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"An experimental gene therapy that turns a patients own blood cells into cancer killers worked in a major study with more than onethird of very sick lymphoma patients showing no sign of disease six months after a single treatment its maker said Tuesday. In all percent of patients had their cancer shrink at least by half at some point in the study. Its sponsor Californiabased Kite Pharma is racing Novartis AG to become the first to win approval of the treatment called CART cell therapy in the U.S. It could become the nations first approved gene therapy. A hopeful sign the number in complete remission at six months percent is barely changed from partial results released after three months suggesting this onetime treatment might give lasting benefits for those who do respond well. This seems extraordinary ... extremely encouraging said one independent expert Dr. Roy Herbst cancer medicines chief at the Yale Cancer Center. The worry has been how long Kites treatment would last and its side effects which he said seem manageable in the study. Followup beyond six months is still needed to see if the benefit wanes Herbst said but added this certainly is something I would want to have available. The therapy is not without risk. Three of the patients in the study died of causes unrelated to worsening of their cancer and two of those deaths were deemed due to the treatment. It was developed at the governments National Cancer Institute and then licensed to Kite. The Leukemia and Lymphoma Society helped sponsor the study. Results were released by the company and have not been published or reviewed by other experts. Full results will be presented at the American Association for Cancer Research conference in April. The company plans to seek approval from the U.S. Food and Drug Administration by the end of March and in Europe later this year. The treatment involves filtering a patients blood to remove key immune system soldiers called Tcells altering them in the lab to contain a gene that targets cancer and giving them back intravenously. Doctors call it a living drug permanently altered cells that multiply in the body into an army to fight the disease. Patients in the study had one of three types of nonHodgkin lymphoma a blood cancer and had failed all other treatments. Median survival for such patients has been about six months. Kite study patients seem to be living longer but median survival isnt yet known. With nearly nine months of followup more than half are still alive. Six months after treatment percent still had a partial response cancer shrunk at least in half and percent were in complete remission no sign of disease. The numbers are fantastic said Dr. Fred Locke a blood cancer expert at Moffitt Cancer Center in Tampa who coled the study and has been a paid adviser to Kite. These are heavily treated patients who have no other options. One of his patients yearold Dimas Padilla of Orlando was driving when he got a call saying his cancer was worsening chemotherapy was no longer working and there was no match to enable a second try at a stem cell transplant. I actually needed to park ... I was thinking how am I going to tell this to my mother my wife my children he said. But after CART therapy last August he saw his tumors shrink like ice cubes and is now in complete remission. They were able to save my life Padilla said. Of the study participants percent developed a dangerous condition where the immune system overreacts in fighting the cancer but that rate is lower than in some other tests of CART therapy. The rate fell during the study as doctors got better at detecting and treating it sooner. Roughly a third of patients developed anemia or other bloodcountrelated problems which Locke said were easily treated. And percent had neurological problems such as sleepiness confusion tremor or difficulty speaking but these typically lasted just a few days Locke said. Its a safe treatment certainly a lot safer than having progressive lymphoma and comparable to combination chemotherapy in terms of side effects said the cancer institutes Dr. Steven Rosenberg who had no role in Kites study. The first lymphoma patient Rosenberg treated this way a Florida man is still in remission seven years later. There were no cases of swelling and fluid in the brain in this or any other study testing Kites treatment company officials said. That contrasts with Juno Therapeutics which has had a CART study put on hold twice after five patient deaths due to this problem. Company officials would not say what the treatment might cost but other types of immune system therapies have been very expensive. Its also being tested for some other types of blood cancer."
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"When it comes to preventing blood clots after a knee replacement good old aspirin may be just as effective as newer more expensive drugs. That swap could help reduce the cost of caring for the nearly million Americans who have a knee fixed each year Michigan Medicine researchers say. After knee surgery theres a risk of blood clots in the legs or lungs. So its routine for patients to take clotpreventing drugs for some time afterward. Some doctors choose powerful anticlotting drugs like heparin Lovenox and rivaroxaban Xarelto but it hasnt been clear whether these expensive prescription drugs work any better than cheap readily available aspirin. Aspirin alone may provide similar protection compared to anticoagulation treatments says Brian R. Hallstrom M.D. an orthopaedic surgeon and associate chair for quality and safety at the University of Michigan Department of Orthopaedic Surgery. Hallstrom is the lead author of a new study published in JAMA Surgery that found few patients developed a blood clot after surgery and those patients on aspirin fared just as well as those on anticoagulants. Aspirin use growing During the twoyear study period from to aspirin use rose from percent to percent among the patients cared for by orthopaedic surgeons in the Michigan Arthroplasty Registry Collaborative Quality Initiative a statewide effort to give patients the best possible recovery and outcomes after hip and knee replacements. Since then the shift has become even more distinct Aspirin prescribing has risen to percent among Michigan surgeons says Hallstrom who is codirector of the initiative and a health services researcher at UMs Institute for Healthcare Policy and Innovation. Based on the experience of Michigan patients undergoing knee replacement the study may further the debate about the routine use of aspirin for clot prevention. A recent Canadian study looked at the issue but the analysis had a caveat Each of the more than clinical trial patients received rivaroxaban the first five days after surgery. After that they continued with the drug or switched to aspirin. The new UM study suggests patients may be adequately protected if they take aspirin alone from day one. This study is truly a realworld experience of what happened in Michigan when the majority of surgeons switched to aspirin Hallstrom says. The incidence of blood clots pulmonary embolus and death did not increase despite this dramatic change in practice. Shifting procedure and dialogue Over the past decade surgeons have turned away from powerful anticoagulants and toward aspirin used in addition to nondrug improvements such as compression devices for thwarting clots. These days most patients have a generally low risk of blood clots after knee replacement for a number of reasons. Those reasons include shorter surgical times less invasive procedures and use of regional anesthesia that allows early mobilization after surgery Hallstrom says. Some patients are even going home the same day. The most important way to prevent blood clots is getting moving says Hallstrom noting that people are at risk for blood clots when they sit or lie in one position for too long such as on an airplane or a hospital bed. Still pharmaceutical recommendations vary. The critical care specialists who make up the American College of Chest Physicians favor heparin to reduce the risk of blood clots while the American Academy of Orthopaedic Surgeons guidelines state that no one drug is better than another for preventing clots. Advantages of aspirin The UM study involved patients undergoing knee replacement surgery at any of the Michigan hospitals in the surgical quality group. Onethird of the patients took aspirin alone percent took only an anticoagulant and percent took an aspirinanticoagulant combination. Over three months just . percent of aspirin patients developed a serious blood clot. That was true for . percent of anticoagulant patients according to the Michigan study. This was not statistically different. So neither drug appeared better than the other but aspirin has some obvious advantages. Aspirin is easy to take and much less expensive Hallstrom says. Patients can get it over the counter for pennies while the other anticoagulants require monitoring injections frequent dose adjustments and are extremely expensive. The reported cost for a day supply of rivaroxaban is approximately to heparin is estimated at to . Although warfarin costs a few dollars for a day supply its cost approaches that of the other anticoagulants when doctor visits for monitoring are factored in Hallstrom says. In contrast aspirin costs approximately a month. The study suggests most patients can have just aspirin without increasing the risk for venous thromboembolism but doctors need to consider factors such as a patients history of clots obesity and ability to mobilize after surgery when determining the best measure for clot prevention Hallstrom adds."
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"Depression affects more than million Americans a year https but fewer than half get treatment https Now researchers are turning to social media to shrink that gap and give doctors another way to find people at risk. A study published Monday http in the Proceedings of the National Academy of Sciences suggests that analyzing language from Facebook posts can predict whether a user is depressed three months before the person receives a medical diagnosis. The work is still in very early stages the researchers from the University of Pennsylvania and Stony Brook University cautioned. The study was based on a group of fewer than users and the predictive model is only moderately accurate. But this approach could hold promise for the future they said. Depression is a really debilitating disease and we have treatments that can help people said Raina Merchant one of the study authors and director of the Penn Medicine Center for Digital Health. We want to think of new ways to get people resources and identification for depression earlier. Researchers recruited participants for the study from a hospital emergency department asking for permission to access their electronic medical records and Facebook history. For every participant who had a diagnosis of depression in the medical records researchers found five people who did not creating a sample that mirrored rates of depression in the national population. Examining more than Facebook posts from both groups researchers determined which words post lengths frequency of posting and timing of posts were most associated with a depression diagnosis. They found people with depression used the words I my and me as well as such words as hurt tired and hospital more often than others in the months preceding their diagnosis. Using indicators such as these they built a computer model that could predict which people would receive a depression diagnosis with comparable accuracy to commonly used clinical surveys. The model worked best when using Facebook data from the three months right before a participant received a depression diagnosis. When longer periods of Facebook data were included the model became less precise. Were at the very beginning of trying to understand how this data is sometimes people just saying hi to each other but sometimes it can give us insight into the health of individuals and communities Merchant said. Depression symptoms manifest differently by race gender and age https and can be affected by other diseases httpcare.diabetesjournals.orgcontent making it difficult to diagnose. Most screening tools rely on people accurately reporting their own symptoms and answering survey questions which can be interpreted differently https based on a persons cultural background and language skills. Primarycare doctors can screen for depression but their visits with patients are often short and months apart leaving the discussion focused on crises and immediate concerns. With social media and other data you can start to fill in those gaps said Munmun De Choudhury an assistant professor in Georgia Techs School of Interactive Computing who was not involved in the study. Her previous research has shown that Twitter data can be used to predict http_.pdf which users will develop symptoms of depression. In the future if patients shared social media data with their doctors it could create more personalized care De Choudhury said. How is their social life Are they getting enough sleep A lot of these attributes you can measure using social media she said. Social media data could be used for public health too De Choudhury said. For example the Centers for Disease Control and Prevention could figure out which communities are most at risk for suicide by examining their online posts and then target specific prevention measures to them. Facebook and Google have started taking steps in this direction. Facebook uses artificial intelligence to flag posts httpsnewsroom.fb.comnewsbuildingasafercommunitywithnewsuicidepreventiontools that indicate risks of self harm or suicide. From there an employee can direct people to national suicide prevention resources. Google prompts users who search depressionrelated terms httpfortune.comgoogledepressionscreening to take a screening questionnaire. Advertisement Its encouraging to see these companies take social responsibility De Choudhury said but this can be only one aspect of mental health care. Predictive models built on social media are not highly accurate yet. Theyre also built on small sample sizes which means they may not work the same in a large diverse population. You shouldnt be using such an algorithm by itself at any point in time she said. It needs to be combined with traditional screening surveys for depression and clinical expertise. Another reason to be cautious with the use of social media for health care is the issue of privacy Merchant said. We should see this data the way we do any health data she said. It is the data of the patients. But its a tricky premise given recent highprofile data breaches including one that compromised millions of Facebook users http There are also concerns that social media do more than reflect ones mental health. Some studies have shown that those with greater social media use are more likely to be depressed https or have eating disorders httpsonlinelibrary.wiley.comdoiabs.eat.. But other studies show social media can be helpful in connecting people http to resources and peer support. More research is needed Merchant said. We need a better understanding of not just how it tells us about our health but also how the use of technology affects our health."
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"Coronary artery disease is a condition in which a waxy substance called plaque builds up inside the arteries which supply oxygenrich blood to your heart. Eventually an area of plaque can rupture and cause a blood clot to form on the plaques surface. If the blockage isnt treated quickly the portion of heart muscle fed by the artery begins to die. This heart damage may go unrecognized and lead to severe or longlasting problems. Coronary artery bypass grafting CABG is a surgical procedure that improves blood flow to the heart by bypassing clogged arteries. CABG was once thought to be too risky for patients with the longterm effects of coronary artery disease left ventricular dysfunction when the left side of the heart is unable to pump normally and heart failure when the heart cant pump enough blood to meet the bodys needs. Early studies of the safety and effectiveness of CABG excluded most patients with these conditions. The procedure was typically used to relieve disabling angina or chest pain. A team led by Dr. Eric J. Velazquez of Duke University Medical Center conducted a year randomized controlled trial to investigate the effects of CABG on patients with coronary artery disease that shows sign of left ventricular dysfunction and heart failure. More than patients were included in the clinical trial. They were randomly assigned to receive either CABG plus medical treatment or medical treatment alone. The medical treatment included guidelinedirected medications and devices. Patients had followup evaluations every months for the first year and then every subsequent months. An extension study evaluated the year outcomes of the surgical intervention. Almost all the participants were included in the year followup results. The research was funded by NIHs National Heart Lung and Blood Institute NHLBI. Results were published online in the New England Journal of Medicine on April . Death from any cause occurred in patients in the CABG group and in patients receiving medical treatment alone. A total of patients in the CABG group and patients in the medical treatment group died from cardiovascular causes. In addition the bypass surgery was associated with an overall .year increase in median survival time . vs. . years. These results show that CABG improves survival for people with coronary artery disease left ventricular dysfunction and heart failure. The current year followup provides new important insights about patient subgroups that are more likely to benefit from CABG as compared to medical therapy alone explains NHLBI Director Dr. Gary H. Gibbons. As such we now have a solid evidence base to inform patient care and the future development of clinical practice recommendations. Related Links Who to Treat with Statins https Fending Off Cardiovascular Disease https Coronary Heart Disease http Coronary Heart Disease Risk Factors http Heart Disease in Women http What is Heart Surgery http Heart Failure http References CoronaryArtery Bypass Surgery in Patients with Ischemic Cardiomyopathy. https Velazquez EJ Lee KL Jones RH AlKhalidi HR Hill JA Panza JA Michler RE Bonow RO Doenst T Petrie MC Oh JK She L Moore VL DesvigneNickens P Sopko G Rouleau JL STICHES Investigators. N Engl J Med. Apr . Epub ahead of print. PMID . Funding NIHs National Heart Lung and Blood Institute NHLBI."
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"Following a concussion or mild traumatic brain injury TBI patients may suffer from light sensitivity or photophobia making it challenging to return to normal activities. The sensitivity may also trigger or exacerbate headaches. While sunglasses can provide some relief from photophobia wearing them all the time is not always a practical solution nor is it pleasant for patients to live in a dark room for days at a time. A new study from the University of Cincinnati UC published online this week in the Journal of Athletic Training httpnatajournals.orgdoipdf... assessed the use of colored lenses in postconcussion patients and found wearing certain colortinted sunglasses may be a good alternative to dark sunglasses. While sunglasses can provide some relief they are not very practical indoors or in low light environments says Joe Clark PhD professor in the Department of Neurology and Rehabilitation Medicine at the UC College of Medicine and lead author of the study. What is needed is a light mitigation strategy that can be readily employed indoors which can optimize relief in those who suffer from photophobia or light sensitivity. Clark and researchers at the College of Medicine assessed visual symptoms of concussion patients and used frames with varying colored lenses to find out if certain hues provided relief from photophobia. We found that percent of patients reporting photophobia had relief of the symptoms with one or more colors blue green red and purplewith no reported adverse events Clark says. Sensitivity to light can be common and impact activities of daily life suggesting that light mitigation might improve quality of life in many of these patients. Photophobia is a common symptom for patients following traumatic brain injury. Our goal in this study was to provide medical staff like athletic trainers with a method and means to assess and subsequently provide relief to an athlete who may be experiencing symptoms of photophobia Clark adds. The goal is to help the concussion patient feel better as the brain heals. We compare the colored glasses to being like a brace or cast but for the brain he says. It is temporary but prevents further injury or pain. At least . million people in the United States sustain a concussion or traumatic brain injury every year many not for the first time. As with many other health conditions the presentation of concussion symptoms can vary greatlywhile some individuals exhibit very little to no change in functionality and may report no symptoms at all others may report confusion headache decreased balance and vision disturbances including blurry vision trouble focusing and sensitivity to light. Photophobia is so common that many neurosurgical intensive care units consider it standard operating procedure to keep lights dimmed in rooms containing TBI patients says Clark. In addition to trying coloredlens sunglasses the article suggests other ways to mitigate photophobia including wearing a widebrimmed hat when outdoors adjusting digital screen and device settings to an appropriate hue and brightness or purchasing filters for screens. However the researchers noted they do not recommend wearing colored glasses while driving. Certain colors make seeing stop lights or emergency vehicle lights difficult. We believe that an athletic trainer in consultation with team physicians may find it useful to apply this photophobia assessment and recommend colored glasses to his or her athlete Clark says. The use of the colored glasses in the high school college or other setting can allow a person to engage in some medically approved activities while minimizing the risk of symptom exacerbation. We believe the use of the colored glasses that provide photophobia mitigation has added benefits superior to dark sunglasses especially for indoor lighting. Additional researchers on the study include Jon Divine MD a professor in the Department of Orthopaedic Surgery at the UC College of Medicine and head team physician for University of Cincinnati Athletics. There was no funding used for this study."
