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  • Interventional
  • He published numerous papers on research focussed on evidence-based medicine and interventional and observational trials on postoperative nausea and vomiting and other issues in conjunction with perioperative medicine and associated topics. (wikipedia.org)
  • The main area of expertise and emphasis of Kranke's scientific work was in the area of observational and interventional trials on risk factors for PONV as well as investigator initiated trials and industry-driven trials to investigate interventions aiming at the prevention or treatment of PONV. (wikipedia.org)
  • mammalian
  • Mammalian orthoreovirus type 3 (strain dearing-T3D) induces cell death preferentially in transformed cells and therefore displays inherent oncolytic properties. (wikipedia.org)
  • Therapy
  • Topics characterized as pseudoscience Ionized bracelet Earthing Therapy Water ionizer https://jnrbm.biomedcentral.com/articles/10.1186/1477-5751-12-14 https://skeptoid.com/episodes/4084 https://sciencebasedmedicine.org/pseudoscience-sells http://www.badscience.net/category/ions http://www.chem1.com/CQ/wonkywater.html Terman, M. (wikipedia.org)
  • drug
  • FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. (wikipedia.org)
  • This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license application meeting. (wikipedia.org)
  • FDA: Clinical trial endpoints for the approval of cancer drugs and biologics provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. (wikipedia.org)
  • The randomization is discussed in: FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications, chapter 6. (wikipedia.org)
  • In July 2007, the open Investigational New Drug (IND) was transferred to Tikvah Therapeutics Inc. in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. (wikipedia.org)
  • Rectal application of UC-781 gel, a potent antiretroviral (ARV) drug, was shown to be safe and acceptable to the 36 men and women in the trial. (wikipedia.org)
  • After a decade of work in drug discovery Caro was recruited again by the Brody School of Medicine at ECU, where he became the Associate Dean for Clinical Investigation and the founding Director of the ECU Metabolic Institute. (wikipedia.org)
  • practice
  • ICH E6(R2): Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. (wikipedia.org)
  • Among others, Kranke's interest was in evaluating alternative methods for the provision of labour analgesia and its safe implementation in clinical practice. (wikipedia.org)
  • NCCN Clinical Practice Guidelines in Oncology: Non-small Cell Lung Cancer V.2.2009 available from www.nccn.org Azzoli CG, Kris MG, Pfister DG (June 2007). (wikipedia.org)
  • At the time of such work the gastric bypass surgery was an experimental procedure, which is now well accepted in standard clinical practice. (wikipedia.org)
  • agonists
  • Attempts by Eli Lilly and AstraZeneca to replicate findings showing potent partial agonist action of mGluR2/3 agonists at D2 receptors were unsuccessful. (wikipedia.org)
  • Melatonin and melatonin receptor agonists, on market or in clinical trials, all bind to and activate both receptor types. (wikipedia.org)
  • CANCER
  • This makes it a topic of interest in cancer research, both as a potential method for healthy cells to prevent cancer and a weakness to target within existing cancer cells. (wikipedia.org)
  • investigators
  • In this phase, the investigators aim at maintaining the capacity to collect data on PROBE, and the infrastructure will also be modified in order to allow for longitudinal collection of PROBE data (in previous phases, the investigators only collected anonymized data). (clinicaltrials.gov)
  • With this effort Caro became one of the 25 principal investigators of the diabetes prevention program, a landmark -nationwide clinical trial- to show that lifestyle changes or metformin can effectively prevent type 2 diabetes. (wikipedia.org)
  • studies
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (clinicaltrials.gov)
  • Integrating the PROBE questionnaire in clinical trials, longitudinal studies, health technology assessment studies, routine clinical care, and registries. (clinicaltrials.gov)
  • This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies. (wikipedia.org)
  • Kranke is known for the design and conduct of clinical studies and for performing systematic reviews in the context of perioperative medicine. (wikipedia.org)
  • The working group "clinical studies" and trial management, headed by Kranke, compiles systematic reviews on interventions in health care with associated economic benefit assessment according to the criteria of the cochrane collaboration, other systematic reviews and has a coordinating role with respect to clinical trials. (wikipedia.org)
  • Among these trials, many studies were aiming to get a label for the indication of PONV prevention (phase II and III trials). (wikipedia.org)
  • development
  • However, pharmaceutical company Eli Lilly terminated further development of the compound in 2012 after it failed in phase II clinical trials. (wikipedia.org)
  • It was in phase II clinical trials in 2008 but appears to have been discontinued as it is no longer in the company's development pipeline. (wikipedia.org)
  • Several compounds are currently in early phase clinical development as potential treatments for solid and hematological cancers both as monotherapy and in combination with cytotoxics and differentiation agents. (wikipedia.org)
  • Scientists working on the University of California, Los Angeles (UCLA's) Microbicide Development Program initiated the first Phase I RM safety trial, investing the safety and acceptability of UC-781, in December 2006. (wikipedia.org)
  • In September 2009, 18 men and women began enrolling in the trial, which was sponsored by the Microbicide Trials Network (MTN) and UCLA's Microbicide Development Program. (wikipedia.org)
  • In June 2012, Emergent, along with Novartis and the Texas A&M University System was selected by the U.S. Department of Health and Human Services as one of the three Centers for Innovation in Advanced Development and Manufacturing. (wikipedia.org)
  • acute
  • This recovery at week 72 could not yet completely offset deterioration from baseline through the acute phase: GS010-treated eyes were still below baseline by 0.192 LogMAR (-10 ETDRS letters equivalent), compared to 0.380 LogMAR (-19 ETDRS letters equivalent) at Week 48. (bioportfolio.com)
  • inhibitors
  • Some trials with dual inhibitors of DPP-4 and vasopeptidase have been represented, since vasopeptidase inhibition is believed to enhance the antidiabetic effect of DPP-4 inhibition by stimulating insulin secretion. (wikipedia.org)
  • baseline
  • Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits. (clinicaltrials.gov)
  • EMA/CHMP/295050/2013: Adjustment for baseline covariates in clinical trials (EMA) provides advice on how to address important baseline covariates in designing, analysing and reporting clinical trials. (wikipedia.org)
  • early
  • Early human trials using this prodrug form of LY-404,039 gave encouraging results. (wikipedia.org)
  • Very early, and based on results of conducted systematic reviews, Kranke and colleagues highlighted the suspicious trial results published by Fujii and colleagues. (wikipedia.org)
  • aims
  • The List is associated with the Wikipedia page Guidances for statistics in regulatory affairs that aims to address the various topics of the listed guidances. (wikipedia.org)
  • Results
  • The trial showed no improvement over control group and Axovant lost 70% of its value upon the announcement of the trial results. (wikipedia.org)
  • Intepirdine also entered clinical trials for dementia with Lewy bodies, also with negative results. (wikipedia.org)
  • Eliminating the MTH1 gene in mice results in over three times more mice developing tumors compared to a control group. (wikipedia.org)
  • mild
  • There were no major and serious side effects in phase I trials, and mild side effects such as diarrhea, conjunctivitis and laryngitis were observed in few cases. (wikipedia.org)
  • safety
  • This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data andSafety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring. (wikipedia.org)
  • Phase I trials normally focus solely on safety and acceptability, but researchers used a novel approach in this trial: taking rectal tissue biopsies from participants and exposing them to HIV ex vivo in the laboratory. (wikipedia.org)