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1. Pulmonary Fibrosis Stakeholder Summit: A Joint NHLBI, Three Lakes Foundation, and Pulmonary Fibrosis Foundation Workshop Report.

Author

Hariri, Lida, Hogaboam, Cory, Jenkins, R, Kaminski, Naftali, Kim, Grace, Königshoff, Melanie, Kolb, Martin, Kotton, Darrell, Kropski, Jonathan, Lasky, Joseph, Magin, Chelsea, Maher, Toby, McCormick, Mark, Moore, Bethany, Nickerson-Nutter, Cheryl, Oldham, Justin, Podolanczuk, Anna, Raghu, Ganesh, Rosas, Ivan, Rowe, Steven, Schmidt, William, Schwartz, David, Shore, Jessica, Spino, Cathie, Craig, J, Martinez, Fernando, Montesi, Sydney, Gomez, Christian, Beers, Michael, Brown, Robert, Chattopadhyay, Ishanu, Flaherty, Kevin, Garcia, Christine, and Gomperts, Brigitte

Subjects
interstitial lung disease, pulmonary fibrosis, United States, Humans, National Heart, Lung, and Blood Institute (U.S.), Lakes, Idiopathic Pulmonary Fibrosis, Risk Factors, Biomedical Research
Abstract

Despite progress in elucidation of disease mechanisms, identification of risk factors, biomarker discovery, and the approval of two medications to slow lung function decline in idiopathic pulmonary fibrosis and one medication to slow lung function decline in progressive pulmonary fibrosis, pulmonary fibrosis remains a disease with a high morbidity and mortality. In recognition of the need to catalyze ongoing advances and collaboration in the field of pulmonary fibrosis, the NHLBI, the Three Lakes Foundation, and the Pulmonary Fibrosis Foundation hosted the Pulmonary Fibrosis Stakeholder Summit on November 8-9, 2022. This workshop was held virtually and was organized into three topic areas: 1) novel models and research tools to better study pulmonary fibrosis and uncover new therapies, 2) early disease risk factors and methods to improve diagnosis, and 3) innovative approaches toward clinical trial design for pulmonary fibrosis. In this workshop report, we summarize the content of the presentations and discussions, enumerating research opportunities for advancing our understanding of the pathogenesis, treatment, and outcomes of pulmonary fibrosis.

Published
2024

2. Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial

Author

Podolanczuk, Anna J, Kim, John S, Cooper, Christopher B, Lasky, Joseph A, Murray, Susan, Oldham, Justin M, Raghu, Ganesh, Flaherty, Kevin R, Spino, Cathie, Noth, Imre, and Martinez, Fernando J

Subjects
Rare Diseases, Clinical Trials and Supportive Activities, Genetics, Lung, Complementary and Integrative Health, Clinical Research, Autoimmune Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Respiratory, Good Health and Well Being, Humans, Acetylcysteine, Double-Blind Method, Genotype, Idiopathic Pulmonary Fibrosis, Treatment Outcome, Vital Capacity, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Clinical Trials, Phase III as Topic, IPF, Clinical trial, Protocol, N-acetylcysteine, PRECISIONS Study Team, Cardiorespiratory Medicine and Haematology, Respiratory System
Abstract

BackgroundIdiopathic pulmonary fibrosis (IPF) is a progressive lung disease with few treatment options. N-acetylcysteine (NAC) is a well-tolerated, inexpensive treatment with antioxidant and anti-fibrotic properties. The National Heart, Lung, and Blood Institute (NHLBI)-sponsored PANTHER (Prednisone Azathioprine and NAC therapy in IPF) trial confirmed the harmful effects of immunosuppression in IPF, and did not show a benefit to treatment with NAC. However, a post hoc analysis revealed a potential beneficial effect of NAC in a subgroup of individuals carrying a specific genetic variant, TOLLIP rs3750920 TT genotype, present in about 25% of patients with IPF. Here, we present the design and rationale for the Phase III, multi-center, randomized, double-blind, placebo-controlled Prospective Treatment Efficacy in IPF Using Genotype for NAC Selection (PRECISIONS) clinical trial.MethodsThe PRECISIONS trial will randomize 200 patients with IPF and the TOLLIP rs3750920 TT genotype 1:1 to oral N-acetylcysteine (600 mg tablets taken three times a day) or placebo for a 24-month duration. The primary endpoint is the composite of time to 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or death from any cause. Secondary endpoints include change in patient-reported outcome scores and proportion of participants with treatment-emergent adverse events. Biospecimens, including blood, buccal, and fecal will be collected longitudinally for future research purposes. Study participants will be offered enrollment in a home spirometry substudy, which explores time to 10% relative FVC decline measured at home, and its comparison with study visit FVC.DiscussionThe sentinel observation of a potential pharmacogenetic interaction between NAC and TOLLIP polymorphism highlights the urgent, unmet need for better, molecularly focused, and precise therapeutic strategies in IPF. The PRECISIONS clinical trial is the first study to use molecularly-focused techniques to identify patients with IPF most likely to benefit from treatment. PRECISIONS has the potential to shift the paradigm in how trials in this condition are designed and executed, and is the first step toward personalized medicine for patients with IPF. Trial Registration ClinicalTrials.gov identifier: NCT04300920. Registered March 9, 2020. https://clinicaltrials.gov/ct2/show/NCT04300920.

Published
2022

3. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial

Author

Elmunzer, B. Joseph, Foster, Lydia D., Serrano, Jose, Coté, Gregory A., Edmundowicz, Steven A., Wani, Sachin, Shah, Raj, Bang, Ji Young, Varadarajulu, Shyam, Singh, Vikesh K., Khashab, Mouen, Kwon, Richard S., Scheiman, James M., Willingham, Field F., Keilin, Steven A., Papachristou, Georgios I., Chak, Amitabh, Slivka, Adam, Mullady, Daniel, Kushnir, Vladimir, Buxbaum, James, Keswani, Rajesh, Gardner, Timothy B., Forbes, Nauzer, Rastogi, Amit, Ross, Andrew, Law, Joanna, Yachimski, Patrick, Chen, Yen-I, Barkun, Alan, Smith, Zachary L., Petersen, Bret, Wang, Andrew Y., Saltzman, John R., Spitzer, Rebecca L., Ordiah, Collins, Spino, Cathie, Higgins, Peter D.R., Forster, Erin, Moran, Robert A., Brauer, Brian, Wamsteker, Erik J., Cai, Qiang, Qayed, Emad, Groce, Royce, Krishna, Somashekar G., Faulx, Ashley, Glessing, Brooke, Rabinovitz, Mordechai, Lang, Gabriel, Aadam, Aziz, Komanduri, Srinadh, Adler, Jefferey, Gordon, Stuart, Mohamed, Rachid, Olyaee, Mojtaba, Wood-Williams, April, Depue Brewbaker, Emily K., Thornhill, Andre, Gould, Mariana, Clasen, Kristen, Olsen, Jama, Simon, Violette C., Kamal, Ayesha, Volk, Sarah L., Merchant, Ambreen A., Lahooti, Ali, Furey, Nancy, Anderson, Gulsum, Hollander, Thomas, Vazquez, Alejandro, Li, Thomas Y., Hadley, Steven M., Chau, Millie, Mendoza, Robinson, Tangwongchai, Tida, Koza, Casey L., Geraci, Olivia, Nunez, Lizbeth, Waters, Alexander M., Durkalski-Mauldin, Valerie, Elmunzer, B Joseph, Foster, Lydia D, Coté, Gregory A, Edmundowicz, Steven A, Singh, Vikesh K, Kwon, Richard S, Scheiman, James M, Willingham, Field F, Keilin, Steven A, Papachristou, Georgios I, Gardner, Timothy B, Smith, Zachary L, Wang, Andrew Y, Saltzman, John R, and Spitzer, Rebecca L

Published
2024
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4. Trainee Participation and Outcomes in High-risk Endoscopic Retrograde Cholangiopancreatography: A Secondary Analysis of the Stent Versus Indomethacin Trial

Author

Serrano, Jose, Coté, Gregory A., Edmundowicz, Steven A., Shah, Raj, Bang, Ji Young, Varadarajulu, Shyam, Singh, Vikesh K., Khashab, Mouen, Kwon, Richard S., Scheiman, James M., Willingham, Field F., Keilin, Steven A., Papachristou, Georgios I., Chak, Amitabh, Slivka, Adam, Mullady, Daniel, Kushnir, Vladimir, Buxbaum, James, Keswani, Rajesh, Gardner, Timothy B., Forbes, Nauzer, Rastogi, Amit, Ross, Andrew, Law, Joanna, Yachimski, Patrick, Chen, Yen-I, Barkun, Alan, Smith, Zachary L., Petersen, Bret, Wang, Andrew Y., Saltzman, John R., Spitzer, Rebecca L., Gallegos, Jazmyne, Brennan, Case, Ordiah, Collins, Spino, Cathie, Wani, Sachin, Zhang, Jingwen, Foster, Lydia D., Durkalski-Mauldin, Valerie, and Elmunzer, B. Joseph

