Sentences with phrase «including clinical trials studies»

She has over 10 years of experience in the research field in various areas including clinical trials studies, neuroimaging studies, drug addiction, and developmental psychology.

Not exact matches

Some small studies have suggested that synbiotics could provide benefits to a range of other conditions influenced by the gut microbiome as well, including obesity, diabetes, and non-alcoholic fatty liver disease, but larger - scale clinical trials focusing on each of those conditions are needed.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

Studies — including at least one clinical trial with 100 participants — have found that this diet can significantly alter signs of disease, reduce weight and body fat, lower blood pressure, decrease levels of biomarkers associated with cancer, and improve blood - sugar levels.

There are about 120 studies ongoing in Israel, including clinical trials looking at the effects of cannabis on autism, epilepsy, psoriasis, and tinnitus.

Amarin's clinical development program for Vascepa includes a trial known as the REDUCE - IT cardiovascular outcomes study, an 8,175 - patient study commenced in 2011.

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).

Controlled clinical trials and observational studies including an internal comparison group

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).

Since the neuronal death can be recapitulated in directly reprogrammed patient neurons, Yoo said the new technique offers a way to study the details of how potential therapies — including drugs that are currently being tested in clinical trials — could rescue medium spiny neurons from death.

Unlike many clinical trials that emphasize relief of symptoms as their primary objective, the ezogabine study's goal is to gauge how well the therapy addresses some of the biological underpinnings of depression — in this case, whether the drug lessens the hyperactivity of the reward circuit that includes VTA neurons.

Participants in the study included 588 men diagnosed with intermediate risk prostate cancer (i.e., clinical stage T1c - T2b) and enrolled in the trial between 2003 and 2012.

If dozens of human and animal studies published over the past six years are borne out by large clinical trials, nicotine — freed at last of its noxious host, tobacco, and delivered instead by chewing gum or transdermal patch — may prove to be a weirdly, improbably effective drug for relieving or preventing a variety of neurological disorders, including Parkinson's disease, mild cognitive impairment (MCI), Tourette's and schizophrenia.

Published in the journal Molecular Cancer Therapeutics, the study also found that use of a second inhibitor might improve the effectiveness of these drugs by possibly preventing resistance, and it recommends that clinical trials should be designed to include a second inhibitor.

These techniques include: human tissue created by reprogramming cells from people with the relevant disease (dubbed «patient in a dish»); «body on a chip» devices, where human tissue samples on a silicon chip are linked by a circulating blood substitute; many computer modelling approaches, such as virtual organs, virtual patients and virtual clinical trials; and microdosing studies, where tiny doses of drugs given to volunteers allow scientists to study their metabolism in humans, safely and with unsurpassed accuracy.

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.

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.

«Once we've shown that this can safely be used in human patients with pulmonary hypertension — and we've got a clinical trial in progress right now — we'll be able to conduct studies of inhaled NO delivered in ambulatory settings, including patients» homes, to treat chronic pulmonary hypertension, right - sided heart failure and chronic obstructive pulmonary disease.»

The team used gene expression profiling and found that canine B - cell lymphoma expression profiles were similar in many ways to human B - cell lymphoma, thus paving the way for future studies, including therapeutic clinical trials in dogs and humans.

Investigative studies of human biology with an emphasis on disease, including small clinical trials

The study analyzed data from three randomized, controlled clinical trials conducted between 2001 and 2015 called INFANT, PEAK and MIST that included 736 children.

The National Institutes of Health (NIH) in Bethesda, Maryland, has confirmed that the agency's definition of clinical trials now includes imaging studies of normal brain function that do not test new treatments.

Beginning with the Nazi Doctors» Trial at the 1946 Nuremberg Trial (1), coverage includes publication of Henry Beecher's «Ethics and Clinical Research» (2), The New York Times exposure of the public health service syphilis study in Macon County, Alabama (the infamous «Tuskeegee case»)(3), the University of Pennsylvania / Gelsinger gene transfer case, and The Washington Post series on international clinical drug testing abuClinical Research» (2), The New York Times exposure of the public health service syphilis study in Macon County, Alabama (the infamous «Tuskeegee case»)(3), the University of Pennsylvania / Gelsinger gene transfer case, and The Washington Post series on international clinical drug testing abuclinical drug testing abuses (4).

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.»

