Sentences with phrase «study endpoint»

Proportion of responders at end of treatment or at study endpoint if treatment was longer than 6 weeks (based on score improvements on Hamilton Rating Scale for Depression (HAMD), the Clinical Global Impression index (CGI), rating as at least «much improved» on global improvement subscale, Depression Scale von Zerssen (DS) or any other clinical response measure); safety (proportion of dropouts due to adverse events).

So we cast a wider net and collected data from Rottweiler owners nationwide, focusing our attention on exceptional longevity, not average age at death, as our study endpoint.

Although clinical malaria episodes were not formally assessed as a study endpoint, malaria microscopy was performed for diagnostic purposes whenever participants presented with symptoms suggestive of malaria.

The first study endpoint was positivity for at least two diabetes - associated autoantibodies by the age of six years.

The Scientific Review Committee (SRC) ensures that all cancer clinical trials conducted under the auspices of the Vanderbilt - Ingram Cancer Center meet peer - reviewed standards of scientific design, including appropriate scientific rationale, specific aims, study endpoints, biostatistical analysis, and adequate ability to accrue patients.

Not exact matches

«While we are disappointed CheckMate - 026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase III CheckMate - 227 study exploring the potential of the combination of Opdivo plus [our other cancer immunotherapy] Yervoy for PD - L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD - L1 negative patients,» he added.

On February 24th, the New York - based drug giant announced that Prevenar 13, a drug widely used to prevent infection in children, met its primary endpoint in a post-approval study consisting of 85,000 individuals aged 65 and older.

What: Shares of Alkermes (NASDAQ: ALKS) shed up to 43 % of their value on extraordinary volume in early morning trading today after the company announced that its orally administered drug ALKS - 5461, indicated for major depressive disorder (MDD), failed to meet its primary endpoints in two late - stage studies.

The company designs its clinical trials to guarantee that its studies are structure / function compliant and follow strict guidelines issued by FTC, FDA, and EFSA for subject population and endpoint selection.

In the new study, patients receiving angioplasty with the new stents had a 47 percent higher risk of one of the outcomes identified as a primary endpoint in the study: death, heart attack and subsequent procedure to clear blocked arteries, as compared to patients who received bypass.

But he adds, «While these findings could translate into substantial benefit to patients, this study is preliminary with regard to clinical endpoints such as recurrence of disease and prostate cancer - specific mortality.»

«It was a study with no defined endpoint, so risky that he didn't try very hard to get outside funding for it,» Pennisi writes, and» [a] fter 25 years and 58,000 bacterial generations, Lenski's bacteria are still growing, mutating, and evolving.

In the new study, 71 percent of patients treated with a surgical procedure called catheter ablation were free of atrial fibrillation, the study's primary endpoint, after two years of follow - up, while only 34 percent of patients who took the antiarrhythmic drug Amiodarone were free of symptoms at that point.

«Enrolling only those likely to develop specific disease endpoints can reduce the number of people needing study and ensure the trial achieves an optimal mix of patients.»

As reported in 2015, the study met its primary endpoint after a median follow up of 2.3 years, with ipilimumab significantly improving recurrence - free survival.2 The drug was subsequently approved by the US Food and Drug Administration as adjuvant therapy for stage III melanoma.

The study experienced very rapid enrollment and at the preplanned independent data and safety monitoring review panel, the study was stopped early only 10 months after the study commenced because it met the primary endpoint of improving progression - free survival (time to cancer relapse).

«The reason KEYNOTE - 024 met its primary endpoint, in contrast with other studies, is probably because the trial only included patients who had PD - L1 expression of at least 50 % and were therefore optimal candidates for treatment with pembrolizumab,» he added.

«This is the first placebo - controlled, randomized study of a vaccine for glioblastoma to show a significant benefit in a clinically meaningful endpoint, progression - free survival.

The authors believe theirs is among the first human studies to investigate the influence of phthalate exposure on sperm epigenetics, embryo development and whether DNA methylation in sperm cells may be a path by which a father's environmental exposure influences these endpoints.

«Traditional methods of infectious disease research using animal models have provided limited information about disease progression until the study's endpoint, when investigators could analyze tissues from those animals,» he said.

Lead author Johan den Boon, associate scientist with the Morgridge Institute for Research at the University of Wisconsin - Madison, says the research team used gene expression profiling on 128 specimens from the Study to Understand Cervical Cancer Early Endpoints and Determinants, or SUCCEED.

«The current results do not exclude the possibility that the early dietary modification may affect the latter phase, and therefore it is extremely important to continue to follow the study participants into the final endpoint, which is the age of ten years.

The study failed to meet both of its co-primary endpoints in that it did not show a significant benefit of steroid treatment over placebo in terms of either the overall rate of death or a composite metric that included death, heart attack, stroke, new renal failure or respiratory failure.

However, a pre-specified examination of the study's secondary endpoints, which included the rate of heart attacks, revealed that patients who received the methylprednisolone faced a 15 percent greater risk of death or heart attack and a 21 percent greater risk of heart attack alone, a pattern that was consistent across all subgroups.

