Researchers
studying patient safety in states with «caps» (like Texas) found «consistent evidence that patient safety generally falls» after caps are enacted.
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).
Presentations will highlight the short and long - term effects of Ingrezza on tardive dyskinesia symptoms by body region, long term
safety and efficacy data from the KINECT 4 phase 3 open label
study and also from RE-KINECT (real - world screening
study of
patients with possible TD).
Whether or not the problems are huge, at least someone goes to the trouble of identifying and quantifying them (e.g., the new
study in the Journal of
Patient Safety — a whole freakkin» journal devoted to safety, who
Safety — a whole freakkin» journal devoted to
safety, who
safety, who knew?)
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.»
In order to protect infant
safety and ensure the
patient and human rights of mothers and babies, we have built a non-profit organization committed to: (1) the
study of exclusive breastfeeding complications that can result in brain injury and, in the most severe instances, death; and (2) raising public awareness to signs of infant hunger and the consequences that can result based on peer - reviewed research.
As mentioned already the «Centre for policy
studies» has said that the NHSLA has liabilities of some # 16.8 billion, reducing this figure would make huge inroads to the efficiency saving the NHS has to make without compromising
patient safety and staff numbers It would be wise for those within the NHS and from the «Centre for policy
studies» to look to their own as for the reason why
patients look to the law for recompense, before we say that the compensation culture is «ingrained in the national psyche as a warped form of normal behaviour».
«While the small - scale
study suggests that beta - blockers may reduce the risk of breast cancer returning, more research is needed in this area to determine the effectiveness and
safety of the treatment before it can be routinely offered to breast cancer
patients.
Further
studies in animal models and
patients (with altered TRPM7 channel function) have been initiated, in order to evaluate the efficacy and
safety of magnesium as a therapeutic for this disease.
Specifically, at the end of the
study period, all 15
patients appeared to have a favorable
safety profile and to be generally well tolerated.
The grant was to
study what types of computational systems, in conjunction with physiological
patient monitors, could be implemented into vehicles to achieve the
safety objective.
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.
The largest urban health systems, which serve as
safety nets for large
patient populations with lower socioeconomic status and greater likelihood to speak English as a second language, do worse on government
patient satisfaction scores than smaller, non-urban hospitals likely to serve white customers with higher education levels, according to a new
study by Mount Sinai researchers published this month in the Journal of Hospital Medicine.
For example, the results of one
study, known as UPLIFT, one of four large - scale
studies conducted in 2008, demonstrated the effectiveness and
safety of a drug called Spirivain about 6,000
patients with respiratory disease.
«The results from the exenatide
studies justify continued testing, but clinicians and
patients are urged not to add exenatide to their regimens until more is known about their
safety and impact on Parkinson's.»
Following the success of this preliminary
safety and feasibility
study, more
patients are being recruited for a larger clinical trial of the procedure to test the efficacy and durability of the procedure.
To help our
patients suffering from this disorder, we need to gather reliable data to evaluate the effectiveness and
safety profile of new treatment options,» said lead
study author Liang Zheng from the department of gastroenterology, the Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine.
Apart from
patient testimonials and a few preliminary
studies in tumor cell lines and in mice, critics say, there is no evidence of the
safety or efficacy of the compound, popularly known as the «cancer pill» or «fosfo.»
Many
patients and physicians assume that the
safety and effectiveness of newly approved drugs is well understood by the federal Food and Drug Administration (FDA)-- but a new
study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.
The imaging software — developed and currently in use only at Cincinnati Children's — mathematically determines the lowest possible radiation dose for the
patient before a scan is performed, according to the
study led by David Larson, MD, radiology quality and
safety director at the medical center and principal architect of the technology.
«While Massachusetts
safety - net hospitals (many of which are minority - serving) received large cuts in payments with the idea that other hospitals would assume the care of previously uninsured
patients, this
study demonstrates the importance of securing the future of
safety - net and minority - serving hospitals through policy - based interventions to assure the continued care of vulnerable and underserved
patient populations.»
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.
Because bazedoxifene has already undergone
safety and efficacy
studies as a treatment for osteoporosis, it may be a viable near - term option for
patients with advanced breast cancer whose tumors have become resistant to other treatment options, Wardell reported.
The data
safety monitoring board of the trial, as mandated by the
study protocol, continues to monitor outcomes in
patients with a Recurrence Score of 11 to 25 randomized to chemo - endocrine therapy or endocrine therapy alone.
Lisa K. McIntyre, M.D., of the University of Washington Medical Center, Seattle, and colleagues conducted a
study that included 173 general surgical
patients (91 men) who were identified as being unplanned readmissions within 30 days among 2,100 discharges (8 percent) at a Level I trauma center and
safety - net hospital.
