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54. S3. Methods for ellagic acid, urolithin A, quercetin, and resveratrol pharmacokinetics from Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial

Author

Paller, Channing J., primary, Zhou, Xian C., primary, Heath, Elisabeth I., primary, Taplin, Mary-Ellen, primary, Mayer, Tina, primary, Stein, Mark N., primary, Bubley, Glenn J., primary, Pili, Roberto, primary, Hudson, Tamaro, primary, Kakarla, Radhika, primary, Abbas, Muneer M., primary, Anders, Nicole M., primary, Dowling, Donna, primary, King, Serina, primary, Bruns, Ashley B., primary, Wagner, William D., primary, Drake, Charles G., primary, Antonarakis, Emmanuel S., primary, Eisenberger, Mario A., primary, Denmeade, Samuel R., primary, Rudek, Michelle A., primary, Rosner, Gary L., primary, and Carducci, Michael A., primary

Published
2023
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55. S4. Supplementary Results: Prior ADT Treatment from Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial

Author

Paller, Channing J., primary, Zhou, Xian C., primary, Heath, Elisabeth I., primary, Taplin, Mary-Ellen, primary, Mayer, Tina, primary, Stein, Mark N., primary, Bubley, Glenn J., primary, Pili, Roberto, primary, Hudson, Tamaro, primary, Kakarla, Radhika, primary, Abbas, Muneer M., primary, Anders, Nicole M., primary, Dowling, Donna, primary, King, Serina, primary, Bruns, Ashley B., primary, Wagner, William D., primary, Drake, Charles G., primary, Antonarakis, Emmanuel S., primary, Eisenberger, Mario A., primary, Denmeade, Samuel R., primary, Rudek, Michelle A., primary, Rosner, Gary L., primary, and Carducci, Michael A., primary

Published
2023
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56. Supplementary Figure S4.1 from Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial

Author

Paller, Channing J., primary, Zhou, Xian C., primary, Heath, Elisabeth I., primary, Taplin, Mary-Ellen, primary, Mayer, Tina, primary, Stein, Mark N., primary, Bubley, Glenn J., primary, Pili, Roberto, primary, Hudson, Tamaro, primary, Kakarla, Radhika, primary, Abbas, Muneer M., primary, Anders, Nicole M., primary, Dowling, Donna, primary, King, Serina, primary, Bruns, Ashley B., primary, Wagner, William D., primary, Drake, Charles G., primary, Antonarakis, Emmanuel S., primary, Eisenberger, Mario A., primary, Denmeade, Samuel R., primary, Rudek, Michelle A., primary, Rosner, Gary L., primary, and Carducci, Michael A., primary

Published
2023
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57. Supplemental Figure 2 from A Phase I Trial of a Guadecitabine (SGI-110) and Irinotecan in Metastatic Colorectal Cancer Patients Previously Exposed to Irinotecan

Author

Lee, Valerie, primary, Wang, Judy, primary, Zahurak, Marianna, primary, Gootjes, Elske, primary, Verheul, Henk M., primary, Parkinson, Rose, primary, Kerner, Zachary, primary, Sharma, Anup, primary, Rosner, Gary, primary, De Jesus-Acosta, Ana, primary, Laheru, Daniel, primary, Le, Dung T., primary, Oganesian, Aram, primary, Lilly, Ellen, primary, Brown, Thomas, primary, Jones, Peter, primary, Baylin, Stephen, primary, Ahuja, Nita, primary, and Azad, Nilofer, primary

Published
2023
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58. Data from Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial

Author

Paller, Channing J., primary, Zhou, Xian C., primary, Heath, Elisabeth I., primary, Taplin, Mary-Ellen, primary, Mayer, Tina, primary, Stein, Mark N., primary, Bubley, Glenn J., primary, Pili, Roberto, primary, Hudson, Tamaro, primary, Kakarla, Radhika, primary, Abbas, Muneer M., primary, Anders, Nicole M., primary, Dowling, Donna, primary, King, Serina, primary, Bruns, Ashley B., primary, Wagner, William D., primary, Drake, Charles G., primary, Antonarakis, Emmanuel S., primary, Eisenberger, Mario A., primary, Denmeade, Samuel R., primary, Rudek, Michelle A., primary, Rosner, Gary L., primary, and Carducci, Michael A., primary

Published
2023
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59. S1: MPX Manufacturing Process and Chemical Constituents from Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial

Author

Paller, Channing J., primary, Zhou, Xian C., primary, Heath, Elisabeth I., primary, Taplin, Mary-Ellen, primary, Mayer, Tina, primary, Stein, Mark N., primary, Bubley, Glenn J., primary, Pili, Roberto, primary, Hudson, Tamaro, primary, Kakarla, Radhika, primary, Abbas, Muneer M., primary, Anders, Nicole M., primary, Dowling, Donna, primary, King, Serina, primary, Bruns, Ashley B., primary, Wagner, William D., primary, Drake, Charles G., primary, Antonarakis, Emmanuel S., primary, Eisenberger, Mario A., primary, Denmeade, Samuel R., primary, Rudek, Michelle A., primary, Rosner, Gary L., primary, and Carducci, Michael A., primary

Published
2023
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60. Supplemental Data from Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer

Author

Parsons, Heather A., primary, Beaver, Julia A., primary, Cimino-Mathews, Ashley, primary, Ali, Siraj M., primary, Axilbund, Jennifer, primary, Chu, David, primary, Connolly, Roisin M., primary, Cochran, Rory L., primary, Croessmann, Sarah, primary, Clark, Travis A., primary, Gocke, Christopher D., primary, Jeter, Stacie C., primary, Kennedy, Mark R., primary, Lauring, Josh, primary, Lee, Justin, primary, Lipson, Doron, primary, Miller, Vincent A., primary, Otto, Geoff A., primary, Rosner, Gary L., primary, Ross, Jeffrey S., primary, Slater, Shannon, primary, Stephens, Philip J., primary, VanDenBerg, Dustin A., primary, Wolff, Antonio C., primary, Young, Lauren E., primary, Zabransky, Daniel J., primary, Zhang, Zhe, primary, Zorzi, Jane, primary, Stearns, Vered, primary, and Park, Ben H., primary

Published
2023
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61. Supplemental Figure 1 from A Phase I Trial of a Guadecitabine (SGI-110) and Irinotecan in Metastatic Colorectal Cancer Patients Previously Exposed to Irinotecan

Author

Lee, Valerie, primary, Wang, Judy, primary, Zahurak, Marianna, primary, Gootjes, Elske, primary, Verheul, Henk M., primary, Parkinson, Rose, primary, Kerner, Zachary, primary, Sharma, Anup, primary, Rosner, Gary, primary, De Jesus-Acosta, Ana, primary, Laheru, Daniel, primary, Le, Dung T., primary, Oganesian, Aram, primary, Lilly, Ellen, primary, Brown, Thomas, primary, Jones, Peter, primary, Baylin, Stephen, primary, Ahuja, Nita, primary, and Azad, Nilofer, primary

Published
2023
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62. Supplemental Figures and Tables from A Phase I Study of Topotecan, Carboplatin and the PARP Inhibitor Veliparib in Acute Leukemias, Aggressive Myeloproliferative Neoplasms, and Chronic Myelomonocytic Leukemia

Author

Pratz, Keith W., primary, Rudek, Michelle A., primary, Gojo, Ivana, primary, Litzow, Mark R., primary, McDevitt, Michael A., primary, Ji, Jiuping, primary, Karnitz, Larry M., primary, Herman, James G., primary, Kinders, Robert J., primary, Smith, B. Douglas, primary, Gore, Steven D., primary, Carraway, Hetty E., primary, Showel, Margaret M., primary, Gladstone, Douglas E., primary, Levis, Mark J., primary, Tsai, Hua-Ling, primary, Rosner, Gary, primary, Chen, Alice, primary, Kaufmann, Scott H., primary, and Karp, Judith E., primary

