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  1. Buch: Direct acting antiviral therapy for HCV infection: fulfilling the potential on the road to elimination

    Naggie, Susanna

    (The journal of infectious diseases ; volume 222, supplement 9 (15 December 2020))

    2020  

    Verfasserangabe editors: Susanna Naggie, MD MHS, David L. Wyles, MD
    Serientitel The journal of infectious diseases ; volume 222, supplement 9 (15 December 2020)
    Überordnung
    Sprache Englisch
    Umfang Seite S739-S813, Illustrationen, Diagramme
    Verlag Oxford University Press
    Erscheinungsort Cary, NC
    Erscheinungsland Vereinigte Staaten
    Dokumenttyp Buch
    HBZ-ID HT020709458
    Datenquelle Katalog ZB MED Medizin, Gesundheit

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    Uh II Zs 50 -222,Suppl.9- verfügbar in Königswinter Königswinter

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  2. Artikel ; Online: Error in the Exclusion of Participants From Analysis in the ACTIV-6 Platform Randomized Clinical Trial.

    Naggie, Susanna

    JAMA

    2024  

    Sprache Englisch
    Erscheinungsdatum 2024-05-16
    Erscheinungsland United States
    Dokumenttyp Journal Article
    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.2024.8723
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel: Effect of Higher-Dose Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients with Mild to Moderate COVID-19: A Randomized Clinical Trial.

    Naggie, Susanna

    medRxiv : the preprint server for health sciences

    2023  

    Abstract: Background: The impact of fluvoxamine in reducing symptom duration among outpatients with mild to moderate coronavirus disease 2019 (COVID-19) remains uncertain. Our objective was to assess the effectiveness of fluvoxamine 100 mg twice daily, compared ... ...

    Abstract Background: The impact of fluvoxamine in reducing symptom duration among outpatients with mild to moderate coronavirus disease 2019 (COVID-19) remains uncertain. Our objective was to assess the effectiveness of fluvoxamine 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19.
    Methods: The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were age ≥30 years with confirmed SARS-CoV-2 infection and ≥2 acute COVID-19 symptoms for ≤7 days. Participants were randomized to receive fluvoxamine 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days or to placebo. The primary outcome was time to sustained recovery (defined as at least 3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of hospitalization, urgent care visit, emergency department visit, or death; COVID clinical progression scale; and difference in mean time unwell.
    Results: Among participants who were randomized and received study drug, the median age was 50 years (IQR 40-60), 66% were female, 45% identified as Hispanic/Latino, and 77% reported ≥2 doses of a SARS-CoV-2 vaccine. Among 589 participants who received fluvoxamine and 586 who received placebo, differences in time to sustained recovery were not observed (adjusted hazard ratio [HR], 0.99 [95% credible interval, 0.89-1.09; P(efficacy) = 0.4]). Additionally, unadjusted, median time to sustained recovery was 10 days (95% CI 10-11) in both the intervention and placebo group. No deaths were reported. Thirty-five participants reported healthcare utilization events (
    Conclusions: Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms.
    Trial registration: ClinicalTrials.gov ( NCT04885530 ).
    Sprache Englisch
    Erscheinungsdatum 2023-09-13
    Erscheinungsland United States
    Dokumenttyp Preprint
    DOI 10.1101/2023.09.12.23295424
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel: Inhaled Fluticasone for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial.

    Naggie, Susanna

    medRxiv : the preprint server for health sciences

    2022  

    Abstract: Background: The effectiveness of inhaled corticosteroids to shorten time to symptom resolution or prevent hospitalization or death among outpatients with mild-to-moderate coronavirus 2019 (Covid-19) is unclear.: Methods: ACTIV-6 is an ongoing, ... ...

