Search Results - "Nicolle, M M"

Unilateral cortical FLAIR-hyperintense Lesions in Anti-MOG-associated Encephalitis with Seizures (FLAMES): characterization of a distinct clinico-radiographic syndrome by Budhram, A., Mirian, A., Le, C., Hosseini-Moghaddam, S. M., Sharma, M., Nicolle, M. W.

“…Objective To characterize the clinical symptoms and magnetic resonance imaging (MRI) findings of unilateral cortical FLAIR-hyperintense Lesions in…”
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SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real‐World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility by Campbell, Ulka B., Honig, Nicholaas, Gatto, Nicolle M.

“…Based on recent guidance and publicly available approvals, the US Food and Drug Administration (FDA) has demonstrated its openness to considering evidence of…”
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The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework by Gatto, Nicolle M., Campbell, Ulka B., Rubinstein, Emily, Jaksa, Ashley, Mattox, Pattra, Mo, Jingping, Reynolds, Robert F.

“…To complement real‐world evidence (RWE) guidelines, the 2019 Structured Preapproval and Postapproval Comparative study design framework to generate valid and…”
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A Structured Process to Identify Fit‐for‐Purpose Study Design and Data to Generate Valid and Transparent Real‐World Evidence for Regulatory Uses by Gatto, Nicolle M., Vititoe, Sarah E., Rubinstein, Emily, Reynolds, Robert F, Campbell, Ulka B.

“…Generating evidence from real‐world data requires fit‐for‐purpose study design and data. In addition to validity, decision makers require transparency in the…”
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Socioeconomic differences in nicotine exposure and dependence in adult daily smokers by Chen, Allshine, Machiorlatti, Michael, Krebs, Nicolle M, Muscat, Joshua E

“…Socioeconomic status (SES) is a major determinant of tobacco use but little is known whether SES affects nicotine exposure and the degree of nicotine…”
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Income as a moderator of psychological stress and nicotine dependence among adult smokers by Hobkirk, Andréa L., Krebs, Nicolle M., Muscat, Joshua E.

“…Perceived stress and psychological distress are associated with more cigarette craving and withdrawal, higher nicotine dependence, and less success during quit…”
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Causal identification: a charge of epidemiology in danger of marginalization by Schwartz, Sharon, PhD, Gatto, Nicolle M., PhD, Campbell, Ulka B., PhD

“…Abstract The requirement for framing all causal questions as well-defined interventions is being promoted in the causal inference literature within…”
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Is the “well-defined intervention assumption” politically conservative? by Schwartz, Sharon, Prins, Seth J., Campbell, Ulka B., Gatto, Nicolle M.

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A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions by Gatto, Nicolle M., Reynolds, Robert F., Campbell, Ulka B.

“…Real‐world evidence provides important information about the effects of medicines in routine clinical practice. To engender trust that evidence generated for…”
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Stereoselective Synthesis of Highly Substituted Tetrahydrofurans through Diverted Carbene OH Insertion Reaction by Nicolle, Simon M., Lewis, William, Hayes, Christopher J., Moody, Christopher J.

“…Copper‐ or rhodium‐catalyzed reactions of diazocarbonyl compounds with β‐hydroxyketones give highly substituted tetrahydrofurans with excellent…”
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Real‐World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID‐19 by Franklin, Jessica M., Lin, Kueiyu Joshua, Gatto, Nicolle M., Rassen, Jeremy A., Glynn, Robert J., Schneeweiss, Sebastian

“…The emergence and global spread of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has resulted in an urgent need for evidence on medical…”
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Nicotine metabolite ratio predicts smoking topography: The Pennsylvania Adult Smoking Study by Chen, Allshine, Krebs, Nicolle M., Zhu, Junjia, Muscat, Joshua E.

“…•Faster nicotine metabolism is associated with greater total daily (TD) puffs.•Faster nicotine metabolism is associated with greater TD puff volume.•Smokers…”
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Multi-set canonical correlation analysis for the fusion of concurrent single trial ERP and functional MRI by Correa, Nicolle M., Eichele, Tom, Adalı, Tülay, Li, Yi-Ou, Calhoun, Vince D.

