Sentences with phrase «include efficacy studies»

The brochures contain information about toxicology, pharmacology, and animal safety studies used to determine the potential risk a particular therapy may pose to humans, but they also include efficacy studies done in animal models to demonstrate a therapy's potential benefit.

Not exact matches

Topics included: early reporting on inaccuracies in the articles of The New York Times's Judith Miller that built support for the invasion of Iraq; the media campaign to destroy UN chief Kofi Annan and undermine confidence in multilateral solutions; revelations by George Bush's biographer that as far back as 1999 then - presidential candidate Bush already spoke of wanting to invade Iraq; the real reason Bush was grounded during his National Guard days — as recounted by the widow of the pilot who replaced him; an article published throughout the world that highlighted the West's lack of resolve to seriously pursue the genocidal fugitive Bosnian Serb leader Radovan Karadzic, responsible for the largest number of European civilian deaths since World War II; several investigations of allegations by former members concerning the practices of Scientology; corruption in the leadership of the nation's largest police union; a well - connected humanitarian relief organization operating as a cover for unauthorized US covert intervention abroad; detailed evidence that a powerful congressional critic of Bill Clinton and Al Gore for financial irregularities and personal improprieties had his own track record of far more serious transgressions; a look at the practices and values of top Democratic operative and the clients they represent when out of power in Washington; the murky international interests that fueled both George W. Bush's and Hillary Clinton's presidential campaigns; the efficacy of various proposed solutions to the failed war on drugs; the poor - quality televised news program for teens (with lots of advertising) that has quietly seeped into many of America's public schools; an early exploration of deceptive practices by the credit card industry; a study of ecosystem destruction in Irian Jaya, one of the world's last substantial rain forests.

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).

Several of these syntheses included measures of self - efficacy beliefs, where the investigators examined the extent to which the relationship between helpgiving practices and the study outcomes were mediated by belief appraisals.22, 5

The new study was a prospective, randomized, investigator - blinded study that included more than 250 daptomycin - exposed children, ages 1 to 17, to document safety and efficacy of the antibiotic in treating pediatric skin and skin structure infections.

Some companies may prefer to keep information confidential because they worry about the competition, or they may believe that animal efficacy studies are too complex for most IRB members — which usually include nonscientists — to review.

In 1998, the group funded 43 studies, including investigations into the effect of acupuncture on alcoholism, the value of melatonin in Parkinson's - induced sleep disorders, and the efficacy of «calming music and hand massage on the agitated elderly.»

Although other drug developers, including Pfizer, had already dropped FAAH inhibitors because of disappointing efficacy studies, most of the molecules were shown to be safe, as the U.S. Food and Drug Administration confirmed in August 2016.

The laboratory's Oncology Preclinical Services team, which offers preclinical efficacy studies using PDX and other models, including humanized (hu)- NSG mice, is also under his direction.

The results from our new study suggest that entinostat may enhance the anti-tumor efficacy of PD - 1 targeted therapy through MDSC targeting, potentially providing an effective combination treatment approach for patients with solid tumors, including lung and renal cell carcinoma.»

«We are exploring alternative directions for developing this compound, including potential use of the animal efficacy rule,» Cihlar said, referring to a regulatory mechanism under which the U.S. Food and Drug Administration may consider efficacy findings from adequate and well - controlled animal studies of a drug in cases where it is not feasible or ethical to conduct human trials.

«We're looking forward to longer - term results to come in the next five years from various ongoing observational studies,» Dr. Arterburn said: The Utah Obesity Study, the Michigan Bariatric Surgery Collaborative, and large cohorts from Veterans Affairs health system and the HMO Research Network (including Group Health) and should yield important long - term information comparing the efficacy, safety, and costs of surgical and non-surgical care for severe obesity.

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.

In the ensuing months, the two companies have published detailed, promising animal studies of their immunotherapies, including preclinical efficacy studies in animal models of human synucleinopathies.

The study evaluated the efficacy and safety of cabozantinib compared to placebo in 9 different solid tumor types including breast, lung, ovarian, and prostate.

A recent retrospective multicenter study evaluated the efficacy of anti — PD - 1 agents in rare subtypes of melanoma, including 35 patients with mucosal melanoma and 25 patients with acral melanoma.

Dr. Jain is regarded as a trailblazer in the study of tumor microenvironment, examining in detail the notion that the relationships between tumors and their surrounding non-tumor tissue — including blood vessels — are essential determinants of disease progression, therapeutic efficacy, and patient prognosis.

The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the application.

Being able to measure the navigational impairment caused by Alzheimer's disease in both species gives us the potential to directly compare results across species, including studies of drug efficacy.

The ketogenic diet is a high fat, restricted carbohydrate regime that has been used since the 1920s; efficacy in epilepsy has been demonstrated in many studies including a randomised controlled trial (3).

