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VACC dumps with Real exam Questions and Practice Test - smresidences.com.ph

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Medical VACC Vascular Access

FDA permits advertising of first catheter-based mostly techniques used to create vascular access for hemodialysis sufferers | killexams.com Real Questions and Pass4sure dumps

SILVER SPRING, Md., June 22, 2018 /PRNewswire-USNewswire/ -- nowadays, the U.S. meals and Drug Administration authorised advertising and marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with persistent kidney disorder who want hemodialysis. 

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

exceptionally, the FDA granted marketing authorization for the use of the Ellipsys Vascular entry device and the everlinQ endoAVF system to make what's known as an arteriovenous (AV) fistula for sufferers who need hemodialysis access.

"Dialysis is a fundamental and life-saving procedure for thousands of people. With ultra-modern action, there can be additional, much less-invasive vascular access alternatives for sufferers who will require hemodialysis," referred to Bram Zuckerman, M.D., director of the Division of Cardiovascular contraptions within the FDA's core for gadgets and Radiological fitness.

in keeping with the national Institutes of fitness, greater than 661,000 americans have kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or synthetic kidney, to filter a affected person's blood outdoor of their body. earlier than sufferers can beginning dialysis, however, they deserve to have an AV fistula created. An AV fistula is traditionally made by surgically joining an artery and a vein beneath the skin within the arm. After a while, the mature vein can then acquire both needles used for every hemodialysis session. Surgically created AV fistulas typically take a number of months to heal and for the vein to mature before being usable for hemodialysis.

The instruments granted advertising and marketing authorization nowadays are designed to create AV fistulas percutaneously (during the dermis). A catheter is inserted into a blood vessel within the arm and is guided to the site of the planned AV fistula. The gadgets then deliver power to kind a connection between an higher forearm artery and an adjacent vein. The Ellipsys Vascular entry system makes use of one catheter, the everlinQ endoAVF gadget uses two.

For the Ellipsys Vascular entry equipment, the FDA reviewed records from a non-randomized, multi-core study of 103 sufferers. The Ellipsys Vascular entry equipment was utilized in a method to create an AV fistula in these patients, of which 92 patients (89.3 p.c) met the standards for a usable AV fistula within three months after the process.  just about all sufferers (ninety six.1 p.c) required an extra method (comparable to balloon angioplasty) within the first twelve months to keep the fistula.

For the everlinQ endoAVF system, the FDA reviewed records from a non-randomized, multi-center study of 60 sufferers, besides helping data from three different studies and medical use of the machine outdoor the U.S. The everlinQ endoAVF system turned into utilized in a process to create an AV fistula in these patients. primarily look at, fifty two patients (86.7 %) met the criteria for a usable AV fistula within three months after the technique.  just about all sufferers (ninety six.7 percent) required an further procedure at the time the fistula turned into created, while 28.three percent of patients required an extra manner (comparable to balloon angioplasty) within the first 365 days to maintain the fistula.

both instruments are contraindicated, or should no longer be used, for advent of anastomoses (connections) in vessels which are less than two millimeters in diameter or too a long way aside (for instance, within the wrist or within the hand). For each devices, complications encompass blocking (occlusion) or give way (stenosis) of the fistula, bruising and wish for additional strategies.

The Ellipsys Vascular entry gadget and everlinQ endoAVF system have been reviewed during the De Novo premarket evaluate pathway, a regulatory pathway for some low to average possibility instruments of a brand new classification. This action additionally creates a new regulatory classification, which ability that subsequent gadgets with the identical intended use can also go through the FDA's 510(ok) method, whereby instruments can attain advertising authorization with the aid of demonstrating big equivalence to a predicate equipment.

The FDA granted marketing authorization of the Ellipsys Vascular entry equipment to Avenu medical.

The FDA granted advertising authorization of the everlinQ endoAVF system to TVA clinical, Inc.

greater information:FDA: recently permitted DevicesFDA: De novo pathwayNIH: Hemodialysis

The FDA, an company within the U.S. branch of fitness and Human features, protects the public health by means of assuring the defense, effectiveness, and safety of human and veterinary medication, vaccines and other biological products for human use, and clinical devices. The agency is also accountable for the security and security of their nation's meals deliver, cosmetics, dietary dietary supplements, products that provide off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, stephanie.caccomo@fda.hhs.gov  purchaser Inquiries: 888-data-FDA

Cision View long-established content with multimedia:https://www.prnewswire.com/information-releases/fda-allows-advertising-of-first-catheter-based-systems-used-to-create-vascular-access-for-hemodialysis-patients-300670882.html

source U.S. meals and Drug Administration


The Anti-Vaccination flow: Spreading Misconceptions,Fueling Epidemics,Circulating Misinformation | killexams.com Real Questions and Pass4sure dumps

“out of date” diseases, such as measles, have affected over 900 individuals during the past three years in the united states. “informed” celebrities, equivalent to Dr. Oz, have spread misconceptions about autism in relation to vaccination. One component’s for certain: “dangerous,” “unchecked,” and “needless” vaccinations are the motives for the end of polio, measles, smallpox, and pertussis epidemics. on the close of the 18th century, Edward Jenner invented the primary vaccine through injecting cowpox-infected bodily fluid into a boy that become contaminated with the ailment. Ever due to the fact then, lethal ailments had preventions as soon as ethical, acceptable, and safe vaccines hit the market. For many years and even centuries, americans felt privileged to have access to this scientific innovation that saved tens of millions of lives internationally. lately, despite the fact, preventable illnesses exceptional in many years have resurfaced on account of the anti-vaccination flow. This stream resulted from residents of first world countries taking this privilege without any consideration by way of believing that ailments such as measles were fully eradicated. Misconceptions about inoculation blew absolutely out of share, ranging from unscientific hyperlinks with autism to fraudulent anecdotes and experiences. subsequently, medical doctors reminiscent of Paul Offit have committed their lives to putting off the negative stigma that commonly surrounds immunization. The anti-vaccination movement, fueling misconceptions and catastrophically harming toddlers, threatens the smartly-being of society. Vaccinations ought to be reinstated as one of the crucial constructive and a must have modern-day tendencies of mankind to avoid further denouncement and devaluation incited by skeptics.

