Sentences with phrase «effects over the trial»

Not exact matches

And while early results have been promising, some skeptics have held out on the hype due to concerns over side effects and whether results will persist in later - stage trials.

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).

Eating about 3/4 cup (130 grams) each day of these foods known as pulses led to a weight loss of 0.34 kilograms (just over half a pound), in a systematic review and meta - analysis of all available clinical trials on the effects of eating pulses.

Scientists have observed the CO2 fertilization effect in natural ecosystems, including in a series of trials conducted over the past couple decades in outdoor forest plots.

However, if SSRIs had indeed acted merely by means of a placebo effect, these drugs should not outperform actual placebo in clinical trials where patients have been treated with an SSRI or with ineffective placebo pills, and where neither the physician nor the patient knows which treatment the patient has been given until the study is over.

The HIV - specific IgG3 response correlated with decreased infection risk, but the effect waned over time, similar to the declining efficacy observed in the RV144 trial.

The study, published in the July issue of the journal Epidemiology, offers benefits over typically used randomized clinical trials, as such studies are often too small to identify rare side effects or may be performed in a group of patients who do not take other types of medications or have other conditions that could skew the drug's effect in a broader group following approval.

«Many parents of children with autism are already obtaining and using oxytocin nasal spray with their child, and clinical trials of the spray's effects are underway all over the world.

Rythm recently published a paper in Frontiers in Human Neuroscience using data from its users» experiences and a clinical trial, which includes a finding that its effects did not diminish over 10 nights of use.

We used random effects methods to compare dichotomous outcomes (risk ratio for efficacy and odds ratio for safety); therefore estimates meta - analysed over multiple trials are average treatment effects.

One eight - month IER trial in obesity - prone rats reported an increase in theproduction of reactive oxygen species (ROS), with no clear mechanistic explanations.26 Another trial, this time over six months, showed that IER - fed rats displayed marked reductions in diastolic compliance and cardiac reserve due to observed reductions in cardiomyocyte size and increased myocardial fibrosis.23 No human trials to date have reported any adverse effects on cardiovascular health during long - term IER.

27 Studies cited by the 2010 DGAC Report demonstrate varied metabolic responses to lowered dietary saturated fat, with certain subpopulations exhibiting adverse rather than improved health outcomes.3 Two recent comprehensive meta - analyses indicate that saturated fat is not linked to heart disease.28, 29 In fact, in a definitive review of forty - eight clinical trials, with over sixty - five thousand participants, the reduction or modification of dietary fat had no effect on mortality, cardiovascular mortality, heart attacks, stroke, cancer, or diabetes.30 Yet, avoiding saturated fat remains a cornerstone of national dietary guidance.

We have known for over forty years that PUFAs alter the vitamin E requirement in a potentially time - dependent manner and that trials lasting fewer than eight years are insufficient to demonstrate the long - term effects of consuming vegetable oils.

Randomized trials of fibre supplements show relatively modest weight loss effects with a mean weight loss is 1.3 — 1.9 kg (2.9 — 4.2 pounds) over a period of up to 12 months.

However, over the last few years various studies and trials have been conducted to try and unravel the positive effect meditation has on us.

And after numerous vitamin E trials over the years, concerns arose that it might increase the risk for adverse effects (like mortality) when doses exceeded 400 IU.

So overall it looks like you may be correct in identifying that honey has advantages over sugar, but we will need a few more larger scale trials over a longer period to see if this can really have long term health benefits, rather than short term effects.

During the trial and over the next week we also look for possible negative effects, such as a headache or feeling light - headed.

Of interest is one trial that specifically tested the effects of fruits and vegetables on weight over 1 year (Djuric et al., 2002).

The Chicago trial provided evidence that the program affected perceptions of school and academic climate and had a small effect on academic achievement over the period covered by the study.

The funding from the Institute of Education Sciences will allow the researchers to evaluate the effects of the Supporting Knowledge in Language and Literacy (SKILL) curriculum in a large randomized clinical trial in Utah and Texas over the next 4 years.

