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Off label use of Aripiprazole shows promise as a treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): a retrospective study of 101 patients treated with a low dose of Aripiprazole

JOURNAL OF TRANSLATIONAL MEDICINE (2021)

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JOURNAL OF TRANSLATIONAL MEDICINE

卷 19, 期 1, 页码 -

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BMC

DOI: 10.1186/s12967-021-02721-9

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Medicine, Research & Experimental

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NIAID NIH HHS [R25 AI147369] Funding Source: Medline

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Off label use of Aripiprazole shows promise as a treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): a retrospective study of 101 patients treated with a low dose of Aripiprazole (vol 19, 50, 2021)

L. D. Crosby, S. Kalanidhi, A. Bonilla, A. Subramanian, J. S. Ballon, H. Bonilla

Summary: The amendment to the paper has been published and can be accessed through the original article.

JOURNAL OF TRANSLATIONAL MEDICINE (2021)

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Review Immunology

The Gut Microbiome in Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)

Rahel S. Konig, Werner C. Albrich, Christian R. Kahlert, Lina Samira Bahr, Ulrike Lober, Pietro Vernazza, Carmen Scheibenbogen, Sofia K. Forslund

Summary: Myalgic encephalomyelitis (ME) or Chronic Fatigue Syndrome (CFS) is a neglected, debilitating disease with unclear etiology and pathophysiology. The gut microbiome may play a role in CFS and further research is needed to explore potential diagnostic and therapeutic approaches.

FRONTIERS IN IMMUNOLOGY (2022)

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Review Pharmacology & Pharmacy

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): Where will the drugs come from?

Peter L. Toogood, Daniel J. Clauw, Sameer Phadke, David Hoffman

Summary: ME/CFS is a chronic debilitating disease characterized by severe fatigue, pain, sleep disruption, and cognitive dysfunction. Current treatments focus on symptom management and addressing psychological sequelae, with ongoing efforts towards identifying effective therapies and understanding the mechanistic basis of the disease.

PHARMACOLOGICAL RESEARCH (2021)

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Article Multidisciplinary Sciences

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): A preliminary survey among patients in Switzerland

Rea Tschopp, Rahel S. Konig, Protazy Rejmer, Daniel H. Paris

Summary: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a poorly understood chronic debilitating disease. A survey conducted in Switzerland revealed that the majority of ME/CFS patients were females, single and without children. Many patients reported a progressively worsening condition, with infectious diseases and viral infections being common triggering factors. Patients experienced various symptoms and suffered from co-morbidities.

HELIYON (2023)

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Article Chemistry, Medicinal

The Occurrence of Hyperactivated Platelets and Fibrinaloid Microclots in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Jean M. Nunes, Arneaux Kruger, Amy Proal, Douglas B. Kell, Etheresia Pretorius

Summary: The study found that individuals with ME/CFS exhibit significant changes in coagulability, platelet hyperactivation, and fibrinaloid microclot formation. However, the fibrinaloid microclot load is not as severe as in Long COVID/PASC. Fibrinaloid microclots may contribute to ME/CFS symptoms, such as fatigue, by temporarily blocking microcapillaries and causing ischemia. Additionally, fibrinaloid microclots may damage the endothelium. The discovery of these biomarkers is important for ME/CFS research and suggests potential treatment strategies targeting systemic vascular pathology and endothelial inflammation.

PHARMACEUTICALS (2022)

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Article Health Care Sciences & Services

Evaluation of a Webinar to Increase Health Professionals' Knowledge about Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Laura Froehlich, Jasmin Niedrich, Daniel B. R. Hattesohl, Uta Behrends, Claudia Kedor, Johannes-Peter Haas, Michael Stingl, Carmen Scheibenbogen

Summary: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe chronic illness that is often not properly addressed by healthcare professionals in Germany and other countries due to their lack of knowledge about the condition. This research aimed to fill this knowledge gap by providing a webinar for German-speaking health professionals, which resulted in an increase in knowledge about ME/CFS among participants.

