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  1. Moderate to severe acute pancreatitis (AP) is associated with a high rate of complications and increased mortality, yet no targeted pharmacologic treatment currently exists. As pain is a dominant symptom in AP...

    Authors: Cecilie Siggaard Knoph, Mathias Ellgaard Cook, Camilla Ann Fjelsted, Srdan Novovic, Michael Bau Mortensen, Liv Bjerre Juul Nielsen, Mark Berner Hansen, Jens Brøndum Frøkjær, Søren Schou Olesen and Asbjørn Mohr Drewes

    Citation: Trials 2021 22:940

    Content type: Study protocol

    Published on:

  2. Young adult offenders represent a third of the UK prison population and are at risk of poor health outcomes including drug and alcohol misuse, self-harm and suicide. Court diversion interventions aim to reduce...

    Authors: A. Cochrane, A. Booth, I. Walker, S. Morgan, A. Mitchell, M. Barlow-Pay, C. Hewitt, B. Taylor, C. Chapman, J. Raftery, J. Fleming, D. Torgerson and J. Parkes

    Citation: Trials 2021 22:939

    Content type: Study protocol

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  3. Aquagenic pruritus (AP), an intense sensation of scratching induced after water contact, is the most troublesome aspect of BCR-ABL1-negative myeloproliferative neoplasms (MPNs). Mostly described in polycythemi...

    Authors: C. Le Gall-Ianotto, R. Verdet, E. Nowak, L. Le Roux, A. Gasse, A. Fiedler, D. Carlhant-Kowalski, P. Marcorelles, L. Misery and J. C. Ianotto

    Citation: Trials 2021 22:938

    Content type: Study protocol

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  4. Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions...

    Authors: V. Shepherd, F. Wood, M. Robling, E. Randell and K. Hood

    Citation: Trials 2021 22:935

    Content type: Research

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  5. Most cancer patients, under active treatment or not, are sedentary, despite increasing scientific and clinical understanding of the benefits of exercise and physical activity, such as improving quality of life...

    Authors: Luiz Augusto Riani Costa, Raphael F. Barreto, Sarah Milani Moraes de Leandrini, Aline Rachel Bezerra Gurgel, Gabriel Toledo de Sales, Vanessa Azevedo Voltarelli, Gilberto de Castro Jr., Sally A. M. Fenton, James E. Turner, Christian Klausener, Lucas Melo Neves, Carlos Ugrinowitsch, Jose Carlos Farah, Cláudia Lúcia de Moraes Forjaz, Christina May Moran Brito and Patricia Chakur Brum

    Citation: Trials 2021 22:934

    Content type: Study protocol

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  6. Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known tradit...

    Authors: Yun Du, Yatong Li, Xianyun Fu, Chenjie Li and Luo Yanan

    Citation: Trials 2021 22:933

    Content type: Study protocol

    Published on:

    The Correction to this article has been published in Trials 2021 22:967

  7. Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The n...

    Authors: Laura Puerto Valencia, Diamantes Arampatzis, Heidrun Beck, Karsten Dreinhöfer, David Drießlein, Wilfried Mau, Julia-Marie Zimmer, Michael Schäfer, Friedemann Steinfeldt and Pia-Maria Wippert

    Citation: Trials 2021 22:932

    Content type: Study protocol

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  8. Second-line treatment of HIV-2 in resource-limited settings (RLS) is complicated by a lack of controlled trial data, limited availability of HIV-2-active antiretroviral drugs, and inadequate access to drug res...

    Authors: Dana N. Raugi, Khardiata Diallo, Mouhamadou Baïla Diallo, Dominique Faye, Ousseynou Cisse, Robert A. Smith, Fatima Sall, El Hadji Ibrahima Sall, Khadim Faye, Jean Philippe Diatta, Binetou Diaw, Jacques Sambou, Jean Jacques Malomar, Stephen E. Hawes, Moussa Seydi and Geoffrey S. Gottlieb

    Citation: Trials 2021 22:931

    Content type: Research

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  9. Caregivers’ influence on young children’s eating behaviors is widely recognized. Nutritional interventions that focus on the promotion of children’s healthy diet should actively involve parents, focusing on th...