The study, a retrospective survival analysis, included 229 patients who participated in two randomized, controlled clinical trials focused on relief of constipation for patients receiving palliative care for various types of late - stage cancer and other terminal diseases.

The white paper recommends that practitioners follow relevant guidance documents and that deviation from consensus recommendations should be supported by clinical studies or pursued in the setting of a clinical trial approved by an institutional review board; that practitioners receive training in a new procedure before beginning its practice, that the training should include a practical, «hands - on» component and that all team members directly involved with the radiation therapy decisions should participate in at least five proctored cases before performing similar procedures independently; and that professional societies should accelerate the generation of new or updated guidance documents for the following disease sites and techniques: skin, central nervous system, gastrointestinal, lung or endobronchial and esophagus, and, while outside the charge of this panel, assess the need for updated guidance documents for accelerated partial breast irradiation using electronic brachytherapy.

Porter points out that tPA was not included in the clinical trial because a good result was seen with ultrasound / microbubbles alone in the pig study.

Limitations of the study include losing about half of the participants to long - term follow - up during the transition from a randomized clinical trial to a cohort study.

Based on results from this and previous studies, pemetrexed and gemcitabine were included in a St. Jude - led multicenter clinical trial of children and adolescents newly diagnosed with medulloblastoma.

Wong was not involved in the study, but he is part of a team of researchers currently testing the device in a phase III clinical trial, which includes more than 200 glioblastoma patients in the United States and Europe.

The current study combines data from five clinical trials involving a total of 1,287 people, including the SWIFT PRIME trial led by Saver, that show these devices improved outcomes for people with acute ischemic strokes due to large vessel blockage.

Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.

The aim of the Interdisciplinary Training in Cancer Research training program is to train young scientists to design and conduct research on significant problems in cancer by combining information and approaches from different scientific disciplines, including basic cellular and molecular biology, epidemiology, clinical trials and studies, and behavioral - social sciences.

Clinical trials are research studies that look at new ways to prevent, detect, or treat diseases and conditions, including OCD.

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.

In addition to Davis and Clark, other coauthors on the study, entitled «CRLX101 nanoparticles localize in human tumors and not in adjacent, nonneoplastic tissue after intravenous dosing,» include Devin Wiley (MS» 11, PhD» 13) and Jonathan Zuckerman (PhD» 12); Paul Webster of the Oak Crest Institute of Science; Joseph Chao and James Lin at City of Hope; and Yun Yen of Taipei Medical University, who was at City of Hope and a visitor in the Davis lab at the initiation of the clinical trial.

Her research interests include study design, clinical trials, data management methodology, and electronic data capture methodologies.

The authors of the current study conducted a randomized, multicenter, clinical trial that included 1,000 Chinese women with PCOS at 21 sites in China.

Likewise, it does not include the pre-clinical studies that take place prior to registering for a clinical trial.

Physicians and scientists at the University of Chicago Comprehensive Cancer Center are studying cancer at every point along the research spectrum, including gastrointestinal cancer clinical trials.

The new network is also taking steps to standardize the prioritization of new studies and to put in place a unified system — including a central institutional review board that will cover studies conducted by the entire system — to protect research subjects at more than 3,000 clinical trial sites.

Clinical trials are research studies that look at new ways to prevent, detect, or treat diseases and conditions, including ADHD.

The authors concluded that although the studies included in this review provided important information, double - blinded, sham - controlled phase II and phase III clinical trials with larger sample sizes are needed to validate this novel therapeutic approach.

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.

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

We also participate in several national and international clinical trials including First - in - Man applications as well as first - in - class studies.

But all of these studies, including more than 25 phase II and III clinical trials, have failed to offer significant benefit to patients.

In a substudy, review outcomes were also compared across different types of clinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanClinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified human tissue.

In one eye - opening review of recent research, Charles Drake, M.D., Ph.D., of Johns Hopkins, who is also a member of CRI's clinical trials network, discussed several cancer vaccines that are making progress, including coxsackievirus A21, an oncolytic virus vaccine being studied in late stage melanoma, and NewLink's algenpantucel - L in pancreatic cancer (HyperAcute ® pancreas).

Impediments to conducting clinical trials include long bureaucratic delays, the tendency of ethical committees to be overcautious, overly restrictive confidentiality rules, unrealistic study designs, and a separation between those who look after patients and those who conduct clinical studies.