Search Results - "LaVange, L"

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization by Amur, S, LaVange, L, Zineh, I, Buckman-Garner, S, Woodcock, J

“…The discovery, development, and use of biomarkers for a variety of drug development purposes are areas of tremendous interest and need. Biomarkers can become…”
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Discussion of “Optimal test procedures for multiple hypotheses controlling the familywise expected loss” by Willi Maurer, Frank Bretz, and Xiaolei Xun by LaVange, L.M., Alt, E.M., Ibrahim, J.G.

“…We provide commentary on the paper by Willi Maurer, Frank Bretz, and Xiaolei Xun entitled, “Optimal test procedures for multiple hypotheses controlling for the…”
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The role of nonrandomized trials in the evaluation of oncology drugs by Simon, R, Blumenthal, GM, Rothenberg, ML, Sommer, J, Roberts, SA, Armstrong, DK, LaVange, LM, Pazdur, R

“…Although randomized trials provide the most reliable evidence of a drug's safety and efficacy, there are situations where randomized trials are not possible or…”
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Double-Masked, Placebo-Controlled Safety and Efficacy Trial of Diquafosol Tetrasodium (INS365) Ophthalmic Solution for the Treatment of Dry Eye by Tauber, J, Davitt, W F, Bokosky, J E, Nichols, K K, Yerxa, B R, Schaberg, A E, LaVange, L M, Mills-Wilson, M C, Kellerman, D J

“…PURPOSE:To investigate the safety and efficacy of diquafosol tetrasodium, a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular…”
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Applying sample survey methods to clinical trials data by LaVange, L. M., Koch, G. G., Schwartz, T. A.

“…This paper outlines the utility of statistical methods for sample surveys in analysing clinical trials data. Sample survey statisticians face a variety of…”
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Maintenance Phase Efficacy of Sertraline for Chronic Depression: A Randomized Controlled Trial by Keller, Martin B, Kocsis, James H, Thase, Michael E, Gelenberg, Alan J, Rush, A. John, Koran, Lorrin, Schatzberg, Alan, Russell, James, Hirschfeld, Robert, Klein, Daniel, McCullough, James P, Fawcett, Jan A, Kornstein, Susan, LaVange, Lisa, Harrison, Wilma, for the Sertraline Chronic Depression Study Group

“…CONTEXT.— The chronic form of major depression is associated with a high rate of prevalence and disability, but no controlled research has examined the impact…”
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Phase 2 Randomized Safety and Efficacy Trial of Nebulized Denufosol Tetrasodium in Cystic Fibrosis by Deterding, Robin R, LaVange, Lisa M, Engels, Jean M, Mathews, Dave W, Coquillette, Sarah J, Brody, Alan S, Millard, Steve P, Ramsey, Bonnie W, Cystic Fibrosis Therapeutics Development Network and Inspire 08-103 Working Group

“…Denufosol tetrasodium is a selective P2Y(2) agonist that enhances mucosal hydration and mucus clearance by activating Cl(-) secretion and inhibiting epithelial…”
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Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using “Real-World” Data by Jarow, Jonathan P, LaVange, Lisa, Woodcock, Janet

“…Jarow et al describes the use of real-world evidence (RWE) to define the multidimensional evidence generation and FDA regulatory decision making. The other…”
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Infant health and development program for low birth weight, premature infants : program elements, family participation, and child intelligence by RAMEY, C. T, BRYANT, D. ML, WASIK, B. H, SPARLING, J. J, FENDT, K. H, LAVANGE, L. M

“…The Infant Health and Development Program was an eight-site randomized controlled trial testing the efficacy of early intervention to enhance the cognitive,…”
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Predictors of emotional numbing in posttraumatic stress disorder by Litz, B T, Schlenger, W E, Weathers, F W, Caddell, J M, Fairbank, J A, LaVange, L M

“…Little is known about the mechanisms underlying emotional numbing (EN). The functional relationship between other classes of posttraumatic stress disorder…”
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Urinary cotinine and parent history (questionnaire) as indicators of passive smoking and predictors of lower respiratory illness in infants by Margolis, Peter A., Keyes, Lynette L., Greenberg, Robert A., Bauman, Karl E., LaVange, Lisa M.

