Sentences with phrase «effects on a clinical trial»

Researchers are now looking into the drugs effects on a clinical trial group of 30 middle - aged dogs.

Not exact matches

Earlier this year Merck halted trials on its once - promising Alzheimer's drug after an independent panel of ruled there was «virtually no chance of finding a positive clinical effect.»

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Some retrospective studies and preclinical work have indicated that it might also lower a person's risk of cancer, though at least one clinical trial wasn't able to show that it had any protective effect on esophageal cancer.

There are about 120 studies ongoing in Israel, including clinical trials looking at the effects of cannabis on autism, epilepsy, psoriasis, and tinnitus.

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).

However, a recent clinical trial (39) did not find any beneficial effects of short - term (6 wk) dark chocolate and cocoa consumption on cardiovascular outcomes or on neuropsychological tests.

The 12 week clinical study from the US of 303 participants is the first prospective, randomised clinical trial to directly compare the effects of water and diet beverages on weight loss within a behavioural weight loss program.

Although a considerable body of scientific evidence substantiates the positive correlation between curcumin consumption and a reduction in the risk of cancer, the paucity of suitably designed human clinical trials that clearly demonstrate any direct effect of curcumin on cancer markers may prevent Health Canada from approving a cancer risk reduction claim for curcumin within the current regulatory framework.

«There's more emphasis now and there will be more emphasis because of the Affordable Care Act [on] offering mental health services in primary care settings,» suggests Curry, who is about to start a clinical trial looking at the effects of cognitive behavior therapy for adolescents with depression and substance abuse problems.

The effect of topical virgin coconut oil on SCORAD index, transepidermal water loss, and skincapacitance in mild to moderate pediatric atopic dermatitis: a randomized, double - blind, clinical trial.

Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 DiabetesThe TRIGR Randomized Clinical Trial.

Collectively, the evidence from longitudinal research, clinical trials, and neurodevelopmental research is beginning to provide a compelling case for the view that breastfeeding may have longer - term effects on individual cognitive ability and educational achievement.

Because the trial found no differences in the effect of type of care on any primary clinical outcome, the economic analysis compares only the costs of care rather than their cost - effectiveness.

Despite aromatherapy's long history of use, there is still a lack of large - scale clinical trials exploring the effects of aromatherapy on anxiety.

There are several randomized controlled clinical trials (RCTs) evaluating the effect of probiotic bacteria on the prevention and treatment of allergic disease.

The PhD course focuses on various aspects of human (donor) milk, with as main study a randomized clinical trial towards the effects of human donor milk in very low birth weight infants (the Early Nutrition Study).

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.

Although some SIDS experts and policy - makers endorse pacifier use recommendations that are similar to those of the AAP, 272,273 concerns about possible deleterious effects of pacifier use have prevented others from making a recommendation for pacifier use as a risk reduction strategy.274 Although several observational studies275, — , 277 have found a correlation between pacifiers and reduced breastfeeding duration, the results of well - designed randomized clinical trials indicated that pacifiers do not seem to cause shortened breastfeeding duration for term and preterm infants.278, 279 The authors of 1 study reported a small deleterious effect of early pacifier introduction (2 — 5 days after birth) on exclusive breastfeeding at 1 month of age and on overall breastfeeding duration (defined as any breastfeeding), but early pacifier use did not adversely affect exclusive breastfeeding duration.

While anecdotal and clinical experience supports improvement in milk production for women with insulin resistance who start or resume metformin, Vanky and colleagues (Vanky, Nordskar, Leithe, Hjorth - Hansen, Martinussen, & Carlsen, 2012) reported after a randomized, controlled trial that metformin had no effect on breast changes / size increase in pregnancy or breastfeeding in women who were obese.

Randomized clinical trial of pacifier use and bottle - feeding or cupfeeding and their effect on breastfeeding

The Effect of Timing of Cord Clamping on Neonatal Venous Hematocrit Values and Clinical Outcome at Term: A Randomized, Controlled Trial José M. Ceriani Cernadas, Guillermo Carroli, Liliana Pellegrini, Lucas Otaño, Marina Ferreira, Carolina Ricci, Ofelia Casas, Daniel Giordano and Jaime Lardizábal Pediatrics 2006; 117; 779 - 786; originally published online Mar 27, 2006; DOI: 10.1542 / peds.2005 - 1156 Download file in 380 kb - 10 pages The online version of this article, along with updated information and services, is located on the World Wide Web at: http://www.pediatrics.org/cgi/content/full/117/4/e779 Background: The umbilical cord is usually clamped immediately after birth.

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.

Another clinical trial, which Kaplitt is not involved in, is testing the effect on depression of a deep brain stimulator implanted into the same brain area.