HEALTHCARE (2023)

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Article Medicine, Research & Experimental

Natural killer cytotoxicity in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): a multi-site clinical assessment of ME/CFS (MCAM) sub-study

Troy Querec, Jin-Mann S. Lin, Yang Chen, Britany Helton, Andreas Kogelnik, Nancy Klimas, Daniel Peterson, Lucinda Bateman, Charles Lapp, Richard Podell, Benjamin Natelson, Elizabeth Unger

Summary: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a multisystem illness characterized by reduced function and unexplained fatigue. The study found that reduced natural killer (NK) cell count and cytotoxicity, which have been investigated as potential biomarkers for ME/CFS, do not show statistically significant differences between patients with ME/CFS and healthy controls. The results suggest that more studies are needed to explore other immune parameters that may be involved in the pathophysiology of ME/CFS.

JOURNAL OF TRANSLATIONAL MEDICINE (2023)

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Article Public, Environmental & Occupational Health

Prevalence of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in Australian primary care patients: only part of the story?

Nneka Orji, Julie A. Campbell, Karen Wills, Martin Hensher, Andrew J. Palmer, Melissa Rogerson, Ryan Kelly, Barbara de Graaff

Summary: This study reported the prevalence of ME/CFS in Australian primary care settings from 2015 to 2019. Qualitative evidence highlighted barriers to diagnosis and limited interactions with primary care. Prevalence rates varied across different age and gender groups.

BMC PUBLIC HEALTH (2022)

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Review Hematology

Cardiovascular and haematological pathology in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): A role for viruses

Jean M. Nunes, Douglas B. Kell, Etheresia Pretorius

Summary: ME/CFS is a chronic condition that often develops after viral or bacterial infection, and studying Long COVID/PASC could provide insights into the pathophysiological mechanisms of ME/CFS. Both conditions share similar disease presentations, with some Long COVID patients meeting the diagnostic criteria for ME/CFS. Cardiovascular and hematological abnormalities, including endothelial dysfunction and clotting processes, are present in ME/CFS cohorts. Dysfunction in the autonomic nervous system may contribute to cardiac abnormalities in ME/CFS. It is important to determine the contribution of these abnormalities to symptom severity and explore therapeutic targets in the cardiovascular and hematological systems.

BLOOD REVIEWS (2023)

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Article Medicine, General & Internal

Shadow Burden of Undiagnosed Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) on Society: Retrospective and Prospective-In Light of COVID-19

Diana Araja, Uldis Berkis, Asja Lunga, Modra Murovska

Summary: ME/CFS is a complex disorder with severe fatigue and other symptoms, causing substantial reductions in functional activity and quality of life. The study investigates undiagnosed ME/CFS patients, with a focus on potential post-viral CFS as a consequence of COVID-19. Results show that former COVID-19 patients report more anxiety and fatigue symptoms compared to ME/CFS patients and undiagnosed patients.

JOURNAL OF CLINICAL MEDICINE (2021)

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Article Medicine, General & Internal

Health, Wellbeing, and Prognosis of Australian Adolescents with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Case-Controlled Follow-Up Study

Elisha K. Josev, Rebecca C. Cole, Adam Scheinberg, Katherine Rowe, Lionel Lubitz, Sarah J. Knight

Summary: The majority of Australian adolescents with ME/CFS continue to fulfill diagnostic criteria at follow-up, with fatigue, pain, and health-related quality of life representing domains particularly relevant to perpetuation of ME/CFS symptoms in the early years following diagnosis. This highlights the need for early intervention and realistic prognosis for young people with ME/CFS.

