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Wednesday, March 6, 2013
Tuesday, March 5, 2013
Daily-use HIV prevention approaches prove ineffective among women, study suggests
Mar. 4, 2013 ? Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa. For reasons that are unclear, a majority of study participants -- particularly young, single women -- were unable to use their assigned approaches daily as directed, according to findings presented today by one of the study's co-leaders at the Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.
The Vaginal and Oral Interventions to Control the Epidemic (VOICE) study, or MTN 003, was designed to evaluate the safety and efficacy of three HIV prevention strategies compared to placebo. Specifically, the trial tested an investigational vaginal gel containing the antiretroviral drug tenofovir, a pill form of tenofovir (brand name Viread), and a pill containing a combination of tenofovir and emtricitabine (brand name Truvada). The study was sponsored and largely funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
In the trial, the three strategies were tested among 5,029 sexually active women 18 to 45 years of age at 15 sites in South Africa, Uganda and Zimbabwe. Nearly half of the study participants were under the age of 25, and most were unmarried (79 percent). Participants in each of the three groups were counseled to use their assigned pill or gel once daily and received free condoms, ongoing counseling on how to reduce their HIV risk, and testing and treatment for sexually transmitted infections. Prior to enrollment, all potential study participants engaged in an oral and written consent process explaining the details of the study.
Study results presented today indicate that most VOICE participants did not adhere to the daily use schedule. Moreover, single women 25 years of age and younger were the least likely to use the investigational products and the most likely to become infected with HIV. The rate of new HIV infections among these young women was nearly 10 percent at some of the study sites in South Africa, reflecting a very high incidence of HIV infection among young women in these communities.
"We do not know why many participants in the VOICE study did not adhere to daily use of these HIV prevention strategies," said NIAID Director Anthony S. Fauci, M.D. "We must continue to conduct research to find additional HIV prevention tools that women will find acceptable and use consistently to protect themselves against infection."
In other HIV prevention studies involving different study populations, including men and women, both oral Truvada and oral tenofovir have demonstrated an ability to reduce the risk of HIV infection when used consistently. However, the VOICE study results are consistent with another clinical trial known as the FEM-PrEP study, which tested daily use of oral Truvada among a similar population of women. Like the VOICE study, researchers found that the majority of FEM-PrEP participants did not follow the daily regimen.
The VOICE study, which launched in 2009, was led by co-investigators Zvavahera Mike Chirenje, M.D., of the University of Zimbabwe in Harare, and Jeanne Marrazzo, M.D., M.P.H., from the University of Washington, Seattle. In fall 2011, oral tenofovir and tenofovir vaginal gel were dropped from the VOICE trial after separate routine reviews of the study data by an independent data and safety monitoring board determined that while each product was safe, neither was effective in preventing HIV compared with placebo. Researchers continued to evaluate oral Truvada until the study's scheduled conclusion in August 2012. Results presented today at the CROI meeting by Dr. Marazzo provided an analysis for each of the study's three product arms.
Of the 5,029 women who enrolled in the VOICE study, 312 became infected with HIV for an overall 5.7 percent rate of new HIV infections -- reflecting a very high overall rate of infection among women in these areas. Twenty-two women were found to be HIV-infected at time of enrollment; therefore, the study's primary analysis was based on 5,007 participants.
There was no statistically significant difference in the rate of new infections between women assigned to the three investigational products and women using placebo. Among the 994 women who were assigned to daily use of Truvada, 61 women became infected with HIV (4.7 percent rate of new infections) compared with 60 of 1,008 women who became infected in the oral placebo group (4.6 percent rate of new infections). Of the 1,002 participants in the daily oral tenofovir group, 60 women acquired HIV. However, the rate of new HIV infections was calculated to reflect what had occurred up until Oct. 3, 2011, when study sites began informing participants that testing of oral tenofovir would end. At this time, 52 women acquired HIV (6.3 percent rate of new infections) compared with 35 of 1,008 women who became infected in the placebo arm (4.2 percent rate of new infections). Of the 1,003 women assigned to use daily tenofovir gel, 61 became infected with HIV (5.9 percent rate of new infections), and 70 infections occurred among the 1,000 women in the placebo gel group (6.8 percent rate of new infections). Women who became infected with HIV during the VOICE study were referred to local sites for appropriate medical care and treatment.
