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  1. Content type: Methodology

    Triggered monitoring in clinical trials is a risk-based monitoring approach where triggers (centrally monitored, predefined key risk and performance indicators) drive the extent, timing, and frequency of monit...

    Authors: Carlos Diaz-Montana, William J. Cragg, Rahela Choudhury, Nicola Joffe, Matthew R. Sydes and Sally P. Stenning

    Citation: Trials 2019 20:227

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  2. Content type: Research

    The Cord Pilot Trial compared two alternative policies for cord-clamping at very preterm birth at eight UK tertiary maternity units: clamping after at least 2 min and immediate neonatal care with cord intact, ...

    Authors: Lucy Bradshaw, Alexandra Sawyer, Eleanor Mitchell, Lindsay Armstrong-Buisseret, Susan Ayers and Lelia Duley

    Citation: Trials 2019 20:225

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  3. Content type: Research

    Recruitment to randomised controlled trials (RCTs) is challenging. Pre-trial qualitative research provides insights into the feasibility and acceptability of proposed trial designs and delivery; however, this ...

    Authors: Samantha Husbands, Fergus Caskey, Helen Winton, Andy Gibson, Jenny L. Donovan and Leila Rooshenas

    Citation: Trials 2019 20:224

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  4. Content type: Study protocol

    Patients with lower neurogenic bladder dysfunction are at an increased risk of suffering from recurrent urinary tract infections. Recurrent symptomatic urinary tract infection is occasionally treated with anti...

    Authors: Derick Wade, James Cooper, Fadel Derry and Julian Taylor

    Citation: Trials 2019 20:223

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  5. Content type: Study protocol

    Physical activity (PA) improves functional capacity and quality of life and provides secondary prevention benefits in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC). Howe...

    Authors: Ukachukwu O. Abaraogu, Philippa M. Dall, Julie Brittenden, Wesley Stuart, Garry A. Tew, Jon Godwin and Christopher A. Seenan

    Citation: Trials 2019 20:222

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  6. Content type: Study protocol

    Polycystic ovary syndrome (PCOS) is a reproductive-metabolic condition. Insulin resistance is a hallmark of PCOS and is related to increased hyperandrogenism that drives inherent metabolic, reproductive and ps...

    Authors: Danielle Hiam, Rhiannon Patten, Melanie Gibson-Helm, Alba Moreno-Asso, Luke McIlvenna, Itamar Levinger, Cheryce Harrison, Lisa J Moran, Anju Joham, Alex Parker, Soulmaz Shorakae, David Simar and Nigel Stepto

    Citation: Trials 2019 20:221

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  7. Content type: Study protocol

    Pain after major head and neck cancer surgery is underestimated and has both nociceptive and neuropathic characteristics. Extended resection, flap coverage, nerve lesions, inflammation, and high-dose opioid ad...

    Authors: Edris Omar, Grégoire Wallon, Christian Bauer, Grégory Axiotis, Cécile Bouix, Jean-Luc Soubirou and Frédéric Aubrun

    Citation: Trials 2019 20:220

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  8. Content type: Study protocol

    Diabetes is increasing in incidence, morbidity and treatment costs globally, hence prevention strategies need to be explored. Animal studies and some human data have shown that zinc can improve glycaemic contr...

    Authors: Roseanne Peel, Alexis Hure, John Wiggers, Mark McEvoy, Elizabeth Holliday, Andrew Searles, Penny Reeves, Priyanga Ranasinghe, Ranil Jayawardena, Samir Samman, Shamasunder Acharya, Judy Luu, Chris Rissel and John Attia

    Citation: Trials 2019 20:219

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  9. Content type: Study protocol

    Hypertension is a major risk factor for cardio-cerebrovascular disease. Songling Xuemaikang capsules (SXC), a formulation of Chinese herbal patent medicine, has been used as a complementary medicine with conve...

    Authors: Yuerong Jiang, Haiyan Guo, Yue Liu, Xin Wang, Jiaqi Liang, Ruixi Xi, Ruina Bai and Dazhuo Shi

    Citation: Trials 2019 20:218

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  10. Content type: Study protocol

    Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as me...

    Authors: Youme Ko, Seung-Ho Sun, In-Sik Han, Ho-Yeon Go, Tae-Hun Kim, Jin-Moo Lee, Jun-Bok Jang, Kyoung Sun Park, Yun-Kyung Song, Kyou-Young Lee, Chan-Yong Jeon and Seong-Gyu Ko

    Citation: Trials 2019 20:217

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  11. Content type: Research

    Low back pain (LBP) is common, with a lifetime prevalence of 80%, and as such it places substantial social and economic burden on individuals and society. Chuna manual therapy (CMT) combines aspects of physiol...

