Sentences with phrase «based on the clinical trial»
The approval was based on a clinical trial comparing brentuximab vedotin plus conmbination chemotherapy (Adriamycin [doxorubicin], vinblastine and dacarbazine, or AVD) vs a chemotherapy - only regimen commonly used to treat cHL (AVD plus bleomycin, also known as ABVD).
http://www.cancernetwork.com/
Based on the clinical trial, each visit may include free exams, free laboratory work and diagnostic tests, free clinical testing medications, and free prescription diet food.
Until today, the regimen outlined on mifepristone's label was based on clinical trials from way back in the «90s.
Not exact matches
The approval was based on two clinical trials of the device and lowers the barrier of entry for other similar devices, by establishing criteria that classify these systems as moderate risk medical devices, the FDA announced.
It can be everything from an über - helpful call - center rep to an oncology adviser, recommending cancer treatments on the basis of a patient's genetic profile and thousands of clinical trials and medical journal articles it has analyzed.
In 2000 - 10 roughly 80,000 patients took part in clinical trials based on research that was later retracted because of mistakes or improprieties.
The payments are dependent on reaching certain milestones based on the commencement and outcome of clinical trials.
On the heels of a 2013 double - blind clinical trial which showed Axiom Foods» Oryzatein ® plant - based brown rice protein parallels animal - based whey in building and repairing muscle, Oryzatein ® has now become the very first brown rice protein to be granted GRAS approval.
In this randomized, double - blind clinical trial, virgin coconut oil was the clear winner: «among pediatric patients with mild to moderate AD, topical application of virgin coconut oil for eight weeks was superior to that of mineral oil based on clinical (SCORAD) and instrumental (TEWL, skin capacitance) assessments.»
Additionally, in a clinical trial Axiom's signature, hexane - free and non-GMO Oryzatein ® rice protein, showed that plant - based rice protein rivals dairy - based whey for muscle building, fat reduction and muscle repair on March 9, 2013.
(Culver City, CA April 8, 2014)-- On the heels of a 2013 double - blind clinical trial which proved Axiom Food's Oryzatein ® plant - based brown rice protein equals animal - based whey in building and repairing muscles, Oryzatein has now become the very first brown rice protein to be granted GRAS approval.
In my experience, there actually are NDs whose care is rooted in science - and evidence - based medicine, and who base their recommendations on scientific studies and clinical trials.
The «unexpected deaths» were based on data from an industry - funded, academic - researcher - run clinical trial described in two papers published in 1999 and 2000.
Refusal by the drug's manufacturer to release full details of their clinical trials, has forced the government to make a decision on stockpiling that is not based on the evidence.
Based on Han's presentation to the Depression Club, the group decided to move forward with a clinical trial in patients.
The FDA reviews more liver health data and approves duloxetine for depression and diabetic neuropathy (pain), based on another set of clinical trials.
The clinical trial in humans was based on positive results of a study in mice published in Nature Communications in Sept. 2015.
«If you don't use as close to the total physiological system that you can, you're likely to run into troubles,» like being surprised by side effects later on in clinical trials, says William Haseltine, founder and former chairman and CEO of Rockville, Md. — based Human Genome Sciences.
Based on results of the current study described in a report online June 18 in the journal Cancer Cell, Johns Hopkins researchers say they are planning a phase I clinical trial to test the paclitaxel - fostamatinib combination therapy in patients with recurrent advanced ovarian cancer.
AveXis, Inc., a clinical - stage gene therapy company developing treatments for patients suffering from rare and life - threatening neurological genetic diseases, announced in July 2016 that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the treatment based on preliminary clinical results from the trial of AVXS - 101.
The piece based its recommendation on a meta - analysis of 27 clinical trials published in the same issue that concluded statins significantly reduce the risk of heart attacks and other cardiovascular events in healthy people without posing substantial risks.
In the other two locations, clinical trials are about to start based on a similar results.
The recent phase 2 STEP trial of the HIV vaccine (V520) showed disappointing results, but another vaccine made by GeoVax will be moving into phase 2 clinical trials in the next few months based on promising phase 1 results.
Clinical trials for targeted therapies, selected on the basis of the genomic tests, are scheduled to begin in early 2007.
The result will be corresponding data representations for clinical and trial data, both based on the RIM.
Findings were presented at the WCLC are based on the updated results of 12 lung cancer patients enrolled in the clinical trial with pembro and irinotecan or gemcitabine with or without vinorelbine or docetaxel.