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"In the past all forms of metastatic prostate cancer have been considered incurable. In recent years the FDA has approved six drugs for men with metastatic disease all of which can increase survival. In a study httpdx.doi.org.j.urology... published in Urology http researchers demonstrate for the first time that an aggressive combination of systemic therapy drug treatment with local therapy surgery and radiation directed at both the primary tumor and metastasis can eliminate all detectable disease in selected patients with metastatic prostate cancer. While the study is only a first step onefifth of the patients treated had no detectable disease with an undetectable prostatespecificandrogen PSA and normal blood testosterone after months. The results suggest that some men who have previously been considered incurable can possibly be cured investigators also establish a new paradigm for testing various drug combinations in conjunction with local treatment of the prostate to determine which is the best approach ie has the highest undetectable disease rate. Such results could not have been achieved with any single therapy alone. According to lead investigator Howard I. Scher MD Chief of the Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center in New York City The sequential use of the three different modalities helped illustrate the role and importance of each in achieving the undetectable PSA with normal testosterone level end point which represents a noevidence of disease status. Longer followup is needed to determine whether these patients were in fact cured. Twenty men with metastatic prostate cancer five with extrapelvic lymph nodal disease and with bone with or without nodal disease were treated with androgen deprivation therapy ADT radical surgery that included a retroperitoneal lymph node dissection as needed and radiation therapy to visible metastatic lesions in bone. ADT was stopped after a minimum of six months if an undetectable PSA was achieved after combined modality therapy. Other patients were treated continuously. The combined treatment regimen including surgery was well tolerated. Matthew J. OShaughnessy MD PhD Urology Service Department of Surgery Memorial Sloan Kettering Cancer Center commented While the role of local therapy in metastatic prostate cancer is still under investigation aggressive resection of visible disease performed by experienced surgeons was critical to the outcome. Of the five patients with extrapelvic lymph node involvement four achieved an undetectable PSA after ADT and surgery while the fifth needed radiation to reach this milestone. However none achieved the primary end point of undetectable PSA with testosterone recovery at months after initiation of therapy with ADT alone although one patient had a PSA of . ngmL with a testosterone level of ngdL at months. Of the patients with bone metastases reached an undetectable PSA when ADT surgery and radiation were used. Ultimately four achieved the proposed end point a PSA of . ngmL and serum testosterone of ngdL at months after the start of ADT which remained undetectable in two patients for and months respectively. Commenting on the study Oliver Sartor MD Cancer Research Department of Medicine and Urology Tulane University School of Medicine New Orleans LA stated The end point deserves special mention as the end point of undetectable PSA after testosterone recovery has been previously discussed but rarely studied. The authors proposed that this end point may serve as a first step toward establishing a curative paradigm. Many in the field agree but note that the longevity of effect is essential to prove the point of curability. Regardless the movement toward a curative paradigm is much needed and the investigators are to be congratulated for setting forth a paradigm that can be used to assess the possibility of cure in a reasonable period of time. A multimodal treatment strategy for patients who present with disease that is beyond the limits of curability by any single modality enables the evaluation of new approaches in order to prioritize largescale testing in early stages of advanced disease. The end point also shifts the paradigm from palliation to cure remarked Dr. Scher. It is expected that an upcoming Phase trial will further test this endpoint and combined modality approach."
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"When it comes to shedding pounds and improving or eliminating type diabetes gastric bypass surgery may be better than other surgical weightloss procedures two new studies find. But obese patients should be careful to choose surgeons who have performed a high volume of these procedures before committing said Dr. Guilherme M. Campos lead author of one of two papers appearing in the February issue of the Archives of Surgery. Gastric bypass and lapbanding are the two most common surgical weightloss procedures performed in the United States. The former involves stapling the stomach so food has to bypass a section of the small intestine meaning you get full faster and less food gets absorbed into the gut. Lapbanding introduced in involves separating the stomach into two sections with a band so simply speaking eating too much becomes more difficult. Its a diet with a seatbelt said Dr. Mitchell Roslin chief of bariatric surgery at Lenox Hill Hospital in New York City and Northern Westchester Hospital in Mt. Kisco N.Y. In a third type of weightloss procedure known as sleeve gastrectomy surgeons remove part of the stomach. The study led by Campos compared weight loss and diabetes outcomes in patients who underwent gastric bypass surgery with patients who underwent lapbanding. Gastric bypass is considered riskier and more technically demanding than the band. All patients were morbidly obese with a bodymass index higher than and in each group had type diabetes. Although Campos is now an associate professor of surgery at the University of Wisconsin School of Medicine and Public Health in Madison he conducted the study while at the University of California San Francisco. In the bypass group patients lost an average of percent of their excess weight vs. percent for those in the lapbanding group. Threequarters of those undergoing gastric bypass surgery saw their diabetes improve or resolve vs. only half in the other group. The average cost of a bariatric surgery is nearly according to a recent study from Johns Hopkins University. Like all surgeries weightloss surgery carries its own set of possible risks including bleeding blood clots infection and leaks from sites where body tissues are sewn or stapled together according to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases. Later complications may include malnutrition hernias and a tendency in about one in people to regain much of the weight they lost as a result of the procedure. In Campos study roughly equal numbers of patients in each group experienced complications after one year percent in the gastric bypass group compared to percent in the lapbanding group these included infection internal bleeding and blood clots but no deaths. More people in the bypass group had complications right after the surgery. More of those undergoing lapbanding however needed repeat surgeries percent vs. percent. The second study conducted in Taiwan and led by Dr. WeiJei Lee of the MinSheng General Hospital involved randomly assigning obese but not morbidly obese patients with type diabetes to receive gastric bypass surgery or sleeve gastrectomy. Almost all of those undergoing gastric bypass surgery percent had their diabetes resolved vs. only half in the other group these numbers declined to percent and percent after a year. Those in the gastric bypass group also lost more weight and there were no serious complications in either group. There are various theories to explain why gastric bypass may be superior including one that attributes the success to changes in hormones that control the metabolism of blood sugar. And certain procedures may still be preferable for certain patient populations added Roslin such as bands for patients with lower BMI who dont have so many metabolic challenges. Everyone thinks that all weightloss operations are the same even the doctors and the surgeons. But theyre different and they have different resolutions of comorbidities and probably should be used for different indications he said. An editorial accompanying the studies noted the results should be interpreted with caution since longerterm data is not yet available. More information Visit the American Society for Metabolic and Bariatric Surgery for more on weightloss procedures http_fs_surgery.pdf. SOURCES Guilherme M. Campos M.D. Ph.D. associate professor surgery University of Wisconsin School of Medicine and Public Health Madison Mitchell Roslin M.D. chief bariatric surgery Lenox Hill Hospital New York City and Northern Westchester Hospital Mt. KisCo N.Y. February Archives of Surgery"
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"When Kelly Hidleburgs confounding case of anemia was traced to heavy bleeding due to uterine fibroids she faced the same tough choice that confronts thousands of American women every year. She could have her uterus or just the fibroids surgically removed or she could try one of several newer procedures aimed at shrinking the usually benign but troublesome tumors. At she could try waiting a few years to see whether menopause with its natural decline in hormones would solve the problem. Hidleburgs options were even more limited however because she didnt want to have surgery with a long recovery time that would take her away from work and family. And even with iron supplements her anemia was so severe that waiting out the fibroids wasnt looking good either. But then her gynecologist Minda Green suggested another option a new tool that requires no incision and uses heat to damage the fibroids which then shrink. Though the tool is still being tested what Hidleburg heard sounded too good to pass up. With this option I had a better chance of recovery and going back to work more quickly said Hidleburg who lives in Olney. Last month the mother of two grown children underwent the outpatient procedure at Hahnemann Hospital without a hitch and returned home the same day. A few days later she was back at work as a Philadelphia correctional officer. Sonata which stands for sonographyguided transcervical ablation a device made by Californiabased Gynesonics shows promise as an addition to the arsenal of ways to treat a condition that is common but that has defied easy solutions. This is probably the most minimally invasive surgical procedure you can do said Green an assistant professor in Drexel Universitys College of Medicine who is coinvestigator in the devices trial at Drexelaffiliated Hahnemann. Thats hugely important. . . . You can get back to work and life. Thats what women want. Sonata uses a probe that is inserted through the cervix into the uterus. The probe not only allows the doctor to see the fibroid using ultrasound but it also has a radiofrequency device at the tip. The doctor hits a foot pedal to send energy through the probe to heat the fibroid shrinking it over time. The body absorbs the dead tissue so it does not have to be surgically removed. The tool is also being tested at other sites in the United States including Cooper University Hospital and Christiana Care Health System. Fibroids are muscular tumors usually benign that grow in the wall of the uterus. They can affect up to percent of women by the time they reach age but in most cases the fibroids cause no symptoms. Sometimes symptoms are mild enough that women can be treated with hormone therapy or can wait them out until menopause. But for some women significant fibroids can mean profuse bleeding cramping and pain from the pressure they can exert. They also can pose problems during childbirth and in rare cases can even affect fertility. An estimated onefourth of all women with fibroids require treatment according to the National Uterine Fibroids Foundation. Hidleburg lost so much blood during her heavy menstrual cycles that she was extremely anemic. Of her five fibroids four were deep in the uterine wall. The options Hundreds of thousands of hysterectomies are performed each year in the U.S. mostly to treat uterine fibroids making the procedure the most common choice. But this is major surgery that can mean a lengthy recovery time increasing demand for alternatives from hormone therapy to more complicated procedures. Though hysterectomies are not performed as frequently as they once were their rates are widely considered to be too high. Another option is to have just the fibroids removed a procedure known as myomectomy. But that also is an invasive procedure requiring an incision and longer recovery time. And unlike a hysterectomy there is no guarantee that fibroids wont grow back after myomectomy. Power morcellation a technique that cuts up the uterus or just the fibroids for removal through tiny incisions seemed to be the answer for some promising swifter recovery times than the traditional open hysterectomy. But in some cases the FDA estimates one in the device disseminates an undiagnosed cancer that preoperative screening tests cannot reliably detect. The FDA has advised physicians and hospitals not to use it except in rare cases. Sonata is not the first procedure aimed at shrinking fibroids without surgery though it is touted as less invasive. In uterine artery embolization UAE an interventional radiologist uses a catheter in the groin to deliver small particles that block blood flow to the fibroids. But some women including Hidleburg turn it down because it can be painful while the fibroids shrink. Other options include Acessa a therapy which employs laparoscopic radiofrequency waves to destroy the tissue. Also tested at Hahnemann it was approved in and heats the fibroid but requires two small incisions and uses multiple tools unlike the allinone Sonata probe. ExAblate is an MRIguided technology that uses magnetically focused energy to eliminate the tissue. It can take hours and shrinks fibroids less than percent studies indicate. While the list of options looks long each has its drawbacks according to gynecologists. The market is not overcrowded by any means says Erin Carey an assistant professor at the University of North CarolinaChapel Hill and division director of minimally invasive gynecology surgery who is not involved in the Sonata trial. Theres huge room for growth. Dipak Delvadia a Drexel assistant professor of obgyn who is a principal investigator for the trial said it was appropriate for fibroids in the uterine wall that are between and centimeters. Weve been trying to get to these types of fibroids and tumors for a long time in a minimally invasive way he said. In the OR During the procedure Hidleburg was under general anesthesia though Sonata can be used in an office setting with partial sedation according to Gynesonics. Green who under Delvadias supervision was performing the procedure for the first time guided the probe through the cervix to the uterus where she could see a clear D image of the fibroids. Then Green deployed the electrodes which reach degrees Fahrenheit being careful to ablate or heat as much of the fibroid as possible without harming surrounding tissue. The system calibrates how long the ablation will take depending on the fibroids location and characteristics. Hidleburgs first fibroid required minutes and seconds. Then Green was on to treat the next one. Compared with the Acessa procedure which requires the physician to manipulate multiple devices Sonata is much easier Green said afterward. She also noted that the procedure doesnt require a radiologist. Sonata was approved in Europe a few years ago and has been getting positive reviews so far here. But because its still under investigation in the U.S. its not covered by insurance patients such as Hidleburg who participate in a trial are treated for free. If insurance doesnt pay for Sonata no one is going to get it said Jay Goldberg a professor at Einstein Medical Center and director of its Philadelphia Fibroid Center. He notes that ExAblate which typically isnt covered by insurance can cost tens of thousands of dollars out of pocket one reason it is not often used. Sonatas manufacturer declined to say what the procedure might cost once the trials are complete and it is approved. The company has said one advantage of Sonata is that it is simpler to perform putting it within reach of more doctors. But Goldberg notes that such minimally invasive procedures require a lot of skill to perform safely. You need a really experienced surgeon he says. Will it translate to the average obgyn Fibroids rarely are malignant but UNCs Carey noted that because tissue is not removed with the Sonata method it cannot be biopsied to be certain. Carey also wants to know more about Sonatas potential impact on fertility. The trial targets women who do not want future pregnancies so that question will not be put to rest in the trial although the procedure anecdotally does not appear to hurt fertility according to Gynesonics medical director David Toub. If confirmed through additional studies that it doesnt affect fertility Carey says that would make Sonata a gamechanger. This is what would elevate the product. Meanwhile Hidleburg is happy with her choice which she said was painfree and allowed her to get back to her routine quickly. Everything went well she says. It was in and out."
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"Hispanic middle school children at high risk for being overweight or obese reduced their Body Mass Index BMI when they adhered to a nutrition intervention that included a snack of peanuts compared to those children who did not. The week study was conducted by researchers at the University of Houston Department of Health and Human Performance HHP Baylor College of Medicine and Texas Womans University. Their findings are published in the Journal of Applied Research on Children. Obesity is the most pressing health issue facing us today said Craig Johnston HHP assistant professor. Wed like to think its preventable but from where I sit right now there hasnt been a lot shown to be very effective on a large scale. The study acknowledged that snacking is more common during the adolescent years and that the unhealthy eating habit can lead to an unhealthy weight. This is especially true if a student doesnt have access to other meals during the school day. We have a lot of kids skipping meals for a whole bunch of reasons he said. What we found is that kids get home from school around p.m. Theres less supervision by parents and less structure. Kids are sitting down at the TV and eating eating eating because they really didnt eat at school. Instructors guided Latino adolescents from three Houstonarea charter schools through a program of physical activity and nutrition education. About half the students received a snack of peanuts or peanut butter three to four times a week while the rest received the snack fewer than once a week. The snack was administered after school as students were boarding the school bus to go home. Peanuts were chosen because nuts are nutrientdense snacks that promote a feeling of being full. Following the week intervention students spent more weeks maintaining the healthy snacking habit. At the end of the period those students who received the snack more regularly experienced a decrease in their overall BMI .kgm compared to those who did not receive the regular peanut snack .kgm. The researchers conclude that afterschool programs and schools can replace energy dense unhealthy snacks with peanuts to provide a healthier alternative for children researchers in the study ensured students did not suffer from nut allergies. Johnston says the fight against obesity needs creative solutions that help people manage their weight appetite and hunger by offering socially acceptable food choices. Schools are doing a great job of teaching kids getting them workforce ready and a whole bunch of other things. Weve just got to make sure that our kids are going to live long happy lives with that kind of education he said. Participants in the study were part of a larger longitudinal study on a schoolbased obesity intervention program. The Family Lifestyle Overweight FLOW Prevention Program is a schoolbased pediatric intervention for urban lowincome minority students."
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"The gene responsible for cystic fibrosis httpshealth.nytimes.comhealthguidesdiseasecysticfibrosisoverview.htmlinlinenytclassifier was discovered in . Now years later a drug that tries to compensate for the genetic defect might be nearing the market. Vertex Pharmaceuticals https announced Wednesday morning that the drug VX https improved lung function in people with cystic fibrosis in a latestage clinical trial. The drug also reduced the frequency of disease exacerbations that required treatment with antibiotics httpstopics.nytimes.comtopnewshealthdiseasesconditionsandhealthtopicsantibioticsindex.htmlinlinenytclassifier. The caveat is that VX is designed to counter one specific genetic mutation that accounts for about percent of cases of cystic fibrosis. Vertex is working on another drug for the most common mutation but that one is further behind in development. Still the news is expected to be greeted favorably by doctors and patients and by Wall Street. Ive been doing clinical trials for years in C.F. and these are amazing results Dr. Bonnie W. Ramsey https_Bonnie.html a lead investigator in the trial said in an interview. Dr. Ramsey a professor of pediatrics httpstopics.nytimes.comtopnewshealthdiseasesconditionsandhealthtopicspediatricsindex.htmlinlinenytclassifier at the University of Washington httpstopics.nytimes.comtopreferencetimestopicsorganizationsuuniversity_of_washingtonindex.htmlinlinenytorg was briefed on the results by Vertex. The results were announced by a press release httpsinvestors.vrtx.comreleasedetail.cfmReleaseID and have not been peer reviewed by experts. About Americans and people worldwide have cystic fibrosis a disease caused by defects in a gene responsible for the transport of chloride ions across cell membranes. People with the disease tend to have very thick mucus in their lungs which leads to infections and lung damage. Many do not live past age . Two inhaled antibiotics and one drug that loosens mucus are approved to treat cystic fibrosis but nothing that directly improves chloride ion transport. In the trial those who received VX gained . percentage points more on a lung function test after weeks than those getting a placebo a difference that statistically was highly significant. Patients continued to take either drug or placebo for another weeks and the improvement was sustained. Lung function the primary endpoint of the trial was measured by how much a person could exhale in one second a standard test. Investors had been expecting around a percentage point improvement. In a note to clients Tuesday evening before the results were known an analyst at ISI Group Mark Schoenebaum https said that an improvement of percent would be a home run that could lead to million in annual sales for the drug. Dr. Ramsey who has received research grants from Vertex said that some patients could perceive a percentage point change in lung function. She said other results of the trial were encouraging. These included fewer exacerbations of the disease in those who got the drug fewer selfreported respiratory symptoms and a gain in weight which is good for people with cystic fibrosis who often have digestive problems. The saltiness of their sweat a measure used to diagnose the disease was markedly reduced suggesting that the drug was having an effect on chloride ion transport. The trial involved people age and older all with at least one copy of the particular mutation known as GD. The main side effects Vertex said were headache httpshealth.nytimes.comhealthguidessymptomsheadacheoverview.htmlinlinenytclassifier upper respiratory tract infections nasal congestion httpshealth.nytimes.comhealthguidessymptomsnasalcongestionoverview.htmlinlinenytclassifier rash and dizziness httpshealth.nytimes.comhealthguidessymptomsdizzinessoverview.htmlinlinenytclassifier. Vertex said it hoped to apply in the second half of the year for approval of VX in the United States and Europe. The company is awaiting results of a second trial of the drug this one in younger children. Vertex has not said how much it will charge for VX. But since there are only about Americans who are candidates for the drug the price is likely to be tens of thousands of dollars a year. Vertex based in Cambridge Mass. was founded in coincidentally the same year the cystic fibrosis gene was discovered. It has not yet had a big commercial success and had a . billion net loss in the last five years. The company is hoping that by late May it will win approval to sell a new type of drug for hepatitis C httpshealth.nytimes.comhealthguidesdiseasehepatitiscoverview.htmlinlinenytclassifier which analysts expect will be a blockbuster. The long time needed to develop a drug for cystic fibrosis is a lesson for those expecting a quick payout from the sequencing of the human genome which was completed a decade ago. It is not enough to know the gene behind a disease. It can take years of research to determine how a mutation actually causes a disease and then to design a drug that corrects the problem. Vertex received million in financial support from the Cystic Fibrosis Foundation one of the first nonprofit disease groups to give money to companies. These results are highly encouraging Robert J. Beall president of the foundation said in a statement Wednesday. They provide scientific evidence that support our longstanding belief that targeting the underlying defect of C.F. may have a profound effect on the disease."
