Sentences with phrase «clinical outcomes resulted»

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.

Indeed, Berdan links this shift in mindset and leadership makeup to better results in patient safety, clinical outcomes, and clinical efficiency.

The results, presented to the public for the first time in A Good Birth, show what really matters goes beyond the clinical outcome or even the usual questions of hospital versus birthing center, and reveal universal needs of women, like the importance of feeling connected, safe, and respected.

Though clinical studies show that technology is better at finding potential tumors, and less likely to result in false alarms, there is not yet long - term research to show whether it saves lives or otherwise improves outcomes.

When subsequent studies found that CellSearch results had no influence on clinical outcomes, though, insurers lost interest in paying for it.

«These results should enable predictions of better clinical outcomes with therapeutic nonsense suppression,» the researchers write in their paper.

Poor diuretic response is associated with worse in - hospital and post-discharge clinical outcomes, results of the RELAX - AHF trial reveal.

Stitziel and his colleagues pointed out that this question will be addressed later this month with the reporting of results from a large clinical trial called IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE - IT).

Consequently, they hope that their results will «motivate the incorporation of assays measuring ex-vivo T - cell function into ongoing and planned clinical trials of HDAC inhibitors, and that immunosuppression will be considered as a potential factor limiting the effectiveness of any observed outcomes.»

«STS public reporting uses detailed clinical registry data and outcomes that have been risk adjusted, meaning that the results take into account the condition of the patient at the time of surgery and whether or not there were other health problems, such as diabetes.»

Ya'ara Leibovici - Weissman from Tel Aviv University said: «In treating cholera a quick and accurate diagnosis remains key, but it is clear from the results that antimicrobials result in substantial improvements in clinical and microbiological outcomes, with similar effects observed in severely and non-severely ill patients.

«Although hypothermia is a promising strategy to improve resuscitation and brain recovery following cardiac arrest, the results of the current study do not support routine use of cold intravenous fluid in the prehospital setting to improve clinical outcomes,» the authors write.

«This is the first national study to identify specific regions of the United States where residents may be at an increased risk for poor clinical outcomes — including misdiagnoses and late detection — as a result of limited access to specialized gynecologic cancer care,» says David Shalowitz, MD, a fellow in the division of Gynecologic Oncology at the Perelman School of Medicine at the University of Pennsylvania, and lead author on the study.

The results in this clinical study will open up a new treatment modality for glaucoma other than taking daily eye drops, and will greatly enhance patient compliance and improve treatment outcomes,» she said.

The first, by researchers based in the UK, Europe and USA, examined data from observational studies and clinical trials (an umbrella review) to summarisze health outcomes associated with vitamin D levels, both naturally circulating and as a result of taking supplements.

«The results of this study were of particular interest because more than half of the pregnant women with migraine experienced some type of adverse birth outcome, suggesting that these pregnancies should be considered high risk,» said study author Matthew S. Robbins, M.D., director of inpatient services at Montefiore Headache Center, chief of neurology at Jack D. Weiler Hospital of Montefiore, and associate professor of clinical neurology at Albert Einstein College of Medicine.

The clinical trial differs from the pig trial in that it is testing whether ultrasound / microbubbles alone administered to heart attack patients both before and after balloon angioplasty and stenting results in better patient outcomes compared with balloon angioplasty and stenting alone.

The clinical trial will help to determine if the early microbubble intervention results in overall better outcomes for patients.

The research, led by Daniel Krauss, M.D., a radiation oncologist, Beaumont Hospital — Royal Oak, found an association between positive post-radiation therapy biopsy results and subsequent clinical outcomes in men with localized prostate cancer.

«The potential clinical impact of these results is significant and will allow clinicians to counsel patients effectively in regard to the potential HRQoL outcomes associated with AS.»

The project would also attempt to link an individual patient's genetic results with clinical outcome and lifestyle factors such as smoking, which TCGA didn't do.

However, our results showed that hospital - acquired anemia was associated with worse clinical outcomes after leaving the hospital so it needs to be taken more seriously,» said senior author Dr. Ethan Halm, Director of UT Southwestern's Center for Patient - Centered Outcomes Research and Chief of the William T. and Gay F. Solomon Division of General Internal Medicine at UT Southoutcomes after leaving the hospital so it needs to be taken more seriously,» said senior author Dr. Ethan Halm, Director of UT Southwestern's Center for Patient - Centered Outcomes Research and Chief of the William T. and Gay F. Solomon Division of General Internal Medicine at UT SouthOutcomes Research and Chief of the William T. and Gay F. Solomon Division of General Internal Medicine at UT Southwestern.

It corroborates the findings of another NIAID - funded study demonstrating that TMP - SMX treatment resulted in better clinical outcomes than placebo for MRSA skin abscesses, and also upholds other findings that both clindamycin and TMP - SMX are equally beneficial in treating MRSA skin infections.

GeneAssess is currently validating these results with clinical samples from cancer patients and examining FRY's correlation and association with these samples for diagnostics and outcome predictions.

Assess landmark clinical trial results in the context of how they impact evolving clinical practice paradigms and can be applied to personalize care and optimize outcomes

The synergistic approach has already given outstanding scientific results and clinical outcomes for the benefit of patients.»

Preserving livers at body temperature may improve transplant outcomes and increase viable donor liver numbers, according to the results of a new UK clinical trial.

