Sentences with phrase «efficacy trial of»

Data were collected from 20 groups of participants (94 early adolescents, 120 parents) enrolled in an efficacy trial of a mindfulness - based adaptation of the Strengthening Families Program (MSFP).

In addition, she is co-principal investigator on the ED - funded efficacy trial of Foundations, a positive and proactive approach to schoolwide discipline, and of the National Institute of Justice - funded implementation and evaluation study of positive discipline and trauma - informed services in a large urban school district.

Woodbridge also recently completed an ED - funded efficacy trial of the Cognitive - Behavioral Intervention for Trauma in Schools program, an intervention to improve the behavior and academic performance of students who have experienced significant traumatic stress.

The randomized efficacy trial of TFCO - P started with three groups of preschool - aged children: foster children who received the TFCO - P intervention, foster children who did not received the TFCO - P intervention, and children who were not in foster care.

The study involves data collection with a subsample of 9 — 13 year - old children who participated in a randomized efficacy trial of Treatment Foster Care of Oregon for Preschoolers (TFCO - P).

The Kids in Transition to School (KITS) foster care program began with a 5 - year randomized efficacy trial of a preventive intervention to enhance psychosocial and academic school readiness in foster children as they enter school.

She is also a co-investigator on a randomized efficacy trial of a school readiness intervention program with foster children and a multisite Center investigating the behavioral and neurobiological impacts of early adverse experiences in humans and nonhuman primates.

The Kids in Transition to School — Developmental Disabilities Project was a randomized efficacy trial of a preventive intervention to enhance psychosocial and academic school readiness in children with developmental disabilities as they enter kindergarten.

Abstract: This study examined relationships among language use, mindfulness, and substance - use treatment outcomes in the context of an efficacy trial of mindfulness - based relapse prevention (MBRP) for adults with alcohol and other drug use (AOD) disorders.

This project is a randomized efficacy trial of the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, with children from socioeconomically disadvantaged neighborhoods.

The Kids in Transition to School (KITS)-- Developmental Disabilities Follow - Up is a longitudinal study of the effects of a randomized efficacy trial of a preventive intervention to enhance psychosocial and academic school readiness in children with developmental disabilities and behavior or social difficulties who were entering kindergarten.

She also describes the efficacy trial of this intervention that is currently underway at WCW.

Efficacy trial of the Second Step Early Learning (SSEL) curriculum: Preliminary outcomes.

Intervention to reduce traumatic stress following intimate partner violence: An efficacy trial of the Moms» Empowerment Program (MEP).

The Kids in Transition to School — Developmental Disabilities Project was a randomized efficacy trial of a preventive intervention to enhance psychosocial and academic school readiness in children with developmental disabilities and behavior or social difficulties who are entering kindergarten.

OSLC conducted a randomized efficacy trial of KITS 2005 - 2010 and a follow - up study 2010 - 2015.

The study, «Preparing to Succeed: An Efficacy Trial of Two Early Childhood Curricula Study Overview for Principals,» will examine the effects of Boston Public Schools» preschool program on math, literacy, and socio - emotional and executive functioning outcomes.

The study, «Preparing to Succeed: An Efficacy Trial of Two Early Childhood Curricula Study Overview for Principals,» will examine the effects of Boston...

Based in part on these results, the Butantan Institute in São Paulo, Brazil, this year launched an efficacy trial of the vaccine that plans to enroll 17,000 people.

Dr. Caskey and her team are planning clinical efficacy trials of this approach.

She is the principal investigator on three randomized efficacy trials of the KITS Program including maltreated children in foster care, children with developmental disabilities and co-occurring behavioral or social problems, and children from socioeconomically disadvantaged backgrounds.

The project will extend the evidence on the efficacy of the intervention from two previous randomized efficacy trials of the KITS Program with special needs populations to examine the impacts of the intervention on the broader population of children from disadvantaged backgrounds in general education.

Not exact matches

In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Last year The Ohio State University Wexner Medical Center began clinical trials on the efficacy of SuperBetter to treat traumatic brain injuries, and the University of Pennsylvania Positive Psychology Center greenlighted a randomized controlled user study of the game to treat depression.

