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Showing results for "phase".

  1. effectivehealthcare.ahrq.gov/sites/default/files/pdf/vaccine-safety_research-protocol.pdf
    September 18, 2012 - The clinical evaluation of a vaccine typically consists of three phases.8 Phase I studies—which typically … Phase II studies evaluate the immunogenicity of the vaccine and provide preliminary estimates on the … Phase III trials provide the information on a vaccine’s safety and effectiveness that is required to
  2. effectivehealthcare.ahrq.gov/sites/default/files/ch_1-user-guide-to-ocer_130129.pdf
    August 13, 2012 - The first phase of human testing is usually conducted in a limited number of healthy volunteers (phase … then the drug is further studied in a small number of volunteers who have the targeted condition (phase … If phase 2 studies show that the drug has a therapeutic effect and lacks significant adverse effects … , trials with large numbers of people are conducted to determine the drug’s safety and efficacy (phase … assess the safety of the drug in routine clinical care after the drug is approved for marketing (phase
  3. effectivehealthcare.ahrq.gov/products/prostate-cancer-therapies/protocol
    September 12, 2019 - therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase … Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase … 26 (763246) 29     27 and 28 (43063) 30     limit 29 to (clinical trial, all or clinical trial, phase … i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or clinical trial
  4. #14 SUBSTANCE ABUSE (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/14_substanceabuse_potential_high_impact_june_2012.pdf
    January 01, 2012 - inclusion are those interventions expected to be within 0–4 years of potential diffusion (e.g., in phase … Results The table below lists nine topics for which (1) preliminary phase III data were available for … The buprenorphine implant is in two phase III trials, one of which is funded by the National Institute … Titan Pharmaceuticals presents phase 3 probuphine data at Society for Neuroscience annual meeting. … Titan Pharmaceuticals announces positive top line results in confirmatory phase 3 trial of probuphine
  5. effectivehealthcare.ahrq.gov/news/improved-format-ehc-reports
    Home » News » EHC Reports Have a New Look EHC Reports Have a New Look In an effort to make reports shorter and easier to read, we are phasing in new designs for evidence reports and summaries. Evidence Summaries have been redesigned to be no longer than four pages and pres…
  6. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/obesity_hi_impact.pdf
    April 17, 2012 - III trials for pharmaceuticals or biotechnologies or in phase II or a trial with some preliminary … Results The table below lists the nine topics for which (1) preliminary phase III data on drug topics … Antiobesity Drugs for Treatment of Obesity  Key Facts: Three drugs are in phase III development for … In 2010, Greenway and colleagues announced results from a 56-week phase III trial (COR-I) evaluating … Orexigen Therapeutics announces publication of COR-I phase 3 study of Contrave in lancet.
  7. effectivehealthcare.ahrq.gov/sites/default/files/pdf/TND_0007_03-17-2008.pdf
    January 01, 2008 - populations, interventions, comparators, and outcomes, will be further developed in the refinement phase
  8. effectivehealthcare.ahrq.gov/sites/default/files/pdf/TND_0260_07-16-2010.pdf
    January 01, 2010 - populations, interventions, comparators, and outcomes, will be further developed in the refinement phase
  9. effectivehealthcare.ahrq.gov/sites/default/files/pulmonary-horizon-scan-high-impact-1312.pdf
    December 01, 2013 - Results The table below lists the five topics for which (1) preliminary phase III data on drugs, phase … One of these, thalidomide, has been investigated in a phase III trial for off-label use to treat cough … Several phase III trials have been cosponsored by the Cystic Fibrosis Foundation, of Bethesda, MD. … Food and Drug Administration (FDA) in 2012, continues to be under study in a phase II trial and a phase … Diffusion: The system is in the innovative phase in the United States.
  10. effectivehealthcare.ahrq.gov/products/psoriasis-chronic/research-protocol
    September 27, 2011 - . † Plaque psoriasis development stage is described by: Phase (number of studies): status (if applicable … juvenile idiopathic arthritis in pediatric patients 6 years of age and older Currently available; Phase … I (2): complete; Phase II: complete Certolizumab pegol (CDP870) Cimzia® (injectable) UCB Inc. … Prophylaxis of acute organ rejection in patients receiving renal transplants Currently available; Phase … to the low and very prolonged serum levels common to a particular dosage form Currently available; Phase
  11. effectivehealthcare.ahrq.gov/sites/default/files/pulmonary-horizon-scan-high-impact-1506.pdf
    October 01, 2015 - Results The table below lists the five topics for which (1) preliminary phase III data for drugs or … In the phase III TRAFFIC and TRANSPORT trials, patients treated with lumacaftor/ivacaftor (Orkambi™ … Two phase III studies are ongoing in patients who are 6–11 years old and homozygous for F508del and … Lumacaftor/ivacaftor is also being ES-4 investigated as a fixed-dose combination in a phase III … A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis.
