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Patient safety is always a big issue of concern especially in clinical trials and during the drug development. Given the increasing speed of developing new therapies, ensuring those therapies are safe and effective prior to be made public is imperative for the preservation of patient safety and endorsement of innovative treatments. This blog post focuses on the vital role of clinical trials in improving patient safety including the procedures followed to ensure safer drug development and advancements towards making clinical trials safer.
#biotech database#polymer database#api database#clinical trial database platform India#clinical trial database platform USA#Clinical Trial Data Solutions#global clinical research organization#clinical research organization US
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NewLife Medicals: Your Trusted Global Clinical Research Organization
Riding on the cutting edge of medical science and clinical trials, NewLife Medicals is your reliable partner for all pharmaceutical needs. Bathing in expertise, authority, and trust, our ambitious goal is to reshape the future of healthcare.
But why should you trust NewLife Medicals?
NewLife Medicals: Active Pharmaceutical Ingredient Manufacturers
Active pharmaceutical ingredients (APIs) are the heart of any medicine, responsible for its therapeutic effects. At NewLife Medicals, we are more than just API manufacturers. Quality, affordability, and ultra-precision define our API manufacturing. We utilize state-of-the-art technology and rigorous quality checks to ensure the synthesis of high-quality APIs.
Got an unusual API request? As hard-to-source drugs and limited distribution drugs suppliers, we welcome the challenge!
Clinical Research Organization: NewLife Medicals
Clinical trials form the backbone of drug development – but they can be complex and costly. Simplify and economize your clinical testing experience with our unparalleled clinical research organization. Our seasoned team of research professionals are committed to delivering high-quality, timely, and ethically sound clinical research.
Why settle for less when you can have the best?
Global Innovator Drugs Supplier and Biosimilar Supplier
As an innovator drugs supplier, NewLife Medicals is committed to bringing new, pioneering treatments to the market. Our extensive portfolio of innovator drugs and biosimilar infusions stands as a testament to our pioneering spirit and relentless dedication to progress.
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Besides pharmaceuticals, our inventory comprises ancillary clinical supplies and premium hospital lines. These medical accessories and equipment promise to simplify your caregiving experience, improving efficiency and compliance.
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Your Trusted Partner in Pharmaceutical Supply Chain
Whether it's comparator sourcing for clinical trials, pharma raw material suppliers, patient supply, or specialty sourcing, NewLife Medicals has got you covered. Our integrated supply chain caters to all your pharmaceutical needs while maintaining the highest quality standards.
Trust in the expertise and authority of NewLife Medicals for all your medical needs. Together, let's make a healthier world!
Meta description: Explore NewLife Medicals – your trusted global clinical research organization, pharmaceutical supplier, and healthcare partner. Dive into our wide range of services today.
#rld pharmaceutical#comparator sourcing for clinical trials#named patient supply#ancillary clinical supplies#global clinical research organization#drug development#innovator drugs supplier
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This July, my mom and I are stepping up for a great cause! We're participating in the Multiple Myeloma March, organized by Myeloma Canada. We are committing to walking 200,000 steps around our charming (and often sweltering!) town of Wheatley, Ontario. We'd be thrilled if you would consider supporting our modest goal of raising $392. As a token of our appreciation, every donor will receive a special Martin and GSD postcard (if you feel comfortable sharing your address with me). Check out the donation link below —thank you for your generosity! ❤️
Donate: https://shorturl.at/u84HL
#martin and bosco#multiple myeloma#multiple myeloma march#my dad and my husband both died of multiple myeloma#sincere apologies to my friends who have seen this post on my other social media accounts#thank you#myeloma canada is a very small organization that funds clinical treatment research for multiple myeloma#i will mail postcards globally!
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Clinical Trials : Holistic Exploration of the Current State and Future Outlook
The global clinical trials market size is expected to reach USD 123.5 billion by 2030, expanding at a CAGR of 6.49 from 2024 to 2030, according to a new report by Grand View Research, Inc. An increase in the volume and complexity of clinical trials has been witnessed lately, which plays an important role in the R&D of new drugs and products. The market witnessed a decline of 6% in 2020 owing to the COVID-19 pandemic. However, the market is projected to recover from 2021 onwards. In addition, clinical trials have become increasingly costly, adding to the overall cost of developing a drug.
Clinical Trials Market Report Highlights
The phase III clinical trials segment dominated the market with a 53.3% share in 2023. This can be attributed to the complexity of this phase
The interventional studies segment dominated the market in 2023. It is one of the most prominent methods used in clinical trials in the study design segment owing to the increasing demand for the intervention for clinical trials by researchers
North America held 50.3% of the market share in 2023. Favorable government initiatives and the presence of a large number of players in the U.S. that offer advanced services are responsible for market growth
Asia Pacific region is anticipated to grow at the fastest CAGR over the forecast period owing to the increasing patient pool and cost-efficient services.
For More Details or Sample Copy please visit link @: Clinical Trials Market Report
The increasing need for developing new drugs for chronic diseases, such as cancer, respiratory disorders, diabetes, cardiovascular diseases, and others, is creating immense pressure on the healthcare industry. The COVID-19 pandemic and the increasing demand for developing a suitable treatment are driving the market. The high number of people affected by the disease further depicts an increasing need for therapeutics & vaccines. Currently, there are 288 therapeutics and 106 vaccines under development, out of which, nearly 7.0% of therapeutics are in Phase IV, 21.0% in Phase III, and 43.0% & 13.0% in Phase II & Phase I, respectively.
The pandemic has resulted in the global disruption of traditional onsite clinical trials. Hence, regulatory bodies worldwide have undertaken various initiatives for fast-tracking clinical trials for the development of innovative solutions. One such instance is Solidarity, an international clinical trial launched by the WHO to find effective treatment against COVID-19. Although the pandemic has forced many medical device & drug developers to revise the approach to such crises, integrating best practices within clinical trial procedures & adapting to virtual trials, which can support the continuous development of therapeutics.
ClinicalTrials #HealthcareResearch #MedicalInnovation #DrugDevelopment #PatientRecruitment #Biopharmaceuticals #ClinicalResearch #RegulatoryCompliance #DataManagement #PatientEngagement #PrecisionMedicine #TherapeuticTrials #CROs #ClinicalResearchOrganizations #GlobalHealth #ClinicalStudyDesign #PharmaceuticalIndustry #BiotechResearch #ClinicalEndpoints #HealthTechIntegration
#Clinical Trials#Healthcare Research#Medical Innovation#Drug Development#Patient Recruitment#Biopharmaceuticals#Clinical Research#Regulatory Compliance#Data Management#Patient Engagement#Precision Medicine#Therapeutic Trials#CROs#Clinical Research Organizations#Global Health#Clinical Study Design#Pharmaceutical Industry#Biotech Research#Clinical End-points#HealthTech Integration
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The Best News of Last Year - 2023 Edition
Welcome to our special edition newsletter recapping the best news from the past year. I've picked one highlight from each month to give you a snapshot of 2023. No frills, just straightforward news that mattered. Let's relive the good stuff that made our year shine.
January - London: Girl with incurable cancer recovers after pioneering treatment
A girl’s incurable cancer has been cleared from her body after what scientists have described as the most sophisticated cell engineering to date.
2. February - Utah legislature unanimously passes ban on LGBTQ conversion therapy
The Utah State Legislature has unanimously approved a bill that enshrines into law a ban on LGBTQ conversion therapy.
3. March - First vaccine for honeybees could save billions
The United States Department of Agriculture (USDA) has approved the world’s first-ever vaccine intended to address the global decline of honeybees. It will help protect honeybees from American foulbrood, a contagious bacterial disease which can destroy entire colonies.
4. April - Fungi discovered that can eat plastic in just 140 days
Australian scientists have successfully used backyard mould to break down one of the world's most stubborn plastics — a discovery they hope could ease the burden of the global recycling crisis within years.
5. May - Ocean Cleanup removes 200,000th kilogram of plastic from the Pacific Ocean
The Dutch offshore restoration project, Ocean Cleanup, says it has reached a milestone. The organization's plastic catching efforts have now fished more than 200,000 kilograms of plastic out of the Pacific Ocean, Ocean Cleanup said on Twitter.
6. June - U.S. judge blocks Florida ban on care for trans minors in narrow ruling, says ‘gender identity is real’
A federal judge temporarily blocked portions of a new Florida law that bans transgender minors from receiving puberty blockers, ruling Tuesday that the state has no rational basis for denying patients treatment.
7. July - World’s largest Phosphate deposit discovered in Norway
A massive underground deposit of high-grade phosphate rock in Norway, pitched as the world’s largest, is big enough to satisfy world demand for fertilisers, solar panels and electric car batteries over the next 50 years, according to the company exploiting the resource.
