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  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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

  8. 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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  9. 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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  10. 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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  11. 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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  12. 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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  13. 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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  14. 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

  15. 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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  16. 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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  17. 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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  18. 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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  19. 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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  20. Cardiovascular disease (O'Lone E, Viecelli AK, Craig JC, Tong A, Sautenet B, Herrington WG, et al., Am J Kidney Dis 76(1):109–20, 2020) remains the leading cause of death in Singapore. Uncontrolled hypertensio...

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

  21. 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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  22. Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleedin...

    Authors: Ayla S. Turan, Leon M. G. Moons, Ramon-Michel Schreuder, Erik J. Schoon, Jochim S. Terhaar sive Droste, Ruud W. M. Schrauwen, Jan Willem Straathof, Barbara A. J. Bastiaansen, Matthijs P. Schwartz, Wouter L. Hazen, Alaa Alkhalaf, Daud Allajar, Muhammed Hadithi, Bas W. van der Spek, Dimitri G. D. N. Heine, Adriaan C. I. T. L. Tan…

    Citation: Trials 2021 22:63

    Content type: Study protocol

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  23. 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

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  24. 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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  25. 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

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  26. Spinal manipulative therapy is commonly used in the treatment of adolescent idiopathic scoliosis. Some therapists also rely on physiotherapeutic scoliosis-specific exercise (PSSE). Combining these two modaliti...

    Authors: Li Wang, Chun Wang, Ahmed S. A. Youssef, Jiang Xu, Xiaolin Huang and Nan Xia

    Citation: Trials 2021 22:58

    Content type: Study protocol

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  27. Increasingly, genomics is informing clinical practice, but challenges remain for medical professionals lacking genetics expertise, and in access to and clinical utility of genomic testing for minority and unde...

    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 22:56

    Content type: Study protocol

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  28. Ulcerative colitis (UC) is an intestinal inflammatory disease characterized by inflammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients wi...

    Authors: Zhaofeng Shen, Kai Zheng, Jiandong Zou, Peiqing Gu, Jing Xing, Lu Zhang, Lei Zhu and Hong Shen

    Citation: Trials 2021 22:55

    Content type: Study protocol

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  29. Randomised controlled trials (RCTs) are considered the ‘gold standard’ of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addres...

    Authors: Clare McDermott, Jane Vennik, Carl Philpott, Steffi le Conte, Mike Thomas, Caroline Eyles, Paul Little, Helen Blackshaw, Anne Schilder and Claire Hopkins

    Citation: Trials 2021 22:54

    Content type: Research

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  30. Upper limb and hand motor dysfunction is one of the challenges in rehabilitation after cerebral ischemic stroke (CIS), and the clinical efficacy of rehabilitation needs to be improved. This study aims to combi...

    Authors: Mingzhu Xu, Run Lin, Jing Luo, Chunzhi Tang, Shuhui Wang, John Wong, Meng Wu, Jianting Huang, Peng Shi, Ang Gao, Yuqian Bai, Ying Xie, Jun Luo, Yunqiu Yang and Shaoyang Cui

    Citation: Trials 2021 22:53

    Content type: Study protocol

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  31. Following the World Health Organization’s (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-S...

    Authors: Mohammed Limbada, Chiti Bwalya, David Macleod, Sian Floyd, Ab Schaap, Vasty Situmbeko, Richard Hayes, Sarah Fidler and Helen Ayles

    Citation: Trials 2021 22:52

    Content type: Methodology

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  32. Through the process of normal aging, cognitive decline would cause a lower level of functioning in real life. This flow might interfere with health-related quality of life (QoL). The purpose of this study is t...

    Authors: Leila kazazi, Mohsen Shati, Seyede Salehe Mortazavi, Vahid Nejati and Mahshid Foroughan

    Citation: Trials 2021 22:51

    Content type: Research

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  33. Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We ...

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

    Citation: Trials 2021 22:49

    Content type: Study protocol

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  34. Immunosuppression including high-dose calcineurin inhibitors (CNI) is essential after lung transplantation. Dosing is usually guided by therapeutic drug monitoring adjusted to target trough levels of CNIs to k...

    Authors: Jens Gottlieb, Alexander Reuss, Konstantin Mayer, Karin Weide, Carmen Schade-Brittinger, Susanne Hoyer and Peter Jaksch

    Citation: Trials 2021 22:48

    Content type: Study protocol

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  35. This trial evaluates interventions that utilize data entered at point-of-care in the Palestinian maternal and child eRegistry to generate Quality Improvement Dashboards (QID) for healthcare providers and Targe...

    Authors: Kjersti Mørkrid, Binyam Bogale, Eatimad Abbas, Khadija Abu Khader, Itimad Abu Ward, Amjad Attalh, Tamara Awwad, Mohammad Baniode, Kimberly Suzanne Frost, Michael James Frost, Buthaina Ghanem, Taghreed Hijaz, Mervett Isbeih, Sally Issawi, Zaher A. S. Nazzal, Brian O’Donnell…

    Citation: Trials 2021 22:47

    Content type: Study protocol

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  36. Insomnia affects almost one in four military service members and veterans. The first-line recommended treatment for insomnia is cognitive-behavioral therapy for insomnia (CBTI). CBTI is typically delivered in-...

