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  1. Content type: Study protocol

    Restless legs syndrome (RLS) is a common and burdensome sleep disorder associated with profound impairment of health, well-being, and quality of life. Unfortunately, the medications used for RLS management car...

    Authors: Terry Kit Selfe, Sijin Wen, Karen Sherman, Maryanna Klatt and Kim E. Innes

    Citation: Trials 2019 20:134

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  2. Content type: Study protocol

    Urinary catheter placement is essential before laparoscopic anterior resection for rectal cancer. Whether early removal of the catheter increases the incidence of urinary retention and urinary tract infection ...

    Authors: Lai Xu, Zhi-Yan Tao, Jun-Yang Lu, Guan-Nan Zhang, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Tao Xu and Yi Xiao

    Citation: Trials 2019 20:133

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  3. Content type: Research

    Discrepancies between pre-specified and reported outcomes are an important and prevalent source of bias in clinical trials. COMPare (Centre for Evidence-Based Medicine Outcome Monitoring Project) monitored all...

    Authors: Ben Goldacre, Henry Drysdale, Cicely Marston, Kamal R. Mahtani, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley and Carl Heneghan

    Citation: Trials 2019 20:124

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  4. Content type: Research

    Discrepancies between pre-specified and reported outcomes are an important source of bias in trials. Despite legislation, guidelines and public commitments on correct reporting from journals, outcome misreport...

    Authors: Ben Goldacre, Henry Drysdale, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley, Cicely Marston, Anna Powell-Smith, Carl Heneghan and Kamal R. Mahtani

    Citation: Trials 2019 20:118

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  5. Content type: Study protocol

    More than 60,000 people have health problems due to chemical weapons exposure during the Iran–Iraq war. Respiratory consequences of mustard gas exposure are common and disabling; medical interventions have lim...

    Authors: Mohamad Reza Sedighi Moghadam, Mostafa Ghanei, Klaus Kenn and Nicholas S. Hopkinson

    Citation: Trials 2019 20:132

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  6. Content type: Study protocol

    Acupuncture is safe and effective for reducing the symptoms of knee osteoarthritis (KOA), but the underlying mechanisms of acupuncture for treating KOA are not fully understood.

    Authors: Jing Guo, Yang Chen, Zhengjie Li, Shirui Cheng, Chenjian Tang, Xiaohui Dong, Wenhua He, Yong Huang, Bao Yin, Yu Sheng, Jun Zhou, Aijia Li, Fang Zeng, Lei Lan and Fanrong Liang

    Citation: Trials 2019 20:126

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  7. Content type: Study protocol

    Although negative pressure wound therapy (NPWT) is widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has not yet been adequately investigated, with researc...

    Authors: Cody C. Frear, Bronwyn Griffin, Leila Cuttle, Steven M. McPhail and Roy Kimble

    Citation: Trials 2019 20:130

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  8. Content type: Research

    There are enormous problems in recruiting depressed people into randomised controlled trials (RCTs), with numerous studies consistently failing to recruit to target (Sully et al., Trials 14:166, 2013). Given t...

    Authors: June S. L. Brown, Caroline Murphy, Joanna Kelly and Kimberley Goldsmith

    Citation: Trials 2019 20:131

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  9. Content type: Study protocol

    Binge-eating disorder (BED) is characterized by recurrent episodes of loss of control over eating and is related to a higher prevalence of other mental disorders and somatic consequences associated with overwe...

    Authors: Simone Munsch, Andrea Wyssen, Pierre Vanhulst, Denis Lalanne, Sharon T. Steinemann and Alexandre Tuch

    Citation: Trials 2019 20:128

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  10. Content type: Study protocol

    The clinical efficacy of effect-site targeted patient-maintained propofol sedation (PMPS) compared to anaesthetist-controlled propofol sedation (ACPS) for patients undergoing awake joint replacement surgery is...

    Authors: David W. Hewson, Frank Worcester, James Sprinks, Murray D. Smith, Heather Buchanan, Philip Breedon, Jonathan G. Hardman and Nigel M. Bedforth

    Citation: Trials 2019 20:129

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  11. Content type: Study protocol

    Ascites is one of the most common complications of cirrhosis. Umbilical therapy with traditional Chinese medicines has been increasingly prescribed to treat cirrhotic ascites. However, high-quality evidence fr...

