4 results on '"Tina Tham"'
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2. The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions
- Author
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Steve N. Georas, Rosalind J. Wright, Anastasia Ivanova, Elliot Israel, Lisa M. LaVange, Praveen Akuthota, Tara F. Carr, Loren C. Denlinger, Merritt L. Fajt, Rajesh Kumar, Wanda K. O’Neal, Wanda Phipatanakul, Stanley J. Szefler, Mark A. Aronica, Leonard B. Bacharier, Allison J. Burbank, Mario Castro, Laura Crotty Alexander, Julie Bamdad, Juan Carlos Cardet, Suzy A.A. Comhair, Ronina A. Covar, Emily A. DiMango, Kim Erwin, Serpil C. Erzurum, John V. Fahy, Jonathan M. Gaffin, Benjamin Gaston, Lynn B. Gerald, Eric A. Hoffman, Fernando Holguin, Daniel J. Jackson, John James, Nizar N. Jarjour, Nicholas J. Kenyon, Sumita Khatri, John P. Kirwan, Monica Kraft, Jerry A. Krishnan, Andrew H. Liu, Mark C. Liu, M. Alison Marquis, Fernando Martinez, Jacob Mey, Wendy C. Moore, James N. Moy, Victor E. Ortega, David B. Peden, Emily Pennington, Michael C. Peters, Kristie Ross, Maria Sanchez, Lewis J. Smith, Ronald L. Sorkness, Michael E. Wechsler, Sally E. Wenzel, Steven R. White, Joe Zein, Amir A. Zeki, Patricia Noel, Dean Billheimer, Eugene R. Bleecker, Emily Branch, Michelle Conway, Cori Daines, Isaac Deaton, Alexandria Evans, Paige Field, Dave Francisco, Annette T. Hastie, Bob Hmieleski, Jeffrey O. Krings, Yanqin Liu, Janell L. Merchen, Deborah A. Meyers, Nirushan Narendran, Stephen P. Peters, Anna Pippins, Matthew A. Rank, Ronald Schunk, Raymond Skeps, Benjamin Wright, Tina M. Banzon, Lisa M. Bartnikas, Sachin N. Baxi, Vishwanath Betapudi, Isabelle Brick, Conor Brockway, Thomas B. Casale, Kathleen Castillo-Ruano, Maria Angeles Cinelli, Elena Crestani, Amparito Cunningham, Megan Day-Lewis, Natalie Diaz-Cabrera, Angela DiMango, Brittany Esty, Eva Fandozzi, Jesse Fernandez, Elizabeth Fitzpatrick, Victoria E. Forth, Katarina Gentile, David Gubernick, Seyni Gueye-Ndiaye, Sigfus Gunnlaagsson, Marissa Hauptmann, Stephanie N. Hudey, Donya S. Imanirad, Tiffani Kaage, Nicholas Kolinsky, Brenna LaBere, Peggy Sue Lai, Meghan Le, Dennis K. Ledford, Richard Lockey, Margee Louisias, Andrew J. Macginnitie, Michelle C. Maciag, Allison O’Neill, Amber N. Pepper, Perdita Permaul, Mya Pugh, Dianna Queheillalt, Tarnjot Saroya, William Sheehan, Catherine Smith, Carmela Socolovsky, Else Treffeisen, Lorenzo Trippa, Abigail Tulchinsky, Christina Yee, Tina Carter, Jun Fu, Vanessa Garcia, Jenny Hixon, Carly Jackson, Yuan Ji, Ravi Kalhan, Opinderjit Kaur, Grace Li, Melanie M. Makhija, Spring Maleckar, Edward T. Naureckas, Anju T. Peters, Valerie Press, Mehreen Qureshi, Paul A. Reyfman, Sharon R. Rosenberg, Dominika Ryba, Jianrong Sheng, Ben Xu, Rafeul Alam, Darci Anderson, Sonya Belimezova, Jennifer Bitzan, Geoffrey Chupp, Brian J. Clark, Lauren Cohn, Margaret Hope Cruse, Jean Estrom, Leah Freid, Jose Gomez Villalobos, Nicole Grant, Vamsi P. Guntur, Carole Holm, Christena Kolakowski, Laurie A. Manka, Naomi Miyazawa, Juno Pak, Diana M. Pruitt, Sunita Sharma, Allen D. Stevens, Kisori Thomas, Brooke Tippin, Karissa Valente, Cynthia L. Wainscoat, Michael P. White, Daniel Winnica, Shuyu