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3. Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance after Upfront Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: BMT CTN 1401.

Author

Chung, David, Shah, Nina, Wu, Juan, Logan, Brent, Bisharat, Lina, Callander, Natalie, Cheloni, Giulia, Anderson, Kenneth, Chodon, Thinle, Dhakal, Binod, Devine, Steve, Somaiya Dutt, Poorvi, Efebera, Yvonne, Geller, Nancy, Ghiasuddin, Haider, Hematti, Peiman, Holmberg, Leona, Howard, Alan, Johnson, Bryon, Karagkouni, Dimitra, Lazarus, Hillard, Malek, Ehsan, McCarthy, Philip, McKenna, David, Mendizabal, Adam, Nooka, Ajay, Munshi, Nikhil, ODonnell, Lynn, Rapoport, Aaron, Reese, Jane, Rosenblatt, Jacalyn, Soiffer, Robert, Stroopinsky, Dina, Uhl, Lynne, Vlachos, Ioannis, Waller, Edmund, Young, James, Pasquini, Marcelo, and Avigan, David

Subjects
Humans, Multiple Myeloma, Lenalidomide, Granulocyte-Macrophage Colony-Stimulating Factor, Hematopoietic Stem Cell Transplantation, Transplantation, Autologous, Dendritic Cells, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone
Abstract

PURPOSE: Vaccination with dendritic cell (DC)/multiple myeloma (MM) fusions has been shown to induce the expansion of circulating multiple myeloma-reactive lymphocytes and consolidation of clinical response following autologous hematopoietic cell transplant (auto-HCT). PATIENTS AND METHODS: In this randomized phase II trial (NCT02728102), we assessed the effect of DC/MM fusion vaccination, GM-CSF, and lenalidomide maintenance as compared with control arms of GM-CSF and lenalidomide or lenalidomide maintenance alone on clinical response rates and induction of multiple myeloma-specific immunity at 1-year posttransplant. RESULTS: The study enrolled 203 patients, with 140 randomized posttransplantation. Vaccine production was successful in 63 of 68 patients. At 1 year, rates of CR were 52.9% (vaccine) and 50% (control; P = 0.37, 80% CI 44.5%, 61.3%, and 41.6%, 58.4%, respectively), and rates of VGPR or better were 85.3% (vaccine) and 77.8% (control; P = 0.2). Conversion to CR at 1 year was 34.8% (vaccine) and 27.3% (control; P = 0.4). Vaccination induced a statistically significant expansion of multiple myeloma-reactive T cells at 1 year compared with before vaccination (P = 0.024) and in contrast to the nonvaccine arm (P = 0.026). Single-cell transcriptomics revealed clonotypic expansion of activated CD8 cells and shared dominant clonotypes between patients at 1-year posttransplant. CONCLUSIONS: DC/MM fusion vaccination with lenalidomide did not result in a statistically significant increase in CR rates at 1 year posttransplant but was associated with a significant increase in circulating multiple myeloma-reactive lymphocytes indicative of tumor-specific immunity. Site-specific production of a personalized cell therapy with centralized product characterization was effectively accomplished in the context of a multicenter cooperative group study. See related commentary by Qazilbash and Kwak, p. 4703.

Published
2023

4. Hematopoietic cell transplant compared with standard care in adolescents and young adults with sickle cell disease

Author

Walters, Mark C., Eapen, Mary, Liu, Yiwen, El Rassi, Fuad, Waller, Edmund K., Levine, John E., Strouse, John J., Antin, Joseph H., Parikh, Suhag H., Bakshi, Nitya, Dampier, Carlton, Jaroscak, Jennifer J., Bergmann, Shayla, Wong, Trisha, Kota, Vamsi, Pace, Betty, Lekakis, Lazaros J., Lulla, Premal, Nickel, Robert S., Kasow, Kimberly A., Popat, Uday, Smith, Wally, Yu, Lolie, DiFronzo, Nancy, Geller, Nancy, Kamani, Naynesh, Klings, Elizabeth S., Hassell, Kathryn, Mendizabal, Adam, Sullivan, Keith, Neuberg, Donna, and Krishnamurti, Lakshmanan

Published
2025
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5. Coping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions

Author

Calderazzo, Silvia, Tarima, Sergey, Reid, Carissa, Flournoy, Nancy, Friede, Tim, Geller, Nancy, Rosenberger, James L, Stallard, Nigel, Ursino, Moreno, Vandemeulebroecke, Marc, Van Lancker, Kelly, and Zohar, Sarah

Subjects
Statistics - Applications
Abstract

Clinical trials disruption has always represented a non negligible part of the ending of interventional studies. While the SARS-CoV-2 (COVID-19) pandemic has led to an impressive and unprecedented initiation of clinical research, it has also led to considerable disruption of clinical trials in other disease areas, with around 80% of non-COVID-19 trials stopped or interrupted during the pandemic. In many cases the disrupted trials will not have the planned statistical power necessary to yield interpretable results. This paper describes methods to compensate for the information loss arising from trial disruptions by incorporating additional information available from auxiliary data sources. The methods described include the use of auxiliary data on baseline and early outcome data available from the trial itself and frequentist and Bayesian approaches for the incorporation of information from external data sources. The methods are illustrated by application to the analysis of artificial data based on the Primary care pediatrics Learning Activity Nutrition (PLAN) study, a clinical trial assessing a diet and exercise intervention for overweight children, that was affected by the COVID-19 pandemic. We show how all of the methods proposed lead to an increase in precision relative to use of complete case data only.

Published
2022

6. Antihypertensive therapy and unplanned maternal postpartum healthcare utilization in patients with mild chronic hypertension

Author

Palatnik, Anna, Leach, Justin, Harper, Lorie, Sibai, Baha, Longo, Sherri, Dugoff, Lorraine, Lawrence, Kirsten, Hughes, Brenna L., Bell, Joseph, Edwards, Rodney K., Gibson, Kelly S., Rouse, Caroline, Plante, Lauren, Hoppe, Kara K., Foroutan, Janelle, Tuuli, Methodius, Simhan, Hyagriv N., Frey, Heather, Rosen, Todd, Metz, Torri D., Baker, Susan, Kinzler, Wendy, Su, Emily J., Krishna, Iris, Norton, Mary E., Skupski, Daniel, El-Sayed, Yasser Y., Pereira, Leonardo, Magann, Everett F., Habli, Mounira, Geller, Nancy L., Williams, Shauna, McKenna, David S., Chang, Eugene, Quiñones, Joanne, Szychowski, Jeff M., and Tita, Alan T.N.

Published
2024
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7. Health-related quality of life with gilteritinib vs placebo posttransplant for FLT3-ITD+ acute myeloid leukemia

Author

Hamilton, Betty K., Pandya, Bhavik J., Ivanescu, Cristina, Elsouda, Dina, Hamadani, Mehdi, Chen, Yi-Bin, Levis, Mark J., Ueda Oshima, Masumi, Litzow, Mark R., Soiffer, Robert J., Ustun, Celalettin, Perl, Alexander E., Singh, Anurag K., Geller, Nancy, Hasabou, Nahla, Rosales, Matt, Cella, David, Corredoira, Laura, Pestana, Carolina, Horowitz, Mary M., and Logan, Brent

Published
2024
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8. Association of tricuspid regurgitation with clinical events and quality of life after surgery for severe ischemic mitral regurgitation

Author

Strobel, Raymond J., Kramer, Benjamin P., Overbey, Jessica R., Mehaffey, J. Hunter, Hawkins, Robert B., II, Gammie, James S., Gillinov, Marc, Acker, Michael A., Kramer, Robert S., Smith, Peter K., Kron, Irving L., Voisine, Pierre, Taddei-Peters, Wendy C., Geller, Nancy L., Dagenais, François, Mack, Michael J., Moquete, Ellen G., Marks, Mary E., Iribarne, Alexander, Goldstein, Daniel J., Ailawadi, Gorav, O'Gara, Patrick T., Moskowitz, Alan J., Gelijns, Annetine C., and Bagiella, Emilia

Published
2024
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9. Treatment for Mild Chronic Hypertension during Pregnancy

Author

Tita, Alan T, Szychowski, Jeff M, Boggess, Kim, Dugoff, Lorraine, Sibai, Baha, Lawrence, Kirsten, Hughes, Brenna L, Bell, Joseph, Aagaard, Kjersti, Edwards, Rodney K, Gibson, Kelly, Haas, David M, Plante, Lauren, Metz, Torri, Casey, Brian, Esplin, Sean, Longo, Sherri, Hoffman, Matthew, Saade, George R, Hoppe, Kara K, Foroutan, Janelle, Tuuli, Methodius, Owens, Michelle Y, Simhan, Hyagriv N, Frey, Heather, Rosen, Todd, Palatnik, Anna, Baker, Susan, August, Phyllis, Reddy, Uma M, Kinzler, Wendy, Su, Emily, Krishna, Iris, Nguyen, Nicki, Norton, Mary E, Skupski, Daniel, El-Sayed, Yasser Y, Ogunyemi, Dotum, Galis, Zorina S, Harper, Lorie, Ambalavanan, Namasivayam, Geller, Nancy L, Oparil, Suzanne, Cutter, Gary R, and Andrews, William W

Subjects
Paediatrics, Reproductive Medicine, Biomedical and Clinical Sciences, Lung, Clinical Trials and Supportive Activities, Hypertension, Clinical Research, Preterm, Low Birth Weight and Health of the Newborn, Infant Mortality, Contraception/Reproduction, Cardiovascular, Patient Safety, Pediatric, Conditions Affecting the Embryonic and Fetal Periods, Perinatal Period - Conditions Originating in Perinatal Period, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Reproductive health and childbirth, Good Health and Well Being, Abruptio Placentae, Antihypertensive Agents, Birth Weight, Chronic Disease, Female, Fetal Growth Retardation, Humans, Hypertension, Pregnancy-Induced, Infant, Newborn, Pre-Eclampsia, Pregnancy, Pregnancy Outcome, Premature Birth, Chronic Hypertension and Pregnancy (CHAP) Trial Consortium, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundThe benefits and safety of the treatment of mild chronic hypertension (blood pressure,

