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  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. Content type: Study protocol

    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

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  8. 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

  9. Content type: Study protocol

    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

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  10. Content type: Study protocol

    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

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  12. Content type: Study protocol

    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

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  13. Content type: Study protocol

    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

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  14. Content type: Study protocol

    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

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  15. Content type: Study protocol

    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

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  16. Content type: Study protocol

    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

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  17. Content type: Study protocol

    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

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  18. Content type: Research

    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

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  19. Content type: Research

    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

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  20. Content type: Research

    Delirium is an acute mental disorder and common postoperative complication. Monitoring regional cerebral oxygen saturation (rSO2) in endovascular therapeutic surgery may allow real-time monitoring of cerebral des...

    Authors: Xiaohua Wang, Kunpeng Feng, Haixia Liu, Yanhui Liu, Ming Ye, Guoguang Zhao and Tianlong Wang

    Citation: Trials 2019 20:504

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  21. Content type: Study protocol

    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

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  22. Content type: Study protocol

    Globally, eye care provision is currently insufficient to meet the requirement for eye care services. Lack of access and awareness are key barriers to specialist services; in addition, specialist services are ...

    Authors: Hillary Rono, Andrew Bastawrous, David Macleod, Emmanuel Wanjala, Stephen Gichuhi and Matthew Burton

    Citation: Trials 2019 20:502

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  23. Content type: Study protocol

    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

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  24. Content type: Study protocol

    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

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  25. Content type: Study protocol

    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

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  26. Content type: Study protocol

    Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilizat...

    Authors: Enrique Lluch-Girbés, Lirios Dueñas, Silvia Mena-del Horno, Alejandro Luque-Suarez, Santiago Navarro-Ledesma and Adriaan Louw

    Citation: Trials 2019 20:498

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  27. Content type: Study protocol

    Chronic spinal cord injury (SCI) increases morbidity and mortality associated with cardiometabolic diseases, secondary to increases in central adiposity, hyperlipidaemia and impaired glucose tolerance. While u...

    Authors: David W. McMillan, Jennifer L. Maher, Kevin A. Jacobs, Armando J. Mendez, Mark S. Nash and James L. J. Bilzon

    Citation: Trials 2019 20:497

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  28. Content type: Study protocol

    HIV-testing coverage remains below the targeted 90% despite efforts and resources invested. Home-based HIV-testing is a key approach endorsed by the World Health Organization (WHO), especially to reach individ...

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

    Citation: Trials 2019 20:496

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  29. Content type: Study protocol

    Although anterior cruciate ligament (ACL) tear-prevention programs may be effective in the (secondary) prevention of a subsequent ACL injury, little is known, yet, on their effectiveness and feasibility. This ...

    Authors: Daniel Niederer, Matthias Keller, Andrea Achtnich, Ralph Akoto, Atesch Ateschrang, Winfried Banzer, Alexander Barié, Raymond Best, Andree Ellermann, Andreas Fischer, Daniel Guenther, Mirco Herbort, Jürgen Höher, Maren Janko, Tobias M. Jung, Matthias Krause…

    Citation: Trials 2019 20:495

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  30. Content type: Study protocol

    Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints, causes joint destruction, and leads to physical disability. Advances in the treatment of RA, such as biologic disease-modifying anti-r...

    Authors: Naoki Iwamoto, Shuntaro Sato, Remi Sumiyoshi, Ko Chiba, Nanami Miyamoto, Kumiko Arinaga, Makiko Kobayashi, Hiroshi Yamamoto, Makoto Osaki and Atsushi Kawakami

    Citation: Trials 2019 20:494

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  32. Content type: Research

    Qualitative research has been used to explore patients’ and healthcare professionals’ experiences of surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline par...

    Authors: Emma Elizabeth Phelps, Elizabeth Tutton, Xavier Griffin and Janis Baird

    Citation: Trials 2019 20:492

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  33. Content type: Study protocol

    Recurrent stroke is a major contributor to stroke-related disability and costs. Improving health-risk behaviours and mental health has the potential to significantly improve recovery, enhance health-related qu...

