Beyond Celiac Chosen by 9 Meters Biopharma as Exclusive Patient Organization to Recruit for First-Ever Phase 3 Clinical Trial

Premier Patient Recruiter for Celiac Disease Research, Beyond Celiac Taps Extensive Network to Advance Study

Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3

Philadelphia, PA, Oct. 14, 2020 (GLOBE NEWSWIRE) — Beyond Celiac, the leading catalyst for a celiac disease cure in the United States, today announced it has been chosen by 9 Meters Biopharma, Inc. (Nasdaq: NMTR) as the exclusive patient organization to recruit for the first-ever Phase 3-stage clinical trial therapeutic for treatment of celiac disease. Beyond Celiac will use its unrivaled connection to the celiac disease community and its powerful online patient database to recruit participants for the study of larazotide acetate, which aims to address leaky gut in celiac disease.

“We really listen to our community’s wants and needs. Because of our extensive connection to the people and commitment to connecting researchers with our community, Beyond Celiac has become the partner of choice for leading biotechnology and pharmaceutical companies such as 9 Meters,” said Beyond Celiac CEO Alice Bast. “This is the furthest a celiac disease clinical trial has gone, and it’s an exciting opportunity for our organization to play a vital role in fulfilling its promise.”

9 Meters Biopharma is evaluating larazotide acetate for celiac disease patients who continue to experience gastrointestinal symptoms while following a gluten-free diet. Designed to tighten junctions between intestinal cells, larazotide acetate would act like shoelaces to help restore leaky junctions to a normal state and would be used in addition to the gluten-free diet. It is being tested at more than 100 clinical sites, with a goal of 525 study participants. Results are expected by the end of 2021.

By partnering with Beyond Celiac for recruitment, 9 Meters Biopharma now has access to the power of Go Beyond Celiac, a secure online patient database with thousands of users who share their celiac disease stories and experiences with researchers and seek to become involved in studies.

“Our conservative estimate is that our celiac disease program is at least two years ahead of everyone else’s,” said John Temperato, president and CEO of 9 Meters Biopharma. “Beyond Celiac is going to help us across the finish line in developing the effective treatments that celiac patients deserve.”

Celiac disease is a serious genetic autoimmune disorder that affects an estimated 1 in 133 Americans, more than half of whom are still undiagnosed. The disease causes damage to the small intestine, resulting in debilitating symptoms, and if left untreated, can lead to serious long-term health problems including infertility and some types of cancer.

 

About Beyond Celiac

Founded in 2003,

Read More →

Health systems, govt responses linked to virus tolls

BERLIN (AP) — Scientists say a comparison of 21 developed countries during the start of the coronavirus pandemic shows that those with early lockdowns and well-prepared national health systems avoided large numbers of additional deaths due to the outbreak.

In a study published Wednesday by the journal Nature Medicine, researchers used the number of weekly deaths in 19 European countries, New Zealand and Australia over the past decade to estimate how many people would have died from mid-February to May 2020 had the pandemic not happened.

The authors, led by Majid Ezzati of Imperial College London, then compared the predicted number of deaths to the actual reported figure during that period to determine how many likely occurred due to the pandemic. Such models of ‘excess mortality’ are commonly used by public health officials to better understand disease outbreaks and the effectiveness of counter-measures.

The study found there were about 206,000 excess deaths across the 21 countries during the period, a figure that conforms to independent estimates. In Spain, the number of deaths was 38% higher than would have been expected without the pandemic, while in England and Wales it was 37% higher.

Italy, Scotland and Belgium also had significant excess deaths, while in some countries there was no marked change or even — as in the case of Bulgaria — a decrease.


While the authors note that there are differences in the compositions of populations, such as age and the prevalence of pre-existing conditions that contribute to mortality rates, government efforts to suppress transmission of the virus and the ability of national health systems to cope with the pandemic also played a role.

Amitava Banerjee, a professor of clinical data science at University College London who wasn’t involved in the study, said it was well designed and had used standardized methods.

He noted that the comparison between death rates in the United Kingdom and New Zealand, where the age of the population and the rates of pre-existing conditions such as obesity are similar, supports the argument that other factors contributed to the differing mortality figures.

