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The Department of Health and Human Services.
TLDR
This letter is in response to your two Citizen Petitions, requesting that the Food and Drug Administration (FDA or the Agency) require a cancer warning on cosmetic talc products.Abstract:
This letter is in response to your two Citizen Petitions dated November 17, 1994 and May 13, 2008, requesting that the Food and Drug Administration (FDA or the Agency) require a cancer warning on cosmetic talc products. Your 1994 Petition requests that all cosmetic talc bear labels with a warning such as \"Talcum powder causes cancer in laboratory animals. Frequent talc application in the female genital area increases the risk of ovarian cancer.\" Additionally, your 2008 Petition requests that cosmetic talcum powder products bear labels with a prominent warning such as: \"Frequent talc application in the female genital area is responsible for major risks of ovarian cancer.\" Further, both of your Petitions specifically request, pursuant to 21 CFR 1 0.30(h)(2), a hearing for you to present scientific evidence in support of this petition.read more
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Immunodeficiency at the start of combination antiretroviral therapy in low-, middle-, and high-income countries.
Dorita Avila,Keri N. Althoff,Catrina Mugglin,Kara Wools-Kaloustian,Manuel Koller,François Dabis,Denis Nash,Thomas Gsponer,Somnuek Sungkanuparph,Catherine C. McGowan,Margaret T May,David A. Cooper,Cleophas Chimbetete,Marcelo Wolff,Ann C. Collier,Hamish McManus,Mary-Ann Davies,Dominique Costagliola,Brenda Crabtree-Ramírez,Romanee Chaiwarith,Angela Cescon,Morna Cornell,Lameck Diero,Praphan Phanuphak,Adrien Sawadogo,Jochen Ehmer,Serge Eholié,Patrick C.K. Li,Matthew P. Fox,Neel R. Gandhi,Elsa González,Christopher K C Lee,Christopher J. Hoffmann,Andrew Kambugu,Olivia Keiser,Rossana Ditangco,Hans Prozesky,Fiona C Lampe,Nagalingeswaran Kumarasamy,Mari M. Kitahata,Emmanuel Lugina,Rita Lyamuya,Saphonn Vonthanak,Valeria Fink,Antonella d'Arminio Monforte,Paula M. Luz,Yi Ming Arthur Chen,Albert Minga,Jordi Casabona,Albert Mwango,Jun Yong Choi,Marie-Louise Newell,Elizabeth A. Bukusi,Kapella Zacharia Ngonyani,Tuti Parwati Merati,Juliana A. Otieno,Mwebesa B. Bosco,Sam Phiri,Oon T Ng,Kathryn Anastos,Jürgen K. Rockstroh,Ignacio Santos,Shinichi Oka,Geoffrey Somi,Christoph Stephan,Ramón Teira,Deo Wabwire,Gilles Wandeler,Andrew Boulle,Peter Reiss,Robin Wood,Benjamin H. Chi,Carolyn Williams,Jonathan A C Sterne,Matthias Egger +74 more
TL;DR: Median CD4 cell counts at the start of cART increased 2000–2009 but remained below 200 cells/&mgr;L in LIC and MIC and below 300 cells/ &mgr:L in HIC.
Journal ArticleDOI
Relationship of National Institutes of Health Stroke Scale to 30-Day Mortality in Medicare Beneficiaries With Acute Ischemic Stroke
Gregg C. Fonarow,Jeffrey L. Saver,Eric E. Smith,Joseph P. Broderick,Dawn Kleindorfer,Ralph L. Sacco,Wenqin Pan,DaiWai M. Olson,Adrian F. Hernandez,Eric D. Peterson,Lee H. Schwamm +10 more
TL;DR: The NIHSS provides substantial prognostic information regarding 30-day mortality risk in Medicare beneficiaries with acute ischemic stroke and is a very strong discriminator of mortality risk, whether used as a continuous or categorical risk determinant.
Journal ArticleDOI
Altered Extracellular Vesicle Concentration, Cargo, and Function in Diabetes.
David W. Freeman,Nicole Noren Hooten,Erez Eitan,Jamal Green,Nicolle A. Mode,Monica Bodogai,Yongqing Zhang,Elin Lehrmann,Alan B. Zonderman,Arya Biragyn,Josephine M. Egan,Kevin G. Becker,Mark P. Mattson,Ngozi Ejiogu,Michele K. Evans +14 more
TL;DR: It is found that insulin resistance increases the secretion of EVs, which are preferentially internalized by leukocytes, and alters leukocyte function, and collectively, these results suggest that insulin resistant people have higher levels of EVs.
Journal ArticleDOI
Impact of Meditation on Resting and Ambulatory Blood Pressure and Heart Rate in Youth.
TL;DR: These findings demonstrate the potential beneficial impact of meditation on blood pressure and heart rate in the natural environment in healthy normotensive youth.
Journal ArticleDOI
Common source outbreaks of Campylobacter infection in the USA, 1997-2008.
Ethel Taylor,Karen M Herman,E. C. Ailes,Collette Fitzgerald,J. S. Yoder,Barbara E. Mahon,Robert V. Tauxe +6 more
TL;DR: Reports of reported outbreaks of campylobacteriosis increased during a period of declining overall incidence, and seasonality of outbreaks resembled that of sporadic infections.
References
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An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial
TL;DR: This herbal mixture of Ma Huang and Guarana effectively promoted short-term weight and fat loss and safety with long-term use requires further investigation.
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Historical background of clinical trials involving women and minorities
TL;DR: A historical context for the difficult ethical and clinical issues associated with the inclusion of women and members of minority groups in clinical research is provided.
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Reported Complications of Silicone Gel Breast Implants: An Epidemiologic Review
Barbara G. Silverman,S. L. Brown,Roselie A. Bright,Ronald G. Kaczmarek,J B Arrowsmith-Lowe,D A Kessler +5 more
TL;DR: This review presents an overview of the most common adverse outcomes that have been reported with silicone gel breast implants and focuses on silicone breast implants rather than saline-filled implants, which have been the focus of the greatest health concerns.
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Serum levels of TCDD and dioxin-like chemicals in Rhesus monkeys chronically exposed to dioxin: correlation of increased serum PCB levels with endometriosis
Sherry E. Rier,Wayman E. Turner,Dan C. Martin,Richard W Morris,George W. Lucier,George C. Clark +5 more
TL;DR: It is demonstrated that the serum levels of TCDD and specific dioxin-like PHAH congeners were increased in TCDd-treated animals with endometriosis 13 years after the T CDD exposure, and the severity of disease correlated with the serum concentration of 3,3',4,4'-TCB.
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Aiding troubled employees: The prevalence, cost, and characteristics of employee assistance programs in the United States
Tyler Hartwell,Paul D. Steele,Michael T. French,Frank J. Potter,Nathaniel F. Rodman,Gary A. Zarkin +5 more
TL;DR: EAPs are becoming a more prevalent point of access to health care for workers with personal problems such as substance abuse, family problems, or emotional distress by worksite size, industry, and census region.