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1. Patient Perceptions Of Physical Rehabilitation And Its Method Of Delivery For A Variety Of Adverse Physical Effects Following Breast Cancer Surgery

Author: Deirdre McGhee, Anne McMahon, and Julie Steele
Subjects: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Published: 2023
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2. ESMO / ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2016

Author: Enriqueta Felip, Josep Tabernero, Maria De Santis, Emile Voest, Mark Robson, Fatima Cardoso, Elisabeth G E de Vries, Fedro Alessandro Peccatori, Svetlana Jezdic, Giannis Mountzios, Smita Bhatia, Alexandru Eniu, Luzia Travado, Ulrich Keilholz, Jonas Bergh, Jan Buckner, Friedrich Stiefel, Ahmad Awada, Cristiana Sessa, Olivier Michielin, Marc Ernstoff, Ben Markman, Lisa Licitra, Rossana Berardi, Jill Gilbert, Lidia Schapira, Eva Schernhammer, Jeffrey S Weber, Heinz-Josef Lenz, Piotr Rutkowski, Jennifer Duff, Axel Grothey, Yuichiro Ohe, Saskia Litiere, Hans Wildiers, Christian Dittrich, Michael Kosty, Doug Pyle, Nagi El-Saghir, Jean-Pierre Lotz, Pia Österlund, Nicholas Pavlidis, Gunta Purkalne, Susana Banerjee, Jan Bogaerts, Paolo Casali, Edward Chu, Julia Lee Close, Bertrand Coiffier, Roisin Connolly, Sarah Coupland, Luigi De Petris, Don S Dizon, Linda R Duska, Martin F Fey, Nicolas Girard, Andor W J M Glaudemans, Priya K Gopalan, Stephen M Hahn, Diana Hanna, Christian Herold, Jørn Herrstedt, Krisztian Homicsko, Dennie V Jones, Lorenz Jost, Saad Khan, Alexander Kiss, Claus-Henning Köhne, Rainer Kunstfeld, Stuart Lichtman, Thomas Lion, Lifang Liu, Patrick J Loehrer, Merry Jennifer Markham, Marius Mayerhoefer, Johannes G Meran, Elizabeth Charlotte Moser, Timothy Moynihan, Torsten Nielsen, Kjell Öberg, Antonio Palumbo, Michael Pfeilstöcker, Chandrajit Raut, Scot C Remick, Roberto Salgado, Martin Schlumberger, Hans-Joachim Schmoll, Lowell Schnipper, Charles L Shapiro, Julie Steele, Cora N Sternberg, Florian Strasser, Roger Stupp, Richard Sullivan, Marcel Verheij, Everett Vokes, Jamie Von Roenn, and Yosef Yarden
Subjects: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract: The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) are publishing a new edition of the ESMO/ASCO Global Curriculum (GC) thanks to contribution of 64 ESMO-appointed and 32 ASCO-appointed authors. First published in 2004 and updated in 2010, the GC edition 2016 answers to the need for updated recommendations for the training of physicians in medical oncology by defining the standard to be fulfilled to qualify as medical oncologists. At times of internationalisation of healthcare and increased mobility of patients and physicians, the GC aims to provide state-of-the-art cancer care to all patients wherever they live. Recent progress in the field of cancer research has indeed resulted in diagnostic and therapeutic innovations such as targeted therapies as a standard therapeutic approach or personalised cancer medicine apart from the revival of immunotherapy, requiring specialised training for medical oncology trainees. Thus, several new chapters on technical contents such as molecular pathology, translational research or molecular imaging and on conceptual attitudes towards human principles like genetic counselling or survivorship have been integrated in the GC. The GC edition 2016 consists of 12 sections with 17 subsections, 44 chapters and 35 subchapters, respectively. Besides renewal in its contents, the GC underwent a principal formal change taking into consideration modern didactic principles. It is presented in a template-based format that subcategorises the detailed outcome requirements into learning objectives, awareness, knowledge and skills. Consecutive steps will be those of harmonising and implementing teaching and assessment strategies.
Published: 2016
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3. How much error is associated with calculating breast volume from three-dimensional breast scans obtained when women are standing? Implications for bra design and bra fit

