GBIF launches new Internet tool
A new internet tool (data.gbif/) has been launched by the Global Biodiversity Information Facility (GBIF). The launch event took place at an international meeting for scientific and technical advice to the Parties to the Convention on Biological Diversity (CBD) at the UNESCO building in Paris.
The new GBIF Data Portal is an Internet gateway to more than 130 million data records provided by 200+ institutions scattered over 30+ countries around the world. All of these data (with more to come) can be accessed all at once on the GBIF Data Portal.
Using GBIF's new search engine, you can find where on the globe a species can be found, or get a list of species in your country or your back yard. The data retrieved are instantly mapped by the Portal. The data can also, if the user chooses, be easily plotted on Google Earth.
The Data Portal is a sophisticated tool for users to incorporate biodiversity data into their own websites, or download datasets for ecological studies.
When combined with environmental datasets (soil type, climate, elevation and the like), GBIF data can be used in predicting species' response to climate change, choosing the best places to put protected areas, etc.
"This new Portal is one of the key tools GBIF has been working toward since its inception in 2001," said Dr. Nick King, currently CEO of the Endangered Wildlife Trust, and soon to become Executive Secretary of GBIF. "It will be extremely useful in improving decisions in support of sustainable development."
GBIF is an international organisation founded to make the world's biodiversity data freely and openly available worldwide. Membership now stands at 40 countries and 33 international organisations. Current non-members are welcome and invited to join.
The GBIF Data Portal is capable of handling hundreds of millions of data records. With the launch of the Portal, the GBIF network of data providers is set to grow dramatically, from hundreds to thousands of institutions.
GBIF makes the Portal and its extensive capabilities and services, as well as software for data providers, freely available. Civil society, countries and organisations are invited to utilise GBIF's new Data Portal.
Source: Meredith A. Lane
Global Biodiversity Information Facility
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вторник, 6 сентября 2011 г.
MU Researcher Develops Screening Tool To Identify Patients With Prediabetes
A third of Americans with diabetes do not know that they have it, and many more who have prediabetic conditions are unaware that they are at risk. A University of Missouri researcher has created a clinical tool to identify those at highest risk for having undetected hyperglycemia, impaired fasting glucose (IFG) and undiagnosed diabetes. If these conditions are identified early, patients may benefit from preventative strategies that can minimize progression to diabetes, other diseases and mortality.
"Diabetic risk factors are not equal and assessing a combination of risk factors can be confusing," said Richelle J. Koopman, assistant professor of family and community medicine in the MU School of Medicine. "A tool that weighs the relative contributions of multiple risk factors and creates an overall risk score will help clinicians decide which patients to screen for diabetes. The tool we have developed is easy to use and the screening can be done with pencil and paper. Patients can do it at a health fair or a physician's office."
The Tool to Assess Likelihood of Fasting Glucose Impairment (TAG-IT) is designed to use factors that are self-reported or easily measured. The six factors include: age, sex, BMI, family history, resting heart rate and measured high blood pressure.
The average age of diagnosis for diabetes in the United States is 46 years old. However, patients are likely to develop prediabetic conditions at a younger age. In the United States, 57 million people have IFG. As type 2 diabetes becomes an increasing burden in younger populations, it's important to have a screening tool that can assess undiagnosed diabetes and IFG in people as young as 20, Koopman said.
"There has been increasing evidence that prediabetic states are associated with diseases and other complications, and strategies that prevent diabetes in those with prediabetes are effective," Koopman said. "The TAG-IT tool will help physicians assess patients' risk levels. Hopefully, knowing their TAG-IT scores will encourage high-risk patients to use preventative strategies and make positive changes in their behaviors. The tool has potential as a Web-based screening tool that could improve awareness and encourage compliance with lifestyle changes recommended by physicians."
The study, "Tool to Assess Likelihood of Fasting Glucose Impairment (TAG-IT)" was published in the Annals of Family Medicine and is co-authored by Arch G. Mainous III, Charles J. Everett and Rickey E. Carter.
Source: Kelsey Jackson
University of Missouri-Columbia
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"Diabetic risk factors are not equal and assessing a combination of risk factors can be confusing," said Richelle J. Koopman, assistant professor of family and community medicine in the MU School of Medicine. "A tool that weighs the relative contributions of multiple risk factors and creates an overall risk score will help clinicians decide which patients to screen for diabetes. The tool we have developed is easy to use and the screening can be done with pencil and paper. Patients can do it at a health fair or a physician's office."
The Tool to Assess Likelihood of Fasting Glucose Impairment (TAG-IT) is designed to use factors that are self-reported or easily measured. The six factors include: age, sex, BMI, family history, resting heart rate and measured high blood pressure.
The average age of diagnosis for diabetes in the United States is 46 years old. However, patients are likely to develop prediabetic conditions at a younger age. In the United States, 57 million people have IFG. As type 2 diabetes becomes an increasing burden in younger populations, it's important to have a screening tool that can assess undiagnosed diabetes and IFG in people as young as 20, Koopman said.
"There has been increasing evidence that prediabetic states are associated with diseases and other complications, and strategies that prevent diabetes in those with prediabetes are effective," Koopman said. "The TAG-IT tool will help physicians assess patients' risk levels. Hopefully, knowing their TAG-IT scores will encourage high-risk patients to use preventative strategies and make positive changes in their behaviors. The tool has potential as a Web-based screening tool that could improve awareness and encourage compliance with lifestyle changes recommended by physicians."
The study, "Tool to Assess Likelihood of Fasting Glucose Impairment (TAG-IT)" was published in the Annals of Family Medicine and is co-authored by Arch G. Mainous III, Charles J. Everett and Rickey E. Carter.
Source: Kelsey Jackson
University of Missouri-Columbia
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Health Reform Law Will Benefit Women With Individual, Small Group Insurance
NPR's "Morning Edition" on Friday examined how the new health reform law could "improve women's experiences" with health insurance in the individual and small group markets.
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Under the current system, many health insurers deny or refuse to offer individual or small group coverage for gender-specific conditions, such as female infertility or having a previous caesarean section. Health insurers also frequently charge women higher premiums than men for the same coverage. A 2009 report by the National Women's Law Center found that women in the individual market can be charged up to 84% more than men for similar policies that do not include maternity coverage.
The new reform law will prohibit insurers from setting premium prices based on a consumer's gender or personal health history, "Morning Edition" reports. Policies offered in the new health insurance exchanges, which will take effect in 2014, will be required to provide coverage for pregnancy and related conditions.
Beginning five months from now, new insurance plans will have to allow women to receive care from obstetricians and gynecologists without referrals from primary care providers, according to "Morning Edition." In addition, insurers will be barred from charging copayments or other upfront costs for preventive services like mammograms and Pap tests.
NWLC Co-President Marcia Greenberger said, "Women have an enormous amount to gain from this bill," adding that in addition to the provisions requiring coverage of maternity care and banning industry practices that discriminate against women, the law "requires employers with 50 or more employees to provide a place and time for nursing mothers" to breastfeed or pump (Silberner, "Morning Edition," NPR, 4/23).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2010 The Advisory Board Company. All rights reserved.
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Phase 2 Clinical Trial For Plague Vaccine Candidate RF1V
DynPort Vaccine Company LLC has entered into a phase 2 clinical trial for its recombinant plague vaccine candidate, rF1V.
The phase 2 trial will test different vaccine dosages and schedules in 400 healthy volunteers between the ages of 18 and 55. The clinical trial is underway and will continue into 2007 at eight locations across the United States.
"An effective, licensed plague vaccine is a crucial component of U.S. biodefense initiatives," said Dr. Robert V. House, president and chief scientific officer of DVC. "Plague has been identified as a Category A bioterrorism agent by the Centers for Disease Control and Prevention. The candidate's entry into a phase 2 trial is a significant step toward DVC's goal of a licensed plague vaccine."
The plague vaccine candidate, which is designed to provide protection against the plague bacterium Yersinia pestis, was originally identified and developed by scientists working at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Their work involved the identification of suitable protein antigens and the development of the processes used to assess the performance of the vaccine. Further development and manufacture of the vaccine candidate has been achieved by DVC under the Department of Defense Joint Vaccine Acquisition Program (JVAP) prime systems contract.
JVAP's mission is to develop, produce and stockpile Food and Drug Administration-licensed vaccine products to help protect the warfighter against biological warfare agents. JVAP consolidates the Department of Defense's efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines.
USAMRIID, located at Fort Detrick, Md., is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.
DVC is a technology integrator that provides solutions to protect humanity from emerging threats. DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created to support programs enhancing U.S. security. For more information, visit DVC's Web site at csc/dvc
The safety and efficacy of this product in humans has not been established. This product is currently under clinical investigation and has not been licensed by the FDA.
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Founded in 1959, Computer Sciences Corporation is a leading global information technology (IT) services company. CSC's mission is to provide customers in industry and government with solutions crafted to meet their specific challenges and enable them to profit from the advanced use of technology.
With approximately 79,000 employees, CSC provides innovative solutions for customers around the world by applying leading technologies and CSC's own advanced capabilities. These include systems design and integration; IT and business process outsourcing; applications software development; Web and application hosting; and management consulting. Headquartered in El Segundo, Calif., CSC reported revenue of $14.6 billion for the 12 months ended March 31, 2005. For more information, visit the company's Web site at csc.
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The phase 2 trial will test different vaccine dosages and schedules in 400 healthy volunteers between the ages of 18 and 55. The clinical trial is underway and will continue into 2007 at eight locations across the United States.
"An effective, licensed plague vaccine is a crucial component of U.S. biodefense initiatives," said Dr. Robert V. House, president and chief scientific officer of DVC. "Plague has been identified as a Category A bioterrorism agent by the Centers for Disease Control and Prevention. The candidate's entry into a phase 2 trial is a significant step toward DVC's goal of a licensed plague vaccine."
The plague vaccine candidate, which is designed to provide protection against the plague bacterium Yersinia pestis, was originally identified and developed by scientists working at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Their work involved the identification of suitable protein antigens and the development of the processes used to assess the performance of the vaccine. Further development and manufacture of the vaccine candidate has been achieved by DVC under the Department of Defense Joint Vaccine Acquisition Program (JVAP) prime systems contract.
JVAP's mission is to develop, produce and stockpile Food and Drug Administration-licensed vaccine products to help protect the warfighter against biological warfare agents. JVAP consolidates the Department of Defense's efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines.
USAMRIID, located at Fort Detrick, Md., is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.
DVC is a technology integrator that provides solutions to protect humanity from emerging threats. DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created to support programs enhancing U.S. security. For more information, visit DVC's Web site at csc/dvc
The safety and efficacy of this product in humans has not been established. This product is currently under clinical investigation and has not been licensed by the FDA.
About CSC
Founded in 1959, Computer Sciences Corporation is a leading global information technology (IT) services company. CSC's mission is to provide customers in industry and government with solutions crafted to meet their specific challenges and enable them to profit from the advanced use of technology.
With approximately 79,000 employees, CSC provides innovative solutions for customers around the world by applying leading technologies and CSC's own advanced capabilities. These include systems design and integration; IT and business process outsourcing; applications software development; Web and application hosting; and management consulting. Headquartered in El Segundo, Calif., CSC reported revenue of $14.6 billion for the 12 months ended March 31, 2005. For more information, visit the company's Web site at csc.
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Presidential Candidate Sen. Clinton Announces Proposal To Reduce Health Care Costs
Democratic presidential candidate Sen. Hillary Rodham Clinton (D-N.Y.) in a speech at George Washington University on Thursday introduced a health care cost-cutting plan that she said could save $120 billion annually, the New York Times reports (Seelye, New York Times, 5/25). According to the Washington Post, Clinton has "narrowed her focus to health-care costs, a complex subject but one that resonates among many middle-income Americans." Clinton's plan includes seven measures to reduce costs and improve care in the U.S. health system. The plan says that Clinton would launch a "prevention initiative" to reduce diseases such as diabetes. The plan also calls for the implementation of electronic health records.
In addition, Clinton proposes to overhaul the method of care for the chronically ill, whose costs account for about two-thirds of all U.S. health expenditures. Her plan says it would seek to "en[d] insurance discrimination" by requiring insurance plans to accept anyone regardless of health status (Kornblut, Washington Post, 5/25).
Under Clinton's proposal, insurers also would be prohibited from charging higher rates to people with medical problems (Reichard, CQ HealthBeat, 5/24). The plan calls for legalizing the purchase of lower-cost prescription drugs from other nations and requiring Medicare to negotiate for lower drug prices. In addition, the plan says Clinton will call for instituting "common sense" changes to the medical malpractice system (Washington Post, 5/25).
Another portion of the plan would establish a combination public and private "Best Practices Institute" to finance research comparing treatment efficacy. The organization would issue protocols based on its findings (CQ HealthBeat, 5/24). Clinton said the institute would determine whether new prescription drugs and technologies offer real benefits to patients compared with older therapies or whether they simply boost drug company profits (New York Times, 5/25).
Clinton's proposals announced Thursday were the first phase of what she said would be a three-part plan for correcting the nation's health care problems if she were elected president (CQ HealthBeat, 5/24). Clinton's advisers said that she will outline plans to improve quality of care and implement universal coverage in coming months (Washington Post, 5/25).
In addition, Clinton proposes to overhaul the method of care for the chronically ill, whose costs account for about two-thirds of all U.S. health expenditures. Her plan says it would seek to "en[d] insurance discrimination" by requiring insurance plans to accept anyone regardless of health status (Kornblut, Washington Post, 5/25).
Under Clinton's proposal, insurers also would be prohibited from charging higher rates to people with medical problems (Reichard, CQ HealthBeat, 5/24). The plan calls for legalizing the purchase of lower-cost prescription drugs from other nations and requiring Medicare to negotiate for lower drug prices. In addition, the plan says Clinton will call for instituting "common sense" changes to the medical malpractice system (Washington Post, 5/25).
Another portion of the plan would establish a combination public and private "Best Practices Institute" to finance research comparing treatment efficacy. The organization would issue protocols based on its findings (CQ HealthBeat, 5/24). Clinton said the institute would determine whether new prescription drugs and technologies offer real benefits to patients compared with older therapies or whether they simply boost drug company profits (New York Times, 5/25).
Clinton's proposals announced Thursday were the first phase of what she said would be a three-part plan for correcting the nation's health care problems if she were elected president (CQ HealthBeat, 5/24). Clinton's advisers said that she will outline plans to improve quality of care and implement universal coverage in coming months (Washington Post, 5/25).
Comments
Clinton said, "Now, I've tangled with this issue before, and I've got the scars to show for it." She continued, "But I learned some valuable lessons from that experience. One is that we can't achieve reform without the participation and commitment of health care providers, employers, employees and other citizens who pay for, depend upon and actually deliver health care services" (Zuckman, Chicago Tribune, 5/25).
Clinton said, "In a system of universal coverage, insurance companies cannot as easily shift costs through cherry-picking and other means" of excluding older and sicker patients. She added, "That's how they profit: by avoiding insuring patients who will be expensive and then trying to avoid paying up once the insured patient actually needs treatment." Clinton said, "The money we save from the waste we eliminate and the way we change how we care for people should be used to help finance coverage for the 45 million Americans who have no insurance" (Young, The Hill, 5/24).
"The candidates have different starting positions with the voters on health care," Drew Altman, president and CEO of the Kaiser Family Foundation, which has polled on health policy and the election, said (Washington Post, 5/25). "Even though there was a great failure in the '90s, voters associate her with the issue and know she cares deeply about the issue," Altman said (Chicago Tribune, 5/25).
Mohit Ghose, a spokesperson for America's Health Insurance Plans, said, "We agree that universal access is a goal of even our proposal," adding, "But it's a question of how we get there, and how we make sure we're providing access to as many people as possible while preserving the affordability" (New York Times, 5/25).
Presidential candidate and former Sen. John Edwards (D-N.C.) already has proposed a plan for insuring all U.S. residents by 2012, while Sen. Barack Obama (D-Ill.), another contender for the Democratic nomination, is slated to announce his plan for lowering health care costs and expanding insurance coverage in Iowa City on Tuesday (Chicago Tribune, 5/25).
