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  1. 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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  2. 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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  3. 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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  4. 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

  5. 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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  6. 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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  7. 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

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  8. 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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  9. 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

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

  10. 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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  11. 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

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  12. Transurethral resection of bladder tumor (TURBT) is an essential procedure both for the treatment and staging of bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). The dissemination of ca...

    Authors: Makito Miyake, Nobutaka Nishimura, Takashi Inoue, Shota Suzuki, Tomomi Fujii, Takuya Owari, Shunta Hori, Yasushi Nakai, Michihiro Toritsuka, Hitoshi Nakagawa, Shinji Tsukamoto, Satoshi Anai, Kazumasa Torimoto, Tatsuo Yoneda, Nobumichi Tanaka and Kiyohide Fujimoto

    Citation: Trials 2021 22:136

    Content type: Study protocol

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  13. Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally ...

    Authors: Sai Ho Sin, Jing Wu, Yuchen Kang, Kar Hung Kevin Yip, Ngo Suet Kong, Hei Wan, Bacon Fung Leung Ng and Haiyong Chen

    Citation: Trials 2021 22:135

    Content type: Study protocol

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  14. Following surgery for soft tissue sarcoma of the retroperitoneum, the predominant pattern of failure is local recurrence, which remains the main cause of death. Radiotherapy is utilized to reduce recurrence ra...

    Authors: K. Seidensaal, M. Kieser, A. Hommertgen, C. Jaekel, S. B. Harrabi, K. Herfarth, G. Mechtesheimer, B. Lehner, M. Schneider, H. Nienhueser, S. Fröhling, G. Egerer, J. Debus and M. Uhl

    Citation: Trials 2021 22:134

    Content type: Study protocol

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  15. More than 50% of patients with type 2 diabetes have hypertension in Uganda. Diabetic patients with elevated systolic blood pressure experience higher all-cause mortality and cardiovascular events compared with...

    Authors: William Lumu, Davis Kibirige, Ronald Wesonga and Silver Bahendeka

    Citation: Trials 2021 22:133

    Content type: Study protocol

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  16. Mental health disorders in the context of long-term conditions in children and young people are currently overlooked and undertreated. Evidence-based psychological treatments for common childhood mental health...

    Authors: Sophie D. Bennett, J. Helen Cross, Anna E. Coughtrey, Isobel Heyman, Tamsin Ford, Bruce Chorpita, Rona Moss-Morris, Sarah Byford, Emma Dalrymple, Colin Reilly, Terence Stephenson, Caroline Doré, Sophia Varadkar, James Blackstone, Kashfia Chowdhury, Poushali Ganguli…

    Citation: Trials 2021 22:132

    Content type: Study protocol

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  17. The main objective of this study is to evaluate the effect of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome due or not to Covid-19 pneumonia.

    Authors: Marie Muller, François Lefebvre, Marie-Line Harlay, Ludovic Glady, Guillaume Becker, Charlotte Muller, Ouafaa Aberkane, Mira Tawk, Madoé Julians, Arnaud Romoli, Stéphane Hecketsweiler, Francis Schneider, Julien Pottecher and Thiên-Nga Chamaraux-Tran

    Citation: Trials 2021 22:131

    Content type: Letter

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  18. The primary objectives of the study are to determine the effectiveness of the Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy Treatment to compared with Placebo (Decaffeinated...

    Authors: Anurag Srivastava, Manickavasagam Rengaraju, Saurabh Srivastava, Vimal Narayan, Vivek Gupta and Rashmi Upadhayay

    Citation: Trials 2021 22:130

    Content type: Letter

    Published on:

  19. The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is p...

    Authors: Cathy W. T. Lo, Matthew A. Brodie, William W. N. Tsang, Chun-Hoi Yan, Priscillia L. Lam, Chun-Ming Chan, Stephen R. Lord and Arnold Y. L. Wong

    Citation: Trials 2021 22:129

    Content type: Study protocol

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  20. Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the USA. The United States Preventive Services Task Force (USPSTF) encourages prostate-specif...

    Authors: Danil V. Makarov, Zachary Feuer, Shannon Ciprut, Natalia Martinez Lopez, Angela Fagerlin, Michele Shedlin, Heather T. Gold, Huilin Li, Gina Lynch, Rueben Warren, Peter Ubel and Joseph E. Ravenell

    Citation: Trials 2021 22:128

    Content type: Study protocol

    Published on:

  21. The objective of the study is to measure the efficacy of ionic-iodine polymer complex [1] for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients.

    Authors: Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Muhammad Ahmad Imran, Larab Kalsoom, Uzma Nasim Siddiqui, Iqra Farooq, Muhammad Ghufran, Romaisa Arshad Khokhar, Muhammad Kiwan Akram, Iqra Shahid, Muhammad Sohaib Ur Rehman, Rutaba Akmal, Arbaz Tahir, Ayesha Zahid, Sidra Ashraf…

    Citation: Trials 2021 22:127

    Content type: Letter

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  22. The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory st...

