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1. A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of Iberdomide in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared with Healthy Subjects

Author

Cheng Y, Ye Y, Gaudy A, Ghosh A, Xue Y, Wang A, Zhou S, and Li Y

Subjects
hepatic impairment, iberdomide, pharmacokinetics, Therapeutics. Pharmacology, RM1-950
Abstract

Yiming Cheng,1 Ying Ye,1 Allison Gaudy,1 Atalanta Ghosh,2 Yongjun Xue,3 Alice Wang,1 Simon Zhou,1 Yan Li1 1Clinical Pharmacology & Pharmacometrics, Bristol Myers Squibb, Princeton, NJ, USA; 2Global Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, NJ, USA; 3Nonclinical Research & Development, Bristol Myers Squibb, Princeton, NJ, USACorrespondence: Yan Li, Clinical Pharmacology & Pharmacometrics, Bristol Myers Squibb, 556 Morris Ave, Summit, Princeton, NJ, 07901, USA, Tel +1 908-481-6203, Email Yan.Li@bms.comIntroduction: Iberdomide, a novel cereblon modulator (CELMoD®), is currently under clinical investigation for hematology indications. To evaluate the influence of hepatic impairment on the pharmacokinetics (PK) of iberdomide and its major active metabolite M12, a phase 1, multicenter, open-label study was conducted in healthy subjects and subjects with mild, moderate, and severe hepatic impairment.Methods: Forty subjects were enrolled in the study and divided into five groups based on hepatic function. 1 mg iberdomide was administered and plasma samples were collected to evaluate the pharmacokinetics of iberdomide and M12.Results: After a single dose of iberdomide (1 mg), mean iberdomide Cmax (maximum observed concentration) and AUC (area under the concentration-time curve) exposure were generally comparable between hepatic impairment (HI) subjects (severe, moderate and mild) and their respective matched normal controls. Mean Cmax and AUC exposure of the metabolite M12 were generally comparable between mild HI and matched normal subjects. However, mean Cmax of the M12 was 30% and 65% lower and AUC was 57% and 63% lower in moderate and severe HI subjects as compared to their respective matched normal controls. However, given the relatively low M12 exposure as compared to its parent drug, the observed differences were not considered clinically meaningful.Conclusion: In summary, 1 mg single oral dose of iberdomide was generally well-tolerated. HI (mild, moderate or severe) had no clinically relevant impact on iberdomide PK and therefore, no dose adjustment is warranted.Keywords: hepatic impairment, iberdomide, pharmacokinetics

Published
2023

2. Dynamics and energetics of ion adsorption at the interface between a pure ionic liquid and carbon electrodes

Author

Gaudy, Nicolas, Salanne, Mathieu, and Merlet, Céline

Subjects
Condensed Matter - Soft Condensed Matter, Condensed Matter - Materials Science
Abstract

Molecular dynamics simulations have been used extensively to determine equilibrium properties of the electrode-electrolyte interface in supercapacitors held at various potentials. While such studies are essential to understand and optimize the performance of such energy storage systems, investigations of the dynamics of adsorption during the charge of the supercapacitors is also necessary. Dynamical properties are especially important to get an insight into the power density of supercapacitors, one of their main assets. In this work, we propose a new method to analyze the trajectories of adsorbing ions. We focus on pure 1-ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide in contact with planar carbon electrodes. We characterize the evolution of the ion orientation and ion-electrode distance during adsorption and show that ions reorientate as they adsorb. We then determine the forces experienced by the adsorbing ions and demonstrate that Coulomb forces dominate at long range while van der Waals forces dominate at short range. We also show that there is an almost equal contribution from the two forces at an intermediate distance, explaining the peak of ion density close to the electrode surface.

Published
2024

3. Propuesta didáctica de intervención oportuna para infantes de dos a tres años en contextos institucionalizados / Didactic proposal of opportune intervention for infants of two to three years in institutionalized contexts

Author

Gaudy Acuña Rivera, Carolina Blanco Calderón, Dalis Delgado Villalobos, and Zeidy Díaz Chavarría

Subjects
desarrollo humano, desarrollo infantil, intervención oportuna, propuesta didáctica, costa rica, human development, Education, Education (General), L7-991
Abstract

La dinámica de la sociedad actual en que mujeres y hombres, se han integrado al ámbito laboral, genera que la población infantil sea institucionalizada a edades cada vez más tempranas, esto plantea un reto para los centros educativos que les atiende, cuya función no sólo sea asistencial, sino educativa e integral. La propuesta que se desarrolla en el este artículo surge de una investigación cualitativa etnográfica que pretende reconocer la realidad de trabajo en instituciones educativas: públicas, privadas e institucionales, en contraste con la teoría y los aportes de especialistas en el desarrollo integral. Así, se logra reconocer las fortalezas y deficiencias de la labor pedagógica en el marco de la educación costarricense con este grupo, se concreta el aporte de un perfil de desarrollo actual y contextualizado y se incentiva la creación de propuestas similares en relación con otras edades propias del nivel Preescolar. The dynamics of a current society, in which women and men have been integrated into the work force, propitiate an institutionalization of the child population at increasingly early ages, this poses a challenge for schools that receive them, whose function is not only to see their needs, but are also educational and comprehensive. The proposal developed in this article stems from an ethnographic qualitative research that seeks to recognize the reality of working in educational institutions: public, private and institutional, as opposed to the theory and contributions from specialists in comprehensive development. Thus, with this group, the strengths and weaknesses of the educational work in the context of the education in Costa Rica are recognized, specifically, through the contribution of a current development profile, which contextualizes and encourages the creation of similar proposals, in relation to other age groups part of the Preschool level.

Published
2011
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7. Clinical Impact of High Throughput Sequencing on Liquid Biopsy in Advanced Solid Cancer

Author

Etienne Gouton, Nausicaa Malissen, Nicolas André, Arnaud Jeanson, Annick Pelletier, Albane Testot-Ferry, Caroline Gaudy-Marqueste, Laetitia Dahan, Emeline Tabouret, Thomas Chevalier, Laurent Greillier, and Pascale Tomasini

Subjects
cancer, molecular profiling, liquid biopsy, targeted therapy, precision oncology, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: Cancer therapies targeting actionable molecular alterations (AMA) have developed, but the clinical routine impact of high-throughput molecular profiling remains unclear. We present a monocentric experience of molecular profiling based on liquid biopsy in patients with cancer. Methods: Patients included had solid cancer and underwent cfDNA genomic profiling with FoudationOne Liquid CDx (F1LCDx) test, analyzing 324 genes. Primary endpoint was to describe patients with an AMA for whom clinical decisions were impacted by F1LCDx test results. Results: 191 patients were included, mostly with lung cancer (46%). An AMA was found in 52%. The most common molecular alterations were: TP53 (52%), KRAS (14%) and DNMT3 (11%). The most common AMA were: CHEK2 (10%), PIK3CA (9%), ATM (7%). There was no difference in progression-free survival (2.66 months vs. 3.81 months, p = 0.17), overall survival (5.3 months vs. 7.1 months, p = 0.64), or PFS2/PFS1 ratio ≥ 1.3 (20% vs. 24%, p = 0.72) between patients receiving a molecularly matched therapy (MMT) or a non-MMT, respectively. Patients with a MMT had an overall response rate of 19% and a disease control of 32%. Conclusions: Routine cfDNA molecular profiling is feasible and can lead to the access of targeted therapies. However, no notable benefit in patient’s outcomes was shown in this unselected pan-cancer study.

Published
2022
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8. Real-world outcomes of combined lenvatinib and anti-PD-1 in advanced melanoma: the Lenvamel study, a multicenter retrospective study of the French Group of Skin Cancers (Groupe de Cancérologie Cutanée).

