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1. Discontinuation versus continuation of hypertonic saline or dornase alfa in modulator treated people with cystic fibrosis (SIMPLIFY): results from two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials.

Author

Mayer-Hamblett, Nicole, Ratjen, Felix, Russell, Renee, Donaldson, Scott, Riekert, Kristin, Sawicki, Gregory, Odem-Davis, Katherine, Young, Julia, Rosenbluth, Daniel, Taylor-Cousar, Jennifer, Goss, Christopher, Retsch-Bogart, George, Clancy, John, Genatossio, Alan, OSullivan, Brian, Berlinski, Ariel, Millard, Susan, Omlor, Gregory, Wyatt, Colby, Moffett, Kathryn, Nichols, David, and Gifford, Alex

Subjects
Humans, Cystic Fibrosis, Cystic Fibrosis Transmembrane Conductance Regulator, Deoxyribonuclease I, Lung, Saline Solution, Hypertonic
Abstract

BACKGROUND: Reducing treatment burden is a priority for people with cystic fibrosis, whose health has benefited from using new modulators that substantially increase CFTR protein function. The SIMPLIFY study aimed to assess the effects of discontinuing nebulised hypertonic saline or dornase alfa in individuals using the CFTR modulator elexacaftor plus tezacaftor plus ivacaftor (ETI). METHODS: The SIMPLIFY study included two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials at 80 participating clinics across the USA in the Cystic Fibrosis Therapeutics Development Network. We included individuals with cystic fibrosis aged 12-17 years with percent predicted FEV1 (ppFEV1) of 70% or more, or those aged 18 years or older with ppFEV1 of 60% or more, if they had been taking ETI and either (or both) mucoactive therapies (≥3% hypertonic saline or dornase alfa) for at least 90 days before screening. Participants on both hypertonic saline and dornase alfa were randomly assigned to one of the two trials, and those on a single therapy were assigned to the applicable trial. All participants were then randomly assigned 1:1 to continue or discontinue therapy for 6 weeks using permuted blocks of varying size, stratified by baseline ppFEV1 (week 0; ≥90% or

Published
2023

2. Long-term safety and efficacy of tezacaftor–ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study

Author

Gibson, Ronald L., Jr., Rowe, Steven M., Lechtzin, Noah, Ahrens, Richard C., McCoy, Karen S., Aitken, Moira, Donaldson, Scott H., McBennett, Kimberly Ann, Pilewski, Joseph M., Billings, Joanne, Milla, Carlos, Rubenstein, Ronald, Rosenbluth, Daniel Brian, Linnemann, Rachel, Powers, Michael R., Fortner, Christopher, Frederick, Carla Anne, Liou, Theodore G., Black, Philip, Wang, Janice, Colombo, John L., Berdella, Maria, Indihar, Maria Veronica, Brown, Cynthia D., Anstead, Michael, Bilodeau, Lara, Sicilian, Leonard, Jain, Manu, Tolle, James Jerome, Moffett, Kathryn, Nasr, Samya, Taylor-Cousar, Jennifer, Barto, Tara Lynn, Antos, Nicholas, Rogers, John S., Quick, Bryon, Thompson, Henry R., Sawicki, Gregory, Barnett, Bruce, Zanni, Robert L., Smith, Thomas C., Schultz, Karen D., Keating, Claire, Flume, Patrick, Omlor, Gregory J., Ashare, Alix, Voter, Karen, Mehdi, Nighat, Ortiz, Maria Gabriela Tupayachi, Gardner, Tonia E., Boas, Steven R., Messore, Barbara, Zemanick, Edith, Jain, Raksha, McCarthy, Michael, Kissner, Dana G., Patel, Kapilkumar, McNamara, John, Philley, Julie, Berlinski, Ariel, Calimano, Francisco J., Chin, Terry, Conrad, Douglas, Daines, Cori, Raissy, Hengameh H., Keens, Thomas G., Lascano, Jorge E., McWilliams, Bennie, Morrissey, Brian, Reyes, Santiago, Chittivelu, Subramanyam, Hussain, Sabiha, Stone, Arvey, Wallace, James, Klingsberg, Ross, Biller, Julie A., Bui, Stephanie, Sommerburg, Olaf, Bignamini, Elisabetta, Collura, Mirella, Biner, Reta Fischer, Moller, Alexander, Salvatore, Donatello, Belleguic, Chantal, Bentur, Lea, Efrati, Ori, Kerem, Eitan, Prais, Dario, Gallego, Esther Quintana, Barry, Peter, Livnat-Levanon, Galit, Asensi, Jose Ramon Villa, Armstrong, David Stuart, de la Cruz, Oscar Asensio, Gilchrist, Francis, Tullis, Diana Elizabeth, Quon, Bradley, Lands, Larry C., Morrison, Nancy, Lavoie, Annick, Linnane, Barry, Elidemir, Okan, Ringshausen, Felix, Kappler, Matthias, Hebestreit, Helge, Mainz, Jochen, Kiefer, Alexander, Koerner-Rettberg, Cordula, Staab, Doris, Gleiber, Wolfgang, Pressler, Tacjana, Stehling, Florian, Hector, Andreas, Sutharsan, Sivagurunathan, Naehrlich, Lutz, Fischer, Rainald, Downey, Damian, Davies, Jane Carolyn, Ketchell, Robert Ian, Carroll, Mary Patricia, Doe, Simon, MacGregor, Gordon, Nash, Edward Fairbairn, Withers, Nicholas, Peckham, Daniel Gavin, Ledson, Martin James, Kansra, Sonal, Lee, Timothy William Rayner, Delaisi, Bertrand, Rault, Gilles, Le Bihan, Jean, Hubert, Dominique, Fajac, Isabelle, Sermet-Gaudelus, Isabelle, Bakker, Marleen, Arets, Bert, De Boeck, Christiane, Chiron, Raphael, Reix, Philippe, Mainguy, Catherine, van Braeckel, Eva, Malfroot, Anne, Durieu, Isabelle, Dufeu, Nadine Desmazes, Prevotat, Anne, van der Meer, Renske, Merkus, Petrus, Weersink, E.J.M., Gomez-Aguero, Isabel Barrio, Gartner, Silvia, Jover, Amparo Sole, Fernandez, Antonio Alvarez, Cox, Desmond William, McKone, Edward F., Plant, Barry James, Selvadurai, Hiranjan, Bowler, Simon David, Wainwright, Claire Elizabeth, Smith, Daniel, Middleton, Peter Gordon, Wilson, John William, Volpi, Sonia, Colombo, Carla, Fabrizzi, Benedetta, Lucidi, Vincenzina, Cresta, Federico, Cucchiara, Salvatore, Eber, Ernst, Ellemunter, Helmut, Huttegger, Isidor, Hjelte, Lena, Krantz, Christina, Gilljam, Marita, Flume, Patrick A, Downey, Damian G, Brown, Cynthia, De Boeck, Kris, Sawicki, Gregory S, Chang, Philip, Paz-Diaz, Hildegarde, Rubin, Jaime L, Yang, Yoojung, Hu, Xingdi, Pasta, David J, Millar, Stefanie J, Campbell, Daniel, Wang, Xin, Ahluwalia, Neil, Owen, Caroline A, and Wainwright, Claire E

Published
2021
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3. Giving adolescents with cystic fibrosis a voice: Predicting cystic fibrosis nutritional adherence from their decision-making involvement.

