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SAN DIEGO (CNS) - A COVID-19 vaccine trial sponsored by drugmaker Johnson & Johnson is slated to get underway soon in San Diego, and will include an estimated 2,000 participants at UC San Diego Health, it was announced Thursday.Up to 60,000 participants will be recruited from 10 different countries around the world as the San Diego portion of the trial, dubbed ENSEMBLE, gets underway Oct. 7, according to UCSD.The efficacy, safety and immunogenicity of the drug Ad.26-COV2.S will be tested via a randomized, double-blind, placebo-controlled study, in which half of the participants receive a single-dose injection of the vaccine and the other half receive a placebo. All participants -- who must be 18 years of age or older and in reasonably good health -- will be monitored for signs of infection and COVID-19 over the next two years, according to UCSD.Researchers are particularly interested in recruiting participants at increased risk of SARS-CoV-2 infection due to where they live, their age or personal circumstances, such as working in essential jobs like first responders, health care, maintenance, construction, grocery stores or assisted living facilities.The San Diego trial will also emphasize participation from the region's underserved communities, as communities of color have shown higher rates of COVID-19-related hospitalization and/or death.UCSD cited data from the county showing measurably higher infection rates in the South Bay, including in Chula Vista, Imperial Beach and National City.Susan Little, professor of medicine at UC San Diego School of Medicine and principal investigator of the UC San Diego trial, said, "Many communities of color are experiencing higher rates of hospitalization related to COVID-19 than are observed in white, non-Hispanic people. It is important that these communities are represented in COVID-19 vaccine clinical trials so that we understand if the vaccine will work well within these groups."For more information about participating in the trial at UC San Diego, go to www.covidvaccinesd.com or call 619-742-0433. 2087

SAN DIEGO (CNS) - A day after District Attorney Summer Stephen criticized the San Diego Police Department for employing incomplete testing of DNA evidence in some unsolved rape cases, Chief David Nisleit Wednesday announced that his agency would thoroughly analyze all such materials from now on.On Tuesday, Stephen told Voice of San Diego -- which revealed the contested investigative policy last week in an in-depth investigative story -- that the SDPD should not have performed incomplete examinations of dozens of rape kits while working through a decades-long backlog of open sex-assault cases."I don't think that that's the right thing to do," the district attorney told VOSD.Wednesday afternoon, the police chief announced that he had reached the same decision."We recognize the community has high expectations for us," Nisleit said in a prepared statement. "We also hold ourselves to the highest of standards. In order to meet these expectations, we will be working with a private laboratory to ensure all 1,700 historical kits are tested."When a sexual assault is reported to law enforcement, nurses collect swabs from different parts of a victim's body in search of the perpetrator's genetic material, and file away the DNA samples for testing in the future.Six months ago, San Diego police began testing only a single swab from dozens of previously untested kits, as opposed to the full set of a half- dozen available in each case, VOSD reported. The procedure was reserved for situations in which the district attorney had declined to prosecute, or when a warrant already had been issued for a suspect's arrest.That practice is officially a thing of the past, according to Nisleit."Moving forward, the department will test every single kit using a six-swab method," he said.According to SDPD officials, about 40 rape kits had been tested in the abbreviated manner. Though the department defended the procedure as appropriate in the relatively rare selected cases, an SDPD crime-lab analyst who spoke on condition of anonymity told Voice of San Diego there was another motivation."The reason given was, `We just need to check the box,"' the department staffer said. "There was no scientific reason given, not that `This would be more effective.' There was no indication that this was anything other than a political policy decision."The department canceled the policy in August, a day after Voice of San Diego first asked about it, according to the nonprofit news agency.Stephen said the District Attorney's Office had not approved of -- or even known about -- the investigative shortcuts being employed by the SDPD on some of the old rape kits it was reviewing."We assume that the testing will be done by proper standards," she told VOSD. "We don't get into the technical (aspects), because that's not our area. We trust that forensic experts will make those decisions correctly ... . Mistakes happen, but the key is to not get stuck on ego, to correct and to move forward so we can serve this community."Last year, the District Attorney's Office formalized an agreement with the San Diego County Sheriff's Department and 11 other police departments in the county -- all but the SDPD -- to clear the region's backlog of rape kits by forwarding them to outside laboratories for testing.Declining to join the effort, the SDPD instead opted to create an internal group to tackle the task. The panel included SDPD staffers, the local county prosecutor in charge of sex crimes and a victims' rights advocate. 3523

