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1. 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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2. 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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3. 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

4. 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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5. 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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9. 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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11. 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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14. 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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16. 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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19. 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

20. 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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21. 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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22. 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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23. 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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25. 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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26. 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

27. 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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28. Charting a Roadmap for Heart Failure Biomarker Studies

Author

Ahmad, Tariq, Fiuzat, Mona, Pencina, Michael J, Geller, Nancy L, Zannad, Faiez, Cleland, John GF, Snider, James V, Blankenberg, Stephan, Adams, Kirkwood F, Redberg, Rita F, Kim, Jae B, Mascette, Alice, Mentz, Robert J, O'Connor, Christopher M, Felker, G Michael, and Januzzi, James L

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Heart Disease, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Biomarkers, Cooperative Behavior, Heart Failure, Humans, Prognosis, Research Design, biomarkers, heart failure, studies, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Heart failure is a syndrome with a pathophysiological basis that can be traced to dysfunction in several interconnected molecular pathways. Identification of biomarkers of heart failure that allow measurement of the disease on a molecular level has resulted in enthusiasm for their use in prognostication and selection of appropriate therapies. However, despite considerable amounts of information available on numerous biomarkers, inconsistent research methodologies and lack of clinical correlations have made bench-to-bedside translations rare and left the literature with countless publications of varied quality. There is a need for a systematic and collaborative approach aimed at definitively studying the clinical benefits of novel biomarkers. In this review, on the basis of input from academia, industry, and governmental agencies, we propose a systematized approach based on adherence to specific quality measures for studies looking to augment current prediction model or use biomarkers to tailor therapeutics. We suggest that study quality, rather than results, should determine publication and propose a system for grading biomarker studies. We outline the need for collaboration between clinical investigators and statisticians to introduce more advanced statistical methodologies into the field of biomarkers that would allow for data from a large number of variables to be distilled into clinically actionable information. Lastly, we propose the creation of a heart failure biomarker consortium that would allow for a comprehensive list of biomarkers to be concomitantly analyzed in a pooled sample of randomized clinical trials and hypotheses to be generated for testing in biomarker-guided trials. Such a consortium could collaborate in sharing samples to identify biomarkers, undertake meta-analyses on completed trials, and spearhead clinical trials to test the clinical utility of new biomarkers.

Published
2014

29. Biatrial maze procedure versus pulmonary vein isolation for atrial fibrillation during mitral valve surgery: New analytical approaches and end points

Author

Miller, Marissa A., Taddei-Peters, Wendy C., Buxton, Dennis, Connolly, Amy, 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, Goldfarb, Seth, Gupta, Lopa, Kirkwood, Katherine, Kumbarce, Edlira, Levitan, Ron, O'Sullivan, Karen, Overbey, Jessica, Santos, Milerva, Weglinski, Michael, Williams, Paula, Wood, Carrie, Ye, Xia, 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, Blackwell, Ray, Kerzner, Roger, Banbury, Michael, Squire, Andrea M., Gillinov, A. Marc, Blackstone, Eugene H., Lytle, Bruce, Mihaljevic, Tomislav, Lackner, Pamela, Berroteran, Leoma, Dolney, Diana, Fleming, Suzanne, Palumbo, Roberta, Whitman, Christine, Sankovic, Kathy, Sweeney, Denise Kosty, Pattakos, Gregory, 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, 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, Michler, Robert E., D'Alessandro, David A., DeRose, Joseph J., Jr., Goldstein, Daniel J., Bello, Ricardo, Jakobleff, William, Garcia, Mario, Taub, Cynthia, Spevack, Daniel, Swayze, Roger, Sookraj, Nadia, Perrault, Louis P., Basmadjian, Arsène-Joseph, Bouchard, Denis, Carrier, Michel, Cartier, Raymond, Pellerin, Michel, Tanguay, Jean François, El-Hamamsy, Ismael, Denault, André, Lacharité, Jonathan, Robichaud, Sophie, Adams, David H., Varghese, Robin, Mandel-Portnoy, Yael, Horvath, Keith A., Corcoran, Philip C., Siegenthaler, Michael P., Murphy, Mandy, Iraola, Margaret, Greenberg, Ann, Sai-Sudhakar, Chittoor, Hasan, Ayseha, McDavid, Asia, Kinn, Bradley, Mullen, John C., Choy, Jonathan, Meyer, Steven, Kuurstra, Emily, Gammie, James S., DeFilippi, Christopher R., Gaetani, Dino T., Young, Cindi A., Beach, Dana, Collins, Julia, Bolling, Steven F., Pagani, Francis D., Bloem, Cathie, Acker, Michael A., Woo, Y. Joseph, Mayer, Mary Lou, Bavaria, Joseph E., Szeto, Wilson Y., Margulies, Kenneth, Keane, Martin, Glassberg, Helene, Jagasia, Dinesh, Kirkpatrick, James, Kron, Irving L., Ailawadi, Gorav, Johnston, Karen, Dent, John M., Kern, John, Keim, Jessica, Burks, Sandra, Gahring, Kim, Mangi, Abeel, Akar, Joseph, Yuh, David, Wilson, Lynn, 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., Canty, John M., Jr., 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, Couderc, Jean-Philippe, Balda, Dan, Bowen, Wayne, Wilson, Mauri, Schering, Anne, Chang, Helena L., Rajeswaran, Jeevanantham, Ishwaran, Hemant, Li, Liang, Ehrlinger, John, Couderc, Jean-Phillipe, and Mack, Michael J.

