Sentences with phrase «trial study results»
However, from looking at the trial study results, it seems that the efficacy and safety profile are similar to Tysabri.
https://longtermvalue.wordpress.com/ Not exact matches
While the new mid-stage study results from DNDi were impressive (they showed cure rates of 96 % to 97 % even for the sickest patients and those with liver scarring), more late - stage trials will be necessary before the drug is available on a large scale in the developing world.
Even the glitteriest of gold - standard clinical trials, for instance, are often undone by a leaden follow - up study that has the nerve to arrive at a different result.
Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.
Once the final results of those studies are analyzed this spring — and the early evidence has been encouraging — the challenge will be to get FDA approval for human trials and then bring the treatment to market.
While the asthma trial data is just one point, the study's results could go a long way in assuring scientists that information generated through the platform (at least for certain kinds of studies) is on point.
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).
The results, which mirror those of similar, small - scale studies of the illegal drug in recent years, come as MDMA is about to enter larger, Phase 3 trials this summer.
While Tecentriq's results in Imvigor211 were consistent with its previous study, Roche said, patients getting chemotherapy in the latest trial survived longer than anticipated.
I cant praise God enough for the internet we cant be ignorant these if we want to learn anything all we have to do is to jump on the internet for answers since I have accepted Jesus as my personal savior thirty five years ago i cant stop myself to share my experience with people but since i lost my husband through a tragic accident my life took a different turn my savior became more personal and real to me i give myself full to the lord and the result of that people stat asking me for bible study which i have never done in my life so I decided to search the net and i came across your website which put the whole gospel in a simple way and i am going to use it for my first bible study and see how the holy spirit will lead from there.I came to the conclusion that our trials is a blessing in disguise and i praise God for it.keep up the good work God bless Martina keep me in prayer please
Improved postharvest practices: A recent research study undertaken by WFLO with funding by the Bill & Melinda Gates Foundation provides an great assortment of data on the results of 12 past projects, postharvest losses % for 26 crops, a description of the value chain for 30 crops in 4 countries (Rwanda, Benin, Ghana and India) and 21 field trials of postharvest technologies suitable for helping small farmers reduce losses and improve their incomes.
The result of the study showed that a significant amount more women in the study group went into labor when compared with the control group in each of the three trials.
But this doesn't make sense for everything we do in health care, and we know the information we get from randomized controlled trials doesn't always translate well to real life because 1) the restrictions we put on eligibility for studies rarely allows the results to be generalized to the population as a whole and 2) Adherence to the intervention tends to be higher in a randomized controlled trial than in real life which makes the effect seem «better» than it is.
Although not directly comparable, our findings are in broad agreement with those from routine data in Scotland that have indicated a positive association between Baby Friendly accreditation, but not certification, and breastfeeding at 1 week of age.17 Our findings reinforce those of Coutinho and colleagues who reported that high exclusive breastfeeding rates achieved in Brazilian hospitals implementing staff training with the course content of the Baby Friendly Hospital Initiative were short - lived and not sustained at home unless implemented in combination with post-natal home visits.35 Similarly in Italy, training of staff with an adapted version of the Baby Friendly course content resulted in high breastfeeding rates at discharge, with a rapid decrease in the days after leaving hospital.36 In contrast, a cluster randomized trial in Belarus (PROBIT) found an association between an intervention modelled on the Baby Friendly Initiative with an increased duration of breastfeeding37 an association also reported from an observational study in Germany.38 Mothers in Belarus stay in hospital post-partum for 6 — 7 days, and in Germany for 5 days, with post-natal support likely to be particularly important in countries where mothers stay in the hospital for a shorter time, with early discharge likely to limit the influence of a hospital - based intervention.
However, the results of observational studies from developing countries are consistent with the findings of the two Honduran trials, particularly with respect to growth.
The results of this trial stress the importance of providing premature neonates with raw milk from their own mother,» the study concludes.
Although professional lactation support can improve the duration of overall breast feeding, its effect in improving exclusive breast feeding is unclear.11 18 22 Thus far, studies that report improvement of rates of exclusive breastfeeding have involved mainly community based peer counselling strategies.23 24 25 Even then, a randomised trial in the UK recently cast doubt on the efficacy of this approach.26 There are current recommendations from NICE for the UK - wide implementation of the baby friendly initiative.4 5 6 The 2006 NICE costing report on routine postnatal care of women and their babies estimates that efforts to improve rates of breast feeding will result in substantial cost savings for the NHS.6
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.
This study is a sub-sample of results from a larger study and the outcomes reported in the trial registration document are not reported in this study, However, the full study results have not yet been published to be able to judge this outcome.
The clinical trial in humans was based on positive results of a study in mice published in Nature Communications in Sept. 2015.
Although these facts do not mean that the results are invalid, a 2003 study published in the British Medical Journal suggests that trials funded by drug companies are more likely to report favorable results about their products than are trials funded by independent organizations.
In three randomized trials, treatment of chronic low back pain with radiofrequency denervation, a procedure that can be performed with different techniques including the application of an electric current to the pain - conducting nerve, resulted in either no improvement or no clinically important improvement in chronic low back pain, according to a study published by JAMA.
