Sentences with phrase «in larger clinical studies»

With additional technical improvements related to exam set - up and delivery, the approach is ready for evaluation in larger clinical studies, including multi-center trials.»

Not exact matches

Currently in the U.K., he will go back to Privateer's headquarters in Seattle, then visit Tilray's 60,000 - square foot facilities in British Columbia, Canada, then to Australia, where Tilray has an import license to send marijuana for a clinical trial with a chemotherapy - induced nausea and vomiting study with the University of Sydney, the government of New South Wales and the country's largest cancer hospital.

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).

«The next steps in DPX - RSV will be expensive steps (large RSV infection avoidance studies, or perhaps even challenge studies, will need to be conducted in Phase 3), and so we agree with management's strategy to identify cash - contributing partners before investing its own capital in new DPX - RSV clinical initiatives,» he added.

One the largest analysis of the peer - reviewed literature was published in The American Journal of Clinical Nutrition in 2010, and this meta - analysis looked at almost 350,000 studies published on saturated fats, and concluded:

By the way, a great book by another skeptical OBGYN is called «Born in the USA» only he's skeptical of medicalized birth because he's a clinical scientist as well, unlike our author here and he's realized that home birth is safer than hospital birth according to peer - reviewed large scale studies.

The strengths of the study include the ability to compare outcomes by the woman's planned place of birth at the start of care in labour, the high participation of midwifery units and trusts in England, the large sample size and statistical power to detect clinically important differences in adverse perinatal outcomes, the minimisation of selection bias through achievement of a high response rate and absence of self selection bias due to non-consent, the ability to compare groups that were similar in terms of identified clinical risk (according to current clinical guidelines) and to further increase the comparability of the groups by conducting an additional analysis restricted to women with no complicating conditions identified at the start of care in labour, and the ability to control for several important potential confounders.

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.

These much shorter courses may have additional risks and remain under study in several large U.S. and European clinical trials.

The case - control study, published online in of the Journal of the American Academy of Dermatology, used a large clinical database of electronic medical records to collect detailed data of cutaneous melanomas developing in 462 women aged 49 years or younger.

Nonetheless, this July, the FDA suspended enrollment in Glaxo's large clinical trial comparing the safety of Avandia with that of a competing diabetes drug and may halt the study altogether.

However, the study provides initial clinical evidence that larger, size - matched grafts have the potential to improve outcomes when resurfacing cartilage defects of the femoral head in the hip joint.

The researchers conducted this study using penile swabs collected from uncircumcised heterosexual men in Rakai, Uganda during a large, two - year clinical study.

«This study highlights the importance of confirming the validity of potential biomarkers in a relevant, large animal model and will be useful in the design of future clinical trails,» commented lead investigator Stephen J. Kolb, MD, PhD, Associate Professor, Department of Neurology and Biological Chemistry & Pharmacology, The Ohio State University Wexner Medical Center, Columbus, OH.

The study — the largest to date assessing the mental and emotional health of patients with cancer using a fully standardized, diagnostic face - to - face interview — is published in the October 6 issue of the Journal of Clinical Oncology.

There is «strongly accumulating evidence that it is possible in many cases to increase brain activity [long] after severe injury,» Schiff said, but «there is essentially no infrastructure to have clinical follow - up» or even «larger investigative studies.»

«This vaccine appears to be safe for patients, and elicits a broad anti-tumor immunity — we think it warrants further testing in larger clinical trials,» said study lead author Janos L. Tanyi, MD, an assistant professor of obstetrics and gynecology at Penn Medicine.

But vaccines that only contained HIV's surface protein looked lackluster in animal and test tube studies, and then proved worthless in large - scale clinical trials.

The supplement they took has yet to be proved in large clinical trials, while scientists who have studied it have been caught in the cross fire between converts, willing to take the supplement on faith and anecdotal evidence alone, and skeptics who look askance at all alternative medicine.

Authors analyzed clinical data for patients from two large academic medical centers from 2005 through 2013, resulting in 845,417 hospital discharges in the study group for 458,053 unique individuals.

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.

The Thorough QT clinical assessment also has its limitations, as those studies are done in humans and typically require large numbers of patients.

... Finally, this study draws attention to the need for large controlled clinical trials to determine if a combination of fall prevention strategies and treatment with bone - active drugs might produce additive benefits on fractures, especially in high - risk populations such as those living in nursing homes.

Such investigations required both knowledge of the venom's clinical effects and large volumes of venom, so until now only large species, like snakes, with easily extracted venoms have been studied in any depth.

Other studies have attempted to determine how the research activities of MSTP graduates differ from those of other groups of MD and MD / PhD recipients.7 - 10 Although the data from these studies suggest that a large majority of MSTP graduates hold appointments in clinical departments, and that most have clinical responsibilities, MSTP graduates are less likely than other groups of physician - investigators to publish in journals containing high proportions of clinical observations and clinical studies.

However, they caution that because of the limited number of participants, further larger studies will be needed in general clinical settings to confirm the value of this audiovisual distraction tool.

Dr Matt Hurles, who led the study from the Sanger Institute, said: «This study has the largest cohort of such families in the world, and harnesses the power of the NHS, with 200 clinical geneticists and 4,000 patients.

The largest nationwide clinical trial to study high - dose resveratrol long - term in people with mild to moderate Alzheimer's disease found that a biomarker that declines when the disease progresses was stabilized in people who took the purified form of resveratrol.