    Authors: Anne Germain, Rachel R. Markwald, Erika King, Adam D. Bramoweth, Megan Wolfson, Gilbert Seda, Tony Han, Erin Miggantz, Brian O’Reilly, Lars Hungerford, Traci Sitzer, Vincent Mysliwiec, Joseph J. Hout and Meredith L. Wallace

    Citation: Trials 2021 22:46

    Content type: Study protocol

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  37. Oral anticoagulant drugs represent an essential tool in the prevention of thromboembolic events. The ones in widespread use are vitamin K antagonists, whose plasma level is monitored by measuring prothrombin t...

    Authors: Leovigildo Ginel-Mendoza, Alfonso Hidalgo-Natera, Rocío Reina-Gonzalez, Rafael Poyato-Ramos, Juana Morales-Naranjo, Inmaculada Lupiañez-Pérez, Antonio Baca-Osorio, Miguel Gutiérrez-Jansen, María Paz Fernández-Lara, Diego Lozano-Noriega, Ulises Salgado-Carvallo, Cristina Bandera-García and Francisco Javier Navarro-Moya

    Citation: Trials 2021 22:45

    Content type: Study protocol

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  38. The primary objective of this study is to evaluate the therapeutic potential of hydroxychloroquine (HCQ) in the treatment of adult patients with PCR-confirmed Covid-19 infection in a primary open-care setting,...

    Authors: Petri J. Vainio, Pauliina Hietasalo, Anna-Liisa Koivisto, Susanna Kääriäinen, Jari Turunen, Mika Virtala, Jouni Vuorinen and Mika Scheinin

    Citation: Trials 2021 22:44

    Content type: Letter

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  39. The aim of this study is to assess the effectiveness and safety of glucocorticoid infusion pulse therapy to improve the clinical outcomes of patients with COVID-19 pneumonia with elevated inflammatory biomarkers.

    Authors: Iñigo Les Bujanda, Jose Loureiro-Amigo, Ferran Capdevila Bastons, Iñaki Elejalde Guerra, Javier Anniccherico Sánchez, Anna Murgadella-Sancho, Ruth García Rey, Julián Librero López and Julio Sánchez Álvarez

    Citation: Trials 2021 22:43

    Content type: Letter

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  40. As of December, 1st, 2020, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, resulted in more than 1 472 917 deaths worldwide and death toll is still increasing exponentially. Many COVID-19 infected peopl...

    Authors: W. Dioh, M. Chabane, C. Tourette, A. Azbekyan, C. Morelot-Panzini, L. A. Hajjar, M. Lins, G. B. Nair, T. Whitehouse, J. Mariani, M. Latil, S. Camelo, R. Lafont, P. J. Dilda, S. Veillet and S. Agus

    Citation: Trials 2021 22:42

    Content type: Letter

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  41. The only curative treatment for most esophageal cancers is radical esophagectomy. Minimally invasive esophagectomy (MIE) aims to reduce postoperative morbidity, but is not yet widely established. Linear staple...

    Authors: Felix Nickel, Pascal Probst, Alexander Studier-Fischer, Henrik Nienhüser, Jana Pauly, Karl-Friedrich Kowalewski, Sebastian Weiterer, Philipp Knebel, Markus K. Diener, Markus A. Weigand, Markus W. Büchler, Thomas Schmidt and Beat P. Müller-Stich

    Citation: Trials 2021 22:41

    Content type: Study protocol

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  42. Partial pancreatoduodenectomy (PD) is the indicated surgical procedure for a wide range of benign and malignant diseases of the pancreatic head and distal bile duct and offers the only potential cure for pancr...

    Authors: Rosa Klotz, Colette Dörr-Harim, Thomas Bruckner, Philipp Knebel, Markus K. Diener, Thilo Hackert and André L. Mihaljevic

    Citation: Trials 2021 22:40

    Content type: Study protocol

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  43. In this cluster-randomised controlled study (CoV-Surv Study), four different “active” SARS-CoV-2 testing strategies for general population surveillance are evaluated for their effectiveness in determining and ...

    Authors: Andreas Deckert, Simon Anders, Manuela de Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Kathleen Boerner, Matthias Meurer, Konrad Herbst, Matthias Sand, Lisa Koeppel, Tobias Siems, Lucia Brugnara, Stephan Brenner, Robin Burk, Dan Lou…

    Citation: Trials 2021 22:39

    Content type: Letter

    Published on:

  44. The FLAIR trial in chronic lymphocytic leukaemia has a randomised, controlled, open-label, confirmatory, platform design. FLAIR was successfully amended to include an emerging promising experimental therapy to...

    Authors: Dena R. Howard, Anna Hockaday, Julia M. Brown, Walter M. Gregory, Susan Todd, Tahla Munir, Jamie B. Oughton, Claire Dimbleby and Peter Hillmen

    Citation: Trials 2021 22:38

    Content type: Methodology

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  45. Acute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion. Goal-directed fluid therapy (GDFT) is an individualized fluid...

    Authors: Zheng Guan, Yanfeng Gao, Qiao Qiao, Qiang Wang and Jingjie Liu

    Citation: Trials 2021 22:36

    Content type: Study protocol

    Published on:

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