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"A cancer drug for patients with certain types of leukemia and lymphoma can also prevent reactions to some of the most common airborne allergies according to a recent Northwestern Medicine study. The promising data from this pilot study could have greater implications for adults with food allergies. The cancer patients who were allergic to allergens such as cat dander and ragweed saw their allergic skin test reactivity reduced by to percent in one week and this persisted with continued use of the drug for at least one to two months. The findings were published in the Journal of Allergy and Clinical Immunology in May. It almost completely knocked out the patients skin test and blood cell allergic reactivity said senior author Dr. Bruce Bochner the Samuel M. Feinberg Professor of Medicine at Northwestern University Feinberg School of Medicine. This FDAapproved drug ibrutinib is currently on the market as a successful and lesstoxic alternative to chemotherapy for patients with chronic lymphocytic leukemia and mantle cell lymphoma. In this recent study Bochner and his team performed traditional allergy skin tests and the basophil activation test a related allergy test using blood cells on cancer patients before they had taken ibrutinib and again after one week and after one to two months of taking it. A rather unlikely pairing cancer and allergies Bochner thought to test if a cancer drug could prevent allergic reactions by collaborating with Feinbergs oncology department. He knew that the generally welltolerated cancer drug was successful in blocking a protein inside a cell called Brutons Tyrosine Kinase BTK. BTK plays a crucial role in B cell activation growth and maturation and mast cell and basophil activation the latter two cells being responsible for immediate allergic reactions. Bochner teamed up with Northwestern oncologist Dr. Leo Gordon and colleagues to test if this BTK inhibitor could shut down an enzyme inside cells that is involved when you have an allergic reaction. Ibrutinib is considered a game changer in these two types of cancers said Gordon the Abby and John Friend Professor of Cancer Research at Feinberg. We understood that it might have some biologic effects in what Bruce is interested in so we were happy to participate in his study. Its an interesting repurposing of that drug. While the study was small only two patients qualified out of about that were screened for allergies the implications are much larger for later phases of this study. Bochner and his colleagues Drs. Anne Marie Singh and Melanie Dispenza are now testing how successful the drug is at targeting allergies to food such as tree nuts and peanuts. Preventing or lessening the severity of an allergic reaction to a food youve ingested that youre allergic to is kind of the holy grail of food allergy treatment Bochner said. I dont know if this or similar drugs will ever make it possible for a peanutallergic person to eat peanut butter and jelly sandwiches but were excited to use this approach to teach us how to lessen the risks of food allergy reactions. Currently the study is being expanded to adults with food allergy to see if their skin test and basophil activation test responses show a similar reduction with just a few doses of ibrutinib and how long such benefits might last. If the results are favorable the next step would be to get funding to actually test whether taking a BTK inhibitor will improve the ability of foodallergic adults to eat foods theyre allergic to. The hope is that drugs like BTK inhibitors will protect people with food allergies from having anaphylaxis or at least increase how much of that food they can eat without reacting Bochner said. Maybe theyll increase from being able to eat just one peanut to before they react. Or maybe theyll be able to eat a full meals worth of peanuts. We want to know if this would safely change their actual ability to eat foods that they currently need to avoid."
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"Researchers say theyve developed a nasal spray that could potentially improve memory and other mental capabilities for the more than million Americans suffering from Alzheimers disease. In a pilot study at Wake Forest Baptist Medical Center in WinstonSalem North Carolina researchers studied adults between the ages of and diagnosed with mild cognitive impairment MCI or mild to moderate Alzheimers dementia AD. Participants were nasally administered doses of manmade insulin called insulin detemir for days. The insulin detemir is designed to attach to album a blood protein. Album absorbs the insulin detemir distributing it throughout the body and allowing it to work. Because the insulin detemir dissolves from the protein slowly it has a longer period of exposure in the body lead study author Dr. Suzanne Craft professor of gerontology and geriatric medicine at Wake Forest Baptist told FoxNews.com. Participants who received international unit IU doses of insulin detemir over the course of the trial showed significant improvement in their shortterm ability to retain and process verbal and visual information compared with those who received IU doses or a placebo. According to Craft performance on tests of mental manipulation and memory improved by as much as percent. Even recipients who carried the APOEe gene which is proven to increase Alzheimers risk showed significantly higher memory scores than those who received the lower dosage or placebo. Our team was surprised at the level of improvement for the participants with the gene that raises Alzheimers risk as very few types of therapies have been shown to benefit these patients Craft said. Further research is needed to determine the mechanisms behind insulin detemirs effect on memory. The insulin detemir doses did not cause any negative side effects and Craft said the studys overall results support further investigation of insulin detemir as a treatment for Alzheimers and other neurodegenerative diseases. Researchers hope to follow up on the pilot study in a larger group of participants who would receive the insulin detemir for a longer period of time. Additionally Craft said they would also like to directly compare the insulin detemir to other forms of insulin to see which provides the most therapeutic benefit. Alzheimers is a devastating illness for which even small therapeutic gains have the potential to improve quality of life and significantly reduce the overall burden for patients families and society she said. Future studies are warranted to examine the safety and efficacy of this promising treatment. Study results are published in the Journal of Alzheimers Disease."
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"A recent study from the Center for BrainHealth http at The University of Texas at Dallas shows that a certain type of instructorled brain training protocol can stimulate structural changes in the brain and neural connections even years after a traumatic brain injury TBI. The findings published in Brain and Behavior httponlinelibrary.wiley.comdoi.brb.full further suggest that changes in cortical thickness and neural network connectivity may prove an effective way to quantitatively measure treatment efficacy an ability that has not existed until now. Building upon previous research the study challenges the widely held belief that recovery from a TBI is limited to two years after an injury. A TBI disrupts brain structure. These brain changes can interfere with brain network communication and the cognitive functions those networks support said Dr. Kihwan Han http_usteamkihwanhan research scientist at the Center for BrainHealth and lead author of the study. For people with chronic TBI they may have trouble with daily tasks such as creating shopping lists and resolving conflicts with others for many years after the injury. These findings provide hope for people who thought This is as good as my recovery is going to get and for the medical community who have yet to find a way to objectively measure a patients recovery he said. The study included adults with TBI symptoms lasting an average of eight years. Participants were randomly placed into one of two cognitive training groups strategybased training or knowledgebased training. Over an eightweek period the strategybased training group learned strategies to improve attention and reasoning. The knowledgebased training group learned information about the structure and function of the brain as well as the effects of sleep and exercise on brain performance. Magnetic resonance imaging measured cortical thickness and restingstate functional connectivity rsFC before training after training and three months posttraining. Previous studies have shown that cortical thickness and rsFC can be potential markers for traininginduced brain changes. Individuals in the strategybased reasoning training showed a greater change in cortical thickness and connectivity compared to individuals who received the knowledgebased training. Changes in cortical thickness and functional connectivity also correlated to an individuals ability to switch between tasks quickly and consistently to achieve a specific goal. People who showed the greatest change in cortical thickness and connectivity showed the greatest performance increases in our cognitive tasks. Perhaps future studies could investigate the added benefit of brain stimulation treatments in combination with cognitive training for individuals with chronic TBI who experience problems with attention memory or executive functions Han said. The work was supported by the Department of Defense the Meadows Foundation and the Friends of BrainHealth Distinguished New Scientist Award."
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"Each year thousands of Americans suffer a traumatic brain injury. In about . million TBIrelated https_the_facts.html emergency department visits hospitalizations and deaths occurred in the United States according to the Centers for Disease Control and Prevention. Most of these are what are called mild traumatic brain injuries or mTBIs httpsacrm.orgwpcontentuploadspdfTBIDef_English_.pdf head injuries that dont cause a coma. People with an mTBI typically get better within a few weeks but for as many as percent problems can linger for months or years. Many of these patients find themselves stuck with depression cognitive problems headaches fatigue and other symptoms. Known as postconcussion syndrome this phenomenon is often difficult to treat. Antidepressants can lift moods painkillers can ease headaches and physical therapy may ease dizziness but most researchers agree that these remedies dont heal the injury within the brain. Could oxygen do the trick A growing group of scientists and physicians say that hyperbaric treatment which exposes patients to pure oxygen at higherthannormal air pressure may work. These patients dont have enough oxygen to heal the injured parts of their brains said Shai Efrati a researcher and physician at Tel Aviv University in Israel and a leading hyperbaric scientist. Hyperbaric treatment massively increases the amount of oxygen available to the brain. But other researchers believe that the treatment has no merit and should not be recommended. People want to believe that hyperbaric can fix brain injuries and it cant said David Cifu a researcher at Virginia Commonwealth University in Richmond who has spent much of his career treating veterans with brain injuries. Compressed air has been used by doctors since the th century. In two German inventors first used pressurized pure oxygen to treat decompression sickness which occurs when undersea divers return to the surface too quickly. For the past years hyperbaric therapy has been approved by the Food and Drug Administration as a treatment for nonhealing wounds carbon monoxide poisoning burns and decompression sickness. Over the past decade doctors in the United States and internationally have begun using it to treat mTBIs. MTBIs include sportsrelated concussions and head injuries caused by traffic accidents. Also between and American service members suffered mild traumatic brain injuries according to the Department of Defense httpdvbic.dcoe.milfilestbinumbersWorldwideTotalsQQNov.pdf. Patients with an mTBI typically experience symptoms that include headache dizziness fatigue depression anxiety and cognitive impairment. Known as postconcussion syndrome PCS this phenomenon is difficult to treat. Doctors use antidepressants pain medications biofeedback and physical therapy but these strategies do not always work. The nature of the human brain makes it particularly susceptible to chronic injury. The organ requires large amounts of energy under normal circumstances and even more to heal when injured. And often the initial trauma damages blood vessels that supply the brain with oxygen. So just as the brain needs extra resources it faces an energy crisis. Often Efrati and others say injured brain cells dont die but may persist for years or decades alive but hobbled. Hyperbaric therapy he said can return them to full function even years after the injury. Oxygen is different because it has a direct biological effect on brain tissue said Paul G. Harch a physician in New Orleans who over the past three decades has used hyperbaric oxygen to treat hundreds of people with chronic brain injury as well as stroke. Patients typically receive between and hourlong hyperbaric treatments spread over two to three months. During each treatment they sit or lie inside a hyperbaric chamber which varies in size from a personsize tube to a large room that can hold several patients. While in the chamber patients breathe in pure oxygen typically pressurized to about twice the density of sealevel air in this environment the lungs take in about times as much oxygen as under normal conditions. Researchers say it remains unclear how hyperbaric oxygen affects injured brains. Efrati and others argue that it probably works through several biological pathways. The extra oxygen appears to trigger the healing of brain cells and switches on genes specifically related to brain repair. It increases the number of stem cells that migrate to sites of brain injury promotes the growth of new blood vessels in the brain and boosts the activity of mitochondria which provide energy to cells throughout the body. Scientists have linked increased mitochondrial activity to healing in many kinds of tissue. Efrati said the brain is no different from any other part of the body. Pressurized oxygen has the power to repair many kinds of tissue damage. A nonhealing wound in the leg and a nonhealing wound in the brain he said they are the same basic thing. Efrati came to the field accidentally. Eight years ago as director of research at Assaf Harofeh Medical Center in Tel Aviv he was asked to oversee the hospitals small hyperbaric chamber. He knew little about hyperbaric medicine and wasnt especially interested in it. But he soon noticed that pressurized oxygen seemed to have an unexpected effect. A patient had come for treatment of foot wounds that wouldnt heal a common symptom in diabetes. The man had also suffered a traumatic brain injury several years earlier which left him unable to speak more than a few words. The hyperbaric treatment healed his feet and also revived his ability to speak. Other patients with wounds and brain injuries had similar surprising results. He began to examine how hyperbaric treatment affects the brain and this work has become his focus. In . Efrati founded and now directs the Sagol Center for Hyperbaric Medicine and Research at Tel Aviv University and Assaf Harofeh where he oversees and collaborates with a range of scientists and manages a large hyperbaric treatment facility. As the use of hyperbaric therapy for brain injury has grown it has become increasingly controversial. Critics argue that it remains unproven and that desperate patients are wasting thousands of dollars the treatment typically costs between and per session and is rarely covered by insurance on a technique that rarely if ever helps. Between and Cifu oversaw three https studies httpjournals.sagepub.comdoiabs.url_verZ.rfr_idoriAridAcrossref.orgrfr_datcr_pubDpubmed for the Department of Veterans Affairs httpsinsights.ovid.compubmedpmid reportedly at a taxpayer cost of about million https of about activeduty service members with postconcussion syndrome. The studies found that hyperbaric treatment had little effect on their symptoms. Overall there is relatively little research on hyperbaric treatment for brain injury in part because pressurized oxygen cant be patented which limits its potential profitability. Its very difficult to get funding for studies on this topic Harch said. A few studies besides Cifus have looked at humans. In a paper published https in October Efrati and colleagues examined postconcussion syndrome patients who had received hyperbaric treatment. Using brain imaging the scientists found that after treatment the subjects had increased cerebral blood flow as well as more activity in brain areas that had previously been dormant. They say that this indicates that hyperbaric treatment triggered regeneration of nerve fibers and blood vessels in the brain. In addition tests showed that the subjects had improved memory and processing speed. In another study published in httpjournals.plos.orgplosonearticleid.journal.pone. researchers gave hyperbaric oxygen to patients with prolonged postconcussion syndrome. They found that many patients showed significant improvements in cognitive function and overall quality of life. While the research remains inconclusive some American doctors are using oxygen to treat chronic brain injuries. Ziad Mirza is one of them. For most of his career he dispensed hyperbaric treatment for hospitals around Baltimore. Two years ago he became chief medical officer for Hyperheal Hyperbarics a company with three clinics in the Baltimore area. Since then he said he has treated about a halfdozen braininjury patients with mostly positive results. One of these patients is Parisa Cook who in was found to have a tennis ballsize tumor in her brain. Surgeons removed it but the operation was not a complete success. Cook who lives in Baltimore began to suffer from debilitating symptoms She had problems with her shortterm memory she had constant headaches and couldnt concentrate her vision became blurry and dark and her hearing was altered so that all sounds were jumbled and very loud. Specialists told her the operation probably had caused collateral brain trauma. Over the course of a year she went to eight doctors and tried more than a dozen medications and a variety of other treatments. Nothing helped. A policy analyst for the Maryland Department of Health she worried that she would have to quit her job. She began to consider suicide. I felt completely hopeless she said. Then Cook read about hyperbaric oxygen treatment. She got in touch with Mirza and began treatments. After a single session she said her vision was no longer wobbly after sessions over a month she felt perfect. It was a complete she said. This treatment saved my life. Cooks primarycare doctor Sujay Pathak an internist in Baltimore first saw her in February. Her life was totally interrupted by this. She couldnt function Pathak said. But a few weeks after starting hyperbaric therapy in September she got suddenly and rather miraculously better Pathak said. Of course such anecdotes are not the same as rigorous scientific research. Efrati agreed that hyperbaric treatment requires more research. Definitely we need more science he said. We have a lot to learn. But we are seeing the results with our patients. It works again and again and again."