A kaisernetwork webcast of Clinton's speech is available online. Text of Clinton's plan also is available online.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Advances In Colorectal Cancer Detection, Sedation Procedures And Computer-Assistance
New developments in polyp detection, colonoscopy preparation and sedation techniques that will increase the effectiveness of colonoscopy and ease patient concerns about the procedure were presented at Digestive Disease Week® 2008 (DDW®). Research advances in sedation include computer-assisted sedation systems and the new evidence supporting the administration of propofol by gastroenterologists. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
"A significant percent of the population is not undergoing colorectal cancer screening, despite the fact that it has been proven to save lives," according to Sidney J. Winawer, MD, FASGE, AGAF, Paul Sherlock Chair, gastroenterology and nutrition service, Memorial Sloan-Kettering Cancer Center. "We hope that new research, such as that presented today, will encourage patients to get screened and to work with their doctors to discuss which screening methods may be best for them."
Colorectal cancer is the second leading cause of cancer deaths in the U.S. - more than 24,000 men and nearly 26,000 women die of the disease each year. However, colorectal cancer is curable when detected early. Screening rates for colorectal cancer in the U.S. lag far behind those for other cancers despite research showing that high mortality rates are lowered by detecting colorectal cancer at an early stage.
"The most common neoplastic outcome of colorectal cancer screening is the identification of polyps which require follow-up. Colorectal cancer is curable and preventable when polyps are found and removed early," said Dr. Winawer. "If physicians followed recommended screening guidelines, there would be more appropriate surveillance which would help shift resources to screening."
A Computer-Assisted Personalized Sedation System to Administer Propofol Versus Standard of Care Sedation for Colonoscopy and EGD: A 1000 Subject Randomized, Controlled, Multi-Center Pivotal Trial (Late Breaking Abstract)
During endoscopic procedures, patients are placed under moderate sedation, which allows them to undergo these procedures comfortably. Traditional sedation agents, such as midazolam, meperidine and fentanyl, are often administered by the endoscopy team during the procedure. Propofol is an alternative medication which takes effect quickly and allows for a quicker recovery period, but may place the patient under a deeper sedation. Currently, propofol is administered by anesthesiologists or nurse anaesthetists.
The SEDASYS™ System is a computer-assisted personalized sedation (CAPS) monitor that allows an endoscopist and nurse team to administer on-label, propofol sedation during colonoscopy and endoscopy procedures. The system delivers propofol to the patient following the endoscopist's instructions and closely monitors the patient to help assure that the level of sedation is appropriate - even more closely than a human. This 1,000 subject controlled, randomized, multi-center trial sought to test the safety and efficacy of this sedation method, as well as the benefits to both physicians and patients.
"A computer-assisted system of this type allows for sedation to be completely personalized to the patient, giving the physician greater, more precise control with improved safety," said Robert Hardi, MD, clinical faculty at George Washington University Hospital in Washington, DC. "The machine, which may have beneficial cost implications, also allows for a shorter recovery time."
The study found that physician and nurse teams were able to safely and effectively administer propofol sedation using the SEDASYS System during both colonoscopy and endoscopy procedures. In fact, patients who experienced SEDASYS sedation had significantly lower measure of cumulative oxygen desaturation (17.8 percent per second) compared to those who underwent traditional sedation (98.8 percent per second). Additionally, both patients and physicians were surveyed using a list of measures to determine the quality of their experience with their sedation and the procedure overall. Both the subjects treated with the SEDASYS System and particularly the physicians administering the procedure reported higher satisfaction with the sedation achieved with the SEDASYS System.
American College of Radiology (ACR) Recommendations for CT Colonography (CTC) Interpretation: Implications for Resection of High Risk Adenoma Findings (Abstract # 878)
The American College of Radiology (ACR) has released guidelines recommending that polyps < 5 mm in size not be reported on computed tomographic colonography (CTC) studies. As a result, investigators set out to determine the effect of the ACR guidelines by applying them to an endoscopic database that collected information about polyps that have been removed and processed.
The database results included information for 10,780 polyps that were removed from 5,079 patients (among 10,034 colonoscopies) over a five-year interval. These patients were then broken into two groups, those with low risk - whose findings included no more than one to two tubular adenomas (benign tumors) and who were recommended to go five to 10 years before receiving a follow-up colonoscopy - and those with high risk - whose findings include advanced adenoma or three or more adenomas of any size.
"Our findings suggest that because of the ACR's de-emphasis of small polyps, CTC may not identify enough patients with important polyp findings," said Douglas Rex, MD, Chancellors professor of medicine, Indiana University School of Medicine and director of endoscopy at Indiana University Hospital. "The full implications and impact of these findings on cancer prevention is not yet known, because the natural history of small adenomas is still not understood."
Researchers sought to determine how many patients would have been identified as high risk according to the post-polypectomy surveillance guidelines if they had undergone CTC as their initial diagnostic test instead of colonoscopy. In all, 5,079 patients (51 percent) had at least one polyp and 2,907 (29 percent) had at least one adenoma. More than 1,000 (10 percent) had high risk findings, including 421 patients (4.1 percent) with one adenoma that was >1 cm in size. Two hundred and ninety-three patients had > three adenomas Buy Prograf Without Prescription
"A significant percent of the population is not undergoing colorectal cancer screening, despite the fact that it has been proven to save lives," according to Sidney J. Winawer, MD, FASGE, AGAF, Paul Sherlock Chair, gastroenterology and nutrition service, Memorial Sloan-Kettering Cancer Center. "We hope that new research, such as that presented today, will encourage patients to get screened and to work with their doctors to discuss which screening methods may be best for them."
Colorectal cancer is the second leading cause of cancer deaths in the U.S. - more than 24,000 men and nearly 26,000 women die of the disease each year. However, colorectal cancer is curable when detected early. Screening rates for colorectal cancer in the U.S. lag far behind those for other cancers despite research showing that high mortality rates are lowered by detecting colorectal cancer at an early stage.
"The most common neoplastic outcome of colorectal cancer screening is the identification of polyps which require follow-up. Colorectal cancer is curable and preventable when polyps are found and removed early," said Dr. Winawer. "If physicians followed recommended screening guidelines, there would be more appropriate surveillance which would help shift resources to screening."
A Computer-Assisted Personalized Sedation System to Administer Propofol Versus Standard of Care Sedation for Colonoscopy and EGD: A 1000 Subject Randomized, Controlled, Multi-Center Pivotal Trial (Late Breaking Abstract)
During endoscopic procedures, patients are placed under moderate sedation, which allows them to undergo these procedures comfortably. Traditional sedation agents, such as midazolam, meperidine and fentanyl, are often administered by the endoscopy team during the procedure. Propofol is an alternative medication which takes effect quickly and allows for a quicker recovery period, but may place the patient under a deeper sedation. Currently, propofol is administered by anesthesiologists or nurse anaesthetists.
The SEDASYS™ System is a computer-assisted personalized sedation (CAPS) monitor that allows an endoscopist and nurse team to administer on-label, propofol sedation during colonoscopy and endoscopy procedures. The system delivers propofol to the patient following the endoscopist's instructions and closely monitors the patient to help assure that the level of sedation is appropriate - even more closely than a human. This 1,000 subject controlled, randomized, multi-center trial sought to test the safety and efficacy of this sedation method, as well as the benefits to both physicians and patients.
"A computer-assisted system of this type allows for sedation to be completely personalized to the patient, giving the physician greater, more precise control with improved safety," said Robert Hardi, MD, clinical faculty at George Washington University Hospital in Washington, DC. "The machine, which may have beneficial cost implications, also allows for a shorter recovery time."
The study found that physician and nurse teams were able to safely and effectively administer propofol sedation using the SEDASYS System during both colonoscopy and endoscopy procedures. In fact, patients who experienced SEDASYS sedation had significantly lower measure of cumulative oxygen desaturation (17.8 percent per second) compared to those who underwent traditional sedation (98.8 percent per second). Additionally, both patients and physicians were surveyed using a list of measures to determine the quality of their experience with their sedation and the procedure overall. Both the subjects treated with the SEDASYS System and particularly the physicians administering the procedure reported higher satisfaction with the sedation achieved with the SEDASYS System.
American College of Radiology (ACR) Recommendations for CT Colonography (CTC) Interpretation: Implications for Resection of High Risk Adenoma Findings (Abstract # 878)
The American College of Radiology (ACR) has released guidelines recommending that polyps < 5 mm in size not be reported on computed tomographic colonography (CTC) studies. As a result, investigators set out to determine the effect of the ACR guidelines by applying them to an endoscopic database that collected information about polyps that have been removed and processed.
The database results included information for 10,780 polyps that were removed from 5,079 patients (among 10,034 colonoscopies) over a five-year interval. These patients were then broken into two groups, those with low risk - whose findings included no more than one to two tubular adenomas (benign tumors) and who were recommended to go five to 10 years before receiving a follow-up colonoscopy - and those with high risk - whose findings include advanced adenoma or three or more adenomas of any size.
"Our findings suggest that because of the ACR's de-emphasis of small polyps, CTC may not identify enough patients with important polyp findings," said Douglas Rex, MD, Chancellors professor of medicine, Indiana University School of Medicine and director of endoscopy at Indiana University Hospital. "The full implications and impact of these findings on cancer prevention is not yet known, because the natural history of small adenomas is still not understood."
Researchers sought to determine how many patients would have been identified as high risk according to the post-polypectomy surveillance guidelines if they had undergone CTC as their initial diagnostic test instead of colonoscopy. In all, 5,079 patients (51 percent) had at least one polyp and 2,907 (29 percent) had at least one adenoma. More than 1,000 (10 percent) had high risk findings, including 421 patients (4.1 percent) with one adenoma that was >1 cm in size. Two hundred and ninety-three patients had > three adenomas Buy Prograf Without Prescription
Options For University Implementation Of NIH Policy Offered By New Whitepaper
SPARC (the Scholarly Publishing and Academic Resources Coalition), Science Commons, and the Association of Research Libraries (ARL) have jointly released a white paper to help university and medical school administrators ensure their institutions comply with public access requirements that are soon to be a condition of National Institutes of Health (NIH) funding.
Effective April 7, 2008, investigators must deposit articles stemming from NIH funding into the agency's PubMed Central online archive, to be made publicly available no later than 12 months after publication in a journal. Complying with the National Institutes of Health Public Access Policy: Copyright Considerations and Options will help provosts, research administrators, and campus counsel understand their institution's copyright-related obligations and options under the new Congressionally mandated policy, which was announced in January and replaces an earlier voluntary approach.
The timely analysis was prepared by Michael W. Carroll, an attorney, copyright expert, and faculty member at Villanova University law school. Carroll reviews the policy and its background, explains the legal context, and presents six alternative copyright management strategies that will help grantee institutions assure they reserve the necessary rights for articles to be made available in PubMed Central.
Carroll has been involved for several years in copyright issues as a member of the Creative Commons board and an advisor to Science Commons. In 2004 he worked with SPARC to develop the popular SPARC Author Addendum (arl/sparc/author/), which enables authors to reserve rights to deposit their works in open online archives.
"The benefits to biomedical research of the new NIH policy are ultimately nothing short of tremendous," said Heather Joseph, executive director of SPARC. "The sooner we can get effective implementing mechanisms in place, the sooner researchers, institutions, and the public can put PubMed Central to work. With April implementation drawing near, this paper will be a great tool to help administrators jumpstart the local planning process."
"Congress and the NIH recognize that the Internet makes a difference," said John Wilbanks, Vice President of Science Commons. "Faculty authors can no longer sign away their copyrights in a business-as-usual manner when doing so means that their work will never be openly accessible over the Internet. This white paper is a step in making sure authors and universities understand how to move forward with a solid legal footing."
Karla Hahn, Director of the ARL Office of Scholarly Communication, added, "The new NIH requirement should accelerate ongoing efforts to establish norms for authors to routinely retain rights to deposit works in local as well as national digital repositories. Carroll's much-needed analysis clarifies the new opportunities for institutions to develop strategic approaches to rights management issues."
Complying with the National Institutes of Health Public Access Policy: Copyright Considerations and Options is available free on the SPARC Web site at arl/sparc/advocacy/nih/copyright.html.
SPARC
SPARC (Scholarly Publishing and Academic Resources Coalition), with SPARC Europe and SPARC Japan, is an international alliance of more than 800 academic and research libraries working to create a more open system of scholarly communication. SPARC's advocacy, educational and publisher partnership programs encourage expanded dissemination of research. SPARC is on the Web at arl/sparc/.
Science Commons
Science Commons designs strategies and tools for faster, more efficient web-enabled scientific research. Science Commons identifies unnecessary barriers to research, crafts policy guidelines and legal agreements to lower those barriers, and develops technology to make research data and materials easier to find and use. The goal of Science Commons is to speed the translation of data into discovery and to unlock the value of research so more people can benefit from the work scientists are doing.
Association of Research Libraries
The Association of Research Libraries (ARL) is a nonprofit organization of 123 research libraries in North America. Its mission is to influence the changing environment of scholarly communication and the public policies that affect research libraries and the diverse communities they serve. ARL pursues this mission by advancing the goals of its member research libraries, providing leadership in public and information policy to the scholarly and higher education communities, fostering the exchange of ideas and expertise, and shaping a future environment that leverages its interests with those of allied organizations. ARL is located on the Web at arl/.
Source: Jennifer McLennan
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Effective April 7, 2008, investigators must deposit articles stemming from NIH funding into the agency's PubMed Central online archive, to be made publicly available no later than 12 months after publication in a journal. Complying with the National Institutes of Health Public Access Policy: Copyright Considerations and Options will help provosts, research administrators, and campus counsel understand their institution's copyright-related obligations and options under the new Congressionally mandated policy, which was announced in January and replaces an earlier voluntary approach.
The timely analysis was prepared by Michael W. Carroll, an attorney, copyright expert, and faculty member at Villanova University law school. Carroll reviews the policy and its background, explains the legal context, and presents six alternative copyright management strategies that will help grantee institutions assure they reserve the necessary rights for articles to be made available in PubMed Central.
Carroll has been involved for several years in copyright issues as a member of the Creative Commons board and an advisor to Science Commons. In 2004 he worked with SPARC to develop the popular SPARC Author Addendum (arl/sparc/author/), which enables authors to reserve rights to deposit their works in open online archives.
"The benefits to biomedical research of the new NIH policy are ultimately nothing short of tremendous," said Heather Joseph, executive director of SPARC. "The sooner we can get effective implementing mechanisms in place, the sooner researchers, institutions, and the public can put PubMed Central to work. With April implementation drawing near, this paper will be a great tool to help administrators jumpstart the local planning process."
"Congress and the NIH recognize that the Internet makes a difference," said John Wilbanks, Vice President of Science Commons. "Faculty authors can no longer sign away their copyrights in a business-as-usual manner when doing so means that their work will never be openly accessible over the Internet. This white paper is a step in making sure authors and universities understand how to move forward with a solid legal footing."
Karla Hahn, Director of the ARL Office of Scholarly Communication, added, "The new NIH requirement should accelerate ongoing efforts to establish norms for authors to routinely retain rights to deposit works in local as well as national digital repositories. Carroll's much-needed analysis clarifies the new opportunities for institutions to develop strategic approaches to rights management issues."
Complying with the National Institutes of Health Public Access Policy: Copyright Considerations and Options is available free on the SPARC Web site at arl/sparc/advocacy/nih/copyright.html.
SPARC
SPARC (Scholarly Publishing and Academic Resources Coalition), with SPARC Europe and SPARC Japan, is an international alliance of more than 800 academic and research libraries working to create a more open system of scholarly communication. SPARC's advocacy, educational and publisher partnership programs encourage expanded dissemination of research. SPARC is on the Web at arl/sparc/.
Science Commons
Science Commons designs strategies and tools for faster, more efficient web-enabled scientific research. Science Commons identifies unnecessary barriers to research, crafts policy guidelines and legal agreements to lower those barriers, and develops technology to make research data and materials easier to find and use. The goal of Science Commons is to speed the translation of data into discovery and to unlock the value of research so more people can benefit from the work scientists are doing.
Association of Research Libraries
The Association of Research Libraries (ARL) is a nonprofit organization of 123 research libraries in North America. Its mission is to influence the changing environment of scholarly communication and the public policies that affect research libraries and the diverse communities they serve. ARL pursues this mission by advancing the goals of its member research libraries, providing leadership in public and information policy to the scholarly and higher education communities, fostering the exchange of ideas and expertise, and shaping a future environment that leverages its interests with those of allied organizations. ARL is located on the Web at arl/.
