Sentences with phrase «received study drug»

George L. Bakris, M.D., of University of Chicago Medicine, and colleagues randomly assigned 823 patients (821 received study drug) with diabetes and elevated albuminuria who were receiving an angiotensin - converting enzyme inhibitor or angiotensin receptor blocker to varying doses of the drug finerenone or placebo.

There is a 2 and 3 chance that you will receive the study drug.

During a clinical trial, participants receive the study drug at no cost to them.

Part 1 subjects will begin receiving the Study Drug every 2 weeks, otherwise known as a treatment cycle.

Such a modification is seen in the introduction of an open verum treatment arm, in which participants are certain to receive the study drug.

As part of an NIH - funded PrEP Demonstration Project (R01AA022067), Sarit Golub receives study drug and partial support for DBS testing from Gilead Sciences.

Not exact matches

Valeant, however, received an incomplete grade for three follow - up studies required to explore the interaction between the drug and alcohol.

This study, which recently commenced, potentially positions Vascepa to be the first prescription grade EPA product to receive drug approval in China.

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 SDrug 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 Sdrug 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).

And Onyx could receive milestone payments and royalties from palbociclib, a drug that Pfizer Inc. is studying as a breast cancer treatment.

In response to reports that women may be using this unapproved drug, to increase milk production (lactation), the WHO and FDA are warning breastfeeding women of safety concerns as «there have been several published reports and case studies of cardiac arrhythmias, cardiac arrest and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from the market in a number of countries.»

About.5 percent of the infants studied in the research received the medication within the first year of their lives, and half of those babies received the drugs before they were 4 months old.

In controlled drug studies, some study participants receive the drug under testing; others get a placebo, which is like a sugar pill that has none of the drug being texted.

People who received kidneys from donors infected with hepatitis C did not become ill with the virus, thanks to treatment with newer drugs that can cure the disease, a small study reports.

Researchers looked at data on 74 300 patient who received metformin and sulfonylurea, another common diabetes drug, over a 25 - year study period.

In the study, 64 patients received the topical ocular insert containing the glaucoma drug bimatoprost.

Patients with age - related macular degeneration who received seven or more eye injections of the drug bevacizumab annually had a higher risk of having glaucoma surgery, according to a study published online by JAMA Ophthalmology.

These antianxiety drugs «are known to be safe, and we are using them at very low levels here,» study author Scheuer notes, adding he is not concerned about human patients receiving low doses of antianxiety drugs off - label.

Results of a Johns Hopkins study may explain why a chemotherapy drug called cyclophosphamide prevents graft - versus - host (GVHD) disease in people who receive bone marrow transplants.

Fewer veterans received prescriptions for risky dosages of opioid painkillers after a national initiative took aim at reducing high doses and potentially dangerous drug combinations, a new study finds.

The NAPOLI - 1 (NAnoliPOsomaL Irinotecan) Phase 3 study — a final confirmation of a drug's safety and effectiveness — was conducted among patients with metastatic pancreatic cancer who previously received gemcitibine, which has been the standard - of - care therapy for such patients.

PreScience Labs, a U.S. company founded by Geschwind, received approval for a phase I study from the U.S. Food and Drug Administration in 2013.

A 2002 study in the Journal of the American Medical Association (JAMA) found that 87 percent of guideline authors received industry funding and 59 percent were paid by the manufacturer of a drug affected by the guidelines they wrote.

Study subjects who received a 3 - milligram (3 - mg) dose of liraglutide lost an average of 8 percent of their body weight (18.7 pounds), compared with just 2.6 percent (6.2 pounds) for subjects receiving a placebo, or «dummy» drug, the investigators reported.

Liu recently received a two - year grant from the Bright Focus Foundation (brightfocus.org /) that is enabling next - step studies such as exploration of the impact of current drug therapy on miR - 182.

Currently there are no registries of egg donors in the UK or in the US, and there are only a few long - term follow up studies on egg donors who have received fertility drugs to help others.