Published
2024
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5. Longitudinal Outcomes in Young Patients with Alpha-1-Antitrypsin Deficiency with Native Liver Reveal that Neonatal Cholestasis is a Poor Predictor of Future Portal Hypertension

Author

Teckman, Jeffrey, Rosenthal, Philip, Hawthorne, Kieran, Spino, Cathie, Bass, Lee M, Murray, Karen F, Kerkar, Nanda, Magee, John C, Karpen, Saul, Heubi, James E, Molleston, Jean P, Squires, Robert H, Kamath, Binita M, Guthery, Stephen L, Loomes, Kathleen M, Sherker, Averell H, Sokol, Ronald J, ChiLDReN, Alonso, Estella, Bass, Lee, Kelly, Susan, Riordan, Mary, Melin-Aldana, Hector, Bezerra, Jorge, Bove, Kevin, Heubi, James, Miethke, Alexander, Tiao, Greg, Denlinger, Julie, Chapman, Erin, Sokol, Ronald, Feldman, Amy, Mack, Cara, Narkewicz, Michael, Suchy, Frederick, Sundaram, Shikha, Van Hove, Johan, Garcia, Benigno, Kauma, Mikaela, Kocher, Kendra, Steinbeiss, Matthew, Lovell, Mark, Loomes, Kathleen, Piccoli, David, Rand, Elizabeth, Russo, Pierre, Spinner, Nancy, Erlichman, Jessi, Stalford, Samantha, Pakstis, Dina, King, Sakya, Squires, Robert, Sindhi, Rakesh, Venkat, Veena, Bukauskas, Kathy, McKiernan, Patrick, Haberstroh, Lori, Squires, James, Bull, Laura, Curry, Joanna, Langlois, Camille, Kim, Grace, Teckman, Jeffery, Kociela, Vikki, Nagy, Rosemary, Patel, Shraddha, Cerkoski, Jacqueline, Bozic, Molly, Subbarao, Girish, Klipsch, Ann, Sawyers, Cindy, Cummings, Oscar, Horslen, Simon, Murray, Karen, Hsu, Evelyn, Cooper, Kara, Young, Melissa, Finn, Laura, Kamath, Binita, Ng, Vicky, Quammie, Claudia, Putra, Juan, Sharma, Deepika, Parmar, Aishwarya, Guthery, Stephen, Jensen, Kyle, Rutherford, Ann, Lowichik, Amy, Book, Linda, Meyers, Rebecka, Hall, Tyler, Wang, Kasper, Michail, Sonia, Thomas, Danny, Goodhue, Catherine, Kohli, Rohit, Wang, Larry, and Soufi, Nisreen

Subjects
Paediatrics, Biomedical and Clinical Sciences, Digestive Diseases, Liver Disease, Pediatric, Hypertension, Clinical Research, Rare Diseases, Transplantation, Chronic Liver Disease and Cirrhosis, 2.1 Biological and endogenous factors, Aetiology, Oral and gastrointestinal, Good Health and Well Being, Adolescent, Adult, Child, Child, Preschool, Cholestasis, Intrahepatic, Disease Progression, Female, Humans, Hypertension, Portal, Infant, Infant, Newborn, Liver Transplantation, Longitudinal Studies, Male, Young Adult, alpha 1-Antitrypsin Deficiency, ChiLDReN, cirrhosis, jaundice, liver enzymes, liver transplant, metabolic liver disease, Human Movement and Sports Sciences, Paediatrics and Reproductive Medicine, Pediatrics
Abstract

ObjectivesTo identify predictors of portal hypertension, liver transplantation, and death in North American youth with alpha-1-antitrypsin (AAT) deficiency, and compare with patients with AAT deficiency elsewhere.Study designThe Childhood Liver Disease Research Network Longitudinal Observational Study of Genetic Causes of Intrahepatic Cholestasis is a prospective, cohort study of pediatric cholestatic liver diseases, including AAT deficiency, enrolling PIZZ and PISZ subjects 0-25 years of age seen since November 2007 at 17 tertiary care centers in the US and Canada. Data from standard-of-care baseline and annual follow-up visits were recorded from medical records, history, physical examination, and laboratory studies. Participants with portal hypertension were identified based on data collected.ResultsWe enrolled 350 participants (60% male) with a native liver; 278 (79%) entered the cohort without portal hypertension and 18 developed portal hypertension during follow-up. Thirty participants required liver transplantation; 2 patients died during 1077 person-years of follow-up. There was no difference in participants with or without preceding neonatal cholestasis progressing to transplantation or death during the study (12% vs 7%; P = .09), or in experiencing portal hypertension (28% vs 21%; P = .16); the hazard ratio for neonatal cholestasis leading to portal hypertension was P = .04. Development of portal hypertension was associated with a reduced height Z-score.ConclusionsPortal hypertension in youth with AAT deficiency impacts growth measures. Progression to liver transplantation is slow and death is rare, but the risk of complications and severe liver disease progression persists throughout childhood. A history of neonatal cholestasis is a weak predictor of severe disease.

Published
2020

7. Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator‐Initiated, Multicenter, Double‐Blind, Randomized, Placebo‐Controlled Trial

Author

Khanna, Dinesh, Spino, Cathie, Johnson, Sindhu, Chung, Lorinda, Whitfield, Michael L, Denton, Christopher P, Berrocal, Veronica, Franks, Jennifer, Mehta, Bhavan, Molitor, Jerry, Steen, Virginia D, Lafyatis, Robert, Simms, Robert W, Gill, Anna, Kafaja, Suzanne, Frech, Tracy M, Hsu, Vivien, Domsic, Robyn T, Pope, Janet E, Gordon, Jessica K, Mayes, Maureen D, Schiopu, Elena, Young, Amber, Sandorfi, Nora, Park, Jane, Hant, Faye N, Bernstein, Elana J, Chatterjee, Soumya, Castelino, Flavia V, Ajam, Ali, Wang, Yue, Wood, Tammara, Allanore, Yannick, Matucci‐Cerinic, Marco, Distler, Oliver, Singer, Ora, Bush, Erica, Fox, David A, and Furst, Daniel E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Brain Disorders, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Abatacept, Adult, Double-Blind Method, Female, Gene Expression, Gene Expression Profiling, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Scleroderma, Diffuse, Sequence Analysis, RNA, Severity of Illness Index, Skin, Treatment Outcome, Tumor Necrosis Factor Inhibitors, Visual Analog Scale, Vital Capacity, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

ObjectiveT cells play a key role in the pathogenesis of early systemic sclerosis. This study was undertaken to assess the safety and efficacy of abatacept in patients with diffuse cutaneous systemic sclerosis (dcSSc).MethodsIn this 12-month, randomized, double-blind, placebo-controlled trial, participants were randomized 1:1 to receive either subcutaneous abatacept 125 mg or matching placebo, stratified by duration of dcSSc. Escape therapy was allowed at 6 months for worsening disease. The coprimary end points were change in the modified Rodnan skin thickness score (MRSS) compared to baseline and safety over 12 months. Differences in longitudinal outcomes were assessed according to treatment using linear mixed models, with outcomes censored after initiation of escape therapy. Skin tissue obtained from participants at baseline was classified into intrinsic gene expression subsets.ResultsAmong 88 participants, the adjusted mean change in the MRSS at 12 months was -6.24 units for those receiving abatacept and -4.49 units for those receiving placebo, with an adjusted mean treatment difference of -1.75 units (P = 0.28). Outcomes for 2 secondary measures (Health Assessment Questionnaire disability index and a composite measure) were clinically and statistically significantly better with abatacept. The proportion of subjects in whom escape therapy was needed was higher in the placebo group relative to the abatacept group (36% versus 16%). In the inflammatory and normal-like skin gene expression subsets, decline in the MRSS over 12 months was clinically and significantly greater in the abatacept group versus the placebo group (P < 0.001 and P = 0.03, respectively). In the abatacept group, adverse events occurred in 35 participants versus 40 participants in the placebo group, including 2 deaths and 1 death, respectively.ConclusionIn this phase II trial, abatacept was well-tolerated, but change in the MRSS was not statistically significant. Secondary outcome measures, including gene expression subsets, showed evidence in support of abatacept. These data should be confirmed in a phase III trial.

