Sentences with phrase «used in clinical trials on»

Not exact matches

Freenome, a liquid biopsy startup that's looking to enter clinical trials, is working on technology that would be able to detect cancer in the body, including its location and type, using only blood samples.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

The biotech plans to shed 20 % of its nearly 600 employees in order to secure yearly cost - savings of about $ 21 million — money which can then be used to double down on late - stage clinical trials for its experimental Parkinson's drug.

And the San Francisco Chronicle reports that over 100 clinical trials listed on the ClinicalTrials.gov website feature Fitbit trackers in addition to those trials using the Apple Watch, Jawbone, Garmin, Pebble and other devices.

In addition, there was no effect on breastfeeding duration when the pacifier was introduced at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from clinical trials) does not support an adverse relationship between pacifier use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifieIn addition, there was no effect on breastfeeding duration when the pacifier was introduced at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from clinical trials) does not support an adverse relationship between pacifier use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifiein observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifier.

The team hopes to begin clinical trials in 2017, but this depends on getting permission to use lab - made sperm to fertilise a human egg.

«If you don't use as close to the total physiological system that you can, you're likely to run into troubles,» like being surprised by side effects later on in clinical trials, says William Haseltine, founder and former chairman and CEO of Rockville, Md. — based Human Genome Sciences.

As Scientific American reported earlier this year, more than half of the current cancer clinical trials do incorporate some form of immunotherapy but still oncologists are often only in the early stages of understanding how to use such treatment on a larger scale.

CDC based its decision for children under 10 to receive two doses on preliminary data from clinical trials of the vaccines being used in the United States, but he said more complete data should emerge soon.

In 1996, when RMP - 7 was first used on brain cancer patients in a Phase 1 clinical trial at UCLA, it was found to be safe, with virtually no side effectIn 1996, when RMP - 7 was first used on brain cancer patients in a Phase 1 clinical trial at UCLA, it was found to be safe, with virtually no side effectin a Phase 1 clinical trial at UCLA, it was found to be safe, with virtually no side effects.

«We set out on a mission to show if you treat patients with the doses that were used in the clinical trials, they will do better.

Instead of simply tracking what the outlets were publishing and analyzing their impact on public opinion, the researchers took an approach similar to that used in clinical trials to evaluate the effects of new drugs.

The Institute of Medicine (IOM) report says that so - called «omics» tests — diagnostic tools based on molecular patterns — are highly prone to errors; it recommends they be rigorously validated before being used in clinical trials.

Building on this breakthrough research, the researchers sought to translate that discovery into a practical prognostic test that doctors could use to assess care and enroll patients in clinical trials.

In a particularly dramatic demonstration at the Stanford site of the pilot clinical trial, a woman identified as «T6,» who is diagnosed with amyotrophic lateral sclerosis, was able to use BrainGate for six sessions of a few hours each over the course of 42 days without any interruptions for explicit recalibration after the decoder was initialized on the first day.

Just a few weeks ago, WHO said that using any of the experimental drugs or vaccines in the pipeline simply wasn't in the cards, because none of them have been through a phase I clinical study, the type of trial in which medical products are tested on healthy volunteers to study their toxicity.

The researchers then tested their scoring method using data on 688 AML patients in three different clinical trials, In each of these groups, patients with low scores (methylation patterns similar to normal HSCs) had approximately twice the median survival time of patients with high scorein three different clinical trials, In each of these groups, patients with low scores (methylation patterns similar to normal HSCs) had approximately twice the median survival time of patients with high scoreIn each of these groups, patients with low scores (methylation patterns similar to normal HSCs) had approximately twice the median survival time of patients with high scores.

Today, The New York Times reports that on Sunday Duke decided to halt enrollment in three clinical trials in which Potti and Duke's Joseph Nevins were using gene - expression signatures to predict a patient's response to chemotherapy.

Vaccine developers are trying to improve vaccines for transplant recipients and other people with a weak immune system, and the samples used in this study came from a clinical trial of different versions of a flu vaccine in patients on immune - suppressive drugs.

Overall, the investigators found that foods, nutrients, dietary patterns or supplement use assessed before the start of the clinical trial had no measurable influence on the effectiveness of a multivitamin on CVD risk in middle - aged and older men.

