Sentences with phrase «trial design with»

This study aimed to evaluate the efficacy of the Fun to Learn for the Young (FLY) program using randomized controlled trial design with no blinding of participants.

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.

But the short answer for anyone who doesn't want to buy a book is that the standard old - fashioned clinical trial is designed to answer a specific question about a population with lots of different specific characteristics.

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.

Many have used this data in designing new methods to supplement and even replace clinical trials, which are notoriously difficult to fill with patients.

«It essentially gives us a periodic table,» Ron DePinho, President of MD Anderson Cancer Center says, which has provided us with both diagnostic and therapeutic value as well as helped us design clinical trials to accelerate the development of new cancer drugs,».

Included with your FREE trial membership — Jim Cramer's best - selling book Get Rich Carefully, plus exclusive bonus reports all designed to help you become a more successful investor — FREE!

The candidate should be experienced designing and running clinical trials and interacting with regulatory authorities.

One of Juno's rivals, Kite Pharma, yesterday said it had completed its enrollment of 72 patients with diffuse large B - cell lymphoma in the Phase II portion of the ZUMA - 1 trial, designed to assess KTE - C19.

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,

However, let's not miss that God designed marriage not only to stretch us beyond our selfishness to become more like Jesus through trials, but also to bring great joy to our lives with the myriad of gifts marriage provides.

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,...

After trials and design approaches along with Château de Pommard's team and its glass supplier, Appartement 103 was able to bring what it claims to be the first bottle in the world without a neck ring to life, achieving the intended shape from bottom to top.

Our New Resident packet contains valuable information and trial coupons designed to help new residents get acquainted with the variety of programs, services, amenities and facilities located throughout the Arlington Heights area.

This STEAM engineering challenge was a hit, with plenty of trial and error and then some very cool designs in the end.

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.

Trials are needed that examine interventions designed specifically for women with multiples and delivered by people with training about how to overcome the particular challenges of breastfeeding more than one infant.

The trial was designed to test the safety and efficacy of omega - 3 — fortified formulas compared with unfortified formulas or breast milk in 288 premature infants.

Legacy was developed by CDC in collaboration with the University of Miami, UCLA, and RTI International, and designed as a randomized controlled trial to test the idea that the Legacy intervention during early childhood might improve children's development.

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

Cluster trial with no apparent adjustment for design effect.

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».

Without the trial, few of Howe's interactions with the Cuomo administration would be public — despite a slew of state laws and regulations designed to make government interactions with lobbyists, and conflicts of interest those interactions can create, open to the public.

They may have done a thesis with a translational focus, but few will have received training in the requirements for doing modern patient - oriented research, which includes large doses of epidemiology, statistics, and human - subject trial design.

Amyloid buildup is a key pathological feature of Alzheimer's, and determining the degree to which someone's brain is riddled with the molecule is essential for designing effective clinical trials.

The clinical trial is designed to assess safety and activity of escalating doses of the special cells (AST - OPC1) for individuals with a complete cervical spinal cord injury.

However, as many anti-inflammatory drugs are already available, there may be a relatively short path to designing clinical trials for drugs that modulate the inflammatory response in people with neurodegenerative disease.

«Complex models are needed to effectively evaluate PMed study designs, and this proof - of - concept trial validates the dog with cancer as a model for clinical evaluation of novel PMed approaches,» said Dr. Melissa Paoloni, the study's lead author and former director of the COTC.

In this new study and for the first time, scientists used functional magnetic resonance imaging (fMRI) combined with a standard clinical trial design to derive an unbiased brain - based neurological marker to predict analgesia associated with placebo treatment in patients with chronic knee osteoarthritis pain.

He, along with his colleague Mark Rubinstein, Ph.D. also of the Hollings Cancer Center, designed a clinical trial that started in 2016.

Four years ago Cochlear, a firm based in Sydney, Australia, ran trials of a prototype implant in three patients, with mixed results, says Jan Janssen, head of Cochlear's design and development.

Researchers are designing the first clinical trials of stem cell treatments for fetuses afflicted with rare bone and blood diseases.

The next step, says Salem, will be to try to correlate these findings with patient treatment outcomes, initially as a retrospective, or backward looking study, and then hopefully design a forward looking clinical trial to determine which treatments may be best for patients with SBAs.

«The current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell - based interventions with respect to the design, initiation and conduct of U.S. clinical trials,» the authors wrote.

«It was clear from our findings that many people with IBS should have their vitamin D levels tested, and the data suggests that they may benefit from supplementation with vitamin D. «As a result of this exploratory study, we're now able to design and justify a larger and more definitive clinical trial.»

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

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 design of such antennas can still be a largely trial - and - error affair, with technicians moving elements from place to place in the laboratory as you might move your own body in order to pull in a weak broadcast.

This is the first time a phase III trial has been designed to selectively enroll patients with a particular molecular subtype of DLBCL.

He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials.

Hodi designed this investigator - initiated clinical trial to find out if giving sargramostim along with ipilimumab would have a synergistic effect against the melanoma — like pressing the immune system's accelerator while releasing the brake.

Some of my duties include the design, testing, and manufacturing of the product; working with the contractors and clinical - trials teams; and exploring different distribution systems.

He and colleagues are collaborating with the Sanford Burnham Prebys Medical Discovery Institute to design new assays to discover the next generation of CRF receptor - 1 antagonists for testing in early phase human safety trials.

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

It was conducted under a special protocol assessment with the US Food and Drug Administration, which considers an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses acceptable for FDA approval.

But he says their findings may have more immediate implications as well, for the design of clinical trials evaluating the benefits of providing nutrients to patients with sepsis.

With «a little chemistry and some trial and error,» they should be able to design drugs which mimic arachdonic acid, but plug the pocket.

According to the trial's crossover design, patients with refractory chronic cough of at least eight weeks» duration were randomly assigned initially to either AF - 219 or placebo treatment twice daily for two weeks, followed by a washout period, and further followed by crossover to the alternative treatment arm (AF - 219 or placebo) for an additional two weeks.

With CROs now often involved in every step of the process — from planning, trial design, volunteer recruitment and trial implementation to data analysis and dealing with regulatory authorities — it is the strategic account leader's job to ensure the process is integrated and runs efficienWith CROs now often involved in every step of the process — from planning, trial design, volunteer recruitment and trial implementation to data analysis and dealing with regulatory authorities — it is the strategic account leader's job to ensure the process is integrated and runs efficienwith regulatory authorities — it is the strategic account leader's job to ensure the process is integrated and runs efficiently.