Published
2020

9. Safety, tolerability, and efficacy of pirfenidone in patients with rheumatoid arthritis-associated interstitial lung disease: a randomised, double-blind, placebo-controlled, phase 2 study

Author

Haynes-Harp, Shana, Poli, Fernando, Vidya, Coimbatore Sree, Baron, Rebecca R., Clouser, Timothy, Doyle, Tracy, Maeda, Anthony, Highland, Kristin B., Albayda, Jemima F., Collins, Sarah E., Suresh, Karthik S., Davis, John M., Limper, Andrew H., Amigues, Isabel, Eliopoulos, Kristina, Swigris, Jeffery J., Humphries, Stephen, Huntwork, John C., Glynn, Chris, Duncan, Steve R., Danila, Maria I., Glassberg, Marilyn K., Oberstein, Elana M., Belloli, Elizabeth A., Briggs, Linda, Nagaraja, Vivek, Cholewa, Linda, DiFranco, Donna, Green, Edward, Liffick, Christie, Naik, Tanvi, Montas, Genevieve, Lebiedz-Odrobina, Dorota, Bissell, Reba, Wener, Mark, Lancaster, Lisa H., Crawford, Leslie J., Chan, Karmela, Kaner, Robert J., Morris, Alicia, Wu, Xiaoping, Khalidi, Nader A., Ryerson, Christopher J., Wong, Alyson W., Fell, Charlene D., LeClercq, Sharon A., Hyman, Mark, Shapera, Shane, Mittoo, Shikha, Shaffu, Shireen, Gaffney, Karl, Wilson, Andrew M., Barratt, Shaney, Gunawardena, Harsha, Hoyles, Rachel K., David, Joel, Kewalramani, Namrata, Maher, Toby M., Molyneaux, Philip L., Kokosi, Maria A., Cates, Matthew J., Mandizha, Mandizha, Ashish, Abdul, Chelliah, Gladstone, Parfrey, Helen, Thillai, Muhunthan, Vila, Josephine, Fletcher, Sophie V., Beirne, Paul, Favager, Clair, Brown, Jo, Dawson, Julie K., Ortega, Pilar Rivera, Haque, Sahena, Watson, Pippa, Khoo, Jun K., Symons, Karen, Youssef, Peter, Mackintosh, John A., Solomon, Joshua J, Danoff, Sonye K, Woodhead, Felix A, Hurwitz, Shelley, Maurer, Rie, Glaspole, Ian, Dellaripa, Paul F, Gooptu, Bibek, Vassallo, Robert, Cox, P Gerard, Flaherty, Kevin R, Adamali, Huzaifa I, Gibbons, Michael A, Troy, Lauren, Forrest, Ian A, Lasky, Joseph A, Spencer, Lisa G, Golden, Jeffrey, Scholand, Mary Beth, Chaudhuri, Nazia, Perrella, Mark A, Lynch, David A, Chambers, Daniel C, Kolb, Martin, Spino, Cathie, Raghu, Ganesh, Goldberg, Hilary J, and Rosas, Ivan O

Published
2023
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13. Improving Clinical Trials for Anticomplement Therapies in Complement-Mediated Glomerulopathies: Report of a Scientific Workshop Sponsored by the National Kidney Foundation

Author

Bomback, Andrew S., Appel, Gerald B., Gipson, Debbie S., Hladunewich, Michelle A., Lafayette, Richard, Nester, Carla M., Parikh, Samir V., Smith, Richard J.H., Trachtman, Howard, Heeger, Peter S., Ram, Sanjay, Rovin, Brad H., Ali, Shadab, Arceneaux, Nicole, Ashoor, Isa, Bailey-Wickins, Laura, Barratt, Jonathan, Beck, Laurence, Cattran, Daniel C., Cravedi, Paolo, Erkan, Elif, Fervenza, Fernando, Frazer-Abel, Ashley A., Fremeaux-Bacchi, Veronique, Fuller, Lindsey, Gbadegesin, Rasheed, Hogan, Jonathan J., Kiryluk, Krzysztof, le Quintrec-Donnette, Moglie, Licht, Christoph, Mahan, John D., Pickering, Matthew C., Quigg, Richard, Rheault, Michelle, Ronco, Pierre, Sarwal, Minnie M., Sethna, Christine, Spino, Cathie, Stegall, Mark, Vivarelli, Marina, Feldman, David L., and Thurman, Joshua M.

Published
2022
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14. Rationale and design of the Nephrotic Syndrome Study Network (NEPTUNE) Match in glomerular diseases: designing the right trial for the right patient, today

Author

Trachtman, Howard, primary, Desmond, Hailey, additional, Williams, Amanda L., additional, Mariani, Laura H., additional, Eddy, Sean, additional, Ju, Wenjun, additional, Barisoni, Laura, additional, Ascani, Heather K., additional, Uhlmann, Wendy R., additional, Spino, Cathie, additional, Holzman, Lawrence B., additional, Sedor, John R., additional, Gadegbeku, Crystal, additional, Subramanian, Lalita, additional, Lienczewski, Chrysta C., additional, Manieri, Tina, additional, Roberts, Scott J., additional, Gipson, Debbie S., additional, Kretzler, Matthias, additional, Massengill, Susan, additional, Lo, Layla, additional, Dell, Katherine, additional, O’Toole, John, additional, Sedor, John, additional, Martin, Blair, additional, Macumber, Ian, additional, Sharma, Silpa, additional, Srivastava, Tarak, additional, Markus, Kelsey, additional, Sethna, Christine, additional, Vento, Suzanne, additional, Canetta, Pietro, additional, Olabisi, Opeyemi, additional, Gbadegesin, Rasheed, additional, Smith, Maurice, additional, Greenbaum, Laurence, additional, Wang, Chia-shi, additional, Yun, Emily, additional, Adler, Sharon, additional, LaPage, Janine, additional, Amarah, Amatur, additional, Itteera, Mathew, additional, Atkinson, Meredith, additional, Williams, Miahje, additional, Lieske, John, additional, Hogan, Marie, additional, Fervenza, Fernando, additional, Selewski, David, additional, Alston, Cheryl, additional, Reidy, Kim, additional, Ross, Michael, additional, Kaskel, Frederick, additional, Flynn, Patricia, additional, Malaga-Dieguez, Laura, additional, Zhdanova, Olga, additional, Pehrson, Laura Jane, additional, Miranda, Melanie, additional, Almaani, Salem, additional, Roberts, Laci, additional, Lafayette, Richard, additional, Dave, Shiktij, additional, Lee, Iris, additional, Shah, Shweta, additional, Batla, Sadaf, additional, Reich, Heather, additional, Hladunewich, Michelle, additional, Ling, Paul, additional, Romano, Martin, additional, Brakeman, Paul, additional, Dylewski, James, additional, Rogers, Nathan, additional, McCarthy, Ellen, additional, Creed, Catherine, additional, Fornoni, Alessia, additional, Bandes, Miguel, additional, Mariani, Laura, additional, Modi, Zubin, additional, Williams, A., additional, Ni, Roxy, additional, Nachman, Patrick, additional, Rheault, Michelle, additional, Kowalski, Amy, additional, Rauwolf, Nicolas, additional, Derebail, Vimal, additional, Gibson, Keisha, additional, Froment, Anne, additional, Kelley, Sara, additional, Holzman, Lawrence, additional, Meyers, Kevin, additional, Kallem, Krishna, additional, Edwards, Aliya, additional, Sharma, Samin, additional, Roehm, Elizabeth, additional, Sambandam, Kamalanathan, additional, Brown, Elizabeth, additional, Hellewege, Jamie, additional, Jefferson, Ashley, additional, Hingorani, Sangeeta, additional, Tuttle, Katherine, additional, Manahan, Linda, additional, Pao, Emily, additional, Kuykendall, Kelli, additional, Lin, Jen Jar, additional, Dharnidharka, Vikas, additional, Gillespie, Brenda, additional, Salmon, Eloise, additional, Trachtman, Howard, additional, Mainieri, Tina, additional, Alter, Gabrielle, additional, Arbit, Michael, additional, Fermin, Damian, additional, Larkina, Maria, additional, Lienczewski, Chrysta, additional, Scherr, Rebecca, additional, Troost, Jonathan, additional, Williams, Amanda, additional, Zhai, Yan, additional, Kincaid, Colleen, additional, Li, Shengqian, additional, Li, Shannon, additional, Sampson, Matthew G., additional, Smith, Abigail, additional, Zee, Jarcy, additional, Avila-Casado, Carmen, additional, Bagnasco, Serena, additional, Bu, Lihong, additional, Caltharp, Shelley, additional, Cassol, Clarissa, additional, Demeke, Dawit, additional, Hassler, Jared, additional, Herlitz, Leal, additional, Hewitt, Stephen, additional, Hodgin, Jeff, additional, Holanda, Danni, additional, Kambham, Neeraja, additional, Lemley, Kevin, additional, Messias, Nidia, additional, Mikhailov, Alexei, additional, Moreno, Vanessa, additional, Najafian, Behzad, additional, Palmer, Matthew, additional, Rosenberg, Avi, additional, Royal, Virginie, additional, Sekulik, Miroslav, additional, Stokes, Barry, additional, Thomas, David, additional, Wu, Ming, additional, Yamashita, Michifumi, additional, Yin, Hong, additional, Zuo . Cochairs, Yiqin, additional, and Nast, Cynthia, additional

Published
2024
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17. Development and Validation of a Quantitative Measure of Adaptive Behaviors in Women With Pelvic Floor Disorders.