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"A procedure that delivers the anesthetic lidocaine Xylocaine directly to nerves in the back of the nasal cavity appears to offer significant relief to migraine sufferers preliminary research indicates. Early findings suggest that a single outpatient treatment can reduce migraine pain levels by about percent for up to a month after the procedure according to this small ongoing study. The technique is a minimally invasive treatment option said the studys lead author Dr. Kenneth Mandato a vascular and interventional radiologist at Albany Medical Center in Albany N.Y. He added that he views the new procedure as a clear simple alternative to standard migraine treatments. This nasal spray option is safe convenient and innovative said Mandato. In the new study his team focused on patients averaging about years of age. All had been diagnosed with either migraines or another type of intensely painful and cyclically occurring headache known as cluster headaches. Before participating in the study patients were asked to indicate their pain levels according to a standardized scale from to . Pretreatment pain scores averaged more than Mandato said. The participants all underwent a session of imageguided therapy in which a spaghettisized catheter was inserted through a nostril and into the nasal passage to deliver a dose of lidocaine to a nerve center known as the sphenopalatine ganglion. This was then repeated in the opposite nostril according to the researchers. Mandato stressed that no one in the study required sedation to undergo the procedure. The target nerve bundle explained Mandato resembles a complex highway crossing with many nerve signals and exits going in all directions. And he said the hope was that lidocaine would essentially shortcircuit that bundles headachecausing pathway. The day after the procedure average migraine pain levels had dropped from about to just over . Pain scores rose only marginally a week after the procedure and reached an average of just over by the one month postprocedure mark according to the study. The procedure didnt help everyone though. Seven of the patients about percent failed to get any benefit from the treatment the investigators found. However percent of those in the study reported needing less standard pain relief medication after the procedure. The researchers acknowledged that this procedure is a temporary solution that would need to be repeated. Mandato said his team is continuing to monitor patients to see how well the nasal spray approach holds up six months out. Dr. Richard Lipton director of the Montefiore Headache Center in New York City described the findings as very dramatic. Unmet treatment needs in chronic migraine are huge as is the overuse of medications he noted. When a body gets used to having a chronic headache suppressor the patient can experience a rebound in the absence of that suppressor. So developing an effective treatment that can reduce the need for acute medicine would be very valuable Lipton explained. These results sound very promising Lipton added. Of course it remains to be seen if the demonstrated benefit already seen holds up over a longer period of time and with a bigger group of patients. Mandato and colleagues are scheduled to present their findings Sunday at the Society of Interventional Radiology annual meeting in Atlanta. Findings presented at meetings are generally viewed as preliminary until theyve been published in a peerreviewed journal. The study received no funding from private industry. More information Theres more on migraine treatment at the U.S. National Institute of Neurological Disorders and Stroke https SOURCES Kenneth Mandato M.D. vascular and interventional radiologist Albany Medical Center Albany N.Y. Richard B. Lipton M.D. director Montefiore Headache Center and professor of neurology Albert Einstein College of Medicine New York City March Society of Interventional Radiology meeting Atlanta"
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"A traditional Chinese herbal treatment may reduce fever from HN swine flu influenza just as well as the prescription medication Tamiflu a new study suggests. For thousands of years Chinese herbs have been used to treat influenza study coauthors Dr. Chen Wang and Dr. Bin Cao of Beijing ChaoYang Hospital Capital Medical University in China said in an email. The pandemic influenza gave us the opportunity to evaluate a standard Chinese herb formula designed to target the flu they added. Cao and Wang who specialize in infectious diseases and clinical microbiology said the herbal recipe known as maxingshiganyinqiaosan MY is easily accessible throughout China and much less expensive than Tamiflu oseltamivir. However finding the medicine in the United States is difficult if not impossible given that it contains the stimulant ephedra. The United States has banned or restricted the sale of ephedra products because of concerns about possible complications such as heart attack stroke and even death related to its use as a weightloss supplement. The authors discuss their findings in the Aug. issue of the Annals of Internal Medicine. The HN swine flu pandemic sparked influenza cases around the globe resulting in nearly deaths the authors said. Per World Health Organization WHO recommendations in most instances Tamiflu was the treatment of choice where it was available. However it is often out of reach in less developed parts of the world such as rural China where traditional herbal medicines are a likely default treatment. The MY flu preparation is composed of herbs ephedrae zhimu qinghao shigao yinhua huangqin chaoxingren lianqiao bohe zhebeimu niubangzi and gancao. To compare the relative effectiveness of MY and Tamiflu in treating HN influenza the authors focused on previously healthy patients who were diagnosed with a very mild form of the illness. The men and women were relatively young with an average age of . They were being treated in different medical facilities across four Chinese provinces during the height of the pandemic between July and November of to prevent spreading the flu not because their symptoms were severe. Within hours of the onset of symptoms the patients were assigned to one of four fiveday treatment groups. One group was given milligrams of Tamiflu twice a day in capsule form a second group received milliliters of MY four times a day in liquid form a third group took the same dosages of Tamiflu and MY together and a fourth group received no treatment. All of the herbs were screened for quality and the MY mixture was deemed to meet Chinese safety standards. The results Both MY and Tamiflu were effective at eliminating fever whether administered on their own or in combination. All three approaches helped to resolve fever sooner than no intervention whatsoever the authors said noting it appeared that fever dissipated fastest when MY and Tamiflu were given together. However none of the treatment methods appeared to be superior in terms of overall viral control and side effects were minimal in all cases. Even though the ephedracontaining herbal is not readily available in the United States the MY herbal formula is available in many countries besides China including Korea Japan India and Germany the study authors noted. Duffy MacKay vice president of scientific and regulatory affairs at the Council for Responsible Nutrition which represents the dietary supplement industry believes that fears over ephedras use as a weightcontrol agent have overlooked its more traditional and much safer role as a medicine against lung inflammation. MacKay said that in China traditional medicine is seamlessly integrated into everyday medical practice. Here in the U.S. we do things differently he said. We have our prescription drugs on the one hand and then we have dietary supplements on the other. But MacKay continued it should also be understood that these two treatments actually work very differently. Tamiflu works to stop viral replication. But the herbal formula is working on symptoms to help people become more comfortable. And those are two very different goals he noted. So our advice MacKay added is that because HN can be very serious its very important to see your doctor. And once youre under the care of your licensed physician theres certainly a lot of things in the world of botanicals that might help. More information For more on the flu and traditional medicine visit the U.S. National Center for Complementary and Alternative Medicine httpnccam.nih.govhealthfluD_GTF.pdf. SOURCES Chen Wang M.D. Ph.D. and Bin Cao M.D. department of infectious diseases and clinical microbiology Beijing ChaoYang Hospital Beijing Institute of Respiratory Medicine Capital Medical University Beijing Duffy MacKay N.D. vice president scientific and regulatory affairs Council for Responsible Nutrition Washington D.C. Aug. Annals of Internal Medicine"
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"As a particularly nasty flu season rages across the United States scientists have found a powerful new disinfectant that makes light work of the virus. Researchers say a certain spectrum of ultraviolet light called farUVC easily kills airborne flu viruses while posing no risk to people. It could offer a new inexpensive way to eliminate airborne flu viruses in indoor public spaces such as hospitals doctors offices schools airports and aircraft said the team from Columbia University Medical Center in New York City. The disinfecting success of initial experiments still need to be confirmed said lead research David Brenner. But he believes the use of overhead lowlevel farUVC light in public locations would be a safe and efficient method for limiting the transmission and spread of airbornemediated microbial diseases such as influenza and tuberculosis. As the researchers explained broadspectrum UVC light kills viruses and bacteria and it is currently used to decontaminate surgical equipment. But this type of light can cause skin cancer and cataracts so its not used in public spaces. However Brenner and his colleagues wondered if a much narrower spectrum of ultraviolet light farUVC might be a safer option. In prior studies they found that farUVC light killed methicillinresistant S. aureus MRSA bacteria a common and dangerous superbug without harming human or mouse skin. In this new study they found that farUVC light also killed airborne HN virus a common strain of flu virus. FarUVC light has a very limited range and cannot penetrate through the outer deadcell layer of human skin or the tear layer in the eye so its not a human health hazard said Brenner who directs Columbias Center for Radiological Research. However because viruses and bacteria are much smaller than human cells farUVC light can reach their DNA and kill them he said in a university news release. Lamps with this type of UV light currently cost less than Brenner said but that price would likely fall if the lamps were massproduced. And unlike flu vaccines farUVC is likely to be effective against all airborne microbes even newly emerging strains he said. Two flu experts were encouraged by the findings. The prospect of reducing the transmission of influenza and other respiratory viruses using farUV radiation is very exciting said Dr. Michael Grosso chief medical officer at Huntington Hospital in Huntington N.Y. Though handwashing remains critically important it does not prevent every instance of transmission Grosso said. Immunization and antiviral medications are also important but again have limitations. It appears that lowdose farUV light is safe and effective and has the advantage of inactivating a wide range of diseasecausing viruses. Dr. Len Horovitz a pulmonary specialist at Lenox Hill Hospital in New York City agreed. He noted that the technologys cost is not prohibitive and it is safe. This use can sterilize the air in a public space reducing the spread of respiratory droplets containing flu viruses and other bacteria and viruses. The findings were published online Feb. in the journal Scientific Reports. More information The U.S. Centers for Disease Control and Prevention has more on flu https SOURCES Michael Grosso M.D. chair pediatrics and chief medical officer Huntington Hospital N.Y. Len Horovitz M.D. pulmonary specialist Lenox Hill Hospital New York City Columbia University Medical Center news release Feb."
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"Doctors typically wait until smokers are ready to quit before prescribing pills to help them do it. But a new study has found that even for those who are not ready to stop smoking immediately medicine taken over time can substantially improve their chances of eventually quitting. Clinical practice guidelines have long advised doctors to have their patients set a precise quit date before prescribing medicine such as Chantix the pills used to treat nicotine httphealth.nytimes.comhealthguidespoisonnicotineoverview.htmlinlinenytclassifier addiction that were examined in the study. The idea was that such medicine should not be prescribed for someone who is not serious about quitting. In some cases insurance plans would not pay for the pills if no quit date had been set. But in a study published httpjama.jamanetwork.comarticle.aspxdoi.jama.. in JAMA on Tuesday researchers found that even for patients who wanted to stop smoking eventually the pills were effective opening the way to a much larger population of patients whom doctors could potentially treat. David Abrams executive director of the Schroeder Institute for Tobacco Research and Policy Studies said studies of nicotine replacement therapy such as patches and gum had long shown that attempts to quit gradually over time are a good way to change lifetime habits. The current study appears to show the same for pills he said. Sometimes serious addiction needs to be coaxed down the stairs one at a time not thrown off the top floor said Dr. Abrams who was not involved in the study. The study was funded by Pfizer the drug company that makes Chantix a treatment that costs about a month. Federal regulators require companies to conduct studies proving the effectiveness of such therapies and monitor them closely. The practice is common for smoking cessation therapies said Robert West director of tobacco studies at University College London who was among the studys authors. If such studies were funded by the government which sustains a lot of academic research taxpayers would bear the burden for what the company would eventually profit from he said. Still some researchers not involved in the study said the topic required more work. The approach taken here is a very reasonable one that appears to have been successful said Gary A. Giovino a professor of health behavior at the State University of New York at Buffalo. But the findings from one study do not make a fact. We need more studies funded by someone other than the company that makes the product. Smoking is the largest cause of preventable death in the United States killing more than Americans a year. The smoking rate has declined substantially since the s but the pace of decline has slowed in recent years and health experts are trying to figure out how to get more smokers to quit. About patients at clinics in the United States and abroad participated in the study. None were willing to quit immediately but all said they wanted to smoke less and to quit for good within three months. They were randomly assigned to two groups. One got Chantix the brand name of the drug varenicline which is taken twice a day by mouth as a pill the other group got a placebo. Almost a third of the patients who got the drug quit within six months of starting the pills compared with percent who took the placebo. The study did not follow patients long term so it was unclear whether those who quit smoking httphealth.nytimes.comhealthguidesspecialtopicsmokingtipsonhowtoquitoverview.htmlinlinenytclassifier had permanently rid themselves of the habit. The study cited a survey of smokers http that found about a third of the million smokers in the United States wanted to quit in the next one to six months and concluded that the more gradual treatment could be effective for as many as million American smokers. It is unclear what the finding will mean for the clinical guidelines which were set most recently in by a panel of experts convened by the Public Health Service which is part of the Department of Health and Human Services. The studys authors said the findings had the potential to change practice. Its a paradigm shift because instead of only giving the medication to patients who have set a quit date you are potentially giving it to every smoker said Dr. Jon O. Ebbert one of the authors who is a professor of medicine at the Mayo Clinic College of Medicine in Minnesota. It opens the door to a much larger population of smokers that we can treat. Most surprising he said was the fact that the rates of quitting for smokers in this study who received the treatment and did not want to quit right away were about the same as those in previous studies of patients who wanted to quit abruptly."
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"The consensusone of the first of its kindcomes on the eve of the Ryder Cup the biennial golf tournament between Europe and the US. Amid a growing body of evidence on the health impacts of the sport the consensus aims to help current and wouldbe players maximise the health pros and minimise the health cons of golf and to guide policymakers and industry leaders on how best to make golf more inclusive and accessible and so encourage more people from all walks of life to take up the sport. The statement draws on a systematic review of the available published evidence eligible studies and discussions among an international working group of experts in public health and health policy and industry leaders. Agreement was reached on statements in three areas. These set out what is currently known about golfs associations with health the factors that may help or hinder takeup of the sport and a series of recommendations for golfers industry leaders and policy makers on how best to maximise its health benefits promote sustainability and widen participation. The evidence shows that playing golf regularly is associated with longevity and reducing the risk factors for heart diseasestroke. And it can boost older peoples strength and balance. The sport is also associated with good mental health and improving the overall health of those with disabilities. Compared with other sports the risk of injury is moderate but as its an outdoor activity golfers may be more at risk of skin cancer. Golf is sociable and gets people outdoors connecting with nature. It can provide moderate intensity aerobic physical activity and its health benefits are greatest for players and spectators who walk round the course rather than opt for a golf cart. While around million people play golf at least twice every year the participant profile is quite narrow players tend to be middle aged to older male of white European heritage relatively well off and living in North America Europe and Australasia. And the sport is often perceived as expensive male dominated difficult to learn and not a game for the young or those on the lower rungs of the social ladder. This can put people off says the statement. The sport needs to be more inclusive and welcoming of people from all walks of life and ethnic backgrounds and any such initiatives should be supported it says. More people might be keen to take it up if golf were promoted as an enjoyable lifelong outdoors activity that affords a sense of community and competitive challenge while providing some me time as well as helping to fulfil recommended exercise quotas says the statement. And the sport can do its bit for sustainability by practices that prioritise diversity healthy societies connection with and care of the environment environmental integrity and health and wellbeing the statement suggests. Among its raft of recommendations the consensus statement says that Golfers Should aim to play for minutesweek or do less but couple golf with other physical activity and walk the course rather than ride a golf cart Do warmupstrengthening exercises to cut the risk of injury and use suncream and wear collared shirtsblouses to minimise the risk of skin cancer Make everyone feel welcome ClubsIndustry should Build on existing initiatives to promote inclusivity and develop environments and price structures that will be attractive to everyone Develop a culture that will inspire more women and girls to play golf Make every effort to promote equality and diversity and boost accessibility Promote sustainability through wildlife conservation and by restricting the use of water energy and pesticides Provide additional facilities at clubs such as a gym walking routes crches and improve the focus on health and safety with the provision of healthy foods defibrillators and speed limiters on golf carts for example Policy makers should Promote the benefits of regular physical activity including golf for people of all ages genders and income brackets Promote the specific health enhancing aspects of golf Support diversity equality and sustainability Work with industry and national associations to boost take up of the sport particularly in groups where physical activity levels are low Work with industry and regulatory bodies to get golf included in the Paralympics These outputs if widely shared and adopted will contribute to an improved understanding of golf and health and aid these groups in making evidenceinformed decisions and to improve health and wellbeing the consensus statement concludes."