    Authors: Xianzhao Yang, Shuying Ru, Lin Luo, Xiaoying Lv, Wenjing Bai, Fuwen Zhang and Feng Jiang

    Citation: Trials 2019 20:127

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  12. Content type: Study protocol

    The discovery that voltage-gated calcium channel genes such as CACNA1C are part of the aetiology of psychiatric disorders has rekindled interest in the therapeutic potential of L-type calcium channel (LTCC) antag...

    Authors: Lauren Z. Atkinson, Lucy Colbourne, Alexander Smith, Catherine H. Harmer, Anna C. Nobre, Jennifer Rendell, Helen Jones, Christopher Hinds, Arne Mould, Elizabeth M. Tunbridge, Andrea Cipriani, John R. Geddes, Kate E. A. Saunders and Paul J. Harrison

    Citation: Trials 2019 20:120

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  13. Content type: Study protocol

    Despite evidence from clinical trials that intravenous (IV) thrombolysis is a cost-effective treatment for selected acute ischaemic stroke patients, there remain large variations in the rate of IV thrombolysis...

    Authors: Christopher I. Price, Lisa Shaw, Peter Dodd, Catherine Exley, Darren Flynn, Richard Francis, Saiful Islam, Mehdi Javanbakht, Rachel Lakey, Joanne Lally, Graham McClelland, Peter McMeekin, Helen Rodgers, Helen Snooks, Louise Sutcliffe, Pippa Tyrell…

    Citation: Trials 2019 20:121

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  14. Content type: Study protocol

    In the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST) < 400 μm, as per National Institute for Health and Care Excellence guid...

    Authors: Noemi Lois, Evie Gardner, Norman Waugh, Augusto Azuara-Blanco, Hema Mistry, Danny McAuley, Nachiketa Acharya, Tariq M. Aslam, Clare Bailey, Victor Chong, Louise Downey, Haralabos Eleftheriadis, Samia Fatum, Sheena George, Faruque Ghanchi, Markus Groppe…

    Citation: Trials 2019 20:122

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  15. Content type: Study protocol

    Tranexamic acid (TXA) has been routinely delivered in multisegmental spinal decompression and bone graft fusion surgeries with satisfactory outcomes in minimizing gross blood loss and transfusion demands. Howe...

    Authors: Shangyi Hui, Liyuan Tao, Feroze Mahmood, Derong Xu, Zhinan Ren, Xin Chen, Lin Sheng, Qianyu Zhuang, Shugang Li and Yuguang Huang

    Citation: Trials 2019 20:125

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  16. Content type: Study protocol

    Cognitive impairment and cerebrovascular pathology are both frequent with ageing. Cognitive impairment due to vascular pathology of the brain, termed vascular cognitive impairment (VCI), is one of the most fre...

    Authors: Ana Verdelho, Sofia Madureira, Manuel Correia, José Manuel Ferro, Mário Rodrigues, Manuel Gonçalves-Pereira, Mafalda Gonçalves, Ana Catarina Santos, Pedro Vilela, Helena Bárrios, Mariana Borges and Helena Santa-Clara

    Citation: Trials 2019 20:114

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  17. Content type: Research

    Historically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders. We ai...

    Authors: Joanna C. Crocker, Keira Pratt-Boyden, Jenny Hislop, Sian Rees, Louise Locock, Sophie Olszowski, Alan Chant, Shaun Treweek, Jonathan A. Cook, Kerry Woolfall, Nicola Farrar, Jennifer Bostock and Richard Bulbulia

    Citation: Trials 2019 20:119

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  18. Content type: Study protocol

    Autism spectrum disorder (ASD) is a common lifelong condition affecting 1 in 100 people. ASD affects how a person relates to others and the world around them. Difficulty responding to sensory information (nois...

    Authors: Elizabeth Randell, Rachel McNamara, Sue Delport, Monica Busse, Richard P. Hastings, David Gillespie, Rhys Williams-Thomas, Lucy Brookes-Howell, Renee Romeo, Janet Boadu, Alka S. Ahuja, Anne Marie McKigney, Martin Knapp, Kathryn Smith, Jacqui Thornton and Gemma Warren

    Citation: Trials 2019 20:113

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  19. Content type: Research

    Several hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to u...

