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  1. Content type: Study protocol

    The benefit of physical exercise in ageing and particularly in frailty has been the aim of recent research. Moreover, physical activity in the elderly is associated with a decreased risk of mortality, of commo...

    Authors: Alvaro Casas-Herrero, Ivan Anton-Rodrigo, Fabricio Zambom-Ferraresi, Mikel L. Sáez de Asteasu, Nicolás Martinez-Velilla, Jaione Elexpuru-Estomba, Itxaso Marin-Epelde, Fernanda Ramon-Espinoza, Roberto Petidier-Torregrosa, Juan L. Sanchez-Sanchez, Berta Ibañez and Mikel Izquierdo

    Citation: Trials 2019 20:362

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  2. Content type: Study protocol

    HIV therapeutic vaccination aims to improve the immune responses against HIV in order to control viral replication without the need for combined antiretroviral therapy (cART). iHIVARNA-01 is a novel vaccine co...

    Authors: Wesley de Jong, Joeri Aerts, Sabine Allard, Christian Brander, Jozefien Buyze, Eric Florence, Eric van Gorp, Guido Vanham, Lorna Leal, Beatriz Mothe, Kris Thielemans, Montse Plana, Félipe Garcia and Rob Gruters

    Citation: Trials 2019 20:361

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  4. Content type: Study protocol

    Total hip replacement has recently followed a progressive evolution towards principles of bone- and soft-tissue-sparing surgery. Regarding femoral implants, different stem designs have been developed as an alt...

    Authors: I. Tatani, A. Panagopoulos, I. Diamantakos, G. Sakellaropoulos, Sp Pantelakis and P. Megas

    Citation: Trials 2019 20:359

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  5. Content type: Study protocol

    Psoriasis vulgaris is a common skin disease characterized by persistent localized erythematous scaly plaques, typically on the elbows, knees, and scalp. It is an immune-abnormal disease that progresses slowly ...

    Authors: Jingwen Deng, Chuanjian Lu, Yu Xiang, Hao Deng, Zehuai Wen, Danni Yao, Meiling Xuan and Yuhong Yan

    Citation: Trials 2019 20:358

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  6. Content type: Study protocol

    Intraoperative and postoperative management of cardiac surgery patients is complex, involving the application of differential vasopressors and volume therapy. It has been shown that a positive fluid balance ha...

    Authors: Carmen A. Pfortmueller, Anna S. Messmer, Benjamin Hess, David Reineke, Laura Jakob, Stefanie Wenger, Jan Waskowski, Patrick Zuercher, Frederik Stoehr, Gabor Erdoes, Markus M. Luedi, Stephan M. Jakob, Lars Englberger and Joerg C. Schefold

    Citation: Trials 2019 20:357

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  7. Content type: Study protocol

    Earlier nonrandomized studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous compared with open distal pancreatectomy (ODP) regarding hospital stay, blood loss, and recovery. Only...

    Authors: Bergthor Björnsson, Per Sandström, Anna Lindhoff Larsson, Claes Hjalmarsson and Thomas Gasslander

    Citation: Trials 2019 20:356

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  8. Content type: Study protocol

    People living with chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (ILD) suffer impaired quality of life due to burdensome symptoms and depression. The ...

    Authors: Bridget A. Graney, David H. Au, Anna E. Barón, Andrew Cheng, Sara A. Combs, Thomas J. Glorioso, Grady Paden, Elizabeth C. Parsons, Borsika A. Rabin, Debra P. Ritzwoller, Jessica-Jean Stonecipher, Carolyn Turvey, Carolyn H. Welsh and David B. Bekelman

    Citation: Trials 2019 20:355

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  9. Content type: Commentary

    Expert trial managers with the training and experience to overcome operational challenges are often the difference between the success and failure of a clinical trial. Considerable importance is given to the b...