Source: Jennifer McLennan
SPARC
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Skin Sterol Provides New Information About Heart Disease Risk
The ability to identify those at greatest risk for heart disease remains a significant public health challenge. The accumulation of sterol in the skin tissues, as measured by the PREVU* Point of Care Sterol Test, provides new information about a patient's risk of coronary artery disease (CAD), according to data presented yesterday at the annual Canadian Cardiovascular Congress. Additionally, skin sterol, specifically skin tissue cholesterol, measured non-invasively, may have value in stratifying patients with established CAD who have been treated with cholesterol-lowering medications.
"Our findings confirm previous clinical evidence that skin sterol provides new information about heart disease risk independent of blood cholesterol and other traditional risk factors," said Dr. Milan Gupta, Assistant Clinical Professor, Department of Medicine, McMaster University, in Hamilton, Ontario, and Cardiologist, Division of Cardiology, William Osler Health Centre, in Brampton, Ontario, principal investigator of the clinical trial. "Additionally, we have gained important new data about skin sterol levels in high-risk patients, particularly patients with a history of angina and diabetes."
The abstract presented at the conference, held in Calgary, Alberta, was Skin Tissue Cholesterol is Associated with Angina, Diabetes and History of Stroke/TIA in Subjects with Coronary Artery Disease, by Dr. Milan Gupta; Michelle Tsigoulis; and Michael Evelegh, PhD, of IMI International Medical Innovations
About the Study
Skin sterol was evaluated in 300 patients with proven CAD, 90% of whom were taking statins. Patients were examined at baseline and annual clinic visits as part of the PRACTICE clinical registry (Prospective Assessment of Cardiovascular Risk and Treatment in Canadians of Varying Ethnicity), which is ongoing. Other novel markers of risk measured in the study included hs-CRP, lipoprotein (a), apolipoprotein B and measures of insulin sensitivity.
Key findings of the study included:
пїЅ Skin sterol appears to provide new information about CAD risk;
пїЅ Skin sterol levels were elevated in high-risk subjects, demonstrating a positive correlation to angina (p=0.01) and diabetes (p=0.001) when adjusted for age and race;
пїЅ Serum, or blood, markers were not positively correlated with prior stroke, angina or diabetes; and
пїЅ Skin sterol values were higher in Caucasians than in non-Caucasians (p=0.002).
Previous studies of patients not taking cholesterol-lowering medications have shown that skin sterol and blood cholesterol are not correlated, but that there is a relationship between skin sterol and history of heart attacks, as well as a correlation to various markers of cardiovascular risk, including Framingham risk score, ICAM-1, coronary calcium, and coronary artery disease.
Skin sterol tests are marketed worldwide by McNeil Consumer Healthcare under the brand name PREVU* Skin Sterol Test and were developed by IMI International Medical Innovations Inc. (TSX:IMI; Amex: IME).
About PREVU*
PREVU* Point of Care Skin Sterol Test, which does not require fasting or the drawing of blood, tests the amount of sterol in the skin tissue. Clinical studies have shown that high levels of skin sterol are correlated with higher incidence of CAD as measured by angiography and Electron Beam Computed Tomography. PREVU* POC has been approved for sale in Canada, the U.S. and Europe.
About IMI
IMI is a world leader in predictive medicine, dedicated to developing rapid, non-invasive tests for the early detection of life-threatening diseases. IMI's head office is located in Toronto, and its research and product development facility is at McMaster University in Hamilton, Ontario. For further information, please visit imimedical.
About McNeil
McNeil Consumer Healthcare is a member of the Johnson & Johnson family of companies that manufactures and sells innovative health care and consumer products in Canada and around the world. McNeil's Canadian head office is located in Guelph, Ontario.
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"Our findings confirm previous clinical evidence that skin sterol provides new information about heart disease risk independent of blood cholesterol and other traditional risk factors," said Dr. Milan Gupta, Assistant Clinical Professor, Department of Medicine, McMaster University, in Hamilton, Ontario, and Cardiologist, Division of Cardiology, William Osler Health Centre, in Brampton, Ontario, principal investigator of the clinical trial. "Additionally, we have gained important new data about skin sterol levels in high-risk patients, particularly patients with a history of angina and diabetes."
The abstract presented at the conference, held in Calgary, Alberta, was Skin Tissue Cholesterol is Associated with Angina, Diabetes and History of Stroke/TIA in Subjects with Coronary Artery Disease, by Dr. Milan Gupta; Michelle Tsigoulis; and Michael Evelegh, PhD, of IMI International Medical Innovations
About the Study
Skin sterol was evaluated in 300 patients with proven CAD, 90% of whom were taking statins. Patients were examined at baseline and annual clinic visits as part of the PRACTICE clinical registry (Prospective Assessment of Cardiovascular Risk and Treatment in Canadians of Varying Ethnicity), which is ongoing. Other novel markers of risk measured in the study included hs-CRP, lipoprotein (a), apolipoprotein B and measures of insulin sensitivity.
Key findings of the study included:
пїЅ Skin sterol appears to provide new information about CAD risk;
пїЅ Skin sterol levels were elevated in high-risk subjects, demonstrating a positive correlation to angina (p=0.01) and diabetes (p=0.001) when adjusted for age and race;
пїЅ Serum, or blood, markers were not positively correlated with prior stroke, angina or diabetes; and
пїЅ Skin sterol values were higher in Caucasians than in non-Caucasians (p=0.002).
Previous studies of patients not taking cholesterol-lowering medications have shown that skin sterol and blood cholesterol are not correlated, but that there is a relationship between skin sterol and history of heart attacks, as well as a correlation to various markers of cardiovascular risk, including Framingham risk score, ICAM-1, coronary calcium, and coronary artery disease.
Skin sterol tests are marketed worldwide by McNeil Consumer Healthcare under the brand name PREVU* Skin Sterol Test and were developed by IMI International Medical Innovations Inc. (TSX:IMI; Amex: IME).
About PREVU*
PREVU* Point of Care Skin Sterol Test, which does not require fasting or the drawing of blood, tests the amount of sterol in the skin tissue. Clinical studies have shown that high levels of skin sterol are correlated with higher incidence of CAD as measured by angiography and Electron Beam Computed Tomography. PREVU* POC has been approved for sale in Canada, the U.S. and Europe.
About IMI
IMI is a world leader in predictive medicine, dedicated to developing rapid, non-invasive tests for the early detection of life-threatening diseases. IMI's head office is located in Toronto, and its research and product development facility is at McMaster University in Hamilton, Ontario. For further information, please visit imimedical.
About McNeil
McNeil Consumer Healthcare is a member of the Johnson & Johnson family of companies that manufactures and sells innovative health care and consumer products in Canada and around the world. McNeil's Canadian head office is located in Guelph, Ontario.
Contact: Tracy Krughoff
tkrughoffenvironics-usa
2022962002 - 102
eci.environics
Buy Truvada Without Prescription
Young Boys' Academic Functioning May Be Adversely Affected By Video-Game Ownership
Parents of young boys may want to encourage moderation when it comes to their kids' video game habits. According to new findings in Psychological Science, a journal of the Association for Psychological Science, owning a video-game system may hamper academic development in some children.
Psychological scientists Robert Weis and Brittany C. Cerankosky of Denison University conducted a study examining short-term effects of video-game ownership on academic development in young boys. Families with boys between the ages of 6 to 9 were recruited for this study. The families did not own video-game systems, but the parents had been considering buying one for their kids. The children completed intelligence tests as well as reading and writing assessments. In addition, the boys' parents and teachers filled out questionnaires relating to their behavior at home and at school. Half of the families were selected to receive a video-game system (along with three, age-appropriate video games) immediately, while the remaining families were promised a video-game system four months later, at the end of the experiment. Over the course of the four months, the parents recorded their children's activities from the end of the school day until bedtime. At the four-month time point, the children repeated the reading and writing assessments and parents and teachers again completed the behavioral questionnaires.
The results of this study showed that the boys who received the video-game system immediately spent more time playing video games and less time engaged in after-school academic activities than boys who received the video-game system at the end of the experiment. Furthermore, the boys who received the video-game system at the beginning of the study had significantly lower reading and writing scores four months later compared with the boys receiving the video-game system later on. Although there were no differences in parent-reported behavioral problems between the two groups of kids, the boys who received the video-game system immediately had greater teacher-reported learning problems.
Further analysis revealed that the time spent playing video games may link the relationship between owning a video-game system and reading and writing scores. These findings suggest that video games may be displacing after-school academic activities and may impede reading and writing development in young boys. The authors note that when children have problems with language at this young age, they tend to have a tougher time acquiring advanced reading and writing skills later on. They conclude, "Altogether, our findings suggest that video-game ownership may impair academic achievement for some boys in a manner that has real-world significance."
Source:
Barbara Isanski
Association for Psychological Science
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Psychological scientists Robert Weis and Brittany C. Cerankosky of Denison University conducted a study examining short-term effects of video-game ownership on academic development in young boys. Families with boys between the ages of 6 to 9 were recruited for this study. The families did not own video-game systems, but the parents had been considering buying one for their kids. The children completed intelligence tests as well as reading and writing assessments. In addition, the boys' parents and teachers filled out questionnaires relating to their behavior at home and at school. Half of the families were selected to receive a video-game system (along with three, age-appropriate video games) immediately, while the remaining families were promised a video-game system four months later, at the end of the experiment. Over the course of the four months, the parents recorded their children's activities from the end of the school day until bedtime. At the four-month time point, the children repeated the reading and writing assessments and parents and teachers again completed the behavioral questionnaires.
The results of this study showed that the boys who received the video-game system immediately spent more time playing video games and less time engaged in after-school academic activities than boys who received the video-game system at the end of the experiment. Furthermore, the boys who received the video-game system at the beginning of the study had significantly lower reading and writing scores four months later compared with the boys receiving the video-game system later on. Although there were no differences in parent-reported behavioral problems between the two groups of kids, the boys who received the video-game system immediately had greater teacher-reported learning problems.
Further analysis revealed that the time spent playing video games may link the relationship between owning a video-game system and reading and writing scores. These findings suggest that video games may be displacing after-school academic activities and may impede reading and writing development in young boys. The authors note that when children have problems with language at this young age, they tend to have a tougher time acquiring advanced reading and writing skills later on. They conclude, "Altogether, our findings suggest that video-game ownership may impair academic achievement for some boys in a manner that has real-world significance."
Source:
Barbara Isanski
Association for Psychological Science
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Why HIV Progresses Faster In Women Than In Men With Same Viral Load
One of the continuing mysteries of the HIV/AIDS epidemic is why women usually develop lower viral levels than men following acute HIV-1 infection but progress faster to AIDS than men with similar viral loads. Now a research team based at the Ragon Institute of Massachusetts General Hospital (MGH), MIT and Harvard has found that a receptor molecule involved in the first-line recognition of HIV-1 responds to the virus differently in women, leading to subsequent differences in chronic T cell activation, a known predictor of disease progression. Their paper, which will be published in an upcoming issue of Nature Medicine, is receiving early online release.
"This study may help to account for reported gender differences in HIV-1 disease progression by demonstrating that women and men differ in the way their immune systems respond to the virus," says Marcus Altfeld, MD, PhD, of the Ragon Institute and the MGH Division of Infectious Disease, the study's senior author. "Focusing on immune activation separately from viral replication might give us new therapeutic approaches to limiting HIV-1-induced pathology."
It has become apparent in recent years that HIV-1-infected patients with a high level of immune activation progress to AIDS more rapidly. Why this happens is an area of intense investigation. To explore whether gender-based differences in immune activation were responsible for faster disease progression in women, the Ragon Institute team and their collaborators focused on plasmacytoid dendritic cells (pDCs), among the first cells of the immune system to respond to HIV-1 and other viral pathogens. Earlier studies indicated that pDCs recognize HIV-1 using a receptor called Toll-like receptor 7 (TLR7), leading to production of interferon-alpha and other important immune system molecules.
After initial in vitro experiments showed that a higher percentage of pDCs from uninfected women produced interferon-alpha in response to TLR7 stimulation by HIV-1 than did cells from uninfected men, the researchers examined whether women's hormone levels had any effect on pDC activation. Supporting previous evidence that progesterone may modulate pDC activity, the researchers found that pDCs from postmenopausal women produced levels of interferon-alpha in response to HIV-1 that were closer to levels observed in men. They also found that, in premenopausal women, higher progesterone levels correlated with increased activation of pDCs in response to HIV-1.
Since it is known that the activation of T cells predicts the progression of HIV-1 infection to AIDS, the research team conducted a series of in vitro experiments showing that the stimulation of pDCs in response to HIV-1 led to the subsequent activation of CD8+ T cells by means of interferon-alpha secretion. They then tested blood samples taken from a group of chronically HIV-1-infected women and men prior to treatment initiation and confirmed that women had higher levels of CD8+ T cell activation than did men with the same blood levels of HIV-1.
"Taken together, these results support a model in which the same amount of virus induces stronger pDC activation in women than in men. While stronger activation of the immune system might be beneficial in the early stages of infection, resulting in lower levels of HIV-1 replication, persistent viral replication and stronger chronic immune activation can lead to the faster progression to AIDS that has been seen in women," Altfeld explains.
He adds that the study's results raise a number of important new questions, including exactly how sex hormones modulate the TLR7-mediated response of pDCs to HIV-1 and whether anti-TLR agents may help reduce immune activation in chronic HIV-1 infection. His team is beginning preliminary laboratory studies of the ability of TLR antagonists to reduce HIV-1-induced activation of pDCs.
Notes:
Altfeld is an associate professor of Medicine at Harvard Medical School and director of the Innate Immunity Program at the Ragon Institute of MGH, MIT and Harvard. Co-lead authors of the Nature Medicine paper are Angela Meier, MD, PhD, and J. Judy Chang, PhD, of the Ragon Institute. Additional co-authors are Harlyn Sidhu, Tom Fang Wen, Robert Lindsay, Suzane Bazner, Hendrik Streeck, MD, and Galit Alter, PhD, Ragon Institute; Gregory Robbins, MD, MGH Division of Infectious Diseases; Ronald Bosch, PhD, Ellen Chan, PhD, and Liliana Orellana, Harvard School of Public Health; Richard Pollard, MD, University of California at Davis Medical Center; Smita Kulkarni, PhD, Jeffrey Lifson, MD, and Mary Carrington, PhD, National Cancer Institute; and Donna Mildvan, MD, Beth Israel Medical Center, New York. The study was supported by grants from the National Institute of Allergy and Infectious Diseases, the Harvard Center for AIDS Research, the Bill & Melinda Gates Foundation, the Doris Duke Charitable Foundation, and the National Cancer Institute.
Source:
Sue McGreevey
Massachusetts General Hospital
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"This study may help to account for reported gender differences in HIV-1 disease progression by demonstrating that women and men differ in the way their immune systems respond to the virus," says Marcus Altfeld, MD, PhD, of the Ragon Institute and the MGH Division of Infectious Disease, the study's senior author. "Focusing on immune activation separately from viral replication might give us new therapeutic approaches to limiting HIV-1-induced pathology."
It has become apparent in recent years that HIV-1-infected patients with a high level of immune activation progress to AIDS more rapidly. Why this happens is an area of intense investigation. To explore whether gender-based differences in immune activation were responsible for faster disease progression in women, the Ragon Institute team and their collaborators focused on plasmacytoid dendritic cells (pDCs), among the first cells of the immune system to respond to HIV-1 and other viral pathogens. Earlier studies indicated that pDCs recognize HIV-1 using a receptor called Toll-like receptor 7 (TLR7), leading to production of interferon-alpha and other important immune system molecules.
After initial in vitro experiments showed that a higher percentage of pDCs from uninfected women produced interferon-alpha in response to TLR7 stimulation by HIV-1 than did cells from uninfected men, the researchers examined whether women's hormone levels had any effect on pDC activation. Supporting previous evidence that progesterone may modulate pDC activity, the researchers found that pDCs from postmenopausal women produced levels of interferon-alpha in response to HIV-1 that were closer to levels observed in men. They also found that, in premenopausal women, higher progesterone levels correlated with increased activation of pDCs in response to HIV-1.
