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  1. Content type: Study protocol

    Radical inguinal lymphadenectomy (ILND) for metastatic melanoma is associated with a high complication rate. Seroma is often the first postoperative complication, followed by prolonged wound healing sometimes ...

    Authors: Mads Gustaf Jørgensen, Navid Mohammadpour Toyserkani, Nana Hyldig, Annette Hougaard Chakera, Lisbet Rosenkrantz Hölmich, Jørn Bo Thomsen and Jens Ahm Sørensen

    Citation: Trials 2018 19:441

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  2. Content type: Study protocol

    In hospital settings, delirium affects as many as 50% of older patients, aggravating their symptoms and worsening their condition, and therefore increasing the risk of in-hospital complications and death. The ...

    Authors: Karolina Piotrowicz, Krzysztof Rewiuk, Stanisław Górski, Weronika Kałwak, Barbara Wizner, Agnieszka Pac, Michał Nowakowski and Tomasz Grodzicki

    Citation: Trials 2018 19:439

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  3. Content type: Study protocol

    One out of five patients is unsatisfied to some extent after total knee arthroplasty (TKA). Unmet expectations are the main driver of post-operative dissatisfaction. Improved pre-operative education on realist...

    Authors: Jaap J. Tolk, Rob P. A. Janssen, Tsjitske M. Haanstra, Sita M. A. Bierma-Zeinstra and Max Reijman

    Citation: Trials 2018 19:437

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  4. Content type: Study protocol

    The care needs of patients with a limited prognosis (<12 months median) are complex and dynamic. Patients and caregivers must cope with many challenges, including physical symptoms and disabilities, uncertaint...

    Authors: Anja Siegle, Matthias Villalobos, Jasmin Bossert, Katja Krug, Laura Hagelskamp, Johannes Krisam, Violet Handtke, Nicole Deis, Jana Jünger, Michel Wensing and Michael Thomas

    Citation: Trials 2018 19:438

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  5. Content type: Research

    Institutional review boards must guarantee the ethical acceptability of a randomized controlled trial before it is conducted. However, some may regard an unbalanced randomization ratio as reflecting an absence...

    Authors: Clarisse Dibao-Dina, Agnès Caille and Bruno Giraudeau

    Citation: Trials 2018 19:440

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  6. Content type: Study protocol

    An adolescent's school is often the second most important place for his development and education after the home. However, reports highlight the recurrence of the use of violent discipline in schools. There ar...

    Authors: Joseph Ssenyonga, Katharin Hermenau, Mabula Nkuba and Tobias Hecker

    Citation: Trials 2018 19:435

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  7. Content type: Study protocol

    Bipolar disorder is a chronic and disabling psychiatric condition, characterised by recurrent episodes of mania, hypomania and depression. It places a heavy burden on sufferers and families, with high societal...

    Authors: Emma O’Donoghue, Abigail Clark, Matthew Richardson, John Hodsoll, Sunil Nandha, Eric Morris, Fergus Kane, Deirdre O’Keeffe, Lucy Butler and Suzanne Jolley

    Citation: Trials 2018 19:436

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  8. Content type: Study protocol

    Selective serotonin reuptake inhibitors (SSRIs) are amongst the most prescribed antidepressants for adolescents with depressive symptoms and major depressive disorder. However, SSRIs have significant shortcomi...

    Authors: Richard M. Stewart, Sean D. Hood, Pradeep Rao, Julia K. Moore, Kevin C. Runions, Susannah E. Murphy, Janice W. Y. Wong and Florian D. Zepf

    Citation: Trials 2018 19:434

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  9. Content type: Study protocol

    Although radical gastrectomy with D2 lymph node dissection has become the standard surgical approach for locally advanced gastric cancer, patients still have a poor prognosis after operation. Previously, we pr...

    Authors: Jie Shen, Beibei Cao, Yatao Wang, Aitang Xiao, Jichao Qin, Jianhong Wu, Qun Yan, Yuanlong Hu, Chuanyong Yang, Zhixin Cao, Junbo Hu, Ping Yin, Daxing Xie and Jianping Gong

    Citation: Trials 2018 19:432

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  10. Content type: Study protocol

    Heart failure (HF) is an important public health problem, considered a new epidemic with high morbidity and mortality. The progression of HF often determines weight reduction, muscle mass loss, and reduced phy...

