Sentences with phrase «future trials studying»
«Future trials studying the effects of self - titration on cardiovascular events are needed.
https://www.sciencedaily.com/ 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).
(Reuters)- Sage Therapeutics Inc's shares tumbled 23 percent on Tuesday after its drug to treat a life - threatening seizure disorder failed to meet the main goal of a key trial, raising concerns about the future of the study.
In future updates, we will use fixed - effect meta - analysis for combining data where it is reasonable to assume that studies are estimating the same underlying treatment effect: i.e. where trials are examining the same intervention, and the trials» populations and methods are judged sufficiently similar.
«We are extremely encouraged by the results of this study and hope that this technology will be adapted for patients for testing in clinical trials in the not - too - distant future.»
«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.
«The study results elucidate the molecular mechanisms underlying disease progression in multiple sclerosis models, providing a basis for future clinical trials to determine safety and efficacy of these chemical agents in humans with demyelinating disorders,» says Patrizia Casaccia, MD, PhD, Professor of Neuroscience, Genetics and Genomic Sciences at Mount Sinai and senior author of the study.
«Overall the turnaround for sample analyses fit a relevant clinical window for future comparative oncology trials to model human PMed advancements,» said Dr. William Hendricks, a TGen Staff Scientist and another author of the study.
«We are excited that our translational research team of clinicians and basic researchers have come together to present these novel findings and hope that future studies and trials based on this work can move forward to bring targeted therapies for TED,» commented Dr. Phipps.
White and colleagues will work with other collaborators at the Cancer Institute to develop early - phase patient clinical trials based on the findings from this study in the near future.
«We have shown that a large number of study participants are routinely exposed to the risks of trial participation without the benefits that sharing and publishing results would have for patients in the future.
But the implications of a recent study demonstrating this relationship are anything but simple and could influence both the design of future clinical trials and the goals of oncologists treating cancer.
An analysis of diagnostic test results from the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial — in which patients with stable chest pain were randomized to either anatomic or functional testing as an initial diagnostic strategy — showed that the presence and extent of coronary artery disease detected by CT angiography better predicted the risk for future cardiac events than did measures of exercise tolerance or restricted blood flow to the heart muscle.
The current study directly analyzed associations between the results of all diagnostic tests and the risk of future cardiac events in around 9,100 of the more than 10,000 patients in the PROMISE trial.
The team used gene expression profiling and found that canine B - cell lymphoma expression profiles were similar in many ways to human B - cell lymphoma, thus paving the way for future studies, including therapeutic clinical trials in dogs and humans.
The authors of the current study hypothesize that these previous trials may have inadvertently selected subjects who would be nonresponsive to the medication and conclude that future efficacy trials may require the identification of subgroups of patient populations.
«The majority of cancer patients we work with are excited to participate in clinical trials that could benefit future patient outcomes down the line,» says co-senior author Bryan Allen, who led the clinical side of the study.
Our findings clarify the disease's distinctive genetic signature, which should, in the future, help improve clinical trials, and lead to more targeted treatments,» said the study's lead author, Dr Jose Bras (UCL Institute of Neurology and Alzheimer's Society senior research fellow).
She suggested that this SAMPRISS trial, as it was called, would be a good model for future post-market studies, though she also argued that the FDA should have more authority to recall unsafe and ineffective devices after approval.
Our results suggest the need for future studies involving long - term ambulatory cardiac monitoring to better delineate the risk associated with transient vs persistent perioperative AF, as well as randomized clinical trials to determine optimal strategies for antithrombotic therapy in patients with perioperative AF and a significant burden of other risk factors for stroke,» the authors write.
The group hopes to examine the effect in clinical trials in the future, and plans to look at the function of the other six genes their study identified.
A Houston Methodist team led by Mauro Ferrari, PhD and Jenny Chang, MD has received funding from the U.S. Department of Defense to complete preclinical efficacy studies and a future clinical trial testing a breast cancer precision drug.
