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  1. Developing a safe and effective vaccine will be the principal way of controlling the COVID-19 pandemic. However, current COVID-19 vaccination trials are not adequately representing a diverse participant popula...

    Authors: Sonika Sethi, Aditi Kumar, Anandadeep Mandal, Mohammed Shaikh, Claire A. Hall, Jeremy M. W. Kirk, Paul Moss, Matthew J. Brookes and Supratik Basu

    Citation: Trials 2021 22:296

    Content type: Research

    Published on:

  2. Symptomatic knee osteoarthritis (KOA) is common in China. Pharmacological therapy is not the first recommendation because of its safety issues. Nonpharmacological therapy, such as lifestyle adjustments, weight...

    Authors: Danghan Xu, Minghui Lee, Cihui Huang, Jia Wei, Mengxue Zhou, Taotao Yao, Jingjing Lu, Wenjing Zhao, Nuo Xu, Ruina Huang, Jun He and Liang Zheng

    Citation: Trials 2021 22:295

    Content type: Study protocol

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  3. Patients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in ...

    Authors: Pia Grabbe, Kathrin M. Gschwendtner, Imad Maatouk, Sophia B. Strobel, Martin Salzmann, Julia Bossert, Wolfgang Eich, Beate Wild, Friedegund Meier, Jessica C. Hassel and Christiane Bieber

    Citation: Trials 2021 22:294

    Content type: Study protocol

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  4. Heart failure with preserved ejection fraction (HFpEF) is a clinical syndrome characterized by diastolic dysfunction. Despite the increasing incidence of HFpEF, there is no available therapy that reduces the m...

    Authors: Na Zhang, Yingli Zhao, Yu Liu, Nuo Tang, Wang Zheng, Meijiao Mao, Qingcheng Liu, Lin Shen and Bing Deng

    Citation: Trials 2021 22:293

    Content type: Study protocol

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  5. Cystic fibrosis (CF) is a genetic disorder, which is caused by the CFTR protein defects. Along with CFTR dysfunction, inflammation plays a key role in the disease outcomes. Inflammation may develop due to the ...

    Authors: Saeedeh Talebi, Mahammad Safarian, Mahmood Reza Jaafari, Seyed Javad Sayedi, Zahra Abbasi, Golnaz Ranjbar and Hamid Reza Kianifar

    Citation: Trials 2021 22:292

    Content type: Study protocol

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  6. Having access to parenting interventions in the early years is key to improve the developmental outcomes of children with neurodevelopmental problems. The Incredible Years® (IY) Parent Program is a group inter...

    Authors: Fátima Valencia, Elena Urbiola, Marina Romero-González, Inmaculada Navas, María Elías, Alexandra Garriz, Almudena Ramírez and Laia Villalta

    Citation: Trials 2021 22:291

    Content type: Study protocol

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  7. As treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight managem...

    Authors: Anna Guerrini Usubini, Roberto Cattivelli, Emanuele Maria Giusti, Francesco Vailati Riboni, Giorgia Varallo, Giada Pietrabissa, Gian Mauro Manzoni, Simone Consoli, Ilaria Bastoni, Valentina Granese, Clarissa Volpi, Valentina Villa, Annalisa Caretti, Michela Bottacchi, Gianluca Castelnuovo and Enrico Molinari

    Citation: Trials 2021 22:290

    Content type: Study protocol

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  8. Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic ef...

    Authors: Raluca Diana Georgescu, Anca Dobrean, Cristina Alina Silaghi and Horatiu Silaghi

    Citation: Trials 2021 22:289

    Content type: Study protocol

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  9. The primary objective is to demonstrate that, in patients with PCR-confirmed SARS-CoV-2 resulting in Acute Respiratory Distress Syndrome (ARDS), administration of 120mg/kg of body weight of intravenous Prolast...

    Authors: Natalie L. McEvoy, Jennifer L. Clarke, Oliver J. Mc Elvaney, Oisin F. Mc Elvaney, Fiona Boland, Deirdre Hyland, Pierce Geoghegan, Karen Donnelly, Oisin Friel, Ailbhe Cullen, Ann M. Collins, Daniel Fraughen, Ignacio Martin-Loeches, Martina Hennessy, John G. Laffey, Noel G. Mc Elvaney…

    Citation: Trials 2021 22:288

    Content type: Letter

    Published on:

  10. Arthroscopic shoulder surgery causes severe postoperative pain. An interscalene brachial plexus block provides adequate analgesia, but unintended spread of the local anesthetic administered may result in a phr...