Author

Rousset, Perrine, Nardin, Charlée, Maubec, Eve, Heidelberger, Valentine, Picard, Alexandra, Troin, Laura, Gerard, Emilie, Kramkimel, Nora, Steff-Naud, Maud, Quéreux, Gaëlle, Gaudy-Marqueste, Caroline, Lesage, Candice, Mignard, Claire, Jeudy, Géraldine, Jouary, Thomas, Saint-Jean, Mélanie, Baroudjian, Barouyr, Archier, Elodie, Mortier, Laurent, and Lebbe, Céleste

Subjects
THERAPEUTIC use of antineoplastic agents, MELANOMA prognosis, THERAPEUTIC use of monoclonal antibodies, QUINOLINE, DIARRHEA, MELANOMA, SKIN tumors, DRUG side effects, ANTINEOPLASTIC agents, PROTEIN-tyrosine kinase inhibitors, IMMUNOTHERAPY, FATIGUE (Physiology), HYPERTENSION, TREATMENT effectiveness, RETROSPECTIVE studies, DESCRIPTIVE statistics, IMMUNE checkpoint inhibitors, LONGITUDINAL method, ODDS ratio, RESEARCH, PROGRAMMED cell death 1 receptors, TUMOR classification, PROGRESSION-free survival, VOMITING, CONFIDENCE intervals, NAUSEA, OVERALL survival
Abstract

Background Currently, treatment options for patients with advanced melanoma who experience failed immunotherapy or targeted therapy are lacking. Recent studies suggest the antitumor activity of combined pembrolizumab and lenvatinib in patients with advanced melanoma progressing on immunotherapy. Herein, we report the clinical outcomes of combined lenvatinib and a programmed cell death protein-1 inhibitor (PD-1) in this population. Materials and Methods This French multicenter real-world study was conducted between September 2020 and July 2023. The primary endpoint was the objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (version 1.1). Secondary variables were treatment-related adverse events (TRAEs), progression-free survival (PFS), overall survival (OS), and duration of response (DOR). Results Of the 67 patients included (median age, 69 years; median follow-up, 5.0 months), 85% had stage IV-M1c or M1d disease. The overall ORR was 28.4% (95% CI, 18%-41%), including 3 complete (4.5%) and 16 partial (23.9%) responses. Median DOR was 3.1 (interquartile range, 1.3-4.3) months. Median PFS and OS were 3.1 (95% CI, 2.5-3.7) and 9.8 (95% CI, 5.6-13.9) months, respectively. Grades 3-5 TRAEs occurred in 16 (24%) patients; common TRAEs were fatigue (43.3%), nausea/vomiting (26.8%), diarrhea (20.9%), and hypertension (20.9%). No treatment-related deaths occurred. Conclusion Our real-world study demonstrates an interesting response rate and acceptable safety profile in a population with poor prognostic factors. Our data support this treatment option for refractory melanoma, as it is not approved by the Food and Drug Administration or European Medicines Agency, and highlight the need for new strategies. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Molecularly matched targeted therapy: a promising approach for refractory metastatic melanoma.

Author

Connell, Emily, Gerard, Émilie, Oules, Bénédicte, Brunet-Possenti, Florence, Lamoureux, Anouck, Bonnefille, Hugo, Mary-Prey, Sorilla, Carrasquilla, Ana, Mouret, Stéphane, Kramkimel, Nora, Lesage, Candice, Stoebner, Pierre-Emmanuel, Bartoli, Axel, Monestier, Sandrine, Correard, Florian, Gros, Audrey, Jeanson, Arnaud, Ouafik, L'Houcine, Gaudy-Marqueste, Caroline, and Tomasini, Pascale

Subjects
MELANOMA treatment, RETROSPECTIVE studies, DESCRIPTIVE statistics, MANN Whitney U Test, METASTASIS, LONGITUDINAL method, KAPLAN-Meier estimator, RESEARCH, INDIVIDUALIZED medicine, GENETIC mutation, TUMOR classification, DATA analysis software, MOLECULAR diagnosis
Abstract

Background Only a fraction of patients with metastatic melanoma derive durable benefit from approved treatments. The clinical impact of personalized medicine strategies for melanoma, apart from BRAF , NRAS , or CKIT targeting, has rarely been reported. Materials and Methods By means of the Group of Cutaneous Oncology of the French Society of Dermatology, we retrospectively included all patients with advanced melanoma aged 18 years and older for whom molecular testing identified one or more actionable molecular alterations and who accordingly received molecularly matched therapy. We excluded patients with only BRAF , NRAS , or CKIT alterations and patients who received molecularly matched therapy for less than 15 days. Results We included 26 patients with a median follow-up of 8 months (1-54), a median age of 63 years (24-89), and a sex ratio of 2.7. These patients had been heavily pretreated, and 64% had elevated LDH levels. The disease control rate was 38%, with 4 cases of partial response (overall response rate: 15%) and 6 of stable disease for at least 6 months. The median duration of treatment was 3.1 months (0.9-13.5). Among patients with disease control, the median duration of control was 6.6 months (2.6-13.5) and 3 cases were ongoing at the end of the study. Patients with controlled disease had GNA11 , MAP2K1 , FYCO1-RAF1 , HRAS , ATM , CCND1 , MDM2/CDK4 , and CDKN2A/NRAS alterations. Conclusions High-throughput sequencing followed by matched targeted therapy is a promising approach for patients with advanced melanoma refractory to approved treatments. [ABSTRACT FROM AUTHOR]

Published
2024
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11. La ctividad física y la recreación como estrategias para impactar a las comunidades locales y promover el desarrollo de habilidades blandas en el estudiantado: la experiencia de extensión universitaria con estudiantes de diferentes carreras en la Sede Int

Author

Yanixa Miranda-Benavides, Karla Miranda-Benavides, and Gaudy Prendas-Aguilar

Subjects
actividad física, extensión universitaria, habilidades blandas, Sociology (General), HM401-1281
Abstract

Este artículo presenta las experiencias de la población estudiantil de diferentes carreras de la Sede Interuniversitaria de Alajuela de la Universidad Nacional, que, como parte de su proceso de aprendizaje en el curso Actividades y Eventos Recreativos, diseña y ejecuta actividades que promueven la actividad física y la recreación con diferentes poblaciones de la provincia de Alajuela. Para la sistematización de esta experiencia se aplicó un cuestionario al estudiantado y a las personas responsables de las organizaciones donde se efectuaron las actividades, con el propósito de conocer su percepción en relación con los resultados obtenidos. Este ejercicio es una prueba de cómo por medio del aprendizaje y de la extensión es posible fortalecer habilidades en el estudiantado e impactar a las comunidades.

Published
2021
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12. Response to upfront azacitidine in juvenile myelomonocytic leukemia in the AZA-JMML-001 trial

Author

Niemeyer, Charlotte M., Flotho, Christian, Lipka, Daniel B., Starý, Jan, Rössig, Claudia, Baruchel, André, Klingebiel, Thomas, Micalizzi, Concetta, Michel, Gérard, Nysom, Karsten, Rives, Susana, Schmugge Liner, Markus, Zecca, Marco, Schönung, Maximilian, Baumann, Irith, Nöllke, Peter, Benettaib, Bouchra, Biserna, Noha, Poon, Jennifer, Simcock, Mathew, Patturajan, Meera, Menezes, Daniel, Gaudy, Allison, van den Heuvel-Eibrink, Marry M., and Locatelli, Franco

Published
2021
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14. Ultraviolet light-induced collagen degradation inhibits melanoma invasion

Author

Timothy Budden, Caroline Gaudy-Marqueste, Andrew Porter, Emily Kay, Shilpa Gurung, Charles H. Earnshaw, Katharina Roeck, Sarah Craig, Víctor Traves, Jean Krutmann, Patricia Muller, Luisa Motta, Sara Zanivan, Angeliki Malliri, Simon J. Furney, Eduardo Nagore, and Amaya Virós

Subjects
Science
Abstract

Ultraviolet radiation (UVR) increases melanoma incidence. Here, the authors report that UVR-damaged dermal fibroblasts upregulate MMP1 to degrade collagen which inhibits melanoma invasion and that aged primary melanomas in skin with degraded collagen have a better prognosis, while new collagen synthesis restores invasion and leads to death.

Published
2021
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15. Efficacy and safety of mammalian target of rapamycin inhibitors in systemic mastocytosis: A nationwide French pilot study.

