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).
In independent
trials at North Carolina State University, a panel of trained sensory experts found HarvestPro ™ Pea Protein 83EF offered «significantly
lower» bitter green pea notes
than other samples.
The Functional Food Centre of Oxford Brookes University conducted a
trial using Aduna Baobab Powder and found that human participants who consumed a milk containing baobab had a
lower blood glucose response
than those who had a control drink with no baobab.
• A controlled
trial of a brief (one postpartum session) group intervention with mothers and fathers, addressing infant behaviour and couple - relationship management, found dramatically
lower instances of depression / anxiety among women who had attended the couples - group - session
than among those who had met with a health visitor at home (Fisher et al, 2010).
In this
trial, which involved only women at
low risk of bleeding, active management was associated with a post partum hemorrhage (blood loss greater
than 500 ml) rate of 6.8 %, compared with 16.5 % for expectant (non-active) management.
A series of randomized control
trials of a nurse home visitation program show a range of positive effects on maternal health, including decreases in prenatal cigarette smoking, fewer hypertensive disorders in pregnancy, and fewer closely spaced subsequent pregnancies., A randomized control study of another program that works with a particularly high - risk population found that participant mothers showed significantly
lower depressive symptoms
than those in the control group and were less likely to report feeling stressed a year after participation.
Multiple
trials of
low risk of bias contributed to each outcome, and there were precise estimates with no heterogeneity greater
than 60 %.
The wife of former top Cuomo aide Joseph Percoco was paid more
than $ 22,500 for less
than half a week's worth of work at an alleged «
low - show» job, according to testimony at her husband's corruption
trial Wednesday.
This dose would now be considered a
low dose, but the authors note that randomised
trials of higher doses have not found that statins cause an increase in muscle related symptoms, other
than the very small increase in myopathy.
Rather
than create drastic salt policies based on conflicting data, Alderman and his colleague Hillel Cohen propose that the government sponsor a large, controlled clinical
trial to see what happens to people who follow
low - salt diets over time.
However he points out that the pregnancy rate among the women in the
trial who didn't undergo CGH, although
lower than the group who did, was still much higher
than average, meaning that data is needed from other centres to confirm the reported successes.
In a
trial that involved nearly 900 South African women, those who received a vaginal gel that contains an anti-HIV drug had a 39 %
lower chance of becoming infected by the virus
than those who received a placebo.
A second study showed that training in realistic environments, including practiced encounters with armed - opponent actors in buildings and streets, improved their shooting accuracy under stress Similarly,
trials with 66 of the officers revealed that those who trained weekly on their own in a combat sport such as karate or kickboxing performed better under high - anxiety fights
than those with no additional training, although both groups suffered performance decreases when conditions shifted from
low to high anxiety.
At the end of the
trial, those who received the high - dose vaccine scored an average of 39 percent
lower on symptoms and medication use
than did those who got the dummy shots.
Brachytherapy is an extremely efficient and safe radiation oncology modality, and this
trial shows that it can have a wider field of applicability
than simply in very localised and
low risk tumours when combined with other techniques — in this case, androgen deprivation therapy and external bean radiation therapy.»
The study demonstrated that a group of
trial participants with
low 21 - gene recurrence score (Oncotype DX ® Recurrence Score ®) results of 10 or less who received hormonal therapy alone without chemotherapy had less
than a one percent chance of distant recurrence at five years.
He launched the study when he discovered heart attack patients were being treated with much
lower doses of beta - blockers
than were used in clinical
trials.
When people with early - stage symptoms took omega - 3 supplements for three months, they had much
lower rates of progression
than those who did not, according to one small - scale
trial.
For instance, recent
trials show that if people are treated when their blood contains 350 to 500 cells per cubic millimetre, their risk of transmitting the virus is 96 per cent
lower than if they begin treatment when their counts fall below 350.
The pH of the vaccine used in the
trials was found to be
lower than usual, and subsequent studies have shown that the
lower - pH formulation provokes a weaker immune response.
The relatively
low degree of protection found in the Colombian
trials might be partly explained, says Patarroyo, by problems with the formulation of the vaccine at the time it was made, more
than two years ago.
In his presentation, Malvy focused on a group of 40 patients who began the
trial with
lower viral loads
than 29 others who clearly did not benefit from favipiravir.
The
trial was limited by its
lower -
than - expected event rate, which adds uncertainly about the lack of statistical significance of some of the small differences seen.
Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical
trial site activation or enrollment rates that are
lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.
This likely contributed to the
lower -
than - expected number of deaths on both arms in the
trial.
The study tested a
lower dose of the oral multi-targeted tyrosine kinase inhibitor sunitinib
than in previous
trials, where toxicity proved too much of a problem.
An analysis of HIV vaccine
trials (mostly ones that use DNA vaccines) showed that women showed better T - cell responses to such vaccines
than men, and people with a
lower body mass index showed better T - cell responses
than people with a higher body mass index.
