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Tampilkan postingan dengan label trial. Tampilkan semua postingan
Tampilkan postingan dengan label trial. Tampilkan semua postingan

Rabu, 28 September 2011

Success in trial of cancer drug

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24 September 2011 Last updated at 01:32 GMT By James Gallagher Health reporter, BBC News Alpha particle emissions Alpha particles can damage cells A trial of a new cancer drug, which accurately targets tumours, has been so successful it has been stopped early.

Doctors at London's Royal Marsden Hospital gave prostate cancer patients a powerful alpha radiation drug and found that they lived longer, and experienced less pain and side effects.

The medics then stopped the trial of 922 people, saying it was unethical not to offer all of them the treatment.

Lead researcher Dr Chris Parker said it was "a significant step forward".

Cancer Research UK said it was a very important and promising discovery.

Radiation has been used to treat tumours for more than a century. It damages the genetic code inside cancerous cells.

Alpha particles are the big, bulky, bruisers of the radiation world. It is a barrage of helium nuclei, which are far bigger than beta radiation, a stream of electrons, or gamma waves.

Dr Parker told the BBC: "It's more damaging. It takes one, two, three hits to kill a cancer cell compared with thousands of hits for beta particles."

Alpha particles also do less damage to surrounding tissue. He added: "They have such a tiny range, a few millionths of a metre. So we can be sure that the damage is being done where it should be."

Continue reading the main story Each year in the UK about 36,000 men are diagnosed with prostate cancer; about 10,000 die from itIn most cases, it is a slow-growing cancer and may never cause any symptoms or problems.Some men will have a fast growing cancer that needs treatment Worldwide, an estimated 913,000 men were diagnosed with prostate cancer in 2008, and more than two-thirds of cases are diagnosed in developed countriesIn 90% of patients with advanced prostate cancer, the tumour will have spread to the bone. At this stage there are no treatments which affect survival.

The study looked at patients with these secondary cancers, as the source of radiation - radium-223 chloride - acts like calcium and sticks to bone.

Half were given the radium-223 chloride drug alongside traditional chemotherapy, while the other patients received chemotherapy and a dummy pill.

The death rate was 30% lower in the group taking radium-223. Those patients survived for 14 months on average compared to 11 months in the dummy group.

The trial was abandoned as "it would have been unethical not to offer the active treatment to those taking placebo", said Dr Parker.

He added: "I think it will be a significant step forward for cancer patients".

Researchers also said the treatment was safe. Curiously there were fewer side-effects in the group taking the treatment than those taking the dummy medicine.

The findings are being presented at the European Multidisciplinary Cancer Congress but they have not yet been peer-reviewed by other academics.

Prof Gillies McKenna, Cancer Research UK's radiotherapy expert and director of the Gray Institute for Radiation Oncology and Biology, said: "This appears to be an important study using a highly targeted form of radiation to treat prostate cancer that has spread to the bones.

"This research looks very promising and could be an important addition to approaches available to treat secondary tumours - and should be investigated further."



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Peliculas Online

Selasa, 27 September 2011

Roche bone drug eases pain in prostate cancer trial

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A worker makes its way on a bridge at Swiss pharmaceutical company Roche plant in Basel February 2, 2011. REUTERS/Christian Hartmann

A worker makes its way on a bridge at Swiss pharmaceutical company Roche plant in Basel February 2, 2011.

Credit: Reuters/Christian Hartmann

By Kate Kelland

STOCKHOLM | Sun Sep 25, 2011 6:29am EDT

STOCKHOLM (Reuters) - Roche's bone strengthening drug Boniva is as good for pain relief as single dose radiotherapy in patients whose prostate cancer has spread to their bones, according to data from a late-stage trial released on Sunday.

Trial investigators said the level side effects of Boniva -- known generically as ibandronate (IB) -- were also comparable with radiotherapy, suggesting it could offer an alternative option for advanced cancer patients suffering pain.

Bone metastases, or secondary tumors in the bone, are common in many advanced cancers and "are a serious problem for men with prostate cancer," said Peter Hoskin a professor clinical oncology at University College, London, who presented the data at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm on Sunday.