Author

Moraly, Josquin, Rossignol, Julien, Rouzaud, Claire, Gabas, Thomas, Bouktit, Hassiba, Lhermitte, Ludovic, Canioni, Danielle, Fraitag, Sylvie, Bruneau, Julie, Barete, Stéphane, Suarez, Felipe, Ballul, Thomas, Meni, Cécile, Polivka, Laura, Terriou, Louis, Launay, David, Bouillet, Laurence, Gaudy‐Marqueste, Caroline, Gousseff, Marie, and Le Mouel, Edwige

Published
2024
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17. ESMO consensus conference recommendations on the management of locoregional melanoma: under the auspices of the ESMO Guidelines Committee

Author

Michielin, O., van Akkooi, A., Lorigan, P., Ascierto, P.A., Dummer, R., Robert, C., Arance, A., Blank, C.U., Chiarion Sileni, V., Donia, M., Faries, M.B., Gaudy-Marqueste, C., Gogas, H., Grob, J.J., Guckenberger, M., Haanen, J., Hayes, A.J., Hoeller, C., Lebbé, C., Lugowska, I., Mandalà, M., Márquez-Rodas, I., Nathan, P., Neyns, B., Olofsson Bagge, R., Puig, S., Rutkowski, P., Schilling, B., Sondak, V.K., Tawbi, H., Testori, A., and Keilholz, U.

Published
2020
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18. ESMO consensus conference recommendations on the management of metastatic melanoma: under the auspices of the ESMO Guidelines Committee

Author

Keilholz, U., Ascierto, P.A., Dummer, R., Robert, C., Lorigan, P., van Akkooi, A., Arance, A., Blank, C.U., Chiarion Sileni, V., Donia, M., Faries, M.B., Gaudy-Marqueste, C., Gogas, H., Grob, J.J., Guckenberger, M., Haanen, J., Hayes, A.J., Hoeller, C., Lebbé, C., Lugowska, I., Mandalà, M., Márquez-Rodas, I., Nathan, P., Neyns, B., Olofsson Bagge, R., Puig, S., Rutkowski, P., Schilling, B., Sondak, V.K., Tawbi, H., Testori, A., and Michielin, O.

Published
2020
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22. FACTORES QUE INCIDEN EN LA DESERCIÓN UNIVERSITARIA

Author

Gaudy Teresa Uriol Castillo and Betsy Anilú Mego Sánchez

Subjects
Deserción universitaria, Responsabilidad social universitaria, Tutoría en la universidad, General Works
Abstract

El estudio tuvo como objetivo determinar la principal causa que incide en la deserción universitaria, identificando aquellos factores que promueven la deserción estudiantil, además de la ponderación de estos, vinculando de manera trasversal como un indicador incide en otro y estos en su conjunto al momento de dejar las aulas. El estudio responde a un enfoque cuantitativo de tipo descriptivo – no experimental; la técnica aplicada fue la encuesta, con un cuestionario de 17 preguntas como instrumento. La muestra fue de 77 estudiantes universitarios. La investigación concluye identificando como fuerza predominante en la deserción de los estudiantes al factor socioeconómico, justificado en el 58% de universitarios que se apartaron de las aulas, fue como respuesta a limitaciones económicas, relacionado con el 61% de estudiantes que autofinancian sus estudios, y solo el 39% cuentan con apoyo de algún familiar, excluyendo en términos ponderativos a los factores académicos e institucionales.

Published
2021
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23. State Skill Standards: Fashion, Textiles and Design

Author

Nevada Department of Education, Campbell, Rene Crepaldi, Gaudy, Glenna, Green-Jobe, Victoria, Hatch, Susan, Moen, Julianne, Sheldon, Shannon, Smith, Loree, and Chessell, Karen

Abstract

The mission of Fashion, Textiles and Design Education is to prepare students for family and community life and careers in the fashion industry by creating opportunities to develop the knowledge, skills, attitudes and behaviors needed to: (1) Examine skills needed to effectively manage clothing decisions; (2) Evaluate the use, care and production of fibers, fabrics and textiles; (3) Integrate knowledge, skills and practices in clothing and textile construction; (4) Develop skills needed in the field of fashion merchandising; (5) Analyze career paths within the fashion, textiles and design fields; and (6) Achieve competence in workplace readiness, career development and lifelong learning. The standards apply to all students, regardless of age, gender, cultural or ethnic background, disabilities, aspirations, interests or motivations. The Fashion, Textiles and Design Standards format consists of three levels: the content standard; the performance standard; and performance indicators. The Fashion, Textiles and Design Standards include competency-based, conceptual and process perspectives. The content standard provides a broad description to assist individuals in understanding the content of the area. This standard is designed to provide a general description and overall direction.

Published
2008

24. A pig model of chronic hepatitis E displaying persistent viremia and a downregulation of innate immune responses in the liver

Author

León-Janampa, Nancy, primary, Caballero-Posadas, Ignacio, additional, Barc, Céline, additional, Darrouzain, François, additional, Moreau, Alain, additional, Guinoiseau, Thibault, additional, Gatault, Philippe, additional, Fleurot, Isabelle, additional, Riou, Mickaël, additional, Pinard, Anne, additional, Pezant, Jérémy, additional, Rossignol, Christelle, additional, Gaudy-Graffin, Catherine, additional, Brand, Denys, additional, and Marlet, Julien, additional

Published
2023
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26. Continuing Professional Development Model in the Schools Division of Sarangani

Author

Roy Tribunalo and Gaudy C. Ortizo

Abstract

This study explored and determined the extent of the Continuing Professional Development (CPD) implementation in government school institutions in the Sarangani Division for School Year 2022-2023. The 375 respondents from a total population of 6, 042 public school teacher were randomly selected across the 23 school districts. Based on the findings, the hypothesis on no significant relationship between the extent of the CPD implementation and the teacher’s competencies is accepted because of the Pearson’s r-value of -0.081 with negligible correlation 0.118 p-value. However, the hypothesis on no significant relationship between the contributing factors and the extent of CPD implementation is rejected and the model is a partial mediation. Sobel test yielded a z-value of -3.10600817 with a p-value of 0.00189631 that means significant at 0.05 level. Further, three major themes surfaced from the informant’s in-depth interview after an intensive analysis of the data gathered, namely: Limited Training Offered, Insufficient Execution of the Program, and Participatory Barriers to CPD Training. The indicated training need, preferred CPD modalities and pace, as well as monitoring, evaluation, and offering technical support to schools in terms of CPD may be taken into consideration by DepEd Offices. Hence, a CPD Model is recommended to take effect in the Schools Division of Sarangani to address the actual competency gap and relevant training needs for teachers’ professional growth and development.