    Authors: Ashleigh Guillaumier, Sam McCrabb, Neil J. Spratt, Michael Pollack, Amanda L. Baker, Parker Magin, Alyna Turner, Christopher Oldmeadow, Clare Collins, Robin Callister, Chris Levi, Andrew Searles, Simon Deeming, Olivia Wynne, Alexandra M. J. Denham, Brigid Clancy…

    Citation: Trials 2019 20:491

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  34. Content type: Study protocol

    Partial pancreatoduodenectomy is performed for malignant and benign diseases of the pancreatic head region. The procedure is considered highly difficult and highly invasive. Postoperative pancreatic fistula (P...

    Authors: Kazuto Shibuya, Jin-Young Jang, Sohei Satoi, Masayuki Sho, Suguru Yamada, Manabu Kawai, Hongbeom Kim, Song Cheol Kim, Jin Seok Heo, Yoo-Seok Yoon, Joon Seong Park, Ho Kyoung Hwang, Isaku Yoshioka, Toshio Shimokawa, Hiroki Yamaue and Tsutomu Fujii

    Citation: Trials 2019 20:490

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  35. Content type: Study protocol

    Human papilloma viruses (HPVs) infect squamous epithelial cells and form verrucous lesions, or warts. Besides the psychosocial problems caused by the disfiguring warts, a subset of HPVs can be the primary etio...

    Authors: Takashi Nomura, Eriko Sumi, Gyohei Egawa, Saeko Nakajima, Eiko Toichi, Ryuji Uozumi, Harue Tada, Takayuki Nakagawa, Masatoshi Hagiwara and Kenji Kabashima

    Citation: Trials 2019 20:489

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  36. Content type: Study protocol

    The objective of this study is to evaluate the effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health-related quality of life (HRQoL) and direct cost of treatme...

    Authors: Atta Abbas Naqvi, Mohamed Azmi Hassali, Syed Baqir Shyum Naqvi and Muhammad Tariq Aftab

    Citation: Trials 2019 20:488

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  37. Content type: Study protocol

    The underlying mechanisms of non-specific chronic neck pain relapses are not clear, but they could be associated with a deficit and alteration of neck muscles propioception that play a decisive role in cervica...

    Authors: Carlos Bernal-Utrera, Juan José González-Gerez, Manuel Saavedra-Hernandez, Miguel Ángel Lérida-Ortega and Cleofás Rodríguez-Blanco

    Citation: Trials 2019 20:487

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  38. Content type: Study protocol

    The treatment of mental health issues among people living with HIV (PLH) in Botswana is yet to be addressed. A recent study revealed that depressive symptoms are highly prevalent in a sample of PLH in Botswana...

    Authors: Boitumelo Vavani, Vivian Kraaij, Phillip Spinhoven and Nadia Garnefski

    Citation: Trials 2019 20:486

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  40. Content type: Study protocol

    African Americans have a disproportionate prevalence and incidence of type 2 diabetes compared with Caucasians. Recent evidence indicates that low cardiorespiratory fitness (CRF) level, an independent risk fac...

    Authors: Joshua E. McGee, Savanna G. Barefoot, Nicole R. Gniewek, Patricia M. Brophy, Angela Clark, Gabriel S. Dubis, Terence E. Ryan, Joseph A. Houmard, Paul Vos, Thomas D. Raedeke and Damon L. Swift

    Citation: Trials 2019 20:484

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  41. Content type: Study protocol

    Prolonged acute hospital stays are a major problem for older people and for health services. Failure to effectively manage the psychological and social aspects of illness is an important cause of prolonged hos...

    Authors: Jane Walker, Katy Burke, Mark Toynbee, Maike van Niekerk, Chris Frost, Nicholas Magill, Simon Walker, Mark Sculpher, Ian R. White and Michael Sharpe

    Citation: Trials 2019 20:483

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  42. Content type: Study protocol

    Neuralgic amyotrophy (NA) is a distinct peripheral neurological disorder of the brachial plexus with a yearly incidence of 1/1000, which is characterised by acute severe upper extremity pain. Weakness of the s...