“Even if vaccines and better treatments for severe (COVID-19) infection are developed, the way to minimise excess deaths is to reduce the infection rate through population level measures,” said Banerjee.

These include lockdowns, protecting high risk groups,and establishing effective “test, trace and isolate” systems, he said.

___

Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

Source Article

Read More →

Do Musical Instruments Spread the Coronavirus?

As with pretty much every other activity right now, having the quintet gather outdoors is a great idea. If any neighbors complain, explain that the backyard practices are part of a global effort to keep them from dying. If anyone happens to be infected, any virus that emanates in the heat of performance will likely fade into the sky and disperse like the music itself. Indoors, as any parent of a child who’s learning an instrument knows, everything is trapped and can echo around the room indefinitely.

Some instruments do seem to pose more risk than others. Obviously, string instruments can be played without even opening your mouth, but it sounds like your daughter’s quintet is too far along to take kindly to a suggestion that they all learn new instruments. Because the virus is sent into the air by talking, coughing, and singing—any forcible exhalation of air through the pharynx—playing a woodwind or brass instrument would logically pose a risk. These instruments are effectively designed to amplify what’s coming out of our mouths and to carry the sound. A 2011 study of vuvuzelas (the long, straight plastic horns that people blow at soccer games) found that their capacity for spreading infections could be tremendous. Compared with shouting, blowing through the horn sent several hundred times more particles into the air.

Thankfully for everyone, kids don’t train for vuvuzela quintets. Woodwind and brass instruments send air through a maze of twists and turns, and buttons create turbulent airflow patterns that don’t simply shoot everything out in a piercing plume. Breathing into a convoluted contraption such as a saxophone or a tuba, then, actually serves as a sort of filter that collects the larger droplets you might be spewing out. This is familiar to anyone who has emptied a spit valve and seen what pours out.

The real question is the potential danger of smaller, aerosolized particles that can blast out of an instrument and linger in the air. In May, the Vienna Philharmonic reported that it had conducted a study of the aerosols from various instruments. Researchers hooked tubes up to musicians’ noses, and as they played, they inhaled an aerosolized salt solution that could be visualized when it was exhaled. The researchers mapped the clouds of air around musicians while they were playing and reported that none of the instruments sent respiratory droplets beyond the commonly recommended radius of six feet. In most cases, no significant amount of the aerosolized salt particles were detectable coming out the end of the wind and brass instruments. Flutes were the worst offender, passing a “large amount” of aerosol in a cloud covering two and a half feet.

In July, another study in Germany offered findings and hope similar to those from Vienna. But neither study measured actual coronavirus particles, and the overall evidence is still thin. Doctors at the University of Iowa have expressed concern about the rigor of both findings, given

Read More →

First Databank Selected as Drug Database Provider for CliniComp, Intl.’s Full-Service EHR Pharmacy Solution

Healthcare industry’s most trusted drug database to drive streamlined inpatient pharmacy workflows for hospitals using CliniComp’s EHR

First Databank, Inc. (FDB), the leading provider of drug and medical device knowledge that helps healthcare professionals make precise decisions, has been selected to supply the drug database for a new and expanded EHR pharmacy module to be offered by CliniComp, Intl., a global provider of hospital-wide clinical documentation systems and electronic health record (EHR) solutions.

CliniComp will integrate the FDB MedKnowledge® database into its EHR to drive a single, full-service pharmacy and medication management system designed to simplify all inpatient pharmacy workflows, including computerized physician order enter (CPOE), medication dispensing and administration.

“Hospitals today need a more robust integrated pharmacy workflow management system within the EHR to make ordering, conflict checking, documenting and dispensing medications easier and more accurate,” said Nancy Pratt, RN, MSN, Senior Vice President Clinical Product Design of CliniComp, Intl. “FDB MedKnowledge will support CliniComp to deliver a more intuitive, easy-to-use solution across all medication workflows, while facilitating meaningful clinical decision support [CDS] alerts, seamless interoperability and smarter data analytics.”

Pratt explained: “We also chose MedKnowledge because the database features excellent organization and structure. This will enable CliniComp to furnish clinicians with access to the right medication information appropriate for their contexts, as well as detailed drug product classifications for more precise selection of drugs.”