«Given the continued high prevalence of multivitamin use in the US, it remains critical for us to understand its role on nutritional status and other long - term health outcomes through clinical trials such as PHS II and other new research initiatives.»

Gemcitabine is used on bladder, pancreas and ovary cancer, whilst DON has been tested in clinical trials.

The white paper recommends that practitioners follow relevant guidance documents and that deviation from consensus recommendations should be supported by clinical studies or pursued in the setting of a clinical trial approved by an institutional review board; that practitioners receive training in a new procedure before beginning its practice, that the training should include a practical, «hands - on» component and that all team members directly involved with the radiation therapy decisions should participate in at least five proctored cases before performing similar procedures independently; and that professional societies should accelerate the generation of new or updated guidance documents for the following disease sites and techniques: skin, central nervous system, gastrointestinal, lung or endobronchial and esophagus, and, while outside the charge of this panel, assess the need for updated guidance documents for accelerated partial breast irradiation using electronic brachytherapy.

«Our data argue for developing new clinical trials focused specifically on using these T memory cells, in order to determine if it would indeed be better than current therapeutic options,» said Dr. Snyder.

Although the molecule used in this study isn't one of the molecules under clinical trial, Zlotnick said the mechanism sheds light on the behavior of the experimental drugs.

The treatment is widely used in some intensive care units in Europe and North America, but there have been few clinical trials to assess the effects on patients» long - term recovery.

«When we embarked on this study, early clinical trials and laboratory studies supported the possibility (or hypothesis) that earlier therapy in appropriate patients with docetaxel, used in combination before hormonal resistance occurred, could have greater benefit, but required proof in a definitive study.

«Many clinical trials in pulmonary hypertension also use the catheter test as an outcome measure, but it could provide a significant advantage to be able to replace it with a less invasive MRI scan, as our model also provides more detailed information on physical changes to the heart itself.»

I think only the future will be able to show whether we can use these strategies really to improve clinical deficits first in animal models, and then later on, of course, also in clinical trials.

Dr. Xianmin Zeng is currently in discussions with the NIH (National Institutes of Health) Center for Regenerative Medicine and the NIH Clinic Center on using the cells for a Phase I clinical trial.

She ends the session on stem cells by describing the path to using stem cells in clinical trials.

«Lithium, long used in mental health as a highly effective mood stabiliser, has been on the radar as a potential disease modifying treatment for Alzheimer's disease with positive evidence from preclinical studies and a number of small clinical trials.

Oncologists will potentially be able to use the results to pair patients with the most effective drugs for their tumors, and researchers may improve clinical trial results by selecting those patients most likely to respond to a specific drug based on the mutations in their prostate tumors.

The GDC will support clinical trials that focus on single patients, known as «n of 1» clinical trials, and will become an important component in how precision medicine is used to treat individual patients.

The data from extensive laboratory studies on correlates of risk of HIV infection will be used in one aspect of the clinical trial design.

As we'll see later on, this has already contributed to their receiving FDA - approval for use in a clinical trial.

For the first time, a team of Chinese scientists will use the CRISPR - Cas9 gene editing technique in a clinical trial on lung cancer patients.

The website is a perfect complement to the «Stem Cells in Focus» blog, housing informational pages on basic stem cell biology, the process by which science becomes medicine, clinical trials and the use of stem cells in understanding and potentially treating specific health conditions.

In this role, Ms. Roxland re-launched and chaired J&J's Ethics Committee, created an enterprise - wide consultation service for teams and individuals confronting complex research ethics issues, and provided guidance on issues such as post-trial access for former research participants, conducting clinical trials in war - torn regions, testing of a potential Ebola vaccine during a public health crisis, commercialization of stem cell therapies, subject recruitment and withdrawal, and expanded access / compassionate usIn this role, Ms. Roxland re-launched and chaired J&J's Ethics Committee, created an enterprise - wide consultation service for teams and individuals confronting complex research ethics issues, and provided guidance on issues such as post-trial access for former research participants, conducting clinical trials in war - torn regions, testing of a potential Ebola vaccine during a public health crisis, commercialization of stem cell therapies, subject recruitment and withdrawal, and expanded access / compassionate usin war - torn regions, testing of a potential Ebola vaccine during a public health crisis, commercialization of stem cell therapies, subject recruitment and withdrawal, and expanded access / compassionate use.