    Authors: Ana Isabel Gomes, Ana Isabel Pereira, Tiago Guerreiro, Diogo Branco, Magda Sofia Roberto, Ana Pires, Joana Sousa, Tom Baranowski and Luísa Barros

    Citation: Trials 2021 22:930

    Content type: Study protocol

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  10. Prone position ventilation is a widely used lung protection ventilation strategy. The strategy is more convenient to implement in children compared to adults. Due to the precise mechanism of improving oxygenat...

    Authors: Yu-lu Xu, Ya-ping Mi, Meng-xin Zhu, Yue-hong Ren, Wei-juan Gong, Wei-jia Fu, Hui-mei Wang, Lan Ye, Yin Wang, Xiao-yan Zhou, Yan Chen, Yan-yan Chen, Li-qiong Gu, Ying Gu, Bing Jia, Jing Hu…

    Citation: Trials 2021 22:929

    Content type: Research

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  11. People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalabl...

    Authors: Anuradhani Kasturiratne, Khadija I. Khawaja, Sajjad Ahmad, Samreen Siddiqui, Khurram Shahzad, Lathika K. Athauda, Ranil Jayawardena, Sara Mahmood, Mirthe Muilwijk, Tayyaba Batool, Saira Burney, Matthew Glover, Saranya Palaniswamy, Vodathi Bamunuarachchi, Manju Panda, Suren Madawanarachchi…

    Citation: Trials 2021 22:928

    Content type: Study protocol

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  12. The low-grade inflammation is pivotal in obesity and its comorbidities; however, the inflammatory proteins are out of target for traditional drug therapy. Omega-3 (ω3) fatty acids can modulate the downstream s...

    Authors: Ellencristina Silva Batista, Thaiane da Silva Rios, Vitor Rosetto Muñoz, Joyce Santos Jesus, Marcel Monteiro Vasconcelos, Diogo Thimóteo da Cunha, Jose Luis Marques-Rocha, Susana Castelo Branco Ramos Nakandakari, Roberta Lara, Adelino Sanchez Ramos da Silva, José Rodrigo Pauli, Eduardo Rochete Ropelle, Rania Angelina Mekary, Leandro Pereira de Moura, Enilton Aparecido Camargo and Dennys Esper Cintra

    Citation: Trials 2021 22:927

    Content type: Study protocol

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  13. There is strong evidence that noninvasive ventilation (NIV) improves the outcomes of patients hospitalized with severe COPD exacerbation, and NIV is recommended as the first-line therapy for these patients. Ye...

    Authors: Mihaela S. Stefan, Penelope S. Pekow, Christopher M. Shea, Ashley M. Hughes, Nicholas S. Hill, Jay S. Steingrub, Mary Jo S. Farmer, Dean R. Hess, Karen L. Riska, Taylar A. Clark and Peter K. Lindenauer

    Citation: Trials 2021 22:926

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Implementation Science Communications 2020 1:46

  14. Depression is most common among the elderly and is associated with major impairment. With limited accessible treatments available, remotely provided interventions are needed. Internet-based interventions have ...

    Authors: Jonas Eimontas, Vilmantė Pakalniškienė, Ieva Biliunaite and Gerhard Andersson

    Citation: Trials 2021 22:925

    Content type: Study protocol

    Published on:

  15. Tobacco use during pregnancy is the most important modifiable risk factor associated with adverse pregnancy outcomes, increasing the risk of preterm birth, intrauterine growth restriction and sudden infant dea...

    Authors: Harvey J. Murff, Robert A. Greevy, Reesha S. Sanghani, Katherine E. Hartmann, Tina V. Hartert, Cornelia R. Graves, Scott S. Lee and Hilary A. Tindle

    Citation: Trials 2021 22:922

    Content type: Study protocol

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  16. Diminished ovarian reserve (DOR) is the precursor state of ovarian failure and can cause the decline of women’s reproductive function. DOR also leads to poor outcome of in vitro fertilization and embryo transf...

