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  1. Content type: Study protocol

    Nonspecific neck pain (NSNP) is one of the most common musculoskeletal problems treated by orthopaedic physicians and physiotherapists. Posture has emerged as one of the major risk factors associated with NSNP...

    Authors: Ahmed S. A. Youssef, Nan Xia, Shimaa T. E. Emara, Ibrahim M. Moustafa and Xiaolin Huang

    Citation: Trials 2019 20:248

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  2. Content type: Study protocol

    Cancer survivors and their informal caregivers (family members, close friends) often experience significant impairments in health-related quality of life (HRQOL), including disruptions in psychological, physic...

    Authors: Thaddeus W. W. Pace, Sally E. Dodds, Alla Sikorskii, Terry A. Badger, Chris Segrin, Lobsang Tenzin Negi, Timothy Harrison and Tracy E. Crane

    Citation: Trials 2019 20:247

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  3. Content type: Study protocol

    Chronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be include...

    Authors: Carl Philpott, Steffi le Conte, David Beard, Jonathan Cook, William Sones, Steve Morris, Caroline S. Clarke, Mike Thomas, Paul Little, Jane Vennik, Valerie Lund, Helen Blackshaw, Anne Schilder, Stephen Durham, Spiros Denaxas, James Carpenter…

    Citation: Trials 2019 20:246

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  4. Content type: Study protocol

    Among patients with hepatocellular carcinoma (HCC), 85% of patients have an advanced disease stage at diagnosis and curative therapies cannot be performed. Prognosis has been quite poor as until recently there...

    Authors: Jie Shi, Juxian Sun, Chang Liu, Zongtao Chai, Nanya Wang, Hui Zhang and Shuqun Cheng

    Citation: Trials 2019 20:245

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  5. Content type: Study protocol

    Depression is among the leading causes of disability worldwide. Not all people with depression respond adequately to standard treatments. An innovative therapy that has shown promising results in controlled tr...

    Authors: Jaakko Erkkilä, Olivier Brabant, Suvi Saarikallio, Esa Ala-Ruona, Martin Hartmann, Nerdinga Letulė, Monika Geretsegger and Christian Gold

    Citation: Trials 2019 20:244

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  6. Content type: Study protocol

    Pancreatic cancer is a refractory malignancy, and the development of a new effective treatment strategy is needed. We generated a dendritic cell vaccine by culturing monocytes obtained by apheresis of blood fr...

    Authors: Masahiro Katsuda, Motoki Miyazawa, Toshiyasu Ojima, Akio Katanuma, Kenichi Hakamada, Kentaro Sudo, Shingo Asahara, Itaru Endo, Makoto Ueno, Kazuo Hara, Suguru Yamada, Tsutomu Fujii, Sohei Satoi, Tatsuya Ioka, Masaichi Ohira, Takahiro Akahori…

    Citation: Trials 2019 20:242

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  7. Content type: Methodology

    Monitoring and managing data returns in multi-centre randomised controlled trials is an important aspect of trial management. Maintaining consistently high data return rates has various benefits for trials, in...

    Authors: William J. Cragg, Fay Cafferty, Carlos Diaz-Montana, Elizabeth C. James, Johnathan Joffe, Monica Mascarenhas and Victoria Yorke-Edwards

    Citation: Trials 2019 20:241

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  8. Content type: Study protocol

    Anxiety disorders affect a quarter of the population during their lifetime, and typically emerge in childhood or adolescence. Anxiety disorders disrupt young people’s social, emotional and academic development...

    Authors: Lucy Taylor, Polly Waite, Brynjar Halldorsson, Ray Percy, Mara Violato and Cathy Creswell

    Citation: Trials 2019 20:240

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  9. Content type: Study protocol

    Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15–20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (cathe...

    Authors: Janneke van Grinsven, Sven M. van Dijk, Marcel G. Dijkgraaf, Marja A. Boermeester, Thomas L. Bollen, Marco J. Bruno, Sandra van Brunschot, Cornelis H. Dejong, Casper H. van Eijck, Krijn P. van Lienden, Djamila Boerma, Peter van Duijvendijk, Muhammed Hadithi, Jan Willem Haveman, René W. van der Hulst, Jeroen M. Jansen…

    Citation: Trials 2019 20:239

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  10. Content type: Update

    People who sustain spinal cord injuries in low- and middle-income countries are vulnerable to life-threatening complications after discharge. The aim of this trial is to determine the effect on all-cause morta...

    Authors: Robert D. Herbert, Lisa A. Harvey, Mohammad S. Hossain, Md. Shofiqul Islam, Qiang Li and Laurent Billot

    Citation: Trials 2019 20:238

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  11. Content type: Study protocol

    Stress urinary incontinence (SUI) is highly prevalent during pregnancy and after delivery. It is often associated with a failing pelvic floor, sphincteric and/or supportive system. Pelvic-floor-muscle training...

    Authors: Heidi F. A. Moossdorff-Steinhauser, Esther M. J. Bols, Marc E. A. Spaanderman, Carmen D. Dirksen, Mirjam Weemhoff, Fred H. M. Nieman and Bary Berghmans

    Citation: Trials 2019 20:237

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  12. Content type: Study protocol

    In routine intensive care unit (ICU) practice, fluids are often administered without a safety limit, which may lead to fluid overload and decreased survival. Recently, B-lines score (BLS) has been validated as...

