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  • Monitoring Board says Trial Data suggests Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

    NIH: Monitoring Board says Trial Data suggests Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine| site |


    (November 16, 2020) - - Today the National Institutes of Health (NIH) published the following information: An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 15, 2020. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers. The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%. The findings are statistically significant, meaning they are likely not due to chance. 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. ...
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  • FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

    U.S. Food and Drug Administration Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development | site |




    (November 9, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:


    November 09, 2020

    Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations. We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, a
    ...
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  • NIH begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19

    National Institutes of Health begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19 | site |





    (October 16, 2020) - - Today, October 16, 2020, The National Institutes of Health (NIH) published the following information:

    The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive
    Colorized scanning electron micrograph of an apoptotic cell (green) heavily infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. Graphic courtesy NIAID
    amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome,...
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  • BULLETIN—NIAID Stops Enrollment of Severely Ill COVID-19 Participants in Clinical Trial of Investigational Treatments

    BULLETIN—NIAID Stops Enrollment of Severely Ill COVID-19 Participants in Clinical Trial of Investigational Treatments | site |


    ACTT-3 Study Will Continue for Hospitalized Participants with Less Severe Illness


    Editor's note: Please note that this BULLETIN was published on September 29, 2020


    (September 29, 2020) - - On September 29, 2020, the National Institute of Allergy and Infectious Diseases published the following information:

    The Adaptive COVID-19 Treatment Trial 3 (ACTT-3), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will no longer enroll hospitalized participants with severe COVID-19 requiring high-flow oxygen, and will not begin to enroll patients requiring non-invasive or invasive mechanical ventilation. This action is being taken after an interim review of safety data by the study’s Data and Safety Monitoring Board (DSMB)
    ...
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  • Lilly Statement on the National Institute of Allergy and Infectious Diseases Decision to Pause Enrollment in ACTIV-3 Clinical Trial

    Lilly Statement on the National Institute of Allergy and Infectious Diseases Decision to Pause Enrollment in ACTIV-3 Clinical Trial | site |



    (October 14, 2020) - - Lilly (the Eli Lilly Company) has published a statement addressing the National Institute of Allergy and Infectious Diseases (NIAID) decision to Pause Enrollment in ACTIV-3 Clinical Trial.

    The Lilly statement is located at https://www.lilly.com/news/stories/s...use-enrollment or please press HERE
    ...
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  • NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin plus Remdesivir to Treat COVID-19 Begins

    National Institutes of Health Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin plus Remdesivir to Treat COVID-19 Begins | site |


    Editor's note: Please note that this article was published on October 8, 2020

    (October 8, 2020) - - On October 8, 2020, the National Institutes of Health (NIH) published the following information:

    A clinical trial to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, has begun. The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico and 16 other countries on five continents. The National


    Graphic courtesy NIH/NIAID
    Institute of Allergy...
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  • NIH Study aims to Identify promising COVID-19 Treatments for larger Clinical Trials

    National Institutes of Health Study aims to Identify promising COVID-19 Treatments for larger Clinical Trials | site |



    (October 13, 2020) - - Today, the National Institutes of Health published the following information:

    The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show




    This scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. The virus shown was isolated from a patient in the U.S.
    Graphic courtesy NIAID

    promise against COVID-19 and merit...
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  • Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials

    Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials | site |



    (October 12, 2020) - - Today, October 12, 2020, Johnson & Johnson published the following information:



    Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials


    At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.

    We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines,
    ...
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  • NIH expands Clinical Trials to Test Convalescent Plasma against COVID-19

    National Institutes of Health expands Clinical Trials to Test Convalescent Plasma against COVID-19 | site |


    Rigorous studies to build on earlier efforts to test the experimental treatment


    (September 22, 2020) - - Today the National Institutes of Health published the following information: Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19. Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and
    ...
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  • National Institutes of Health Clinical Trial of Investigational Vaccine for COVID-19 begins

    National Institutes of Health Clinical Trial of Investigational Vaccine for COVID-19 begins| site |


    Study enrolling Seattle-based healthy adult volunteers.