    Authors: Le Yang, Hanwang Zhang, Li Zhou, Ying Gao, Lijuan Yang, Yajun Hu, Lu Xu and Dongmei Huang

    Citation: Trials 2021 22:921

    Content type: Study protocol

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  17. Emotional dysregulation (ED) constitutes a relevant factor involved in the onset and maintenance of many mental disorders. Targeting ED during adolescence could be a determinant both to identify high-risk indi...

    Authors: Laura Pedrini, Roberta Rossi, Laura Rosa Magni, Mariangela Lanfredi, Serena Meloni, Clarissa Ferrari, Ambra Macis, Nicola Lopizzo, Valentina Zonca and Annamaria Cattaneo

    Citation: Trials 2021 22:920

    Content type: Study protocol

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  18. It is known that only 50% of patients diagnosed with major depressive disorders (MDD) respond to the first-line antidepressant treatment. Accordingly, there is a need to improve response rates to reduce health...

    Authors: Céline K. Stäuble, Markus L. Lampert, Samuel Allemann, Martin Hatzinger, Kurt E. Hersberger, Henriette E. Meyer zu Schwabedissen, Christian Imboden and Thorsten Mikoteit

    Citation: Trials 2021 22:919

    Content type: Study protocol

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  19. Schizophrenia is a persistent psychotic disorder often accompanied by severe disability and premature mortality. New pharmacological treatments are urgently needed. Sodium benzoate, a common food preservative ...

    Authors: Andrea Baker, Lachlan Clarke, Peter Donovan, Jacobus P. J. Ungerer, Gunter Hartel, George Bruxner, Luca Cocchi, Anne Gordon, Vikas Moudgil, Gail Robinson, Digant Roy, Ravinder Sohal, Emma Whittle and James G. Scott

    Citation: Trials 2021 22:918

    Content type: Study protocol

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  20. In recent years, the prevalence of infertility has significantly increased and has become a global reproductive health problem. The female ovarian reserves have been shown to decrease progressively with an inc...

    Authors: Yingjie Ma, Xianling Cao, Jingyan Song, Dandan Gao, Xinlei Wang, Li Li and Zhengao Sun

    Citation: Trials 2021 22:917

    Content type: Study protocol

    Published on:

  21. The improvement of psychological treatments for depression in young adults is a pressing issue highlighted in the literature. Its relevance is determined not only because young adults are underrepresented in r...

    Authors: Adrián Montesano, Joan C. Medina, Clara Paz, Helena García-Mieres, Noelia Niño-Robles, Eugeni García-Grau, Josep Cañete Crespillo, Alejandro García-Gutiérrez, Miquel Alabèrnia-Segura and Guillem Feixas

    Citation: Trials 2021 22:916

    Content type: Study protocol

    Published on:

  22. Cervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries. Progression from a pre-invasive phase to that of an invasive phase generally ...

    Authors: S. Yogeshkumar, Jean Anderson, Enriquito Lu, Edward Kenyi, Margaret Mensa, Katrina Thaler, Ramalingappa Antartani, Kasturi Donimath, Basavaraj Patil, Santosh Chikaraddi, Shailaja Bidri, Aruna Biradar, Muttappa R. Gudadinni, Laxmikant Lokare, Gayane Yenokyan, Mrutyunjaya B. Bellad…

    Citation: Trials 2021 22:915

    Content type: Study protocol

    Published on:

  23. The combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experien...

    Authors: Tamsen J. Rochat, Samukelisiwe Dube, Kobus Herbst, Cecilia A. Hoegfeldt, Stephanie Redinger, Thandeka Khoza, Ruth Margret Bland, Linda Richter, Louise Linsell, Chris Desmond, Aisha K. Yousafzai, Michelle Craske, Ed Juszczak, Melanie Abas, Taygen Edwards, David Ekers…

    Citation: Trials 2021 22:914

    Content type: Study protocol

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  24. Theoretical models of insomnia suggest that stressful life events, such as the COVID-19 pandemic, can cause acute insomnia (short-term disruptions to sleep). Early interventions may prevent short-term sleep pr...

