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  1. To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS.

    Authors: Zhuoran Kuang, Xiaoyan Li, Jianxiong Cai, Yaolong Chen, Xiaoyuan Qiu and Xiaojia Ni

    Citation: Trials 2021 22:188

    Content type: Research

    Published on:

    The Correction to this article has been published in Trials 2021 22:259

  2. The Tight Control of psoriatic arthritis (TICOPA) trial confirmed improved clinical outcomes with a treat to target (T2T) strategy in psoriatic arthritis (PsA). This consisted of 4-weekly review and escalation...

    Authors: Ines Rombach, William Tillett, Deepak Jadon, Laura Tucker, Marion Watson, Anne Francis, Yvonne Sinomati, Lucy Eldridge, Melina Dritsaki, Susan J. Dutton, Hussein Al-Mossawi, Nicola Gullick, Ben Thompson and Laura C. Coates

    Citation: Trials 2021 22:185

    Content type: Study protocol

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  3. Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. However, there is insufficient evidence regarding the effects of DS on ankle sprains. ...

    Authors: Jae-Hong Kim, Cham-Kyul Lee, Eun-Yong Lee, Myoung-Rae Cho, Young-Su Lee and Jeong-Soon Lee

    Citation: Trials 2021 22:184

    Content type: Research

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  4. In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions regarding which operating characteristics sh...

    Authors: Elias Laurin Meyer, Peter Mesenbrink, Tobias Mielke, Tom Parke, Daniel Evans and Franz König

    Citation: Trials 2021 22:183

    Content type: Review

    Published on:

  5. This article has been retracted. Please see the Retraction Notice for more detail: https://doi.org/10.1186/s13063-021-05154-3.

    Authors: Christoph Schnelle, Steffen Messerschmidt, Eunice J. Minford, Kate Greenaway-Twist, Maxine Szramka, Marianna Masiorski, Michelle Sheldrake and Mark Jones

    Citation: Trials 2021 22:182

    Content type: Retraction Note

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    The original article was published in Trials 2017 18:328

  6. Posttraumatic stress disorder (PTSD) may develop after exposure to a traumatic event. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based psychological treatment for PTSD. It is yet uncle...

    Authors: Eka Susanty, Marit Sijbrandij, Wilis Srisayekti and Anja C. Huizink

    Citation: Trials 2021 22:181

    Content type: Study protocol

    Published on:

  7. There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the...

    Authors: Anca Vasiliu, Sabrina Eymard-Duvernay, Boris Tchounga, Daniel Atwine, Elisabete de Carvalho, Sayouba Ouedraogo, Michael Kakinda, Patrice Tchendjou, Stavia Turyahabwe, Albert Kuate Kuate, Georges Tiendrebeogo, Peter J. Dodd, Stephen M. Graham, Jennifer Cohn, Martina Casenghi and Maryline Bonnet

    Citation: Trials 2021 22:180

    Content type: Study protocol

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  8. Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75–95%. Health care systems, especially in rural regions in India, face substantia...

    Authors: Mercian Daniel, Pallab K. Maulik, Sudha Kallakuri, Amanpreet Kaur, Siddhardha Devarapalli, Ankita Mukherjee, Amritendu Bhattacharya, Laurent Billot, Graham Thornicroft, Devarsetty Praveen, Usha Raman, Rajesh Sagar, Shashi Kant, Beverley Essue, Susmita Chatterjee, Shekhar Saxena…

    Citation: Trials 2021 22:179

    Content type: Study protocol

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  9. Low recruitment in clinical trials is a common and costly problem which undermines medical research. This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-c...

    Authors: Larissa Niemeyer, Konstantin Mechler, Jan Buitelaar, Sarah Durston, Bram Gooskens, Bob Oranje, Tobias Banaschewski, Ralf W. Dittmann and Alexander Häge

    Citation: Trials 2021 22:178

    Content type: Research

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  10. Mitochondrial disease is a rare, hereditary disease with a heterogeneous clinical presentation. However, fatigue is a common and burdensome complaint in children and adolescents with mitochondrial disease. No ...

    Authors: I. L. Klein, K. F. E. van de Loo, T. J. Hoogeboom, M. C. H. Janssen, J. A. M. Smeitink, E. van der Veer, C. M. Verhaak and J. A. E. Custers

    Citation: Trials 2021 22:177

    Content type: Study protocol

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  12. The optimal analgesic strategy for surgical pain after lobectomy remains undefined. To compare the combination of flurbiprofen axetil and dezocine with flurbiprofen axetil alone and dezocine alone, in post-lob...

