viernes, 7 de agosto de 2020

Trials | Articles

Trials | Articles



  1. While the evolution of technology provides new opportunities to manage chronic refractory pain using different waveform modalities of spinal cord stimulation in failed back surgery syndrome (FBSS), there is no...
    Authors:Maxime Billot, Nicolas Naiditch, Claire Brandet, Bertille Lorgeoux, Sandrine Baron, Amine Ounajim, Manuel Roulaud, Aline Roy-Moreau, Géraldine de Montgazon, Elodie Charrier, Lorraine Misbert, Benjamin Maillard, Tanguy Vendeuvre and Philippe Rigoard
    Citation:Trials 2020 21:696
    Content type:Study protocol
     
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  2. Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly pr...
    Authors:Giovanni Ostuzzi, Chiara Gastaldon, Angelo Barbato, Barbara D’Avanzo, Mauro Tettamanti, Igor Monti, Andrea Aguglia, Eugenio Aguglia, Maria Chiara Alessi, Mario Amore, Francesco Bartoli, Massimo Biondi, Paola Bortolaso, Camilla Callegari, Giuseppe Carrà, Rosangela Caruso…
    Citation:Trials 2020 21:695
    Content type:Study protocol
     
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  3. Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of under-served groups in clinical researc...
    Authors:Miles D. Witham, Eleanor Anderson, Camille Carroll, Paul M. Dark, Kim Down, Alistair S. Hall, Joanna Knee, Rebecca H. Maier, Gail A. Mountain, Gary Nestor, Laurie Oliva, Sarah R. Prowse, Amanda Tortice, James Wason and Lynn Rochester
    Citation:Trials 2020 21:694
    Content type:Research
     
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  4. Approximately 30 to 50% of women are unable to correctly perform pelvic floor muscle (PFM) contractions. For women to benefit from a pelvic floor muscle training (PFMT) programme for stress urinary incontinenc...
    Authors:Letícia de Azevedo Ferreira, Fátima Faní Fitz, Márcia Maria Gimenez, Mayanni Magda Pereira Matias, Maria Augusta Tezelli Bortolini and Rodrigo Aquino Castro
    Citation:Trials 2020 21:693
    Content type:Study protocol
     
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  5. Harmful alcohol use is a leading cause of global disability and death. However, increased detection and brief intervention capacity of more severe alcohol use disorders has not been accompanied by increased av...
    Authors:Nicolas A. Barticevic, Fernando Poblete, Soledad M. Zuzulich, Victoria Rodriguez and Laura Bradshaw
    Citation:Trials 2020 21:692
    Content type:Study protocol
     
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  6. Stage 1: To evaluate the safety and efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage.
    Authors:Tom Wilkinson, Rupert Dixon, Clive Page, Miles Carroll, Gareth Griffiths, Ling-Pei Ho, Anthony De Soyza, Timothy Felton, Keir E. Lewis, Karen Phekoo, James D. Chalmers, Anthony Gordon, Lorcan McGarvey, Jillian Doherty, Robert C. Read, Manu Shankar-Hari…
    Citation:Trials 2020 21:691
    Content type:Letter
     
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  7. To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: de...
    Authors:Ing Ni Lu, Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Sonakshi Kadyan, Simon Bond, Sam Norton, Andrew Cope, James Galloway, Frances Hall, David Jayne, Ian B. Wilkinson and Joseph Cheriyan
    Citation:Trials 2020 21:690
    Content type:Letter
     
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  8. Hydroxychloroquine has shown to have antiviral activity in vitro against coronaviruses, specifically SARS-CoV-2. It is believed to block virus infection by increasing endosomal pH required for virus cell fusion a...
    Authors:Oriana Nanni, Pierluigi Viale, Bernadette Vertogen, Claudia Lilli, Chiara Zingaretti, Caterina Donati, Carla Masini, Manuela Monti, Patrizia Serra, Roberto Vespignani, Veruska Grossi, Annibale Biggeri, Emanuela Scarpi, Francesca Galardi, Lucia Bertoni, Americo Colamartini…
    Citation:Trials 2020 21:689
    Content type:Study protocol
     
