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Article ; Online: Targeting Macrophage Dysregulation for Viral Infections: Novel Targets for Immunomodulators.

Reece, Monica D / Taylor, Ruby R / Song, Colin / Gavegnano, Christina

2021 Volume 12, Page(s) 768695

Abstract: A major barrier to human immunodeficiency virus (HIV-1) cure is the latent viral reservoir, which persists despite antiretroviral therapy (ART), including across the non-dividing myeloid reservoir which is found systemically in sanctuary sites across ... ...

Abstract	A major barrier to human immunodeficiency virus (HIV-1) cure is the latent viral reservoir, which persists despite antiretroviral therapy (ART), including across the non-dividing myeloid reservoir which is found systemically in sanctuary sites across tissues and the central nervous system (CNS). Unlike activated CD4+ T cells that undergo rapid cell death during initial infection (due to rapid viral replication kinetics), viral replication kinetics are delayed in non-dividing myeloid cells, resulting in long-lived survival of infected macrophages and macrophage-like cells. Simultaneously, persistent inflammation in macrophages confers immune dysregulation that is a key driver of co-morbidities including cardiovascular disease (CVD) and neurological deficits in people living with HIV-1 (PLWH). Macrophage activation and dysregulation is also a key driver of disease progression across other viral infections including SARS-CoV-2, influenza, and chikungunya viruses, underscoring the interplay between macrophages and disease progression, pathogenesis, and comorbidity in the viral infection setting. This review discusses the role of macrophages in persistence and pathogenesis of HIV-1 and related comorbidities, SARS-CoV-2 and other viruses. A special focus is given to novel immunomodulatory targets for key events driving myeloid cell dysregulation and reservoir maintenance across a diverse array of viral infections.
MeSH term(s)	COVID-19/immunology ; HIV Infections/immunology ; HIV-1/immunology ; Humans ; Immunologic Factors/immunology ; Macrophages/immunology ; SARS-CoV-2/immunology ; Virus Diseases/immunology
Chemical Substances	Immunologic Factors
Language	English
Publishing date	2021-11-01
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2021.768695
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Article ; Online: Honokiol hexafluoro confers reversal of neuropathological markers of HIV infection in a murine SCID model.

Zhang, Zhan / Scanlan, Aaron / Koneru, Rajeth / Morrell, Chelsea Richardson / Reece, Monica D / Edwards, Emily / Roa, Sebastian / Gavegnano, Christina / Bimonte-Nelson, Heather / Arbiser, Jack / Tyor, William

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics

2024 Volume 21, Issue 2, Page(s) e00329

Abstract: Cognitive impairment remains a persistent challenge in people living with HIV (PWLH) despite antiretroviral therapy (ART) due to ART's inability to eliminate brain HIV. HIV-induced cognitive dysfunction results from immune dysregulation, ongoing ... ...

Abstract	Cognitive impairment remains a persistent challenge in people living with HIV (PWLH) despite antiretroviral therapy (ART) due to ART's inability to eliminate brain HIV. HIV-induced cognitive dysfunction results from immune dysregulation, ongoing neuroinflammation, and the continuous virus presence, collectively contributing to cognitive deficits. Therefore, adjunctive therapies are needed to reduce cerebral HIV reservoirs, mitigate neuroinflammation, and impede cognitive dysfunction progression. Our study focused on Honokiol, known for its anti-inflammatory and neuroprotective properties, in an experimental mouse model simulating HIV-induced cognitive dysfunction. Using Honokiol Hexafluoro (HH), a synthetic analogue, we comprehensively evaluated its potential to ameliorate cognitive dysfunction and cerebral pathology in HIV-associated cognitive dysfunction. Our findings showed that HH treatment effectively reversed HIV-induced cognitive dysfunction, concurrently suppressing astrocyte activation, restoring neuronal dendritic arborization, and reducing microglial activation. Furthermore, HH remodeled the metabolic profile of HIV-infected human monocyte-derived macrophages, resulting in decreased activation and the promotion of a quiescent state in vitro.
MeSH term(s)	Humans ; Mice ; Animals ; HIV Infections/complications ; HIV Infections/drug therapy ; HIV Infections/pathology ; Neuroinflammatory Diseases ; Mice, SCID ; Macrophages ; Allyl Compounds ; Biphenyl Compounds ; Phenols
Chemical Substances	honokiol (11513CCO0N) ; Allyl Compounds ; Biphenyl Compounds ; Phenols
Language	English
Publishing date	2024-02-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	2316693-9
ISSN	1878-7479 ; 1933-7213
ISSN (online)	1878-7479
ISSN	1933-7213
DOI	10.1016/j.neurot.2024.e00329
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Article ; Online: Ex Vivo Differentiation of Resting CD4+ T Lymphocytes Enhances Detection of Replication Competent HIV-1 in Viral Outgrowth Assays.

