Search Results - "Simon, L.S"

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis by Kloppenburg, M, Maheu, E, Kraus, V.B, Cicuttini, F, Doherty, M, Dreiser, R.-L, Henrotin, Y, Jiang, G.-L, Mandl, L, Martel-Pelletier, J, Nelson, A.E, Neogi, T, Pelletier, J.-P, Punzi, L, Ramonda, R, Simon, L.S, Wang, S

“…Summary Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much…”
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OARSI Clinical Trials Recommendations: An abbreviated regulatory guide to the clinical requirements for development of therapeutics in osteoarthritis by Simon, L.S

“…Summary In this brief abbreviated review of regulatory issues regarding the development of drugs and or devices for the treatment of osteoarthritis (OA), the…”
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OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hip osteoarthritis by Lane, N.E, Hochberg, M.C, Nevitt, M.C, Simon, L.S, Nelson, A.E, Doherty, M, Henrotin, Y, Flechsenhar, K

“…Summary The ability to assess the efficacy and effectiveness of an intervention for the treatment of hip osteoarthritis (OA) requires strong clinical trial…”
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Outcome measures in placebo-controlled trials of osteoarthritis: responsiveness to treatment effects in the REPORT database by Dworkin, R.H, Peirce-Sandner, S, Turk, D.C, McDermott, M.P, Gibofsky, A, Simon, L.S, Farrar, J.T, Katz, N.P

“…Summary Introduction Treatment response in randomized clinical trials (RCT) of osteoarthritis (OA) has been assessed by multiple primary and secondary…”
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Corrigendum to “OARSI Clinical Trials Recommendations: design and conduct of clinical trials for hip osteoarthritis” [Osteoarthritis Cartilage 23 (2015) 761–771] by Lane, N.E, Hochberg, M.C, Nevitt, M.C, Simon, L.S, Nelson, A.E, Doherty, M, Henrotin, Y, Flechsenhar, K

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Expanding the Measurement of Treatment Benefit in Rheumatoid Arthritis: The Role of the Patient-Reported Outcome Consortium’s RA Working Group by Naegeli, A.N, Nikaï, E, Burke, L.B, Coons, S.J, Strand, V, Simon, L.S, Piault, E, Hayes, R.P

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Safety issues in the development of treatments for osteoarthritis: recommendations of the Safety Considerations Working Group by Strand, V, Bloch, D.A, Leff, R, Peloso, P.M, Simon, L.S

“…Summary Objective The symptomatic treatment of osteoarthritis (OA) remains to be improved, as many patients do not respond well to current palliative therapies…”
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Corrigendum to “Outcome measures in placebo-controlled trials of osteoarthritis: responsiveness to treatment effects in the REPORT database” [Osteoarthritis and Cartilage 19 (2011) 483–492] by Dworkin, R.H, Peirce-Sandner, S, Turk, D.C, McDermott, M.P, Gibofsky, A, Simon, L.S, Farrar, J.T, Katz, N.P

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Coxibs and NSAIDs – Is the air any clearer? Perspectives from the OARSI/International COX-2 Study Group Workshop 2007 by Moskowitz, R.W., M.D, Abramson, S.B., M.D, Berenbaum, F., M.D, Simon, L.S., M.D, Hochberg, M., M.D., M.P.H

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Critical appraisal of intra-articular glucocorticoid injections for symptomatic osteoarthritis of the knee by Samuels, J., Pillinger, M.H., Jevsevar, D., Felson, D., Simon, L.S.

“…Intra-articular (IA) injections of glucocorticoids (GCs) have been shown to decrease pain, increase mobility, and improve quality of life in patients with…”
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Vulnerability-in-Production: A Spatial History of Nature, Affluence, and Fire in Oakland, California by Simon, Gregory L.

“…Vulnerability-in-production is offered as a theoretical construct to highlight two interrelated aspects of vulnerability: a process where landscapes are…”
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Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs by Kraus, V.B., Simon, L.S., Katz, J.N., Neogi, T., Hunter, D., Guermazi, A., Karsdal, M.A.