Author

Kelleher, Jennifer, Durkin, Kristine, Fedele, David A, Moffett, Kathryn, Filigno, Stephanie S, Lynn, Courtney, Everhart, Robin S, Stark, Lori J, and Duncan, Christina L

Subjects
CYSTIC fibrosis, TEENAGERS, DECISION making, CAREGIVERS, ELECTRONICS in surveying, FORECASTING, PARENT-child relationships
Abstract

Objective Suboptimal nutritional adherence in adolescents with cystic fibrosis (awCF) has been associated with lower lung function. AwCF often have more independence in dietary decisions than younger children, yet little research has examined how adolescent decision-making relates to nutritional adherence. This study explored whether components of adolescent decision-making involvement facilitate enzyme and caloric adherence in awCF. Methods 37 families participated and completed study procedures. AwCF and caregivers completed electronic surveys, including the Decision-Making Involvement Scale (DMIS). The DMIS evaluated awCF behaviors during nutrition-related decision-making/discussions with caregivers using DMIS subscales: Child Seek (asking for help/advice from caregivers), Child Express (awCF stating opinions) and Joint/Options (awCF participating in joint decision-making or caregiver providing options). AwCF completed 2, 24-hr diet recalls via videoconferencing/phone to estimate adherence. Chart reviews collected medical information. DMIS subscales were regressed onto enzyme and caloric adherence. Results 43% of awCF met calorie recommendations; 48.6% took all enzymes as prescribed. Caloric adherence was positively correlated with adolescent- and parent-reported Child Seek (r  =   0.53; r  =   0.36) and adolescent-reported Joint/Options (r  =   0.41). Per adolescent-report, the caloric adherence regression model was significant, with Child Seek contributing unique variance in caloric adherence (β  = .62, p  = .03). Parent-reported adolescent-decision-making involvement significantly predicted caloric adherence, but none of the subscales contributed unique variance. No other regressions were significant. Conclusions When awCF participated in nutrition-related discussions with a caregiver, especially with questions, caloric adherence was better. Future research should examine whether family factors influence these results. AwCF are encouraged to ask questions in nutrition discussions. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients

Author

Bradley, John S, Armstrong, Jon, Arrieta, Antonio, Bishai, Raafat, Das, Shampa, Delair, Shirley, Edeki, Timi, Holmes, William C, Li, Jianguo, Moffett, Kathryn S, Mukundan, Deepa, Perez, Norma, Romero, José R, Speicher, David, Sullivan, Janice E, and Zhou, Diansong

Subjects
Clinical Research, Pediatric, Patient Safety, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adolescent, Azabicyclo Compounds, Ceftazidime, Child, Child, Preschool, Drug Combinations, Female, Hospitals, Pediatric, Humans, Infant, Male, beta-Lactamase Inhibitors, Microbiology, Medical Microbiology, Pharmacology and Pharmaceutical Sciences
Abstract

This study aimed to investigate the pharmacokinetics (PK), safety, and tolerability of a single dose of ceftazidime-avibactam in pediatric patients. A phase I, multicenter, open-label PK study was conducted in pediatric patients hospitalized with an infection and receiving systemic antibiotic therapy. Patients were enrolled into four age cohorts (cohort 1, ≥12 to

Published
2016

5. Increasing dental and medical students' understanding of race as a social construct.

Author

Nield, Linda S., Nease, Emily K., Cottrell, Lesley E., Moffett, Kathryn S., Saggio, Renee B., and Price, Shelia S.

Abstract

Purpose: To improve health equity, dental and medical students must have a firm grasp of the proper use of race as a social construct. The purpose of this study was to determine the degree to which an innovative learning event affected students' understanding of race as a social construct. It also sought to examine the effects that personally experienced and/or witnessed racism and previous education had on students' responses to the learning event. Methods: In 2022, all incoming first‐year dental (N = 48) and medical (N = 114) students completed an online pre‐matriculation assignment about the use of race in healthcare. Students initially completed an anonymous 14‐item pre‐survey and then read assigned publications, followed by answering questions about a real‐life vignette concerning the topic of race as a social construct. Students finished the assignment by completing an anonymous seven‐item post‐survey. Data from the pre‐ and post‐surveys were collected and analyzed to assess if differences existed among students and between the two surveys. Results: Dental and medical students were significantly more likely to endorse race as a social construct after the learning experience (p < 0.001). Students who had experienced discrimination or obtained training were more likely to define race as a social construct before and after the learning event. Conclusion: Dental and medical schools can increase students' understanding of race as a social construct, rather than a biological construct, with educational interventions. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Forced Expiratory Volume in 1 Second Variability Helps Identify Patients with Cystic Fibrosis at Risk of Greater Loss of Lung Function