Wonderlich, Elizabeth R / Reece, Monica D / Kulpa, Deanna A

Methods in molecular biology (Clifton, N.J.)

2019 Volume 2407, Page(s) 315–331

Abstract: Quantifying the number of cells harboring inducible and replication competent HIV-1 provirus is critical to evaluating HIV-1 cure interventions, but precise quantification of the latent reservoir has proven to be technically challenging. Existing ... ...

Abstract	Quantifying the number of cells harboring inducible and replication competent HIV-1 provirus is critical to evaluating HIV-1 cure interventions, but precise quantification of the latent reservoir has proven to be technically challenging. Existing protocols to quantify the frequency of replication-competent HIV-1 in resting CD4+ T cells from long-term ART treated individuals have helped to investigate the dynamics of reservoir stability, however these approaches have significant barriers to the induction of HIV-1 expression required to effectively evaluate the intact reservoir. Differentiation of CD4+ T cells to an effector memory phenotype is a successful strategy for promoting latency reversal in vitro, and significantly enhances the performance and sensitivity of viral outgrowth assays.
MeSH term(s)	CD4-Positive T-Lymphocytes/metabolism ; Cell Differentiation ; HIV Infections ; HIV-1 ; Humans ; Proviruses ; Viral Load ; Virus Latency ; Virus Replication
Language	English
Publishing date	2019-11-22
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ISSN	1940-6029
ISSN (online)	1940-6029
DOI	10.1007/978-1-0716-1871-4_21
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Article ; Online: Repurposing BCL-2 and Jak 1/2 inhibitors: Cure and treatment of HIV-1 and other viral infections.

Reece, Monica D / Song, Colin / Hancock, Sarah C / Pereira Ribeiro, Susan / Kulpa, Deanna A / Gavegnano, Christina

Frontiers in immunology

2022 Volume 13, Page(s) 1033672

Abstract: B cell lymphoma 2 (BCL-2) family proteins are involved in the mitochondrial apoptotic pathway and are key modulators of cellular lifespan, which is dysregulated during human immunodeficiency virus type 1 (HIV-1) and other viral infections, thereby ... ...

Abstract	B cell lymphoma 2 (BCL-2) family proteins are involved in the mitochondrial apoptotic pathway and are key modulators of cellular lifespan, which is dysregulated during human immunodeficiency virus type 1 (HIV-1) and other viral infections, thereby increasing the lifespan of cells harboring virus, including the latent HIV-1 reservoir. Long-lived cells harboring integrated HIV-1 DNA is a major barrier to eradication. Strategies reducing the lifespan of reservoir cells could significantly impact the field of cure research, while also providing insight into immunomodulatory strategies that can crosstalk to other viral infections. Venetoclax is a first-in-class orally bioavailable BCL-2 homology 3 (BH3) mimetic that recently received Food and Drug Administration (FDA) approval for treatment in myeloid and lymphocytic leukemia. Venetoclax has been recently investigated in HIV-1 and demonstrated anti-HIV-1 effects including a reduction in reservoir size. Another immunomodulatory strategy towards reduction in the lifespan of the reservoir is Jak 1/2 inhibition. The Jak STAT pathway has been implicated in BCL-2 and interleukin 10 (IL-10) expression, leading to a downstream effect of cellular senescence. Ruxolitinib and baricitinib are FDA-approved, orally bioavailable Jak 1/2 inhibitors that have been shown to indirectly decay the HIV-1 latent reservoir, and down-regulate markers of HIV-1 persistence, immune dysregulation and reservoir lifespan
MeSH term(s)	United States ; Humans ; HIV Infections ; Virus Latency ; HIV-1 ; Janus Kinases/metabolism ; Drug Repositioning ; Signal Transduction ; COVID-19 ; STAT Transcription Factors/metabolism ; Proto-Oncogene Proteins c-bcl-2/metabolism
Chemical Substances	venetoclax (N54AIC43PW) ; ruxolitinib (82S8X8XX8H) ; baricitinib (ISP4442I3Y) ; Janus Kinases (EC 2.7.10.2) ; STAT Transcription Factors ; Proto-Oncogene Proteins c-bcl-2
Language	English
Publishing date	2022-12-09
Publishing country	Switzerland
Document type	Journal Article ; Review ; Research Support, N.I.H., Extramural
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.1033672
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Article ; Online: Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma.