Since it is known that the activation of T cells predicts the progression of HIV-1 infection to AIDS, the research team conducted a series of in vitro experiments showing that the stimulation of pDCs in response to HIV-1 led to the subsequent activation of CD8+ T cells by means of interferon-alpha secretion. They then tested blood samples taken from a group of chronically HIV-1-infected women and men prior to treatment initiation and confirmed that women had higher levels of CD8+ T cell activation than did men with the same blood levels of HIV-1.
"Taken together, these results support a model in which the same amount of virus induces stronger pDC activation in women than in men. While stronger activation of the immune system might be beneficial in the early stages of infection, resulting in lower levels of HIV-1 replication, persistent viral replication and stronger chronic immune activation can lead to the faster progression to AIDS that has been seen in women," Altfeld explains.
He adds that the study's results raise a number of important new questions, including exactly how sex hormones modulate the TLR7-mediated response of pDCs to HIV-1 and whether anti-TLR agents may help reduce immune activation in chronic HIV-1 infection. His team is beginning preliminary laboratory studies of the ability of TLR antagonists to reduce HIV-1-induced activation of pDCs.
Notes:
Altfeld is an associate professor of Medicine at Harvard Medical School and director of the Innate Immunity Program at the Ragon Institute of MGH, MIT and Harvard. Co-lead authors of the Nature Medicine paper are Angela Meier, MD, PhD, and J. Judy Chang, PhD, of the Ragon Institute. Additional co-authors are Harlyn Sidhu, Tom Fang Wen, Robert Lindsay, Suzane Bazner, Hendrik Streeck, MD, and Galit Alter, PhD, Ragon Institute; Gregory Robbins, MD, MGH Division of Infectious Diseases; Ronald Bosch, PhD, Ellen Chan, PhD, and Liliana Orellana, Harvard School of Public Health; Richard Pollard, MD, University of California at Davis Medical Center; Smita Kulkarni, PhD, Jeffrey Lifson, MD, and Mary Carrington, PhD, National Cancer Institute; and Donna Mildvan, MD, Beth Israel Medical Center, New York. The study was supported by grants from the National Institute of Allergy and Infectious Diseases, the Harvard Center for AIDS Research, the Bill & Melinda Gates Foundation, the Doris Duke Charitable Foundation, and the National Cancer Institute.
Source:
Sue McGreevey
Massachusetts General Hospital
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Bringing Hope To Angolan Children: Mass Health Campaign Begins To Help 3.5 Million
The government of Angola, and its
partners in the Measles Initiative, the Global Fund on AIDS, Tuberculosis
and Malaria, and the U.S. President's Malaria Initiative are launching a
major health campaign to provide life-saving interventions for Angolan
children. The integrated campaign is targeting more than 3.5 million
children with measles and polio vaccinations, vitamin A, de-worming
medication, and, in seven provinces, long-lasting insecticide treated nets
(LLIN's). The campaign begins on July 12 in Luanda, with an official launch
event on July 13 in Mbaza Congo.
This campaign is a follow-up to a previous measles campaign in 2003,
which reached 96 percent of the targeted group. The current campaign
demonstrates the importance of follow-up immunization activities in a
country where only 64 percent of children receive routine measles
immunizations. As a part of the Angolan government's Maternal and Child
Health Mortality Reduction Program, the campaign will focus on vulnerable
children, especially those in border regions where there has been a
re-emergence of measles outbreaks.
"The number of reported measles cases declined dramatically after the
successful 2003 campaign," says Angela Kearney, a representative of UNICEF
Angola, "but routine coverage still requires strengthening in many
provinces."
Drawing on the successful experience in 2003, additional life-saving
health interventions will be integrated into the upcoming measles campaign.
Approximately 800,000 insecticide treated nets will be distributed across
seven provinces where malaria transmission rates are highest. Insecticide
treated nets are proven to be one of the most effective methods for
preventing malaria, a leading cause of death and disability for children in
Angola. Children under age five will also receive polio vaccinations,
vitamin A and de-worming medication.
The integrated campaign will be carried out with support from the
Measles Initiative, a partnership formed to reduce measles deaths in
sub-Saharan Africa that is led by the American Red Cross, United Nations
Foundation, World Health Organization (WHO), United Nations Children's Fund
(UNICEF) and U.S. Centers for Disease Control and Prevention (CDC).
Additional supporters in this campaign include: USAID, the U.S.
President's Malaria Initiative, the Global Fund, CORE, the governments of
Japan and Norway, CIDA, Rotary International and DFID. ExxonMobil
contributed financial resources and will provide approximately 70,000
LLIN's to protect children against malaria.
Since 2001, the Measles Initiative has vaccinated more than 213 million
children in more than 40 African countries, saving approximately 1.2
million lives. Through the financial and technical support of the Measles
Initiative and the commitment of African governments, measles deaths in
Africa have fallen 60 percent between 1999 and 2004. This decline
represents significant progress toward the overall goal of reducing measles
deaths worldwide by 90 percent by 2010.
Background:
The Measles Initiative, launched in 2001, is a long-term commitment and
partnership among leaders in public health and supports the goal of
reducing measles deaths globally by 90 percent by 2010 compared to 2000.
Measles Initiative partners include the American Red Cross, United Nations
Foundation, CDC, WHO and UNICEF.
Largely due to the technical and financial support of the Measles
Initiative and the commitment from African governments, more than 200
million children have been vaccinated against measles and an estimated 1.2
million lives have been saved since 2001. Building on this achievement, in
2005, the Initiative has expanded its technical and financial support to
countries in Asia, where total measles deaths are highest outside of
sub-Saharan Africa.
The Initiative will also continue to carry out integrated campaigns in
which health workers provide not only measles vaccines, but also other
interventions such as insecticide-treated nets for malaria prevention,
vitamin A, de-worming medication and polio vaccines.
Since 2001, the Measles Initiative has mobilized more than $200 million
and supported more than 40 African countries and three Asian countries to
implement high-quality measles vaccination campaigns. As a result of these
campaigns, as well as improvements in routine immunization activities,
global measles deaths have dropped by 48 percent from 871,000 in 1999 to an
estimated 454,000 in 2004. The largest reduction occurred in Africa, the
region with the highest burden of disease, where estimated measles cases
and deaths dropped by 60 percent.
Supporters of the Measles Initiative also include: the Global Alliance
for Vaccines and Immunization (GAVI Alliance), The Bill and Melinda Gates
Foundation, Vodafone Group Foundation, Canadian International Development
Agency (CIDA), Japanese International Agency for Cooperation (JICA),
Department for International Development of the United Kingdom (DFID),
International Federation of Red Cross and Red Crescent Societies
(Federation), the Church of Jesus Christ of Latter-Day Saints, Izumi
Foundation, Becton, Dickinson and Company, and governments.
Measles is one of the leading vaccine-preventable childhood killers in
the world. In 2004, it was estimated that there were 454,000 measles deaths
globally -- this translates to more than 1,200 deaths every day or 50 every
hour. The overwhelming majority of these deaths, that is 410,000 out of
454,000, are children under the age of five.
A safe and highly effective vaccine has been available for more than 40
years and costs less than US $1, making measles vaccinations one of the
most cost-effective public health interventions available for preventing
deaths. Despite this, millions of children remain at risk.
For more information about the Measles Initiative, log on to
measlesinitiative. To make a financial contribution, call
1-800 RED CROSS or to make a secure online donation, log on to
measlesinitiative.
American Red Cross
measlesinitiative
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partners in the Measles Initiative, the Global Fund on AIDS, Tuberculosis
and Malaria, and the U.S. President's Malaria Initiative are launching a
major health campaign to provide life-saving interventions for Angolan
children. The integrated campaign is targeting more than 3.5 million
children with measles and polio vaccinations, vitamin A, de-worming
medication, and, in seven provinces, long-lasting insecticide treated nets
(LLIN's). The campaign begins on July 12 in Luanda, with an official launch
event on July 13 in Mbaza Congo.
This campaign is a follow-up to a previous measles campaign in 2003,
which reached 96 percent of the targeted group. The current campaign
demonstrates the importance of follow-up immunization activities in a
country where only 64 percent of children receive routine measles
immunizations. As a part of the Angolan government's Maternal and Child
Health Mortality Reduction Program, the campaign will focus on vulnerable
children, especially those in border regions where there has been a
re-emergence of measles outbreaks.
"The number of reported measles cases declined dramatically after the
successful 2003 campaign," says Angela Kearney, a representative of UNICEF
Angola, "but routine coverage still requires strengthening in many
provinces."
Drawing on the successful experience in 2003, additional life-saving
health interventions will be integrated into the upcoming measles campaign.
Approximately 800,000 insecticide treated nets will be distributed across
seven provinces where malaria transmission rates are highest. Insecticide
treated nets are proven to be one of the most effective methods for
preventing malaria, a leading cause of death and disability for children in
Angola. Children under age five will also receive polio vaccinations,
vitamin A and de-worming medication.
The integrated campaign will be carried out with support from the
Measles Initiative, a partnership formed to reduce measles deaths in
sub-Saharan Africa that is led by the American Red Cross, United Nations
Foundation, World Health Organization (WHO), United Nations Children's Fund
(UNICEF) and U.S. Centers for Disease Control and Prevention (CDC).
Additional supporters in this campaign include: USAID, the U.S.
President's Malaria Initiative, the Global Fund, CORE, the governments of
Japan and Norway, CIDA, Rotary International and DFID. ExxonMobil
contributed financial resources and will provide approximately 70,000
LLIN's to protect children against malaria.
Since 2001, the Measles Initiative has vaccinated more than 213 million
children in more than 40 African countries, saving approximately 1.2
million lives. Through the financial and technical support of the Measles
Initiative and the commitment of African governments, measles deaths in
Africa have fallen 60 percent between 1999 and 2004. This decline
represents significant progress toward the overall goal of reducing measles
deaths worldwide by 90 percent by 2010.
Background:
The Measles Initiative, launched in 2001, is a long-term commitment and
partnership among leaders in public health and supports the goal of
reducing measles deaths globally by 90 percent by 2010 compared to 2000.
Measles Initiative partners include the American Red Cross, United Nations
Foundation, CDC, WHO and UNICEF.
Largely due to the technical and financial support of the Measles
Initiative and the commitment from African governments, more than 200
million children have been vaccinated against measles and an estimated 1.2
million lives have been saved since 2001. Building on this achievement, in
2005, the Initiative has expanded its technical and financial support to
countries in Asia, where total measles deaths are highest outside of
sub-Saharan Africa.
The Initiative will also continue to carry out integrated campaigns in
which health workers provide not only measles vaccines, but also other
interventions such as insecticide-treated nets for malaria prevention,
vitamin A, de-worming medication and polio vaccines.
Since 2001, the Measles Initiative has mobilized more than $200 million
and supported more than 40 African countries and three Asian countries to
implement high-quality measles vaccination campaigns. As a result of these
campaigns, as well as improvements in routine immunization activities,
global measles deaths have dropped by 48 percent from 871,000 in 1999 to an
estimated 454,000 in 2004. The largest reduction occurred in Africa, the
region with the highest burden of disease, where estimated measles cases
and deaths dropped by 60 percent.
Supporters of the Measles Initiative also include: the Global Alliance
for Vaccines and Immunization (GAVI Alliance), The Bill and Melinda Gates
Foundation, Vodafone Group Foundation, Canadian International Development
Agency (CIDA), Japanese International Agency for Cooperation (JICA),
Department for International Development of the United Kingdom (DFID),
International Federation of Red Cross and Red Crescent Societies
(Federation), the Church of Jesus Christ of Latter-Day Saints, Izumi
Foundation, Becton, Dickinson and Company, and governments.
Measles is one of the leading vaccine-preventable childhood killers in
the world. In 2004, it was estimated that there were 454,000 measles deaths
globally -- this translates to more than 1,200 deaths every day or 50 every
hour. The overwhelming majority of these deaths, that is 410,000 out of
454,000, are children under the age of five.
A safe and highly effective vaccine has been available for more than 40
years and costs less than US $1, making measles vaccinations one of the
most cost-effective public health interventions available for preventing
deaths. Despite this, millions of children remain at risk.
For more information about the Measles Initiative, log on to
measlesinitiative. To make a financial contribution, call
1-800 RED CROSS or to make a secure online donation, log on to
measlesinitiative.
American Red Cross
measlesinitiative
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Improper Use Of High-decibel Holiday Toys May Hurt Children's Hearing, UC-Irvine Researchers Advise
The High School Musical Rockerz Jammin Guitar and the Cheetah Girls In Concert Collection Doll may be what kids want most this holiday season, but if parents aren't careful about how these and other popular toys are used, a season of joy might turn into a lifetime of hearing loss for their children.
In measuring the loudness of many desired toys, University of California, Irvine researchers warn that many emit sounds at decibel levels high enough to cause permanent hearing damage if not used properly. The researchers tested the loudness of popular toys and found that a number of them reach decibel levels of 100 or more, equivalent to the sound of a power saw, subway train or power mower.
This doesn't make these toys unsafe, they say.
"All the toys we tested are safe when used as they are designed," said Jeff Carroll, gradate researcher in biomedical engineering who tested 17 toys. "But kids don't always use toys as they were designed, and some of their sound levels can be dangerous. So it's advisable for parents to offer greater guidance for their proper and safe use."
The High School Musical Rockerz Jammin Guitar, which is recommended for children age 3 and up, topped the list at 106 decibels, followed by the Cheetah Girls In Concert Collection Doll (104 decibels), Hannah Montana In Concert Collection Doll (103 decibels), VTech V.Smile Baby (103 decibels), CAT Motorized Dump Truck (102 decibels) and Tickle Me Elmo (100 decibels). Sound levels were measured approximately one inch from the speaker on each device, much closer than they should be used.
According to Occupational Safety and Health Administration (OSHA) and the National Institute of Occupational Safety and Health (NIOSH), prolonged exposure to loud sound can cause permanent hearing damage. For comparison, OSHA notes that it's safe to listen to a 100 decibel sound for up to two hours a day, while NIOSH recommends less than 10 minutes daily for the same sound.
Because prolonged exposure to high decibel sound is damaging, the researchers say, it's important to make sure children keep the toy or device at a reasonable distance from their ears. While the toy may emit a 100-plus decibel sound from its speaker, the sound level can drop considerably a few feet away, making the toy safer to use for a longer period of time.
Personal media devices such as iPods and MP3 players also have the potential to inflict lifelong harm. Professor Fan-Gang Zeng, research director in the Department of Otolaryngology, advises parents to help their children understand volume controls on their new devices, because hearing damage is irreversible. A general guideline he suggests: The louder it is, the shorter the time you use it.
"Children are very sensitive to toys and other devices that emit loud and high pitch sounds or that rely on earphones. The hearing loss from noise damage is permanent and currently is not curable," adds Dr. Hamid Djalilian, an assistant professor of otolaryngology who treats and studies hearing disorders.
The study was a joint venture between the Center for Hearing Research and the Lions Club at UC Irvine.
Toys Sampled: Decibel Level
High School Musical Rockerz Jammin Guitar: 106
Cheetah Girls - In Concert Collection Doll: 104
Hannah Montana - In Concert Collection Doll: 103
VTech V.Smile Baby: 103
CAT Motorized Dump Truck: 102
Tickle Me Elmo: 100
Transformers Trans-portable Activity Center: 99
Tonka Lights and Sounds Hummer: 97
Bob the Builder Deluxe Talking Tool Belt: 96
Bosch Toy Chainsaw: 95
Tickle Me Cookie Monster: 94
Little People Dump Truck: 92
Cabbage Patch Kids Babies: 91
Leap Frog Learning Lily: 90
Tickle Me Ernie: 90
Playskool Gloworm: 85
Little People School Bus: 80
About the University of California, Irvine: The University of California, Irvine is a top-ranked university dedicated to research, scholarship and community service. Founded in 1965, UCI is among the fastest-growing University of California campuses, with more than 27,000 undergraduate and graduate students and about 1,800 faculty members. The second-largest employer in dynamic Orange County, UCI contributes an annual economic impact of $3.7 billion. For more UCI news, visit today.uci.edu.
For UCI breaking news, visit zotwire.uci.edu/.