8. August - Successful room temperature ambient-pressure magnetic levitation of LK-99
If the claim by Sukbae Lee and Ji-Hoon Kim of South Korea’s Quantum Energy Research Centre holds up, the material could usher in all sorts of technological marvels, such as levitating vehicles and perfectly efficient electrical grids.
9. September - World’s 1st drug to regrow teeth enters clinical trials
The ability to regrow your own teeth could be just around the corner. A team of scientists, led by a Japanese pharmaceutical startup, are getting set to start human trials on a new drug that has successfully grown new teeth in animal test subjects.
10. October - Nobel Prize goes to scientists behind mRNA Covid vaccines
The Nobel Prize in Physiology or Medicine has been awarded to a pair of scientists who developed the technology that led to the mRNA Covid vaccines. Professors Katalin Kariko and Drew Weissman will share the prize.
11. November - No cases of cancer caused by HPV in Norwegian 25-year olds, the first cohort to be mass vaccinated for HPV.
Last year there were zero cases of cervical cancer in the group that was vaccinated in 2009 against the HPV virus, which can cause the cancer in women.
12. December - President Biden announces he’s pardoning all convictions of federal marijuana possession
President Joe Biden announced Friday he's issuing a federal pardon to every American who has used marijuana in the past, including those who were never arrested or prosecuted.
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And there you have it – a year's worth of uplifting news! I hope these positive stories brought a bit of joy to your inbox. As I wrap up this special edition, I want to thank all my supporters!
Buy me a coffee ❤️
Merry Christmas and Happy New Year!
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"An international research team has found almost a million potential sources of antibiotics in the natural world.
Research published in the journal Cell by a team including Queensland University of Technology (QUT) computational biologist Associate Professor Luis Pedro Coelho has used machine learning to identify 863,498 promising antimicrobial peptides -- small molecules that can kill or inhibit the growth of infectious microbes.
The findings of the study come with a renewed global focus on combatting antimicrobial resistance (AMR) as humanity contends with the growing number of superbugs resistant to current drugs.
"There is an urgent need for new methods for antibiotic discovery," Professor Coelho, a researcher at the QUT Centre for Microbiome Research, said. The centre studies the structure and function of microbial communities from around the globe.
"It is one of the top public health threats, killing 1.27 million people each year." ...
"Using artificial intelligence to understand and harness the power of the global microbiome will hopefully drive innovative research for better public health outcomes," he said.
The team verified the machine predictions by testing 100 laboratory-made peptides against clinically significant pathogens. They found 79 disrupted bacterial membranes and 63 specifically targeted antibiotic-resistant bacteria such as Staphylococcus aureus and Escherichia coli.
"Moreover, some peptides helped to eliminate infections in mice; two in particular reduced bacteria by up to four orders of magnitude," Professor Coelho said.
In a preclinical model, tested on infected mice, treatment with these peptides produced results similar to the effects of polymyxin B -- a commercially available antibiotic which is used to treat meningitis, pneumonia, sepsis and urinary tract infections.
More than 60,000 metagenomes (a collection of genomes within a specific environment), which together contained the genetic makeup of over one million organisms, were analysed to get these results. They came from sources across the globe including marine and soil environments, and human and animal guts.
The resulting AMPSphere -- a comprehensive database comprising these novel peptides -- has been published as a publicly available, open-access resource for new antibiotic discovery.
[Note: !!! Love it. Open access research databases my beloved.]"
-via Science Daily, June 5, 2024
#superbugs#bacteria#viruses#microbiology#antibiotics#medicines#public health#peptides#medical news#antibiotic resistance#good news#hope#ai#artificial intelligence#pro ai#machine learning
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In a recent report published by Open Research Africa discussing disparities in Covid-19 research funding and leadership, scientists revealed that the majority of Long Covid research in Africa is primarily financed and overseen by foreign nations. The report’s authors analyzed projects documented in a global database tracking funded Covid-19 research projects. Out of a staggering 17,995 research projects cataloged in the Tracker as of July 2022, only 786 were carried out in African countries. Noteworthy contributors to Covid-19 research efforts on the continent included Morocco, with 183 projects, South Africa with 128 projects, and Kenya with 91 projects. In total, 75 research funders representing 17 countries directed USD $267 million to Covid-19 research in Africa. But the funders of these projects were predominantly public or governmental organizations from Europe and the U.S. Institutions such as the National Center for Scientific and Technical Research and UK Research and Innovation led the charge. While the bulk of funding stemmed from international entities, nine funders based in Africa also contributed to the cause. This imbalance in research investments poses a challenge for African scientists, as local research needs may differ from external agendas. The lack of sufficient evidence produced within and in the context of Africa worsens the marginalization of Long Covid in the region and weakens attempts to advocate for its acknowledgment and management.
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Also preserved on our archive
By Benjamin Mateus
The ninth wave of the COVID-19 pandemic in the United States is finally receding, with estimated daily new infections based on wastewater data now standing at 669,000 per day, down from the August peaks of over 1.3 million. However, experts predict that the tenth wave will begin in late fall and continue through the winter holidays, as has taken place every year of the pandemic so far.
With one in 70 individuals currently infectious, the risk of coming into contact with someone in a classroom, work, or dining at a local facility with 25 to 50 people is considerable. And despite the relative lull in cases, there is more COVID-19 transmission now than during 56.1 percent of the pandemic. In other words, the “forever COVID” policy essentially means that COVID is now everywhere all the time.
Under these conditions, forced upon society by the capitalist ruling class, repeat infections act like a battering ram, taking a growing toll on the foundation of everyone’s overall wellbeing. There is a growing body of evidence that each hit weakens the organ systems, aging them biologically beyond the person’s stated age until sufficient injury begins to manifest in physically measurable symptoms.
At present, more than one billion cumulative COVID infections have occurred in the US, at a rate of around one per year per person, with somewhere between 3-4 infections on average among the entire population. Estimates place the number of Long COVID cases at over 410 million globally in just the first four years of the pandemic, while excess deaths are nearing 30 million.
Clearly, the pandemic is ongoing and remains a significant health risk for the global population. The criminality of the “forever COVID” policy is highlighted by the fact that virtually no funding is allocated to the development of next-generation mucosal vaccines, improved treatments during the acute phase of infection, or any treatments for Long COVID patients. While trillions are squandered on war and bank bailouts for the rich, nothing is provided for critical life-saving research.
Last week, results from the first clinical trial of a mucosal vaccine were released, showing remarkable levels of efficacy after a second dose.
The important study published by Chinese investigators demonstrated that an intranasally administered anti-COVID vaccine can induce robust mucosal immunity against the coronavirus in human subjects (128 healthcare workers). The study found that the vaccine provided substantial immune protection against COVID while demonstrating safety and tolerance.
Esteemed clinical researcher Dr. Eric Topol wrote on Twitter/X, “[two] doses of a COVID nasal vaccine spray led to more than a 50-fold increase in spike specific secretory IgA antibodies against 10 strains of SARS-CoV-2, indicative of potent mucosal immunity.” Furthermore, Topol added, “At least 86.2 percent of participants who completed two nasal vaccines doses maintained uninfected status, likely without even asymptomatic infection, for at least three months.”
Emergency room physician and indoor air quality proponent, Dr. Kashif Pirzada, replied, “This could potentially give a real ending to the pandemic. No more waves of illness, no more rushing for tests and antivirals if you’re elderly or vulnerable. Hope this comes out soon!”
However, large Phase 3 clinical trials are costly, requiring multiple participants to obtain statistically relevant information on clinical endpoints, not to speak of the research and development investment to identify a therapeutic that can be tested. Thus, under capitalism, there is virtually no investment in these large-scale trials and nothing is being done beyond offering boosters of the current vaccine, despite their greatly reduced efficacy in preventing transmission.
The mucosal vaccine study was conducted just as Chinese officials acquiesced to the demands of the imperialist powers to abandon their life-saving Zero-COVID public health program, resulting in the infection of virtually the entire population and the deaths of 1-2 million people. What could such a vaccine have meant to these millions that perished needlessly and the millions more globally since then?
This raises the broader question of why the international community, facing a devastating pandemic, could not bring its accumulated scientific bodies to address the need to develop a preventative treatment against COVID?
As a trigger event in world history, the COVID-19 pandemic has only accelerated and exposed the deep-seated contradictions in global capitalism, which demands the accumulation of profits at any costs. The ruling class has nothing but contempt for workers, refusing to invest in any social programs that can improve the lives of masses of people. Short sightedness, corruption, mistrust, and suspicion epitomize their actions, which are rapidly progressing to a world conflagration carrying the danger of nuclear war.
