The development track will begin with a Phase I trial to test the vaccine regimen's safety and immunogenicity and depending on those study results,
a larger efficacy study will follow.
Not exact matches
Topics included: early reporting on inaccuracies in the articles of The New York Times's Judith Miller that built support for the invasion of Iraq; the media campaign to destroy UN chief Kofi Annan and undermine confidence in multilateral solutions; revelations by George Bush's biographer that as far back as 1999 then - presidential candidate Bush already spoke of wanting to invade Iraq; the real reason Bush was grounded during his National Guard days — as recounted by the widow of the pilot who replaced him; an article published throughout the world that highlighted the West's lack of resolve to seriously pursue the genocidal fugitive Bosnian Serb leader Radovan Karadzic, responsible for the
largest number of European civilian deaths since World War II; several investigations of allegations by former members concerning the practices of Scientology; corruption in the leadership of the nation's
largest police union; a well - connected humanitarian relief organization operating as a cover for unauthorized US covert intervention abroad; detailed evidence that a powerful congressional critic of Bill Clinton and Al Gore for financial irregularities and personal improprieties had his own track record of far more serious transgressions; a look at the practices and values of top Democratic operative and the clients they represent when out of power in Washington; the murky international interests that fueled both George W. Bush's and Hillary Clinton's presidential campaigns; the
efficacy of various proposed solutions to the failed war on drugs; the poor - quality televised news program for teens (with lots of advertising) that has quietly seeped into many of America's public schools; an early exploration of deceptive practices by the credit card industry; a
study of ecosystem destruction in Irian Jaya, one of the world's last substantial rain forests.
It may have to do with Addyi's high pricing (on par with Viagra at $ 26 per pill without an assistance program), its daily intake requirement (unlike Viagra, it adds up to $ 780 per month), its potentially deleterious side effects (low blood pressure and fainting), its restrictions on alcohol consumption (abstinence vs.
large quantities not recommended for Viagra patients), a 10 %
efficacy rate (whereas Viagra works 50 % of the time compared to a placebo, according to a recent
study), and its subtle neurotransmitter - targeting mechanism (contrast that to the obvious hydraulics of Viagra).
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).
«Randomized trials have confirmed the value of radiation dose escalation for prostate tumors, and the potential benefits of
larger radiation doses in fewer fractions, are expected to increase the therapeutic
efficacy for men with prostate cancer,» said Anders Widmark, MD, a professor of radiation sciences at Umeå University in Umeå, Sweden and lead author of the
study.
The company plans in October to conduct a separate test specifically to
study the seasonal flu vaccine's effectiveness among 480 elderly participants (a demographic often encouraged to get seasonal flu shots), and Phase III
efficacy trials across a
larger set of demographics are scheduled to begin early next year.
And scientists who conduct human challenge
studies, which typically involve a few dozen participants, say they have critical benefits: In addition to saving time and money, they can reveal harm caused by a potential drug or vaccine before it enters
large - scale human
efficacy trials.
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
largest CBD
study presented
efficacy and safety data on GW Pharmaceutical's investigational medicine, Epidiolex (cannabidiol) from open - label Expanded Access programs at 16 sites.
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.
Our
study is one of the
largest to explore the
efficacy and safety of anti-TNF therapy in a
large independent cohort of JDM patients.»
Strollo led a
large study of the new treatment, a yearlong safety and
efficacy trial involving 126 people with moderate to severe obstructive apnea.
Connie Celum, an epidemiologist at the University of Washington, Seattle, who ran a
large oral PrEP
study with Truvada that had 73 %
efficacy, says it will be important to compare VOICE and CAPRISA 004 for differences in sexual behaviors, sexually transmitted infections, cervicovaginal inflammation, and contraceptive use.
A brain plaque inhibitor developed by Merck is now being tested in
larger studies for
efficacy against the still unstoppable neurodegenerative disease
«We're looking forward to longer - term results to come in the next five years from various ongoing observational
studies,» Dr. Arterburn said: The Utah Obesity
Study, the Michigan Bariatric Surgery Collaborative, and
large cohorts from Veterans Affairs health system and the HMO Research Network (including Group Health) and should yield important long - term information comparing the
efficacy, safety, and costs of surgical and non-surgical care for severe obesity.
This result implies that only
large treatment effects can be detected by
efficacy studies in hAPP mice, since the number of mice per group will likely not be greater than 50, for practical and ethical reasons.
A Phase 3, Randomized, Open - Label
Study Evaluating the
Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed / Refractory Diffuse
Large B Cell Lymphoma (ZUMA - 7)
The
study was the
largest yet focused on the safety and
efficacy of proactive antibiotic therapy to prevent infections in pediatric ALL patients during induction therapy.
MHRP is proud to have led a
large group that executed the landmark RV144 vaccine trial, the first
study to show
efficacy in preventing HIV infection.
In the meantime, some patients will continue to use marijuana even though
large studies havent tested its safety and
efficacy.
In 2010, The University of Texas MD Anderson Cancer Center received more than $ 4.5 million — one of the
largest yoga - related grants ever — from the National Institutes of Health's National Cancer Institute to support an ongoing
study of the
efficacy of yoga as part of a treatment program for women with breast cancer.
Many of these conditions are evident in other strands of our
larger study including, for example, teachers «dispositions toward collaboration, teacher
efficacy, trust, academic press, and disciplinary climate.
In two
large clinical
studies, SIMBADOL (buprenorphine injection) was well tolerated and demonstrated safety and
efficacy for post operative pain control in cats.2
Can you cite controlled
studies — with
large samples — that show the
efficacy of this diet for preventing / heading off periodontal disease?