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"Philippe Autier is willing to bet that taking vitamin D supplements will never be proved to do anything beyond helping to build strong bones and certainly not to prevent heart disease cancer diabetes depression multiple sclerosis or the common cold as many claim. In fact the physician has wagered a few good bottles of champagne that none of three large randomized trials now underway will find proof of positive effects. To Autier a researcher at the Strathclyde Institute of Pharmacy and Biomedical Sciences in Glasgow Scotland the widespread faith in vitamin Ds benefits is like a religion. People want to have a simple story they can believe in he says. Cedric Garland meanwhile hews just as strongly to the opposite view that vitamin D supplements confer a slew of benefits including warding off colon cancer breast cancer even Type diabetes http The science is in my opinion unassailable says Garland an adjunct professor of epidemiology at the University of California at San Diego. Its just preposterous to say its not proven. In January Autier published a statistical analysis http of results from hundreds of studies of vitamin D. He concluded Unfortunately there is probably no benefit to expect from vitamin D supplementation in normally healthy people. Garland on the other hand is the coauthor of dozens of studies http showing a strong inverse association between vitamin D levels and seemingly every disease under the sun. Indeed sun exposure is Garlands explanation for why rates of cancer Type diabetes and other diseases tend to be higher the farther people live from the equator. Vitamin D after all is the sunshine vitamin synthesized from cholesterol in the skin in response to sunlight. Its a mathematical relationship he said in a telephone interview. The higher your latitude and the greater your areas average cloud cover the higher your rates of cancer. Since he and his late brother Frank Garland published the first study httpije.oxfordjournals.orgcontent.abstract in revealing that relationship hundreds of other studies have explored the link between vitamin D including supplements and health but none were large enough long enough or designed well enough to convince the skeptics. Now three nationally recognized researchers are leading landmark studies designed to settle at least some of the questions about vitamin D once and for all. The one thing the research leaders are certain of is that the publics faith in vitamin D as a modern panacea has far outpaced what the scientific evidence proves. Theres been a rush to judgment on vitamin D says JoAnn E. Manson chief of the division of preventive medicine at Brigham and Womens Hospital in Boston and a professor of medicine at Harvard Medical School. Everyone has gotten on the bandwagon. Unfortunately the lessons of history have shown repeatedly that many of these supplements that appeared to be very promising did not pan out in more rigorous testing. Manson should know. She has led or collaborated on more than a dozen large randomized placebocontrolled studies http dating back more than two decades which found none of the expected protection against cancer heart disease dementia or other diseases that scientists once attributed to beta carotene vitamin E or vitamin C supplements. She did find however that supplementation with folic acid vitamin B and vitamin B offered modest protection http against agerelated macular degeneration and for those with a diet low in B vitamins to begin with a hint of protection http against the loss of cognitive abilities. Now Manson is codirecting the Vitamin D and Omega Trial VITAL http testing whether compared with placebo a daily supplement of either international units IU of vitamin D or one gram of fish oil another widely touted substance reduces the risk of stroke cancer heart disease and other health problems. The fiveyear study involving men and women is scheduled to end in October . Another trial is testing whether a daily supplement of IU of vitamin D will prevent Type diabetes. The socalled Dd study which will run for four years is seeking to enroll people older than who are at high risk of developing diabetes due to weight or bloodsugar levels but who have not yet been diagnosed with the disease. I would call myself an optimistic skeptic says Anastasios Pittas principal investigator of the Dd study and a professor of medicine at Tufts School of Medicine in Boston. The indirect evidence is very strong. People with higher levels of vitamin D in their blood have been shown again and again to have a lower risk of developing diabetes in the future. These studies are as consistent as we have ever seen with any nutrient. But he adds those studies do not prove cause and effect. Before we make a blanket recommendation for the million people in the United States who are at risk for Type diabetes to go out and buy vitamin D supplements we need to know for sure if they help. A third trial designed to test whether IU of vitamin D per day will slow the progression of multiple sclerosis in patients is being led by Ellen Mowry an associate professor of neurology at the Johns Hopkins University School of Medicine. I do discuss vitamin D with my patients Mowry says. But I point out that we dont yet have randomized controlledtrials data to back it up. Thats why there are no official recommendations yet from any medical organizations. We have to be sure. So what are people to do in the meantime Four years ago Manson sat on a committee established by the Institute of Medicine to review how much vitamin D and calcium Americans need each day to maintain health and prevent disease. The report concluded that both are necessary for bone health but that as for preventing cancer heart disease diabetes and autoiummune disorders the evidence was inconsistent inconclusive as to causality and insufficient to inform nutritional requirements. Even so the committee recommended that children and adults up to age get IU of vitamin D daily from food and if necessary supplements and that adults age and older get IU. Some studies have found no ill effects from taking far higher amounts and many of the prospective but not proven benefits against cancer and other diseases are believed to require doses ranging from to IU. Manson urges people to rely on the Institute of Medicine report which set a safe upper limit of IU of vitamin D per day. Its fine to take that amount Manson said. But keep in mind there isnt yet evidence that taking those higher amounts will confer any benefits beyond the recommended daily allotment of to IU. Some studies she noted have even found evidence that very high levels of vitamin D circulating in the blood might be just as unhealthful as very low levels. A study http for instance found that people with the highest levels of vitamin D in their blood more than nanograms per milliliter were significantly more likely to die in the three months following a hospitalization as were people whose levels were between and . ngmL. Such findings are why she Mowry and Pittas strongly advise people against taking more than the currently recommended upper daily limit of IU even though doses as high as IU are available online https and at many stores. Frustrated by the uncertainty Pittas takes it in stride. This is the beauty of medical research he says where you have some people convinced that vitamin D does nothing and others who believe its already proved to work. There is such controversy now that the only way to convince people who sit on those sides of the equation is to complete rigorous randomized trials. Well see what happens. I have a hypothesis that vitamin D will work but we have to test it. At the end of the studies one of us will be right. I just dont know which one. Hurley is a science journalist and author of Natural Causes Death Lies and Politics in Americas Vitamin and Herbal Supplement Industry http Broadway Books ."
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"A breakthrough in helping the body to produce more insulin could make tedious injections of the hormone history. In type diabetes httptopics.time.comdiabetes the body gradually loses its ability to make enough insulin to keep up with the sugar coming in from the diet. Eventually the overwhelmed system leaves these sugars in the form of glucose to build up in the blood which can lead to obesity damage the heart and cause other metabolic problems. And while insulin injections are an effective way to break down the glucose keeping track of blood sugar levels with regular finger pricks and repeated insulin shots arent an ideal way to treat a chronic disease. But despite decades of research scientists havent found a better way to address the problem. MORE Half of Diabetes Cases Are Undiagnosed httphealthland.time.comhalfofdiabetescasesareundiagnosed Now researchers working with mice at the Harvard Stem Cell Institute report in the journal Cell that they have discovered a hormone betatrophin that can prompt the body to generate more insulinproducing beta cells and if the work is confirmed the hormone could potentially do away with the need for regular insulin shots. We dont understand the cause of type diabetes but everyone agrees that having more beta cells is better says Douglas Melton http senior author of the paper and codirector of the Harvard Stem Cell Institute. No one doubts thats not a good idea. MORE Should You Take Statins Study Says Heart Benefits Outweigh Diabetes Risk httphealthland.time.comshouldyoutakestatinsstudysaysheartbenefitsoutweighdiabetesrisk Its an exciting breakthrough in diabetes research which for many years was focused on finding ways to externally supplement the bodys waning insulin levels. Thats because experts believed that once the pancreatic islet cells the bodys insulinmaking factories were compromised they couldnt be made to work again. Whats more they also surmised that only a specialized set of beta cells were equipped to make insulin and that once diabetes set in too few of these cells remained to pump out the critical hormone. Melton however whose work focuses on understanding how stem cells might enhance beta cell production admits that he is obsessed with the insulinmaking cells and reported in that all beta cells appeared to have the ability to produce insulin. His pursuit of a better understanding of this population and the forces that cause them to falter in diabetes led his team to the discovery of betatrophin. MORE Stem Cell Research The Quest Resumes http In animal studies mice that were treated with another compound that compromised their ability to respond to insulin suddenly revved up production of more beta cells to compensate and Meltons team was able to isolate the hormone responsible betatrophin. Over the course of a few weeks mice bred to develop diabetes but injected with betatrophin were increased their beta cell population by times. I was impressed by the fact that the number of beta cells in the mice doubled in one week with one injection says Melton. Thats a huge difference. Whats more it appears the cells are relatively longlasting which could indicate they are robust enough to bring glucose levels in diabetics under control. In theory if the same results occur in people its possible that those on the verge of developing diabetes might never progress to develop the disease since the high blood sugar levels that can cause damage to tissues and lead the body to become less responsive to insulin could be avoided. Its also possible that diabetics could lower their dependence on insulin and might even be able to wean themselves off of the injection altogether if their beta cell production is robust enough to provide the insulin they need. MORE Type Diabetes Is Tougher to Treat in Kids and Teens httphealthland.time.comtypediabetesistoughertotreatinkidsandteens Even if it doesnt address insulin resistance what betatrophin will do is lower blood sugar and anything that lowers blood sugar can make you healthier he says. More work will be needed to confirm what benefit betatrophin might have on diabetic patients before that might be possible however. John Anderson president of medicine and science for the American Diabetes Association says Its very promising and opens up new avenues of research but we are a long way from replacing insulin or a cure or even knowing how this hormone will work in human tissue. Those concerns arent lost on Melton who also recognizes that more research is needed to confirm that betatrophin may benefit patients. I am aware of the fact that given our level of ignorance everything seems simple and straightforward he says. But I am prepared to have it become more complicated."
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"A bonestrengthening drug given by IV every months greatly lowered the risk of fracture in certain older women a large study found. The results suggest these medicines might help more people than those who get them now and can be used less often too. Broken bones are a scourge of aging. A hip fracture can start a long decline that lands someone in a nursing home. The risk is most common in women after menopause. According to a study a bonestrengthening drug given intravenously every months greatly lowered the risk of fracture in certain older women. Nam Y. Huh The Associated Press file photo But who should use drugs called bisphosphonates is debatable. Theyre recommended for people with severely brittle bones called osteoporosis but their value is less clear for millions of others with moderate bone loss. Yet thats the group in whom per cent of fractures occur and the new results suggest they also may benefit from treatment said Dr. Ian Reid of the University of Auckland in New Zealand. He led the study reported Monday at an American Society for Bone and Mineral Research meeting in Montreal and published by the New England Journal of Medicine. Estrogen keeps bones strong they weaken after menopause when levels of that hormone drop. It often gets worse after and women of that age are advised to have a bone mineral density scan a lowdose Xray to estimate bone strength. If osteoporosis is found treatment usually is Fosamax Boniva or generic versions of these drugs which help prevent bone from being lost faster than the body is able to renew it. Some people dont stick with the pills or endure digestive side effects so the medicines also can be given by IV usually once a year. However concern about some rare side effects have limited their use along with a lack of evidence that they might help before bone loss becomes severe. The study involved women average age with moderate bone loss. One quarter had previously had a fracture. They were assigned to get a Novartis drug sold as Reclast in the United States and Aclasta elsewhere or a placebo IV solution every months. After six years women in the drug group had broken a bone versus of those on placebo a per cent lowered risk. The drug also cut in half the risk of a vertebral fracture when bone compression causes part of the spine to collapse. For every women like this treated for six years one fracture was prevented a ratio that some experts said makes treatment worth considering. Two rare problems are tied to bisphosphonates deterioration of the jawbone and unusual leg fractures. No cases of either occurred but the study wasnt big enough to rule out this risk. Other results stood out Fewer women in the drug group were found to have cancer versus in the placebo group. However the study was not designed to test for this so other factors such as a family history of cancer may have influenced those numbers. Deaths and heart attacks also were fewer in the drug group but the difference was so small it could have occurred by chance alone. Still doctors said these were encouraging signs also seen in some earlier research. It now raises the question should we be doing additional studies to look for cancer and heart benefits from these drugs said Dr. Michael Econs an Indiana University professor who is president of the bone society. Novartis supplied the drug but had no role in the study a New Zealand government health agency sponsored it. Reid consults for the company and other drugmakers. An IV infusion of generic Reclast costs to depending on insurance and other factors several doctors said. Other bisphosphonates may give similar benefits but we cant be certain of that Reid said. The benefits also cant be assumed to extend to women under or to men said Dr. Clifford J. Rosen of Maine Medical Center Research Institute and an editor at the medical journal. Gauging a patients risk and need for treatment should focus on age and previous broken bones not just the bone mineral density score Rosen said. But if youre at high risk and youre going to be treated this is the kind of therapy you probably should get he said."
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"A modified version of the polio vaccine infused straight into aggressive brain tumors helped some patients live for years longer than they normally would have doctors reported Tuesday. Its no miracle cure only about percent of patients with gliomas were helped but some are alive six years later the team reported in the New England Journal of Medicine. https Its a hopeful enough finding to move forward and test the vaccine in more people the team at the Duke University School of Medicine said. Its very unusual almost unprecedented to get this kind of longterm survival neurologist Dr. Darell Bigner who led the study team told NBC News. The Duke team tested glioma patients over five years. They all had grade IV gliomas a group of brain tumors that includes glioblastoma. These patients have a dismal prognosis the Duke team wrote in the New England Journal of Medicine. There is currently no effective therapy. Standard treatment of brain tumors includes surgery if the tumor is somewhere reachable chemotherapy and radiation. But if the tumor is aggressive its usually fatal. These are people who failed everything Bigner said. Virtually all patients no matter what you treat them with are dead within in two years. About a third of all brain tumors are gliomas according to the National Brain Tumor Society. About people a year are diagnosed with a brain tumor and about of those are malignant. The average survival rate for all malignant brain tumor patients is only . percent the group says. But theres evidence that some viruses can home in on tumors and kill them. Its not clear why but viruses can also make tumors more visible to the immune system. The team at Duke worked with the National Cancer Institute to design and manufacture a modified version of polio vaccine virus. Polio viruses are attracted to nerve cells thats why they cause paralysis. The medical team used polio viruses already weakened and altered for use in polio vaccines and genetically engineered them to carry parts of a common cold virus called a rhinovirus known to be attracted to glioma cells. They infused various doses into the tumors of the glioma patients. We inject the virus directly into brain tumors and it kills all the tumor cells it comes in contact with Bigner said. The most important thing is it sets up a secondary immune response and really destroys the distant tumor cells. Im amazed The very first patient was Stephanie Hopper who was diagnosed with a glioblastoma when she was just . I was throwing up and I had a headache behind my eye. I didnt even know I had cancer until after the surgery to remove the tumor Hopper told NBC News. It was the size of a tennis ball. Hopper was a little wary of being infused with a polio virus but was ready to try. It worked. Shes still alive married and working as a nurse in Greenville South Carolina more than six years later. Im amazed she said. I never really felt like I was going die. I think my life was just put on hold. After three years percent of patients were still alive the team reported. That compares to months or less on average for similar patients. One patient had a hemorrhage and percent had a notable adverse event the team reported. More than half had headaches and half had hemiparesis weakness or paralysis on one side of the body. Another percent had a seizure. More than a quarter had aphasia brain damage that makes speaking and communication difficult. The patient who had the hemorrhage suffered aphasia but was still alive more nearly five years later. Two patients died during the trial. The nature of the treatment causes sideeffects Bigner said. The virus infection causes a very potent inflammation response and that response causes brain swelling. The cancer drug Avastin is used in low doses to control the swelling the team said. Its not clear why just one in five patients benefits said Dr. Annick Desjardins who worked on the study team. vaccine helped halt the growth of malignant brain tumors called gliomas in percent of patientsCourtesy Duke University Duke University Similar to many immunotherapies it appears that some patients dont respond for one reason or another but if they respond they often become longterm survivors Desjardins said. The big question is how can we make sure that everybody responds The Duke team compared their volunteers to similar past patients who did not get the treatment. All but one of those previous patients died after an average of months. Just percent were still alive two years after diagnosis and percent were alive three years later. But the percent or so of patients helped by the vaccine all survived at least three years. As of March of this year eight patients had no evidence of the tumors growing any more and two had no evidence of a brain tumor at all."
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"The Food and Drug Administration approved a second version of a groundbreaking treatment Wednesday that genetically alters patients cells to attack cancer this time to fight aggressive nonHodgkin lymphoma. The treatment is for adults with certain types of large Bcell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment such as chemotherapy and bonemarrow transplants. The group numbers about patients a year in the United States. The onetime infusion known as CAR Tcell therapy is made by Kite Pharma which is based in Santa Monica Calif. and recently was bought https_term.fbda by Gilead Sciences for . billion. Kite announced Wednesday that the treatments brand name will be Yescarta and its price will be . In late August the FDA cleared https_term.efccb the first CAR Tcell therapy which is designed for children and young adults whose leukemia doesnt respond to standard treatments. About patients in the United States fall into that category every year. Kymriah which costs is manufactured by Novartis. Biotech analysts had expected the Kite price to be lower than Kymriahs in part because the number of eligible patients is larger and the response rates are lower. Even so Yescartas cost is likely to stoke the ongoing debate about high drug prices. The FDA approval is the latest step forward for the fastmoving field of immunotherapy which aims to bolster the immune system to attack malignancies. CAR Tcell therapies are among several approaches along with treatments called checkpoint inhibitors https_story.htmlutm_term.bdfd and cancer vaccines but they have recently grabbed much of the attention. Dozens of other companies also are working on them. Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases FDA Commissioner Scott Gottlieb said in a statement adding that the approval demonstrates the continued momentum of this promising new area of medicine. A CAR Tcell therapy involves a complicated and customized procedure in which T cells sometimes called the foot soldiers of the immune system are removed from the patient. They are sent to a special lab and genetically modified to target a protein on the surface of the patients cancer cells. Once the modified cells are returned to the patient their numbers expand exponentially as they become an army of cancer fighters. In Marie Miceli was diagnosed with nonHodgkin lymphoma at Siteman Cancer Center in St. Louis which is jointly owned by BarnesJewish Hospital and Washington University School of Medicine. She received chemo and underwent a bonemarrow transplant. Neither worked. The doctors were saying Go see an attorney and get your life in order the yearold Realtor recalled. Then they offered her a slot in Kites clinical trial a lastresort effort. I could feel it when they put those T cells back in she said. It was the craziest feeling in the world. When she was checked a month later she said her cancer was gone. It hasnt returned. Kites veintovein turnaround period from cell extraction to reinfusion is about days according to Frederick Locke an oncologist at Moffitt Cancer Center in Tampa and coleader of the Kite trial. The FDA said the safety and efficacy of Yescarta were established in a multicenter trial of more than adults with large Bcell lymphoma. An independent review committee found that percent of patients treated with a single infusion responded to therapy including percent who then showed no evidence of remaining cancer. Kite has said that at six months percent of patients were still responding with percent having no sign of cancer. This is not just an incremental benefit said David Chang Kites chief medical officer. It raises the potential that a cure can be possible. Some of the first patients who underwent treatment now have been in remission for three to five years he said although he cautioned that its still too early to know whether those patients are cured. Locke said about percent of patients in the trial had a severe side effect https_term.ecdaca known as cytokine release syndrome which produces high fevers low blood pressure and other flulike symptoms. Twentyeight percent had neurological events such as severe confusion three patients died of complications caused by the treatment. These are patients who knew they were out of options he said noting that lymphoma patients who relapse or dont respond to treatment have just a percent chance of surviving for six months. Because of the side effects the treatment will carry a boxed warning the FDAs most serious. In addition the agency is requiring hospitals and clinics that dispense Yescarta to be certified after undergoing special training. Diffuse large Bcell lymphoma is the most common type of nonHodgkin lymphoma in adults. This type of cancer begins in the immune system and can be fast or slowgrowing the FDA noted. Kites CAR Tcell product was developed years ago at the National Cancer Institute by pioneering scientist Steven Rosenberg and licensed to the company for commercialization. Armin Ghobadi an oncologist at Siteman who was an investigator in the Kite trial said the new treatment is just the first step and that researchers are working to make it safer and more effective. He said the therapy already has been lifechanging for many of his patients and for him. Theres nothing worse than telling patients Im sorry we are done here we dont have anything else to offer he said."