    (March 16, 2020) - - Today (March 16, 2020), the National Institutes of Health (NIH) published the following information:

    A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today. The study is evaluating different doses of the experimental vaccine for
    ...
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  • National Institutes of Health Clinical Trial of Remdesivir to Treat COVID-19 Begins

    National Institutes of Health Clinical Trial of Remdesivir to Treat COVID-19 Begins | site |



    Study Enrolling Hospitalized Adults with COVID-19 in Nebraska



    (February 25, 2020) - - Today, the National Institutes of Health (NIH) published the following information: A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. The trial regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. This is the first clinical trial in the United States to evaluate an experimental treatment for COVID-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China. The first trial participant is an American who was repatriated after being quarantined...
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  • CDC says Initial State Findings Point to Clinical Similarities in Illnesses Among People Who Use E-cigarettes or Vape

    CDC says Initial State Findings Point to Clinical Similarities in Illnesses Among People Who Use E-cigarettes or "Vape"| site |


    CDC says no single product linked to all cases of lung disease (September 6, 2019) - - Today (September 6, 2019), the Centers for Disease Control and Prevention (CDC) published the following information: Initial findings from the investigation into serious lung illnesses associated with e-cigarette products point to clinical similarities among those affected. Patients report similar exposures, symptoms and clinical findings and these align with the CDC health advisory released last week. While many of the patients, but not all, reported recent use of THC-containing products, some reported using both THC- and nicotine-containing products. A smaller group reported using nicotine only. No evidence of infectious diseases has been identified in these patients, therefore lung illnesses are likely associated with a chemical exposure. However, it is ...
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  • U.S. Food and Drug Administration Awards 12 Grants to Fund New Clinical Trials to Advance the Development of Medical Products for the Treatment of Rare Diseases

    U.S. Food and Drug Administration Awards 12 Grants to Fund New Clinical Trials to Advance the Development of Medical Products for the Treatment of Rare Diseases



    (September 24, 2018) - - The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country. “Developing a treatment for a rare disease can be especially challenging. Given the often small number of patients affected by certain very rare diseases, there can be limited markets for new treatments, and as a result fewer resources devoted to researching these opportunities,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to doing it...
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  • Staff Reporter 1
    Monitoring Board says Trial Data suggests Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
    by Staff Reporter 1
    NIH: Monitoring Board says Trial Data suggests Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine| site |


    (November 16, 2020) - - Today the National Institutes of Health (NIH) published the following information: An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 15, 2020. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers. The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%. The findings are statistically significant, meaning they are likely not due to chance. 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. ...
    11-16-2020, 08:11 PM
  • Staff Reporter 1
    FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
    by Staff Reporter 1
    U.S. Food and Drug Administration Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development | site |




    (November 9, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:


    November 09, 2020

    Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations. We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, a
    ...
    11-09-2020, 09:31 PM
  • Staff Reporter 1
    NIH begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19
    by Staff Reporter 1
    National Institutes of Health begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19 | site |





    (October 16, 2020) - - Today, October 16, 2020, The National Institutes of Health (NIH) published the following information:

    The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive
    Colorized scanning electron micrograph of an apoptotic cell (green) heavily infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. Graphic courtesy NIAID
    amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome,...
    10-18-2020, 05:50 AM
  • Staff Reporter 1
    BULLETIN—NIAID Stops Enrollment of Severely Ill COVID-19 Participants in Clinical Trial of Investigational Treatments
    by Staff Reporter 1
    BULLETIN—NIAID Stops Enrollment of Severely Ill COVID-19 Participants in Clinical Trial of Investigational Treatments | site |


    ACTT-3 Study Will Continue for Hospitalized Participants with Less Severe Illness


    Editor's note: Please note that this BULLETIN was published on September 29, 2020


    (September 29, 2020) - - On September 29, 2020, the National Institute of Allergy and Infectious Diseases published the following information:

    The Adaptive COVID-19 Treatment Trial 3 (ACTT-3), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will no longer enroll hospitalized participants with severe COVID-19 requiring high-flow oxygen, and will not begin to enroll patients requiring non-invasive or invasive mechanical ventilation. This action is being taken after an interim review of safety data by the study’s Data and Safety Monitoring Board (DSMB)
    ...
    10-15-2020, 04:12 AM
  • Staff Reporter 1
    Lilly Statement on the National Institute of Allergy and Infectious Diseases Decision to Pause Enrollment in ACTIV-3 Clinical Trial
    by Staff Reporter 1
    Lilly Statement on the National Institute of Allergy and Infectious Diseases Decision to Pause Enrollment in ACTIV-3 Clinical Trial | site |



    (October 14, 2020) - - Lilly (the Eli Lilly Company) has published a statement addressing the National Institute of Allergy and Infectious Diseases (NIAID) decision to Pause Enrollment in ACTIV-3 Clinical Trial.

    The Lilly statement is located at https://www.lilly.com/news/stories/s...use-enrollment or please press HERE
    ...
    10-15-2020, 03:46 AM

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