Author

Morgan, Wayne, Konstan, Michael, Liou, Ted, McColley, Susanna, McMullen, Ann, Quittner, Alexandra, Regelmann, Warren, Ren, Clement, Rosenfeld, Margaret, Sawicki, Greg, Schechter, Michael, VanDevanter, Donald, Wagener, Jeffrey, Woo, Marlyn, Brasfield, Dana, Lyrene, Raymond, Sindel, Lawrence, Roberts, Dion, Carroll, John, Warren, Robert, Nassri, Louay, Anderson, Paula, Brown, Mark, Silverthorn, Amy, Radford, Peggy, Gong, Gerald, Legris, Gregory, Greene, Gerald, Sudhakar, Reddivalam, Platzker, Arnold, Nickerson, Bruce, Hardy, Karen, Harwood, Ivan, Shay, Gregory, Quick, Bryon, Lieberthal, Allan, Moss, Richard, Landon, Chris, Fanous, Yvonne, Lieberman, Jay, Spiritus, Eugene, Chipps, Bradley, McDonald, Ruth, Pian, Mark, Cropp, Gerd, Lewis, Nancy, Nielson, Dennis, Shapiro, Bertrand, Wagener, Jeff, Accurso, Frank, Saavedra, Milene, Daigle, Karen, Hen, Jacob, Palazzo, Regina, Dodds, Kathryn, Pad-man, Raj, Goodill, John, Winnie, Glenna, Davies, Lea, Kriseman, Tony, Sallent, Jorge, Chiaro, Joseph, Kubiet, Martin, Goldfinger, Sue, Schwartzman, Morton, Diaz, Carlosenrique, Maupin, Kevin, Riff, Eduardo, Geller, David, Livingston, Floyd, Mavunda, Kunjana, Birriel, Jose, Jr., Faverio, Luis, Rosenberg, David, Schaeffer, David, Sherman, James, Wagner, Mary, Light, Michael, Schnapf, Bruce, Montgomery, Gary, Kirchner, Kevin, Weatherly, Mark, Caplan, Daniel, Guill, Margaret, Hudson, Valera, Akhter, Javeed, Davison, Donald, Boas, Steven, Chung, Youngran, Latner, Rennee, Aljadeff, Gabriel, Chan, Youngran, Kraut, Jerome, Stone, Arvey, Still, John Lloyd, Sharma, Girish, Eagleton, Lanie, Hopkins, Patricia, Chatrath, Umesh, Lester, Lucille, Kim, Young-Jee, Anthony, Veena, Eigan, Howard, Howenstine, Michelle, James, Pushpom, Gergesha, Edward, Harris, James, Plant, Robert, Zivkovich, Veljko, Collins, Angela, Nassif, Edward, Ahrens, Richard, Doornbos, Daniel, Kanarek, Joseph, Leff, Richard, Shaw, Pamela, Demoss, Elanor, Riva, Maria, Sullivan, Leonard, Anstead, Michael, Kanga, Jamshed, Eid, Nemr, Morton, Ron, Hilman, Bettina, Jones, Kim, Davis, Scott, Harder, Ralph, Lever, Tom, Cairns, Anne Marie, Caldwell, Edgar, Zuckerman, Jonathan, Mogayzel, Peter, Rosenstein, Beryl, McQuestion, John, Perry, Donna, Rosenberg, Samuel, Gerstle, Robert, Colin, Andrew, Wohl, Mary Ellen, Lapey, Allan, Yee, William, O'Sullivan, Brian, Zwerdling, Robert, Abdulhamid, Ibrahim, O'Hagan, Adrian, Schuen, John, Kurlandsky, Lawrence, Honicky, Richard, Homnick, Douglas, Marks, John, Pichurko, Bohdan, Maxvold, Norma, Nasr, Samya, Simon, Richard, Tsai, Wan, Kissner, Dana, McNamara, John, Henry, Nancy, Marker, Stephen, Pryor, Michael, Walker, Lynn, Woodward, Jim, Mizell, Louis, Miller, Suzanne, Rosenbluth, Daniel, Black, Philip, McCubbin, Michael, Cohen, Alan, Ferkol, Thomas, Mallory, George, Rejent, Anthony, Rubin, Bruce, Graff, Gavin, Konig, Peter, Colombo, John, Murphy, Peter, Boyle, William, Parker, Worth, Patton, Chandler, Zanni, Robert, Atlas, Arthur, Turcios, Nelson, Laraya-Cuasay, Lourdes, Bisberg, Dorothy, Aguila, Helen, Allen, Sarah, James, David, Perkett, Elizabeth, Thompson, Marsha, Budhecha, Sonia, Diaz, Ruben, Rosen, Jonathan, Kaslovsky, Robert, Percciacante, Ronald, Borowitz, Drucy, Cronin, Joseph, McMahon, Colin, Quittell, Lynne, Giusti, Robert, Cohen, Rubin, DeCelie-Germana, Joan, Gorvoy, Jack, Patel, Kalpan, Kattan, Meyer, Dozor, Allen, DiMango, Emily, Berdella, Maria, Anbar, Ran, Ianuzzi, Debra, Sexton, James, Tayag-Kier, Catherine, McBride, John, Voter, Karen, Dimaio, Mary, Georgitis, John, Majure, Joseph Marc, Martinez, Maria, McIntosh, Clarke, Leigh, Margaret, Black, Hugh, Hughes, James, Kantak, Anand, Wilmott, Robert, Omlor, Gregory, Stone, Robert, McCoy, Karen, Acton, James, Doershuk, Carl, Fink, Robert, Steffan, Michael, Vauthy, Pierre, Joseph, Patricia, Reyes, Santiago, Kramer, John, Royall, James, Eisenberg, Jay, Wall, Michael, Fiel, Stanley, Scanlin, Thomas, Phadke, Shroti, Weinberg, Joel, Sexauer, William, Wolf, Stephen, Holsclaw, Douglas, Klein, Debra, Warren, Stuart, Kinsey, Robert, Perez, Carlos, Ganeshanathan, Muttiah, Shinnick, James, Panitch, Howard, Varlotta, Laurie, Robinson, Cynthia, Santana, Jose Rodriguez, Passero, Mary Ann, Gwinn, Jane, Baker, Robert, Bowman, Michael, Flume, Patrick, Brown, Daniel, Marville, Roxanne, Wallace, James, Parry, Rodney, Ellenburg, Don, Rogers, John, Mohon, Ricky, Ledbetter, Joel, Hanissian, Aram, Schoumacher, Robert, Campbell, Preston, Harris, Christopher, Slovis, Bonnie, Stokes, Dennis, Hale, Kathryn, Katz, Marcia, Seilheimer, Dan, Sockrider, Marianne, Frank, Allan, Daniel, James, Cunningham, James, Browning, Iley, Bray, John, Dove, Amanda, Mandujano, Fernando, Tremper, Larry, Morse, Martha, Willey-Courand, Donna, Copenhaver, Steven, Pohl, John, McWilliams, Bennie, Martine-Logvinoff, Marie, Wallace, Marsh, Klein, Robert, Amaro, Rodolfo, Couch, Leslie, Brown, Michael, Prestidge, Claude, Inscore, Stephen, Lipton, Andrew, Chatfield, Barbara, Liou, Theodore, Marshall, Bruce, Lahiri, Thomas, Swartz, Donald, Whittaker, Laurie, Karlson, Karl, Ropoll, Ignacio, Rubio, Thomas, Schmidt, Joel, Thomas, David, Osborn, John, Froh, Deborah, Gaston, Benjamin, Elliott, Greg, Gibson, Ronald, Ramsey, Bonnie, McCarthy, Michael, Larson, Lawrence, Ricker, David, Robbins, Mark, Aitken, Moira, Emerson, Julia, Aronoff, Stephen, Moffett, Kathryn, Biller, Julie, Splaingard, Mark, Sullivan, Bradley, Pritchard, Paul, Adair, Stu, Holzwarth, Peter, Dopico, Guillermo, Meyer, Keith, Green, Christopher, Rock, Michael, Morgan, Wayne J., VanDevanter, Donald R., Pasta, David J., Foreman, Aimee J., Wagener, Jeffrey S., and Konstan, Michael W.

Published
2016
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9. COVID-19 Seroprevalence in a Mixed Cohort of SARS-CoV-2 PCR Positive and Exposed Subjects.

Author

Knowles, Giles, Winkie, Colin, Umer, Amna, Moffett, Kathryn, Weisse, Martin, and Gupta, Shipra

Subjects
COVID-19 pandemic, PUBLIC health, SEROPREVALENCE, POLYMERASE chain reaction, SARS-CoV-2
Abstract

Early in the SARS-CoV-2 pandemic, polymerase chain reaction (PCR) testing was reserved for symptomatic patients. However, many infections were asymptomatic or mildly symptomatic. Positive serologic antibody (Ab) testing is theorized to be a marker of prior infection, allowing for identification of the true burden of the disease and the establishment of links between outbreaks. The objective was to assess serologic testing in subjects after PCR testing and compare seropositivity rates of household vs. non-household close contacts. We identified subjects who were PCR-positive between March 2020 and May 2021. Index cases and close contacts then underwent serologic testing for IgG against the SARS-CoV-2 nucleocapsid N-protein. One hundred and thirteen subjects underwent serologic testing with a sensitivity of 65.0%, specificity of 78.9%, positive predictive value of 92.9%, and negative predictive value of 34.9%. Index cases comprised 20.5% of subjects, and 73.9% were seropositive (p = 0.01). Close contacts included 72% household contacts and 28% non-household contacts. One seropositive case had no prior PCR and four were PCR negative. No statistical difference existed in seropositivity between household and non-household contact (53.1% vs. 43.8%, p = 0.4). Testing for IgG against SARS-CoV-2 N-protein may identify previously unrecognized infections in the community. Seropositivity rates of household vs. non-household contacts were not significantly different, and >50% of household contacts were seropositive. [ABSTRACT FROM AUTHOR]

Published
2023
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13. A Randomized Clinical Trial of Antimicrobial Duration for Cystic Fibrosis Pulmonary Exacerbation Treatment