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"Researchers hope a new treatment developed in the United Kingdom will prove vital in controlling future flu pandemics such as HN swine flu bird flu as well as ending the need for annual flu jabs. Developed by scientists at Oxford University the new vaccine works by targeting protein cells inside the influenza A virus instead of current vaccines that attack proteins on the outside of the flu virus. According to Sarah Gilbert head of the project at Oxfords Jenner Institute this method is effective because proteins inside the virus are far more similar across all the influenza strains and are less likely to mutate. In the first successful trial on humans healthy people were vaccinated and infected with the seasonal flu strain along with nonvaccinated volunteers. Flu kills every year. Its not just swine flu. Normally its the very old or very young that die from flu but every year there are deaths from influenza A. Sarah Gilbert from Oxford Universitys Jenner Institute. The results say Gilbert are important in developing a new form of protection that researchers hope could spell the end of flu vaccination supply problems. The most recent global pandemic was the HN flu pandemic in which the estimates of deaths ranged as high as in the U.S. alone according to the Centers for Disease Control and Prevention. Gilbert explained With the swine flu pandemic it took four months before the first doses of the vaccine were available and there was only a small amount available Gilbert explained. It took a further six months before it was possible to vaccinate a large number of people. With this type of vaccine you would at least be able to start using the vaccine as soon as you knew a new pandemic was starting. You could stockpile the vaccine and wouldnt have this wait to make a new pandemicspecific vaccine she said. The vaccine would be an important step in treating seasonal flu not just pandemics. Flu kills every year. Its not just swine flu. Normally its the very old or very young that die from flu but every year there are deaths from influenza A said Gilbert. In the U.S alone its believed about people die from seasonal flurelated causes in an average year according to the CDC. The initial results are positive says Peter Palese professor and chair of microbiology at Mount Sinai School of Medicine New York but more research is needed before the new treatment is approved. I think its a very interesting and very elegant approach and the data so far looks very very good he said. But although the vaccine has been give to humans unfortunately there is no evidence presented to say if it really results in protection against infection. Gilbert agrees more work is required before the vaccine becomes available estimating a wait of at least five year but says the results are a fundamental next step in the treatment of flu. Its fairly certain flu vaccines are going to change a lot in the next few years she said. Whether its this vaccine or another one someone else develops I dont think well be continuing with the type of flu vaccines that we have at the moment."
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"Exercise can reverse damage to sedentary aging hearts and help prevent risk of future heart failure if its enough exercise and if its begun in time according to a new study by cardiologists at UT Southwestern and Texas Health Resources. To reap the most benefit the exercise regimen should begin by late middle age before age when the heart apparently retains some plasticity and ability to remodel itself according to the findings by researchers at the Institute for Exercise and Environmental Medicine IEEM which is a collaboration between UT Southwestern Medical Center and Texas Health Presbyterian Hospital Dallas. And the exercise needs to be performed four to five times a week. Two to three times a week was not enough the researchers found in an earlier study. Based on a series of studies performed by our team over the past years this dose of exercise has become my prescription for life said senior author Dr. Benjamin Levine Director of the Institute and Professor of Internal Medicine at UT Southwestern. I think people should be able to do this as part of their personal hygiene just like brushing your teeth and taking a shower. The regimen included exercising four to five times a week generally in minute sessions plus warmup and cooldown One of the weekly sessions included a highintensity minute workout such as aerobic interval sessions in which heart rate tops percent of peak rate for minutes with minutes of recovery repeated four times a socalled x . Each interval session was followed by a recovery session performed at relatively low intensity. One days session lasted an hour and was of moderate intensity. As a prescription for life Levine said this longer session could be a fun activity such as tennis aerobic dancing walking or biking. One or two other sessions were performed each week at a moderate intensity meaning the participant would break a sweat be a little short of breath but still be able to carry on a conversation the talk test. In the study exercise sessions were individually prescribed based on exercise tests and heart rate monitoring. One or two weekly strength training sessions using weights or exercise machines were included on a separate day or after an endurance session. Study participants built up to those levels beginning with three minute moderate exercise sessions for the first months and peaked at months when two highintensity aerobic intervals were added. The more than participants in the study were divided into two groups one of which received two years of supervised exercise training and the other group a control group which participated in yoga and balance training. At the end of the twoyear study those who had exercised showed an percent improvement in their maximum oxygen intake during exercise and a more than percent improvement in compliance or elasticity of the left ventricular muscle of the heart Dr. Levine noted. He compared the change in the heart to a stretchy new rubber band versus one that has gotten stiff sitting in a drawer. Sedentary aging can lead to a stiffening of the muscle in the hearts left ventricle the chamber that pumps oxygenrich blood back out to the body he explained. When the muscle stiffens you get high pressure and the heart chamber doesnt fill as well with blood. In its most severe form blood can back up into the lungs. Thats when heart failure develops said Dr. Levine who holds the S. Finley Ewing Chair for Wellness at Texas Health Dallas and the Harry S. Moss Heart Chair for Cardiovascular Research. He also holds the Distinguished Professorship in Exercise Sciences at UT Southwestern which is celebrating its th anniversary this year. Earlier research by UT Southwestern cardiologists showed that left ventricular stiffening often shows up in middle age in people who dont exercise and arent fit leaving them with small stiff chambers that cant pump blood as well. However the researchers also found that the heart chamber in competitive masterslevel athletes remains large and elastic and that even four to five days of committed exercise over decades is enough for noncompetitive athletes to reap most of this benefit. In the current study researchers wanted to know if exercise can restore the hearts elasticity in previously sedentary individuals especially if begun in late middle age. Previous studies from Dr. Levines research program have shown substantial improvements in cardiac compliance in young individuals after a year of training but surprisingly little change if the training was started after age . To start the study researchers recruited participants ages to . Many came from the Dallas Heart Study which includes Dallas residents and is the only singlecenter heart study of its size and multiethnic composition. The Dallas Heart Study is designed to improve the diagnosis prevention and treatment of heart disease. The new study appears in Circulation a journal of the American Heart Association. Collaborators on the study included first author Dr. Erin Howden Research Fellow with UT Southwesterns Graduate School of Biomedical Sciences and the IEEM and now a faculty member at the Baker Heart and Diabetes Institute in Melbourne Australia. Funding came from the National Institutes of Health and the American Heart Association. About UT Southwestern Medical Center UT Southwestern one of the premier academic medical centers in the nation integrates pioneering biomedical research with exceptional clinical care and education. The institutions faculty has received six Nobel Prizes and includes members of the National Academy of Sciences members of the National Academy of Medicine and Howard Hughes Medical Institute Investigators. The faculty of more than is responsible for groundbreaking medical advances and is committed to translating sciencedriven research quickly to new clinical treatments. UT Southwestern physicians provide care in about specialties to more than hospitalized patients emergency room cases and oversee approximately . million outpatient visits a year."
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"For decades research has suggested a link between oral health and inflammatory diseases affecting the entire body in particular heart attacks and strokes. The results released today from a randomized trial of a novel plaque identifying toothpaste Plaque HD show statistically significant reductions in dental plaque and inflammation throughout the body. Inflammation throughout the body is accurately measured by high sensitivity Creactive protein hsCRP a sensitive marker for future heart attacks and strokes. These results published today online ahead of print in the American Journal of Medicine with an accompanying editorial by the editorinchief show that Plaque HD produced statistically significant reductions in dental plaque and inflammation throughout the body as measured by hsCRP. In this trial all randomized subjects were given the same brushing protocol and received a day supply of toothpaste containing either Plaque HD or an identical nonplaque identifying placebo toothpaste. To assess dental plaque all subjects utilized a fluorescein mouth rinse and intraoral photographs were taken under black light imaging. For hsCRP levels were measured by an independent laboratory using an enzyme linked immunosorbent assay. While the findings on reducing dental plaque extend a previous observation the findings on decreasing inflammation are new and novel said Charles H. Hennekens M.D. Dr.P.H. senior author and first Sir Richard Doll Professor and senior academic advisor to the dean in the Charles E. Schmidt College of Medicine at Florida Atlantic University. Last month the prestigious New England Journal of Medicine ranked the original manuscript by Hennekens and colleagues on aspirin inflammation and cardiovascular disease published in as their most influential original report of the last years. The original research from the landmark Physicians Health Study in which Hennekens was the founding principal investigator was the first to demonstrate that hsCRP predicted future heart attacks and strokes. In the accompanying editorial titled Can a Toothpaste Reduce Heart Attacks and Strokes Joseph S. Alpert M.D. an internationally renowned cardiologist noted the importance and timeliness of these findings and commented on how his father a dentist had told him even before he went to medical school that dental health may affect heart attacks and strokes. Plaque HD is the first toothpaste that reveals plaque so that it can be removed with directed brushing. In addition the products proprietary formulation contains unique combinations and concentrations of cleaning agents that weaken the core of the plaque structure to help the subject visualize and more effectively remove the plaque. This investigator initiated randomized trial was published in collaboration with academic collaborators from the University of Illinois at the Chicago School of Dentistry and the University of Wisconsin School of Medicine and Public Health. Based on these findings Hennekens and colleagues are drafting an investigator initiated research grant proposal to the National Institutes of Health NIH under the direction of coauthor Patrick E. McBride M.D. M.P.H. professor of medicine and interim associate dean for faculty affairs at the University of Wisconsin School of Medicine and Public Health. This large scale randomized trial will test whether Plaque HD reduces risks of heart attacks and strokes. The trial will be conducted in the Wisconsin Network for Health Research WiNHR and the Wisconsin Research and Education Network WREN both of which McBride directs. Among the numerous honors and recognition Hennekens has received include the Fries Prize for Improving Health for his seminal contributions to the treatment and prevention of cardiovascular disease the Presidential Award from his alma mater Queens College for his distinguished contributions to society and the honoree of the American Heart Association which he shared with FAUs College of Medicine for reducing premature deaths from heart attacks and strokes. From to Science Watch ranked Hennekens as the third most widely cited medical researcher in the world and five of the top were his former trainees andor fellows. In Science Heroes ranked Hennekens No. in the history of the world for having saved more than . million lives. In he received the Ochsner Award for reducing premature deaths from cigarettes. In he was ranked the No. Top Scientist in the World with an Hindex of . About Florida Atlantic University Florida Atlantic University established in officially opened its doors in as the fifth public university in Florida. Today the University with an annual economic impact of . billion serves more than undergraduate and graduate students at sites throughout its sixcounty service region in southeast Florida. FAUs worldclass teaching and research faculty serves students through colleges the Dorothy F. Schmidt College of Arts and Letters the College of Business the College for Design and Social Inquiry the College of Education the College of Engineering and Computer Science the Graduate College the Harriet L. Wilkes Honors College the Charles E. Schmidt College of Medicine the Christine E. Lynn College of Nursing and the Charles E. Schmidt College of Science. FAU is ranked as a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. The University is placing special focus on the rapid development of critical areas that form the basis of its strategic plan Healthy aging biotech coastal and marine issues neuroscience regenerative medicine informatics lifespan and the environment. These areas provide opportunities for faculty and students to build upon FAUs existing strengths in research and scholarship. For more information visit http"
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"A pilot feasibility study to determine if young children with autism spectrum disorder ASD and their parents would tolerate and adhere to an office and homebased acupunctureacupressure intervention showed completion of all biweekly sessions and measurements of their effects before during and after the protocol. The study design and results which suggest further controlled studies of this intervention approach in ASD are published in the Journal of Alternative and Complementary Medicine JACM a peerreviewed publication from Mary Ann Liebert Inc. publishers http The article is available free on the JACM httponline.liebertpub.comdoifull.acm.. website until July . Coauthors Lana Warren EdD OTL and Patricia Rao PhD Kennedy Krieger Institute Baltimore MD and David Paton DAc LAc Starting Point Acupuncture and Health Services Catonsville MD identified the most positive outcome of the study as the high compliance rate with all parents of the children ages completing the intervention. The researchers measured the effects of the intervention on factors such as the childrens behavior ability to pay attention sleep and aspects of parenting stress. In the article entitled A Pilot Observational Study of an AcupressureAcupuncture Intervention in Children with Autism Spectrum Disorder httponline.liebertpub.comdoifull.acm.. most parents reported that the intervention had a positive impact on their relationship with their child. While a small study the tolerance and adherence with acupressure this pilot are both hopeful signs for families of those in their care with autism spectrum disorder states JACM EditorinChief John Weeks johnweeksintegrator.com Seattle WA. About the Journal The Journal of Alternative and Complementary Medicine JACM http is a monthly peerreviewed journal published online with open access options and in print. Led by John Weeks johnweeksintegrator.com the Cofounder and past Executive Director of the Academic Collaborative for Integrative Health JACM publishes controlled trials observational studies scientific reviews and leading commentary intended to help medical organizations and governmental organizations optimize the use of integrative products practices and practitioners in patient care and in delivery and payment strategies. Complete tables of content and a sample issue may be viewed on the JACM http website. About the Publisher Mary Ann Liebert Inc. publishers http is a privately held fully integrated media company known for establishing authoritative peerreviewed journals in many promising areas of science and biomedical research including Alternative and Complementary Therapies Medical Acupuncture and Journal of Medicinal Food. Its biotechnology trade magazine GEN Genetic Engineering Biotechnology News was the first in its field and is today the industrys most widely read publication worldwide. A complete list of the firms more than journals books and newsmagazines is available on the Mary Ann Liebert Inc. publishers website http"
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"When it comes to preventing recurrent bladder infections cranberry capsules do not work as well as daily antibiotics a new study shows. But the supplements do have a real upside they are less likely to have side effects and to spark the growth of antibiotic resistant strains of bacteria. For women who are concerned about drugresistant bacteria the use of cranberry for the prevention of urinary tract infections may be the best approach Dr. Marielle A. J. Beerepoot and her colleagues concluded in a study in the Archives of Internal Medicine on Monday. The new study followed premenopausal women who reported having at least three urinary tract infections or UTIs in the previous year. Beerepoot a researcher with the Academic Medical Center in Amsterdam randomly chose of the women to be treated with daily doses of an antibiotic while the other were treated with capsules containing mg of cranberry twice a day for a year. By end of the study there were more than twice as many UTIs in the cranberry treated group compared to those who got antibiotics percent versus . percent. After just one month though . percent of the E coli samples from the antibiotictreated women were showing resistance to the medications. Thats compared to . percent from women treated with cranberry supplements. Its no surprise that cranberry isnt as effective as antibiotics but they still may hold more appeal for many patients said Dr. Megan Schimpf an assistant clinical professor of obstetrics and gynecology at the Perelman School of Medicine at the University of Pennsylvania. There are women who would prefer to take something natural with a lower risk of side effects even if they know that theyll have slightly increased risk of a urinary tract infection according to Schimpf. Studies like this might tempt women to treat themselves rather than seeing a doctor first. Thats a bad idea. We know that women can sometimes mix up urinary tract infections with vaginal infections with yeast or bacteria she explained. And there is a concern that the urinary tract infection is already severe enough to have generated a kidney infection. Those usually come with fever and back pain. For women who want to eschew antibiotics there are other choices these days Schimpf said. She treats her patients with an antiseptic medication called Hiprex methenamine. Its a medication that gets metabolized into a compound in the urine that makes it very unfavorable for bacteria to grow Schimpf said. I tell my patients to combine that with cranberry."
