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  1. 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

    Content type: Study protocol

    Published on:

  2. 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

    Content type: Study protocol

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  3. 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

    Content type: Study protocol

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  4. 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

    Content type: Research

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  5. 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

    Content type: Study protocol

    Published on:

  6. 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

    Content type: Study protocol

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    The Correction to this article has been published in Trials 2019 20:617

  7. 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

    Content type: Study protocol

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  8. 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

    Content type: Study protocol

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  9. 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

    Content type: Study protocol

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  10. 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

    Content type: Study protocol

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  11. 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

    Content type: Study protocol

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  12. 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

    Content type: Study protocol

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  13. 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

    Content type: Study protocol

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  14. 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

    Content type: Study protocol

    Published on:

  15. 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

    Content type: Study protocol

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  16. 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

    Content type: Research

    Published on:

  17. 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

    Content type: Study protocol

    Published on:

  18. 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

    Content type: Study protocol

    Published on:

  19. 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

    Content type: Methodology

    Published on:

    The Correction to this article has been published in Trials 2019 20:606

  20. 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

    Content type: Study protocol

    Published on:

  21. 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

    Content type: Study protocol

    Published on:

  22. 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

    Content type: Study protocol

    Published on:

  23. 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

    Content type: Study protocol

    Published on:

  25. 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

    Content type: Study protocol

    Published on:

  26. 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

    Content type: Research

    Published on:

  27. 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

    Content type: Methodology

    Published on:

  28. 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

    Content type: Study protocol

    Published on:

  29. 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

    Content type: Study protocol

    Published on:

  30. 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

    Content type: Study protocol

    Published on:

  31. 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

    Content type: Study protocol

    Published on:

  32. 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

    Content type: Study protocol

    Published on:

  33. 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

    Content type: Study protocol

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  34. Irritable bowel syndrome with diarrhoea (IBS-D) affects up to 4% of the general population. Symptoms include frequent, loose, or watery stools with associated urgency, resulting in marked reduction of quality ...

    Authors: David Gunn, Ron Fried, Rabia Lalani, Amanda Farrin, Ivana Holloway, Tom Morris, Catherine Olivier, Rachael Kearns, Maura Corsetti, Mark Scott, Adam Farmer, Anton Emmanuel, Peter Whorwell, Yan Yiannakou, David Sanders, John Mclaughlin…

    Citation: Trials 2019 20:517

    Content type: Study protocol

    Published on:

  35. 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

    Content type: Correction

    Published on:

    The original article was published in Trials 2019 20:431

  36. Current population surveys suggest around 20% of Australians meet diagnostic criteria for an alcohol use disorder. However, only a minority seek professional help due to individual and structural barriers, suc...

    Authors: Dan I. Lubman, Jasmin Grigg, Victoria Manning, Kate Hall, Isabelle Volpe, Stephanie Dias, Amanda Baker, Petra K. Staiger, John Reynolds, Anthony Harris, Jonathan Tyler and David Best

    Citation: Trials 2019 20:515

    Content type: Study protocol

    Published on:

  37. Zygomaticomaxillary complex (ZMC) and zygomatic arch (ZA) fractures are common injuries resulting from facial trauma and frequently require surgical management (Huang et al., Craniomaxillofac Trauma Reconstr 8...

    Authors: Andrew Higgins, Michael Hurrell, Richard Harris, Geoffrey Findlay, Michael David and Martin Batstone

    Citation: Trials 2019 20:514

    Content type: Study protocol

    Published on:

  39. Obesity is a major public health problem in recent decades. The accumulation of excessive fat promotes inflammatory status. Meanwhile, herbal products are marketed for their weight-loss properties, such as Nigell...

    Authors: Elham Razmpoosh, Sara Safi, Mahta Mazaheri, Amin Salehi-Abargouei, Nooshin Abdollahi, Majid Nazari, Hossein Fallahzadeh and Azadeh Nadjarzadeh

    Citation: Trials 2019 20:512

    Content type: Study protocol

    Published on:

  40. Growth restriction in the newborn (GRN) can predispose to severe complications including hypoglycemia, sepsis, and necrotizing enterocolitis. Different interventions and treatments, such as feeding strategies,...