On February 28, 1998, an article become posted within the Lancet titled, “Ileal-lymphoid-nodular hyperplasia, non-selected colitis, and pervasive developmental ailment in little ones”Wakefield). The doctor in the back of the article, Andrew Wakefield, turned into certainly the man that sparked the autistic aspect of the anti-vaccine move. Wakefield became the first to ever post a look at that confirmed a correlation between autism and vaccination. This test became fully disproved and even retracted with the aid of the Lancet, however its have an impact on when it comes to the anti-vaccine flow become incredibly devastating. The doctor’s statistics became discovered fraudulent and falsified, and he was sooner or later stripped of his scientific license. Scientists, medical doctors, and clinical specialists had a good time; they idea an era of false impression related to vaccination became ending rather than starting.

despite these findings and former Dr. Wakefield’s finished lack of credibility, commonplace anti-vaccine figures reminiscent of Jenny McCarthy found thought in these findings. McCarthy, mother of an autistic son, has been the use of her newborn’s analysis as a way to win public consideration within the anti-vaccination movement. She claims that inoculating her infant led to his autism. McCarthy quickly grew to become one of the vital largest anti-vaccination advocates within the united states, without any possible proof at the back of her autism-vaccine hyperlink. This hyperlink is a logical fallacy, the place a correlation between vaccination and autism is believed handiest as a result of each are existing in a child. in reality, McCarthy’s son may have autism for another excuse--McCarthy’s behaviors and addictions before pregnancy. Maternal drug abuse is at once correlated with autism in babies, which Jenny McCarthy became all too proud to promote earlier than and all the way through her misconception-propelled anti-vaccination campaign begun. as an example, McCarthy noted herself as a “getting better Catholic,” after making an attempt every little thing from ecstasy to prescription capsules and ultimately getting hooked on Vicodin. These medicine really had a negative influence on McCarthy’s son as a transforming into fetus (Marcus). although it cannot be mentioned for definite that her addictions ended in his autism, that argument is plenty more plausible than the one accusing vaccinations. The AAP, or American Academy of Pediatrics, posted in a comprehensive vaccine-autism analysis paper, “studies don't exhibit any link between autism and MMR vaccine, thimerosal, distinct vaccines given without delay, fevers or seizures” (“Vaccines”). Autism Speaks, a charity revolving round enhancing the satisfactory of lifestyles for babies and adults diagnosed with autism, claimed, “each and every family has a distinct journey with an autism analysis, and for some it corresponds with the timing of their infant’s vaccinations. The effects of...research is clear: Vaccines do not cause autism” (“What causes Autism?”). naturally, credible sources have denounced the autism-vaccine link as non-existent; besides the fact that toddlers are clinically determined with autism across the equal time as they're initially inoculated, the two aren’t correlated.

There are surely aspect outcomes to immunization, however they don’t examine to the catastrophic consequences of contracting a lethal virus. about 1 in 3 americans document complications following vaccination, and 1 in 100 even whinge of a high fever as a side effect. nonetheless, diseases that vaccines steer clear of, corresponding to measles, have tremendously worse and constantly deadly penalties. A measles contraction starts with a rash that slowly spreads throughout the entire physique. as the rash progresses, the contaminated have extremely high fevers. Their immune equipment weakens and they become greater liable to other deadly infections. in the early 2000s, best about 37 individuals in the u.s. died from measles annually. recently, as a result of the anti-vaccine there have been essentially 650 cases in a 12 months (“Measles”). Minimal side results of vaccination can't start to compare to the devastating consequences of contracting deadly ailments.

Paul Offit, in his ebook deadly decisions: How the Anti-Vaccine movement Threatens Us All, asserts that movements in opposition t vaccination are misinformed and because of this bad to the neatly-being of society. Offit, a scientific doctor, intelligently refutes each possible argument made in opposition t vaccination, gives a number of anecdotes, and supports every declare he makes with a number of scientific evidence. He eliminates all arguments against vaccination with the intention to t cease fogeys from being misinformed when making a choice on even if or not to vaccinate, in addition to to discourage the additional spread of anti-vaccine propaganda on media systems. Offit makes an attempt to influence the public to make recommended choices with their babies by using warning them concerning the tragic penalties if they don’t. all the way through his publication, Offit items scientists that have made strides towards accurately informing the general public about inoculation. Samuel Berkovic, a neurologist, realized the existence of a link between Dravet’s Syndrome and epilepsy following vaccinations. This discovery undermined each media figure, similar to Lea Thompson, who claimed that vaccinations led to seizures. Berkovic, besides the fact that children, didn’t get the focus he deserved for this dazzling scientific link in 2006. The neurologists and other advised docs that worked with him diagnosed his work as whatever thing superb, however the americans circulating anti-vaccination propaganda continued their battle despite it all. Rorke-Adams, yet another scientist mentioned with the aid of Offit in his analysis, examined over thirty toddlers whose parents claimed had seizures after vaccinations; every single baby she examined ended up having a different cause in the back of the epilepsy, ranging from vascular problems to degenerative diseases. As Offit cited, “...despite her competencies, and however that she has supported her reviews with cogent, smartly-researched opinions, Rorke-Adams often finds that petitioners be successful” (Offit ninety).

several types of vaccines are administered counting on the age and maturity level of the child. subsequently, herd immunity plays an incredibly crucial function before the infant can acquire the shot. Herd immunity, often known as neighborhood immunity, occurs when adequate individuals in a group are vaccinated in order that the few that aren’t will even be included. besides the fact that children, as the quantity of people not vaccinating grows tremendously, herd immunity decreases on the equal cost. Physicians Phoebe Day Danzinger and Rebekah Diamond suggest an excessive solution: don’t provide the anti-vaxxers a choice. both medical doctors wrote, “Neither of us imagined they would commit so a lot of their time to working with folks who oppose what is arguably the very greatest invention of modern medicine” (Danzinger and Diamond). in addition, they assert why there should be no inoculation exemptions, despite own option or values. The certainty is that these ailments put all and sundry at risk, given that immunity is just a sound theory when enough americans are immunized. This proposition is one feasible answer to the chance of dropping group immunity far and wide the U.S..

Some suggest a special solution: inform folks earlier than their infants are born to provide them a higher opportunity of making informed choices in terms of immunization. Matthew Daley and Jason Glanz, in their Scientific American article “Straight discuss Vaccination,” believe a variety of methods to inform parents about the significance of vaccination. This comprises encouraging a prenatal type or featuring a forum for parents to focus on the concern amongst themselves. the most feasible suggestion, despite the fact, is figuring out a stronger means for doctors to agenda visits to absolutely supply parents with assistance about vaccination. Daley and Glanz also imply scheduling separate visits for typical prenatal checkups and vaccine guidance classes. this may permit medical doctors to take extra time carefully explaining why inoculation shouldn’t be taken frivolously. They also well known that often times, misinformation isn’t the fogeys’ fault, but the media and influences they’ve been surrounded with. therefore, it's the accountability of medical experts to aid cease the unfold of misconceptions.

1796 become one of the most essential years in scientific historical past when the primary vaccine came into existence. Its existence for the past couple of centuries has shifted public opinion of it for the worse. A bad stigma now surrounds the note vaccination, as if it’s some thing dangerous and fatal, in preference to the diseases it prevents. a lot of docs, together with Paul Offit, Rorke-Adams, Day Danzinger, and Rebekah Diamond have closely recommended for inoculation as a method to preserve epidemics from going on. professionals outweigh the credibility of the likes of Jenny McCarthy and Dr. Oz, who have been serious promoters of the anti-vaccine move. Vaccination is and remains fundamental in normal existence, from conserving herd immunity to ensuring the safeguard of toddlers from resurfacing deadly ailments and infections. average, the anti-vaccination stream is one sparked via misconceptions and misinformation that need to be stopped to keep toddlers fit and the world epidemic-free.