Ye, Pamela L. Zeitlin, Julia Bach, Joshua Brownell, Lauren Castro, Julie DeLisa, Sean B. Fain, Paul S. Fichtinger, Heather Floerke, James E. Gern, Vinay Goswamy, Jenelle Grogan, Wendy Hasse, Rick L. Kelley, Danika Klaus, Stephanie LaBedz, Paige Lowell, Andrew Maddox, Sameer K. Mathur, Amanda McIntyre, Lourdes M. Norwick, Sharmilee M. Nyenhuis, Matthew J. O’Brien, Tina Palas, Andrea A. Pappalardo, Mark Potter, Sima K. Ramratnam, Daniel L. Rosenberg, Eric M. Schauberger, Mark L. Schiebler, Angela Schraml, Mohamed Taki, Matthew C. Tattersall, Jissell Torres, Lori Wollet, Simon Abi-Saleh, Lisa Bendy, Larry Borish, James F. Chmiel, Aska Dix, Lisa France, Rebecca Gammell, Adam Gluvna, Brittany Hirth, Bo Hu, Elise Hyser, Kirsten M. Kloepfer, Michelle Koo, Nadia L. Krupp, Monica Labadia, Joy Lawrence, Laurie Logan, Angela Marko, Brittany Matuska, Deborah Murphy, Rachel Owensby, Erica A. Roesch, Don B. Sanders, Jackie Sharp, W. Gerald Teague, Laura Veri, Kristin Wavell Shifflett, Matt Camiolo, Sarah Collins, Jessa Demas, Courtney Elvin, Marc C. Gauthier, Melissa Ilnicki, Jenn Ingram, Lisa Lane, Seyed Mehdi Nouraie, John B. Trudeau, Michael Zhang, Jeffrey Barry, Howard Brickner, Janelle Celso, Matejka Cernelc-Kohan, Damaris Diaz, Ashley Du, Sonia Jain, Neiman Liu, Yusife Nazir, Julie Ryu, Pandurangan Vijayanand, Rogelio Almario, Ariana Baum, Kellen Brown, Marilynn H. Chan, Barbara Gale, Angela Haczku, Richart W. Harper, Raymond Heromin, Celeste Kivler, Brooks T. Kuhn, Ngoc P. Ly, Paula McCourt, Xavier Orain, Audrey Plough, Karla Ramirez, Ellese Roberts, Michael Schivo, Amisha Singapuri, Tina Tham, Daniel Tompkins, Patricia Michelle Twitmyer, Jade Vi, Jarron Atha, Jennifer Bedard, Jonathan S. Boomer, Andrew Chung, Vanessa Curtis, Chase S. Hall, Emily Hart, Fatima Jackson, Pamela Kemp, Sharli Maxwell, Maggie Messplay, Crystal Ramirez, Brynne Thompson, Ashley Britt, Hope Bryan, Nathan M. Gotman, Yue Jiang, Michael R. Kosorok, David T. Mauger, Kelsey Meekins, Jeanette K. Mollenhauer, Sarah Moody, Cheyanne Ritz, Stefanie Schwartz, Chalmer Thomlinson, and Nicole Wilson
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Severe asthma ,Exacerbation ,Allergy ,Disease ,non-type 2 asthma ,Severity of Illness Index ,asthma exacerbation ,Clinical Protocols ,Immunology and Allergy ,Precision Medicine ,Tomography ,Lung ,education.field_of_study ,X-Ray Computed ,Asthma Control Questionnaire ,Research Design ,Respiratory ,biomarker ,medicine.medical_specialty ,precision medicine ,Population ,Advisory Committees ,Clinical Trials and Supportive Activities ,Immunology ,patient advisory committee ,Natural history of disease ,Article ,Clinical Trials, Phase II as Topic ,Clinical Research ,medicine ,Humans ,type 2 asthma ,Clinical Trials ,Intensive care medicine ,education ,PrecISE Study Team ,Disease burden ,Asthma ,adaptive clinical trial design ,non–type 2 asthma ,business.industry ,Phase II as Topic ,medicine.disease ,Precision medicine ,respiratory tract diseases ,Good Health and Well Being ,business ,Tomography, X-Ray Computed ,Biomarkers - Abstract
Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. Acurrent challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.
