How To Use Clinical trial In A Sentence
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The development of oncology is always following the anti - tumor new - medicine research and the clinical trial.
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Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxon's business, including, without limitation, Somaxon's interpretation of its communications and interactions with the FDA relating to the requirements for approval of the NDA for Silenor, and the FDA's agreement with such interpretation; Somaxon's interpretation of the results of the clinical trials for Silenor, the timing of the interpretation of such results and the FDA's agreement with such interpretation; the potential for Somaxon to make a resubmission to the Silenor NDA; the potential for Silenor to receive regulatory approval for one or more indications on a timely basis or at all; the potential for the FDA to impose non-clinical, clinical or other requirements to be completed before or after regulatory approval of Silenor; Somaxon's ability to demonstrate to the satisfaction of the FDA that potential NDA approval of Silenor is appropriate prior to the completion of standard, long-term carcinogenicity studies, given the context of completed trials and pending studies; the timing and results of non-clinical studies for Silenor, and the FDA's agreement with Somaxon's interpretation of such results;
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Additionally, FDA officials decided the drug must carry a warning on its label stating, "An increased rate of stroke was observed following Xarelto discontinuation in clinical trials" in patients with the faulty heartbeat known as atrial fibrillation.
FDA Approves Anticlotting Drug
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Several clinical trials are in progress for therapeutic application of genetic diseases, such as hemophilia, cystic fibrosis, ornithine transcarbamylase deficiencies.
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It said Plavix "has met the long-felt need for an effective and safe antiplatelet drug," as evidenced by clinical trials proving its safety and effectiveness versus aspirin.
Sanofi, Bristol Reap Two Victories on Plavix
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Stanford will develop new megavoltage X-ray detection hardware and image reconstruction software, and will validate the new technology in a clinical trial to be conducted by
Varian Medical Systems and Stanford University Win $3.6 Million Five-Year NIH/NCI Research Grant to Develop Advanced Imaging Technology - Yahoo! Finance
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The clinical trial will be starting in late July.
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A high quality metaanalysis cannot resurrect poor quality clinical trials.
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We may soon be able to test drugs in clinical trials.
The Sun
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The chemical synthesis, pharmacological action and clinical trial of exemestane were reviewed.
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An investigational antiandrogen showed substantial antitumor activity in men with castration-resistant prostate cancer, data from a preliminary clinical trial showed.
Social Security Reports, News and Informaion
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The company said clinical trials showed the drug helps patients achieve lower blood sugar when injected prior to meals.
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Take clinical trials, the lifeblood of the industry.
Times, Sunday Times
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Many families report not being made aware of clinical trials, which for critically ill patients are often the only hope of prolonging life.
Times, Sunday Times
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Horses Mouth February 22, 2007 4:57 PM
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However, some ophthalmologists have treated patients with eye injections of an anti-inflammatory corticosteroid called triamcinolone, though its effectiveness had not been tested in a clinical trial.
Kansas City infoZine Headlines
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These agents are now being tested in clinical trials with people at risk. 6.
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The fi nal galenic formulation and dosage Each change in the study course should be noti fi ed forms of the study drug is required for the conduct to the authorities by fi lling speci fi c administration of phase IIb. forms (protocol modi fi cation, study suspension, Phase III should con fi rm the ef fi cacy and safety study completion). of the optimal dose and dose regimen in a large Noti fi cation 698 of May 1980 does not provide group of patients under the usual therapeutic con - much more information regarding clinical trials, ditions.
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We are attempting to scale up and to introduce nutrients by creating a special bioreactor to have live in cells in good bulk to be able to do first animal experiments and then human clinical trials.
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Inadequate allocation concealment can bias the results of clinical trials.
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Clinical trials must use similar protocols to interpret positive results.
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Since then, Wellcome has been scaling up production to prepare for clinical trials.
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Adverse reactions reported by 5 to 14 percent of clinical trial participants include vaginitis, headache, upper respiratory tract infection, leukorrhea, sinusitis, weight gain, and nausea.
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The clinical trial process follows a very regimented format.
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The first stages of a clinical trial are to prove the safety, the quality and the efficacy of a drug.
Times, Sunday Times
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Future clinical trials may be aimed at specific patient populations determined by genetic polymorphism and other risk factors.
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That could take five to ten years of clinical trials.
Times, Sunday Times
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We now report results from the first phase II clinical trial developed exclusively for SCUC, to our knowledge.