Munshi, Nikhil C / Anderson, Larry D / Shah, Nina / Madduri, Deepu / Berdeja, Jesús / Lonial, Sagar / Raje, Noopur / Lin, Yi / Siegel, David / Oriol, Albert / Moreau, Philippe / Yakoub-Agha, Ibrahim / Delforge, Michel / Cavo, Michele / Einsele, Hermann / Goldschmidt, Hartmut / Weisel, Katja / Rambaldi, Alessandro / Reece, Donna /

Petrocca, Fabio / Massaro, Monica / Connarn, Jamie N / Kaiser, Shari / Patel, Payal / Huang, Liping / Campbell, Timothy B / Hege, Kristen / San-Miguel, Jesús

The New England journal of medicine

2021 Volume 384, Issue 8, Page(s) 705–716

Abstract: Background: Idecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic effects in patients with relapsed and ... ...

Abstract	Background: Idecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic effects in patients with relapsed and refractory multiple myeloma. Methods: In this phase 2 study, we sought to confirm the efficacy and safety of ide-cel in patients with relapsed and refractory myeloma. Patients with disease after at least three previous regimens including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody were enrolled. Patients received ide-cel target doses of 150 × 10 Results: Of 140 patients enrolled, 128 received ide-cel. At a median follow-up of 13.3 months, 94 of 128 patients (73%) had a response, and 42 of 128 (33%) had a complete response or better. Minimal residual disease (MRD)-negative status (<10 Conclusions: Ide-cel induced responses in a majority of heavily pretreated patients with refractory and relapsed myeloma; MRD-negative status was achieved in 26% of treated patients. Almost all patients had grade 3 or 4 toxic effects, most commonly hematologic toxic effects and cytokine release syndrome. (Funded by bluebird bio and Celgene, a Bristol-Myers Squibb company; KarMMa ClinicalTrials.gov number, NCT03361748.).
MeSH term(s)	Adult ; Aged ; Biomarkers/blood ; Cytokine Release Syndrome/etiology ; Drug Resistance, Neoplasm ; Female ; Hematologic Diseases/chemically induced ; Humans ; Immunotherapy, Adoptive/adverse effects ; Male ; Middle Aged ; Multiple Myeloma/immunology ; Multiple Myeloma/therapy ; Progression-Free Survival ; Receptors, Chimeric Antigen/therapeutic use ; Recurrence
Chemical Substances	Biomarkers ; Receptors, Chimeric Antigen ; idecabtagene vicleucel (8PX1X7UG4D)
Language	English
Publishing date	2021-02-24
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2024850
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Article ; Online: In situ Study Unravels Bio-Nanomechanical Behavior in a Magnetic Bacterial Nano-cellulose (MBNC) Hydrogel for Neuro-Endovascular Reconstruction.

Pavón, Juan Jose / Allain, Jean Paul / Verma, Devendra / Echeverry-Rendón, Mónica / Cooper, Christy L / Reece, Lisa M / Shetty, Akshath R / Tomar, Vikas

Macromolecular bioscience

2018 Volume 19, Issue 2, Page(s) e1800225

Abstract: Surgical clipping and endovascular coiling are well recognized as conventional treatments of Penetrating Brain Injury aneurysms. These clinical approaches show partial success, but often result in thrombus formation and the rupture of aneurysm near ... ...