Works CitedDaley, Matthew F., and Jason M. Glanz. "Straight discuss Vaccination." Scientific American. eleven Aug. 2011. internet. 30 Mar. 2017.Danziger, Phoebe Day, and Rebekah Diamond. "we are able to’t persuade Anti-Vaxxers of Science. They deserve to Mandate Vaccination."Slate journal. 25 July 2016. internet. 29 Mar. 2017.Marcus, Stephanie. "Jenny McCarthy Ecstasy: Actress Tried To Have sex With A Tree while On Ecstasy." The Huffington post. TheHuffingtonPost, 09 Nov. 2012. internet. 28 Mar. 2017."Measles." KidsHealth. Ed. Scott A. Barron. The Nemours foundation, Feb. 2015. internet. 29 Mar. 2017."Measles situations and Outbreaks." facilities for disease handle and Prevention. centers for disease handle and Prevention, 06 Mar. 2017. net. 27 Mar. 2017.Offit, Paul A. deadly decisions: How the Anti-vaccine movement Threatens Us All. ny: basic , a Member of the Persecus book neighborhood, 2015. Print."possible facet-results from Vaccines." facilities for ailment manage and Prevention. centers for disease control and Prevention, 02 Dec. 2016. net. 29 Mar. 2017.U.S. department of fitness and Human features. "Vaccines" Vaccines. U.S. department of fitness and Human capabilities, eleven Oct. 2006. internet. 29 Mar. 2017."Vaccines cause Seizures?: Samuel Berkovic, An Unsung Hero." Parenting Patch. 02 Dec. 2013. net. 29 Mar. 2017.Wakefield, Andrew. "Ileal-lymphoid-nodular Hyperplasia, Non-certain Colitis, and Pervasive Developmental ailment in children." The Lancet. Elsevier limited, 28 Feb. 1998. internet. 27 Mar. 2017."What explanations Autism?" Autism Speaks. 24 July 2012. internet. 29 Mar. 2017.


Influenza Vaccination Reduces Dementia possibility in continual Kidney ailment patients: A population-based Cohort analyze | killexams.com Real Questions and Pass4sure dumps

INTRODUCTION

continual kidney ailment (CKD) is linked to a high risk of cardiovascular ailments, conclusion-stage renal ailment (ESRD), infection, and malignancy and excessive mortality. 1 Taiwan has the maximum incidence of ESRD worldwide. 2 a big Taiwanese cohort analyze proven a excessive prevalence of CKD (11.9%) in adults and a fair better prevalence (37.2%) among the many aged population. 3 Wen et al demonstrated that sufferers with CKD had eighty three% better mortality for all causes and a hundred% bigger mortality for cardiovascular diseases. three A reasonable reduction in the glomerular filtration expense (GFR), described as a serum creatinine level ≥1.5 mg/dL (133 μmol/L) for men and ≥1.three mg/dL (one hundred fifteen μmol/L) for girls, is linked to accelerated cognitive decline and multiplied dementia possibility in aged americans. 4–6 Renal impairment is associated with vascular dementia in individual with good to mind-blowing fitness. in addition, sooner GFR decline is associated with greater big cognitive decline. 7 These observations are per collected facts displaying an increase in the chance of coronary coronary heart ailment in patients with gentle to moderate CKD. therefore, CKD is regarded a manifestation of vascular illnesses.

patients with CKD have a 100% higher possibility of cardiovascular ailments, and many studies have shown that cardiovascular illnesses are associated with dementia. eight–11 The incidence of dementia amongst Taiwanese people aged sixty five years and older accelerated from 4.1% in 1980 to 10.2% in 2007. A study of the population of Taiwan revealed that the occurrence of dementia became ∼1.7% to four.3% amongst elderly individuals. 12 In Taiwan, the high incidence of CKD may well be correlated with dementia. setting up health guidelines for decreasing dementia risk in sufferers with CKD is important for lowering the societal burden and the care cost.

The influenza vaccination coverage in Taiwan has step by step expanded from high-possibility populations to key spreaders to extra in the reduction of the variety of influenza cases and deaths. patients with CKD are regarded a excessive-chance population for influenza. therefore, the government broadcasts the precedence organizations for vaccinations each year on the basis of the techniques of the Advisory Committee on Immunization Practices (ACIP). 13 here, they estimated the association between influenza vaccination and dementia possibility in sufferers with CKD to verify whether influenza vaccination reduces dementia possibility in such patients.

sufferers and strategies

The country wide medical health insurance (NHI) program, which turned into based in 1995, at present provides finished medical insurance coverage to 98% of >23 million individuals. during this study, facts from the national medical insurance research Database (NHIRD) were used. No statistically big alterations were accompanied in age, intercourse, or healthcare charges between the pattern community and all enrollees. based on the Taiwan middle for ailment manage, the influenza season is described because the interval from October to March. data in the NHIRD that could be used to identify sufferers or care providers, together with scientific associations and physicians, are scrambled before being despatched to the country wide health research Institutes for database construction and are additional scrambled earlier than being launched to researchers. Theoretically, querying the facts by myself to establish individuals at any level by using this database is impractical. All researchers using the NHIRD and the data subsets need to sign a written settlement declaring that they haven't any intention of trying to acquire information that may probably violate the privacy of patients or care providers. 14

The look at cohort comprised all sufferers diagnosed with CKD (based on international Classification of illnesses, Ninth Revision, medical modification [ICD-9-CM] codes) at healthcare amenities in Taiwan (n = 32,844) from January 1, 2000, to December 31, 2007. They excluded all sufferers with no subsequent outpatient visit, emergency branch discuss with, or inpatient hospitalization for CKD within one year of the primary presentation (n = 9535), as a result of they have been regarded to not have CKD (determine 1). They additionally excluded 27,276 patients who have been <60 years (n = 8557) and had a historical past of any inpatient or outpatient analysis regarding cancer earlier than the enrollment date (n = 1605) or these vaccinated inside 6 months earlier than the enrollment date (n = 1386).

In Taiwan, influenza vaccination has been free of can charge and informed for prime-chance adults aged ≥50 years (i.e., these with type 2 diabetes, chronic liver infection or liver cirrhosis, cardiovascular diseases, or persistent pulmonary ailments) due to the fact that 1998 and for all adults aged >sixty five years because 2001. The vaccination repute turned into identified the usage of the ICD-9-CM code V048 and/or using vaccine (established by means of drug codes). 15 Their remaining look at cohort contained 11,943 sufferers clinically determined with CKD in Taiwan >8-yr period; 5745 were vaccinated in opposition t influenza and 6198 have been now not. every affected person changed into followed as much as check the possibility of dementia or shielding elements: the demographic features of age and intercourse; the comorbidities of diabetes, hypertension, dyslipidemia, cerebrovascular illnesses, parkinsonism, epilepsy, substance- and alcohol-use problems, mood disorder, nervousness ailment, psychotic disease, and sleep disorder; urbanization degree; month-to-month profits; and statin, metformin, aspirin, and angiotensin-changing enzyme inhibitor (ACEI) use. A propensity rating (PS) turned into derived using a logistic regression mannequin to estimate the impact of vaccination by way of accounting for the covariates predicting receiving the intervention (vaccine). This formula is used in observational studies to reduce preference bias. 16 The covariates mainly model had been adjusted for PSs of age, intercourse, comorbidities, urbanization degree (city, suburban, and rural), month-to-month salary (0; NT$1–NT$21,000; NT$21,000–NT$33,300; and ≥NT$33,301; NT$ represents new Taiwan dollars) (desk 2). The endpoint became the incidence of dementia (ICD-9-CM codes 331.0, 290.4, and 290.0–290.3) in vaccinated or unvaccinated patients with a subsequent outpatient talk over with, emergency department consult with, or inpatient hospitalization for dementia inside twelve months, and unvaccinated sufferers served as the reference arm. since the protecting effect of vaccination is particular to the influenza season, evaluating the noninfluenza season could point out the viable contribution of bias to the estimates followed all through the influenza season. the relationship between the seasonal effect of vaccination and dementia chance became also analyzed. The cumulative incidence of dementia in vaccinated and unvaccinated CKD sufferers turned into estimated using the Kaplan–Meier method. To check the impact of the entire variety of vaccinations on the cumulative incidence of dementia, they labeled sufferers into 4 companies in line with the vaccination repute: unvaccinated and 1, 2 to three, and ≥four total vaccinations.

