Sentences with phrase «therapy trials data»

Not exact matches

The idea for the database is to create a single repository for both patients» clinical trial data and the genetic specifics of their cancers, including which therapies they've been given and how effective they were.

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).

Katherine High, Spark's president and chief scientific officer, expressed her enthusiasm for the early clinical data related to SPK - 8011: «The encouraging start of our SPK - 8011 clinical trial reinforces the strength of our gene therapy platform, delivers human proof - of - concept in a second liver - mediated disease — a significant achievement in the gene therapy field — and positions us well to potentially transform the current treatment approach for this life - altering disease with a one - time intervention.»

In a retrospective analysis of clinical trial data, they found that melanoma patients with highly aneuploid tumors were less likely to benefit from immune checkpoint blockade therapy than patients whose tumors showed fewer chromosomal disruptions.

Using data from a randomized trial of 206 men treated with either radiation or, radiation and six months of hormonal therapy, researchers compared early markers of prostate cancer death to identify men at risk of dying early.

Data from the clinical trial did show that the combination therapy substantially decreased the number of pulmonary exacerbations and hospitalizations, while also beneficially increasing the weight of CF patients.

Once the investigators reported their landmark data in 2011, all infected study participants were offered the opportunity to begin antiretroviral therapy right away, and the trial continued for another four years, concluding this spring.

The research team used data from the recently published EORTC 22991 trial to study men with intermediate - risk prostate cancer randomized to either radiation therapy or radiation therapy and 6 months hormone therapy.

«Initial data from TAILORx breast cancer trial published: TAILORx trial finds 99 percent of women with low Oncotype DX ® Recurrence Score ® are free of breast cancer recurrence after 5 years of hormone therapy alone.»

The data safety monitoring board of the trial, as mandated by the study protocol, continues to monitor outcomes in patients with a Recurrence Score of 11 to 25 randomized to chemo - endocrine therapy or endocrine therapy alone.

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.

To gauge the risks of various ailments from hormone therapy, Jacques E. Rossouw of the National Heart, Lung and Blood Institute in Bethesda, Md., and his colleagues combined data from two trials that included more than 27,000 women.

The researchers caution that the reliable detection of small to moderate risks and benefits of drug therapies requires cogent data from large - scale randomized trials designed a priori to test the hypothesis.

Initial data shows that both dabrafenib alone and combined dabrafenib / trametinib therapy are well tolerated by patients, resulting in a 50 to 54 percent response rate among the patients advanced BRAF - mutated papillary thyroid cancer participating in the trial.

Moreover, clinical trial data suggest that a considerable proportion of patients receiving anti-TNF-alpha therapy may become resistant to treatment in the first few years.

«Five - year survival data: Brentuximab vedotin may be curative in some with Hodgkin lymphoma: Phase II trial suggests therapy should be standard of care for patients facing relapsed or treatment - resistant Hodgkin lymphoma.»

«To evaluate these findings in a group with only one HER2 treatment, we are currently analyzing data from another clinical trial, the GeparQuinto clinical trial, which is a randomized, phase III clinical trial evaluating two different neoadjuvant therapy regimens with a single anti-HER2 treatment [trastuzumab or lapatinib] for women with HER2 - positive breast cancer,» said Loibl.

Purpose: The development of the UNC Immuno - Oncology Patient Centered Translational Research (IMPACT) Biorepository involves the collection of tumor tissue and blood, as well as data (e.g., demographic, clinical, questionnaire) from patients attending Oncology Clinics at UNC Hospital and undergoing immune therapy through participation in a Merck IT trial at UNC.

Data from this trial was previously presented at World Advanced Therapies and Regenerative Medicine (May 17 - 19,2017; London, UK) and the 20th Annual Meeting American Society of Gene and Cell Therapy (ASGCT, May 10 - 13, 2017; DC, USA).

Cell Trials Data is devoted to compilations of data about cell therapy trials and cell therapy proTrials Data is devoted to compilations of data about cell therapy trials and cell therapy produData is devoted to compilations of data about cell therapy trials and cell therapy produdata about cell therapy trials and cell therapy protrials and cell therapy products.

They also argue that as long as patients with dementia are excluded from clinical trials of therapies for common age - related diseases, such as osteoporosis or arthritis, physicians will have insufficient data to make evidence - based recommendations for this rapidly growing group.

The comprehensive information presented for each cell therapy includes: an overview of the therapy, a list of therapeutic cells utilized in the specific treatment, mode and regimen of cell delivery, mechanism of action, formulation, in vitro data, animal models, preclinical data and related clinical trials.