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The proportion of biomedical research paid for by industry has changed little during the past 10 years, but the pharmaceutical industry has shifted its focus away from preclinical research and towards clinical trials.
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If you live in a large city, your local newspaper may carry advertisements for clinical trials at nearby research centers.
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We may soon be able to test drugs in clinical trials.
The Sun
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The fund contributes no money toward animal testing, concentrating instead on clinical trials using human volunteers.
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Even today, scientists working with animals tend to think it sentimental to describe animals as feeling "pain" and generally replace the word "painful" with "nociception" in clinical trials.
Telegraph.co.uk - Telegraph online, Daily Telegraph and Sunday Telegraph
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Clinical trials of the new drug may take five years.
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It is available in Britain but only in two clinical trials, which end soon.
Times, Sunday Times
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Horses Mouth February 22, 2007 4:57 PM
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Clinical trials have no special monopoly on the high intellectual road and certainly not on the truth about suffering people.
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We may soon be able to test drugs in clinical trials.
The Sun
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These banks also supply material for clinical trials and stem-cell research.
Times, Sunday Times
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Two rival laser surgery systems are undergoing clinical trials in the US.
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Similar problems of interpretation arise in the evaluation of clinical trials to test the efficacy of pharmaceutical drugs.
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The latter requirement is similar to that of clinical equipoise when human subjects participate in clinical trials.
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We don't know that for sure till we do this clinical trial, but it is a possibility.
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Only about one in ten medicines that enter clinical trials get as far as patients.
Times, Sunday Times
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Many families report not being made aware of clinical trials, which for critically ill patients are often the only hope of prolonging life.
Times, Sunday Times
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The fund employs a research nurse who supports patients on the ward and is involved with clinical trials.
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VATICAN CITY (RNS) A top Vatican official has criticized a decision by the Food and Drug Administration to allow the world's first clinical trials using stem cells derived from human embryos.
Vatican Blasts FDA Over Stem Cell Ruling
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His professional interests include movement and inherited neurological disorders, with special interest in experimental therapeutics, neuropharmacology, public policy, and clinical trials.
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His point, a valid one, is that clinical trials have tended to get longer, larger, and more expensive, while patent lifetimes aren't changing.
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The drug has undergone a number of clinical trials.
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Horses Mouth January 22, 2007 4:24 PM
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In meticulous detail it explained that some patients responded better to placebos than others, that they might respond at some times and not at others, and that considering the placebo response was essential in clinical trials.
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Clinical trials not only collect and analyze medical data, they also gather information on the costs of alternative treatments.
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At that point, a number of drugs in clinical trials could be administered that may postpone or perhaps prevent the onset of dementia.
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Clinical trials with PPC are ongoing in patients with alcoholic liver disease.
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PenWest Pharmaceuticals slid 95 cents, or 18%, to 4.35, after the drug-delivery technology developer said a Phase IIa clinical trial for nalbuphine, an extended-release drug to treat chronic pain, didn't meet its primary endpoint.
Hot Topic,
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These banks also supply material for clinical trials and stem-cell research.
Times, Sunday Times
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In pre-clinical trials, Zalypsis demonstrated strong in vitro and in vivo antitumoural activity in a wide variety of solid and haematological tumour cell lines and human transplantable breast, gastric, prostate and renal xenografted tumours.
Health News from Medical News Today
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These programmes include awareness campaigns to support recruitment of potential participants into clinical trials.
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Those results will reveal whether the drug is suitable for human clinical trials.
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At least two small clinical trials, both fundedby the manufacturer, have tested a supplement containing bromelain plus two other substances that theoretically might ease arthritis — the enzyme trypsin and the antioxidant rutin.
Q&A: Pineapple pills for arthritis pain?
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They're doing clinical trials on a new drug.
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-- On November 25, 2009 - Ipsen announced the initiation of an international, multi-center, controlled, randomized Phase II clinical trial to evaluate the safety and efficacy of BN83495, its investigational first-in-class steroid sulfatase (STS) inhibitor, in advanced endometrial cancer.
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These cancer surveillance programmes are now widely implemented despite not having been subjected to clinical trial.
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The team is now seeking approval to carry out clinical trials at the Churchill Hospital in Oxford.
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The high cost of clinical trials and animal tests has forced Beecham to hold back products that looked promising in research.