    Authors: Renee Lustenhouwer, Nens van Alfen, Ian G. M. Cameron, Ivan Toni, Alexander C. H. Geurts, Rick C. Helmich, Baziel G. M. van Engelen and Jan T. Groothuis

    Citation: Trials 2019 20:482

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  43. Content type: Study protocol

    Autosomal dominant polycystic kidney disease (ADPKD) is one of the most common potentially life-threatening inherited kidney diseases. It is the fourth most common cause of end-stage renal disease requiring re...

    Authors: Jing Gan, Yansheng Wu, Xuezhong Gong, Yiyi Ma, Shengqiang Yu and Jiandong Gao

    Citation: Trials 2019 20:481

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  44. Content type: Study protocol

    Heel pain is a common foot disorder that causes pain and functional limitations. The prevalence of disabling foot pain will increase as the population ages. Previous studies have reported the positive therapeu...

    Authors: Lai Fun Ho, Yuanqi Guo, Jessica Yuet-Ling Ching, Kam Leung Chan, Ping Him Tsang, Man Hin Wong, Liyi Chen, Bacon Fung-Leung Ng and Zhi-Xiu Lin

    Citation: Trials 2019 20:480

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  45. Content type: Study protocol

    A disturbance in the early colonisation of the gut by microorganisms is associated with an aberrant innate immune system and a variety of clinical conditions later in life. Several factors are considered to in...

    Authors: Thomas H. Dierikx, Daniel J. C. Berkhout, Laura Visser, Marc A. Benninga, Guus Roeselers, Nanne K. H. de Boer, Johanna I. P. de Vries and Tim G. J. de Meij

    Citation: Trials 2019 20:479

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  46. Content type: Study protocol

    Mild cognitive impairment (MCI) is defined as an intermediate stage between normal aging and Alzheimer’s disease (AD), and early and easily available interventions to delay the progress of MCI to AD are necess...

    Authors: Jae-Hong Kim, Jae-Young Han, Gwang-Cheon Park and Jeong-Soon Lee

    Citation: Trials 2019 20:478

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  47. Content type: Update

    The WBRTMel trial is a multinational, open-label, phase III randomised controlled trial comparing whole brain radiotherapy (WBRT) to observation following local treatment of one to three melanoma brain metasta...

    Authors: Serigne N. Lo, Angela M. Hong, Lauren E. Haydu, Tasnia Ahmed, Elizabeth J. Paton, Victoria Steel, George Hruby, Anh Tran, Rachael L. Morton, Anna K. Nowak, Janette L. Vardy, Katharine J. Drummond, Haryana M. Dhillon, Catherine Mandel, Richard A. Scolyer, Mark R. Middleton…

    Citation: Trials 2019 20:477

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    The Study protocol to this article has been published in BMC Cancer 2011 11:142

  48. Content type: Update

    Chronic rejection is the single biggest cause of premature kidney graft failure. HLA antibodies (Ab) are an established prognostic biomarker for premature graft failure so there is a need to test whether treat...

    Authors: Dominic Stringer, Leanne M. Gardner, Janet L. Peacock, Irene Rebollo-Mesa, Rachel Hilton, Olivia Shaw, Richard Baker, Brendan Clark, Raj C. Thuraisingham, Matthew Buckland, Michael Picton, Judith Worthington, Richard Borrows, David Briggs, Sapna Shah, Kin Yee Shiu…

    Citation: Trials 2019 20:476

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    The Study protocol to this article has been published in Trials 2014 15:30

  49. Content type: Study protocol

    Humeral shaft fractures constitute around 1% of adult fractures in the UK, with an annual incidence of approximately 13 per 100,000 population. Historically, these injuries have been primarily managed non-oper...

    Authors: William M. Oliver, Thomas H. Carter, Catriona Graham, Timothy O. White, Nicholas D. Clement, Andrew D. Duckworth and Samuel G. Molyneux

    Citation: Trials 2019 20:475

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  50. Content type: Commentary

    Around two million adults in the UK have significantly impaired decision-making capacity. However, there are concerns that this population is under-represented in research, due in part to the challenges around...

    Authors: Victoria Shepherd, Fiona Wood, Richard Griffith, Mark Sheehan and Kerenza Hood

    Citation: Trials 2019 20:474

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ISSN: 1745-6215