JOURNAL OF CLINICAL MEDICINE (2021)

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Review Medicine, Research & Experimental

Pathophysiology of skeletal muscle disturbances in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Klaus J. Wirth, Carmen Scheibenbogen

Summary: ME/CFS is hypothesized to be caused by autonomic nervous system dysfunction and vascular dysregulation due to β2AdR dysfunction, resulting in excessive release of vasoconstrictors in skeletal muscles. The bioenergetic disturbance in skeletal muscle contributes to postexertional malaise, exercise intolerance, and disease chronification.

JOURNAL OF TRANSLATIONAL MEDICINE (2021)

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Article Orthopedics

Possible involvement of the autonomic nervous system in cervical muscles of patients with myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS)

Takayoshi Matsui, Kazuhiro Hara, Makoto Iwata, Shuntaro Hojo, Nobuyuki Shitara, Yuzo Endo, Hideoki Fukuoka, Masaki Matsui, Hiroshi Kawaguchi

Summary: This observational study investigated the pathophysiology of ME/CFS by comparing patients with and without recovery through local modulation of the cervical muscles. The results showed a strong association between the recovery of ME/CFS and other whole-body symptoms, potentially linked to improvement of the autonomic nervous system in the cervical muscles. Recovery rates were consistent across sex, age strata, and hospitalization period.

BMC MUSCULOSKELETAL DISORDERS (2021)

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Review Medicine, General & Internal

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): An Overview

Undine-Sophie Deumer, Angelica Varesi, Valentina Floris, Gabriele Savioli, Elisa Mantovani, Paulina Lopez-Carrasco, Gian Marco Rosati, Sakshi Prasad, Giovanni Ricevuti

Summary: ME/CFS is a chronic systemic disease with various complex symptoms and varying severity. There are currently no reliable biomarkers for diagnosis, and the pathogenesis of the disease may be related to infectious, genetic, hormonal factors, gut microbiota, and non-coding RNA.

JOURNAL OF CLINICAL MEDICINE (2021)

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Article Multidisciplinary Sciences

Potential role of microbiome in Chronic Fatigue Syndrome/Myalgic Encephalomyelits (CFS/ME)

Giuseppe Francesco Damiano Lupo, Gabriele Rocchetti, Luigi Lucini, Lorenzo Lorusso, Elena Manara, Matteo Bertelli, Edoardo Puglisi, Enrica Capelli

Summary: The study revealed significant differences in the intestinal microbiota and metabolomic profile between CFS/ME patients and healthy controls, indicating characteristics of dysbiosis. Specific microbial compositions were observed in the oral and fecal samples of CFS/ME patients, along with abnormal levels of certain substances detected in the metabolomic analysis. Further research is needed to determine the causality and potential relationship between microbial changes and the onset of CFS/ME, as well as their association with secondary symptoms.

SCIENTIFIC REPORTS (2021)

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Article Immunology

Long-Term Accuracy of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Interferon-γ Release Assay and Its Application in Household Investigation

Kanagavel Murugesan, Prasanna Jagannathan, Jonathan Altamirano, Yvonne A. Maldonado, Hector F. Bonilla, Karen B. Jacobson, Julie Parsonnet, Jason R. Andrews, Run-Zhang Shi, Scott Boyd, Benjamin A. Pinsky, Upinder Singh, Niaz Banaei

Summary: SARS-CoV-2 immunodiagnostics, such as the interferon-gamma release assay, are important for identifying infected individuals and assessing vaccine response. This study demonstrates that the assay maintains sensitivity up to 10 months post-infection and detects more household contacts than IgG.