Author: Celeste Coltman, Julie Steele, and Deirdre McGhee
Subjects: Physical Therapy, Sports Therapy and Rehabilitation, Human Factors and Ergonomics
Abstract: A lying prone position is recommended when scanning women's breasts to ensure the entire breast can be visualised. However, several large databases contain three-dimensional scans of women's breasts and torsos that were obtained while the women were standing. This study aimed to establish the error associated with calculating breast volume from three-dimensional breast scans taken when women were standing relative to lying prone.Breast volume was derived for 378 women with Small, Medium, Large and Hypertrophic breast sizes from scans taken while the women were standing and then lying prone.The magnitude of error associated with breast volume derived from scans obtained while women stood compared to lying prone, ranged from ∼8-22% and increased with increasing breast size.Errors associated with breast volume data derived from breast scans collected while women stand must be accounted for, particularly for women with Medium, Large and Hypertrophic breast sizes.
Published: 2022

4. Long-term lessons learned in biomechanics: 2021 Geoffrey Dyson Lecture

Author: Julie Steele
Subjects: Physical Therapy, Sports Therapy and Rehabilitation, Orthopedics and Sports Medicine
Abstract: After recently accepting an offer to retire, I have taken the opportunity to reflect on long-term lessons learned throughout my 40-year career as a biomechanist in academia. These lessons formed the basis of my 2021 Geoffrey Dyson Lecture and are summarised within this article. Most of these lessons are targeted at early career researchers, although my recent transition into retirement revealed some unexpected lessons that apply to senior academics. The lessons presented relate to the need to be passionate and persistent about your research, the importance of being unique and embracing failure as a mentor, as well as running with opportunities that arise. Appreciating that a career takes time to evolve, strategies to nurture a committed and supportive research team, the importance of committing to a professional society, and the need to be kind to yourself are also discussed. Why so few women receive career awards in biomechanics and when should academics retire are also addressed. I hope that highlighting lessons learned over an academic career as a biomechanist, combined with suggested practical strategies to thrive in academia, ensure academics can savour a fulfiling career in biomechanics while producing high-quality research into the future.
Published: 2022

5. Short bowel syndrome in infancy: recent advances and practical management

Author: Natalia Iglesias, Nkem Onyeador, Elena Cernat, Akshay Batra, Chloe Corlett, and Julie Steele
Subjects: 0301 basic medicine, medicine.medical_specialty, 030109 nutrition & dietetics, Hepatology, business.industry, Gastroenterology, Disease, medicine.disease, Short bowel syndrome, Enteral administration, Teduglutide, 03 medical and health sciences, Liver disease, chemistry.chemical_compound, 0302 clinical medicine, Parenteral nutrition, chemistry, 030225 pediatrics, Medicine, Lipid emulsion, In patient, business, Intensive care medicine, Small Bowel and Nutrition
Abstract: Short bowel syndrome (SBS) is a rare condition characterised by extensive loss of intestinal mass secondary to congenital or acquired disease. The outcomes are determined by dependency on parenteral nutrition (PN), its possible complications and factors that influence intestinal adaptation. In order to achieve the best results, patients should be managed by a specialised multidisciplinary team with the aims of promoting growth and development, stimulating intestinal adaptation and preventing possible complications. This involves timely surgical management aimed at rescuing maximum bowel length and eventually re-establishing intestinal continuity where appropriate. A combination of enteral and parenteral nutrition needs to be targeted towards maintaining a balance between fulfilling the nutritional and metabolic needs of the child while preventing or at least minimising potential complications. Enteral nutrition and establishment of oral feeding play a fundamental role in stimulating bowel adaptation and promoting enteral autonomy. Other measures to promote enteral autonomy include the chyme recycling in patients where bowel is not in continuity, autologous gastrointestinal reconstruction and pharmacological treatments, including promising new therapies like teduglutide. Strategies such as lipid reduction, changing the type of lipid emulsion and cycling PN are associated with a reduction in the rates of intestinal failure–associated liver disease. Even though vast improvements have been made in the surgical and medical management of SBS, there is still lack of consensus in many aspects and collaboration is essential.
Published: 2020