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"Brynne Henn leaned back onto a pristine white couch and settled whiteandred headphones over her ears. She picked up a handset grasping one buzzer in each hand closed her eyes and the session began. The room was quiet. Through the headphones Henn heard an alternating tone first in the right ear then the left back and forth. The handset buzzed in synchrony rightleftrightleft part of a trauma treatment that also involves recalling painful memories. She turned her thoughts to the day her brother Nate died. Nate Henn had been visiting relatives and working with Invisible Children a nonprofit in Kampala Uganda. On July he was at a sports complex with friends enjoying the broadcast of a World Cup soccer match when terrorists struck. Nate was only when shrapnel from a bomb ended his life. The years hadnt diminished Brynne Henns pain. Your brothers dead and you need to come home to take care of your mom she remembered her father saying. With those simple words her brother was gone and she felt compelled to take control in the ensuing chaos. Henn who had been visiting her boyfriend in Chapel Hill immediately returned home to Raleigh N.C. I didnt stop for the first week after Nate died she said. The ordeal didnt end with the news of Nates death. Her other brother Kyle rushed home from Delaware to be with the family. But the private plane carrying him crashed the next day in nearby Chapel Hill. The pilot was killed and the copilot was seriously injured but Kyle survived. And then the media storm went crazy Henn said. The family already had received inquiries from journalists about Nates death Kyles brush with death only intensified the interest of media outlets from Philadelphia to Raleigh. It made it so much worse Henn said. At age she began functioning as the family spokeswoman. I felt like I had to protect my family from all of it she said. She occupied herself with press inquiries and funeral arrangements. But after the whirlwind passed unaddressed grief remained with her. Complicated grief When a person experiences trauma the associated memories can remain as vivid and urgent as on the day the event happened. The brain perceives the trauma as happening in the present and reacts accordingly even in safe situations. When Henns traumatic memories of her brothers violent death were triggered they popped and glowed in her mind as if they were being shown on a projector screen. All these memories around me started playing like a video loop Henn said. Her body remembered the sensations vividly the heat and discomfort of the summer day the pain of her high heels as she delivered the eulogy at the funeral. Henn did cognitive behavioral therapy a form of conventional talk therapy for five years. It helped me realize feelings were normal she explained and that she was not weak for reeling from the tragedy. But I never felt like I was getting over it. Random memories could send her spiraling into panic and fear. Talk therapy helped her manage those attacks but it didnt address the root cause. Henn was initially diagnosed with a condition known as complicated grief she was diagnosed with posttraumatic stress disorder only last year. She was surprised. She had thought of PTSD as an affliction of soldiers and others directly involved in horrendous events not of people like her suffering from the ripple effects of a bombing in Uganda. It was Kyle Henn recovering from his own PTSD after surviving the plane crash who recommended eye movement desensitization and reprocessing therapy or EMDR. Psychologist Francine Shapiro developed EMDR http in . Three years later she founded the EMDR Institute which has trained more than practitioners. Some therapists use sounds from headphones during a session. Others use eye movement moving a finger or object back and forth as the patient follows eyes moving left to right and back again. Others employ a bar on which small bulbs light up from one side to another. Patients follow the light or object with their eyes or listen to the alternating tone while thinking about a specific traumatic memory or series of memories. They describe the memories to the therapist who gives guidance as needed. The idea is that reliving the memories helps remove the sting and that the urgency of the memories can be reduced as the brain begins to move them from shortterm to longterm memory. The sound or the eye movement is supposed to activate both sides of the brain in an imitation of REM sleep when the brain usually converts shortterm memories into longterm recollections. Studies have found benefits httpjournals.cambridge.orgactiondisplayAbstractfromPageonlineaidfileIdS to EMDR. But there is debate about whether the eye movement http makes a difference http Stephen Holland founder of the Capital Institute for Cognitive Therapy and coauthor of the textbook Treatment Plans and Interventions for Depression and Anxiety Disorders. The question is whether stimulation adds to it. He does not use it in his practice because he considers it no more effective than cognitive behavioral therapy. Brynne Henn who lives in the District began seeing a licensed clinical psychologist who practices EMDR last September. In Gail Kalins office nestled in a treeshaded apartment building in Northwest Washington Henn confronted the trauma that still haunted her. The techniques associated with EMDR may merely have a placebo effect some psychologists say. In early sessions Henn focused on the headphones and handset they helped distract her from the terror of reliving the traumatic events surrounding her brothers death she said. This distraction had a positive effect on her she said allowing her to dive deeply into the therapy without freezing in the face of fear. Some insurance plans cover EMDR. Henns does not she pays for the sessions out of pocket. Henn who is a communications associate at a Washington research institution was initially very skeptical of EMDR. It is so weird she said. When I first got there and she hands me these two paddles that vibrate in my hands and then I put on these giant headphones I was like What is this a hearing test What are we doing But Henn was encouraged by the progress she made. I started getting really interested in it she said. Why is my brain coming up with this What in the world are you doing to me that this is what I came up with Henn was surprised by the vivid memories some of which she hadnt known existed that resurfaced after so much time had passed. Reliving the memories It didnt matter to her whether research supported EMDR what mattered was whether it worked for her. Each time a particularly painful memory resurfaced Henn said you have to go through it again until it has no meaning. By confronting the trauma headon she added it became less powerful. Its integrating whats stuck in time explained Kalin the psychologist. Memories formed under the adrenaline of trauma are never put to rest she said. EMDR processing is untangling the knot. Once the memories are processed therapists say they are less vivid less like the film reel Henn would see in her mind. Henn was able to recall processed memories without feeling panic. EMDRs central appeal lies in the possibility of closure an end to PTSD and to therapy for it. Im going to come out equipped with tools to take care of myself Henn said. She already has put these tools to the test Two months after she started EMDR terrorists hit Paris killing at least people. Soon after that attack she heard reports that a video possibly from the Islamic State contained a threat to hit Washington next and she had a fullfledged panic attack she said. I was not sure where I was I was sweating profusely but also really cold she said. She stepped onto the thfloor terrace at work and looked down. The thought came into my head I just need to walk off and that will wake me up Henn remembered. And I had enough awareness that I sat myself down and was trying to think of calming breaths and going back and forth actions reminiscent of EMDR processing. It took a while and it was a little terrifying that I had that thought she said. But the process of being able to calm myself down was much better than anything I had been equipped with before. In a few weeks Henn mentioned to Kalin she would be marrying her college sweetheart. Beneath the excitement she felt a twinge of panic How would she react to her brothers absence from the wedding She asked a close friend to write a speech from Nates point of view as if he were speaking at the celebration. But Henn admitted she was worried that the speech would trigger an extreme emotional reaction a fear shared by many who suffer from PTSD. They never know when the trauma will reignite it can spread from the smallest spark even on the happiest day. Does EMDR deal with the future she asked Kalin. Kalin nodded and they began processing memories again. Among the painful recollections Henn encountered a happy memory friends who arrived at the funeral to support the family and a smile broke through the tears. It felt like a gift from Nate she said. EMDR Henn said allowed her to have a doover to be able to grieve properly and then to move beyond grief. She was finally able to remember the good times with her brother without being overwhelmed by pain. Im still sad but Im not hurt by it anymore she said. Its not opening up any fresh wounds. As Henn walked outside into a brisk April evening after her session there was a new easiness to her as though something had finally been freed."
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"About percent of patients with moderate to severe psoriasis saw their disease completely or almost completely cleared with a new drug called ixekizumab according to three large longterm clinical trials led by Northwestern Medicine. The results of these phase III trials were compiled in a paper published in the New England Journal of Medicine. This group of studies not only shows very high and consistent levels of safety and efficacy but also that the great majority of the responses persist at least weeks said Dr. Kenneth Gordon a professor of dermatology at Northwestern University Feinberg School of Medicine and first author of the paper. Affecting about percent of the worlds population psoriasis is an immunemediated inflammatory disease that causes itchy dry and red skin. It is also associated with an increased risk for depression heart disease and diabetes among other conditions. Ixekizumab works by neutralizing a pathway in the immune system known to promote psoriasis. To test the drugs efficacy over time and to help clinicians determine whether its benefits outweigh any risks the three studies enrolled a total of adult patients at more than study sites in countries. All participants had moderate to severe psoriasis which is defined as covering percent or more of the body. Patients were randomly assigned to receive injections of ixekizumab at various doses or a placebo over a period of more than a year. The investigators assessed whether the drug reduced the severity of psoriasis symptoms compared to the placebo and evaluated safety by monitoring adverse events. By the th week . to . percent of patients has their psoriasis classified as clear or minimal compared to . of patients on the placebo. By the th week . to . percent of patients had maintained their improvement. Based on these findings we expect that percent of patients will have an extremely high response rate to ixekizumab and about percent will be completely cleared of psoriasis Gordon said. Ten years ago we thought complete clearance of this disease was impossible. It wasnt something we would even try to do. Now with this drug were obtaining response levels higher than ever seen before. Adverse events associated with ixekizumab included slightly higher rates of neutropenia low white blood cell count yeast infection and inflammatory bowel disease compared to the placebo. The safety of therapy longer than weeks will need to be monitored in the future. The drug has been approved by the Food and Drug Administration since the trials were completed. This research was funded by Eli Lilly and Company the manufacturer of ixekizumab. Dr. Gordon is a paid consultant for Eli Lilly and Company."
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"Researchers say theyve discovered a twodrug combination that delays treatment resistance in patients with advanced melanoma. By targeting different points in the same growthfactor pathway the kinase inhibitor drugs dabrafenib and trametinib postponed the development of drug resistance in patients with BRAFpositive metastatic melanoma the study authors said. Melanoma is the most serious and often deadly form of skin cancer. In about half of patients with melanoma that has spread tumor growth is caused by genetic mutations that keep the BRAF protein part of the MAPK cell growth pathway constantly activated. Drugs that inhibit BRAF activity can rapidly stop and reverse tumor growth in about percent of patients. But the response is temporary in most cases and tumor growth resumes in six or seven months the researchers explained. Previous research suggested that this drug resistance develops because the MAPK pathway gets turned back on through activation of MEK another protein that is part off the MAPK pathway. We investigated this drug combination because of research we and others have conducted into the molecular underpinnings of resistance to BRAF inhibitor therapy study lead author Dr. Keith Flaherty of the Massachusetts General Hospital Cancer Center said in a hospital news release. The phase and study was sponsored by GlaxoSmithKline which developed both drugs. We found that adding the MEK inhibitor trametinib to BRAF inhibitor dabrafenib clearly delays the emergence of resistance. In fact the combination was at least twice as effective as BRAF inhibition alone he said. One expert agreed that the results were encouraging. This study addresses the problem of resistance to the mitogenactivated protein kinase MAPK pathway. This study combined dabrafenib a selective BRAF inhibitor and trametinib a selective MAPK kinase MEK inhibitor. These drugs can be safely combined and the survival was significantly improved without untoward side effects said Dr. Michele Green a dermatologist at Lenox Hill Hospital in New York City. The study was conducted at sites in the United States and Australia and included patients who received different dose combinations of the drugs two daily milligram mg doses of dabrafenib plus one mg dose of trametinib the same dabrafenib dose with a mg dose of trametinib or treatment with dabrafenib alone. Patients who received dabrafenib alone were able to receive the fulldose combination treatment if their cancer resumed progression. Treatment with both combinations of dabrafenib and trametinib led to a fourmonth longer delay in drug resistance than treatment with dabrafenib alone. After one year of treatment percent of patients receiving the fulldose combination treatment had no progression of their melanoma compared with percent of those receiving dabrafenib alone. Among patients receiving the combination treatment the development of side effects such as skin rash and a less dangerous type of skin cancer called squamous cell carcinoma was similar to that typically seen in patients taking only one of the drugs. The study was scheduled for presentation Saturday at the European Society for Medical Oncology meeting in Vienna and simultaneous publication in the New England Journal of Medicine. The drug combination is now being tested in a larger phase study which is required for U.S. Food and Drug Administration approval. More information The American Cancer Society has more about melanoma http SOURCE Michele Green M.D. dermatologist Lenox Hill Hospital New York City Massachusetts General Hospital news release Sept."
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"A nonsurgical treatment could improve quality of life for patients with knee pain due to osteoarthritis according to new research presented today at the Society of Interventional Radiologys Annual Scientific Meeting. In the first U.S. clinical trial on geniculate artery embolization GAE a minimally invasive imageguided treatment that blocks key arteries in the knee to reduce inflammation and pain resulted in a majority of study participants achieving significant pain reduction and improvements in range of motion avoiding more invasive measures. A majority of our patients with osteoarthritis of the knee saw significant pain reduction not only just a few days after the procedure but a month after as well making this an accessible treatment for patients looking to improve their quality of life without surgery said Sandeep Bagla M.D. director of interventional radiology at the Vascular Institute of Virginia and lead author of the study. We are very encouraged by the results and the implications for the millions suffering from this common yet debilitating condition. Interventional radiologists perform GAE for knee pain by inserting catheters through a pinholesized incision blocking the very small arteries or capillaries within the lining of the knee reducing the inflammation caused by osteoarthritis. As an outpatient treatment GAE does not require open surgery or physical therapy and takes minutes to perform. This prospective multicenter clinical trial evaluated patients with severe osteoarthritis pain. Each patients pain and disability were measured along two scales with evaluations before and after the treatment. The treatment was successfully completed in all patients with no adverse events. One month later researchers followed the progress of eight patients and found that GAE significantly decreased pain mm on the Visual Analog Scale reduced stiffness and increased physical function . on the Western Ontario and McMaster University Osteoarthritis Index. Together the scales represent an percent improvement in function compared with preprocedure conditions. This procedure could have a significant impact in the treatment of osteoarthritis pain as a whole said Bagla. The current mainstay of treatment in patients who have arthritis are pain medications which come with significant side effects and risks. But GAE provides another option for patients struggling with pain and may even allow patients to avoid the painful recovery of knee surgery and the need for the kind of opioid pain medications associated with the dangerous epidemic in the United States. This study builds on the growing international research around GAE and osteoarthritis. While preliminary data shows that the treatment does work and is feasible it has only been used in a clinical trial setting. The study has completed enrollment of patients and final results are expected in summer . A second randomized controlled clinical trial began in February and will provide further data on what types of patients are the best candidates for this treatment and how it could move toward clinical practice. Abstract Geniculate Artery Embolization GAE for Osteoarthritis OArelated Knee Pain Interim Results from a Multicenter US Trial. S. Bagla R. Piechowiak T. Hartman J. Orlando A. Isaacson Vascular Institute of Virginia Woodbridge VA UNC Chapel Hill Chapel Hill NC University of North Carolina Chapel Hill. SIR Annual Scientific Meeting March . This abstract can be found at sirmeeting.org http About the Society of Interventional Radiology The Society of Interventional Radiology is a nonprofit professional medical society representing more than practicing interventional radiology physicians trainees students scientists and clinical associates dedicated to improving patient care through the limitless potential of imageguided therapies. SIRs members work in a variety of settings and at different professional levelsfrom medical students and residents to university faculty and private practice physicians. Visit sirweb.org http The Society of Interventional Radiology is holding its Annual Scientific Meeting March at the Los Angeles Convention Center in Los Angeles Calif. Visit sirmeeting.org http"
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"Its notoriously hard to treat depression in kidsthe antidepressants we rely on to treat adults seem to be less effective and more dangerous when used on younger minds. New research out of Oxford http helps confirm this and then some The researchers metaanalysis on how commercially available antidepressants compare with a placebo showed that just one of the antidepressants examined was significantly better than a placebo in treating depression in children and adolescents. The only drug to pass the test was fluoxetine sold in the U.S. under the trade name Prozac. It outperformed all other antidepressants in both efficacy and tolerability a term that researchers use to mean how often patients had to quit the drug due to negative side effects. Prozac is also the only antidepressant approved by the Food and Drug Administration to treat depression in people under . Thats because the FDA has deemed that Prozac has demonstrated benefits that outweigh one of the suspected downsides of antidepressants in kids and teens disrupting brain development. Dr. Andrea Cipriani psychiatrist and lead author on the study says these are concerns that practicing psychiatrists confront daily. From a clinical point of view we tend to be very cautious when prescribing medication to children and adolescents because of the unknown effects on the developing brain he said. Theres good reason for this. Researchers have long worried about the effects of psychoactive drugs on people whose brains are still developing. Back in researchers at Harvard Medical School released a study http that sought to answer questions about the safety of certain drugs and chemicals including antidepressants in adolescents. The study which used rats in lieu of human children found evidence that reward pathways are severely altered following exposure to drugs that affect the brain. Research on how antidepressants actually affect human childrens brain development is extremely hard to come by given the limited numbers of actual children on antidepressants and the complications of gaining consent to study them. But other research on antidepressants suggest they negatively affect brain plasticity http and memory http that would be problematic while the brain is still developing. And theres another major problem with the use of many antidepressants in children They may increase suicidal thoughts and behavior. Since the FDA has advised http that antidepressants not be prescribed to individuals under due to the increased risk in suicidality especially during the early phases of treatment. Dr. Mina Fazel child psychiatrist at the Oxford University Childrens Hospital says Its complicated because youre giving antidepressants when youre very worried about that young persons mood. Essentially the moment when it seems most necessary to prescribe the drugs may also be the moment when the patient is most at risk of suicide. Untangling this cause and effect has thus far eluded researchers though there is some evidence http to suggest that antidepressants spark a chemical reaction in the brain that does in fact increase the risk of suicide. So far the FDA is erring on the side of caution. A comment attached to the Oxford paper written by Dr. Jon Jureidini a child psychiatrist at the Womens and Childrens Hospital in Adelaide Australia goes even further in decrying the use of antidepressants in kids. Only if the discounted benefit outweighs the boosted harm should the treatment be prescribed he writes. For antidepressants in adolescents this equation will rarely favor prescribing in younger children almost never. To be clear Jureidini believes there is almost never a justification for prescribing antidepressants to children or adolescents. I called him to be sure. Theyre not better than nothing he said and theres quite clear evidence that theyre more dangerous than nothing. He arrived at this conclusion after applying the customary dose of skepticism doctors are taught to apply when translating research findings to clinical practice. His wariness of antidepressants being prescribed for kids Prozac included is further bolstered by the theory that these drugs dont work well in children because they werent designed for children. They were designed for adults and adults have very different physiological states than adolescents. The Oxford paper notes that percent of children ages and nearly percent of teenagers ages suffered from major depressive disorder the psychiatric term for what is colloquially known as depression. Given the U.S. population that works out to more than a million children and adolescents. The disease manifests differently in kids Whereas adults might report feeling apathetic unmotivated unfocused and just plain sad children with this disorder tend to be irritable and aggressive and as a result have trouble navigating social situations with adults and peers. That means that one of the first battles in treating depression in kids is recognizing it in the first place. Of course having an effective intervention once it is recognized would help. If theres an upside to be found in how ineffective antidepressants likely are for kids its that pharmacological solutions are not the recommended first line of defense anyway. Guidelines from the psychiatric associations in most countries recommend that doctors first try psychotherapy or talk therapy which is has been shown to work at least by participants own assessment of their depression levels its very hard to test therapy against a placebo for obvious reasons. Methods such as cognitive behavioral therapy in which psychiatrists help patients overcome destructive behaviors and thought patterns and interpersonal therapy which focuses more on the effect depression has on relationships seem to be equally effective http in treating depression particularly in adolescents. Of course this is a highcost intervention in terms of both dollars and time invested and it may not always be readily available http_hrmentalhealth_oct.pdfbut the upside is that there is no reason to believe it is harmful. Like in nearly all areas of science biomedical or otherwise our understanding is limited and further research is required to find out more about both potential treatment options. Adolescent depression is particularly difficult since gaining consent to study interventions in children is more complicated than it is in adults. If we are to answer these big unknowns regarding the safety of antidepressants in young patients critical because therapy and medication are more effective together than in isolation http_psychologicaltherapiesversusantidepressantmedicationaloneandincombinationfordepressioninchildrenandadolescents we need more data."