Professor Cyrus Cooper, Professor of Rheumatology and Director of the MRC Lifecourse Epidemiology Unit, University of Southampton, added: «This study forms part of a larger programme of work addressing risk factors for fracture across the lifecourse, and demonstrates the importance of the University of Southampton and MRC Lifecourse Epidemiology Unit in leading large, UK wide analyses on the internationally leading UK Clinical Practice Research Datalink dataset.

The study takes another important step toward larger clinical trials targeting androgen receptors in breast cancer.

«Low birth weight and preterm birth have been proposed as risk factors in schizophrenia in general, but past studies have not shown a large effect on risk,» says Dr. Bassett, who is also the Director of the Clinical Genetics Research Program at CAMH.

A Commentary article in the same issue of The Lancet Diabetes and Endocrinology by Harvard Professor Matthew W. Gillman notes that the study had a large sample size, reasonably precise information about the timing of the famine, geographical variation in the same country, and clinical outcomes — a combination of strengths missing in other famine studies.

Over the last decade there have been multiple large studies trying to determine a clinical use for iNO in preterm neonates, but despite evidence of short - term benefit, this drug has not been shown to improve long - term outcomes in preemies.

In order to investigate whether a healthy lifestyle can mitigate genetic risk, the multi-institutional research team analyzed genetic and clinical data from more than 55,000 participants in four large - scale studieIn order to investigate whether a healthy lifestyle can mitigate genetic risk, the multi-institutional research team analyzed genetic and clinical data from more than 55,000 participants in four large - scale studiein four large - scale studies.

Researchers are planning to extend the clinical trial to a much larger number of patients in a multinational study, to demonstrate not only a reduced infarct size, but also a reduced mortality in patients who receive early metoprolol during transit to hospital.

Called the high - dimensional propensity score algorithm (hd - PS), it is a tool for improving not randomized clinical trials but broader observational studies, in which researchers watch a large pool of participants and look for correlations — like the fact that wine drinkers live longer than other drinkers.

The results of the mouse, human and lab studies have been so successful that Dr. Bauman has started a larger clinical trial in volunteers previously cured of head and neck cancer.

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.

This study was designed to use readily available agents in an accepted large - animal model of human heart attack with the goal of obtaining evidence that this treatment is ready to be moved into human clinical trials.»

But most large clinical trials of ACEI / ARB exclude patients with the most advanced stage of CKD predialysis, perhaps out of concern that the drugs can cause renal failure and the need for dialysis, so it remains unclear whether that therapy is effective in patients with advanced CKD, according to the study background.

Dr Toral Gathani, a clinical epidemiologist at the University of Oxford [1], told the 10th European Breast Cancer Conference (EBCC - 10) today (Thursday) that findings from the largest study to date of tumour characteristics in relation to ethnicity suggested that inherent differences in tumour biology between the ethnic groups were unlikely to play a role.

«This large population - based study in women with ICP found increased risks of later hepatobiliary cancer and immune - mediated diseases and a small increased risk of later cardiovascular disease,» explained principal investigator Hanns - Ulrich Marschall, MD, of Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.

«The results in our study are very similar to those obtained in a large European randomized clinical study (ERSPC) thus confirming the effect of PSA testing on the risk of prostate cancer death.

Michael Huerta, associate director of the National Institute of Mental Health, was instrumental in starting, in 1993, the Human Brain Project (HBP), a large - scale, multi-institute initiative that combined informatics with basic research and clinical studies in neuroscience.

Should the results of this study be repeated in the larger Phase III trial, it would lead to a new standard of care for kidney cancer patients, said Dr. Hammers, formerly of Johns Hopkins medical system, who holds the Eugene P. Frenkel, M.D. Scholar in Clinical Medicine at UT Southwestern.

Researchers leading the largest genomic tumor profiling effort of its kind say such studies are technically feasible in a broad population of adult and pediatric patients with many different types of cancer, and that some patients can benefit by receiving precision drugs targeted to their tumors» mutations or being enrolled in clinical trials.

«The fact that this relationship was established in a large - scale, clinical human study is very important,» Przybelski says, «but there's still a lot we don't know.»

In a presentation of early clinical trial data to the 20th Annual Scientific Meeting of the Society for Neuro - Oncology, physician scientists from the University of New Mexico Comprehensive Cancer Center reported that a large number of study participants responded well to the drug combination.

The current study presents the largest analysis of demography, mortality and disorder prevalence in GSDs based exclusively on primary - care veterinary clinical records reported to date.

In this study, to our knowledge the largest randomized clinical trial of robotic - assisted laparoscopic surgery for patients with rectal adenocarcinoma suitable for curative resection, there were no statistically significant differences in the rates of conversion to open laparotomy for robotic - assisted laparoscopic surgery compared with conventional laparoscopic surgery (8.1 % vs 12.2 %, respectively), and there were no statistically significant differences in CRM +, complication rates, or quality of life at 6 monthIn this study, to our knowledge the largest randomized clinical trial of robotic - assisted laparoscopic surgery for patients with rectal adenocarcinoma suitable for curative resection, there were no statistically significant differences in the rates of conversion to open laparotomy for robotic - assisted laparoscopic surgery compared with conventional laparoscopic surgery (8.1 % vs 12.2 %, respectively), and there were no statistically significant differences in CRM +, complication rates, or quality of life at 6 monthin the rates of conversion to open laparotomy for robotic - assisted laparoscopic surgery compared with conventional laparoscopic surgery (8.1 % vs 12.2 %, respectively), and there were no statistically significant differences in CRM +, complication rates, or quality of life at 6 monthin CRM +, complication rates, or quality of life at 6 months.