“…Studies of the effects of passive smoking on lower respiratory illness (LRI) have relied on questionnaires to measure exposure. We studied the association…”
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Lower respiratory illness in infants and low socioeconomic status by Margolis, P A, Greenberg, R A, Keyes, L L, LaVange, L M, Chapman, R S, Denny, F W, Bauman, K E, Boat, B W

“…Infants from families of low socioeconomic status are said to suffer higher rates of lower respiratory illness, but this assertion has not been carefully…”
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Prevalence of Hypertension, Awareness, Treatment, and Control in the Hispanic Community Health Study/Study of Latinos by Sorlie, Paul D., Allison, Matthew A., Avilés-Santa, M. Larissa, Cai, Jianwen, Daviglus, Martha L., Howard, Annie G., Kaplan, Robert, LaVange, Lisa M., Raij, Leopoldo, Schneiderman, Neil, Wassertheil-Smoller, Sylvia, Talavera, Gregory A.

“…BACKGROUND The prevention and control of hypertension is an essential component for reducing the burden of cardiovascular diseases. Here we describe the…”
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Statistical approaches to effectiveness measurement and outcome-driven re-randomizations in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) studies by Davis, Sonia M, Koch, Gary G, Davis, C E, LaVange, Lisa M

“…The design of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia and Alzheimer's disease studies pose several statistical…”
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Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes by Tamborlane, William V, Beck, Roy W, Bode, Bruce W, Buckingham, Bruce, Chase, H Peter, Clemons, Robert, Fiallo-Scharer, Rosanna, Fox, Larry A, Gilliam, Lisa K, Hirsch, Irl B, Huang, Elbert S, Kollman, Craig, Kowalski, Aaron J, Laffel, Lori, Lawrence, Jean M, Lee, Joyce, Mauras, Nelly, O'Grady, Michael, Ruedy, Katrina J, Tansey, Michael, Tsalikian, Eva, Weinzimer, Stuart, Wilson, Darrell M, Wolpert, Howard, Wysocki, Tim, Xing, Dongyuan

“…In this randomized study, patients undergoing intensive therapy for type 1 diabetes mellitus who had glycated hemoglobin levels of 7.0 to 10.0% were stratified…”
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Sertraline versus imipramine to prevent relapse in chronic depression by Koran, Lorrin M., Gelenberg, Alan J., Kornstein, Susan G., Howland, Robert H., Friedman, Richard A., DeBattista, Charles, Klein, Daniel, Kocsis, James H., Schatzberg, Alan F., Thase, Michael E., Rush, A.John, Hirschfeld, Robert M.A., LaVange, Lisa M., Keller, Martin B.

“…Background: Chronic depressions are common, disabling and under-treated, and long-term treatment is little studied. We report the continuation phase results…”
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Evaluation of a home-based intervention program to reduce infant passive smoking and lower respiratory illness by GREENBERG, R. A, STRECHER, V. J, GLOVER, L. H, HALEY, N. J, LODA, F. A, BAUMAN, K. E, BOAT, B. W, FOWLER, M. G, KEYES, L. L, DENNY, F. W, CHAPMAN, R. S, STEDMAN, H. C, LAVANGE, L. M

“…We conducted a randomized controlled trial to determine whether a home-based intervention program could reduce infant passive smoking and lower respiratory…”
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MSQ: Migraine-Specific Quality-of-Life Questionnaire. Further investigation of the factor structure by Jhingran, P, Davis, S M, LaVange, L M, Miller, D W, Helms, R W

“…MSQ, the 16-item Migraine-Specific Quality-of-Life Questionnaire (Version 1.0), was developed by Glaxo Wellcome Inc. to assess the effect of migraine and its…”
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Quality control of oncology clinical trials by Meyerson, L J, Wiens, B L, LaVange, L M, Koutsoukos, A D

“…This article discusses issues that are essential to ensuring the reliability of the conclusions of oncology clinical trials. Though quality control is…”
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Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both by Woodcock, Janet, LaVange, Lisa M

“…This review considers master protocols, which involve the study of one or more interventions in multiple diseases or of a single disease with multiple…”
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