Author

Wei, John T, Dunn, Rodney, Nygaard, Ingrid, Burgio, Kathryn, Lukacz, Emily S, Markland, Alayne, Wren, Patricia A, Brubaker, Linda, Barber, Matthew D, Jelovsek, J Eric, Spino, Cathie, Meikle, Susie, Janz, Nancy, and PFDN

Subjects
PFDN
Abstract

To establish validity for the Pelvic Floor Disorders Network (PFDN) self-administered Adaptive Behavior Index (ABI) and to assess whether ABI assesses known discordance between severity of pelvic floor symptoms and self-reported bother.In addition to the ABI questionnaire, participants in 1 of 6 Pelvic Floor Disorders Network trials completed condition-specific measures of pretreatment symptom severity (including Pelvic Floor Distress Inventory; PFDI) and health-related quality of life (Pelvic Floor Impact Questionnaire; PFIQ). The final survey was developed from an iterative process using subject and expert endorsement, factor analyses, and response distributions. Domains were created using a development cohort (n = 304 women), reliability and validity were established using a validation cohort (n = 596 women), and test-retest reliability was assessed (n = 111 women).Factor analyses supported an 11-item avoidance domain and a 6-item hygiene domain. Cronbach' alphas were 0.88 and 0.68, respectively. Test-retest reliability was 0.84 for both domains. Construct validity was demonstrated in correlations between the ABI domains and baseline PFDI and PFIQ (r values, 0.43-0.79 with all P values

Published
2017

18. Safety and efficacy of abatacept in early diffuse cutaneous systemic sclerosis (ASSET): open-label extension of a phase 2, double-blind randomised trial

Author

Chung, Lorinda, Spino, Cathie, McLain, Richard, Johnson, Sindhu R, Denton, Christopher P, Molitor, Jerry A, Steen, Virginia D, Lafyatis, Robert, Simms, Robert W, Kafaja, Suzanne, Frech, Tracy M, Hsu, Vivien, Domsic, Robyn T, Pope, Janet E, Gordon, Jessica K, Mayes, Maureen D, Sandorfi, Nora, Hant, Faye N, Bernstein, Elana J, Chatterjee, Soumya, Castelino, Flavia V, Ajam, Ali, Allanore, Yannick, Matucci-Cerinic, Marco, Whitfield, Michael L, Distler, Oliver, Singer, Ora, Young, Amber, Nagaraja, Vivek, Fox, David A, Furst, Daniel E, and Khanna, Dinesh

Published
2020
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19. Longitudinal Outcomes in Young Patients with Alpha-1-Antitrypsin Deficiency with Native Liver Reveal that Neonatal Cholestasis is a Poor Predictor of Future Portal Hypertension

Author

Alonso, Estella, Bass, Lee, Kelly, Susan, Riordan, Mary, Melin-Aldana, Hector, Bezerra, Jorge, Bove, Kevin, Heubi, James, Miethke, Alexander, Tiao, Greg, Denlinger, Julie, Chapman, Erin, Sokol, Ronald, Feldman, Amy, Mack, Cara, Narkewicz, Michael, Suchy, Frederick, Sundaram, Shikha, Van Hove, Johan, Garcia, Benigno, Kauma, Mikaela, Kocher, Kendra, Steinbeiss, Matthew, Lovell, Mark, Loomes, Kathleen, Piccoli, David, Rand, Elizabeth, Russo, Pierre, Spinner, Nancy, Erlichman, Jessi, Stalford, Samantha, Pakstis, Dina, King, Sakya, Squires, Robert, Sindhi, Rakesh, Venkat, Veena, Bukauskas, Kathy, McKiernan, Patrick, Haberstroh, Lori, Squires, James, Rosenthal, Philip, Bull, Laura, Curry, Joanna, Langlois, Camille, Kim, Grace, Teckman, Jeffery, Kociela, Vikki, Nagy, Rosemary, Patel, Shraddha, Cerkoski, Jacqueline, Molleston, Jean P., Bozic, Molly, Subbarao, Girish, Klipsch, Ann, Sawyers, Cindy, Cummings, Oscar, Horslen, Simon, Murray, Karen, Hsu, Evelyn, Cooper, Kara, Young, Melissa, Finn, Laura, Kamath, Binita, Ng, Vicky, Quammie, Claudia, Putra, Juan, Sharma, Deepika, Parmar, Aishwarya, Guthery, Stephen, Jensen, Kyle, Rutherford, Ann, Lowichik, Amy, Book, Linda, Meyers, Rebecka, Hall, Tyler, Wang, Kasper, Michail, Sonia, Thomas, Danny, Goodhue, Catherine, Kohli, Rohit, Wang, Larry, Soufi, Nisreen, Thomas, Daniel, Karpen, Saul, Gupta, Nitika, Romero, Rene, Jr., Vos, Miriam B., Tory, Rita, Berauer, John-Paul, Abramowsky, Carlos, McFall, Jeanette, Shneider, Benjamin, Harpavat, Sanjiv, Hertel, Paula, Leung, Daniel, Tessier, Mary, Schady, Deborah, Cavallo, Laurel, Olvera, Diego, Banks, Christina, Tsai, Cynthia, Thompson, Richard, Doo, Edward, Hoofnagle, Jay, Sherker, Averell, Torrance, Rebecca, Hall, Sherry, Magee, John, Merion, Robert, Spino, Cathie, Ye, Wen, Teckman, Jeffrey, Hawthorne, Kieran, Bass, Lee M., Murray, Karen F., Kerkar, Nanda, Magee, John C., Heubi, James E., Squires, Robert H., Kamath, Binita M., Guthery, Stephen L., Loomes, Kathleen M., Sherker, Averell H., and Sokol, Ronald J.

Published
2020
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20. Cardiovascular Autonomic Neuropathy and Risk of Kidney Function Decline in Type 1 and Type 2 Diabetes: Findings From the PERL and ACCORD Cohorts.

Author

Tang, Yaling, Ang, Lynn, Jaiswal, Mamta, Dillon, Brendan R., Esfandiari, Nazanene H., Shah, Hetal S., Spino, Cathie, Plunkett, Cindy, Perkins, Bruce A., Pop-Busui, Rodica, and Doria, Alessandro

Subjects
TYPE 1 diabetes, TYPE 2 diabetes, KIDNEY physiology, HEART beat, PEOPLE with diabetes
Abstract

Results of previous studies have suggested that cardiovascular autonomic neuropathy (CAN) may predict rapid kidney function decline among people with diabetes. We analyzed the association between baseline CAN and subsequent glomerular filtration rate (GFR) decline among individuals with type 1 diabetes (T1D) from the Preventing Early Renal Loss in Diabetes (PERL) study (N = 469) and with type 2 diabetes (T2D) from Action to Control Cardiovascular Risk in Diabetes (ACCORD) (N = 7,973). Baseline CAN was ascertained with electrocardiogram-derived heart rate variability indices. Its association with GFR slopes, rapid kidney function decline (GFR loss of ≥5 mL/min/1.73 m2/year), and ≥40% GFR loss was evaluated by linear mixed-effects, logistic, and Cox regression, respectively. Participants with CAN experienced more rapid GFR decline, by an excess 1.15 mL/min/1.73 m2/year (95% CI −1.93 to −0.37; P = 4.0 × 10−3) in PERL and 0.34 mL/min/1.73 m2/year (95% CI −0.49 to −0.19; P = 6.3 × 10−6) in ACCORD. This translated to 2.11 (95% CI 1.23–3.63; P = 6.9 × 10−3) and 1.39 (95% CI 1.20–1.61; P = 1.1 × 10−5) odds ratios of rapid kidney function decline in PERL and ACCORD, respectively. Baseline CAN was also associated with a greater risk of ≥40% GFR loss events during follow-up (hazard ratio 2.60 [95% CI 1.15–5.45], P = 0.02, in PERL and hazard ratio 1.54 [95% CI 1.28–1.84], P = 3.8 × 10−6, in ACCORD). These associations remained significant after adjustment for potential confounders, including baseline GFR and albuminuria. Our findings indicate that CAN is a strong, independent predictor of rapid kidney function decline in both T1D and T2D. Further studies of the link between these two complications may help with development of new therapies to prevent kidney function decline in patients with diabetes. Article Highlights: Cardiovascular autonomic neuropathy is a strong and independent predictor of rapid kidney function decline in both type 1 and type 2 diabetes. Autonomic nervous system dysfunction may serve as a novel target to develop new therapies to prevent kidney function loss in diabetes. Electrocardiogram-derived indices of cardiovascular autonomic neuropathy might be useful, when added to known clinical risk factors, to improve the identification of patients at high risk of rapid kidney function loss and select them for intensive preventive treatments. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Impact of Socioeconomic Factors on Patient Desire for Early LVAD Therapy Prior to Inotrope Dependence

Author

Tchoukina, Inna, Shah, Keyur B., Thibodeau, Jennifer T., Estep, Jerry D., Lala, Anuradha, Lanfear, David E., Gilotra, Nisha A., Pamboukian, Salpy V., Horstmanshof, Douglas A., Mcnamara, Dennis M., Haas, Donald C., Jorde, Ulrich P., Mclean, Rhondalyn C., Cascino, Thomas M., Khalatbari, Shokoufeh, Richards, Blair, Yosef, Matheos, Spino, Cathie, Baldwin, J. Timothy, Mann, Douglas L., Aaronson, Keith D., and Stewart, Garrick C.

