Sentences with phrase «of clinical trial study»

Not exact matches

The Chinese government financed nationwide studies into cockroaches» medical value that, after more than two decades of laboratory investigation and clinical trials, had discovered or confirmed dozens of disease - fighting proteins and biochemical compounds with huge potential value in medicine.
In health care, this amounts to an hourly avalanche of new research papers, clinical trials, scientific studies, and patient health information.
Shorn of human weaknesses like the need to eat or sleep, computers are now speed - reading through not only the vast academic literature but also CT scans, electronic medical records, and mountains of data from clinical trials and genomic studies.
Some small studies have suggested that synbiotics could provide benefits to a range of other conditions influenced by the gut microbiome as well, including obesity, diabetes, and non-alcoholic fatty liver disease, but larger - scale clinical trials focusing on each of those conditions are needed.
And Marathon barely did any actual clinical legwork to get the drug cleared for Duchenne — it relied on 1990 - era clinical trial data before tacking on just enough study material to win an approval that doesn't even address the root cause of the disease.
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.
Some retrospective studies and preclinical work have indicated that it might also lower a person's risk of cancer, though at least one clinical trial wasn't able to show that it had any protective effect on esophageal cancer.
Inovio's vaccine against HPV is currently in Phase II clinical studies, and Kim says «about 50 percent» of the subjects in that trial are defeating the disease.
The company points to a simple resource allocation problem that's hindered the most effective patient care: the fact that it is physically impossible for oncologists to keep track of every study, every clinical trial, and every breakthrough in the wildly stratified world of cancer research.
Currently in the U.K., he will go back to Privateer's headquarters in Seattle, then visit Tilray's 60,000 - square foot facilities in British Columbia, Canada, then to Australia, where Tilray has an import license to send marijuana for a clinical trial with a chemotherapy - induced nausea and vomiting study with the University of Sydney, the government of New South Wales and the country's largest cancer hospital.
Last year The Ohio State University Wexner Medical Center began clinical trials on the efficacy of SuperBetter to treat traumatic brain injuries, and the University of Pennsylvania Positive Psychology Center greenlighted a randomized controlled user study of the game to treat depression.
Speaking of checkpoint inhibitor drugs... Merck's star cancer immunotherapy treatment Keytruda is facing some troubling clinical trial incidents which have now compelled the Food and Drug Administration (FDA) to halt three studies of the drug in multiple myeloma, a rare blood cancer, after a number of patient deaths.
But while thousands of clinical trials on immunotherapy drugs, of which many are predicted to fail, are springing up, the depth of information on neoantigen vaccines is much shallower: Just two studies on neoantigen vaccines for melanoma, recently profiled in Nature, were completed last year in Boston and Germany.
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.
Swiss drug giant Novartis is partnering with California - based Science 37 in an effort to expand clinical study participation (while lowering the costs of such studies) through «virtual» trials.
Besides randomized controlled clinical trials, there are a number of ways researchers can study how a particular cancer treatment is playing out in the real world: there are retrospective studies, observational studies, and even prospective research done using patient registries.
Studies — including at least one clinical trial with 100 participants — have found that this diet can significantly alter signs of disease, reduce weight and body fat, lower blood pressure, decrease levels of biomarkers associated with cancer, and improve blood - sugar levels.
First, the topline numbers: The study was an observational one rather than a randomized control trial, the latter of which is considered to be the «gold standard» of clinical studies.
There are about 120 studies ongoing in Israel, including clinical trials looking at the effects of cannabis on autism, epilepsy, psoriasis, and tinnitus.
The Food and Drug Administration (FDA) has given Alnylam Pharmaceuticals the green light to relaunch clinical trials of its treatment for the bleeding disorder hemophilia after pausing the studies after a patient death.
NOVARTIS PARTNERS WITH SCIENCE 37 TO DEVELOP «VIRTUAL TRIALS»: Swiss drugmaker Novartis announced plans to work with virtual clinical trial company Science 37 to develop «remote trial» technology that uses video conferencing to lower the barrier of entry for recruiting study participants, according to Reuters.