    Authors: Elisa Maia dos Santos, Roger de Moraes, Eduardo Vera Tibiriça, Grazielle Vilas Bôas Huguenin, Annie Seixas Belo Moreira and Andrea Rocha De Lorenzo

    Citation: Trials 2018 19:431

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  11. Content type: Correction

    In the original publication [1] the abbreviation for Core outcome sets (COS) was pluralized unnecessarily throughout the next.

    Authors: Alice M. Biggane, Lucy Brading, Philippe Ravaud, Bridget Young and Paula R. Williamson

    Citation: Trials 2018 19:430

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    The original article was published in Trials 2018 19:113

  12. Content type: Study protocol

    The proportion of patients with controlled hypertension (< 140/90 mmHg) is very low in India. Thus, there is a need to improve blood pressure management among patients with uncontrolled hypertension through in...

    Authors: Nikhil Srinivasapura Venkateshmurthy, Vamadevan S Ajay, Sailesh Mohan, Devraj Jindal, Shuchi Anand, Dimple Kondal, Nikhil Tandon, Malipeddi Bhaskara Rao and Dorairaj Prabhakaran

    Citation: Trials 2018 19:429

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  13. Content type: Study protocol

    Osteoarthritis often results in prolonged periods of reduced physical activity and is associated with adverse health outcomes, including increased risk of cardiovascular and metabolic diseases. Exercise interv...

    Authors: Jane O’Brien, Kyra Hamilton, Andrew Williams, James Fell, Jonathan Mulford, Michael Cheney, Sam Wu and Marie-Louise Bird

    Citation: Trials 2018 19:425

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  14. Content type: Study protocol

    Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professional...

    Authors: Nicola L. Harman, John Wilding, Dave Curry, James Harris, Jennifer Logue, R. John Pemberton, Leigh Perreault, Gareth Thompson, Sean Tunis and Paula R. Williamson

    Citation: Trials 2018 19:427

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  15. Content type: Study protocol

    The stellate ganglion block (SGB) can lead to vasodilation of the head and neck. However, controversy remains concerning the changes in extracerebral blood flow. The objective of this study is to assess the ef...

    Authors: Shaofeng Pu, Jie Chen, Xing Gu, Yongming Xu, Junzhen Wu, Yingying Lv and Dongping Du

    Citation: Trials 2018 19:426

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  16. Content type: Study protocol

    Thermal ablation techniques have become the first-line treatment of truncal veins in the management of chronic venous disease (CVD). Despite excellent outcomes, these methods are often associated with pain; ge...

    Authors: Amjad Belramman, Roshan Bootun, Tjun Yip Tang, Tristan R. A. Lane and Alun H. Davies

    Citation: Trials 2018 19:428

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  17. Content type: Study protocol

    Children in Sub-Saharan Africa (SSA) comprise half of the total regional population, yet existing mental health services are severely under-equipped to meet their needs. Although effective interventions for th...

    Authors: Fred M. Ssewamala, Ozge Sensoy Bahar, Mary M. McKay, Kimberly Hoagwood, Keng-Yen Huang and Beverly Pringle

    Citation: Trials 2018 19:423

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  18. Content type: Study protocol

    Palliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families....

    Authors: Rachel Wells, Macy L. Stockdill, J. Nicholas Dionne-Odom, Deborah Ejem, Kathryn L. Burgio, Raegan W. Durant, Sally Engler, Andres Azuero, Salpy V. Pamboukian, Jose Tallaj, Keith M. Swetz, Elizabeth Kvale, Rodney O. Tucker and Marie Bakitas

    Citation: Trials 2018 19:422

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  19. Content type: Study protocol

    Core-specific sensorimotor exercises are proven to enhance neuromuscular activity of the trunk, improve athletic performance and prevent back pain. However, the dose-response relationship and, therefore, the d...

    Authors: Juliane Mueller, Josefine Stoll, Steffen Mueller and Frank Mayer

    Citation: Trials 2018 19:424

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  20. Content type: Update

    The Healthy Hands Project (HHP) is a randomised clinical trial aiming to determine the effectiveness of an intervention program in the prevention of hand dermatitis in healthcare workers (HCWs). The interventi...