    Authors: Iwein Gyselinck, Laurens Liesenborghs, Ewout Landeloos, Ann Belmans, Geert Verbeke, Peter Verhamme, Robin Vos and W. Janssens

    Citation: Trials 2021 22:126

    Content type: Study protocol

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    The Correction to this article has been published in Trials 2021 22:187

  23. Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy ca...

    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 22:125

    Content type: Study protocol

    Published on:

  24. Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention ...

    Authors: J. Dubreucq, M. Faraldo, M. Abbes, B. Ycart, H. Richard-Lepouriel, S. Favre, F. Jermann, J. Attal, M. Bakri, T. Cohen, C. Cervello, I. Chereau, C. Cognard, M. De Clercq, A. Douasbin, J. Y. Giordana…

    Citation: Trials 2021 22:124

    Content type: Study protocol

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  25. Neck pain is a common clinical disease, which seriously affects people’s mental health and quality of life and results in loss of social productivity. Improving neck pain’s curative effect and reducing its rec...

    Authors: Mingcai Zhang, Guoqing Du, Congying Liu, Wei Li, Jiayu Yang, Bo Chen, Xiaoyue Yu, Yizhe Xiong, Enyu Jiang, Ningyang Gao, Sumin Jiang, Zhenqiu Xu, Xiang Wang and Hongsheng Zhan

    Citation: Trials 2021 22:123

    Content type: Study protocol

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

    Authors: John C. Allen Jr, Benjamin Halaand, Rupesh M. Shirore and Tazeen H. Jafar

    Citation: Trials 2021 22:122

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:66

  27. Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are ...

    Authors: Rui Luo, Fangfang Zheng, Haobo Zhang, Weiquan Zhu, Penghui He and Dongning Liu

    Citation: Trials 2021 22:121

    Content type: Study protocol

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  28. Skilled nursing facility (SNF) patients are medically complex with multiple, advanced chronic conditions. They are dependent on caregivers and have experienced recent acute illnesses. Among SNF patients, the r...

    Authors: M. Toles, C. Colón-Emeric, L. C. Hanson, M. Naylor, M. Weinberger, J. Covington and J. S. Preisser

    Citation: Trials 2021 22:120

    Content type: Study protocol

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  29. Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information c...

    Authors: Jeffrey P. Hau, Penelope M. A. Brasher, Amber Cragg, Serena Small, Maeve Wickham and Corinne M. Hohl

    Citation: Trials 2021 22:119

    Content type: Study protocol

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  30. Chronic non-specific low back pain (CLBP) is a common musculoskeletal disorder for which patients seek complementary and alternative medical treatments, including laser acupuncture (LA). Invasive LA (ILA) invo...

    Authors: Jae-Hong Kim, Chang-Su Na, Gwang-Cheon Park and Jeong-Soon Lee

    Citation: Trials 2021 22:118

    Content type: Study protocol

    Published on:

  31. This article describes how one trial site of the Refugee Emergency: Defining and Implementing Novel Evidence-based psychosocial interventions (RE-DEFINE) study, designed to evaluate a Self Help+ intervention w...

    Authors: Lauren Walker, Della Bailey, Rachel Churchill and Emily Peckham

    Citation: Trials 2021 22:117

    Content type: Letter

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  32. Baricitinib is supposed to have a double effect on SARS-CoV2 infection. Firstly, it reduces the inflammatory response through the inhibition of the Januse-Kinase signalling transducer and activator of transcri...

    Authors: G. Moreno-González, A. Mussetti, A. Albasanz-Puig, I. Salvador, A. Sureda, C. Gudiol, R. Salazar, M. Marin, M. Garcia, V. Navarro, I. de la Haba Vaca, E. Coma, G. Sanz-Linares, X. Dura, S. Fontanals, G. Serrano…

    Citation: Trials 2021 22:116

    Content type: Letter

    Published on:

  33. The aim of the RAAS-COVID-19 randomized control trial is to evaluate whether an upfront strategy of temporary discontinuation of renin angiotensin aldosterone system (RAAS) inhibition versus continuation of RA...

    Authors: Mona Aflaki, Alexandria Flannery, João Pedro Ferreira, Matthew Pellan Cheng, Nadine Kronfli, Ariane Marelli, Faiez Zannad, James Brophy, Jon Afillalo, Thao Huynh, Nadia Giannetti, Amal Bessissow, Justin A. Ezekowitz, Renato D. Lopes, Andrew P. Ambrosy, Morgan Craig…

    Citation: Trials 2021 22:115

    Content type: Study protocol

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  34. This manuscript provides a research update to the ongoing pragmatic trial of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment), an emergency department-based peer recovery coaching interv...

    Authors: Allyson L. Dir, Dennis P. Watson, Matthew Zhiss, Lisa Taylor, Bethany C. Bray and Alan McGuire

    Citation: Trials 2021 22:114

    Content type: Update

    Published on:

  35. Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to prom...