"We found that using IB was as good as single dose radiotherapy in controlling pain," he said.

Boniva is one of a class of osteoporosis drugs known as bisphosphonates, which work by sticking to calcium and binding to it. Others in the same class include Novartis's Zometa and Merck's Fosamax.

They prevent bone loss by inhibiting the activity of cells that break down bone, called osteoclasts.

For the late stage, or Phase III, trial, researchers gave 470 patients with painful secondary tumors in the bone either a single dose of radiation or an intravenous infusion of Boniva.

Patients reported their main site of pain when they began the trial, and then again at four, eight, 12, 26 and 52 weeks after treatment.

Those who had not responded to the first treatment at four weeks crossed over to the alternative therapy and received their second treatment no later than week eight.

Pain levels were measured at four and 12 weeks by analysing how many painkillers patients were needing to take, and by scoring their reported pain levels using two standard methods called the WHO pain ladder and the Mercadante method.

"Although there were more patients in the IB group with worse Mercadante scores at four weeks who needed re-treatment, at six and 12 months, there was no long-term difference in pain relief between the two groups," Hoskin said

The median survival of the four groups was 11.8 months for those on radiotherapy only, 11.4 months for those on the Roche drug only, 12.7 months for those on radiotherapy then Boniva, and 16.8 months for those on Boniva and then radiotherapy.

But Hoskin said it was too early to draw any conclusions from these data about the drug's relative impact on survival in this group of patients.

"We hope to analyze these survival differences further in the hope that it can give us... pointers as to how and whether we should use a combination of treatments," he said. "Currently we are unsure about the optimal timing and scheduling of treatment for these patients."

For now Hoskin said Boniva, which is also sold under the brand name Bonviva, would be addition to the arsenal of other possible treatments for cancer pain and could potentially be useful in other types of the diseases such as breast cancer, where secondary bone tumors are also common.

(Editing by John Stonestreet)



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Peliculas Online

Senin, 26 September 2011

Italian Scientists On Trial Over Deadly Earthquake

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The trial of seven Italian scientists began this week. They are charged with manslaughter for failing to adequately warn the residents of L'Aquila, Italy, about the risk of an earthquake in 2009. Host Scott Simon speaks with Rick Aster, president of the Seismological Society of America, about the trial.

Copyright © 2011 National Public Radio®. For personal, noncommercial use only. See Terms of Use. For other uses, prior permission required.

SCOTT SIMON, host: This is WEEKEND EDITION from NPR News. I'm Scott Simon. The trial of seven Italian scientists began this week. They're charged with manslaughter, for failing to adequately warn the residents of L'Aquila, Italy about the risk of an earthquake in 2009. Now the scientists were members of a provincial disaster risk committee. They met in March 2009 to discuss the earthquake risk posed by recent small tremors.

The scientific community tells me there is no danger, a committee spokesman said at the time, because there is an ongoing discharge of energy. The situation looks favorable. Six days later an earthquake killed more than 300 people in L'Aquila. Now the scientists who sat on that committee could face up to 12 years in prison.

Rick Aster is president of the Seismological Society of America. He and his colleagues around the world sent a petition with more than 5,000 signatures calling for the charges to be dropped. Dr. Aster joins us from the New Mexico Institute of Mining and Technology. Thanks for being with us.

RICK ASTER: My pleasure, Scott.

SIMON: What was your first reaction when you first heard about these charges?

ASTER: Well, the initial reaction of the seismological, and I think the broader scientific community, was that this was outrageous, given the fact that earthquakes are unpredictable at this stage in our state of knowledge. Indeed, they're the last great natural disaster for which there is no predictive capacity. And the statement that an ongoing discharge of energy was occurring, so the situation looked favorable was demonstratively scientifically incorrect. Small earthquakes do not function as a safety valve, in a sense, for large earthquakes.

SIMON: Can you see where families of people who've lost loved ones would feel from would feel a lot of frustration by being told the situation looks favorable and then just six days later, well, just six days later 300 people die.