A time-dependent Cox proportional hazard mannequin changed into used to calculate the hazard ratios (HRs) of dementia amongst vaccinated and unvaccinated patients with CKD. The HRs have been adjusted for age, sex, baseline comorbidities, and metformin, statin, aspirin, and ACEI use in the multivariate analysis. A stratified evaluation turned into performed to evaluate the effect of vaccination on age and sex (table 2). All analyses had been carried out using SAS application, version 9.three (SAS, Cary, NC); 2-tailed P < 0.05 become regarded colossal. In sensitivity analyses, external changes enrich the knowing of the results of medication and different covariates in epidemiologic database experiences. 17 hence, within the sensitivity analysis, changes have been made to estimate the affiliation of age and sex; diabetes, dyslipidemia, hypertension, cerebrovascular diseases, and anxiety sickness; and statin, metformin, ACEI, and aspirin use with the incidence of dementia in different models. The models stratified by way of different seasons were adjusted for covariates commonly mannequin and each further covariate (Tables three–5).

outcomes

The analyze cohort comprised eleven,943 sufferers, of whom 5745 (48%) bought influenza vaccination and the last 6198 (52%) didn't (table 1). the overall follow-up duration became 17,234.8 and 35,899.1 person-years for unvaccinated and vaccinated sufferers, respectively. in comparison with vaccinated patients, unvaccinated patients exhibited a better incidence of preexisting clinical comorbidities together with diabetes (P < 0.001), cerebrovascular diseases (P < 0.001), hypertension (P < 0.001), dyslipidemia (P < 0.001), substance- and alcohol-use issues (P = 0.037), anxiety disease (P < 0.001), and sleep sickness (P < 0.001). in contrast, vaccinated patients exhibited a better prevalence of comorbidities similar to parkinsonism (P < 0.001), temper ailment (P < 0.001), and psychotic disease (P = 0.018). moreover, significant differences have been accompanied within the distributions of age, month-to-month income, and urbanization stage in addition to statin, aspirin, ACEI, and metformin use between vaccinated and unvaccinated patients (desk 1). a much better proportion of unvaccinated sufferers used statin, metformin, ACEI, and aspirin for < 365 days; although, most vaccinated patients used these medication for >three hundred and sixty five days. A lower proportion of vaccinated sufferers had a monthly earnings of ≥NT$33,301 and resided in urban areas. table 2 shows the chance of dementia among the many unvaccinated and vaccinated patients in the study cohort. After adjustment for age, sex, comorbidities, urbanization level, and monthly profits, they analyzed the PS. The adjusted HRs (aHRs) of dementia lowered in vaccinated patients in comparison with these in unvaccinated sufferers (influenza season, noninfluenza season, and all seasons: aHRs = 0.68, 0.fifty eight, and 0.64; P < 0.0001, P < 0.0001, and P < 0.0001, respectively). The stratified analysis showed that the aHRs nonetheless vastly reduced in vaccinated sufferers, peculiarly in sufferers aged ≥70 years, regardless of intercourse. throughout the noninfluenza season, the aHRs decreased regardless of age or intercourse, apart from the 60 to sixty nine age group, whose pattern measurement turned into quite small in comparison with that of the different subgroups (desk 2).

TABLE 1

desk 1

TABLE 2

table 2

in the sensitivity evaluation, alterations were made to estimate the affiliation of age and sex; diabetes, dyslipidemia, hypertension, cerebrovascular ailments, and nervousness ailment; and statin, metformin, ACEI, and aspirin use with the incidence of dementia in distinct fashions. table three indicates that the consequences of vaccination remained large in the subgroups of various covariates throughout the influenza season. Vaccination dose-dependently reduced the possibility of dementia in all subgroups and the main model with further covariates (statin, metformin, ACEI, or aspirin use). All aHRs indicated that vaccination triggered >4-fold statistically huge savings within the possibility of dementia in all subgroups, in spite of comorbidities or drug use (P < 0.001). Their information published that the vaccination frequency mirrored the defensive effect towards dementia throughout the influenza season. The protective impact was greater predominant in sufferers aged ≥70 years (≥4 vaccinations: aHR = 0.29, 95% self belief interval [CI]: 0.23, 0.33) and in those with diabetes (≥4 vaccinations: aHR = 0.30, 95% CI: 0.22, 0.forty one) and dyslipidemia (≥4 vaccinations: aHR = 0.31, ninety five% CI: 0.23, 0.forty two). As shown in table four, they analyzed the sensitivity analysis adjustments within the noninfluenza season. a more robust protective impact in opposition t dementia changed into proven throughout the noninfluenza season. less usual vaccination statistically enormously reduced dementia. Vaccination at a frequency of two to 3 instances conferred a shielding impact to CKD patients. The protective effect became more predominant in sufferers aged ≥70 years (2–three vaccinations: aHR = 0.fifty six, 95% CI: 0.43, 0.72; ≥4 vaccinations: aHR = 0.27, ninety five% CI: 0.21, 0.35) and in those with diabetes (2–3 vaccinations: aHR = 0.58, ninety five% CI: 0.forty two, 0.80; ≥4 vaccinations: aHR = 0.25, 95% CI: 0.17, 0.38), dyslipidemia (2–three vaccinations: aHR = 0.fifty three, ninety five% CI: 0.37, 0.76; ≥four vaccinations: aHR = 0.31, ninety five% CI: 0.21, 0.45), hypertension (2–3 vaccinations: aHR = 0.fifty eight, ninety five% CI: 0.forty six, 0.75; ≥four vaccinations: aHR = 0.30, 95% CI: 0.23, 0.39), and cardiovascular ailments (2–3 vaccinations: aHR = 0.59, ninety five% CI: 0.42, 0.84; ≥four vaccinations: aHR = 0.29, ninety five% CI: 0.19, 0.forty four). all through all seasons (desk 5), the trend of dementia discount nonetheless reflected the frequency of vaccination. The shielding impact become greater predominant in sufferers aged ≥70 years (2–3 vaccinations: aHR = 0.69, ninety five% CI: 0.fifty nine, 0.80; ≥4 vaccinations: aHR = 0.28, 95% CI: 0.23, 0.33) and in these with diabetes (2–3 vaccinations: aHR = 0.seventy four, 95% CI: 0.61, 0.90; ≥4 vaccinations: aHR = 0.28, 95% CI: 0.22, 0.36), dyslipidemia (2–three vaccinations: aHR = 0.66, 95% CI: 0.fifty four, 0.eighty two; ≥four vaccinations: aHR = 0.31, ninety five% CI: 0.25, 0.39), hypertension (2–3 vaccinations: aHR = 0.74, 95% CI: 0.sixty three, 0.86; ≥4 vaccinations: aHR = 0.34, 95% CI: 0.29, 0.40), and cardiovascular illnesses (2–three vaccinations: aHR = 0.seventy seven, ninety five% CI: 0.62, 0.ninety six; ≥4 vaccinations: aHR = 0.29, ninety five% CI: 0.33, 0.44). in spite of statin, metformin, ACEI, or aspirin use, vaccination turned into an unbiased shielding element and dose-dependently reduced dementia in patients with CKD.