Abstract	Surgical clipping and endovascular coiling are well recognized as conventional treatments of Penetrating Brain Injury aneurysms. These clinical approaches show partial success, but often result in thrombus formation and the rupture of aneurysm near arterial walls. The authors address these challenging brain traumas with a unique combination of a highly biocompatible biopolymer hydrogel rendered magnetic in a flexible and resilient membrane coating integrated to a scaffold stent platform at the aneurysm neck orifice, which enhances the revascularization modality. This work focuses on the in situ diagnosis of nano-mechanical behavior of bacterial nanocellulose (BNC) membranes in an aqueous environment used as tissue reconstruction substrates for cerebral aneurysmal neck defects. Nano-mechanical evaluation, performed using instrumented nano-indentation, shows with very low normal loads between 0.01 to 0.5 mN, in the presence of deionized water. Mechanical testing and characterization reveals that the nano-scale response of BNC behaves similar to blood vessel walls with a very low Young´s modulus, E (0.0025 to 0.04 GPa), and an evident creep effect (26.01 ± 3.85 nm s
MeSH term(s)	Cellulose/therapeutic use ; Cerebral Revascularization/methods ; Endovascular Procedures/adverse effects ; Endovascular Procedures/methods ; Gluconacetobacter xylinus/metabolism ; Humans ; Hydrogels/therapeutic use ; Intracranial Aneurysm/physiopathology ; Intracranial Aneurysm/surgery ; Magnetite Nanoparticles/therapeutic use ; Mechanical Phenomena ; Surgical Instruments
Chemical Substances	Hydrogels ; Magnetite Nanoparticles ; Cellulose (9004-34-6)
Language	English
Publishing date	2018-11-19
Publishing country	Germany
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2039130-4
ISSN	1616-5195 ; 1616-5187
ISSN (online)	1616-5195
ISSN	1616-5187
DOI	10.1002/mabi.201800225
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Article ; Online: Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial.

Grosicki, Sebastian / Simonova, Maryana / Spicka, Ivan / Pour, Ludek / Kriachok, Iryrna / Gavriatopoulou, Maria / Pylypenko, Halyna / Auner, Holger W / Leleu, Xavier / Doronin, Vadim / Usenko, Ganna / Bahlis, Nizar J / Hajek, Roman / Benjamin, Reuben / Dolai, Tuphan K / Sinha, Dinesh K / Venner, Christopher P / Garg, Mamta / Gironella, Mercedes /

Jurczyszyn, Artur / Robak, Pawel / Galli, Monica / Wallington-Beddoe, Craig / Radinoff, Atanas / Salogub, Galina / Stevens, Don A / Basu, Supratik / Liberati, Anna M / Quach, Hang / Goranova-Marinova, Vesselina S / Bila, Jelena / Katodritou, Eirini / Oliynyk, Hanna / Korenkova, Sybiryna / Kumar, Jeevan / Jagannath, Sundar / Moreau, Phillipe / Levy, Moshe / White, Darrell / Gatt, Moshe E / Facon, Thierry / Mateos, Maria V / Cavo, Michele / Reece, Donna / Anderson, Larry D / Saint-Martin, Jean-Richard / Jeha, Jacqueline / Joshi, Anita A / Chai, Yi / Li, Lingling / Peddagali, Vishnuvardhan / Arazy, Melina / Shah, Jatin / Shacham, Sharon / Kauffman, Michael G / Dimopoulos, Meletios A / Richardson, Paul G / Delimpasi, Sosana

Lancet (London, England)

2020 Volume 396, Issue 10262, Page(s) 1563–1573

Abstract: Background: Selinexor combined with dexamethasone has shown activity in patients with heavily pre-treated multiple myeloma. In a phase 1b/2 study, the combination of oral selinexor with bortezomib (a proteasome inhibitor) and dexamethasone induced high ... ...