Published
2022

10. Social Isolation and Incident Heart Failure Hospitalization in Older Women: Women’s Health Initiative Study Findings

Author

Cené, Crystal W, Leng, Xiaoyan Iris, Faraz, Khushnood, Allison, Matthew, Breathett, Khadijah, Bird, Chloe, Coday, Mace, Corbie‐Smith, Giselle, Foraker, Randi, Ijioma, Nkechinyere N, Rosal, Milagros C, Sealy‐Jefferson, Shawnita, Shippee, Tetyana P, Kroenke, Candyce H, Rossouw, Jacques, Ludlam, Shari, McGowan, Joan, Ford, Leslie, Geller, Nancy, Anderson, Garnet, Prentice, Ross, LaCroix, Andrea, Kooperberg, Charles, Manson, JoAnn E, Howard, Barbara V, Stefanick, Marcia L, Jackson, Rebecca, Thomson, Cynthia A, Wactawski‐Wende, Jean, Limacher, Marian, Robinson, Jennifer, Kuller, Lewis, Shumaker, Sally, and Brunner, Robert

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cardiovascular, Heart Disease, Behavioral and Social Science, Prevention, Depression, Aging, Clinical Research, Mental Health, Good Health and Well Being, Aged, Female, Heart Failure, Hospitalization, Humans, Incidence, Postmenopause, Risk Factors, Social Isolation, Women's Health, heart failure, older adults, social isolation, women, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background The association of social isolation or lack of social network ties in older adults is unknown. This knowledge gap is important since the risk of heart failure (HF) and social isolation increase with age. The study examines whether social isolation is associated with incident HF in older women, and examines depressive symptoms as a potential mediator and age and race and ethnicity as effect modifiers. Methods and Results This study included 44 174 postmenopausal women of diverse race and ethnicity from the WHI (Women's Health Initiative) study who underwent annual assessment for HF adjudication from baseline enrollment (1993-1998) through 2018. We conducted a mediation analysis to examine depressive symptoms as a potential mediator and further examined effect modification by age and race and ethnicity. Incident HF requiring hospitalization was the main outcome. Social isolation was a composite variable based on marital/partner status, religious ties, and community ties. Depressive symptoms were assessed using CES-D (Center for Epidemiology Studies-Depression). Over a median follow-up of 15.0 years, we analyzed data from 36 457 women, and 2364 (6.5%) incident HF cases occurred; 2510 (6.9%) participants were socially isolated. In multivariable analyses adjusted for sociodemographic, behavioral, clinical, and general health/functioning; socially isolated women had a higher risk of incident HF than nonisolated women (HR, 1.23; 95% CI, 1.08-1.41). Adding depressive symptoms in the model did not change this association (HR, 1.22; 95% CI, 1.07-1.40). Neither race and ethnicity nor age moderated the association between social isolation and incident HF. Conclusions Socially isolated older women are at increased risk for developing HF, independent of traditional HF risk factors. Registration URL: http://www.clinicaltrials.gov; Unique identifier: NCT00000611.

Published
2022

11. Mass-Fix better predicts for PFS and OS than standard methods among multiple myeloma patients participating on the STAMINA trial (BMT CTN 0702 /07LT)

Author

Dispenzieri, Angela, Krishnan, Amrita, Arendt, Bonnie, Blackwell, Beth, Wallace, Paul K, Dasari, Surendra, Vogl, Dan T, Efebera, Yvonne, Fei, Mingwei, Geller, Nancy, Giralt, Sergio, Hahn, Theresa, Howard, Alan, Kohlhagen, Mindy, Landau, Heather, Hari, Parameswaran, Pasquini, Marcelo C, Qazilbash, Muzaffar H, McCarthy, Philip, Shah, Nina, Vesole, David H, Stadtmauer, Edward, and Murray, David

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Research, Hematology, Cancer, Humans, Diterpenes, Flow Cytometry, Multiple Myeloma, Neoplasm, Residual, Prognosis, Progression-Free Survival, Treatment Outcome, Cardiorespiratory Medicine and Haematology, Oncology and Carcinogenesis, Cardiovascular medicine and haematology, Oncology and carcinogenesis
Abstract

Measuring response among patients with multiple myeloma is essential for the care of patients. Deeper responses are associated with better progression free survival (PFS) and overall survival (OS). To test the hypothesis that Mass-Fix, a mass spectrometry-based means to detect monoclonal proteins, is superior to existing methodologies to predict for survival outcomes, samples from the STAMINA trial (NCT01109004), a trial comparing three transplant approaches, were employed. Samples from 575 patients from as many as three time points (post-induction [post-I; pre-maintenance [pre-M]; 1 year post enrollment [1YR]) were tested when available. Four response parameters were assessed: Mass-Fix, serum immunofixation, complete response, and measurable residual disease (MRD) by next generation flow cytometry. Of the four response measures, only MRD and Mass-Fix predicted for PFS and OS at multiple testing points on multivariate analyses. Although MRD drove Mass-Fix from the model for PFS at post-I and pre-M, 1YR Mass-Fix was independent of 1YR MRD. For OS, the only prognostic pre-I measure was Mass-Fix, and the only 1YR measures that were prognostic on multivariate analysis were 1YR MRD and 1YR Mass-Fix. SIFE and CR were not. Mass-Fix is a powerful means to track response.

Published
2022

13. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement

Author

Miller, Marissa A., Taddei-Peters, Wendy C., Jeffries, Neal O., Buxton, Dennis, Geller, Nancy L., Gordon, David, Burke, Catherine, Lee, Albert, Smith, Tyrone, Moy, Claudia S., Gombos, Ilana Kogan, Weisel, Richard, Gardner, Timothy J., O'Gara, Patrick T., Rose, Eric A., Gelijns, Annetine C., Parides, Michael K., Ascheim, Deborah D., Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, Shah, Kinjal, Overbey, Jessica R., Pan, Stephanie, Chang, Helena, Chase, Melissa, Goldfarb, Seth, Gupta, Lopa, Kirkwood, Katherine, Dobrev, Edlira, Levitan, Ron, O'Sullivan, Karen, Santos, Milerva, Ye, Xia, Mack, Michael, Winkle, Rachelle, Boswell, Haley, Fenlon, Amanda, Johnson, Melissa, Jones, Jessica, Kolb, Megan, Lam, Sarah, Miranda, Lucy, Ward, Jackie, Whitman, Renessa, Zingler, Brittany, Ryan, William, Smith, Robert L., Grayburn, Paul, Nosnik, Pedro, Gillinov, A. Marc, Blackstone, Eugene H., Moazami, Nader, Starling, Randall C., Barzilai, Benico, Grimm, Richard A., Soltesz, Edward G., Katzan, Irene, Strippy, Brian, Smith, Shoi, Garcia, Michelle, Alice bowman, Mary, Geither, Carrie, Wang, Robert, Argenziano, Michael, Borger, Michael, Takayama, Hiroo, Leon, Martin B., Goldsmith, Lyn, Schwartz, Allan, Sookraj, Nadia, McCright-Gill, Talaya, Sreekanth, Sowmya, McCullough, Jock N., Iribarne, Alexander, DeSimone, Joseph P., DiScipio, Anthony W., Stokes, Henry, Ivany, Amanda St., Petty, Gaylin, Smith, Peter K., Alexander, John H., Milano, Carmelo A., Glower, Donald D., Huber, Joel, Morganlander, Joel, Mathew, Joseph P., Welsh, Stacey, Casalinova, Sarah, Johnson, Victoria, Lane, Kathleen, Smith, Derek, Tipton, Greg, Berry, Mark F., Williams, Judson B., Englum, Brian, Hartwig, Matthew, Thourani, Vinod H., Guyton, Robert, Lattouf, Omar, Chen, Edward, Vega, J. David, Baer, Jefferson, Nguyen, Duc, Halkos, Michael, Baio, Kim, Prince, Tamara, Cook, Natascha, Neill, Alexis A., Voisine, Pierre, Senechal, Mario, Dagenais, François, Laforce, Robert, Jr., O'Connor, Kim, Dussault, Gladys, Caouette, Manon, Tremblay, Hugo, Gagne, Nathalie, Dumont, Julie, Landry, Patricia, Groh, Mark A., Trichon, Benjamin H., Binns, Oliver A., Ely, Stephen W., Johnson, Alan M., Hansen, Todd H., Short, John G., Taylor, Reid D., Mangusan, Ralph, Nanney, Tracy, Aubart, Holly, Cross, Kristin, McPeters, Leslie, Riggsbee, Christina, Rixey, Lucy, Michler, Robert E., DeRose, Joseph J., Jr., Goldstein, Daniel J., Bello, Ricardo A., Taub, Cynthia, Spevack, Daniel, Kirchoff, Kathryn, Meli, Rebecca, Garcia, Juan, Goldenberg, Jon, Kealy, Lauren, Perrault, Louis P., Bouchard, Denis, Tanguay, Jean François, O'Meara, Eileen, Lacharité, Jonathan, Robichaud, Sophie, Horvath, Keith A., Corcoran, Philip C., Siegenthaler, Michael P., Murphy, Mandy, Iraola, Margaret, Greenberg, Ann, Kumkumian, Greg, Milner, Mark, Nadareishvili, Zurab, Whitson, Bryan A., Hasan, Ayesha, McDavid, Asia, Fadorsen, Denise, Ouzounian, Maral, Yau, Terry, Farkouh, Michael, Woo, Anna, Cusimano, Robert James, David, Tirone, Feindel, Christopher, Fumakia, Nishit, Christie, Shakira, Mullen, John C., Bissonauth, Asvina, Hripko, Alexandra, Gammie, James S., Noor, Zahid, Mackowick, Kristen, Deasey, Stephanie, Al-Suqi, Manal, Collins, Julia, Acker, Michael A., Messé, Steven, Kirkpatrick, James, Mayer, Mary Lou, McDonald, Caitlin, Fok, Holley, Maffei, Breanna, Cresse, Stephen, Gepty, Christine, Bowdish, Michael, Starnes, Vaughn A., Shavalle, David, Heck, Christi, Hackmann, Amy, Baker, Craig, Fleischman, Fernando, Cunningham, Mark, Lozano, Edward, Hernandez, Michelle, Ailawadi, Gorav, Kron, Irving L., Johnston, Karen, Ghanta, Ravi K., Dent, John M., Kern, John, Yarboro, Leora, Ragosta, Michael, Annex, Brian, Bergin, Jim, Burks, Sandra, Cosner, Mike, Green, China, Loya, Samantha, Kim, Hye Ryun, Bull, David A., Desvigne-Nickens, Patrice, Dixon, Dennis O., Gottesman, Rebecca, Haigney, Mark, Holubkov, Richard, Iadecola, Constantino, Jacobs, Alice, Meslin, Eric M., Murkin, John M., Spertus, John A., Sellke, Frank, McDonald, Cheryl L., Canty, John, Dickert, Neal, Ikonomidis, John S., Kim, KyungMann, Williams, David O., Yancy, Clyde W., Chaturvedi, Seemant, Chimowitz, Marc, Fang, James C., Richenbacher, Wayne, Rao, Vivek, Furie, Karen L., Miller, Rachel, Cook, Jennifer, D'Alessandro, David, Han, Frederick, Pinney, Sean, Walsh, Mary N., Greer, David, Ishida, Koto, Stapf, Christian, Hung, Judy, Zeng, Xin, Hung, David, Satitthummanid, Sudarat, Billelo, Michel, Davatzikos, Christos, Erus, Guray, Karpf, Lauren, Desiderio, Lisa, Browndyke, Jeffrey N., James, Michael L., Toulgoat-Dubois, Yanne, Brassard, Rachele, Virmanu, Renu, Romero, Maria E., Braumann, Ryan, Messé, Steven R., Mack, Michael J., Southerland, Andrew M., Moy, Claudia Scala, and Bowdish, Michael E.

