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Article: Treatment of COPD: a matrix perspective.

Dunsmore, Sarah E

International journal of chronic obstructive pulmonary disease

2008 Volume 3, Issue 1, Page(s) 113–122

Abstract: Fundamental physical properties, such as the intrinsic recoil of the lung, are governed by the extracellular matrix. The prototypical roles of the matrix proteins, collagen and elastin, in pulmonary fibrosis and emphysema have long been recognized, and ... ...

Abstract	Fundamental physical properties, such as the intrinsic recoil of the lung, are governed by the extracellular matrix. The prototypical roles of the matrix proteins, collagen and elastin, in pulmonary fibrosis and emphysema have long been recognized, and much research effort has been devoted to understanding mechanisms of extracellular matrix synthesis and turnover in the lung. Yet, despite extensive knowledge of the biochemical properties of collagen and elastin, none of the present clinical strategies for treating COPD directly target the extracellular matrix. From a matrix perspective, therapeutic interventions that limit elastic fiber destruction and/or restore function to damaged alveolar units merit particular consideration as clinical strategies for treating the emphysema component of COPD. Effective treatment of the bronchiolar component of COPD requires a better understanding of the relationship between airway fibrosis and airflow obstruction. Translating basic knowledge of extracellular matrix biology into the clinical venue will be essential in the development of new approaches to COPD treatment.
MeSH term(s)	Collagen/physiology ; Elastin/physiology ; Extracellular Matrix/physiology ; Humans ; Pulmonary Alveoli/pathology ; Pulmonary Disease, Chronic Obstructive/etiology ; Pulmonary Disease, Chronic Obstructive/pathology ; Pulmonary Disease, Chronic Obstructive/therapy
Chemical Substances	Collagen (9007-34-5) ; Elastin (9007-58-3)
Language	English
Publishing date	2008-05-16
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	2212419-6
ISSN	1178-2005 ; 1176-9106
ISSN (online)	1178-2005
ISSN	1176-9106
DOI	10.2147/copd.s1119
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Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

Lane, Karen / Palm, Marisha E / Marion, Eve / Kay, Marie T / Thompson, Dixie / Stroud, Mary / Boyle, Helen / Hillery, Shannon / Nanni, Angeline / Hildreth, Meghan / Nelson, Sarah / Burr, Jeri S / Edwards, Terri / Poole, Lori / Waddy, Salina P / Dunsmore, Sarah E / Harris, Paul / Wilkins, Consuelo / Bernard, Gordon R /

Dean, J Michael / Dwyer, Jamie / Benjamin, Daniel K / Selker, Harry P / Hanley, Daniel F / Ford, Daniel E

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e131

Abstract: One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but ...

Abstract	One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
Language	English
Publishing date	2023-05-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.560
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Article ; Online: The Trial Innovation Network Liaison Team: building a national clinical and translational community of practice.

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e249

Abstract: In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ ... ...

Abstract	In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.
Language	English
Publishing date	2023-11-06
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.675
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Article ; Online: Inhaled Fluticasone Furoate for Outpatient Treatment of Covid-19.

The New England journal of medicine

2023 Volume 389, Issue 12, Page(s) 1085–1095

Abstract: Background: The effectiveness of inhaled glucocorticoids in shortening the time to symptom resolution or preventing hospitalization or death among outpatients with mild-to-moderate coronavirus disease 2019 (Covid-19) is unclear.: Methods: We ... ...