    Authors: Danielle Beaumont, Monica Arribas, Lauren Frimley, Eni Balogun, Ian Roberts and Haleema Shakur-Still

    Citation: Trials 2019 20:354

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  10. Content type: Study protocol

    Exotoxins are important virulence factors in Staphylococcus aureus. Clindamycin, a protein synthesis inhibitor antibiotic, is thought to limit exotoxin production and improve outcomes in severe S. aureus infectio...

    Authors: Ravindra Dotel, Steven Y. C. Tong, Asha Bowen, Jane N. Nelson, Matthew V. N. O’Sullivan, Anita J. Campbell, Brendan J. McMullan, Philip N. Britton, Joshua R. Francis, Damon P. Eisen, Owen Robinson, Laurens Manning and Joshua S. Davis

    Citation: Trials 2019 20:353

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  11. Content type: Study protocol

    Unipolar depression is one of the most important mental disorders. Insomnia is a symptom of cardinal importance in depression. It increases the risk to develop depression, negatively affects disease trajectory...

    Authors: Gavin Brupbacher, Doris Straus, Hildburg Porschke, Thea Zander-Schellenberg, Markus Gerber, Roland von Känel and Arno Schmidt-Trucksäss

    Citation: Trials 2019 20:352

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  12. Content type: Study protocol

    THRIVE is a three-arm randomised controlled trial (RCT) that aims to evaluate whether antenatal and early postnatal interventions, Enhanced Triple B for Baby (ETPB) plus care as usual (CAU) or Mellow Bumps (MB...

    Authors: Rosaleen O’Brien, Katie Buston, Daniel Wight, Elizabeth McGee, Jane White and Marion Henderson

    Citation: Trials 2019 20:351

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  13. Content type: Study protocol

    Epidermolysis bullosa (EB) is a group of rare, genetic diseases that affect the integrity of epithelial tissues, most notably the skin. Patients experience recurrent skin wounding, with severity depending on t...

    Authors: Johannes S. Kern, Agnes Schwieger-Briel, Sandra Löwe, Mark Sumeray, Charles Davis and Anna E. Martinez

    Citation: Trials 2019 20:350

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  14. Content type: Study protocol

    Normal levels of plasma antithrombin (AT) activity might decrease heparin requirements to achieve an adequate level of anticoagulation during treatment with extracorporeal membrane oxygenation (ECMO). Acquired...

    Authors: Mauro Panigada, Elena Spinelli, Alberto Cucino, Elisa Cipriani, Stefano De Falco, Giovanna Panarello, Giovanna Occhipinti, Antonio Arcadipane, Gabriele Sales, Vito Fanelli, Luca Brazzi, Cristina Novembrino, Dario Consonni, Antonio Pesenti and Giacomo Grasselli

    Citation: Trials 2019 20:349

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  15. Content type: Commentary

    An international workshop on population health intervention research (PHIR) was organized to foster exchanges between experts from different disciplines and different fields. This paper aims to summarize the d...

    Authors: Graham Moore, Linda Cambon, Susan Michie, Pierre Arwidson, Grégory Ninot, Christine Ferron, Louise Potvin, Nadir Kellou, Julie Charlesworth and François Alla

    Citation: Trials 2019 20:285

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    The Commentary to this article has been published in Trials 2019 20:309

  16. Content type: Research

    Electronic consultation (eConsult) services are secure online applications facilitating provider-to-provider communication. They have been found to improve access to specialist care. However, little is known a...

    Authors: Clare Liddy, Isabella Moroz, Erin Keely, Monica Taljaard, Catherine Deri Armstrong, Amir Afkham and Claire E. Kendall

    Citation: Trials 2019 20:348

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  17. Content type: Study protocol

    Impulsivity is a core feature of borderline personality disorder (BPD) and is closely related to suicide risk and destructive and aggressive behaviors. Although transcranial direct current stimulation (tDCS) h...