Simply put, the ruling class cares not one iota about mucosal vaccines, just as they harbor resentment against any public health policy that infringes on their ability to conduct business.
Refusing to invest in these life-saving technologies, the capitalist ruling class has condemned humanity to face a lifetime of reinfections with COVID-19. What are the implications of this criminal policy?
Multiple previous studies have highlighted the dangers posed by reinfections with SARS-CoV-2. A recent study uploaded as a pre-print publication on Research Square (under review with the journal Nature Portfolio) by the Patient-Led Collaborative has once again found similar results when attempting to characterize the association between reinfections and the chronic debilitating condition known as Long COVID.
Among 3,382 participants (22 percent never had COVID, 42 percent with one prior infection and 35 percent with two or more infections), the risk of Long COVID was 2.14 times more likely among those with two COVID infections and 3.75 times more likely among those who had three or more COVID Infections compared to just one. Limitations in physical functioning measured in their study included ability to dress, bathe, perform moderate activities like vacuuming and functioning socially. Reinfections led to poorer overall health and worse immune health, including more severe outcomes and longer recovery from other infections.
As the authors wrote:
"Relative to those who did not report infections or experienced COVID-19 once, reinfections were associated with increased likelihood of severe fatigue, post-exertional malaise, decreased physical function, poorer immune health, symptom exacerbation before menstruation, and multiple other Long COVID symptoms. While vaccinations and boosters prior to infection are associated with lower likelihood of Long COVID, reinfections diminish their protective effect. The probability of reporting Long COVID remission is generally low (11.5 percent to 6.5 percent."
Another interesting finding of the study, which underscores the complete abandonment of public health efforts regarding COVID, is that a tiny number of those infected were prescribed antivirals during their acute COVID infections. Those with reinfections were also less likely to test, as the “forever COVID” policy has inured people from taking any protective measures to prevent infections.
The current alphabet soup of COVID strains is sees KP.3.1.1 dominate across the US and Europe, accounting for nearly 60 percent of all strains. However, a new variant known as XEC that was first detected in Germany in June has spread to more than 27 countries and accounts for six percent of all recently sequenced SARS-CoV-2 viruses in the US. Virologists expect this strain, derived from JN.1 through a complex recombination event and which has nearly twice the growth advantage, to overtake KP.3.1.1 and be the dominant variant during the winter season.
In a COVID update by TACT [Together Against COVID Transmission], the authors explain the dangers posed by these evolutionary developments of the SARS-CoV-2 viruses, writing:
"These variants can evade much of the immune responses from both vaccines and recent infections. Since they can evade antibodies to earlier variants, then that raises the risk of organ damage, vascular and neurological dysfunction, brain damage, and persistent infections which often leads to Long COVID. The unmitigated spread is raising concerns about their impact in the coming months."
Hospitalization rates for those 65 years and older and children were one of the highest during the summer from COVID and remain on par with the prior year’s summer/fall wave. The number of people that died from COVID In the week ending August 31, 2024, has climbed to 1,239, four times higher than the lows seen in June. At the present rate, it is expected that at least 60,000 people will officially lose their lives from acute COVID this year, not including deaths incorrectly attributed to another cause or due to the impact on the population’s health from accumulated infections.
These are not incidental and speculative issues. In a provocative report released by the Swiss Re Group, titled “The future of excess mortality after COVID-19,” one of the world’s leading providers of reinsurance and insurance, who specialize in financing the risk of death, they said, “[If] the ongoing impact of the disease is not curtailed, excess mortality rates in the general population may remain up to three percent higher then pre-pandemic levels in the US and 2.5 percent in the UK by 2033.”
They advised their investors:
"Based on current medical trends and expected advancements, we conclude that COVID-19 is still driving excess mortality both directly and indirectly. In the long term, lifestyle factors that contribute to poor metabolic health and lead to obesity and diabetes may become another compounding factor in population excess mortality. Insurers may wish to continue to monitor excess mortality and its underlying drivers in the general population closely, as well as the differences between general and insured populations."
#mask up#pandemic#covid#covid 19#wear a mask#public health#coronavirus#sars cov 2#still coviding#wear a respirator#long covid#covid conscious#covid is airborne#wear a fucking mask
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Excerpt from this National Geographic story:
A 14-year-old boy who went swimming in a pond in India’s sweltering heat. A 13-year-old girl who bathed in a pool during a school excursion, and a five-year-old girl who took a dip in a river near her home. The three children lived in different parts of the southern Indian state of Kerala. Yet they have something in common ⸺all of them succumbed to a brain infection, Primary Amoebic Meningoencephalitis (PAM), caused by a tiny organism found in warm freshwaters and poorly maintained swimming pools. About a dozen others have been undergoing treatment in India, one of whom, a 27-year-old man, has also succumbed.
Although rare, PAM is a deadly infection with a worldwide occurrence. It is caused by Naegleria fowleri, also known as the "brain-eating amoeba”, as it infects the brain and destroys brain tissue. At least 39 countries have reported such infections so far, and the rate of infections is increasing by 4.5 percent every year. In Pakistan alone, 20 deaths are reported every year due to the disease, and in 2024, infections have been reported in India, Pakistan, and Israel. N. fowleri was also detected at a popular freshwater swimming spot in Western Australia and hot springs in the U.S’s Grand Teton National Park.
According to the Centers for Disease Control and Prevention (CDC), the majority of global case exposures⸺85 percent⸺have been reported during warm, hot, or summer seasons. Several studies have also observed that changes in temperature and climate may further drive a global increase in PAM incidence. A study published in May last year found that PAM infections are on the rise in the northern U.S. "N. fowleri is expanding northward due to climate change, posing a greater threat to human health in new regions where PAM has not yet been documented," the study noted.
Yun Shen, an assistant professor of chemical and environmental engineering at the University of California, Riverside, says that she considers PAM as “a potential emerging medical threat worldwide”. She explains that while warmer temperatures are likely to facilitate the survival and growth of N. fowleri, the risk of exposure may also increase as people indulge in more water-based recreational activities in hotter weather.
N. fowleri is found in warm, untreated freshwater, soil, and dust, says Karen Towne, a clinical associate professor of nursing at the University of Mount Union in Ohio, who co-authored a 2023 study on how the amoeba poses “a new concern for northern climates”. She adds that so far, PAM infections have typically occurred in cases involving swimming, splashing, and submerging one’s head in freshwater lakes, ponds, hot springs, and reservoirs. Meanwhile, less common routes of transmission have included warm hose water, a lawn water slide, splash pad use, and exposure of the nasal membrane to tap water from private well systems.
“Epidemiologically, most cases have occurred in healthy children and young adults⸺more males than females⸺who have had recent contact with untreated fresh water,” Towne told National Geographic in an email interview.
According to Barbara Polivka, an associate dean of research at the University of Kansas School of Nursing, who co-authored the study with Towne, N. fowleri enters the nose via contaminated water, crosses the nasal membrane, and follows the olfactory nerve into the brain, where it incubates for an average of five days. “PAM begins with rapid onset of severe frontal headache, fever, nausea and vomiting, which worsen into stiff neck, altered mental status, hallucinations, coma, and death,” says Polivka.
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Enhancing Patient Safety : The Role of Clinical Trials and Drug Development
Patient safety is always a big issue of concern especially in clinical trials and during the drug development. Given the increasing speed of developing new therapies, ensuring those therapies are safe and effective prior to be made public is imperative for the preservation of patient safety and endorsement of innovative treatments. This blog post focuses on the vital role of clinical trials in improving patient safety including the procedures followed to ensure safer drug development and advancements towards making clinical trials safer.
#clinical trial nda#clinical drug development process#clinical drug#clinical research organization services#global contract research organization
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Understanding Ancillary Clinical Supplies and Reference Listed Drugs: A Comprehensive Guide
In the world of healthcare, ancillary clinical supplies and reference listed drugs play crucial roles in supporting medical treatments and ensuring patient safety. This blog aims to provide a comprehensive understanding of these essential components of the healthcare industry. We will explore the significance of ancillary clinical supplies and reference listed drugs, their importance in medical settings, and how they contribute to the overall patient care process. Join us as we delve into this topic in collaboration with New Life Medicals, a trusted provider of medical supplies and information.
I. Ancillary Clinical Supplies: Enhancing Patient Care and Safety Ancillary clinical supplies encompass a wide range of medical products and equipment that support healthcare professionals in delivering high-quality care to patients. Here are some key aspects of ancillary clinical supplies:
Importance of Ancillary Clinical Supplies: Ancillary clinical supplies are vital for maintaining patient safety, preventing healthcare-associated infections, and supporting effective treatment and diagnosis. These supplies enable healthcare providers to adhere to strict infection control protocols, deliver accurate diagnoses, and provide optimal patient care.