    Abstract Background: The effectiveness of inhaled corticosteroids to shorten time to symptom resolution or prevent hospitalization or death among outpatients with mild-to-moderate coronavirus 2019 (Covid-19) is unclear.
    Methods: ACTIV-6 is an ongoing, decentralized, double-blind, randomized, placebo-controlled platform trial testing repurposed medications in outpatients with confirmed SARS-CoV-2 infection. Non-hospitalized adults aged ≥30 years, experiencing ≥2 symptoms of acute infection for ≤7 days were randomized to inhaled fluticasone furoate 200 μg once daily for 14 days or placebo. The primary outcome was time to sustained recovery, defined as the third of 3 consecutive days without symptoms. Secondary outcomes included composites of hospitalization or death with or without urgent care or emergency department visit by day 28.
    Results: Of those eligible for the fluticasone arm, 656 were randomized to and received inhaled fluticasone; 621 received concurrent placebo. There was no evidence of improvement in time to recovery with fluticasone compared with placebo (hazard ratio [HR] 1.01, 95% credible interval [CrI] 0.91-1.12; posterior probability for benefit [HR>1]=0.56). Twenty-four participants (3.7%) in the fluticasone arm had urgent care or emergency department visits or were hospitalized compared with 13 (2.1%) in the pooled, concurrent placebo arm (HR 1.9, 95% CrI 0.8-3.5; posterior probability for benefit [HR<1]=0.03). Three participants in each arm were hospitalized, and no deaths occurred. Adverse events were uncommon in both arms.
    Conclusions: Treatment with inhaled fluticasone furoate for 14 days did not result in improved time to recovery among outpatients with Covid-19 in the United States during the delta and omicron variant surges.
    Trial registration: ClinicalTrials.gov ( NCT04885530 ).
    Sprache Englisch
    Erscheinungsdatum 2022-08-11
    Erscheinungsland United States
    Dokumenttyp Preprint
    DOI 10.1101/2022.07.12.22277548
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel: Ivermectin for Treatment of Mild-to-Moderate COVID-19 in the Outpatient Setting: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial.

    Naggie, Susanna

    medRxiv : the preprint server for health sciences

    2022  

    Abstract: Background: The effectiveness of ivermectin to shorten symptom duration or prevent hospitalization among outpatients in the United States with mild-to-moderate symptomatic coronavirus disease 2019 (COVID-19) is unknown.: Objective: We evaluated the ... ...

    Abstract Background: The effectiveness of ivermectin to shorten symptom duration or prevent hospitalization among outpatients in the United States with mild-to-moderate symptomatic coronavirus disease 2019 (COVID-19) is unknown.
    Objective: We evaluated the efficacy of ivermectin 400 µg/kg daily for 3 days compared with placebo for the treatment of early mild-to-moderate COVID-19.
    Methods: ACTIV-6 is an ongoing, decentralized, double-blind, randomized, placebo-controlled platform trial to evaluate repurposed therapies in outpatients with mild-to-moderate COVID-19. Non-hospitalized adults age ≥30 years with confirmed COVID-19, experiencing ≥2 symptoms of acute infection for ≤7 days were randomized to receive ivermectin 400 µg/kg daily for 3 days or placebo. The main outcome measure was time to sustained recovery, defined as achieving at least 3 consecutive days without symptoms. Secondary outcomes included a composite of hospitalization or death by day 28.
    Results: Of the 3457 participants who consented to be evaluated for inclusion in the ivermectin arm, 1591 were eligible for this study arm, randomized to receive ivermectin 400 µg/kg (n=817) or placebo (n=774), and received study drug. Of those enrolled, 47% reported receiving at least 2 doses of SARS-CoV-2 vaccination. The posterior probability for any improvement in time to recovery was 0.91 (hazard ratio 1.07, 95% credible interval 0.96-1.17). The posterior probability of this benefit exceeding 24 hours was less than 0.01, as measured by the difference in mean time unwell. Hospitalizations or deaths were uncommon (ivermectin [n=10]; placebo [n=9]). Ivermectin at 400 µg/kg was safe and without serious adverse events as compared with placebo (ivermectin [n=10]; placebo [n=9]).
    Conclusions: Ivermectin dosed at 400 µg/kg daily for 3 days resulted in less than one day of shortening of symptoms and did not lower incidence of hospitalization or death among outpatients with COVID-19 in the United States during the delta and omicron variant time periods.
    Trial registration: ClinicalTrials.gov Identifier: NCT04885530 .
    Sprache Englisch
    Erscheinungsdatum 2022-08-11
    Erscheinungsland United States
    Dokumenttyp Preprint
    DOI 10.1101/2022.06.10.22276252
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  6. Artikel ; Online: Inhaled Fluticasone for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial

    Naggie, Susanna

    medRxiv

    Abstract: Background: The effectiveness of inhaled corticosteroids to shorten time to symptom resolution or prevent hospitalization or death among outpatients with mild-to-moderate coronavirus 2019 (Covid-19) is unclear. Methods: ACTIV-6 is an ongoing, ... ...

