Sentences with phrase «trials designed on»

Identifying the molecular causes of disease represented a major breakthrough in the history of medicine, moving the discipline from pattern recognition and therapeutic strategies based on syndromic pathophysiology to molecular mechanism and evidence ‐ based therapies derived from clinical trials designed on the basis of molecular mechanism.

Not exact matches

In December, Tehrani signed a deal with GlaxoSmithKline that will allow the pharmaceutical giant to test at least four of its drug candidates on a Zymeworks - designed platform, which combines a computer simulation with a way of engineering protein molecules and allows products to be refined before they move to expensive clinical trials.

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.

After Abbott, he co-founded DCVC company BlueTalon, which was initially focused on enterprise data security for data - driven clinical trial design and population health management.

NOVA Intelligent Design on Trial http://www.pbs.org/wgbh/nova/evolution/intelligent-design-trial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parTrial http://www.pbs.org/wgbh/nova/evolution/intelligent-design-trial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover partrial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover partrial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parents,

Intelligent Design / Creationism was put on trial in court and their criticisms of evolution were found lacking.

NOVA Intelligent Design on Trial — PBS http://www.pbs.org/wgbh/nova/evolution/intelligent-design-trial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parentTrial — PBS http://www.pbs.org/wgbh/nova/evolution/intelligent-design-trial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parenttrial.html Nov 13, 2007 — Featuring trial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parenttrial reenactments based on court transcripts and interviews with key participants, including expert scientists and Dover parents,...

The Bronze Medal Sponsors are: American Medical Response, American Horse Trials Foundation, Auburn Labs Advanced Protection Formula, Big Horse Feeds, Cavalor, The Chronicle of the Horse, CWD, Finish Line, Freedom RV Rentals, Geranium Street Equestrian, Point Two Air Jackets, Riding Magazines Inc., Ride On Video, San Luis Rey Equine Hospital, Triple Crown Nutrition and Voltaire Design.

The launch of the new Hiram Walker Watermelon Sour Schnapps will be supported in both the on premise and at off premise retail through custom designed POS and table tents that will encourage trial of signature watermelon recipes.

Although a considerable body of scientific evidence substantiates the positive correlation between curcumin consumption and a reduction in the risk of cancer, the paucity of suitably designed human clinical trials that clearly demonstrate any direct effect of curcumin on cancer markers may prevent Health Canada from approving a cancer risk reduction claim for curcumin within the current regulatory framework.

Our study illustrates that a randomized intervention trial with good socioeconomic information can help assess interventions designed to improve population health not only by examining the intervention effects on primary outcomes but also by evaluating the intervention's impact on socioeconomic inequalities.

DF and K - TT advised on the study design, coordinated the study, liaised with participants, entered data, and monitored the trial.

Although some SIDS experts and policy - makers endorse pacifier use recommendations that are similar to those of the AAP, 272,273 concerns about possible deleterious effects of pacifier use have prevented others from making a recommendation for pacifier use as a risk reduction strategy.274 Although several observational studies275, — , 277 have found a correlation between pacifiers and reduced breastfeeding duration, the results of well - designed randomized clinical trials indicated that pacifiers do not seem to cause shortened breastfeeding duration for term and preterm infants.278, 279 The authors of 1 study reported a small deleterious effect of early pacifier introduction (2 — 5 days after birth) on exclusive breastfeeding at 1 month of age and on overall breastfeeding duration (defined as any breastfeeding), but early pacifier use did not adversely affect exclusive breastfeeding duration.

We excluded a further 13 trials as the intervention was not designed to support continued breastfeeding; these studies examined more general interventions in the postnatal period (Ball 2011; Barlow 2006; Barnet 2002; Black 2001; Gagnon 1997; MacArthur 2002; Peterson 2002; Pollard 2011; Ratner 1999; Rush 1991; Serrano 2010; Thomson 2009; Wiggins 2005); a further trial by Baqui 2008 focused on breastfeeding initiation only, rather than on postnatal support to encourage continuation.

Declan Devane is a co-author in one of the included trials in this review (Begley 2011) Jane Sandall was and is principal investigator for two studies evaluating models of midwife - led continuity of care (Sandall 2001), and co-investigator on the «Birthplace in England Research Programme», an integrated programme of research designed to compare outcomes of births for women planned at home, in different types of midwifery units, and in hospital units with obstetric services.

The motion notes that the Scottish Premier League is planning to initiate trials and calls on the government to recognise «improvements in stadium design and technology mean that, with rigorous safety specifications, standing areas can be safely introduced».

And in several large - scale pharmaceutical trials, drugs specifically designed to elevate HDL had no effect on heart disease risk.

Two other multi-national trials randomized 27,438 patients to either bococizumab or placebo and were designed to evaluate the impact of the drug on cardiovascular outcomes, including nonfatal heart attack and stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death.

«This study's results can have practice changing implications on how future prostate cancer trials are designed in terms of identifying the men for these studies who are at high risk for early death due to ineffective initial treatment for their prostate cancer,» stated Anthony Victor D'Amico, MD, PhD, chief, Genitourinary Radiation Oncology, Brigham and Women's Hospital and senior author of the study.

He says results from phase II and III trials on these new therapies designed to stall the disease are slated to come out within the year.

To be sure, scientists have zeroed in on some promising vaccine - adjuvant combinations, and a few well - designed trials are now under way.