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Clinical trials not only collect and analyze medical data, they also gather information on the costs of alternative treatments.
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The drug must first be tested in clinical trials to see if it works on other cancers.
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One of the documents, dated November 1988, reported that in clinical trials Prozac could cause behavioural disturbances.
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Coordination of clinical trials throughout Europe could greatly enhance the potential of new investment in this area and would avoid duplication of effort.
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A 6-month regimen is recommended for tuberculosis at multiple sites and for miliary tuberculosis, although there are limited data from controlled clinical trials addressing this issue.
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The news coming from the landmark gene therapy clinical trial for Leber congenital amaurosis (LCA) at The Children's Hospital of Philadelphia (CHOP) continues to be very encouraging.
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Investigators financial conflict of interest in clinical research may negatively influent clinical trials.
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Adverse reactions reported by 5 to 14 percent of clinical trial participants include vaginitis, headache, upper respiratory tract infection, leukorrhea, sinusitis, weight gain, and nausea.
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The pilot data was supportive of Dr. Xiao's procedure, and now an NIH sponsored clinical trial is being conducted to further study lumbar to sacral nerve rerouting in spina bifida patients.
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Successful clinical trials could offer hope to millions around the world.
The Sun
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Sign up for our Clinical Trial Registry!
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A number of such vectors are currently being developed and tested in preclinical and early phase clinical trials.
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MedTone inhaler, which is different from the one used during clinical trials.
Verdict on MNKD's Afrezza Deferred - Yahoo! Finance
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Auspex Pharmaceuticals, a developer of next-generation medicines with improved safety and performance through the targeted deuteration of clinically validated drugs, today announced positive results from its Phase 1 clinical trial evaluating SD-254, a Selective Serotinin-Norepinephrine Reuptake Inhibitor (SNRI).
Medlogs - Recent stories
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Evidence shows that the way results of clinical trials are presented influences both physicians and funders of health care.
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If and when the clinical trials comparying "riva" with warfarin in chronic atrial fibrillation demonstrates similar good results we may finally have a new oral anticoagulant than does not require frequent blood test monitoring and may be free of much of the vexing vagaries of trying to get the dose of warfarin right and keeping it there. posted by james gaulte @ 4:05 AM
This time,new oral anticoagulants may well make it to the market
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Goss PE, Reid CL, Bailey D, Dennis JW (1997) Phase IB clinical trial of the oligosaccharide processing inhibitor swainsonine in patients with advanced malignancies.
PLoS ONE Alerts: New Articles
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The next step is to carry out clinical trials on humans.
The Sun
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The online journal of current clinical trials, a scientific electronic journal, is to be launched this month.
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Von Hoff and his team also are conducting clinical trials that combine gemcitabine with another anti-cancer drug called nab-paclitaxel.
Azcentral.com | news
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A company called Astrogenetix has started the approval process for putting their salmonella vaccine through the clinical trial wringer.
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Since then, Wellcome has been scaling up production to prepare for clinical trials.
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The Hopkins group is conducting a clinical trial of xenograft model.
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Clinical trials showed that clioquinol had no value as a diarrhea-preventative measure (a popular application).
We are in Mexico and my husband is ill
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A vaccine against thrush could be available by the end of the decade after early clinical trials showed strong results.
Times, Sunday Times
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Perhaps unusually, clinical trials appear to allel group).
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Corthera is developing the medication for some types of heart disease, relaxin, which is currently undergoing Phase III clinical trials to test its efficacy.
Turkish Press
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The new drug is undergoing clinical trials.
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Insurers have everything to gain by supporting clinical trials.
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They also do the vast majority of drug development, from preclinical animal studies through human clinical trials (the latter in collaboration with academic medical centers), and bear the economic risk.
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We believe that these cases illustrate the principle that interpretations of clinical trial results are often neither objective nor value-free.
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In 2010, the first TandAb antibody AFM13 entered clinical trials and the bispecific, tetravalent human antibody has shown very promising safety, tolerability and activity in the treatment of Hodgkin Lymphoma.
Reuters: Press Release
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In a number of laboratory and clinical trials, dendritic cell immunotherapy had succeeded in eliciting a powerful immune response against brain tumor cells, but significant improvements in length of survival had not been realized.
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A vaccine against thrush could be available by the end of the decade after early clinical trials showed strong results.