    Authors: Maryam Soltanipoor, Sanja Kezic, Judith Sluiter and Rebecca Holman

    Citation: Trials 2018 19:421

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    The Study protocol to this article has been published in Trials 2017 18:92

  21. Content type: Research

    The ELCID (Early Lung Cancer Investigation and Diagnosis) trial was a feasibility randomised controlled trial examining the effect on lung cancer diagnosis of lowering the threshold for referral for urgent che...

    Authors: Hayley C. Prout, Allan Barham, Emily Bongard, Rhiannon Tudor-Edwards, Gareth Griffiths, Willie Hamilton, Emily Harrop, Kerry Hood, Chris N. Hurt, Rosie Nelson, Catherine Porter, Kirsty Roberts, Trevor Rogers, Emma Thomas-Jones, Angela Tod, Seow Tien Yeo…

    Citation: Trials 2018 19:419

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  22. Content type: Study protocol

    Maintaining quality of care in family planning (FP) counselling in low-resource settings is challenging. Job aids can help providers give more accurate and client-specific advice but require a provider to use ...

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

    Citation: Trials 2018 19:420

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  23. Content type: Study protocol

    Young men in South Africa face concurrent epidemics of HIV, drug and alcohol abuse, and unemployment. Standard HIV prevention programs, located in healthcare settings and/or using counseling models, fail to en...

    Authors: Mary Jane Rotheram-Borus, Mark Tomlinson, Andile Mayekiso, Jason Bantjes, Danielle M. Harris, Jacqueline Stewart and Robert E. Weiss

    Citation: Trials 2018 19:417

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  24. Content type: Study protocol

    Cisplatin-based chemoradiation is the standard of care for patients with locally advanced cervical cancer. Nevertheless, an increasing number of radio-resistant tumors still recur.

    Authors: Shengjun Ji, Qunchao Hu, Jiahao Zhu, Jie Chen, Qingqing Chen, Zhengcao Liu, Chen Shen, Ru Yang, Haoyao Sun, Jinchang Wu and Ke Gu

    Citation: Trials 2018 19:416

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  25. Content type: Study protocol

    Mental illness is a major public health concern. Despite progress understanding which treatments work, a significant treatment gap remains. An ongoing concern is treatment length. Modular, flexible, transdiagn...

    Authors: Laura K. Murray, Emily E. Haroz, S. Benjamin Doty, Namrita S. Singh, Sergey Bogdanov, Judith Bass, Shannon Dorsey and Paul Bolton

    Citation: Trials 2018 19:418

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  26. Content type: Study protocol

    Up to 95% of people entering treatment for use of alcohol or other drugs (AOD) smoke tobacco. Smokers receiving treatment for AOD use are interested in quitting and make quit attempts, but relapse is more comm...

    Authors: Ashleigh Guillaumier, Victoria Manning, Olivia Wynne, Coral Gartner, Ron Borland, Amanda L. Baker, Catherine J. Segan, Eliza Skelton, Lyndell Moore, Ramez Bathish, Dan I. Lubman and Billie Bonevski

    Citation: Trials 2018 19:415

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  27. Content type: Study protocol

    While it is has been proven that tranexamic acid (TXA) reduces blood loss in primary total hip and knee arthroplasty (THA and TKA), there is little published evidence on the use of TXA beyond 3 h post-operativ...

    Authors: Janet Hill, Paul Magill, Alastair Dorman, Rosemary Hogg, Andrew Eggleton, Gary Benson, Margaret McFarland, Lynn Murphy, Evie Gardner, Leeann Bryce, Una Martin, Catherine Adams, Jennifer Bell, Christina Campbell, Ashley Agus, Glenn Phair…

    Citation: Trials 2018 19:413

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  28. Content type: Research

    Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled...

    Authors: Nefyn H. Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A. Hughes, Eifiona Wood, Nadine E. Foster, David Walsh, Dawn Carnes, Valerie Sparkes, Elaine M. Hay, John Isaacs, Kika Konstantinou, Dylan Morrissey, Jaro Karppinen, Stephane Genevay…

    Citation: Trials 2018 19:408

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  29. Content type: Methodology

    Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological i...

    Authors: Paul Montgomery, Sean Grant, Evan Mayo-Wilson, Geraldine Macdonald, Susan Michie, Sally Hopewell and David Moher

    Citation: Trials 2018 19:407

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  30. Content type: Study protocol

    Although major depression is a frequent disorder in non-professional caregivers and there are effective psychological interventions to prevent it, caregivers have difficulty accessing them. Interventions for d...