Published
2024
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14. Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry

Author

Pereira, Naveen L, Avram, Robert, So, Derek Y, Iturriaga, Erin, Byrne, Julia, Lennon, Ryan J, Murthy, Vishakantha, Geller, Nancy, Goodman, Shaun G, Rihal, Charanjit, Rosenberg, Yves, Bailey, Kent, Pletcher, Mark J, Marcus, Gregory M, Farkouh, Michael E, and Olgin, Jeffrey E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Patient Safety, Clinical Research, Cardiovascular, Good Health and Well Being, COVID-19, Clopidogrel, Continuity of Patient Care, Feasibility Studies, Follow-Up Studies, Genotype, Geographic Information Systems, Health Surveys, Humans, Internet-Based Intervention, Ischemia, Mobile Applications, Multicenter Studies as Topic, Patient Compliance, Patient Generated Health Data, Patient Participation, Percutaneous Coronary Intervention, Postoperative Complications, Pragmatic Clinical Trials as Topic, Purinergic P2Y Receptor Antagonists, Randomized Controlled Trials as Topic, Registries, Research Design, SARS-CoV-2, Telephone, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

BackgroundTailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y12 inhibitor therapy in improving ischemic outcomes after PCI. The trial has been extended from the original 12- to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described.MethodsA total of 930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls. Eureka, a direct-to-participant digital research platform, is used to consent and collect prospective data on patients for the digital study. Patients are asked to answer health-related surveys at fixed intervals using the Eureka mobile app and or desktop platform. The likelihood of patients enrolled in a randomized clinical trial transitioning to a registry using digital technology, the reasons for nonparticipation and engagement rates are evaluated. To capture hospitalizations, patients may optionally enable geofencing, a process that allows background location tracking and triggering of surveys if a hospital visit greater than 4 hours is detected. In addition, patients answer digital hospitalization surveys every month. Hospitalization data received from the Digital Study will be compared to data collected from study coordinator telephone visits during the same time frame.ConclusionsThe TAILOR-PCI Digital Study evaluates the feasibility of transitioning a large multicenter randomized clinical trial to a digital registry. The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials. Such a digital approach may be especially pertinent in the era of COVID-19.

Published
2021

15. Genetic-Guided Oral P2Y12 Inhibitor Selection and Cumulative Ischemic Events After Percutaneous Coronary Intervention

Author

Ingraham, Brenden S., Farkouh, Michael E., Lennon, Ryan J., So, Derek, Goodman, Shaun G., Geller, Nancy, Bae, Jang-Ho, Jeong, Myung Ho, Baudhuin, Linnea M., Mathew, Verghese, Bell, Malcolm R., Lerman, Amir, Fu, Yi-Ping, Hasan, Ahmed, Iturriaga, Erin, Tanguay, Jean-Francois, Welsh, Robert C., Rosenberg, Yves, Bailey, Kent, Rihal, Charanjit, and Pereira, Naveen L.

Published
2023
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16. Orphan Drugs and Rare Diseases

Author

Valentine, James E., Sasinowski, Frank J., Friedman, Lawrence, Section editor, Geller, Nancy L, Section editor, Piantadosi, Steven, editor, and Meinert, Curtis L., editor

Published
2022
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20. Clinical Trials in Children

Author

Pearson, Gail D., Burns, Kristin M., Pemberton, Victoria L., Friedman, Lawrence, Section editor, Geller, Nancy L, Section editor, Piantadosi, Steven, editor, and Meinert, Curtis L., editor

Published
2022
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22. Trials in Older Adults

Author

Romashkan, Sergei, Ryan, Laurie, Friedman, Lawrence, Section editor, Geller, Nancy L, Section editor, Piantadosi, Steven, editor, and Meinert, Curtis L., editor

Published
2022
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25. Fraud in Clinical Trials

Author

George, Stephen L., Buyse, Marc, Piantadosi, Steven, Friedman, Lawrence, Section editor, Geller, Nancy L, Section editor, Piantadosi, Steven, editor, and Meinert, Curtis L., editor

Published
2022
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27. Trials in Minority Populations

Author

Brawley, Otis W., Friedman, Lawrence, Section editor, Geller, Nancy L, Section editor, Meinert, Curtis L., Section editor, Piantadosi, Steven, Section editor, Piantadosi, Steven, editor, and Meinert, Curtis L., editor

Published
2022
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30. Three prophylaxis regimens (tacrolimus, mycophenolate mofetil, and cyclophosphamide; tacrolimus, methotrexate, and bortezomib; or tacrolimus, methotrexate, and maraviroc) versus tacrolimus and methotrexate for prevention of graft-versus-host disease with haemopoietic cell transplantation with reduced-intensity conditioning: a randomised phase 2 trial with a non-randomised contemporaneous control group (BMT CTN 1203)

Author

Bolaños-Meade, Javier, Reshef, Ran, Fraser, Raphael, Fei, Mingwei, Abhyankar, Sunil, Al-Kadhimi, Zaid, Alousi, Amin M, Antin, Joseph H, Arai, Sally, Bickett, Kate, Chen, Yi-Bin, Damon, Lloyd E, Efebera, Yvonne A, Geller, Nancy L, Giralt, Sergio A, Hari, Parameswaran, Holtan, Shernan G, Horowitz, Mary M, Jacobsohn, David A, Jones, Richard J, Liesveld, Jane L, Logan, Brent R, MacMillan, Margaret L, Mielcarek, Marco, Noel, Pierre, Pidala, Joseph, Porter, David L, Pusic, Iskra, Sobecks, Ronald, Solomon, Scott R, Weisdorf, Daniel J, Wu, Juan, Pasquini, Marcelo C, and Koreth, John

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Trials and Supportive Activities, Hematology, Transplantation, Cancer, Rare Diseases, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Aged, Bortezomib, Cyclophosphamide, Drug Interactions, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Male, Maraviroc, Methotrexate, Middle Aged, Mycophenolic Acid, Tacrolimus, Transplantation Conditioning, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular medicine and haematology
Abstract

BackgroundPrevention of graft-versus-host disease (GvHD) without malignant relapse is the overall goal of allogeneic haemopoietic cell transplantation (HCT). We aimed to evaluate regimens using either maraviroc, bortezomib, or post-transplantation cyclophosphamide for GvHD prophylaxis compared with controls receiving the combination of tacrolimus and methotrexate using a novel composite primary endpoint to identify the most promising intervention to be further tested in a phase 3 trial.MethodsIn this prospective multicentre phase 2 trial, adult patients aged 18-75 years who received reduced-intensity conditioning HCT were randomly assigned (1:1:1) by random block sizes to tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide (cyclophosphamide 50 mg/kg on days 3 and 4, followed by tacrolimus starting on day 5 and mycophenolate mofetil starting on day 5 at 15 mg/kg three times daily not to exceed 1 g from day 5 to day 35); tacrolimus, methotrexate, and bortezomib (bortezomib 1·3 mg/m2 intravenously on days 1, 4, and 7 after HCT); or tacrolimus, methotrexate, and maraviroc (maraviroc 300 mg orally twice daily from day -3 to day 30 after HCT). Methotrexate was administered as a 15 mg/m2 intravenous bolus on day 1 and 10 mg/m2 intravenous bolus on days 3, 6, and 11 after HCT; tacrolimus was given intravenously at a dose of 0·05 mg/kg twice daily (or oral equivalent) starting on day -3 (except the post-transplantation cyclophosphamide, as indicated), with a target level of 5-15 ng/mL. Tacrolimus was continued at least until day 90 and was tapered off by day 180. Each study group was compared separately to a contemporary non-randomised prospective cohort of patients (control group) who fulfilled the same eligibility criteria as the trial, but who were treated with tacrolimus and methotrexate at centres not participating in the trial. The primary endpoint (GvHD-free, relapse-free survival [GRFS]) was defined as the time from HCT to onset of grade 3-4 acute GvHD, chronic GvHD requiring systemic immunosuppression, disease relapse, or death. The study was analysed by modified intention to treat. The study is closed to accrual and this is the planned analysis. This trial is registered with ClinicalTrials.gov, number NCT02208037.FindingsBetween Nov 17, 2014, and May 18, 2016, 273 patients from 31 US centres were randomly assigned to the three study arms: 89 to tacrolimus, methotrexate, and bortezomib; 92 to tacrolimus, methotrexate, and maraviroc; 92 to tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide; and six were excluded. Between Aug 1, 2014, and Sept 14, 2016, 224 controls received tacrolimus and methotrexate. Controls were generally well matched except for more frequent comorbidities than the intervention groups and a different distribution of types of conditioning regimens used. Compared with controls, the hazard ratio for GRFS was 0·72 (90% CI 0·54-0·94; p=0·044) for tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide, 0·98 (0·76-1·27; p=0·92) for tacrolimus, methotrexate, and bortezomib, and 1·10 (0·86-1·41; p=0·49) for tacrolimus, methotrexate, and maraviroc. 238 patients experienced grade 3 or 4 toxicities: 12 (13%) had grade 3 and 67 (73%) grade 4 events with tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide; ten (11%) had grade 3 and 68 (76%) had grade 4 events with tacrolimus, methotrexate, and bortezomib; and 18 (20%) had grade 3 and 63 (68%) had grade 4 events with tacrolimus, methotrexate, and maraviroc. The most common toxicities were haematological (77 [84%] for tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide; 73 [82%] for tacrolimus, methotrexate, and bortezomib; and 78 [85%] for tacrolimus, methotrexate, and maraviroc) and cardiac (43 [47%], 44 [49%], and 43 [47%], respectively).InterpretationTacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide was the most promising intervention, yielding the best GRFS; this regimen is thus being prospectively compared with tacrolimus and methotrexate in a phase 3 randomised trial.FundingUS National Health, Lung, and Blood Institute; National Cancer Institute; National Institute of Allergy and Infectious Disease; and Millennium Pharmaceuticals.