Rather than create drastic salt policies based on conflicting data, Alderman and his colleague Hillel Cohen propose that the government sponsor a large, controlled clinical trial to see what happens to people who follow low - salt diets over time.
Currently, clinical trials are under way to test the effectiveness of mechanically pumping large amounts of these proteins into the affected area of patients» brains on a continuing basis.
The German biotech CureVac, for example, has brought mRNA - based vaccines for rabies and cancer to clinical trials, and Karikó now heads a research team at BioNTech in Mainz, Germany, that focuses on mRNA - based drugs.
«With knowledge like this, we can design clinical trials using JAK inhibitors for SS patients based on their JAK mutations,» said Elenitoba - Johnson.
It estimates the societal burden of 1,400 medical conditions in the U.S. over a 12 - year timespan, based on frequency of diagnosis and health care insurance costs, as well as research publications, awarded grants and clinical trials for each condition.
The determination of each efficacy level was also based on the rigor and quantity of published studies on the drug class: to be in Level A, for example, a class of drugs must have been supported by at least two «Class I» studies — well - designed, double - blind, randomized, placebo - controlled clinical trials.
Sean Morrison, Professor and Director of the Children's Medical Center Research Institute at UT Southwestern Medical Center in the United States, who is not an author on the paper, added: «Patients are ultimately not helped by therapies that are not based on sound science and that are not tested in systematic clinical trials.
According to lead author Mr James Oliver of the Arthritis Research UK, Centre for Genetics and Genomics, Centre for Musculoskeletal Research, University of Manchester, UK, «in current clinical practice, RA drugs are administered on a trial and error basis; there are no clinical biomarkers of response to guide treatment decisions.
CDC based its decision for children under 10 to receive two doses on preliminary data from clinical trials of the vaccines being used in the United States, but he said more complete data should emerge soon.
But the Harvard stem cell and regenerative biologist Amy Wagers, a co-author on three of the mouse papers, said in an email to STAT that she does not agree that her teams» studies provide a scientific basis for Maharaj's clinical trial.
If you treat a patient on the basis of data from clinical trials, you ought to be sure that the patient actually is a member of the population sampled to perform the trial.
Balkwill's first clinical trial starts later this year, based on developments in her laboratory.
Independent of these preclinical studies, Clementia Pharmaceuticals is currently conducting phase 2 clinical trials in individuals with FOP, based on the 2011 preclinical results published by Pacifici and Iwamoto.
Today's catch phrase is «evidence - based medicine,» and that «evidence» typically takes the form of results from clinical trials, in which potential treatments are tested on large groups of people.
Dr. Sparano continued: «This is the first prospectively conducted clinical trial evaluating this assay — or any multigene expression assay for that matter — in which patients with early stage breast cancer were uniformly treated based on their assay results.
Phages would require a less traditional approach to get official approval, such as the annual process for influenza vaccines in which manufacturers secure approval of new formulas based on the flu bug that is going around that year, instead of conducting big clinical trials every time.
«This concern has increased in the last few years based on the results of a clinical trial and two observational studies,» he said.
The study included 124 newly diagnosed patients at 25 clinical trial sites in the U.S. Two - thirds of the patients were treated with ICT - 107, an experimental vaccine based on immune system cells called dendritic cells that were exposed to six synthetic proteins, or antigens, known to be involved in GBM development.
White and colleagues will work with other collaborators at the Cancer Institute to develop early - phase patient clinical trials based on the findings from this study in the near future.
Cantley hopes to soon start clinical trials that will select cancer patients based on KRAS or BRAF mutations and possibly GLUT1 status.
The lab is also working with the Breast Oncology Program at UCSF to make this data part of an adaptive clinical trial called I - SPY, which lets researchers identify the most effective therapies based on patient molecular profiling, and is collaborating with members of the UCSF Institute for Computational Health Sciences (ICHS) to put these and other public data into a centralized database that clinicians can access through an app to help make the most appropriate treatment decisions.
Professor John Simes, Director of the NHMRC Clinical Trials Centre, University of Sydney, who over-saw the trial conduct said «This is an excellent example of ensuring patients will receive optimal care for their cancer based on a well conducted trial.
The Mayo task force found no evidence from clinical trials to recommend treating people only on the basis of age in the absence of risk factors, high cholesterol or inflammation.
On the basis of the results, insurers agreed to pay for the drug in six more Dutch patients, and Vertex is following up with the first clinical trial of ivacaftor in CF patients with rare mutations.