    Authors: P. Oliver-Fornies, J. P. Ortega Lahuerta, R. Gomez Gomez, I. Gonzalo Pellicer, L. Oliden Gutierrez, J. Viñuales Cabeza, L. Gallego Ligorit and C. E. Orellana Melgar

    Citation: Trials 2021 22:287

    Content type: Study protocol

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  11. The LEAP-MS (Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis) study has developed an individualised supported self-management approach for physical activity for p...

    Authors: Rachel Lowe, Christy Barlow, Barry Lloyd, Julie Latchem-Hastings, Vincent Poile, Charlotte Scoble, Andrew Dean-Young, Kate Button, Rebecca Playle and Monica Busse

    Citation: Trials 2021 22:286

    Content type: Commentary

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  12. Delayed cerebral infarction (DCI) is a major cause of death and poor neurological outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Direct intrathecal therapies with fibrinolytic and spasmoly...

    Authors: Roland Roelz, Fabian Schubach, Volker A. Coenen, Carolin Jenkner, Christian Scheiwe, Jürgen Grauvogel, Wolf-Dirk Niesen, Horst Urbach, Christian Taschner, Jochen Seufert, Jürgen Kätzler, Jürgen Beck and Peter C. Reinacher

    Citation: Trials 2021 22:285

    Content type: Study protocol

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  13. Although clozapine is the most effective antipsychotic drug for treatment-resistant schizophrenia, it leads to a poor or partial response in 40 to 70% of patients. Augmentation of clozapine with electroconvuls...

    Authors: Virginie Moulier, Mohamed Wassim Krir, Marine Dalmont, Olivier Guillin and Maud Rothärmel

    Citation: Trials 2021 22:284

    Content type: Study protocol

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  14. The association of scaling and root planing (SRP) with systemic metronidazole (MTZ) plus amoxicillin (AMX) has shown to be an effective treatment protocol, particularly for periodontitis stages III and IV, gen...

    Authors: Belen Retamal-Valdes, Wim Teughels, Laryssa Macedo Oliveira, Rebeca Nascimento da Silva, Aretuza Fritoli, Patricia Gomes, Geisla Mary Silva Soares, Natalie Temporão, Camila Pinheiro Furquim, Poliana Mendes Duarte, Helio Doyle, Marcelo Faveri, Luciene Cristina Figueiredo and Magda Feres

    Citation: Trials 2021 22:283

    Content type: Study protocol

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  15. Children frequently present to the emergency department (ED) with forearm injuries and often have x-rays to determine if there is a fracture. Bedside ultrasound, also known as point-of-care ultrasound (POCUS),...

    Authors: Peter J. Snelling, Gerben Keijzers, Joshua Byrnes, David Bade, Shane George, Mark Moore, Philip Jones, Michelle Davison, Rob Roan and Robert S. Ware

    Citation: Trials 2021 22:282

    Content type: Study protocol

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  16. Dyslipidemia and local inflammation at sites of lipid deposition on blood vessel walls have been demonstrated to be risk factors for patients with acute aortic dissection (AAD). Statins have anti-inflammatory ...

    Authors: Yequn Chen, Nianling Xiong, Xin Wang, Shiwan Wu, Liangli Hong, Xiru Huang, Chang Chen, Weiping Li, Bin Wang, Shu Ye and Xuerui Tan

    Citation: Trials 2021 22:281

    Content type: Study protocol

    Published on:

  17. The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve transparent reporting of randomised clinical trials. It comprises a participant flow diagram with the reporting of essential n...

    Authors: Thea Nørgaard Rønsbo, Jens Laigaard, Casper Pedersen, Ole Mathiesen and Anders Peder Højer Karlsen

    Citation: Trials 2021 22:280

    Content type: Review

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  18. The COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring...

    Authors: Sharon B. Love, Emma Armstrong, Carrie Bayliss, Melanie Boulter, Lisa Fox, Joanne Grumett, Patricia Rafferty, Barbara Temesi, Krista Wills and Andrea Corkhill

    Citation: Trials 2021 22:279

    Content type: Research

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  19. The unprecedented demand placed on healthcare systems from the COVID-19 pandemic has forced a reassessment of clinical trial conduct and feasibility. Consequently, the Australasian Kidney Trials Network (AKTN)...

    Authors: Laura Robison, Yeoungjee Cho, Andrea K. Viecelli, David W. Johnson, Carmel M. Hawley, Andrea Valks, Peta-Anne Paul-Brent, Ruth Stastny, Julie Varghese, Charani Kiriwandeniya, Elaine M. Pascoe, Liza A. Vergara, Magid A. Fahim, Neil Boudville, Rathika Krishnasamy and Donna Reidlinger

    Citation: Trials 2021 22:278

    Content type: Commentary

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  20. Effective team communication, coordination, and situational awareness (SA) by team members are critical components to deliver optimal cardiopulmonary resuscitation (CPR). Complexity of care during CPR, involve...