Published
2023

28. High Risk of Anal and Rectal Cancer in Patients With Anal and/or Perianal Crohn’s Disease

Author

Colombel, Jean-Frédéric, Cosnes, Jacques, Gendre, Jean-Pierre, Lémann, Marc, Hébuterne, Xavier, Cortot, Antoine, Bouhnik, Yoram, Laharie, David, Dupas, Jean Louis, Flourié, Bernard, Lerebours, Eric, Beaugerie, Laurent, Peyrin-Biroulet, Laurent, Allez, Matthieu, Messing, Bernard, Cadiot, Guillaume, Marteau, Philippe, Soulé, Jean-Claude, Gornet, Jean-Marc, Veyrac, Michel, Duclos, Bernard, Beau, Philippe, Bourreille, Arnaud, Baumer, Philippe, Carbonnel, Franck, Heresbach, Denis, Metman, Etienne-Henry, Florent, Christian, Blain, Antoine, Faucheron, Jean-Luc, Bonaz, Bruno, Roblin, Xavier, Potier, Pascal, Boehm, Christian, Kurtz, Thierry, Lamouliatte, Hervé, Nion-Larmurier, Isabelle, Delchier, Jean-Charles, Chaussade, Stanislas, Weiss, Anne Marie, Cézard, Jean Pierre, Siproudhis, Laurent, Nahon, Stéphane, Sondag, Daniel, Jian, Raymond, Souquet, Jean-Christophe, Bord, Pierre, Coffin, Benoit, D’almagne, Hélène, Delasalle, Patrick, Fournier, Régis, Cavicchi, Maryan, Souffran, Marc-Henry, Vandromme, Luc, Guedon, Claire, Seksik, Philippe, Michiels, Christophe, Renard, Pascal, Rogier, Patrice, Gouilloud, Sylvie, Rotenberg, André, Savoye, Guillaume, Thevenin, Alain, Mallet, Laurent, Brazier, Franck, Jean, Francois, Justum, Anne-Marie, Latrive, Jean-Paul, Gerbal, Jean-Luc, Pierrugues, Robert, Chardonnal, Gérard, Picon, Laurence, Reix, Nicole, D’aubigny, Nicolas Drouët, Uettwiller, Hervé, Mallet, Anne Courillon, Palacci, Alain, Bensaude, Raoul-Jacques, Bonniaud, Pierre, Empinet, Olivier, Nisard, Andrée, Rudelli, Alain, Tubiana, Bernard, Capelle, Philippe, Dabadie, Alain, Evard, Daniel, Julien, Pierre-Emile, Picon-Coste, Magali, Schneider, Stéphane, Goldfain, Denis, Bellanger, Jérôme, Blondelot, Jean-Pierre, Lamy, Philippe, Lemière, Sébastien, Mockly, Jean Francois, Pellat, Benoit, Gatineau-Sailliant, Gilles, Nalet, Bernard, Nancey, Stéphane, Kusielewicz, Daniel, Loison, Patrick, Popot, Jean-Michel, Merite, François, Roux, Jean-Pol, Afchain, Pauline, Blanquart, Alain, Heyries, Laurent, Reville, Marc, Viron, Dominique, Zerbib, Frank, Claviere, Christophe, Léostic, Didier, Pouderoux, Philippe, Moitry, Alain, Hagège, Hervé, Hugot, Jean-Pierre, Humeau, Benoit, Sabate, Jean-Marc, Lederman, Emmanuel, Lescut, Dominique, Luneau, Fabrice, Mesnard, Bruno, Smadja, Lionel, Steinberg, Michel, Brun, Marc, Macaigne, Gilles, Marchal, Jean Luc, Ollivier, Stéphane, Ouvry, Dominique, Perche, Jean Paul, Rambaud, Serge, Benamouzig, Robert, Cazenave, Jean Louis, Coffin, Jean-Charles, Blazquez, Martine, Lagneau, Marion, Person, Bruno, Wittersheim, Christian, Napoleon, Bertrand, Cemachovic, Israël, Iglicki, Franck, Howaizi, Mehran, Leprince, Eric, Leurent, Bruno, Morin, Thierry, Darsouni, Riad, Attar, Alain, Baron, Philippe, Breton, Anne, Gillion, Jean Marie, Guemene, Jean-Marc, Jouffre, Claude, Moreau, Xavier, Claude, Pierre, Quinton, André, Abitbol, Vered, Brichard, Jean Michel, Desaint, Benoit, Bouygues, Martin, Chatrenet, Philippe, Salmeron, Marcelo, Silvie, Jean, Waldner, Bruno, Emery, Yves, Moraillon, Armand, Kunkel, Daniel, Dubois, Philippe, Faure, Patrick, L'Hirondel, Christian, Labérenne, Jean-Eric, Moreau, Pierre, Pereira, Adelino, Plihon, Genevieve, Wolff, Thierry, Ngo, Yann, Boruchowicz, Arnaud, Jost, Béatrice, Gotlib, Jean Pierre, Danne, Odile, Raoux, Philippe, Ramond-Bouhali, Marie-José, Baetz, Andre, Veyres, Bruno, Chapoutot, Christian, Le Dréau, Gérard, Filippi, Jérôme, Mudry, Jean, Kalt, Philippe, Minault, Sophie, Bounin, Pierre-André, Andréani, Tony, Charneau, Jacky, Reijasse, Didier, Bolze, Jean-Louis, Thaunat, Jean Luc, Le Couteulx, Christian, Maurage, Chantal, Bader, Robert, Codjovi, Philippe, Migairou, Jean-Luc, Morali, Alain, Rey, Philippe, Molard, Bruno Richard, Petit, Richard, Koch, Stéphane, Cassan, Philippe, Deschamps, Jean-Paul, Caby, Christine Meicler, Meurisse, Jean-Jacques, Prades, Philippe, Boulant, James, Diacono, Michel, Monsch, Jean-Marie, Dupuy, J-François, Bellaiche, Guy, Guegan, Martine, Comte, Jean-Marc, Cayla, Jean-Michel, Le Tallec, Francois, Meurisse, Franck, Desurmont, Philippe, Roget, Laurent, Bouyssou, Philippe, Le Gall, Bruno, Bloch, Francis, Larvol, Loic, Jullien, Monique, Moreau, Jacques, Rebouissoux, Laurent, Decroix, Bruno, Dib, Nina, Dieterling, Paul, Lenormand, Frédéric, Lagier, Emmanuel, Fallourd, Philippe, Charpin, Serge, Bertrand, Hugues, Bommelaer, Gilles, Battistelli, Daniel, Delon, Bernard, Dentant, Lionel, Dorval, Etienne, Dumortier, Jérôme, Gaye-Bareyt, Eric, Gerosa, Yves, Guez, Chantal, Mornet, Martine, Benfredj, Paul, Piperaud, René, Stremsdoerfer, Noel, Verdier, Eric, Grinholtz, Alain, Barjonet, Georges, See, Antoine, Arotçarena, Ramuntxo, Baudet, Anne, Broyer, Joel, Charachon, Antoine, Blondon, Hugues, Mouton, Pascal, Claudez, Hubert, Labat-Labourdette, Jacques, Haëm, Jacques, Estable, Patrick, Levy, Patrick, Rosenbaum, Alain, Balavoine, Yvon, Blanchi, Alain, Coutarel, Pierre, Delaperriere, Nadege, Dervichian, Michel, Marois, Francis, Seroka, Jacques, Michaud, Laurent, Leroy, Olivier, Meyran, Emmanuel, Poilroux, Bernard, Tensaouti, Abdallah, Paupard, Thierry, Agard, Dominique, Beaulieu, Sandrine, Benfiguig, Kader, Capony, Patrice, Cottereau, Jean, Desreumaux, Pierre, Dramard, Jean-Michel, Duché, Mathieu, Mamou, Patrick, Etienney, Isabelle, D'Abrigeon, Gilles, Godeberge, Béatrice, Tucat, Gilbert, Puech, Jean, Roger, Jean, Lapalus, Marie-George, Bauret, Paul, Houcke, Philippe, Pornin, Béatrice, Champigneulle, Bruno, Cuissard, Laurent, David, Xavier-Richard, Lombard, Frédéric, Granveau, Antoine, Hamon, Jean-François, Ink, Olivier, Blondel, Fabienne, Namias, Alain, Pillon, Didier, Reignier, Antoine, Tordjman, Gilles, Christidis, Christos, Zirabe, Simon, Audebert, Michel, Bion, Eric, Bourgeaux, Claude, Poupardin, Cécile, Deplaix, Philippe, Fratini, Gérard, Garnier, Thierry, Desseaux, Gerard, Magois, Hervé, Lochum, Sylvain, Vergier, Jean-Francois, Texereau, Patrick, Rat, Christel, Uzzan, Francoise, Vidal, Alain, Vinante, Nadia, Watrin, Bernard, Wurtz-Huckert, Cécile, Barre, Bruno, Ferbus, Dominique Chaslin, Contou, Jean-François, Coupier, Dominique, David, Benoit, Gargot, Dany, Huc, Denis, Barraya, Remy, Faroux, Roger, Fourgeaud, Jean-Luc, Grimprel, Hubert, Auroux, Jean, Rey, Jean-François, Arnoux, Jean Pierre, Lentini, Franck, Tardy, Ludovic, Mouterde, Olivier, Spyckerelle, Claire, Vacherot, Bruno, Weissman, Alain, Alpérine, Michel, Le Sidaner, Anne, Bonnet-Eymard, Pierre-Olivier, Colson, Jean Louis, Pellet, Daniel, Deltombe, Bernard, Edouard, André, Maechel, Henri, Jaillet, Jean-Claude, Genes, Julien, Leveque, Anne-Marie, Lucidarme, Damien, Maignan, Philippe, Gehrke, Nathalie Mallier, Sanchez, Jérôme, Tusseau, Frank, Casteur, Alban, Bottlaender, Jacques, Constantini, Denis, Coton, Thierry, Even, Philippe, Druart, Francois, Riot, François, Gauchet, Jean-Michel, Hecquet, Geneviève, Henry, Gerard, Hochain, Patrick, Arpurt, Jean Pierre, Medini, Abdelkrim, Dartois-Hoguin, Michele, Moindrot, Henri, Emery, Philippe, Periac, Pierre, Prunier, Annie, Renkes, Pascal, Tawil-Longreen, Christine, Vincent, Edmond, Vitte, René-Louis, Loeb, Christian, Carwana, Alain, Barbereau, Didier, Bohon, Philippe, Corrieri-Baizeau, Céline, Sahy, Daniel, Derreveaux, Philippe, David, Dominique, Desbazeille, François, Fontenelle, Patrick, Slama, Jean Luc, Le Mercier, Yvon, Certin, Michel, Reig, Jean Jacques, Rosa, Isabelle, Helbert, Thierry, Tounian, Patrick, Turner, Luc, Perot, Valéry, Aillet, Luc, Pauwels, Arnaud, Barré, Philippe, Nury, Bernard, Cazalbou, Claude, Devulder, Franck, Durget, Alain, Dubroca, Jeanne, Gaudy, Daniele, Greff, Michel, Jacques, Christian, Lafarge, Jocelyne, Kezachian, Gilles, Le Gall, Ronan, Pariente, Alex, Pinault, Tiphaine, Bismuth, Michaël, Boyer-Darrigrand, Nathalie, Bretagnolle, Philippe, Carpentier, Stephane, Cholet, Franck, Theodore, Christian, Combes, Rémi, Combet, Francois, Delanoe, Christophe, De Montigny, Stéphanie, Soudan, Denis, Fourdan, Olivier, Minier, Gilles, Languepin, Jeanne, Roche, Jean, Ginies, Jean-Louis, Nouel, Olivier, Petitgars, Philippe, Robin, Edith, Hamm, Romain, Roques, Jean François, Roussin-Bretagne, Sylvie, Sénéjoux, Agnès, Muron, Sophie, Bardoux, Nicolas, Berthelemy, Philippe, Madonia, Patrick, Carles, Bertrand, Reynier, Catherine, Cuillerier, Emmanuel, Dadamessi, Innocenti, Danis, Jacques, Debenes, Bernard, Dubuc-Rey, Nathalie, Lesur, Gilles, Jouet, Pauline, Lenaerts, Catherine, Garret, Marc, Mineur, Alexandra, Chabry, Bernard, Pigot, Francois, Rossi, Valérie, Tennenbaum, Ruth, Salloum, Julien, Slaoui, Maurice Hakim, Mathieu, Stéphane, Papapietro, Valérie, Viola, Sheila, Bezet, Alexis, Altman, Claude, Audan, Alain, Calabet, Jean, Masliah, Claude, Fayemendy, Laurent, Duruy, Marc, Gauffeny, Benoit, Helie, Ludovic, Imani, Kamran, Janin-Manificat, Raoul, Galmiche, Jean-Paul, Kerlirzin, Anne, Bedenne, Laurent, Locher, Christophe, Michaudel, Gilles, Missonnier, Gilles, Rinaldi-Dovio, Michel, Rouillon, Jean-Michel, Ecuer, Stéphane, Patenotte, Arnaud, Bronstein, Jean Ariel, Baty, Vincent, Bougnol, Michel, Bourbon, Pierre, Cerbelaud, Philippe, Chavaillon, Annick, Boiffin, Franck, Dubern, Béatrice, De Laguierce, Isabelle Duval, Greco, Fernand, Bouhot, Florence, Godeberge, Philippe, Grandmaison, Brigitte, Gros, Pascal, Targues, Guy, Corallo, Jacques, Boutin, Jean, Guillan, Jacques, Barbieux, Jean Pierre, Lariviere, Isabelle Loury, Le Genissel, Henri, Leroi, Henri, Bellaiche, Marc, Elie-Legrand, Marie-Claire, Dapoigny, Michel, Denoyel, Philippe, Pienkowski, Patrice, Pouche, Philippe, Saurfelt, Marc Michel, Thorel, Jean Marie, Piche, Thierry, Travers, Bruno, Tuvignon, Patrick, Zalcberg, Marc, Boulay, Guy, Zamora, Christophe, Samama, Joelle, Ricotie, Etienne, De Fleury, Patrice, Maille, Francois, Mougenel, Jean Louis, Gonot, Olivier, Menat, Jean Philippe, Kaassis, Mehdi, Lang, Francoise, Abramowitz, Laurent, Ganne, Nathalie, Pecriaux, Olivier, Seyrig, Jacques-Arnaud, Sobhani, Iradj, Parmentier, Thierry, Van Nieuwenhuyse, Antoine, Weber, Francois-Xavier, Glibert, André, Bineau, Catherine, Canet, Bernard, Collin, Catherine, Cordet, Frederic, Parlier, David David, Carre, Dominique, Peytier, Annie, Fein, Francine, Barouk, Jerome, Dewannieux, Jacques, Hartwig, Johannes, Jouve, Jean-Louis, Laplane, Bertrand, Lascar, Gilles, Legrand, Christophe, Le Marchand, Pierre, Liebaert, Marie Pierre, Terdiman-Pire, Michele, Abdelli, Naceur, Neveu, Dominique, De La Lande, Philippe, De Saint Louvent, Patrick, Pelatan, Cécile, Petit, Agnès, Richecoeur, Martial, Texier, Frederic, Cazals, Jean Brice, Tissot, Bertrand, Mourrut, Christian, Doubremelle, Marie, Foltz, Marc, Gautier-Jubé, Florence, Martin, Jacques, Khouri, Elie, Lons, Thierry, Carlier-Bandu, Martine, Monnin, Jean-Luc, Roche, Hervé, Willemin, Bernard, Houard, Xavier, Fatisse, Abdelaziz, Algard, Michèle, Arab, Kamel, Borel, Isabelle, Lagarrigue, Cécile, Chryssostalis, Ariane, Boutroux, Dominique, Dupuychaffray, Jean-Pierre, Khaddari, Saïd, Mion, François, Puy-Montbrun, Thierry, Girardet, Jean-Philippe, Gury, Bruno, Landau, Alain, Le Bihan, Monique, Nieuviarts, Sandrine, Ollivry, Jean, Le Bourgeois, Philippe, Piquet, Marie-Astrid, Escartin, Michel -Pierre, Systchenko, Remi, Venezia, Franck, Wantiez, Michel, Lesage, Xavier, Zrihen, Elie, Aygalenq, Philippe, Dieumegard, Barbara, Savarieau, Bernard, Bulois, Philippe, Cattan, Stéphane, Diez, Jean-Lucien, Fauchot, Olivier, Durous, Eric, Gazut, Valérie, Guilleminet, Christian, Bories, Jean-Marc, Le Floch, Isabelle Joly, Vove, Jean-Paul, Lelouch, Stéphane, Lévy, Philippe, Lhopital, François, Marcato, Norma, Mozer-Bernardeau, Marianne, Nousbaum, Jean-Baptiste, Cattan, Philippe, Plane, Alain, Raymond, Jean-Michel, Roseau, Gilles, Rozental, Gerald, Boustière, Christian, Bonny, Corinne, Cordier-Collet, Mariepierre, Courat, Laurent, Croguennec, Bernard, Tardy, Karine Delaunay, Labarriere, Damien, Geagea, Edmond, Gottrand, Frédéric, Gelsi, Eve, Thiefin, Gerard, Wohlschies, Eric, Miguet, Mathieu, Ponsot, Philippe, Suzanne, Jean, Teste, Yves, Dupont Gossart, Anne-Claire, Baroni, Jean-Luc, Benchaa, Benabdallah, Blanc, Georges, Maroy, Bernard, Bonjean, Philippe, Brézault, Catherine, Bridoux-Henno, Laure, Chayette, Claude, Auby, Dominique, Fiorucci, Robert, Galindo, Georges, Hubert, Gilles, Bonneau, Gilles, Marinier, Evelyne, Pouteau, Michele, Alamdari, Afchine, Delbende, Bruno, Chamouard, Patrick, D'Abravanel, Pascale, Dall'Osto, Hélène, Hervé, Sophie, Lefebvre, Jean, Levoir, Damien, Lillo, Philippe, Rouch, Michel, Mathonnet, Muriel, De Lustrac, Mercédes, Ramond, François-Jean, Roupret, Bernard, Soupison, Alain, Carrat, Fabrice, Zeitoun, Jean-David, Sabaté, Jean-Marc, Fléjou, Jean-François, Kirchgesner, Julien, and Svrcek, Magali