TABLE 3

table three

TABLE 4

table four

TABLE 5

desk 5

discussion

so far, few experiences have investigated the affiliation between dementia risk and influenza vaccination. Nichol et al demonstrated that the influenza vaccination of aged sufferers is linked to decreased risks of heart and cerebrovascular ailments. 18 viable mechanisms of the improved possibility of cerebrovascular and cardiovascular routine after upper respiratory tract illnesses (e.g., influenza) include modifications in circulating clotting components, inflammatory response protein stages, and cytokine ranges and platelet aggregation and lysis. These changes could raise thrombotic inclinations, impair vasodilation, or trigger endothelial harm. clinical manifestations of cardiovascular ailments and markers of atherosclerotic disease burden may additionally also be used to establish americans at risk for cognitive decline and dementia. 19–22 Verreault et al showed that old influenza vaccination may protect towards Alzheimer disease (ad) construction. 23 Cerebrovascular illnesses and ad generally coexist. Hypertension is the basic chance ingredient for vascular ailments within the brain. Cerebrovascular illnesses are linked to deteriorated cognitive performance in ad sufferers, and clinicopathologic reports have advised that cerebrovascular ailments reduce the brink for scientific dementia in sufferers with a neuropathologic diagnosis of advert. 24,25 Their discovering that influenza vaccination decreased dementia chance may replicate the response of heart ailment, cerebrovascular illnesses, and advert lowering. in accordance with their literature assessment, this is the primary analyze to exhibit the association of dementia risk with influenza vaccination in patients with CKD.

A average discount in GFR is associated with accelerated cognitive decline and expanded dementia chance in elderly sufferers. 5,6 amongst americans with good to staggering fitness, renal impairment is associated with vascular dementia, however not advert. sooner GFR decline is also linked to extra huge cognitive decline. 7 Their observations are in keeping with gathered records displaying an increase in the chance of coronary heart ailment in patients with light to average CKD; therefore, CKD is regarded a manifestation of vascular illnesses. 26–28 Vascular risk factors such as hypertension, dyslipidemia, and diabetes are associated with cognitive decline and all-cause dementia and advert and vascular dementia in my opinion. Influenza vaccination reduces the chance of cerebrovascular and cardiovascular ailments. 18 Vaccination predominately reduced dementia in patients aged ≥70 years (2–three vaccinations: aHR = 0.69, ninety five% CI: 0.59, 0.80; ≥4 vaccinations: aHR = 0.28, ninety five% CI: 0.23, 0.33) and in those with diabetes (2–3 vaccinations: aHR = 0.seventy four, 95% CI: 0.61, 0.90; ≥4 vaccinations: aHR = 0.28, ninety five% CI: 0.22, 0.36), dyslipidemia (2–three vaccinations: aHR = 0.sixty six, 95% CI: 0.54, 0.eighty two; ≥four vaccinations: aHR = 0.31, 95% CI: 0.25, 0.39), hypertension (2–3 vaccinations: aHR = 0.seventy four, 95% CI: 0.63, 0.86; ≥4 vaccinations: aHR = 0.34, 95% CI: 0.29, 0.40), and cardiovascular diseases (2–three vaccinations: aHR = 0.77, ninety five% CI: 0.sixty two, 0.96; ≥four vaccinations: aHR = 0.29, ninety five% CI: 0.33, 0.forty four). Their results suggest that influenza vaccination reduces dementia chance in patients with CKD.

patients with CKD show an multiplied possibility of an infection. 29,30 The 2012 Kidney disorder: enhancing world results (KDIGO) instructions suggest that sufferers with all tiers of CKD may still be annually vaccinated against influenza, until contraindicated. 31 youngsters, no matter if influenza vaccination reduces the morbidity or mortality of CKD patients is doubtful. reviews have advised that vaccination is associated with a diminished incidence of influenza and all-trigger hospitalization, enhancing the survival of such patients. 32,33 although, these consequences may also had been confounded by means of unmeasured prognostic variables. in addition, a study revealed that the antibody response to the influenza vaccine in CKD sufferers become lessen than that in the widespread population. 34 This response, in distinction to that to other vaccines, changed into not drastically diverse from that in controls, despite the fact the number of CKD patients investigated was exceptionally low. In their study, the largest latest collection of CKD patients had been analyzed, and the shielding effect against dementia became glaring. The influenza vaccination of sufferers with CKD reduced no longer most effective mortality (controversial) 33 however also dementia.

In clinical follow, they imply that CKD patients with excessive dementia possibility be vaccinated. 5–7 Whitmer et al identified that hypertension, excessive ldl cholesterol, and diabetes at midlife were linked to a 20% to 40% raise in dementia chance; varied chance elements have been dose-dependently linked to a stronger risk of dementia. 35 In their look at, dementia chance discount and the protective impact were more predominant in patients with diabetes, dyslipidemia, hypertension, and cerebrovascular illnesses compared with other patients. here is because the presence of additional dementia possibility factors might proportionally enhance the incidence of dementia in sufferers with CKD; hence, the protective impact of influenza vaccination became more suitable. CKD is considered a manifestation of vascular ailments. 26–28 CKD patients with additional possibility factors are extra vulnerable to dementia. Their findings display that influenza vaccination had dose-stylish protecting effects on aged CKD patients, certainly those with diabetes, dyslipidemia, hypertension, and cerebrovascular illnesses (Tables three–5).

in this look at, the magnitude of the bias verified with the aid of the associations observed all through the noninfluenza season changed into enough to completely account for the associations observed during the influenza season. A competing risk element exists between influenza and noninfluenza seasons. reviews have demonstrated an improved risk of hospital admission and a high mortality expense amongst elderly men all through the influenza season. 33,36,37 The better mortality chance all over the influenza season may masks the incidence of dementia episodes, and CKD patients may die earlier than dementia construction. here's why influenza vaccination had a more robust protective impact towards dementia all through the noninfluenza season (Tables three and four).