- Published
- 2022
3. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE)
- Author
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Gerard J. Criner, Richard Sue, Shawn Wright, Mark Dransfield, Hiram Rivas-Perez, Tanya Wiese, Frank C. Sciurba, Pallav L. Shah, Momen M. Wahidi, Hugo Goulart de Oliveira, Brian Morrissey, Paulo F. G. Cardoso, Steven Hays, Adnan Majid, Nicholas Pastis, Lisa Kopas, Mark Vollenweider, P. Michael McFadden, Michael Machuzak, David W. Hsia, Arthur Sung, Nabil Jarad, Malgorzata Kornaszewska, Stephen Hazelrigg, Ganesh Krishna, Brian Armstrong, Narinder S. Shargill, Dirk-Jan Slebos, Francis Cordova, Parag Desai, Nathaniel Marchetti, Victor Kim, Kartik Shenoy, John Travaline, Jiji Thomas, Lii-Yoong H. Criner, Aaron Thornburg, Terry Thomas, Surya Bhatt, James Michael Wells, Necole Seabron-Harris, Umair Gauhar, Crissie Despirito, Frank Sciurba, Jessica Bon Field, Divay Chandra, Joseph Leader, Roy Semaan, Christina Ledezma, Pallav Shah, Samuel Kemp, Justin Garner, Arafa Aboelhassan, Karthi Srikanthan, Eric Tenda, Anita Abraham, Cai Sim, Momen Wahidi, Kamran Mahmood, Scott Shofer, Kathleen Coles, Guilherme Augusto Oliveira, Betina Machado, Igor Benedetto, Fabio Svartman, Amarilio de Macedo Neto, Leonardo Schreiner, Taiane Vieira, Ken Yoneda, Tina Tham, Daniel Tompkins, Paulo F. Guerreiro Cardoso, Rodrigo Athanazio, Felipe Nominando, Samia Rached, Luciana Cassimiro, Eric Seeley, Pavan Shrestha, Gabriela R. Dincheva, Daniel Alape-Moya, Mihir Parikh, Alichia Paton, Alexis Agnew, Charlie Strange, Tatsiana Beiko, Danielle Woodford, Mary Blanton, Timothy Connolly, Jose Fernando Santacruz, Bhavin Shah, Luis Herrera, Rumi Khan, Kristine Sernulka, Richard Barbers, Michelle Hernandez, Francisco Almeida, Joseph Cicenia, Thomas Gildea, Atul Mehta, Sonali Sethi, Yvonne Meli, David Hsia, Richard Casaburi, William Stringer, Leticia Diaz, Meghan Ramsey, Ryan Van Wert, Karen Morris, Tim Batchelor, Iara Sequeiros, Katy Tucker, Malgorzata Kornaszweska, Hazem Fallouh, Ramsey Sabit, Hatam Naase, Joseph George, Azin Salimian, Helen Dyer, Kristal Adams, Karen Bade, Bryan S. Benn, Michelle Canfield, Sharmila Vetri Villalan, Travis Stewart, Nick H. T. ten Hacken, Karin Klooster, Jorine Hartman, Sonja Augustijn, and Groningen Research Institute for Asthma and COPD (GRIAC)
- Subjects
Male ,Pulmonary and Respiratory Medicine ,CLINICAL-OUTCOMES ,medicine.medical_specialty ,Randomization ,SURGERY ,lung reduction ,Bronchi ,Critical Care and Intensive Care Medicine ,OBSTRUCTIVE PULMONARY-DISEASE ,chronic obstructive pulmonary disease ,MEDICAL THERAPY ,Collateral ventilation ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Primary outcome ,Randomized controlled trial ,law ,Forced Expiratory Volume ,Surveys and Questionnaires ,Internal medicine ,Bronchoscopy ,Correspondence ,Humans ,COPD ,Medicine ,030212 general & internal medicine ,LUNG-VOLUME-REDUCTION ,Respiratory system ,Exercise Tolerance ,IMPORTANT DIFFERENCE ,business.industry ,Walk distance ,OPERATIVE MORTALITY ,Endobronchial valve ,Equipment Design ,Prostheses and Implants ,Middle Aged ,NATIONAL EMPHYSEMA ,medicine.disease ,Treatment Outcome ,emphysema ,Pulmonary Emphysema ,030228 respiratory system ,TESTS ,Female ,business - Abstract