    Authors: Jian Zhou, Qiang Pu, Lin Lin, Weelic Chong, Boran Chen, Yang Hai, Fei Liu and Lunxu Liu

    Citation: Trials 2021 22:175

    Content type: Study protocol

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  13. Delirium has been long considered as a major contributor to cognitive impairments and increased mortality following a critical illness. Pharmacologic and non-pharmacologic strategies are used against delirium ...

    Authors: Aileen C. Naef, Marie-Madlen Jeitziner, Stephan M. Gerber, Béatrice Jenni-Moser, René M. Müri, Stephan M. Jakob, Tobias Nef and Matthias Hänggi

    Citation: Trials 2021 22:174

    Content type: Study protocol

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  14. During trials that span decades, new evidence including progress in statistical methodology, may require revision of original assumptions. An example is the continued use of a constant-effect approach to analy...

    Authors: Matthew Burnell, Aleksandra Gentry-Maharaj, Steven J. Skates, Andy Ryan, Chloe Karpinskyj, Jatinderpal Kalsi, Sophia Apostolidou, Naveena Singh, Anne Dawnay, Robert Woolas, Lesley Fallowfield, Stuart Campbell, Alistair McGuire, Ian J. Jacobs, Mahesh Parmar and Usha Menon

    Citation: Trials 2021 22:173

    Content type: Update

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  15. The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The...

    Authors: Jan Maláska, Jan Stašek, František Duška, Martin Balík, Jan Máca, Jan Hruda, Tomáš Vymazal, Olga Klementová, Jan Zatloukal, Tomáš Gabrhelík, Pavel Novotný, Regina Demlová, Jana Kubátová, Jana Vinklerová, Adam Svobodník, Milan Kratochvíl…

    Citation: Trials 2021 22:172

    Content type: Letter

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  16. The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and p...

    Authors: Noemi Anja Brog, Julia Katharina Hegy, Thomas Berger and Hansjörg Znoj

    Citation: Trials 2021 22:171

    Content type: Study protocol

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  17. As of mid-June 2020, 7,500,000 people were infected with SARS-CoV-2 worldwide and 420,000 people died, mainly from coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS). COVID-...

    Authors: Aurélien Mazeraud, Bruno Gonçalves, Philippe Aegerter, Letizia Mancusi, Christine Rieu, Fernando Bozza, Khaoussou Sylla, Shidasp Siami and Tarek Sharshar

    Citation: Trials 2021 22:170

    Content type: Study protocol

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  18. Although tube feeding routinely saves the lives of children who do not eat by mouth, chronic tube feeding can be a burden to patients, caregivers, and families. Very few randomized trials exist regarding the b...

    Authors: Sarah Edwards, Paul E. Hyman, Hayat Mousa, Amanda Bruce, Jose Cocjin, Kelsey Dean, Kandace Fleming, Rebecca Swinburne Romine and Ann M. Davis

    Citation: Trials 2021 22:169

    Content type: Study protocol

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  19. Invasive mediastinal nodal staging is recommended by guidelines in selected patients with resectable non-small cell lung cancer (NSCLC). Endosonography is recommended as initial staging technique, followed by ...

    Authors: Jelle E. Bousema, Jouke T. Annema, Erik H. F. M. van der Heijden, Ad F. T. M. Verhagen, Marcel G. W. Dijkgraaf and Frank J. C. van den Broek

    Citation: Trials 2021 22:168

    Content type: Update

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    The Study protocol to this article has been published in BMC Surgery 2018 18:27

  20. Patients with acute low back pain frequently request diagnostic imaging, and clinicians feel pressure to acquiesce to such requests to sustain patient trust and satisfaction. Spinal imaging in patients with ac...

    Authors: Joshua J. Fenton, Anthony Jerant, Peter Franks, Melissa Gosdin, Ilona Fridman, Camille Cipri, Gary Weinberg, Andrew Hudnut and Daniel J. Tancredi

    Citation: Trials 2021 22:167

    Content type: Study protocol

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  21. The StayBalanced programme has shown positive effects on fall prevention, balance control and fear of falling. Despite convincing evidence on the efficacy and effectiveness of balance training, there is a gap ...

