Sentences with phrase «impact on clinical trials»

Not exact matches

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

«[ResearchKit] has an impact on the way we can learn about new procedures, the way we can conduct clinical trials, about everything.

Impact of breastpumping on lactogenesis stage II after cesarean delivery: A randomized clinical trial.

Impact on breastfeeding practices promoted by lay counselors: a randomized and controlled clinical trial

Also, FDA clears the party drug ecstasy for post-traumatic stress disorder clinical trials, and U.S. courts rule that the federal government must consider the impacts of major energy projects on climate change.

Dr. Siddiqui says randomized clinical trials will be needed to determine the impact of targeted biopsy on clinical outcomes.

Although the analysis found pulses had little impact on «second meal food intake,» the amount of food someone eats at his or her next meal, these findings support longer term clinical trials that have shown a weight loss benefit of dietary pulses.

Last month, Biopure launched a revamped clinical development program, emphasizing testing in Europe, with three phase II clinical trials planned for 2008 to study the impact of its product on heart attack patients, chemotherapy patients with anemia and the terminally ill.

«We are pleased to have demonstrated such a potent and durable immune response to the vaccine,» said the study's lead author, Sita Awasthi, PhD, a research associate professor of Infectious Diseases at Penn. «If found effective in clinical trials, the vaccine will have a huge impact on reducing the overall prevalence of genital herpes infections and could reduce new HIV infections as well, especially in high - burden regions of sub-Saharan Africa.»

«The CASTLE - AF clinical trial represents a landmark in the history of cardiovascular medicine because of its potential impact on our patients who are suffering from heart failure,» said James Fang, M.D., Chief of Cardiovascular Medicine at the University of Utah Health.

More than 500 clinical trials are underway to explore the impact of these and other checkpoint inhibitors on a dozen varieties of cancer, alone or with other immunotherapies, as well as conventional treatments.

Since L - arginine can be given to women as a simple, safe, and inexpensive food supplement, (in peanuts, for example) in pregnancy, Dr. Kain and Dr. McDonald are now planning human clinical trials to assess its impact on human birth outcomes.

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.

«While dozens of clinical trials have demonstrated the effectiveness of collaborative care for treating depression in primary care, comparatively few have addressed anxiety, despite their similar prevalence and adverse impact on health - related quality of life and excess utilization of health services,» said Bruce L. Rollman, M.D., M.P.H., professor of medicine and director of Pitt's Center for Behavioral Health and Smart Technology.

In addition, the team applied this simple enrollment criterion to a hypothetical 3 - year clinical trial to evaluate the impact on reducing the sample size while increasing the statistical power.

Studies in mice specially bred to have features of the disease found that DHA reduces beta - amyloid plaques, abnormal protein deposits in the brain that are a hallmark of Alzheimer's, although a clinical trial of DHA showed no impact on people with mild to moderate Alzheimer's disease.

However, the results suggest that future clinical trial research is needed to quantify the impact of a combined lifestyle intervention on ADHD symptoms.

The material will need to go through rigorous clinical trials and only once it has been approved, scientists at the University of Sheffield hope this breakthrough research will have a hugely positive impact on millions of women across the globe.

They plan to leverage a recently awarded Innovative and Novel Computational Impact on Theory and Experiment (INCITE) allocation from DOE to perform larger simulations on the Titan supercomputer to gain deeper understanding of how bacterial efflux pumps function, identify more potent efflux pump inhibitors and optimize the best antibiotic - plus - inhibitor combinations to make them suitable for clinical trials.

Findings may be having a profound impact on everything from animal behavior experiments to human clinical trials

News and reports of the latest clinical trials, translational medicine, drug development and research with potential for direct impact on human health.

Of note today: non-exclusive breastfeeding increases the risk of HIV transmission via the alteration of gut microbiome / T - cell activation; Fasting altered the gut microbiome in beneficial ways but only in mice previously fed a high fat diet; An investigation into new species of the honey and bumblebee gut commensal genus Gilliamella; Catfish development shapes gut microbial community structure independent of diet; A metagenomic analysis of the skin microbiome of the frog, Craugastor fitzingeri; The microbiome is altered during the bioremediation of herbicide contaminated soil; The impact of urban density on the soil microbiome; A randomized placebo controlled clinical trial of a microbiota based drug for the prevention of Clostridium difficile Infection; and the virome of the Cuatro Ciénegas Basin of Mexico

A planned clinical trial will evaluate the impact of an anti-PD-1 checkpoint inhibitor with adjunctive microbiome therapy on patient outcomes.

Impact of Rifabutin or Rifampin on Bedaquiline Safety, Tolerability, and Pharmacokinetics Assessed in a Randomized Clinical Trial with Healthy Adult Volunteers.

8/6/2008 Medicinal Marijuana Effective for Neuropathic Pain in HIV In a double - blind, placebo - controlled clinical trial to assess the impact of smoked medical cannabis, or marijuana, on the neuropathic pain associated with HIV, researchers at the University of California, San Diego School of Medicine found that repo... More...