    Authors: Olivia L. Sawdon, Greg J. Elder, Nayantara Santhi, Pamela Alfonso-Miller and Jason G. Ellis

    Citation: Trials 2021 22:913

    Content type: Update

    Published on:

    The Letter to this article has been published in Trials 2020 21:704

  25. Gastric cancer, which is the fifth most common malignancy and the third most common cause of cancer-related death, is particularly predominant in East Asian countries, such as China, Japan and Korea. It is a s...

    Authors: Cheng Meng, Shougen Cao, Xiaodong Liu, Leping Li, Qingsi He, Lijian Xia, Lixin Jiang, Xianqun Chu, Xinjian Wang, Hao Wang, Xizeng Hui, Zuocheng Sun, Shusheng Huang, Quanhong Duan, Daogui Yang, Huanhu Zhang…

    Citation: Trials 2021 22:912

    Content type: Study protocol

    Published on:

  26. Prior to the COVID-19 pandemic, the majority of clinical trial activity took place face to face within clinical or research units. The COVID-19 pandemic resulted in a significant shift towards trial delivery w...

    Authors: Jane A. H. Masoli, Kim Down, Gary Nestor, Sharon Hudson, John T. O’Brien, James D. Williamson, Carolyn A. Young and Camille Carroll

    Citation: Trials 2021 22:911

    Content type: Commentary

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  27. The COVID-19 pandemic poses challenges for timely outcome assessment in randomized clinical trials (RCT). Our aim was to describe our remote neurocognitive testing (NCT) protocol administered by telephone in p...

    Authors: Annie C. Lajoie, Joelle Crane, Ann R. Robinson, Anne-Louise Lafontaine, Andrea Benedetti, R. John Kimoff and Marta Kaminska

    Citation: Trials 2021 22:910

    Content type: Letter

    Published on:

  28. The Philippines has been severely affected by the methamphetamine crisis. The government has launched a policy war against drug use, although the severe sanctions imposed on drug users have been criticized int...

    Authors: Takayuki Harada, Toshiaki Baba, Tomohiro Shirasaka and Shogo Kanamori

    Citation: Trials 2021 22:909

    Content type: Study protocol

    Published on:

  29. A clinical pattern of damage to the auditory, visual, and vestibular sensorimotor systems, known as multi-sensory impairment, affects roughly 2% of the US population each year. Within the population of US mili...

    Authors: Ann-Margret Ervin, Michael C. Schubert, Americo A. Migliaccio, Jamie Perin, Hamadou Coulibaly, Jennifer L. Millar, Dale Roberts, Mark Shelhamer, Daniel Gold, Stephanie Beauregard, Robin Pinto, Douglas Brungart and Bryan K. Ward

    Citation: Trials 2021 22:908

    Content type: Study protocol

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  30. Musculoskeletal disorders (MSDs) including upper crossed syndrome (UCS) are considered as the leading cause of work-related issues worldwide among office workers. Therefore, the present study aims to evaluate ...

    Authors: Zohreh Yaghoubitajani, Mehdi Gheitasi, Mohammad Bayattork and Lars Louis Andersen

    Citation: Trials 2021 22:907

    Content type: Study protocol

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  31. Electroconvulsive therapy (ECT) is the most effective treatment for treatment-resistant depression (TRD), especially for acute suicidal ideation, but the associated cognitive adverse effects and negative stigm...