    Authors: Juliana Teti Mayer, Magali Nicolier, Damien Gabriel, Caroline Masse, Julie Giustiniani, Charline Compagne, Pierre Vandel, Lionel Pazart, Emmanuel Haffen and Djamila Bennabi

    Citation: Trials 2019 20:347

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  18. Content type: Study protocol

    Radical lymph node dissection (LND) along the left recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question of whether robot-assisted...

    Authors: Yin-Kai Chao, Zhi-Gang Li, Yu-Wen Wen, Dae-Joon Kim, Seong-Yong Park, Yu-Ling Chang, Pieter C. van der Sluis, Jelle P. Ruurda and Richard van Hillegersberg

    Citation: Trials 2019 20:346

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  19. Content type: Study protocol

    Due to an ageing population in Australia there has been an increase in the number of older adults with subjective cognitive impairment (SCI), a self-reported decline in cognitive function associated with an in...

    Authors: Adele E. Cave, Dennis H. Chang, Gerald W. Münch and Genevieve Z. Steiner

    Citation: Trials 2019 20:345

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  20. Content type: Study protocol

    Neurological injuries remain the leading cause of death in comatose patients resuscitated from out-of-hospital cardiac arrest (OHCA). Adequate blood pressure is of paramount importance to optimize cerebral per...

    Authors: Simon Mölström, Troels Halfeld Nielsen, Carl H. Nordström, Christian Hassager, Jacob Eifer Møller, Jesper Kjærgaard, Sören Möller, Henrik Schmidt and Palle Toft

    Citation: Trials 2019 20:344

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  21. Content type: Study protocol

    Spleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic sy...

    Authors: Xu Zhou, Dong-mei Yan, Wei-feng Zhu, Wen-jun Liu, He-yun Nie, Sheng Xu, Yi-ping Jiang, Kun-he Zhang, Ying Fu, Yi-ye Wan, Xin-yu Yu, Hong Li, Xin Sun and Xiao-fan Chen

    Citation: Trials 2019 20:343

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  22. Content type: Study protocol

    Postoperative infection is a serious problem in New Zealand and internationally with considerable human and financial costs. Also, in New Zealand, certain factors that contribute to postoperative infection are...

    Authors: Alan F. Merry, Derryn A. Gargiulo, Ian Bissett, David Cumin, Kerry English, Christopher Frampton, Richard Hamblin, Jacqueline Hannam, Matthew Moore, Papaarangi Reid, Sally Roberts, Elsa Taylor and Simon J. Mitchell

    Citation: Trials 2019 20:342

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  23. Content type: Study protocol

    Individuals with two copies of the apolipoprotein-1 (APOL1) gene risk variants are at high risk (HR) for non-diabetic kidney disease. The presence of these risk variants is highest in West Africa, specifically in...

    Authors: Muktar H. Aliyu, Usman J. Wudil, Donna J. Ingles, Bryan E. Shepherd, Wu Gong, Baba M. Musa, Hamza Muhammad, Mahmoud U. Sani, Aliyu Abdu, Aisha M. Nalado, Akinfenwa Atanda, Aima A. Ahonkhai, Talat A. Ikizler, Cheryl A. Winkler, Jeffrey B. Kopp, Paul L. Kimmel…

    Citation: Trials 2019 20:341

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  24. Content type: Study protocol

    Sufficient physical activity and a limited amount of sedentary behaviour can prevent a range of chronic diseases. However, most adults do not meet the recommendations for physical activity and sedentary behavi...

    Authors: Helene Schroé, Celien Van der Mispel, Ilse De Bourdeaudhuij, Maïté Verloigne, Louise Poppe and Geert Crombez

    Citation: Trials 2019 20:340

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  25. Content type: Study protocol

    Radial dysplasia (RD) is a disfiguring, potentially disabling congenital upper limb anomaly. Multiple surgical techniques are in current use, with little agreement on the optimal treatment approach. At present...

