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  1. 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

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  2. 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

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  3. 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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  4. 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

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  5. 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

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  6. 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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  7. 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

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  8. The volume of residual alveolar bone is critical to the survival of dental implants. When the volume of alveolar bone in the posterior maxillary region is less than 4 mm, maxillary sinus floor elevation (MSFE)...

    Authors: Zhaoguo Yue, Qi Liu, Haidong Zhang, Jingwen Yang and Jianxia Hou

    Citation: Trials 2021 22:101

    Content type: Study protocol

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  9. 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

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

  10. 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

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  11. Sweden is home to a large and growing population of refugee youths who may be at risk of mental health problems such as post-traumatic stress disorder (PTSD). Thus, there is a need for interventions that addre...

    Authors: Natalie Durbeej, Serena McDiarmid, Anna Sarkadi, Inna Feldman, Raija-Leena Punamäki, Reeta Kankaanpää, Arnfinn Andersen, Per Kristian Hilden, An Verelst, Ilse Derluyn and Fatumo Osman

    Citation: Trials 2021 22:98

    Content type: Study protocol

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

    Authors: Penelope Schofield, Karla Gough, Amelia Hyatt, Alan White, Mark Frydenberg, Suzanne Chambers, Louisa G. Gordon, Robert Gardiner, Declan G. Murphy, Lawrence Cavedon, Natalie Richards, Barbara Murphy, Stephen Quinn and Ilona Juraskova

    Citation: Trials 2021 22:97

    Content type: Correction

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    The original article was published in Trials 2021 22:49

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

    Authors: Gordon McGregor, Harbinder Sandhu, Julie Bruce, Bartholomew Sheehan, David McWilliams, Joyce Yeung, Christina Jones, Beatriz Lara, Jessica Smith, Chen Ji, Elaine Fairbrother, Stuart Ennis, Peter Heine, Sharisse Alleyne, Jonathan Guck, Emma Padfield…

    Citation: Trials 2021 22:96

    Content type: Correction

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    The original article was published in Trials 2021 22:8

  14. Epidemiological studies have shown that young women often suffer from primary dysmenorrhea (PD) which is a common cause that affects their routine work and quality of life. Chinese herbal medicine has been wid...

    Authors: Geng Li, Zhe Zhang, Li Zhou, Shaojun Liao, Jing Sun, Yinghua Liu, Xin Wang and Zehuai Wen

    Citation: Trials 2021 22:95

    Content type: Study protocol

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  15. Previous studies suggest that health intervention designed to increase cervical cancer screening has been effective to reduce cervical cancer incidence and mortality. The aim of this study is to determine the ...

    Authors: Aamod Dhoj Shrestha, Dinesh Neupane, Sarita Ghimire, Christine Campbell and Per Kallestrup

    Citation: Trials 2021 22:94

    Content type: Study protocol

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  16. All of the existing medication and surgical therapies currently cannot completely inhibit intracerebral hemorrhage (ICH)-mediated brain damage, resulting in disability in different degrees in the involved pati...

    Authors: Zhiying Chen, Jiayue Ding, Xiaoqin Wu, Bing Bao, Xianming Cao, Xiangbin Wu, Xiaoping Yin and Ran Meng

    Citation: Trials 2021 22:93

    Content type: Study protocol

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  17. The high incidence of cerebral apoplexy makes it one of the most important causes of adult disability. Gait disorder is one of the hallmark symptoms in the sequelae of cerebral apoplexy. The recovery of walkin...

    Authors: Huihui Cai, Tao Lin, Lina Chen, Huidan Weng, Ruihan Zhu, Ying Chen and Guoen Cai

    Citation: Trials 2021 22:91

    Content type: Study protocol

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  18. New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional r...

    Authors: Guillaume Marquis-Gravel, Holly Robertson, W. Schuyler Jones, Danielle Riley, Daniel E. Ford, David Crenshaw, Yvonne A. Joosten, Lindsey Rudov, Adrian F. Hernandez and Rachel Hess

    Citation: Trials 2021 22:90

    Content type: Commentary

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  19. Previous study drew different conclusions on significant differences between saline and balanced crystalloid solution infused in critical illness but both showed a statistical difference in the sepsis subgroup...