In fact, one of Marathon's clinical trials that the FDA used as part of its decision - making process was conducted more than 20 years ago, saving the firm plenty of study costs.
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).
If we are required by the FDA, the EMA, or other regulatory authorities to perform studies in addition to those we currently anticipate, or if there are any delays in completing our clinical trials or the development of our current product candidates, our expenses could increase and our ability to generate revenue could be further delayed.
The 12 week clinical study from the US of 303 participants is the first prospective, randomised clinical trial to directly compare the effects of water and diet beverages on weight loss within a behavioural weight loss program.
The study comes on the heels of a 2013 clinical trial that showed rice protein paralleled whey protein in its ability to build muscle and improve strength and power for the first time.
At The Fertility Center of Las Vegas, each clinical trial is designed as a prospective, randomized study.
Much of the evidence against BPA comes from large population studies rather than controlled clinical trials.
If you decide not to take part in a research study or clinical trial, you and your baby will continue to receive the same quality of care from the health care team and the hospital.
In addition, structured training in study design, epidemiology, clinical investigation and health policy research is available for fellows interested in systematic pursuit of a career in clinical research or clinical trials.
The PhD course focuses on various aspects of human (donor) milk, with as main study a randomized clinical trial towards the effects of human donor milk in very low birth weight infants (the Early Nutrition Ststudy a randomized clinical trial towards the effects of human donor milk in very low birth weight infants (the Early Nutrition StudyStudy).
This study is a randomized clinical trial of 125 mother / infant pairs.
In addition, there was no effect on breastfeeding duration when the pacifier was introduced at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from clinical trials) does not support an adverse relationship between pacifier use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifier.
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.
The bill would make it mandatory for researchers to publish all information from cancer clinical trials, with the goal being to get more researchers to work together and bring down the number of duplicative studies.
Since the neuronal death can be recapitulated in directly reprogrammed patient neurons, Yoo said the new technique offers a way to study the details of how potential therapies — including drugs that are currently being tested in clinical trials — could rescue medium spiny neurons from death.
Unlike many clinical trials that emphasize relief of symptoms as their primary objective, the ezogabine study's goal is to gauge how well the therapy addresses some of the biological underpinnings of depression — in this case, whether the drug lessens the hyperactivity of the reward circuit that includes VTA neurons.
The clinical trial in humans was based on positive results of a study in mice published in Nature Communications in Sept. 2015.
The lead author of the study was Jacqueline French, MD, professor of neurology and director of Translational Research & Clinical Trials Epilepsy at NYU Langone's Comprehensive Epilepsy Center.
But a blood test could help researchers more easily identify people who might be good candidates for clinical trials of early interventions, says Steven Kiddle, a biostatistician at the University of Cambridge, who wasn't part of either study.
«I've been involved in clinical trials for 30 years,» says the study's lead author Bonnie Ramsey, a professor of pediatrics at the University of Washington School of Medicine in Seattle.
Helen McShane, a Professor in the Nuffield Department of Medicine at the University of Oxfordled the 2013 clinical trial who led the 2013 clinical trial, described the CSU study as «really important.»
As CRISPR - Cas9 starts to move into clinical trials, a new study published in Nature Methods has found that the gene - editing technology can introduce hundreds of unintended mutations into the genome.
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.
This study represents a significant step towards the development of clinical trials in gene therapy for the curative treatment of hereditary deafness and balance loss in humans.
«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.»
«By identifying and enrolling these men in clinical trials immediately, the hope is to take a prostate cancer that appears to be incurable and make it curable» stated Trevor J. Royce, MD, senior resident in the department of Radiation Oncology at BWH, and corresponding author of the study.
In the CSU study, Orme and his team found that BCG strongly inhibited a number of virulent strains of TB obtained from the clinical trial site around Cape Town.
The 21 - patient study, sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), launched in 2004 as the first U.S. clinical trial of a psychedelic drug in 35 years.
A damning report on how the University of Minnesota (UM) protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects.
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