in accordance with their analysis, here's the primary study to display the association of influenza vaccination with the possibility of dementia in CKD patients. outdated reviews confirmed that patients with CKD had a high possibility of influenza-connected mortality and excessive chance of dementia; although, they don't have satisfactory evidence to unravel the problem in patients with CKD. Their findings reveal that the shielding effect towards dementia chance in patients with CKD became dose elegant. The fundamental solution might be the common influenza vaccination of CKD sufferers, specifically these with dementia risk factors similar to hypertension, dyslipidemia, diabetes, and cerebrovascular diseases. Tables 3–5 exhibit the sensitivity analysis of the aHRs of age, intercourse, comorbidities, urbanization level, and month-to-month income in the PS. The models were adjusted for covariates often model and each further covariate to estimate the discount in dementia chance all over the follow-up duration. The dose-based protecting effect of influenza vaccination changed into observed inspite of age and intercourse; diabetes, hypertension, dyslipidemia, cerebrovascular ailments, and nervousness ailment; or ACEI, metformin, statin, and aspirin use, with stratification by means of a number of frequencies of influenza vaccination. The dose-stylish shielding impact of influenza vaccination was followed for different conditional statuses. furthermore, this is the first analyze to evaluate the dose–response effect of influenza vaccination on dementia possibility. Their outcomes reveal that influenza vaccination became much less constructive in reducing dementia simplest as soon as. Influenza vaccines should still be administered as a minimum as soon as or >2 to three times for reaching a significant shielding effect in CKD sufferers with dementia chance elements all through the noninfluenza season (table four). The larger the frequency of influenza vaccination is, the extra colossal the defensive effect against dementia in CKD sufferers turns into. The electricity of the existing analyze is its colossal sample size. The consequences indicate that the incidence of dementia changed into reduced in CKD patients during the preventive method of influenza vaccination. this is the first examine to reveal that influenza vaccination exerts dose–response and synergistic protecting outcomes in opposition t dementia in CKD patients with dementia risk factors by reducing the incidence of dementia.

This examine has talents obstacles. evidence from observational experiences suggests that culture components, particularly social, mental, and physical recreation, are inversely associated with the risk of cognitive decline and dementia. despite the fact, methodologic considerations may additionally vague the specific relationship between these elements and dementia risk. One theory states that higher academic tiers and cognitive exercise produce a cognitive reserve that reduces the impact of neurodegeneration on cognitive characteristic. In their look at, they used the PS to fit age, sex, comorbidities, urbanization stage, and monthly revenue. The urbanization level and month-to-month earnings are unvalidated options to subculture elements and the tutorial degree. To reap such tips, a large randomized trial should practice a suitable routine to appropriately selected patients for comparing average approaches. additionally, the diagnoses of dementia and all different comorbidities have been completely based on the ICD codes. nevertheless, the national medical health insurance Administration randomly stories clinical records and interviews sufferers to validate diagnoses. Hospitals with outlier diagnoses and practices may be audited and as a result closely penalized if malpractice and discrepancies are found. an additional drawback is that information on several unmeasured confounders, including body mass index, smoking, alcohol consumption, and use of other over-the-counter drugs (which are associated with dementia), is not available within the NHIRD. youngsters, in view that the magnitude and importance of the accompanied outcomes, it is not likely that these obstacles compromised the consequences. eventually, their study isn't a potential randomized blinded examine; therefore, a cause–impact relationship couldn't be established. The findings of this study suggest that influenza vaccination exerts a major shielding effect in opposition t dementia in CKD patients with dementia chance components by using cutting back the incidence of dementia. additional randomized reviews are required to determine these findings.

CONCLUSIONS

Influenza vaccination exerts dose–response and synergistic defensive outcomes against dementia in CKD patients with dementia chance elements by way of decreasing the incidence of dementia.

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Andrassy KM. feedback on ’KDIGO 2012 clinical apply guiding principle for the contrast and management of persistent Kidney ailment’. Kidney Int 2013; eighty four:622–623. 32. Wang CS, Wang ST, Lai CT, et al. affect of influenza vaccination on important trigger-selected mortality. Vaccine 2007; 25:1196–1203. 33. Liu IF, Huang CC, Chan WL, et al. results of annual influenza vaccination on mortality and hospitalization in elderly sufferers with ischemic coronary heart disease: a nationwide inhabitants-primarily based examine. Prev Med 2012; fifty four:431–433. 34. Remschmidt C, Wichmann O, more durable T. Influenza vaccination in sufferers with conclusion-stage renal disorder: systematic assessment and assessment of pleasant of facts involving vaccine efficacy, effectiveness, and protection. BMC Med 2014; 12:244. 35. Whitmer RA, Sidney S, Selby J, et al. Midlife cardiovascular possibility components and risk of dementia in late existence. Neurology 2005; sixty four:277–281. 36. Lau D, Eurich DT, Majumdar SR, et al. Effectiveness of influenza vaccination in working-age adults with diabetes: a population-primarily based cohort study. Thorax 2013; sixty eight:658–663. 37. Dodds L, McNeil SA, Fell DB, et al. have an impact on of influenza publicity on fees of medical institution admissions and health practitioner visits as a result of respiratory disease amongst pregnant women. CMAJ 2007; 176:463–468. Copyright © 2016 The Authors. posted via Wolters Kluwer fitness, Inc. fitness, Inc. All rights reserved. source

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FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients | killexams.com real questions and Pass4sure dumps

SILVER SPRING, Md., June 22, 2018 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration permitted marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis. 

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

Specifically, the FDA granted marketing authorization for the use of the Ellipsys Vascular Access System and the everlinQ endoAVF System to make what's called an arteriovenous (AV) fistula for patients who need hemodialysis access.

"Dialysis is a necessary and life-saving procedure for thousands of individuals. With today's action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis," said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health.

According to the National Institutes of Health, more than 661,000 Americans have kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or artificial kidney, to filter a patient's blood outside of their body. Before patients can start dialysis, however, they need to have an AV fistula created. An AV fistula is traditionally made by surgically joining an artery and a vein under the skin in the arm. After some time, the mature vein can then receive the two needles used for each hemodialysis session. Surgically created AV fistulas typically take several months to heal and for the vein to mature before being usable for hemodialysis.

The devices granted marketing authorization today are designed to create AV fistulas percutaneously (through the skin). A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned AV fistula. The devices then deliver energy to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System uses one catheter, the everlinQ endoAVF System uses two.

For the Ellipsys Vascular Access System, the FDA reviewed data from a non-randomized, multi-center study of 103 patients. The Ellipsys Vascular Access System was used in a procedure to create an AV fistula in these patients, of which 92 patients (89.3 percent) met the criteria for a usable AV fistula within three months after the procedure.  Almost all patients (96.1 percent) required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.

For the everlinQ endoAVF System, the FDA reviewed data from a non-randomized, multi-center study of 60 patients, in addition to supporting data from three other studies and clinical use of the device outside the U.S. The everlinQ endoAVF System was used in a procedure to create an AV fistula in these patients. In the main study, 52 patients (86.7 percent) met the criteria for a usable AV fistula within three months after the procedure.  Almost all patients (96.7 percent) required an additional procedure at the time the fistula was created, while 28.3 percent of patients required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.

Both devices are contraindicated, or should not be used, for creation of anastomoses (connections) in vessels that are less than two millimeters in diameter or too far apart (for example, in the wrist or in the hand). For both devices, complications include blocking (occlusion) or collapse (stenosis) of the fistula, bruising and need for additional procedures.

The Ellipsys Vascular Access System and everlinQ endoAVF System were reviewed through the De Novo premarket review pathway, a regulatory pathway for some low to moderate risk devices of a new type. This action also creates a new regulatory classification, which means that subsequent devices with the same intended use may go through the FDA's 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Ellipsys Vascular Access System to Avenu Medical.

The FDA granted marketing authorization of the everlinQ endoAVF System to TVA Medical, Inc.