    Authors: Fang Liu, Jing Zhang, Yuan Zhu, Lianjiu Su, Yiming Li, Li He, Li Yu and Zhiyong Peng

    Citation: Trials 2021 22:89

    Content type: Study protocol

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  20. There is a trend to increasing use of routinely collected health data to ascertain outcome measures in trials. We report on the completeness and accuracy of national ovarian cancer and death registration in th...

    Authors: Jatinderpal K. Kalsi, Andy Ryan, Aleksandra Gentry-Maharaj, Danielle Margolin-Crump, Naveena Singh, Matthew Burnell, Elizabeth Benjamin, Sophia Apostolidou, Mariam Habib, Susan Massingham, Chloe Karpinskyj, Robert Woolas, Martin Widschwendter, Lesley Fallowfield, Stuart Campbell, Steven Skates…

    Citation: Trials 2021 22:88

    Content type: Research

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  21. Spinal cord stimulation (SCS) is an effective method to treat neuropathic pain; however, it is challenging to compare different stimulation modalities in an individual patient, and thus, it is largely unknown ...

    Authors: Rezvan Ahmadi, Benito Campos, Mohammad Mehdi Hajiabadi, Colette Doerr-Harim, Solveig Tenckhoff, Dirk Rasche, Andreas Unterberg, Jan Vesper, Tom Bruckner and Volker Tronnier

    Citation: Trials 2021 22:87

    Content type: Study protocol

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  22. The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preve...

    Authors: Moses Badio, Edouard Lhomme, Mark Kieh, Abdoul Habib Beavogui, Stephen B. Kennedy, Seydou Doumbia, Bailah Leigh, Samba O. Sow, Alpha Diallo, Daniela Fusco, Matthew Kirchoff, Monique Termote, Renaud Vatrinet, Deborah Wentworth, Helène Esperou, H. Clifford Lane…

    Citation: Trials 2021 22:86

    Content type: Study protocol

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  23. Dyslipidemia is a major risk factor for atherosclerotic cardiovascular disease and a leading cause of death worldwide. The clinical utility of commonly used lipid-lowering drugs such as statins and fibrates is...

    Authors: Ying Zhao, Yuan-Yuan Yang, Bao-Lin Yang, Ya-Wei Du, Da-Wei Ren, Hong-Mei Zhou, Jing Wang, Hui-Min Yang, Yao-Xian Wang, Ying-Ying Zhang and Sheng-Xian Wu

    Citation: Trials 2021 22:85

    Content type: Study protocol

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  24. The lack of approved treatments for the majority of rare diseases is reflective of the unique challenges of orphan drug development. Novel methodologies, including new functionally relevant endpoints, are need...

    Authors: T. Fields, M. Patterson, T. Bremova-Ertl, G. Belcher, I. Billington, G. C. Churchill, W. Davis, W. Evans, S. Flint, A. Galione, U. Granzer, J. Greenfield, R. Karl, R. Kay, D. Lewi, T. Mathieson…

    Citation: Trials 2021 22:84

    Content type: Study protocol

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  25. Sleep-disordered breathing (SDB) is highly prevalent in acute ischaemic stroke and is associated with worse functional outcome and increased risk of recurrence. Recent meta-analyses suggest the possibility of ...

    Authors: Simone B. Duss, Anne-Kathrin Brill, Sébastien Baillieul, Thomas Horvath, Frédéric Zubler, Dominique Flügel, Georg Kägi, Gabriel Benz, Corrado Bernasconi, Sebastian R. Ott, Lyudmila Korostovtseva, Yurii Sviryaev, Farid Salih, Matthias Endres, Renaud Tamisier, Haralampos Gouveris…

    Citation: Trials 2021 22:83

    Content type: Study protocol

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  26. Prevention of neurodevelopmental impairment due to preterm birth is a major health challenge. Despite advanced obstetric and neonatal care, to date there are few neuroprotective molecules available. Melatonin ...

    Authors: Francesca Garofoli, Stefania Longo, Camilla Pisoni, Patrizia Accorsi, Micol Angelini, Salvatore Aversa, Camilla Caporali, Sara Cociglio, Annalisa De Silvestri, Elisa Fazzi, Vittoria Rizzo, Chryssoula Tzialla, Marco Zecca and Simona Orcesi

    Citation: Trials 2021 22:82

    Content type: Study protocol

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  27. The prevalence of hypertension is high and increasing in China in recent years. The treatment and control of hypertension calls for long-term management beyond hospital, which is hard to implement in tradition...