Even Venter acknowledges that syn3.0's genome, although new, was designed by trial and error, rather than being based on a fundamental understanding of how to build a functioning genome.

«With knowledge like this, we can design clinical trials using JAK inhibitors for SS patients based on their JAK mutations,» said Elenitoba - Johnson.

According to Dr. Sumowski, «The significant effect of warmer weather on cognition should be considered when designing and conducting clinical trials.

The determination of each efficacy level was also based on the rigor and quantity of published studies on the drug class: to be in Level A, for example, a class of drugs must have been supported by at least two «Class I» studies — well - designed, double - blind, randomized, placebo - controlled clinical trials.

Scientists are aware of their biases, and use techniques such as blind trials to minimise them, but the pressure to get things done faster leads to some people skimping on experimental design, said Dr Head.

Rwanda will present safety and efficacy data on 50 patients at the American Urology Association in May 2011, and a randomized, controlled trial with 150 participants, designed to compare PrePex with the conventional surgical method is currently ongoing.

The FDA already has a 6 - year - old program called the Critical Path Initiative that, according to its Web site, funds a number of research projects on topics such as clinical trial design.

«Part of what was exciting about the design of this clinical trial is that we decided early on to accept women from a younger and generally sicker population than is typically enrolled in clinical trials,» says Dr. Cristofanilli, who is also a researcher at the Sidney Kimmel Cancer Center at Thomas Jefferson University.

In 1982 results came in from the Multiple Risk Factors Intervention Trial, which was designed to reduce the risk of coronary heart disease by counseling an experimental group to stop smoking, lower their blood pressure and cut back on saturated fat.

The implication is that patients should be stratified by the cause of their sepsis, and trials should be designed based on that.»

Working with the pharma and biotech industries, Poirier focuses on both performing the genetic tests in his laboratory and designing the clinical drug trials.

A chemical cocktail designed to prevent pregnancy, and which may simultaneously reduce the risk of breast cancer, is to go on trial in Britain.

Senior CRAs can become project managers, responsible for the design and overall management of a trial, and then on to be programme managers or directors in charge of multiple drug trials or of a therapeutic area.

The pharmaceutical industry, the National Institutes of Health, the FDA, academia, clinical research organizations and other key stakeholders will have the opportunity to focus on these disparities and identify the barriers and challenges in educating, recruiting and designing clinical trials.

The Maternal Vitamin D Osteoporosis Study (MAVIDOS) is the first randomised, placebo - controlled trial designed to measure the impact of pregnancy vitamin D supplementation on the bone health of babies using bone density scanning.

Similar advances should allow chemists to design new molecules on computers instead of by lengthy trial - and - error.

Based on this review, they suggest a «probable» association between vitamin D levels and birth weight, dental caries in children, maternal vitamin D levels at term and parathyroid hormone levels in chronic kidney disease patients requiring dialysis, but «further studies and better designed trials are needed to draw further conclusions.»

An expeditionary cruise aboard the Schmidt Ocean Institute's (SOI) research vessel Falkor leaves on March 10 for open - ocean sea trials of MBARI's newly - designed LRAUVs.

For 40 days Judge John Jones presided over the intelligent design trial in Pennsylvania and now he aims to decide by 1 January whether teaching ID in US science classes alongside evolution violates the constitutional ban on religious indoctrination in schools.

Appel and Sacks led three earlier clinical trials that tested ways to reduce the risk of cardiovascular disease and diabetes, providing volunteers with carefully designed diets and measuring the effects on key health indicators.

Based on these studies, the authors are designing a clinical trial to test whether DNA repair inhibitors, such as olaparib, are active against IDH1 - and IDH2 - mutant tumors.

The French trial was designed to give early treatment to children with a fatal disease, severe combined immunodeficiency (SCID), caused by a mutation on the X chromosome (ScienceNOW, 28 April 2000).

However, questions about the design and ethics of the trial have cast a negative light on the field, particularly gene therapy for non-life-threatening diseases.

«Based on the results seen with ADRCs in the PRECISE trial, we designed ATHENA to look at these cells as a possible treatment option for people with refractory chronic myocardial ischemia.»

Led by University of Texas Austin researcher Dr Steve Bellan, and in collaboration with the U.S. Centers for Disease Control and Prevention (CDC), the study on the design of CDC's vaccine trial in Sierra Leone is published in The Lancet Infectious Diseases.

Matthew is the author of the books Forty Days and Forty Nights, which gives his first hand account of the 2005 Kitzmiller intelligent design trial in Dover, Pennsylvania, and also his first book, Trials of the Monkey: An Accidental Memoir, which is a personal memoir centered on a trip to Dayton, Tennessee to witness a reenactment of the Scopes trial.

The work should be significant for pharmaceutical companies that design drugs through painstaking processes and at great cost by eliminating some of the trial and error in identifying new sites on proteins that could be more easily manipulated to treat disease, said Rice biological physicist José Onuchic.

This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on Lombardi website, design of electronic case report forms for institutional trials.

In part 1 of this special Darwin Day podcast, celebrating the 200th anniversary of the birth of Darwin on February 12th, Richard Milner performs part of his one - man show about Darwin; Scientific American Editor in Chief John Rennie and Darwin descendant Matthew Chapman read from The Origin of Species; and Chapman talks about his book 40 Days and 40 Nights, about the Dover intelligent design trial as well as about his efforts to get presidential candidates to discuss science — a project called ScienceDebate