Source:
Tom Vasich
University of California - Irvine
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In measuring the loudness of many desired toys, University of California, Irvine researchers warn that many emit sounds at decibel levels high enough to cause permanent hearing damage if not used properly. The researchers tested the loudness of popular toys and found that a number of them reach decibel levels of 100 or more, equivalent to the sound of a power saw, subway train or power mower.
This doesn't make these toys unsafe, they say.
"All the toys we tested are safe when used as they are designed," said Jeff Carroll, gradate researcher in biomedical engineering who tested 17 toys. "But kids don't always use toys as they were designed, and some of their sound levels can be dangerous. So it's advisable for parents to offer greater guidance for their proper and safe use."
The High School Musical Rockerz Jammin Guitar, which is recommended for children age 3 and up, topped the list at 106 decibels, followed by the Cheetah Girls In Concert Collection Doll (104 decibels), Hannah Montana In Concert Collection Doll (103 decibels), VTech V.Smile Baby (103 decibels), CAT Motorized Dump Truck (102 decibels) and Tickle Me Elmo (100 decibels). Sound levels were measured approximately one inch from the speaker on each device, much closer than they should be used.
According to Occupational Safety and Health Administration (OSHA) and the National Institute of Occupational Safety and Health (NIOSH), prolonged exposure to loud sound can cause permanent hearing damage. For comparison, OSHA notes that it's safe to listen to a 100 decibel sound for up to two hours a day, while NIOSH recommends less than 10 minutes daily for the same sound.
Because prolonged exposure to high decibel sound is damaging, the researchers say, it's important to make sure children keep the toy or device at a reasonable distance from their ears. While the toy may emit a 100-plus decibel sound from its speaker, the sound level can drop considerably a few feet away, making the toy safer to use for a longer period of time.
Personal media devices such as iPods and MP3 players also have the potential to inflict lifelong harm. Professor Fan-Gang Zeng, research director in the Department of Otolaryngology, advises parents to help their children understand volume controls on their new devices, because hearing damage is irreversible. A general guideline he suggests: The louder it is, the shorter the time you use it.
"Children are very sensitive to toys and other devices that emit loud and high pitch sounds or that rely on earphones. The hearing loss from noise damage is permanent and currently is not curable," adds Dr. Hamid Djalilian, an assistant professor of otolaryngology who treats and studies hearing disorders.
The study was a joint venture between the Center for Hearing Research and the Lions Club at UC Irvine.
Toys Sampled: Decibel Level
High School Musical Rockerz Jammin Guitar: 106
Cheetah Girls - In Concert Collection Doll: 104
Hannah Montana - In Concert Collection Doll: 103
VTech V.Smile Baby: 103
CAT Motorized Dump Truck: 102
Tickle Me Elmo: 100
Transformers Trans-portable Activity Center: 99
Tonka Lights and Sounds Hummer: 97
Bob the Builder Deluxe Talking Tool Belt: 96
Bosch Toy Chainsaw: 95
Tickle Me Cookie Monster: 94
Little People Dump Truck: 92
Cabbage Patch Kids Babies: 91
Leap Frog Learning Lily: 90
Tickle Me Ernie: 90
Playskool Gloworm: 85
Little People School Bus: 80
About the University of California, Irvine: The University of California, Irvine is a top-ranked university dedicated to research, scholarship and community service. Founded in 1965, UCI is among the fastest-growing University of California campuses, with more than 27,000 undergraduate and graduate students and about 1,800 faculty members. The second-largest employer in dynamic Orange County, UCI contributes an annual economic impact of $3.7 billion. For more UCI news, visit today.uci.edu.
For UCI breaking news, visit zotwire.uci.edu/.
Source:
Tom Vasich
University of California - Irvine
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ROCHE, Baylor Research Institute Partner In Human Immunology Research
Baylor Research Institute (BRI), the research arm of Baylor Health Care System, announced that it has formed a three-year partnership with Roche (SIX: RO, ROG; OTCQX: RHHBY) to jointly develop programs emerging from the human immunology platforms developed at the Baylor Institute for Immunology Research (BIIR), a component of BRI.
These programs will leverage BIIR's leading position in human immunology with particular focus on cancer vaccines, auto-immune disease diagnostics and treatment, proprietary platforms in biosignature and antibody development, with a view at identifying new leads that could be in-licensed by Roche. A Joint Research Committee will determine the most promising projects in that context, to be funded by Roche over a three-year period.
BRI will retain sole responsibility for programs outside the jointly developed projects.
"The worldwide reputation in human immunology established by Jacques Banchereau and his team over the years and the uniqueness of some of their programs clearly fit Roche's strategic discovery plans for novel approaches in diagnosing and treating diseases where our company wants to expand its franchise," said Jean-Jacques Garaud, MD., Head of Roche Pharma Research & Early Development (pRED).
1. A biosignature is a set of biological markers (DNA, mRNA, protein, metabolites, etc.), or biomarkers, that collectively reflects a biological state. A biosignature can: (1) show whether or not a person is healthy, (2) enable diagnosis and prognosis, and (3) show whether a therapy is safe and effective.
2. Jacques Banchereau is Senior Vice President, Head of the Inflammation and Virology Discovery and Translational Areas and Chief Scientific Officer at Roche (formerly the Director at BIIR).
Source:
Baylor Research Institute
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These programs will leverage BIIR's leading position in human immunology with particular focus on cancer vaccines, auto-immune disease diagnostics and treatment, proprietary platforms in biosignature and antibody development, with a view at identifying new leads that could be in-licensed by Roche. A Joint Research Committee will determine the most promising projects in that context, to be funded by Roche over a three-year period.
BRI will retain sole responsibility for programs outside the jointly developed projects.
"The worldwide reputation in human immunology established by Jacques Banchereau and his team over the years and the uniqueness of some of their programs clearly fit Roche's strategic discovery plans for novel approaches in diagnosing and treating diseases where our company wants to expand its franchise," said Jean-Jacques Garaud, MD., Head of Roche Pharma Research & Early Development (pRED).
1. A biosignature is a set of biological markers (DNA, mRNA, protein, metabolites, etc.), or biomarkers, that collectively reflects a biological state. A biosignature can: (1) show whether or not a person is healthy, (2) enable diagnosis and prognosis, and (3) show whether a therapy is safe and effective.
2. Jacques Banchereau is Senior Vice President, Head of the Inflammation and Virology Discovery and Translational Areas and Chief Scientific Officer at Roche (formerly the Director at BIIR).
Source:
Baylor Research Institute
Buy Chloramphenicol Without Prescription
Migraines During Pregnancy Linked To Stroke And Other Vascular Diseases
Migraines during pregnancy are strongly linked to vascular diseases, such as stroke and heart disease, according to research that will be presented at the American Academy of Neurology's 59th Annual Meeting in Boston, April 28 May 5, 2007.
Researchers looked at a national database of nearly 17 million women discharged for pregnancy deliveries from 2000-2003. A total of 33,956 of the women were treated for migraines.
The study found women treated for migraines during pregnancy were 19 times more likely to suffer a stroke, five times more likely to have a heart attack and more than twice as likely to have heart disease, blood clots and other vascular problems.
"Women with persistent migraine during pregnancy should be aware of their risk factors, such as high blood pressure, high cholesterol, diabetes, history of blood clots, heart disease, and prior stroke," said study author Cheryl Bushnell, MD, with Duke University in Durham, NC, and Fellow of the American Academy of Neurology. Bushnell says there also seems to be a connection between migraines and preeclampsia, the most common and dangerous complication of pregnancy. "Good prenatal care is essential," she adds.
The study also found a link between migraines and the age of the mother. Women who were 35 or older when they delivered were more likely to have migraines during pregnancy.
Migraines with aura, or an unpleasant sensation most often in the form of bright light, have previously been linked to stroke and heart disease in women. "This study now supports the same association in women who are pregnant," said Bushnell. "However, further studies are still needed to validate these findings."
The American Academy of Neurology, an association of over 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer's disease, epilepsy, multiple sclerosis, Parkinson's disease, and stroke. For more information about the American Academy of Neurology, visit aan.
American Academy of Neurology (AAN)
1080 Montreal Ave.
St. Paul, MN 55116
United States
neurology
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Researchers looked at a national database of nearly 17 million women discharged for pregnancy deliveries from 2000-2003. A total of 33,956 of the women were treated for migraines.
The study found women treated for migraines during pregnancy were 19 times more likely to suffer a stroke, five times more likely to have a heart attack and more than twice as likely to have heart disease, blood clots and other vascular problems.
"Women with persistent migraine during pregnancy should be aware of their risk factors, such as high blood pressure, high cholesterol, diabetes, history of blood clots, heart disease, and prior stroke," said study author Cheryl Bushnell, MD, with Duke University in Durham, NC, and Fellow of the American Academy of Neurology. Bushnell says there also seems to be a connection between migraines and preeclampsia, the most common and dangerous complication of pregnancy. "Good prenatal care is essential," she adds.
The study also found a link between migraines and the age of the mother. Women who were 35 or older when they delivered were more likely to have migraines during pregnancy.
Migraines with aura, or an unpleasant sensation most often in the form of bright light, have previously been linked to stroke and heart disease in women. "This study now supports the same association in women who are pregnant," said Bushnell. "However, further studies are still needed to validate these findings."
The American Academy of Neurology, an association of over 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer's disease, epilepsy, multiple sclerosis, Parkinson's disease, and stroke. For more information about the American Academy of Neurology, visit aan.
American Academy of Neurology (AAN)
1080 Montreal Ave.
St. Paul, MN 55116
United States
neurology
Buy Cyklokapron Without Prescription
VELCADE(reg) for injection receives EU authorisation for second-line use in multiple myeloma
Expanded label for VELCADE(reg), the only approved drug therapy to offer a significant survival advantage in relapsed
multiple myeloma -
Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, today announced that the European Commission has approved the
use of VELCADE(reg) (bortezomib) for Injection as a second-line treatment in patients with multiple myeloma. It is indicated as
monotherapy for use in patients who have received at least one prior therapy and who have already undergone or are unsuitable
for bone marrow transplantation. With today's announcement, more multiple myeloma patients can hope to receive earlier access
to VELCADE(reg) treatment. This decision formally ratifies the Committee for Human Medicinal Product Opinion made on 16th March
2005.
VELCADE(reg) received U.S. Food and Drug Administration (FDA) approval for second-line use in multiple myeloma in March of this
year. It is indicated in the U.S. for patients who have received at least one prior line of therapy.
Multiple myeloma is the second most common blood cancer, representing approximately one percent of all cancers and two
percent of all cancer deaths.(ref 1) In 2002 there were approximately 85,700 cases of multiple myeloma worldwide, with over
26,000 of these cases occurring in the EU.(ref 2) Only 30 percent of multiple myeloma patients survive longer than five
years.(ref 3) More than 18,000 people in the EU die each year from the disease. (ref 2)
Professor Jesus San Miguel, Professor of Medicine at the University Hospital in Salamanca, Spain, commented, "The results
we've seen in patients who have received VELCADE(reg) as the backbone at an earlier stage in the treatment cycle have been highly
promising."
VELCADE(reg) offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the
proteasome. First approved in Europe on 26th April 2004 for the treatment of multiple myeloma patients who had received at
least two prior therapies, VELCADE(reg) was the first treatment in more than a decade to be approved for this group of patients.
Assessment of Proteasome Inhibition on EXtending (APEX) Remission Results
The second line approval is based on the results of the APEX trial (ref 4), an international phase III study comparing
VELCADE(reg) against standard therapy high-dose dexamethasone in patients with relapsed multiple myeloma. The study demonstrated
a significant survival advantage with VELCADE(reg) in patients who had received one to three prior therapies. Importantly, this
pronounced survival advantage also was observed in the second-line multiple myeloma patients where 55 percent fewer patients
died in the VELCADE(reg) arm relative to dexamethasone.(ref 4)
Eric Low, Executive Director, International Myeloma Foundation U.K. commented, "If cutting-edge treatments such as VELCADE(reg)
can be used to treat at an early stage, this is good news for patients. The myeloma community will continue to support any
advances in the treatment of this disease."
VELCADE(reg) has a predictable safety profile and a favourable risk-to-benefit ratio. The most common side effects reported with
VELCADE(reg) include reversible new or worsening neuropathy; orthostatic hypotension - an abnormal decrease in blood pressure
upon standing; congestive heart failure; and gastrointestinal adverse events.
VELCADE(reg) is currently available in more than 46 countries worldwide including the U.S., most of Europe, and a number of
countries within Latin America and South-East Asia such as Argentina, China, Korea, Singapore and Thailand. There are
approximately 80 ongoing clinical trials (in Europe and the U.S.) investigating the use of VELCADE(reg) in all stages of multiple
myeloma and other solid tumour and haematological cancers.
VELCADE(reg) is being co-developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Millennium
Pharmaceuticals, Inc. Millennium is responsible for the commercialization of VELCADE(reg) in the U.S.; Ortho Biotech and
Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is
responsible for Japan.
References:
1. multiplemyeloma.
2. GLOBOCAN 2002, dep.iarc.fr.
3. Brenner H. Long-term survival rates of cancer patients achieved by the end of the 20th century: a period analysis. Lancet
2002; 360:1131-1135.
4. Abstract 336.5 presented at American Society of Hematology 47th Annual Meeting. Richardson P et al. Bortezomib
demonstrates superior efficacy to high-dose dexamethasone in relapse multiple myeloma: Final report of the APEX Study.
Contact: Monica Shuman
monica_shumanuk.bm
44-20-7300-6281
Burson-Marsteller
bm
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multiple myeloma -
Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, today announced that the European Commission has approved the
use of VELCADE(reg) (bortezomib) for Injection as a second-line treatment in patients with multiple myeloma. It is indicated as
monotherapy for use in patients who have received at least one prior therapy and who have already undergone or are unsuitable
for bone marrow transplantation. With today's announcement, more multiple myeloma patients can hope to receive earlier access
to VELCADE(reg) treatment. This decision formally ratifies the Committee for Human Medicinal Product Opinion made on 16th March
2005.
VELCADE(reg) received U.S. Food and Drug Administration (FDA) approval for second-line use in multiple myeloma in March of this
year. It is indicated in the U.S. for patients who have received at least one prior line of therapy.
Multiple myeloma is the second most common blood cancer, representing approximately one percent of all cancers and two
percent of all cancer deaths.(ref 1) In 2002 there were approximately 85,700 cases of multiple myeloma worldwide, with over
26,000 of these cases occurring in the EU.(ref 2) Only 30 percent of multiple myeloma patients survive longer than five
years.(ref 3) More than 18,000 people in the EU die each year from the disease. (ref 2)
Professor Jesus San Miguel, Professor of Medicine at the University Hospital in Salamanca, Spain, commented, "The results
we've seen in patients who have received VELCADE(reg) as the backbone at an earlier stage in the treatment cycle have been highly
promising."
VELCADE(reg) offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the
proteasome. First approved in Europe on 26th April 2004 for the treatment of multiple myeloma patients who had received at
least two prior therapies, VELCADE(reg) was the first treatment in more than a decade to be approved for this group of patients.
Assessment of Proteasome Inhibition on EXtending (APEX) Remission Results
The second line approval is based on the results of the APEX trial (ref 4), an international phase III study comparing
VELCADE(reg) against standard therapy high-dose dexamethasone in patients with relapsed multiple myeloma. The study demonstrated
a significant survival advantage with VELCADE(reg) in patients who had received one to three prior therapies. Importantly, this
pronounced survival advantage also was observed in the second-line multiple myeloma patients where 55 percent fewer patients
died in the VELCADE(reg) arm relative to dexamethasone.(ref 4)
Eric Low, Executive Director, International Myeloma Foundation U.K. commented, "If cutting-edge treatments such as VELCADE(reg)
can be used to treat at an early stage, this is good news for patients. The myeloma community will continue to support any
advances in the treatment of this disease."
VELCADE(reg) has a predictable safety profile and a favourable risk-to-benefit ratio. The most common side effects reported with
VELCADE(reg) include reversible new or worsening neuropathy; orthostatic hypotension - an abnormal decrease in blood pressure
upon standing; congestive heart failure; and gastrointestinal adverse events.
VELCADE(reg) is currently available in more than 46 countries worldwide including the U.S., most of Europe, and a number of
countries within Latin America and South-East Asia such as Argentina, China, Korea, Singapore and Thailand. There are
approximately 80 ongoing clinical trials (in Europe and the U.S.) investigating the use of VELCADE(reg) in all stages of multiple
myeloma and other solid tumour and haematological cancers.