Published
2019
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32. Secondary surgical-site infection after coronary artery bypass grafting: A multi-institutional prospective cohort study

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, Gardner, Timothy J., O'Gara, Patrick T., Gelijns, Annetine C., Parides, Michael K., Ascheim, Deborah D., Moskowitz, Alan J., Moquete, Ellen, Rose, Eric A., Chase, Melissa, Chen, Yingchun, Gagliardi, Rosemarie, Gupta, Lopa, Kumbarce, Edlira, Levitan, Ron, O'Sullivan, Karen, Santos, Milerva, Weinberg, Alan, Williams, Paula, Wood, Carrie, Ye, Xia, 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, Smith, Peter K., Welsh, Stacey, Alexander, John H., Milano, Carmelo A., Glower, Donald D., Mathew, Joseph P., Harrison, J. Kevin, 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., 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, Ismael, Denault, André, Lacharité, Jonathan, Robichaud, Sophie, Horvath, Keith A., Corcoran, Philip C., Siegenthaler, Michael P., Murphy, Mandy, Iraola, Margaret, Greenberg, Ann, Acker, Michael A., Woo, Y. Joseph, Mayer, Mary Lou, Kron, Irving L., Ailawadi, Gorav, Johnston, Karen, Dent, John M., Kern, John, Sandra Burks, Jessica Keim, 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., Richenbacher, Wayne, Rao, Vivek, Furie, Karen L., Miller, Rachel, Pinney, Sean, Roberts, William C., Huprikar, Shirish, Levi, Marilyn, Gulack, Brian C., Kirkwood, Katherine A., Shi, Wei, Burks, Sandra G., Goldfarb, Seth D., and Bowdish, Michael E.

Published
2018
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33. A Pharmacogenetic versus a Clinical Algorithm for Warfarin Dosing

Author

Kimmel, Stephen E, French, Benjamin, Kasner, Scott E, Johnson, Julie A, Anderson, Jeffrey L, Gage, Brian F, Rosenberg, Yves D, Eby, Charles S, Madigan, Rosemary A, McBane, Robert B, Abdel-Rahman, Sherif Z, Stevens, Scott M, Yale, Steven, Mohler, Emile R, Fang, Margaret C, Shah, Vinay, Horenstein, Richard B, Limdi, Nita A, Muldowney, James AS, Gujral, Jaspal, Delafontaine, Patrice, Desnick, Robert J, Ortel, Thomas L, Billett, Henny H, Pendleton, Robert C, Geller, Nancy L, Halperin, Jonathan L, Goldhaber, Samuel Z, Caldwell, Michael D, Califf, Robert M, and Ellenberg, Jonas H