ASTER: Indeed. That really was a tragic miscommunication on the part of Italy's Department of Civil Protection.

SIMON: Why then have you organized this petition and why do you feel that geologists shouldn't be held responsible (technical difficulty).

ASTER: Well, I guess again, Scott, one has to realize one's dealing with an inherently unpredictable phenomena. So the ability to inform people and keep the population ready has to be weighed against the cost of false alarms in this situation, which is very high.

SIMON: Mm-hmm.

ASTER: Because if in a situation like this, you told people to expect an earthquake then you'd be wrong 99 times out of 100. So you get into both the disruption to society and the crying wolf scenario, where you worry that if, you know, you issue false alarms much, much more frequently than you issue true alarms, that process is also useless, unfortunately.

SIMON: Do you have any concern as a scientist, Dr. Aster, that when even if scientists are right, as you suggest 99 percent of the time, that when a mistake like this is made it tends to undercut the credibility of everybody in the field?

ASTER: Well, I think people have to realize, and the community is very honest about it, that earthquake prediction is an extremely daunting scientific, technical and indeed, a political issue, so I don't think we're misrepresenting our ability to predict earthquakes; everyone would agree is essentially null.

SIMON: Rick Aster is the president of the Seismological Society of America. Thanks very much.

ASTER: Thank you, Scott.

Copyright © 2011 National Public Radio®. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to National Public Radio. This transcript is provided for personal, noncommercial use only, pursuant to our Terms of Use. Any other use requires NPR's prior permission. Visit our permissions page for further information.

NPR transcripts are created on a rush deadline by a contractor for NPR, and accuracy and availability may vary. This text may not be in its final form and may be updated or revised in the future. Please be aware that the authoritative record of NPR's programming is the audio.



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Peliculas Online

Minggu, 25 September 2011

Success in trial of cancer drug

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AppId is over the quota
24 September 2011 Last updated at 01:32 GMT By James Gallagher Health reporter, BBC News Alpha particle emissions Alpha particles can damage cells A trial of a new cancer drug, which accurately targets tumours, has been so successful it has been stopped early.

Doctors at London's Royal Marsden Hospital gave prostate cancer patients a powerful alpha radiation drug and found that they lived longer, and experienced less pain and side effects.

The medics then stopped the trial of 922 people, saying it was unethical not to offer all of them the treatment.

Lead researcher Dr Chris Parker said it was "a significant step forward".

Cancer Research UK said it was a very important and promising discovery.

Radiation has been used to treat tumours for more than a century. It damages the genetic code inside cancerous cells.

Alpha particles are the big, bulky, bruisers of the radiation world. It is a barrage of helium nuclei, which are far bigger than beta radiation, a stream of electrons, or gamma waves.

Dr Parker told the BBC: "It's more damaging. It takes one, two, three hits to kill a cancer cell compared with thousands of hits for beta particles."

Alpha particles also do less damage to surrounding tissue. He added: "They have such a tiny range, a few millionths of a metre. So we can be sure that the damage is being done where it should be."

Continue reading the main story Each year in the UK about 36,000 men are diagnosed with prostate cancer; about 10,000 die from itIn most cases, it is a slow-growing cancer and may never cause any symptoms or problems.Some men will have a fast growing cancer that needs treatment Worldwide, an estimated 913,000 men were diagnosed with prostate cancer in 2008, and more than two-thirds of cases are diagnosed in developed countriesIn 90% of patients with advanced prostate cancer, the tumour will have spread to the bone. At this stage there are no treatments which affect survival.

The study looked at patients with these secondary cancers, as the source of radiation - radium-223 chloride - acts like calcium and sticks to bone.

Half were given the radium-223 chloride drug alongside traditional chemotherapy, while the other patients received chemotherapy and a dummy pill.

The death rate was 30% lower in the group taking radium-223. Those patients survived for 14 months on average compared to 11 months in the dummy group.

The trial was abandoned as "it would have been unethical not to offer the active treatment to those taking placebo", said Dr Parker.

He added: "I think it will be a significant step forward for cancer patients".

Researchers also said the treatment was safe. Curiously there were fewer side-effects in the group taking the treatment than those taking the dummy medicine.