VELCADE(reg) is being co-developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Millennium
Pharmaceuticals, Inc. Millennium is responsible for the commercialization of VELCADE(reg) in the U.S.; Ortho Biotech and
Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is
responsible for Japan.
References:
1. multiplemyeloma.
2. GLOBOCAN 2002, dep.iarc.fr.
3. Brenner H. Long-term survival rates of cancer patients achieved by the end of the 20th century: a period analysis. Lancet
2002; 360:1131-1135.
4. Abstract 336.5 presented at American Society of Hematology 47th Annual Meeting. Richardson P et al. Bortezomib
demonstrates superior efficacy to high-dose dexamethasone in relapse multiple myeloma: Final report of the APEX Study.
Contact: Monica Shuman
monica_shumanuk.bm
44-20-7300-6281
Burson-Marsteller
bm
Buy Detrol Without Prescription
Track Your Kid's Eating Habits Online
Soon parents in Houston, Texas, may have more influence on what their children eat by keeping track of eating habits via computer and blocking certain foods from the menu. At an automated cafeteria, parents will be able to know what choices their children are making.
You can make certain foods off limits for your child. In order to do this you have to sign up to a prepaid account. As a subscriber, you can go online, see what your child has been eating, and make alterations (basically, tell the child what is permitted and what is not).
Imagine you wish to allow your son or daughter French fries just once a week - you can do this. Go online, get into your account, and arrange it so that French fries are on the menu for just Mondays.
A great device for parents who are concerned about what their children are eating at school. Some say that parents who already provide their children with a balanced diet may be the only ones who sign up to this.
The company providing this service is called Pearland Food Services.
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You can make certain foods off limits for your child. In order to do this you have to sign up to a prepaid account. As a subscriber, you can go online, see what your child has been eating, and make alterations (basically, tell the child what is permitted and what is not).
Imagine you wish to allow your son or daughter French fries just once a week - you can do this. Go online, get into your account, and arrange it so that French fries are on the menu for just Mondays.
A great device for parents who are concerned about what their children are eating at school. Some say that parents who already provide their children with a balanced diet may be the only ones who sign up to this.
The company providing this service is called Pearland Food Services.
Buy Armour Without Prescription
SEC Must Approve Automakers' Accounting Methods Before VEBA Can Take Effect
The Securities and Exchange Commission must approve General Motors' and Ford Motor's accounting methods before voluntary employees' beneficiary association plans can take effect, the Detroit Free Press reports. The automakers during last year's contract negotiations with United Auto Workers agreed to contribute a specified amount of money to a health care trust that would be responsible for retiree health care, thus removing those liabilities from their books.
However, the VEBAs cannot "go into effect until Detroit automakers get their preferred bookkeeping vetted by federal bureaucrats -- and if they object, automakers can quit the deal on short notice," according to the Free Press. Lynn Turner, former chief accountant for SEC, said, "The question is, what's the likely total obligation, and what is GM still on the hook for?" adding, "That's where the attention of the SEC and investors will be."
Under the VEBA deals, if SEC rejects the automakers' plans, they can reopen negotiations with UAW to try to settle SEC's objections, or they could back out of their VEBA plans. GM in its annual report to SEC wrote, "GM may immediately terminate the settlement agreement if, after discussions with the SEC, GM does not believe that the accounting treatment ... is satisfactory to GM."
According to the Free Press, there is "no indication when the SEC might give approval" to the VEBA deals (Hyde, Detroit Free Press, 3/14).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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However, the VEBAs cannot "go into effect until Detroit automakers get their preferred bookkeeping vetted by federal bureaucrats -- and if they object, automakers can quit the deal on short notice," according to the Free Press. Lynn Turner, former chief accountant for SEC, said, "The question is, what's the likely total obligation, and what is GM still on the hook for?" adding, "That's where the attention of the SEC and investors will be."
Under the VEBA deals, if SEC rejects the automakers' plans, they can reopen negotiations with UAW to try to settle SEC's objections, or they could back out of their VEBA plans. GM in its annual report to SEC wrote, "GM may immediately terminate the settlement agreement if, after discussions with the SEC, GM does not believe that the accounting treatment ... is satisfactory to GM."
According to the Free Press, there is "no indication when the SEC might give approval" to the VEBA deals (Hyde, Detroit Free Press, 3/14).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Massachusetts Health Insurance Connector Approves 10% Premium Increases; State Finance Officer Says Program Is Underfunded
The Massachusetts Health Insurance Connector Authority on Thursday voted to approve a 10% increase in premiums for insurers participating in Commonwealth Care, less than the 15% plans had originally requested, the Boston Globe reports. Under the new contract, the state would assume more of the financial risk if beneficiaries use more medical services than expected. The board also increased premiums and copayments for some beneficiaries to partially offset increased payments to insurers (Dembner, Boston Globe, 3/21).
Between 35% and 40% of Commonwealth Care beneficiaries with incomes greater than 100% of the federal poverty level will face premium increases (AP/Boston Herald, 3/20). Commonwealth Care premiums paid by beneficiaries will increase by an average of 10%, and after the increases take effect on July 1, the lowest premiums will range from $39 to $116 per month. According to the Globe, copayments for visits to a primary care physician will increase by $5, $10 or $15. Copays for drugs also will increase. In addition, higher-income beneficiaries will contribute higher copays for emergency department care and outpatient surgery. Out-of-pocket expenses for all medical care, excluding medications, will be capped for the first time at $750 or $1,500 depending on an individual's income. A separate cap will be placed on prescription drug spending.
Between 35% and 40% of Commonwealth Care beneficiaries with incomes greater than 100% of the federal poverty level will face premium increases (AP/Boston Herald, 3/20). Commonwealth Care premiums paid by beneficiaries will increase by an average of 10%, and after the increases take effect on July 1, the lowest premiums will range from $39 to $116 per month. According to the Globe, copayments for visits to a primary care physician will increase by $5, $10 or $15. Copays for drugs also will increase. In addition, higher-income beneficiaries will contribute higher copays for emergency department care and outpatient surgery. Out-of-pocket expenses for all medical care, excluding medications, will be capped for the first time at $750 or $1,500 depending on an individual's income. A separate cap will be placed on prescription drug spending.
Budget
State Secretary of Administration and Finance Leslie Kirwan on Thursday said that Commonwealth Care will cost "significantly" more than the $869 million included in Gov. Deval Patrick's (D) fiscal year 2009 state budget proposal. During the Connector meeting at which the contract and premium increases were approved, Kirwan said, "We have closed some of the fiscal gap here, but we have not closed most of it." According to Kirwan, higher-than-expected enrollment in the program for the current fiscal year and next year has contributed to the gap.
State officials have been meeting over the past two weeks to discuss ways to reduce costs and raise revenue. Kirwan would not discuss details of the proposals or the size of the budget shortfall but said that without changes, the state does not expect "to be able to live within" the proposed budget (Boston Globe, 3/21).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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GeneThera Releases Results From Initial Animal Tests Of E.Coli O157:h7 Vaccine Amid News Of Increase Of E.Coli Discoveries In Beef Products
GeneThera, Inc. (Pink Sheets: GTHR), released information about its Eli O157:H7 vaccine.
The vaccine consists of Live Attenuated Bacterial Vaccine to Reduce or Inhibit Carriage and Shedding of Enterohemorrihagic Escherichia Coli in Cattle. This vaccine was developed for use against Shiga toxin-producing Eli (STEC) in cattle. This strategy is to construct mutants that have deletion in the genes responsible for Eli O157:H7 toxicity. Along with the mutation to inactivate the Shiga toxin gene, the modified bacteria also carry a mutation that inactivates genes that allows the growth of the Eli 0157:H7 in the cow intestine. These modifications will greatly attenuate bacterial virulence.
According to Dr. Tony Milici MD, PhD, GeneThera's Chairman and CEO, "Initial experimental animal trials in both challenged rabbits and mice showed a reduction of 99% Eli shedding in vaccinated animals when compared with control animals." GeneThera is aggressively pursuing a distribution partner to assist in bringing this vaccine/therapy technology to market.
Their efforts are bolstered by the recent report from the Washington Post dated November 10, which stated "...There were 21 beef recalls in the United States in 2007, compared with eight the year before. About a third of the recalls were prompted by reports of human illness, while none of the 2006 recalls were. This year, meat inspectors from the U.S. Department of Agriculture have continued to see more contaminated beef samples. Through mid-October, they had recorded 50 percent more than at the same time last year."
Officials have assumed that these numbers reflect an overall increase in the prevalence of the Eli strain in cattle, but no one has been able to explain why the dangerous bacteria have become more abundant.
Given the recent emergence of a similar product from a competitor, we feel that now is the time to begin a full court press to bring our vaccine to the forefront of the agricultural and food industries. We believe very strongly that our vaccine is a far superior product to that of our competition.
To help bring awareness to GeneThera and its efforts, we have engaged two very well known multimedia investor relations firms, Wallst and StockBully.
Both firms are multimedia investor relation's sources that seek out promising and mostly undiscovered companies in the market place and enable their clients to utilize multimedia marketing to gain exposure via the information highway.
"GeneThera is a fantastic company with a solid business model and superior management. We are extremely pleased to have the opportunity to assist them in their effort to increase investor awareness in the financial market," said Adam Ben-Evi, President of Stockbully.
About Eli O157:h7
There are a variety of Escherichia coli bacteria present in nature. They are usually found in the intestines of healthy humans and healthy animals. Even though these bacteria offer beneficial properties, there are those variations, or strains that are pathogenic (have the ability to cause disease). Escherichia coli 0157:H7 is one particular strain that is "... an emerging cause of food borne illness ..." Symptoms such as bloody diarrhea and abdominal cramps may be observed or no such symptoms may appear. The elderly and children under five years old are highly susceptible to Hemolytic Uremic Syndrome, a disease in which red blood cells are destroyed and kidneys fail.
According to the CDC "...there may be about 70,000 infections with E. Coli O157:H7 each year in the United States. We can only estimate because we know that many infected people do not seek medical care, many do not submit a stool specimen for testing, and many labs do not test for STEC. The bacteria that make these toxins are called 'Shiga toxin producing' E. coli, or STEC for short." Shiga toxin is one of the most potent toxins known to man, so much so that the Centers for Disease Control and Prevention (CDC) lists it as a potential bioterrorist agent (CDC, n.d.).
ABOUT GENETHERA, INC.
GeneThera, Inc. is a molecular biotechnology company located in Wheat Ridge, Colorado. The Company provides genetic diagnostic solutions for the veterinary and agricultural industries with future plans to include the healthcare industry. The Company's proprietary diagnostic solution is based on a genetic expression assay, GES(TM), a protocol designed to function on a highly automated Fluorogenic PCR platform. This platform enables GeneThera to offer tests that are presently not available from other technologies. The GES is designed for a host of individual diseases, the current priorities being Mad Cow disease, Chronic Wasting Disease, E. coli 0157:H7 and Johne's disease, all diseases affecting cattle worldwide.
This press release contains forward-looking statements, which are made pursuant to the Safe-Harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "believes," and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of products and technologies, the ability to secure additional sources of finance, the ability to reduce operating expenses, and other factors described in the Company's filings with the Securities and Exchange Commission. The actual results that the Company achieves may differ materially from any forward-looking statement due to such risks and uncertainties. The Company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.
GeneThera, Inc.
genethera
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The vaccine consists of Live Attenuated Bacterial Vaccine to Reduce or Inhibit Carriage and Shedding of Enterohemorrihagic Escherichia Coli in Cattle. This vaccine was developed for use against Shiga toxin-producing Eli (STEC) in cattle. This strategy is to construct mutants that have deletion in the genes responsible for Eli O157:H7 toxicity. Along with the mutation to inactivate the Shiga toxin gene, the modified bacteria also carry a mutation that inactivates genes that allows the growth of the Eli 0157:H7 in the cow intestine. These modifications will greatly attenuate bacterial virulence.
According to Dr. Tony Milici MD, PhD, GeneThera's Chairman and CEO, "Initial experimental animal trials in both challenged rabbits and mice showed a reduction of 99% Eli shedding in vaccinated animals when compared with control animals." GeneThera is aggressively pursuing a distribution partner to assist in bringing this vaccine/therapy technology to market.
Their efforts are bolstered by the recent report from the Washington Post dated November 10, which stated "...There were 21 beef recalls in the United States in 2007, compared with eight the year before. About a third of the recalls were prompted by reports of human illness, while none of the 2006 recalls were. This year, meat inspectors from the U.S. Department of Agriculture have continued to see more contaminated beef samples. Through mid-October, they had recorded 50 percent more than at the same time last year."
Officials have assumed that these numbers reflect an overall increase in the prevalence of the Eli strain in cattle, but no one has been able to explain why the dangerous bacteria have become more abundant.
Given the recent emergence of a similar product from a competitor, we feel that now is the time to begin a full court press to bring our vaccine to the forefront of the agricultural and food industries. We believe very strongly that our vaccine is a far superior product to that of our competition.
To help bring awareness to GeneThera and its efforts, we have engaged two very well known multimedia investor relations firms, Wallst and StockBully.
Both firms are multimedia investor relation's sources that seek out promising and mostly undiscovered companies in the market place and enable their clients to utilize multimedia marketing to gain exposure via the information highway.
"GeneThera is a fantastic company with a solid business model and superior management. We are extremely pleased to have the opportunity to assist them in their effort to increase investor awareness in the financial market," said Adam Ben-Evi, President of Stockbully.
About Eli O157:h7
There are a variety of Escherichia coli bacteria present in nature. They are usually found in the intestines of healthy humans and healthy animals. Even though these bacteria offer beneficial properties, there are those variations, or strains that are pathogenic (have the ability to cause disease). Escherichia coli 0157:H7 is one particular strain that is "... an emerging cause of food borne illness ..." Symptoms such as bloody diarrhea and abdominal cramps may be observed or no such symptoms may appear. The elderly and children under five years old are highly susceptible to Hemolytic Uremic Syndrome, a disease in which red blood cells are destroyed and kidneys fail.
According to the CDC "...there may be about 70,000 infections with E. Coli O157:H7 each year in the United States. We can only estimate because we know that many infected people do not seek medical care, many do not submit a stool specimen for testing, and many labs do not test for STEC. The bacteria that make these toxins are called 'Shiga toxin producing' E. coli, or STEC for short." Shiga toxin is one of the most potent toxins known to man, so much so that the Centers for Disease Control and Prevention (CDC) lists it as a potential bioterrorist agent (CDC, n.d.).
ABOUT GENETHERA, INC.
GeneThera, Inc. is a molecular biotechnology company located in Wheat Ridge, Colorado. The Company provides genetic diagnostic solutions for the veterinary and agricultural industries with future plans to include the healthcare industry. The Company's proprietary diagnostic solution is based on a genetic expression assay, GES(TM), a protocol designed to function on a highly automated Fluorogenic PCR platform. This platform enables GeneThera to offer tests that are presently not available from other technologies. The GES is designed for a host of individual diseases, the current priorities being Mad Cow disease, Chronic Wasting Disease, E. coli 0157:H7 and Johne's disease, all diseases affecting cattle worldwide.
This press release contains forward-looking statements, which are made pursuant to the Safe-Harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "believes," and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of products and technologies, the ability to secure additional sources of finance, the ability to reduce operating expenses, and other factors described in the Company's filings with the Securities and Exchange Commission. The actual results that the Company achieves may differ materially from any forward-looking statement due to such risks and uncertainties. The Company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.
GeneThera, Inc.
genethera
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Simultaneous Pneumococcal And Shingles Vaccines Safe - FDA Concerns Challenged
Giving patients both the herpes zoster and pneumococcal vaccines simultaneously does not seem to undermine the zoster vaccine's protective effect, despite FDA concerns to the contrary, researchers from Kaiser Permanente wrote in the journal Vaccine.
The package insert of the zoster vaccine says the two should be given in separate doctor visits. Doing them both at the same time is much more convenient and cheaper for the patient. If it is also safe, there seems no point in doing them separately, the authors wrote.
The FDA had asked the manufacturer of the zoster vaccine to mention in the package insert that the concurrent use of both vaccines detrimentally affects the zoster vaccines ability to generate an immune response.