Published
2020
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22. Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL): Rationale, design, baseline characteristics, and inclusion criteria performance

Author

Aaronson, Keith D., Stewart, Garrick C., Pagani, Francis D., Stevenson, Lynne W., Palardy, Maryse, McNamara, Dennis M., Mancini, Donna M., Grady, Kathleen, Gorcsan, John, Kormos, Robert, Jeffries, Neal, Taddei-Peters, Wendy C., Richards, Blair, Khalatbari, Shokoufeh, Spino, Cathie, Baldwin, J. Timothy, and Mann, Douglas L.

Published
2020
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23. Pulmonary Fibrosis Stakeholder Summit: A Joint National Heart, Lung, and Blood Institute, Three Lakes Foundation, and Pulmonary Fibrosis Foundation Workshop Report

Author

Montesi, Sydney B, primary, Gomez, Christian R, additional, Beers, Michael, additional, Brown, Robert, additional, Chattopadhyay, Ishanu, additional, Flaherty, Kevin R., additional, Garcia, Christine Kim, additional, Gomperts, Brigitte, additional, Hariri, Lida P, additional, Hogaboam, Cory M, additional, Jenkins, R. Gisli, additional, Kaminski, Naftali, additional, Kim, Grace Hyun J., additional, Königshoff, Melanie, additional, Kolb, Martin, additional, Kotton, Darrell N, additional, Kropski, Jonathan A., additional, Lasky, Joseph, additional, Magin, Chelsea M., additional, Maher, Toby M., additional, McCormick, Mark, additional, Moore, Bethany B, additional, Nickerson-Nutter, Cheryl, additional, Oldham, Justin, additional, Podolanczuk, Anna J., additional, Raghu, Ganesh, additional, Rosas, Ivan, additional, Rowe, Steven M, additional, Schmidt, William T., additional, Schwartz, David, additional, Shore, Jessica E, additional, Spino, Cathie, additional, Craig, Matthew, additional, and Martinez, Fernando J., additional

Published
2023
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24. FSGS Recurrence Collaboration: Report of a symposium

Author

Gipson, Debbie S., primary, Wang, Chia-shi, additional, Salmon, Eloise, additional, Gbadegesin, Rasheed, additional, Naik, Abhijit, additional, Sanna-Cherchi, Simone, additional, Fornoni, Alessia, additional, Kretzler, Matthias, additional, Merscher, Sandra, additional, Hoover, Paul, additional, Kidwell, Kelley, additional, Saleem, Moin, additional, Riella, Leonardo, additional, Holzman, Lawrence, additional, Jackson, Annette, additional, Olabisi, Opeyemi, additional, Cravedi, Paolo, additional, Freedman, Benjamin Solomon, additional, Himmelfarb, Jonathan, additional, Vivarelli, Marina, additional, Harder, Jennifer, additional, Klein, Jon, additional, Burke, George, additional, Rheault, Michelle, additional, Spino, Cathie, additional, Desmond, Hailey E., additional, and Trachtman, Howard, additional

Published
2023
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25. FRI055 LYNC-LD: Prospective Multicenter Natural History Study Of Lipodystrophy Syndromes To Determine Prevalence, Incidence And Predictors Of Diabetes And Severe Hypertriglyceridemia, And Their Complications

Author

Foss de Freitas, Maria Cristina, primary, Rosenberg, Drake Stanton, additional, Guler, Merve Celik, additional, Yosef, Matheos, additional, Khalatbari, Shoukoufeh, additional, Carman, Richison, additional, DillGomes, Anabela, additional, Ashmus, Michelle, additional, Spino, Cathie, additional, Akinci, Baris, additional, Brown, Rebecca J, additional, and Oral, Elif A, additional

Published
2023
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26. Baseline Analysis of a Young α‐1‐Antitrypsin Deficiency Liver Disease Cohort Reveals Frequent Portal Hypertension

Author

Teckman, Jeffrey H, Rosenthal, Philip, Abel, Robert, Bass, Lee M, Michail, Sonia, Murray, Karen F, Rudnick, David A, Thomas, Daniel W, Spino, Cathie, Arnon, Ronen, Hertel, Paula M, Heubi, James, Kamath, Binita M, Karnsakul, Wikrom, Loomes, Kathleen M, Magee, John C, Molleston, Jean P, Romero, Rene, Shneider, Benjamin L, Sherker, Averell H, Sokol, Ronald J, and Network, Childhood Liver Disease Research

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Digestive Diseases, Liver Disease, Rare Diseases, Chronic Liver Disease and Cirrhosis, Pediatric, Aetiology, 2.1 Biological and endogenous factors, Oral and gastrointestinal, Adolescent, Adult, Child, Child, Preschool, Cohort Studies, Female, Humans, Hypertension, Portal, Infant, Infant, Newborn, Jaundice, Liver, Longitudinal Studies, Male, Prospective Studies, Young Adult, alpha 1-Antitrypsin, alpha 1-Antitrypsin Deficiency, cirrhosis, jaundice, liver enzymes, liver transplant, metabolic liver disease, Childhood Liver Disease Research Network, Medical and Health Sciences, Gastroenterology & Hepatology, Clinical sciences, Nutrition and dietetics, Paediatrics
Abstract

Objectivesα-1-Antitrypsin (A1AT) deficiency is a common genetic disease with an unpredictable and highly variable course. The Childhood Liver Disease Research and Education Network is a National Institutes of Health, multicenter, longitudinal consortium studying pediatric liver diseases, with the objective of prospectively defining natural history and identifying disease modifiers.MethodsLongitudinal, cohort study of A1AT patients' birth through 25 years diagnosed as having liver disease, type PIZZ or PISZ. Medical history, physical examination, laboratory, imaging, and standardized survey tool data were collected during the provision of standard of care.ResultsIn the present report of the cohort at baseline, 269 subjects were enrolled between November 2008 and October 2012 (208 with their native livers and 61 postliver transplant). Subjects with mild disease (native livers and no portal hypertension [PHT]) compared to severe disease (with PHT or postliver transplant) were not different in age at presentation. A total of 57% of subjects with mild disease and 76% with severe disease were jaundiced at presentation (P = 0.0024). A total of 29% of subjects with native livers had PHT, but age at diagnosis and growth were not different between the no-PHT and PHT groups (P > 0.05). Subjects with native livers and PHT were more likely to have elevated bilirubin, ALT, AST, INR, and GGTP than the no-PHT group (P <

Published
2015

27. Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (MiACLR): A Protocol for a Randomized Clinical Trial

Author

Rodriguez, Kazandra, Garcia, Steven A., Spino, Cathie, Lepley, Lindsey K., Pang, Yuxi, Wojtys, Edward, Bedi, Asheesh, Angelini, Mike, Ruffno, Bethany, Bolley, Tyler, Block, Corey, Kellum, Jessica, Swartout, Andrew, and Palmieri-Smith, Riann M.

Subjects
Muscle strength -- Measurement -- Health aspects, Extremities, Lower -- Muscles, Leg -- Muscles, Health
Abstract

Objective. Restoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may prevent the posttraumatic osteoarthritis that affects over 50% of knees with ACLR. However, a fundamental gap exists in our understanding of how to maximize muscle strength through rehabilitation. Neurological deficits and muscle atrophy are 2 of the leading mechanisms of muscle weakness after ACLR. High-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise (ECC) have been shown to independently target these mechanisms. If delivered in succession, NMES and then ECC may be able to significantly improve strength recovery. The objectives of this study were to evaluate the ability of NMES combined with ECC to restore quadriceps strength and biomechanical symmetry and maintain cartilage health at 9 and 18 months after ACLR. Methods. This study is a randomized, double-blind, placebo-controlled, single-center clinical trial conducted at the University of Michigan. A total of 112 participants between the ages of 14 and 45 years and with an anterior cruciate ligament rupture will be included. Participants will be randomly assigned 1:1 to NMES combined with ECC or NMES placebo combined with ECC placebo. NMES or NMES placebo will be delivered 2 times per week for 8 weeks beginning 10 to 14 days postoperatively and will be directly followed by 8 weeks of ECC or ECC placebo delivered 2 times per week. The co-primary endpoints are change from baseline to 9 months and change from baseline to 18 months after ACLR in isokinetic quadriceps strength symmetry. Secondary outcome measures include isometric quadriceps strength, quadriceps activation, quadriceps muscle morphology (cross-sectional area), knee biomechanics (sagittal plane knee angles and moments), indexes of patient-reported function, and cartilage health (T1[rho] and T2 relaxation time mapping on magnetic resonance imaging). Impact. The findings from this study might identify an intervention capable of targeting the lingering quadriceps weakness after ACLR and in turn prevent deterioration in cartilage health after ACLR, thereby potentially improving function in this patient population., Anterior cruciate ligament (ACL) reconstruction (ACLR) leads to significant reductions in quadriceps strength, (1-3) and this decreased strength is related to a decreased quality of life, (4) higher risk of [...]