CLINICAL INFECTIOUS DISEASES (2022)

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Article Immunology

Favipiravir for Treatment of Outpatients With Asymptomatic or Uncomplicated Coronavirus Disease 2019: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial

Marisa Holubar, Aruna Subramanian, Natasha Purington, Haley Hedlin, Bryan Bunning, Katharine S. Walter, Hector Bonilla, Athanasia Boumis, Michael Chen, Kimberly Clinton, Liisa Dewhurst, Carol Epstein, Prasanna Jagannathan, Richard H. Kaszynski, Lori Panu, Julie Parsonnet, Elizabeth L. Ponder, Orlando Quintero, Elizabeth Sefton, Upinder Singh, Luke Soberanis, Henry Truong, Jason R. Andrews, Manisha Desai, Chaitan Khosla, Yvonne Maldonado

Summary: This study found that commonly used doses of favipiravir did not show significant effectiveness in treating uncomplicated COVID-19 in outpatient settings. Further research is needed to determine if higher doses of favipiravir are effective and safe for patients with COVID-19.

CLINICAL INFECTIOUS DISEASES (2022)

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Article Infectious Diseases

Inflammatory but not respiratory symptoms are associated with ongoing upper airway viral shedding in outpatients with uncomplicated COVID-19

Karen B. Jacobson, Natasha Purington, Julie Parsonnet, Jason Andrews, Vidhya Balasubramanian, Hector Bonilla, Karlie Edwards, Manisha Desai, Upinder Singh, Haley Hedlin, Prasanna Jagannathan

Summary: The study found that most COVID-19 patients had a prolonged time to symptom resolution and viral shedding cessation. SARS-CoV-2 IgG seropositivity at enrollment was associated with faster resolution of viral shedding, but not with symptom resolution. Inflammatory symptoms were significantly associated with oropharyngeal viral detection, while respiratory symptoms were not.

DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE (2022)

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Article Immunology

Comparative Analysis of Extracellular Vesicles in Patients with Severe and Mild Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Hector Bonilla, Dylan Hampton, Erika G. Marques de Menezes, Xutao Deng, Jose G. Montoya, Jill Anderson, Philip J. Norris

Summary: Myalgic encephalomyelitis, or chronic fatigue syndrome (ME/CFS), is a serious disease with an unknown cause and objective markers. This study found potential dysregulation of B cell and platelet activation or homeostasis in ME/CFS patients, which could be important for diagnosis and treatment.

FRONTIERS IN IMMUNOLOGY (2022)

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Article Biology

Early immune markers of clinical, virological, and immunological outcomes in patients with COVID-19: a multi-omics study

Zicheng Hu, Kattria van der Ploeg, Saborni Chakraborty, Prabhu S. Arunachalam, Diego A. M. Mori, Karen B. Jacobson, Hector Bonilla, Julie Parsonnet, Jason R. Andrews, Marisa Holubar, Aruna Subramanian, Chaitan Khosla, Yvonne Maldonado, Haley Hedlin, Lauren de la Parte, Kathleen Press, Maureen Ty, Gene S. Tan, Catherine Blish, Saki Takahashi, Isabel Rodriguez-Barraquer, Bryan Greenhouse, Atul J. Butte, Upinder Singh, Bali Pulendran, Taia T. Wang, Prasanna Jagannathan, Miles P. Davenport

Summary: Using host proteomics and transcriptomics, the trajectory of immune response in COVID-19 patients was characterized. Early immune markers were found to be associated with disease progression, control of viral shedding, and SARS-CoV-2-specific T cell and antibody responses. Machine-learning models accurately predicted patient outcomes.

ELIFE (2022)

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Article Clinical Neurology

Characterization of autonomic symptom burden in long COVID: A global survey of 2,314 adults

Nicholas W. Larsen, Lauren E. Stiles, Ruba Shaik, Logan Schneider, Srikanth Muppidi, Cheuk To Tsui, Linda N. Geng, Hector Bonilla, Mitchell G. Miglis

Summary: This study assessed the prevalence, severity, and risk factors of autonomic dysfunction in PASC patients and found that 66% of patients had moderate to severe autonomic dysfunction. Furthermore, the study also found that the severity of autonomic dysfunction was not associated with the severity of acute COVID-19 illness.