    Authors: Kyeong-Tae Lim, Eui-Hyoung Hwang, Jae-Heung Cho, Jae-Young Jung, Koh-Woon Kim, In-Hyuk Ha, Me-riong Kim, Kibong Nam, Min ho Lee A, Jun-Hwan Lee, Namkwen Kim and Byung-Cheul Shin

    Citation: Trials 2019 20:216

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  12. Content type: Study protocol

    There are many comorbidities associated with Down syndrome (DS), including obstructive sleep apnea (OSA) and masticatory muscle alteration. Muscular hypotonia, in particular, of the masticatory and oropharynge...

    Authors: Lilian Chrystiane Giannasi, Marignês T. S. Dutra, Vera L. S. Tenguan, Gabriela P. Mancilha, Gabriela R. C. Silva, Elaine Fillietaz-Bacigalupo, Daniel B. da Silva, Fabiano Politti, Sergio R. Nacif, Ezequiel F. de Oliveira, João C. da Rocha, Carolina T. Rocha, Mateus M. Romero, Claudia S. de Oliveira, Luis V. F. de Oliveira, Sigmar de Mello Rode…

    Citation: Trials 2019 20:215

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  13. Content type: Study protocol

    Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality. Both thoracic surgery and intraoperative mechanical ventilation settings add considerably to th...

    Authors: T. Kiss, J. Wittenstein, C. Becker, K. Birr, G. Cinnella, E. Cohen, M. R. El Tahan, L. F. Falcão, C. Gregoretti, M. Granell, T. Hachenberg, M. W. Hollmann, R. Jankovic, W. Karzai, J. Krassler, T. Loop…

    Citation: Trials 2019 20:213

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  14. Content type: Research

    This research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase IV c...

    Authors: Yorokpa Joachim Doua, Hanneke Dominicus, Julius Mugwagwa, Suzelle Magalie Gombe and Jude Nwokike

    Citation: Trials 2019 20:212

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  15. Content type: Correction

    After publication of the original article [1], the authors have notified us of an additional acknowledgement they wish to bring for their paper.

    Authors: Muriel Vray, Boris G. Hedible, Pierrick Adam, Laura Tondeur, Alexandre Manirazika, Rindra Randremanana, Halima Mainassara, André Briend, Cecile Artaud, Cassandre von Platen, Mathias Altmann and Ronan Jambou

    Citation: Trials 2019 20:211

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    The original article was published in Trials 2018 19:666

  16. Content type: Research

    Drug eluting stent (DES) decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. Bioresorb...

    Authors: Thibault Lhermusier, Paul Ohayon, Nicolas Boudou, Frederic Bouisset, Francisco Campelo-Parada, Jerome Roncalli, Meyer Elbaz and Didier Carrié

    Citation: Trials 2019 20:210

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  17. Content type: Study protocol

    Intravenous morphine titration (IVMT) is the French gold standard for opioid treatment in the emergency department (ED). Nebulized morphine titration (NMT) may represent an alternative without venous access, b...

    Authors: Virginie Eve Lvovschi, Justine Joly, Nicolas Lemaire, Maxime Maignan, Pauline Canavaggio, Anne-Marie Leroi, Marie-Pierre Tavolacci and Luc-Marie Joly

    Citation: Trials 2019 20:209

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  18. Content type: Study protocol

    Benefits from cardiac rehabilitation (CR) programs are evidence-based and widely recognized. Less than 50% of people who participate in hospital-based CR programs maintain an exercise regime for as long as six...

    Authors: Rita Pinto, Vitor Angarten, Vanessa Santos, Xavier Melo and Helena Santa-Clara

    Citation: Trials 2019 20:208

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  19. Content type: Methodology

    Recruitment to trials can be difficult. Despite careful planning and research that outlines ways to improve recruitment, many trials do not achieve their target on time and require extensions of funding or time.

    Authors: W. Bertram, A. Moore, V. Wylde and R. Gooberman-Hill

    Citation: Trials 2019 20:207

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  20. Content type: Study protocol

    Surgery is the gold standard treatment for local advanced disease, while definitive concurrent chemoradiotherapy (DCRT) is recommended for those who are medically unable to tolerate major surgery or medically ...