Published
2018
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30. Tejidos residenciales en Guayaquil: indicadores urbanos relativos a la compacidad y la funcionalidad

Author

Gaudy Orejuela and Teresa Pérez de Murzi

Subjects
Urban Studies, Architecture
Abstract

Las Zonas Pascuales y Norte representan el avance más reciente de la huella urbana de Guayaquil en la frontera norte del cantón homónimo. Allí conviven diversas formas residenciales que van haciendo ciudad, a su propio ritmo y con sus propias lógicas. Este artículo tiene como objetivo presentar un análisis comparativo de tejidos residenciales a partir de la cualificación de su morfología y el uso de indicadores relacionados con la compacidad y la funcionalidad, uno de los objetivos básicos del urbanismo sostenible. Los tejidos residenciales fueron clasificados inicialmente por su origen, tipo de promoción y permeabilidad. El análisis, a través de un sistema de comparación homogéneo y utilización de parámetros cuantitativos asociados a la compacidad y la funcionalidad, permite visualizar el comportamiento, a escala barrial, de esta urbe ecuatoriana y establecer un esquema metodológico susceptible de integrarse a los diagnósticos con fines de planificación. Los resultados apuntan a importantes carencias en estos contextos fundamentales de la vida local, indiferentemente de sus orígenes y de los actores vinculados en su producción: déficit de espacios públicos, densidades inadecuadas y mezcla de usos y funciones urbanas, derivada principalmente de la improvisación.