FRONTIERS IN NEUROLOGY (2022)

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Article Medicine, Research & Experimental

Establishing a consensus on ME/CFS exclusionary illnesses

Leonard A. Jason, Suvetha Ravichandran, Ben Z. Z. Katz, Benjamin H. Natelson, Hector Fabio Bonilla

Summary: In the diagnosis of ME/CFS, it is important to exclude other conditions that could be causing the symptoms. Standardizing the exclusionary conditions is crucial for consistency and reproducibility in research studies. A consensus list of exclusionary comorbid conditions has been created, consisting of 14 categories and 53 specific examples.

FATIGUE-BIOMEDICINE HEALTH AND BEHAVIOR (2023)

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Article Immunology

Evaluation of Acebilustat, a Selective Inhibitor of Leukotriene B4 Biosynthesis, for Treatment of Outpatients With Mild-Moderate Coronavirus Disease 2019 (COVID-19): A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

Joseph E. Levitt, Haley Hedlin, Sophie Duong, Di Lu, Justin Lee, Bryan Bunning, Nadia Elkarra, Benjamin A. Pinsky, Eileen Heffernan, Eric Springman, Richard B. Moss, Hector F. Bonilla, Julie Parsonnet, Roham T. Zamanian, Jamison J. Langguth, Jenna Bollyky, Chaitan Khosla, Mark R. Nicolls, Manisha Desai, Angela J. Rogers

Summary: The study aimed to evaluate the effectiveness of Acebilustat in treating outpatients with COVID-19, and the results showed that the medication did not shorten symptom duration.

CLINICAL INFECTIOUS DISEASES (2023)

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Article Medicine, General & Internal

Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection

Tanayott Thaweethai, Sarah E. Jolley, Elizabeth W. Karlson, Emily B. Levitan, Bruce Levy, Grace A. McComsey, Lisa McCorkell, Girish N. Nadkarni, Sairam Parthasarathy, Upinder Singh, Tiffany A. Walker, Caitlin A. Selvaggi, Daniel J. Shinnick, Carolin C. M. Schulte, Rachel Atchley-Challenner, Leora I. Horwitz, Andrea S. Foulkes

Summary: SARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, known as postacute sequelae of SARS-CoV-2 infection (PASC), or long COVID. This study developed a definition of PASC based on self-reported symptoms and described the frequencies of PASC across cohorts, vaccination status, and number of infections.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2023)

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Reductions in synaptic marker SV2A in early-course Schizophrenia

Jong H. Yoon, Zhener Zhang, Elizabeth Mormino, Guido Davidzon, Michael J. Minzenberg, Jacob Ballon, Agnieszka Kalinowski, Kate Hardy, Mika Naganawa, Richard E. Carson, Mehdi Khalighi, Jun Hyung Park, Douglas F. Levinson, Frederick T. Chin

Summary: Excess synaptic pruning during neurodevelopment is a leading hypothesis for schizophrenia, and the availability of the first-in-human in vivo synaptic marker allows for precise testing of this hypothesis. This study found significant reductions in binding in early-course schizophrenia patients, replicating findings from chronic patients. These results add to the growing evidence that excess synaptic pruning is a major disease mechanism for schizophrenia.

JOURNAL OF PSYCHIATRIC RESEARCH (2023)

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Review Immunology

Therapeutic trials for long COVID-19: A call to action from the interventions taskforce of the RECOVER initiative

Hector Bonilla, Michael J. Peluso, Kathleen Rodgers, Judith A. Aberg, Thomas F. Patterson, Robert Tamburro, Lawrence Baizer, Jason D. Goldman, Nadine Rouphael, Amelia Deitchman, Jeffrey Fine, Paul Fontelo, Arthur Y. Kim, Gwendolyn Shaw, Jeran Stratford, Patricia Ceger, Maged M. Costantine, Liza Fisher, Lisa O'Brien, Christine Maughan, John G. Quigley, Vilma Gabbay, Sindhu Mohandas, David Williams, Grace A. McComsey

Summary: Although most individuals recover from acute SARS-CoV-2 infection, a significant number continue to suffer from long-term symptoms known as long COVID. Ongoing pathobiology studies have provided clues to potential mechanisms contributing to this condition, including persistent viral material, immune dysregulation, and gut dysbiosis. Therapeutic trials targeting these biological pathways are needed, but off-label experimentation in uncontrolled settings should be discouraged.