Published
2019

31. Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial

Author

Stadtmauer, Edward A, Pasquini, Marcelo C, Blackwell, Beth, Hari, Parameswaran, Bashey, Asad, Devine, Steven, Efebera, Yvonne, Ganguly, Siddharta, Gasparetto, Cristina, Geller, Nancy, Horowitz, Mary M, Koreth, John, Knust, Kristin, Landau, Heather, Brunstein, Claudio, McCarthy, Philip, Nelson, Courtney, Qazilbash, Muzaffar H, Shah, Nina, Vesole, David H, Vij, Ravi, Vogl, Dan T, Giralt, Sergio, Somlo, George, and Krishnan, Amrita

Subjects
Cancer, Clinical Trials and Supportive Activities, Hematology, Clinical Research, Rare Diseases, Transplantation, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Consolidation Chemotherapy, Dexamethasone, Disease Progression, Female, Hematopoietic Stem Cell Transplantation, Humans, Lenalidomide, Maintenance Chemotherapy, Male, Melphalan, Middle Aged, Multiple Myeloma, Myeloablative Agonists, Progression-Free Survival, Prospective Studies, Remission Induction, Reoperation, Time Factors, Transplantation, Autologous, United States, Young Adult, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeSingle-cycle melphalan 200 mg/m2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression.Patients and methodsPatients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS.ResultsThe study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms.ConclusionSecond AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population.

Published
2019

32. Comparison of Bayesian and frequentist monitoring boundaries motivated by the Multiplatform Randomized Clinical Trial.

Author

Joo, Jungnam, Leifer, Eric S, Proschan, Michael A, Troendle, James F, Reynolds, Harmony R, Hade, Erinn A, Lawler, Patrick R, Kim, Dong-Yun, and Geller, Nancy L

Subjects
CLINICAL trials, FUTILE medical care, EXPERIMENTAL design, COMPARATIVE studies, COVID-19
Abstract

Background: The coronavirus disease 2019 pandemic highlighted the need to conduct efficient randomized clinical trials with interim monitoring guidelines for efficacy and futility. Several randomized coronavirus disease 2019 trials, including the Multiplatform Randomized Clinical Trial (mpRCT), used Bayesian guidelines with the belief that they would lead to quicker efficacy or futility decisions than traditional "frequentist" guidelines, such as spending functions and conditional power. We explore this belief using an intuitive interpretation of Bayesian methods as translating prior opinion about the treatment effect into imaginary prior data. These imaginary observations are then combined with actual observations from the trial to make conclusions. Using this approach, we show that the Bayesian efficacy boundary used in mpRCT is actually quite similar to the frequentist Pocock boundary. Methods: The mpRCT's efficacy monitoring guideline considered stopping if, given the observed data, there was greater than 99% probability that the treatment was effective (odds ratio greater than 1). The mpRCT's futility monitoring guideline considered stopping if, given the observed data, there was greater than 95% probability that the treatment was less than 20% effective (odds ratio less than 1.2). The mpRCT used a normal prior distribution that can be thought of as supplementing the actual patients' data with imaginary patients' data. We explore the effects of varying probability thresholds and the prior-to-actual patient ratio in the mpRCT and compare the resulting Bayesian efficacy monitoring guidelines to the well-known frequentist Pocock and O'Brien–Fleming efficacy guidelines. We also contrast Bayesian futility guidelines with a more traditional 20% conditional power futility guideline. Results: A Bayesian efficacy and futility monitoring boundary using a neutral, weakly informative prior distribution and a fixed probability threshold at all interim analyses is more aggressive than the commonly used O'Brien–Fleming efficacy boundary coupled with a 20% conditional power threshold for futility. The trade-off is that more aggressive boundaries tend to stop trials earlier, but incur a loss of power. Interestingly, the Bayesian efficacy boundary with 99% probability threshold is very similar to the classic Pocock efficacy boundary. Conclusions: In a pandemic where quickly weeding out ineffective treatments and identifying effective treatments is paramount, aggressive monitoring may be preferred to conservative approaches, such as the O'Brien–Fleming boundary. This can be accomplished with either Bayesian or frequentist methods. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Risk for non-home discharge following surgery for ischemic mitral valve disease

Author

DeRose, Joseph J., Wang, Alice, Smith, Peter K., Acker, Michael A., Ailawadi, Gorav, Miller, Marissa A., Taddei-Peters, Wendy C., Buxton, Dennis, Caulder, Ron, Geller, Nancy L., Gordon, David, Jeffries, Neal O., Lee, Albert, Gombos, Ilana Kogan, Ralph, Jennifer, Weisel, Richard D., Gardner, Timothy J., O'Gara, Patrick T., Rose, Eric A., Gelijns, Annetine C., Parides, Michael K., Ascheim, Deborah D., Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, Chang, Helena, Chase, Melissa, Foo, James, Chen, Yingchun, Goldfarb, Seth, Gupta, Lopa, Kirkwood, Katherine, Dobrev, Edlira, Levitan, Ron, O'Sullivan, Karen, Overbey, Jessica, Santos, Milerva, Williams, Deborah, Weglinski, Michael, Williams, Paula, Wood, Carrie, Ye, Xia, Nielsen, Sten Lyager, Wiggers, Henrik, Malgaard, Henning, Mack, Michael, Adame, Tracine, Settele, Natalie, Adams, Jenny, Ryan, William, Smith, Robert L., Grayburn, Paul, Chen, Frederick Y., Nohria, Anju, Cohn, Lawrence, Shekar, Prem, Aranki, Sary, Couper, Gregory, Davidson, Michael, Bolman, R. Morton, III, Burgess, Anne, Conboy, Debra, Lawrence, Rita, Noiseux, Nicolas, Stevens, Louis-Mathieu, Prieto, Ignacio, Basile, Fadi, Dionne, Joannie, Fecteau, Julie, Blackstone, Eugene H., Gillinov, A. Marc, Lackner, Pamela, Berroteran, Leoma, Dolney, Diana, Fleming, Suzanne, Palumbo, Roberta, Whitman, Christine, Sankovic, Kathy, Sweeney, Denise Kosty, Geither, Carrie, Doud, Kristen, Pattakos, Gregory, Clarke, Pamela A., Argenziano, Michael, Williams, Mathew, Goldsmith, Lyn, Smith, Craig R., Naka, Yoshifumi, Stewart, Allan, Schwartz, Allan, Bell, Daniel, Van Patten, Danielle, Sreekanth, Sowmya, Alexander, John H., Milano, Carmelo A., Glower, Donald D., Mathew, Joseph P., Harrison, J. Kevin, Welsh, Stacey, Berry, Mark F., Parsa, Cyrus J., Tong, Betty C., Williams, Judson B., Ferguson, T. Bruce, Kypson, Alan P., Rodriguez, Evelio, Harris, Malissa, Akers, Brenda, O'Neal, Allison, Puskas, John D., Thourani, Vinod H., Guyton, Robert, Baer, Jefferson, Baio, Kim, Neill, Alexis A., Voisine, Pierre, Senechal, Mario, Dagenais, François, O'Connor, Kim, Dussault, Gladys, Ballivian, Tatiana, Keilani, Suzanne, Speir, Alan M., Magee, Patrick, Ad, Niv, Keyte, Sally, Dang, Minh, Slaughter, Mark, Headlee, Marsha, Moody, Heather, Solankhi, Naresh, Birks, Emma, Groh, Mark A., Shell, Leslie E., Shepard, Stephanie A., Trichon, Benjamin H., Nanney, Tracy, Hampton, Lynne C., Mangusan, Ralph, Michler, Robert E., D'Alessandro, David A., DeRose, Joseph J., Jr., Goldstein, Daniel J., Bello, Ricardo, Jakobleff, William, Garcia, Mario, Taub, Cynthia, Spevak, Daniel, Swayze, Roger, Sookraj, Nadia, Perrault, Louis P., Basmadjian, Arsène-Joseph, Bouchard, Denis, Carrier, Michel, Cartier, Raymond, Pellerin, Michel, Tanguay, Jean François, El-Hamamsy, Ismail, Denault, André, Demers, Philippe, Jonathan Lacharité, Sophie Robichaud, Horvath, Keith A., Corcoran, Philip C., Siegenthaler, Michael P., Murphy, Mandy, Iraola, Margaret, Greenberg, Ann, Sai-Sudhakar, Chittoor, Hasan, Ayseha, McDavid, Asia, Kinn, Bradley, Pagé, Pierre, Sirois, Carole, Latter, David, Leong-Poi, Howard, Bonneau, Daniel, Errett, Lee, Peterson, Mark D., Verma, Subodh, Feder-Elituv, Randi, Cohen, Gideon, Joyner, Campbell, Fremes, Stephen E., Moussa, Fuad, Christakis, George, Karkhanis, Reena, Yau, Terry, Farkouh, Michael, Woo, Anna, Cusimano, Robert James, David, Tirone, Feindel, Christopher, Garrard, Lisa, Fredericks, Suzanne, Mociornita, Amelia, Mullen, John C., Choy, Jonathan, Meyer, Steven, Kuurstra, Emily, Gammie, James S., Young, Cindi A., Beach, Dana, Villanueva, Robert, Atluri, Pavan, Woo, Y. Joseph, Mayer, Mary Lou, Bowdish, Michael, Starnes, Vaughn A., Shavalle, David, Matthews, Ray, Javadifar, Shadi, Romar, Linda, Kron, Irving L., Johnston, Karen, Dent, John M., Kern, John, Keim, Jessica, Burks, Sandra, Gahring, Kim, Bull, David A., Dixon, Dennis O., Haigney, Mark, Holubkov, Richard, Jacobs, Alice, Miller, Frank, Murkin, John M., Spertus, John, Wechsler, Andrew S., Sellke, Frank, Byington, Robert, Dickert, Neal, Ikonomidis, John S., Williams, David O., Yancy, Clyde W., Fang, James C., Giannetti, Nadia, Richenbacher, Wayne, Rao, Vivek, Furie, Karen L., Miller, Rachel, Pinney, Sean, Roberts, William C., Walsh, Mary N., Hung, Judy, Zeng, Xin, Kilcullen, Niamh, Hung, David, Keteyian, Stephen J., Brawner, Clinton A., Aldred, Heather, Browndyke, Jeffrey, Toulgoat-Dubois, Yanne, Lala, Anuradha, Chang, Helena L., Liu, Xiaoyu, Charles, Eric J., Yerokun, Babatunde A., Bowdish, Michael E., Mack, Michael J., and Stevenson, Lynne W.