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"Scientists using brain https scanning technologies say they have been able to predict with accuracy which children with dyslexia https will be able to improve reading skills over a period of a few years. Researchers say their findings reveal activity in specific brain https regions during reading that could eventually lead to new treatments for people with dyslexia. At this time we cannot say which treatment type will each child benefit from study researcher Fumiko Hoeft MD PhD an imaging expert at Stanford University tells WebMD in an email. But with more research and if researchers combine it with intervention studies then we should be able to identify brain https patterns that are predictive of responding to one type of intervention or another. She says in a news release that the study gives us hope that we can identify which children might get better over time and that the findings represent a huge step forward. The discovery of brain https regions involved in the learning disorder may provide a mechanism for enduring improvement that promotes relatively successful reading development according to the study published in the Dec. issue of the Proceedings of the National Academy of Sciences. Study Suggests Interventions to Help Dyslexics Learn to Read Dyslexia is a learning disability https that impairs a persons ability to read and affects to of children in the U.S. About of youths with dyslexia develop adequate reading skills by the time they are adults. But until now what happens in the brain that permits improvement has not been known the researchers say. Brain imaging studies in the past have shown greater activation of specific brain regions in children and adults with dyslexia while they are performing readingrelated tasks. In particular an area known as the interior frontal gyrus seems to be hyperactivated in dyslexic people. Hoeft and colleagues set out to determine whether neuroimaging could predict which children with dyslexia would gain improvement in reading skills using functional magnetic resonance imaging https fMRI which shows oxygen use by areas in the brain and diffusion tensor magnetic resonance imaging DTI which shows connections between brain areas. Study Involves Youths With Dyslexia and Normal Readers For the study the researchers enrolled children with dyslexia and without all between ages and and evaluated their reading skills using standardized tests. They used the two types of brain imaging fMRIs and DTIs observing the brains of the youths while they read. Then . years later they reevaluated reading performance. They found that no behavioral measure including standardized reading and language tests reliably predicted reading gains. But the children with dyslexia who showed greater activation in the right inferior frontal gyrus showed greater improvement over the . years from the studys start. The scientists also examined white matter connected to the right frontal region and children in whom this was better organized also showed improvement. Predicting Learning Improvement May Lead to New Treatments Using these techniques the researchers say they were able to predict with significant accuracy future reading gains in youths with dyslexia. The reason this is exciting is that until now there have been no known measures that predicted who will learn to compensate Hoeft says in a news release. By understanding whats going on in the brains of these children scientists may now be better equipped to develop interventions that focus on brain regions involved and thus help adolescents learn to read faster. Coauthor Bruce McCandliss PhD of Vanderbilt University says in a news release that insights from the brain scans may be crucial for new educational research on how to best meet the individual needs of struggling readers. He tells WebMD in an email that the findings could be used to investigate the possibility that brain activity patterns and structural differences hold clues as to how to match treatment approaches to the particular needs of such children. Alan E. Guttmacher MD director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development says the study creates insights into how certain people with dyslexia learn to compensate for reading difficulties. Understanding the brain activity associated with compensation may lead to ways to help individuals with this capacity draw upon their strengths he says. Similarly learning why other individuals have difficulty compensating may lead to new treatments to help them overcome reading disability. Hoeft says the findings suggest brain imaging can help determine which kinds of treatments are likely to work. She also suggests that the study may show that youths with dyslexia use right brain frontal regions to compensate for reading problems rather than the areas in the left side of the brain as typical readers do."
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"Study in adults with treatmentresistant depression marks the first time an antidepressant has achieved superiority in a clinical trial for major depressive disorder that included a newly initiated oral antidepressant in both the control and placebo groups Study in elderly patients is the first large clinical trial in treatmentresistant depression in this population Results demonstrate the potential of esketamine nasal spray to address a significant unmet need for the more than percent of people suffering from major depressive disorder who do not respond to two or more currently available antidepressants News provided by Janssen Pharmaceutical Companies of Johnson Johnson https May ET Share this article javascriptvoid javascriptvoid javascriptvoid javascriptvoid javascriptvoid javascriptvoid TITUSVILLE N.J. May PRNewswire The Janssen Pharmaceutical Companies of Johnson Johnson today announced the results from two Phase clinical studies of the investigational compound esketamine nasal spray in patients with treatmentresistant depression. These studies will be presented at the American Psychiatric Association Annual Meeting taking place May in New York NY. Data from a study in adults with treatmentresistant depression showed that flexibly dosed esketamine nasal spray plus a newly initiated oral antidepressant demonstrated a statistically significant clinically meaningful rapid reduction of depressive symptoms as compared to placebo nasal spray plus a newly initiated oral antidepressant. The study defined treatmentresistant as patients who had not responded to two or more currently available antidepressants of adequate dose and duration in the current episode of depression. Data from a second study in elderly patients aged and older with treatmentresistant depression which is the first study of its kind showed treatment with flexibly dosed esketamine plus a newly initiated oral antidepressant demonstrated clinically meaningful effects compared to placebo nasal spray plus a newly initiated oral antidepressant. However the study narrowly missed statistical significance for its primary efficacy endpoint. If approved by the U.S. Food and Drug Administration FDA esketamine would be one of the first new approaches to treat refractory major depressive disorder available to patients in the last years. With about percent of patients with major depression failing to respond to currently available antidepressants treatmentresistant depression represents a major public health need said Husseini K. Manji MD Global Head Neuroscience Therapeutic Area Janssen Research Development LLC. The positive Phase results for esketamine nasal spray in adults with treatmentresistant depression are exciting particularly as they mark the first time an antidepressant has achieved superiority versus an active comparator in any clinical trial for major depressive disorder. What makes this even more significant is that the response was rapid and this milestone was achieved in patients deemed to be treatmentresistant. We are also pleased with the clinically meaningful outcomes for esketamine nasal spray in elderly patients a population that often has greater disability and lower response rates. Theres a critical need for new rapidly acting and effective treatment options for people with major depressive disorder who do not respond to existing therapies said Mathai Mammen M.D. Ph.D. Global Head Janssen Research Development LLC. Janssen is fully committed to exploring the newest science in the area of mood disorders and bringing these discoveries to patients in need. Click to Tweet httpsctt.ecPLxd Janssen announces new Phase data re. treatmentresistant depression httppo.stMUWqV Results of the Study in Adults with TreatmentResistant Depression In the Phase study of adults with treatmentresistant depression patients were randomized to flexibly dosed esketamine nasal spray mg or mg added to a newly initiated oral antidepressant or placebo nasal spray added to a newly initiated oral antidepressant. Primary Efficacy Endpoint The primary efficacy endpoint change from baseline in the Montgomerysberg Depression Rating Scale MADRS total score demonstrated the statistically significant clinical improvement in patients depressive symptoms for esketamine nasal spray plus an oral antidepressant at day Least Squares Mean Difference Standard Error from placebo nasal spray plus a newly initiated oral antidepressant . . Confidence Interval CI . . onesided p.. Secondary and Other Efficacy Endpoints The first key secondary endpoint onset of clinical response by hours postdose that is maintained through day numerically favored esketamine nasal spray plus an oral antidepressant vs. placebo nasal spray plus an oral antidepressant but did not meet statistical significance sided p.. The other two key secondary endpoints Sheehan Disability Scale SDS a subjectreported outcome measure widely used and accepted for assessment of functional impairment and associated disability and Patient Health Questionnaire PHQ a selfreport scale assessing depressive symptoms could not be formally evaluated since onset of clinical response was not statistically significant. Among other endpoints response rate was notable with . responding in the esketamine group vs. in the placebo group at days response improvement in MADRS from baseline. Remission rate MADRS total score at day was . and . for the esketamine and placebo groups respectively. The most common treatmentemergent adverse events reported in the esketamine group were metallic taste nausea vertigo dizziness headache drowsiness dissociation blurred vision paraesthesia tingling sensation and anxiety. The most common treatmentemergent adverse events reported in the placebo group were metallic taste and headache. Results of the Study in Elderly Patients with TreatmentResistant Depression Janssen conducted a separate Phase study in elderly patients with treatmentresistant depression. Elderly populations with major depressive disorder are historically hard to treat and often have comorbidities and longstanding depression. To improve tolerability patients were given a lower starting dose mg of esketamine nasal spray flexibly dosed at mg mg or mg plus a newly initiated oral antidepressant or placebo nasal spray plus a newly initiated oral antidepressant. Primary Efficacy Endpoint Although statistical significance for the primary endpoint for the overall patient population studied was narrowly missed results favored the esketamine nasal spray plus a newly initiated oral antidepressant group median unbiased estimate of the difference from placebo nasal spray plus a newly initiated oral antidepressant . CI . . onesided p.. To put this into context an analysis of placebocontrolled data from three prior studies conducted by Duru and Fantino determined that a minimum change in MADRS of . was clinically meaningful. In addition the average difference is between points for currently approved antidepressants vs. placebo. Safety results were consistent with previous studies of esketamine in younger adult populations. The most common treatmentemergent adverse events reported in the esketamine group were dizziness nausea headache fatigue increased blood pressure vertigo and dissociation. There were no treatmentemergent adverse events reported in of patients in the placebo group. Esketamine nasal spray has an acceptable safety and tolerability profile based on the adverse event data from both Phase studies. Adverse events and associated symptoms were seen predominately on the day of dosing and were generally transient and resolved on the day of dosing. These findings represent two of the five Phase studies that comprise Janssens treatmentresistant depression program with esketamine nasal spray. The results from these studies will inform regulatory filings for esketamine nasal spray in treatmentresistant depression for which Janssen has received Breakthrough Therapy Designations from the U.S. FDA. Data from other Phase studies will be presented later in . About the Studies In both Phase studies esketamine or placebo was provided in disposable nasal spray devices containing l of solution i.e. two sprays and administered under the supervision of a health care professional. A bittering agent was added to placebo to simulate the taste of esketamine to help mask the treatment assignment. The study in adults with treatmentresistant depression was a Phase doubleblind activecontrol flexibly dosed multicenter study using blinded raters conducted at sites in Czech Republic Germany Poland Spain and the United States from August to November . The study enrolled adults with moderatetosevere nonpsychotic recurrent or persistent depression and history of nonresponse to antidepressants in the current episode of depression with one of them assessed prospectively. Nonresponders were randomized to flexiblydosed esketamine nasal spray or mg twice weekly plus a newly initiated oral antidepressant N or placebo nasal spray plus a newly initiated oral antidepressant N. The primary efficacy endpoint change from baseline to day in MADRS total score was assessed among patients who received dose of nasal spray and oral study medication by mixedeffects model using repeated measures using a onesided significance level of .. .. For further information about this study visit the ClinicalTrials.gov httpsclinicaltrials.govctshowNCTtermNCTrank website. The study in elderly patients with treatmentresistant depression was a Phase doubleblind multicenter activecontrolled study. Patients years of age were randomized to either esketamine nasal spray plus a new oral antidepressant N or placebo nasal spray plus a new oral antidepressant N. The primary endpoint was the change in the MADRS total score from day baseline to day . Statistical analysis employed mixedeffects model repeated measures MMRM with a weighted combination test to account for an interim analysis for sample size reestimation using a onesided significance level of .. For further information about this study visit the ClinicalTrials.gov httpsclinicaltrials.govctshowNCTtermNCTrank website. About Esketamine Esketamine nasal spray is an investigational compound being studied by Janssen Research Development LLC as part of a global development program. Esketamine is a noncompetitive NmethylDaspartate NMDA receptor antagonist also known as a glutamate receptor modulator thought to help restore synaptic connections in brain cells in people with major depressive disorder. It has a novel mechanism of action meaning it works differently than currently available therapies for depression. Esketamine received Breakthrough Therapy Designations from the U.S. FDA in November for treatmentresistant depression and in August for the indication of major depressive disorder with imminent risk for suicide. About Major Depressive Disorder Major depressive disorder affects nearly million people of all ages globally and is the leading cause of disability worldwide. Individuals with depression including major depressive disorder experience continuous suffering from a serious biologically based disease which has a significant negative impact on all aspects of life including quality of life and function. Although currently available antidepressants are effective for many patients about one third of patients do not respond to treatment and are thought to have treatmentresistant depression. About the Janssen Pharmaceutical Companies of Johnson Johnson At the Janssen Pharmaceutical Companies of Johnson Johnson we are working to create a world without disease. Transforming lives by finding new and better ways to prevent intercept treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http Follow us at http and http Cautions Concerning ForwardLooking Statements This press release contains forwardlooking statements as defined in the Private Securities Litigation Reform Act of regarding product development and the potential benefits of esketamine. The reader is cautioned not to rely on these forwardlooking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize actual results could vary materially from the expectations and projections of Janssen Research Development LLC andor Johnson Johnson. Risks and uncertainties include but are not limited to challenges and uncertainties inherent in product research and development including the uncertainty of clinical success and of obtaining regulatory approvals uncertainty of commercial success competition including technological advances new products and patents attained by competitors challenges to patents manufacturing difficulties and delays changes in behavior and spending patterns or financial distress of purchasers of health care products and services changes to applicable laws and regulations including global health care reforms and trends toward health care cost containment. A further list and description of these risks uncertainties and other factors can be found in Johnson Johnsons Annual Report on Form K for the fiscal year ended January including in Exhibit thereto and the companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http http or on request from Johnson Johnson. None of the Janssen Pharmaceutical Companies or Johnson Johnson undertakes to update any forwardlooking statement as a result of new information or future events or developments. . National Institute of Mental Health. Sequenced Treatment Alternatives to Relieve Depression STARD Study. Available at http_edn http Accessed May . . The clinical relevance of changes in the MontgomeryAsberg Depression Rating Scale using the minimum clinically important difference approach. Available at https Accessed May . . Khin NA https_uid et.al. Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications Journal of Clinical Psychiatry. April . Available at https Accessed May . . Johnson Johnson Press Release. Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide. Available at https Accessed May . . World Health Organization. Depression. Available at http Accessed May . . Thase ME. Update on partial response in depression. J Clin Psychiatry. suppl ."
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"A couple of extra minutes attached to the umbilical cord at birth may translate into a small boost in neurodevelopment several years later a study suggests. Children whose cords were cut more than three minutes after birth had slightly higher social skills and fine motor skills than those whose cords were cut within seconds. The results showed no differences in IQ. There is growing evidence from a number of studies that all infants those born at term and those born early benefit from receiving extra blood from the placenta at birth said Dr. Heike Rabe http a neonatologist at Brighton Sussex Medical School in the United Kingdom. Rabes editorial accompanied the study httpdx.doi.org.jamapediatrics.. published Tuesday in the journal JAMA Pediatrics. Delaying the clamping of the cord allows more blood to transfer from the placenta to the infant sometimes increasing the infants blood volume by up to a third. The iron in the blood increases infants iron storage and iron is essential for healthy brain development. The extra blood at birth helps the baby to cope better with the transition from life in the womb where everything is provided for them by the placenta and the mother to the outside world Rabe said. Their lungs get more blood so that the exchange of oxygen into the blood can take place smoothly. Article continues after this message from our sponsor Past studies have shown higher levels of iron http and other positive effects http later in infancy among babies whose cords were clamped after several minutes but few studies have looked at results past infancy. In this study researchers randomly assigned half of healthy Swedish fullterm newborns to have their cords clamped more than three minutes after birth. The other half were clamped less than seconds after birth. Four years later the children underwent a series of assessments for IQ motor skills social skills problemsolving communication skills and behavior. Those with delayed cord clamping showed modestly higher scores in social skills and fine motor skills. When separated by sex only the boys showed statistically significant improvement. We dont know exactly why but speculate that girls receive extra protection through higher estrogen levels whilst being in the womb Rabe said. The results in term infants are consistent with those of followup in preterm infants. Delayed cord clamping has garnered more attention in the past few years for its potential benefits to the newborn. Until recently clinicians believed early clamping reduced the risk of hemorrhaging in the mother but research hasnt borne http that out. Much of the research has focused on preterm infants http who appear to benefit most http from delayed cord clamping Rabe said. Preemies who have delayed cord clamping tend to have better blood pressure in the days immediately after birth need fewer drugs to support blood pressure need fewer blood transfusions have less bleeding into the brain and have a lower risk of necrotizing enterocolitis http a lifethreatening bowel injury she said. This study is among the few looking at healthy fullterm infants in a country high in resources as opposed to developing countries where iron deficiency may be more likely. The American Congress of Obstetricians and Gynecologists has not yet endorsed the practice http citing insufficient http evidence for fullterm infants. The World Health Organization recommends delayed cord clamping http_recommendationscord_clampingen of not less than one minute. It is unclear whether the practice could harm infants health. Some studies have found a higher risk of jaundice http a buildup of bilirubin in the blood from the breakdown of red blood cells. Jaundice is treated with blue light therapy and rarely has serious complications http Another potential risk is a condition called polycythemia a very high red blood cell count said Dr. Scott Lorch http an associate professor of pediatrics at the University of Pennsylvania Perelman School of Medicine and director of the Center for Perinatal and Pediatric Health Disparities Research at Childrens Hospital of Philadelphia. Polycythemia can have medical consequences for the infant including blood clots respiratory distress and even strokes in the worstcase scenario Lorch said. Some studies have found higher levels of red blood cells http in babies with delayed cord clamping but there were no complications. Lorch also pointed out that this study involved a mostly homogenous population in a country outside the U.S. We should see whether similar effects are seen in higherrisk populations such as the low socioeconomic population racial and ethnic minorities and those at higher risk for neurodevelopmental delay Lorch said. So far studies on delayed cord clamping have excluded infants born in distress such as those with breathing difficulties or other problems. But Rabe said these infants may actually benefit most from the practice. These babies often need more blood volume to help with blood pressure breathing and circulation problems Rabe said. Also the placental blood is rich with stem cells which could help to repair any brain damage the baby might have suffered during a difficult birth she added. Milking of the cord would be the easiest way to get the extra blood into the baby quickly in an emergency situation."
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