“…Functional magnetic resonance imaging (fMRI) data and electroencephalography (EEG) data provide complementary spatio-temporal information about brain function…”
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Tobacco Use Changes and Perceived Health Risks among Current Tobacco Users during the COVID-19 Pandemic by Yingst, Jessica M, Krebs, Nicolle M, Bordner, Candace R, Hobkirk, Andrea L, Allen, Sophia I, Foulds, Jonathan

“…COVID-19 has become a global pandemic, with over 81 million cases worldwide. To assess changes in tobacco use as a result of the pandemic, we surveyed a…”
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Impact of warmer climate periods on flood hazard in the European Alps by Wilhelm, B., Rapuc, W., Amann, B., Anselmetti, F. S., Arnaud, F., Blanchet, J., Brauer, A., Czymzik, M., Giguet-Covex, C., Gilli, A., Glur, L., Grosjean, M., Irmler, R., Nicolle, M., Sabatier, P., Swierczynski, T., Wirth, S. B.

“…Flooding is a pervasive natural hazard—costly in both human and economic terms—and climate change will probably exacerbate risks around the world. Mountainous…”
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An international, phase III, randomized trial of mycophenolate mofetil in myasthenia gravis by SANDERS, D. B, HART, I. K, MANTEGAZZA, R, SHUKLA, S. S, SIDDIQI, Z. A, DE BAETS, M. H. V, MELMS, A, NICOLLE, M. W, SOLOMONS, N, RICHMAN, D. P

“…This prospective, randomized, double-blind, placebo-controlled, phase III trial assessed the efficacy, safety, and tolerability of mycophenolate mofetil (MMF)…”
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Inhibition of Benzo[a]pyrene-induced DNA Adduct in Buccal Cells of Smokers by Black Raspberry Lozenges by Chen, Kun-Ming, Krebs, Nicolle M, Sun, Yuan-Wan, Sun, Dongxiao, Liao, Jiangang, Reinhart, Lisa, Krzeminski, Jacek, Amin, Shantu, Stoner, Gary, Mallery, Susan R, El-Bayoumy, Karam

“…Using LC-MS/MS analysis we previously showed for the first time (Carcinogenesis 43:746-753, 2022) that levels of DNA damage-induced by benzo[a]pyrene (B[a]P),…”
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Hybrid strategy in neonates with ductal-dependent systemic circulation and multiple risk factors by Ceneri, Nicolle M., Desai, Manan H., Tongut, Aybala, Ozturk, Mahmut, Ramakrishnan, Karthik, Staffa, Steven J., Zurakowski, David, Donofrio, Mary T., Downing, Tacy, d’Udekem, Yves, Jonas, Richard A., Yerebakan, Can, Clauss, Sarah, Kalinger, Kathleen, Kanter, Joshua, Munoz, Ricardo, Peer, Syed M., Sinha, Pranava, Wernovsky, Gil

“…The study objective was to analyze outcomes of the hybrid strategy for ductal-dependent systemic circulation consisting of bilateral pulmonary artery banding…”
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Macrophage IL-1β promotes arteriogenesis by autocrine STAT3- and NF-κB-mediated transcription of pro-angiogenic VEGF-A by Mantsounga, Chris S., Lee, Cadence, Neverson, Jade, Sharma, Sheila, Healy, Abigail, Berus, Joshua M., Parry, Crystal, Ceneri, Nicolle M., López-Giráldez, Francesc, Chun, Hyung J., Lu, Qing, Sellke, Frank, Choudhary, Gaurav, Morrison, Alan R.

“…Peripheral artery disease (PAD) leads to considerable morbidity, yet strategies for therapeutic angiogenesis fall short of being impactful. Inflammatory…”
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Detection of DNA adducts derived from the tobacco carcinogens, benzo[a]pyrene and dibenzo[def,p]chrysene in human oral buccal cells by Chen, Kun-Ming, Sun, Yuan-Wan, Krebs, Nicolle M, Sun, Dongxiao, Krzeminski, Jacek, Reinhart, Lisa, Gowda, Krishne, Amin, Shantu, Mallery, Susan, Richie, John P, El-Bayoumy, Karam

“…Abstract Polycyclic aromatic hydrocarbons (PAHs) are recognized as potential etiological agents in the development of oral cancer in smokers. In particular,…”
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