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The star of the Netflix documentary "Tiger King" Joe Exotic sued the United States Justice Department Wednesday because they rejected his request for a presidential pardon.According to court documents obtained by CBS11 and Courthouse News, lawyers for Exotic, whose real name Joseph Maldonado-Passage, argued that the rejection isn't valid because Acting Pardon Attorney Rosalind Sargent-Burns didn't give his official request to President Donald Trump himself.According to the six-page complaint filed in federal court in Fort Worth, Exotic's legal team named Sargent-Burns because she allegedly never gave President Trump a formal recommendation, which according to the lawsuit, she's required to do.Currently, Maldonado-Passage is serving a 22-year prison sentence in Fort Worth after he was found guilty in April 2019 for animal cruelty and trying to hire someone to murder Carole Baskin, who's a big-cat rights activist.The complaint also names Donald Trump Jr. as a supporter, CBS11 reported. 1006

The spread of COVID-19 is tough to trace and even tougher to predict, but researchers at Pittsburgh’s Carnegie Mellon University created an early warning system to help protect you from the virusMathematics professor Po-Shen Loh developed an app called NOVID, a contact-tracing app, to help communities see the virus coming before they get infected.On top of creating a brand new app, Loh teaches math to middle-school students online from his own office-turned-broadcast studio. He’s also the national coach for the United States Math Olympiad team that competes around the world.But when the pandemic hit, Loh wanted to take on one more project. “I like things that are supposed to be impossible, that can’t be done,” said Loh. Stopping the spread of the coronavirus seemed to fit the bill.“The problem with COVID is it spreads before you know you have it, that’s what makes COVID different," Loh said. "The only way you can control this disease is in helping people to know whether or not COVID is coming close to them in advance."That’s where the NOVID app can help, said Loh. “Shows the virus coming towards you based on your relationship network, so that you can protect yourselves from others before you actually get infected," Loh explained of the app. "This is in contrast to most other contact tracing apps that are designed to protect others from you."The app shows you positive cases in degrees of separation. A positive case in the first degree would be someone you live with. The second degree could be your coworker or a friend. The third degree would be that person’s spouse or child. Each degree of separation is a possible pathway for you to come in contact with COVID-19.“This thing shows you the virus coming towards you, kind of like a hurricane satellite shows you a hurricane coming towards you,” said Loh.In addition to showing you cases as they pop up around you, the app can track the distance between phones down to the inch.It uses both Bluetooth and ultrasound waves to give you that measurement to make sure you’re safely social distancing.“We don’t know of any other contact-tracing app in the entire world which will tell you, ‘here’s how far away we think the device was,’” said Loh.The safety of your personal information is one of the most important features of this app. It collects data, while you stay completely anonymous.“Many people are distrustful of an app that does contact tracing,” said Loh. “We never ask for your phone number or email."Those who are positive can self-report their case in the app. Loh is also working with cities and counties to integrate NOVID into health departments across the country. He said the health departments would issue a ticket with a number to each person who tests positive for the virus.That person would enter the number into their NOVID app, anonymously reporting the positive case in the community.“If this thing actually caught on, you’d see in all the cities and towns, whether it’s rural or urban, whenever COVID starts to rise up, you’d start to see everyone take caution. Not because anyone forced them to, but because they saw this is what would be useful,” said Loh.To create the powerful community resource Loh is hoping for, he said more people need to know about the app.“Right now, we only respond when the intensive care units are full, and then it’s too late, and people die on the sidewalk. But, what we wish would happen, is that people could see it coming, and then, everyone starts to be careful at the right time. With more traction, we can save more lives,” he said.Loh is hoping he can not only help save lives but help bring back life as we knew it.“The goal of what we’re trying to do is to give people headlights to drive in the dark. Our app is not designed to let other people control you; our app is designed to help you control your life,” said Loh.For more information on NOVID or to download it, click HERE. 3928

The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___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. 6274

The Vatican released a letter Monday from Pope Francis directly addressing for the first time the latest accusations of sexual abuse by priests. Here is the full text of the letter. 189

The United States and North Korea have been holding secret, direct talks to prepare for a summit between President Donald Trump and North Korea leader Kim Jong Un, a sign that planning for the highly anticipated meeting is progressing, several administration officials familiar with the discussions tell CNN.Central Intelligence Agency Director Mike Pompeo and a team at the CIA have been working through intelligence back-channels to make preparations for the summit, the officials said. American and North Korean intelligence officials have spoken several times and have even met in a third country, with a focus on nailing down a location for the talks.Although the North Korean regime has not publicly declared its invitation by Kim Jong Un to meet with Trump, which was conveyed last month by a South Korean envoy, several officials say North Korea has since acknowledged Trump's acceptance, and Pyongyang has reaffirmed Kim is willing to discuss the denuclearization of the Korean peninsula. 1005