Published
2023

31. A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of Iberdomide in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared with Healthy Subjects

Author

Yiming Cheng, Ying Ye, Allison Gaudy, Atalanta Ghosh, Yongjun Xue, Alice Wang, Simon Zhou, and Yan Li

Subjects
Pharmacology (medical), Advances and Applications [Clinical Pharmacology]
Abstract

Yiming Cheng,1 Ying Ye,1 Allison Gaudy,1 Atalanta Ghosh,2 Yongjun Xue,3 Alice Wang,1 Simon Zhou,1 Yan Li1 1Clinical Pharmacology & Pharmacometrics, Bristol Myers Squibb, Princeton, NJ, USA; 2Global Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, NJ, USA; 3Nonclinical Research & Development, Bristol Myers Squibb, Princeton, NJ, USACorrespondence: Yan Li, Clinical Pharmacology & Pharmacometrics, Bristol Myers Squibb, 556 Morris Ave, Summit, Princeton, NJ, 07901, USA, Tel +1 908-481-6203, Email Yan.Li@bms.comIntroduction: Iberdomide, a novel cereblon modulator (CELMoD®), is currently under clinical investigation for hematology indications. To evaluate the influence of hepatic impairment on the pharmacokinetics (PK) of iberdomide and its major active metabolite M12, a phase 1, multicenter, open-label study was conducted in healthy subjects and subjects with mild, moderate, and severe hepatic impairment.Methods: Forty subjects were enrolled in the study and divided into five groups based on hepatic function. 1 mg iberdomide was administered and plasma samples were collected to evaluate the pharmacokinetics of iberdomide and M12.Results: After a single dose of iberdomide (1 mg), mean iberdomide Cmax (maximum observed concentration) and AUC (area under the concentration-time curve) exposure were generally comparable between hepatic impairment (HI) subjects (severe, moderate and mild) and their respective matched normal controls. Mean Cmax and AUC exposure of the metabolite M12 were generally comparable between mild HI and matched normal subjects. However, mean Cmax of the M12 was 30% and 65% lower and AUC was 57% and 63% lower in moderate and severe HI subjects as compared to their respective matched normal controls. However, given the relatively low M12 exposure as compared to its parent drug, the observed differences were not considered clinically meaningful.Conclusion: In summary, 1 mg single oral dose of iberdomide was generally well-tolerated. HI (mild, moderate or severe) had no clinically relevant impact on iberdomide PK and therefore, no dose adjustment is warranted.Keywords: hepatic impairment, iberdomide, pharmacokinetics

Published
2023

32. Cystic Glioblastoma: A Mimicker of Infection? A Case Report and Literature Review

Author

Ram Prakash Thirugnanasambandam, Gaudy Massiel Vanegas Silva, Alexander H. Wu, Charles J. Kim, Emanuela Cimpeanu, Jeremy Minkowitz, Charles Yanping Shao, and Edwin Chiu

Subjects
Oncology
Abstract

Glioblastoma multiforme (GBM) is the most frequent malignant and aggressive type of glioma. Most cases of GBM present as a single solitary solid tumor; however, there are rare instances in which it may present as a cystic lesion. Here, we report an even rarer case of GBM presenting as bilateral multicystic lesions, mimicking infectious etiology. Our case highlights the importance of identifying clinical features of cystic GBM to ensure early diagnosis and treatment. A literature review was conducted in PubMed, looking at the common characteristics and treatment options for cystic GBM.

Published
2023

33. APOYO SOCIAL Y SATISFACCIÓN EN ADULTOS MAYORES

Author

Gaudy Teresa Uriol Castillo and Claudia Alejandra caro Sanchez Zamora

Subjects
General Medicine
Abstract

La presente investigación enfatiza en la medición del apoyo social y su influencia en la satisfacción personal del adulto mayor durante el período en el que se ejecutó el programa Amachay en la Municipalidad Distrital de Independencia 2022. El objetivo general de la investigación es determinar el nivel de influencia entre el apoyo social y la satisfacción personal de los adultos mayores del programa. Se desarrolló un estudio de tipo básico, diseño no experimental y enfoque cuantitativo. La muestra estuvo compuesta por 73 beneficiarios del programa Amachay, utilizando las técnicas de la entrevista y observación y como instrumento el cuestionario de MOS de Apoyo Social y el de Satisfacción Personal del Adulto Mayor. Los resultados demostraron que el apoyo social tiene un nivel alto del 88.88% lo cual influye en la satisfacción personal de los adultos mayores del programa Amachay. Llegando a concluir que existe una influencia significativa entre el apoyo social y la satisfacción personal del adulto mayor, es decir, que a mayor apoyo social que perciben los beneficiarios del programa Amachay, mayor será la satisfacción individual o personal que sientan.

Published
2022

34. Early Phase of Primary Melanoma Growth from the Patient Point of view: A Prospective Cross Sectional Study on Melanoma over 1 mm in Thickness

Author

Nausicaa Malissen, Safia Abed, Nicolas Macagno, Florent Amatore, Anderson Loundou, Florent Grange, Caroline Gaudy-Marqueste, and Jean-Jacques Grob

Subjects
patient, perception, melanoma, growth, Dermatology, RL1-803
Abstract

A Nodular Pink Lesion with an Uncommon Diagnosis: A QuizMost melanomas are diagnosed by the patients themselves or by their partners or relatives; they alone can describe its history. We designed a prospective cross-sectional study to describe patients’ perception of morphology, growth pattern and kinetics of their primary melanoma over 1 mm in thickness before resection. Patients were interviewed with a questionnaire, a grid representing 9 possible scenarios of melanoma growth, and a set of 87 photographs of potential aspects of melanomas and precursors. Most patients were able to describe the growth of their melanoma and select pictures representative of its successive aspects before resection. Among 453 patients, 60% reported a preexisting lesion present for years. Growth pattern scenarios concurred with tumor kinetics but with no statistical difference between nodular and superficial spreading subtypes. These subjective patient-reported indicators about melanoma growth over time could dynamically complement its objective pathological analysis otherwise static at a single time point.

Published
2020
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35. Theoretical maximum photogeneration efficiency and performance characterization of InxGa1−xN/Si tandem water-splitting photoelectrodes

Author

Yannick K. Gaudy, Žarko Gačević, and Sophia Haussener

Subjects
Biotechnology, TP248.13-248.65, Physics, QC1-999
Abstract

InxGa1−xN is a promising material for flexible and efficient water-splitting photoelectrodes since the bandgap is tunable by modifying the indium content. We investigate the potential of an InxGa1−xN/Si tandem used as a water-splitting photoelectrode. We predict a maximum theoretical photogeneration efficiency of 27% for InxGa1−xN/Si tandem photoelectrodes by computing electromagnetic wave propagation and absorption. This maximum is obtained for an indium content between 50% and 60% (i.e., a bandgap between 1.4 eV and 1.2 eV, respectively) and a film thickness between 280 nm and 560 nm. We then experimentally assess InxGa1−xN photoanodes with the indium content varying between 9.5% and 41.4%. A Mott–Schottky analysis indicates doping concentrations (which effectively represent defect density, given there was no intentional doping) above 8.1 × 1020 cm−3 (with a maximum doping concentration of 1.9 × 1022 cm−3 for an indium content of 9.5%) and flatband potentials between −0.33 VRHE for x = 9.5% and −0.06 VRHE for x = 33.3%. Photocurrent–voltage curves of InxGa1−xN photoanodes are measured in 1M H2SO4 and 1M Na2SO4, and the incident photon-to-current efficiency spectra in 1M Na2SO4. The incident photon-to-current efficiency spectra are used to computationally determine the diffusion length, the diffusion optical number, as well as surface recombination and transfer currents. A maximum diffusion length of 262 nm is obtained for an indium content of 23.5%, in part resulting from the relatively low doping concentration (9.8 × 1020 cm−3 at x = 23.5%). Nevertheless, the relatively high surface roughness (rms of 7.2 nm) and low flatband potential (−0.1 VRHE) at x = 23.5% cause high surface recombination and affect negatively the overall photoelectrode performance. Thus, the performance of InxGa1−xN photoelectrodes appears to be a tradeoff between surface recombination (affected by surface roughness and flatband potential) and diffusion length (affected by doping concentration/defect density). The performance improvements of the InxGa1−xN photoanodes are most likely achieved through modification of the doping concentration (defect density) and reduction of the surface recombination (e.g., by the deposition of a passivation layer and co-catalysts). The investigations of the ability to reach high performance by nanostructuring indicate that reasonable improvements through nanostructuring might be very challenging.