The findings are being presented at the European Multidisciplinary Cancer Congress but they have not yet been peer-reviewed by other academics.

Prof Gillies McKenna, Cancer Research UK's radiotherapy expert and director of the Gray Institute for Radiation Oncology and Biology, said: "This appears to be an important study using a highly targeted form of radiation to treat prostate cancer that has spread to the bones.

"This research looks very promising and could be an important addition to approaches available to treat secondary tumours - and should be investigated further."



View the original article here



Peliculas Online

Brain-collection practices on trial in Maine

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ALFRED, Maine (AP) — The practices of a prestigious medical research institute that studies schizophrenia and bipolar disorder are on trial in Maine, where the organization collected at least 99 brains from organ donors.

Anne Mozingo, of York, contends that the Stanley Medical Research Institute and a man working on its behalf removed her late husband's entire brain without her consent after he died of a brain aneurism in 2000. She said she agreed to donate only small brain tissue samples.

Mozingo learned nearly five years after her husband's death that his entire brain — along with its lining, plus his liver, spleen and pituitary gland — had been removed and sent to the institute. She filed suit in 2005 against the Bethesda, Md., institute and its Maine representative, Matthew Cyr.

Her claims include infliction of emotional distress, fraud and negligent misrepresentation. After Mozingo learned that her husband's entire brain had been removed, she suffered extreme emotional and mental distress and had nightmares in which her husband's body was being mutilated, she said in court documents.

The lawsuit accused the defendants of acting "beyond all possible bounds of decency."

The institute and Cyr, of Bucksport, deny any wrongdoing. The institute has repeatedly said over the years that it never knowingly obtained brains without full consent from next of kin.

From the mid-1990s to 2003, Stanley Medical Research Institute used a network of "brain harvesters" in Maine and three other states to collect hundreds of brains for use in the study of schizophrenia and bipolar disorder. The brains were packed in dry ice and shipped by FedEx to the institute.

Cyr, who also worked for the Maine Medical Examiner's Office, was paid more than $150,000 to collect brains and other organs from at least 99 bodies from 1999 to 2003, according to court documents.

Mozingo's lawsuit is one of more than a dozen that were filed against the institute by Maine families alleging that their relatives' full brains were removed without their consent.

Most of the complaints have been settled out of court, but three have gone to trial.

The first one to go resulted in a mistrial in January 2010 after the plaintiff testified that he chose to put the case before a jury because he didn't want to settle. The judge ruled the statement implied to jurors that the defendant was offered a financial settlement to avoid a trial.

A second case went to trial last fall, with the jury siding with Stanley, Cyr and the institute's former executive director, Dr. E. Fuller Torrey.

Mozingo's case began this week in York County Superior Court.

On the first day of the trial, her attorney held up a model of brain as a prop while giving his opening statement. Mozingo told jurors that she was misled and betrayed during a time of grieving and stress. The institute's lawyers questioned her reliance on notes to recount her conversation with Cyr after her husband died.

Mozingo's lawyer, Thomas Douglas, declined to comment on the case because court proceedings were ongoing. Philip Coffin, who represents the institute, also declined to comment.

Mozingo's trial is expected to conclude Friday or Monday, but it likely won't be the final court case.

Portland attorney John Campbell said he expects his client, Ray Martin, of Old Orchard Beach, to have his day in court next spring. Martin's case was the one that ended in a mistrial, and Campbell said it's the last remaining case in Maine.

"Mr. Martin feels very strongly about going back to trial," the attorney said.

Associated Press

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Peliculas Online

Jumat, 23 September 2011

First European Embryonic Stem Cell Trial Gets Green Light

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Health authorities in the U.K. approved on Thursday Europe's first clinical trial involving embryonic stem cells.

Surgeons at Moorfields Eye Hospital in London will treat 12 patients with Stargardt's macular dystrophy, a major cause of blindness in young people. Patients with Stargardt's gradually lose retinal pigment epithelial cells, or RPE cells, which are essential for maintaining the proper environment that encourages retinal cells to grow.