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  9. The aim of this study is to assess the efficacy of the use of pre-exposure prophylaxis (PrEP) with hydroxychloroquine against placebo in healthcare workers with high risk of severe acute respiratory syndrome c...
    Authors:Berta Grau-Pujol, Daniel Camprubí, Helena Marti-Soler, Marc Fernández-Pardos, Caterina Guinovart and Jose Muñoz
    Citation:Trials 2020 21:688
    Content type:Letter
     
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  10. The trial objective is to determine if Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) is clinically effective compared to standard oxygen therapy in patients with confirmed or susp...
    Authors:Gavin D. Perkins, Keith Couper, Bronwen Connolly, J. Kenneth Baillie, Judy M. Bradley, Paul Dark, Anthony De Soyza, Ellen Gorman, Alasdair Gray, Louisa Hamilton, Nicholas Hart, Chen Ji, Ranjit Lall, Nicola McGowan, Scott Regan, Anita K. Simonds…
    Citation:Trials 2020 21:687
    Content type:Letter
     
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  11. Allergic rhinitis (AR) in children is a major respiratory inflammatory disease with a high incidence that is increasing yearly. In China, 54.93% of children with asthma have AR, which often requires synchronou...
    Authors:Ming Chen, YuFen Wu, Shuhua Yuan, Jiande Chen, Luanluan Li, Jinhong Wu, Jing Zhang and Yong Yin
    Citation:Trials 2020 21:686
    Content type:Study protocol
     
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  12. Traumatic brain injury (TBI) is the most common trauma worldwide and is a leading cause of injury-related death and disability. Inflammation is initiated as a result of the TBI, which is in association with se...
    Authors:Seyed Mostafa Arabi, Alireza Sedaghat, Mohammad Reza Ehsaei, Mohammad Safarian, Golnaz Ranjbar, Hamid Rezaee, Reza Rezvani, Hamed Tabesh and Abdolreza Norouzy
    Citation:Trials 2020 21:685
    Content type:Study protocol
     
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  13. Bronchial asthma is one of the most common inflammatory airway disorders. As one of the main non-drug therapies, the Sanfu herbal patch (SHP) has been widely used to treat bronchial asthma, although the eviden...
    Authors:Xiaoyan Xie, Danghan Xu, Lixing Zhuang, Hui Liu, Sui Tan, Yanqing Lu, Meiyi Su, Jie Chen, Haihua Pan, Lu Lu, Yiming Xu, Muxi Liao, Zhanqiong Xu and Jun He
    Citation:Trials 2020 21:684
    Content type:Study protocol
     
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  14. Working memory deficit is one of the most critical complex cognitive impairments in schizophrenia. Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy, but not still unsatisfac...
    Authors:Jiaqi Song, Dan Liu, Meng Zhang, Huiqiu Wang and Shuping Tan
    Citation:Trials 2020 21:683
    Content type:Study protocol
     
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  15. Nonspecific chronic neck pain is a fairly common disorder that causes a great impact, and it is greatly influenced by psychosocial factors. Among a number of treatment modalities described for its management, ...
    Authors:Carlos Bernal-Utrera, Juan Jose Gonzalez-Gerez, Ernesto Anarte-Lazo and Cleofas Rodriguez-Blanco
    Citation:Trials 2020 21:682
    Content type:Research
     
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  16. Early treatment with tranexamic acid may reduce deaths after traumatic brain injury (TBI). In mild and moderate TBI, there is a time to treatment interaction, with early treatment being most beneficial. Time t...
    Authors:Raoul Mansukhani, Lauren Frimley, Haleema Shakur-Still, Linda Sharples and Ian Roberts
    Citation:Trials 2020 21:681
    Content type:Research
     
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  17. An effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resour...
    Authors:Neema Toto, Elaine Douglas, Markus Gmeiner, Lynn K. Barrett, Robert Lindblad, Lumbani Makhaza, Wilfred Nedi, Jacob Phulusa, Gerald V. Quinnan, Leigh A. Sawyer, Herbert Thole, Wesley C. Van Voorhis and Pui-Ying Iroh Tam
    Citation:Trials 2020 21:680
    Content type:Methodology
     