    Authors: George R. F. Murphy, Malcolm Logan, Gill Smith and Bran Sivakumar

    Citation: Trials 2019 20:339

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  26. Content type: Study protocol

    Medical professionals are at high risk of job stress and burnout. Research shows that work-related stress can be reduced through enhancing psychological resources, in particular, self-efficacy and perceived so...

    Authors: Ewelina Smoktunowicz, Magdalena Lesnierowska, Roman Cieslak, Per Carlbring and Gerhard Andersson

    Citation: Trials 2019 20:338

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  27. Content type: Study protocol

    NHS community pharmacies provide effective smoking cessation services; however, there is scope for increasing throughput and improving quit rates. This trial examines whether the Smoking Treatment Optimisation...

    Authors: Ratna Sohanpal, Sandra Jumbe, Wai-Yee James, Liz Steed, Tammy Yau, Carol Rivas, Vichithranie Madurasinghe, Colin Houlihan, Vlad Berdunisov, Matthew Taylor, Stephanie J. C. Taylor, Chris Griffiths, Sandra Eldridge and Robert Walton

    Citation: Trials 2019 20:337

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  28. Content type: Study protocol

    The benefit of pulmonary rehabilitation (PR) in symptomatic chronic obstructive pulmonary disease (COPD) is well known. However, advanced patients with chronic respiratory failure (CRF), a category excluded fr...

    Authors: Michele Vitacca, Irene Pietta, Marta Lazzeri and Mara Paneroni

    Citation: Trials 2019 20:336

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  29. Content type: Study protocol

    Earlier vascular healing after drug-eluting stent (DES) implantation may reduce the incidence of late stent thrombosis and provide theoretical evidence to shorten dual antiplatelet therapy duration in patients...

    Authors: Bo Li, Qin Hua Jin, Yun Dai Chen, Chang Qian Wang, Bei Shi, Xi Su, Guo Sheng Fu, Yan Qing Wu, Xu Chen Zhou and Zu Yi Yuan

    Citation: Trials 2019 20:335

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  30. Content type: Research

    ‘Conditional trial design’ is a framework for efficiently planning new clinical trials based on a network of relevant existing trials. The framework considers whether new trials are required and how the existi...

    Authors: Adriani Nikolakopoulou, Sven Trelle, Alex J. Sutton, Matthias Egger and Georgia Salanti

    Citation: Trials 2019 20:334

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  31. Content type: Study protocol

    Virtual reality training (VRT) uses computer software to track a user’s movements and allow him or her to interact with a game presented on a television screen. VRT is increasingly being used for the rehabilit...

    Authors: Lisa Sheehy, Anne Taillon-Hobson, Heidi Sveistrup, Martin Bilodeau, Christine Yang, Vivian Welch, Alomgir Hossain and Hillel Finestone

    Citation: Trials 2019 20:333

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  32. Content type: Study protocol

    The placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head...

    Authors: Joerg Kaiser, Willem Niesen, Pascal Probst, Thomas Bruckner, Colette Doerr-Harim, Oliver Strobel, Phillip Knebel, Markus K. Diener, André L. Mihaljevic, Markus W. Büchler and Thilo Hackert

    Citation: Trials 2019 20:332

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  33. Content type: Study protocol

    Evidence is conflicting about a causal role of inflammation in psychosis and, specifically, regarding antibodies binding to neuronal membrane targets, especially N-methyl-D-aspartate receptors. NMDAR, LGI1 and...

    Authors: Belinda Lennox, Ksenija Yeeles, Peter B. Jones, Michael Zandi, Eileen Joyce, Ly-Mee Yu, Giuliano Tomei, Rebecca Pollard, Sally-Anne Vincent, Mio Shimazaki, Iona Cairns, Francis Dowling, Thomas Kabir, Thomas R. E. Barnes, Anne Lingford Hughes, Akram A. Hosseini…

    Citation: Trials 2019 20:331

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  34. Content type: Study protocol

    Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection with a hospital mortality in excess of 40%. Along with insufficient and delayed empirical antimicrobial therap...