    Authors: Zheyu Wang, Chengling Li, Wencai Huang, Yan Chen, Yuqiong Li, Libin Huang, Mei Zhang, Dan Wu, Li Wang, Huilong Duan, Jiye An and Ning Deng

    Citation: Trials 2021 22:81

    Content type: Study protocol

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  28. Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a prior...

    Authors: Bastiaan C. ter Meulen, Johanna M. van Dongen, Marinus van der Vegt, Henry C. Weinstein and Raymond W. J. G. Ostelo

    Citation: Trials 2021 22:80

    Content type: Update

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    The Study protocol to this article has been published in BMC Musculoskeletal Disorders 2017 18:215

  29. Postoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupo...

    Authors: Huiqing Xu, Xu Wei, Ranxing Zhang, Ling Li, Zhijun Zhang, Ruo Jia, Xiaofei Zhang, Xiumei Gao, Xicheng Dong and Junjun Pan

    Citation: Trials 2021 22:79

    Content type: Study protocol

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  30. For prospective meta-analyses (PMAs), eligible studies are identified, and the PMA hypotheses, selection criteria, and analysis methods are pre-specified before the results of any of the studies are known. This r...

    Authors: A. L. Seidler, K. E. Hunter, D. Espinoza, S. Mihrshahi and L. M. Askie

    Citation: Trials 2021 22:78

    Content type: Research

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  31. Arterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa. Only a few and mostly small randomized trials have studied antihypertensive treatments in people of Afr...

    Authors: Herry Mapesi, Ravi Gupta, Herieth Ismael Wilson, Blaise Lukau, Alain Amstutz, Aza Lyimo, Josephine Muhairwe, Elizabeth Senkoro, Theonestina Byakuzana, Madavida Mphunyane, Moniek Bresser, Tracy Renée Glass, Mark Lambiris, Günther Fink, Winfrid Gingo, Manuel Battegay…

    Citation: Trials 2021 22:77

    Content type: Study protocol

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  32. Chronic nonspecific low back pain (CNSLBP) troubles approximately 30% of people worldwide. Silver needle therapy (SNT) is a treatment method to relieve soft tissue pain through heating. Therefore, this study a...

    Authors: Xuesong Hu, Shaoxing Dong, Bing Zhang, Xuan Wang, Yanwei Yin, Chuansheng Liu, Junmin Yu, Xing Wu, Fenghu Xu and Chao Meng

    Citation: Trials 2021 22:75

    Content type: Research

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  33. The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years. There has been no specific etiological treatment for HT. Even though with normal level of thyroid hormone, the patients...

    Authors: Shanze Wang, Jiping Zhao, Weimei Zeng, Wanqing Du, Tenghui Zhong, Hui Gao, Yi Xiao and Chao Yang

    Citation: Trials 2021 22:74

    Content type: Study protocol

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  34. Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could...

    Authors: Fangyuan Li, Hua Lu, Xinxin Wang, Qi Zhang, Qianchen Liu and Tong Wang

    Citation: Trials 2021 22:73

    Content type: Study protocol

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  35. In the healthcare system in Germany, different institutions and actors play specific roles in the discharge and transition of patients from hospitals into primary care (Sachverständigenrat zur Begutachtung der...

    Authors: Terese Dehl, Ulf Sauerbrey, Adina Dreier-Wolfgramm, Angela Nikelski, Nino Chikhradze, Armin Keller, Jessica Laufer, Fanny Schumacher-Schoenert, Stefan Kreisel, Jochen René Thyrian, Wolfgang Hoffmann and Horst Christian Vollmar

    Citation: Trials 2021 22:72

    Content type: Study protocol

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    The Study protocol to this article has been published in Trials 2019 20:543

  36. SARS-CoV-2, the virus that causes COVID-19, enters the cells through a mechanism dependent on its binding to angiotensin-converting enzyme 2 (ACE2), a protein highly expressed in the lungs. The putative viral-...