SAN DIEGO (CNS) - A former U.S. Navy captain and two chief petty officers were indicted in San Diego Friday on charges they allegedly received cash bribes, lavish hotel suites and the services of prostitutes from a foreign defense contractor and allegedly reciprocated by using their influence within the Navy's Seventh Fleet to approve inflated invoices from the contractor.Retired U.S. Navy Capt. David Williams Haas, 50, faces charges of conspiracy to commit bribery, bribery and conspiracy to commit honest services fraud. He allegedly received at least 5,000 in bribes from defense contractor Leonard Francis, who plied him with parties at luxurious hotels, prostitutes, top-shelf booze and food, according to indictments handed down by a federal grand jury.RELATED: 783

SAN DIEGO (CNS and KGTV) - The San Diego Humane Society announced Thursday that its Humane Law Enforcement division conducted a one-day sweep of pet stores and issued more than 100 citations for violations of a partial state ban on the sale of dogs, cats and rabbits.Assembly Bill 485, which went into effect at the beginning of this year, requires pet stores to get their animals from a partnered shelter or rescue center in an effort to curb the sale of pets from so-called puppy mills and kitten factories that breed animals for sale en masse, often in inhumane conditions.Humane Law Enforcement officers issued 39 citations to Broadway Puppies and 38 to Bark Avenue, both located in Escondido, for failing to provide a documented agreement with a public or private animal shelter or rescue organization, according to Humane Society spokeswoman Dariel Walker. Officers also issued 25 citations to Pups & Pets in Santee for improper signage on the cages holding its available animals, she said.RELATED: 26-pound cat helping raise awareness on pet obesity10News spoke to Mindy Patterson, Co-President of "The Cavalry Group," an organization that represents animal businesses. One of their members is Broadway Puppies in Escondido. Patterson said AB485 treats legitimate pet stores unfairly."To mandate that a store is required to obtain and source their animals for sale, from a specific source is unconstitutional," Patterson said. "All I know is that our members are in accordance with the law."Patterson said she wants the public to recognize the difference between illegitimate backyard breeders and USDA-certified breeders. She said both of them are often lumped into the same negative category of "puppy mills.""They are licensed, regulated and regularly inspected facilities that meet very stringent standards," Patterson said. Cavalry Group co-founder Mark Patterson said the store "and its parent organization are faithfully following the letter of the law in this case and will be exonerated of these citations. Other pet stores in San Diego County have been subject to similar harassment by SDHS only to have the citations dismissed in court."Representatives of the other two pet stores could not immediately be reached for comment on the citations, which were issued during a countywide sweep Wednesday of pet stores under the Humane Society's purview.Last July, the county's Department of Animal Services ceded nearly all countywide animal control duties to the Humane Society, except unincorporated areas of the county that are served by the department's shelters in Carlsbad and Bonita.RELATED: San Diego Humane Society sees surge in young wildlife in need of care"My advice is beware," said Humane Law Enforcement Officer Allen Villasenor. "As a brand-new law takes effect, people will use different methods to try to circumvent the law and at this point it's our job to make sure everything is in compliance. I always suggest looking into shelters first, go to the adoption agencies first and see if you can find the right fit for your family there."Residents can report possible violations of the state pet sale laws by calling the Humane Society's Law Enforcement division at 619-299-7012. 3221

SAN DIEGO (CNN) - Two years ago, Brendan Tyne pleaded with the Food and Drug Administration to approve a drug that he was hopeful could finally bring his mother some peace.She could no longer move without assistance and had fallen victim to the debilitating and frightening psychosis that haunts many people with Parkinson's disease."She thinks there are people in the house and animals are trying to get her," he told an FDA advisory committee.He believed that a new medication called Nuplazid, made by San Diego-based Acadia Pharmaceuticals, was the answer.Nuplazid's review was being expedited because it had been designated a "breakthrough therapy" -- meaning that it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market. Congress created this designation in 2012 in an effort to speed up the FDA's approval process, which has long been criticized for being too slow. Around 200 drugs have been granted this designation since its creation.Still, to recommend approval, the advisory committee would have to find that the drug's potential benefits outweighed its risks for its intended patients.Some FDA officials concluded that Nuplazid's public health benefit was enough to merit approval of the drug. Their argument echoed the pleas of family members and caregivers like Tyne: It could possibly help patients with no other alternative. Several of the people who spoke said their loved ones had been transformed during the clinical trials, though some said there was no way for them to know whether they were on Nuplazid or a placebo.But the physician who led the FDA's medical review, Dr. Paul Andreason, warned that patients taking the drug during the company's clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. The company's limited testing, he said, had not convinced him that the benefits outweighed the risks.While Tyne had heard about these risks, he said he "discounted death as a real statistical possibility" and was willing to try anything to help his mother."I have two young children who love their grandmother," he told the committee. "If nothing is done to bring her back to some semblance of normalcy, my children will never remember their grandmother for who she is: a loving, funny, caring woman who has improved the lives of all of the loved ones who surround her. Please, I beg you, do not deprive my children and their grandmother of experiencing that love."The committee voted 12-2 and recommended that the FDA approve Nuplazid for the treatment of Parkinson's disease psychosis based on a six-week study of about 200 patients. Three previous studies of the drug did not show that it was effective, Andreason said in his medical review, though they showed similar risk.Even some committee members who voted in favor of the drug expressed reservations, according to the hearing transcript. "I guess I'm hoping that the risks are going to be small, and I think the benefits for some of these people who are very sick and whose families are affected by this, I think they're probably willing to take that risk," one physician stated. Another committee member said she wouldn't have voted for the drug's approval if there had been a safe and effective alternative on the market. A third made a "plea" to the FDA to "consider a large observational study so we can ensure that, once it goes into real-world use, that the benefits will outweigh the risks."It hit the market in June 2016. As caregivers and family members rushed to get their loved ones on it, sales climbed to roughly 5 million in 2017.Tyne got his mother on the drug as soon as it became available. But after trying it for months, he says he was devastated to see that it was doing nothing to halt the awful progression of the disease, and her hallucinations became more frequent and harder to manage. "She has gone straight downhill to the point she really can't function at all," he said.Shortly after the drug's release, patients' family members, doctors and other health care professionals started reporting "adverse events" possibly linked to the medication -- including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.Creatures like cats and snakes can haunt patients with Parkinson's disease psychosis, as shown in Acadia's TV commercial.In November, an analysis released by a nonprofit health care organization, the Institute for Safe Medication Practices, warned that 244 deaths had been reported to the FDA between the drug's launch and March 2017. The organization also noted that hundreds of reports suggested the drug was "not providing the expected benefit" or potentially worsening the condition.Tracked by the FDA, these so-called "adverse event reports" document deaths, side effects and other issues, and can be made directly by consumers, caregivers and other medical professionals. Reports are submitted to either the FDA or to the drugmaker, which is required to pass along any it receives to the federal government. In some cases, the person filing the report is convinced the side effects were caused by the drug; in others, the reporter ascribes no cause but notes that the patient was on the drug.An adverse event report does not mean that a suspected medication has been ruled the cause of harm and is typically not the result of an official investigation. But the FDA uses the information to monitor potential issues with a drug and can take action as needed -- updating a medication's label, for instance, or restricting its use or pulling it off the market.After analyzing the adverse event data for Nuplazid, the Institute for Safe Medication Practices concluded that this batch of reports "reinforces the concerns of those who warned that (Nuplazid) might do more harm than good." Thomas Moore, senior scientist for drug safety and policy for the nonprofit, said the deaths are an "important warning signal" and warrant further review by the FDA -- and possible action, depending on what the review finds.Since the institute released its analysis, FDA data shows that the number of reported deaths has risen to more than 700. As of last June, Nuplazid was the only medication listed as "suspect" in at least 500 of the death reports.Physicians, medical researchers and other experts told CNN that they worried that the drug had been approved too quickly, based on too little evidence that it was safe or effective. And given these mounting reports of deaths, they say that more needs to be done to assess Nuplazid's true risks."This is almost unheard of, to have this many deaths reported," said Diana Zuckerman, founder and president of the nonprofit thinktank the National Center for Health Research, adding that because reports are voluntary, potential problems may be underreported. "You just don't see this with most new drugs -- you don't see all these reports -- so you have to take it seriously."Acadia and the FDA maintain that the medication's potential benefits continue to outweigh the risks and help fill a desperate need. Psychosis affects up to 50% of the roughly one million Americans suffering from Parkinson's disease, according to the FDA, and Nuplazid is the first drug to be approved to treat this specific condition.Acadia said there are a number of reasons for the higher volume of death reports. Parkinson's disease psychosis is more commonly seen in patients in the most advanced