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  1. Recurrence of cancer after curative surgery is a major problem after most cancer treatments. Increased sympathetic activity during the perioperative period could promote cancer cell invasion to blood vessels a...

    Authors: Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Takashi Nojiri, Masato Aragaki, Nao Horie, Norihiro Sato and Yasuhiro Hida

    Citation: Trials 2019 20:715

    Content type: Study protocol

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  2. Investigator-led multicentre randomised trials are essential to generate evidence on the optimal use of medical interventions. These non-commercial trials are often hampered by underfunding, which may lead to ...

    Authors: Hilde Nevens, Jillian Harrison, France Vrijens, Leen Verleye, Nelle Stocquart, Elisabeth Marynen and Frank Hulstaert

    Citation: Trials 2019 20:714

    Content type: Methodology

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  3. In medical oncology settings, early specialist palliative care interventions have demonstrated improvements in patient quality of life and survival compared with usual oncologic care. However, the effect of ea...

    Authors: Myrick C. Shinall Jr, Aimee Hoskins, Alexander T. Hawkins, Christina Bailey, Alaina Brown, Rajiv Agarwal, Maria C. Duggan, Laura M. Beskow, Vyjeyanthi S. Periyakoil, David F. Penson, Ryan T. Jarrett, Rameela Chandrasekhar and E. Wesley Ely

    Citation: Trials 2019 20:713

    Content type: Study protocol

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  4. Active self-management is a process where patients are fully engaged in managing their health in daily life by having access to contextualized health data and tailored guidance to support a healthy lifestyle. ...

    Authors: Johnathan Tam, Diane Lacaille, Teresa Liu-Ambrose, Chris Shaw, Hui Xie, Catherine L. Backman, John M. Esdaile, Kimberly Miller, Robert Petrella and Linda C. Li

    Citation: Trials 2019 20:712

    Content type: Study protocol

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  5. Pragmatic trials have been suggested as a way to improve the relevance of clinical trial results to practice. PRECIS-2 (Pragmatic Explanatory Continuum Indicator Summary-2) is a trial design tool which conside...

    Authors: Gordon Forbes, Kirsty Loudon, Megan Clinch, Stephanie J. C. Taylor, Shaun Treweek and Sandra Eldridge

    Citation: Trials 2019 20:711

    Content type: Research

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  6. Prolonged treatment with analgesic and sedative drugs in the pediatric intensive care unit (PICU) may lead to undesirable effects such as dependence and tolerance. Moreover, during analgosedation weaning, pati...

    Authors: Maria Cristina Mondardini, Francesca Sperotto, Marco Daverio, Fabio Caramelli, Dario Gregori, Maria Francesca Caligiuri, Francesca Vitale, Maria Teresa Cecini, Marco Piastra, Aldo Mancino, Andrea Pettenazzo, Giorgio Conti and Angela Amigoni

    Citation: Trials 2019 20:710

    Content type: Study protocol

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  7. Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is ...

    Authors: Aisha Shafayat, Emese Csipke, Lucy Bradshaw, Georgina Charlesworth, Florence Day, Phuong Leung, Esme Moniz-Cook, Alan A. Montgomery, Steve Morris, Gail Mountain, Reuben Ogollah, Kirsty Sprange, Lauren Yates and Martin Orrell

    Citation: Trials 2019 20:709

    Content type: Study protocol

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  8. Knowledge of what the pharmaceutical industry emphasizes when assessing trial sites during site selection is sparse. A better understanding of this issue can improve the collaboration on clinical trials and in...

    Authors: Tilde Dombernowsky, Merete Haedersdal, Ulrik Lassen and Simon Francis Thomsen

    Citation: Trials 2019 20:708

    Content type: Research

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  9. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major cause of hospital admissions and dyspnoea is its main symptom. Some studies have concluded that a new modality of acupuncture, ca...

    Authors: Carles Fernández-Jané and Jordi Vilaró

    Citation: Trials 2019 20:707

    Content type: Study protocol

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  10. The weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be us...