Abstract	Background: Selinexor combined with dexamethasone has shown activity in patients with heavily pre-treated multiple myeloma. In a phase 1b/2 study, the combination of oral selinexor with bortezomib (a proteasome inhibitor) and dexamethasone induced high response rates with low rates of peripheral neuropathy, the main dose-limiting toxicity of bortezomib. We aimed to evaluate the clinical benefit of weekly selinexor, bortezomib, and dexamethasone versus standard bortezomib and dexamethasone in patients with previously treated multiple myeloma. Methods: This phase 3, randomised, open-label trial was done at 123 sites in 21 countries. Patients aged 18 years or older, who had multiple myeloma, and who had previously been treated with one to three lines of therapy, including proteasome inhibitors, were randomly allocated (1:1) to receive selinexor (100 mg once per week), bortezomib (1·3 mg/m Findings: Of 457 patients screened for eligibility, 402 were randomly allocated-195 (49%) to the selinexor, bortezomib, and dexamethasone group and 207 (51%) to the bortezomib and dexamethasone group-and the first dose of study medication was given between June 6, 2017, and Feb 5, 2019. Median follow-up durations were 13·2 months [IQR 6·2-19·8] for the selinexor, bortezomib, and dexamethasone group and 16·5 months [9·4-19·8] for the bortezomib and dexamethasone group. Median progression-free survival was 13·93 months (95% CI 11·73-not evaluable) with selinexor, bortezomib, and dexamethasone and 9·46 months (8·11-10·78) with bortezomib and dexamethasone (hazard ratio 0·70 [95% CI 0·53-0·93], p=0·0075). The most frequent grade 3-4 adverse events were thrombocytopenia (77 [39%] of 195 patients in the selinexor, bortezomib, and dexamethasone group vs 35 [17%] of 204 in the bortezomib and dexamethasone group), fatigue (26 [13%] vs two [1%]), anaemia (31 [16%] vs 20 [10%]), and pneumonia (22 [11%] vs 22 [11%]). Peripheral neuropathy of grade 2 or above was less frequent with selinexor, bortezomib, and dexamethasone (41 [21%] patients) than with bortezomib and dexamethasone (70 [34%] patients; odds ratio 0·50 [95% CI 0·32-0·79], p=0·0013). 47 (24%) patients in the selinexor, bortezomib, and dexamethasone group and 62 (30%) in the bortezomib and dexamethasone group died. Interpretation: A once-per-week regimen of selinexor, bortezomib, and dexamethasone is a novel, effective, and convenient treatment option for patients with multiple myeloma who have received one to three previous lines of therapy. Funding: Karyopharm Therapeutics.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bortezomib/administration & dosage ; Bortezomib/adverse effects ; Dexamethasone/administration & dosage ; Dexamethasone/adverse effects ; Drug Administration Schedule ; Female ; Humans ; Hydrazines/administration & dosage ; Hydrazines/adverse effects ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Multiple Myeloma/drug therapy ; Progression-Free Survival ; Triazoles/administration & dosage ; Triazoles/adverse effects
Chemical Substances	Antineoplastic Agents ; Hydrazines ; Triazoles ; selinexor (31TZ62FO8F) ; Bortezomib (69G8BD63PP) ; Dexamethasone (7S5I7G3JQL)
Language	English
Publishing date	2020-11-13
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(20)32292-3
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Article ; Online: Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection.

Thaweethai, Tanayott / Jolley, Sarah E / Karlson, Elizabeth W / Levitan, Emily B / Levy, Bruce / McComsey, Grace A / McCorkell, Lisa / Nadkarni, Girish N / Parthasarathy, Sairam / Singh, Upinder / Walker, Tiffany A / Selvaggi, Caitlin A / Shinnick, Daniel J / Schulte, Carolin C M / Atchley-Challenner, Rachel / Alba, George A / Alicic, Radica / Altman, Natasha / Anglin, Khamal /