6. Evaluation of an Opioid-Free Anesthesia Protocol for Elective Abdominal Surgery in a Community Hospital

Author: Julie, Steele, Rebecca, Spencer, Susan, Emery, and Katherine, Pereira
Subjects: Adult, Analgesics, Opioid, Pain, Postoperative, Humans, Anesthesia, Hospitals, Community, Abdominal Muscles
Abstract: Utilization of opioids for acute pain control during surgical procedures is commonplace for anesthesia providers. Opioid use is associated with many undesirable side effects, including opioid use disorder. Opioid-free anesthesia for surgical procedures using a multimodal approach can reduce these side effects. This quality improvement project evaluated the implementation of an opioid-free anesthesia protocol for elective abdominal surgical procedures in a community hospital. The project had specific aims of detecting a reduction in opioid consumption in the operating room and the first 30 minutes in the post anesthesia recovery unit (PACU) while confirming pain relief comparable to that seen with opioid analgesia. Implementation of the quality improvement protocol resulted in a 79% reduction in the number of patients who received opioids during surgery and provided pain relief through the first 30 minutes in PACU comparable to anesthesia that included opioids. This project confirmed that an opioid-free anesthesia protocol could be successfully implemented within a community hospital for healthy adults undergoing elective abdominal surgery.
Published: 2022

7. Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

Author: Mantegazza, R., Wolfe, G. I., Muppidi, S., Wiendl, H., Fujita, K. P., O'Brien, F. L., Booth, H. D. E., Howard, J. F., Claudio Gabriel Mazia, Miguel, Wilken, Fabio, Barroso, Juliet, Saba, Marcelo, Rugiero, Mariela, Bettini, Marcelo, Chaves, Gonzalo, Vidal, Alejandra Dalila Garcia, Jan De Bleecker, Guy Van den Abeele, Kathy de Koning, Katrien De Mey, Rudy, Mercelis, Délphine, Mahieu, Linda, Wagemaekers, Philip Van Damme, Annelies, Depreitere, Caroline, Schotte, Charlotte, Smetcoren, Olivier, Stevens, Sien Van Daele, Nicolas, Vandenbussche, Annelies, Vanhee, Sarah, Verjans, Jan, Vynckier, Ann, D'Hont, Petra, Tilkin, Alzira Alves de Siqueira Carvalho, Igor Dias Brockhausen, David, Feder, Daniel, Ambrosio, Gabor Lovasamela César, Ana Paula Melo, Renata Martins Ribeiro, Rosana, Rocha, Bruno Bezerra Rosa, Thabata, Veiga, Luiz Augusto da Silva, Murilo Santos Engel, Jordana Gonçalves Geraldo, Maria da Penha Ananias Morita, Erica Nogueira Coelho, Gabriel, Paiva, Marina, Pozo, Natalia, Prando, Debora Dada Martineli Torres, Cristiani Fernanda Butinhao, Gustavo, Duran, Tomás Augusto Suriane Fialho, Tamires Cristina Gomes da Silva, Luiz Otavio Maia Gonçalves, Lucas Eduardo Pazetto, Luciana Renata Cubas Volpe, Luciana Souza Duca, Maurício AndréGheller Friedrich, Alexandre, Guerreiro, Henrique, Mohr, Maurer Pereira Martins, Daiane da Cruz Pacheco, Luciana, Ferreira, Ana Paula Macagnan, Graziela, Pinto, Aline de Cassia Santos, Acary Souza Bulle Oliveira, Ana Carolina Amaral de Andrade, Marcelo, Annes, Liene Duarte Silva, Valeria Cavalcante Lino, Wladimir, Pinto, Natália, Assis, Fernanda, Carrara, Carolina, Miranda, Iandra, Souza, Patrícia, Fernandes, Zaeem, Siddiqi, Cecile, Phan, Jeffrey, Narayan, Derrick, Blackmore, Ashley, Mallon, Rikki, Roderus, Elizabeth, Watt, Stanislav, Vohanka, Josef, Bednarik, Magda, Chmelikova, Marek, Cierny, Stanislava, Toncrova, Jana, Junkerova, Barbora, Kurkova, Katarina, Reguliova, Olga, Zapletalova, Jiri, Pitha, Iveta, Novakova, Michaela, Tyblova, Ivana, Jurajdova, Marcela, Wolfova, Henning, Andersen, Thomas, Harbo, Lotte, Vinge, Susanne, Krogh, Anita, Mogensen, John, Vissing, Joan, Højgaard, Nanna, Witting, Anne Mette Ostergaard Autzen, Jane, Pedersen, Juha-Pekka, Erälinna, Mikko, Laaksonen, Olli, Oksaranta, Tuula, Harrison, Jaana, Eriksson, Csilla, Rozsa, Melinda, Horvath, Gabor, Lovas, Judit, Matolcsi, Gedeonne, Jakab, Gyorgyi, Szabo, Brigitta, Szabadosne, Laszlo, Vecsei, Livia, Dezsi, Edina, Varga, Monika, Konyane, Antonini, Giovanni, Antonella Di Pasquale, Garibaldi, Matteo, Morino, Stefania, Troili, Fernanda, Fionda, Laura, Amelia, Evoli, Paolo Emilio Alboini, Valentina, D'Amato, Raffaele, Iorio, Inghilleri, Maurizio, Frasca, Vittorio, Elena, Giacomelli, Gori, MARIA CRISTINA, Diego, Lopergolo, Onesti, Emanuela, Maria, Gabriele, Francesco, Saccà, Alessandro, Filla, Teresa, Costabile, Enrico, Marano, Angiola, Fasanaro, Angela, Marsili, Giorgia, Puorro, Carlo, Antozzi, Silvia, Bonanno, Giorgia, Camera, Alberta, Locatelli, Lorenzo, Maggi, Maria, Pasanisi, Angela, Campanella, Akiyuki, Uzawa, Tetsuya, Kanai, Naoki, Kawaguchi, Masahiro, Mori, Yoko, Kaneko, Akiko, Kanzaki, Eri, Kobayashi, Hiroyuki, Murai, Katsuhisa, Masaki, Dai, Matsuse, Takuya, Matsushita, Taira, Uehara, Misa, Shimpo, Maki, Jingu, Keiko, Kikutake, Yumiko, Nakamura, Yoshiko, Sano, Kimiaki, Utsugisawa, Yuriko, Nagane, Ikuko, Kamegamori, Tomoko, Tsuda, Yuko, Fujii, Kazumi, Futono, Yukiko, Ozawa, Aya, Mizugami, Yuka, Saito, Makoto, Samukawa, Hidekazu, Suzuki, Miyuki, Morikawa, Sachiko, Kamakura, Eriko, Miyawaki, Meinoshin, Okumura, Soichiro, Funaka, Tomohiro, Kawamura, Masayuki, Nakamori, Masanori, Takahashi, Namie, Taichi, Tomoya, Hasuike, Eriko, Higuchi, Hisako, Kobayashi, Kaori, Osakada, Hirokazu, Shiraishi, Teiichiro, Miyazaki, Masakatsu, Motomura, Akihiro, Mukaino, Shunsuke, Yoshimura, Shizuka, Asada, Seiko, Yoshida, Shoko, Amamoto, Tomomi, Kobashikawa, Megumi, Koga, Maeda, Yasuko, Kazumi, Takada, Mihoko, Takada, Masako, Tsurumaru, Yumi, Yamashita, Yasushi, Suzuki, Tetsuya, Akiyama, Koichi, Narikawa, Ohito, Tano, Kenichi, Tsukita, Rikako, Kurihara, Fumie, Meguro, Yusuke, Fukuda, Miwako, Sato, Tomihiro, Imai, Emiko, Tsuda, Shun, Shimohama, Takashi, Hayashi, Shin, Hisahara, Jun, Kawamata, Takashi, Murahara, Masaki, Saitoh, Shuichiro, Suzuki, Daisuke, Yamamoto, Yoko, Ishiyama, Naoko, Ishiyama, Mayuko, Noshiro, Rumi, Takeyama, Kaori, Uwasa, Ikuko, Yasuda, Anneke van der Kooi, Marianne de Visser, Tamar, Gibson, Byung-Jo, Kim, Chang Nyoung Lee, Yong Seo Koo, Hung Youl Seok, Hoo Nam Kang, Hyejin, Ra, Byoung Joon Kim, Eun Bin Cho, Misong, Choi, Hyelim, Lee, Ju-Hong, Min, Jinmyoung, Seok, Jieun, Lee, Da Yoon Koh, Juyoung, Kwon, Sangae, Park, Eun Haw Choi, Yoon-Ho, Hong, So-Hyun, Ahn, Dae Lim Koo, Jae-Sung, Lim, Chae Won Shin, Ji Ye Hwang, Miri, Kim, Seung Min Kim, Ha-Neul, Jeong, Jinwoo, Jung, Yool-Hee, Kim, Hyung Seok Lee, Ha Young Shin, Eun Bi Hwang, Miju, Shin, Carlos, Casasnovas, Maria Antonia Alberti Aguilo, Christian, Homedes-Pedret, Natalia Julia Palacios, Laura Diez Porras, Valentina Velez Santamaria, Ana, Lazaro, Josep Gamez Carbonell, Pilar, Sune, Maria Salvado Figueras, Gisela, Gili, Gonzalo, Mazuela, Isabel, Illa, Elena Cortes Vicente, Jordi, Diaz-Manera, Luis Antonio Querol Gutiérrez, Ricardo Rojas Garcia, Nuria, Vidal, Elisabet, Arribas-Ibar, Exuperio Diez Tejedor, Pilar Gomez Salcedo, Mireya, Fernandez-Fournier, Pedro Lopez Ruiz, Francisco Javier Rodriguez de Rivera, Maria, Sastre, Fredrik, Piehl, Albert, Hietala, Lena, Bjarbo, Ihsan, Sengun, Arzu, Meherremova, Pinar, Ozcelik, Bengu, Balkan, Celal, Tuga, Muzeyyen, Ugur, Sevim, Erdem-Ozdamar, Can Ebru Bekircan-Kurt, Nazire Pinar Acar, Ezgi, Yilmaz, Yagmur, Caliskan, Gulsah, Orsel, Husnu, Efendi, Seda, Aydinlik, Hakan, Cavus, Ayse, Kutlu, Gulsah, Becerikli, Cansu, Semiz, Ozlem, Tun, Murat, Terzi, Baki, Dogan, Musa Kazim Onar, Sedat, Sen, Tugce Kirbas Cavdar, Adife, Veske, Fiona, Norwood, Aikaterini, Dimitriou, Jakit, Gollogly, Mohamed, Mahdi-Rogers, Arshira, Seddigh, Giannis, Sokratous, Gal, Maier, Faisal, Sohail, Saiju, Jacob, Girija, Sadalage, Pravin, Torane, Claire, Brown, Amna, Shah, Sivakumar, Sathasivam, Heike, Arndt, Debbie, Davies, Dave, Watling, Anthony, Amato, Thomas, Cochrane, Mohammed, Salajegheh, Kristen, Roe, Katherine, Amato, Shirli, Toska, Nicholas, Silvestri, Kara, Patrick, Karen, Zakalik, Jonathan, Katz, Robert, Miller, Marguerite, Engel, Dallas, Forshew, Elena, Bravver, Benjamin, Brooks, Mohammed, Sanjak, Sarah, Plevka, Maryanne, Burdette, Scott, Cunningham, Megan, Kramer, Joanne, Nemeth, Clara, Schommer, Tierney, Scott, Vern, Juel, Jeffrey, Guptill, Lisa, Hobson-Webb, Janice, Massey, Kate, Beck, Donna, Carnes, John, Loor, Amanda, Anderson, Robert, Pascuzzi, Cynthia, Bodkin, John, Kincaid, Riley, Snook, Sandra, Guingrich, Angela, Micheels, Vinay, Chaudhry, Andrea, Corse, Betsy, Mosmiller, Andrea, Kelley, Doreen, Ho, Jayashri, Srinivasan, Michal, Vytopil, Jordan, Jara, Nicholas, Ventura, Cynthia, Carter, Craig, Donahue, Carol, Herbert, Stephanie, Scala, Elaine, Weiner, Sharmeen, Alam, Jonathan, Mckinnon, Laura, Haar, Naya, Mckinnon, Karan, Alcon, Kaitlyn, Mckenna, Nadia, Sattar, Kevin, Daniels, Dennis, Jeffery, Miriam, Freimer, Joseph Chad