Author

Goss, Christopher H., primary, Heltshe, Sonya L., additional, West, Natalie E., additional, Skalland, Michelle, additional, Sanders, Don B., additional, Jain, Raksha, additional, Barto, Tara L., additional, Fogarty, Barbra, additional, Marshall, Bruce C., additional, VanDevanter, Donald R., additional, Flume, Patrick A., additional, Omlor, Gregory, additional, Bourne, Brenda, additional, Roberts, Dion, additional, Roberts, Vicki, additional, Nasr, Samya, additional, Kruse, Dawn, additional, Linnemann, Rachel, additional, Hailemichael, Tsion, additional, Forseen, Caralee, additional, Stapp, Heidi, additional, West, Natalie, additional, Patel, S., additional, Claudio, A., additional, Lysinger, Jerimiah, additional, Harmala, Amy, additional, Solomon, George, additional, Kersh, Latona, additional, Miller, Karen, additional, Durham, Dixie, additional, Uluer, Ahmet, additional, Fowler, Robert, additional, Frederick, Carla, additional, Caci, Nadine, additional, Teneback, Charlotte, additional, Sweet, Julie, additional, Parkins, Michael, additional, Smith, Clare, additional, Goralski, Jennifer, additional, Haywood, Kelsey, additional, Flume, Patrick, additional, Brailsford, Caroline, additional, Albon, Dana, additional, Aderholt, Christie, additional, McBennett, Kimberly, additional, Schaefer, Cindy, additional, Patel, Alpa, additional, Hunt, April, additional, Schumacher, Lauren, additional, Polenakovik, Hari, additional, Clark, Linda, additional, Nick, Jerry, additional, Poch, Katie, additional, Kissner, Dana, additional, Cahill, James, additional, Lascano, Jorge, additional, Silverman, Erin, additional, McArdle, John, additional, Champagne, Alison, additional, Vender, Robert, additional, Allwein, Lisa, additional, Cohen, Lance, additional, Barton, Norma (Jean), additional, Barto, Tara, additional, Patel, Ami, additional, Brown, Cynthia, additional, Vorhees, Nia, additional, Crosser, Michael, additional, Scott, Lawrence, additional, Ashare, Alix, additional, Rodgers, Barbara, additional, Zanni, Robert, additional, Koval, Lisa, additional, Braun, Andrew, additional, Stevens, Sophia Chiron, additional, Ortiz, Maria Tupayachi, additional, Graham, Patricia, additional, Biller, Julie, additional, Hubertz, Erin, additional, Moffett, Kathryn, additional, Clark, Tammy, additional, Griffith, Rebecca, additional, Martinez, Nancy, additional, Hussain, Sabiha, additional, Chen, Fei, additional, Egan, Marie, additional, Guzman, Catalina, additional, Wang, Janice, additional, Espinal, Aileen, additional, Walker, Patricia, additional, Kukral, Anne, additional, DiMango, Emily, additional, Francis, Sarah Fracasso, additional, Milla, Carlos, additional, Dunn, Colleen, additional, Chittivelu, Subramanyam, additional, Scott, Ashley, additional, Dorgan, Daniel, additional, Ng, Sharon, additional, Pilewski, Joseph, additional, Lanzo, Rose, additional, Chaudary, Nauman, additional, Hayden, Ryan, additional, Scofield, Steven, additional, Johnson, Barb, additional, Morrissey, Brian, additional, Robinson, Brandt, additional, Conrad, Douglas, additional, Mielke, Jenna, additional, Aitken, Moira, additional, Sanlors, Chami, additional, Nayak, Ravi, additional, Branch, Freda, additional, Rosenbluth, Daniel, additional, Siegel, Molly, additional, Ghimire, Anil, additional, Forell, Mary, additional, Daines, Cori, additional, Varela, Monica, additional, Couch, Leslie, additional, Hibbard, Rebekah, additional, Dozor, Allen, additional, Ramirez, Armando, additional, Ortega, Victor, additional, Kennedy, Kathryn, additional, Fish, David, additional, and Longtine, Karen, additional

Published
2021
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14. Long-term safety and efficacy of tezacaftor–ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study

Author

Flume, Patrick A, primary, Biner, Reta Fischer, additional, Downey, Damian G, additional, Brown, Cynthia, additional, Jain, Manu, additional, Fischer, Rainald, additional, De Boeck, Kris, additional, Sawicki, Gregory S, additional, Chang, Philip, additional, Paz-Diaz, Hildegarde, additional, Rubin, Jaime L, additional, Yang, Yoojung, additional, Hu, Xingdi, additional, Pasta, David J, additional, Millar, Stefanie J, additional, Campbell, Daniel, additional, Wang, Xin, additional, Ahluwalia, Neil, additional, Owen, Caroline A, additional, Wainwright, Claire E, additional, Gibson, Ronald L., additional, Rowe, Steven M., additional, Lechtzin, Noah, additional, Ahrens, Richard C., additional, McCoy, Karen S., additional, Aitken, Moira, additional, Donaldson, Scott H., additional, McBennett, Kimberly Ann, additional, Pilewski, Joseph M., additional, Billings, Joanne, additional, Milla, Carlos, additional, Rubenstein, Ronald, additional, Rosenbluth, Daniel Brian, additional, Linnemann, Rachel, additional, Powers, Michael R., additional, Fortner, Christopher, additional, Frederick, Carla Anne, additional, Liou, Theodore G., additional, Black, Philip, additional, Wang, Janice, additional, Colombo, John L., additional, Berdella, Maria, additional, Indihar, Maria Veronica, additional, Brown, Cynthia D., additional, Anstead, Michael, additional, Bilodeau, Lara, additional, Sicilian, Leonard, additional, Tolle, James Jerome, additional, Moffett, Kathryn, additional, Nasr, Samya, additional, Taylor-Cousar, Jennifer, additional, Barto, Tara Lynn, additional, Antos, Nicholas, additional, Rogers, John S., additional, Quick, Bryon, additional, Thompson, Henry R., additional, Sawicki, Gregory, additional, Barnett, Bruce, additional, Zanni, Robert L., additional, Smith, Thomas C., additional, Schultz, Karen D., additional, Keating, Claire, additional, Flume, Patrick, additional, Omlor, Gregory J., additional, Ashare, Alix, additional, Voter, Karen, additional, Mehdi, Nighat, additional, Ortiz, Maria Gabriela Tupayachi, additional, Gardner, Tonia E., additional, Boas, Steven R., additional, Messore, Barbara, additional, Zemanick, Edith, additional, Jain, Raksha, additional, McCarthy, Michael, additional, Kissner, Dana G., additional, Patel, Kapilkumar, additional, McNamara, John, additional, Philley, Julie, additional, Berlinski, Ariel, additional, Calimano, Francisco J., additional, Chin, Terry, additional, Conrad, Douglas, additional, Daines, Cori, additional, Raissy, Hengameh H., additional, Keens, Thomas G., additional, Lascano, Jorge E., additional, McWilliams, Bennie, additional, Morrissey, Brian, additional, Reyes, Santiago, additional, Chittivelu, Subramanyam, additional, Hussain, Sabiha, additional, Stone, Arvey, additional, Wallace, James, additional, Klingsberg, Ross, additional, Biller, Julie A., additional, Bui, Stephanie, additional, Sommerburg, Olaf, additional, Bignamini, Elisabetta, additional, Collura, Mirella, additional, Moller, Alexander, additional, Salvatore, Donatello, additional, Belleguic, Chantal, additional, Bentur, Lea, additional, Efrati, Ori, additional, Kerem, Eitan, additional, Prais, Dario, additional, Gallego, Esther Quintana, additional, Barry, Peter, additional, Livnat-Levanon, Galit, additional, Asensi, Jose Ramon Villa, additional, Armstrong, David Stuart, additional, de la Cruz, Oscar Asensio, additional, Gilchrist, Francis, additional, Tullis, Diana Elizabeth, additional, Quon, Bradley, additional, Lands, Larry C., additional, Morrison, Nancy, additional, Lavoie, Annick, additional, Linnane, Barry, additional, Elidemir, Okan, additional, Ringshausen, Felix, additional, Kappler, Matthias, additional, Hebestreit, Helge, additional, Mainz, Jochen, additional, Kiefer, Alexander, additional, Koerner-Rettberg, Cordula, additional, Staab, Doris, additional, Gleiber, Wolfgang, additional, Pressler, Tacjana, additional, Stehling, Florian, additional, Hector, Andreas, additional, Sutharsan, Sivagurunathan, additional, Naehrlich, Lutz, additional, Downey, Damian, additional, Davies, Jane Carolyn, additional, Ketchell, Robert Ian, additional, Carroll, Mary Patricia, additional, Doe, Simon, additional, MacGregor, Gordon, additional, Nash, Edward Fairbairn, additional, Withers, Nicholas, additional, Peckham, Daniel Gavin, additional, Ledson, Martin James, additional, Kansra, Sonal, additional, Lee, Timothy William Rayner, additional, Delaisi, Bertrand, additional, Rault, Gilles, additional, Le Bihan, Jean, additional, Hubert, Dominique, additional, Fajac, Isabelle, additional, Sermet-Gaudelus, Isabelle, additional, Bakker, Marleen, additional, Arets, Bert, additional, De Boeck, Christiane, additional, Chiron, Raphael, additional, Reix, Philippe, additional, Mainguy, Catherine, additional, van Braeckel, Eva, additional, Malfroot, Anne, additional, Durieu, Isabelle, additional, Dufeu, Nadine Desmazes, additional, Prevotat, Anne, additional, van der Meer, Renske, additional, Merkus, Petrus, additional, Weersink, E.J.M., additional, Gomez-Aguero, Isabel Barrio, additional, Gartner, Silvia, additional, Jover, Amparo Sole, additional, Fernandez, Antonio Alvarez, additional, Cox, Desmond William, additional, McKone, Edward F., additional, Plant, Barry James, additional, Selvadurai, Hiranjan, additional, Bowler, Simon David, additional, Wainwright, Claire Elizabeth, additional, Smith, Daniel, additional, Middleton, Peter Gordon, additional, Wilson, John William, additional, Volpi, Sonia, additional, Colombo, Carla, additional, Fabrizzi, Benedetta, additional, Lucidi, Vincenzina, additional, Cresta, Federico, additional, Cucchiara, Salvatore, additional, Eber, Ernst, additional, Ellemunter, Helmut, additional, Huttegger, Isidor, additional, Hjelte, Lena, additional, Krantz, Christina, additional, and Gilljam, Marita, additional

