Solidarity Trial
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Solidarity Trial
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness. The trial was announced 18 March 2020, and as of 6 August 2021, 12,000 patients in 30 countries had been recruited to participate in the trial. In May, the WHO announced an international coalition for simultaneously developing several candidate vaccines to prevent COVID-19 disease, calling this effort the Solidarity trial for vaccines. The treatments being investigated are remdesivir, lopinavir/ritonavir combined, lopinavir/ritonavir combined with interferon-beta, and hydroxychloroquine or chloroquine. Hydroxychloroquine or chloroquine investigation was discontinued in June 2020 due to concluding that it provided no benefit. Solidarity trial for treatment candidates The trial intends to rapidly assess thousands of COVID-19 infected people for th ...
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Phases Of Clinical Research
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over sever ...
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Randomized Controlled Trial
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By Random assignment, randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing Standard of care#Medical standard of care, ...
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Charitable Organization
A charitable organization or charity is an organization whose primary objectives are philanthropy and social well-being (e.g. educational, Religion, religious or other activities serving the public interest or common good). The legal definition of a charitable organization (and of charity) varies between countries and in some instances regions of the country. The Charity regulators, regulation, the tax treatment, and the way in which charity law affects charitable organizations also vary. Charitable organizations may not use any of their funds to profit individual persons or entities. (However, some charitable organizations have come under scrutiny for spending a disproportionate amount of their income to pay the salaries of their leadership). Financial figures (e.g. tax refund, revenue from fundraising, revenue from sale of goods and services or revenue from investment) are indicators to assess the financial sustainability of a charity, especially to charity evaluators. This ...
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Emergency Use Authorization
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Act of Congress, Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by , to allow the use of a drug prior to approved drug, approval. It does not constitute ''approval'' of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security. Use EUAs have historically been infrequent. A review article by Rizk et al. provides a summary of the US experience in 2020 with pharmacological EUA approvals during the COVID-19 pandemic. It also provides a descripti ...
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The Guardian
''The Guardian'' is a British daily newspaper. It was founded in 1821 as ''The Manchester Guardian'', and changed its name in 1959. Along with its sister papers ''The Observer'' and ''The Guardian Weekly'', ''The Guardian'' is part of the Guardian Media Group, owned by the Scott Trust. The trust was created in 1936 to "secure the financial and editorial independence of ''The Guardian'' in perpetuity and to safeguard the journalistic freedom and liberal values of ''The Guardian'' free from commercial or political interference". The trust was converted into a limited company in 2008, with a constitution written so as to maintain for ''The Guardian'' the same protections as were built into the structure of the Scott Trust by its creators. Profits are reinvested in journalism rather than distributed to owners or shareholders. It is considered a newspaper of record in the UK. The editor-in-chief Katharine Viner succeeded Alan Rusbridger in 2015. Since 2018, the paper's main news ...
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Arrhythmia
Arrhythmias, also known as cardiac arrhythmias, heart arrhythmias, or dysrhythmias, are irregularities in the heartbeat, including when it is too fast or too slow. A resting heart rate that is too fast – above 100 beats per minute in adults – is called tachycardia, and a resting heart rate that is too slow – below 60 beats per minute – is called bradycardia. Some types of arrhythmias have no symptoms. Symptoms, when present, may include palpitations or feeling a pause between heartbeats. In more serious cases, there may be lightheadedness, passing out, shortness of breath or chest pain. While most cases of arrhythmia are not serious, some predispose a person to complications such as stroke or heart failure. Others may result in sudden death. Arrhythmias are often categorized into four groups: extra beats, supraventricular tachycardias, ventricular arrhythmias and bradyarrhythmias. Extra beats include premature atrial contractions, premature ventricular contract ...
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Hydroxychloroquine
Hydroxychloroquine, sold under the brand name Plaquenil among others, is a medication used to prevent and treat malaria in areas where malaria remains sensitive to chloroquine. Other uses include treatment of rheumatoid arthritis, lupus, and porphyria cutanea tarda. It is taken by mouth, often in the form of hydroxychloroquine sulfate. Common side effects may include vomiting, headache, changes in vision, and muscle weakness. Severe side effects may include allergic reactions, vision problems, and heart problems. Although all risk cannot be excluded, it remains a treatment for rheumatic disease during pregnancy. Hydroxychloroquine is in the antimalarial and 4-aminoquinoline families of medication. Hydroxychloroquine was approved for medical use in the United States in 1955. It is on the World Health Organization's List of Essential Medicines. In 2020, it was the 126th most commonly prescribed medication in the United States, with more than 4million prescriptions. Hydrox ...
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Lopinavir/ritonavir
Lopinavir/ritonavir (LPV/r), sold under the brand name Kaletra among others, is a fixed-dose combination antiretroviral medication for the treatment and prevention of HIV/AIDS. It combines lopinavir with a low dose of ritonavir. It is generally recommended for use with other antiretrovirals. It may be used for prevention after a needlestick injury or other potential exposure. It is taken by mouth as a tablet, capsule, or solution. Common side effects include diarrhea, vomiting, feeling tired, headaches, and muscle pains. Severe side effects may include pancreatitis, liver problems, and high blood sugar. It is commonly used in pregnancy and it appears to be safe. Both medications are HIV protease inhibitors. Ritonavir functions by slowing down the breakdown of lopinavir. Lopinavir/ritonavir as a single medication was approved for use in the United States in 2000. It is on the World Health Organization's List of Essential Medicines. Medical uses Lopinavir/ritonavir was once a ...
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Remdesivir
Remdesivir, sold under the brand name Veklury, Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged. is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein. During the COVID‑19 pandemic, remdesivir was approved or authorized for emergency use to treat COVID‑19 in numerous countries. Remdesivir was originally developed to treat hepatitis C, and was subsequently investigated for Ebola virus disease and Marburg virus infections before being studied as a post-infection treatment for COVID‑19. Remdesivir is a prodrug that is intended to allow intracellular delivery of GS-441524 monophosphate and subsequent biotransformation into GS-441524 triphosphate, a ribonucleotide analogue inhibitor of viral RNA polymerase. The most common side effect in healthy volunteers is raised blood levels of liver enzymes. ...
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Committee
A committee or commission is a body of one or more persons subordinate to a deliberative assembly. A committee is not itself considered to be a form of assembly. Usually, the assembly sends matters into a committee as a way to explore them more fully than would be possible if the assembly itself were considering them. Committees may have different functions and their types of work differ depending on the type of the organization and its needs. A member of a legislature may be delegated a committee assignment, which gives them the right to serve on a certain committee. Purpose A deliberative assembly may form a committee (or "commission") consisting of one or more persons to assist with the work of the assembly. For larger organizations, much work is done in committees. Committees can be a way to formally draw together people of relevant expertise from different parts of an organization who otherwise would not have a good way to share information and coordinate actions. They may ...
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Research Council Of Norway
The Research Council (also the Research Council of Norway; no, Norges forskningsråd) is a Norwegian government agency that funds research and innovation projects. On behalf of the Government, the Research Council invests NOK 11,9 billion (2021) annually. The Research Council is responsible for promoting basic and applied research and innovation. This is done by managing research funding and by advising the authorities on research policy, among other things through proposals for the research budget in the National Budget. The Research Council works to promote international research and innovation cooperation, and has a number of schemes to mobilise Norwegian applicants for the EU Research and Innovation Programme. Other tasks include creating meeting places for researchers, trade and industry, public administration, public actors and other users of research. The Research Council was established in 1993 through the merging of five different previously created research councils. ...
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