Times, Sunday Times
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Giving the two together as Contrave, in a sustained-release formulation taken twice a day, led to average weight loss that ranged from 5% to 9.3% of a patient's body weight in four clinical trials.
Regulators to Review New Drugs to Curb Appetite
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It must first be refined so it is stable and safe enough for use in clinical trials on humans.
The Sun
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Several clinical trials are in progress for therapeutic application of genetic diseases, such as hemophilia, cystic fibrosis, ornithine transcarbamylase deficiencies.
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Queensland heroin users will be able to detoxify rapidly on Naltrexone after a two-year clinical trial of the controversial drug begins in Brisbane this week.
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Queensland heroin users will be able to detoxify rapidly on Naltrexone after a two-year clinical trial of the controversial drug begins in Brisbane this week.
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Should the clinician and patient simply press ahead with yet another poorly controlled clinical trial?
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They also reported that activity of the enzyme, known as aldose reductase, can be significantly reduced by compounds that have already undergone clinical trials as treatments for complications of diabetes.
The Daily News - News
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It is often assumed that participation in clinical trials confers benefit to patients.
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The unit is licensed by the MHRA to develop and manufacture biological anticancer agents for use in early phase clinical trials.
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A British biotechnology company, already developing a vaccine to help addicts kick cocaine, said on Monday it had started clinical trials on the world's first nicotine addiction vaccine.
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The use of the function GLMMPQL( ) in the statistical package R is demonstrated through analyzing a real data set arising in a clinical trial.
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Based on preclinical studies and clinical trials in other cancers, we believe that our technology has the potential to be a safe and effective treatment for this challenging disease.
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Their current place in medicine is in properly supervised clinical trials.
Times, Sunday Times
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I think what might even be more interesting for drug development is to pursue what they all pharmacogenomics in the clinical trials world, where they know that certain subpopulations of humans, genetically, respond differently to drugs, and it may be possible to make chips that effectively represent whole populations and thus you could be doing that kind of pharmacogenomics, if you like, but doing it on, you know, thousands of little micro channels on a chip the size of your hand, and multiplexing and doing (unintelligible).
NPR Topics: News
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She also guided several important national clinical trials of potential new therapies, including chemoendocrine therapy for premenopausal breast cancer and antiangiogenesis therapy for advanced disease.
Medlogs - Recent stories
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Horses Mouth January 22, 2007 4:24 PM
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Manchester scientists are testing an emerging therapy called radioimmunotherapy (RIT) in early phase clinical trials, according to a presentation at the University of Manchester has benefited substantially from Experimental Cancer Medicine Centre
Cancer Research UK - RSS Feed
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There are 60 different microbicide products in development and 11 of them are being tested in clinical trials on people.
Times, Sunday Times
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Different medications treating these diseases have been used in clinical trials.
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The program has led to at least one clinical trial.
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Most of these funds ($48.5 million) would go to develop and use imaging as an endpoint in clinical trials.
The Scientist
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Publication bias: the case for an international registry of clinical trials.
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The team is now seeking approval to carry out clinical trials at the Churchill Hospital in Oxford.
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In a report in the journal Stroke, Dr. Sylvie Perreault of McGill University, Montreal, and colleagues note that the benefits of blood pressure-lowering, or "antihypertensive," therapy on major cardiovascular outcomes have been demonstrated in clinical trials.
Medlogs - Recent stories
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Although women report that hormone replacement therapy improves various menopausal symptoms, randomised clinical trials have proved that it is effective for only vasomotor and urogenital symptoms.
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The drugs are in clinical and preclinical trials.
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Most clinical trials have used 10-to 14-day courses of antibiotic therapy.
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The news coming from the landmark gene therapy clinical trial for Leber congenital amaurosis (LCA) at The Children's Hospital of Philadelphia (CHOP) continues to be very encouraging.
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In the clinical trials, people with depression were treated with either an antidepressant or a placeable (placebo), a pill that contains no medicine.
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It must first be refined so it is stable and safe enough for use in clinical trials on humans.
The Sun
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Since then, Wellcome has been scaling up production to prepare for clinical trials.
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Potentially this may indeed lead to new diagnostics, new ways of conducting clinical trials, and conceivably a more rational approach to therapy in common multifactorial diseases.
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Ensure clinical trial is completed in a timely manner to support product registration.
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In 2001 and 2002 we completed all of our clinical trials, our preclinical trials, and the animal work and bench work on the product.