When it comes to consumable calming aids, such as chews or drops, it is important to offer a variety of solutions, such as those with different delivery systems, flavors and ingredients, since one product may have more of an effect than another, or the dog may prefer one over the other, says Cromer, adding that it's a little bit of trial and error.

As I dug deeper I was struck by the sense of outrage and loss this painting aroused in so many people: The family of Lea Bondi, determined to reclaim the stolen portrait she had failed to recover in her lifetime; the Manhattan District Attorney who sent shock waves through the international art world and enraged many of New York's most prominent cultural organizations when he issued a subpoena and launched a criminal investigation following the surprise resurfacing of Portrait of Wally; the New York art dealer who tipped off a reporter about the painting during the opening of the Schiele exhibition at MoMA; the Senior Special Agent at the Department of Homeland Security who vowed not to retire until the fight was over; the art theft investigator who unearthed the post-war subterfuge and confusion that ultimately landed the painting in the hands of a young, obsessed Schiele collector; the museum official who testified before Congress that the seizure of Portrait of Wally could have a crippling effect on the ability of American museums to borrow works of art; the Assistant United States Attorney who took the case to the eve of trial; and the legendary Schiele collector who bartered for Portrait of Wally in the early 1950s and fought to the end of his life to bring it home to Vienna.

«The sum of the evidence against saturated fat over the past half - century amounts to this: the early trials condemning saturated fat were unsound; the epidemiological data showed no negative association; saturated fat's effect on LDL - cholesterol (when properly measured in subfractions) is neutral; and a significant body of clinical trials over the past decade has demonstrated the absence of any negative effect of saturated fat on heart disease, obesity, or diabetes.

The effect of this was to render the original trial result moot, as if it had never happened, and the parties had to start all over again.

Justice Mercier acknowledged at the trial level in R v. Squires that the concerns over disruptive and prejudicial effect that cameras in courtrooms and need to maintain the right to a fair trial could potentially be addressed through time and experience, and envisioned circumstances where the court rules could be amended to allow televising of court proceedings.

«Especially if you're a complainant who has actually been a victim of a crime, one could only imagine the psychological effect that delays have, and that can result in revictimization over the months and years leading to a trial.»

Individuals with psychotic disorders might choose to forgo antipsychotic medication because of side effects.1 Over 40 randomised controlled trials (RCT) have demonstrated that cognitive behavioural therapy for psychosis (CBTp) is generally efficacious in improving symptoms, with small to medium effect sizes in individuals with psychotic disorders.2 It was unknown, until now, if individuals with psychotic disorders who were antipsychotic - free could tolerate CBTp and benefit from it.

The trial - based economic evaluation results will be expressed as the change in costs of the intervention compared with usual care, relative to the change in effects of the intervention over and above the usual care arm at 2 years.

Delivered in 8 sessions over 2 months, FOK was evaluated in a randomized, longitudinal trial in which the study cohort was followed for 48 months after intervention.12 A significant intervention impact was noted on rates of protected sexual intercourse 6 months after intervention, although by 12 months this effect was no longer apparent.

The study replicates the null effect from an earlier, smaller and thus underpowered trial.2 It is possible that such interventions need to be delivered over a longer period to reduce vascular and other metabolic risk factors to depression.5 - 7

Second, in a field that is moving rapidly from developer - led efficacy trials, to implementation trials in complex real - world services, we need to be sure that effect sizes are not declining over time, as developer control over trials is relaxed.

August and colleagues (2002) examined the effects of the Early Risers «Skills for Success» Program over a 3 - year intervention trial in two semirural, Midwestern geographical sites consisting of white families of low to low — middle socioeconomic status.

This summary of the evidence is based on a systematic search of the literature, and correspondence with leading researchers, to identify all well - conducted randomized controlled trials of the full Triple P System that evaluated its effect over a sustained period of time.

The first trial had a sample of over 100 African American children living in poverty in the mid-1960s; it reported sizable, sustained effects on participants» life outcomes.