During the course of the study, adherence to each of the three approaches was anticipated to be roughly 90 percent based on what study participants reported to clinic site staff and monthly counts of unused gel applicators and leftover study pills that were returned to the sites. However, in a blood sample analysis of 773 participants, including 185 participants who became HIV-infected, it became clear that adherence was low across each of the study's three investigational product groups. Drug was detected in the blood of 29 percent of the women in the Truvada group, 28 percent in the oral tenofovir group and 23 percent among those in the tenofovir gel group. When examining the data by age, young, single women were less likely to use their assigned treatment strategy. For example, among the women assigned to use oral Truvada, drug was detected in the blood of only 21 percent of young, single women compared to 54 percent of those married and over the age of 25.
"Based on our findings, it is clear that young, single women in Africa continue to be at very high risk for HIV infection and may need the greatest assistance with using prevention strategies consistently," said Dr. Marrazzo. Among VOICE study participants, the rate of new HIV infections was nearly 9 percent among unmarried women under the age of 25 compared to 0.8 percent for older married women, a statistically significant difference.
Through two ongoing behavioral studies involving VOICE participants, researchers are hoping to gain insight as to why the women did or did not use the investigational products. Results from those two studies are expected later this year.
NIAID funded the VOICE study with co-funding from the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, also part of the NIH. The trial was conducted by the NIH-funded Microbicide Trials Network (MTN). Gilead Sciences, Inc., of Foster City, Calif., donated the tenofovir and Truvada tablets. CONRAD of Arlington, Va., provided the tenofovir gel and applicators used to insert the product.
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Story Source:
The above story is reprinted from materials provided by NIH/National Institute of Allergy and Infectious Diseases, via EurekAlert!, a service of AAAS.
Note: Materials may be edited for content and length. For further information, please contact the source cited above.
Note: If no author is given, the source is cited instead.
Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.
Source: http://feeds.sciencedaily.com/~r/sciencedaily/~3/c3MrH1OsvV4/130304151856.htm
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Daily-use HIV prevention approaches prove ineffective among women, study suggests
Mar. 4, 2013 ? Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa. For reasons that are unclear, a majority of study participants -- particularly young, single women -- were unable to use their assigned approaches daily as directed, according to findings presented today by one of the study's co-leaders at the Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.
The Vaginal and Oral Interventions to Control the Epidemic (VOICE) study, or MTN 003, was designed to evaluate the safety and efficacy of three HIV prevention strategies compared to placebo. Specifically, the trial tested an investigational vaginal gel containing the antiretroviral drug tenofovir, a pill form of tenofovir (brand name Viread), and a pill containing a combination of tenofovir and emtricitabine (brand name Truvada). The study was sponsored and largely funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
In the trial, the three strategies were tested among 5,029 sexually active women 18 to 45 years of age at 15 sites in South Africa, Uganda and Zimbabwe. Nearly half of the study participants were under the age of 25, and most were unmarried (79 percent). Participants in each of the three groups were counseled to use their assigned pill or gel once daily and received free condoms, ongoing counseling on how to reduce their HIV risk, and testing and treatment for sexually transmitted infections. Prior to enrollment, all potential study participants engaged in an oral and written consent process explaining the details of the study.
Study results presented today indicate that most VOICE participants did not adhere to the daily use schedule. Moreover, single women 25 years of age and younger were the least likely to use the investigational products and the most likely to become infected with HIV. The rate of new HIV infections among these young women was nearly 10 percent at some of the study sites in South Africa, reflecting a very high incidence of HIV infection among young women in these communities.
"We do not know why many participants in the VOICE study did not adhere to daily use of these HIV prevention strategies," said NIAID Director Anthony S. Fauci, M.D. "We must continue to conduct research to find additional HIV prevention tools that women will find acceptable and use consistently to protect themselves against infection."
In other HIV prevention studies involving different study populations, including men and women, both oral Truvada and oral tenofovir have demonstrated an ability to reduce the risk of HIV infection when used consistently. However, the VOICE study results are consistent with another clinical trial known as the FEM-PrEP study, which tested daily use of oral Truvada among a similar population of women. Like the VOICE study, researchers found that the majority of FEM-PrEP participants did not follow the daily regimen.
The VOICE study, which launched in 2009, was led by co-investigators Zvavahera Mike Chirenje, M.D., of the University of Zimbabwe in Harare, and Jeanne Marrazzo, M.D., M.P.H., from the University of Washington, Seattle. In fall 2011, oral tenofovir and tenofovir vaginal gel were dropped from the VOICE trial after separate routine reviews of the study data by an independent data and safety monitoring board determined that while each product was safe, neither was effective in preventing HIV compared with placebo. Researchers continued to evaluate oral Truvada until the study's scheduled conclusion in August 2012. Results presented today at the CROI meeting by Dr. Marazzo provided an analysis for each of the study's three product arms.