More information:FDA: Recently Approved DevicesFDA: De novo pathwayNIH: Hemodialysis

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of their nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, stephanie.caccomo@fda.hhs.gov  Consumer Inquiries: 888-INFO-FDA

Cision View original content with multimedia:https://www.prnewswire.com/news-releases/fda-permits-marketing-of-first-catheter-based-systems-used-to-create-vascular-access-for-hemodialysis-patients-300670882.html

SOURCE U.S. Food and Drug Administration


The Anti-Vaccination Movement: Spreading Misconceptions,Fueling Epidemics,Circulating Misinformation | killexams.com real questions and Pass4sure dumps

“Outdated” diseases, such as measles, have affected over 900 people in the past three years in the United States. “Informed” celebrities, such as Dr. Oz, have spread misconceptions about autism in relation to vaccination. One thing’s for certain: “dangerous,” “unchecked,” and “useless” vaccinations are the reasons for the end of polio, measles, smallpox, and pertussis epidemics. At the close of the 18th century, Edward Jenner invented the first vaccine by injecting cowpox-infected bodily fluid into a boy that was infected with the disease. Ever since then, deadly diseases had preventions as soon as ethical, acceptable, and safe vaccines hit the market. For decades and even centuries, people felt privileged to have access to this medical innovation that saved millions of lives internationally. Lately, however, preventable diseases unheard of in decades have resurfaced as a result of the anti-vaccination movement. This movement resulted from citizens of first world countries taking this privilege for granted by believing that diseases such as measles were completely eradicated. Misconceptions about inoculation blew completely out of proportion, ranging from unscientific links with autism to fraudulent anecdotes and studies. Consequently, medical doctors such as Paul Offit have dedicated their lives to eliminating the negative stigma that frequently surrounds immunization. The anti-vaccination movement, fueling misconceptions and catastrophically harming children, threatens the well-being of society. Vaccinations must be reinstated as one of the most valuable and vital modern-day developments of mankind to prevent further denouncement and devaluation incited by skeptics.

On February 28, 1998, an article was published in The Lancet titled, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children”Wakefield). The doctor behind the article, Andrew Wakefield, was undoubtedly the man that sparked the autistic side of the anti-vaccine movement. Wakefield was the first to ever publish a study that showed a correlation between autism and vaccination. This experiment was completely disproved and even retracted by the Lancet, but its impact in terms of the anti-vaccine movement was incredibly devastating. The doctor’s data was found fraudulent and falsified, and he was ultimately stripped of his medical license. Scientists, doctors, and medical professionals rejoiced; they thought an era of misconception regarding vaccination was ending rather than beginning.

Despite these findings and former Dr. Wakefield’s complete lack of credibility, popular anti-vaccine figures such as Jenny McCarthy found inspiration in these findings. McCarthy, mother of an autistic son, has been using her child’s diagnosis as a means to win public attention in the anti-vaccination movement. She claims that inoculating her child led to his autism. McCarthy soon became one of the biggest anti-vaccination advocates in the United States, without any feasible evidence behind her autism-vaccine link. This link is a logical fallacy, where a correlation between vaccination and autism is assumed only because both are present in a child. In fact, McCarthy’s son may have autism for another reason--McCarthy’s behaviors and addictions before pregnancy. Maternal drug abuse is directly correlated with autism in babies, which Jenny McCarthy was all too proud to advertise before and during her misconception-propelled anti-vaccination campaign started. For instance, McCarthy referred to herself as a “recovering Catholic,” after trying everything from ecstasy to prescription pills and ultimately getting hooked on Vicodin. These drugs definitely had a negative influence on McCarthy’s son as a growing fetus (Marcus). Although it cannot be stated for certain that her addictions led to his autism, that argument is much more plausible than the one accusing vaccinations. The AAP, or American Academy of Pediatrics, published in a comprehensive vaccine-autism research paper, “Studies do not show any link between autism and MMR vaccine, thimerosal, multiple vaccines given at once, fevers or seizures” (“Vaccines”). Autism Speaks, a charity revolving around improving the quality of life for children and adults diagnosed with autism, claimed, “Each family has a unique experience with an autism diagnosis, and for some it corresponds with the timing of their child’s vaccinations. The results of...research is clear: Vaccines do not cause autism” (“What Causes Autism?”). Evidently, credible sources have denounced the autism-vaccine link as non-existent; even though children are diagnosed with autism around the same time as they are initially inoculated, the two aren’t correlated.

There are undoubtedly side effects to immunization, but they don’t compare to the catastrophic consequences of contracting a deadly virus. Approximately 1 in 3 people report headaches following vaccination, and 1 in 100 even complain of a high fever as a side effect. On the other hand, diseases that vaccines prevent, such as measles, have incredibly worse and usually fatal consequences. A measles contraction starts with a rash that slowly spreads through the entire body. As the rash progresses, the infected have extremely high fevers. Their immune system weakens and they become more susceptible to other deadly infections. In the early 2000s, only about 37 people in the United States died from measles annually. Recently, due to the anti-vaccine there have been almost 650 cases in a year (“Measles”). Minimal side effects of vaccination cannot begin to compare to the devastating consequences of contracting fatal diseases.

Paul Offit, in his book Deadly Choices: How the Anti-Vaccine Movement Threatens Us All, asserts that movements against vaccination are misinformed and consequently dangerous to the well-being of society. Offit, a medical doctor, intelligently refutes every possible argument made against vaccination, provides a variety of anecdotes, and supports every claim he makes with plenty of scientific evidence. He eliminates all arguments against vaccination in order to t stop parents from being misinformed when choosing whether or not to vaccinate, as well as to discourage the further spread of anti-vaccine propaganda on media platforms. Offit attempts to persuade the public to make informed decisions with their children by warning them about the tragic consequences if they don’t. Throughout his book, Offit presents scientists that have made strides towards accurately informing the public about inoculation. Samuel Berkovic, a neurologist, realized the existence of a link between Dravet’s Syndrome and epilepsy following vaccinations. This discovery undermined every media figure, such as Lea Thompson, who claimed that vaccinations caused seizures. Berkovic, however, didn’t get the recognition he deserved for this brilliant medical link in 2006. The neurologists and other informed doctors that worked with him recognized his work as something remarkable, but the people circulating anti-vaccination propaganda continued their fight despite it all. Rorke-Adams, another scientist mentioned by Offit in his research, examined over thirty children whose parents claimed had seizures after vaccinations; every single child she examined ended up having a different reason behind the epilepsy, ranging from vascular disorders to degenerative diseases. As Offit stated, “...despite her expertise, and despite the fact that she has supported her evaluations with cogent, well-researched opinions, Rorke-Adams often finds that petitioners prevail” (Offit 90).

Different types of vaccines are administered depending on the age and maturity level of the child. As a result, herd immunity plays an incredibly important role before the child can receive the shot. Herd immunity, also known as community immunity, occurs when enough people in a group are vaccinated so that the few that aren’t will also be protected. However, as the amount of people not vaccinating grows tremendously, herd immunity decreases at the same rate. Physicians Phoebe Day Danzinger and Rebekah Diamond propose an extreme solution: don’t give the anti-vaxxers a choice. The two doctors wrote, “Neither of us imagined they would devote so much of their time to working with parents who oppose what is arguably the very greatest invention of modern medicine” (Danzinger and Diamond). Furthermore, they assert why there should be no inoculation exemptions, regardless of personal preference or values. The truth is that these diseases put everyone at risk, since immunity is only a valid concept when enough people are immunized. This proposition is one possible solution to the threat of losing community immunity all over the United States.