Completion of the six - minute walk test (6MWT) was required at baseline, and the primary endpoint of the study was improvement in this test at week 24.

Unlike previous ovarian clinical trials of bevacizumab, this study's primary endpoint was overall survival.

The study's primary endpoint was reduction in daytime cough frequency as measured objectively using an ambulatory cough recorder.

However, there was no difference between the two groups in terms of the study's primary endpoint.

The favorable effects on cholesterol did not translate into any reduction in the study's primary endpoint: the amount of time until cardiovascular death, heart attack, stroke, coronary artery bypass surgery or hospitalization for chest pain due to unstable angina, a restriction in the flow of blood through the heart's arteries.

Many speakers argued that more research is needed on tools like surrogate endpoints that promise to expedite the FDA review process: «We need to do better studies to validate whether these surrogates are as good as we think, and not just assume things about them,» said Avorn.

The FDA's accelerated approval regulatory option, for example, is specifically designed to allow FDA validation based on studies measuring «surrogate endpoints.»

Both ticagrelor doses reduced the chances of cardiovascular death, heart attack or stroke, the study's primary endpoint, with a 15 percent reduction in the 90 - mg group and a 16 percent reduction in the 60 - mg group compared to the placebo group.

«The benefit we saw was remarkably consistent across the individual components of the endpoint and in all the major subgroups of patients,» said Marc S. Sabatine, M.D., M.P.H., chair of the TIMI Study Group, a senior physician in the Cardiovascular Division at Brigham and Women's Hospital and Harvard Medical School in Boston, and the study's principal investigStudy Group, a senior physician in the Cardiovascular Division at Brigham and Women's Hospital and Harvard Medical School in Boston, and the study's principal investigstudy's principal investigator.

The prospective cohort study met both its primary endpoints: to determine the association between troponin T levels measured by a high - sensitivity troponin T assay and the risk of death within a month of non-cardiac surgery, and to identify diagnostic criteria for myocardial injury after non-cardiac surgery that defines whether or not serious injury to the heart has occurred.

Most studies look at very specific endpoints: how much a gene contributes to muscle strength or maximal aerobic capacity, because those endpoints are very easy to measure from a research standpoint.

«Most clinicians have felt that «more was better» when it came to blocking testosterone in prostate cancer patients, however, results for the specific endpoints we focused on, OS and DSS, indicate that this was clearly not the case,» said Amin Mirhadi, MD, lead author of the study and a radiation oncologist at Cedars - Sinai Medical Center in Los Angeles.

The study did not show a significant reduction in one of its two primary endpoints, a composite rate of death, heart attack or stroke 30 days after a catheterization procedure.

In the study of HBeAg - negative patients, 94 % (268 of 285) of patients receiving TAF and almost 93 % (130 of 140) of patients receiving TDF achieved the primary endpoint.

In the study of HBeAg - positive patients, almost 64 % (371 of 581) of patients receiving TAF and almost 67 % (195 of 292) of patients receiving TDF achieved the primary endpoint.

Overall, the response rates in both studies met the primary endpoint of non-inferiority of TAF compared to TDF.

In addition, the study had a higher - than - usual bar for statistical significance due to its inclusion of two co-primary endpoints instead of only one.

Patients with acute coronary syndrome undergoing angioplasty who received the anticoagulant drug bivalirudin did not show significant improvements in either of two co-primary endpoints — a composite of rate of death, heart attack or stroke at 30 days, or a composite of those events plus major bleeding — as compared to patients receiving standard anticoagulation therapy, according to a study presented at the American College of Cardiology's 64th Annual Scientific Session.

The researchers examined data from the international Screening for Pregnancy Endpoints (SCOPE) study, which recruited more than 5600 women expecting their first babies in the early stages of pregnancy.

The study's primary limitation is that the sample was not large enough to detect differences in the components of the primary endpoint, only a composite of these outcomes.

Additional limitations to the traditional approach include: costly failures to replicate positive results in larger trials; difficulty in determining the reasons for negative results; low yield in terms of identifying disease or intervention mechanisms due to an exclusive focus on symptom change and clinical endpoints; and, the expensive and very lengthy practice of first establishing multi-component psychosocial treatments followed by years of «unpacking» studies.

The study is ongoing and patients will continue to be followed to further evaluate the primary and secondary endpoints.

The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics.

Drs. Colleen Delaney, Harlan Robins named 2016 Leaders in Health Care; Hutch study finds CMV viral load can act as surrogate endpoint for clinical trials; A new target for Tumor Paint: BLZ - 100 lights up head and neck cancers; Dr. Stephen Tapscott appointed to NIAMS advisory council

In subsequent in vivo studies, NPT088 effectively reduced the levels of Aβ plaque and tau aggregate in a mouse model of Alzheimer's disease, resulting in improvements in functional endpoints, including cognition.

For many HD studies that are focused on movement symptoms, the endpoint is some score that describes how bad a subjects movement symptoms are.