    Authors: Zafiris J. Daskalakis, Shawn M. McClintock, Itay Hadas, Elisa Kallioniemi, Reza Zomorrodi, Alanah Throop, Lucy Palmer, Faranak Farzan, Kevin E. Thorpe, Carol Tamminga and Daniel M. Blumberger

    Citation: Trials 2021 22:906

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2021 22:786

  32. Chronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve ou...

    Authors: Rong Cai Jiang, Dong Wang, Shi Guang Zhao, Ren Zhi Wang, De Zhi Kang, Xin Gen Zhu, Zong Mao Zhao, Jun Ji Wei, Ying Huang, Yan Qu, Xiao Chuan Sun, Hong Ming Ji, Xiao Chun Jiang, Jin Fang Liu, Xi De Zhu, Jian Jun Wang…

    Citation: Trials 2021 22:905

    Content type: Study protocol

    Published on:

  33. Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for...

    Authors: Nynke L. Rauwerda, Hans Knoop, Irene Pot, Annemieke van Straten, Marian E. Rikkert, Anouk Zondervan, Thom P. J. Timmerhuis, Annemarie M. J. Braamse and H. Myrthe Boss

    Citation: Trials 2021 22:904

    Content type: Study protocol

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  34. Asthma and/or airway hyper-responsiveness (AHR) are common in elite endurance athletes with a high prevalence rate of beta-2 adrenoreceptor (beta-2) agonists use. Nevertheless, there are data on dose-dependent...

    Authors: Martina Zügel, Daniel A. Bizjak, Dorle Nussbaumer, Kay Winkert, Kensuke Takabayashi, Johannes Kirsten, Mickel Washington, Gunnar Treff, Jens Dreyhaupt, Luise Steeb, Patrick Diel, Maria Kristina Parr, Jürgen M. Steinacker and Hasema Persch

    Citation: Trials 2021 22:903

    Content type: Study protocol

    Published on:

  35. Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects 10 to 20% of children and between 2 and 15% of the adults in Western Europe. Since 2000, therapeutic clothing or functional textiles b...

    Authors: Aviël Ragamin, Karin B. Fieten, Ron A. Tupker, Jill de Wit, Minke M. F. van Mierlo, Marieke S. Jansen, Madelon B. Bronner, Renske Schappin, Frank H. J. Schuren, Margreet L. E. Romeijn, Bernd W. M. Arents, Suzanne Polinder, Marlies de Graaf, Thomas Rustemeyer, Marie L. A. Schuttelaar and Suzanne G. M. A. Pasmans

    Citation: Trials 2021 22:902

    Content type: Study protocol

    Published on:

  36. Given the increasing rates of antimicrobial resistance (AMR), recurrent urinary tract infection (rUTI) is becoming refractory more and more. Antibiotic prophylaxis including continuous low-dose antibiotic ther...

    Authors: Tonglu Li, Yingru Xu and Xuezhong Gong

    Citation: Trials 2021 22:901

    Content type: Study protocol

    Published on:

  37. Little is known regarding treatment of urinary incontinence (UI) in women with chronic obstructive pulmonary disease (COPD). The aim of the study was to explore the efficacy of pelvic floor muscle training (PF...

    Authors: Stacey Haukeland-Parker, Bente Frisk, Martijn A. Spruit, Signe Nilssen Stafne and Hege Hølmo Johannessen

    Citation: Trials 2021 22:900

    Content type: Research

    Published on:

  38. Beta-casein is a major protein in cow’s milk, of which A1 and A2 are the most frequent variants. Recent evidence implicates A1 beta-casein consumption in mechanisms that are of potential importance to mental h...

    Authors: Meghan Hockey, Hajara Aslam, Michael Berk, Julie A. Pasco, Anu Ruusunen, Mohammadreza Mohebbi, Helen Macpherson, Mary Lou Chatterton, Wolfgang Marx, Adrienne O’Neil, Tetyana Rocks, Amelia J. McGuinness, Lauren M. Young and Felice N. Jacka

    Citation: Trials 2021 22:899

    Content type: Study protocol

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  39. Kawasaki disease (KD) is an acute systemic vasculitis of unclear etiology that mainly affects infants and young children. Strategies to reduce the incidence and severity of coronary artery lesions (CALs), the ...