Of the 5,029 women who enrolled in the VOICE study, 312 became infected with HIV for an overall 5.7 percent rate of new HIV infections -- reflecting a very high overall rate of infection among women in these areas. Twenty-two women were found to be HIV-infected at time of enrollment; therefore, the study's primary analysis was based on 5,007 participants.
There was no statistically significant difference in the rate of new infections between women assigned to the three investigational products and women using placebo. Among the 994 women who were assigned to daily use of Truvada, 61 women became infected with HIV (4.7 percent rate of new infections) compared with 60 of 1,008 women who became infected in the oral placebo group (4.6 percent rate of new infections). Of the 1,002 participants in the daily oral tenofovir group, 60 women acquired HIV. However, the rate of new HIV infections was calculated to reflect what had occurred up until Oct. 3, 2011, when study sites began informing participants that testing of oral tenofovir would end. At this time, 52 women acquired HIV (6.3 percent rate of new infections) compared with 35 of 1,008 women who became infected in the placebo arm (4.2 percent rate of new infections). Of the 1,003 women assigned to use daily tenofovir gel, 61 became infected with HIV (5.9 percent rate of new infections), and 70 infections occurred among the 1,000 women in the placebo gel group (6.8 percent rate of new infections). Women who became infected with HIV during the VOICE study were referred to local sites for appropriate medical care and treatment.
During the course of the study, adherence to each of the three approaches was anticipated to be roughly 90 percent based on what study participants reported to clinic site staff and monthly counts of unused gel applicators and leftover study pills that were returned to the sites. However, in a blood sample analysis of 773 participants, including 185 participants who became HIV-infected, it became clear that adherence was low across each of the study's three investigational product groups. Drug was detected in the blood of 29 percent of the women in the Truvada group, 28 percent in the oral tenofovir group and 23 percent among those in the tenofovir gel group. When examining the data by age, young, single women were less likely to use their assigned treatment strategy. For example, among the women assigned to use oral Truvada, drug was detected in the blood of only 21 percent of young, single women compared to 54 percent of those married and over the age of 25.
"Based on our findings, it is clear that young, single women in Africa continue to be at very high risk for HIV infection and may need the greatest assistance with using prevention strategies consistently," said Dr. Marrazzo. Among VOICE study participants, the rate of new HIV infections was nearly 9 percent among unmarried women under the age of 25 compared to 0.8 percent for older married women, a statistically significant difference.
Through two ongoing behavioral studies involving VOICE participants, researchers are hoping to gain insight as to why the women did or did not use the investigational products. Results from those two studies are expected later this year.
NIAID funded the VOICE study with co-funding from the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, also part of the NIH. The trial was conducted by the NIH-funded Microbicide Trials Network (MTN). Gilead Sciences, Inc., of Foster City, Calif., donated the tenofovir and Truvada tablets. CONRAD of Arlington, Va., provided the tenofovir gel and applicators used to insert the product.
Share this story on Facebook, Twitter, and Google:
Other social bookmarking and sharing tools:
Story Source:
The above story is reprinted from materials provided by NIH/National Institute of Allergy and Infectious Diseases, via EurekAlert!, a service of AAAS.
Note: Materials may be edited for content and length. For further information, please contact the source cited above.
Note: If no author is given, the source is cited instead.
Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.
Source: http://feeds.sciencedaily.com/~r/sciencedaily/~3/c3MrH1OsvV4/130304151856.htm
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Sunday, March 3, 2013
Pregnancy permanently changes foot size
Mar. 1, 2013 ? A new University of Iowa study confirms what many women have long suspected -- that pregnancy permanently changes the size and shape of a woman's feet.
Flat feet are a common problem for pregnant women. The arch of the foot flattens out, possibly due to the extra weight and increased looseness (laxity) of the joints associated with pregnancy. The new study, published in the March issue of the American Journal of Physical Medicine & Rehabilitation, suggests that this loss of arch height is permanent.
"I had heard women reporting changes in their shoe size with pregnancy, but found nothing about that in medical journals or textbooks," says Neil Segal, M.D., UI associate professor of orthopaedics and rehabilitation. "In order to study this more scientifically, we measured women's feet at the beginning of their pregnancy and five months after delivery. We found that pregnancy does indeed lead to permanent changes in the feet."
The UI study followed 49 pregnant women and collected static and dynamic arch measurements during the first trimester of pregnancy and again about five months after childbirth. The researchers found that for about 60 to 70 percent of the women in the study, their feet became longer and wider.