    Authors: Martine Knol, Helena Wang, Frank Bloomfield, Tabitha Piet, Stefanie Damhuis, Asma Khalil, Wessel Ganzevoort and Sanne Gordijn

    Citation: Trials 2019 20:511

    Content type: Study protocol

    Published on:

  41. Opioids and acetaminophen are both widely used to relieve pain after non-operative treatment of limb fractures, but evidence for the superiority of opioids versus acetaminophen is lacking. In this study, we ai...

    Authors: Tao Gao, Hongyi Zhu, Changqing Zhang, Yimin Chai, Cheng Guo, Xiaozhong Zhu, Bingbo Bao, Xingwei Li, Junqing Lin and Xianyou Zheng

    Citation: Trials 2019 20:510

    Content type: Study protocol

    Published on:

  42. E-mental health has become increasingly popular in interventions for individuals with eating disorders (EDs). It has the potential to offer low-threshold interventions and guide individuals to the needed care ...

    Authors: Pieter J. Rohrbach, Alexandra E. Dingemans, Philip Spinhoven, Elske Van den Akker-Van Marle, Joost R. Van Ginkel, Marjolein Fokkema, Markus Moessner, Stephanie Bauer and Eric F. Van Furth

    Citation: Trials 2019 20:509

    Content type: Study protocol

    Published on:

  43. Beneficial effects of placebos are high in double-blind hot flush trials. Studies in various conditions suggest that honestly prescribed placebos may elicit symptom improvement.

    Authors: Yiqi Pan, Ramona Meister, Bernd Löwe, Anne Winkelmann, Ted J. Kaptchuk, Kai J. Buhling and Yvonne Nestoriuc

    Citation: Trials 2019 20:508

    Content type: Study protocol

    Published on:

  44. Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource ...

    Authors:

    Citation: Trials 2019 20:507

    Content type: Study protocol

    Published on:

  45. The AMBER (Assessment, Management, Best Practice, Engagement, Recovery Uncertain) care bundle is a complex intervention used in UK hospitals to support patients with uncertain recovery. However, it has yet to ...

    Authors: J. Koffman, E. Yorganci, D. Yi, W. Gao, F. Murtagh, A. Pickles, S. Barclay, H. Johnson, R. Wilson, L. Sampson, J. Droney, M. Farquhar, T. Prevost and C. J. Evans

    Citation: Trials 2019 20:506

    Content type: Research

    Published on:

  46. Public health systems in resource-constrained settings have a critical role to play in the elimination of HIV transmission but are often financially constrained. This study is an evaluation of a mother-infant-...

    Authors: Sydney Chauwa Phiri, Sandra Mudhune, Margaret L. Prust, Prudence Haimbe, Hilda Shakwelele, Tina Chisenga, Mwangelwa Mubiana-Mbewe, Maureen Mzumara, Elizabeth McCarthy and Marta R. Prescott

    Citation: Trials 2019 20:505

    Content type: Research

    Published on:

  47. Radiation-induced dysphagia is common in patients with head and neck cancer (HNC). Available evidence suggests that exercise therapy prior to oncological treatment could potentially improve deglutition and qua...

    Authors: Anna Guillen-Sola, Neus Bofill Soler, Ester Marco, Oscar Pera-Cegarra and Palmira Foro

    Citation: Trials 2019 20:503

    Content type: Study protocol

    Published on:

  48. Chronic pancreatitis (CP) is a progressive, fibro-inflammatory disease characterized by enzymatic autoactivation and subsequent fibrotic replacement of acinar cells. A significant proportion of patients develo...

    Authors: Mitchell L. Ramsey, Janet Nuttall and Phil A. Hart

    Citation: Trials 2019 20:501

    Content type: Study protocol

    Published on:

  49. Persons with mild to borderline intellectual disabilities generally show dysfunctions in mentalization and stress regulation, resulting in problematic social relationships and personal distress. Intervention p...

    Authors: Suzanne Derks, Suze van Wijngaarden, Mirjam Wouda, Carlo Schuengel and Paula S. Sterkenburg

    Citation: Trials 2019 20:500

    Content type: Study protocol

    Published on:

  50. Growing evidence suggests that experiences in the early years play a major role in children’s development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives...

    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 20:499

    Content type: Study protocol

    Published on:

    The Correction to this article has been published in Trials 2019 20:557

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