Richard serves as a research consultant studying the efficacy of the Integrative Restoration — iRest Yoga Nidra Meditation protocol he's developed for health, healing, well - being, and awakening with populations including military, students, and the homeless, with issues including sleep, PTSD, TBI, pain, chemical dependency, and well - being.

He also serves as the Principal Investigator on a range of Research Alliance studies including those examining the efficacy of on - track indicators for different grade levels; performance trends in NYC high schools; and the effects of school closure.

Whoever these individuals are, they should be alarmed by how little we know about the efficacy of various sets of materials, and all the more so given the handful of studies — including the one we describe here — showing great potential for more effective curriculum materials to improve student achievement.

Many of these conditions are evident in other strands of our larger study including, for example, teachers «dispositions toward collaboration, teacher efficacy, trust, academic press, and disciplinary climate.

This study was conducted in two phases including focus groups to determine teachers» perceptions on the effectiveness of arts integration among their special needs populations and a pilot project that examined the efficacy of rubrics in measuring various skill areas.

We built this powerful adaptive assessment and instructional tool based on the feedback and needs of educators — including our own experiences — and now we're backing it up with in - depth efficacy studies.

Although we worked collaboratively with the classroom teacher, she was not included in data collection or analysis, since teacher efficacy or pedagogy were not under investigation; rather, the students» capacities for historical thinking as they interacted with various digital technologies were the focus of the study.

Dr. Bry's systematic program of prevention research has included studies that: 1) search for precursors that differentiate adolescents who will develop conduct or substance use problems from those who will not and environmental factors that might reduce or buffer those precursors; 2) investigate whether these factors actually precede or reduce future problems; and 3) test the outcome efficacy and effectiveness of experimental methods to modify these factors.

At Match Education, she supported in - district high school math tutoring programs, including a gold - standard study by the University of Chicago Urban Education Lab on the efficacy of 2:1 tutoring in improving outcomes and reducing violence in at - risk youth.

We also support studies including efficacy, bioavailability (absorption) and safety at leading veterinary schools.

Increased weed and pest pressure associated with longer growing seasons and warmer winters will be an increasingly important challenge; there are already examples of earlier arrival and increased populations of some insect pests such as corn earworm.64 Furthermore, many of the most aggressive weeds, such as kudzu, benefit more than crop plants from higher atmospheric carbon dioxide, and become more resistant to herbicide control.72 Many weeds respond better than most cash crops to increasing carbon dioxide concentrations, particularly «invasive» weeds with the so - called C3 photosynthetic pathway, and with rapid and expansive growth patterns, including large allocations of below - ground biomass, such as roots.73 Research also suggests that glyphosate (for example, Roundup), the most widely - used herbicide in the United States, loses its efficacy on weeds grown at the increased carbon dioxide levels likely to occur in the coming decades.74 To date, all weed / crop competition studies where the photosynthetic pathway is the same for both species favor weed growth over crop growth as carbon dioxide is increased.72

CBT has been shown in hundreds of studies (see Efficacy of CBT, Outcome Studies & Empirical Status of CBT) to be effective for many conditions, including depression, anxiety disorders (including generalised anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, social anxiety, panic disorder with / without agoraphobia, phobias), eating disorders, bipolar disorder, and many studies (see Efficacy of CBT, Outcome Studies & Empirical Status of CBT) to be effective for many conditions, including depression, anxiety disorders (including generalised anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, social anxiety, panic disorder with / without agoraphobia, phobias), eating disorders, bipolar disorder, and many Studies & Empirical Status of CBT) to be effective for many conditions, including depression, anxiety disorders (including generalised anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, social anxiety, panic disorder with / without agoraphobia, phobias), eating disorders, bipolar disorder, and many others.

Summary: (To include comparison groups, outcomes, measures, notable limitations) This study compared the efficacy of a manualized cognitive behavior therapy that addresses both posttraumatic stress disorder (PTSD) and substance abuse (Seeking Safety (SS)-RRB- with a manualized cognitive behavior therapy that addresses only substance abuse (Relapse Prevention) and with standard community care for the treatment of comorbid posttraumatic stress disorder (PTSD) and substance use disorder.

Summary: (To include comparison groups, outcomes, measures, notable limitations) This study examined the efficacy of Attachment and Biobehavioral Catch - up (ABC).

Large scale outcome studies were conducted to evaluate the efficacy of anti-depressant treatments including medications and psychotherapies.

