What can we conclude about the role of IV vitamin C after 33
years of trials involving at least 1,600 patients?
Not exact matches
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).
A new book on the Canadian workplace — Work on
Trial: Canadian Labour Law Struggles, edited by Judy Fudge and Eric Tucker — provides an engaging and accessible account
of various labour battles in the courts over the past 85
years involving human rights, employment fairness and union recognition.
The readers, which were tested during a
trial involving 40 churches last
year, are capable
of supporting 500 transactions without recharging, although the vast bulk
of regular donating is expected to continue by standing order.
Involved with these considerations is the question
of the
year in which the last supper and the
trial and crucifixion
of Jesus took place.
For the very lucky, you only have to clean up a small pond's worth
of pee over the course
of a few weeks before you're in the clear, but for most people, potty training a kid
involves a series
of trials and tribulations that can take months (or in some cases
years; our thoughts are with you).
Talk about ethics reform in the new legislative session has been largely muted this
year, even as a
year filled with corruption
trials involving prominent New York figures is underway, including the ongoing
trial this week
of Joe Percoco, a former close aide to Governor Andrew Cuomo.
Next
year, a former top aide to Gov. Andrew Cuomo, Joe Percoco, will go on
trial along with the former president
of SUNY Nanotech and upstate developers, who are accused
of being
involved in a bribery and bid - rigging scheme for economic development projects.
The Silver retrial is the second
of four corruption
trials involving state government to take place this
year.
«Your brother did not die in vain,» stated Cuomo
of Brodwer's brother Kalief, who committed suicide in 2015, two
years after being released from Rikers Island, where he had spent three
years awaiting
trial on charges
involving a stolen backpack.
DeFrancisco, 71, immediately emphasized what he sees as the governor's vulnerabilities: several economic development projects in upstate New York that have sputtered, chronic delays in the New York City subway system and a corruption
trial involving the 60 -
year - old governor's close confidant Joe Percoco — the first
of six
trials this
year involving state figures.
After 6 weeks
of studying the over one
year court proceedings on the ongoing
trial involving four suspects; Osarfo Anthony, Ekow Micah, Sarah Kwablah, and Chris Handler, accused
of allegedly conspiring to extort money from Asamoah Gyan, the new Attorney General headed by Madam Gloria Akuffo, is set to appear in court for
trial to continue.
Next
year will also feature two federal corruption
trials involving some
of Cuomo's top allies: Alain Kaloyeros, the former president
of State University
of New York Polytechnic Institute, and Joe Percoco, who managed Cuomo's past two campaigns and has been likened to a brother.
Another corruption
trial scheduled to begin this
year involves Alain Kaloyeros, who was president
of SUNY Polytechnic Institute and is accused
of rigging bids for projects part
of the «Buffalo Billion,» one
of Cuomo's top economic development programs.
The
year after his
trial, the U.S. Supreme Court, in a case
involving Bob McDonnell, ex-governor
of Virginia, narrowed the types
of official actions that would constitute quid pro quo.
Nine people have pleaded guilty or been indicted in connection with alleged bid rigging and other corruption charges
involving some
of Governor Cuomo's economic development programs, and they face
trial later this
year.
«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.
After pooling the results
of 27
trials involving 165,149 people, the meta - analysis reported that people are 21 percent less likely to suffer a serious vascular event such as a heart attack, stroke or bypass surgery after their cholesterol drops by the amount that might be expected after taking statins for a
year than are similar people who do not take the pills.
«There are currently no therapies which successfully reverse the damage seen in the more than 12,000 individuals who suffer a spinal cord injury each
year in the United States alone,» says Dr. Richard G. Fessler, professor
of neurological surgery at Rush University Medical Center and principal investigator for the Phase 1 clinical
trial involving AST - OPC1 (oligodendrocyte progenitor cells).
The
trial, which began in 2001 and spanned 13
years,
involved 24 people with a severe form
of MS.. During that period, the positive results endured.
It typically takes many
years to initiate such
trials because
of the stringent safety testing that must be done before testing in humans begins, but Reynolds said it may be possible to move faster as the therapy only
involves modifying a patient's dietary intake and supplementing with a medium - chain triglyceride oil, both
of which have no known side effects.
The
trials lasted from 3 months to 6
years, and the children
involved were followed up for various lengths
of time after the
trials had ended.
Kovatchev has racked up nearly 184,000 patient - hours, and counting,
of clinical
trials involving his version
of an artificial pancreas — the time equivalent
of one person wearing his device for more than 20
years.
However, Esther and the UNC coauthors, who were not
involved in the clinical
trial, said that a statistically significant increase in lung function is thought to lead to fewer CF - related flare - ups over the course
of a
year.
The new six -
year study, «Cognitive enhancement therapy for adult autism spectrum disorder: Results
of an 18 - month randomized clinical
trial,»
involved 54 adults and was led by Shaun Eack, Ph.D., M.S.W., Pitt's David E. Epperson Professor
of Social Work and Psychiatry, and Nancy Minshew, M.D., Pitt professor
of psychiatry and neurology.
Beer's team
of prostate cancer researchers at OHSU's Knight Cancer Institute have been
involved in, or led, clinical
trials for three
of the five new treatments developed for prostate cancer in recent
years.