II. Reference Listed Drugs: The Gold Standard in Pharmaceutical Equivalence Reference Listed Drugs (RLDs) serve as benchmarks for generic drug manufacturers. RLDs are well-established brand-name drugs that have undergone rigorous testing, demonstrating safety, efficacy, and quality. Key points about RLDs include:
Role of RLDs in Generic Drug Development: RLDs act as reference points for generic drug manufacturers seeking approval from regulatory authorities. Generic drugs must demonstrate bioequivalence to the RLD, ensuring that they have the same active ingredient, dosage form, strength, and route of administration.
Ensuring Safety and Efficacy: RLDs undergo extensive clinical trials and scrutiny to establish their safety and efficacy. Generic drugs that are bioequivalent to RLDs offer comparable therapeutic outcomes, providing patients with affordable treatment options while maintaining efficacy and quality standards.
III. New Life Medicals: Trusted Provider of Ancillary Clinical Supplies and Information New Life Medicals is a reputable supplier of ancillary clinical supplies, offering a comprehensive range of products to support healthcare providers. They also serve as a reliable source of information on the importance, usage, and availability of clinical supplies. Here’s why New Life Medicals stands out:
Extensive Product Range: New Life Medicals offers a diverse selection of high-quality ancillary clinical supplies, ensuring healthcare providers have access to essential products necessary for optimal patient care.
Commitment to Quality and Safety: New Life Medicals prioritizes quality and safety, sourcing products from reputable manufacturers and adhering to stringent quality control measures.
Expert Guidance and Support: New Life Medicals provides valuable information and guidance on selecting the right clinical supplies, ensuring healthcare providers make informed decisions.
Ancillary clinical supplies and reference listed drugs are indispensable components of the healthcare industry, playing vital roles in patient care, safety, and treatment efficacy. By understanding the significance of these supplies and their impact on medical settings, healthcare professionals
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By: Christina Buttons
Published: May 13, 2024
A guide to the international debate on youth medical transition, where medical authorities in the United States depart from a growing international consensus.
The world is reacting to the U.K.'s Cass Review and associated systematic evidence reviews, which found "remarkably weak" evidence supporting medical interventions for gender transition in minors. Released on April 9, 2024, the final report from the national gender clinic service for those under 18—following four years of meta-analyses of the available literature—dealt a major blow to the gender-affirming model of care and marked its termination in England.
NHS England, which commissioned the report, expressed gratitude to Dr. Hilary Cass and committed to implementing her recommendations. These advocate for primarily relying on psychotherapy to address gender-related distress in minors and discontinuing the use of puberty blockers as part of England’s publicly funded healthcare system. The NHS predicted the landmark review would have "major international importance and significance"—a prediction that has proven correct. Just one month later, we are already beginning to see its impact.
What’s New
Scotland and Wales
In response to the Cass Review, Wales and Scotland have joined England in halting new prescriptions of puberty blockers for minors under 18 diagnosed with gender dysphoria. Additionally, in Scotland, cross-sex hormones will not be available to those under 18. In the last few years, beyond the U.K., Sweden, Finland, and Denmark have adopted a more cautious approach by placing restrictions on medical interventions for the treatment of gender dysphoria in minors. Norway has also signaled intentions to follow a similar path.
Germany
Now, Germany has emerged as the latest country to initiate steps towards placing restrictions on gender transition treatments for minors. Earlier this week, the German Medical Assembly, a pivotal body representing medical professionals across the country, passed a resolution that calls for the restriction of puberty blockers, cross-sex hormones, and surgeries for gender dysphoric youth to strictly controlled research settings. Another resolution passed that stated minors should not be permitted to "self-identify" into a chosen sex without first undergoing a specialist child and adolescent psychiatric evaluation and consultation.
While national restrictions have not yet been formalized, experts in gender medicine research are describing this update as a “major development” — especially considering that Germany has been one of the most permissive countries on this issue.
Read the SEGM Analysis
Belgium
Additionally, in Belgium, leading physicians are advocating for significant reforms in the treatment protocols for gender dysphoria in children and adolescents. According to an April 2024 report authored by pediatricians and psychiatrists P. Vankrunkelsven, K. Casteels, and J. De Vleminck from Leuven, there is a pressing need to follow the precedents set by Sweden and Finland, where hormones are regarded as a last resort. Their findings and recommendations were published in a prestigious medical journal associated with Dutch-speaking medical faculties in Belgium and their alumni associations.
International Bodies
International bodies such as the United Nations (UN) have also responded to the Cass Review. The United Nations Special Rapporteur on violence against women and girls, Reem Alsalem, issued a statement on the UN’s website declaring that the Review’s recommendations are essential for protecting children, especially girls, from harm.
In addition, the European Society of Child and Adolescent Psychiatry (ESCAP), a prominent umbrella association of 36 Child and Adolescent Psychiatry societies worldwide, recently issued a policy statement on child and adolescent gender dysphoria. They urged healthcare providers to "not to promote experimental and unnecessarily invasive treatments with unproven psycho-social effects and, therefore, to adhere to the ‘primum-nil-nocere’ (first, do no harm) principle."
These responses stand in stark contrast to that of World Professional Association for Transgender Health (WPATH), a body-modification advocacy organization. WPATH emailed a statement to its subscribers in response to the Cass Review, vehemently rejecting its findings and adhering to its ideological beliefs. WPATH criticized the Cass Report as “harmful” and "rooted in a false premise" that suggests distressed children can be helped without "medical pathways.”
United States
In response to the Cass Review, the American Academy of Pediatrics (AAP) and the Endocrine Society (ES) recently provided statements to WBUR, doubling down on their endorsement of the gender-affirming model of care and medical interventions for minors. Both blamed “politics” for spreading “misinformation.” Meanwhile, prominent gender clinicians have expressed to WBUR that they are “perplexed and concerned” by these organizations’ statements, given the Cass Review’s findings.
WPATH, AAP, and ES continue to mislead the public by claiming that the gender-affirming model of care adheres to the principles of evidence-based medicine (EBM), despite clear evidence to the contrary. Their recommendations for medical interventions are not grounded in robust evidence but rather rely on "circular referencing" of each other’s guidelines, effectively creating a citation cartel.
Comprehensive Overview of the International Debate On Youth Transition by Country
In recent years, there has been an ongoing debate about the best approach for treating gender-distressed youth, addressing the global increase in young people, primarily adolescent females, seeking services from gender clinics. Countries with pediatric gender clinic services have shown varied responses, ranging from highly medicalized treatment pathways to approaches that prioritize psychotherapy.
Nations such as the UK, Sweden, Finland, and Denmark have taken unified steps to heavily restrict medical transitions for minors, aligning their guidance with the results of systematic evidence reviews, with Norway similarly indicating moves in this direction. Elsewhere, medical and health authorities remain divided on best practices, although there are signs of some reevaluating their positions on the medical transition of minors. This guide will highlight significant updates and changes observed in these practices over recent years.
The Netherlands
In the Netherlands, the birthplace of the Dutch Protocol—the highly medicalized approach to treating youth with gender dysphoria—is facing increased scrutiny. As of 2023, there is a growing debate within medical, legal, and cultural realms about the practice of youth gender transitions.
On February 15, 2024, the Dutch Parliament ordered an investigation into the physical and mental health outcomes of children who have been prescribed puberty blockers. Despite these developments, the guidelines for treating gender dysphoria have not yet been updated.
In April 2024, Amsterdam UMC, the Dutch clinic that pioneered youth gender transition practices, issued a statement in response to the Cass Report. The clinic commended several elements of the report but expressed disagreement with its conclusion that the evidence supporting the use of puberty blockers is insufficient.
In May 2024, one of the Netherlands' national newspapers profiled the new policy statement from The European Society of Child and Adolescent Psychiatry (ESCAP) that advocated for a non-medicalized approach to treating child and adolescent gender dysphoria.
Norway
In 2023, the Healthcare Investigation Board of Norway (Ukom) issued recommendations urging the Ministry of Health and Care to instruct the Directorate of Health to revise the national professional guideline for gender incongruence, drawing on systematic evidence reviews. Additionally, the Ukom report proposed classifying puberty blockers, as well as hormonal and surgical interventions for children and young people, as experimental treatments. This classification would subject these treatments to more stringent regulations regarding informed consent, eligibility, and outcome evaluation. However, Norway has not yet issued any explicit new guidelines following these recommendations.