    Authors: Tomotsugu Seki, Morio Aki, Hirotsugu Kawashima, Tomotaka Miki, Shiro Tanaka, Koji Kawakami and Toshi A. Furukawa

    Citation: Trials 2019 20:706

    Content type: Study protocol

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  11. Innovations in clinical training and support that enhance fidelity to evidence-based treatment (EBT) for adolescent behavior problems are sorely needed. This study will develop an online training system to add...

    Authors: Aaron Hogue, Molly Bobek, Alexandra MacLean, Nicole Porter, Amanda Jensen-Doss and Craig E. Henderson

    Citation: Trials 2019 20:700

    Content type: Study protocol

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  12. Oral hygiene is of paramount importance for the preservation of oral health, and for patients affected by periodontal disease establishing an effective oral hygiene routine is the first step of therapy. Severa...

    Authors: Valentin Garyga, Florian Pochelu, Béatrice Thivichon-Prince, Walid Aouini, Julie Santamaria, France Lambert, Delphine Maucort-Boulch, Francois Gueyffier, Kerstin Gritsch and Brigitte Grosgogeat

    Citation: Trials 2019 20:699

    Content type: Study protocol

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  13. The incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the De...

    Authors: Annabel Allison, Ellie Edlmann, Angelos G. Kolias, Carol Davis-Wilkie, Harry Mee, Eric P. Thelin, Carole Turner, Peter J. Hutchinson and Simon Bond

    Citation: Trials 2019 20:698

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2018 19:670

  14. Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS...

    Authors: Margreet S. H. Wortman, Johannes C. van der Wouden, Janneke P. C. Grutters, Bart Visser, Willem J. J. Assendelft, Henriëtte E. van der Horst and Tim C. olde Hartman

    Citation: Trials 2019 20:697

    Content type: Study protocol

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  15. Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomi...

    Authors: Yen-I Chen, Kashi Callichurn, Avijit Chatterjee, Etienne Desilets, Donnellan Fergal, Nauzer Forbes, Ian Gan, Sana Kenshil, Mouen A. Khashab, Rastislav Kunda, Eric Lam, Gary May, Rachid Mohamed, Jeff Mosko, Sarto C. Paquin, Anand Sahai…

    Citation: Trials 2019 20:696

    Content type: Study protocol

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  16. After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2]. We would like to formally apologize and give credi...

    Authors: Carinne Brody, Sovannary Tuot, Pheak Chhoun, Dallas Swendeman, Kathryn C. Kaplan and Siyan Yi

    Citation: Trials 2019 20:695

    Content type: Correction

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    The original article was published in Trials 2018 19:235

  17. There is widespread concern across the clinical and research communities that clinical trials, powered for patient-reported outcomes, testing new surgical procedures are often expensive and time-consuming, par...

    Authors: Nick Parsons, Nigel Stallard, Helen Parsons, Philip Wells, Martin Underwood, James Mason and Andrew Metcalfe

    Citation: Trials 2019 20:694

    Content type: Methodology

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  18. Orthopaedic infections, such as osteomyelitis, diabetic foot infection and prosthetic joint infection, are most commonly treated by a combination of surgical debridement and a prolonged course of systemic anti...

    Authors: Maria Dudareva, Michelle Kümin, Werner Vach, Klaus Kaier, Jamie Ferguson, Martin McNally and Matthew Scarborough

    Citation: Trials 2019 20:693

    Content type: Study protocol

    Published on:

  19. Due to the progressive aging of the population, programs to promote active aging have been recommended. However, older adults have difficulty accessing them. Interventions administered through online video gam...

    Authors: Fernando L. Vázquez, Ángela J. Torres, Patricia Otero, Vanessa Blanco, Lara López, Antonio García-Casal and Manuel Arrojo

    Citation: Trials 2019 20:692

    Content type: Study protocol

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  20. Aortic arch surgery remains the only viable life-saving treatment for aortic arch disease. However, the necessity for cessation of systemic blood flow with hypothermic cardiac arrest carries substantial risk o...

    Authors: Habib Jabagi, George Wells and Munir Boodhwani

    Citation: Trials 2019 20:691

    Content type: Study protocol

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  21. All clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially ...