«Our results show that, in an era in which high - resolution molecular typing for class I and class II HLA [human leukocyte antigen] loci has significantly improved the clinical outcome of unrelated donor HSCT by decreasing the risk of immunological complications, lowering the ATLG dose to 15 mg / kg did not affect the time to engraftment and, more importantly, the incidence of acute or chronic GVHD [graft - vs - host disease], and was associated with an improved probability of event - free survival, mainly due to a reduced risk of nonrelapse mortality,» wrote Franco Locatelli, MD, of the department of oncoematologia pediatrica, IRCCS Ospedale «Bambino Gesù» in Rome, and colleagues.

Small cell lung cancer (SCLC) accounts for 14 percent of all lung cancers and is often rapidly resistant to chemotherapy resulting in poor clinical outcomes.

No Association Between Response Rates and Survival in Newly Diagnosed Multiple Myeloma: Results of a recent meta - regression analysis of 63 randomized clinical trials out of Greece concluded that there was no association between conventional response outcomes, such as complete response (CR) or very good partial response (VGPR), and overall (OS) or progression - free survival (PFS) in patients with newly diagnosed multiple myeloma in populations of patients who received stem cell transplant and those who did not.

MRD detection by Next - Generation Sequencing has demonstrated utility in predicting clinical outcomes and in generating clinically actionable results allowing early intervention, confirmation of disease status prior to transplant, and increased confidence in remission status.

Through these studies, she has redefined the molecular map of breast cancer, resulting in the discovery of novel patient subgroups with distinct clinical outcomes.

Armed with this knowledge, and the results of an initial feasibility study, the Dream Team will conduct a clinical trial to evaluate if personalized therapy, based on the genetic profile of each individual patient's cancer, improves outcomes.

«The lack of association between response rates and hard clinical outcomes raises concerns about fast track approval of new drugs, based on results from trials utilizing solely these surrogate markers,» the researchers wrote.

â $ œFor the first time, a clinical trial has shown that administration of a cellular therapeutic results in an improvement in cardiac outcomes based on a prespecified analysis, â $ an editorial accompanying the paper in The Lancet says.

Scientific contributions include publication of the first randomized trials to assess the impact of common complex genetic risk markers, empirically measuring the outcomes of DTC genetic testing, design of a variant classification pipeline and single page summary for reporting clinical results of whole genome sequencing.

A primary objective of the program is to start at the clinic, analyzing patient samples from clinical trials testing novel cancer immunotherapies and correlating these results with clinical outcomes.

The results of oncogenomic research should provide new insights into cancer diagnosis, predicting clinical outcomes, and new molecular targets for anti-cancer therapy.

Ultimately the results will help the field of cancer research to learn how to combine and develop different therapies to achieve better clinical outcomes for leukaemia patients.

«The potential clinical impact of these results is significant and will allow clinicians to counsel patients effectively in regard to the potential health - related quality - of - life outcomes associated with active surveillance,» Porter said.

The outcomes of this preliminary study have resulted in the implementation of larger, placebo - controlled clinical studies to assess if individuals with heart failure as well as diabetes show improvement in their exercise capacity when given epicatechin - rich cocoa.

Disappointments with outcomes - based studies investigating α - tocopherol are, in large part, the result of abstracting this single compound from the vitamin E family and ignoring the interplay among the eight isomers that constitute natural vitamin E. Best clinical outcomes will be achieved with vitamin E supplementation providing mixed tocopherols and tocotrienols in ratios similar to those found in nature.

«The results indicate that when the cholesterol and particle measures of LDL disagree, the clinical and subclinical outcomes track with LDL - P more so than with LDL - C» http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3070150/

Although I am still learning about the science of this approach, I do have clinical experience and direct observation of people of all different shapes and sizes eating the same amount of food with different results in weight regulation and health outcomes.

Childhood allergies: A systematic review and meta - analysis of 10 prospective cohort studies and 5 randomized clinical trials on omega - 3 intakes during pregnancy and outcomes of childhood allergic disease (eczema, rhino - conjunctivitis, and asthma) found inconsistent results [164].

Sadly, the RCTs looking at how this effected long term clinical outcomes had mixed results: there were some studies where glycemic control was improved but other metabolic parameters and outcomes where not as positive (i.e. uric acid levels, etc).

Results: Three randomized controlled clinical trials of fasting in humans were identified, and the results were published in 5 articles, all of which evaluated the effects of fasting on surrogate ouResults: Three randomized controlled clinical trials of fasting in humans were identified, and the results were published in 5 articles, all of which evaluated the effects of fasting on surrogate ouresults were published in 5 articles, all of which evaluated the effects of fasting on surrogate outcomes.

A proprietary nutrient formula containing 36 separate constituents, including chelated minerals, vitamins, and trace elements, may reduce symptoms of mania, depressed mood, and psychosis in bipolar patients when taken alone or used as an adjunct to conventional mood - stabilizing medications.35 - 39 Beneficial clinical outcomes in bipolar disorder may result from correction of hereditary metabolic errors in genetically predisposed individuals when select micronutrients are deficient or absent in the diet.37

The template prepared by the Subcommittee to review the clinical trials included the citation, the design, populations, groups, outcomes, duration, baseline level for the different endpoints, results, and relevant comments.

The higher intake level is compared with the lowest intake level and the results are reported as odds ratios or RRs for each clinical outcome.