Some propose a different solution: inform parents before their children are born to give them a better chance of making informed decisions in terms of immunization. Matthew Daley and Jason Glanz, in their Scientific American article “Straight Talk about Vaccination,” consider a variety of ways to inform parents about the importance of vaccination. This includes encouraging a prenatal class or providing a forum for parents to discuss the issue amongst themselves. The most feasible proposal, however, is figuring out a better way for doctors to schedule visits to fully provide parents with information about vaccination. Daley and Glanz also suggest scheduling separate visits for standard prenatal checkups and vaccine information sessions. This would allow doctors to take more time carefully explaining why inoculation shouldn’t be taken lightly. They also acknowledge that often times, misinformation isn’t the parents’ fault, but the media and influences they’ve been surrounded with. Therefore, it is the responsibility of medical professionals to help stop the spread of misconceptions.

1796 was one of the most important years in medical history when the first vaccine came into existence. Its existence for the past couple of centuries has shifted public opinion of it for the worse. A negative stigma now surrounds the word vaccination, as if it’s something dangerous and fatal, rather than the diseases it prevents. Plenty of doctors, including Paul Offit, Rorke-Adams, Day Danzinger, and Rebekah Diamond have heavily advocated for inoculation as a means to keep epidemics from happening. Professionals outweigh the credibility of the likes of Jenny McCarthy and Dr. Oz, who have been serious promoters of the anti-vaccine movement. Vaccination is and continues to be essential in everyday life, from protecting herd immunity to ensuring the safety of children from resurfacing fatal diseases and infections. Overall, the anti-vaccination movement is one sparked by misconceptions and misinformation that must be stopped to keep children healthy and the world epidemic-free.

Works CitedDaley, Matthew F., and Jason M. Glanz. "Straight Talk about Vaccination." Scientific American. 11 Aug. 2011. Web. 30 Mar. 2017.Danziger, Phoebe Day, and Rebekah Diamond. "We Can’t Convince Anti-Vaxxers of Science. They Need to Mandate Vaccination."Slate Magazine. 25 July 2016. Web. 29 Mar. 2017.Marcus, Stephanie. "Jenny McCarthy Ecstasy: Actress Tried To Have Sex With A Tree While On Ecstasy." The Huffington Post. TheHuffingtonPost, 09 Nov. 2012. Web. 28 Mar. 2017."Measles." KidsHealth. Ed. Scott A. Barron. The Nemours Foundation, Feb. 2015. Web. 29 Mar. 2017."Measles Cases and Outbreaks." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 06 Mar. 2017. Web. 27 Mar. 2017.Offit, Paul A. Deadly Choices: How the Anti-vaccine Movement Threatens Us All. New York: Basic , a Member of the Persecus Book Group, 2015. Print."Possible Side-effects from Vaccines." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 02 Dec. 2016. Web. 29 Mar. 2017.U.S. Department of Health and Human Services. "Vaccines" Vaccines. U.S. Department of Health and Human Services, 11 Oct. 2006. Web. 29 Mar. 2017."Vaccines Cause Seizures?: Samuel Berkovic, An Unsung Hero." Parenting Patch. 02 Dec. 2013. Web. 29 Mar. 2017.Wakefield, Andrew. "Ileal-lymphoid-nodular Hyperplasia, Non-specific Colitis, and Pervasive Developmental Disorder in Children." The Lancet. Elsevier Limited, 28 Feb. 1998. Web. 27 Mar. 2017."What Causes Autism?" Autism Speaks. 24 July 2012. Web. 29 Mar. 2017.


Researchers develop new method to generate human antibodies | killexams.com real questions and Pass4sure dumps

IMAGE: An electron microscopy image shows an antibody-secreting plasma cell generated using antigen- and CpG-coated nanoparticles. view more 

Credit: Sanjuan Nandin et al., 2017

An international team of scientists has developed a method to rapidly produce specific human antibodies in the laboratory. The technique, which will be described in a paper to be published July 24 in The Journal of Experimental Medicine, could speed the production of antibodies to treat a wide range of diseases and facilitate the development of new vaccines.

Antibodies are produced by the body's B cells to fight off infections by bacteria, viruses, and other invasive pathogens. When an individual B cell recognizes a specific pathogen-derived "antigen" molecule, it can proliferate and develop into plasma cells that secrete large amounts of antibody capable of binding to the antigen and fending off the infection.

Researchers have sought to replicate this process in the laboratory to produce specific antibodies from B cells isolated from patient blood samples. However, in addition to encountering a specific antigen, B cells need a second signal to start proliferating and developing into plasma cells. This second signal can be provided by short DNA fragments called CpG oligonucleotides, which activate a protein inside B cells named TLR9. But treating patient-derived B cells with CpG oligonucleotides stimulates every B cell in the sample, not just the tiny fraction capable of producing a particular antibody.

A team of researchers led by Facundo Batista, from the Francis Crick Institute in London and the Ragon Institute of MGH, MIT, and Harvard, have been able to produce specific human antibodies in the laboratory by treating patient-derived B cells with tiny nanoparticles coated with both CpG oligonucleotides and the appropriate antigen. With this technique, CpG oligonucleotides are only internalized into B cells that recognize the specific antigen, and these cells are therefore the only ones in which TLR9 is activated to induce their proliferation and development into antibody-secreting plasma cells.

The team successfully demonstrated their approach using various bacterial and viral antigens, including the tetanus toxoid and proteins from several strains of influenza A. In each case, the researchers were able to produce specific, high-affinity antibodies in just a few days. Some of the anti-influenza antibodies generated by the technique recognized multiple strains of the virus and were able to neutralize its ability to infect cells.

The procedure does not depend on the donors having been previously exposed to any of these antigens through vaccination or infection; the researchers were able to generate anti-HIV antibodies from B cells isolated from HIV-free patients.

Batista and colleagues hope that their approach will help researchers rapidly generate therapeutic antibodies for the treatment of infectious diseases and other conditions such as cancer.

"Specifically, it should allow the production of these antibodies within a shorter time frame in vitro and without the need for vaccination or blood/serum donation from recently infected or vaccinated individuals," Batista says. "In addition, their method offers the potential to accelerate the development of new vaccines by allowing the efficient evaluation of candidate target antigens."

###

Sanjuan Nandin et al., 2017. J. Exp. Med. http://jem. rupress. org/ cgi/ doi/ 10. 1084/ jem. 20170633?PR

About The Journal of Experimental Medicine

The Journal of Experimental Medicine (JEM) features peer-reviewed research on immunology, cancer biology, stem cell biology, microbial pathogenesis, vascular biology, and neurobiology. All editorial decisions are made by research-active scientists in conjunction with in-house scientific editors. JEM provides free online access to many article types from the date of publication and to all archival content. Established in 1896, JEM is published by The Rockefeller University Press. For more information, visit jem.org.

Visit their Newsroom, and sign up for a weekly preview of articles to be published. Embargoed media alerts are for journalists only.

Follow JEM on Twitter at @JExpMed and @RockUPress.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.



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