Published
2020

28. Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse

Author

Barber, Matthew D, Brubaker, Linda, Burgio, Kathryn L, Richter, Holly E, Nygaard, Ingrid, Weidner, Alison C, Menefee, Shawn A, Lukacz, Emily S, Norton, Peggy, Schaffer, Joseph, Nguyen, John N, Borello-France, Diane, Goode, Patricia S, Jakus-Waldman, Sharon, Spino, Cathie, Warren, Lauren Klein, Gantz, Marie G, and Meikle, Susan F

Subjects
Clinical Trials and Supportive Activities, Contraception/Reproduction, Urologic Diseases, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.4 Surgery, Renal and urogenital, Reproductive health and childbirth, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine
Published
2014

29. Use of Corticosteroids After Hepatoportoenterostomy for Bile Drainage in Infants With Biliary Atresia: The START Randomized Clinical Trial

Author

Bezerra, Jorge A, Spino, Cathie, Magee, John C, Shneider, Benjamin L, Rosenthal, Philip, Wang, Kasper S, Erlichman, Jessi, Haber, Barbara, Hertel, Paula M, Karpen, Saul J, Kerkar, Nanda, Loomes, Kathleen M, Molleston, Jean P, Murray, Karen F, Romero, Rene, Schwarz, Kathleen B, Shepherd, Ross, Suchy, Frederick J, Turmelle, Yumirle P, Whitington, Peter F, Moore, Jeffrey, Sherker, Averell H, Robuck, Patricia R, and Sokol, Ronald J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Digestive Diseases, Rare Diseases, Liver Disease, Patient Safety, Clinical Research, Pediatric, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Oral and gastrointestinal, Administration, Oral, Adrenal Cortex Hormones, Biliary Atresia, Bilirubin, Double-Blind Method, Drainage, Female, Humans, Infant, Infusions, Intravenous, Male, Methylprednisolone, Portoenterostomy, Hepatic, Prednisolone, Survival Analysis, Treatment Outcome, Childhood Liver Disease Research and Education Network, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ImportanceBiliary atresia is the most common cause of end-stage liver disease in children. Controversy exists as to whether use of steroids after hepatoportoenterostomy improves clinical outcome.ObjectiveTo determine whether the addition of high-dose corticosteroids after hepatoportoenterostomy is superior to surgery alone in improving biliary drainage and survival with the native liver.Design, setting, and patientsThe multicenter, double-blind Steroids in Biliary Atresia Randomized Trial (START) was conducted in 140 infants (mean age, 2.3 months) between September 2005 and February 2011 in the United States; follow-up ended in January 2013.InterventionsParticipants were randomized to receive intravenous methylprednisolone (4 mg/kg/d for 2 weeks) and oral prednisolone (2 mg/kg/d for 2 weeks) followed by a tapering protocol for 9 weeks (n = 70) or placebo (n = 70) initiated within 72 hours of hepatoportoenterostomy.Main outcomes and measuresThe primary end point (powered to detect a 25% absolute treatment difference) was the percentage of participants with a serum total bilirubin level of less than 1.5 mg/dL with his/her native liver at 6 months posthepatoportoenterostomy. Secondary outcomes included survival with native liver at 24 months of age and serious adverse events.ResultsThe proportion of participants with improved bile drainage was not statistically significantly improved by steroids at 6 months posthepatoportoenterostomy (58.6% [41/70] of steroids group vs 48.6% [34/70] of placebo group; adjusted relative risk, 1.14 [95% CI, 0.83 to 1.57]; P = .43). The adjusted absolute risk difference was 8.7% (95% CI, -10.4% to 27.7%). Transplant-free survival was 58.7% in the steroids group vs 59.4% in the placebo group (adjusted hazard ratio, 1.0 [95% CI, 0.6 to 1.8]; P = .99) at 24 months of age. The percentage of participants with serious adverse events was 81.4% [57/70] of the steroids group and 80.0% [56/70] of the placebo group (P > .99); however, participants receiving steroids had an earlier time of onset of their first serious adverse event by 30 days posthepatoportoenterostomy (37.2% [95% CI, 26.9% to 50.0%] of steroids group vs 19.0% [95% CI, 11.5% to 30.4%] of placebo group; P = .008).Conclusions and relevanceAmong infants with biliary atresia who have undergone hepatoportoenterostomy, high-dose steroid therapy following surgery did not result in statistically significant treatment differences in bile drainage at 6 months, although a small clinical benefit could not be excluded. Steroid treatment was associated with earlier onset of serious adverse events in children with biliary atresia.Trial registrationclinicaltrials.gov Identifier: NCT00294684.

Published
2014

30. Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial

Author

Barber, Matthew D, Brubaker, Linda, Burgio, Kathryn L, Richter, Holly E, Nygaard, Ingrid, Weidner, Alison C, Menefee, Shawn A, Lukacz, Emily S, Norton, Peggy, Schaffer, Joseph, Nguyen, John N, Borello-France, Diane, Goode, Patricia S, Jakus-Waldman, Sharon, Spino, Cathie, Warren, Lauren Klein, Gantz, Marie G, and Meikle, Susan F

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Research, Comparative Effectiveness Research, Clinical Trials and Supportive Activities, Urologic Diseases, Prevention, Evaluation of treatments and therapeutic interventions, 6.4 Surgery, Reproductive health and childbirth, Renal and urogenital, Adult, Aged, Aged, 80 and over, Behavior Therapy, Exercise Therapy, Female, Gynecologic Surgical Procedures, Humans, Middle Aged, Pelvic Floor, Suburethral Slings, Treatment Outcome, Urinary Incontinence, Stress, Urination, Uterine Prolapse, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ImportanceMore than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.ObjectiveTo compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence.Design, setting, and participantsMulticenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%.InterventionsThe surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188).Main outcomes and measuresThe primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success.ResultsAt 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months.Conclusions and relevanceTwo years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.Trial registrationclinicaltrials.gov Identifier: NCT00597935.

Published
2014

31. Cardiovascular autonomic neuropathy and risk of kidney function decline in type 1 and type 2 diabetes: findings from the PERL and ACCORD cohorts

Author

Tang, Yaling, primary, Ang, Lynn, additional, Jaiswal, Mamta, additional, Dillon, Brendan R., additional, Esfandiari, Nazanene H., additional, Shah, Hetal S., additional, Spino, Cathie, additional, Plunkett, Cindy, additional, Perkins, Bruce A., additional, Busui, Rodica Pop, additional, and Doria, Alessandro, additional

Published
2023
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32. Neurodevelopmental Outcome of Young Children with Biliary Atresia and Native Liver: Results from the ChiLDReN Study

Author

Hertel, Paula M., Harpavat, Sanjiv, Brandt, Mary L., Leung, Daniel H., Karnsakul, Wikrom, Torrance, Rebecca, Hall, Sherry, Doo, Edward, Hoofnagle, Jay H., Whitington, Peter, Bass, Lee, Miethke, Alexander G., Heubi, James E., Setchell, Kenneth, Bove, Kevin E., Tiao, Greg, Mack, Cara L., Narkewicz, Michael R., Feldman, Amy G., Sundaram, Shikha S., Suchy, Frederick J., Karrer, Frederick M., Lovell, Mark, Van Hove, Johan L., Rand, Elizabeth B., Squires, James E., Venkat, Veena L., Sindhi, Rakesh, Ranganathan, Sarangarajan, Bull, Laura, Teckman, Jeffrey, Bozic, Molly, Subbarao, Girish, Horslen, Simon, Hsu, Evelyn, Finn, Laura, Healey, Patrick, Kohli, Rohit, Thomas, Danny, Soufi, Nisreen, Michail, Sonia, Clifton, Matt, Gupta, Nitika, Romero, Rene, Vos, Miriam, Caltharp, Shelley, Kamath, Binita M., Ling, Simon C., Gold, Anna, Fecteau, Annie, Guthery, Stephen L., Jensen, Kyle, Meyers, Rebecka, Lowichik, Amy, Book, Linda, Merion, Robert M., Spino, Cathie, Jones, Karen, Ng, Vicky L., Sorensen, Lisa G., Alonso, Estella M., Fredericks, Emily M., Ye, Wen, Moore, Jeff, Karpen, Saul J., Shneider, Benjamin L., Molleston, Jean P., Bezerra, Jorge A., Murray, Karen F., Loomes, Kathleen M., Rosenthal, Philip, Squires, Robert H., Wang, Kasper, Arnon, Ronen, Schwarz, Kathleen B., Turmelle, Yumirle P., Haber, Barbara H., Sherker, Averell H., Magee, John C., and Sokol, Ronald J.