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  18. Degenerative lumbar spinal stenosis (DLSS) is a common condition secondary to degenerative changes. Acupuncture may be effective for treating DLSS. However, there is a lack of sufficient evidence showing the e...
    Authors:Jing Zhou, Sixing Liu, Yuanjie Sun, Weiming Wang and Zhishun Liu
    Citation:Trials 2020 21:679
    Content type:Study protocol
     
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  19. Neoadjuvant chemoradiotherapy followed by surgery is the mainstay treatment for locally advanced rectal cancer, leading to significant decrease in tumor size (downsizing) and a shift towards earlier disease st...
    Authors:Igor Monsellato, Elisabetta Garibaldi, Elisa Cassinotti, Ludovica Baldari, Luigi Boni, Ugo Elmore, Roberto Delpini, Riccardo Rosati, Roberto Perinotti, Filippo Alongi, Elisa Bertocchi, Stefania Gori, Giacomo Ruffo, Graziano Pernazza, Fabio Pulighe, Carlo De Nisco…
    Citation:Trials 2020 21:678
    Content type:Study protocol
     
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  20. Guideline-based medical care has been identified to improve outcomes in stroke. However, data acquisition and medical quality management during hospital stay still need to be improved in China. We have develop...
    Authors:Yi Chen, Wansi Zhong, Xiaoxian Gong, Haitao Hu, Shenqiang Yan, Xuting Zhang, Zhicai Chen, Ying Zhou and Min Lou
    Citation:Trials 2020 21:677
    Content type:Study protocol
     
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  21. Approximately 8–15% of patients undergoing bariatric surgery develop symptomatic gallstone disease within 24 months after surgery. Ursodeoxycholic acid (UDCA) seems to effectively prevent the formation of gall...
    Authors:Sylke Haal, Maimoena S. S. Guman, L. Maurits de Brauw, Ruben N. van Veen, Ruben Schouten, Paul Fockens, Victor E. A. Gerdes, Marcel G. W. Dijkgraaf and Rogier P. Voermans
    Citation:Trials 2020 21:676
    Content type:Update
     
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    The Study protocol to this article has been published in BMC Gastroenterology 2017 17:164
  22. Process evaluation can illuminate barriers and facilitators to intervention implementation as well as the drivers of intervention outcomes. However, few obesity intervention studies have documented process eva...
    Authors:Jacob P. Beckerman-Hsu, Alyssa Aftosmes-Tobio, Adam Gavarkovs, Nicole Kitos, Roger Figueroa, Z. Begum Kalyoncu, Kindra Lansburg, Xinting Yu, Crystal Kazik, Adrienne Vigilante, Jessie Leonard, Merieka Torrico, Janine M. Jurkowski and Kirsten K. Davison
    Citation:Trials 2020 21:674
    Content type:Study protocol
     
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  23. In China, psychodynamic psychotherapies are widely used as a treatment for depression. However, very few efficacy studies of psychodynamic therapies have been conducted with the Chinese population. This paper ...
    Authors:Lanlan Wang, Qian Wang, Wenhui Jiang, Jianfeng Luo, Jun Tong, Xiaosi Li, Fang Fang, Hongyan Wang, Wenqing Zhao, Diana Koszycki and Jianyin Qiu
    Citation:Trials 2020 21:673
    Content type:Study protocol
     
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  24. Patients living in rural areas experience a variety of unmet needs that result in healthcare disparities. The triple threat of rural geography, racial inequities, and older age hinders access to high-quality p...
    Authors:Kristen Allen Watts, Shena Gazaway, Emily Malone, Ronit Elk, Rodney Tucker, Susan McCammon, Michele Goldhagen, Jacob Graham, Veronica Tassin, Joshua Hauser, Sidney Rhoades, Marjorie Kagawa-Singer, Eric Wallace, James McElligott, Richard Kennedy and Marie Bakitas
    Citation:Trials 2020 21:672
    Content type:Study protocol
     
