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The Food and Drug Administration on Wednesday authorized the first rapid coronavirus test that doesn’t need any special computer equipment to get results.The 15-minute test from Abbott Laboratories will sell for , giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.It’s the latest cheaper, simpler test to hit the U.S. market, providing new options to expand testing as schools and businesses struggle to reopen and flu season approaches. The FDA also recently greenlighted a saliva test from Yale University that bypasses some of the supplies that have led to testing bottlenecks.Both tests have limitations and neither can be done at home. Several companies are developing rapid, at-home tests, but none have yet won approval. Abbott’s new test still requires a nasal swab by a health worker, like most older coronavirus tests. The Yale saliva test eliminates the need for a swab, but can only be run at high-grade laboratories.And in general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases. The agency granted Abbott’s test an emergency use authorization late Wednesday for patients with suspected COVID-19.The two additions should help expand the number of available tests. The U.S. is now testing about 690,000 people per day, down from a peak of 850,000 daily tests late last month. Many public health experts believe the country will soon need to test vastly more people to find those who are infected, isolate them and contain the virus.The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.Since the start of the pandemic, nasal swab tests that are sent to a lab have been the standard for COVID-19 screening. While considered highly accurate, the tests rely on expensive, specialized machines and chemicals. Shortages of those supplies have led to repeated delays in reporting results, especially during a spike in cases last month.Government and health experts view rapid tests that can be run outside the laboratory system as key to boosting capacity.“Those screening tests are what we need in schools, workplaces and nursing homes in order to catch asymptomatic spreaders,” said Dr. Jonathan Quick of the Rockefeller Foundation, in an interview earlier this month. The nonprofit group has called for the U.S. to conduct about 4 millions per day by October, mostly rapid, point-of-care tests.Abbott’s BinaxNOW is the fourth rapid test that detects COVID-19 antigens, proteins found on the surface of the coronavirus, rather than the virus itself. It’s considered a faster, though sometimes less precise, screening method. The other tests need to be inserted into a small machine.Inside the Abbott test is a specially coated strip that interacts with COVID-19 antigens. The patient’s nasal swab is inserted into the card and a few drops of a chemical solution are added. Markings appear on the card to indicate whether the sample is positive or negative — much like a pregnancy test.Two other makers of antigen tests — Quidel and Becton Dickinson have said they haven’t been able to meet demand for the tests. A third, LumiraDx, plans to begin shipping its recently approved antigen tests by the end of this month. Abbott expects to begin shipping tests in September, reaching 50 million tests a month in October.The influx of antigen tests will go a long way toward meeting the Trump administration’s projection that 90 million COVID-19 tests a month will be available by September if needed. But U.S. “testing czar” Adm. Brett Giroir has stressed that the U.S. can contain the outbreak with far fewer tests.“That’s the capacity ... we do not need that many tests to safely and sensibly reopen,” Giroir told reporters on a recent call. He pointed to several key indicators that have been falling, including new infections and hospitalizations, even as testing has slowed.Earlier this month, the FDA authorized Yale’s saliva-based test, which is expected to cut the time and cost compared with similar tests. It’s the fifth COVID-19 saliva tests OK’d by regulators. All require lab processing.Developed by Yale’s School of Public Health, SalivaDirect can use any sterile container to collect a sample, not the special tube needed with earlier tests, and requires less chemicals. Outside experts welcomed the new approach but noted its limitations.“It’s not a rapid test, it’s a laboratory-based test that will still be prone to the same massive delays as any other test,” said Dr. Michael Mina of Harvard University.___Follow Matthew Perrone on Twitter: @ AP_FDAwriter.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 5201
The Food and Drug Administration approved on Wednesday a treatment for the Ebola virus. This is the first FDA-approved treatment for Zaire ebolavirus infection in adults and kids.Zaire ebolavirus is one of four Ebola virus species that can cause potentially deadly infections. It is transmitted through direct contact with blood, tissue or body fluids of an infected person or wild animal.The treatment, Inmazeb, is a mixture of three monoclonal antibodies and was created by Regeneron Pharmaceuticals. The three antibodies work together to bind to the glycoprotein on the surface of the Ebola virus and block it from entry into the body’s cells.Inmazeb was tested in the Democratic Republic of the Congo during an Ebola virus outbreak in 2018-2019 through a partnership between the local government and the National Institutes of Health.A vaccine for Ebola virus was approved by the FDA in December 2019.Regeneron is also the company behind an experimental antibody cocktail that was given to President Donald Trump following his diagnosis of COVID-19, and which he said “cured” him. Trump was also prescribed the antiviral drug remdesivir and the steroid dexamethasone at the time.Regeneron’s COVID-19 treatment is a mix of two powerful antibodies that are believed to boost the immune response to the coronavirus. Early results seem promising, according to initial tests and a press release from the company.The company has submitted an application to the FDA to get emergency approval of their COVID-19 treatment. 1525