Once a scientist identifies a drug that can be repurposed using the database, the drug's potential effect must be then tested on a new disease, both in animal models and human clinical trials.

In Louisiana, the 4 - year - old TCA Cellular Therapy company has several ongoing FDA - approved clinical trials on humans, using patients» own stem cells to treat heart and vascular diseases.

In a substudy, review outcomes were also compared across different types of clinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified human tissuIn a substudy, review outcomes were also compared across different types of clinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified human tissuin large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanClinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified human tissue.

In addition to ushering in a new era of personalized healthcare, we hope that our Organs - on - Chips technology will reduce the use of animals in clinical drug trialIn addition to ushering in a new era of personalized healthcare, we hope that our Organs - on - Chips technology will reduce the use of animals in clinical drug trialin a new era of personalized healthcare, we hope that our Organs - on - Chips technology will reduce the use of animals in clinical drug trialin clinical drug trials.

«To evaluate cause - and - effect relationships between long - term PPI use and possible effects on cognition in the elderly, randomized, prospective clinical trials are needed,» said corresponding author Britta Haenisch, from the German Center for Neurodegenerative Diseases in Bonn.

The growing use of a popular drug in the long - term treatment of bipolar disorder is based largely on a single, flawed clinical trial that may be steering doctors and patients away from drugs with a more established track record, a new review suggests.

Information such as dosage, serving size and, in many cases, suggested use are based on the doses used in actual clinical trials.

The typical dosage of NAC given as an oral supplement in clinical trials is 600 mg b.i.d., although 200 mg t.i.d. has been shown to provide benefit in just 8 weeks.27 On the other hand, doses as high as 1 gram t.i.d. have been used in cystic fibrosis patients for 4 - 12 weeks with no adverse effects, and in AIDs patients, oral NAC doses up to 8 grams / day did not cause clinically significant adverse reactions.42 43 44 45 46 47

Some important studies include: • Beneficial effects of a high carbohydrate, high fiber diet on hyperglycemic diabetic men (1976) • Response of non-insulin-dependent diabetic patients to an intensive program of diet and exercise (1982) • Diet and exercise in the treatment of NIDDM: The need for early emphasis (1994) • Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a low fat, vegetarian diet (1999) • The effects of a low - fat, plant - based dietary intervention on body weight, metabolism, and insulin sensitivity (2005) • A low - fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes (2006) • A low - fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74 - wk clinical trial (2009) • Vegetarian diet improves insulin resistance and oxidative stress markers more than conventional diet in subjects with Type 2 diabetes (2011) • Glycemic and cardiovascular parameters improved in type 2 diabetes with the high nutrient density (HND) diet (2012)

1935 Effects of the high carbohydrate - low calorie diet upon carbohydrate tolerance in diabetes mellitus 1955 Low - fat diet and therapeutic doses of insulin in diabetes mellitus 1958 Effect of rice diet on diabetes mellitus associated with vascular disease 1976 Beneficial effects of a high carbohydrate, high fiber diet on hyperglycemic diabetic men 1977 Effect of carbohydrate restriction and high carbohydrates diets on men with chemical diabetes 1979 High - carbohydrate, high - fiber diets for insulin - treated men with diabetes mellitus 1981 High carbohydrate high in fibre diet in diabetes 1982 Response of non-insulin-dependent diabetic patients to an intensive program of diet and exercise 1983 Long - term use of a high - complex - carbohydrate, high - fiber, low - fat diet and exercise in the treatment of NIDDM patients 1994 Diet and exercise in the treatment of NIDDM: the need for early emphasis 1999 Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet 2005 The effects of a low - fat, plant - based dietary intervention on body weight, metabolism, and insulin sensitivity 2006 A low - fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes 2006 Effect of short ‐ term Pritikin diet therapy on the metabolic syndrome 2009 A low - fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74 - wk clinical trial

Several well - designed clinical trials have examined the use of fish oil on nonsteroidal anti-inflammatory drug (NSAIDS) use or steroid use in non-surgical back pain and rheumatoid arthritis.