Bob Katter, President of FDB, said the alliance will streamline pharmacy workflows to make ordering and dispensing medications more efficient for clinicians. “We will provide CliniComp’s users with meaningful, targeted and actionable medication guidance to support their clinical decision-making,” Katter said. “This will help further improve patient care and safety.”

The new CliniComp pharmacy system powered by FDB MedKnowledge will:

  • Save clinicians time with faster order processing via intelligent dispensing. The system will automate package choice and medication ordering based on criteria such as patient-specific parameters and medication inventory.

  • Save hospitals implementation time via the use of prebuilt medication concepts offered within MedKnowledge. The new full function pharmacy system will provide a foundation from which hospitals can more quickly tailor a solution to meet specific needs.

  • Save hospitals time and resources in updating medication information while ensuring the latest drug data is readily available to clinicians. MedKnowledge will facilitate automated medication updates with minimal post-load maintenance, so there is no downtime.

In addition to FDB MedKnowledge, CliniComp plans to implement the FDB Interoperability Module™ to enhance medication reconciliation and interoperability with external hospital systems, such as automated dispensing cabinets.

About First Databank (FDB)

First Databank (FDB) is the leading provider of drug and medical device knowledge that helps healthcare professionals make precise decisions. We empower our information system developer partners to deliver valuable, useful, and differentiated solutions used by millions of clinicians, business associates, and patients every day. For more than four decades, our medical knowledge has helped improve patient safety, operational efficiency, and healthcare outcomes. For a complete look at our solutions and services, please visit www.fdbhealth.com and follow us on

Read More →

Coronavirus UK: Man who couldn’t see a dentist pulls out own teeth

A labourer who lost his income during lockdown pulled out two of his own teeth with pliers and downed eight cans of Stella Artois to numb the pain because he couldn’t get a dental appointment due to the coronavirus crisis.

Chris Savage, 42, resorted to yanking two of his own teeth out in his bedroom because he couldn’t register with a dentist or book an emergency appointment, calling last Thursday’s procedure ‘the most horrible thing I’ve ever done’.

He said he had been in ‘agony’ for days, and revealed that just touching the tooth with his rusty pair of pliers set off waves of ‘agonising pain’.

The labourer, from Southsea in Portsmouth, Hampshire, admitted to getting ‘very drunk’ beforehand by downing eight cans of Stella Artois to mask the pain before he pulled out the first tooth. He then waited a day before pulling out the second tooth.

His case has now been raised with the NHS by a health watchdog who said Mr Savage has been ‘severely let down’ by services in the city.

He said: ‘I ended up having to get very drunk the first time. Nobody wants to take part of their own face away with a set of pliers and no real painkillers.

‘I put the pliers on my tooth and the second I did that it hurt. So I took them away, waited five minutes, built up again and then thought I’ve just got to do it.

Chris Savage, 42, resorted to yanking two of his own teeth out in his bedroom because he couldn't register with a dentist or book an emergency appointment

Chris Savage, 42, resorted to yanking two of his own teeth out in his bedroom because he couldn’t register with a dentist or book an emergency appointment

The labourer said he had been in 'agony' for days, and revealed that just touching the tooth with his rusty pair of pliers set off waves of 'agonising pain'

The labourer said he had been in ‘agony’ for days, and revealed that just touching the tooth with his rusty pair of pliers set off waves of ‘agonising pain’

‘It was a proper yank, a grip and pull — there’s no mucking about once you get to the point it’s started coming out.’

Mr Savage added that though there wasn’t much blood there was ‘enough to be scary’, and that it was ‘worth the risk of infection’.

The father-of-three didn’t register with an NHS dentist when he moved to Portsmouth from Alton three years ago. He lost his two front teeth in a bicycle crash last year, and when he began to experience pain recently he called around 20 dental practices, none of whom were taking on new patients.

He then phoned 111, who directed him to a practice that had volunteered to do triage appointments during the pandemic to help the NHS, but was referred back to 111 when he contacted them.

‘It was like a massive game of pass the parcel’, he said.

Mr Savage signed up to receive Universal Credit during lockdown, leaving him with £50 a week for food and bills, meaning he was reluctant to spend the £100 per tooth it would have cost him to have them removed privately.