Published
2021
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34. Predictors of Major Atrial Fibrillation Endpoints in the National Heart, Lung, and Blood Institute HCMR

Author

Kramer, Christopher M., DiMarco, John P., Kolm, Paul, Ho, Carolyn Y., Desai, Milind Y., Kwong, Raymond Y., Dolman, Sarahfaye F., Desvigne-Nickens, Patrice, Geller, Nancy, Kim, Dong-Yun, Maron, Martin S., Appelbaum, Evan, Jerosch-Herold, Michael, Friedrich, Matthias G., Schulz-Menger, Jeanette, Piechnik, Stefan K., Mahmod, Masliza, Jacoby, Daniel, White, James, Chiribiri, Amedeo, Helms, Adam, Choudhury, Lubna, Michels, Michelle, Bradlow, William, Salerno, Michael, Dawson, Dana K., Weinsaft, Jonathan W., Berry, Colin, Nagueh, Sherif F., Buccarelli-Ducci, Chiara, Owens, Anjali, Casadei, Barbara, Watkins, Hugh, Weintraub, William S., and Neubauer, Stefan

Published
2021
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36. Both Light Intensity and Moderate‐to‐Vigorous Physical Activity Measured by Accelerometry Are Favorably Associated With Cardiometabolic Risk Factors in Older Women: The Objective Physical Activity and Cardiovascular Health (OPACH) Study

Author

LaMonte, Michael J, Lewis, Cora E, Buchner, David M, Evenson, Kelly R, Rillamas‐Sun, Eileen, Di, Chongzhi, Lee, I‐Min, Bellettiere, John, Stefanick, Marcia L, Eaton, Charles B, Howard, Barbara V, Bird, Chloe, LaCroix, Andrea Z, Rossouw, Jacques, Ludlam, Shari, Burwen, Dale, McGowan, Joan, Ford, Leslie, Geller, Nancy, Anderson, Garnet, Prentice, Ross, Kooperberg, Charles, Manson, JoAnn E, Jackson, Rebecca, Thomson, Cynthia A, Wactawski‐Wende, Jean, Limacher, Marian, Wallace, Robert, Kuller, Lewis, and Shumaker, Sally

Subjects
Clinical Research, Heart Disease, Cardiovascular, Aging, Prevention, Metabolic and endocrine, Actigraphy, Age Factors, Aged, Aged, 80 and over, Cardiovascular Diseases, Chi-Square Distribution, Cross-Sectional Studies, Exercise, Female, Fitness Trackers, Humans, Logistic Models, Middle Aged, Multivariate Analysis, Odds Ratio, Predictive Value of Tests, Prognosis, Prospective Studies, Risk Assessment, Risk Factors, Risk Reduction Behavior, Sex Factors, Time Factors, United States, Women's Health, aging, coronary heart disease, exercise, risk factor, women and minorities, Cardiorespiratory Medicine and Haematology
Abstract

BackgroundThe relationship between light intensity physical activity (PA), which is common in older adults, and cardiovascular disease (CVD) risk factors is unclear. This study examined associations of accelerometer-measured PA intensity with CVD risk factors in older women of different race-ethnicities.Methods and resultsCross-sectional analyses were conducted in 4832 women (mean age 78.9 years; 52.5% white, 30.5% black, 17.1% Hispanic) who were without known CVD and wore triaxial accelerometers a minimum of 4 of 7 days with ≥10 hours/d awake wear-time. Vector magnitude counts per 15-s epoch were used to define time spent in low light (19-225 counts/15 s), high light (226-518), and moderate-to-vigorous; ≥519) intensity PA. Fasting CVD biomarkers, resting blood pressure, waist girth, body mass index, and 10-year predicted CVD risk (Reynolds Risk Score) were measured. After adjusting for age, wear time, race-ethnicity, and potential confounders, each PA measure was favorably associated with mean high-density lipoprotein, triglyceride, glucose, C-reactive protein, body mass index, waist girth, and Reynolds Risk Score (P

Published
2017

38. A Conversation with Robert C. Elston

Author

Zheng, Gang, Li, Zhaohai, and Geller, Nancy L.

Subjects
Statistics - Other Statistics
Abstract

Robert C. Elston was born on February 4, 1932, in London, England. He went to Cambridge University to study natural science from 1952-1956 and obtained B.A., M.A. and Diploma in Agriculture (Dip Ag). He came to the US at age 24 to study animal breeding at Cornell University and received his Ph.D. in 1959. From 1959-1960, he was a post-doctoral fellow in biostatistics at University of North Carolina (UNC), Chapel Hill, where he studied mathematical statistics. He then rose through the academic ranks in the department of biostatistics at UNC, becoming a full professor in 1969. From 1979-1995, he was a professor and head of the Department of Biometry and Genetics at Louisiana State University Medical Center in New Orleans. In 1995, he moved to Case Western Reserve University where he is a professor of epidemiology and biostatistics and served as chairman from 2008 to 2014. Between 1966 and 2013, he directed 42 Ph.D. students and mentored over 40 post-doctoral fellows. If one regards him as a founder of a pedigree in research in genetic epidemiology, it was estimated in 2007 that there were more than 500 progeny. Among his many honors are a NIH Research Career Development Award (1966-1976), the Leadership Award from International Society of Human Genetics (1995), William Allan Award from American Society of Human Genetics (1996), NIH MERIT Award (1998) and the Marvin Zelen Leadership Award, Harvard University (2004). He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics as well as a Fellow of the Ohio Academy of Science. A leader in research in genetic epidemiology for over 40 years, he has published over 600 research articles in biostatistics, genetic epidemiology and applications. He has also coauthored and edited 9 books in biostatistics, population genetics and methods for the analysis of genetic data., Comment: Published at http://dx.doi.org/10.1214/14-STS497 in the Statistical Science (http://www.imstat.org/sts/) by the Institute of Mathematical Statistics (http://www.imstat.org)

Published
2015
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41. Cost-effectiveness of coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone for moderate ischemic mitral regurgitation