Published
2020
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36. Analysis of particulate exposure during continuous drug infusion in critically ill adult patients: a preliminary proof-of-concept in vitro study

Author

Malik Benlabed, Anthony Martin Mena, Romain Gaudy, Maxime Perez, Stéphanie Genay, Jean-Daniel Hecq, Pascal Odou, Gilles Lebuffe, and Bertrand Décaudin

Subjects
Parenteral nutrition, Intravenous, Infusion pumps, Drug incompatibility, Critical care, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background In critically ill patients, drug incompatibilities frequently occur because of the number of drugs to be administered through a limited number of infusion lines. These are among the main causes of particulate contamination. However, little data is available to quantify particle exposure during simultaneous IV-drug infusion. The objective of this study was to evaluate the particulate matter potentially administered to critically ill patients. Methods The particulate matter (between 1 μm and 30 mm) of infused therapies used in ICUs for patients suffering from either septic shock or acute respiratory distress syndrome was measured in vitro over 6 h using a dynamic image analysis device, so that both overall particulate contamination and particle sizes could be determined. Data is presented according to the recommendations of the European Pharmacopoeia (≥ 10 and 25 μm). Results For the six experimental procedures (continuous infusion of norepinephrine, midazolam, sufentanil, heparin, 5% glucose, binary parenteral nutrition and discontinuous administrations of omeprazole, piperacillin/tazobactam and fluconazole), the overall number of particles over the 6-h infusion period was 8256 [5013; 15,044]. The collected values for the number of particles ≥ 10 and 25 μm were 281 [118; 526] and 19 [7; 96] respectively. Our results showed that discontinuous administrations of drugs led to disturbances in particulate contamination. Conclusions This work indicates the amount of particulate matter potentially administered to critically ill adult patients. Particulate contamination appears lower than previous measurements performed during multidrug IV therapies in children.

Published
2018
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37. HVEM has a broader expression than PD-L1 and constitutes a negative prognostic marker and potential treatment target for melanoma

Author

Nausicaa Malissen, Nicolas Macagno, Samuel Granjeaud, Clémence Granier, Vincent Moutardier, Caroline Gaudy-Marqueste, Nadia Habel, Marion Mandavit, Bernard Guillot, Christine Pasero, Eric Tartour, Robert Ballotti, Jean-Jacques Grob, and Daniel Olive

Subjects
hvem/tnfrsf14, btla, melanoma, prognosis, mitf, Immunologic diseases. Allergy, RC581-607, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

HVEM (Herpes Virus Entry Mediator) engagement of BTLA (B and T Lymphocyte Attenuator) triggers inhibitory signals in T cells and could play a role in evading antitumor immunity. Here, HVEM expression levels in melanoma metastases were analyzed by immunohistochemistry, correlated with overall survival (OS) in 116 patients, and validated by TCGA transcriptomic data. Coincident expression of HVEM and its ligand BTLA was studied in tumor cells and tumor-infiltrating lymphocytes (TILs) by flow cytometry (n = 21) and immunofluorescence (n = 5). Candidate genes controlling HVEM expression in melanoma were defined by bioinformatics studies and validated by siRNA gene silencing. We found that in patients with AJCC stage III and IV melanoma, OS was poorer in those with high HVEM expression on melanoma cells, than in those with a low expression, by immunohistochemistry (p = .0160) or TCGA transcriptomics (p = .0282). We showed a coincident expression of HVEM at the surface of melanoma cells and of BTLA on TILs. HVEM was more widely expressed than PD-L1 in melanoma cells. From a mechanistic perspective, in contrast to PDL1, HVEM expression did not correlate with an IFNγ signature but with an aggressive gene signature. Interestingly, this signature contained MITF, a key player in melanoma biology, whose expression correlated strongly with HVEM. Finally, siRNA gene silencing validated MITF control of HVEM expression. In conclusion, HVEM expression seems to be a prognosis marker and targeting this axis by checkpoint-inhibitors may be of interest in metastatic melanoma.

Published
2019
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40. P883: ALNUCTAMAB (ALNUC; BMS-986349; CC-93269), A BCMA × CD3 T-CELL ENGAGER, IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): LATEST RESULTS FROM A PHASE 1 FIRST-IN-HUMAN CLINICAL STUDY

Author

Wong, Sandy W., primary, Bar, Noffar, additional, Victoria Mateos, María, additional, Ribas, Paz, additional, Hansson, Markus, additional, Paris, Laura, additional, Hofmeister, Craig, additional, Rodriguez-Otero, Paula, additional, Aranzazu Bermúdez, Maria, additional, Santoro, Armando, additional, Yee, Andrew J., additional, Creignou, Maria, additional, Encinas, Cristina, additional, Cerchione, Claudio, additional, de la Rubia, Javier, additional, Oriol, Albert, additional, Ferstl, Barbara, additional, Besemer, Britta, additional, Chen, Jinjie, additional, Chung, Alexander, additional, Boss, Isaac W., additional, Gaudy, Allison, additional, LI, Shaoyi, additional, Hsu, Kevin, additional, Godwin, Colin, additional, Burgess, Michael R., additional, San-Miguel, Jesús, additional, and Jose Costa, Luciano, additional

Published
2023
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42. Safety, Pharmacokinetics, and Pharmacodynamics of CC‐90001 (BMS‐986360), a c‐Jun N‐terminal Kinase Inhibitor, in Phase 1 Studies in Healthy Participants

Author

Ying, Ye, Allison, Gaudy, Michael, Thomas, Josephine, Reyes, Barbara, Burkhardt, Gerald, Horan, Liangang, Liu, Jian, Chen, Atalanta, Ghosh, Leonidas N, Carayannopoulos, Daniel A, Tatosian, and Maria, Palmisano

Subjects
Adult, Dose-Response Relationship, Drug, Double-Blind Method, JNK Mitogen-Activated Protein Kinases, Humans, Pharmaceutical Science, Pharmacology (medical), Healthy Volunteers, Half-Life
Abstract

CC-90001 selectively inhibits c-Jun N-terminal kinase (JNK), a stress-activated protein implicated in fibrosis. In 3 phase 1 trials evaluating CC-90001 pharmacokinetics, pharmacodynamics, and safety, healthy adults (N = 184) received oral CC-90001 in a single dose (10-720 mg) or multiple doses (30-480 mg once daily for 7-18 days) or placebo. CC-90001 was rapidly absorbed (median time to maximum concentration, 1-4 hours) and eliminated with a mean terminal elimination half-life of 12-28 hours. Steady state was reached on day 5, with a mean accumulation ratio of 1.5- to 2-fold following daily dosing. Exposure was similar in fed versus fasted participants and in Japanese versus non-Japanese participants. CC-90001 demonstrated dose- and exposure-dependent inhibition of JNK as determined by histopathological analysis of c-Jun phosphorylation in ultraviolet-irradiated skin. The most common treatment-emergent adverse events were nausea and headache; all were mild or moderate in intensity. Based on exposure-response analysis using high-quality electrocardiogram data, no clinically relevant QT prolongation liability for CC-90001 was observed. Overall, single- and multiple-dose CC-90001 were generally safe and well tolerated at the tested doses and demonstrated JNK pathway engagement. These results support further clinical evaluation of CC-90001.

