Sentences with phrase «effect in clinical trials»

The group hopes to examine the effect in clinical trials in the future, and plans to look at the function of the other six genes their study identified.

This oral product was potent, well tolerated, and showed no serious side effects in clinical trials.

What's particularly concerning is that these three medications displayed small or negligible effects in clinical trials that probably already inflated how well the drugs work, Ioannidis says.

Unlike prescription products, Red Yeast Rice has shown no serious adverse side effects in clinical trials.

Not exact matches

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.

Merck is the latest company to weather bad news in the Alzheimer's drug race, halting a late - stage trial yesterday in an experimental amyloid - targeting candidate called verubecestat after a data monitoring committee said there was «virtually no chance of finding a positive clinical effect,» Reuters reported.

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).

Sanitarium conducted a clinical trial involving Australian adults with high cholesterol in 2016 with University of South Australia researchers to confirm the cholesterol lowering effects of the cereal.

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.

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.

«This double - blind RCT [randomized clinical trial] found no significant effect of pasteurized donor milk during the first 10 days of life for preventing serious infections, NEC and all - cause mortality in premature neonates.

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 pacifieIn 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 pacifiein 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.

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.

Maria Makrides, Joanna S Hawkes, Mark A Neumann, Robert A Gibson; Nutritional effect of including egg yolk in the weaning diet of breast - fed and formula - fed infants: a randomized controlled trial, The American Journal of Clinical Nutrition, Volume 75, Issue 6, 1 June 2002, Pages 1084 — 1092, https://doi.org/10.1093/ajcn/75.6.1084

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.

One large clinical trial known as JUPITER reported in 2008 that rosuvastatin (Crestor) lowers the risk of heart attacks and other events by 44 percent in healthy subjects but experts have since raised questions about its methodology in part because the trial was stopped early, which might have created the effect of overestimating the drug's benefits.

He points out that clinical trial volunteers are regularly quizzed about possible side effects — and says that asking the question may plant the suggestion in their minds.

«We also know from Novartis» early - stage clinical trials that the drug exhibits few documented side effects in people.»

The first was to confirm preliminary findings of the PROTECT trial, which found that poor diuretic response is a serious clinical problem.2 The second was to investigate whether the beneficial effects of serelaxin discovered in the primary analysis were related to improvement of the diuretic response.

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.

However, some mice experienced dangerous levels of brain swelling, a side effect of the immune response triggered by the engineered cells, the researchers said, adding that extreme caution will be needed to introduce the approach in human clinical trials.

The neuroprotective effects of nicotine were studied in a randomized clinical trial involving 67 subjects in the early stages of Alzheimer's disease, where memory was slightly impaired but decision - making and other cognitive abilities remained intact.

«The greater the improvement in patients treated with placebo in clinical trials, the more difficult it can be to demonstrate the beneficial effects of pain - relieving medications,» said Robert H. Dworkin, Professor of Anesthesiology, Neurology, and Psychiatry at the University of Rochester School of Medicine and Dentistry.

In rodents, repeated messenger RNA treatment produces no dangerous side effects, setting stage for clinical trial

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.

«Imagine a drug that could act like Viagra in the inner ear,» says Lin, who notes that clinical trials are already underway to study the effects of such disease - modifying drugs.

In June, Winfried Häuser at the Technical University of Munich published a review paper showing that in many clinical trials, placebos produce fully half as many reported side effects as real drugs dIn June, Winfried Häuser at the Technical University of Munich published a review paper showing that in many clinical trials, placebos produce fully half as many reported side effects as real drugs din many clinical trials, placebos produce fully half as many reported side effects as real drugs do.

Although we can not determine what the effects of AF267B will be in humans until clinical trials are complete, we are very excited by the results our study has yielded.»

A non-hormonal option for male contraception is preferable to hormonal treatments currently in clinical trials, because the types of hormones that make men infertile have more severe side effects than those used in the female pill.

Estrogens have been reported to exert protective vascular effects in animal and observational but randomized clinical trials did not report such effects in older women, even suggesting the possibility of an increased CVD risk in this setting, especially with combined estrogen plus progestin therapy.

But some clinical trials have suggested that such antioxidants, which sop up DNA - damaging molecules called free radicals, have the opposite effect and raise cancer risk in certain people.

Thus far, such side effects seen in clinical trials have been minor, but it sometimes takes years of exposure to a drug before deadly infections show up, he says.

A phase III clinical trial in hundreds of people must be performed before the treatment could be recommended for smokers, and Dr. Yuan warned that while eating cruciferous vegetables, such as watercress and broccoli, is good for people, they are unlikely to have the same pronounced effect as the extract.

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 settinIn 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 settinin advanced melanoma in the adjuvant setting, and, in this same setting, the first to study an immune checkpoint inhibitor in the adjuvant settinin the adjuvant setting, and, in this same setting, the first to study an immune checkpoint inhibitor in the adjuvant settinin this same setting, the first to study an immune checkpoint inhibitor in the adjuvant settinin 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 groupIn 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 groupin clinical trials, could be explained by different expectancies in the drug and placebo groupin the drug and placebo groups.

While there is a lot of excitement about the drug, which improved seniors» response to the flu vaccine in a clinical trial last year, there are concerns about its side effects, especially with long - term use.

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.

Sometimes, toxic side effects aren't discovered until fairly late in the drug development process, when substantial amounts of time and money have already been invested in clinical trials.

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 effectIn 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 effectin a Phase 1 clinical trial at UCLA, it was found to be safe, with virtually no side effects.

While other randomized clinical trials have evaluated the effects of varying weight loss in people with obesity, this is thought to be the first time a trial has separated weight loss outcomes in people who achieved a 5 percent weight loss from those who achieved a 10 percent or greater weight loss.

Of the 10 patients enrolled in the study — a clinical trial designed to evaluate safety and feasibility — none of the participants experienced any dangerous side effects and one patient's disease remained stable after 18 months.