Abstract	Background: The effectiveness of inhaled glucocorticoids in shortening the time to symptom resolution or preventing hospitalization or death among outpatients with mild-to-moderate coronavirus disease 2019 (Covid-19) is unclear. Methods: We conducted a decentralized, double-blind, randomized, placebo-controlled platform trial in the United States to assess the use of repurposed medications in outpatients with confirmed coronavirus disease 2019 (Covid-19). Nonhospitalized adults 30 years of age or older who had at least two symptoms of acute infection that had been present for no more than 7 days before enrollment were randomly assigned to receive inhaled fluticasone furoate at a dose of 200 μg once daily for 14 days or placebo. The primary outcome was the time to sustained recovery, defined as the third of 3 consecutive days without symptoms. Key secondary outcomes included hospitalization or death by day 28 and a composite outcome of the need for an urgent-care or emergency department visit or hospitalization or death through day 28. Results: Of the 1407 enrolled participants who underwent randomization, 715 were assigned to receive inhaled fluticasone furoate and 692 to receive placebo, and 656 and 621, respectively, were included in the analysis. There was no evidence that the use of fluticasone furoate resulted in a shorter time to recovery than placebo (hazard ratio, 1.01; 95% credible interval, 0.91 to 1.12; posterior probability of benefit [defined as a hazard ratio >1], 0.56). A total of 24 participants (3.7%) in the fluticasone furoate group had urgent-care or emergency department visits or were hospitalized, as compared with 13 participants (2.1%) in the placebo group (hazard ratio, 1.9; 95% credible interval, 0.8 to 3.5). Three participants in each group were hospitalized, and no deaths occurred. Adverse events were uncommon in both groups. Conclusions: Treatment with inhaled fluticasone furoate for 14 days did not result in a shorter time to recovery than placebo among outpatients with Covid-19 in the United States. (Funded by the National Center for Advancing Translational Sciences and others; ACTIV-6 ClinicalTrials.gov number, NCT04885530.).
MeSH term(s)	Adult ; Humans ; Ambulatory Care ; Androstadienes/administration & dosage ; Androstadienes/adverse effects ; Androstadienes/therapeutic use ; COVID-19/diagnosis ; COVID-19/therapy ; COVID-19 Drug Treatment/adverse effects ; COVID-19 Drug Treatment/methods ; Double-Blind Method ; Administration, Inhalation ; Remission Induction ; Glucocorticoids/administration & dosage ; Glucocorticoids/adverse effects ; Glucocorticoids/therapeutic use ; Time Factors
Chemical Substances	Androstadienes ; fluticasone furoate (JS86977WNV) ; Glucocorticoids
Language	English
Publishing date	2023-09-21
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2209421
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Article ; Online: Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

Hanley, Daniel F / Bernard, Gordon R / Wilkins, Consuelo H / Selker, Harry P / Dwyer, Jamie P / Dean, J Michael / Benjamin, Daniel Kelly / Dunsmore, Sarah E / Waddy, Salina P / Wiley, Kenneth L / Palm, Marisha E / Mould, W Andrew / Ford, Daniel F / Burr, Jeri S / Huvane, Jacqueline / Lane, Karen / Poole, Lori / Edwards, Terri L / Kennedy, Nan /

Boone, Leslie R / Bell, Jasmine / Serdoz, Emily / Byrne, Loretta M / Harris, Paul A

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e170

Abstract: New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by ... ...

Abstract	New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Language	English
Publishing date	2023-07-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.597
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Article ; Online: Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.

Harris, Paul A / Dunsmore, Sarah E / Atkinson, Jane C / Benjamin, Daniel Kelly / Bernard, Gordon R / Dean, J Michael / Dwyer, Jamie P / Ford, Daniel F / Selker, Harry P / Waddy, Salina P / Wiley, Kenneth L / Wilkins, Consuelo H / Cook, Sarah K / Burr, Jeri S / Edwards, Terri L / Huvane, Jacqueline / Kennedy, Nan / Lane, Karen / Majkowski, Ryan /

Nelson, Sarah / Palm, Marisha E / Stroud, Mary / Thompson, Dixie D / Busacca, Linda / Elkind, Mitchell S V / Kimberly, Robert P / Reilly, Muredach P / Hanley, Daniel F

JAMA network open

2023 Volume 6, Issue 10, Page(s) e2336470

Abstract: Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. ... ...

Abstract	Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN's challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support. Observations: The TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN's impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic. Conclusions and relevance: The TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.
MeSH term(s)	United States ; Humans ; COVID-19 ; Pandemics ; Translational Science, Biomedical ; Awards and Prizes ; Communication
Language	English
Publishing date	2023-10-02
Publishing country	United States
Document type	Multicenter Study ; Journal Article ; Research Support, N.I.H., Extramural
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2023.36470
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Article ; Online: Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial.