Hoyle, John, Kissel, Julie, Agriesti, Sharon, Chelnick, Louisa, Mezache, Colleen, Pineda, Filiz, Muharrem, Chafic, Karam, Julie, Khoury, Tessa, Marburger, Harpreet, Kaur, Diana, Dimitrova, James, Gilchrist, Brajesh, Agrawal, Mona, Elsayed, Stephanie, Kohlrus, Angela, Ardoin, Taylor, Darnell, Laura, Golden, Barbara, Lokaitis, Jenna, Seelbach, Neelam, Goyal, Sarada, Sakamuri, Yuen, T So, Shirley, Paulose, Sabrina, Pol, Lesly, Welsh, Ratna, Bhavaraju-Sanka, Alejandro Tobon Gonzalez, Lorraine, Dishman, Floyd, Jones, Anna, Gonzalez, Patricia, Padilla, Amy, Saklad, Marcela, Silva, Sharon, Nations, Jaya, Trivedi, Steve, Hopkins, Mohamed, Kazamel, Mohammad, Alsharabati, Liang, Lu, Kenkichi, Nozaki, Sandi, Mumfrey-Thomas, Amy, Woodall, Tahseen, Mozaffar, Tiyonnoh, Cash, Namita, Goyal, Gulmohor, Roy, Veena, Mathew, Fatima, Maqsood, Brian, Minton, H James Jones, Jeffrey, Rosenfeld, Rebekah, Garcia, Laura, Echevarria, Sonia, Garcia, Michael, Pulley, Shachie, Aranke, Alan Ross Berger, Jaimin, Shah, Yasmeen, Shabbir, Lisa, Smith, Mary, Varghese, Laurie, Gutmann, Ludwig, Gutmann, Nivedita, Jerath, Christopher, Nance, Andrea, Swenson, Heena, Olalde, Nicole, Kressin, Jeri, Sieren, Richard, Barohn, Mazen, Dimachkie, Melanie, Glenn, April, Mcvey, Mamatha, Pasnoor, Jeffery, Statland, Yunxia, Wang, Tina, Liu, Kelley, Emmons, Nicole, Jenci, Jerry, Locheke, Alex, Fondaw, Kathryn, Johns, Gabrielle, Rico, Maureen, Walsh, Laura, Herbelin, Charlene, Hafer-Macko, Justin, Kwan, Lindsay, Zilliox, Karen, Callison, Valerie, Young, Beth, Disanzo, Kerry, Naunton, Michael, Benatar, Martin, Bilsker, Khema, Sharma, Anne, Cooley, Eliana, Reyes, Sara-Claude, Michon, Danielle, Sheldon, Julie, Steele, Rebecca, Traub, Manisha, Chopra, Tuan, Vu, Lara, Katzin, Terry, Mcclain, Brittany, Harvey, Adam, Hart, Kristin, Huynh, Said, Beydoun, Amaiak, Chilingaryan, Victor, Doan, Brian, Droker, Hui, Gong, Sanaz, Karimi, Frank, Lin, Krishna, Polaka, Akshay, Shah, Anh, Tran, Salma, Akhter, Ali, Malekniazi, Rup, Tandan, Michael, Hehir, Waqar, Waheed, Shannon, Lucy, Michael, Weiss, Jane, Distad, Susan, Strom, Sharon, Downing, Bryan, Kim, Tulio, Bertorini, Thomas, Arnold, Kendrick, Henderson, Rekha, Pillai, Liu, Ye, Lauren, Wheeler, Jasmine, Hewlett, Mollie, Vanderhook, Richard, Nowak, Daniel, Dicapua, Benison, Keung, Aditya, Kumar, Huned, Patwa, Kimberly, Robeson, Irene, Yang, Joan, Nye, and Hong, Vu
Subjects: Adult, Male, 0301 basic medicine, medicine.medical_specialty, Clinical Neurology, Antibodies, Monoclonal, Humanized, Placebo, Article, Antibodies, Post-intervention, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Refractory, law, Internal medicine, Monoclonal, Myasthenia Gravis, Medicine and Health Sciences, Humans, Medicine, Humanized, Science & Technology, business.industry, Middle Aged, Eculizumab, Complement Inactivating Agents, Female, Treatment Outcome, EFFICACY, medicine.disease, Myasthenia gravis, Clinical trial, 030104 developmental biology, SAFETY, Neurosciences & Neurology, Neurology (clinical), business, Life Sciences & Biomedicine, COMPLEMENT INHIBITOR ECULIZUMAB, 030217 neurology & neurosurgery, medicine.drug
Abstract: ObjectiveTo evaluate whether eculizumab helps patients with anti–acetylcholine receptor–positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension.MethodsPatients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study.ResultsA total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1–4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected.ConclusionEculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population.ClinicalTrials.gov IdentifierREGAIN, NCT01997229; REGAIN open-label extension, NCT02301624.Classification of EvidenceThis study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo.
Published: 2020

