Sentences with phrase «for additional clinical trials»

The researchers are recruiting for additional clinical trials involving 20 tDCS sessions and a randomized sham - controlled protocol, to look for additional evidence of benefits of tDCS.
The U-M team has new NIH funding for an additional clinical trial to further refine the approach.

Not exact matches

The FDA added that «additional well - controlled clinical trials are needed prior to the resubmission of the [new drug application] for ALKS 5461,» the release said.
Searching the Cochrane PCG Register retrieved 30 reports, searching ClinicalTrials.gov retrieved one report, searching the WHO International Clinical Trials Registry Platform (ICTRP) retrieved four, and the PCG search identified two additional reports for included studies (Graffy 2004; Paul 2012).
Prof Tilley and her team are currently working with experts from Japanese anti-cancer drug giant Takeda Pharmaceutical Company Limited and Swiss - based foundation Medicines for Malaria Venture to identify additional classes of parasite specific proteasome inhibitors that could be advanced to clinical trials.
«For the next few years, we will be exploring IAB2M in additional clinical trials.
Dr. Ianchulev expects additional clinical trials to begin within the next 12 months to further evaluate the technology for treating patients with glaucoma, as well as for pupil dilation.
The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.
There will be additional needs for scientists (Ph.D. and medical) with bench experience to maintain the anticipated mushrooming of central clinical trial laboratories.
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
In a small, single - center clinical trial, Chadwick Miller, M.D., M.S., and colleagues found that evaluating older, more complex patients in the observation unit with stress cardiac MRI, as opposed to usual inpatient care, reduced hospital readmissions, coronary revascularization procedures and the need for additional cardiac testing.
Calling their compound a new therapeutic candidate for people with severe asthma and other chronic airway diseases, researchers say with additional research and development their discovery could lead to future clinical trials for asthma, Cystic Fibrosis and Chronic Obstructive Pulmonary Disease (COPD).
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.
We have one of the most comprehensive CAR T cell programs in the world, with 14 CAR T clinical trials ongoing and plans to open numerous additional trials in the coming year, including for patients with multiple myeloma, prostate cancer, liver cancer and breast cancer.
For additional information on clinical trials by investigator or sponsor, please visit clinicaltrials.gov
For additional information about clinical trials at Rutgers Cancer Institute, please call 732-235-8675 or view our list of active clinical trials.
These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, uncertainty regarding potential future deterioration in the market for auction rate securities which could result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.
Safety, immunologic, and clinical outcomes will be similar to those in the original trial; subjects will be followed for a total of 6 additional months.
Potential cardioprotection was based on generally supportive data on lipid levels in intermediate outcome clinical trials, trials in nonhuman primates, and a large body of observational studies suggesting a 40 % to 50 % reduction in risk among users of either estrogen alone or, less frequently, combined estrogen and progestin.2 - 5 Hip fracture was designated as a secondary outcome, supported by observational data as well as clinical trials showing benefit for bone mineral density.6, 7 Invasive breast cancer was designated as a primary adverse outcome based on observational data.3, 8 Additional clinical outcomes chosen as secondary outcomes that may plausibly be affected by hormone therapy include other cardiovascular diseases; endometrial, colorectal, and other cancers; and other fractures.3, 6,9
Partial clinical hold on high dose SGT - 001 resolved, additional information requested on full clinical hold NIH grant will further development of replacement beta cells for type 1 and type 2 diabetes New trial will assess MSCs to improve heart function in heart failure patients ReNeuron wins grant for retinal cell therapy development
Turnstone is currently expanding its pipeline to include products for prostate and HPV - related cancers, and anticipates opening two additional clinical trials in 2017 — 2018.
The OPARATIC trial has paved the way for two additional clinical trials — PARADIGM and PARADIGM - 2 — testing olaparib in combination with radiotherapy and temozolomide in patients with newly diagnosed glioblastoma.
Today the FDA issued a Complete Response Letter regarding PTC Therapeutics» application for ataluren, noting that «an additional adequate and well - controlled clinical trial (s) will be necessary at a minimum to provide substantial evidence of effectiveness.»
The regional clinical trials network New England Oncology Network (NEON) provides additional opportunities for collaboration.
Yet another study, a meta - analysis of seven clinical trials involving about 1,150 patients with bleeding ulcers, found that higher doses of proton pump inhibitors did not reduce the risk of additional bleeding, need for surgery, or death more effectively than lower doses did.
If you believe you have a patient who is eligible for a specific study, or if you would like additional information regarding clinical trials at the Veterinary Medical Center, you can click here to fill out a survey, or contact us directly via e-mail: [email protected].
Summit raised the additional capital through an issue of 8,333,333 new ordinary shares (before expenses) whereby the proceeds will be used to: accelerate preparatory activities for a placebo controlled clinical trial of the utrophin modulator ezutromid in patients with -LSB-...]
Before a covered entity could use or disclose protected health information of an individual pursuant to a request the covered entity made, we proposed to require the entity to obtain an authorization containing the minimum elements described above and the following additional elements: except for authorizations requested for clinical trials, a statement that the entity will not condition treatment or payment on the individual's authorization; a description of the purpose of the requested use or disclosure; a statement that the individual may inspect or copy the information to be used or disclosed and may refuse to sign the authorization; and, if the use or disclosure of the requested information will result in financial gain to the entity, a statement that such gain will result.
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