    Authors: Alexandra Halvarsson, Kirsti Skavberg Roaldsen, Per Nilsen, Ing-Mari Dohrn and Agneta Ståhle

    Citation: Trials 2021 22:166

    Content type: Study protocol

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  22. One in three individuals who live in Rio de Janeiro experience a traumatic event within a period of 12 months. In the favelas particularly, trauma exposure is ongoing. Psychological sequalae include posttraumatic...

    Authors: Fernanda Serpeloni, Jeanine Arabella Narrog, Simone Gonçalves de Assis, Joviana Quintes Avanci, Samuel Carleial and Anke Koebach

    Citation: Trials 2021 22:165

    Content type: Study protocol

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  23. Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) ...

    Authors: J. Dietzel, S. Hörder, I. V. Habermann, G. Meyer-Hamme, K. Hahn, M. Ortiz, S. Roll, K. Linde, D. Irnich, M. Hammes, R. Nögel, M. Wullinger, V. Wortman, J. Hummelsberger, S. N. Willich, S. Schröder…

    Citation: Trials 2021 22:164

    Content type: Study protocol

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  24. Video-assisted thoracoscopic surgery (VATS) lobectomy is currently the recommended approach for treating early-stage non-small cell lung cancer (NSCLC). Different VATS approaches have been proposed so far, and...

    Authors: Paolo Mendogni, Alessandra Mazzucco, Alessandro Palleschi, Lorenzo Rosso, Ilaria Righi, Rosaria Carrinola, Francesco Damarco, Emilia Privitera, Jacopo Fumagalli, Gianluca Bonitta, Mario Nosotti and Davide Tosi

    Citation: Trials 2021 22:163

    Content type: Study protocol

    Published on:

  25. To investigate if traditional Chinese medicine (TCM) auricular point acupressure (APA) can alleviate and (or) reduce the pain (including injection site pain, headache, other muscle and joint pain), fatigue, an...

    Authors: Qinwei Fu, Hui Xie, Li Zhou, Xinrong Li, Yang Liu, Min Liu, Chaoyu Wang, Xiaocen Wang, Zhiqiao Wang, Jinfan Tang, Huan Xiao, Zhiyong Xiao, Jing Zhou, Chengzhi Feng, Li Wang, Zhimin Ao…

    Citation: Trials 2021 22:162

    Content type: Letter

    Published on:

  26. The third most frequent chronic condition, and the fourth most common cause of death, in Poland is chronic obstructive pulmonary disease (COPD). The diagnosis and treatment of COPD is the responsibility of the...

    Authors: Anna Kowalczyk, Izabela Zakowska, Ewa Andrzejewska, Katarzyna Kosiek and Maciek Godycki-Cwirko

    Citation: Trials 2021 22:161

    Content type: Study protocol

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  27. Endovascular therapy (EVT) for acute ischemic stroke due to proximal occlusion of the anterior intracranial circulation, started within 6 h from symptom onset, has been proven safe and effective. Recently, EVT...

    Authors: F. A. V. ( Anne) Pirson, Wouter H. Hinsenveld, Robert-Jan B. Goldhoorn, Julie Staals, Inger R. de Ridder, Wim H. van Zwam, Marianne A. A. van Walderveen, Geert J. Lycklama à Nijeholt, Maarten Uyttenboogaart, Wouter J. Schonewille, Aad van der Lugt, Diederik W. J. Dippel, Yvo B. W. E. M. Roos, Charles B. L. M. Majoie and Robert J. van Oostenbrugge

    Citation: Trials 2021 22:160

    Content type: Study protocol

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  28. Atypical antipsychotic medications, which are effective for the treatment of schizophrenia and bipolar disorder, are associated with features of metabolic syndrome, such as weight gain, hyperglycemia, dyslipid...

    Authors: Chenchen Liu, Dongyu Kang, Jingmei Xiao, Yuyan Huang, Xingjie Peng, Weiyan Wang, Peng Xie, Ye Yang, Jingping Zhao and Renrong Wu

    Citation: Trials 2021 22:159

    Content type: Study protocol

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  29. Congenital diaphragmatic hernia (CDH) is, depending of the severity, a birth defect associated with significant mortality and morbidity. Prenatal screening by ultrasound may detect this condition and comprehen...