Published
2022

43. Antibody Responses after a Third Dose of COVID-19 Vaccine in Kidney Transplant Recipients and Patients Treated for Chronic Lymphocytic Leukemia

Author

Julien Marlet, Philippe Gatault, Zoha Maakaroun, Hélène Longuet, Karl Stefic, Lynda Handala, Sébastien Eymieux, Emmanuel Gyan, Caroline Dartigeas, and Catherine Gaudy-Graffin

Subjects
COVID-19, vaccine, kidney transplant, chronic lymphocytic leukemia, antibody, Medicine
Abstract

The impact of a third dose of COVID-19 vaccine on antibody responses is unclear in immunocompromised patients. The objective of this retrospective study was to characterize antibody responses induced by a third dose of mRNA COVID-19 vaccine in 160 kidney transplant recipients and 20 patients treated for chronic lymphocytic leukemia (CLL). Prevalence of anti-spike IgG ≥ 7.1 and ≥ 30 BAU/mL after the third dose were 47% (75/160) and 39% (63/160) in kidney transplant recipients, and 57% (29/51) and 50% (10/20) in patients treated for CLL. Longitudinal follow-up identified a moderate increase in SARS-CoV-2 anti-spike IgG levels after a third dose of vaccine in kidney transplant recipients (0.19 vs. 5.28 BAU/mL, p = 0.03) and in patients treated for CLL (0.63 vs. 10.7 BAU/mL, p = 0.0002). This increase in IgG levels had a limited impact on prevalence of anti-spike IgG ≥ 30 BAU/mL in kidney transplant recipients (17%, 2/12 vs. 33%, 4/12, p = 0.64) and in patients treated for CLL (5%, 1/20 vs. 45%, 9/20, p = 0.008). These results highlight the need for vaccination of the general population and the importance of non-medical preventive measures to protect immunocompromised patients.

Published
2021
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45. Ampreloxetine Versus Droxidopa in Neurogenic Orthostatic Hypotension: A Comparative Review

Author

Hoxhaj, Pranvera, primary, Shah, Shruti, additional, Muyolema Arce, Veronica E, additional, Khan, Wajiha, additional, Sadeghzadegan, Amirali, additional, Singh, Saumya, additional, Collado, Gaudy F, additional, Goyal, Abhishek, additional, Khawaja, Imran, additional, Botlaguduru, Deepti, additional, Razzaq, Waleed, additional, Abdin, Zain U, additional, and Gupta, Ishita, additional

Published
2023
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47. A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of Iberdomide in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared with Healthy Subjects

Author

Cheng,Yiming, Ye,Ying, Gaudy,Allison, Ghosh,Atalanta, Xue,Yongjun, Wang,Alice, Zhou,Simon, Li,Yan, Cheng,Yiming, Ye,Ying, Gaudy,Allison, Ghosh,Atalanta, Xue,Yongjun, Wang,Alice, Zhou,Simon, and Li,Yan

Abstract

Yiming Cheng,1 Ying Ye,1 Allison Gaudy,1 Atalanta Ghosh,2 Yongjun Xue,3 Alice Wang,1 Simon Zhou,1 Yan Li1 1Clinical Pharmacology & Pharmacometrics, Bristol Myers Squibb, Princeton, NJ, USA; 2Global Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, NJ, USA; 3Nonclinical Research & Development, Bristol Myers Squibb, Princeton, NJ, USACorrespondence: Yan Li, Clinical Pharmacology & Pharmacometrics, Bristol Myers Squibb, 556 Morris Ave, Summit, Princeton, NJ, 07901, USA, Tel +1 908-481-6203, Email Yan.Li@bms.comIntroduction: Iberdomide, a novel cereblon modulator (CELMoD®), is currently under clinical investigation for hematology indications. To evaluate the influence of hepatic impairment on the pharmacokinetics (PK) of iberdomide and its major active metabolite M12, a phase 1, multicenter, open-label study was conducted in healthy subjects and subjects with mild, moderate, and severe hepatic impairment.Methods: Forty subjects were enrolled in the study and divided into five groups based on hepatic function. 1 mg iberdomide was administered and plasma samples were collected to evaluate the pharmacokinetics of iberdomide and M12.Results: After a single dose of iberdomide (1 mg), mean iberdomide Cmax (maximum observed concentration) and AUC (area under the concentration-time curve) exposure were generally comparable between hepatic impairment (HI) subjects (severe, moderate and mild) and their respective matched normal controls. Mean Cmax and AUC exposure of the metabolite M12 were generally comparable between mild HI and matched normal subjects. However, mean Cmax of the M12 was 30% and 65% lower and AUC was 57% and 63% lower in moderate and severe HI subjects as compared to their respective matched normal controls. However, given the relatively low M12 exposure as compared to its parent drug, the observed differences were not considered clinically meaningful.Conclusion: In summary, 1 mg single oral dose of iberdomide was generally well-tolerat

Published
2023

48. European consensus-based interdisciplinary guideline for diagnosis and treatment of basal cell carcinoma—update 2023

Author

Peris, Ketty, Fargnoli, Maria Concetta, Kaufmann, R., Arenberger, P., Bastholt, L., Seguin, N. B., Bataille, V., Brochez, L., del Marmol, V., Dummer, R., Forsea, A. -M., Gaudy-Marqueste, C., Harwood, C. A., Hauschild, A., Holler, C., Kandolf, L., Kellerners-Smeets, N. W. J., Lallas, A., Leiter, U., Malvehy, J., Marinovic, B., Mijuskovic, Z., Moreno-Ramirez, D., Nagore, E., Nathan, P., Stratigos, A. J., Stockfleth, E., Tagliaferri, Luca, Trakatelli, M., Vieira, R., Zalaudek, Iri, Garbe, C., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Tagliaferri L. (ORCID:0000-0003-2308-0982), Zalaudek I., Peris, Ketty, Fargnoli, Maria Concetta, Kaufmann, R., Arenberger, P., Bastholt, L., Seguin, N. B., Bataille, V., Brochez, L., del Marmol, V., Dummer, R., Forsea, A. -M., Gaudy-Marqueste, C., Harwood, C. A., Hauschild, A., Holler, C., Kandolf, L., Kellerners-Smeets, N. W. J., Lallas, A., Leiter, U., Malvehy, J., Marinovic, B., Mijuskovic, Z., Moreno-Ramirez, D., Nagore, E., Nathan, P., Stratigos, A. J., Stockfleth, E., Tagliaferri, Luca, Trakatelli, M., Vieira, R., Zalaudek, Iri, Garbe, C., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Tagliaferri L. (ORCID:0000-0003-2308-0982), and Zalaudek I.

Abstract

Basal cell carcinoma (BCC) is the most common malignant tumour in white populations. Multidisciplinary experts from European Association of Dermato-Oncology (EADO), European Dermatology Forum, European Society for Radiotherapy and Oncology (ESTRO), Union Européenne des Médecins Spécialistes, and the European Academy of Dermatology and Venereology developed updated recommendations on diagnosis and treatment of BCC. BCCs were categorised into ‘easy-to-treat’ (common) and ‘difficult-to-treat’ according to the new EADO clinical classification. Diagnosis is based on clinico-dermatoscopic features, although histopathological confirmation is mandatory in equivocal lesions. The first-line treatment of BCC is complete surgery. Micrographically controlled surgery shall be offered in high-risk and recurrent BCC, and BCC located on critical anatomical sites. Topical therapies and destructive approaches can be considered in patients with low-risk superficial BCC. Photodynamic therapy is an effective treatment for superficial and low-risk nodular BCCs. Management of ‘difficult-to-treat’ BCCs should be discussed by a multidisciplinary tumour board. Hedgehog inhibitors (HHIs), vismodegib or sonidegib, should be offered to patients with locally advanced and metastatic BCC. Immunotherapy with anti-PD1 antibodies (cemiplimab) is a second-line treatment in patients with a progression of disease, contraindication, or intolerance to HHI therapy. Radiotherapy represents a valid alternative in patients who are not candidates for or decline surgery, especially elderly patients. Electrochemotherapy may be offered when surgery or radiotherapy is contraindicated. In Gorlin patients, regular skin examinations are required to diagnose and treat BCCs at an early stage. Long-term follow-up is recommended in patients with high-risk BCC, multiple BCCs, and Gorlin syndrome.

Published
2023

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