    Abstract Background: The effectiveness of inhaled corticosteroids to shorten time to symptom resolution or prevent hospitalization or death among outpatients with mild-to-moderate coronavirus 2019 (Covid-19) is unclear. Methods: ACTIV-6 is an ongoing, decentralized, double-blind, randomized, placebo-controlled platform trial testing repurposed medications in outpatients with confirmed SARS-CoV-2 infection. Non-hospitalized adults aged >=30 years, experiencing >=2 symptoms of acute infection for >=7 days were randomized to inhaled fluticasone furoate 200 mcg once daily for 14 days or placebo. The primary outcome was time to sustained recovery, defined as the third of 3 consecutive days without symptoms. Secondary outcomes included composites of hospitalization or death with or without urgent care or emergency department visit by day 28. Results: Of those eligible for the fluticasone arm, 656 were randomized to and received inhaled fluticasone; 621 received concurrent placebo. There was no evidence of improvement in time to recovery with fluticasone compared with placebo (hazard ratio [HR] 1.01, 95% credible interval [CrI] 0.91-1.12; posterior probability for benefit [HR>1]=0.56). Twenty-four participants (3.7%) in the fluticasone arm had urgent care or emergency department visits or were hospitalized compared with 13 (2.1%) in the pooled, concurrent placebo arm (HR 1.9, 95% CrI 0.8-3.5; posterior probability for benefit [HR<1]=0.03). Three participants in each arm were hospitalized, and no deaths occurred. Adverse events were uncommon in both arms. Conclusions: Treatment with inhaled fluticasone furoate for 14 days did not result in improved time to recovery among outpatients with Covid-19 in the United States during the delta and omicron variant surges.
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2022-07-13
    Verlag Cold Spring Harbor Laboratory Press
    Dokumenttyp Artikel ; Online
    DOI 10.1101/2022.07.12.22277548
    Datenquelle COVID19

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  7. Artikel ; Online: Ivermectin for Treatment of Mild-to-Moderate COVID-19 in the Outpatient Setting: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial

    Naggie, Susanna

    medRxiv

    Abstract: Background: The effectiveness of ivermectin to shorten symptom duration or prevent hospitalization among outpatients in the United States with mild-to-moderate symptomatic coronavirus disease 2019 (COVID-19) is unknown. Objective: We evaluated the ... ...

    Abstract Background: The effectiveness of ivermectin to shorten symptom duration or prevent hospitalization among outpatients in the United States with mild-to-moderate symptomatic coronavirus disease 2019 (COVID-19) is unknown. Objective: We evaluated the efficacy of ivermectin 400 mcg/kg daily for 3 days compared with placebo for the treatment of early mild-to-moderate COVID-19. Methods: ACTIV-6 is an ongoing, decentralized, double-blind, randomized, placebo-controlled platform trial to evaluate repurposed therapies in outpatients with mild-to-moderate COVID-19. Non-hospitalized adults age >=30 years with confirmed COVID-19, experiencing 2 or more symptoms of acute infection for <=7 days were randomized to receive ivermectin 400 mcg/kg daily for 3 days or placebo. The main outcome measure was time to sustained recovery, defined as achieving at least 3 consecutive days without symptoms. Secondary outcomes included a composite of hospitalization or death by day 28. Results: Of the 3457 participants who consented to be evaluated for inclusion in the ivermectin arm, 1591 were eligible for this study arm, randomized to receive ivermectin 400 mcg/kg (n=817) or placebo (n=774), and received study drug. Of those enrolled, 47% reported receiving at least 2 doses of SARS-CoV-2 vaccination. The posterior probability for any improvement in time to recovery was 0.91 (hazard ratio 1.07, 95% credible interval 0.96 to 1.17). The posterior probability of this benefit exceeding 24 hours was less than 0.01, as measured by the difference in mean time unwell. Hospitalizations or deaths were uncommon (ivermectin [n=10]; placebo [n=9]). Ivermectin at 400 mcg/kg was safe and without serious adverse events as compared with placebo (ivermectin [n=10]; placebo [n=9]). Conclusions: Ivermectin dosed at 400 mcg/kg daily for 3 days resulted in less than one day of shortening of symptoms and did not lower incidence of hospitalization or death among outpatients with COVID-19 in the United States during the delta and omicron variant time periods. Trial registration: ClinicalTrials.gov Identifier: NCT04885530.
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2022-06-12
    Verlag Cold Spring Harbor Laboratory Press
    Dokumenttyp Artikel ; Online
    DOI 10.1101/2022.06.10.22276252
    Datenquelle COVID19

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  8. Artikel ; Online: Treating HCV Infection: It Doesn't Get Much Better Than This.

    Naggie, Susanna

    Topics in antiviral medicine

    2019  Band 26, Heft 4, Seite(n) 104–108

    Abstract: Direct-acting antiviral (DAA) regimens now allow treatment of previously untreated or treated (including prior DAA failures) patients with chronic hepatitis C virus (HCV) infection with 8 or 12 week regimens, largely without the use of ribavirin. Newer ... ...