Published
2021
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17. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial

Author

Heijerman, Harry G M, primary, McKone, Edward F, additional, Downey, Damian G, additional, Van Braeckel, Eva, additional, Rowe, Steven M, additional, Tullis, Elizabeth, additional, Mall, Marcus A, additional, Welter, John J, additional, Ramsey, Bonnie W, additional, McKee, Charlotte M, additional, Marigowda, Gautham, additional, Moskowitz, Samuel M, additional, Waltz, David, additional, Sosnay, Patrick R, additional, Simard, Christopher, additional, Ahluwalia, Neil, additional, Xuan, Fengjuan, additional, Zhang, Yaohua, additional, Taylor-Cousar, Jennifer L, additional, McCoy, Karen S, additional, McCoy, Karen, additional, Donaldson, Scott, additional, Walker, Seth, additional, Chmiel, James, additional, Rubenstein, Ronald, additional, Froh, Deborah K., additional, Neuringer, Isabel, additional, Jain, Manu, additional, Moffett, Kathryn, additional, Taylor-Cousar, Jennifer L., additional, Barnett, Bruce, additional, Mueller, Gary, additional, Flume, Patrick, additional, Livingston, Floyd, additional, Mehdi, Nighat, additional, Teneback, Charlotte, additional, Welter, John, additional, Jain, Raksha, additional, Kissner, Dana, additional, Patel, Kapilkumar, additional, Calimano, Francisco J., additional, Johannes, Jimmy, additional, Daines, Cori, additional, Keens, Thomas, additional, Scher, Herschel, additional, Chittivelu, Subramanyam, additional, Reddivalam, Sudhakar, additional, Klingsberg, Ross Carl, additional, Johnson, Larry G., additional, Verhulst, Stijn, additional, Macedo, Patricia, additional, Downey, Damien, additional, Connett, Gary, additional, Nash, Edward, additional, Withers, Nicholas, additional, Lee, Timothy, additional, Bakker, Marleen, additional, Heijerman, Harry, additional, Vermeulen, Francois, additional, Knoop, Christiane, additional, De Wachter, Elke, additional, van der Meer, Renske, additional, Merkus, Petrus, additional, and Majoor, Christof, additional

Published
2019
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25. Rash in an Extremely Low Birth Weight Infant

Author

Akers Stephen M, Barretto Greg A, Mitchell Michelle L, Moffett Kathryn S, Yossuck Panitan, and Kiefer Autumn S

Subjects
Pediatrics, medicine.medical_specialty, business.industry, Medicine, medicine.symptom, business, Extremely low birth weight infant, Rash
Published
2018

27. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents

Author

Gonzalez, Daniel, primary, James, Laura P., additional, Al-Uzri, Amira, additional, Bosheva, Miroslava, additional, Adler-Shohet, Felice C., additional, Mendley, Susan R., additional, Bradley, John S., additional, Espinosa, Claudia, additional, Tsonkova, Eva, additional, Moffett, Kathryn, additional, Marquez, Lucila, additional, Simonsen, Kari A., additional, Stoilov, Stefan, additional, Boakye-Agyeman, Felix, additional, Jasion, Theresa, additional, Hornik, Christoph P., additional, Hernandez, Robert, additional, Benjamin, Daniel K., additional, and Cohen-Wolkowiez, Michael, additional

Published
2018
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28. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508delmutation: a double-blind, randomised, phase 3 trial

Author

Heijerman, Harry G M, McKone, Edward F, Downey, Damian G, Van Braeckel, Eva, Rowe, Steven M, Tullis, Elizabeth, Mall, Marcus A, Welter, John J, Ramsey, Bonnie W, McKee, Charlotte M, Marigowda, Gautham, Moskowitz, Samuel M, Waltz, David, Sosnay, Patrick R, Simard, Christopher, Ahluwalia, Neil, Xuan, Fengjuan, Zhang, Yaohua, Taylor-Cousar, Jennifer L, McCoy, Karen S, McCoy, Karen, Donaldson, Scott, Walker, Seth, Chmiel, James, Rubenstein, Ronald, Froh, Deborah K., Neuringer, Isabel, Jain, Manu, Moffett, Kathryn, Taylor-Cousar, Jennifer L., Barnett, Bruce, Mueller, Gary, Flume, Patrick, Livingston, Floyd, Mehdi, Nighat, Teneback, Charlotte, Welter, John, Jain, Raksha, Kissner, Dana, Patel, Kapilkumar, Calimano, Francisco J., Johannes, Jimmy, Daines, Cori, Keens, Thomas, Scher, Herschel, Chittivelu, Subramanyam, Reddivalam, Sudhakar, Klingsberg, Ross Carl, Johnson, Larry G., Verhulst, Stijn, Macedo, Patricia, Downey, Damien, Connett, Gary, Nash, Edward, Withers, Nicholas, Lee, Timothy, Bakker, Marleen, Heijerman, Harry, Vermeulen, Francois, Van Braeckel, Eva, Knoop, Christiane, De Wachter, Elke, van der Meer, Renske, Merkus, Petrus, and Majoor, Christof

Abstract

Cystic fibrosis transmembrane conductance regulator (CFTR) modulators correct the basic defect caused by CFTR mutations. Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508delmutation. The addition of elexacaftor (VX-445), a next-generation CFTR corrector, to tezacaftor plus ivacaftor further improved F508del-CFTR function and clinical outcomes in a phase 2 study in people with cystic fibrosis homozygous for the F508delmutation.