Hung Fu Tseng, PhD, MPH, said:
"Our study found no evidence that receiving the zoster vaccine and pneumococcal vaccine on the same day would compromise the immune response necessary to protect against herpes zoster, also known as shingles."
This study, which started on January 1, 2007 and ended on June 30, 2010, involved two groups of patients aged 60+. 7,187 patients received both vaccines simultaneously while 7,179 received them non-concurrently (at different times).
They identified 56 cases of herpes zoster in the simultaneous group and 58 in the other - no statistically significant difference in shingles incidence.
Dr. Tseng adds:
"Ideally, when a new vaccine is introduced to the public, one should consider giving it at the same time as other vaccines to increase coverage levels and minimize administration costs, if there are no immune response issues or safety concerns."
The pneumococcal polysaccharide vaccine protects against 23 kinds of pneumococcal bacteria, including the most commonly serious disease-causing ones for humans. Pneumococcal infection can lead to complications, resulting in hearing loss, limb loss, brain damage, and sometimes death. The majority of healthy patients (adults) who are vaccinated become immune to either most or all of these 23 types within two to three weeks of receiving their injection.
Humans have a 30% risk of developing shingles at some time during their life. In the USA there are over a million shingles episodes annually. Shingles, a painful condition, can persist for months and even years and can have a significant impact on the patient's quality of life. By the end of 2008, less than 7% of America's population was vaccinated for herpes zoster.
If a patient is eligible for both vaccines, the CDC still recommends they both be administered at the same time, despite FDA concerns.
A Merck study found that when patients were given both vaccines at the same time, there was a higher risk of lower levels of herpes zoster antibodies.
Dr. Tseng wrote:
"However that study used the antibody level as the marker of protection, but it is the cell-mediated immunity against the herpes virus, instead of the antibody level, that protects against the disease.
"This new study provides even stronger data because it relies on the measurement of the occurrence of disease rather than intermediate markers of immunity."
"Evaluation of the incidence of herpes zoster after concomitant administration of zoster vaccine and polysaccharide pneumococcal vaccine"
Hung Fu Tsengnext termCorresponding Author Contact Information, a, E-mail The Corresponding Author, Ning Smitha, Lina S. Sya and Steven J. Jacobsen
Vaccine. Volume 29, Issue 20, 9 May 2011, Pages 3628-3632
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The package insert of the zoster vaccine says the two should be given in separate doctor visits. Doing them both at the same time is much more convenient and cheaper for the patient. If it is also safe, there seems no point in doing them separately, the authors wrote.
The FDA had asked the manufacturer of the zoster vaccine to mention in the package insert that the concurrent use of both vaccines detrimentally affects the zoster vaccines ability to generate an immune response.
Hung Fu Tseng, PhD, MPH, said:
"Our study found no evidence that receiving the zoster vaccine and pneumococcal vaccine on the same day would compromise the immune response necessary to protect against herpes zoster, also known as shingles."
This study, which started on January 1, 2007 and ended on June 30, 2010, involved two groups of patients aged 60+. 7,187 patients received both vaccines simultaneously while 7,179 received them non-concurrently (at different times).
They identified 56 cases of herpes zoster in the simultaneous group and 58 in the other - no statistically significant difference in shingles incidence.
Dr. Tseng adds:
"Ideally, when a new vaccine is introduced to the public, one should consider giving it at the same time as other vaccines to increase coverage levels and minimize administration costs, if there are no immune response issues or safety concerns."
The pneumococcal polysaccharide vaccine protects against 23 kinds of pneumococcal bacteria, including the most commonly serious disease-causing ones for humans. Pneumococcal infection can lead to complications, resulting in hearing loss, limb loss, brain damage, and sometimes death. The majority of healthy patients (adults) who are vaccinated become immune to either most or all of these 23 types within two to three weeks of receiving their injection.
Humans have a 30% risk of developing shingles at some time during their life. In the USA there are over a million shingles episodes annually. Shingles, a painful condition, can persist for months and even years and can have a significant impact on the patient's quality of life. By the end of 2008, less than 7% of America's population was vaccinated for herpes zoster.
If a patient is eligible for both vaccines, the CDC still recommends they both be administered at the same time, despite FDA concerns.
A Merck study found that when patients were given both vaccines at the same time, there was a higher risk of lower levels of herpes zoster antibodies.
Dr. Tseng wrote:
"However that study used the antibody level as the marker of protection, but it is the cell-mediated immunity against the herpes virus, instead of the antibody level, that protects against the disease.
"This new study provides even stronger data because it relies on the measurement of the occurrence of disease rather than intermediate markers of immunity."
"Evaluation of the incidence of herpes zoster after concomitant administration of zoster vaccine and polysaccharide pneumococcal vaccine"
Hung Fu Tsengnext termCorresponding Author Contact Information, a, E-mail The Corresponding Author, Ning Smitha, Lina S. Sya and Steven J. Jacobsen
Vaccine. Volume 29, Issue 20, 9 May 2011, Pages 3628-3632
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Prime-Boost Vaccine Study Shows Modest Effect In Preventing HIV
Global Solutions for Infectious Diseases ("GSID") announced today that a Phase III clinical trial of an investigational HIV vaccine regimen has been shown to be safe and modestly effective in preventing HIV infection. The double-blind, placebo controlled study was conducted in Thailand among more than 16,000 volunteers.
The clinical trial (RV 144), the world's largest study of an HIV/AIDS vaccine regimen, demonstrated that the combination of a priming vaccine developed by sanofi pasteur (ALVAC®HIV vCP1521) and GSID's boosting vaccine (AIDSVAX®B/E) reduced HIV infection in a community-based population by 31.2% compared with placebo. In the final analysis of the trial, 74 placebo recipients became infected with HIV compared to 51 vaccine recipients. The efficacy result is considered statistically significant with a p-value of 0.04 and a 95% confidence interval having a lower bound greater than zero.
Additional research will be required to clarify the public health benefits of this outcome, including whether boosters would be needed and whether the vaccine combination would yield the same results against different strains of the virus found in other parts of the world. One of the most critical steps now will be to manufacture new lots of AIDSVAX for a variety of possible future studies in combination with ALVAC. GSID will make AIDSVAX at a qualified contract manufacturer.
"As the first HIV vaccine trial to demonstrate some level of reduced infection among the entire trial population, this is an encouraging step forward in the struggle to develop an effective HIV/AIDS vaccine," said Donald Francis, M.D., D.Sc., GSID's executive director. "This trial will provide researchers with valuable data and insights to continue the development of a vaccine that can hopefully one day eradicate this terrible disease."
He congratulated the Thai Ministry of Public Health and the U.S. Army who collaborated to make this trial successful, and further expressed his appreciation to the National Institute of Allergy and Infectious Diseases (NIAID) for its scientific and financial support.
The vaccine combination tested in Thailand was developed based on the strains of HIV that circulate in that country. Separate versions of the vaccine may have to be manufactured and developed for HIV strains that predominate elsewhere in the world, including North America. The Thai study, which began in 2003, was designed to test the vaccine regimen's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected during the trial. The study did not show a statistically significant result in reducing the viral load in the HIV-infected volunteers.
After initial development at Genentech, the AIDSVAX technology was transferred to VaxGen Inc., which completed two Phase III trials of AIDSVAX alone in high risk populations in Thailand, North America and Europe in 2003. Both trials did not show a statistically significant reduction in HIV infection overall. GSID obtained certain intellectual property and manufacturing rights related to AIDSVAX in 2008.
Thai Trial Summary
The trial included non-infected volunteers between 18 and 30 years of age who were at average risk of HIV infection. Approximately 40% of the volunteers were women. Volunteers who acquired HIV infection during the trial were given free access to HIV care and treatment, including highly active antiretroviral therapy (HAART), according to the guidelines of the Thai Ministry of Public Health.
The study was made possible by an international collaboration involving numerous partners from the Thai and U.S. governments, private-sector companies and non-profit organizations.
"This study is encouraging not only for the outcome but for the extraordinary cooperation among the numerous entities that joined in this effort," Francis said. "We look forward to continuing our collaboration with our partners in Thailand, the U.S. government and the private sector to advance this product. I also want to offer my personal gratitude to the more than 16,000 Thai volunteers who stepped forward to participate in this study and stayed with it for six years. They are the real heroes today."
Source
Global Solutions for Infectious Diseases
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The clinical trial (RV 144), the world's largest study of an HIV/AIDS vaccine regimen, demonstrated that the combination of a priming vaccine developed by sanofi pasteur (ALVAC®HIV vCP1521) and GSID's boosting vaccine (AIDSVAX®B/E) reduced HIV infection in a community-based population by 31.2% compared with placebo. In the final analysis of the trial, 74 placebo recipients became infected with HIV compared to 51 vaccine recipients. The efficacy result is considered statistically significant with a p-value of 0.04 and a 95% confidence interval having a lower bound greater than zero.
Additional research will be required to clarify the public health benefits of this outcome, including whether boosters would be needed and whether the vaccine combination would yield the same results against different strains of the virus found in other parts of the world. One of the most critical steps now will be to manufacture new lots of AIDSVAX for a variety of possible future studies in combination with ALVAC. GSID will make AIDSVAX at a qualified contract manufacturer.
"As the first HIV vaccine trial to demonstrate some level of reduced infection among the entire trial population, this is an encouraging step forward in the struggle to develop an effective HIV/AIDS vaccine," said Donald Francis, M.D., D.Sc., GSID's executive director. "This trial will provide researchers with valuable data and insights to continue the development of a vaccine that can hopefully one day eradicate this terrible disease."
He congratulated the Thai Ministry of Public Health and the U.S. Army who collaborated to make this trial successful, and further expressed his appreciation to the National Institute of Allergy and Infectious Diseases (NIAID) for its scientific and financial support.
The vaccine combination tested in Thailand was developed based on the strains of HIV that circulate in that country. Separate versions of the vaccine may have to be manufactured and developed for HIV strains that predominate elsewhere in the world, including North America. The Thai study, which began in 2003, was designed to test the vaccine regimen's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected during the trial. The study did not show a statistically significant result in reducing the viral load in the HIV-infected volunteers.
After initial development at Genentech, the AIDSVAX technology was transferred to VaxGen Inc., which completed two Phase III trials of AIDSVAX alone in high risk populations in Thailand, North America and Europe in 2003. Both trials did not show a statistically significant reduction in HIV infection overall. GSID obtained certain intellectual property and manufacturing rights related to AIDSVAX in 2008.
Thai Trial Summary
The trial included non-infected volunteers between 18 and 30 years of age who were at average risk of HIV infection. Approximately 40% of the volunteers were women. Volunteers who acquired HIV infection during the trial were given free access to HIV care and treatment, including highly active antiretroviral therapy (HAART), according to the guidelines of the Thai Ministry of Public Health.
The study was made possible by an international collaboration involving numerous partners from the Thai and U.S. governments, private-sector companies and non-profit organizations.
"This study is encouraging not only for the outcome but for the extraordinary cooperation among the numerous entities that joined in this effort," Francis said. "We look forward to continuing our collaboration with our partners in Thailand, the U.S. government and the private sector to advance this product. I also want to offer my personal gratitude to the more than 16,000 Thai volunteers who stepped forward to participate in this study and stayed with it for six years. They are the real heroes today."
Source
Global Solutions for Infectious Diseases
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Swedish Study Of HIV Vaccine Produces Unique Results
A Swedish HIV vaccine study conducted by researchers at Karolinska Institutet (KI), Karolinska University Hospital and the Swedish Institute for Infectious Disease Control (SMI) has produced surprisingly good results. Over 90 per cent of the subjects in the phase 1 trials developed an immune response to HIV. "Never has such a good result been seen with a vaccine of this type," says Professor Eric Sandstrom, Chief Physician at Karolinska University Hospital.
A vaccine developed by SMI scientists has now undergone the first clinical study on healthy individuals in Sweden in order to examine its safety and different methods of administration. The vaccine is what is known as a genetic vaccine, which uses parts of the virus DNA to stimulate the rapid endogenous production of the proteins for which the injected DNA codes.
The trial subjects were vaccinated on three occasions with this vaccine using a needle-free method of injection. In order to enhance the effect, the researchers also gave the subjects a fourth dose of a vaccine in which parts of the HIV virus DNA had been integrated into another virus (vaccinia = the cowpox virus). This vaccine-based HIV vaccine is produced by the USA's National Institutes of Health and was donated for use in this Swedish study.
"Our vaccine is designed in such a way that it's able to protect against many of the circulating HIV types in Africa and the West," says Professor Britta Wahren at the SMI/KI.
Over 90 per cent of the trial subjects developed an immune response to HIV, and the vaccines have been tolerated well.
Data from the study will be presented at the four-day HIV vaccine conference in Amsterdam starting 29 August under the heading "Multigene, multiclade HIV-1 plasmid DNA prime and MVA boost is safe and highly immunogenic in healthy human volunteers".
Scientists now hope to follow up the Swedish study with a larger phase 1 - phase 2 study in Tanzania, planned to commence this autumn, in order to corroborate the Swedish results on African subjects and to help train Tanzanians to carry out parts of the study, including sophisticated laboratory examinations, on site.
The project is being led by KI professors Gunnel Biberfeld and Britta Wahren at the SMI and Eric Sandstrom at Karolinska University Hospital.
SMI has been running major projects in the HIV field since 1986 with the support of Sida/SAREC, the EU's 5th Framework Programme, the Swedish Research Council, Karolinska Institutet, and Karolinska University Hospital. Over the past few years, the projects have tended more and more towards developing a vaccine for the prevention of HIV.
Data from the study was released at the conference presentation on 30 August.
For further information, please contact:
Gunnel Biberfeld, Professor of Immunology, SMI and KI:
E-mail: gunnel.biberfeldsmi.ki.se
Eric Sandstrom, Professor of Dermatovenerology,
Chief Physician at Karolinska University Hospital
E-mail: eric.sandstromkarolinska.se
Britta Wahren, Professor of Virology, SMI and KI
E-mail: britta.wahrensmi.ki.se
Press contacts:
Aase Sten,
SMI press officer
E-mail: aase.stensmi.ki.se
Ulla Sorensen,
Karolinska University Hospital press officer
E-mail: ulla.sorensenkarolinska.se
Contact: Katarina Sternudd
Karolinska Institutet
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A vaccine developed by SMI scientists has now undergone the first clinical study on healthy individuals in Sweden in order to examine its safety and different methods of administration. The vaccine is what is known as a genetic vaccine, which uses parts of the virus DNA to stimulate the rapid endogenous production of the proteins for which the injected DNA codes.
The trial subjects were vaccinated on three occasions with this vaccine using a needle-free method of injection. In order to enhance the effect, the researchers also gave the subjects a fourth dose of a vaccine in which parts of the HIV virus DNA had been integrated into another virus (vaccinia = the cowpox virus). This vaccine-based HIV vaccine is produced by the USA's National Institutes of Health and was donated for use in this Swedish study.
"Our vaccine is designed in such a way that it's able to protect against many of the circulating HIV types in Africa and the West," says Professor Britta Wahren at the SMI/KI.
Over 90 per cent of the trial subjects developed an immune response to HIV, and the vaccines have been tolerated well.
Data from the study will be presented at the four-day HIV vaccine conference in Amsterdam starting 29 August under the heading "Multigene, multiclade HIV-1 plasmid DNA prime and MVA boost is safe and highly immunogenic in healthy human volunteers".
Scientists now hope to follow up the Swedish study with a larger phase 1 - phase 2 study in Tanzania, planned to commence this autumn, in order to corroborate the Swedish results on African subjects and to help train Tanzanians to carry out parts of the study, including sophisticated laboratory examinations, on site.
The project is being led by KI professors Gunnel Biberfeld and Britta Wahren at the SMI and Eric Sandstrom at Karolinska University Hospital.
SMI has been running major projects in the HIV field since 1986 with the support of Sida/SAREC, the EU's 5th Framework Programme, the Swedish Research Council, Karolinska Institutet, and Karolinska University Hospital. Over the past few years, the projects have tended more and more towards developing a vaccine for the prevention of HIV.
Data from the study was released at the conference presentation on 30 August.