The focus of many protests going on around the country is centered around a number of topics. Social Injustice, police brutality, and, more specifically, victims of these, like George Floyd. While each topic is distinct, with its own intricacies, they generally all fall under the same umbrella of systemic racism.But what does that mean exactly?“I think of systems in play that keeps you from being great specifically because of your race,” R. Kweku Smith, a licensed psychologist said. “It’s something that holds you down in a way that appears to be invisible but has very visible results.”“It’s acknowledging the ways in which we have looked at race as part of the institutions that make up our lives,” Monique Liston, Chief Strategist at Ubuntu Research and Evaluation said. “There is no such thing as a race-neutral situation because race is so deeply embedded in what it means to live, to work, and to play. That’s what systemic racism is.”Liston has her Ph.D. in urban education. She says, as a Black woman, she experiences the effects of systemic racism regularly when people discount her expertise in the education field.“I say something about education and I have a Ph.D. in it and people will be like, I don’t think so,” Liston said of how people question her. “There is presumed incompetence, a presumed questioning. That assumption you don’t quite know what you’re talking about.”As a psychologist, R. Kweku Smith looks at the impact experiences, like the one Liston described, can impact the psyche of African Americans.“It weighs extremely heavy,” Smith said. “Part of that racial socialization, part of that talk is a speech that you have [growing up], that you have to be twice as good to get half as far. As a child, imagine the ramifications on your mind and thinking, you hear America is a place for the great, for the free, equal opportunity for all. It’s the contradiction living within it. To be in a place that’s most beautiful, the riches, all of the great things that come with America. Yet, the juxtaposition with all the ugliness that comes in, specifically the people who look [like me], it’s a hard thing to swallow.”Smith says there are examples of systemic racism in almost everything.“When you look at stillbirths, low birth rates, look at detentions and suspensions and special education,” Smith said. “Lower employment, underemployment, prison placement, early deaths. We rank high on all of those. Why is that? It’s systemic racism.”Both Liston and Smith acknowledge some people don’t believe systemic racism exists, despite pointing out the areas where African Americans are impacted disproportionately. They say, because white people don’t physically experience any of these issues on a wide scale, it’s hard to believe it’s true.“If it’s this invisible issue, you don’t have to deal with it,” Smith said. “It doesn’t seem real.”“It’s easy to acknowledge something doesn’t exist when it doesn’t affect you,” Liston said. “It’s denying air exists when I don’t see it. It’s like, OK. True. But, when I go through the science of why you’re breathing, air does exist. The same thing applies to systemic racism. The reason you’re not impacted by it is that it exists.”While Smith’s examples were some big picture issues facing people of color in health, education, and the prison system, Liston gave examples that are more personal and not as complex but still cause challenges.“People being judged by names on job applications,” Liston said. “A name similar to mine, Monique, might be something where, oh we can’t hire her. She’s not someone we’re looking for. Another one is addresses. When you have addresses on job applications, we don’t want someone represented from that neighborhood. It comes into inherently believing I’m incompetent because I'm Black.”Even daily tasks for women like Liston are impacted by systemic racism.“Is it easy for me to buy stuff for my hair at the store?” Liston said. “No. Is it easy for me to buy the makeup I want? Absolutely. If I needed something special for my hair, I had to go someplace else other than where my friends were going. It’s like the world is set up for me to be used to, not being catered to. That’s the difference. The world doesn’t cater to me and I’m used to it. The world caters to white folks and they’re used to that.”In order to better understand what systemic racism feels like, Liston gave the example of swimming.“Tell me about one of your experiences going swimming,” Liston said. “Then, someone says, no you didn’t. That’s not how it felt. That’s not what you experienced.”Liston says, that process repeats itself over and over for people of color. It can take a toll on them mentally, leaving to them feeling their experiences, opinions and really, their existence, doesn’t matter.Even though she joked around about how ridiculous some of her examples are, Liston says it causes a tremendous amount of pain for her. Humor is a coping mechanism for her but it shouldn’t be taken as a reason to further discount her experience as a Black woman.