    Authors: Stefan Hagel, Sandra Fiedler, Andreas Hohn, Alexander Brinkmann, Otto R. Frey, Heike Hoyer, Peter Schlattmann, Michael Kiehntopf, Jason A. Roberts and Mathias W. Pletz

    Citation: Trials 2019 20:330

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  35. Content type: Methodology

    Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. Alth...

    Authors: Katy Davis, Nicole Minckas, Virginia Bond, Cari Jo Clark, Tim Colbourn, Sarah J. Drabble, Therese Hesketh, Zelee Hill, Joanna Morrison, Oliver Mweemba, David Osrin, Audrey Prost, Janet Seeley, Maryam Shahmanesh, Esther J. Spindler, Erin Stern…

    Citation: Trials 2019 20:329

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  36. Content type: Study protocol

    Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations to repair the torn rotator cuff has risen sig...

    Authors: Chris Littlewood, Marcus Bateman, Kendra Cooke, Susie Hennnings, Tina Cookson, Kieran Bromley, Martyn Lewis, Lennard Funk, Jean Denton, Maria Moffatt, Rachel Winstanley, Saurabh Mehta, Gareth Stephens, Lisa Dikomitis, Linda Chesterton and Nadine E. Foster

    Citation: Trials 2019 20:328

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  37. Content type: Study protocol

    Inflammatory bowel disease (IBD) is a chronic condition characterized by recurrent episodes of intestinal inflammation and is thought to be related to an autoimmune reaction to genetic and environmental factor...

    Authors: Eleonora Scaioli, Andrea Belluzzi, Luigi Ricciardiello, Daniele Del Rio, Enrica Rotondo, Pedro Mena, Eleonora Derlindati and Francesca Danesi

    Citation: Trials 2019 20:327

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  38. Content type: Study protocol

    Chronic urticaria (CU) is a refractory skin disease with long duration and a high recurrence rate. Acupuncture has been widely used for the treatment of CU in clinical practice in China. However, until now, th...

    Authors: Yunzhou Shi, Hui Zheng, Siyuan Zhou, Qianhua Zheng, Leixiao Zhang, Xianjun Xiao, Wei Cao, Ying Liu and Ying Li

    Citation: Trials 2019 20:326

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  39. Content type: Study protocol

    There are currently no approved pharmacotherapies for managing methamphetamine dependence. N-acetylcysteine (NAC) has been found to reduce the craving for methamphetamine and other drugs, but its effect on metham...

    Authors: Rebecca McKetin, Olivia M. Dean, Alyna Turner, Peter J. Kelly, Brendan Quinn, Dan I. Lubman, Paul Dietze, Gregory Carter, Peter Higgs, Amanda L. Baker, Barbara Sinclair, David Reid, Victoria Manning, Nina te Pas, Wenbin Liang, Tamsin Thomas…

    Citation: Trials 2019 20:325

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  40. Content type: Study protocol

    There are no standardized therapy guidelines for rehabilitation of calcaneus fractures. While there is consensus on non or partial weight-bearing, the use of supporting devices such as specific foot ankle orth...

    Authors: Hagen Schmal, Anders Holsgaard Larsen, Lonnie Froberg, Julie Ladeby Erichsen, Carsten Fladmose Madsen and Lasse Pedersen

    Citation: Trials 2019 20:324

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  41. Content type: Study protocol

    Process evaluation is increasingly common alongside complex randomised controlled trials (RCTs). This evaluation helps in understanding the mechanisms of impact and how the study processes were executed, and i...