Author

Miller, Marissa A., Taddei-Peters, Wendy C., Buxton, Dennis, Caulder, Ron, Geller, Nancy L., Gordon, David, Jeffries, Neal O., Lee, Albert, Moy, Claudia S., Gombos, Ilana Kogan, Ralph, Jennifer, Weisel, Richard, Gardner, Timothy J., O'Gara, Patrick T., Rose, Eric A., Gelijns, Annetine C., Parides, Michael K., Ascheim, Deborah D., Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, Chang, Helena, Chase, Melissa, Chen, Yingchun, Goldfarb, Seth, Gupta, Lopa, Kirkwood, Katherine, Dobrev, Edlira, Levitan, Ron, O'Sullivan, Karen, Overbey, Jessica, Santos, Milerva, Weglinski, Michael, Williams, Paula, Wood, Carrie, Ye, Xia, Nielsen, Sten Lyager, Wiggers, Henrik, Malgaard, Henning, Mack, Michael, Adame, Tracine, Settele, Natalie, Adams, Jenny, Ryan, William, Smith, Robert L., Grayburn, Paul, Chen, Frederick Y., Nohria, Anju, Cohn, Lawrence, Shekar, Prem, Aranki, Sary, Couper, Gregory, Davidson, Michael, Bolman, R. Morton, III, Burgess, Anne, Conboy, Debra, Noiseux, Nicolas, Stevens, Louis-Mathieu, Prieto, Ignacio, Basile, Fadi, Dionne, Joannie, Fecteau, Julie, Blackstone, Eugene H., Gillinov, A. Marc, Lackner, Pamela, Berroteran, Leoma, Dolney, Diana, Fleming, Suzanne, Palumbo, Roberta, Whitman, Christine, Sankovic, Kathy, Sweeney, Denise Kosty, Pattakos, Gregory, Clarke, Pamela A., Argenziano, Michael, Williams, Mathew, Goldsmith, Lyn, Smith, Craig R., Naka, Yoshifumi, Stewart, Allan, Schwartz, Allan, Bell, Daniel, Van Patten, Danielle, Sreekanth, Sowmya, Smith, Peter K., Alexander, John H., Milano, Carmelo A., Glower, Donald D., Mathew, Joseph P., Harrison, J. Kevin, Welsh, Stacey, Berry, Mark F., Parsa, Cyrus J., Tong, Betty C., Williams, Judson B., Ferguson, T. Bruce, Kypson, Alan P., Rodriguez, Evelio, Harris, Malissa, Akers, Brenda, O'Neal, Allison, Puskas, John D., Thourani, Vinod H., Guyton, Robert, Baer, Jefferson, Baio, Kim, Neill, Alexis A., Voisine, Pierre, Senechal, Mario, Dagenais, François, O'Connor, Kim, Dussault, Gladys, Ballivian, Tatiana, Keilani, Suzanne, Speir, Alan M., Magee, Patrick, Ad, Niv, Keyte, Sally, Dang, Minh, Slaughter, Mark, Headlee, Marsha, Moody, Heather, Solankhi, Naresh, Birks, Emma, Groh, Mark A., Shell, Leslie E., Shepard, Stephanie A., Trichon, Benjamin H., Nanney, Tracy, Hampton, Lynne C., Michler, Robert E., D'Alessandro, David A., DeRose, Joseph J., Jr., Goldstein, Daniel J., Bello, Ricardo, Jakobleff, William, Garcia, Mario, Taub, Cynthia, Spevak, Daniel, Swayze, Roger, Perrault, Louis P., Basmadjian, Arsène-Joseph, Bouchard, Denis, Carrier, Michel, Cartier, Raymond, Pellerin, Michel, Tanguay, Jean François, El-Hamamsy, Ismail, Denault, André, Demers, Philippe, Robichaud, Sophie, Horvath, Keith A., Corcoran, Philip C., Siegenthaler, Michael P., Murphy, Mandy, Iraola, Margaret, Greenberg, Ann, Sai-Sudhakar, Chittoor, Hasan, Ayseha, McDavid, Asia, Kinn, Bradley, Pagé, Pierre, Sirois, Carole, Latter, David, Leong-Poi, Howard, Bonneau, Daniel, Errett, Lee, Peterson, Mark D., Verma, Subodh, Feder-Elituv, Randi, Cohen, Gideon, Joyner, Campbell, Fremes, Stephen E., Moussa, Fuad, Christakis, George, Karkhanis, Reena, Yau, Terry, Farkouh, Michael, Woo, Anna, Cusimano, Robert James, David, Tirone, Feindel, Christopher, Garrard, Lisa, Fredericks, Suzanne, Mociornita, Amelia, Mullen, John C., Choy, Jonathan, Meyer, Steven, Kuurstra, Emily, Gammie, James S., Young, Cindi A., Beach, Dana, Acker, Michael A., Atluri, Pavan, Woo, Y. Joseph, Mayer, Mary Lou, Bowdish, Michael, Starnes, Vaughn A., Shavalle, David, Matthews, Ray, Javadifar, Shadi, Romar, Linda, Kron, Irving L., Ailawadi, Gorav, Johnston, Karen, Dent, John M., Kern, John, Keim, Jessica, Burks, Sandra, Gahring, Kim, Bull, David A., Desvigne-Nickens, Patrice, Dixon, Dennis O., Haigney, Mark, Holubkov, Richard, Jacobs, Alice, Miller, Frank, Murkin, John M., Spertus, John, Wechsler, Andrew S., Sellke, Frank, McDonald, Cheryl L., Byington, Robert, Dickert, Neal, Ikonomidis, John S., Williams, David O., Yancy, Clyde W., Fang, James C., Giannetti, Nadia, Richenbacher, Wayne, Rao, Vivek, Furie, Karen L., Miller, Rachel, Pinney, Sean, Roberts, William C., Walsh, Mary N., Keteyian, Stephen J., Brawner, Clinton A., Aldred, Heather, Hung, Judy, Zeng, Xin, Browndyke, Jeffrey, Toulgoat-Dubois, Yanne, Ferket, Bart S., Hohmann, Samuel F., Chang, Helena L., Mick, Stephanie L., Hung, Judy W., Overbey, Jessica R., and Lala, Anuradha

Published
2020
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42. Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplant for Patients with Multiple Myeloma: Long-Term Follow-Up Results from the Blood and Marrow Transplant Clinical Trials Network 0102 Trial

Author

Giralt, Sergio, Costa, Luciano J., Maloney, David, Krishnan, Amrita, Fei, Mingwei, Antin, Joseph H., Brunstein, Claudio, Geller, Nancy, Goodman, Stacey, Hari, Parameswaran, Logan, Brent, Lowsky, Robert, Qazilbash, Muzaffar H., Sahebi, Firoozeh, Somlo, George, Rowley, Scott, Vogl, Dan T., Vesole, David H., Pasquini, Marcelo, and Stadtmauer, Edward

Published
2020
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43. Low macular pigment optical density is associated with manifest primary open-angle glaucoma in older women

Author

Liu, Yao, primary, Lawler, Thomas, additional, Liu, Zhe, additional, Thuruthumaly, Catherine, additional, Vajaranant, Thasarat, additional, Wallace, Robert, additional, Tinker, Lesley, additional, Nalbandyan, Marine, additional, Mares, Julie, additional, Anderson, Garnet, additional, Prentice, Ross, additional, LaCroix, Andrea, additional, Kooperberg, Charles, additional, Blodi, Barbara, additional, Liu, Yao, additional, Domalpally, Amitha, additional, Engelman, Corinne, additional, Gangnon, Ronald, additional, Sarto, Gloria, additional, Bailey, Steven, additional, LeBlanc (Kaiser-Permanente), Erin, additional, Gehrs, Karen, additional, Robinson, Jennifer, additional, Snodderly, D. Max, additional, Hammond, Randy, additional, Millen, Amy, additional, Wooten, Bill, additional, Johnson, Elizabeth, additional, Jennifer Maykoski, B.S., additional, Lundquist, Ann, additional, Chris Smith, B.S., additional, Wood, Kim, additional, Perry-Raymond, Jennie, additional, Heather Stockman, B.S., additional, Walshire, Jean, additional, Sinkey, Christine, additional, Manson, JoAnn E., additional, Howard, Barbara V., additional, Stefanick, Marcia L., additional, Jackson, Rebecca, additional, Thomson, Cynthia A., additional, Wactawski-Wende, Jean, additional, Limacher, Marian, additional, Kuller, Lewis, additional, Shumaker, Sally, additional, Brunner, Robert, additional, Courtney Blomme, M.S., additional, Hall, Kristen, additional, Pauk, Diane, additional, Mezhibovsky, Esther, additional, Christensen, Krista, additional, Espeland, Mark, additional, Rossouw, Jacques, additional, Ludlam, Shari, additional, McGowan, Joan, additional, Ford, Leslie, additional, and Geller, Nancy, additional

Published
2024
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45. Treatment for Mild Chronic Hypertension During Pregnancy

Author

Tita, Alan T., Szychowski, Jeff M., Boggess, Kim, Dugoff, Lorraine, Sibai, Baha, Lawrence, Kirsten, Hughes, Brenna L., Bell, Joseph, Aagaard, Kjersti, Edwards, Rodney K., Gibson, Kelly, Haas, David M., Plante, Lauren, Metz, Torri, Casey, Brian, Esplin, Sean, Longo, Sherri, Hoffman, Matthew, Saade, George R., Hoppe, Kara K., Foroutan, Janelle, Tuuli, Methodius, Owens, Michelle Y., Simhan, Hyagriv N., Frey, Heather, Rosen, Todd, Palatnik, Anna, Baker, Susan, August, Phyllis, Reddy, Uma M., Kinzler, Wendy, Su, Emily, Krishna, Iris, Nguyen, Nicki, Norton, Mary E., Skupski, Daniel, El-Sayed, Yasser Y., Ogunyemi, Dotum, Galis, Zorina S., Harper, Lorie, Ambalavanan, Namasivayam, Geller, Nancy L., Oparil, Suzanne, Cutter, Gary R., and Andrews, William W.

Published
2022
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46. Gilteritinib as Post-Transplant Maintenance for Acute Myeloid Leukemia With Internal Tandem Duplication Mutation of FLT3