    Authors: Fernando L. Vázquez, Ángela Torres, Olga Díaz, Mario Páramo, Patricia Otero, Vanessa Blanco and Lara López

    Citation: Trials 2018 19:414

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  31. Content type: Methodology

    The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the C...

    Authors: Sean Grant, Evan Mayo-Wilson, Paul Montgomery, Geraldine Macdonald, Susan Michie, Sally Hopewell and David Moher

    Citation: Trials 2018 19:406

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  32. Content type: Study protocol

    The prevalence of musculoskeletal pain (MSP) is persistently high throughout the world. Work-related factors such as high physical workload (lifting, bending and twisting of the back) are considered to be amon...

    Authors: Charlotte Diana Nørregaard Rasmussen, Peter Rasmus Hendriksen, Malene Jagd Svendsen, Dorte Ekner, Klaus Hansen, Ole Henning Sørensen, Susanne Wulff Svendsen, Allard J. van der Beek and Andreas Holtermann

    Citation: Trials 2018 19:411

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  33. Content type: Research

    Solar Disinfection (SODIS) of water is an economical, user-friendly, and environmentally safe household water treatment method that has been advocated as a means of decreasing the burden of diarrhea among chil...

    Authors: Bikes Destaw Bitew, Yigzaw Kebede Gete, Gashaw Andargie Biks and Takele Tadesse Adafrie

    Citation: Trials 2018 19:412

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  34. Content type: Research

    Cluster randomised trials (CRTs) are a key instrument to evaluate public health interventions. Fidelity assessment examines study processes to gauge whether an intervention was delivered as initially planned. ...

    Authors: Myriam Cielo Pérez, Nanor Minoyan, Valéry Ridde, Marie-Pierre Sylvestre and Mira Johri

    Citation: Trials 2018 19:410

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  35. Content type: Study protocol

    Laparoscopic gastrectomy (LG) has several benefits as a treatment of gastric cancer (GC), including reduced pain, early recovery of intestinal function, and shorter hospital stay. LG still has several drawback...

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

    Citation: Trials 2018 19:409

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  36. Content type: Study protocol

    The “Age of Blood in Children in Pediatric Intensive Care Unit” (ABC PICU) study is a randomized controlled trial (RCT) that aims to determine if red blood cell (RBC) unit storage age affects outcomes in criti...

    Authors: Marisa Tucci, Jacques Lacroix, Dean Fergusson, Allan Doctor, Paul Hébert, Robert A. Berg, Jaime Caro, Cassandra D. Josephson, Stéphane Leteurtre, Kusum Menon, Kenneth Schechtman, Marie E. Steiner, Alexis F. Turgeon, Lucy Clayton, Tina Bockelmann and Philip C. Spinella

    Citation: Trials 2018 19:404

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  37. Content type: Study protocol

    Current therapies for heart failure (HF) are followed by strategies to improve quality of life and exercise tolerance, besides reducing morbidity and mortality. Some HF patients present changes in the musculos...

    Authors: Carla Pinheiro Lopes, Luiz Claudio Danzmann, Ruy Silveira Moraes, Paulo José Cardoso Vieira, Francisco França Meurer, Douglas Santos Soares, Gaspar Chiappa, Luciano Santos Pinto Guimarâes, Santiago Alonso Tobar Leitão, Jorge Pinto Ribeiro and Andreia Biolo

    Citation: Trials 2018 19:405

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  38. Content type: Study protocol

    UK deaths due to chronic liver diseases such as cirrhosis have quadrupled over the last 40 years, making this condition now the third most common cause of premature death. Most patients with advanced cirrhosis...

    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 19:401

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  39. Content type: Study protocol

    A secure attachment with one or more caregivers is one of the most important predictors of cognitive development and emotional wellbeing. Persons with intellectual disabilities (ID) have extra need for secure ...

    Authors: Evelien van Wingerden, Paula S. Sterkenburg and Mirjam Wouda

    Citation: Trials 2018 19:400

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  40. Content type: Study protocol

    The incidence of obesity is increasing worldwide. In selected individuals, bariatric surgery may offer a means of achieving long-term weight loss, improved health, and healthcare cost reduction. Physiological ...

