Additionally, UC Davis is conducting 11
other clinical trials in veterinary ophthalmology.
Other clinical trials in cancer patients have studied the effects of acupuncture on cancer symptoms and side effects caused by cancer treatment, including weight loss, cough, coughing up blood, fever, anxiety, depression, proctitis, speech problems, blocked esophagus, and hiccups.
«The magnitude of the reduction in thickening of the carotid artery in the treatment group, relative to the control group, is similar to what has been observed in
other clinical trials in high risk populations.
The other clinical trial in melanoma is evaluating safety and response to the combination of LV305 and KEYTRUDA in patients who have not yet responded to treatment with KEYTRUDA alone after three months of treatment.
Not exact matches
Then, they plan to get started with
clinical trials in their journey toward FDA approval, starting with peanuts, but expanding out to the
other top food allergies, such as soy, wheat, milk, and eggs.
These risks and uncertainties include, among
others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and
other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from
clinical trials may be interpreted by the FDA
in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our
clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine;
clinical development activities may not be completed on time or at all; the results of our
clinical development activities may not be positive, or predictive of real - world results or of results
in subsequent
clinical trials; regulatory submissions may not occur or be submitted
in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction
in payment rate or reimbursement for the company's products or an increase
in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors»
in the company's most recent Annual Report on Form 10 - K and
in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.
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.
The new Alzheimer's framework may not be much of a surprise given numerous, high - profile, late - stage
clinical trial failures
in the field by companies like Eli Lilly and Merck, and the decision by
other companies (such as Pfizer) to back away from the risk - prone field.
GUMC says its researchers are now planning larger
clinical trials with nilotinib for patients with Parkinson's and
other similar diseases including Alzheimer's disease, likely to begin
in 2016.
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).
«Many investors expected a more lengthy FDA review process of the JCAR015
trial (and potentially
other CAR - T programs) and feared that a higher - degree regulatory scrutiny could increase the development risk of CAR T cell,» Leerink Research said
in a note co-authored by analysts Michael Schmidt, Ph.D., Jonathan Chang, Ph.D., and Varun Kumar, Ph.D. «While it may take several weeks to reopen all
clinical sites of the ROCKET
trial, we believe the
trial shouldn't be delayed by more than ~ 3 months.»
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.
And the San Francisco Chronicle reports that over 100
clinical trials listed on the ClinicalTrials.gov website feature Fitbit trackers
in addition to those
trials using the Apple Watch, Jawbone, Garmin, Pebble and
other devices.
But topping the list is Vertex (VRTX), which has a veritable plethora of HCV drugs
in late - stage
clinical trials, which are used either alone, or
in combination with
other drugs.
«We have also funded our own
clinical trial at the University of Guelph to confirm, substantiate and broaden the beneficial properties of cinnamon and bitter melon
in the treatment of diabetes, high cholesterol and
other related cardiovascular conditions,» the company added.
He contributes to
other large - scale
clinical trials including SAVE (evaluating whether treatment of obstructive sleep apnoea with continuous positive airways pressure can reduce the incidence of serious CV events
in patients with established CVD), and CREDENCE, a randomised, double - blind, placebo - controlled
trial assessing whether canagliflozin can slow the progression of diabetic nephropathy
in patients with type 2 diabetes.
Other PMT - derived programs — for example, Project SafeCare
in Oklahoma — have also shown significant promise for reducing child maltreatment
in randomized
clinical trials at the state and local level.
She visits OBGYN, perinatal, urology, family practice and internal medicine offices to educate them on The Fertility Center of Las Vegas by providing information on the practice, advances
in reproductive endocrinology and infertility, new
clinical trial research, success rates and
other important information.
In other words, without a double - blind clinical trial there is no evidence that breastfeeding CAUSES a decrease in SID
In other words, without a double - blind
clinical trial there is no evidence that breastfeeding CAUSES a decrease
in SID
in SIDS.
As part of a major medical center, we can offer our young patients evaluation and treatment that includes access to state - of - the - art equipment, advanced therapies,
clinical trials and a team of specialists
in pulmonology and from
other clinical disciplines.
We searched the following databases to 18 February 2016: the Cochrane Central Register of Controlled
Trials (CENTRAL)(the Cochrane Library), MEDLINE including In - Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing t
Trials (CENTRAL)(the Cochrane Library), MEDLINE including
In - Process &
Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled
Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing t
Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International
Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing t
Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing
trialstrials.
(Researchers try to tease out true causal relationships through randomized controlled
clinical trials, which,
in this case, randomly assign some kids to consume omega - 3 supplements and randomly assign
others not to.
And «information regarding safety is lacking» is NOT an endorsement of giving the drug (and yes,
in this context hops are a drug)
in any context
other than a
clinical trial.