    Authors: Gregory E. Simon, Susan M. Shortreed, Rebecca C. Rossom, Robert B. Penfold, Jo Ann M. Sperl-Hillen and Patrick O’Connor

    Citation: Trials 2019 20:690

    Content type: Methodology

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  22. Acute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children. Previous studies have shown that pediatric Tuina, a traditional Chinese...

    Authors: Taoying Lu, Huiyan Zhang, Lingjia Yin, Jianxiong Cai, Meiling Li, Lin Dai, Conghao Zhu, Yongping Zhang, Feng Xiang, Li Wang, Lu Li, Lixin Wang and Darong Wu

    Citation: Trials 2019 20:689

    Content type: Study protocol

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  23. Convincing evidence suggests that the risk of colorectal cancer (CRC) is increased by the typical Western diet characterized by high consumption of red and processed meat. In addition, some epidemiological stu...

    Authors: Francesco Sofi, Monica Dinu, Giuditta Pagliai, Fabrice Pierre, Francoise Gueraud, Jildau Bowman, Philippe Gerard, Vincenzo Longo, Lisa Giovannelli, Giovanna Caderni and Carlotta de Filippo

    Citation: Trials 2019 20:688

    Content type: Study protocol

    Published on:

  24. Individuals diagnosed with autism spectrum disorder (ASD) experience impairing challenges in social communication and interaction across multiple contexts. While social skills group training (SSGT) has shown m...

    Authors: Bahareh Afsharnejad, Marita Falkmer, Melissa H. Black, Tasha Alach, Fabian Lenhard, Anna Fridell, Christina Coco, Kelly Milne, Nigel T. M. Chen, Sven Bölte and Sonya Girdler

    Citation: Trials 2019 20:687

    Content type: Study protocol

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  25. Large-scale studies risk generating inaccurate and missing data due to the complexity of data collection. Technology has the potential to improve data quality by providing operational support to data collector...

    Authors: Jessica E. Lockery, Taya A. Collyer, Christopher M. Reid, Michael E. Ernst, David Gilbertson, Nino Hay, Brenda Kirpach, John J. McNeil, Mark R. Nelson, Suzanne G. Orchard, Kunnapoj Pruksawongsin, Raj C. Shah, Rory Wolfe and Robyn L. Woods

    Citation: Trials 2019 20:686

    Content type: Methodology

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  26. Insomnia is among the most prevalent of the sleep-related disorders. Insomnia disorder is associated with a brain hyperarousal state manifested by abnormal regional brain activity and resting state functional ...

    Authors: Jing Guo, Siyi Yu, Chunhong Liu, Guiling Wang and Bin Li

    Citation: Trials 2019 20:685

    Content type: Study protocol

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  27. Fresh frozen plasma (FFP) is the accepted standard treatment for clotting factor replacement in bleeding patients during or immediately after cardiac surgery. In the United Kingdom prothrombin complex concentr...

    Authors: Laura Green, Neil Roberts, Jackie Cooper, Jane Field, Ravi Gill, Andrew Klein, Seema Agarwal, Simon Stanworth, Atholl Johnston, Vivienne Monk and Ben O’Brien

    Citation: Trials 2019 20:684

    Content type: Study protocol

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  28. Adenotonsillectomy is the most frequently performed operation in children worldwide. For decades, prophylactic antibiotics have been prescribed to limit postoperative complications. The effect of this antibiot...

    Authors: Denis R. Katundu, Peter S. Shija, Baltazari Nyombi, Hadija Semvua, Fieke K. Oussoren and Niels van Heerbeek

    Citation: Trials 2019 20:683

    Content type: Study protocol

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  29. Much evidence is available demonstrating that both vitamin D and omega-3 fatty acids block the development and progression of colonic carcinogenesis. The results of animal studies have shown that the consumpti...

    Authors: Fatemeh Haidari, Behnaz Abiri, Masood Iravani, Seyed-Mohsen Razavi, Parvin Sarbakhsh, Kambiz Ahmadi-Angali and Mohammadreza Vafa

    Citation: Trials 2019 20:682

    Content type: Study protocol

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  30. Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants’ response to mailed invi...