Argueta, Urania / Ashktorab, Hassan / Baslet, Gaston / Bassett, Ingrid V / Bateman, Lucinda / Bedi, Brahmchetna / Bhattacharyya, Shamik / Bind, Marie-Abele / Blomkalns, Andra L / Bonilla, Hector / Bush, Patricia A / Castro, Mario / Chan, James / Charney, Alexander W / Chen, Peter / Chibnik, Lori B / Chu, Helen Y / Clifton, Rebecca G / Costantine, Maged M / Cribbs, Sushma K / Davila Nieves, Sylvia I / Deeks, Steven G / Duven, Alexandria / Emery, Ivette F / Erdmann, Nathan / Erlandson, Kristine M / Ernst, Kacey C / Farah-Abraham, Rachael / Farner, Cheryl E / Feuerriegel, Elen M / Fleurimont, Judes / Fonseca, Vivian / Franko, Nicholas / Gainer, Vivian / Gander, Jennifer C / Gardner, Edward M / Geng, Linda N / Gibson, Kelly S / Go, Minjoung / Goldman, Jason D / Grebe, Halle / Greenway, Frank L / Habli, Mounira / Hafner, John / Han, Jenny E / Hanson, Keith A / Heath, James / Hernandez, Carla / Hess, Rachel / Hodder, Sally L / Hoffman, Matthew K / Hoover, Susan E / Huang, Beatrice / Hughes, Brenna L / Jagannathan, Prasanna / John, Janice / Jordan, Michael R / Katz, Stuart D / Kaufman, Elizabeth S / Kelly, John D / Kelly, Sara W / Kemp, Megan M / Kirwan, John P / Klein, Jonathan D / Knox, Kenneth S / Krishnan, Jerry A / Kumar, Andre / Laiyemo, Adeyinka O / Lambert, Allison A / Lanca, Margaret / Lee-Iannotti, Joyce K / Logarbo, Brian P / Longo, Michele T / Luciano, Carlos A / Lutrick, Karen / Maley, Jason H / Marathe, Jai G / Marconi, Vincent / Marshall, Gailen D / Martin, Christopher F / Matusov, Yuri / Mehari, Alem / Mendez-Figueroa, Hector / Mermelstein, Robin / Metz, Torri D / Morse, Richard / Mosier, Jarrod / Mouchati, Christian / Mullington, Janet / Murphy, Shawn N / Neuman, Robert B / Nikolich, Janko Z / Ofotokun, Ighovwerha / Ojemakinde, Elizabeth / Palatnik, Anna / Palomares, Kristy / Parimon, Tanyalak / Parry, Samuel / Patterson, Jan E / Patterson, Thomas F / Patzer, Rachel E / Peluso, Michael J / Pemu, Priscilla / Pettker, Christian M / Plunkett, Beth A / Pogreba-Brown, Kristen / Poppas, Athena / Quigley, John G / Reddy, Uma / Reece, Rebecca / Reeder, Harrison / Reeves, W B / Reiman, Eric M / Rischard, Franz / Rosand, Jonathan / Rouse, Dwight J / Ruff, Adam / Saade, George / Sandoval, Grecio J / Schlater, Shannon M / Shepherd, Fitzgerald / Sherif, Zaki A / Simhan, Hyagriv / Singer, Nora G / Skupski, Daniel W / Sowles, Amber / Sparks, Jeffrey A / Sukhera, Fatima I / Taylor, Barbara S / Teunis, Larissa / Thomas, Robert J / Thorp, John M / Thuluvath, Paul / Ticotsky, Amberly / Tita, Alan T / Tuttle, Katherine R / Urdaneta, Alfredo E / Valdivieso, Daisy / VanWagoner, Timothy M / Vasey, Andrew / Verduzco-Gutierrez, Monica / Wallace, Zachary S / Ward, Honorine D / Warren, David E / Weiner, Steven J / Welch, Shelley / Whiteheart, Sidney W / Wiley, Zanthia / Wisnivesky, Juan P / Yee, Lynn M / Zisis, Sokratis / Horwitz, Leora I / Foulkes, Andrea S

JAMA

2023 Volume 329, Issue 22, Page(s) 1934–1946

Abstract: Importance: SARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, termed postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID. Characterizing PASC ... ...

Abstract	Importance: SARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, termed postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID. Characterizing PASC requires analysis of prospectively and uniformly collected data from diverse uninfected and infected individuals. Objective: To develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections. Design, setting, and participants: Prospective observational cohort study of adults with and without SARS-CoV-2 infection at 85 enrolling sites (hospitals, health centers, community organizations) located in 33 states plus Washington, DC, and Puerto Rico. Participants who were enrolled in the RECOVER adult cohort before April 10, 2023, completed a symptom survey 6 months or more after acute symptom onset or test date. Selection included population-based, volunteer, and convenience sampling. Exposure: SARS-CoV-2 infection. Main outcomes and measures: PASC and 44 participant-reported symptoms (with severity thresholds). Results: A total of 9764 participants (89% SARS-CoV-2 infected; 71% female; 16% Hispanic/Latino; 15% non-Hispanic Black; median age, 47 years [IQR, 35-60]) met selection criteria. Adjusted odds ratios were 1.5 or greater (infected vs uninfected participants) for 37 symptoms. Symptoms contributing to PASC score included postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements. Among 2231 participants first infected on or after December 1, 2021, and enrolled within 30 days of infection, 224 (10% [95% CI, 8.8%-11%]) were PASC positive at 6 months. Conclusions and relevance: A definition of PASC was developed based on symptoms in a prospective cohort study. As a first step to providing a framework for other investigations, iterative refinement that further incorporates other clinical features is needed to support actionable definitions of PASC.
MeSH term(s)	Female ; Adult ; Humans ; Middle Aged ; Male ; SARS-CoV-2 ; COVID-19/complications ; Prospective Studies ; Post-Acute COVID-19 Syndrome ; Cohort Studies ; Disease Progression ; Fatigue
Language	English
Publishing date	2023-05-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2023.8823
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Article ; Online: GA4GH: International policies and standards for data sharing across genomic research and healthcare.