    Authors: Vivien P. Nichols, David R. Ellard, Frances E. Griffiths, Martin Underwood, Stephanie J. C. Taylor and Shilpa Patel

    Citation: Trials 2019 20:323

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  42. Content type: Correction

    After publication of the original article [1], the authors have notified us of an error in language used in the text:

    Authors: Clifton O. Bingham III, Carol L. Gaich, Amy M. DeLozier, Kathryn D. Engstrom, April N. Naegeli, Stephanie de Bono, Pixy Banerjee and Peter C. Taylor

    Citation: Trials 2019 20:322

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    The original article was published in Trials 2019 20:182

  43. Content type: Study protocol

    Long-lasting insecticidal nets (LLINs) are a key malaria control intervention, but their effectiveness is threatened by resistance to pyrethroid insecticides. Some new LLINs combine pyrethroids with piperonyl ...

    Authors: Sarah G. Staedke, Moses R. Kamya, Grant Dorsey, Catherine Maiteki-Sebuguzi, Samuel Gonahasa, Adoke Yeka, Amy Lynd, Jimmy Opigo, Janet Hemingway and Martin J. Donnelly

    Citation: Trials 2019 20:321

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  44. Content type: Study protocol

    Both-bone forearm fractures are a common fracture, accounting for 3.4% of all paediatric fractures. For now, elastic stable intramedullary nailing (ESIN) and open reduction and internal fixation (ORIF) are the...

    Authors: Chunhui Chen, Linzhen Xie, Wenhao Zheng, Hua Chen and Leyi Cai

    Citation: Trials 2019 20:320

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  45. Content type: Study protocol

    Antidepressants are used both for treating acute episodes and for prophylaxis to prevent future episodes of depression, also called maintenance treatment. This article describes the protocol for a randomised c...

    Authors: Larisa Duffy, Faye Bacon, Caroline S. Clarke, Yvonne Donkor, Nick Freemantle, Simon Gilbody, Rachael Hunter, Tony Kendrick, David Kessler, Michael King, Paul Lanham, Gemma Lewis, Dee Mangin, Louise Marston, Michael Moore, Irwin Nazareth…

    Citation: Trials 2019 20:319

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  46. Content type: Study protocol

    Melanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK...

    Authors: P. Murchie, J. Masthoff, F. M. Walter, K. Rahman, J. L. Allan, N. Burrows, C. Proby, A. J. Lee, M. Johnston, A. Durrani, I. Depasquale, B. Brant, A. Neilson, F. Meredith, S. Treweek, S. Hall…

    Citation: Trials 2019 20:318

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  47. Content type: Study protocol

    The risk of falling is significantly higher in people with chronic stroke and it is, therefore, important to design interventions to improve mobility and decrease falls risk. Minimum toe clearance (MTC) is the...

    Authors: Rezaul Begg, Mary P. Galea, Lisa James, W. A. Tony Sparrow, Pazit Levinger, Fary Khan and Catherine M. Said

    Citation: Trials 2019 20:317

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  48. Content type: Commentary

    A malaria vaccine as part of the integrated malaria control and elimination efforts will have a major impact on public health in sub-Sahara Africa. The first malaria vaccine, RTS,S, now enters pilot implementa...

    Authors: Machteld van den Berg, Bernhards Ogutu, Nelson K. Sewankambo, Nikola Biller-Andorno and Marcel Tanner

    Citation: Trials 2019 20:316

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  49. Content type: Study protocol

    Taurine (Tau) is involved in many biochemical functions such as regulation of glucose and lipid metabolism, enhancement of energy expenditure, anti-inflammatory effects and appetite control. The most important...

    Authors: Fatemeh Haidari, Maryam Asadi, Javad mohammadi-asl and Kambiz Ahmadi-Angali

    Citation: Trials 2019 20:315

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  50. Content type: Study protocol

    Patients undergoing cardiac surgery with cardiopulmonary bypass are at an increased risk of developing postoperative pulmonary complications, potentially leading to excess morbidity and mortality. It is likely...

    Authors: Brian O’Gara, Balachundhar Subramaniam, Shahzad Shaefi, Ariel Mueller, Valerie Banner-Goodspeed and Daniel Talmor

    Citation: Trials 2019 20:312

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