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.

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).

Announced a clinical trial collaboration with Pfizer, Inc. (Pfizer) to evaluate the safety and efficacy of the investigational combination of Yescarta and Pfizer's utomilumab, a fully humanized 4 - 1BB agonist monoclonal antibody, in patients with refractory large B - cell lymphoma.

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

A stroke drug invented at The Scripps Research Institute has shown signs of safety and efficacy in a mid-stage clinical trial.

In a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerability.

Most biotechs would have shuttered a clinical program that showed absolutely no efficacy whatsoever in a late - stage trial, but Novavax has instead doubled down on RSV by going forth with its phase 3 trial of the RSV F vaccine for infants via maternal immunization, and begun planning for another trial in older adults that's reportedly on track to kick off in 2018.

Efficacy of tart cherry juice in reducing muscle pain during running: a randomized controlled trial.

A systematic review of the efficacy of herbal galactagogues published in the Journal on Lactation found five trials that showed an increase in breast milk production.

The efficacy of malunggay (moringa oleifera) given to near term pregnant women in inducing early postpartum breast milk production - a double blind randomized clinical trial.

The aim of this trial is to evaluate the safety and efficacy of continuous KMC initiated immediately after birth compared to the current recommendation of initiating continuous KMC after stabilization, in improving survival of neonates with birth weight from 1.0 to < 1.8 kg.

In the third trial of the nurse home visitor program, nurse - visited, 6 - month - old infants born to mothers with low psychological resources (i.e., maternal IQ, mental health, and sense of efficacy) displayed fewer aberrant emotional expressions (e.g., low levels of affect and lack of social referencing of mother) associated with child maltreatment.18

The DAME trial was a multi-site, randomised controlled trial of antenatal expression of colostrum in late pregnancy for women with diabetes in pregnancy to explore the safety and efficacy for mother, foetus and infant.

The trial was designed to test the safety and efficacy of omega - 3 — fortified formulas compared with unfortified formulas or breast milk in 288 premature infants.

Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial.

A randomized trial assessing the efficacy of peer counseling on exclusive breastfeeding in a predominantly Latina low - income community

The efficacy and safety of the probiotic bacterium Lactobacillus reuteri DSM 17938 for infantile colic: A meta - analysis of randomized controlled trials.

Although professional lactation support can improve the duration of overall breast feeding, its effect in improving exclusive breast feeding is unclear.11 18 22 Thus far, studies that report improvement of rates of exclusive breastfeeding have involved mainly community based peer counselling strategies.23 24 25 Even then, a randomised trial in the UK recently cast doubt on the efficacy of this approach.26 There are current recommendations from NICE for the UK - wide implementation of the baby friendly initiative.4 5 6 The 2006 NICE costing report on routine postnatal care of women and their babies estimates that efforts to improve rates of breast feeding will result in substantial cost savings for the NHS.6

The efficacy of these treatments for other anxiety disorders in children and adolescents has been supported by multiple randomized controlled trials (e.g., Walkup et al., 2008).

Its role in the initiation of labour is poorly understood and data examining its efficacy within a clinical trial are limited.

The effect of interactive web - based breastfeeding monitoring on maternal breastfeeding self - efficacy and satisfaction: a randomized control trial

Efficacy of an online breastfeeding tutorial and maternal needs assessment in increasing breastmilk - only feeding in a pediatric practice: results of a randomized controlled trial

Trials are currently underway to evaluate the safety and efficacy of antiretroviral regimens taken by the mother and / or infant after delivery to prevent transmission through breastfeeding.

Improving Breastfeeding Outcomes: a Pilot Randomized Controlled Trial of a Self - Efficacy Intervention with Primiparous Mothers [thesis]

«This phase III trial will be noteworthy for being the first prostate cancer trial to assess a biomarker, namely AR - V7 in circulating tumour cells, as a predictor of response at the same time as testing the efficacy of the drug,» Prof Taplin will conclude.