Dr. O'Haire says the valuable data from the pilot
study helped secure the NIH R21 grant to conduct the
large - scale, clinical trial to further investigate the
efficacy and role of service dogs for military veterans with PTSD and their spouses.
There is no
large and growing body of published
studies demonstrating the existence and
efficacy of «mystery forcings» capable of explaining modern warming.
Increased weed and pest pressure associated with longer growing seasons and warmer winters will be an increasingly important challenge; there are already examples of earlier arrival and increased populations of some insect pests such as corn earworm.64 Furthermore, many of the most aggressive weeds, such as kudzu, benefit more than crop plants from higher atmospheric carbon dioxide, and become more resistant to herbicide control.72 Many weeds respond better than most cash crops to increasing carbon dioxide concentrations, particularly «invasive» weeds with the so - called C3 photosynthetic pathway, and with rapid and expansive growth patterns, including
large allocations of below - ground biomass, such as roots.73 Research also suggests that glyphosate (for example, Roundup), the most widely - used herbicide in the United States, loses its
efficacy on weeds grown at the increased carbon dioxide levels likely to occur in the coming decades.74 To date, all weed / crop competition
studies where the photosynthetic pathway is the same for both species favor weed growth over crop growth as carbon dioxide is increased.72
Large scale outcome
studies were conducted to evaluate the
efficacy of anti-depressant treatments including medications and psychotherapies.
Recent theoretical work suggests that bullying might arise out of early cognitive deficits — including language problems, imperfect causal understanding, and poor inhibitory control — that lead to decreased competence with peers, which over time develops into bullying.14, 15 A small number of
studies provide circumstantial evidence that such a hypothesis might have merit7: 1
study found a link between poor early cognitive stimulation and (broadly defined) inappropriate school behavior, 16 and another found cognitive stimulation at age 3 years to be protective against symptoms of attention - deficit disorder at age 7 years.17 A
study of Greek children found that academic self -
efficacy and deficits in social cognition were related to bullying behavior.18 A
large US national survey found that those who perceive themselves as having average or below - average academic achievement (as opposed to very good achievement) are 50 % to 80 % more likely to be bullies.8 Yet these
studies are based on cross-sectional surveys, with the variables all measured at a single point in time.
Participants were drawn from a
larger study examining (i) the effects of trauma on children over time and (ii) the
efficacy of the SAFE Homes intervention, a DCF program in which children who have been removed from their parents» care are placed temporarily in state - run facilities rather than immediate foster care to facilitate assessment and treatment planning.
While
large - scale randomised clinical trials have demonstrated the
efficacy of schema therapy (ST) for borderline personality disorder (BPD) and other PDs, current
studies are expanding to assess its usefulness for other disorders and particular treatment settings.
Conclusions: The overall results of this
study are encouraging, but VIPP - Co must be evaluated with
larger samples to explore its
efficacy.
The sample reported in this article was part of a
large - scale, two - phase demonstration
study testing the
efficacy of BSFT with high - risk minority youth (first - phase: see above summary of Santisteban, Coatsworth, Perez - Vidal et al., 1997).
The
study looked at cases in the 4th
largest jurisdiction in the United States, 11th Judicial Circuit in Florida with the goal of assessing expectations, perceptions and perceived
efficacy of parenting coordination from the point of view of family law attorneys, judges and parenting coordinators.
All foster care children were part of a
larger efficacy trial to evaluate Multidimensional Treatment Foster Care for Preschoolers (MTFC - P)[now called Treatment Foster Care Oregon for Preschoolers (TFCO - P)-RSB- and were assigned to intervention or comparison groups at
study entry.
This is, to our knowledge, the first
study that assessed the prospective longitudinal and bidirectional association between depressive symptoms and academic, social and emotional self -
efficacy in a
large adolescent sample.
As this
study shows, when the «dose» is
large enough, parent training seems more effective than when data from all participants are used in an intent to treat analysis; (c) the present
study provided a more rigorous test than most prior
studies by only admitting children to treatment who met DSM - IV criteria for ODD; and, perhaps most importantly, (d) this
study was designed as an effectiveness trial, while most prior
studies were
efficacy - oriented.
Given those developments and the findings concerning the link between depressive symptoms and self -
efficacy, this
study was to our knowledge, the first to investigate the mutual influence between depressive symptoms and academic, social and emotional self -
efficacy in a
large adolescent sample, spanning 2.5 years over a period of early to mid adolescence.
Since it is argued that self -
efficacy and depressive symptoms might influence each other over time, the current
study examined the longitudinal and bidirectional associations between depressive symptoms and academic, social and emotional self -
efficacy in a
large sample spanning early to middle adolescence.
Studies demonstrating the
efficacy of PMT interventions show improvements in parental perceptions and parenting skills, improvements in children's social skills and school adjustment, and reductions in behaviour and attention problems.66, 67 PMT interventions are associated with
large effect sizes, 68 the effects often generalize to a variety of home and community settings, 69,70 they are maintained over time, 71 and are associated with high levels of consumer satisfaction.72 PMT has been successfully used with two - biological - parent families, step - parents and single parents.
In addition, she is co-principal investigator on the ED - funded
efficacy trial of Foundations, a positive and proactive approach to schoolwide discipline, and of the National Institute of Justice - funded implementation and evaluation
study of positive discipline and trauma - informed services in a
large urban school district.
This finding is consistent with a recent analysis of data from a
large Australian cohort (the Longitudinal
Study of Australian Children, LSAC), which reported that child behaviour was positively associated with quality of parenting by the father (warmth, self -
efficacy and good co-parental relationship), but not with father's contact time, after adjusting for mother's parenting and many other potential confounders [37].