The Biomarkers for Spinal Muscular Atrophy (BforSMA) clinical trial is a current pilot study looking to identify potential biomarkers (measures) that can be used to evaluate SMA disease severity and future treatments.
While this is still only interim data from an early phase trial, this study is a positive result for Spark Therapeutics and Pfizer, as well as future patients.
Future studies will involve clinical trials testing enzyme inhibitors in shock patients.
The positive safety profile to date, the evidence supporting engraftment of the cells post-implantation, and the improvements we are seeing in upper extremity motor function highlight the promising findings coming from this Phase 1 / 2a clinical trial, which will guide us as we work to design future studies.
Objective: The primary objective of the present study was to estimate how large a sample size would be needed for future clinical trials for AD - modifying treatments in Japan using atrophy measures of the brain as a surrogate biomarker.
NJTV - New Pancreatic Study May Offer Hope for the Future - November 17, 2011 CINJ Deputy Director Dr. Edmund Lattime and Co-Director of CINJ's Gastrointestinal - Hepatobiliary Oncology Program Dr. Elizabeth Poplin discuss early results to a unique clinical trial that uses vaccine therapy to target pancreatic cancer.
Your study teams are empowered with up - to - date, accurate and actionable insights on biospecimen and related patient informed consent activities, boosting trial execution productivity while reducing operational and compliance risks for both ongoing trials and future translational medicine studies.
Still, the study «certainly sets the stage for future clinical trials of drugs that show promise to (one day) improve the health of older adults.»
Immune responses of patients could point way forward for future vaccines.In the latest study, researchers involved with the trial at Mahidol University in Bangkok and the U.S. Military HIV Research Program in Washington DC assembled a team to scour the blood of trial participants for immune indicators that differed between 41 people who received the vaccine and contracted HIV and 205 participants who did not become infected.
A major goal of the study is to improve prediction of individual clinical responses in future treatment trials in which brain imaging may be unavailable, and to study the mechanisms of antidepressant response in Major Depression.
The study did not test whether the rate of food absorption played a role in opioid release but Tuominen would like to consider this in future trials.
Stress resistance has not been assessed however and so the biological relevance of this finding is currently unknown.32 Several IER trials (75 - 85 % ER on restricted days) in overweight / obese populations have reported reductions in various markers of oxidative stress 37, 41, which in one study was accompanied by a complementary increase in the anti-oxidant uric acid.37 In a direct comparison of IER (75 % ER for two days / week) and CER, both ER strategies displayed equal efficacy in reducing levels of fast - acting advanced oxidation protein products (AOPP) after six months, which displayed a tendency to occur earlier (i.e. at three months) in the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directions
Future evaluation of dietary patterns, including their nutrient and food components, in cohort studies and randomized trials is recommended.
The school - based research approach meant that causal influences could not be robustly identified; the quantitative component of the study primarily sought to provide an estimated effect size for any intervention that could be used in future trials.
The press release quotes the Vice Chairman, Richard Mulligan, Ph.D, as saying «While we may evaluate PEG - SN38 in earlier lines of colorectal cancer treatment in future clinical trials, at this time, resources associated with such trials are better directed toward areas of study with nearer - term commercial potential.»
Results of this study will be used to help design future clinical trials evaluating VSV - IFNβ - NIS in dogs with relapsed or refractory cancer.
As a tribute to Sophie, who is the inspiration for Lessons From A Paralyzed Dog, I plan to share a veterinary study or clinical trial that will allow your pet and future cats and dogs to live the longest and healthiest life they can.
We expect that this study and the future research that flows from it will provide valuable insight to practicing attorneys who do the vast majority of their work in the state and federal trial courts.
Future studies should follow guidance on the development and evaluation of complex interventions (such as the Medical Research Council's guidance).76 The results of all phases of intervention development also need to be published alongside trial results, as current studies alone do not allow us to fully understand why interventions have not produced expected effects.
Before widespread implementation of this mindfulness - based program in clinical practice is recommended, we recommend future studies using randomized controlled trials to compare the effectiveness of a mindfulness - based program to an active control treatment, preferably in a group setting with the same time investment.