Rehm, Heidi L / Page, Angela J H / Smith, Lindsay / Adams, Jeremy B / Alterovitz, Gil / Babb, Lawrence J / Barkley, Maxmillian P / Baudis, Michael / Beauvais, Michael J S / Beck, Tim / Beckmann, Jacques S / Beltran, Sergi / Bernick, David / Bernier, Alexander / Bonfield, James K / Boughtwood, Tiffany F / Bourque, Guillaume / Bowers, Sarion R / Brookes, Anthony J /

Brudno, Michael / Brush, Matthew H / Bujold, David / Burdett, Tony / Buske, Orion J / Cabili, Moran N / Cameron, Daniel L / Carroll, Robert J / Casas-Silva, Esmeralda / Chakravarty, Debyani / Chaudhari, Bimal P / Chen, Shu Hui / Cherry, J Michael / Chung, Justina / Cline, Melissa / Clissold, Hayley L / Cook-Deegan, Robert M / Courtot, Mélanie / Cunningham, Fiona / Cupak, Miro / Davies, Robert M / Denisko, Danielle / Doerr, Megan J / Dolman, Lena I / Dove, Edward S / Dursi, L Jonathan / Dyke, Stephanie O M / Eddy, James A / Eilbeck, Karen / Ellrott, Kyle P / Fairley, Susan / Fakhro, Khalid A / Firth, Helen V / Fitzsimons, Michael S / Fiume, Marc / Flicek, Paul / Fore, Ian M / Freeberg, Mallory A / Freimuth, Robert R / Fromont, Lauren A / Fuerth, Jonathan / Gaff, Clara L / Gan, Weiniu / Ghanaim, Elena M / Glazer, David / Green, Robert C / Griffith, Malachi / Griffith, Obi L / Grossman, Robert L / Groza, Tudor / Auvil, Jaime M Guidry / Guigó, Roderic / Gupta, Dipayan / Haendel, Melissa A / Hamosh, Ada / Hansen, David P / Hart, Reece K / Hartley, Dean Mitchell / Haussler, David / Hendricks-Sturrup, Rachele M / Ho, Calvin W L / Hobb, Ashley E / Hoffman, Michael M / Hofmann, Oliver M / Holub, Petr / Hsu, Jacob Shujui / Hubaux, Jean-Pierre / Hunt, Sarah E / Husami, Ammar / Jacobsen, Julius O / Jamuar, Saumya S / Janes, Elizabeth L / Jeanson, Francis / Jené, Aina / Johns, Amber L / Joly, Yann / Jones, Steven J M / Kanitz, Alexander / Kato, Kazuto / Keane, Thomas M / Kekesi-Lafrance, Kristina / Kelleher, Jerome / Kerry, Giselle / Khor, Seik-Soon / Knoppers, Bartha M / Konopko, Melissa A / Kosaki, Kenjiro / Kuba, Martin / Lawson, Jonathan / Leinonen, Rasko / Li, Stephanie / Lin, Michael F / Linden, Mikael / Liu, Xianglin / Udara Liyanage, Isuru / Lopez, Javier / Lucassen, Anneke M / Lukowski, Michael / Mann, Alice L / Marshall, John / Mattioni, Michele / Metke-Jimenez, Alejandro / Middleton, Anna / Milne, Richard J / Molnár-Gábor, Fruzsina / Mulder, Nicola / Munoz-Torres, Monica C / Nag, Rishi / Nakagawa, Hidewaki / Nasir, Jamal / Navarro, Arcadi / Nelson, Tristan H / Niewielska, Ania / Nisselle, Amy / Niu, Jeffrey / Nyrönen, Tommi H / O'Connor, Brian D / Oesterle, Sabine / Ogishima, Soichi / Wang, Vivian Ota / Paglione, Laura A D / Palumbo, Emilio / Parkinson, Helen E / Philippakis, Anthony A / Pizarro, Angel D / Prlic, Andreas / Rambla, Jordi / Rendon, Augusto / Rider, Renee A / Robinson, Peter N / Rodarmer, Kurt W / Rodriguez, Laura Lyman / Rubin, Alan F / Rueda, Manuel / Rushton, Gregory A / Ryan, Rosalyn S / Saunders, Gary I / Schuilenburg, Helen / Schwede, Torsten / Scollen, Serena / Senf, Alexander / Sheffield, Nathan C / Skantharajah, Neerjah / Smith, Albert V / Sofia, Heidi J / Spalding, Dylan / Spurdle, Amanda B / Stark, Zornitza / Stein, Lincoln D / Suematsu, Makoto / Tan, Patrick / Tedds, Jonathan A / Thomson, Alastair A / Thorogood, Adrian / Tickle, Timothy L / Tokunaga, Katsushi / Törnroos, Juha / Torrents, David / Upchurch, Sean / Valencia, Alfonso / Guimera, Roman Valls / Vamathevan, Jessica / Varma, Susheel / Vears, Danya F / Viner, Coby / Voisin, Craig / Wagner, Alex H / Wallace, Susan E / Walsh, Brian P / Williams, Marc S / Winkler, Eva C / Wold, Barbara J / Wood, Grant M / Woolley, J Patrick / Yamasaki, Chisato / Yates, Andrew D / Yung, Christina K / Zass, Lyndon J / Zaytseva, Ksenia / Zhang, Junjun / Goodhand, Peter / North, Kathryn / Birney, Ewan