“…In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval regulations that allow drugs or biologics for serious conditions that fill…”
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Physicians’ vs patients’ global assessments of disease activity in rheumatology and musculoskeletal trials: A meta-research project with focus on reasons for discrepancies by Lynæs, Christian, Lynæs, Maria, Simon, Lee S, Tugwell, Peter, D'Agostino, Maria-Antonietta, Strand, Vibeke, Juhl, Carsten B., Nielsen, Sabrina M., De Witt, Maarten, Beaton, Dorcas, Maxwell, Lara J., Meara, Alexa S., Christensen, Robin

“…In most rheumatic and musculoskeletal diseases (RMDs), global assessments of disease activity by physicians and patients are ‘anchor outcomes’ in therapeutic…”
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Planet Hunters TESS. V. A Planetary System Around a Binary Star, Including a Mini-Neptune in the Habitable Zone by Eisner, Nora L., Grunblatt, Samuel K., Barragán, Oscar, Faridani, Thea H., Lintott, Chris, Aigrain, Suzanne, Johnston, Cole, Mason, Ian R., Stassun, Keivan G., Bedell, Megan, Boyle, Andrew W., Ciardi, David R., Clark, Catherine A., Hebrard, Guillaume, Hogg, David W., Howell, Steve B., Klein, Baptiste, Llama, Joe, Winn, Joshua N., Zhao, Lily L., Murphy, Joseph M. Akana, Beard, Corey, Brinkman, Casey L., Chontos, Ashley, Cortes-Zuleta, Pia, Delfosse, Xavier, Giacalone, Steven, Gilbert, Emily A., Heidari, Neda, Holcomb, Rae, Jenkins, Jon M., Kiefer, Flavien, Lubin, Jack, Martioli, Eder, Polanski, Alex S., Saunders, Nicholas, Seager, Sara, Shporer, Avi, Tyler, Dakotah, Van Zandt, Judah, Alhassan, Safaa, Amratlal, Daval J., Antonel, Lais I., Bentzen, Simon L. S., Bosch, Milton K. D, Bundy, David, Chitsiga, Itayi, Delaunay, Jérôme F., Doisy, Xavier, Ferstenou, Richard, Fynø, Mark, Geary, James M., Haynaly, Gerry, Hermes, Pete, Huten, Marc, Lee, Sam, Metcalfe, Paul, Pennell, Garry J., Puszkarska, Joanna, Schäfer, Thomas, Stiller, Lisa, Tanner, Christopher, Tarr, Allan, Wilkinson, Andrew

“…Abstract We report on the discovery and validation of a transiting long-period mini-Neptune orbiting a bright ( V = 9.0 mag) G dwarf (TOI 4633; R = 1.05 R ⊙ ,…”
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PMS82 - Expanding the Measurement of Treatment Benefit in Rheumatoid Arthritis: The Role of the Patient-Reported Outcome Consortium’s RA Working Group by Naegeli, A.N., Nikaï, E., Burke, L.B., Coons, S.J., Strand, V., Simon, L.S., Piault, E., Hayes, R.P.

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Remoção Cirúrgica de Dente Deslocado Acidentalmente para o Interior do Seio Maxilar: Relato de Caso by Fabris, V., Simon, L.S., Manfro, R., Malmann, F., Derech, E.D.

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Fechamento de Diastema com Resina Composta: Relato de Caso by Schwarz, V., Simon, L.S., Silva, S.A., Ghiggi, P.C., Cericato, G.O.

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Osteoarthritis, imaging and guidance for approval of a structural “indication” by Simon, L.S.

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New and future drug therapies for rheumatoid arthritis by Simon, L S, Yocum, D

“…Several new drugs have recently been introduced for the treatment of rheumatoid arthritis (RA). These include the cyclooxygenase-2 inhibitor, celecoxib, the…”
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Severity of dyspepsia assessment (SODA) results from the ‘celexocib long-term arthritis safety study’ a randomized trial comparing celecoxib and diclofenac by Goldstein, J.L, Pẽa, B.M, Dedhiya, S, Simon, L.S

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