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Clinical trials of the new drug may take five years.
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The International Committee of Medical Journal Editors is considering requiring all clinical trials submitted for publication to be listed in a registry.
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In clinical trials, moodiness was more common among users of Ortho Tri Cyclen than in placebo users, but overall occurred in less than 10% of users.
Walmart offering $9 Birth Control Pills
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Some women find colposcopy very painful while others hardly notice it, according to a clinical trial testing topical benzocaine and ibuprofen against placebo.
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Preliminary results of the company's ongoing Phase I/IIa clinical trial with Apoptone (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC) were presented on November 16, 2009 at the Molecular Targets and Cancer Therapeutics Conference.
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Objective This clinical trial is to evaluate the therapeutic efficacy of Bonin.
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The company will fund clinical trials necessary for the compounds to be shuttled through the federal drug approval process.
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Most patients in clinical trials had osteolytic bone metastases on imaging studies.
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The first clinical trial had shown that treatment with streptomycin alone resulted in the emergence of drugresistant tubercle bacilli.
Times, Sunday Times
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Pharmaceutical companies make an important contribution to medical research, providing much of the cash for clinical trials of new drugs.
Times, Sunday Times
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Teaching pupils the rudiments of double-blind tests, clinical trial methods and general principles of factoring studies for other influences would clear these scientific confusions.
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He conducted a promising small clinical trial that indicated that a drug that binds metals, clioquinol, actually slows the progression of Alzheimer's.
The Big "A"
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Later in 2009, we expect our partner Morphotek, a wholly-owned subsidiary of Eisai, to initiate a first phase 1 clinical trial with MT228, a glycolipid-binding human antibody.
Undefined
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In early clinical trials in Bulgaria, researchers reported that noni concentrate could banish flu symptoms in as little as two hours; and in America, family doctors have reported using it successfully to ward off colds and flu.
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This 8-week, open-label clinical trial used two different dose escalation regimens to evaluate the safety and efficacy of the combination of bupropion and bromocriptine in the treatment of cocaine dependence.
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This will mostly be used in clinical trials, although some is expected to go to those with official medical approval.
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The drug has undergone extensive clinical trials .
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The effects of the drugs on clinical outcomes have not been compared in long term clinical trials in hypertensive type 2 diabetic patients.
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Queensland heroin users will be able to detoxify rapidly on Naltrexone after a two-year clinical trial of the controversial drug begins in Brisbane this week.
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Had preclinical trials involved 50 rhesus monkeys instead of 20, and also involved chimpanzees as well as rats, mice and rabbits, then the potential for a catastrophic event in humans might have been detected.
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We may soon be able to test drugs in clinical trials.
The Sun
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Biological therapy is now being studied in clinical trials for use in colon cancer treatment.
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See our clinical trial database for current information.
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For drug companies, the placebo effect can pose an obstacle to profits--if their medications fail to outperform placebos in clinical trials, they won't get approved by the FDA.
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The blood sugar-lowering action of the fresh juice or unripe fruit has been established in animal experimental models as well as human clinical trials.
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He found that the vast majority of 42 clinical trials submitted to the FDA between 1987 and 1999 for such best selling selective serotonin reuptake inhibitor drugs as Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor, showed no improvement compare to placebos.
Robert Kuttner: A Depressing Story You Need to Read
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Why didn't the clinical trial include more people?
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Although clinical trials have found no evidence that spinal manipulation is an effective treatment for asthma, hypertension, or dysmenorrhea, spinal manipulation may be as effective as some medications for both migraine and tension headaches and may offer short-term benefits to those suffering from neck pain.
The Doctor is In
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Queensland heroin users will be able to detoxify rapidly on Naltrexone after a two-year clinical trial of the controversial drug begins in Brisbane this week.
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Clinical trials to further test antifungal therapy for chronic sinusitis are being planned.
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Indeed, the potential use of placebos for medical benefit and their continued use in clinical trials are recent subjects of considerable interest and controversy among the lay public and scientists alike.
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The seven subjects in this trial experienced the same general type of mild acute side effects described in the prior pilot clinical trial which used one-half of the dose in the current study.
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Ipsen (Paris: IPN) today announced the initiation of an international, multi-center, controlled, randomized Phase II clinical trial to evaluate the safety and efficacy of BN83495, its investigational first-in-class steroid sulfatase (STS) inhibitor, in advanced endometrial cancer.