    Authors: Daniel-Mihai Rusu, Ianis Siriopol, Ioana Grigoras, Mihaela Blaj, Adi-Ionut Ciumanghel, Dimitrie Siriopol, Ionut Nistor, Mihai Onofriescu, Gigel Sandu, Beatrice Cobzaru, Dragos Viorel Scripcariu, Olguta Diaconu and Adrian Constantin Covic

    Citation: Trials 2019 20:236

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  13. Content type: Study protocol

    Latino children in the US experience high rates of obesity, increasing their risk of subsequent diabetes. There are few clinical trials among low-income, Latino families to test interventions that account for ...

    Authors: Byron A. Foster, Kelsey Weinstein and Jackilen Shannon

    Citation: Trials 2019 20:235

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  14. Content type: Research

    Insufficient physical activity (PA) is a major public health issue. Whilst PA is an important contributor to disease prevention, engagement in PA decreases with age, particularly among women in socio-economica...

    Authors: Emma R. Lawlor, Margaret E. Cupples, Michael Donnelly and Mark A. Tully

    Citation: Trials 2019 20:234

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  15. Content type: Research

    Research involving adults who lack the capacity to provide informed consent can be challenging. In England and Wales there are legal provisions for consulting with others who know the person with impaired capa...

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

    Citation: Trials 2019 20:233

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  16. Content type: Study protocol

    During total aortic arch replacement surgery (TARS) for patients with acute type A aortic dissection, the organs in the lower body, such as the viscera and spinal cord, are at risk of ischemia even when antegr...

    Authors: Jing Lin, Zhaoxia Tan, Hao Yao, Xiaolin Hu, Dafa Zhang, Yuan Zhao, Jiyue Xiong, Bo Dou, Xueshuang Zhu, Zhong Wu, Yingqiang Guo, Deying Kang and Lei Du

    Citation: Trials 2019 20:232

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  17. Content type: Study protocol

    Chronic obstructive pulmonary disease (COPD) leads to peripheral and respiratory muscle dysfunctions. Nowadays, inspiratory muscle training can be geared toward strength or endurance gains. This study aims to ...

    Authors: Catharinne Angélica Carvalho de Farias, Lucien Peroni Gualdi, Selma Bruno da Silva, Verônica Franco Parreira, Dayane Montemezzo, Vanessa R. Resqueti and Guilherme A. F. Fregonezi

    Citation: Trials 2019 20:231

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  18. Content type: Methodology

    MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programm...

    Authors: Helen Blackshaw, Jane Vennik, Carl Philpott, Mike Thomas, Caroline Eyles, James Carpenter, Caroline S. Clarke, Steve Morris, Anne Schilder, Valerie Lund, Paul Little, Stephen Durham, Spiros Denaxas, Elizabeth Williamson, David Beard, Jonathan Cook…

    Citation: Trials 2019 20:230

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  19. Content type: Study protocol

    The potential of non-invasive repetitive transcranial magnetic stimulation (rTMS) to improve auditory verbal hallucinations (AVH) in schizophrenia patients has been increasingly explored over the past decade. ...

    Authors: Fanny Thomas, Noomane Bouaziz, Cécile Gallea, Palmyre Schenin-King Andrianisaina, Florence Durand, Ombline Bolloré, René Benadhira, Clémence Isaac, Sonia Braha-Zeitoun, Virginie Moulier, Antoni Valero-Cabré and Dominique Januel

    Citation: Trials 2019 20:229

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  20. Content type: Research

    Research has shown that mobile phone contraceptive behavioral interventions can increase knowledge and use of contraception, but other studies have failed to demonstrate a beneficial effect. The objective of t...

    Authors: Ona L. McCarthy, Hanadi Zghayyer, Amina Stavridis, Samia Adada, Irrfan Ahamed, Baptiste Leurent, Phil Edwards, Melissa Palmer and Caroline Free

    Citation: Trials 2019 20:228

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  21. 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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  22. Content type: Study protocol

    Assessment of disease activity is a critical component of tight-control, treat-to-target treatment strategies of rheumatoid arthritis (RA). Recently, the HandScan has been validated as a novel method for objec...

    Authors: N. J. Besselink, A. A. A. Westgeest, R. Klaasen, M. Gamala, J. M. van Woerkom, J. Tekstra, M. M. A. Verhoeven, W. E. Van Spil, F. P. J. G. Lafeber, A. C. A. Marijnissen, J. M. Van Laar and J. W. G. Jacobs

    Citation: Trials 2019 20:226

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  23. 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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  24. 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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  25. 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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  26. 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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  27. 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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  28. 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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  29. 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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  30. 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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  31. 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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  32. 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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  33. 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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  34. 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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    The Correction to this article has been published in Trials 2019 20:259

  35. 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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  36. 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

  37. 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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  38. 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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  39. 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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  40. 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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  41. 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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  42. 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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  43. 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

  44. 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

  45. 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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  46. 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

  47. 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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  48. 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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  49. 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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