Specifically, the study showed that, on average, arch height and measures of arch rigidity decreased significantly comparing early pregnancy with five months after childbirth, causing corresponding increases in foot length (between 2 and 10 mm) and arch drop. However, no significant change in the distribution of foot pressure was detected. The study also suggested that first pregnancies may account for most of the observed changes, while second, third, or higher pregnancies may not further alter foot structure.
"We know that women, and especially women who have had children, are disproportionately affected by musculoskeletal disorders," says Segal, who also is an associate professor of radiology and epidemiology, and director of the Clinical Osteoarthritis Research Program. "It is possible that these foot changes that occur during pregnancy may help explain why, in comparison with men, women are at higher risk for pain or arthritis in their feet, knees, hips and spines."
Segal plans to conduct follow-up studies to assess whether these foot changes lead to health problems, like arthritis, later in life. He also is conducting studies of how women's musculoskeletal health can be protected during pregnancy.
In addition to Segal, the research team included Elizabeth Boyer; Patricia Teran-Yengle; Natalie Glass; Howard Hillstrom; and John Yack. The study was funded in part by grants from the American Geriatrics Society and the National Institute on Aging. The research team can be contacted at 319-335-7900.
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The above story is reprinted from materials provided by University of Iowa. The original article was written by Jennifer Brown.
Note: Materials may be edited for content and length. For further information, please contact the source cited above.
Journal Reference:
- Neil A. Segal, Elizabeth R. Boyer, Patricia Teran-Yengle, Natalie A. Glass, Howard J. Hillstrom, H. John Yack. Pregnancy Leads to Lasting Changes in Foot Structure. American Journal of Physical Medicine & Rehabilitation, 2013; 92 (3): 232 DOI: 10.1097/PHM.0b013e31827443a9
Note: If no author is given, the source is cited instead.
Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.
Source: http://feeds.sciencedaily.com/~r/sciencedaily/strange_science/~3/cWsMycPC-Q4/130301122306.htm
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If You Are Reading This Here You Have Already Failed At Unplugging
Are you noticing that some things are a bit different today? People in cafes are actually talking to each other, no laptops in sight? Drivers at stoplights are accelerating as soon as the light turns green, without that "oops I was just finishing this text" lag? Don't panic, you haven't been somehow transported back to 1995 (though that might be kind of fun, actually.)Source: http://feedproxy.google.com/~r/Techcrunch/~3/SpqWFWOVdNA/
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Saturday, March 2, 2013
Bradley Manning pleads guilty to misusing classified data in WikiLeaks case
FORT MEADE, Maryland (Reuters) - The U.S. Army private accused of providing diplomatic cables and other secret documents to the WikiLeaks website pleaded guilty on Thursday to misusing classified material, but denied the most serious charge in the case, aiding the enemy.
Private First Class Bradley Manning, 25, entered the pleas prior to his court martial, which is set to begin on June 3, in a case that centers on the biggest leak of government secrets in U.S. history.
"I believe that if the general public ... had access to the information ... this could spark a domestic debate as to the role of the military and foreign policy in general," Manning, dressed in full military uniform, testified calmly.
Reading from a 35-page statement as he remained seated next to his lawyers, the short, slight private described his feelings after he submitted the secret information to WikiLeaks.
"I felt I accomplished something that would allow me to have a clear conscience," said Manning, who spoke under oath for more than an hour.
At the hearing, Manning pleaded not guilty to the most serious charge, aiding the enemy, through his attorney. Manning, who has been jailed at Quantico Marine Base in Virginia for more than 1,000 days, could face life imprisonment if convicted of that charge.
He pleaded guilty to a series of 10 lesser charges that he misused classified information at the hearing before military judge Colonel Denise Lind. He faces a maximum of 20 years in prison for those charges.
Under a ruling last month by Lind, Manning would have any sentence reduced by 112 days to compensate for the markedly harsh treatment he received during his confinement. While at Quantico, Manning was placed in solitary confinement for up to 23 hours a day with guards checking on him every few minutes.
Manning admitted to unauthorized possession and willful communication of information from military databases, including the Combined Information Data Network Exchange Iraq and Combined Information Data Network Exchange Afghanistan.
He also admitted to misuse of documents from the U.S. Southern Command pertaining to Guantanamo Bay, a memo from an unnamed intelligence agency, and records from a military operation in Farah province in Afghanistan.
Manning, an Army intelligence officer, was arrested in May 2010 while serving in Iraq and charged with downloading thousands of intelligence documents, diplomatic cables and combat videos and forwarding them to WikiLeaks.