    Authors: Ruinuo Jia, Weijiao Yin, Shuoguo Li, Ruonan Li, Junqiang Yang, Tanyou Shan, Dan Zhou, Wei Wang, Lixin Wan, Fuyou Zhou and Shegan Gao

    Citation: Trials 2019 20:206

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  21. Content type: Study protocol

    Transvaginal oocytes retrieval is an essential step in in-vitro fertilization treatment. There are different pain relief methods, but none has been shown to be superior than the others. Transcutaneous electric...

    Authors: Queenie Ho Yan Wong, Man Wa Lui, Sofie Shuk Fei Yung, Jennifer Ka Yee Ko, Raymond Hang Wun Li and Ernest Hung Yu Ng

    Citation: Trials 2019 20:205

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  22. Content type: Correction

    After publication of the original article [1], the authors have notified us that the Trial registration number NCT03274713 should be replaced by NCT03366363 in the Abstract section of the paper.

    Authors: Jian-Feng Tu, Jing-Wen Yang, Lu-Lu Lin, Tian-Qi Wang, Yu-Zheng Du, Zhi-Shun Liu, Hui Hu, Jing-Jie Zhao, Xiao-Gang Yu, Chun-Sheng Jia, Jun Wang, Tong Wang, Ya-Quan Hou, Xuan Zou, Yu Wang, Jia-Kai Shao…

    Citation: Trials 2019 20:204

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    The original article was published in Trials 2019 20:79

  23. Content type: Update

    CADENCE-BZ is a multi-centre, parallel-group, double-blind randomized controlled trial designed to examine the clinical efficacy and safety of an accessible food preservative, sodium benzoate, as an add-on tre...

    Authors: Carmen Lim, Andrea Baker, Sukanta Saha, Sharon Foley, Anne Gordon, David Ward, Bjorn Burgher, Frances Dark, Martin Beckmann, Stephen Stathis, George Bruxner, Alex Ryan, Drew Richardson, Sean Hatherill, Michael Berk, Olivia Dean…

    Citation: Trials 2019 20:203

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    The Study protocol to this article has been published in Trials 2017 18:165

  24. Content type: Study protocol

    To date, surgeons and physicians have found positive results treating metabolic syndrome with surgical and non-surgical weight loss therapies. The purpose of this study was to evaluate changes in telomere leng...

    Authors: Oral Ospanov, Galymgan Eleuov, Irina Kadyrova and Farida Bekmurzinova

    Citation: Trials 2019 20:202

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  25. Content type: Correction

    Following publication of the original article [1], the authors notified us that a comment in the Peripheral and neural biomarkers and genotype section was incorrectly phrased during editing. “4 weeks of treatment...

    Authors: Caroline V. Ott, Maj Vinberg, Christopher R. Bowie, Ellen Margrethe Christensen, Gitte M. Knudsen, Lars V. Kessing and Kamilla W. Miskowiak

    Citation: Trials 2019 20:201

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    The original article was published in Trials 2018 19:487

  26. Content type: Study protocol

    Temporomandibular disorder (TMD) is the most common cause of orofacial and cervical skull pain and is considered to be a public health problem, affecting 5% to 12% of the world population. TMD is multifactoria...

    Authors: Fernando Rodrigues Carvalho, Rafael Queiroz Barros, Alyne Simões Gonçalves and Patrícia Moreira Freitas

    Citation: Trials 2019 20:200

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  27. Content type: Study protocol

    Cognitive deficits are core symptoms of schizophrenia that occur from the early stages of the disorder. There is reliable evidence that cognitive deficits are associated with outcomes in schizophrenia; thus, e...

    Authors: Thais Rabanea-Souza, Sheila M. C. Cirigola, Cristiano Noto, July S. Gomes, Caroline C. Azevedo, Ary Gadelha, Quirino Cordeiro, Álvaro M. Dias and Acioly L. T. Lacerda

    Citation: Trials 2019 20:199

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  28. Content type: Study protocol

    Suicide amongst Australian Aboriginal and Torres Strait Islander communities occurs at twice the rate of the general population and, with significant barriers to treatment, help-seeking prior to a suicide atte...

    Authors: Fiona Shand, Andrew Mackinnon, Kathleen O’Moore, Rebecca Ridani, Bill Reda, Mel Hoy, Todd Heard, Luke Duffy, Marian Shanahan, Lisa Jackson Pulver and Helen Christensen

    Citation: Trials 2019 20:198

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  29. Content type: Study protocol

    Sepsis accounts for 30% to 50% of all in-hospital deaths in the United States. Other than antibiotics and source control, management strategies are largely supportive with fluid resuscitation and respiratory, ...