Rationale: This is the first multicenter randomized controlled trial to evaluate the effectiveness and safety of Zephyr Endobronchial Valve (EBV) in patients with little to no collateral ventilation out to 12 months.Objectives: To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation in the treated lobe.Methods: Subjects were enrolled with a 2:1 randomization (EBV/standard of care [SoC]) at 24 sites. Primary outcome at 12 months was the Delta EBV-SoC of subjects with a post-bronchodilator FEV1 improvement from baseline of greater than or equal to 15%. Secondary endpoints included absolute changes in post-bronchodilator FEV1, 6-minute-walk distance, and St. George's Respiratory Questionnaire scores.Measurements and Main Results: A total of 190 subjects (128 EBV and 62 SoC) were randomized. At 12 months, 47.7% EBV and 16.8% SoC subjects had a Delta FEV1 greater than or equal to 15% (P Conclusions: Zephyr EBV provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea, and quality of life out to at least 12 months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe.
- Published
- 2018
4. Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial
- Author
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Mark T. Dransfield, Justin L. Garner, Surya P. Bhatt, Dirk-Jan Slebos, Karin Klooster, Frank C. Sciurba, Pallav L. Shah, Nathaniel T. Marchetti, Richard D. Sue, Shawn Wright, Hiram Rivas-Perez, Tanya A. Wiese, Momen M. Wahidi, Hugo Goulart de Oliveira, Brian Armstrong, Sri Radhakrishnan, Narinder S. Shargill, Gerard J. Criner, Lewis Katz, Francis Cordova, Parag Desai, Nathaniel Marchetti, Victor Kim, Kartik Shenoy, John Travaline, Jiji Thomas, Lii-Yoong H. Criner, Richard Sue, Aaron Thornburg, Terry Thomas, Mark Dransfield, Surya Bhatt, James Michael Wells, Necole Seabron-Harris, Umair Gauhar, Crissie Despirito, Frank Sciurba, Jessica Bon Field, Divay Chandra, Joseph Leader, Roy Semaan, Christina Ledezma, Pallav Shah, Samuel Kemp, Justin Garner, Arafa Aboelhassan, Karthi Srikanthan, Eric Tenda, Anita Abraham, Cai Sim, Momen Wahidi, Kamran Mahmood, Scott Shofer, Kathleen Coles, Guilherme Augusto Oliveira, Betina Machado, Igor Benedetto, Fabio Svartman, Amarilio de Macedo Neto, Leonardo Schreiner, Taiane Vieira, Brian Morrissey, Ken Yoneda, Tina Tham, Daniel Tompkins, Paulo F. Guerreiro Cardoso, Rodrigo Athanazio, Felipe Nominando, Samia Rached, Luciana Cassimiro, Steven Hays, Eric Seeley, Pavan Shrestha, Gabriela R. Dincheva, Adnan Majid, Daniel Alape-Moya, Mihir Parikh, Alichia Paton, Alexis Agnew, Nicholas Pastis, Charlie Strange, Tatsiana Beiko, Danielle Woodford, Mary Blanton, Lisa Kopas, Timothy Connolly, Jose Fernando Santacruz, Bhavin Shah, Mark Vollenweider, Luis Herrera, Rumi Khan, Kristine Sernulka, P. Michael McFadden, Richard Barbers, Michelle Hernandez, Michael Machuzak, Francisco Almeida, Joseph Cicenia, Thomas Gildea, Atul Mehta, Sonali Sethi, Yvonne Meli, David Hsia, Richard Casaburi, William Stringer, Leticia