  12. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/10_obesity_potential_high_impact_2012-12-11.pdf
    January 01, 2012 - Results The table below lists the four topics for which (1) preliminary phase III data for drugs, phase … FDA approved the drug on June 27, 2012, on the basis of three completed phase III trials. … According to the company’s drug pipeline, liraglutide 3 mg (NN8022) is 4 in phase III trials … FDA approved the drug on July 17, 2012, on the basis of two completed, phase III trials. … This study is an extension of a phase III, clinical trial (CONQUER).
  13. effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-guidance-topic-refinement_methods.pdf
    January 01, 2013 - We use the term “provisional” to refer to the elements of the initial topic refinement phase. … previous phase (e.g., Key Questions developed in the initial topic refinement). … to the systematic review phase. … Initial Topic Refinement Phase During the initial topic refinement phase, the topic refinement team … • Input about issues not adequately addressed in the initial topic refinement phase.
  14. effectivehealthcare.ahrq.gov/news/health-systems-journal-article
    July 03, 2020 - Home » News » AHRQ Researchers Show How Learning Health Systems Can Help Organizations Improve Practice AHRQ Researchers Show How Learning Health Systems Can Help Organizations Improve Practice A recent Journal of Hospital Medicine article by AHRQ researchers explored ho…
  15. effectivehealthcare.ahrq.gov/sites/default/files/related_files/surveillance-report-3-nonopioid-pharm-chronic-pain.pdf
    July 01, 2022 - A randomized, double-blind, placebo- controlled phase III trial of duloxetine in Japanese patients … Randomized, double-blind, placebo- controlled phase III trial of duloxetine monotherapy in Japanese … A randomized, double-blind, placebo- controlled phase III trial of duloxetine in Japanese fibromyalgia … Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised … Open- label phase 3 study of diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate: ONO-
  16. effectivehealthcare.ahrq.gov/products/suicide-prevention/research-protocol
    December 28, 2015 - The results of this phase will inform KQs 1, 2 and 3. … This phase will further inform KQ 1. … The primary data abstraction processes are described in detail for each phase of the review. … The final coding schema will be similar to the schema used for the systematic review phase. … in the data synthesis phase of KQ 1.
  17. Untitled (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/pdf/suicide-prevention_research-protocol.pdf
    December 23, 2015 - The results of this phase will inform KQs 1, 2 and 3. … This phase will further inform KQ 1. … The primary data abstraction processes are described in detail for each phase of the review. … The final coding schema will be similar to the schema used for the systematic review phase. … in the data synthesis phase of KQ 1.
  18. effectivehealthcare.ahrq.gov/sites/default/files/related_files/surveillance-report-1-nonopioid-pharm-chronic-pain.pdf
    April 01, 2022 - Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised … in patients with knee pain due to osteoarthritis: an exploratory post hoc analysis of a Japanese phase … or chronic low back pain with early pain reduction: an exploratory post- hoc analysis of Japanese phase … Open- label phase 3 study of diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate: ONO- … ][TM]s effect in Chinese patients with chronic pain due to osteoarthritis: post hoc analyses of a phase
  19. effectivehealthcare.ahrq.gov/sites/default/files/related_files/surveillance-report-3-noninvasive-nonpharma.pdf
    August 01, 2022 - Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine … Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. … Rimegepant for the acute treatment of migraine: subgroup analyses from 3 phase 3 clinical trials by … STOP 301: A Phase 3, open-label study of safety, tolerability, and exploratory efficacy of INP104, … Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of phase
  20. effectivehealthcare.ahrq.gov/sites/default/files/related_files/episodic-migraine-surveillance-report-3.pdf
    August 01, 2022 - Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. … Ubrogepant for the acute treatment of migraine: pooled efficacy from ACHIEVE I and ACHIEVE II phase … Rimegepant for the acute treatment of migraine: subgroup analyses from 3 phase 3 clinical trials by … STOP 301: A Phase 3, open-label study of safety, tolerability, and exploratory efficacy of INP104, … Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of phase

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