In addition, results from these trials were not consistent with results found in similar studies by other researchers.»
The researchers were never able to obtain the data from the original clinical trial sponsor and in the end had to painstakingly reconstruct the study results from the information collected at each individual study site.
Based on results of the current study described in a report online June 18 in the journal Cancer Cell, Johns Hopkins researchers say they are planning a phase I clinical trial to test the paclitaxel - fostamatinib combination therapy in patients with recurrent advanced ovarian cancer.
«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.
In an effort to find out, Stephen P. Juraschek, M.D., Ph.D., research and clinical fellow in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues used data from the DASH (Dietary Approaches to Stop Hypertension) clinical trial, a widely popular and often - cited study whose results were first published in 1997.
«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.
Boni E. Elewski, M.D., professor of dermatology, is the principal investigator of the Efficacy of Response And Safety of two fixed secUkinumab REgimens in psoriasis (ERASURE) trial, one of two studies in the recent New England Journal of Medicine article «Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials.»
«We know that urate has neuroprotective properties in animal models, and an unusual convergence of human studies suggested its possible use as a disease - modifying strategy in Parkinson's; so the positive results of this trial are very encouraging.»
«The results of the phase III clinical trial show that a target fusion biopsy detects more clinically significant prostate cancer,» said Art Rastinehad, DO, principal investigator of the study and director of interventonal urologic oncology at North Shore - LIJ's Arthur Smith Institute for Urology, in New Hyde Park, NY.
In a trio of studies to be presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, investigators at Dana - Farber Cancer Institute will present the results of clinical trials showing that new drug combinations can significantly extend the time in which multiple myeloma is kept in check in patients with relapsed or treatment - resistant forms of the disease.
People diagnosed with cancer gained 3.34 million years of life thanks to cancer clinical trials run by SWOG and supported with public funds, according to new study results to be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), the world's largest clinical cancer research meeting.
Although we can not determine what the effects of AF267B will be in humans until clinical trials are complete, we are very excited by the results our study has yielded.»
Promising results from the new trial would be a major step forward for a field that has long been criticized for studies that are poorly designed, incomplete or lack control - group comparisons, as well as for the peddling of unproved therapies in many clinics worldwide.
In a study to be presented Thursday, Jan. 26, in the oral concurrent session at 1:15 p.m. PST, at the Society for Maternal - Fetal Medicine's annual meeting, The Pregnancy Meeting ™, researchers with the Université de Sherbrooke in Sherbrooke, Quebec, Canada will present their findings in a study titled, Reduction of total labor length through the addition of parenteral dextrose solution in induction of labor in nulliparous: results of DEXTRONS prospective randomized controlled trial.
The new study helps explain why so many results in animal studies don't hold up in human trials, says Malcolm Macleod, a neurologist at the University of Edinburgh.
«Such biases, conscious or unconscious, can make candidate medical treatments look better than they actually are, the authors of the analysis warn, and lead to eye - catching results that can't be replicated in larger or more rigorous animal studies — or in human trials.»
«This is a really very small trial and the results should not be over-interpreted,» says Tony Wyss - Coray, a neurologist at Stanford University in California who led the study.
«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.»
The new study may help explain why so many encouraging results in animal studies don't hold up in human trials.
«Our review of the literature showed several positive trial results, but we also found important research limitations in the studies, indicating a need for higher quality, more definitive trials on antidepressant use for postsurgical pain.»
In 2011, Science's editors will be watching a smaller detector at the Large Hadron Collider called LHCb, which will study B mesons in great detail; new techniques that should lead to the discovery of many more genes contributing to adaptation; an ignited fusion burn at the National Ignition Facility; broadly neutralizing antibodies, which are capable of disabling a wide range of viral variants; the first plug - in hybrid electric cars whose batteries are charged from a wall socket go on the market; and the results of the first phase III trial of a malaria vaccine.
«But as a clinician, if there are randomized data that would allow us to go from a pilot study to a phase 3 clinical trial, and if the results are good, then we would have to come back to Francis Collins, and say, «This needs to be exported to other communities and ramped up.»
The clear result of this clinical study — that the combination reduced strokes, heart attacks and cardiovascular death by practically 25 per cent compared to either drug alone in both patients with stable coronary or peripheral artery disease — caused the clinical trial to be stopped early, after 23 months, in February 2017.
The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.
«Nondrug approaches effective for treatment of common pain conditions, review suggests: US study reviews trial results on complementary health approaches for pain relief; aims to assist with pain management.»
Independent of these preclinical studies, Clementia Pharmaceuticals is currently conducting phase 2 clinical trials in individuals with FOP, based on the 2011 preclinical results published by Pacifici and Iwamoto.
In a pilot study that included children at high risk for type 1 diabetes, daily high - dose oral insulin, compared with placebo, resulted in an immune response to insulin without hypoglycemia, findings that support the need for a phase 3 trial to determine whether oral insulin can prevent islet autoimmunity and diabetes in high - risk children, according to a study in the April 21 issue of JAMA, a theme issue on child health.