    Authors: Jamie J. Kirkham, Sarah Gorst, Douglas G. Altman, Jane M. Blazeby, Mike Clarke, Sean Tunis and Paula R. Williamson

    Citation: Trials 2019 20:116

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  20. Content type: Study protocol

    Mild cognitive impairment (MCI) is known as a transitional status between normal cognitive function and Alzheimer’s disease (AD). Acupuncture and Chinese herbal medicines (CHMs) are considered to be beneficial...

    Authors: Yueqi Chen, Wenjing Zhang, Huangan Wu, Lixing Lao, Jian Xu and Shifen Xu

    Citation: Trials 2019 20:117

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  21. Content type: Study protocol

    Catheter-related bacteremia (CRB) is the most frequent nosocomial infection in neonatal intensive care unit (NICU) patients, especially in very low-birth-weight infants. Administration of injectable drugs in p...

    Authors: Aurélie Maiguy-Foinard, Bertrand Décaudin, Pierre Tourneux, Bernard Guillois, Thierry Blanc, Sophie Galène-Gromez, Morgane Masse, Pascal Odou, Fannette Denies, Benoît Dervaux, Alain Duhamel and Laurent Storme

    Citation: Trials 2019 20:115

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  22. Content type: Study protocol

    Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard prev...

    Authors: Saho Wada, Ryoichi Sadahiro, Yutaka J. Matsuoka, Yosuke Uchitomi, Takuhiro Yamaguchi and Ken Shimizu

    Citation: Trials 2019 20:110

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  23. Content type: Study protocol

    Children born to parents with a severe mental illness, like schizophrenia, bipolar disorder, or major recurrent depression, have an increased risk of developing a mental illness themselves during life. These c...

    Authors: Anne D. Müller, Ida C. T. Gjøde, Mette S. Eigil, Helle Busck, Merete Bonne, Merete Nordentoft and Anne A. E. Thorup

    Citation: Trials 2019 20:112

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  24. Content type: Research

    Inter-observer variability in stroke aetiological classification may have an effect on trial power and estimation of treatment effect. We modelled the effect of misclassification on required sample size in a h...

    Authors: Azmil H. Abdul-Rahim, David Alexander Dickie, Johann R. Selvarajah, Kennedy R. Lees and Terence J. Quinn

    Citation: Trials 2019 20:107

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  25. Content type: Study protocol

    The prevalence of hypertension among people with chronic kidney disease is high with over 60% of people not attaining recommended targets despite taking multiple medications. Given the health and economic impl...

    Authors: Stephanie Thompson, Natasha Wiebe, Gabor Gyenes, Rachelle Davies, Jeyasundar Radhakrishnan and Michelle Graham

    Citation: Trials 2019 20:109

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  26. Content type: Methodology

    The research study titled “Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out-of-hospital...

    Authors: Maria J. Robinson, Jodi Taylor, Stephen J. Brett, Jerry P. Nolan, Matthew Thomas, Barnaby C. Reeves, Chris A. Rogers, Sarah Voss, Madeleine Clout and Jonathan R. Benger

    Citation: Trials 2019 20:108

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  27. Content type: Research

    Context matters for the successful implementation of medical interventions, but its role remains surprisingly understudied. Against the backdrop of antimicrobial resistance, a global health priority, we invest...

    Authors: Marco J. Haenssgen, Nutcha Charoenboon, Nga T. T. Do, Thomas Althaus, Yuzana Khine Zaw, Heiman F. L. Wertheim and Yoel Lubell

    Citation: Trials 2019 20:111

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  28. Content type: Study protocol

    While the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them.

    Authors: Marlise Poolman, Jessica Roberts, Anthony Byrne, Paul Perkins, Zoe Hoare, Annmarie Nelson, Julia Hiscock, Dyfrig Hughes, Betty Foster, Julie O’Connor, Liz Reymond, Sue Healy, Rossela Roberts, Bee Wee, Penney Lewis, Rosalynde Johnstone…

    Citation: Trials 2019 20:105

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  29. Content type: Study protocol

    Urinary tract infections (UTIs) are the second most common infection presenting in the community. Clinical guidelines and decision aids assist health practitioners to treat a UTI; however, treatment practices ...

    Authors: Sinead Duane, Akke Vellinga, Andrew W. Murphy, Martin Cormican, Andrew Smyth, Patricia Healy, Michael Moore, Paul Little and Declan Devane

    Citation: Trials 2019 20:106

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  30. Content type: Study protocol

    There is compelling evidence of beneficial effects of non-immersive virtual reality (VR)-based intervention in the rehabilitation of patients with stroke, whereby patients experience both the real world and th...