    Authors: David N. Hager, Michael H. Hooper, Gordon R. Bernard, Laurence W. Busse, E. Wesley Ely, Alpha A. Fowler, David F. Gaieski, Alex Hall, Jeremiah S. Hinson, James C. Jackson, Gabor D. Kelen, Mark Levine, Christopher J. Lindsell, Richard E. Malone, Anna McGlothlin, Richard E. Rothman…

    Citation: Trials 2019 20:197

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  30. Content type: Study protocol

    Psychotherapy for borderline personality disorder is often lengthy and resource-intensive. However, the current length of outpatient treatments is arbitrary and based on trials that never tested if the treatme...

    Authors: Sophie Juul, Susanne Lunn, Stig Poulsen, Per Sørensen, Mehrak Salimi, Janus Christian Jakobsen, Anthony Bateman and Sebastian Simonsen

    Citation: Trials 2019 20:196

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  31. Content type: Study protocol

    Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or ...

    Authors: Mui Teng Chua, Faheem Ahmed Khan, Wei Ming Ng, Qingshu Lu, Matthew Jian Wen Low, Ying Wei Yau, Amila Punyadasa and Win Sen Kuan

    Citation: Trials 2019 20:195

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  32. Content type: Research

    Intravenous (IV) iron is frequently used to treat iron deficiency/anemia in patients who are unable to tolerate oral iron or the oral iron is not sufficient toreplete iron requirements. However, safety concern...

    Authors: Ahmed Ziedan and Sunil Bhandari

    Citation: Trials 2019 20:194

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  33. Content type: Research

    Primary care access can be challenging for older, rural, socio-economically disadvantaged populations. Here we report the I-ACT cluster feasibility trial which aims to assess the feasibility of trial design an...

    Authors: John A. Ford, Andy P. Jones, Geoff Wong, Garry Barton, Allan Clark, Erika Sims, Ann Marie Swart and Nick Steel

    Citation: Trials 2019 20:193

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  34. Content type: Methodology

    Multicentre randomised trials provide some of the key evidence underpinning healthcare practice around the world. They are also hard work and generally expensive. Some of this work and expense are devoted to s...

    Authors: Hanne Bruhn, Shaun Treweek, Anne Duncan, Kirsty Shearer, Sarah Cameron, Karen Campbell, Karen Innes, Dawn McRae and Seonaidh C. Cotton

    Citation: Trials 2019 20:192

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  35. Content type: Study protocol

    Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue currently approved for type 2 diabetes and obesity. Preclinical evidence in transgenic models of Alzheimer’s disease suggests that liraglutide exerts n...

    Authors: Grazia Daniela Femminella, Eleni Frangou, Sharon B. Love, Gail Busza, Clive Holmes, Craig Ritchie, Robert Lawrence, Brady McFarlane, George Tadros, Basil H. Ridha, Carol Bannister, Zuzana Walker, Hilary Archer, Elizabeth Coulthard, Ben R. Underwood, Aparna Prasanna…

    Citation: Trials 2019 20:191

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  36. Content type: Study protocol

    A recent study shows that a multifaceted strategy using an individualised intra-abdominal pressure titration strategy during colorectal laparoscopic surgery results in an acceptable workspace at low intra-abdo...

    Authors: O. Diaz-Cambronero, G. Mazzinari, C. L. Errando, M. J. Schultz, B. Flor Lorente, N. García-Gregorio, M. Vila Montañés, Daniel Robles-Hernández, L. E. Olmedilla Arnal, A. Martín-De-Pablos, A. Marqués Marí and M. P. Argente Navarro

    Citation: Trials 2019 20:190

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  37. Content type: Study protocol

    Early adolescence is a period of dynamic neurobiological change. Converging lines of research suggest that regular physical activity (PA) and improved aerobic fitness have the potential to stimulate positive b...

    Authors: T. M. Wassenaar, C. M. Wheatley, N. Beale, P. Salvan, A. Meaney, J. B. Possee, K. E. Atherton, J. L. Duda, H. Dawes and H. Johansen-Berg

    Citation: Trials 2019 20:189

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  38. Content type: Study protocol

    The common cold is a highly prevalent illness with significant impact on society and health care. Common cold with heat syndrome (CCHS) is one of the most common types based on syndrome differentiation by trad...

    Authors: Jie Min, Bin She, Xin Zhang, Bing Mao and Yan Chen

    Citation: Trials 2019 20:187

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  39. Content type: Update

    In the context of major trauma, the rate of wound infection in surgical incisions created during fracture fixation amongst patients with closed high-energy injuries is high. One of the factors which may reduce...