    Authors: Rachel Fulton, Jonathan E. Millar, Megan Merza, Helen Johnston, Amanda Corley, Daniel Faulke, Ivan Rapchuk, Joe Tarpey, Philip Lockie, Shirley Lockie and John F. Fraser

    Citation: Trials 2018 19:402

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  41. Content type: Study protocol

    According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hub...

    Authors: Huanfang Xu, Hong Zhao, Liping Kang, Shixi Huang, Yin Shi, Wei Su, Mingjuan Han, Wenyan Wang, Chunyan Wang, Yuan Zhang and Lanping Guo

    Citation: Trials 2018 19:403

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  42. Content type: Study protocol

    Treatment for drug-sensitive tuberculosis (TB) is taken for at least 6 months and problems with adherence are common. Therefore, there is substantial interest in the possible use of eHealth interventions to su...

    Authors: James J. Lewis, Xiaoqiu Liu, Zhiying Zhang, Bruce V. Thomas, Anna Vassall, Sedona Sweeney, Xu Caihong, Hu Dongmei, Li Xue, Gao Yongxin, Shitong Huan, Jiang Shiwen and Katherine L. Fielding

    Citation: Trials 2018 19:398

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  43. Content type: Study protocol

    Australia and New Zealand have the highest incidence rates of colorectal cancer worldwide. In Australia there is significant unwarranted variation in colorectal cancer screening due to low uptake of the immuno...

    Authors: Jennifer G. Walker, Finlay Macrae, Ingrid Winship, Jasmeen Oberoi, Sibel Saya, Shakira Milton, Adrian Bickerstaffe, James G. Dowty, Richard De Abreu Lourenço, Malcolm Clark, Louise Galloway, George Fishman, Fiona M. Walter, Louisa Flander, Patty Chondros, Driss Ait Ouakrim…

    Citation: Trials 2018 19:397

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  44. Content type: Study protocol

    Low back pain (LBP) is the most common musculoskeletal disorder and a leading cause of disability worldwide. It impacts daily life and work capacity and is the most common reason for consulting a general pract...

    Authors: Allan Riis, Jan Hartvigsen, Michael Skovdal Rathleff, Tamana Afzali and Martin Bach Jensen

    Citation: Trials 2018 19:399

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  45. Content type: Study protocol

    “Challenging” HIV-infected patients, those not retained in treatment, represent a critical focus for positive prevention, as linkage to care, early initiation of antiretroviral therapy, adherence and retention...

    Authors: Omar Sued, Isabel Cassetti, Diego Cecchini, Pedro Cahn, Lina Bofill de Murillo, Stephen M. Weiss, Lissa N. Mandell, Manasi Soni and Deborah L. Jones

    Citation: Trials 2018 19:396

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  46. Content type: Study protocol

    Most adults with diabetes who are at high risk for complications have family or friends who are involved in their medical and self-care (“family supporters”). These family supporters are an important resource ...

    Authors: Ann-Marie Rosland, John D. Piette, Ranak Trivedi, Eve A. Kerr, Shelley Stoll, Adam Tremblay and Michele Heisler

    Citation: Trials 2018 19:394

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  47. Content type: Study protocol

    Sepsis is one of the most important causes of maternal death and severe morbidity worldwide. Studies conducted both in the UK and US have documented an additional risk associated with operative vaginal deliver...

    Authors: Marian Knight, Linda Mottram, Shan Gray, Christopher Partlett and Ed Juszczak

    Citation: Trials 2018 19:395

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  48. Content type: Correction

    Following publication of the original article [1], the author reported the errors in the figure and in text reference in the published article. These errors are detailed below. The original article has been co...

    Authors: Sasha-Denise Grünzig, Harald Baumeister, Jürgen Bengel, David Ebert and Lena Krämer

    Citation: Trials 2018 19:393

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    The original article was published in Trials 2018 19:285

  49. Content type: Study protocol

    Obese women have fewer oocytes retrieved, an increased cancelation rate, a higher miscarriage rate, and a lower live birth rate after assisted reproductive technology (ART) treatment compared with women with n...

    Authors: Jing Li, Ze Wang, Daimin Wei, Hong Liu, Jiangtao Zhang, Jianfeng Wang, Yuhua Shi and Zi-Jiang Chen

    Citation: Trials 2018 19:391

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