Notably, while baseline antibody levels among children in this
trial were about 10-fold to 50-fold
lower than pre-immunization levels in adults at this same site, children achieved post-immunization AMA1 antibody levels that were at least as high as those seen in vaccinated adults [17], [20].
That's much more dramatic
than what happens in a huntingtin -
lowering treatment
trial.
The clinical
trial included more
than 400 people who ate the so - called DASH diet (which features high amounts of fruits, vegetables,
low - fat dairy and
low amounts of fats and saturated fats), or a typical American diet.
Yet another study, a meta - analysis of seven clinical
trials involving about 1,150 patients with bleeding ulcers, found that higher doses of proton pump inhibitors did not reduce the risk of additional bleeding, need for surgery, or death more effectively
than lower doses did.
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.
Over 20 randomized controlled
trials have now shown that
low - carb diets lead to 2 - 3 times more weight loss
than low - fat diets (20, 21, 22).
He organized three controlled
trials with increasing demands for testing the adequacy of diets
lower in protein
than commonly recommended.
Finally, numerous recent clinical
trials have shown high - protein,
low - glycemic load diets to be more effective
than low - fat, high - carbohydrate diets in promoting weight loss and keeping it off.
In the Prostate Cancer Prevention
Trial, a study involving more
than 18,000 men, subjects taking dutasteride had a
lower rate of prostate cancer, but a significantly higher rate of aggressive prostate cancers
than the placebo group.
FACT: When the results of the DASH Sodium
trial are examined (see diagram in Figure 4), it is immediately apparent that merely moving to a DASH diet (red line) has a significantly greater impact on blood pressure
than simply
lowering salt consumption.
In the Prostate Cancer Prevention
Trial, a study involving more
than eighteen thousand men, subjects taking dutasteride had a
lower rate of prostate cancer, but a significantly higher rate of aggressive prostate cancers
than the placebo group.
Dr. Neil Barnard's study «A
Low - Fat Vegan Diet Improves Glycemic Control and Cardiovascular Risk Factors in a Randomized Clinical
Trial in Individuals With Type 2 Diabetes» Diabetes Care 29:1777 — 1783, 2006 on the effects of a WFPB diet on people who have type 2 diabetes showed a WFPB diet was more effective
than the diet recommended by the American Diabetes Association (ADA)(hardly a meat heavy diet).
Some important studies include: • Beneficial effects of a high carbohydrate, high fiber diet on hyperglycemic diabetic men (1976) • Response of non-insulin-dependent diabetic patients to an intensive program of diet and exercise (1982) • Diet and exercise in the treatment of NIDDM: The need for early emphasis (1994) • Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a
low fat, vegetarian diet (1999) • The effects of a
low - fat, plant - based dietary intervention on body weight, metabolism, and insulin sensitivity (2005) • A
low - fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical
trial in individuals with type 2 diabetes (2006) • A
low - fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74 - wk clinical
trial (2009) • Vegetarian diet improves insulin resistance and oxidative stress markers more
than conventional diet in subjects with Type 2 diabetes (2011) • Glycemic and cardiovascular parameters improved in type 2 diabetes with the high nutrient density (HND) diet (2012)
Chasteberry has been proven to help
low progesterone in more
than sixty years of clinical research, including five randomized
trials.12 Turner S., et al. «A double - blind clinical
trial on a herbal remedy for premenstrual syndrome: A case study.»
Despite those drawbacks, that
trial, called Enhance, also showed that patients on Vytorin had
lower LDL levels
than those on Zocor alone.
In fact, in every study — including the «gold standard» for evidence, randomized controlled
trials — VLCKDs perform at least as well and generally better
than low - fat diets for this purpose.
I actually don't know what that is, but it's clearly significantly harder
than 55 % of VO2max, because two thirds of the subjects (who were trained, recreationally competitive cyclists) were unable to complete the
trial at that level and had to
lower the power to 50 % Wmax during the later stages of the
trial.
In contrast, large reviews of previous
trials suggest that very LC diets may have less favorable effects on LDL cholesterol
than conventional high - carb,
low - fat diets (13, 14).
Long - term effects of advice to consume a high - protein,
low - fat diet, rather
than a conventional weight - loss diet, in obese adults with Type 2 diabetes: one - year follow - up of a randomised
trial.
Some people need amino acid support in more
than just the
low serotonin area so we review the amino acid questionnaire and consider
trials of GABA and other amino acids too.
If someone is very sensitive to small amount of supplements, we may have them do a
trial with a dab or two rather
than a whole capsule and start really
low during the next week.
In a prospective, randomized, controlled
trial with a
low fat and a
low fat plus high Dietary Fiber groups, the group consuming high Dietary Fiber exhibited a greater average reduction (13 percent) in serum total cholesterol concentration
than the
low fat (9 percent) and the usual diet (7 percent) groups (Anderson et al., 1992a).
The study, a re-analysis of data from 11 clinical
trials comprising more
than 31,000 people age 65 and older, found that vitamin D supplements — which are often combined with calcium supplements — are associated with a
lower risk of bone fracture only when taken at high doses.