Recent theoretical work suggests that bullying might arise out of early cognitive deficits — including language problems, imperfect causal understanding, and poor inhibitory control — that lead to decreased competence with peers, which over time develops into bullying.14, 15 A small number of studies provide circumstantial evidence that such a hypothesis might have merit7: 1 study found a link between poor early cognitive stimulation and (broadly defined) inappropriate school behavior, 16 and another found cognitive stimulation at age 3 years to be protective against symptoms of attention - deficit disorder at age 7 years.17 A study of Greek children found that academic self - efficacy and deficits in social cognition were related to bullying behavior.18 A large US national survey found that those who perceive themselves as having average or below - average academic achievement (as opposed to very good achievement) are 50 % to 80 % more likely to be bullies.8 Yet these studies are based on cross-sectional surveys, with the variables all measured at a single point in time.

In a recent review of the distribution of research grant emphases in the area of violence, several NIH institutes classified their studies into one of three categories: (a) preintervention studies, which included risk or protective studies, population - based epidemiological studies, or basic prevention development; (b) efficacy studies, which included laboratory trials of the impact of specific preventive or treatment interventions targeted at disruptive behavior disorders, including conduct disorder; and (c) effectiveness research, which included studies of the effectiveness, dissemination, or transportability of interventions into community (nonacademic) settings.

Contrary to the meta - analyses of Crits - Christoph5 andAnderson and Lambert, 7 studies of IPT werenot included (eg, Elkin et al30 and Wilfleyet al31), because the relation of IPT to STPPis controversial, and empirical results suggest that IPT is very close toCBT.9 Thus, this review includes only studiesfor which there is a general agreement that they represent models of STPP.As it is questionable to aggregate the results of very different outcome measuresthat refer to different areas of psychological functioning, we assessed theefficacy of STPP separately for target symptoms, general psychiatric symptoms (ie, comorbid symptoms), and social functioning.32 Thisprocedure is analogous to the meta - analysis of Crits - Christoph.5 Asoutcome measures of target problems, we included patient ratings of targetproblems and measures referring to the symptoms that are specific to the patientgroup under study, eg, measures of anxiety for studies investigating treatmentsof anxiety disorders.33 For the efficacy ofSTPP in general psychiatric symptoms, broad measures of psychiatric symptomssuch as the Symptom Checklist - 90 and specific measures that do not refer specificallyto the disorder under study were included; eg, the Beck Depression Inventoryapplied in patients with personality disorders.34, 35 Forthe assessment of social functioning, the Social Adjustment Scale and similarmeasures were included.36

Medication is not appropriate for children whose symptoms do not meet DSM - IV criteria for diagnosis of ADHD, although behavior therapy does not require a specific diagnosis, and many of the efficacy studies have included children without specific mental behavioral disorders.

In addition, Dr. Kim is closely involved in two randomized control efficacy studies to test effects of the Kids in Transition to School (KITS) program which was designed to increase school readiness among at - risk populations including children in foster care.

Summary: (To include comparison groups, outcomes, measures, notable limitations) This study explored the preliminary efficacy, parent acceptability, and economic cost of delivering Step One within Stepped Care Trauma - Focused Cognitive Behavioral Therapy (SC - TF - CBT).

Summary: (To include comparison groups, outcomes, measures, notable limitations) The current study evaluates the feasibility and efficacy of Risk Reduction through Family Therapy (RRFT) for reducing substance use risk and trauma - related mental health problems among sexually assaulted adolescents.

Studies generally supports the idea that positive self - concept, including high levels of self - esteem and self - efficacy are associated with secure attachment to parents in infancy, childhood, and adolescence (Thompson, 1999; Arbona and Power, 2003).

Summary: (To include comparison groups, outcomes, measures, notable limitations) This study examined the efficacy of Collaborative Problem Solving in affectively dysregulated children with oppositional defiant disorder (ODD).

Summary: (To include comparison groups, outcomes, measures, notable limitations) The purpose of the current study was to evaluate the feasibility of implementation and initial efficacy of Risk Reduction through Family Therapy (RRFT) with adolescents who had experienced at least one memorable sexual assault in their lifetime.

Summary: (To include comparison groups, outcomes, measures, notable limitations) This study evaluated the efficacy of a culturally adapted version of the Early Pathways (EP) program [now called the Early Pathways Program (EPP)-RSB- for children severe behavior and emotional problems, such as aggression, oppositional behavior, self - injury and property destruction.

Summary: (To include comparison groups, outcomes, measures, notable limitations) In this study, the efficacy of the Strong African American Families Program (SAAF) was tested in regards to communicative parenting and youth protective factors between SAAF participants and control group members.

Summary: (To include comparison groups, outcomes, measures, notable limitations) This purpose of this study was to examine the efficacy of Project Healthy Grandparents (PHG) to improve reduce psychological stress, improve physical and mental health, and strengthen the social support and resources of grandparents raising grandchildren.

Summary: (To include comparison groups, outcomes, measures, notable limitations) This study examined the efficacy of group Interpersonal Psychotherapy (IPT) in relieving depressive symptoms and improving functioning and evaluated the feasibility of such studies in sub-Saharan Africa.