated that there is some benefit from continuous intrapartum fetal monitoring using cardiotocography, there is ...

    Authors: D. Turnbull, A. Salter, B. Simpson, B. W. Mol, E. Chandraharan, A. McPhee, I. Symonds, M. Benton, S. Kuah, G. Matthews, K. Howard and C. Wilkinson

    Citation: Trials 2019 20:539

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  27. Content type: Study protocol

    Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. Currently, the treatment for HSPN is always selected based on the Kidney Disease Improving Global Outcomes...

    Authors: Ying Ding, Xia Zhang, Xianqing Ren, Wensheng Zhai, Liyun He, Jianping Liu, Chen Yao, Shanshan Han and Long Wang

    Citation: Trials 2019 20:538

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  28. Content type: Study protocol

    Immunologic derangement may be the critical pathophysiologic mechanism in sepsis, and immunotherapy might be a potential new treatment. Si-ni-tang (SNT), an ancient Chinese herbal formula documented in Shanghan L...

    Authors: Ruifeng Zeng, Yi Zheng, Rongrong Fan, Gengbiao Zhou, Yan Zhang, Shutao Mai, Dongping Xie, Yanna Weng, Jiongdong Du, Yun Han and Fang Lai

    Citation: Trials 2019 20:537

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  29. Content type: Study protocol

    Tuberculosis is one of the greatest global health concerns and disease management is challenging particularly in low- and middle-income countries. Despite improvements in addressing this epidemic in Georgia, t...

    Authors: Ivdity Chikovani, Karin Diaconu, Predrag Duric, Lela Sulaberidze, Maia Uchaneishvili, Nuredin Ibrahim Mohammed, Akaki Zoidze and Sophie Witter

    Citation: Trials 2019 20:536

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  30. Content type: Research

    Clinical Trials Registry - India (CTRI) was established in July 2007 and today hosts thousands of trials, a significant fraction of them registered in the last couple of years. We wished to undertake an up-to-...

    Authors: Mounika Pillamarapu, Abhilash Mohan and Gayatri Saberwal

    Citation: Trials 2019 20:535

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  31. Content type: Study protocol

    Accidental Accidental awareness during general anesthesia (AAGA) occurs in 1–2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Howev...

    Authors: Sébastien Rimbert, Denis Schmartz, Laurent Bougrain, Claude Meistelman, Cédric Baumann and Philippe Guerci

    Citation: Trials 2019 20:534

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  32. Content type: Study protocol

    A classical approach to produce interscalene brachial plexus block (ISBPB) consistently spares the posterior aspect of the shoulder and ulnar sides of the elbow, forearm, and hand, which are innervated by the ...

    Authors: Eugene Kim, Chang Hyuk Choi and Jong Hae Kim

    Citation: Trials 2019 20:533

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  33. Content type: Methodology

    Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early...

    Authors: Devin S. McCaskell, Alexander J. Molloy, Laura Childerhose, F. Aileen Costigan, Julie C. Reid, Magda McCaughan, France Clarke, Deborah J. Cook, Jill C. Rudkowski, Christopher Farley, Tim Karachi, Bram Rochwerg, Anastasia Newman, Alison Fox-Robichaud, Margaret S. Herridge, Vincent Lo…

    Citation: Trials 2019 20:532

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  34. Content type: Study protocol

    Carpal tunnel syndrome (CTS) is a common cause of pain, weakness, sensory loss, and activity limitations. Currently, the most common initial treatment is use of a rigid splint immobilizing the wrist, usually d...

    Authors: Isam Atroshi, Kamelia Tadjerbashi, Steven J. McCabe and Jonas Ranstam

    Citation: Trials 2019 20:531

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  35. Content type: Study protocol

    Guidelines in pediatric restorative dentistry recommend the use of preformed pediatric stainless steel crowns (SSCs) in cases of severe tooth decay of at least two surfaces. This clinically effective and safe ...

    Authors: Serena Lopez-Cazaux, Elody Aiem, Ana Miriam Velly and Michèle Muller-Bolla

    Citation: Trials 2019 20:530

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  36. Content type: Study protocol

    Systemic lupus erythematosus (SLE or lupus) is a chronic autoimmune disease that is associated with increased morbidity, mortality, healthcare costs and decreased quality of life. African Americans in the USA ...

    Authors: Edith M. Williams, Leonard Egede, Jim C. Oates, Clara L. Dismuke, Viswanathan Ramakrishnan, Trevor D. Faith, Hetlena Johnson and Jillian Rose

    Citation: Trials 2019 20:529

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  37. Content type: Study protocol

    The prognostic benefits and safety of extended lymphadenectomy for hilar cholangiocarcinoma remain uncertain. The available evidence is still insufficient concerning its retrospective aspect. The aim of this s...

    Authors: Min He, Xinsen Xu, Hao Feng, Wei Chen, Houbao Liu, Yongjie Zhang, Jianming Wang, Zhimin Geng, Yudong Qiu, Weidong Duan, Xiangcheng Li, Xuting Zhi, Weihua Zhu, Fuyu Li, Jiangtao Li, Shengping Li…

    Citation: Trials 2019 20:528

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  38. Content type: Study protocol

    Persons with spinal cord injury (SCI) are at heightened risks of developing unfavorable cardiometabolic consequences due to physical inactivity. Functional electrical stimulation (FES) and surface neuromuscula...

    Authors: Ashraf S. Gorgey, Refka E. Khalil, John C. Davis, William Carter, Ranjodh Gill, Jeannie Rivers, Rehan Khan, Lance L. Goetz, Teodoro Castillo, Timothy Lavis, Adam P. Sima, Edward J. Lesnefsky, Christopher C. Cardozo and Robert A. Adler

    Citation: Trials 2019 20:526

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  39. Content type: Research

    Unanticipated responses by research participants can influence randomised controlled trials (RCTs) in multiple ways, many of which are poorly understood. This study used qualitative interviews as part of an em...

    Authors: Meriel Norris, Leon Poltawski, Raff Calitri, Anthony I. Shepherd and Sarah G. Dean

    Citation: Trials 2019 20:525

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  40. Content type: Methodology

    In some randomised trials, the primary interest is in the mechanisms by which an intervention exerts its effects on health outcomes. That is, clinicians and policy-makers may be interested in how the intervent...

    Authors: Hopin Lee, Robert D. Herbert, Sarah E. Lamb, Anne M. Moseley and James H. McAuley

    Citation: Trials 2019 20:524

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  41. Content type: Study protocol

    The global prevalence of diabetes mellitus (DM) has been increasing over recent decades. In Germany, the prevalence for DM type 1 and type 2 in adults is estimated at about 7.7%. Hence, diabetes has to be clas...

    Authors: M. Bernard, N. Müller, L. Hecht, G. Fabisch, A. Harder and C. Luck-Sikorski

    Citation: Trials 2019 20:523

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  42. Content type: Study protocol

    There is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access cont...

    Authors: Alain Amstutz, Thabo Ishmael Lejone, Lefu Khesa, Josephine Muhairwe, Bienvenu Lengo Nsakala, Katleho Tlali, Moniek Bresser, Fabrizio Tediosi, Mathebe Kopo, Mpho Kao, Thomas Klimkait, Manuel Battegay, Tracy Renée Glass and Niklaus Daniel Labhardt

    Citation: Trials 2019 20:522

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  43. Content type: Study protocol

    Early detection of diabetic foot ulcerations (DFUs) can avoid or delay any progression into more severe stages, which may require limb amputation or lead to infectious sequelae and death. However, frequent cli...

    Authors: Antao Ming, Isabell Walter, Ahmad Alhajjar, Martin Leuckert and Peter R. Mertens

    Citation: Trials 2019 20:521

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  44. Content type: Study protocol

    Coronary artery disease (CAD) is one of the most common types of the cardiovascular disease. Previous pilot trials have suggested that Traditional Chinese Medicine (TCM) has brought clinical benefits for patie...

    Authors: Xiao Jin, Biqi Pan, Huanlin Wu, Bingxin Wu, Yukai Li, Xia Wang, Guoqing Liu, Xiaojing Dang and Danping Xu

    Citation: Trials 2019 20:520

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  45. Content type: Study protocol

    Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revasc...

    Authors: Louisa J. D. van Dijk, Jihan Harki, Desirée van Noord, Hence J. M. Verhagen, Jeroen J. Kolkman, Robert H. Geelkerken, Marco J. Bruno and Adriaan Moelker

    Citation: Trials 2019 20:519

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  46. Content type: Study protocol

    Amnestic mild cognitive impairment (aMCI) is a syndrome characterized by significant forgetfulness that does not meet the criteria of dementia. Individuals with aMCI are at greater risk of progressing to demen...

    Authors: Shengnan Yue, Ting He, Baiyang Li, Yanqin Qu, Hongmei Peng, Jinxin Chen, Ming Lei, Chongli Chen and Wenbin Wu

    Citation: Trials 2019 20:518

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  47. Content type: Correction

    Following publication of the original article [1], the authors notified us of a few requested editions that were not implemented adequately during proofing. The publisher apologizes for the inconvenience cause...

    Authors: Juan Carlos Villar, Víctor Mauricio Herrera, Juan Guillermo Pérez Carreño, Eliana Váquiro Herrera, Yeny Zulay Castellanos Domínguez, Skarlet Marcell Vásquez, Zulma Milena Cucunubá, Nilda Graciela Prado and Yolanda Hernández

    Citation: Trials 2019 20:516

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    The original article was published in Trials 2019 20:431

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