Published
2023
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63. S2: Methods for SOD2 Genotyping and Validation from Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial

Author

Paller, Channing J., primary, Zhou, Xian C., primary, Heath, Elisabeth I., primary, Taplin, Mary-Ellen, primary, Mayer, Tina, primary, Stein, Mark N., primary, Bubley, Glenn J., primary, Pili, Roberto, primary, Hudson, Tamaro, primary, Kakarla, Radhika, primary, Abbas, Muneer M., primary, Anders, Nicole M., primary, Dowling, Donna, primary, King, Serina, primary, Bruns, Ashley B., primary, Wagner, William D., primary, Drake, Charles G., primary, Antonarakis, Emmanuel S., primary, Eisenberger, Mario A., primary, Denmeade, Samuel R., primary, Rudek, Michelle A., primary, Rosner, Gary L., primary, and Carducci, Michael A., primary

Published
2023
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65. Phase II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation for B Cell Lymphoma with Post-Transplantation Rituximab and Donor Selection Based First on Non-HLA Factors

Author

Kanakry, Jennifer A., Gocke, Christopher D., Bolaños-Meade, Javier, Gladstone, Douglas E., Swinnen, Lode J., Blackford, Amanda L., Fuchs, Ephraim J., Huff, Carol Ann, Borrello, Ivan, Matsui, William H., Brodsky, Robert A., Rosner, Gary L., Shanbhag, Satish, Luznik, Leo, Jones, Richard J., Ambinder, Richard F., and Kasamon, Yvette L.

Published
2015
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66. Risk-stratified outcomes of nonmyeloablative HLA-haploidentical BMT with high-dose posttransplantation cyclophosphamide

Author

McCurdy, Shannon R., Kanakry, Jennifer A., Showel, Margaret M., Tsai, Hua-Ling, Bolaños-Meade, Javier, Rosner, Gary L., Kanakry, Christopher G., Perica, Karlo, Symons, Heather J., Brodsky, Robert A., Gladstone, Douglas E., Huff, Carol Ann, Pratz, Keith W., Prince, Gabrielle T., Dezern, Amy E., Gojo, Ivana, Matsui, William H., Borrello, Ivan, McDevitt, Michael A., Swinnen, Lode J., Smith, B. Douglas, Levis, Mark J., Ambinder, Richard F., Luznik, Leo, Jones, Richard J., Fuchs, Ephraim J., and Kasamon, Yvette L.

Published
2015
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67. Additional file 1 of A study of using epigenetic modulators to enhance response to pembrolizumab (MK-3475) in microsatellite stable advanced colorectal cancer

Author

Baretti, Marina, Murphy, Adrian G., Zahurak, Marianna, Gianino, Nicole, Parkinson, Rose, Walker, Rosalind, Lopez-Vidal, Tamara Y., Zheng, Lei, Rosner, Gary, Ahuja, Nita, Kurt, Schalper, and Azad, Nilofer S.

Abstract

Additional file 1: Table S1. CD8+ by study arm (natural scale). Aza, azacitidine plus pembrolizumab (Arm A); Rom, romidepsin plus pembrolizumab (arm B); Aza + Rom, azacitidine plus romidepsin plus embrolizumab (Arm C). Table S2. CD8+/CD4+ by study arm (natural scale). Aza, azacitidine plus pembrolizumab (Arm A); Rom, romidepsin plus pembrolizumab (arm B); Aza + Rom, azacitidine plus romidepsin plus pembrolizumab (Arm C). Table S3. ANOVA log(CD8+) and log(CD8+/CD4+) changes. Aza, azacitidine plus pembrolizumab (Arm A); Rom, romidepsin plus pembrolizumab (arm B); Aza + Rom, azacitidine plus romidepsin plus pembrolizumab (Arm C).