    Authors: Richard Haynes, Fang Chen, Elizabeth Wincott, Rejive Dayanandan, Michael J. Lay, Sarah Parish, Louise Bowman, Martin J. Landray and Jane Armitage

    Citation: Trials 2019 20:681

    Content type: Research

    Published on:

  31. Functional training has been shown to be a viable alternative for the elderly and patients with chronic obstructive pulmonary disease (COPD). However, whether the combination of this type of training with aero...

    Authors: Fabiano Francisco de Lima, Carlos Augusto Camillo, Isis Grigoletto, Juliana Souza Uzeloto, Franciele Marques Vanderlei, Dionei Ramos and Ercy Mara Cipulo Ramos

    Citation: Trials 2019 20:680

    Content type: Study protocol

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  32. Child mortality due to pneumonia is a major global health problem and is associated with hypoxemia. Access to safe and continuous oxygen therapy can reduce mortality; however, low-income countries may lack the...

    Authors: Nicholas Conradi, Qaasim Mian, Sophie Namasopo, Andrea L. Conroy, Laura L. Hermann, Charles Olaro, Jackson Amone, Robert O. Opoka and Michael T. Hawkes

    Citation: Trials 2019 20:679

    Content type: Study protocol

    Published on:

  33. Endovenous treatment of varicose veins has increased in popularity over the last decade. There remains, however, a degree of uncertainty regarding the role of compression bandaging or hosiery following this in...

    Authors: Doireann P. Joyce, Stewart R. Walsh, Charyl J. Q. Yap, Tze T. Chong and Tjun Y. Tang

    Citation: Trials 2019 20:678

    Content type: Study protocol

    Published on:

  34. Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of an...

    Authors: Jose Andonegui, Ferran Capdevila, Alicia Zubicoa and Berta Ibáñez

    Citation: Trials 2019 20:677

    Content type: Study protocol

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  35. Biannual, mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. Subgroup analysis suggested that the strongest effects were in the youngest childre...

    Authors: Ali Sié, Mamadou Ouattara, Mamadou Bountogo, Cheik Bagagnan, Boubacar Coulibaly, Valentin Boudo, Elodie Lebas, Jessica M. Brogdon, Ying Lin, Till Bärnighausen, Travis C. Porco, Thuy Doan, Thomas M. Lietman and Catherine E. Oldenburg

    Citation: Trials 2019 20:675

    Content type: Study protocol

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  36. Psoriasis is a chronic, immune-mediated disorder with chronic plaque psoriasis being the primary manifestation during the remission stage. Patients often have a slow course and long history of the disease. The...

    Authors: Zhaoxia Chen, Dongmei Zhou, Yan Wang, Haibing Lan, Xingwu Duan, Bohua Li, Jingxia Zhao, Wei Li, Zhengrong Liu, Tingting Di, Xinwei Guo, Jinchao Zhang, Bo Li, Shuo Feng and Ping Li

    Citation: Trials 2019 20:674

    Content type: Study protocol

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  37. Knee osteoarthritis (KOA) is one of the most common bone and joint diseases. As one of the main non-drug therapies, acupuncture is widely used to treat KOA, although the evidence for its efficacy is inconclusi...

    Authors: Yuan-Bo Fu, Bin Li, San-Feng Sun, Hui-Lin Liu, Xin Wang, Shao-Song Wang, Fan Zhang, Xin Du, Du-Juan Ge, Lei Shang, Rui-Li Liang, Li-Na Wang, Fang Yuan, Jing-Qing Sun and Jun-Wei Chen

    Citation: Trials 2019 20:673

    Content type: Study protocol

    Published on:

  38. Mental health has long been recognised as a major global health issue. Some work-related characteristics have been identified to be associated with common mental health problems, and thus the workplace is an i...

    Authors: Lawrence T. Lam, Prudence Wong and Mary K. Lam

    Citation: Trials 2019 20:672

    Content type: Study protocol

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  39. Ethiopia is one of the ten countries in the world that together account for almost 60% of all maternal deaths. Recent reductions in maternal mortality have been seen, yet just 26% of women who gave birth in Et...

