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 St
study 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.