He said: ‘I could’ve waited a week — borrowed money, and had it done in hygienic

Read More →

Most governments listen to scientists

Billionaire philanthropist Bill Gates criticized the U.S. response to the coronavirus, telling CNBC the nation ranks “quite low compared to other countries” in executing testing and delivering a clear message on safe social practices such as wearing masks.

“Our response in most respects has not been very good. And we would have expected it to be good,” the Microsoft co-founder told “Squawk Box” co-host Becky Quick in an interview that aired Wednesday.

President Donald Trump, recovering from Covid-19 himself, has been dismissive of masks and even mocked Democratic presidential nominee Joe Biden in their first debate for wearing them. Trump, who returned to the campaign trail this week, has also repeatedly flouted advice from medical experts on the importance of social distancing by holding packed rallies with spotty mask-wearing among supporters. Trump has defended having crowds at his recent campaign events, saying they’re being held outside, where coronavirus transmission is less likely than indoors.

Without mentioning Trump, Gates said that unlike the U.S., many countries have “done very, very well” using the behavioral tools available to help blunt the spread of the coronavirus. The founder of the Bill and Melinda Gates Foundation, which works to tackle complex global health challenges, said it has nothing to do with politics.

“That’s a purely technical thing, not a political thing. Most governments take advantage of their scientists and listen to them. They don’t undermine them and attack them,” he said. “Mask compliance in the United States is quite poor. And yet the cost of the mask and the productivity lost from [not wearing] the mask, it’s quite an intervention.”

Gates also pointed out that social measures such as masks, social distancing and hand-washing are the primary tools to fight Covid-19 until “therapeutics or vaccines get out there in big numbers.”

Source Article

Read More →

The best fitness watches you can still get on sale for Prime Day

We’ve also added a few fitness watch accessories for you!

Fitness trackers are on sale for Amazon Prime Day.

Fitness trackers are on sale for Amazon Prime Day.

adamkaz/Getty Images

More now than ever before, Americans are focused on their wellness. We have finally become more mindful of the quality of foods we eat, our daily water intake, the amount of exercise we do, and how much sleep we get.

And, in typical modern fashion, we can rely on technology to keep track of it all – right on our wrists. Fitness watches are not new to the worlds of fashion or wellness, but they’re cheaper than they’ve ever been. For less than $150, you can easily track your heart rate, workouts, sleep, calorie consumption, blood pressure, and even catch up on the latest news.

As always, your Chron Shopping team has done a little digging through thousands of products on sale for Amazon’s Prime Day and found the best deals on fitness watches and accessories for you.

Fitness Watches on Sale for Prime Day

Fitbit Versa 2 Health and Fitness Smartwatch with Heart Rate, Music, Alexa Built-In – amazon.com

179.95Shop Now

Fitbit Versa 2 on sale for $127.95.

ANBES Health and Fitness Smartwatch with Heart Rate Monitor – amazon.com

35.99Shop Now

ANBES Smart Watch on sale for $26.99.

Garmin 010-02064-00 Instinct, Rugged Outdoor Watch with GPS – amazon.com

229.99Shop Now

Garmin Rugged Outdoor Smart Watch on sale for $149.99.

Smart Watch, UMIDIGI Uwatch 2S Fitness Tracker – amazon.com

29.99Shop Now

UMIDIGI Uwatch 2S on sale for $23.99.

LETSCOM Smart Watch – amazon.com

39.99Shop Now

LETSCOM Smart Watch on sale for $31.99 plus an extra 5% off when adding to your cart.

Fitness Watch Accessories on Sale for Prime Day

Wepro Replacement Bands Compatible with Fitbit Versa SmartWatch, Versa 2 and Versa Lite SE Sports Watch – amazon.com

5.99Shop Now

Wepro Bands in black on sale for $4.79.

2 Pack Screen Protector Case for Fitbit Versa – amazon.com

6.99Shop Now

Screen Protector available in 7 colors on sale for $5.59.

REDOVER-Bluetooth Body Fat Scale with Smartphone App, Smart Wireless Digital Bathroom Scale – amazon.com

29.99Shop Now

Redover Smart Scale on sale for $18.89.