Published
2023
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68. Single-agent GVHD prophylaxis with posttransplantation cyclophosphamide after myeloablative, HLA-matched BMT for AML, ALL, and MDS

Author

Kanakry, Christopher G., Tsai, Hua-Ling, Bolaños-Meade, Javier, Smith, B. Douglas, Gojo, Ivana, Kanakry, Jennifer A., Kasamon, Yvette L., Gladstone, Douglas E., Matsui, William, Borrello, Ivan, Huff, Carol Ann, Swinnen, Lode J., Powell, Jonathan D., Pratz, Keith W., DeZern, Amy E., Showel, Margaret M., McDevitt, Michael A., Brodsky, Robert A., Levis, Mark J., Ambinder, Richard F., Fuchs, Ephraim J., Rosner, Gary L., Jones, Richard J., and Luznik, Leo

Published
2014
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69. Pharmacotypes across the Genomic Landscape of Pediatric Acute Lymphoblastic Leukemia and Impact on Treatment Response

Author

Lee, Shawn, primary, Yang, Wenjian, additional, Gocho, Yoshihiro, additional, John, August, additional, Rowland, Lauren, additional, Smart, Brandon, additional, Williams, Hannah, additional, Maxwell, Dylan, additional, Hunt, Jeremy, additional, Yang, Wentao, additional, Crews, Kristine R., additional, Roberts, Kathryn G, additional, Jeha, Sima, additional, Cheng, Cheng, additional, Karol, Seth E., additional, Relling, Mary V., additional, Rosner, Gary, additional, Inaba, Hiroto, additional, Mullighan, Charles G., additional, Pui, Ching-Hon, additional, Evans, William E., additional, and Yang, Jun J., additional

Published
2022
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74. ANOVA DDP Models: A Review

Author

De Iorio, Maria, Müller, Peter, Rosner, Gary L., MacEachern, Steven N., Bickel, P., editor, Diggle, P., editor, Fienberg, S., editor, Krickeberg, K., editor, Olkin, I., editor, Wermuth, N., editor, Zeger, S., editor, Denison, David D., editor, Hansen, Mark H., editor, Holmes, Christopher C., editor, Mallick, Bani, editor, and Yu, Bin, editor

Published
2003
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75. A Bayesian model with application for adaptive platform trials having temporal changes.

Author

Wang, Chenguang, Lin, Min, Rosner, Gary L., and Soon, Guoxing

Subjects
EBOLA virus disease, HIDDEN Markov models, COMPUTATIONAL neuroscience, EXPERIMENTAL design, CLINICAL trials, VASCULAR surgery
Abstract

Temporal changes exist in clinical trials. Over time, shifts in patients' characteristics, trial conduct, and other features of a clinical trial may occur. In typical randomized clinical trials, temporal effects, that is, the impact of temporal changes on clinical outcomes and study analysis, are largely mitigated by randomization and usually need not be explicitly addressed. However, temporal effects can be a serious obstacle for conducting clinical trials with complex designs, including the adaptive platform trials that are gaining popularity in recent medical product development. In this paper, we introduce a Bayesian robust prior for mitigating temporal effects based on a hidden Markov model, and propose a particle filtering algorithm for computation. We conduct simulation studies to evaluate the performance of the proposed method and provide illustration examples based on trials of Ebola virus disease therapeutics and hemostat in vascular surgery. [ABSTRACT FROM AUTHOR]

Published
2023
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83. Semiparametric PK/PD Models

Author

Müller, Peter, Rosner, Gary, Bickel, P., editor, Diggle, P., editor, Fienberg, S., editor, Krickeberg, K., editor, Olkin, I., editor, Wermuth, N., editor, Zeger, S., editor, Dey, Dipak, editor, Müller, Peter, editor, and Sinha, Debajyoti, editor

Published
1998
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