THE MEDICAL NEWS
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The treatment will go to clinical trials.
The Sun
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Every clinical trial published in first and second tier medical journals contains statistics, and most of those journals employ at least one biostatistician to verify clinical trial statistics.
Doctors, Pharmaceuticals, and Statisticians, Arnold Kling | EconLog | Library of Economics and Liberty
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The chapter could also have included a final paragraph on the generality of the results of clinical trials, in which the mortality rate is so much lower than those observed in complete registers of all heart attack admissions.
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He couldn't run a clinical trial on human beings.
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The drug must first be tested in clinical trials to see if it works on other cancers.
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A recent clinical trial found that one antidepressant, called desipramine Norpramin, and lidocaine -- used either alone or together -- appeared no better than inactive placebo pills and ointments.
Reuters: Press Release
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He had been given Prozac, a new anti-depressant, still undergoing clinical trials, by Dr Rosamund Plaidy.
SPLITTING
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Yet another product outlines the results of a NIDA clinical trial comparing short-term detoxification with buprenorphine versus clonidine, another addiction treatment.
EurekAlert! - Breaking News
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The clinical trial will be starting in late July.
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Two rival laser surgery systems are undergoing clinical trials in the US.
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We are working hard to commercialise this science and will be doing the essential clinical trials until the end of next year.
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Research and development is currently at preclinical stage, progressing to Phase I clinical trials in 2005.
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Queensland heroin users will be able to detoxify rapidly on Naltrexone after a two-year clinical trial of the controversial drug begins in Brisbane this week.
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On December 2, pharmaceutical giant GlaxoSmithKline quietly halted a clinical trial of SRT501, a concentrated form of resveratrol, which is the much-hyped substance found in red wine grapes.
Arlene Weintraub: Drug Trial Raises Doubts About Resveratrol's Anti-Aging Powers
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The more health insurance plans opened their floodgates for bone marrow transplantation, the more women fled from clinical trials, fearing that they might be assigned to the nontreatment arm by what amounted to a coin flip.
The Emperor of All Maladies
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The treatment will go to clinical trials.
The Sun
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There has been some investigation into the natural alkylating agent 4-ipomeanol, but investigation was suspended after the first clinical trials.
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If clinical trials are successful the drug could be on the market early next year.
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So far, the clinical trials have focused on patients with arthritis, wasting syndrome and high cholesterol.
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The online journal of current clinical trials, a scientific electronic journal, is to be launched this month.
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Queensland heroin users will be able to detoxify rapidly on Naltrexone after a two-year clinical trial of the controversial drug begins in Brisbane this week.
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Pharmacogenetics is increasingly driven by industrial researchers, partly because of their ready access to clinical trial data on which pharmacogenetic research can be carried out.
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The news coming from the landmark gene therapy clinical trial for Leber congenital amaurosis (LCA) at The Children's Hospital of Philadelphia (CHOP) continues to be very encouraging.
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Hopefully we'll retest it, it will go into clinical trials and it will help somebody.
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Teaching pupils the rudiments of double-blind tests, clinical trial methods and general principles of factoring studies for other influences would clear these scientific confusions.
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The first clinical trials were expected to begin next year.
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The discovery has the potential to revolutionise pre-clinical cancer research and clinical diagnostic practice, and it makes use of compounds that have already been approved for treating patients: the anti-cancer drug bevacizumab (Avastin) and Copper-64, a radioactive copper nuclide, which is approved by the US Food and Drug Administration (FDA) for some clinical trials.
Health News from Medical News Today
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The midstage clinical trial "Quantum" was testing 235 patients who were receiving PSI-938 alone, or in combination with PSI-7977, or in combination with both PSI-7977 and another drug called ribavirin.
Pharmasset Halts Hepatitis C Drug in Test
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- the medical literature terms it "macrosomia" has not not been found, in meta-analyses of clinical trials - to be, in itself, an indication for cesarean.
Celebrity Baby Blog
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Clinical trials of new antipruritic agents are in progress.
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Many families report not being made aware of clinical trials, which for critically ill patients are often the only hope of prolonging life.
Times, Sunday Times
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The first clinical trials were done in people having onchocerciasis infections.
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Drug therapy for hypercholesterolaemia has remained controversial mainly because of insufficient clinical trial evidence for improved survival.
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