Not exact matches
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.
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.
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).
One the
largest analysis
of the peer - reviewed literature was published in The American Journal
of Clinical Nutrition in 2010, and this meta - analysis looked at almost 350,000
studies published on saturated fats, and concluded:
By the way, a great book by another skeptical OBGYN is called «Born in the USA» only he's skeptical
of medicalized birth because he's a
clinical scientist as well, unlike our author here and he's realized that home birth is safer than hospital birth according to peer - reviewed
large scale
studies.
The strengths
of the
study include the ability to compare outcomes by the woman's planned place
of birth at the start
of care in labour, the high participation
of midwifery units and trusts in England, the
large sample size and statistical power to detect clinically important differences in adverse perinatal outcomes, the minimisation
of selection bias through achievement
of a high response rate and absence
of self selection bias due to non-consent, the ability to compare groups that were similar in terms
of identified
clinical risk (according to current
clinical guidelines) and to further increase the comparability
of the groups by conducting an additional analysis restricted to women with no complicating conditions identified at the start
of care in labour, and the ability to control for several important potential confounders.
Much
of the evidence against BPA comes from
large population
studies rather than controlled
clinical trials.
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.
UKPDS - Implications for the care
of people with Type 2 diabetes The United Kingdom Prospective Diabetes
Study (UKPDS), the largest clinical research study of diabetes ever conducted, has provided conclusive evidence that the life threatening complications of Type 2 diabetes (non insulin dependent diabetes) can be significantly reduced by appropriate treat
Study (UKPDS), the
largest clinical research
study of diabetes ever conducted, has provided conclusive evidence that the life threatening complications of Type 2 diabetes (non insulin dependent diabetes) can be significantly reduced by appropriate treat
study of diabetes ever conducted, has provided conclusive evidence that the life threatening complications
of Type 2 diabetes (non insulin dependent diabetes) can be significantly reduced by appropriate treatment.
The case - control
study, published online in
of the Journal
of the American Academy
of Dermatology, used a
large clinical database
of electronic medical records to collect detailed data
of cutaneous melanomas developing in 462 women aged 49 years or younger.
«We now hope to design
larger clinical studies to treat patients» tumors harboring these novel genomic aberrations to further explore the precise extent
of clinical benefit for patients with primary or advanced cholangiocarcinoma.»
If dozens
of human and animal
studies published over the past six years are borne out by
large clinical trials, nicotine — freed at last
of its noxious host, tobacco, and delivered instead by chewing gum or transdermal patch — may prove to be a weirdly, improbably effective drug for relieving or preventing a variety
of neurological disorders, including Parkinson's disease, mild cognitive impairment (MCI), Tourette's and schizophrenia.
Nonetheless, this July, the FDA suspended enrollment in Glaxo's
large clinical trial comparing the safety
of Avandia with that
of a competing diabetes drug and may halt the
study altogether.
However, the
study provides initial
clinical evidence that
larger, size - matched grafts have the potential to improve outcomes when resurfacing cartilage defects
of the femoral head in the hip joint.
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
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
Clinical Oncology (ASCO), the world's
largest clinical cancer research
clinical cancer research meeting.
«This
study highlights the importance
of confirming the validity
of potential biomarkers in a relevant,
large animal model and will be useful in the design
of future
clinical trails,» commented lead investigator Stephen J. Kolb, MD, PhD, Associate Professor, Department
of Neurology and Biological Chemistry & Pharmacology, The Ohio State University Wexner Medical Center, Columbus, OH.
The
study — the
largest to date assessing the mental and emotional health
of patients with cancer using a fully standardized, diagnostic face - to - face interview — is published in the October 6 issue
of the Journal
of Clinical Oncology.
Following the success
of this preliminary safety and feasibility
study, more patients are being recruited for a
larger clinical trial
of the procedure to test the efficacy and durability
of the procedure.
The authors do note that this
large study can not definitively prove cause and effect; nonetheless, the findings are strongly consistent with «a wealth
of existing observational and
clinical trial data to support health benefits
of nut consumption on many chronic diseases.»
«This
study shows the power
of using
large databases to glean meaningful
clinical and economic information that can significantly impact health care costs,» Born said.
«This vaccine appears to be safe for patients, and elicits a broad anti-tumor immunity — we think it warrants further testing in
larger clinical trials,» said
study lead author Janos L. Tanyi, MD, an assistant professor
of obstetrics and gynecology at Penn Medicine.
«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.»
Wyss - Coray, whose group did most
of the mouse
studies that inspired the
clinical trial, now plans to conduct a second,
larger trial using plasma from which many proteins and other molecules have been removed.
By cutting the budget
of the famed Framingham Heart
Study and suspending
clinical exams its participants receive, the National Heart, Lung, and Blood Institute may be signaling that the era
of such
large, costly long - term
studies is drawing to a close.
Using simple statistics, without data about published research, Ioannidis argued that the results
of large, randomized
clinical trials — the gold standard
of human research — were likely to be wrong 15 percent
of the time and smaller, less rigorous
studies are likely to fare even worse.
Aggressive treatment
of high blood pressure comes with risks, and the
study, a
large clinical trial sponsored by the National Institutes
of Health, has not yet been peer - reviewed or published.