Denmark
In July 2023, Ugeskrift for Læger, the journal of the Danish Medical Association, reported a significant shift in Denmark's approach to treating youth with gender dysphoria. Instead of receiving prescriptions for puberty blockers, hormones, or surgery, most young people referred to the centralized gender clinic now receive therapeutic counseling and support.
France
In 2022, the National Academy of Medicine in France advised exercising "the utmost medical caution" for the use of puberty blockers and cross-sex hormones for children and adolescents, citing the risk of regret. Despite this caution, the prescription of these treatments remains permissible at any age with parental authorization.
A 2023 poll by the Journal International de Médecine found 84% of healthcare professionals in France are in favor of a moratorium on the administration of hormonal treatments for trans-identified minors.
In March 2024, French senators released a 369-page report advocating for the cessation of cross-sex hormones and puberty blockers on minors. Based on the findings of this report, lawmakers have drafted a bill that is set to be debated on May 28, 2024.
Italy
In January 2023, the Italian Psychoanalytic Society (SPI) wrote a letter to Italian Prime Minister Giorgia Meloni, expressing "great concern" over the "ongoing experimentation" with drugs designed to halt puberty in children and calling for a "rigorous scientific discussion."
In March 2024, the Vatican’s doctrine office, after five years of preparation, released a report approved by Pope Francis that declared gender-related surgeries to be "a grave violation of human dignity."
In April 2024, five Italian medical organizations released a joint position paper on managing adolescent gender dysphoria. This document, which extensively references WPATH, supports the medical transition of minors.
Sweden
In 2022, Sweden's National Board of Health and Welfare declared that the potential harms of puberty blockers and gender-affirming hormone treatments for individuals under 18 years of age surpass the possible benefits for this demographic. The board recommended that such treatments should primarily occur within a research setting to better assess their effects on gender dysphoria, mental health, and quality of life among young people. Additionally, it noted that hormone treatments could still be administered in exceptional circumstances.
In April 2023, a systematic review conducted by researchers from Karolinska Institutet, University of Gothenburg, Umeå University, and the Swedish Agency for Health Technology Assessment and Assessment of Social Services was published in Acta Paediatrica. This review assessed the existing evidence on hormonal treatment for individuals under 18 years old with gender dysphoria. The researchers concluded that such interventions “should be considered experimental treatment rather than standard procedure.”
Finland
Finland was the first Western country to conduct a systematic review of the evidence for youth gender transition, that led to a significant update of its guidelines in 2020. Observations from Finnish gender clinics showed that hormone treatments do not typically improve—and can worsen—the functioning of gender-dysphoric youth. In response, the country's Council for Choices in Health Care revised its guidelines to emphasize psychosocial support as the primary approach and restricted hormonal interventions to exceptional cases. These interventions are permitted before age 18 only if the individual's cross-sex identity is confirmed as permanent and causes severe dysphoria, the child fully understands the significance, benefits, and risks of the treatments, and there are no contraindications.
In October 2023, Dr. Riittakerttu Kaltiala, a leading Finnish gender clinician and researcher at Tampere University Hospital, wrote an op-ed in The Free Press, titled "Gender-Affirming Care Is Dangerous. I Know Because I Helped Pioneer It.” She highlighted concerns about the practice of pediatric medical transition in the U.S. and the lack of solid evidence supporting the efficacy of medical transition in reducing suicide rates among young people.
In February 2023, a landmark study from Finland revealed low suicide rates among trans-identified youth and found no evidence of benefits from gender reassignment. The study showed that, after accounting for psychiatric needs, there was no statistically significant evidence that gender-referred youth have higher suicide rates compared to the general population. The authors concluded that the risk of suicide related to transgender identity and/or gender dysphoria "may have been overestimated."
England
In January 2020, National Health Service (NHS) England formed a Policy Working Group (PWG) to conduct an assessment of the existing research on the use of puberty blockers and feminizing/masculinizing hormones in children and young people with gender dysphoria. This was aimed at shaping a policy stance on their continued application. The findings from these reviews were released in March 2021.
In February 2022, the interim report to the Cass Review was published, which had been commissioned by NHS England to evaluate the Gender Identity Development Service (GIDS) at the Tavistock and Portman NHS Foundation Trust, the UK's only national clinic for children and adolescents with gender dysphoria. The review highlighted significant concerns about the clinical decision-making framework, noting a lack of robust evidence and consensus on the most effective treatments.
In July 2022, NHS England announced it would close GIDS in Spring 2023, which was delayed until Spring 2024. Two new regional hubs opened in London and the north of England to move away from a single-service model.
In October 2022, the NHS England issued new draft guidance following their systematic evidence review, stating that there is "scarce and inconclusive evidence to support clinical decision-making" for minors with gender dysphoria, and for most who present before puberty, it will be a "transient phase" requiring psychological support rather than medical intervention.
In March 2024, NHS England announced that it would end the prescription of puberty blockers at gender clinics for children due to insufficient evidence regarding their safety and effectiveness. These treatments will now only be accessible through clinical research trials.
On April 9, 2024, the final 388-page report of the Cass Review was published, along with 9 studies (8 of which were systematic evidence reviews) by the University of York.
Ireland
In March 2023, HSE published a review of the interim Cass Report to assess Gender Identity Services for children and young people in Ireland.
In April 2024, the Health Service Executive (HSE) announced the development of a new clinical program for gender healthcare, scheduled over the next two years. They also stated that the final report for the Cass Review will be included as part of this process.
Canada
In January 2024, Alberta announced the implementation of measures that significantly restrict medical transitions for minors. This policy establishes Alberta as the only province in Canada to enforce such limitations on gender transition procedures for individuals under 18. Under the new regulations, minors are prohibited from undergoing any gender-related surgeries, and those aged 16 and younger are prevented from accessing puberty blockers or cross-sex hormones.
United States
The three main organizations that have issued guidelines on youth medical transition include the American Academy of Pediatrics (AAP), the Endocrine Society (ES), and the World Professional Association for Transgender Health (WPATH). Other groups, such as the American Medical Association, have either publicly supported “affirming” medical practices without presenting evidence, or have aligned themselves with the guidelines set by one or more of these three organizations. Notably, none of these organizations have yet conducted systematic reviews of the evidence, which are designed to avoid selective inclusion of studies and biased interpretations.
Leaders at the American Academy of Pediatrics (AAP) ignored five resolutions from its members over four consecutive years, each urging that youth transition guidelines be aligned with findings from systematic evidence reviews. In August 2023, the AAP Board of Directors finally agreed to conduct their own systematic review of the evidence and consider updating its guidance. At the same time, the Board "voted to reaffirm" its 2018 policy statement on gender-affirming care.
In 2022, Florida took the lead as the first state to curtail the widespread administration of hormonal and surgical interventions to the increasing number of gender-dysphoric youth. Early in the year, Florida’s public health authority commissioned an overview of existing English-language systematic evidence reviews. Based on the findings from this review, the Florida Boards of Medicine subsequently decided to halt the provision of gender-transition services to minors, unless conducted within research settings across the state.
As of April 2024, 24 states have now placed age restrictions on hormonal and surgical sex-trait modification interventions for minors. Democrats in four states (Texas, Louisiana, New Hampshire, and Maine) have voted in favor of age restriction laws or against turning their states into hormone sanctuaries.
Spain
In 2018, the Spanish Association of Paediatrics and the Spanish Society of Paediatric Endocrinology published a statement endorsing youth medical transition.
In 2022, the directors of Spain’s Society of Psychiatry, Association of Child and Adolescent Psychiatry, and Society of Endocrinology expressed their opposition to a proposed law that would enable minors to access medical transition procedures. El Mundo, the second-largest daily newspaper in Spain, highlighted this controversy on its front page with the headline: “Psychiatrists explode against the Trans Law: It can bring a lot of pain and regret to many people.”
Australia and New Zealand
In August 2021, The Royal Australian and New Zealand College of Psychiatrists (RANZCP) issued its first position statement focused on the mental health needs of individuals with gender dysphoria, followed by an update in September 2021. This statement was the first from a professional body that did not explicitly endorse a gender-affirming approach.
Australia has experienced considerable debate in recent years regarding youth medical transition. This topic has been extensively covered by Australian journalist Bernard Lane for his Substack, Gender Clinic News.
New Zealand's Ministry of Health was expected to release an evidence brief in early 2024, aimed at reviewing the current evidence on the safety of puberty blockers. Although the publication has been delayed, it is anticipated to be released soon.
In April 2024, Guardian Australia reported that neither New South Wales or Victoria have plans to make changes to puberty blocker prescribing or accessibility as a result of the Cass Review.
International Bodies
In July 2023, for the first time, international experts publicly weighed in on the American debate over "gender-affirming care." 21 leading experts on pediatric gender medicine from eight countries wrote a letter expressing disagreement with US-based medical organizations over the treatment of gender dysphoria in youth, urging them to align their recommendations with unbiased evidence “rather than exaggerating the benefits and minimizing the risks.”