Published
2018
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33. Rationale and design of the Nephrotic Syndrome Study Network (NEPTUNE) Match in glomerular diseases: designing the right trial for the right patient, today

Author

Massengill, Susan, Lo, Layla, Dell, Katherine, O’Toole, John, Sedor, John, Martin, Blair, Macumber, Ian, Sharma, Silpa, Srivastava, Tarak, Markus, Kelsey, Sethna, Christine, Vento, Suzanne, Canetta, Pietro, Olabisi, Opeyemi, Gbadegesin, Rasheed, Smith, Maurice, Greenbaum, Laurence, Wang, Chia-shi, Yun, Emily, Adler, Sharon, LaPage, Janine, Amarah, Amatur, Itteera, Mathew, Atkinson, Meredith, Williams, Miahje, Lieske, John, Hogan, Marie, Fervenza, Fernando, Selewski, David, Alston, Cheryl, Reidy, Kim, Ross, Michael, Kaskel, Frederick, Flynn, Patricia, Malaga-Dieguez, Laura, Zhdanova, Olga, Pehrson, Laura Jane, Miranda, Melanie, Almaani, Salem, Roberts, Laci, Lafayette, Richard, Dave, Shiktij, Lee, Iris, Shah, Shweta, Batla, Sadaf, Reich, Heather, Hladunewich, Michelle, Ling, Paul, Romano, Martin, Brakeman, Paul, Dylewski, James, Rogers, Nathan, McCarthy, Ellen, Creed, Catherine, Fornoni, Alessia, Bandes, Miguel, Kretzler, Matthias, Mariani, Laura, Modi, Zubin, Williams, A., Ni, Roxy, Nachman, Patrick, Rheault, Michelle, Kowalski, Amy, Rauwolf, Nicolas, Derebail, Vimal, Gibson, Keisha, Froment, Anne, Kelley, Sara, Holzman, Lawrence, Meyers, Kevin, Kallem, Krishna, Edwards, Aliya, Sharma, Samin, Roehm, Elizabeth, Sambandam, Kamalanathan, Brown, Elizabeth, Hellewege, Jamie, Jefferson, Ashley, Hingorani, Sangeeta, Tuttle, Katherine, Manahan, Linda, Pao, Emily, Kuykendall, Kelli, Lin, Jen Jar, Dharnidharka, Vikas, Gillespie, Brenda, Salmon, Eloise, Trachtman, Howard, Mainieri, Tina, Alter, Gabrielle, Arbit, Michael, Desmond, Hailey, Eddy, Sean, Fermin, Damian, Ju, Wenjun, Larkina, Maria, Lienczewski, Chrysta, Scherr, Rebecca, Troost, Jonathan, Williams, Amanda, Zhai, Yan, Kincaid, Colleen, Li, Shengqian, Li, Shannon, Gadegbeku, Crystal, Barisoni, Laura, Sampson, Matthew G., Smith, Abigail, Zee, Jarcy, Avila-Casado, Carmen, Bagnasco, Serena, Bu, Lihong, Caltharp, Shelley, Cassol, Clarissa, Demeke, Dawit, Hassler, Jared, Herlitz, Leal, Hewitt, Stephen, Hodgin, Jeff, Holanda, Danni, Kambham, Neeraja, Lemley, Kevin, Messias, Nidia, Mikhailov, Alexei, Moreno, Vanessa, Najafian, Behzad, Palmer, Matthew, Rosenberg, Avi, Royal, Virginie, Sekulik, Miroslav, Stokes, Barry, Thomas, David, Wu, Ming, Yamashita, Michifumi, Yin, Hong, Zuo . Cochairs, Yiqin, Nast, Cynthia, Williams, Amanda L., Mariani, Laura H., Ascani, Heather K., Uhlmann, Wendy R., Spino, Cathie, Holzman, Lawrence B., Sedor, John R., Subramanian, Lalita, Lienczewski, Chrysta C., Manieri, Tina, Roberts, Scott J., and Gipson, Debbie S.

Published
2024
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34. Incontinence pessaries: size, POPQ measures, and successful fitting

Author

Nager, Charles W., Richter, Holly E., Nygaard, Ingrid, Fidela Paraiso, Marie, Wu, Jennifer M., Kenton, Kimberly, Atnip, Shanna D., and Spino, Cathie

Subjects
Medicine & Public Health, Gynecology, Incontinence ring, Incontinence dish, Pessary, Stress urinary incontinence
Abstract

The aim of the study was to determine whether successful incontinence pessary fitting or pessary size can be predicted by specific POPQ measurements in women without advanced pelvic organ prolapse.In a multicenter study, women with stress urinary incontinence (SUI) and POPQ stage ≤2 were randomized to three treatment arms: (1) incontinence pessary, (2) behavioral therapy, or (3) both. This study evaluates incontinence pessary size, POPQ measures, and successful fitting in the 266 women assigned to treatment arms 1 and 3.Two hundred thirty-five women (92%) were successfully fitted with an incontinence ring (n = 122) or dish (n = 113). Hysterectomy, genital hiatus (GH), and GH/total vaginal length (TVL) ratios did not predict unsuccessful fitting (p > 0.05). However, mean TVL was greater in women successfully fitted (9.6 vs. 8.8 cm, p  0.05).The vast majority of women with SUI can be successfully fitted with an incontinence pessary, but specific POPQ measures were not helpful in determining incontinence pessary size.

Published
2009

35. Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial

Author

Tellor Pennington, Bethany R, primary, Colquhoun, Douglas A, additional, Neuman, Mark D, additional, Politi, Mary C, additional, Janda, Allison M, additional, Spino, Cathie, additional, Thelen-Perry, Steven, additional, Wu, Zhenke, additional, Kumar, Sathish S, additional, Gregory, Stephen H, additional, Avidan, Michael S, additional, and Kheterpal, Sachin, additional

Published
2023
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37. Sarcopenia is associated with osteopenia and impaired quality of life in children with genetic intrahepatic cholestatic liver disease.

Author

Boster, Julia M., Goodrich, Nathan P., Spino, Cathie, Loomes, Kathleen M., Alonso, Estella M., Kamath, Binita M., Sokol, Ronald J., Karpen, Saul, Miethke, Alexander, Shneider, Benjamin L., Molleston, Jean P., Kohli, Rohit, Horslen, Simon P., Rosenthal, Philip, Valentino, Pamela L., Teckman, Jeffrey H., Hangartner, Thomas N., and Sundaram, Shikha S.

Published
2023
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38. Comorbid Conditions and Health-Related Quality of Life in Ambulatory Heart Failure Patients: REVIVAL (Registry Evaluation of Vital Information for VADs in Ambulatory Life REVIVAL)

Author

Cascino, Thomas M., Kittleson, Michelle M., Lala, Anuradha, Stehlik, Josef, Palardy, Maryse, Pamboukian, Salpy V., Ewald, Gregory A., Mountis, Maria M., Horstmanshof, Douglas A., Robinson, Shawn W., Shah, Palak, Jorde, Ulrich P., McLean, Rhondalyn C., Richards, Blair, Khalatbari, Shokoufeh, Spino, Cathie, Taddei-Peters, Wendy C., Grady, Kathleen L., Mann, Douglas L., Stevenson, Lynne W., Stewart, Garrick C., and Aaronson, Keith D.

Published
2020
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39. Needles in a Haystack: Finding Qualitative and Quantitative Collaborators in Academic Medical Centers

Author

Pomann, Gina-Maria, primary, Truong, Tracy, additional, Boulos, Mary, additional, Boulware, L. Ebony, additional, Brouwer, Rebecca N., additional, Curtis, Lesley H., additional, Kapphahn, Kristopher, additional, Khalatbari, Shokoufeh, additional, McKeel, Julie, additional, Messinger, Shari, additional, O’Hara, Ruth, additional, Pencina, Michael J., additional, Samsa, Greg P., additional, Spino, Cathie, additional, Yang, Lexie Zidanyue, additional, and Desai, Manisha, additional

Published
2023
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40. Safety, tolerability, and efficacy of pirfenidone in patients with rheumatoid arthritis-associated interstitial lung disease: a randomised, double-blind, placebo-controlled, phase 2 study