The attendees developed a list
of top research priorities and a research agenda for exercise in solid organ transplant, which includes the need to conduct
large multicenter intervention
studies, standardize measures
of physical function in
clinical trials, examine the benefits
of novel types
of exercise, and assess the effects
of exercise on measures such as immunity, infection, and cognition.
The Thorough QT
clinical assessment also has its limitations, as those
studies are done in humans and typically require
large numbers
of patients.
... Finally, this
study draws attention to the need for
large controlled
clinical trials to determine if a combination
of fall prevention strategies and treatment with bone - active drugs might produce additive benefits on fractures, especially in high - risk populations such as those living in nursing homes.
«It is still early days but the
study, which was funded through an NIHR
Clinical Lecturer grant and a College
of Emergency Medicine Research Grant, could potentially make a huge difference to
large numbers
of patients.
Such investigations required both knowledge
of the venom's
clinical effects and
large volumes
of venom, so until now only
large species, like snakes, with easily extracted venoms have been
studied in any depth.
His colleague Alex Liddle, an Arthritis Research UK
clinical research fellow who ran the
study, added: «Partial and total knee replacements are both successful treatments and a
large proportion
of patients with end - stage knee osteoarthritis are suitable for either.
Other
studies have attempted to determine how the research activities
of MSTP graduates differ from those
of other groups
of MD and MD / PhD recipients.7 - 10 Although the data from these
studies suggest that a
large majority
of MSTP graduates hold appointments in
clinical departments, and that most have
clinical responsibilities, MSTP graduates are less likely than other groups
of physician - investigators to publish in journals containing high proportions
of clinical observations and
clinical studies.
However, they caution that because
of the limited number
of participants, further
larger studies will be needed in general
clinical settings to confirm the value
of this audiovisual distraction tool.
Dr Matt Hurles, who led the
study from the Sanger Institute, said: «This
study has the
largest cohort
of such families in the world, and harnesses the power
of the NHS, with 200
clinical geneticists and 4,000 patients.
Weissman says that most
clinical studies of stem cells fail to meet what he sees as key criteria: They should be based on clear, peer - reviewed demonstrations
of tissue regeneration, replicated by a
large number
of independent groups that provide rapid, long - lasting benefits.
The
largest nationwide
clinical trial to
study high - dose resveratrol long - term in people with mild to moderate Alzheimer's disease found that a biomarker that declines when the disease progresses was stabilized in people who took the purified form
of resveratrol.
The MIT researchers have started a company to begin a
larger clinical study for validating this approach, and they plan to investigate the possibility
of using this technology for other types
of cancer.
Researchers were able to access CSF samples from the deprenyl and tocopherol antioxidative therapy
of Parkinsonism (DATATOP)
study, which is the
largest cohort assembled to date with longitudinal collection
of biological fluids and
clinical data from PD patients.
Professor Cyrus Cooper, Professor
of Rheumatology and Director
of the MRC Lifecourse Epidemiology Unit, University
of Southampton, added: «This
study forms part
of a
larger programme
of work addressing risk factors for fracture across the lifecourse, and demonstrates the importance
of the University
of Southampton and MRC Lifecourse Epidemiology Unit in leading
large, UK wide analyses on the internationally leading UK
Clinical Practice Research Datalink dataset.
«Low birth weight and preterm birth have been proposed as risk factors in schizophrenia in general, but past
studies have not shown a
large effect on risk,» says Dr. Bassett, who is also the Director
of the
Clinical Genetics Research Program at CAMH.
A Commentary article in the same issue
of The Lancet Diabetes and Endocrinology by Harvard Professor Matthew W. Gillman notes that the
study had a
large sample size, reasonably precise information about the timing
of the famine, geographical variation in the same country, and
clinical outcomes — a combination
of strengths missing in other famine
studies.
Over the last decade there have been multiple
large studies trying to determine a
clinical use for iNO in preterm neonates, but despite evidence
of short - term benefit, this drug has not been shown to improve long - term outcomes in preemies.
Researchers are planning to extend the
clinical trial to a much
larger number
of patients in a multinational
study, to demonstrate not only a reduced infarct size, but also a reduced mortality in patients who receive early metoprolol during transit to hospital.
Called the high - dimensional propensity score algorithm (hd - PS), it is a tool for improving not randomized
clinical trials but broader observational
studies, in which researchers watch a
large pool
of participants and look for correlations — like the fact that wine drinkers live longer than other drinkers.
The results
of the mouse, human and lab
studies have been so successful that Dr. Bauman has started a
larger clinical trial in volunteers previously cured
of head and neck cancer.
From that
larger study of adult Caucasian twins,
study authors analyzed data from a sample
of 1,790 men, provided through structured
clinical interviews that included retrospective reports
of their own drinking as well as their peers» alcohol - related behaviors from adolescence into young adulthood, ages 12 to 25 years.
Promising outcomes
of preliminary
studies in patients in Southeast Asia and parts
of Western and Central Africa led the World Health Organization to make the recommendation, but safety and efficacy have not yet been proven in
large - scale
clinical trials.
This
study was designed to use readily available agents in an accepted
large - animal model
of human heart attack with the goal
of obtaining evidence that this treatment is ready to be moved into human
clinical trials.»
But most
large clinical trials
of ACEI / ARB exclude patients with the most advanced stage
of CKD predialysis, perhaps out
of concern that the drugs can cause renal failure and the need for dialysis, so it remains unclear whether that therapy is effective in patients with advanced CKD, according to the
study background.