Although the trial first received the go - ahead in January last year, it was put on hold the following August by the US Food and Drug Administration, which demanded further evidence that the treatment wouldn't cause cysts like those seen in some animal studies.

Patients with chronic wounds who never receive opioids heal faster than those who do receive the drugs, according to a new study by George Washington University (GW) researcher Victoria Shanmugam, M.D.

Although both studies have limitations, an editorial accompanying Graham's paper considered the findings compelling: «Accumulating concerns about rosiglitazone make it difficultto advance a cogent argument regarding why, exactly, a patient might want to receive the drug.»

According to a more recent study, the drug could also help nondiabetic individuals lose weight as well: Subjects who received the drug reported losing three times more weight over a six - month period than those who received a placebo.

In the MSM trial, a sub-study of people's blood who received Truvada showed that if they had detectable levels of the drug, it reduced their risk of infection by 92 % — more than double what was found in the study as a whole.

Overall, there were three serious adverse events for every 1,000 participants, with several occurring in subjects receiving placebos and others judged unrelated to the study drug or a study procedure.

They were randomized into three treatment groups and received the assigned study drug by injection into the eye until the DME resolved or stabilized.

In a recent study, nearly half of all veterans who died from drug overdoses while prescribed opioids for pain were also receiving benzodiazepines, or benzos, which are common medications for the treatment of anxiety, insomnia and alcohol withdrawal.

In 2008, SPOC received US Food and Drug Administration 510 clearance, after Phase 1 clinical trials at NYU Medical Center and a pilot study at Kaiser Permanente Hospital.

A new study suggests Ontario is nearing ambitious United Nations targets for ending the AIDS epidemics: By 2020, 90 per cent of all people living with HIV should know their HIV status, 90 per cent of all people diagnosed with HIV are receiving sustained antiretroviral drug therapy and 90 per cent of people on ART have a very low or undetectable levels of the virus.

The study involved 21 women randomly assigned to receive a 60 - hour infusion of the drug or a placebo within six months after delivery.

Why some patients diagnosed with malaria did not receive ACTs is more baffling, because there was no shortage of these drugs in the study settings.

All of the mice who received the encapsulated drug survived to the end of the study.

All study participants received a psychostimulant drug called OROS methylphenidate and their parents received behavioral parent training for nine weeks.

«This is the first research project to investigate if having law enforcement officers equipped with naloxone and trained to refer victims to drug rehabilitation will encourage more people to call 911 and receive treatment,» said Peter Davidson, PhD, lead study author and assistant professor in the Department of Medicine at UC San Diego School of Medicine.

The ongoing study will assess quality of life for women receiving the additional drug and the role of secondary surgery before chemotherapy.

Since the outbreak exploded in August, researchers have vigorously debated how to set up Ebola drug and vaccine studies, with some advocating randomized controlled studies, in which one group of patients doesn't receive the drug, as the quickest way to get results.

In pre-clinical studies conducted by the researchers, a one - time, local injection of the hydrogel - drug combo prevented graft rejection for more than 100 days compared to 35.5 days for recipients receiving only tacrolimus and 11 days for recipients without treatment or only receiving hydrogel.

Together with Liberian officials, Lane is poised to launch a randomized study of an antibody cocktail called ZMapp; that study does include a control group in which patients will receive standard care but not the drug.

40 RR - MS patients participated in this study, all of whom were receiving regular drug therapy and were being evaluated for disease progression through clinical examination.

Using 2006 - 11 data from Medicare's Part D drug benefit, the study found that 60 percent of patients with heart problems who saw a cardiologist received ACE inhibitors or angiotensin receptor blockers, versus 44 percent of those who didn't see a cardiologist.

He notes that the placebo effect in the study came not only from participants» belief that they were receiving a real drug, but also from the sheer impact of being in a treatment environment.

For the new study, they studied the brain chemistry of 35 people with untreated major depression, who agreed to try what they thought was a new depression drug, before receiving actual drugs already approved to treat depression.

A study published 2 years ago in Science suggested the strategy might work: It showed that a neoantigen vaccine stimulated immune responses in three advanced melanoma patients who had already received a cancer drug.