Author

Solomon, Joshua J, primary, Danoff, Sonye K, additional, Woodhead, Felix A, additional, Hurwitz, Shelley, additional, Maurer, Rie, additional, Glaspole, Ian, additional, Dellaripa, Paul F, additional, Gooptu, Bibek, additional, Vassallo, Robert, additional, Cox, P Gerard, additional, Flaherty, Kevin R, additional, Adamali, Huzaifa I, additional, Gibbons, Michael A, additional, Troy, Lauren, additional, Forrest, Ian A, additional, Lasky, Joseph A, additional, Spencer, Lisa G, additional, Golden, Jeffrey, additional, Scholand, Mary Beth, additional, Chaudhuri, Nazia, additional, Perrella, Mark A, additional, Lynch, David A, additional, Chambers, Daniel C, additional, Kolb, Martin, additional, Spino, Cathie, additional, Raghu, Ganesh, additional, Goldberg, Hilary J, additional, Rosas, Ivan O, additional, Haynes-Harp, Shana, additional, Poli, Fernando, additional, Vidya, Coimbatore Sree, additional, Baron, Rebecca R., additional, Clouser, Timothy, additional, Doyle, Tracy, additional, Maeda, Anthony, additional, Highland, Kristin B., additional, Albayda, Jemima F., additional, Collins, Sarah E., additional, Suresh, Karthik S., additional, Davis, John M., additional, Limper, Andrew H., additional, Amigues, Isabel, additional, Eliopoulos, Kristina, additional, Swigris, Jeffery J., additional, Humphries, Stephen, additional, Huntwork, John C., additional, Glynn, Chris, additional, Duncan, Steve R., additional, Danila, Maria I., additional, Glassberg, Marilyn K., additional, Oberstein, Elana M., additional, Belloli, Elizabeth A., additional, Briggs, Linda, additional, Nagaraja, Vivek, additional, Cholewa, Linda, additional, DiFranco, Donna, additional, Green, Edward, additional, Liffick, Christie, additional, Naik, Tanvi, additional, Montas, Genevieve, additional, Lebiedz-Odrobina, Dorota, additional, Bissell, Reba, additional, Wener, Mark, additional, Lancaster, Lisa H., additional, Crawford, Leslie J., additional, Chan, Karmela, additional, Kaner, Robert J., additional, Morris, Alicia, additional, Wu, Xiaoping, additional, Khalidi, Nader A., additional, Ryerson, Christopher J., additional, Wong, Alyson W., additional, Fell, Charlene D., additional, LeClercq, Sharon A., additional, Hyman, Mark, additional, Shapera, Shane, additional, Mittoo, Shikha, additional, Shaffu, Shireen, additional, Gaffney, Karl, additional, Wilson, Andrew M., additional, Barratt, Shaney, additional, Gunawardena, Harsha, additional, Hoyles, Rachel K., additional, David, Joel, additional, Kewalramani, Namrata, additional, Maher, Toby M., additional, Molyneaux, Philip L., additional, Kokosi, Maria A., additional, Cates, Matthew J., additional, Mandizha, Mandizha, additional, Ashish, Abdul, additional, Chelliah, Gladstone, additional, Parfrey, Helen, additional, Thillai, Muhunthan, additional, Vila, Josephine, additional, Fletcher, Sophie V., additional, Beirne, Paul, additional, Favager, Clair, additional, Brown, Jo, additional, Dawson, Julie K., additional, Ortega, Pilar Rivera, additional, Haque, Sahena, additional, Watson, Pippa, additional, Khoo, Jun K., additional, Symons, Karen, additional, Youssef, Peter, additional, and Mackintosh, John A., additional

Published
2023
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42. Total Serum Bilirubin within 3 Months of Hepatoportoenterostomy Predicts Short-Term Outcomes in Biliary Atresia

Author

Alonso, Estella, Kaurs, Elizabeth, Kelly, Sue, Bove, Kevin, Heubi, James, Miethke, Alexander, Tiao, Greg, Denlinger, Julie, Ferris, Andrea, Feldman, Amy, Mack, Cara, Suchy, Frederick, Sundaram, Shikha, Van Hove, Johan, Hite, Michelle, Kantor, Susanna, Miller, Todd, Smith, Julia, VanWinkle, Becky, Loomes, Kathleen, Lin, Henry, Piccoli, David, Russo, Pierre, Spinner, Nancy, Brown, Lindsay, Elgert, Emily, Erlichman, Jessi, Alissa, Feras, Lindblad, Douglas, Mazariegos, George, Ortiz-Aguayo, Roberto, Perlmutter, David, Sindhi, Rakesh, Venkat, Veena, Vockley, Jerry, Bukauskas, Kathy, Kufen, Adam, Schulte, Madeline, Bull, Laura, Fleck, Shannon, Langlois, Camille, Teckman, Jeffery, Kociela, Vikki, Postma, Stacy, Harris, Kathleen, Bozic, Molly, Subbarao, Girish, Byam, Beth, Klipsch, Ann, Sawyers, Cindy, Horslen, Simon, Hsu, Evelyn, Cooper, Kara, Young, Melissa, Kamath, Binita, DeAngelis, Maria, O'Connor, Constance, VanRoestel, Krista, Parmar, Arpita, Quammie, Claudia, Hung, Kelsey, Guthery, Stephen, Jensen, Kyle, Rutherford, Ann, Kerker, Nanda, Michail, Sonia, Thomas, Danny, Goodhue, Catherine, Gupta, Nikita, Vos, Mariam, de la Cruz-Tracey, Liezl, Hankerson-Dyson, Dana, Tory, Rita, Turner-Green, Taieshia, Wellons, Allison, Brandt, Mary, Finegold, Milton, Harpavat, Sanjiv, Hertel, Paula, Leung, Daniel, Liwanag, Loriel, Thompson, Richard, Brown, Sherry, Doo, Edward, Hoofnagle, Jay, Hall, Sherry, Torrance, Rebecca, Brown, Jameisha, Kafka, Kimberly, Merion, Robert, Spino, Cathie, Shneider, Benjamin L., Magee, John C., Karpen, Saul J., Rand, Elizabeth B., Narkewicz, Michael R., Bass, Lee M., Schwarz, Kathleen, Whitington, Peter F., Bezerra, Jorge A., Kerkar, Nanda, Haber, Barbara, Rosenthal, Philip, Turmelle, Yumirle P., Molleston, Jean P., Murray, Karen F., Ng, Vicky L., Wang, Kasper S., Romero, Rene, Squires, Robert H., Arnon, Ronen, Sherker, Averell H., Moore, Jeffrey, Ye, Wen, and Sokol, Ronald J.

Published
2016
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43. Additional file 3 of Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial

Author

Podolanczuk, Anna J., Kim, John S., Cooper, Christopher B., Lasky, Joseph A., Murray, Susan, Oldham, Justin M., Raghu, Ganesh, Flaherty, Kevin R., Spino, Cathie, Noth, Imre, and Martinez, Fernando J.

Abstract

Additional file 3: Home Spirometry Survey. Home spirometry survey to be completed at visit 3 and visit 5 by study participants who agreed to enroll in the home spirometry substudy. PRECISIONS logo created by the PRECISIONS study team for the PRECISIONS study. Written permission obtained from the Data Coordinating Center.

Published
2023
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44. Additional file 1 of Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial

Author

Podolanczuk, Anna J., Kim, John S., Cooper, Christopher B., Lasky, Joseph A., Murray, Susan, Oldham, Justin M., Raghu, Ganesh, Flaherty, Kevin R., Spino, Cathie, Noth, Imre, and Martinez, Fernando J.

Abstract

Additional file 1: Baseline COVID-19 Questionnaire. COVID-19 questionnaire to be completed by all study participants at the baseline visit. PRECISIONS logo created by the PRECISIONS study team for the PRECISIONS study. Written permission obtained from the Data Coordinating Center.

Published
2023
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45. Additional file 4 of Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial

Author

Podolanczuk, Anna J., Kim, John S., Cooper, Christopher B., Lasky, Joseph A., Murray, Susan, Oldham, Justin M., Raghu, Ganesh, Flaherty, Kevin R., Spino, Cathie, Noth, Imre, and Martinez, Fernando J.

Abstract

Additional file 4: Home Spirometry Exit Survey. Home spirometry survey to be completed at visit 7 or early termination visit by study participants who agree to enroll in the home spirometry substudy. PRECISIONS logo created by the PRECISIONS study team for the PRECISIONS study. Written permission obtained from the Data Coordinating Center.

Published
2023
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46. Additional file 2 of Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial

Author

Podolanczuk, Anna J., Kim, John S., Cooper, Christopher B., Lasky, Joseph A., Murray, Susan, Oldham, Justin M., Raghu, Ganesh, Flaherty, Kevin R., Spino, Cathie, Noth, Imre, and Martinez, Fernando J.

Abstract

Additional file 2: COVID-19 Questionnaire Follow-Up. COVID-19 questionnaire to be completed by all study participants at each follow-up visit. PRECISIONS logo created by the PRECISIONS study team for the PRECISIONS study. Written permission obtained from the Data Coordinating Center.

Published
2023
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50. Machine-learning classification identifies patients with early systemic sclerosis as abatacept responders via CD28 pathway modulation

Author

Mehta, Bhaven K., primary, Espinoza, Monica E., additional, Franks, Jennifer M., additional, Yuan, Yiwei, additional, Wang, Yue, additional, Wood, Tammara, additional, Gudjonsson, Johann E., additional, Spino, Cathie, additional, Fox, David A., additional, Khanna, Dinesh, additional, and Whitfield, Michael L., additional

Published
2022
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