«Currently, most victims of elder abuse and neglect pass through our emergency departments with a life - threatening condition unidentified,» said the latter paper's lead
study author, Tony Rosen, MD, MPH, of Weill Cornell Medical College in New York, N.Y. «A multi-disciplinary, team - based approach supported by additional research and funding has the potential to improve the identification of elder abuse and improve the health and
safety of our most vulnerable
patients.»
This
study utilized the National Electronic Injury Surveillance System (NEISS) database, which is managed by the Consumer Product
Safety Commission (CPSC) and collects information on emergency room
patients from 100 U.S. hospitals.
The hospital's new surgical
patient safety program, which aligned with NSQIP best practices, quickly resulted in «a dramatic reduction» of SSIs, said Rael Klein, MD, FRCP, a
study coauthor and an anesthesiologist at the University of British Columbia, Vancouver.
Dr Richard Booton, Consultant Respiratory Physician at the North West Lung Centre and senior lecturer at the University's Institute of Inflammation and Repair who led the
study, said: «We wanted to see if there were any differences between
patients aged less than 70 years old and those older than 70, in terms of both the
safety of the technique and how useful it was for diagnosis.
For the new
study, Saint and his colleagues from the
Patient Safety Enhancement Program, a joint U-M and VA program, surveyed infection control leaders at hospitals, as part of an ongoing project that started in 2005.
TIDE, currently taking place worldwide, was designed to provide rigorous evidence about the drug's
safety, and the designers of the
study had plans to enroll up to 15,000 more diabetes
patients.
The
safety study sets the stage for phase II clinical trials looking at whether high dose vitamin C is effective at extending overall lifespan and quality of life for
patients undergoing radiation and chemotherapy.
His team is winding up a
safety study in which 40
patients breathed in a single dose of a lipid - CFTR DNA mixture.
In a
study published online by JAMA Cardiology, Fredrik Björck, M.D., of Umea University, Umea, Sweden and colleagues evaluated the efficacy and
safety of well - managed warfarin therapy in
patients with nonvalvular atrial fibrillation.
As part of the approval, the manufacturer must conduct a five year post approval
study that will follow at least 100
patients and collect additional
safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity - related conditions.
As part of the Cannabis for the Management of Pain: Assessment of
Safety Study (COMPASS), that started in 2004, the researchers followed 215 adult
patients, with chronic non-cancer pain, who used medical cannabis, and compared them to a control group of 216 chronic pain sufferers who were not cannabis users.
Promising outcomes of preliminary
studies in
patients in Southeast Asia and parts of Western and Central Africa led the World Health Organization to make the recommendation, but
safety and efficacy have not yet been proven in large - scale clinical trials.
We hope to move from the
safety study into a full scale efficacy
study in the spring, involving more
patients in centres around the UK and Europe.
To make his point, Representative Andy Harris (R — MD) points to the $ 1.37 billion that NIH spends each year on health services research and $ 1 billion for
studies of
patient safety (both listed here).
In a six - month open - label
study of
patients receiving T - sol, published in The Journal of Urology ®, researchers noted improvement of low sex drive and low energy symptoms, and did not identify new
safety concerns.
Professor Justin Cobb, Chief Investigator, said: «In this
safety study, we are ensuring that the H1 hip resurfacing implant can be used safely on
patients needing hip replacement surgery.
A Canadian research team led by Dr. Mark Ware from the Research Institute of the McGill University Health Centre (RI - MUHC) in Montréal has completed a national multicentre
study looking at the
safety of medical cannabis use among
patients suffering from chronic pain.
«
Study allays concerns over aspirin's
safety for heart failure
patients.»
Our
study is one of the largest to explore the efficacy and
safety of anti-TNF therapy in a large independent cohort of JDM
patients.»
Because almost 70 percent of its
patients are the victims of motor vehicle crashes, automobile
safety is a major focus of
study at the center.
«Across specialties and across the country the rate of compliance has been extremely poor,» says the
study's lead author Christopher Landrigan, a sleep and
patient safety researcher at Brigham and Women's Hospital at Harvard.
In addition to Dr. Aminian,
study authors of the abstract entitled, «A Nationwide
Safety Analysis of Bariatric Surgery in Nonmorbidly Obese
Patients with Type 2 Diabetes,» include John Kirwan, PhD; Bartolome Burguera, MD, PhD; Stacy Brethauer, MD; and Philip Schauer, MD, all from Cleveland Clinic.
Studies presented today at The International Liver Congress ™ 2016 in Barcelona, Spain, demonstrate that tenofovir alafenamide (TAF) improves
patient safety while maintaining efficacy in
patients with chronic Hepatitis B virus (HBV) infection compared to tenofovir disoproxil fumarate (Viread, TDF).
The
study's findings raise «serious concerns about
patient safety» and reveal an «urgent need for greater regulation and oversight in medical app development,» the authors say.
In an effort to reduce the incidence of complications and improve
patient safety, a secondary goal of the
study was to identify risk factors associated with each complication to produce formal practice advisories or guideline recommendations.