“It’s hard for white folks to reconcile that, amidst an anti-Black world, I can experience joy,” Liston said. “It’s hard to believe. Folks won’t take my story as seriously. [They’ll say], it can’t be that bad. You’re smiling. You’re happy. You’re enjoying life. It’s like, no. If I didn’t, the world would kill me.”It’s why she and Smith are so motivated to try and tear down systemic racism and make the world a more equitable place. Despite their own success, they feel an obligation to break down barriers they faced along the way to achieve that equity.“What you don’t recognize is the level of tenacity, resilience, perseverance to obstacles we have had to go through to be able to get to this point,” Smith said. “What would be the case if everyone had a truly level playing field? When you see systemic racism as a Black person who made it, you see all of your friends and families, who are just as talented as you, but maybe not as lucky to get a second or third chance. Or, maybe one of those obstacles got them in a way it didn’t get you.”In order to eliminate systemic racism and the problems it causes, Liston and Smith both just ask for empathy. To understand the white view of the world isn’t the view of every person in the world and the disadvantages they have faced are very real.“We have different ways oppression affects our lives,” Liston said. “In particular, talking to women, they can articulate what it’s like being in a male-dominated society. Let’s put race on top of that. Being able-ist. People with two arms and legs and can move about are living in a different world than folks who don’t have that. Including mental ability too. Being able to be in a space where that is questioned and adding the race question on top of that usually is the ah-ha moment for people. If it’s true here, it must be true in this circumstance as well.”In order to help, Liston suggests white people have more empathy and most importantly, believe their experiences."Follow and trust people of color, specifically Black women, when they tell you what the situation is," Liston said. "Trust it, read on it, and believe it. Then apply it to your own life. Second, unlearning and understanding what whiteness is. White folks don't do that. They want to learn about all of these culturally responsible things. Really, it's an opportunity for white folks to understand whiteness. If white people understand whiteness, the systemic racism issue can really be addressed quickly. Whiteness shapes the world we live in. Everything from the clothes we wear to what's popular on television or who is promoted at work, what names are popular this year. How the media even tells stories. Understand how whiteness was created, who was allowed to be white and how whiteness permeates society is really a great exercise for white folks to go through."This story was first reported by Shaun Gallagher at TMJ4 in Milwaukee, Wisconsin. 7976
The Environmental Protection Agency will allow states to set their own emission standards for coal-fueled power plants, the Wall Street Journal reported Monday. Critics say the decision will result in much more carbon dioxide being released into the atmosphere.The Journal reported that acting EPA Administrator Andrew Wheeler signed a proposal that calls for states to regulate emissions from power plants, undoing a move from President Barack Obama that made those emissions regulated by the federal government for the first time."The entire Obama administration plan was centered around doing away with coal," Wheeler told the Journal in an interview. 662
The Federal Aviation Administration has issued a safety alert about flying with dry ice onboard, in anticipation of the huge nationwide distribution project anticipated to start in the next few days once the Pfizer COVID-19 vaccine is approved for use.The Pfizer and Moderna vaccines both need to be kept at extremely cold temperatures, requiring the use of dry ice during transit.Dry ice is frozen carbon dioxide that is pressed into blocks or pellets. It doesn’t melt into a liquid, it moves directly from a solid to a gas and that process can happen quickly at high altitudes.That can cause problems onboard a plane, such as causing the plane to weigh less at times during the flight and change its center of gravity.“CO2 sensors installed or carried in the aircraft or worn by the pilots and other crewmembers will assist the operator and crew in recognizing hazardous concentrations of CO2 and implementing effective risk controls,” the FAA’s safety alert recommends.In addition, they encourage maximum ventilation onboard while on the ground and in the air, asking crewmembers to check air conditioning units and auxiliary power units before flight.Exposure to elevated levels of CO2 can cause drowsiness or dizziness, and higher levels can impact breathing eventually leading to hypoxia and death.The FAA also recommends that “pilot training on specific conditions and procedures can improve pilot decision-making in the event of a CO2 detector alert or other system abnormalities.”Friday morning, Health and Human Services Director Alex Azar said Americans could begin getting the COVID-19 vaccine next week once the FDA and CDC give it emergency use approval. 1676