Moonooda Watch Band Compatible with Fitbit Versa/Fitbit Versa 2/ Versa Lite Edition/Versa SE Smart Glitter Sparkling Watch – amazon.com

11.98Shop Now

Moonooda Sparkle Band on sale for $9.58.

Hearst Newspapers participates in various affiliate marketing programs, which means we may get paid commissions on editorially chosen products purchased through our links to retailer sites. 

Micolette Davis is a Local Deals Curator for Hearst Newspapers. Email her at [email protected]

Source Article

Read More →

Surgical protocol reduces opioid use for breast reconstruction patients

Breast cancer surgeries can be quite painful, so a team at Houston Methodist West Hospital has worked to develop pain management protocols that help some patients while reducing the use of narcotics.

Dr. Candy Arentz, a breast surgical oncologist, and Dr. Warren Ellsworth, a plastic surgeon, have been using an enhanced recovery after surgery (ERAS) protocol with non-narcotic medications and nerve blocks to lessen pain and the need for narcotics in reconstructive surgeries.


A DIEP flap reconstruction uses tissue and fat from the abdomen and other areas to reconstruct the breast after a lumpectomy or a mastectomy. Ellsworth said the reconstruction can be beneficial because it can look more natural than implants and can last the rest of a patient’s life. But it can be more painful because of the extra incisions. He recognizes that opioid overuse is an issue and said that is just one reason why he and Arentz are working to reduce opioid use.

“We have also, I would say, across the entire house of medicine known about this opioid overuse, opioid dependence and all these challenges that our narcotics impose on our patients, not only the basic side effects of narcotics like nausea, vomiting, constipation, but of course, the dependency,” Ellsworth said.

The ERAS protocol helps patients with pain starting the day before the surgery. “So it prepares their body for the surgery and the pain that could occur, and then we continue the pain control throughout the surgery and then of course postoperatively and have found a significant reduction in the use of narcotics because of this protocol,” Ellsworth said.

As Arentz and Ellsworth were coming up with the protocol, Ellsworth consulted with plastic surgeons at the University of Pennsylvania and Stanford University, modeling the Methodist West protocol after their programs. But according to Ellsworth, Methodist West is the first in the Houston area to make the non-narcotic protocols a priority with their patients in the area of DIEP flap reconstructions.

Ellsworth said starting ERAS required bringing in others in the hospital on board, including the head of anesthesiology so that anesthesiologists could administer nerve blocks, or long-lasting numbing injections into patients’ nerves, and the head of the ICU (intensive care unit) because the new protocols were a big change in pain management. Arentz said it required patient buy-in as well.

“It starts with our conversations in clinic and assuring the patients that they will have decreased pain afterwards than probably what they were expecting,” Arentz said, adding that the protocol is done without using IV medications, which is what most people expect when they are going to have surgery.

Arentz and Ellsworth had planned to start using ERAS in February or March, but COVID-19 shifted it back some. So they started in April. Ellsworth said that all

Read More →

Plexiglass shields are everywhere, but it’s not clear how much they help

Plexiglass shields have become ubiquitous at offices, grocery stores and restaurants across the country in the coronavirus age. They were even installed on the vice presidential debate stage last week.



a group of people standing in a kitchen: Businesses and workplaces say plexiglass dividers are one way they are keeping people safe against the spread of the coronavirus.


© Ethan Miller/Getty Images
Businesses and workplaces say plexiglass dividers are one way they are keeping people safe against the spread of the coronavirus.

Given that they’re just about everywhere, you may wonder how effective they actually are.

Businesses and workplaces have pointed to plexiglass dividers as one tool they are using to keep people safe against the spread of the virus. But it’s important to know there’s little data to support their effectiveness, and even if there were, the barriers have their limits, according to epidemiologists and aerosol scientists, who study airborne transmission of the virus.

The Centers for Disease Control and Prevention (CDC) has offered guidance to workplaces to “install physical barriers, such as clear plastic sneeze guards, where feasible” as a way to “reduce exposure to hazards,” and the Labor Department’s Occupational Safety and Health Administration (OSHA) has issued similar guidance.