Published
2019
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30. Contributors

Author

Aaskov, John, Adachi, Kristina, Aebi, Christoph, Alexander, Kenneth A., Al-Rawahi, Ghada N., Al-Zubeidi, Duha, Anjum, Seher, Ardura, Monica I., Arnon, Stephen S., Arrington, Amy, Arvin, Ann M., Atmar, Robert L., Baker, Amira, Baker, Carol J., Baltimore, Robert S., Barenkamp, Stephen J., Barnett, Elizabeth D., Barton, Theresa, Benard, Gil, Bender, Jeffrey M., Berry, Gregory J., Bhatt, Amit, Bluestone, Charles D., Blumer, Jeffrey L., Bocchini, Claire, Boyer, Kenneth M., Bradley, John S., Brasil, Patricia, Britt, William J., Bronstein, David E., Bruckner, David A., Bryant, Kristina A., Buckingham, Steven C., Byington, Carrie L., Cabada, Miguel M., Cadilla, Adriana, Campbell, Judith R., Caron, Justin E., Carrillo-Marquez, Maria, Casey, Janet R., Castagnini, Luis A., Chacko, Mariam R., Chandramohan, Lakshmi, Chapman, Louisa E., Charrel, Remi N., Chea-Woo, Elsa, Cheifetz, Ira M., Chen, Tempe K., Cherry, James D., Chinen, Javier, Ching, Natascha, Chinn, Ivan K., Christenson, John C., Coffin, Susan E., Correa, Armando G., Cox, Elaine G., Crews, Jonathan D., Cruz, Andrea T., Davidovics, Zev, Dehority, Walter N., de Lamballerie, Xavier, Dennehy, Penelope H., Doan, Minh L., Dobson, Simon R., Drutz, Jan E., Dubray, Kara A., Duppenthaler, Andrea, Dvorak, Christopher C., Edelstein, Paul H., Edwards, Kathryn M., Edwards, Morven S., El-Kamary, Samer S., Englund, Janet A., Ericson, Jessica, Fan, Leland L., Federman, Myke, Fernando, Pedro, Fischer, Philip R., Fisher, Brian T., Fisher, Randall G., Fishman, Douglas S., Flores, Anthony R., Foster, Catherine, Friedman, Ellen M., Gabaglia, Claudia Raja, Garcia, Lynne S., Gauthier, Gregory M., Gershon, Anne A., Gigliotti, Francis, Gilger, Mark A., Gillespie, Susan L., Glaser, Carol A., Goldman, David L., Goldman, Jennifer L., Goldstein, Nira A., Gonzalez, Blanca E., Green, Michael D., Groll, Andreas, Grose, Charles, Gubler, Duane J., Guevara, Javier Nieto, Hall, Caroline B., Hall, Roy A., Halstead, Scott B., Hamano, Shinjiro, Hammerschlag, Margaret R., Hannemann, Nicole L., Hanson, I. Celine, Harik, Nada, Harriman, Kathleen H., Harrison, Gail J., Healy, C. Mary, Heininger, Ulrich, Hemming-Harlo, Maria, Henderson, Sheryl L., Heresi, Gloria P., Hiatt, Peter W., Hill, Harry R., Hilmers, David C., Hoffman, Jill A., Hotez, Peter J., Howard, Leigh M., Hulten, Kristina G., Humphries, Romney M., Hunstad, David A., Hunt, W. Garrett, Huskins, W. Charles, Hyun, David Y., Jackson, Mary Anne, Jacobs, Michael R., Jacobs, Richard F., Jhaveri, Ravi, Odom, Audrey R., Johnston, Samantha H., Julapalli, Meena R., Kaplan, Sheldon L., Kearns, Gregory L., Khouri, Jessica M., Kim, Kwang Sik, Kim, Yae-Jean, King, Katherine Y., Kirchhoff, Louis V., Kleiman, Martin B., Klein, Bruce S., Kohlhoff, Stephan A., Kollmann, Tobias R., Korpe, Poonum S., Kosek, Margaret, Koster, Michael P., Krause, Peter J., Krilov, Leonard R., Krogstad, Paul, Krysan, Damian J., Kuan, Edward, Kuhls, Thomas, Labuda, Sarah M., Lantos, Paul M., La Pine, Timothy R., Heinimäki, Suvi, Larkin, Jerome M., Laurens, Matthew B., Leach, Charles T., Leber, Amy, Leggiadro, Robert J., Lehman, Deborah, Lennon, Diana R., Leung, Daniel H., Levy, Moise L., Linam, W. Matthew, Logan, Latania K., Lotze, Timothy E., Lucero, Yalda C., Lugo, Debra J., Luk, Berkley, Maloney, Susan A., Mann, Michelle C., Marquez, Lucila, Martin, Kimberly C., Mascola, Laurene, Mason, Edward O., Jr, Maspons, Aldo, Mazade, Marc A., McBride, Holly E., McCullers, Jonathan A., McIntosh, Kenneth, McJunkin, James E., McKee, Kelly T., Jr, McKinney, Ross, Jr, McNeil, J. Chase, Mejia, Rojelio, Mejias, Asuncion, Mendes Giannini, Maria José Soares, Michaels, Marian G., Michelow, Ian C., Miller, Marjorie J., Mills, James N., Mithal, Leena B., Moffett, Kathryn S., Montes, Martin, Muller, Martha, Mungwira, Randy George, Murphy, James R., Nadipuram, Santhosh M., Nataro, James P., Needham, Heather, Nielsen-Saines, Karin, Nieves, Delma J., Oberhelman, Richard, Ochoa, Theresa J., Olivero, Rosemary M., O'Ryan, Miguel, Overturf, Gary D., Palazzi, Debra L., Pannaraj, Pia S., Patel, Janak A., Paul, Mary E., Pelton, Stephen I., Pence, Morgan A., Perfect, John R., Peters, C.J., Petri, William A., Jr, Pham, Yen H., Pinheiro, Francisco P., Pinsky, Benjamin A., Pong, Alice, Porsch, Eric A., Purcell, Joan S., Quanquin, Natalie M., Quinn, Kevin K., Abdel-Rahman, Susan M., Ramilo, Octavio, Ramraj, Ramya, Revell, Paula A., Rimoin, Anne W., Romero, José R., Ross, Lawrence, Rowley, Anne H., Rupprecht, Charles E., Saez-Llorens, Xavier, Sammons, Julia Shaklee, Sánchez, Pablo, Sande, Linette, Santisteban-Ponce, Javier, Sass, Laura A., Scholand, Stephen J., Schulte, Danica J., Schuster, Jennifer E., Schutze, Gordon E., Seed, Patrick C., Serpa, Jose A., Shah, Samir S., Shapiro, Eugene D., Shapiro, Nina L., Shearer, William T., Shimizu-Cohen, Robyn, Shulman, Stanford T., Shehab, Kareem W., Shehab, Ziad M., Simos, Constantine, Smit, Michael A., Smith, P. Brian, Soni, Priya R., Sood, Sunil K., Staat, Mary Allen, Stark, Damien, Starke, Jeffrey R., Statler, Victoria A., Stechenberg, Barbara W., Steinbach, William J., St. Geme, Joseph W., III, Suen, Jeffrey, Sung, Lillian, Swanson, Douglas S., Tan, Tina Q., Taylor, Ruston S., Tolle, Michael A., Toltzis, Philip, Tomko, Stuart R., Tosi, Michael F., Tovar Padua, Leidy J., Travassos da Rosa, Amelia P.A., Tsai, Theodore F., Vahabzadeh-Hagh, Andrew M., Velarde, Jorge J., Vallejo, Jesus G., Vanchiere, John A., Venick, Robert S., Verma, Sanjay, Versalovic, James, Vesikari, Timo, Wald, Ellen R., Walsh, Thomas J., Ward, Mark A., Wattier, Rachel L., Way, Sing Sing, Weatherhead, Jill, Weinberg, Michelle, Weinberg, Nicholas, Wellington, Melanie, Welliver, Robert C., Sr, Wheeler, J. Gary, White, A. Clinton, Jr, Whitworth, Suzanne, Wiedermann, Bernhard L., Williams, John V., Williams-Bouyer, Natalie M., Woods, Charles R., Jr, Wright, Terry W., Yeganeh, Nave, Young, Edward J., Zakhour, Ramia, and Zaoutis, Theoklis