Author

Levis, M, Hamadani, M, Logan, B, Jones, R, Singh, A, Litzow, M, Wingard, J, Papadopoulos, E, Perl, A, Soiffer, R, Ustun, C, Ueda Oshima, M, Uy, G, Waller, E, Vasu, S, Solh, M, Mishra, A, Muffly, L, Kim, H, Mikesch, J, Najima, Y, Onozawa, M, Thomson, K, Nagler, A, Wei, A, Marcucci, G, Geller, N, Hasabou, N, Delgado, D, Rosales, M, Hill, J, Gill, S, Nuthethi, R, King, D, Wittsack, H, Mendizabal, A, Devine, S, Horowitz, M, Chen, Y, Agura, E, Altman, J, Anagnostopoulos, A, Anand, S, Artz, A, Aulitzky, W, Balderman, S, Ballen, K, Becker, M, Beguin, Y, Berkahn, L, Berneman, Z, Bhatt, V, Bilmon, I, Bonifazi, F, Briggs, A, Bruno, B, Brunstein, C, Byrne, M, Byrne, J, Cabrero, M, Cairoli, R, Carrum, G, Cerny, J, Cheong, J, Ciceri, F, Colorado, M, Cook, R, Couriel, D, Craddock, C, Damon, L, Deol, A, Desbrosses, Y, Di Grazia, C, Di Stasi, A, Dias, A, Dorritie, K, Essell, J, Eto, T, Farag, S, Forcade, E, Frankfurt, O, Fujiwara, S, Fukuda, T, Fukushima, K, Furst, S, Goto, T, Hall, A, Hatta, S, Hicheri, Y, Horwitz, M, Hou, H, How, J, Howard, D, Hsu, W, Huynh, A, Irvine, D, Ishikawa, T, Jamieson, K, Jedrzejczak, W, Jethava, Y, Jimenez, A, Jung, C, Kanda, J, Karakasis, D, Kato, J, Kekre, N, Khera, N, Klein, A, Kobbe, G, Kornblit, B, Kota, V, Lachance, S, Leber, B, Lee, C, Lee, J, Lin, T, Liu, T, Martelli, M, Martinez, C, Matsuoka, K, Mccarty, J, Mendez, L, Michelis, F, Mineishi, S, Mohty, M, Moors, I, Motyckova, G, Mueller, L, Nakamae, H, Nakano, N, Nathan, S, Nicholson, E, Norkin, M, Ogawa, Y, Olesen, G, Oluwole, O, Pantin, J, Paulson, K, Pemberton, L, Perera, T, Piatkowska-Jakubas, B, Poire, X, Protheroe, R, Rambaldi, A, Ritchie, D, Ross, K, Rubio, M, Santarone, S, Sanz Caballer, J, Sawa, M, Schaar, D, Scheid, C, Schriber, J, Seropian, S, Shah, N, Shore, T, Gil, J, Sobecks, R, Socie, G, Sprague, K, Spyridonidis, A, Stelljes, M, Stiff, P, Stuart, R, Tanaka, M, Tandra, A, Tholouli, E, Thomas, X, Tiribelli, M, Tomlinson, B, Tsirigotis, P, Tzachanis, D, Uchida, N, Ueda, M, Valcarcel Ferreiras, D, Wagner, E, Watson, A, Weisdorf, D, Wolschke, C, Wrobel, T, Yakoub-Agha, I, Yamauchi, T, Yared, J, Yeh, S, Yoon, S, Yoshihara, S, Null, N, Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, Mikesch, Jan-Henrik, Najima, Yuho, Onozawa, Masahiro, Thomson, Kirsty, Nagler, Arnon, Wei, Andrew H., Marcucci, Guido, Geller, Nancy L., Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason, Gill, Stanley C., Nuthethi, Rishita, King, Denise, Wittsack, Heather, Mendizabal, Adam, Devine, Steven M., Horowitz, Mary M., Chen, Yi-Bin, Agura, Ed, Altman, Jessica, Anagnostopoulos, Achiles, Anand, Sarah, Artz, Andrew, Aulitzky, Walter, Balderman, Sophia, Ballen, Karen, Becker, Michael, Beguin, Yves, Berkahn, Leanne, Berneman, Zwi, Bhatt, Vijaya, Bilmon, Ian, Bonifazi, Francesca, Briggs, Adrienne, Bruno, Benedetto, Brunstein, Claudio, Byrne, Michael, Byrne, Jenny, Cabrero, Monica, Cairoli, Roberto, Carrum, George, Cerny, Jan, Cheong, June-Won, Ciceri, Fabio, Colorado, Mercedes, Cook, Rachel, Couriel, Daniel, Craddock, Charles, Damon, Lloyd, Deol, Abhinav, Desbrosses, Yohan, Devine, Steve, Di Grazia, Carmela, Di Stasi, Antonio, Dias, Ajoy, Dorritie, Kathy, Essell, James, Eto, Tetsuya, Farag, Sherif, Forcade, Edouard, Frankfurt, Olga, Fujiwara, Shinichiro, Fukuda, Takahiro, Fukushima, Kentaro, Furst, Sabine, Goto, Tatsunori, Hall, Aric, Hatta, Shunsuke, Hicheri, Yosr, Horwitz, Mitchell, Hou, Hsin-An, How, Jonathan, Howard, Dianna, Hsu, Wei-Hsun (Blake), Huynh, Anne, Irvine, David, Ishikawa, Takayuki, Jamieson, Katarzyna, Jedrzejczak, Wieslaw, Jethava, Yogesh, Jimenez, Antonio, Jung, Chul Won, Kanda, Junya, Karakasis, Dimitrios, Kato, Jun, Kekre, Natasha, Khera, Nandita, Klein, Andreas, Kobbe, Guido, Kornblit, Brian, Kota, Vamsi, Lachance, Silvy, Leber, Brian, Lee, Catherine, Lee, Je Hwan, Lin, Tung-Liang, Liu, Ta-Chih, Martelli, Maurizio, Martinez, Carmen, Matsuoka, Kenichi, McCarty, John, Mendez, Lourdes, Michelis, Fotios, Mineishi, Shin, Mohty, Mohamad, Moors, Ine, Motyckova, Gabriela, Mueller, Lutz, Nakamae, Hirohisa, Nakano, Nobuaki, Nathan, Sunita, Nicholson, Emma, Norkin, Maxim, Ogawa, Yoshiaki, Olesen, Gitte, Oluwole, Olalekan, Pantin, Jeremy, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Piatkowska-Jakubas, Beata, Poire, Xavier, Protheroe, Rachel, Rambaldi, Alessandro, Ritchie, David, Ross, Kelly, Rubio, Marie-Therese, Santarone, Stella, Sanz Caballer, Jaime, Sawa, Masashi, Schaar, Dale, Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart, Shah, Nilay, Shah, Nirav, Shore, Tsiporah, Gil, Jorge Sierra, Singh, Anurag, Sobecks, Ronald, Socie, Gerard, Soiffer, Robert, Sprague, Kellie, Spyridonidis, Alexandros, Stelljes, Matthias, Stiff, Patrick, Stuart, Robert, Tanaka, Masatsugu, Tandra, Anand, Tholouli, Eleni, Thomas, Xavier, Tiribelli, Mario, Tomlinson, Benjamin, Tsirigotis, Panagiotis, Tzachanis, Dimitrios, Uchida, Naoyuki, Ueda, Masumi, Valcarcel Ferreiras, David, Wagner, Eva, Watson, Anne-Marie, Weisdorf, Daniel, Wolschke, Christine, Wrobel, Tomasz, Yakoub-Agha, Ibrahim, Yamauchi, Takuji, Yared, Jean, Yeh, Su-Peng, Yoon, Sung-Soo, Yoshihara, Satoshi, null, null, Levis, M, Hamadani, M, Logan, B, Jones, R, Singh, A, Litzow, M, Wingard, J, Papadopoulos, E, Perl, A, Soiffer, R, Ustun, C, Ueda Oshima, M, Uy, G, Waller, E, Vasu, S, Solh, M, Mishra, A, Muffly, L, Kim, H, Mikesch, J, Najima, Y, Onozawa, M, Thomson, K, Nagler, A, Wei, A, Marcucci, G, Geller, N, Hasabou, N, Delgado, D, Rosales, M, Hill, J, Gill, S, Nuthethi, R, King, D, Wittsack, H, Mendizabal, A, Devine, S, Horowitz, M, Chen, Y, Agura, E, Altman, J, Anagnostopoulos, A, Anand, S, Artz, A, Aulitzky, W, Balderman, S, Ballen, K, Becker, M, Beguin, Y, Berkahn, L, Berneman, Z, Bhatt, V, Bilmon, I, Bonifazi, F, Briggs, A, Bruno, B, Brunstein, C, Byrne, M, Byrne, J, Cabrero, M, Cairoli, R, Carrum, G, Cerny, J, Cheong, J, Ciceri, F, Colorado, M, Cook, R, Couriel, D, Craddock, C, Damon, L, Deol, A, Desbrosses, Y, Di Grazia, C, Di Stasi, A, Dias, A, Dorritie, K, Essell, J, Eto, T, Farag, S, Forcade, E, Frankfurt, O, Fujiwara, S, Fukuda, T, Fukushima, K, Furst, S, Goto, T, Hall, A, Hatta, S, Hicheri, Y, Horwitz, M, Hou, H, How, J, Howard, D, Hsu, W, Huynh, A, Irvine, D, Ishikawa, T, Jamieson, K, Jedrzejczak, W, Jethava, Y, Jimenez, A, Jung, C, Kanda, J, Karakasis, D, Kato, J, Kekre, N, Khera, N, Klein, A, Kobbe, G, Kornblit, B, Kota, V, Lachance, S, Leber, B, Lee, C, Lee, J, Lin, T, Liu, T, Martelli, M, Martinez, C, Matsuoka, K, Mccarty, J, Mendez, L, Michelis, F, Mineishi, S, Mohty, M, Moors, I, Motyckova, G, Mueller, L, Nakamae, H, Nakano, N, Nathan, S, Nicholson, E, Norkin, M, Ogawa, Y, Olesen, G, Oluwole, O, Pantin, J, Paulson, K, Pemberton, L, Perera, T, Piatkowska-Jakubas, B, Poire, X, Protheroe, R, Rambaldi, A, Ritchie, D, Ross, K, Rubio, M, Santarone, S, Sanz Caballer, J, Sawa, M, Schaar, D, Scheid, C, Schriber, J, Seropian, S, Shah, N, Shore, T, Gil, J, Sobecks, R, Socie, G, Sprague, K, Spyridonidis, A, Stelljes, M, Stiff, P, Stuart, R, Tanaka, M, Tandra, A, Tholouli, E, Thomas, X, Tiribelli, M, Tomlinson, B, Tsirigotis, P, Tzachanis, D, Uchida, N, Ueda, M, Valcarcel Ferreiras, D, Wagner, E, Watson, A, Weisdorf, D, Wolschke, C, Wrobel, T, Yakoub-Agha, I, Yamauchi, T, Yared, J, Yeh, S, Yoon, S, Yoshihara, S, Null, N, Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, Mikesch, Jan-Henrik, Najima, Yuho, Onozawa, Masahiro, Thomson, Kirsty, Nagler, Arnon, Wei, Andrew H., Marcucci, Guido, Geller, Nancy L., Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason, Gill, Stanley C., Nuthethi, Rishita, King, Denise, Wittsack, Heather, Mendizabal, Adam, Devine, Steven M., Horowitz, Mary M., Chen, Yi-Bin, Agura, Ed, Altman, Jessica, Anagnostopoulos, Achiles, Anand, Sarah, Artz, Andrew, Aulitzky, Walter, Balderman, Sophia, Ballen, Karen, Becker, Michael, Beguin, Yves, Berkahn, Leanne, Berneman, Zwi, Bhatt, Vijaya, Bilmon, Ian, Bonifazi, Francesca, Briggs, Adrienne, Bruno, Benedetto, Brunstein, Claudio, Byrne, Michael, Byrne, Jenny, Cabrero, Monica, Cairoli, Roberto, Carrum, George, Cerny, Jan, Cheong, June-Won, Ciceri, Fabio, Colorado, Mercedes, Cook, Rachel, Couriel, Daniel, Craddock, Charles, Damon, Lloyd, Deol, Abhinav, Desbrosses, Yohan, Devine, Steve, Di Grazia, Carmela, Di Stasi, Antonio, Dias, Ajoy, Dorritie, Kathy, Essell, James, Eto, Tetsuya, Farag, Sherif, Forcade, Edouard, Frankfurt, Olga, Fujiwara, Shinichiro, Fukuda, Takahiro, Fukushima, Kentaro, Furst, Sabine, Goto, Tatsunori, Hall, Aric, Hatta, Shunsuke, Hicheri, Yosr, Horwitz, Mitchell, Hou, Hsin-An, How, Jonathan, Howard, Dianna, Hsu, Wei-Hsun (Blake), Huynh, Anne, Irvine, David, Ishikawa, Takayuki, Jamieson, Katarzyna, Jedrzejczak, Wieslaw, Jethava, Yogesh, Jimenez, Antonio, Jung, Chul Won, Kanda, Junya, Karakasis, Dimitrios, Kato, Jun, Kekre, Natasha, Khera, Nandita, Klein, Andreas, Kobbe, Guido, Kornblit, Brian, Kota, Vamsi, Lachance, Silvy, Leber, Brian, Lee, Catherine, Lee, Je Hwan, Lin, Tung-Liang, Liu, Ta-Chih, Martelli, Maurizio, Martinez, Carmen, Matsuoka, Kenichi, McCarty, John, Mendez, Lourdes, Michelis, Fotios, Mineishi, Shin, Mohty, Mohamad, Moors, Ine, Motyckova, Gabriela, Mueller, Lutz, Nakamae, Hirohisa, Nakano, Nobuaki, Nathan, Sunita, Nicholson, Emma, Norkin, Maxim, Ogawa, Yoshiaki, Olesen, Gitte, Oluwole, Olalekan, Pantin, Jeremy, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Piatkowska-Jakubas, Beata, Poire, Xavier, Protheroe, Rachel, Rambaldi, Alessandro, Ritchie, David, Ross, Kelly, Rubio, Marie-Therese, Santarone, Stella, Sanz Caballer, Jaime, Sawa, Masashi, Schaar, Dale, Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart, Shah, Nilay, Shah, Nirav, Shore, Tsiporah, Gil, Jorge Sierra, Singh, Anurag, Sobecks, Ronald, Socie, Gerard, Soiffer, Robert, Sprague, Kellie, Spyridonidis, Alexandros, Stelljes, Matthias, Stiff, Patrick, Stuart, Robert, Tanaka, Masatsugu, Tandra, Anand, Tholouli, Eleni, Thomas, Xavier, Tiribelli, Mario, Tomlinson, Benjamin, Tsirigotis, Panagiotis, Tzachanis, Dimitrios, Uchida, Naoyuki, Ueda, Masumi, Valcarcel Ferreiras, David, Wagner, Eva, Watson, Anne-Marie, Weisdorf, Daniel, Wolschke, Christine, Wrobel, Tomasz, Yakoub-Agha, Ibrahim, Yamauchi, Takuji, Yared, Jean, Yeh, Su-Peng, Yoon, Sung-Soo, Yoshihara, Satoshi, and null, null