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  25. Treatment fidelity, defined as ensuring that the recipient receives the intended intervention, is a critical component for accurate estimation of treatment efficacy. Ensuring fidelity and protocol adherence in...
    Authors:Roberta W. Scherer, Sue Ann Erdman, Susan Gold and Craig Formby
    Citation:Trials 2020 21:670
    Content type:Methodology
     
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  26. Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a...
    Authors:Weiming Hao, Liping Zhao, Huiqian Yu and Huawei Li
    Citation:Trials 2020 21:669
    Content type:Study protocol
     
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  27. In sequential and adaptive trials, the delay that happens after the trial is stopped, by a predetermined stopping criterion, takes the name of overrunning. Overrunning consists of extra data, collected by inve...
    Authors:Ileana Baldi, Danila Azzolina, Nicola Soriani, Beatrice Barbetta, Paola Vaghi, Giampaolo Giacovelli, Paola Berchialla and Dario Gregori
    Citation:Trials 2020 21:668
    Content type:Methodology
     
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  28. Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population i...
    Authors:Ioana R. Marian, Esther Williamson, Angela Garrett, Sarah E. Lamb and Susan J. Dutton
    Citation:Trials 2020 21:667
    Content type:Update
     
    Published on: 
  29. To assess the efficacy of local intranasal treatment with budesonide (nasal irrigation), in addition to olfactory rehabilitation, in the management of loss of smell in COVID-19 patients without signs of severi...
    Authors:Mary Daval, Alain Corré, Clement Palpacuer, Juliette Housset, Guillaume Poillon, Michael Eliezer, Benjamin Verillaud, Dorsaf Slama, Denis Ayache, Philippe Herman, Clement Jourdaine, Camille Hervé, Wissame El Bakkouri, Dominique Salmon and Charlotte Hautefort
    Citation:Trials 2020 21:666
    Content type:Letter
     
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  30. In the past two decades, the massive scale-up of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) has led to significant reductions in malaria mortality and morbidity. Nonetheless, the...
    Authors:Guofa Zhou, Ming-chieh Lee, Harrysone E. Atieli, John I. Githure, Andrew K. Githeko, James W. Kazura and Guiyun Yan
    Citation:Trials 2020 21:665
    Content type:Study protocol
     
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  31. Cognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for...
    Authors:Kete M. Klaver, Saskia F. A. Duijts, Chantal A. V. Geusgens, Maureen J. B. Aarts, Rudolf W. H. M. Ponds, Allard J. van der Beek and Sanne B. Schagen
    Citation:Trials 2020 21:664
    Content type:Study protocol
     
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  32. The ability to retrieve specific memories is a cognitive and emotional protective factor. Among the most effective techniques to generate autobiographical memories is the use of audio-visual stimuli, particula...
    Authors:Dolores Fernández, Laura Ros, Roberto Sánchez-Reolid, Jorge Javier Ricarte and José Miguel Latorre
    Citation:Trials 2020 21:663
    Content type:Study protocol
     
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  33. Agitation is common in the early stages of recovery from traumatic brain injury (TBI), when patients are in post-traumatic amnesia (PTA). Agitation is associated with risk of harm to patients and caregivers. R...
    Authors:Ruby K Phyland, Adam McKay, John Olver, Mark Walterfang, Malcolm Hopwood, Amelia J Hicks, Duncan Mortimer and Jennie L Ponsford
    Citation:Trials 2020 21:662
    Content type:Study protocol
     
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  34. Mental health recovery narratives have been defined as first-person lived experience accounts of recovery from mental health problems which refer to events or actions over a period of time and which include el...
    Authors:Stefan Rennick-Egglestone, Rachel Elliott, Melanie Smuk, Clare Robinson, Sylvia Bailey, Roger Smith, Jeroen Keppens, Hannah Hussain, Kristian Pollock, Pim Cuijpers, Joy Llewellyn-Beardsley, Fiona Ng, Caroline Yeo, James Roe, Ada Hui, Lian van der Krieke…
    Citation:Trials 2020 21:661
    Content type:Study protocol
     