    Authors: Frédéric Ehrler, Cyril Sahyoun, Sergio Manzano, Oliver Sanchez, Alain Gervaix, Christian Lovis, Delphine S. Courvoisier, Laurence Lacroix and Johan N. Siebert

    Citation: Trials 2021 22:277

    Content type: Study protocol

    Published on:

  21. The primary objective is to evaluate the efficacy of an inactivated and aluminium hydroxide adsorbed SARS-CoV-2 vaccine (Sinovac, China) in voluntary participants after 14 days of the second dose against RT-PC...

    Authors: Murat Akova and Serhat Unal

    Citation: Trials 2021 22:276

    Content type: Letter

    Published on:

  22. A fundamental challenge for many people with severe mental illness (SMI) is how to deal with cognitive impairments. Cognitive impairments are common in this population and limit daily functioning. Moreover, ne...

    Authors: Anika Poppe, Leonie Bais, Daniëlle van Duin, Branislava Ćurčić-Blake, Gerdina Hendrika Maria Pijnenborg and Lisette van der Meer

    Citation: Trials 2021 22:275

    Content type: Study protocol

    Published on:

  23. In this study, the effect of adding a smartphone app to an 8-week global postural reeducation (GPR) on neck pain, endurance, quality of life, and forward head posture (FHP) in patients with chronic neck pain a...

    Authors: Fatemeh Abadiyan, Malihe Hadadnezhad, Zohre Khosrokiani, Amir Letafatkar and Haniyeh Akhshik

    Citation: Trials 2021 22:274

    Content type: Research

    Published on:

  24. In the early days of neurosurgery, extradural haemorrhages (EDHs) contributed to a high mortality rate after craniotomies. Almost a century ago, Walter Dandy reported dural tenting sutures as an effective way ...

    Authors: Przemysław Kunert, Łukasz Przepiórka, Jan Fortuniak, Karol Wiśniewski, Ernest Jan Bobeff, Patrycja Larysz, Rafał Kruk, Bartłomiej Kulesza, Dariusz Szczepanek, Piotr Ładziński, Jarosław Żyłkowski, Sławomir Kujawski, Kamila Łabędzka, Dariusz Jaskólski, Radosław Rola, Tomasz Trojanowski…

    Citation: Trials 2021 22:273

    Content type: Study protocol

    Published on:

  25. Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium–long term, but 25% of young people disengage in the first 12 months with costs to their ment...

    Authors: Kathryn Greenwood, Rebecca Webb, Jenny Gu, David Fowler, Richard de Visser, Stephen Bremner, Iga Abramowicz, Nicky Perry, Stuart Clark, Anastacia O’Donnell, Dan Charlton, Rebecca Jarvis, Philippa Garety, Sunil Nandha, Belinda Lennox, Louise Johns…

    Citation: Trials 2021 22:272

    Content type: Study protocol

    Published on:

  26. Severe acute respiratory infection (SARI) caused by the SARS-CoV-2 virus may cause lung failure and the need for mechanical ventilation. Infection with SARS-COV-2 can lead to activation of inflammatory factors...

    Authors: Arash Rahimi, Hamid Reza Samimagham, Mehdi Hassani Azad, Dariush Hooshyar, Mohsen Arabi and Mitra KazemiJahromi

    Citation: Trials 2021 22:271

    Content type: Letter

    Published on:

  27. The primary objective of MATIS is to determine the efficacy of ruxolitinib (RUX) or fostamatinib (FOS) compared to standard of care (SOC) with respect to reducing the proportion of hospitalised patients progre...

    Authors: Nikhil Vergis, Rachel Phillips, Victoria Cornelius, Alexia Katsarou, Taryn Youngstein, Lucy Cook, Michelle Willicombe, Clio Pilay, Tina Shturova, Melanie Almonte, Asad Charania, Richard Turner, Onn Min Kon, Graham Cooke, Mark Thursz, Svetlana Cherlin…

    Citation: Trials 2021 22:270

    Content type: Letter

    Published on:

  28. Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might b...