    Authors: Qianqian Huang, Wei Wu, Xiaolong Chen, Bo Wu, Longqiang Wu, Xiaoli Huang, Songhe Jiang and Lejian Huang

    Citation: Trials 2019 20:104

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  31. Content type: Study protocol

    Dating applications are a popular platform to meet new people. At the same time, they have been associated with risks such as unsafe sexual behavior and privacy concerns in young adults. This paper presents a ...

    Authors: Stephanie Tsz Hei Lau, Kitty Wai Ying Choi, Julie Chen, William Pak-hing Mak, Ho Kong Christopher Au Yeung, Joseph Tucker and William Chi-Wai Wong

    Citation: Trials 2019 20:102

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  32. Content type: Study protocol

    The overuse of antibiotics is a major cause for the worldwide rise of antibiotic resistance. Although it is well known that acute respiratory tract infections (ARTI) are mainly caused by viruses and are often ...

    Authors: Anja Wollny, Attila Altiner, Tonia Brand, Katharina Garbe, Martina Kamradt, Petra Kaufmann-Kolle, Mirko Leyh, Regina Poß-Doering, Joachim Szecsenyi, Lorenz Uhlmann, Arwed Voss, Dorothea Weber, Michel Wensing and Christin Löffler

    Citation: Trials 2019 20:103

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  33. Content type: Research

    The present randomized controlled trial (RCT) evaluated the effectiveness of a theory-based physical activity (PA) intervention for rural patients with prediabetes. It was hypothesized that a PA intervention p...

    Authors: Tahereh Shamizadeh, Leila Jahangiry, Parvin Sarbakhsh and Koen Ponnet

    Citation: Trials 2019 20:98

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  34. Content type: Study protocol

    Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia. In healthy and fit individuals, anaemia can be compensated by several mechanisms. Elderly patients, however, have les...

    Authors: Patrick Meybohm, Simone Lindau, Sascha Treskatsch, Roland Francis, Claudia Spies, Markus Velten, Maria Wittmann, Erdem Gueresir, Christian Stoppe, Ana Kowark, Mark Coburn, Sixten Selleng, Marcel Baschin, Gregor Jenichen, Melanie Meersch, Thomas Ermert…

    Citation: Trials 2019 20:101

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  35. Content type: Study protocol

    Melanoma has become a growing interdisciplinary problem in public health worldwide. According to the World Health Organization, the incidence of melanoma is increasing faster than any other cancer in the world...

    Authors: Ingo Stoffels, Ken Herrmann, Jan Rekowski, Philipp Jansen, Dirk Schadendorf, Andreas Stang and Joachim Klode

    Citation: Trials 2019 20:99

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  36. Content type: Study protocol

    Oral mucositis (OM) is the most frequent and debilitating acute side effect associated with head and neck cancer (HNC) treatment. When present, severe OM negatively impacts the quality of life of patients unde...

    Authors: Allisson Filipe Lopes Martins, Túlio Eduardo Nogueira, Marília Oliveira Morais, Angélica Ferreira Oton-Leite, Marize Campos Valadares, Aline Carvalho Batista, Nilceana Maya Aires Freitas, Cláudio Rodrigues Leles and Elismauro Francisco Mendonça

    Citation: Trials 2019 20:97

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  37. Content type: Study protocol

    The highest incidence and prevalence of mental health problems across the lifespan as well as the first onset of most long-term mental health conditions are reported for youths between 14 and 25 years of age. ...

    Authors: Michael Kaess, Sabrina Ritter, Sophia Lustig, Stephanie Bauer, Katja Becker, Heike Eschenbeck, Markus Moessner, Christine Rummel-Kluge, Hans-Joachim Salize, Rainer Thomasius, Franz Resch and Julian Koenig

    Citation: Trials 2019 20:94

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  38. Content type: Study protocol

    Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate above 80% and 1-month mortality around 10%. The European guidelines f...

    Authors: Yonathan Freund, Judith Gorlicki, Marine Cachanado, Sarah Salhi, Vanessa Lemaître, Tabassome Simon and Alexandre Mebazaa

    Citation: Trials 2019 20:95

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  39. Content type: Study protocol

    Hypoparathyroidism is one of the most common complications encountered in thyroidectomy. In addition to parathyroid in-situ preservation, parathyroid autotransplantation (PA) is another important remedial meth...