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  35. An amendment to this paper has been published and can be accessed via the original article.
    Authors:Grazia Daniela Femminella, Eleni Frangou, Sharon B. Love, Gail Busza, Clive Holmes, Craig Ritchie, Robert Lawrence, Brady McFarlane, George Tadros, Basil H. Ridha, Carol Bannister, Zuzana Walker, Hilary Archer, Elizabeth Coulthard, Ben R. Underwood, Aparna Prasanna…
    Citation:Trials 2020 21:660
    Content type:Correction
     
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    The original article was published in Trials 2019 20:191
  36. There is an unmet need for treatment options in intermediate age-related macular degeneration (iAMD). However, for any new interventions to be tested in clinical trials, novel currently unavailable clinical en...
    Authors:Jan H. Terheyden, Frank G. Holz, Steffen Schmitz-Valckenberg, Anna Lüning, Matthias Schmid, Gary S. Rubin, Hannah Dunbar, Adnan Tufail, David P. Crabb, Alison Binns, Clara I. Sánchez, Carel Hoyng, Philippe Margaron, Nadia Zakaria, Mary Durbin, Ulrich Luhmann…
    Citation:Trials 2020 21:659
    Content type:Study protocol
     
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  37. Nocebo effects (‘negative placebo’ effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets...
    Authors:Nigel Kirby, Victoria Shepherd, Jeremey Howick, Sophie Betteridge and Kerenza Hood
    Citation:Trials 2020 21:658
    Content type:Research
     
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  38. Despite the importance of dairy proteins in modifying of metabolic abnormalities, no attention has been given to their effects on endocannabinoids.
    Authors:Fatemeh Haidari, Vahideh Aghamohammadi, Majid Mohammadshahi, Kambiz Ahmadi-Angali and Mohammad Asghari-Jafarabadi
    Citation:Trials 2020 21:657
    Content type:Research
     
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  39. To inform the design of a clinical trial of a targeted screening programme for relatives of individuals affected by thoracic aortic disease, we performed a consensus exercise as to the acceptability of screeni...
    Authors:R. G. Abbasciano, J. Barwell, R. Sayers, M. Bown, D. Milewicz, G. Cooper, G. Mariscalco, N. Wheeldon, C. Fowler, G. Owens and G. J. Murphy
    Citation:Trials 2020 21:656
    Content type:Research
     
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  40. It is estimated that 55 million adults will be 65 years and older in the USA by 2020. These older adults are at increased risk for injury and their recovery is multi-faceted. A collaborative care model may imp...
    Authors:Damaris Ortiz, Ashley D. Meagher, Heidi Lindroth, Emma Holler, Sujuan Gao, Babar Khan, Sue Lasiter, Malaz Boustani and Ben Zarzaur
    Citation:Trials 2020 21:655
    Content type:Study protocol
     
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  41. HIV disproportionately affects men who have sex with men (MSM) in the USA, and new infections continue to increase, particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Rates of HIV testing ...
    Authors:Tyler B. Wray, Philip A. Chan, Jeffrey D. Klausner, Leandro A. Mena, James B. Brock, Erik M. Simpanen, Lori M. Ward and Stafylis Chrysovalantis
    Citation:Trials 2020 21:654
    Content type:Study protocol
     
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  42. Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. The STADPLAN study assesses the effects of conversations on advance care planning (A...
    Authors:Katharina Silies, Rieke Schnakenberg, Almuth Berg, Änne Kirchner, Henriette Langner, Juliane Köberlein-Neu, Gabriele Meyer, Falk Hoffmann and Sascha Köpke
    Citation:Trials 2020 21:653
    Content type:Study protocol
     
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  43. There is limited evidence that rituximab, a B cell depletion therapy, is an effective treatment for systemic lupus erythematosus (SLE). Data on the mechanisms of B cell depletion in SLE indicate that the combi...
    Authors:Patrick Muller, Kashfia Chowdhury, Caroline Gordon, Michael R. Ehrenstein and Caroline J. Doré
    Citation:Trials 2020 21:652
    Content type:Update
     
    Published on: 

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