    Authors: Simen Vergote, Felix De Bie, Jan Bosteels, Holly Hedrick, James Duffy, Beverley Power, Alexandra Benachi, Paolo De Coppi, Caraciolo Fernandes, Kevin Lally, Irwin Reiss and Jan Deprest

    Citation: Trials 2021 22:158

    Content type: Study protocol

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  30. Approximately 418,000 people live in care homes in the UK, yet accessible, robust data on care home populations and organisation are lacking. This hampers our ability to plan, allocate resources or prevent ris...

    Authors: Lisa Irvine, Jennifer Kirsty Burton, Myzoon Ali, Terence J. Quinn and Claire Goodman

    Citation: Trials 2021 22:157

    Content type: Study protocol

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  31. Despite the implementation of the preschool oral healthcare programme (POHP) for 5–6-year-old children over the past 3 decades in Malaysia, dental plaque and caries levels in this age group remain high. Among ...

    Authors: Zamros Yuzadi Mohd Yusof, Nurul Hayati Anwar, Nor Azlida Mohd Nor, Mariani Md Nor and Siti Ezaleila Mustafa

    Citation: Trials 2021 22:156

    Content type: Study protocol

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  32. International guidelines recommend either intravenous immunoglobulin (IVIg) or corticosteroids as first-line treatment for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). IVIg treatment usual...

    Authors: S. R. M. Bus, L. Zambreanu, A. Abbas, Y. A. Rajabally, R. D. M. Hadden, R. J. de Haan, C. A. J. M. de Borgie, M. P. Lunn, I. N. van Schaik and F. Eftimov

    Citation: Trials 2021 22:155

    Content type: Study protocol

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  33. There is an increasing prevalence of physical inactivity during childhood, which is associated with a variety of health problems. However, the mechanisms by which acute exercise benefits cognition in childhood...

    Authors: Lauren B. Raine, Katherine McDonald, Tatsuya T. Shigeta, Shu-Shih Hsieh, Jennifer Hunt, Nathan A. Chiarlitti, Michelle Lim, Kristen Gebhardt, Nina Collins, Michael De Lisio, Sean P. Mullen, Arthur F. Kramer and Charles Hillman

    Citation: Trials 2021 22:154

    Content type: Study protocol

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  34. The sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments. The sharing of trial data is...

    Authors: Rebecca Li, Megan von Isenburg, Marcia Levenstein, Stan Neumann, Julie Wood and Ida Sim

    Citation: Trials 2021 22:153

    Content type: Research

    Published on:

  35. Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain ...

    Authors: J. Weindelmayer, V. Mengardo, A. Veltri, G. L. Baiocchi, S. Giacopuzzi, G. Verlato and G. de Manzoni

    Citation: Trials 2021 22:152

    Content type: Study protocol

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  36. Recurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. Novel diabetic therapeutic footwear consisted of merino wool, vibration chip, and orthopedic insoles is design...

    Authors: Yun Gao, Chun Wang, Dawei Chen, Hui Huang, Lihong Chen, Guanjian Liu, Shuang Lin, Min Liu, Xiaorong Wen, Jae-Hoon Cho, Yong Chen, Yingzhu Li and Xingwu Ran

    Citation: Trials 2021 22:151

    Content type: Study protocol

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  37. Spinal surgery can be associated with significant postoperative pain. Erector spinae plane (ESP) block is a new regional anaesthesia technique, which promises effective postoperative analgesia compared with sy...

    Authors: Dylan T. Finnerty and Donal J. Buggy

    Citation: Trials 2021 22:150

    Content type: Study protocol

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  38. First-line pharmacotherapy for neuropathic pain entails the use of systemic antidepressants and anticonvulsants. These drugs are not optimally effective and poorly tolerated, especially for older patients with...

    Authors: Oli Abate Fulas, André Laferrière, D. Mark A. Ware, Yoram Shir and Terence J. Coderre

    Citation: Trials 2021 22:149

    Content type: Study protocol

    Published on:

  39. Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the g...

    Authors: Edward C. Deehan, Eloisa Colin-Ramirez, Lucila Triador, Karen L. Madsen, Carla M. Prado, Catherine J. Field, Geoff D. C. Ball, Qiming Tan, Camila Orsso, Irina Dinu, Mohammadreza Pakseresht, Daniela Rubin, Arya M. Sharma, Hein Tun, Jens Walter, Christopher B. Newgard…

    Citation: Trials 2021 22:148

    Content type: Study protocol

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  40. Russia has a high prevalence of human immunodeficiency virus (HIV) infections. In 2018, over one million persons were living with HIV (PLWH); over a third were women. A high proportion of HIV-infected women ar...