That’s because the plexiglass shields can in theory protect workers against large respiratory droplets that spread if someone sneezes or coughs next to them, say epidemiologists, environmental engineers and aerosol scientists. Coronavirus is thought to spread from person to person “mainly through respiratory droplets produced when an infected person coughs, sneezes or talks,” according to the CDC.

But those benefits haven’t been proven, according to Wafaa El-Sadr, professor of epidemiology and medicine at Columbia University. She says there have not been any studies that examined how effective plexiglass barriers are at blocking large droplets.

Moreover, the bigger problem is that even if they do, that’s not the only way that the coronavirus spreads. Last week, the CDC released new guidelines saying that the coronavirus can spread through aerosols — tiny particles containing the virus that float in the air and can travel beyond six feet — that are released when people breathe, talk or sneeze.

Most droplets people release when they talk or breathe are in a “size range that will flow past the barrier,” said Pratim Biswas, an aerosol scientist at Washington University in St. Louis.

The dividers “do not address all possible modes of transmission, such as aerosol transmission, or fully protect anyone from Covid-19,” the University of Washington’s Environmental Health and Safety Department said in a July review of the benefits and limitations of plexiglass barriers at campus facilities.

There’s also another problem in some cases: the size of the barriers. Marissa Baker, an assistant professor at the University of Washington, has been conducting a separate study of coronavirus safety measures at nine grocery stores in Seattle and seven in Portland, Oregon, each month since May.

She has observed that plexiglass shields at cash registers and self-checkout stations are often too small to even prevent droplet transmission between customers and workers.

“Some are smaller and don’t even cover the nose of a tall individual,” she said. “The airborne particles are going to

Read More →

NBC Says Trump Will Hold Town Hall Meeting Thursday, Competing Against Biden

President Trump may not be debating Joseph R. Biden Jr. on the same stage on Thursday night as originally planned. But the two candidates will still face off head-to-head.

NBC News confirmed on Wednesday that it would broadcast a prime-time town-hall-style event with Mr. Trump from Miami on Thursday at 8 p.m. Eastern, with the president fielding questions from Florida voters.

The event will directly overlap with an already-scheduled ABC televised town-hall meeting with Mr. Biden in Philadelphia, which will begin at the same time.

Mr. Biden’s town hall has been on the books since last week, after Mr. Trump, who had recently contracted the coronavirus, rejected plans to convert the second formal presidential debate into a virtual matchup; the debate was eventually canceled.

The NBC event, to be moderated by the “Today” show host Savannah Guthrie, had been contingent on the Trump campaign providing independent proof that the president would not pose a safety risk to the other participants — including NBC crew members, voters and Ms. Guthrie herself.

Keep up with Election 2020

As late as Tuesday afternoon, NBC executives were waiting for that proof, but the network determined late Tuesday that it would be comfortable moving forward, according to two people familiar with the planning.

On Wednesday’s “Today” show, the NBC anchor Craig Melvin said the town hall would occur “in accordance with the guidelines set forth by health officials” and proffered a statement from Clifford Lane, a clinical director at the National Institutes of Health.

In the statement, Dr. Lane said he had reviewed medical data about Mr. Trump’s condition, including a so-called P.C.R. test — a widely used diagnostic test for the coronavirus that is considered more reliable than a rapid antigen test — that the N.I.H. “collected and analyzed” on Tuesday. Dr. Lane concluded “with a high degree of confidence” that the president is “not shedding infectious virus,” NBC said.

The network did not explicitly say that Mr. Trump had received a negative result from the P.C.R. test.

Mr. Trump and his aides have not shared extensive details about the president’s medical condition with the public, and over the past few days, NBC executives were no exception. Until late Tuesday, the network had been prepared to cancel the event if the president’s team did not present convincing evidence that Mr. Trump would not potentially infect those around him, one of the people said.

The town hall on Thursday will be held outdoors at the Pérez Art Museum in Miami, and audience members will be required to wear face masks, the network said. Ms. Guthrie and Mr. Trump will be seated at least 12 feet apart.

NBC officials began discussing the possibility of a town hall with the Trump campaign last week, after Mr. Trump pulled out of the second planned presidential debate. The network made clear at the start that it needed outside proof of the president’s medical condition.

NBC officials did not say exactly what testing

Read More →