    Authors: Jaameeta Kurji, Manisha A. Kulkarni, Lakew Abebe Gebretsadik, Muluemebet Abera Wordofa, Sudhakar Morankar, Kunuz Haji Bedru, Gebeyehu Bulcha, Kednapa Thavorn, Ronald Labonte and Monica Taljaard

    Citation: Trials 2019 20:671

    Content type: Study protocol

    Published on:

  40. Observational research suggests that combined therapy with Vitamin C, thiamine and hydrocortisone may reduce mortality in patients with septic shock.

    Authors: Christopher J. Lindsell, Anna McGlothlin, Samuel Nwosu, Todd W. Rice, Alex Hall, Gordon R. Bernard, Laurence W. Busse, E. Wesley Ely, Alpha A. Fowler, David F. Gaieski, Jeremiah S. Hinson, Michael H. Hooper, James C. Jackson, Gabor D. Kelen, Mark Levine, Greg S. Martin…

    Citation: Trials 2019 20:670

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2019 20:197

  41. Open access (OA) journals are becoming a publication standard for health research, but it is not clear how they differ from traditional subscription journals in the quality of research reporting. We assessed t...

    Authors: Iva Jerčić Martinić-Cezar and Ana Marušić

    Citation: Trials 2019 20:669

    Content type: Research

    Published on:

  42. HIV incidence in adolescent girls and young women remains high in sub-Saharan Africa. Progress towards uptake of HIV prevention methods remains low. Studies of oral pre-exposure prophylaxis (PrEP) have shown t...

    Authors: Ranjeeta Thomas, Morten Skovdal, Matteo M. Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B. Hallett and Simon Gregson

    Citation: Trials 2019 20:668

    Content type: Study protocol

    Published on:

  43. A significant proportion of patients with chronic tinnitus report clinical levels of sleep disturbance (insomnia). Despite the significant health and functioning implications of this, no rigorous trials have i...

    Authors: E. Marks, C. Hallsworth and L. McKenna

    Citation: Trials 2019 20:667

    Content type: Study protocol

    Published on:

  44. Idiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. ...

    Authors: Ying-ping Fei, Yun Zheng, Dan Lai, Ping Zhong, Jing-zhe Lu, Gang Li and Peng Liu

    Citation: Trials 2019 20:666

    Content type: Study protocol

    Published on:

  45. Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient a...

    Authors: Farren L. Goulding, Charity D. Evans, Katherine B. Knox, Hyun J. Lim, Michael C. Levin and Sarah J. Donkers

    Citation: Trials 2019 20:664

    Content type: Study protocol

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  46. Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent disorder, seen in 20–30% of young adult prisoners. Pharmacoepidemiological studies, a small randomised controlled trial and open trial data...

    Authors: Philip Asherson, Lena Johansson, Rachel Holland, Tom Fahy, Andrew Forester, Sheila Howitt, Stephen Lawrie, John Strang, Susan Young, Sabine Landau and Lindsay Thomson

    Citation: Trials 2019 20:663

    Content type: Study protocol

    Published on:

  47. Panic disorder (PD), frequently occurring with agoraphobia (AG), and depression are common mental disorders in primary care and associated with considerable individual and societal costs. Early detection and e...

    Authors: Karoline Lukaschek, Karola Mergenthal, Dirk Heider, Alexander Hanke, Kathrein Munski, Anne Moschner, Michelle Emig, Marjan van den Akker, Antonia Zapf, Karl Wegscheider, Hans-Helmut König and Jochen Gensichen

    Citation: Trials 2019 20:662

    Content type: Study protocol

    Published on:

  48. Denture-related stomatitis (DS) is chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganisms held together by a mucus-like matr...

    Authors: Adriana B. Ribeiro, Camila B. de Araújo, Luiz Eduardo V. Silva, Rubens Fazan-Junior, Helio C. Salgado, Aline B. Ribeiro, Caroline V. Fortes, Frank L. Bueno, Viviane C. de Oliveira, Helena de F. O. Paranhos, Evandro Watanabe and Cláudia H. da Silva-Lovato

    Citation: Trials 2019 20:661

    Content type: Study protocol

    Published on:

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