For further information, please contact:
Gunnel Biberfeld, Professor of Immunology, SMI and KI:
E-mail: gunnel.biberfeldsmi.ki.se
Eric Sandstrom, Professor of Dermatovenerology,
Chief Physician at Karolinska University Hospital
E-mail: eric.sandstromkarolinska.se
Britta Wahren, Professor of Virology, SMI and KI
E-mail: britta.wahrensmi.ki.se
Press contacts:
Aase Sten,
SMI press officer
E-mail: aase.stensmi.ki.se
Ulla Sorensen,
Karolinska University Hospital press officer
E-mail: ulla.sorensenkarolinska.se
Contact: Katarina Sternudd
Karolinska Institutet
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ASC X12 Releases Implementation Guide: "Personal Health Record Transfer Between Health Plans"
Standardized requirements for one health insurance plan to electronically send Personal Health Record (PHR) data to another health insurance plan, called the "Personal Health Record (PHR) Transfer Between Health Plans Technical Report, 005050X274," was released by the Accredited Standards Committee (ASC) X12, providing monumental interoperability among insurance companies assisting consumers.
"This Implementation Guide provides a standards-based mechanism to electronically send PHR data from a predecessor to a successor health plan," said Dan Kazzaz, Chair, ASC X12. "It provides needed support to health plans in the role of maintaining longitudinal PHRs for individuals and moving PHRs from health plan to health plan whenever individuals' or companies' health plan coverages shift."
This implementation guide builds on the pioneering work of the Blue Cross and Blue Shield Association and America's Health Insurance Plans (AHIP) in their 005010 implementation guide of the same name. The document brings together work of several standards-setting organizations to describe the business process, message structure, data elements and examples and includes a glossary.
"This announcement by ASC X12 is good news for consumers who, when they change coverage, want to transfer their PHRs to their new health plans and continue with all of the advantages that PHRs bring with them," said AHIP President and CEO Karen Ignagni. "We are pleased that the new standard builds on the work of AHIP and BCBSA, which was designed to be consistent with that of the standards organizations, and to be a building block for their future efforts," Ignagni said.
"BCBSA believes the increased use of personal health records will allow consumers to take a greater role in their own healthcare and ultimately improve quality and health outcomes," said Scott P. Serota, BCBSA president and CEO. "BCBSA is proud of its partnership with ASC X12 and other organizations to promote the use of PHR standards."
The Healthcare Information Technology Standards Panel (HITSP), a cooperative partnership between the public and private sectors has named ASC X12 and Health Level Seven (HL7) standards in their Interoperability Specifications. The "Personal Health Record Transfer Between Health Plans Technical Report" benefits from ASC X12 and HL7 standards. This implementation guide for ASC X12's Patient Information Transaction Set 275 describes a standard method to encapsulate an HL7 Plan-to-Plan Personal Health Record Data Transfer (P2PPHR). Neither the ASC X12 guide, nor the HL7 guide are standalone documents. The X12 guide relies on the HL7 guide, which relies on and references other HL7 documents.
X12 standards provide robust acknowledgments at several levels, from transmission to implementation guide adherence. HL7 standards provide a thorough collection of clinical-based data elements and a rich vocabulary gleaned from other well-known standard coding systems, such as, SNOMED, CPT, and LOINC.
Applications of this standard include:
-- When an employer or coverage sponsor changes from one health plan to
another, the new health plan may request the prior plan to transfer PHR
information of covered individuals.
-- When an individual changes jobs and elects coverage under a new health
plan, he may request the transfer of PHR information for covered
individuals. The prior health plan, with the individual's authorization,
will transfer the PHR information to the new health plan.
-- When an individual or subgroup of individuals changes from one health
plan to another, the new health plan may request the prior health plan to
transfer the PHR information of those covered individuals.
The combination of X12 and HL7 specifications incorporate Clinical Document Architecture (CDA) Release 2 (R2)-defined eXtensible Markup Language (XML) in the 275 transaction to delineate the data elements that are supported by health plan claims, administrative functions, clinical actions, medications, providers, facilities, and other data directly entered by individuals into their PHR.
About ASC X12
Celebrating 30 years of Business Process and Technical Expertise in the Development and Adoption of Electronic Data Exchange Standards
The ASC X12, chartered by the American National Standards Institute (ANSI) in 1979, develops EDI standards and documents for national and global markets. With more than 315 X12 EDI standards and increasing X12 XML schemas, ASC X12 enhances business processes, reduces costs and expands organizational reach. Members include standards experts from health care, insurance, transportation, finance, government, supply chain and other industries. To participate in ASC X12's vital standards-setting role, visit X12, or call 703-970-4480.
Source
DISA
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"This Implementation Guide provides a standards-based mechanism to electronically send PHR data from a predecessor to a successor health plan," said Dan Kazzaz, Chair, ASC X12. "It provides needed support to health plans in the role of maintaining longitudinal PHRs for individuals and moving PHRs from health plan to health plan whenever individuals' or companies' health plan coverages shift."
This implementation guide builds on the pioneering work of the Blue Cross and Blue Shield Association and America's Health Insurance Plans (AHIP) in their 005010 implementation guide of the same name. The document brings together work of several standards-setting organizations to describe the business process, message structure, data elements and examples and includes a glossary.
"This announcement by ASC X12 is good news for consumers who, when they change coverage, want to transfer their PHRs to their new health plans and continue with all of the advantages that PHRs bring with them," said AHIP President and CEO Karen Ignagni. "We are pleased that the new standard builds on the work of AHIP and BCBSA, which was designed to be consistent with that of the standards organizations, and to be a building block for their future efforts," Ignagni said.
"BCBSA believes the increased use of personal health records will allow consumers to take a greater role in their own healthcare and ultimately improve quality and health outcomes," said Scott P. Serota, BCBSA president and CEO. "BCBSA is proud of its partnership with ASC X12 and other organizations to promote the use of PHR standards."
The Healthcare Information Technology Standards Panel (HITSP), a cooperative partnership between the public and private sectors has named ASC X12 and Health Level Seven (HL7) standards in their Interoperability Specifications. The "Personal Health Record Transfer Between Health Plans Technical Report" benefits from ASC X12 and HL7 standards. This implementation guide for ASC X12's Patient Information Transaction Set 275 describes a standard method to encapsulate an HL7 Plan-to-Plan Personal Health Record Data Transfer (P2PPHR). Neither the ASC X12 guide, nor the HL7 guide are standalone documents. The X12 guide relies on the HL7 guide, which relies on and references other HL7 documents.
X12 standards provide robust acknowledgments at several levels, from transmission to implementation guide adherence. HL7 standards provide a thorough collection of clinical-based data elements and a rich vocabulary gleaned from other well-known standard coding systems, such as, SNOMED, CPT, and LOINC.
Applications of this standard include:
-- When an employer or coverage sponsor changes from one health plan to
another, the new health plan may request the prior plan to transfer PHR
information of covered individuals.
-- When an individual changes jobs and elects coverage under a new health
plan, he may request the transfer of PHR information for covered
individuals. The prior health plan, with the individual's authorization,
will transfer the PHR information to the new health plan.
-- When an individual or subgroup of individuals changes from one health
plan to another, the new health plan may request the prior health plan to
transfer the PHR information of those covered individuals.
The combination of X12 and HL7 specifications incorporate Clinical Document Architecture (CDA) Release 2 (R2)-defined eXtensible Markup Language (XML) in the 275 transaction to delineate the data elements that are supported by health plan claims, administrative functions, clinical actions, medications, providers, facilities, and other data directly entered by individuals into their PHR.
About ASC X12
Celebrating 30 years of Business Process and Technical Expertise in the Development and Adoption of Electronic Data Exchange Standards
The ASC X12, chartered by the American National Standards Institute (ANSI) in 1979, develops EDI standards and documents for national and global markets. With more than 315 X12 EDI standards and increasing X12 XML schemas, ASC X12 enhances business processes, reduces costs and expands organizational reach. Members include standards experts from health care, insurance, transportation, finance, government, supply chain and other industries. To participate in ASC X12's vital standards-setting role, visit X12, or call 703-970-4480.
Source
DISA
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First Project Announced By MSD Wellcome Trust Hilleman Laboratories: Feasibility Study On Rotavirus Vaccine For Use In Developing Countries
The MSD Wellcome Trust Hilleman Laboratories have announced that the organization's first project will be a feasibility study into how new technologies might be used to develop a rotavirus vaccine designed specifically with developing country needs in mind. Formulations based on dissolving thin strips or granules will be examined for their potential to improve product stability, ease of use, transportation and affordability. The therapeutic focus of the project has been selected because of the tremendous global impact of rotavirus diarrhea on childhood mortality. If the initial study is successful, options to further develop the technology for rotavirus and other oral vaccines of importance to developing country health will be explored.
"Many first-generation vaccines have not been developed with the specific needs of countries with poor infrastructure for vaccine delivery in mind. This is a much needed exploration of how to tackle one of the greatest public health and logistics challenges in the developing world -- distributing life-saving vaccines without the requirement for large bulk shipments, expensive warehousing and costly, difficult-to-maintain refrigerated shipping paths from the manufacturing plant to the patient," says Hilleman Laboratories Chief Executive Officer, Dr. Altaf A. Lal.
The project is a collaboration among the Hilleman Laboratories, MSD and Medicine in Need (MEND), an international non-profit organization specializing in the application of advanced vaccine formulation technologies. For this feasibility study, MEND is providing the formulation technology and MSD is providing components of its existing rotavirus vaccine.
"With developing country needs in mind, we are targeting heat stability, ease of administration, package size, and cost of goods as key features of the product," said Dr. Akshay Goel, Chief Scientific Officer at Hilleman Laboratories.
"MEND's mission is to formulate life-saving vaccines in ways that allow their availability and sustainability to the impoverished populations who need them most," said Dr. Andrew Schiermeier, CEO at MEND. "Our collaboration with Hilleman Labs and the MSD vaccines group provides an excellent opportunity to leverage the technical expertise of the different groups with the aim of creating a product that will be far-better suited for developing country needs."
"This technology has the potential to be a real game changer in vaccine development and delivery," said Dr. David Heymann, Chairman of the UK's Health Protection Agency who also chairs the Strategic Advisory Group of the Hilleman Laboratories. "This kind of R&D is needed to make effective vaccines available in resource limited countries, so that they can be more easily used to decrease the impact of vaccine preventable diseases. There is tremendous synergy in bringing together the philanthropic, scientific and business prowess of these organizations and their funders to benefit so many of the world's poorest."
The World Health Organization estimates that annually from 10 percent up to 50 percent of vaccines may be wasted globally because of temperature control, shipping, and other logistical issues.
"Although a potential vaccine coming out of the Hilleman Laboratories would be for global needs, nearly 100,000 rotavirus deaths each year occur in India," said Dr. M. K. Bhan, Secretary to the Government of India, Department of Biotechnology, Ministry of Science and Technology. "The Hilleman Laboratories effort to extend the utility of rotavirus vaccine in poor countries is to be welcomed."
Source:
Samantha Cranko
MSD Wellcome Trust Hilleman Laboratories
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"Many first-generation vaccines have not been developed with the specific needs of countries with poor infrastructure for vaccine delivery in mind. This is a much needed exploration of how to tackle one of the greatest public health and logistics challenges in the developing world -- distributing life-saving vaccines without the requirement for large bulk shipments, expensive warehousing and costly, difficult-to-maintain refrigerated shipping paths from the manufacturing plant to the patient," says Hilleman Laboratories Chief Executive Officer, Dr. Altaf A. Lal.
The project is a collaboration among the Hilleman Laboratories, MSD and Medicine in Need (MEND), an international non-profit organization specializing in the application of advanced vaccine formulation technologies. For this feasibility study, MEND is providing the formulation technology and MSD is providing components of its existing rotavirus vaccine.
"With developing country needs in mind, we are targeting heat stability, ease of administration, package size, and cost of goods as key features of the product," said Dr. Akshay Goel, Chief Scientific Officer at Hilleman Laboratories.
"MEND's mission is to formulate life-saving vaccines in ways that allow their availability and sustainability to the impoverished populations who need them most," said Dr. Andrew Schiermeier, CEO at MEND. "Our collaboration with Hilleman Labs and the MSD vaccines group provides an excellent opportunity to leverage the technical expertise of the different groups with the aim of creating a product that will be far-better suited for developing country needs."
"This technology has the potential to be a real game changer in vaccine development and delivery," said Dr. David Heymann, Chairman of the UK's Health Protection Agency who also chairs the Strategic Advisory Group of the Hilleman Laboratories. "This kind of R&D is needed to make effective vaccines available in resource limited countries, so that they can be more easily used to decrease the impact of vaccine preventable diseases. There is tremendous synergy in bringing together the philanthropic, scientific and business prowess of these organizations and their funders to benefit so many of the world's poorest."
The World Health Organization estimates that annually from 10 percent up to 50 percent of vaccines may be wasted globally because of temperature control, shipping, and other logistical issues.
"Although a potential vaccine coming out of the Hilleman Laboratories would be for global needs, nearly 100,000 rotavirus deaths each year occur in India," said Dr. M. K. Bhan, Secretary to the Government of India, Department of Biotechnology, Ministry of Science and Technology. "The Hilleman Laboratories effort to extend the utility of rotavirus vaccine in poor countries is to be welcomed."
Source:
Samantha Cranko
MSD Wellcome Trust Hilleman Laboratories
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First Patient Treated In BioInvent's Phase I Study Of The Drug Candidate BI-505 To Treat Multiple Myeloma
BioInvent International AB (STO:BINV) announced that the first patient has been treated in an open, dose-escalation phase I study of the company's antibody BI-505 for patients with advanced multiple myeloma.
"We are delighted that the clinical studies of BI-505 have started. We believe that BI-505 can address a major unmet medical need and be an important treatment alternative for multiple myeloma."
The phase I study will investigate safety, pharmacokinetics and pharmacodynamics and will aim to define the optimal dose of the antibody for upcoming clinical phase II development. The study will involve 30 - 40 patients. The patients will be treated with intravenous doses of BI-505 every other week for a 28-day period with the possibility of extending the treatment until the condition deteriorates again. The study will be conducted at clinics in the US and will be overseen by renowned multiple myeloma experts.
Last year the US Food & Drug Administration (FDA) approved BioInvent's application to conduct a clinical trial with BI-505 in the US. BI-505 has also been granted orphan drug designation in the US and Europe for multiple myeloma.
BI-505 is a human antibody derived from BioInvent's proprietary n-CoDeR® library based on its ability to bind to a tumour-associated receptor (the adhesion molecule ICAM-1) and induce programmed cell death (apoptosis) in tumour cells. Preclinical studies have shown that the substance also activates the body's own (Fc:Fc gamma receptor dependent) anti-tumour mechanisms and fights cancer more effectively than existing drugs.
Svein Mathisen, CEO of BioInvent, commented: "We are delighted that the clinical studies of BI-505 have started. We believe that BI-505 can address a major unmet medical need and be an important treatment alternative for multiple myeloma."
Source
BioInvent International AB
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"We are delighted that the clinical studies of BI-505 have started. We believe that BI-505 can address a major unmet medical need and be an important treatment alternative for multiple myeloma."
The phase I study will investigate safety, pharmacokinetics and pharmacodynamics and will aim to define the optimal dose of the antibody for upcoming clinical phase II development. The study will involve 30 - 40 patients. The patients will be treated with intravenous doses of BI-505 every other week for a 28-day period with the possibility of extending the treatment until the condition deteriorates again. The study will be conducted at clinics in the US and will be overseen by renowned multiple myeloma experts.
Last year the US Food & Drug Administration (FDA) approved BioInvent's application to conduct a clinical trial with BI-505 in the US. BI-505 has also been granted orphan drug designation in the US and Europe for multiple myeloma.
BI-505 is a human antibody derived from BioInvent's proprietary n-CoDeR® library based on its ability to bind to a tumour-associated receptor (the adhesion molecule ICAM-1) and induce programmed cell death (apoptosis) in tumour cells. Preclinical studies have shown that the substance also activates the body's own (Fc:Fc gamma receptor dependent) anti-tumour mechanisms and fights cancer more effectively than existing drugs.
Svein Mathisen, CEO of BioInvent, commented: "We are delighted that the clinical studies of BI-505 have started. We believe that BI-505 can address a major unmet medical need and be an important treatment alternative for multiple myeloma."
Source
BioInvent International AB
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