stages of the disease, meaning they are already at a high risk of death. Plus, the company distributes Nuplazid through a network of specialty pharmacies that allow them to be in more frequent contact with both patients and caregivers -- meaning it is more likely to receive reports of death, which it is required to pass along to the FDA."If you are actively and regularly engaging patients and/or caregivers, it is inevitable that you will see a higher number of adverse events reported, especially in an older, chronically ill patient population," the company said in a statement.It said its "benefit/risk assessment of Nuplazid remains unchanged," and it carefully monitors and regularly analyzes safety reports from both ongoing studies and adverse event reports. The company noted, for example, that since the drug's approval, two studies of a total of more than 300 patients with Alzheimer's disease did not find a difference in the number of deaths reported between Nuplazid and the placebo.The company also provided CNN with a statement from Dr. Joseph Jankovic, professor of neurology and an expert on movement disorders at Baylor College of Medicine. "I have accumulated a great deal of experience with this drug," Jankovic said in the statement. "While not all patients are completely satisfied, many of my patients have experienced marked improvement in their visual hallucinations, paranoia and other psychotic symptoms."In an interview this week, FDA commissioner Scott Gottlieb was asked by CNN's Dr. Sanjay Gupta about his thoughts on drugs that receive expedited reviews and then prompt concerns about safety once they become available, like Nuplazid. While Gottlieb didn't want to comment on a specific product, he said he is "familiar with the circumstances" and that it's very important for the agency to make sure it is "appropriately balancing" safety with medical need. He said this is a flexible standard, however, and there may be more tolerance for risk in situations where there is a significant need and patients don't have an alternative."You've seen us take regulatory action recently in the post-market setting to limit the use of drugs when new safety concerns became known," he said.The FDA told CNN it will continue to monitor the adverse event reports and review the drug's safety. It added that Nuplazid's "complex safety profile," recognized at the time of its approval, resulted in a requirement that the medication carry a number of warnings on its label so that doctors could analyze potential risks and benefits before prescribing the drug.The cases reported so far, according to the FDA, typically involved elderly patients with advanced-stage Parkinson's disease who suffer from numerous medical conditions and often take other medications that can increase the risk of death."Based on these data, the FDA has, at this time, not identified a specific safety issue that is not already adequately described in the product labeling," the agency said in a statement.The FDA has required antipsychotics to carry its most severe "black box" warning for the treatment of elderly dementia patients, after studies found that the medications increase the risk of death in this population. Between 50% and 80% of Parkinson's patients experience dementia as the disease worsens, according to the Alzheimer's Association. Because Nuplazid is a new kind of antipsychotic that targets a different receptor in the brain, its maker claims it comes with fewer toxic side effects. Even so, Nuplazid also carries a black box warning.Geriatric psychiatrist and former FDA medical officer Susan Molchan said that the number of deaths is alarming and questioned whether patients and their families are aware of the risks associated with the drug.To determine the true risks of Nuplazid, the researchers interviewed by CNN said, the FDA needs to require further scientific studies -- and not just rely on the reports, which are challenging to interpret and are not systematically collected. They also worried that, because the drug was already approved, these studies and any action by the FDA could take years.A CNN review of several hundred adverse event reports shows that the detail provided for each case varies widely and that thorough investigations are rarely conducted -- making it difficult to determine whether Nuplazid might have been involved in the deaths of already sick and elderly patients.In these reports, the physicians who prescribed the drug sometimes suggest that their patients likely died from complications from Parkinson's rather than because of Nuplazid. In other cases, it's unclear when exactly the patient started or stopped taking the medication. And in yet others, family members and sometimes doctors are convinced the drug contributed to the deaths.One report recounts the death of a 73-year-old woman in a long-term care facility who was taking Nuplazid. Just before 8 in the morning, a nurse noted that the woman was "sleepy." Shortly after, she was found unresponsive and without a pulse. Paramedics were not able to revive her and, less than an hour after the nurse's visit, she was pronounced dead. While her physician didn't believe her death was "related" to Nuplazid, her husband was convinced that it had played a role and paid for an autopsy. It showed only that she had pre-existing heart issues and died of cardiac arrest.In another report, an 89-year-old man was taken off the drug after experiencing a significant decline. His doctor blamed Nuplazid for his deteriorating condition. The patient died weeks later. In a third report, a woman flagged her husband's death to the FDA after he was