Published
2019
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31. When kids ask for a pet turtle or hermit crab

Author

Moffett, Kathryn S. and Nield, Linda S.

Subjects
Hermit-crabs -- Health aspects -- Methods, Turtles -- Health aspects -- Methods, Parenting -- Methods -- Health aspects, Disease transmission -- Risk factors, Pets -- Health aspects -- Methods, Health
Abstract

A MOTHER ASKS: My son [aged 8] has wanted a pet turtle or hermit crab for the past 3 years. Maybe I'm a worrywart, but I've heard that animals like [...]

Published
2009

35. Impact of a Multimodal Antimicrobial Stewardship Program onPseudomonas aeruginosaSusceptibility and Antimicrobial Use in the Intensive Care Unit Setting

Author

Slain, Douglas, primary, Sarwari, Arif R., additional, Petros, Karen O., additional, McKnight, Richard L., additional, Sager, Renee B., additional, Mullett, Charles J., additional, Wilson, Alison, additional, Thomas, John G., additional, Moffett, Kathryn, additional, Palmer, H. Carlton, additional, and Dedhia, Harakh V., additional

Published
2011
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37. Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis

Author

Konstan, Michael W., primary, Liou, Theodore G., additional, Strausbaugh, Steven D., additional, Ahrens, Richard, additional, Kanga, Jamshed F., additional, Graff, Gavin R., additional, Moffett, Kathryn, additional, Millard, Susan L., additional, Nasr, Samya Z., additional, Siméon, Édith, additional, Spénard, Jean, additional, and Grondin, Josée, additional

Published
2010
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42. Cool way to make hot food edible

Author

Moffett, Kathryn S.

Subjects
Pediatricians -- Practice, Children -- Food and nutrition, Food
Abstract

Children often have to wait a long time for food to cool before they can eat it safely. This is especially true for pizza, oatmeal, soup, and casseroles. Adding ice [...]

Published
2005

43. Impact of a Multimodal Antimicrobial Stewardship Program on Pseudomonas aeruginosa Susceptibility and Antimicrobial Use in the Intensive Care Unit Setting.

Author

Slain, Douglas, Sarwari, Arif R., Petros, Karen O., McKnight, Richard L., Sager, Renee B., Mullett, Charles J., Wilson, Alison, Thomas, John G., Moffett, Kathryn, Palmer, H. Carlton, and Dedhia, Harakh V.

Abstract

Objective. To study the impact of our multimodal antibiotic stewardship program on Pseudomonas aeruginosa susceptibility and antibiotic use in the intensive care unit (ICU) setting. Methods. Our stewardship program employed the key tenants of published antimicrobial stewardship guidelines. These included prospective audits with intervention and feedback, formulary restriction with preauthorization, educational conferences, guidelines for use, antimicrobial cycling, and de-escalation of therapy. ICU antibiotic use was measured and expressed as defined daily doses (DDD) per 1,000 patient-days. Results. Certain temporal relationships between antibiotic use and ICU resistance patterns appeared to be affected by our antibiotic stewardship program. In particular, the ICU use of intravenous ciprofloxacin and ceftazidime declined from 148 and 62.5 DDD/1,000 patient-days to 40.0 and 24.5, respectively, during 2004 to 2007. An increase in the use of these agents and resistance to these agents was witnessed during 2008-2010. Despite variability in antibiotic usage from the stewardship efforts, we were overall unable to show statistical relationships with P. aeruginosa resistance rate. Conclusion. Antibiotic resistance in the ICU setting is complex. Multimodal stewardship efforts attempt to prevent resistance, but such programs clearly have their limits. [ABSTRACT FROM AUTHOR]

Published
2011
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45. A COMPARISON OF METHODS TO DETERMINE BODY FAT IN INDIVIDUALS WITH CYSTIC FIBROSIS: A PILOT STUDY.

Author

Swisher, Anne K., Yeater, Rachel, Moffett, Kathryn, Baer, Linda, and Stanton, Bonita

Subjects
MALNUTRITION, STARVATION, NUTRITION disorders, CYSTIC fibrosis, LUNG diseases, NUTRITION, SKINFOLD thickness
Abstract

Malnutrition is known to contribute to poor clinical outcome in persons with Cystic Fibrosis (CF). There is a need for accurate, reliable and clinically applicable methods to assess nutritional status. This study compared BOD POD air plethysmography, near-infrared interactance (NIR) and skinfold equations for determining body fat in persons with CF and lean controls. Ten CF subjects (5 males, 5 females) and 10 age- and sex-matched controls had body fat determined by each of the methods in a random order during a single session. Percent fat by BOD POD was 19.4±4.7 in CF females, 9.7±6.1 in CF males, 14.2±3.3 in control females and 15.5±3.7 in control males. Percent fat by NIR was 24.6±4.4 for CF females, 15.5±5.5 for CF males, 23.3±3.9 for control females, and 23.3±3.9 for control males. Percent fat by skinfolds ranged from 15-21% for CF females, 6-8% for CF males, 19-20% for control females, and 14-16% for control males, depending on the number of sites used. Analysis of variance and Pearson product moment correlations were determined for both sexes in CF and control groups. Body fat by NIR was significantly higher than BOD POD and skinfold equations in both sexes in each group. Skinfold equations using 7-sites, 4- sites and 3-sites significantly correlated to BOD POD in CF males (r=0.95-0.96). No skinfold equation was found to correlate significantly with BOD POD in CF females. NIR cannot be recommended, due to its consistent overestimation of body fat levels in lean subjects. The use of skinfold equations to determine body composition in CF can be supported for males only. [ABSTRACT FROM AUTHOR]

Published
2003

47. Quadriplegia Complicating Escherichia coli Meningitis in a Newborn Infant: Case Report and Review of 22 Cases of Spinal Cord Dysfunction in Patients with Acute Bacterial Meningitis.