    Authors: Si-Yuan Lin, Lan He, Li-Ping Xie, Yin Wang, Yi-Xiang Lin, Yin-Yin Cao, Wei-Li Yan, Fang Liu and Guo-Ying Huang

    Citation: Trials 2021 22:898

    Content type: Study protocol

    Published on:

  40. HIV is one of the greatest public health challenges in South Africa. Potential HIV vaccines and antibodies are thought to be cost-effective biomedical HIV prevention methods and are currently under investigati...

    Authors: Jill Hanass-Hancock, Bradley Carpenter, Tarylee Reddy, Ayanda Nzuza, Zakir Gaffoor, Ameena Goga and Michele Andrasik

    Citation: Trials 2021 22:897

    Content type: Research

    Published on:

  41. Major depressive disorder (MDD) is a common, chronic, debilitating mood disorder that causes serious functional impairment and significantly decreased quality of life. Pharmacotherapy represents the first-line...

    Authors: Alessandra Minelli, Stefano Barlati, Erika Vitali, Stefano Bignotti, Vincenzo Dattilo, Giovanni Battista Tura, Elisabetta Maffioletti, Edoardo Giacopuzzi, Vincenza Santoro, Giulia Perusi, Chiara Cobelli, Chiara Magri, Silvia Bonizzato, Luisella Bocchio-Chiavetto, Edoardo Spina, Antonio Vita…

    Citation: Trials 2021 22:896

    Content type: Study protocol

    Published on:

  42. In order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. T...

    Authors: Saad Jwair, Ralf A. Boerboom, Huib Versnel, Robert J. Stokroos and Hans G. X. M. Thomeer

    Citation: Trials 2021 22:895

    Content type: Study protocol

    Published on:

  43. Concerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aim...

    Authors: Dexter J. L. Hayes, Declan Devane, Jo C. Dumville, Valerie Smith, Tanya Walsh and Alexander E. P. Heazell

    Citation: Trials 2021 22:894

    Content type: Study protocol

    Published on:

  44. Authors: Alison H. Howie, Kylie Tingley, Michal Inbar-Feigenberg, John J. Mitchell, Nancy J. Butcher, Martin Offringa, Maureen Smith, Kim Angel, Jenifer Gentle, Alexandra Wyatt, Philippe M. Campeau, Alicia Chan, Pranesh Chakraborty, Farah El Turk, Eva Mamak, Aizeddin Mhanni…

    Citation: Trials 2021 22:893

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:816

  45. Like many helping professionals in emotional labor occupations, clergy experience high rates of mental and physical comorbidities. Regular stress management practices may reduce stress-related symptoms and mor...

    Authors: Logan C. Tice, David E. Eagle, Joshua A. Rash, Jessie S. Larkins, Sofia M. Labrecque, Alyssa Platt, Jia Yao and Rae Jean Proeschold-Bell

    Citation: Trials 2021 22:892

    Content type: Study protocol

    Published on:

  46. Beta-adrenergic receptor blockers (BB) play an important role in the protection of organs that are susceptible for secondary injury due to stress-induced adrenergic surge. However, the use of BB in traumatic b...

    Authors: Ayman El-Menyar, Mohammad Asim, Ahmed Abdel-Aziz Bahey, Talat Chughtai, Abdulnasser Alyafai, Husham Abdelrahman, Sandro Rizoli, Ruben Peralta and Hassan Al-Thani

    Citation: Trials 2021 22:890

    Content type: Study protocol

    Published on:

  47. Increasing rates of antibiotic resistance in Gram-negative organisms due to the presence of extended-spectrum beta-lactamases (ESBL), hyperproduction of AmpC enzymes, carbapenemases and other mechanisms of res...

    Authors: Hugh Wright, Patrick N. A. Harris, Mark D. Chatfield, David Lye, Andrew Henderson, Tiffany Harris-Brown, Anna Donaldson and David L. Paterson

    Citation: Trials 2021 22:889

    Content type: Study protocol

    Published on:

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