Patients in the U.K. trial will receive RPE cells grown from human embryonic stem cells. This is the second human trial to use such cells; the first was approved by the U.S. Food and Drug Administration (FDA) last November, which we described here. In both studies, the cells will be made by Massachusetts-based Advanced Cell Technology (ACT).

The purpose of the trial is to establish the safety of the treatment, so the dozen enrolled patients are at the most advanced stages of the incurable disease. They will receive anywhere from 50,000 to 200,000 cells, injected directly into the eye, behind the retina. Doctors expect that the transplanted cells will then start to grow in their new environment, replacing the diseased and dying ones that have robbed the patients of their vision.

The eye is a good site for testing such a treatment, since it is relatively protected from the immune system; the new cells may therefore be protected from destruction by overzealous defensive cells. The isolated nature of the eye's vitreous cavity, where the cells are injected, also makes it relatively easy for doctors to destroy the transplanted RPE cells should something go wrong, such as if the cells should start forming tumors or migrate to other areas.

The eye trials follow the first ever approved human trial of an embryonic stem cell based-therapy, approved in January 2009 in the U.S. to treat spinal cord injury. The FDA put that trial on hold after some animals receiving the stem cells developed cysts, but the company conducting the trial, Geron, provided additional safety data and new tests for detecting the unusual growths. Last summer the trial was once again allowed to move forward.

Embryonic stem cells could become an important source of replacement cells for a number of different diseases, including diabetes and Parkinson's. As Dr. James Barinbridge, a retinal surgeon at Moorfields and the UCL Institute of Ophthalmology, told the U.K.'s Guardian, "The ability to regenerate retinal cells from stem cells in the laboratory has been a significant advance and the opportunity to help translate such technology into new treatments for patients is hugely exciting. Testing the safety of retinal cell transplantation in this clinical trial will be an important step towards achieving this aim."

Alice Park is a writer at TIME. Find her on Twitter at @aliceparkny. You can also continue the discussion on TIME's Facebook page and on Twitter at @TIME.



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Peliculas Online

Sabtu, 10 September 2011

HEALTH MANAGEMENT. Marshall of Edwards Announces start of phase I clinical trial with lead oncology drug candidate ME-143

Marshall of Edwards, Inc. (NASDAQ: MSHL), the clinical development of novel therapeutics for cancer metabolism, oncology company has today announced the initiation of a phase I clinical trial of the company's drug candidates ME-143 in patients with solid tumors carry fireproof. The study is in collaboration with the Sarah Cannon Research Institute in Nashville, Tennessee, after the adoption of the investigational application administration (FDA) last month is carried out new drug (IND) by the U.S. food and drug.
The phase I dose escalation study evaluates the safety and tolerability of intravenous ME-143 fireproof in patients with solid tumors. In addition, the study is to characterize the pharmacokinetic profile of intravenous ME-143 and describe each preliminary clinical tumor activity observed. The open-label study is to register expected to up to 24 patients with data collected final by in the second half of 2012.
"We are pleased to begin treating patients with ME-143, a promising drug candidate, the anti-tumor activity in pre-clinical studies demonstrated", Robert D. said mass, MD, Chief Medical Officer of Marshall of Edwards. "Together with the Sarah Cannon Research Institute, we are important information on dosage, safety and potential effectiveness of intravenous ME-143 in the coming months, inform the design of our randomized clinical phase II trials in combination with standard of care chemotherapy obtain."
About ME-143
ME-143 is the lead oncology drug candidates by Marshall Edwards' NADH oxidase inhibitor program. It comes from a proprietary isoflavones technology platform that has generated a number of connections with Anti-proliferative activity against cancer cells in laboratory studies. In pre-clinical studies, ME-143 strong activity has shown against a number of tumor cell lines, including breast cancer, colorectal and ovarian cancer. In addition to the wide single-agent activity, ME-143 has shown an ability to the cytotoxic effects of chemotherapy in pre-clinical studies. Marshall of Edwards has exclusive worldwide rights to ME-143. ME-143 was is an investigational drug and not by the FDA for commercial distribution in the United States or other countries.