Author

Moffett, Kathryn S. and Berkowitz, Frank E.

Abstract

We report a case of Escherichia coli meningitis complicated by spinal cord dysfunction in a neonate. This very rare complication of bacterial meningitis was probably caused by ischemia of the cord resulting from vasculitis. We review the 22 other reports of patients with this complication and discuss its pathogenesis. [ABSTRACT FROM PUBLISHER]

Published
1997
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48. Long-term safety and efficacy of tezacaftor–ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR(EXTEND): an open-label extension study

Author

Flume, Patrick A, Biner, Reta Fischer, Downey, Damian G, Brown, Cynthia, Jain, Manu, Fischer, Rainald, De Boeck, Kris, Sawicki, Gregory S, Chang, Philip, Paz-Diaz, Hildegarde, Rubin, Jaime L, Yang, Yoojung, Hu, Xingdi, Pasta, David J, Millar, Stefanie J, Campbell, Daniel, Wang, Xin, Ahluwalia, Neil, Owen, Caroline A, Wainwright, Claire E, Gibson, Ronald L., Rowe, Steven M., Lechtzin, Noah, Ahrens, Richard C., McCoy, Karen S., Aitken, Moira, Donaldson, Scott H., McBennett, Kimberly Ann, Pilewski, Joseph M., Billings, Joanne, Milla, Carlos, Rubenstein, Ronald, Rosenbluth, Daniel Brian, Linnemann, Rachel, Powers, Michael R., Fortner, Christopher, Frederick, Carla Anne, Liou, Theodore G., Black, Philip, Wang, Janice, Colombo, John L., Berdella, Maria, Indihar, Maria Veronica, Brown, Cynthia D., Anstead, Michael, Bilodeau, Lara, Sicilian, Leonard, Jain, Manu, Tolle, James Jerome, Moffett, Kathryn, Nasr, Samya, Taylor-Cousar, Jennifer, Barto, Tara Lynn, Antos, Nicholas, Rogers, John S., Quick, Bryon, Thompson, Henry R., Sawicki, Gregory, Barnett, Bruce, Zanni, Robert L., Smith, Thomas C., Schultz, Karen D., Keating, Claire, Flume, Patrick, Omlor, Gregory J., Ashare, Alix, Voter, Karen, Mehdi, Nighat, Ortiz, Maria Gabriela Tupayachi, Gardner, Tonia E., Boas, Steven R., Messore, Barbara, Zemanick, Edith, Jain, Raksha, McCarthy, Michael, Kissner, Dana G., Patel, Kapilkumar, McNamara, John, Philley, Julie, Berlinski, Ariel, Calimano, Francisco J., Chin, Terry, Conrad, Douglas, Daines, Cori, Raissy, Hengameh H., Keens, Thomas G., Lascano, Jorge E., McWilliams, Bennie, Morrissey, Brian, Reyes, Santiago, Chittivelu, Subramanyam, Hussain, Sabiha, Stone, Arvey, Wallace, James, Klingsberg, Ross, Biller, Julie A., Bui, Stephanie, Sommerburg, Olaf, Bignamini, Elisabetta, Collura, Mirella, Biner, Reta Fischer, Moller, Alexander, Salvatore, Donatello, Belleguic, Chantal, Bentur, Lea, Efrati, Ori, Kerem, Eitan, Prais, Dario, Gallego, Esther Quintana, Barry, Peter, Livnat-Levanon, Galit, Asensi, Jose Ramon Villa, Armstrong, David Stuart, de la Cruz, Oscar Asensio, Gilchrist, Francis, Tullis, Diana Elizabeth, Quon, Bradley, Lands, Larry C., Morrison, Nancy, Lavoie, Annick, Linnane, Barry, Elidemir, Okan, Ringshausen, Felix, Kappler, Matthias, Hebestreit, Helge, Mainz, Jochen, Kiefer, Alexander, Koerner-Rettberg, Cordula, Staab, Doris, Gleiber, Wolfgang, Pressler, Tacjana, Stehling, Florian, Hector, Andreas, Sutharsan, Sivagurunathan, Naehrlich, Lutz, Fischer, Rainald, Downey, Damian, Davies, Jane Carolyn, Ketchell, Robert Ian, Carroll, Mary Patricia, Doe, Simon, MacGregor, Gordon, Nash, Edward Fairbairn, Withers, Nicholas, Peckham, Daniel Gavin, Ledson, Martin James, Kansra, Sonal, Lee, Timothy William Rayner, Delaisi, Bertrand, Rault, Gilles, Le Bihan, Jean, Hubert, Dominique, Fajac, Isabelle, Sermet-Gaudelus, Isabelle, Bakker, Marleen, Arets, Bert, De Boeck, Christiane, Chiron, Raphael, Reix, Philippe, Mainguy, Catherine, van Braeckel, Eva, Malfroot, Anne, Durieu, Isabelle, Dufeu, Nadine Desmazes, Prevotat, Anne, van der Meer, Renske, Merkus, Petrus, Weersink, E.J.M., Gomez-Aguero, Isabel Barrio, Gartner, Silvia, Jover, Amparo Sole, Fernandez, Antonio Alvarez, Cox, Desmond William, McKone, Edward F., Plant, Barry James, Selvadurai, Hiranjan, Bowler, Simon David, Wainwright, Claire Elizabeth, Smith, Daniel, Middleton, Peter Gordon, Wilson, John William, Volpi, Sonia, Colombo, Carla, Fabrizzi, Benedetta, Lucidi, Vincenzina, Cresta, Federico, Cucchiara, Salvatore, Eber, Ernst, Ellemunter, Helmut, Huttegger, Isidor, Hjelte, Lena, Krantz, Christina, and Gilljam, Marita

Abstract

Tezacaftor–ivacaftor is an approved cystic fibrosis transmembrane conductance regulator (CFTR) modulator shown to be efficacious and generally safe and well tolerated over 8–24 weeks in phase 3 clinical studies in participants aged 12 years or older with cystic fibrosis homozygous for the Phe508del CFTRmutation (F/F; study 661-106 [EVOLVE]) or heterozygous for the Phe508del CFTRmutation and a residual function mutation (F/RF; study 661-108 [EXPAND]). Longer-term (>24 weeks) safety and efficacy of tezacaftor–ivacaftor has not been assessed in clinical studies. Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability, and efficacy of tezacaftor–ivacaftor in participants aged 12 years or older with cystic fibrosis who were homozygous or heterozygous for the Phe508del CFTRmutation.

Published
2021
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50. Distinguishing Clubbing From Normal Digital Conformation.

Author

Moffett, Kathryn S.

Subjects
FINGER abnormalities, DIAGNOSIS, PHALANGES, NAILS (Anatomy), ETIOLOGY of diseases
Abstract

The article focuses on the identification of clubbing from normal digital conformation. It states that clubbing is a bulb-like thickening of the soft tissue of the terminal phalanx of a digit with loss of the normal angle between the nail fold and the nail plate. A table of the systemic conditions associated with clubbing is provided. The article also discusses the diagnostic implications and clinical evaluation of clubbing.

Published
2009

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