    Authors: Garry A. Tew, Laura Bissell, Belen Corbacho, Caroline Fairhurst, Jenny Howsam, Jess Hugill-Jones, Camila Maturana, Shirley-Anne S. Paul, Tim Rapley, Jenny Roche, Fi Rose, David J. Torgerson, Lesley Ward, Laura Wiley, David Yates and Catherine Hewitt

    Citation: Trials 2021 22:269

    Content type: Study protocol

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  29. The primary objective of the presented study is to analyze the respiratory and functional effects of a rehabilitation program in patients affected by hospitalization in Intensive Care Unit (ICU) due to COVID-1...

    Authors: Ana Cristina Carvalho, Jorge Moreira, Pedro Cubelo, Pedro Cantista, Catarina Aguiar Branco and Bruno Guimarães

    Citation: Trials 2021 22:268

    Content type: Letter

    Published on:

  30. The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families’ mental health since early lockdown (Co-SPACE) ...

    Authors: Katarzyna Kostyrka-Allchorne, Cathy Creswell, Sarah Byford, Crispin Day, Kimberley Goldsmith, Marta Koch, Walter Muruet Gutierrez, Melanie Palmer, Jasmine Raw, Olly Robertson, James Shearer, Adrienne Shum, Petr Slovak, Polly Waite and Edmund J. S. Sonuga-Barke

    Citation: Trials 2021 22:267

    Content type: Letter

    Published on:

  31. Previous study indicated that transversus abdominis plane (TAP) block could be the principal anesthetic technique for peritoneal dialysis catheter (PDC) implantations. However, a TAP block could not provide an op...

    Authors: Xiao-juan Jiang, Zi Li, Qi Li, Hai-yan Zhang, Xiao-hong Tang and Tao Zhu

    Citation: Trials 2021 22:266

    Content type: Research

    Published on:

  32. Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to...

    Authors: Xin Xue, Xue-Ming Jin, Kai-Liang Luo, Xin-Hao Liu, Li Zhang and Jun Hu

    Citation: Trials 2021 22:265

    Content type: Study protocol

    Published on:

  33. Patients with mild to moderate depressive symptoms can have limited access to regular treatment; to ensure appropriate care, low-threshold treatment is needed. Effective online interventions could increase the...

    Authors: Rico Krämer and Stephan Köhler

    Citation: Trials 2021 22:264

    Content type: Study protocol

    Published on:

  34. To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK.

    Authors: Jeremy Horwood, Melanie Chalder, Ben Ainsworth, James Denison-Day, Frank de Vocht, Martha M. C. Elwenspoek, Pippa Craggs, Rachel Denholm, Jonathan Sterne, Cathy Rice, Sascha Miller, Beth Stuart, Paul Little, Michael Moore, Merlin Willcox, John Macleod…

    Citation: Trials 2021 22:263

    Content type: Letter

    Published on:

  35. The primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of...

    Authors: Patricia J. Garcia, Hansel Mundaca, Cesar Ugarte-Gil, Patricia Leon, German Malaga, Carlos Chaccour and Cesar P. Carcamo

    Citation: Trials 2021 22:262

    Content type: Letter

    Published on:

  36. Autism spectrum disorder (ASD) is a chronic neurodevelopmental condition with a prevalence rate above 1%, characterized by deficits in social communication and interaction; restrictive, repetitive patterns of ...

    Authors: Ludger Tebartz van Elst, Thomas Fangmeier, Ulrich Max Schaller, Oliver Hennig, Meinhard Kieser, Katja Koelkebeck, Charlotte Kuepper, Veit Roessner, Dirk Wildgruber and Isabel Dziobek

    Citation: Trials 2021 22:261

    Content type: Study protocol

    Published on:

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

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

    Citation: Trials 2021 22:259

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:188

  39. Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefo...

    Authors: Xin Ye, Dawei Zhu, Siyuan Chen, Xuefeng Shi, Rui Gong, Juncheng Wang, Huibin Zuo, Mei Zhang and Ping He

    Citation: Trials 2021 22:258

    Content type: Study protocol

    Published on:

  40. Because of the lack of anesthesia workforce, anesthesiologists are forced to work overtime and more night shifts, which can disturb their biological rhythm and cause severe stress and depression, potentially l...

    Authors: Chaojin Chen, Liubing Chen, Ning Shen, Chenfang Luo, Ren Wang, Hongyi Fang, Qi Zhang and Ziqing Hei

    Citation: Trials 2021 22:257

    Content type: Study protocol

    Published on:

  41. Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of labor, and cesarean delivery as well as increase...

    Authors: Suzanne Phelan, Elissa Jelalian, Donald Coustan, Aaron B. Caughey, Kristin Castorino, Todd Hagobian, Karen Muñoz-Christian, Andrew Schaffner, Laurence Shields, Casey Heaney, Angelica McHugh and Rena R. Wing

    Citation: Trials 2021 22:256

    Content type: Study protocol

    Published on:

  42. Osteoarthritis (OA) is a chronic and painful condition where the articular cartilage surfaces progressively degenerate, resulting in loss of function and progressive disability. Obesity is a primary risk facto...