    Authors: Ralph J. DiClemente, Jennifer L. Brown, Ariadna Capasso, Natalia Revzina, Jessica M. Sales, Ekaterina Boeva, Lyudmila V. Gutova, Nadia B. Khalezova, Nikolay Belyakov and Vadim Rassokhin

    Citation: Trials 2021 22:147

    Content type: Study protocol

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  41. An amendment to this paper has been published and can be accessed via the original article.

    Authors: Jacqueline A. Odgis, Katie M. Gallagher, Sabrina A. Suckiel, Katherine E. Donohue, Michelle A. Ramos, Nicole R. Kelly, Gabrielle Bertier, Christina Blackburn, Kaitlyn Brown, Lena Fielding, Jessenia Lopez, Karla Lopez Aguiniga, Estefany Maria, Jessica E. Rodriguez, Monisha Sebastin, Nehama Teitelman…

    Citation: Trials 2021 22:146

    Content type: Correction

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    The original article was published in Trials 2021 22:56

  43. Fixed orthodontic appliances hamper oral hygiene procedures. The consequences are gingivitis and white spot lesions. Fifty to 70% of patients treated with braces encounter these problems. Their care in the USA...

    Authors: Alisée Le Fouler, Sylvie Jeanne, Olivier Sorel and Damien Brézulier

    Citation: Trials 2021 22:144

    Content type: Study protocol

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  45. The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other p...

    Authors: Fiona A. Quirke, Patricia Healy, Elaine Ní Bhraonáin, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David M. Haas, Frank H. Bloomfield, Jamie J. Kirkham, Eleanor J. Molloy and Declan Devane

    Citation: Trials 2021 22:142

    Content type: Study protocol

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  46. Endovascular treatment (EVT) has greatly improved the prognosis of acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation. Currently, there i...

    Authors: Kilian M. Treurniet, Natalie E. LeCouffe, Manon Kappelhof, Bart J. Emmer, Adriaan C. G. M. van Es, Jelis Boiten, Geert J. Lycklama, Koos Keizer, Lonneke S. F. Yo, Hester F. Lingsma, Wim H. van Zwam, Inger de Ridder, Robert J. van Oostenbrugge, Aad van der Lugt, Diederik W. J. Dippel, Jonathan M. Coutinho…

    Citation: Trials 2021 22:141

    Content type: Study protocol

    Published on:

  47. High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-...

    Authors: Yu Wang, Guang-Xia Shi, Zhong-Xue Tian, Jun-Hong Liu, You-Sheng Qi, Jian-Feng Tu, Jing-Wen Yang, Li-Qiong Wang and Cun-Zhi Liu

    Citation: Trials 2021 22:140

    Content type: Study protocol

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  48. Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose cortico...

    Authors: Anne Christin Rahn, Lisa Wenzel, Andrea Icks, Alexander Stahmann, Jutta Scheiderbauer, Kristina Grentzenberg, Markus Vomhof, Joseph Montalbo, Tim Friede, Christoph Heesen and Sascha Köpke

    Citation: Trials 2021 22:139

    Content type: Study protocol

    Published on:

    The Correction to this article has been published in Trials 2021 22:196

  49. Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events. Patients with PAD, even in the absence of a history of myo...

    Authors: M. Elfghi, F. Jordan, D. Dunne, I. Gibson, J. Jones, G. Flaherty, S. Sultan and W. Tawfick

    Citation: Trials 2021 22:138

    Content type: Study protocol

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  50. Liver cirrhosis is the irreversible fibrosis of the liver and causes refractory ascites and hepatic encephalopathy, which might not respond to treatment. Living donor liver transplantation (LDLT) is an effecti...

    Authors: Masafumi Haraguchi, Kunihiro Ichinose, Hisamitsu Miyaaki, Masatoshi Hanada, Masanori Fukushima, Ryu Sasaki, Satoshi Miuma, Takanobu Hara, Tota Kugiyama, Akihiko Soyama, Masaaki Hidaka, Ayumi Tsuji, Rintaro Yano, Motohiro Sekino, Hideaki Takahata, Susumu Eguchi…

    Citation: Trials 2021 22:137

    Content type: Study protocol

    Published on:

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