Diaz, Arthur Sung, Meghan Ramsey, Ryan Van Wert, Karen Morris, Nabil Jarad, Tim Batchelor, Iara Sequeiros, Katy Tucker, Malgorzata Kornaszweska, Hazem Fallouh, Ramsey Sabit, Hatam Naase, Joseph George, Azin Salimian, Helen Dyer, Stephen Hazelrigg, Kristal Adams, Karen Bade, Ganesh Krishna, Bryan S. Benn, Michelle Canfield, Sharmila Vetri Villalan, Travis Stewart, Dirk-Ja n Slebos, Nick H. T. ten Hacken, Jorine Hartman, Sonja Augustijn, and Groningen Research Institute for Asthma and COPD (GRIAC)
- Subjects
Male ,Exacerbation ,medicine.medical_treatment ,EMPHYSEMA ,Bronchoscopic lung volume reduction ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,Quality of life ,law ,Forced Expiratory Volume ,Surveys and Questionnaires ,interventional bronchoscopy ,Medicine ,PREDICTS MORTALITY ,030212 general & internal medicine ,LUNG-VOLUME-REDUCTION ,Pneumonectomy ,Zephyr Valve ,Lung function ,Original Research ,Rehabilitation ,Exercise Tolerance ,Patient-centered outcomes ,Prostheses and Implants ,respiratory system ,Middle Aged ,Treatment Outcome ,Pulmonary Emphysema ,patient-reported outcomes ,Anesthesia ,Female ,Pulmonary and Respiratory Medicine ,REHABILITATION ,Adult ,Bronchi ,Severe copd ,OBSTRUCTIVE PULMONARY-DISEASE ,CAPACITY ,chronic obstructive pulmonary disease ,03 medical and health sciences ,severe emphysema ,SEVERE COPD ,Bronchoscopy ,PATIENT-CENTERED OUTCOMES ,Humans ,Aged ,business.industry ,respiratory tract diseases ,PHYSICAL-ACTIVITY ,030228 respiratory system ,EXACERBATION ,Quality of Life ,business ,Adult Pulmonary - Abstract
Rationale: Bronchoscopic lung volume reduction with Zephyr Valves improves lung function, exercise tolerance, and quality of life of patients with hyperinflated emphysema and little to no collateral ventilation. Objectives: Post hoc analysis of patient-reported outcomes (PROs), including multidimensional measures of dyspnea, activity, and quality of life, in the LIBERATE (Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema) study are reported. Methods: A total of 190 patients with severe heterogeneous emphysema and little to no collateral ventilation in the target lobe were randomized 2:1 to the Zephyr Valve or standard of care. Changes in PROs at 12 months in the two groups were compared: dyspnea with the Transitional Dyspnea Index (TDI), focal score; the Chronic Obstructive Pulmonary Disease Assessment Test (CAT; breathlessness on hill/stairs); Borg; the EXAcerbations of Chronic pulmonary disease Tool–PRO, dyspnea domain; activity with the TDI, magnitude of task/effort/functional impairment, CAT (limited activities), and the St. George’s Respiratory Questionnaire (SGRQ), activity domain; and psychosocial status with the SGRQ, impacts domain, and CAT (confidence and energy). Results: At 12 months, patients using the Zephyr Valve achieved statistically significant and clinically meaningful improvements in the SGRQ; CAT; and the TDI, focal score, compared with standard of care. Improvements in the SGRQ were driven by the impacts and activity domains (P
- Published
- 2020
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