Subjects
Hematology, Genetics, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Adult, Aged, Algorithms, Anticoagulants, Aryl Hydrocarbon Hydroxylases, Cytochrome P-450 CYP2C9, Double-Blind Method, Female, Follow-Up Studies, Genotype, Hemorrhage, Humans, International Normalized Ratio, Male, Pharmacogenetics, Thromboembolism, Treatment Failure, Vitamin K Epoxide Reductases, Warfarin, COAG Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe clinical utility of genotype-guided (pharmacogenetically based) dosing of warfarin has been tested only in small clinical trials or observational studies, with equivocal results.MethodsWe randomly assigned 1015 patients to receive doses of warfarin during the first 5 days of therapy that were determined according to a dosing algorithm that included both clinical variables and genotype data or to one that included clinical variables only. All patients and clinicians were unaware of the dose of warfarin during the first 4 weeks of therapy. The primary outcome was the percentage of time that the international normalized ratio (INR) was in the therapeutic range from day 4 or 5 through day 28 of therapy.ResultsAt 4 weeks, the mean percentage of time in the therapeutic range was 45.2% in the genotype-guided group and 45.4% in the clinically guided group (adjusted mean difference, [genotype-guided group minus clinically guided group], -0.2; 95% confidence interval, -3.4 to 3.1; P=0.91). There also was no significant between-group difference among patients with a predicted dose difference between the two algorithms of 1 mg per day or more. There was, however, a significant interaction between dosing strategy and race (P=0.003). Among black patients, the mean percentage of time in the therapeutic range was less in the genotype-guided group than in the clinically guided group. The rates of the combined outcome of any INR of 4 or more, major bleeding, or thromboembolism did not differ significantly according to dosing strategy.ConclusionsGenotype-guided dosing of warfarin did not improve anticoagulation control during the first 4 weeks of therapy. (Funded by the National Heart, Lung, and Blood Institute and others; COAG ClinicalTrials.gov number, NCT00839657.).

Published
2013

34. Rejoinder.

Author

Uschner, Diane, Sverdlov, Oleksandr, Carter, Kerstine, Chipman, Jonathan J., Kuznetsova, Olga, Renteria, Jone, Lane, Adam, Barker, Chris, Geller, Nancy L., Proschan, Michael, Posch, Martin, Tarima, Sergey, Bretz, Frank, and Rosenberger, William F.

Published
2024
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35. The future of clinical trials: A panel discussion

Author

D'Agostino, Ralph, DeMets, David, Friedewald, William, Goodman, Steven, Witte, John, and Geller, Nancy L

Subjects
Bayes Theorem, Bias, Biomarkers, Clinical Trials as Topic, Endpoint Determination, Forecasting, Group Processes, Patient Dropouts, Research Design, Research Report, Statistics, Public Health and Health Services, Statistics & Probability
Abstract

A panel discussion on the future of clinical trials addressed several issues raised in the course of the first day of the Workshop. The chair posed questions in six areas which the panel and audience addressed. This paper summarizes the panel discussion.

Published
2012

41. Myeloablative versus Reduced-Intensity Conditioning for Hematopoietic Cell Transplantation in Acute Myelogenous Leukemia and Myelodysplastic Syndromes—Long-Term Follow-Up of the BMT CTN 0901 Clinical Trial

Author

Scott, Bart L., Pasquini, Marcelo C., Fei, Mingwei, Fraser, Raphael, Wu, Juan, Devine, Steve M., Porter, David L., Maziarz, Richard T., Warlick, Erica, Fernandez, Hugo F., Soiffer, Robert J., Alyea, Edwin, Hamadani, Mehdi, Bashey, Asad, Giralt, Sergio, Geller, Nancy L., Leifer, Eric, Hourigan, Christopher S., Gui, Gege, Mendizabal, Adam, Horowitz, Mary M., Deeg, H. Joachim, and Horwitz, Mitchell E.

Published
2021
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50. Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma (BMT CTN 0102): a phase 3 biological assignment trial

Author

Krishnan, Amrita, Pasquini, Marcelo C, Logan, Brent, Stadtmauer, Edward A, Vesole, David H, Alyea, Edwin, 3rd, Antin, Joseph H, Comenzo, Raymond, Goodman, Stacey, Hari, Parameswaran, Laport, Ginna, Qazilbash, Muzaffar H, Rowley, Scott, Sahebi, Firoozeh, Somlo, George, Vogl, Dan T, Weisdorf, Daniel, Ewell, Marian, Wu, Juan, Geller, Nancy L, Horowitz, Mary M, Giralt, Sergio, and Maloney, David G

Published
2011
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