McCarthy, Matthew W / Naggie, Susanna / Boulware, David R / Lindsell, Christopher J / Stewart, Thomas G / Felker, G Michael / Jayaweera, Dushyantha / Sulkowski, Mark / Gentile, Nina / Bramante, Carolyn / Singh, Upinder / Dolor, Rowena J / Ruiz-Unger, Juan / Wilson, Sybil / DeLong, Allison / Remaly, April / Wilder, Rhonda / Collins, Sean / Dunsmore, Sarah E /

Adam, Stacey J / Thicklin, Florence / Hanna, George / Ginde, Adit A / Castro, Mario / McTigue, Kathleen / Shenkman, Elizabeth / Hernandez, Adrian F

JAMA

2023 Volume 329, Issue 4, Page(s) 296–305

Abstract: Importance: The effectiveness of fluvoxamine to shorten symptom duration or prevent hospitalization among outpatients with mild to moderate symptomatic COVID-19 is unclear.: Objective: To evaluate the efficacy of low-dose fluvoxamine (50 mg twice ... ...

Abstract	Importance: The effectiveness of fluvoxamine to shorten symptom duration or prevent hospitalization among outpatients with mild to moderate symptomatic COVID-19 is unclear. Objective: To evaluate the efficacy of low-dose fluvoxamine (50 mg twice daily) for 10 days compared with placebo for the treatment of mild to moderate COVID-19 in the US. Design, setting, and participants: The ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) platform randomized clinical trial was designed to test repurposed medications in outpatients with mild to moderate COVID-19. A total of 1288 participants aged 30 years or older with test-confirmed SARS-CoV-2 infection and experiencing 2 or more symptoms of acute COVID-19 for 7 days or less were enrolled between August 6, 2021, and May 27, 2022, at 91 sites in the US. Interventions: Participants were randomized to receive 50 mg of fluvoxamine twice daily for 10 days or placebo. Main outcomes and measures: The primary outcome was time to sustained recovery (defined as the third day of 3 consecutive days without symptoms). There were 7 secondary outcomes, including a composite outcome of hospitalization, urgent care visit, emergency department visit, or death through day 28. Results: Among 1331 participants who were randomized (median age, 47 years [IQR, 38-57 years]; 57% were women; and 67% reported receiving ≥2 doses of a SARS-CoV-2 vaccine), 1288 completed the trial (674 in the fluvoxamine group and 614 in the placebo group). The median time to sustained recovery was 12 days (IQR, 11-14 days) in the fluvoxamine group and 13 days (IQR, 12-13 days) in the placebo group (hazard ratio [HR], 0.96 [95% credible interval, 0.86-1.06], posterior P = .21 for the probability of benefit [determined by an HR >1]). For the composite outcome, 26 participants (3.9%) in the fluvoxamine group were hospitalized, had an urgent care visit, had an emergency department visit, or died compared with 23 participants (3.8%) in the placebo group (HR, 1.1 [95% credible interval, 0.5-1.8], posterior P = .35 for the probability of benefit [determined by an HR <1]). One participant in the fluvoxamine group and 2 participants in the placebo group were hospitalized; no deaths occurred in either group. Adverse events were uncommon in both groups. Conclusions and relevance: Among outpatients with mild to moderate COVID-19, treatment with 50 mg of fluvoxamine twice daily for 10 days, compared with placebo, did not improve time to sustained recovery. These findings do not support the use of fluvoxamine at this dose and duration in patients with mild to moderate COVID-19. Trial registration: ClinicalTrials.gov Identifier: NCT04885530.
MeSH term(s)	Humans ; Female ; Middle Aged ; Male ; COVID-19 ; Fluvoxamine/adverse effects ; SARS-CoV-2 ; Outpatients ; COVID-19 Vaccines ; COVID-19 Drug Treatment
Chemical Substances	Fluvoxamine (O4L1XPO44W) ; COVID-19 Vaccines
Language	English
Publishing date	2023-01-12
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
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.2022.24100
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Article ; Online: Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial.