WikiLeaks began exposing the U.S. government secrets in the same year, stunning diplomats around the world and outraging U.S. officials who said damage to national security from the leaks endangered U.S. lives.
WikiLeaks founder Julian Assange has taken refuge in the Ecuadorean Embassy in London since June to avoid extradition to Sweden for alleged sex crimes.
(Editing by Barbara Goldberg, Paul Simao and Tim Dobbyn)
Source: http://news.yahoo.com/wikileaks-soldier-face-judge-weighing-guilty-plea-offer-143448976--sector.html
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Green Blog: Fracking to Unfold Under a Historic Farm
In its ongoing campaign to win over opponents of hydraulic fracturing, the natural gas industry has succeeded in persuading the owner of a historic Pennsylvania farm to allow gas to be extracted from beneath her property.
The owner, Denise Dennis, initially rejected an approach from Cabot Oil and Gas to lease part of her 153-acre farm in gas-rich Susquehanna County in northeastern Pennsylvania. But late last year she changed her mind and signed a lease that allows the company to drill horizontally below her land without sinking any wells within its boundaries.
Ms. Dennis is a direct descendant of Prince Perkins, a free black veteran of the Revolutionary War who came to Pennsylvania from Connecticut and bought the farm in 1793, beginning a continuous record of family ownership that is now in its eighth generation. Part of that legacy is a trove of historic and archaeological materials, including rare records from the Revolutionary and Civil wars as well as evidence that the farm was a stop on the Underground Railroad for slaves fleeing Southern states.
Its 19th-century farmhouse, of major cultural and historical importance, needs repairs that can now be financed with the money from the lease and from royalties that are expected to flow from deposits of gas within the Marcellus Shale, about a mile below the surface.
?I made the best decision I could for my property,? said Ms. Dennis, who has also set up a charitable land trust to restore the farm. ?We couldn?t move forward without the money.? She spoke after making a presentation earlier this week about the farm?s history at the African American Museum in Philadelphia.
Ms. Dennis declined to disclose the terms of her agreement with Cabot.
Still, she estimated that lease and royalty payments will ?take us a long? way to the $20 million to $25 million that she estimates will be needed to renovate the farm house and build an interpretive center for visitors. ?No way is it going to cover everything,? she added, and she is continuing her fund-raising efforts for the project.
Fracking, which involves injecting vast amounts of chemical-laced water into shale formations under enormous pressure to unlock gas, remains controversial in the region. Philadelphia?s City Council has held hearings on whether public water supplies could be contaminated by gas drilling in Pennsylvania.
In an interview, Ms. Dennis confirmed that she had criticized the gas industry in an ?uncharacteristically outspoken? speech in 2010 to the City Council. But then, she said, she did more research that led her to a more ?balanced view? of the pros and cons of the region?s natural gas boom, which has been enabled by the development of the hydraulic fracturing and horizontal drilling technology.
Critics contend that the gas extraction technique risks contaminating underground drinking water sources with toxic chemicals that can cause cancer and other illnesses. The gas companies counter that there is no evidence of water contamination from fracking and that the chemicals are shielded from aquifers by steel and concrete drill casings before being released thousands of feet below drinking water sources.
Ms. Dennis said she initially rejected Cabot?s offer after learning about the gas industry?s impact on nearby Dimock, Pa.. which became a focus of national attention when some of its residents complained of water contamination and attributed it to drilling by Cabot.
But after further discussions with the company, including a meeting with its chief executive, Dan O. Dinges, Ms. Dennis said, she felt more comfortable with the company?s plan and decided that the gas proceeds presented the only opportunity for restoring and preserving her ancestral property.
She said she was no longer concerned that fracking might contaminate groundwater on her property. ?I guess you could say that if I thought it wasn?t safe, I wouldn?t have done it,? Ms. Dennis said. ?I really believe that our natural spring is going to be perfectly safe, and I mean that with all my heart.?
Cabot, a sponsor of Tuesday night?s museum event, sees its association with Ms. Dennis as a sign of its commitment to Susquehanna County, where it expects to be producing natural gas for at least the next 30 years, said George Stark, a company spokesman.
Mr. Stark said Cabot had so far invested $2 billion in the county in recognition of its exceptionally rich gas reserves. Fifteen of Pennsylvania?s 20 most productive wells in 2012 were Cabot wells in Susquehanna County, he said.
Although the company will now be able to extract gas from under the Dennis Farm, its activities will not disturb the historic property itself, he said.
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