Cell genomics

2022 Volume 1, Issue 2

Abstract: The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic ... ...

Abstract	The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic sequencing (along with other genome-wide molecular assays) and increasing evidence of its clinical utility will soon drive the generation of sequence data from tens of millions of humans, with increasing levels of diversity. In this perspective, we present the GA4GH strategies for addressing the major challenges of this data revolution. We describe the GA4GH organization, which is fueled by the development efforts of eight Work Streams and informed by the needs of 24 Driver Projects and other key stakeholders. We present the GA4GH suite of secure, interoperable technical standards and policy frameworks and review the current status of standards, their relevance to key domains of research and clinical care, and future plans of GA4GH. Broad international participation in building, adopting, and deploying GA4GH standards and frameworks will catalyze an unprecedented effort in data sharing that will be critical to advancing genomic medicine and ensuring that all populations can access its benefits.
Language	English
Publishing date	2022-02-24
Publishing country	United States
Document type	Journal Article
ISSN	2666-979X
ISSN (online)	2666-979X
DOI	10.1016/j.xgen.2021.100029
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Article ; Online: Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial.

Lancet (London, England)

2008 Volume 371, Issue 9606, Page(s) 57–63

Abstract: Background: Aggressive challenging behaviour is frequently reported in adults with intellectual disability and it is often treated with antipsychotic drugs. However, no adequate evidence base for this practice exists. We compared flexible doses of ... ...

Abstract	Background: Aggressive challenging behaviour is frequently reported in adults with intellectual disability and it is often treated with antipsychotic drugs. However, no adequate evidence base for this practice exists. We compared flexible doses of haloperidol (a typical, first-generation antipsychotic drug), risperidone (an atypical, second-generation antipsychotic), and placebo, in the treatment of this behaviour. Methods: 86 non-psychotic patients presenting with aggressive challenging behaviour from ten centres in England and Wales, and one in Queensland, Australia, were randomly assigned to haloperidol (n=28), risperidone (n=29), or placebo (n=29). Clinical assessments of aggression, aberrant behaviour, quality of life, adverse drug effects, and carer uplift (positive feelings about the care of the disabled person) and burden, together with total costs, were recorded at 4, 12, and 26 weeks. The primary outcome was change in aggression after 4 weeks' treatment, which was recorded with the modified overt aggression scale (MOAS). Analysis was by intention to treat. This study is registered as ISRCTN 11736448. Findings: 80 patients had adherence of 80% or more to prescribed drug. Aggression decreased substantially with all three treatments by 4 weeks, with the placebo group showing the greatest change (median decrease in MOAS score after 4 weeks=9 [95% CI 5-14] for placebo, 79% from baseline; 7 [4-14] for risperidone, 58% from baseline; 6.5 [5-14] for haloperidol, 65% from baseline; p=0.06). Furthermore, although no important differences between the treatments were recorded, including adverse effects, patients given placebo showed no evidence at any time points of worse response than did patients assigned to either of the antipsychotic drugs. Interpretation: Antipsychotic drugs should no longer be regarded as an acceptable routine treatment for aggressive challenging behaviour in people with intellectual disability.
MeSH term(s)	Adult ; Aged ; Aggression/drug effects ; Antipsychotic Agents/adverse effects ; Antipsychotic Agents/therapeutic use ; Female ; Haloperidol/adverse effects ; Haloperidol/therapeutic use ; Humans ; Male ; Mental Competency ; Mental Disorders/drug therapy ; Middle Aged ; Patient Compliance ; Risperidone/adverse effects ; Risperidone/therapeutic use
Chemical Substances	Antipsychotic Agents ; Haloperidol (J6292F8L3D) ; Risperidone (L6UH7ZF8HC)
Language	English
Publishing date	2008-01-03
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(08)60072-0
Database	MEDical Literature Analysis and Retrieval System OnLINE

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