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Biomodels' Oral Mucositis Expertise Speeds FDA Approval For ActoGeniX's Phase 1b Trial Of AGO13 In Cancer Patients
Biomodels LLC, a preclinical research organization specializing in cancer support care, announced that its customized research program allowed ActoGeniX NV, a development stage biopharmaceutical company, to rapidly attain Food and Drug Administration (FDA) approval for Phase 1b clinical trials of AGO13 in cancer patients with oral mucositis.
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Covidien Launches Alarm Management System For The Nellcor(TM) OxiMax(TM) N-600x(TM) Pulse Oximeter
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Federal Appeals Court Upholds Virginia Abortion Ban
The full U.S. Court of Appeals for the 4th Circuit in a 6-5 decision on Wednesday upheld Virginia"s 2003 law banning what abortion-rights opponents call "partial-birth" abortion, a procedure known medically as intact dilation and extraction, the AP/Hartford Courant reports (O"Dell, AP/Hartford Courant, 6/24). In 2005, a three-judge panel of the U.S. Court of Appeals for the 4th Circuit ruled 2-1 to strike down the Virginia law on the grounds that it does not include adequate exceptions to protect a woman"s health. The U.S. Supreme Court two years ago ordered the appeals court to revisit the issue when it upheld the Partial Birth Abortion Ban Act of 2003, a federal law similar to the Virginia law (White, Washington Post, 6/25). The three-judge appeals panel again struck down the law in 2008 (AP/Hartford Courant, 6/24). The Virginia law permits women to choose various abortion procedures but makes it a crime for providers to perform an intact dilation and extraction, which involves crushing a fetus" skull to ease removal (Washington Post, 6/25). Abortion-rights supporters said that the Virginia law is unconstitutional because its broad definition of intact dilation and extraction could also prohibit standard dilation and extraction, the more common form of second-trimester abortion. Violations of the law would be considered a felony and punishable by up to 10 years in prison. The case is Richmond Medical Center v. Herring (AP/Hartford Courant, 6/24). William Fitzhugh, the Richmond doctor who challenged the Virginia law, said that the banned procedure is necessary to protect the life of the woman in some cases and that the law could prevent abortion providers from performing legal procedures out of fear of prosecution. Stephanie Toti, a Center for Reproductive Rights attorney who represented the plaintiffs, said that the Virginia law is broader than federal law because it punishes abortion providers who accidentally violate the law while performing legal abortion procedures. Judge"s Opinions Judge Paul Niemeyer in the majority opinion wrote that Virginia law protects physicians who are taking needed steps to save a patient"s life and should prevent "a Morton"s fork, where the doctor must choose between criminal liability or care that the doctor believes is not in the best interest of the patient." He added that the circumstances in which doctors could face criminal liability are so limited that they should not invalidate the law in every other case. Judge Blane Michael wrote in the dissenting opinion that the law will create a "real fear of criminal liability" among physicians because it will have the effect of criminalizing the actions of those who seek to perform legal procedures but need to use the banned procedure in rare instances. Michael wrote that the law therefore "places an undue burden on a woman"s right to obtain a pre-viability second trimester abortion -- a constitutional right repeatedly reaffirmed by the Supreme Court" (Washington Post, 6/25).Next StepsToti said that no decision has been made on whether to appeal the decision to the Supreme Court. The Supreme Court"s 2007 decision on the federal law made it clear that abortion bans must include exceptions for the health of the woman, the AP/Hartford Courant reports. Toti said that the appeals court"s decision "just really ignores that precedent." She added, "It"s really insulting to women"s dignity that the court would put so little priority on protecting women"s health and well-being" (AP/Hartford Courant, 6/25). Toti also said, "It puts doctors in a really untenable position because it forces doctors to choose between taking all the steps necessary to protect their patients and committing a felony" (Washington Post, 6/25). Virginia Attorney General Bill Mims said, "While we anticipate that the U.S. Supreme Court may be asked to review the decision, I am confident that the Supreme Court ultimately will uphold the law" (AP/Hartford Courant, 6/25).
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Nightmares Predict Elevated Suicidal Symptoms

Self-reported nightmares among patients seeking emergency psychiatric evaluation uniquely predicted elevated suicidal symptoms, according to a research abstract presented at SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies. Results indicate that severe nightmares were independently associated with elevated suicidal symptoms after accounting for the influence of depression, whereas symptoms of insomnia were not. These findings suggest that nightmares stand alone as a suicide risk factor. The sample included 82 men and women between the ages of 18 and 66, who were in a community mental health hospital admissions unit awaiting an emergency psychiatric evaluation. Evaluations determined eligibility for crisis stabilization inpatient admittance. Patients" nightmares, insomnia, depression and suicidal tendencies were assessed through several questionnaires, including the Disturbing Dreams and Nightmare Severity Index, Insomnia Severity Index (ISI), Beck Depression Inventory (BDI), and the Beck Scale for Suicide Ideation (BSS). According to principal investigator, Rebecca Bernert, doctoral candidate in clinical psychology at Florida State University, findings of the study emphasize the need for a more thorough assessment of sleep among acutely-ill patients, as it may be an important opportunity for intervention. "Sleep disturbances, especially nightmares, appear to be an acute warning sign and risk factor for suicide," said Bernert. "Given that poor sleep is amenable to treatment, and less stigmatized than depression and suicide, our findings could impact standardized suicide risk assessment and prevention efforts." The study states that sleep complaints are now listed among the top 10 warning signs of suicide by the Substance Abuse and Mental Health Services Administration (SAMHSA). Sleep and mood disturbances are closely related, and depression is the single best predictor of suicide. People who suffer from persistent sleep problems should consult a sleep expert at one of the 1,600 centers accredited by the American Academy of Sleep Medicine (AASM). Those experiencing a suicidal crisis or emotional distress are encouraged to contact the National Suicide Prevention Lifeline, which offers a 24-hour crisis hotline. Abstract Title: Insomnia and Nightmares as Predictors of Elevated Suicide Risk Among Patients Seeking Admission to Emergency Mental Health Facility Presentation Date: Tuesday, June 9 Category: Sleep in Psychiatric Disorders Abstract ID: 1120 Kelly Wagner American Academy of Sleep Medicine


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