    Authors: Qiuxia Cui, Deguang Kong, Zhihua Li, Kun Wang, Dan Zhang, Jianing Tang, Xing Liao, Qianqian Yuan, Yan Gong and Gaosong Wu

    Citation: Trials 2019 20:96

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  40. Content type: Study protocol

    The development of efficacious, cost-effective, and widely accessible programs for the prevention of eating disorders (EDs) is crucial in order to reduce the ED-related burden of illness. Programs using disson...

    Authors: Stephanie Bauer, Sally Bilić, Christina Reetz, Fikret Ozer, Katja Becker, Heike Eschenbeck, Michael Kaess, Christine Rummel-Kluge, Hans-Joachim Salize, Silke Diestelkamp and Markus Moessner

    Citation: Trials 2019 20:91

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  41. Content type: Update

    General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) is a multicentre, individually randomised controlled trial aiming to compare the use of intermitte...

    Authors: Sharmala Thuraisingam, Patty Chondros, Max Catchpool, Kim Dalziel, Jo-Anne Manski-Nankervis, Jane Speight, Elizabeth Holmes-Truscott, Ralph Audehm, Jason Chiang, Irene Blackberry, David O’Neal, Kamlesh Khunti, James Best and John Furler

    Citation: Trials 2019 20:93

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    The Study protocol to this article has been published in Trials 2017 18:174

  42. Content type: Study protocol

    Atrial fibrillation (AF) is frequent and causes great morbidity in the aging population. While initial events may be symptomatic, many patients have silent AF and are at risk of ischemic embolic complications....

    Authors: Sara Schukraft, Marco Mancinetti, Daniel Hayoz, Yannick Faucherre, Stéphane Cook, Diego Arroyo and Serban Puricel

    Citation: Trials 2019 20:92

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  43. Content type: Study protocol

    A stroke often results in gait impairments, activity limitations and restricted participation in daily life. Virtual reality (VR) has shown to be beneficial for improving gait ability after stroke. Previous st...

    Authors: Ilona J. M. de Rooij, Ingrid G. L. van de Port, Johanna M. A. Visser-Meily and Jan-Willem G. Meijer

    Citation: Trials 2019 20:89

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  44. Content type: Study protocol

    Many cancer patients are interested in complementary and integrative medicine during and after regular cancer treatment. Given the high number of users it is important that physicians and patients engage in a ...

    Authors: Stefanie M. Helmer, Alizé A. Rogge, Felix Fischer, Daniel Pach, Markus Horneber, Stephanie Roll and Claudia M. Witt

    Citation: Trials 2019 20:90

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  45. Content type: Study protocol

    Older adults with Mild Cognitive Impairment (MCI) are at high risk of progressing to Alzheimer’s disease (AD). Slowing down the effect of dementia by enhancing brain plasticity represents one of the most promi...

    Authors: Fabienne Marlats, Leila Djabelkhir-Jemmi, Eric Azabou, Marouane Boubaya, Sjaak Pouwels and Anne-Sophie Rigaud

    Citation: Trials 2019 20:88

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  46. Content type: Study protocol

    Persecutory delusions are a major psychiatric problem and are associated with a wide range of adverse outcomes. Our theoretical model views these delusions as unfounded threat beliefs which persist due to defe...

    Authors: Daniel Freeman, Rachel Lister, Felicity Waite, Ly-Mee Yu, Mel Slater, Graham Dunn and David Clark

    Citation: Trials 2019 20:87

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  47. Content type: Study protocol

    Despite the known adverse effects of maternal overt hypothyroidism on the neurocognitive development of children, there is uncertainty regarding the impact of gestational thyroid dysfunction or autoimmune thyr...

    Authors: Sima Nazarpour, Fahimeh Ramezani Tehrani, Firoozeh Sajedi, Razieh Bidhendi Yarandi and Fereidoun Azizi

    Citation: Trials 2019 20:86

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  48. Content type: Study protocol

    Several studies have reported that the triangulating stapling method decreases the incidence of anastomotic stricture after esophagectomy. Our previous randomized controlled trial, however, could not confirm t...

    Authors: Toshiaki Tsuji, Toshiyasu Ojima, Mikihito Nakamori, Masaki Nakamura, Masahiro Katsuda, Keiji Hayata, Junya Kitadani, Shimpei Maruoka, Toshio Shimokawa and Hiroki Yamaue

    Citation: Trials 2019 20:83

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