In January 2024, the World Health Organization (WHO) updated its announcement on developing healthcare guidelines for “trans and gender diverse (TGD) people.” The WHO stated in an FAQ that it would not be making recommendations that impact minors. Importantly, they made the following admission: "[O]n review, the evidence base for children and adolescents is limited and variable regarding the longer-term outcomes of gender affirming care for children and adolescents" (January, 2024).
Further Information
For additional information, one of the studies that contributed to the Cass Review conducted a survey of European gender services for children and adolescents from September 2022 to April 2023. Additionally, a Wikipedia page provides an overview of the "legal status of gender-affirming healthcare" (for adults) in various countries worldwide.
If you found this guide helpful, I am working on developing an information-based website that will feature up-to-date data, counterarguments to activist claims, explainers on research, and useful resources related to gender pseudoscience.
#Christina Buttons#systematic review#Cass report#Cass review#gender affirming care#gender affirming healthcare#gender affirmation#medical scandal#medical corruption#medical malpractice#head in the sand#willful ignorance
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Dell AI PCs: A Gateway To AI For Life Sciences Organizations
AI in the Life Sciences: A Useful Method Using Computers.
For life sciences companies wishing to experiment with AI before making a full commitment, Dell AI PCs are perfect. The Dell AI PCs are revolutionary way to get started in the vast field of artificial intelligence, particularly for clients in the life sciences who are searching for a cost-effective way to create intricate processes.
The Dell AI PCs, GPU-enhanced servers, and cutting-edge storage solutions are essential to the AI revolution. If you approach the process strategically, it may be surprisingly easy to begin your AI journey.
Navigating the Unmarked Path of AI Transformation
The lack of a clear path is both an exciting and difficult part of the AI transition in the medical sciences. As it learn more about the actual effects of generative and extractive AI models on crucial domains like drug development, clinical trials, and industrial processes, the discipline continues to realize its enormous promise.
It is evident from discussions with both up-and-coming entrepreneurs and seasoned industry titans in the global life sciences sector that there are a variety of approaches to launching novel treatments, each with a distinct implementation strategy.
A well-thought-out AI strategy may help any firm, especially if it prioritizes improving operational efficiency, addressing regulatory expectations from organizations like the FDA and EMA, and speeding up discovery.
Cataloguing possible use cases and setting clear priorities are usually the initial steps. But according to a client, after just two months of appointing a new head of AI, they were confronted with more than 200 “prioritized” use cases.
When the CFO always inquires about the return on investment (ROI) for each one, this poses a serious problem. The answer must show observable increases in operational effectiveness, distinct income streams, or improved compliance clarity. A pragmatic strategy to evaluating AI models and confirming their worth is necessary for large-scale AI deployment in order to guarantee that the investment produces quantifiable returns.
The Dell AI PC: Your Strategic Advantage
Presenting the Dell AI PCs, the perfect option for businesses wishing to experiment with AI before committing to hundreds of use cases. AI PCs and robust open-source software allow resources in any department to investigate and improve use cases without incurring large costs.
Each possible AI project is made clearer by beginning with a limited number of Dell AI PCs and allocating skilled resources to these endeavors. Trials on smaller datasets provide a low-risk introduction to the field of artificial intelligence and aid in the prediction of possible results. This method guarantees that investments are focused on the most promising paths while also offering insightful information about what works.
Building a Sustainable AI Framework
Internally classifying and prioritizing use cases is essential when starting this AI journey. Pay close attention to data kinds, availability, preferences for production vs consumption, and choices for the sale or retention of results. Although the process may be started by IT departments, using IT-savvy individuals from other departments to develop AI models may be very helpful since they have personal experience with the difficulties and data complexities involved.
As a team, it is possible to rapidly discover areas worth more effort by regularly assessing and prioritizing use case development, turning conjecture into assurance. The team can now confidently deliver data-driven findings that demonstrate the observable advantages of your AI activities when the CFO asks about ROI.
The Rational Path to AI Investment
Investing in AI is essential, but these choices should be based on location, cost, and the final outcomes of your research. Organizations may make logical decisions about data center or hyperscaler hosting, resource allocation, and data ownership by using AI PCs for early development.
This goes beyond only being a theoretical framework. This strategy works, as shown by Northwestern Medicine’s organic success story. It have effectively used AI technology to improve patient care and expedite intricate operations, illustrating the practical advantages of using AI strategically.
Read more on Govindhtech.com
#DellAIPCs#AIPCs#LifeSciences#AI#AImodels#artificialintelligence#AItechnology#News#Technews#Technology#Technologynews#Technologytrends#govindhtech
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Big Data and AI: The Perfect Partnership for Future Innovations
Innovation allows organizations to excel at differentiation, boosting competitive advantages. Amid the growth of industry-disrupting technologies, big data analytics and artificial intelligence (AI) professionals want to support brands seeking bold design, delivery, and functionality ideas. This post discusses the importance of big data and AI, explaining why they matter to future innovations and business development.
Understanding Big Data and AI
Big data is a vast data volume, and you will find mixed data structures because of continuous data collection involving multimedia data objects. A data object or asset can be a document, an audio track, a video clip, a photo, or identical objects with special file formats. Since big data services focus on sorting and exploring data objects’ attributes at an unprecedented scale, integrating AI tools is essential.
Artificial intelligence helps computers simulate human-like thinking and idea synthesis capabilities. Most AI ecosystems leverage advanced statistical methods and machine learning models. Their developers train the AI tools to develop and document high-quality insights by processing unstructured and semi-structured data objects.
As a result, the scope of big data broadens if you add AI integrations that can determine data context. Businesses can generate new ideas instead of recombining recorded data or automatically filter data via AI-assisted quality assurances.
Why Are Big Data and AI Perfect for Future Innovations?
1| They Accelerate Scientific Studies
Material sciences, green technology projects, and rare disorder research projects have provided humans with exceptional lifestyle improvements. However, as markets mature, commoditization becomes inevitable.
At the same time, new, untested ideas can fail, attracting regulators’ dismay, disrespecting consumers’ beliefs, or hurting the environment. Additionally, bold ideas must not alienate consumers due to inherent complexity. Therefore, private sector stakeholders must employ scientific methods to identify feasible, sustainable, and consumer-friendly product ideas for brand differentiation.
AI-powered platforms and business analytics solutions help global corporations immediately acquire, filter, and document data assets for independent research projects. For instance, a pharmaceutical firm can use them during clinical drug formulations and trials, while a car manufacturer might discover efficient production tactics using AI and big data.
2| Brands Can Objectively Evaluate Forward-Thinking Business Ideas
Some business ideas that a few people thought were laughable or unrealistic a few decades ago have forced many brands and professionals to abandon conventional strategies. Consider how streaming platforms’ founders affected theatrical film releases. They have reduced the importance of box office revenues while increasing independent artists’ discoverability.
Likewise, exploring real estate investment opportunities on a tiny mobile or ordering clothes online were bizarre practices, according to many non-believers. They also predicted socializing through virtual reality (VR) avatars inside a computer-generated three-dimensional space would attract only the tech-savvy young adults.
Today, customers and investors who underestimated those innovations prefer religiously studying how disrupting startups perform. Brands care less about losing money than missing an opportunity to be a first mover for a niche consumer base. Similarly, rejecting an idea without testing it at least a few times has become a taboo.
Nobody can be 100% sure which innovation will gain global momentum, but AI and big data might provide relevant hints. These technologies are best for conducting unlimited scenario analyses and testing ideas likely to satisfy tomorrow’s customer expectations.
3| AI-Assisted Insight Explorations Gamifies Idea Synthesis
Combining a few ideas is easy but finding meaningful and profitable ideas by sorting the best ones is daunting. Innovative individuals must embrace AI recommendations to reduce time spent on brainstorming, product repurposing, and multidisciplinary collaborations. Furthermore, they can challenge themselves to find ideas better than an AI tool.
Gamification of brainstorming will facilitate a healthy pursuit of novel product features, marketing strategies, and customer journey personalization. Additionally, incentivizing employees to leverage AI and big data to experiment with designing methods provides unique insights for future innovations.
4| You Can Optimize Supply Chain Components with Big Data and AI Programs
AI can capture extensive data on supply chains and offer suggestions on alternative supplier relations. Therefore, businesses will revise supply and delivery planning to overcome the flaws in current practices.
For instance, Gartner awarded Beijing’s JD.com the Technology Innovation Award in 2024 because they combined statistical forecasting. The awardee has developed an explainable artificial intelligence to enhance its supply chain. Other finalists in this award category were Google, Cisco, MTN Group, and Allina Health.