«If you don't use as close to the total physiological system that you can, you're likely to run into troubles,» like being surprised by side effects later on in clinical trials, says William Haseltine, founder and former chairman and CEO of Rockville, Md. — based Human Genome Sciences.

Effect of Prehospital Induction of Mild Hypothermia on Survival and Neurological Status Among Adults With Cardiac Arrest A Randomized Clinical Trial.

The TOPCAT trial is the first randomized, double - blind trial to assess the effect of spironolactone on clinical outcomes in these patients with heart failure and preserved ejection fraction.

Several clinical trials have tested whether taking vitamin D as a supplement has an effect on asthma attacks, symptoms and lung function in children and adults with asthma.

The team is now calling for a much larger clinical trial, involving one quarter of a million women, to investigate the effect of the screening using HPV testing on cancer rates.

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.»

Antioxidants can neutralize those effects, although clinical trials on cancer prevention have yielded mixed results.

According to Dr. Sumowski, «The significant effect of warmer weather on cognition should be considered when designing and conducting clinical trials.

In my experience, this marks both the first clinical trial of an approved drug with an effect on survival in advanced melanoma in the adjuvant setting, and, in this same setting, the first to study an immune checkpoint inhibitor in the adjuvant setting.

In the debate among clinics and researchers on SSRIs, it has been argued that SSRIs may lack specific therapeutic properties and that their beneficial effects observed in clinical trials, could be explained by different expectancies in the drug and placebo groups.

High - dose vitamin D supplementation in postmenopausal women was not associated with beneficial effects on bone mineral density, muscle function, muscle mass or falls, according to the results of a randomized clinical trial published online by JAMA Internal Medicine.

Bogyo and his associates focused on a compound called ebselen because, in addition to having a strong inhibitory effect, ebselen also has been tested in clinical trials for chemotherapy - related hearing loss and for stroke.

The GP asked him whether he felt his eczema improved in sunny weather and when the teacher said yes, he was referred to a clinical researcher at the local hospital who was starting a trial into the effects of light on skin conditions, including eczema.

In 1996, when RMP - 7 was first used on brain cancer patients in a Phase 1 clinical trial at UCLA, it was found to be safe, with virtually no side effects.

These were thought to be ketamine's target, but clinical trials of other drugs that target them have largely yielded disappointing effects on depression, says Gould.

Until clinical trials, however, it's impossible to know exactly what the effects will be on humans.

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.

RELAX - AHF was a randomised, double blind controlled trial that evaluated the effects of a 48 - hour infusion of the intravenous drug, serelaxin, on clinical outcomes in 1 161 patients admitted to hospital for acute heart failure.

«Millions of volunteers have participated in clinical trials to help find out more about the effects of treatments on disease, yet the important ethical issue of reporting results has been ignored widely.

The researchers plan to perform further tests on lab animals to assess the fake cells» long - term health effects before running clinical trials.

Clinical trials have previously demonstrated beneficial effects of dairy consumption on cardiovascular health.

It's essential that people feel they are in a safe, comfortable setting with someone who can oversee the experience, says Alicia Danforth, a clinical psychologist at the Harbor — UCLA Medical Center in Torrance, California, who is involved in MAPS - sponsored trials studying MDMA's effects on social anxiety in adults with autism.

Instead of simply tracking what the outlets were publishing and analyzing their impact on public opinion, the researchers took an approach similar to that used in clinical trials to evaluate the effects of new drugs.

«TOPCAT is the first randomized, double - blind trial to assess the effect of a treatment - spironolactone - on clinical outcomes in this patient demographic.»

«Randomized Controlled Pilot Trial of Mindfulness - based Stress Reduction for Breast and Colorectal Cancer Survivors: Effects on Cancer - related Cognitive Impairment,» published online in advance of print in the Journal of Cancer Survivorship, is the first randomized clinical trial to evaluate the effects of mindfulness - based stress reduction, known as MBSR, on fatigued breast and colorectal cancer survivors, the majority of whom had been treated with chemotheTrial of Mindfulness - based Stress Reduction for Breast and Colorectal Cancer Survivors: Effects on Cancer - related Cognitive Impairment,» published online in advance of print in the Journal of Cancer Survivorship, is the first randomized clinical trial to evaluate the effects of mindfulness - based stress reduction, known as MBSR, on fatigued breast and colorectal cancer survivors, the majority of whom had been treated with chemothetrial to evaluate the effects of mindfulness - based stress reduction, known as MBSR, on fatigued breast and colorectal cancer survivors, the majority of whom had been treated with chemotherapy.

But now, as the film is being released in Britain, a bitter twist has emerged: Lorenzo's oil has no effect on the course of ALD, according to clinical trials conducted in the US and Europe, the results of which are explained in the latest issue of the Journal of NIH Research.