Stewart, Thomas G / Rebolledo, Paulina A / Mourad, Ahmad / Lindsell, Christopher J / Boulware, David R / McCarthy, Matthew W / Thicklin, Florence / Garcia Del Sol, Idania T / Bramante, Carolyn T / Lenert, Leslie A / Lim, Stephen / Williamson, John C / Cardona, Orlando Quintero / Scott, Jake / Schwasinger-Schmidt, Tiffany / Ginde, Adit A / Castro, Mario / Jayaweera, Dushyantha / Sulkowski, Mark /

Gentile, Nina / McTigue, Kathleen / Felker, G Michael / DeLong, Allison / Wilder, Rhonda / Rothman, Russell L / Collins, Sean / Dunsmore, Sarah E / Adam, Stacey J / Hanna, George J / Shenkman, Elizabeth / Hernandez, Adrian F / Naggie, Susanna

JAMA

2023 Volume 330, Issue 24, Page(s) 2354–2363

Abstract: Importance: The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain.: Objective: To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for ... ...

Abstract	Importance: The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain. Objective: To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19. Design, setting, and participants: 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, a total of 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were 30 years or older with confirmed SARS-CoV-2 infection and at least 2 acute COVID-19 symptoms for 7 days or less. Interventions: Participants were randomized to receive fluvoxamine, 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days (n = 601), or placebo (n = 607). Main outcomes and measures: 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-19 clinical progression scale score; and difference in mean time unwell. Follow-up occurred through day 28. Results: Among 1208 participants who were randomized and received the study drug, the median (IQR) age was 50 (40-60) years, 65.8% were women, 45.5% identified as Hispanic/Latino, and 76.8% reported receiving at least 2 doses of a SARS-CoV-2 vaccine. Among 589 participants who received fluvoxamine and 586 who received placebo included in the primary analysis, differences in time to sustained recovery were not observed (adjusted hazard ratio [HR], 0.99 [95% credible interval, 0.89-1.09]; P for efficacy = .40]). Additionally, unadjusted median time to sustained recovery was 10 (95% CI, 10-11) days in both the intervention and placebo groups. No deaths were reported. Thirty-five participants reported health care use events (a priori defined as death, hospitalization, or emergency department/urgent care visit): 14 in the fluvoxamine group compared with 21 in the placebo group (HR, 0.69 [95% credible interval, 0.27-1.21]; P for efficacy = .86) There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo) but no deaths. Conclusions and relevance: Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms. Trial registration: ClinicalTrials.gov Identifier: NCT04885530.
MeSH term(s)	Humans ; Female ; Middle Aged ; Male ; COVID-19 ; Fluvoxamine/therapeutic use ; SARS-CoV-2 ; Outpatients ; COVID-19 Vaccines ; Treatment Outcome ; COVID-19 Drug Treatment ; Double-Blind Method
Chemical Substances	Fluvoxamine (O4L1XPO44W) ; COVID-19 Vaccines
Language	English
Publishing date	2023-11-17
Publishing country	United States
Document type	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.2023.23363
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Article ; Online: Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19: A Randomized Clinical Trial.

Naggie, Susanna / Boulware, David R / Lindsell, Christopher J / Stewart, Thomas G / Slandzicki, Alex J / Lim, Stephen C / Cohen, Jonathan / Kavtaradze, David / Amon, Arch P / Gabriel, Ahab / Gentile, Nina / Felker, G Michael / Jayaweera, Dushyantha / McCarthy, Matthew W / Sulkowski, Mark / Rothman, Russell L / Wilson, Sybil / DeLong, Allison / Remaly, April /

Wilder, Rhonda / Collins, Sean / Dunsmore, Sarah E / Adam, Stacey J / Thicklin, Florence / Hanna, George J / Ginde, Adit A / Castro, Mario / McTigue, Kathleen / Shenkman, Elizabeth / Hernandez, Adrian F

JAMA

2023 Volume 329, Issue 11, Page(s) 888–897

Abstract: Importance: It is unknown whether ivermectin, with a maximum targeted dose of 600 μg/kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate COVID-19.: Objective: To evaluate the effectiveness of ivermectin ... ...