Cord blood stem cells can be used to treat dozens of diseases and are being tested
in FDA - regulated
clinical trials to help people with autism, brain injury, and
other conditions.
Nusinersen, approved by the U.S. Food and Drug Administration
in December 2016, became the first drug approved to treat spinal muscular atrophy, with several
other experimental drugs still
in clinical trials.
«
Other people are now moving this into
clinical trials in Rett syndrome,» he says.
AstraZeneca's AKT inhibitor is currently
in clinical trials for prostate, breast and
other cancers.
After years of false starts, a new generation of DNA vaccines and medicines for HIV, influenza and
other stubborn illnesses is now
in clinical trials
But he contends that
other gene therapies already
in clinical trials suggest that the treatment could work.
One large
clinical trial known as JUPITER reported
in 2008 that rosuvastatin (Crestor) lowers the risk of heart attacks and
other events by 44 percent
in healthy subjects but experts have since raised questions about its methodology
in part because the
trial was stopped early, which might have created the effect of overestimating the drug's benefits.
Other reasons for testing tau drugs
in PSP patients have more to do with
clinical trial practicalities.
One potential drug, Tariquidar, is currently
in clinical trials, but
in the past,
other potential drugs have failed at that stage.
Several JAK2 inhibitors have already been approved by the FDA or are currently
in clinical trials for the treatment of
other cancers.
The piece based its recommendation on a meta - analysis of 27
clinical trials published
in the same issue that concluded statins significantly reduce the risk of heart attacks and
other cardiovascular events
in healthy people without posing substantial risks.
«Every day, most of us take for granted that when we will to move, we can move any part of our body with precision and control
in multiple directions and those with traumatic spinal cord injury or any
other form of paralysis can not,» said Benjamin Walter, associate professor of Neurology at Case Western Reserve School of Medicine,
Clinical PI of the Cleveland BrainGate2
trial and medical director of the Deep Brain Stimulation Program at UH Cleveland Medical Center.
Now a University of Colorado Cancer Center study published online ahead of print
in the journal Oncogene offers compelling evidence explaining this failure and offering a possible strategy for the use of retinoic acid or
other retinoids against some breast cancers: Because early
clinical trials are often offered to patients who have already tried
other more established therapies, breast cancer cells may have been pushed past an important tipping point that offers retinoic acid resistance.
In the
other two locations,
clinical trials are about to start based on a similar results.
Mackall's team had already designed a way to make CAR - T cells that attack the GD2 sugar; similar anti-GD2 CAR - T cells are now being tested
in clinical trials in a few
other cancers.
It also has a preliminary program to make
other blood proteins, such as alpha - 1 anti trypsin, and a
clinical trial in the U.S. for ATryn.
He is one of six patients participating
in the
clinical trial, which is being conducted at the University of Southern California and five
other sites across the country.
In 2012, the NHMRC provided almost A$ 3 million in research funding for clinical trials for people with chronic diseases, among many other project
In 2012, the NHMRC provided almost A$ 3 million
in research funding for clinical trials for people with chronic diseases, among many other project
in research funding for
clinical trials for people with chronic diseases, among many
other projects.
Sophisticated analyses of two
clinical trials — one
in the U.S. and the
other in the Australia — suggest that thousands of early preterm births — those at or before 34 weeks» gestation — could be prevented if pregnant women took daily docosahexaenoic acid (DHA) supplements.
The neuroprotective effects of nicotine were studied
in a randomized
clinical trial involving 67 subjects
in the early stages of Alzheimer's disease, where memory was slightly impaired but decision - making and
other cognitive abilities remained intact.
She says a number of experimental drugs now
in clinical trials are designed to target serotonin
in other ways
in the brain, and may have better success than the SSRIs.
Roche has four biologic cancer immunotherapy molecules
in clinical trials that could work
in powerful combinations with each
other or with current drugs, says William Pao, global head of oncology discovery
in Basel.
Northfield and Biopure
in Cambridge, Massachusetts — the company that makes Hemopure, the
other blood substitute that's
in large
clinical trials — vigorously attacked Natanson's article, saying its scientific design was flawed and its conclusions unreliable.
The IU team is now planning studies
in animals and, ultimately, will look to
others to partner on
clinical trials that implement the new treatment
in humans.
Several
other small companies, including Bentley Pharmaceuticals
in Exeter, N.H., are conducting
clinical trials on insulin nasal sprays as well.
Others have speculated that, by being involved
in a
clinical trial, patients
in both arms of the
trial received better care than they would otherwise have done, obfuscating any differences between the groups.
Another problem is that modeling studies, like this one, are inherently less powerful than
other kinds of medical research: randomized
clinical trials, the gold standard
in medical research,
in which patients are randomly assigned different treatments or no treatment; case - control studies, which compare patients who have a condition with those who do not; or cohort studies, which determine the risk of contracting a disease by studying a group of people with similar demographics.