    Authors: Rafael Fortuna, David A. Hart, Keith A. Sharkey, Rachel A. Schachar, Kelly Johnston and Raylene A. Reimer

    Citation: Trials 2021 22:255

    Content type: Study protocol

    Published on:

  43. MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme...

    Authors: Jesus Montero-Marin, Elizabeth Nuthall, Sarah Byford, Catherine Crane, Tim Dalgleish, Tamsin Ford, Poushali Ganguli, Mark T. Greenberg, Obioha C. Ukoumunne, Russell M. Viner, J. Mark G. Williams and Willem Kuyken

    Citation: Trials 2021 22:254

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2017 18:194

  44. Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal diseases. Although acupuncture has become a common alternative therapy for IBS, there is insufficient evidence for its effec...

    Authors: Ling-Yu Qi, Yu Wang, Li-Qiong Wang, Yan-Fen She, Guang-Xia Shi, Ying Li, Li-Li Chi, Bang-Qi Wu, Jian-Feng Tu, Ying Lin, Fang-Ting Yu, Jing-Wen Yang and Cun-Zhi Liu

    Citation: Trials 2021 22:253

    Content type: Study protocol

    Published on:

  45. Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this ...

    Authors: Liz Steed, Karen Heslop-Marshall, Ratna Sohanpal, Sarah Saqi-Waseem, Moira Kelly, Hilary Pinnock and Stephanie Taylor

    Citation: Trials 2021 22:252

    Content type: Research

    Published on:

  46. In a cluster-randomised trial (CRT) of combination HIV prevention (HPTN 071 (PopART)) in 12 Zambian communities and nine South African communities, carried out from 2012 to 2018, the intervention arm A that of...

    Authors: Virginia Bond, Graeme Hoddinott, Lario Viljoen, Fredrick Ngwenya, Melvin Simuyaba, Bwalya Chiti, Rhoda Ndubani, Nozizwe Makola, Deborah Donnell, Ab Schaap, Sian Floyd, James Hargreaves, Kwame Shanaube, Sarah Fidler, Peter Bock, Helen Ayles…

    Citation: Trials 2021 22:251

    Content type: Research

    Published on:

  47. Automated peripheral mechanical stimulation (AMPS) has been proposed as a new complementary therapy with potential for improving motor and cardiovascular abnormalities in Parkinson’s disease (PD). However, AMP...

    Authors: Nicolle Zelada-Astudillo, Vinicius Christianini Moreno, Andrea Herrera-Santelices, Fabio Augusto Barbieri and Antonio Roberto Zamunér

    Citation: Trials 2021 22:250

    Content type: Study protocol

    Published on:

  48. Erector spinae plane block (ESPB) is a novel inter-fascial plane block, which is applied more and more in postoperative pain control, especially in chest surgery. Regional block is advocated in order to decrea...

    Authors: Zhen-Zhen Xu, Xue Li, Zhen Zhang, Zheng-Ye Liu, Lin-Lin Song, Xue-Ying Li and Hong Zhang

    Citation: Trials 2021 22:249

    Content type: Study protocol

    Published on:

  49. Autism spectrum disorder (ASD) is characterized by impaired social communication and interaction, and stereotyped, repetitive behaviour and sensory interests. To date, there is no effective medication that can...

    Authors: Christina Luckhardt, Magdalena Schütz, Andreas Mühlherr, Hannah Mössinger, Sara Boxhoorn, Astrid Dempfle, Ricardo Salvador, Giulio Ruffini, Helena C. Pereira, Miguel Castelo-Branco, Marianne Latinus, Frédérique Bonnet-Brilhault, Julia Siemann, Michael Siniatchkin, Christine Ecker and Christine M. Freitag

    Citation: Trials 2021 22:248

    Content type: Study protocol

    Published on:

  50. This study is conducted to investigate efficacy of pomegranate juice on inflammatory biomarkers, C-reactive protein (CRP), interleukin 6(IL-6), erythrocyte sedimentation rate (ESR) and complete blood count (CB...

    Authors: Mojtaba Yousefi, Mohammadreza Sadriirani, Azizollah PourMahmoudi, Sara Mahmoodi, Bahar Samimi, Mahboobe Hosseinikia, Zaker Saeedinezhad and Seyed Bahman Panahande

    Citation: Trials 2021 22:246

    Content type: Letter

    Published on:

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