NEW: This data set provides the sponsor and collaborators, lead investigator (s), and participating hospitals for all advanced cell therapy trials registered worldwide in 2017.

Dear readers, as you know I have been collecting cell therapy clinical trials data for several years now.

Clinical Trials Research and Billing First in Human / Early Phase PET in Oncology Case - Based Dose Reduction in Pediatric Nuclear Medicine: Practical and Necessary Radioiodine Therapy for Hyperthyroidism: The State of the Art Spondylodiscitis: Role of Imaging for Diagnosis and Monitoring Treatment Response Current Status and Future Prospects: PET and SPECT Instrumentation Alternative Payment Models and Value - Based Health Care: Nuts and Bolts Maximal Tolerated Activity of Radioactive Iodine for Metastatic Thyroid Cancer Teaching Old Radiopharmaceuticals New Tricks Intraoperative Detection Devices and Probes Molecular Imaging of Lung Inflammation Standardization of Advanced PET / SPECT Data Acquisition and Analysis Thyroid Cancer Management: Novel Therapeutics and Management Options Targeting Radionuclide Therapy in Various Non-Malignant Arthritic Conditions Using Radiosynoviorthesis (RSO) Are You Prepared for a Radiation Accident?

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

Positron emission tomography (PET) imaging of metabolic tumor burden at diagnosis and after induction therapy can help identify patients most at risk of follicular lymphoma (FL) recurrence, but more work is needed to differentiate high - risk and moderate - risk patients, suggested findings from a pooled analysis of data from three prospective clinical trials, published in Blood.

«We anticipate,» says Dr. Chou, «that this research will provide important pre-clinical data to support clinical trials using DAC and similar drugs combined with immune therapies targeting antigens like NY - ESO - 1 to treat advanced colorectal cancer and potentially other common cancers.»

A controlled trial of amino acid therapy in amyotrophic lateral sclerosis: I. Clinical, functional, and maximum isometric torque data.

The first ever conducted Bayesian study nf the effects of diet therapy on weight loss (Sackner - Bernstein, Kanter, Kaul), published in October of 2015 evaluated data from 17 randomized controlled trials of 1,797 people who were obese and overweight.

Ensured data quality and integrity across Phase II and III Cardiovascular compounds and all therapy compounds for Phase I clinical trials:

PROFESSIONAL SUMMARY * 18 years of experience in data management * Leading data management staff in support of startup, conduct and close out including the largest cardiovascular outcomes trial in the industry * Managing several direct reports and leading large teams for both study project work in multiple therapy areas and initiatives for operational efficiency * Managing departmental resources, budgets and goals to ensure success * Providing expertise for global filings including preparatio...

Tags for this Online Resume: Monitoring, Protocol, Cardiovascular, Clinical Research, Management, Pharmaceutical, Research, Therapy, Audit, Data Management, Medical Device, CRA, CTM, Clinical Trials

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Efficacy of Mindfulness - Based Cognitive Therapy in Prevention of Depressive Relapse: An Individual Patient Data Meta - analysis From Randomized Trials.

A study of individual cognitive therapy for bipolar disorder showed positive outcomes at 1 - year follow - up, but the benefits were reduced over time, suggesting the need for booster sessions to sustain the gains.19 As with many forms of therapy, CBT has been found to be more successful in reducing relapse in the depressive pole compared with the manic pole.30 A large randomised trial of CBT showed no difference between CBT and treatment as usual, when all participants were included in the analyses.31 However, results of a post-hoc analysis suggested that CBT was effective for participants who reported fewer than 12 prior episodes of illness and were not acutely unwell when therapy began; numbers of episodes of mania rather than depression seemed to predict treatment response.32 Such data can help guide the clinical application of CBT for bipolar patients.

Summary: (To include comparison groups, outcomes, measures, notable limitations) The study provided long - term follow - up data for children with sexual behavior problems from a randomized trial comparing the 12 - session Children with Sexual Behavior Problems Cognitive - Behavioral Treatment Program: School - Age Group and group play therapy (based on a combination of client - centered and psychodynamic play therapy principles).

Our recent study combined data from 14 trials and 1,196 participants to examine the effects of talk therapy for inflammatory bowel disease.

The following data describes treatment outcome maintenance results from a randomized clinical trial investigating the impact of a cognitive behavioral intervention Primary and Secondary Control Enhancement Therapy - Physical Illness (PASCET - PI) as compared to treatment as usual (TAU) on youths with inflammatory bowel disease (IBD).