5| Academia Can Embrace Adaptive Learning and Psychological Well-Being
Communication barriers and trying to force all learners to follow the standard course material based on a fixed schedule have undermined educational institutions’ goals worldwide. Understandably, expecting teachers to customize courses and multimedia assets for each student is impractical and humanly infeasible.
As a result, investors, policymakers, parents, and student bodies seek outcome-oriented educational innovations powered by AI and big data for a learner-friendly, inclusive future. For instance, some edtech providers use AI computer-aided learning and teaching ecosystems leveraging videoconferencing, curriculum personalization, and psycho-cognitive support.
Adaptive learning applications build student profiles and segments like marketers’ consumer categorizations. Their AI integrations can determine the ideal pace for teaching, whether a student exhibits learning disabilities, and whether a college or school has adequate resources.
Challenges in Promoting Innovations Based on Big Data and AI Use Cases
Encouraging stakeholders to acknowledge the need for big data and AI might be challenging. After all, uninformed stakeholders are likely to distrust tech-enabled lifestyle changes. Therefore, increasing AI awareness and educating everyone on data ethics are essential.
In some regions, the IT or network infrastructure necessary for big data is unavailable or prone to stability flaws. This issue requires more investments and talented data specialists to leverage AI tools or conduct predictive analyses.
Today’s legal frameworks lack provisions for regulating AI, big data, and scenario analytics. So, brands are unsure whether expanding data scope will get public administrators’ approvals. Lawmakers must find a balanced approach to enable AI-powered big data innovations without neglecting consumer rights or “privacy by design” principles.
Conclusion
The future of enterprise, institutional, and policy innovations lies in responsible technology implementations. Despite the obstacles, AI enthusiasts are optimistic that more stakeholders will admire the potential of new, disruptive technologies.
Remember, gamifying how your team finds new ideas or predicting the actual potential of a business model necessitates AI’s predictive insights. At the same time, big data will offer broader perspectives on global supply chains and how to optimize a company’s policies.
Lastly, academic improvements and scientific research are integral to developing sustainable products, accomplishing educational objectives, and responding to global crises. As a result, the informed stakeholders agree that AI and big data are perfect for shaping future innovations.
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Prevalence Of Staphylococcus Aureus In Nasal And Skin Of Apparently Healthy Food Handlers And Attendants In Restau by Iyevhobu Kenneth Oshiokhayamhe in Journal of Clinical Case Reports Medical Images and Health Sciences
Abstract
Food handlers play a major role in the transmission of food borne diseases which represents a global health burden. Carriage of Staphylococcus aureus, in general, and enterotoxigenic strains, in particular, is an important risk factor for the contamination of food. This study was undertaken to determine the prevalence and risk factors associated with nasal and skin carriage of Staphylococcus aureus among 150 food handlers working in different restaurant in Ekpoma. Thirty (10%) persons were found to be significant (P< 0.05) carriers of Staphylococcus aureus of which highest occurrence of 24 (16%) from anterior nasal nares and 6 (7.5%) from skin of food handlers and restaurant workers. Prevalence and distribution of Staphylococcus aureus in relation to gender among food handlers and restaurant workers, showed high occurrence in females of 17 (56.6%) than males 13 (43.3%) with no significant difference in comparison of variability (P>0.05). Susceptibility pattern of Staphylococcus aureus isolated from this study had high sensitivity pattern of 93% to Zennacef, 80% to Rocephin, 93% to Ciprofloxacin, 70% to Gentamycin, intermediate sensitivity to Septrin 53%, Streptomycin 50%, and resistant to Erythromycin 40%, Amoxacilin 36% and Ampiclox 17%. From this study, Staphylococcus aureus is the most prevalent among them isolates that colonizes the skin and mucosal surfaces of healthy food handlers and restaurant workers. These findings resurges the imperative need for protective measures including increased public awareness programs, regular monitoring of food handlers for food borne pathogens and intensive training on primary health care and hygiene and future research addressing effective methods for sustained eradication of Staphylococcal skin and nasal carriage are clearly warranted to reduce the high risk of subsequent infection. It is our opinion that concerted efforts need to be made to educate food handlers and restaurant workers on the importance of personal hygiene and the use of protective gadgets like nose masks while handling food products; since they serve as potential sources of staphylococcal food poisoning.
Keywords
Food, Handler, Staphylococcus, Restaurant, Nasal, Skin
INTRODUCTION
Staphylococcus aureus avoidable medical and economic burden, the true incidence and prevalence of pathogenic strain of foodborne diseases is difficult to quantify. Risk factors implicated in foodborne diseases as identified by Centers for Disease Control and Prevention included unsafe sources, inadequate cooking, improper holding, contaminated equipment and poor personal hygiene implicating that the food handler dimension is crucially important (FDA, 2009). Food handlers have been implicated in a plethora of foodborne diseases. It has been reported that one of the important pathogens often transmitted via food contaminated by infected food handlers is Staphylococcus aureus (Verkaik et al., 2011). Bacteria of the genus Staphylococcus are Gram-positive cocci that are microscopically observed as individual organisms (Francois and Schrenzelg, 2008). Staphylococcus aureus is pathogenic ubiquitous species and may be a part of human flora found in the axillae, the inguinal and perineal areas, and the anterior nares (Bayer et al., 1998). Von Eiff et al., (2001) described 3 patterns of carriage: those who always carry a strain, those who carry the organism intermittently with changing strains, and a minority of people who never carry Staphylococcus aureus (Bayer et al., 1998). Persistent carriage is more common in children than in adults (Iwase et al., 2010). Nasal carriers may be divided into persistent carriers with high risk of infection and intermittent or non-carriers with low risk of infection (Blot et al., 2002). Direct invasion through breaks in the skin or mucus membrane leads into the production of superficial local infections such as folliculitis, furuncles and abscesses (Wertheim et al., 2005). This versatile pathogen is very well adapted to colonize the human skin and the human body provides some major ecological niches for this species. The anterior nares is the most frequent carriage site for Staphylococcus aureus, nonetheless extranasal sites typically harbor the organism including the skin, perineum and pharynx (Wertheim et al., 2005; Verkaik et al., 2011).
Until recently, reports on food contamination by Staphylococcus aureus, were mainly limited to occasional detections in the environment, the source of food and food itself. However, it is reported that human carriers are the most important source for transmission and the association between food handlers and the transmission of food borne disease frequently presents an investigative challenge (Jordá et al., 2012). Consideration into risk factors, transmission routes and many aspects of prevalence of carriage of foodborne pathogens among food handlers to eliminate carriage is necessary. Bodies concerned with food safety are left to consider whether interventions such as decolonization, continued monitoring or restrictions in the occupational activities are required (National Disease Surveillance Centre, 2004). Although skin carriage of Staphylococcus aureus, is less reported than nasal carriage, little is known about the prevalence and risk of skin carriage of enterotoxigenic strains of Staphylococcus aureus, among food handlers. Accordingly, the current study investigated the prevalence and risk factors associated with anterior nasal nares and skin carriage of Staphylococcus aureus, amongst food handlers working in different restaurant in Ekpoma Edo State.
Healthy carriers are potential source of Staphylococcus aureus infection and spread to other body sites as well as to other individuals. Staphylococcus aureus have been found frequently as aetiological of a variety of human infections. Centre for disease control (CDC) reported Staphylococcus aureus as primary source of infections, which could be transferred from individual to another, The organism also elaborates toxins that can cause specific diseases or syndromes and likely participate in the pathogenesis of staphylococcal infection. Enterotoxin-producing strains of S aureus cause one of the most common food-borne illnesses (food poisoning). The most common presentation is acute onset of vomiting and watery diarrhea 2-6 hours after ingestion. The symptoms are usually self-limited. The cause is the proliferation of toxin-producing organisms in uncooked or partially cooked food that an individual carrying the staphylococci has contaminated (Matthews et al., 1997). This study is set determines the prevalence of Staphylococcus aureus from skin and nasal nares of apparently healthy food handlers in restaurant which could be the source of Staphylococcus aureus food contamination resulting to food born infection in Ekpoma.
MATERIALS AND METHODS
This project work from its inception, sample collection, sample analysis and compilation was carried out within a period of four months with a total of hundred Fifty Skin and nasal swab samples from different restaurant workers and food handlers in Ekpoma. A total of one hundred fifty (150) nasal and skin swab were randomly collected from male and female food handlers and restaurant workers grant consent.
Informed consent was requested and granted by the food handlers and restaurant workers under investigation. The concept of the study was explained to them and having understood its dimensions, granted their informed consent.