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Low-dose naltrexone use for the management of post-acute sequelae of COVID-19

Hector Bonilla, Lu Tian, Vincent C. Marconi, Robert Shafer, Grace A. Mccomsey, Mitchel Miglis, Philip Yang, Andres Bonilla, Lauren Eggert, Linda N. Geng

Summary: The global prevalence of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) is approximately 43%, while in the United States, around 11% of individuals who have been infected with SARSCoV-2 experience long COVID. The underlying causes of PASC are still under investigation, and there are currently no FDA-approved therapies. Naltrexone, a medication with anti-inflammatory and immunomodulatory properties, has shown potential as a therapeutic intervention for PASC, but further rigorous clinical trials are needed.

INTERNATIONAL IMMUNOPHARMACOLOGY (2023)

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Article Medicine, General & Internal

Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection

Tanayott R. Thaweethai, Sarah E. Jolley, Elizabeth Karlson, Emily M. Levitan, Bruce Levy, Grace McComsey, Lisa S. McCorkell, Girish D. Nadkarni, Sairam E. Parthasarathy, Upinder J. Singh, Tiffany Walker, Caitlin W. Selvaggi, Daniel Shinnick, Carolin C. M. P. Schulte, Rachel M. Atchley-Challenner, Leora Horwitz, Andrea Foulkes

Summary: This study aims to develop a definition of postacute sequelae of SARS-CoV-2 infection (PASC) using self-reported symptoms and analyze the frequencies of PASC across different cohorts, vaccination status, and number of infections. The results show that PASC is associated with various symptoms and around 10% of participants were PASC positive at 6 months after infection.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2023)

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TNF-a+ CD4+ T cells dominate the SARS-CoV-2 specific T cell response in COVID-19 outpatients and are associated with durable antibodies

Kattria van der Ploeg, Adam S. Kirosingh, Diego A. M. Mori, Saborni Chakraborty, Zicheng Hu, Benjamin L. Sievers, Karen B. Jacobson, Hector Bonilla, Julie Parsonnet, Jason R. Andrews, Kathleen D. Press, Maureen C. Ty, Daniel R. Ruiz-Betancourt, Lauren de la Parte, Gene S. Tan, Catherine A. Blish, Saki Takahashi, Isabel Rodriguez-Barraquer, Bryan Greenhouse, Upinder Singh, Taia T. Wang, Prasanna Jagannathan

Summary: This study explores the dynamics of SARS-CoV-2-specific CD4(+) T cells in COVID-19 patients and their correlation with neutralizing antibodies. The results show a shift in the quality of the CD4(+) T cell response over time, with TNF-alpha-producing cells becoming predominant. Higher percentages of TNF-alpha-producing CD4(+) T cells on day 28 correlate with higher levels of neutralizing antibodies. mRNA vaccination after SARS-CoV-2 infection enhances both IFN gamma and TNF-alpha-producing CD4(+) T cells.

CELL REPORTS MEDICINE (2022)

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Article Medicine, Research & Experimental

Gastrointestinal symptoms and fecal shedding of SARS-CoV-2 RNA suggest prolonged gastrointestinal infection

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Summary: This study found that SARS-CoV-2 viral RNA can persist in feces for up to 7 months in individuals with mild to moderate COVID-19. Furthermore, patients with gastrointestinal symptoms are more likely to shed viral RNA in their feces.

MED (2022)

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Off label use of Aripiprazole shows promise as a treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): a retrospective study of 101 patients treated with a low dose of Aripiprazole

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