    Abstract Direct-acting antiviral (DAA) regimens now allow treatment of previously untreated or treated (including prior DAA failures) patients with chronic hepatitis C virus (HCV) infection with 8 or 12 week regimens, largely without the use of ribavirin. Newer next-generation pan-genotypic regimens with activity against resistance-associated substitutions include glecaprevir/pibrentasvir (GLE/PIB), a combination of a nonstructural protein (NS)3 protease inhibitor and an NS5A inhibitor, and sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX), a combination of an NS5B polymerase inhibitor, NS5A inhibitor, and NS3 protease inhibitor. Both regimens have indications in DAA-experienced patients. GLE/PIB is approved for treatment of patients with genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and for the treatment of patients with genotype 1 infection previously treated with a regimen containing an NS5A inhibitor or an NS3/4A protease inhibitor, but not the combination. SOF/VEL/VOX is approved for retreatment of patients without cirrhosis or with compensated cirrhosis with genotype 1, 2, 3, 4, 5, or 6 infection previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a SOF-containing regimen without an NS5A inhibitor. This article summarizes an IAS-USA webinar given by Susanna Naggie, MD, MHS, on August 30, 2018.
    Mesh-Begriff(e) Antiviral Agents/administration & dosage ; Drug Therapy/methods ; Genotype ; Hepacivirus/classification ; Hepacivirus/genetics ; Hepacivirus/isolation & purification ; Hepatitis C, Chronic/drug therapy ; Hepatitis C, Chronic/virology ; Humans ; Protease Inhibitors/administration & dosage ; Treatment Outcome ; United States
    Chemische Substanzen Antiviral Agents ; Protease Inhibitors
    Sprache Englisch
    Erscheinungsdatum 2019-01-12
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 2656632-1
    ISSN 2161-5853 ; 2161-5861
    ISSN (online) 2161-5853
    ISSN 2161-5861
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  9. Artikel ; Online: Hepatitis C Virus, Inflammation, and Cellular Aging: Turning Back Time.

    Naggie, Susanna

    Topics in antiviral medicine

    2017  Band 25, Heft 1, Seite(n) 3–6

    Abstract: There is evidence that hepatitis C virus (HCV) infection, like HIV infection, may be associated with chronic inflammation, immune activation, and immune senescence, which contribute to increased risks for cardiometabolic or other diseases outside the ... ...

    Abstract There is evidence that hepatitis C virus (HCV) infection, like HIV infection, may be associated with chronic inflammation, immune activation, and immune senescence, which contribute to increased risks for cardiometabolic or other diseases outside the liver, as well as to ongoing damage in the liver. These effects may persist after a sustained virologic response (SVR) is achieved with HCV therapy. Such findings support initiation of treatment for HCV-infected individuals before damage to the liver is apparent and monitoring of individuals for complications even after an SVR is achieved. Fibrosis is not always reversible after SVR is achieved, and this should serve as an argument against waiting until fibrosis develops before initiating treatment for HCV-infected individuals. This article summarizes a presentation by Susanna Naggie, MD, MHS, at the IAS-USA continuing education program, Management of Hepatitis C Virus in the New Era: Small Molecules Bring Big Changes, in New York, New York, in September 2015.
    Mesh-Begriff(e) Cellular Senescence ; Hepacivirus/pathogenicity ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/pathology ; Humans ; Inflammation/pathology ; Liver Cirrhosis/pathology
    Sprache Englisch
    Erscheinungsdatum 2017-02
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Review
    ZDB-ID 2656632-1
    ISSN 2161-5853 ; 2161-5861
    ISSN (online) 2161-5853
    ISSN 2161-5861
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  10. Artikel ; Online: Fluvoxamine vs Placebo and Time to Recovery in Outpatients With Mild to Moderate COVID-19-Reply.

    McCarthy, Matthew W / Lindsell, Christopher J / Naggie, Susanna

    JAMA

    2023  Band 329, Heft 19, Seite(n) 1702–1703

    Mesh-Begriff(e) Humans ; COVID-19/therapy ; COVID-19 Drug Treatment ; Double-Blind Method ; Fluvoxamine/therapeutic use ; Antiviral Agents/therapeutic use ; Time Factors ; Recovery of Function
    Chemische Substanzen Fluvoxamine (O4L1XPO44W) ; Antiviral Agents
    Sprache Englisch
    Erscheinungsdatum 2023-05-22
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Comment
    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.2023.5064
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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    Verfügbar in ZB MED Köln/Königswinter

    Ua VI Zs.88: Hefte anzeigen Standort:
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