Sentences with phrase «clinical efficacy of»

Clinical efficacy of methylphenidate in conduct disorder with or without attention deficit hyperactivity disorder

Naaman, S., & Johnson, S. M., & Radwan, K. (in review) Evaluation of the clinical efficacy of emotionally focused therapy on psychological adjustment of couples facing early breast cancer.

Clinical efficacy of computerised cognitive — behavioural therapy for anxiety and depression in primary care: randomised controlled trial

Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs.

This will be the first prospective evaluation of clinical efficacy of tranexamic acid in the dog following trauma and is funded by the United States Special Operations Command to advance trauma care for military dogs.

Clinical efficacy of increased dosages of milbemycin oxime for the treatment of generalized demodicosis in adult dogs.

Other subjects discussed in detail include Calorie Restriction, Intermittent Fasting and how to calculate your Glucose Ketone Index (GKI) a measure which assesses the clinical efficacy of the ketogenic diet;

[102] Together with public and private research groups, these agencies construct databases on supplement properties, perform research on quality, safety, and population trends of supplement use, and evaluate the potential clinical efficacy of supplements for maintaining health or lowering disease risk.

«Clinical efficacy of kava extract WS 1490 in sleep disturbances associated with anxiety disorders.

Zentler - Munro PL, Assoufi BA, Balasubramanian TK, Cornell S, Benoliel D. Therapeutic potential and clinical efficacy of acid - resistant fungal lipase in the treatment of pancreatic steatorrhoea due to cystic fibrosis.

Clinical efficacy of occupational therapy (OT) under routine care conditions has not been investigated yet.

The authors concluded that these meta - analyses support the need for further controlled, larger trials to assess the clinical efficacy of rTMS on negative and positive symptoms of schizophrenia, while suggesting the need for exploration for alternative stimulation protocols.

Building on strong drug discovery and early clinical development expertise, iTeos intends to demonstrate the clinical efficacy of its approach in proof of concept trials, on its own or in co-development with a partner.

A new paper published in the Journal of Allergy and Clinical Immunology has reported on a multicentre trial to test the safety and clinical efficacy of a new vaccine against grass pollen allergy in patients with grass pollen — induced rhinitis and controlled asthma.

The purpose of this study is to examine the response to and clinical efficacy of a new drug, «BAN2401», in subjects with Early Alzheimer's Disease.

The cellular mechanisms that contribute to the clinical efficacy of DBS remain largely unknown, however.

This spring, a clinical trial will start at the Alberta Children's Hospital exploring the clinical efficacy of vorinostat in children who have failed to respond to current anti-seizure medications.

Fischer, in 2000, reported demonstrating the clinical efficacy of gene therapy for the first time, using blood stem cells to treat a fatal genetic disorder called X-linked severe combined immunodeficiency.

These results provide evidence for the clinical efficacy of more subtype - selective α2AR drugs.

The team further tested the clinical efficacy of the TG - 18 hydrogel in a mouse model of inflammatory arthritis.

There is a large and growing amount of scientific literature that is demonstrating the clinical efficacy of using a food elimination diet to improve many different health conditions.

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.

The treatment was approved for the devastating rare disease Duchenne muscular dystrophy but created major divisions within the FDA because it simply hadn't demonstrated a whole lot of efficacy, meaning the pricey therapy is essentially being subjected to a real - world clinical test.

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.

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.

Multicenter study of the lactational amenorrhea method (LAM): I. Efficacy, duration, and implications for clinical application.

Whilst there are no RCT studies available at this time to draw definitive conclusions about the efficacy of this process, many clinical reports exist to indicate that placenta encapsulation is helpful in the postpartum period in terms of increasing milk supply (acting as a galactagogue) and improving mood in the postpartum period.

Luke's Medical Center and at the Rehabilitation Institute about doing clinical studies to demonstrate the efficacy of her firm's brand of adult diapers called Rejoice.

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.

Summary: This study, published in the American Journal of Clinical Nutrition in November 2009, investigated the efficacy of multivitamin supplements at single...

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

The trial needs to involve at least 50 people with OCD and a credible control treatment to really test the efficacy of this idea, says Jon Abramowitz, a clinical psychologist at the University of North Carolina at Chapel Hill.

The disagreement exposes a rift between those scientists who accept only clinical trials as proof of efficacy and those who accept observational data.

Ultimately, AA147 — or some version of it — would need to undergo clinical trials for safety and efficacy before it could potentially be used to treat patients.

The study, «The efficacy of the BCG vaccine against newly emerging clinical strains of Mycobacterium tuberculosis,» was published in the journal PLOS One in September.

Stitziel and his colleagues pointed out that this question will be addressed later this month with the reporting of results from a large clinical trial called IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE - IT).

«The study results elucidate the molecular mechanisms underlying disease progression in multiple sclerosis models, providing a basis for future clinical trials to determine safety and efficacy of these chemical agents in humans with demyelinating disorders,» says Patrizia Casaccia, MD, PhD, Professor of Neuroscience, Genetics and Genomic Sciences at Mount Sinai and senior author of the study.

Previous clinical trials of creatine in symptomatic HD patients have been limited in scale, involved daily doses of 10 grams or less, and did not provide evidence of potential efficacy.

Neurologist Malcolm MacLeod of the Centre for Clinical Brain Sciences at the University of Edinburgh and his colleagues combed through papers reporting the efficacy of drugs in eight animal disease models and checked whether the authors reported four measures that are widely acknowledged to reduce the risk of bias.

Dr. Rassool says that a clinical trial is planned to test whether low doses of a DNMT inhibitor, decitabine, and an investigational PARP inhibitor, talazoparib, can be safely combined and whether this therapy shows efficacy for AML patients, especially those who can not receive intensive chemotherapy, whose leukemia is resistant to treatment, or who have experienced a relapse after treatment.

«The results are relevant for clinical use of specific antibodies or related inhibitors in IL - 17RA dependent severe asthma, suggesting equal efficacy using either agonist or receptor blockade to treat severe asthma crisis,» said Ryffel.

Schlom, of the National Cancer Institute, says the next challenge for researchers is to find ways to combine different immunotherapy drugs into single treatments and measure their efficacy in clinical trials.

Following the success of this preliminary safety and feasibility study, more patients are being recruited for a larger clinical trial of the procedure to test the efficacy and durability of the procedure.

The main objective of this study was to verify the safety of the drug and to confirm its efficacy on the clinical manifestations of the disease.