    Authors: Ruth Knight, Louise M. Spoors, Matthew L. Costa and Susan J. Dutton

    Citation: Trials 2019 20:186

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  40. Content type: Methodology

    Group-randomized trials of communities often rely on the convenience of pre-existing administrative divisions, such as school district boundaries or census entities, to divide the study area into intervention ...

    Authors: Brittany Krzyzanowski, Steven M. Manson, Milton Mickey Eder, Len Kne, Niki Oldenburg, Kevin Peterson, Alan T. Hirsch, Russell V. Luepker and Sue Duval

    Citation: Trials 2019 20:185

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  41. Content type: Study protocol

    Atopic dermatitis is a highly prevalent, chronic, relapsing disease in both adults and children. On the severity spectrum, lower-end patients benefit from small amounts of topical anti-inflammatory treatments ...

    Authors: Catherine Droitcourt, Sébastien Barbarot, Annabel Maruani, Laure Darrieux, Laurent Misery, Emilie Brenaut, Henri Adamski, Cécile Chabbert, Annie Vermersch, Marie Weiborn, Julien Seneschal, Alain Taïeb, Patrice Plantin, Hervé Maillard, Alice Phan, François Skowron…

    Citation: Trials 2019 20:184

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  42. Content type: Update

    For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive dis...

    Authors: Rustam Al-Shahi Salman, Gordon D. Murray, Martin S. Dennis, David E. Newby, Peter A. G. Sandercock, Nikola Sprigg, Cathie L. M. Sudlow, David J. Werring, Philip M. White and William N. Whiteley

    Citation: Trials 2019 20:183

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  43. Content type: Methodology

    Rheumatoid arthritis (RA) is associated with significantly diminished health-related quality of life. Patient-reported outcomes (PROs) are considered important in RA; however, some symptoms such as morning joi...

    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 20:182

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  44. Content type: Research

    EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediate...

    Authors: Kerry Woolfall, Louise Roper, Amy Humphreys, Mark D. Lyttle, Shrouk Messahel, Elizabeth Lee, Joanne Noblet, Anand Iyer, Carrol Gamble, Helen Hickey, Naomi Rainford and Richard Appleton

    Citation: Trials 2019 20:181

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  45. Content type: Study protocol

    Numerous randomized controlled trials on the effects of electro-acupuncture have been conducted to treat dysphagia as a sequela of stroke. However, the normal physiological mechanisms of swallowing and the pat...

    Authors: Minying Li, Lin Wang, Nenggui Xu, Xiaorong Tang, Mindong Xu, Jianhua Liu, Jianpeng Huang and Judith M. Schlaeger

    Citation: Trials 2019 20:180

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  46. Content type: Study protocol

    Early mother–child skin-to-skin contact (SSC) in the first 2 h postpartum is highly beneficial for both mother and child. However, cases have been reported of newborns who have experienced apparently life-thre...

    Authors: Jesús Rodríguez López, Nadia Raquel García Lara, María López Maestro, Javier De la Cruz Bértolo, José Carlos Martínez Ávila, Máximo Vento, Ana Parra Llorca, Isabel Izquierdo Macián, Adelina Pellicer, Natalia Marín Huarte, Izaskun Asla Elorriaga, Lourdes Román Echevarría, Cristina Copons Fernández, Ana Martín Ancel, Fernando Cabañas, Óscar García Algar…

    Citation: Trials 2019 20:179

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  47. Content type: Study protocol

    Transition immediately after birth is a complex physiological process. The neonate has to establish sufficient ventilation to ensure significant changes from intra-uterine to extra-uterine circulation. If hypo...

    Authors: Gerhard Pichler, Sigrid Baumgartner, Marlene Biermayr, Eugene Dempsey, Hans Fuchs, Tom G. Goos, Gianluca Lista, Laila Lorenz, Lukasz Karpinski, Souvik Mitra, Lilijana Kornhauser-Cerar, Alexander Avian, Berndt Urlesberger and Georg M. Schmölzer

    Citation: Trials 2019 20:178

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  48. Content type: Study protocol

    Visible light (400 to 700 nm) is common in our environment, comprising 44% of total solar radiation and a large component of environmental light exposure. The effects of visible light on skin remain undefined....

    Authors: Erica B. Wang, Ramanjot Kaur, Julie Nguyen, Derek Ho, Evan Austin, Emanual Maverakis, Chin-Shang Li, Samuel T. Hwang, R. Rivkah Isseroff and Jared Jagdeo

    Citation: Trials 2019 20:177

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