    Authors: Elaine M. Finucane, Linda Biesty, Deirdre Murphy, Amanda Cotter, Eleanor Molloy, Martin O’Donnell, Shaun Treweek, Paddy Gillespie, Marian Campbell, John J. Morrison, Alberto Alvarez-Iglesias, Gill Gyte and Declan Devane

    Citation: Trials 2021 22:113

    Content type: Study protocol

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  36. Coronavirus disease 2019 (COVID-19) is an infection with possible serious consequences. The plasma of recovered patients might serve as treatment, which we aim to assess in the form of a prospective meta-analy...

    Authors: Lajos Szakó, Nelli Farkas, Szabolcs Kiss, Szilárd Váncsa, Noémi Zádori, Nóra Vörhendi, Bálint Erőss, Péter Hegyi and Hussain Alizadeh

    Citation: Trials 2021 22:112

    Content type: Methodology

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  37. To evaluate whether a single high dose of oral cholecalciferol improves the respiratory outcomes as compared with placebo among adults COVID-19 patients at moderate risk of clinical complications.

    Authors: Javier Mariani, Carlos Tajer, Laura Antonietti, Felipe Inserra, León Ferder and Walter Manucha

    Citation: Trials 2021 22:111

    Content type: Letter

    Published on:

  38. There is a lack of effective pharmacotherapy for prolonged grief disorder (PGD). Evidence suggests that the neurobiology of PGD involves the same circuitry as the reward pathway. Based upon this evidence, we h...

    Authors: James Gang, James Kocsis, Jonathan Avery, Paul K. Maciejewski and Holly G. Prigerson

    Citation: Trials 2021 22:110

    Content type: Study protocol

    Published on:

  39. To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of COVID-19 in Primary Health Care.

    Authors: Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Livia Mitchiguian Hotta, Ana Elisa Madureira Padula, Amarilys de Toledo Cesar, José Nelson Martins Diniz, Crislaine Aparecida Antonio Mestre, Katia Regina Spiller, Lidiamara Soares, Helen de Freitas Santos and Edson Zangiacomi Martinez

    Citation: Trials 2021 22:109

    Content type: Letter

    Published on:

  40. Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality globally. Strong evidence supports the importance of diet and other lifestyle factors in preventing T2DM. Among individuals with T2DM...

    Authors: Kirsten S. Dorans, Lydia A. Bazzano, Lu Qi, Hua He, Lawrence J. Appel, Jonathan M. Samet, Jing Chen, Katherine T. Mills, Bernadette T. Nguyen, Matthew J. O’Brien, Gabriel I. Uwaifo and Jiang He

    Citation: Trials 2021 22:108

    Content type: Study protocol

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  41. Bariatric surgery is an effective approach to weight loss and long-term comorbidity resolution. Although recommended in several guidelines, supervised exercise has not been systematically prescribed after bari...

    Authors: Andrea Herrera-Santelices, Andrea Tabach-Apraiz, Karen Andaur-Cáceres and Antonio Roberto Zamunér

    Citation: Trials 2021 22:107

    Content type: Study protocol

    Published on:

  42. Depression is seriously affecting the physical and mental health of young people worldwide. Subthreshold depression, as an early stage of depression, is essential for early prevention and treatment of depressi...

    Authors: Xiaoting Xie, Jian Song, Jingfang Zhu, Mengyu Han, Youze He, Jia Huang, Jing Tao and Jingsong Wu

    Citation: Trials 2021 22:106

    Content type: Study protocol

    Published on:

  43. Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and psychological...

    Authors: I. Gardoki-Souto, O. Martín de la Torre, B. Hogg, D. Redolar-Ripoll, A. Valiente-Gómez, L. Martínez Sadurní, J. M. Blanch, W. Lupo, V. Pérez, J. Radua, B. L. Amann and A. Moreno-Alcázar

    Citation: Trials 2021 22:104

    Content type: Study protocol

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  44. A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for eviden...

    Authors: Niranjan S. Karnik, Cynthia I. Campbell, Megan E. Curtis, David A. Fiellin, Udi Ghitza, Kathryn Hefner, Yih-Ing Hser, R. Kathryn McHugh, Sean M. Murphy, Sterling M. McPherson, Landhing Moran, Larissa J. Mooney, Li-Tzy Wu, Dikla Shmueli-Blumberg, Matisyahu Shulman, Robert P. Schwartz…

    Citation: Trials 2021 22:102

    Content type: Study protocol

    Published on:

  45. The Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial is a global adaptive platform trial of hospitalized patients with COVID-19. We describe implementation at the first US ...

    Authors:

    Citation: Trials 2021 22:100

    Content type: Methodology

    Published on:

    The Correction to this article has been published in Trials 2021 22:145

  46. The effects of restrictive fluid therapy combined with controlled hypotension in the elderly on systemic oxygen metabolism and renal function are clinical concerns. The aim of this study was to evaluate blood ...

    Authors: Xiaodong Qiu, Zhiying Tan, Wenhao Tang, Hui Ye and Xinjian Lu

    Citation: Trials 2021 22:99

    Content type: Research

    Published on:

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