    Authors: Eli Mansour, Flávia F. Bueno, José C. de Lima-Júnior, Andre Palma, Milena Monfort-Pires, Bruna Bombassaro, Eliana P. Araujo, Ana Flavia Bernardes, Raisa G. Ulaf, Thyago A. Nunes, Luciana C. Ribeiro, Antônio Luís E. Falcão, Thiago Martins Santos, Plinio Trabasso, Rachel P. Dertkigil, Sergio S. Dertkigil…

    Citation: Trials 2021 22:71

    Content type: Study protocol

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  37. COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or ther...

    Authors: Elena Diago-Sempere, José Luis Bueno, Aránzazu Sancho-López, Elena Múñez Rubio, Ferrán Torres, Rosa Malo de Molina, Ana Fernández-Cruz, Isabel Salcedo de Diego, Ana Velasco-Iglesias, Concepción Payares-Herrera, Inmaculada Casas Flecha, Cristina Avendaño-Solà, Rafael Duarte Palomino, Antonio Ramos-Martínez and Belén Ruiz-Antorán

    Citation: Trials 2021 22:70

    Content type: Study protocol

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  38. Neovascular age-related macular degeneration (nAMD) is the most common cause of irreversible vision loss and blindness among the older people aged 50 and over. Although anti-vascular endothelial growth factor ...

    Authors: Yamin Li, Lina Liang, Torkel Snellingen, Kai Xu, Yun Gao, Fengmei Zhang, Chengwei Guo, Tao Zuo, Fengming Liang, Xiaoping Yao and Xueyan Yang

    Citation: Trials 2021 22:69

    Content type: Study protocol

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  39. Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elem...

    Authors: Nikki Totton, Steven Julious, Dyfrig Hughes, Jonathan Cook, Katie Biggs, Lizzie Coates, Andrew Cook, Catherine Hewitt and Simon Day

    Citation: Trials 2021 22:68

    Content type: Study protocol

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  40. Atopic dermatitis (AD) is a complex, common inflammatory skin disease. The Chinese herbal formula Huoxiang Zhengqi (HXZQ) has been a common dermatosis treatment in China for many years, but there is no high-le...

    Authors: Meiling Xuan, Xiaohui Guo, Hongyi Li, Ting Xie, Xiumei Mo and Zehuai Wen

    Citation: Trials 2021 22:67

    Content type: Study protocol

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  41. Cardiovascular disease remains the leading cause of death in Singapore. Uncontrolled hypertension confers the highest attributable risk of CVD and remains a significant public health issue with sub-optimal blo...

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

    Citation: Trials 2021 22:66

    Content type: Update

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    The Correction to this article has been published in Trials 2021 22:122

    The Study protocol to this article has been published in Trials 2018 19:180

  42. The Malawi College of Medicine and its partners are building non-communicable diseases’ (NCDs’) research capacity through a grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Insti...

    Authors: Adamson S. Muula, Mina C. Hosseinipour, Martha Makwero, Johnstone Kumwenda, Prosper Lutala, Mary Mbeba, Sarah Rylance, Collins Mitambo and Moffat Nyirenda

    Citation: Trials 2021 22:65

    Content type: Commentary

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  43. There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the co...

    Authors: Frances Shiely, Jean Foley, Amy Stone, Emma Cobbe, Shaunagh Browne, Ellen Murphy, Maeve Kelsey, Joanne Walsh-Crowley and Joseph A. Eustace

    Citation: Trials 2021 22:62

    Content type: Commentary

    Published on:

  44. Several clinical studies investigated improvements of patient outcomes due to diabetes management interventions. However, chronic disease management is intricate with complex multifactorial behavior patterns. ...

    Authors: Bettina Petersen, Iris Vesper, Bernhild Pachwald, Nicole Dagenbach, Sina Buck, Delia Waldenmaier and Lutz Heinemann

    Citation: Trials 2021 22:61

    Content type: Methodology

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  45. Basic and clinical studies have shown that magnesium sulphate ameliorates lung injury and controls asthma attacks by anti-inflammatory and bronchodilatory effects. Both intravenous and inhaled magnesium sulpha...

    Authors: Guitti Pourdowlat, Seyed Ruhollah Mousavinasab, Behrooz Farzanegan, Alireza Kashefizadeh, Zohreh Akhoundi Meybodi, Maedeh Jafarzadeh and Shadi Baniasadi

    Citation: Trials 2021 22:60

    Content type: Letter

    Published on:

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