Analysis
of data from nine randomised
trials involving 6756 patients (1729 older than 80
years of age) showed that alteplase treatment significantly increased the odds
of a good stroke outcome (no significant disability 3 - 6 months after stroke), with faster treatment offering the best chance
of recovery.
New results from a clinical
trial involving more than 900 military veterans at high risk for keratinocyte carcinoma skin cancer provides evidence that using the generic skin cream fluorouacil 5 percent for two to four weeks may reduce the risk
of a squamous cell carcinoma (SCC) needing surgery by 75 percent within a
year.
This latest
trial involved 320 children aged 4 to 11
years from 43 family practices in the UK who had recent histories
of otitis media and effusion with confirmed fluid in one or both ears.
The
trial involved 12 patients (6 women, 6 men) with moderate to severe depression (average length
of illness was 17.8
years).
An earlier form
of the vaccine was used in the DarDar
Trial, a seven -
year study in Tanzania sponsored by the U.S. National Institutes
of Health
involving patients with HIV infection who at birth had received BCG, the current tuberculosis vaccine.
The multicenter
trial involving 100 patients showed that the addition
of ipilimumab to nivolumab, which is currently FDA - approved for treatment
of kidney cancer, leads to responses that can last beyond two
years.
«They are the most rigorous double - blind placebo - controlled
trials of a psychedelic drug in the past 50
years,» writes David Nutt, a pharmacologist at Imperial College London who was not
involved in the work, in an editorial accompanying the papers.
In a Canadian
trial involving 16 asthma patients, the procedure improved average air - flow rates in and out
of the lungs, even when tested two
years after treatment.
Later - phase clinical
trials, which often take several
years or more to conduct, often
involve hundreds or thousands
of patients.
Despite the studious modesty
of that hope, a handful
of clinical
trials involving Tregs in transplantation and autoimmune diseases are already underway, and the coming
years are poised to see a crop
of promising clinical leads for cancer treatment.
The
trial, a first in islet transplantation, is slated to begin in the fall
of this
year and will
involve approximately 32 new transplants at up to eight clinical centers across North America and Europe.
To verify the effectiveness
of aducanumab, a
trial was set in place that
involved 165 people receiving the drug and over the course
of one
year it was reported that the amyloid - beta levels in these people's brains had declined.
The challenge takes on even more urgency with recent developments, including a federal administration now more open to exploring the potential
of stem cells, the recent FDA approval
of a human
trial involving embryonic stem cells, as well as the reported case
of a young boy who developed a brain tumor four
years after receiving a stem - cell treatment for a rare genetic disorder.
We also performed subgroup meta - analyses by type
of prevention (primary v secondary: in this study,
trials involving healthy populations or patients with any specific disease except for cardiovascular disease were classified as primary prevention
trials, and
trials involving patients with cardiovascular disease were classified as secondary prevention
trials), type
of supplement by quality and dose (each supplement, vitamins only, antioxidants only, or antioxidants excluding vitamins), type
of outcome (cardiovascular death, angina, fatal or non-fatal myocardial infarction, stroke, or transient ischaemic attack), type
of outcome in each supplement, type
of study design (randomised, double blind, placebo controlled
trial v open label, randomised controlled
trial), methodological quality (high v low), duration
of treatment (< 5
years v ≥ 5
years), funding source (pharmaceutical industry v independent organisation), provider
of supplements (pharmaceutical industry v not pharmaceutical industry), type
of control (placebo v no placebo), number
of participants (≥ 10000 v < 10000), and supplements given singly or in combination with other vitamin or antioxidant supplements by quality.
A total
of 27
trials involving 8000 prostate cancer patients showed that total androgen blockade improved the 5 -
year survival rate by only 2 % and the 10 -
year survival rate by only 0.7 %.
In this 8 -
year trial,
involving 41,186 particpants
of the Black Women's Health Study, research data confirmed inverse associations between magnesium, calcium and major food sources in relation to type 2 diabetes that had already been reported in predominantly white populations.
The MCRI
trial with children under the age
of 3
years old
involved one group
of children wearing cotton for the first 6 weeks then changing to wool, and the other group starting with wool for the first 6 weeks then switching to cotton.
The movie is not only too long at 140 minutes, but it's overstuffed as well, so intent on covering every facet
of the
years - long conflict that Ross refuses to trim any fat, particularly a needless (and poorly acted) subplot
involving the 1948 court
trial of Knight's biracial great - grandson, who was prosecuted for marrying a white woman.
One part
of the study is to include the first large randomised control
trial of mindfulness training
involving nearly 6,000 students and running for five
years.
At the end
of last
year I visited Western Port Secondary College in Victoria — one
of 21 government secondaries
involved in the
trial — to talk to assistant principal Hannah Lewis and student Harry Hainsworth.
The first
trial of the system
involved connecting every class in the school from Reception to
Year 6.
A randomized
trial involving 19 elementary schools (K — 5) was conducted to replicate and extend two previous experimental studies
of the effects
of a voluntary summer reading program that provided (a) books matched to students» reading levels and interests and (b) teacher scaffolding in the form
of end -
of -
year comprehension lessons.
The
trial of Accelerated Reader, funded by the EEF and led by the schools themselves,
involved pupils at the start
of year 7 who had not achieved Level 4 in their primary results for English.
Though only one
year of data is available for analysis at this point, the study has
involved a randomized field
trial of over 400 teachers and administrators broken into test and control groups.