Of special note today: A randomized double blind controlled clinical trial on the impacts of probiotics on Alzheimer's demonstrated an improvement in cognitive function, triglycerides, insulin sensitivity and C reactive protein; and a meta - analysis of the lung microbiome in tuberculosis identified specific species that are characteristic of the disease.

«It is exciting to be directly involved in creating an innovative clinical trial infrastructure that will yield important efficacy and safety data on novel asthma interventions,» says Dr. Jain, «I look forward to participating in this work and seeing how it directly impacts asthma patients.»

NIH Clinical Center (CC)-- Est. in 1953 The NIH Clinical Center, America's research hospital, provides a versatile clinical research environment enabling the NIH mission to improve human health by investigating the pathogenesis of disease; conducting first - in - human clinical trials with an emphasis on rare diseases and diseases of high public health impact; developing state - of - the - art diagnostic, preventive, and therapeutic interventions; training the current and next generations of clinical researchers; and, ensuring that clinical research is ethical, efficient, and of high scientific Clinical Center (CC)-- Est. in 1953 The NIH Clinical Center, America's research hospital, provides a versatile clinical research environment enabling the NIH mission to improve human health by investigating the pathogenesis of disease; conducting first - in - human clinical trials with an emphasis on rare diseases and diseases of high public health impact; developing state - of - the - art diagnostic, preventive, and therapeutic interventions; training the current and next generations of clinical researchers; and, ensuring that clinical research is ethical, efficient, and of high scientific Clinical Center, America's research hospital, provides a versatile clinical research environment enabling the NIH mission to improve human health by investigating the pathogenesis of disease; conducting first - in - human clinical trials with an emphasis on rare diseases and diseases of high public health impact; developing state - of - the - art diagnostic, preventive, and therapeutic interventions; training the current and next generations of clinical researchers; and, ensuring that clinical research is ethical, efficient, and of high scientific clinical research environment enabling the NIH mission to improve human health by investigating the pathogenesis of disease; conducting first - in - human clinical trials with an emphasis on rare diseases and diseases of high public health impact; developing state - of - the - art diagnostic, preventive, and therapeutic interventions; training the current and next generations of clinical researchers; and, ensuring that clinical research is ethical, efficient, and of high scientific clinical trials with an emphasis on rare diseases and diseases of high public health impact; developing state - of - the - art diagnostic, preventive, and therapeutic interventions; training the current and next generations of clinical researchers; and, ensuring that clinical research is ethical, efficient, and of high scientific clinical researchers; and, ensuring that clinical research is ethical, efficient, and of high scientific clinical research is ethical, efficient, and of high scientific quality.

As we produce more human - relevant data with our Organ - Chips, we look forward to making a positive impact on informing R&D decisions, reducing drug candidate attrition in human clinical trials, and helping to deliver better and safer medicines to patients.»

The impact of metformin, oral contraceptives and lifestyle modification, on polycystic ovary syndrome in obese adolescent women in two randowmized, placebo - controlled clinical trials.

Controlled clinical trials are needed to define the impact of potatoes on cardiometabolic health.

There is a lack of clinical trial data regarding the impact of potatoes on weight management.

The Women's Health Study is the largest randomized clinical trial to investigate the impact of aspirin and vitamin E on the primary prevention of cardiovascular and cancer...

Dr Ghannoum's lab at Case Western Reserve University has been running some of the most sophisticated clinical trials on bacteria and fungi in the gut, and how they impact a number of health conditions like Crohn's Disease and even our oral health.

In particular, much of his work is on developing methodology to assess and characterize treatment effect heterogeneity in randomized clinical trials and observational studies, and on characterizing variation in treatment impact on post-treatment or latent subgroups such as from non-compliance.

Cloisters has always been at the cutting edge of clinical negligence law, playing a lead role in many of the major cases such as A v Powys Local Health Board (# 10.7 m), the highest ever clinical negligence award at trial and the first to break through the # 10m barrier; Masterman - Lister v Brutton & Co and others, the leading Court of Appeal case on capacity; Iqbal v Whipps Cross University NHS Trust leading Court of Appeal case regarding compensation for the «lost years» and the doctrine of precedent; Crofton v NHSLA in respect of the impact of local authority payments on damages for care; and Lucas v Barking, Havering & Redbridge Hospitals NHS Trust, the leading case on disclosure of draft witness statements and expert reports.

So will a shift in clinical trial and research locations to less affluent countries with a more varied subject pool positively impact on key oncology developments in the future?

On his blog he writes about clinical trials in psychopharmacology, the history of psychopharmacology, and the impact of both trials and psychotropic drugs on our culturOn his blog he writes about clinical trials in psychopharmacology, the history of psychopharmacology, and the impact of both trials and psychotropic drugs on our culturon our culture.

The impact of clinical severity on outcomes of a randomised controlled trial of mentalisation - based treatment (MBT) was contrasted with structured clinical management (SCM).

The following data describes treatment outcome maintenance results from a randomized clinical trial investigating the impact of a cognitive behavioral intervention Primary and Secondary Control Enhancement Therapy - Physical Illness (PASCET - PI) as compared to treatment as usual (TAU) on youths with inflammatory bowel disease (IBD).