taken to the hospital due to dehydration. After he passed away, she said, she was told by "someone at the hospital" that the death was connected to his use of Nuplazid.Acadia said it analyzed these reports and concluded that there "is nothing to suggest a causal relationship to Nuplazid." Acadia calculated a mortality rate for Nuplazid, which it said was lower than what you'd see in the general population of Parkinson's disease psychosis patients covered by Medicare. It calculated this using deaths reported to the FDA and what it considered a conservative estimate of patients on the drug, along with Medicare claims data. However, multiple experts interviewed by CNN said that this is an unreliable calculation since it is comparing apples to oranges.In the weeks after the Institute for Safe Medication Practices issued its report on the deaths, Acadia's stock price dropped by more than 20%. While many large investors remain bullish about the stock, some investment analysts have made public records requests to the FDA for the death reports.Currently, Nuplazid can cost nearly 0 a day, according to wholesale pricing data from First Databank. That can add up to more than ,000 a year for a single patient, though the amount a patient actually pays depends on factors including individual insurance coverage.Acadia expects sales of Nuplazid to at least double this year.Acadia's TV commercial shows how frightening Parkinson's disease psychosis can be.The company, meanwhile, is forging ahead with clinical trials in an attempt to get the medication approved for use in a larger patient population: patients who have dementia-related psychosis. In October, the FDA granted its coveted breakthrough designation for this potential use as well, meaning it will also undergo a speedier review process.While a doctor can legally prescribe a drug for any reason, insurance companies may not approve it for uses that are not FDA-approved. So FDA approval to treat dementia patients would likely result in Nuplazid being prescribed to a much wider population, concerned medical experts told CNN."You would certainly hope they don't approve it for anything else," said Zuckerman of the National Center for Health Research, based on the current research and FDA adverse event reports. "If they're going to approve it for another group of patients that is much, much larger -- that would be unconscionable."That is something they should absolutely not do given these unanswered questions about risk."Roughly two years have passed since that FDA meeting, where family members and caregivers -- some of whom traveled there on Acadia's dime -- gathered with medical experts to debate the merits and potential risks of Nuplazid.Andreason, the physician who led the FDA's medical review of Nuplazid, no longer works for the agency.He said that while he stands by the warnings he made at the time, he understands that other antipsychotics used to treat Parkinson's patients also come with an increased risk of death and that, when patients have a debilitating disease like Parkinson's, physicians and caregivers may choose a medication that improves quality of life even if it could also shorten life expectancy.He said that he was not surprised to hear about the reports of death."This is exactly what I thought was going to happen," he said. "We were going to get a burst of reports of serious adverse events and deaths."Dr. Stephanie Fox-Rawlings, a senior fellow at the National Center for Health Research who spoke against the drug's approval at the FDA committee meeting, recently told CNN she understands how desperate families in these situations are, but she does not think Nuplazid is the answer based on her review of Acadia's public research. She and Zuckerman said that, after previous studies didn't show it was effective, the drugmaker changed the way the medication's ability to improve psychosis was measured, which resulted in a positive outcome. Acadia said its studies have had different objectives and all of them have used "consistent, appropriate, and validated assessment methodology.""If patients know there is some level of benefit, they can judge their risk," said Fox-Rawlings. "But if we don't even know that it does work, how do you even judge that? It's kind of a false hope."Kim Witczak was the consumer representative on the FDA committee evaluating Nuplazid. She and the patient representative were the only two members to vote against its approval. She still can't believe it's on the market."I remember leaving really, really frustrated," she said.CNN reached two of the three family members who petitioned for Nuplazid's approval at the meeting, despite having had no experience with the drug or its clinical trials, to ask whether they tried the medication once it hit the market.One of these was Elaine Casavant. Despite the "staggering cost" of the medication, she said, she was quick to get her husband on it. But after three months, he showed no improvement and they stopped the medication. She has heard success stories, however, and remains optimistic that the drug could be helping certain people.The other person was Tyne.The 43-year-old New Jersey resident works in New York and visits his mother every weekend at a nursing home in the Bronx. Tyne has attempted to move on from the disappointment of Nuplazid, but he still gets frustrated talking about it."Knowing what I know now -- that it didn't work at all -- I wouldn't have gotten my hopes up," he said.But he doesn't regret trying."If there was something that could possibly help my mom and I didn't do it, I wouldn't be able to look at myself in the mirror." 18971