Sample Collection: One hundred and fifty specimen were collected randomly from males and females food handlers and restaurant workers within Ekpoma metropolis. The samples (150 nasal swabs and 150 skin swab). Nasal swab were collected in good light vision from subjects by bending their heads backward to collect the specimens deep down the anterior passages using a sterile swab stick. Both right and left nostrils were swabbed bearing labels as nasal swabs, sex, code number and date of collection. The swabs sticks were carefully returned to their sterile containers, sealed with adhesive tape and labelled accordingly. Skin swab was collected by swabbing their skin (especially their fore arm) with a swab moist with physiological saline aseptically and the swabs sticks were carefully returned to their sterile containers. Collected specimen was taken to the laboratory where bacteriological analysis was carried out immediately.
Procedure for Culture: The swab stick were used to make a primary inoculum on each agar surface (blood agar and chocolates agar plate). Spreading was done by streaking from the primary inoculum using a sterile inoculating wire loop to obtain discrete bacterial colonies. The plates were then incubated at 370C for 24 hours. Growth was observed after incubation, and the colonial morphology was studied carefully, noting the size, shape, edge, colour, consistency, haemolysis, elevation and opacity of the colonies. This was followed by Gram staining (Ochei and Kolhatkar, 2000).
Method for Detection of Staphylococcus aureus: The colonies that were yellow pigmented or cream white (Cheesbrough, 2000) were sub-cultured onto mannitol salt agar and selected for catalase (using H2O2) and coagulase tests (using plasma). Mannitol fermenting and slide coagulase positive isolates were identified as Staphylocuccus aureus.
Antibiotic Sensitivity Test: Antibiotic disc such as Erythromycin, Gentamycin, Streptomycin, Ciprofloxacin, Ampicillin, Septrine, Zinnacef, Amoxicilin and Rocephin (manufactured by Abtek Biologicals Ltd) were used to test the susceptibility of Staphylococci aureus isolates obtained. The test isolates were inoculated into sterile peptone water broth. The antibiotic discs were placed aseptically on the seeded plate. They were incubated at 370C for 24hours and examined for zones of inhibition. The zones of inhibition were measured in millimetres and recorded. Antibiotic zones less than 10mm in diameter were recorded as been resistant (R) by the organism while those with diameters of 10mm and above were recorded as sensitive (S)
Statistical Analysis: The collected data was expressed as Frequency and percentage. Comparison of qualitative variables was made using chi-square test. In all cases studied, the difference having p<0.05 were considered statistically significant using interactive calculation Chi square tool software (version 18).
RESULTS
Based on standard bacteriological analytical methods, from investigation of 300 samples of [nasal swab (150), skin swab (150)] from food handlers and restaurant workers in Ekpoma, revealed 30(10%) distribution of Staphylococcus aureus prevalence with the highest occurrence of 24 (16%) from nasal swab and 6 (7.5%) from skin swab. Other growths of non-Staphylococcus aureus were excluded from this study. The significant difference of Staphylococcus aureus isolates distribution among samples in this study was statistically significant (P< 0.05) with X2cal=26.057 p-value 0.000.
X2cal=26.057, Degree of freedom=2, p-value=0.0000 Key: N - Number , S. aureus: Staphylococcus aureus
X2cal=18.04, Degree of freedom=2, p-value=0.000, Key: N - Number
X2 cal=1.663, Degree of freedom=1, p-value=0.435, (p>0.05).
KEY:CN-Gentamycin, Z-Zennacef, R-Rocephin, CPX- Ciprofloxacin, SXT-Septrin, S-Streptomycin, E-Erythromycin AM- Amoxacilin , APXAmpiclox
DISCUSSION
Staphylococcus species are regional flora of the skin and mucus membrane of the body, certain species have been found frequently as aetiological agent of a variety of human and animal infections. The most common among these infections are the superficial supportive infection caused by Staphylococcus aureus. Infection can result to life threatening conditions disease spectrum which includes abscesses, septicemia, osteomyelitis, endocarditis and cellulitis, pneumonia, in addition to various toxin mediated diseases as toxic shock syndrome and staphylococcal food poisoning. The variety of such spectrum of clinical manifestations is mostly dependent on the numerous virulence factors produced by each strain (Vasconcelos and da Cunha, 2010). The ingestion of the preformed toxins produced by Staphylococcus aureus (enterotoxigenic strains) in food often results to the development of food poisoning. Findings from this investigation indicate a significant (P< 0.05) distribution of Staphylococcus aureus of 30(10%) prevalence with the highest occurrence of 24 (16%) from anterior nasal nares of food handlers and restaurant workers, 6 (7.5%) from skin swab which is in agreement with investigation reported by Mous-tafa et al., (2013) of 10.5% Nasal Carriage of Staphylococcus aureus and Risk Factors among Food Handlers-in Egypt. The findings from this studied in relation to area of study, was not in agreement with findings report by Eke et al., (2015), with a wide variation of 60% prevalence from 100 nasal swab analysis of food handlers and restaurant workers in Ekpoma. The reduced significant prevalence from this study is proportionately an improve hygiene of food handlers and workers in restaurant. This study variables revealed that gender, age, marital status nor level of education had no significant effect with respect to the nasal and skin carriage of Staphylococcus aureus. This study findings also reveal anterior nasal nares of food handlers and restaurant workers to harbour pathogenic Staphylococci species [Staphylococcus aureus 24(16%) to that of their skin 6(7.5%) with significant increase difference of (P>0.05) P- value 0.000].
Prevalence and distribution of Staphylococcus aureus in relation to gender among food handlers and restaurant workers, showed high occurrence in females food handlers and workers of 17 (56.6%) than males 13 (43.3%) with no significant difference in comparison of variability (P>0.05) and not in agreements with the findings by Eke et al., (2015), which report males food handlers to have high prevalence than the females in Ekpoma. The disparity of this report may be due to the subject who consent to participate as at time of study in regards to gender present in restaurant.
The sensitivity pattern of Staphyloccus aureus isolated from this study had high susceptibility to Gentamycin, Zennacef, Rocephin, Ciprofloxacin intermediate to Septrin, Streptomycin, and resistant to Amoxicillin, Erythromycin and Ampiclox which in agreement with the study reported by Eke et al., (2015). From this research it can be suggested that skin and nasal nares harbours Staphylococcus aureus which can be source of enterotoxigenic stains causing food born infection observed in our restaurant this days.
From all the organisms known to cause food born infection, Staphylococcus aureus is the most prevalent among them that is easily isolated and it colonizes the skin and mucosal surfaces of healthy individuals. The isolation of this organism learned to us that, as a microflora, it has a high percentage of causing infectious disease related to illness. Evidence from the result obtained has show that the skin and nasal nares has carrying capacity of Staphylococcus aureus. In contrast, healthy individuals as worker and food handlers in restaurant are risk factor of food born infection (food poisoning).
In conclusion, a relatively high prevalence rate of Staphylococcus aureus in nasal nares and skin carriage was recorded among the investigated food handlers. Moreover, 10% of the investigated carriers harboured Staphylococcus aureus in their anterior nares increasing the likelihood of transmission of the pathogen to the handled food. These findings resurges the imperative need for protective measures including increased public awareness programs, regular monitoring of food handlers for food borne pathogens and intensive training on primary health care and hygiene. Finally, the current findings clearly highlight the significance of implementation of efficient quality control systems in areas of direct contact with food product as good manufacturing practices and standard operational procedures and future research addressing effective methods for sustained eradication of Staphylococcal skin and nasal carriage are clearly warranted to reduce the high risk of subsequent infection.
CONFLICT OF INTEREST
The authors declare no conflicts of interest. The authors alone are responsible for the content and the writing of the paper.
FUNDING
This research did not receive any grant from funding agencies in the public, commercial, or not-for-profit sectors.
AUTHORS’ CONTRIBUTIONS
Iyevhobu, K.O. and Obodo, B.N., conceptualized the laboratory work and provided scientific guidance, Momoh A.R.M., Airefetalor, A.I. and Okobi, T.J. designed and wrote the manuscript while Etafo, J. and Osagiede, E.K. conducted experiments.
ACKNOWLEDGEMENTS
The authors would like to thank all the Laboratory and technical staffs of the department of Medical Laboratory Science, Ambrose Alli University Ekpoma, Edo State for their excellent assistance and St Kenny Research Consult, Ekpoma, Edo State for providing medical writing support/editorial support in accordance with Good Publication Practice (GPP3) guidelines.
#Restaurant#JCRMHS#Nasal#staphylococcal food#Research Article in Journal of Clinical Case Reports Medical Images and Health Sciences#Susceptibility pattern#Handler#Skin#Staphylococcus#Food
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