Abstract

PURPOSEAllogeneic hematopoietic cell transplantation (HCT) improves outcomes for patients with AML harboring an internal tandem duplication mutation of FLT3 (FLT3-ITD) AML. These patients are routinely treated with a FLT3 inhibitor after HCT, but there is limited evidence to support this. Accordingly, we conducted a randomized trial of post-HCT maintenance with the FLT3 inhibitor gilteritinib (ClinicalTrials.gov identifier: NCT02997202) to determine if all such patients benefit or if detection of measurable residual disease (MRD) could identify those who might benefit.METHODSAdults with FLT3-ITD AML in first remission underwent HCT and were randomly assigned to placebo or 120 mg once daily gilteritinib for 24 months after HCT. The primary end point was relapse-free survival (RFS). Secondary end points included overall survival (OS) and the effect of MRD pre- and post-HCT on RFS and OS.RESULTSThree hundred fifty-six participants were randomly assigned post-HCT to receive gilteritinib or placebo. Although RFS was higher in the gilteritinib arm, the difference was not statistically significant (hazard ratio [HR], 0.679 [95% CI, 0.459 to 1.005]; two-sided P =.0518). However, 50.5% of participants had MRD detectable pre- or post-HCT, and, in a prespecified subgroup analysis, gilteritinib was beneficial in this population (HR, 0.515 [95% CI, 0.316 to 0.838]; P =.0065). Those without detectable MRD showed no benefit (HR, 1.213 [95% CI, 0.616 to 2.387]; P =.575).CONCLUSIONAlthough the overall improvement in RFS was not statistically significant, RFS was higher for participants with detectable FLT3-ITD MRD pre- or post-HCT who received gilteritinib treatment. To our knowledge, these data are among the first to support the effectiveness of MRD-based post-HCT therapy.

Published
2024

47. Health-related quality of life with gilteritinib vs placebo posttransplant for FLT3-ITD+acute myeloid leukemia

Author

Hamilton, Betty K., Pandya, Bhavik J., Ivanescu, Cristina, Elsouda, Dina, Hamadani, Mehdi, Chen, Yi-Bin, Levis, Mark J., Ueda Oshima, Masumi, Litzow, Mark R., Soiffer, Robert J., Ustun, Celalettin, Perl, Alexander E., Singh, Anurag K., Geller, Nancy, Hasabou, Nahla, Rosales, Matt, Cella, David, Corredoira, Laura, Pestana, Carolina, Horowitz, Mary M., and Logan, Brent

Abstract

•Gilteritinib maintenance therapy after allogeneic HCT in FLT3-ITDAML is not associated with any difference in HRQOL compared with placebo.•Despite a higher incidence of adverse events, gilteritinib was not associated with any patient-reported impact of side effects.

Published
2024
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48. Robust Tests in Genome-Wide Scans under Incomplete Linkage Disequilibrium

Author

Zheng, Gang, Joo, Jungnam, Zaykin, Dmitri, Wu, Colin, and Geller, Nancy

Subjects
Statistics - Methodology
Abstract

Under complete linkage disequilibrium (LD), robust tests often have greater power than Pearson's chi-square test and trend tests for the analysis of case-control genetic association studies. Robust statistics have been used in candidate-gene and genome-wide association studies (GWAS) when the genetic model is unknown. We consider here a more general incomplete LD model, and examine the impact of penetrances at the marker locus when the genetic models are defined at the disease locus. Robust statistics are then reviewed and their efficiency and robustness are compared through simulations in GWAS of 300,000 markers under the incomplete LD model. Applications of several robust tests to the Wellcome Trust Case-Control Consortium [Nature 447 (2007) 661--678] are presented., Comment: Published in at http://dx.doi.org/10.1214/09-STS314 the Statistical Science (http://www.imstat.org/sts/) by the Institute of Mathematical Statistics (http://www.imstat.org)

Published
2010
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49. Introduction to the Special Issue: Genome-Wide Association Studies

Author

Zheng, Gang, Marchini, Jonathan, and Geller, Nancy L.

Subjects
Statistics - Methodology
Abstract

Introduction to the Special Issue: Genome-Wide Association Studies, Comment: Published in at http://dx.doi.org/10.1214/09-STS310 the Statistical Science (http://www.imstat.org/sts/) by the Institute of Mathematical Statistics (http://www.imstat.org)

Published
2010
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50. Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women: an observational study from the Women's Health Initiative

Author

Salmoirago-Blotcher, Elena, Hovey, Kathleen M, Andrews, Christopher A, Robinson, Jennifer G, Johnson, Karen C, Wassertheil-Smoller, Sylvia, Crawford, Sybil, Qi, Lihong, Martin, Lisa W, Ockene, Judith, Manson, JoAnn E, Nabel, Elizabeth, Rossouw, Jacques, Ludlam, Shari, McGowan, Joan, Ford, Leslie, Geller, Nancy, Prentice, Ross, Anderson, Garnet, LaCroix, Andrea, Kooperberg, Charles L, Patterson, Ruth E, McTiernan, Anne, Stein, Evan, Cummings, Steven, Rajkovic, Aleksandar, Eaton, Charles B, Phillips, Lawrence, Beresford, Shirley, Chlebowski, Rowan, Michael, Yvonne, Caan, Bette, Kotchen, Jane Morley, Howard, Barbara V, Van Horn, Linda, Black, Henry, Stefanick, Marcia L, Lane, Dorothy, Jackson, Rebecca, Lewis, Cora E, Thomson, Cynthia A, Wactawski-Wende, Jean, Robbins, John, Hubbell, F Allan, Nathan, Lauren, Langer, Robert D, Gass, Margery, Limacher, Marian, Curb, J David, Wallace, Robert, Lasser, Norman, O'Sullivan, Mary Jo, Margolis, Karen, Brunner, Robert, Heiss, Gerardo, Kuller, Lewis, Brzyski, Robert, Sarto, Gloria E, Vitolins, Mara, Simon, Michael, and Shumaker, Sally

Subjects
Biomedical and Clinical Sciences, Public Health, Health Sciences, Aging, Women's Health, Clinical Research, Cerebrovascular, Prevention, Stroke, Female, Follow-Up Studies, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Middle Aged, Postmenopause, Proportional Hazards Models, Retrospective Studies, Risk Factors, PREVENTIVE MEDICINE, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

ObjectivesTo determine whether statin treatment is associated with increased risk of haemorrhagic stroke (HS) in older women. A secondary objective was to evaluate HS risk in users of combined statin and antiplatelet treatment.DesignObservational study: secondary data analysis from the Women's Health Initiative (WHI) clinical trials.SettingWomen were recruited from 40 participating sites.ParticipantsCohort of 68,132 women followed through 2005 (parent study) and for an additional 5 years in the extension study.Main outcome measuresStatin use was assessed at baseline and at follow-up visits (1, 3, 6 and 9 years). Women brought medications in original containers for inventory. Strokes were ascertained semiannually and centrally adjudicated. Risk of HS by statin use (time-varying covariate, with the 'no use' category as the referent) was estimated from Cox proportional hazard regression models adjusted for age (model 1); risk factors for HS (model 2); and possible confounders by indication (model 3). Prespecified subgroup analyses were conducted by use of antiplatelet medications.ResultsFinal models included 67,882 women (mean age, 63±7 years). Over a mean follow-up of 12 years, incidence rates of HS were 6.4/10,000 person-years among statin users and 5.0/10,000 person-years among non-users (p=0.11). The unadjusted risk of HS in statin users was 1.21 (CI 0.96 to 1.53); after adjusting for age and HS risk factors the HR was 0.98 (CI 0.76 to 1.26). Risk of HS was higher among women on statins and antiplatelet agents versus women on antiplatelet medications alone (HR=1.59; CI 1.03 to 2.47); p for interaction=0.011.ConclusionsThis retrospective analysis did not show an association between statin use and HS risk among older women. HS risk was higher among women taking statins with antiplatelet agents. These findings warrant further investigation, given potential implications for clinical decision-making.

Published
2015

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