Abstract	Importance: It is unknown whether ivermectin, with a maximum targeted dose of 600 μg/kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate COVID-19. Objective: To evaluate the effectiveness of ivermectin at a maximum targeted dose of 600 μg/kg daily for 6 days, compared with placebo, for the treatment of early mild to moderate COVID-19. Design, setting, and participants: The ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines 6 (ACTIV-6) platform randomized clinical trial was designed to evaluate repurposed therapies among outpatients with mild to moderate COVID-19. A total of 1206 participants older than 30 years with confirmed COVID-19 experiencing at least 2 symptoms of acute infection for less than or equal to 7 days were enrolled at 93 sites in the US from February 16, 2022, through July 22, 2022, with follow-up data through November 10, 2022. Interventions: Participants were randomly assigned to receive ivermectin, with a maximum targeted dose of 600 μg/kg (n = 602) daily, or placebo (n = 604) for 6 days. Main outcomes and measures: The primary outcome was time to sustained recovery, defined as at least 3 consecutive days without symptoms. The 7 secondary outcomes included a composite of hospitalization, death, or urgent/emergent care utilization by day 28. Results: Among 1206 randomized participants who received study medication or placebo, the median (IQR) age was 48 (38-58) years, 713 (59.1%) were women, and 1008 (83.5%) reported receiving at least 2 SARS-CoV-2 vaccine doses. The median (IQR) time to sustained recovery was 11 (11-12) days in the ivermectin group and 11 (11-12) days in the placebo group. The hazard ratio (posterior probability of benefit) for improvement in time to recovery was 1.02 (95% credible interval, 0.92-1.13; P = .68). Among those receiving ivermectin, 34 (5.7%) were hospitalized, died, or had urgent or emergency care visits compared with 36 (6.0%) receiving placebo (hazard ratio, 1.0 [95% credible interval, 0.6-1.5]; P = .53). In the ivermectin group, 1 participant died and 4 were hospitalized (0.8%); 2 participants (0.3%) were hospitalized in the placebo group and there were no deaths. Adverse events were uncommon in both groups. Conclusions and relevance: Among outpatients with mild to moderate COVID-19, treatment with ivermectin, with a maximum targeted dose of 600 μg/kg daily for 6 days, compared with placebo did not improve time to sustained recovery. These findings do not support the use of ivermectin in patients with mild to moderate COVID-19. Trial registration: ClinicalTrials.gov Identifier: NCT04885530.
MeSH term(s)	Humans ; Female ; Middle Aged ; Male ; COVID-19 ; Ivermectin/adverse effects ; SARS-CoV-2 ; Outpatients ; COVID-19 Vaccines ; Vaccines
Chemical Substances	Ivermectin (70288-86-7) ; COVID-19 Vaccines ; Vaccines
Language	English
Publishing date	2023-02-22
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.2023.1650
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Article: The bone marrow leaves its scar: new concepts in pulmonary fibrosis.

Dunsmore, Sarah E / Shapiro, Steven D

The Journal of clinical investigation

2004 Volume 113, Issue 2, Page(s) 180–182

Abstract: Excess collagen deposition occurs in pulmonary fibrosis. A new study suggests that collagen overproduction may originate from cells derived from bone marrow precursors rather than parenchymal lung fibroblasts. ...

Abstract	Excess collagen deposition occurs in pulmonary fibrosis. A new study suggests that collagen overproduction may originate from cells derived from bone marrow precursors rather than parenchymal lung fibroblasts.
MeSH term(s)	Animals ; Bleomycin/pharmacology ; Bone Marrow Cells/pathology ; Cell Lineage ; Collagen/metabolism ; Fibroblasts/metabolism ; Fibrosis/pathology ; Hematopoietic Stem Cells/cytology ; Humans ; Lung/pathology ; Models, Biological ; Pulmonary Fibrosis/pathology ; Stem Cells/metabolism
Chemical Substances	Bleomycin (11056-06-7) ; Collagen (9007-34-5)
Language	English
Publishing date	2004-01
Publishing country	United States
Document type	Comment ; Journal Article ; Review
ZDB-ID	3067-3
ISSN	1558-8238 ; 0021-9738
ISSN (online)	1558-8238
ISSN	0021-9738
DOI	10.1172/JCI20782
Database	MEDical Literature Analysis and Retrieval System OnLINE

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