8. Moves for Launching a New Year of Student-Centered Coaching

Author: Diane Sweeney, Leanna S. Harris, Julie Steele, Diane Sweeney, Leanna S. Harris, and Julie Steele
Subjects: Student-centered learning, Effective teaching, Mentoring in education
Abstract: Engaging teachers in coaching is an ongoing process that requires planning and intentionality. Whether you are new to a school or have been there a while, the beginning of the year brings forth the opportunity to envision what your work will look like and how you will deepen the impact it makes on teacher and student learning. Start the Year Strong with Student-Centered Coaching Designed to ensure a successful start to the school year, this guidebook provides strategies for coaches, principals, and district leaders to successfully launch a new year of Student-Centered Coaching. Organized into fifteen moves, this resource provides: Concrete ideas for how coaches can connect with new and returning teachers Strategies for supporting teachers to increase student engagement and build classroom community Steps for building strong principal and coach partnerships that will last throughout the year Tools and artifacts that can be used to message and market coaching Ideas for scheduling coaching that is flexible and meets teachers'needs Videos and other resources that dig deeper into each of the fifteen coaching moves that are included By investing carefully in the first few weeks of school and crafting a clear plan with this guidebook, the foundation you build will support your work far beyond the start of the school year.
Published: 2023

9. Expanding the Design Space Explored by S3D

Author: Massachusetts Institute of Technology. Department of Mechanical Engineering, Chalfant, Julie Steele, Wang, Zhicheng, Triantafyllou, Michael S, Massachusetts Institute of Technology. Department of Mechanical Engineering, Chalfant, Julie Steele, Wang, Zhicheng, and Triantafyllou, Michael S
Abstract: Modern design processes such as set-based design and TIES (Technology Identification, Evaluation and Selection) depend on the ability to explore a large design space rather than attempting to optimize a single design. In this paper, we investigate methods for expanding the design space that can be explored using the S3D (Smart Ship System Design) software environment. We then detail the most recent advancements in the templating process, with the goal of automated system assembly and evaluation using pre-designed system segments called templates., United States. Office of Naval Research (Award N00014-16-1-2945), United States. Office of Naval Research (Award N00014-16-1-2956), United States. National Oceanic and Atmospheric Administration (Grant NA14OAR4170077)
Published: 2020

10. Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study

Author: Hiroyuki Murai, Akiyuki Uzawa, Yasushi Suzuki, Tomihiro Imai, Hirokazu Shiraishi, Hidekazu Suzuki, Meinoshin Okumura, Fanny O’Brien, Jing-Jing Wang, Kenji P. Fujita, Kimiaki Utsugisawa, Claudio Gabriel Mazia, Miguel Wilken, Fabio Barroso, Juliet Saba, Marcelo Rugiero, Mariela Bettini, Marcelo Chaves, Gonzalo Vidal, Alejandra Dalila Garcia, Jan De Bleecker, Guy Van den Abeele, Kathy de Koning, Katrien De Mey, Rudy Mercelis, Délphine Mahieu, Linda Wagemaekers, Philip Van Damme, Annelies Depreitere, Caroline Schotte, Charlotte Smetcoren, Olivier Stevens, Sien Van Daele, Nicolas Vandenbussche, Annelies Vanhee, Sarah Verjans, Jan Vynckier, Ann D'Hondt, Petra Tilkin, Alzira Alves de Siqueira Carvalho, Igor Dias Brockhausen, David Feder, Daniel Ambrosio, Pamela César, Ana Paula Melo, Renata Martins Ribeiro, Rosana Rocha, Bruno Bezerra Rosa, Thabata Veiga, Luiz Augusto da Silva, Murilo Santos Engel, Jordana Gonçalves Geraldo, Maria da Penha Ananias Morita, Erica Nogueira Coelho, Gabriel Paiva, Marina Pozo, Natalia Prando, Debora Dada Martineli Torres, Cristiani Fernanda Butinhao, Gustavo Duran, Tamires Cristina Gomes da Silva, Luiz Otavio Maia Gonçalves, Lucas Eduardo Pazetto, Tomás Augusto Suriane Fialho, Luciana Renata Cubas Volpe, Luciana Souza Duca, Acary Souza Bulle Oliveira, Ana Carolina Amaral Andrade, Marcelo Annes, Liene Duarte Silva, Valeria Cavalcante Lino, Wladimir Pinto, Natália Assis, Fernanda Carrara, Carolina Miranda, Iandra Souza, Patricia Fernandes, Zaeem Siddiqi, Cecile Phan, Jeffrey Narayan, Derrick Blackmore, Ashley Mallon, Rikki Roderus, Elizabeth Watt, Jana Junkerova, Barbora Kurkova, Katarina Reguliova, Olga Zapletalova, Jiri Pitha, Iveta Novakova, Michaela Tyblova, Ivana Jurajdova, Marcela Wolfova, Henning Andersen, Thomas Harbo, Lotte Vinge, Susanne Krogh, Anita Mogensen, John Vissing, Joan Højgaard, Nanna Witting, Anne Mette Ostergaard Autzen, Jane Pedersen, Juha-Pekka Eralinna, Mikko Laaksonen, Olli Oksaranta, Tuula Harrison, Jaana Eriksson, Csilla Rozsa, Melinda Horvath, Gabor Lovas, Judit Matolcsi, Gyorgyi Szabo, Gedeonne Jakab, Brigitta Szabadosne, Giovanni Antonini, Antonella Di Pasquale, Matteo Garibaldi, Stefania Morino, Fernanda Troili, Laura Fionda, Allessandro Filla, Teresa Costabile, Enrico Marano, Francesco Saccà, Angiola Fasanaro, Angela Marsili, Giorgia Puorro, Renato Mantegazza, Carlo Antozzi, Silvia Bonanno, Giorgia Camera, Alberta Locatelli, Lorenzo Maggi, Maria Pasanisi, Angela Campanella, Amelia Evoli, Paolo Emilio Alboini, Valentina D'Amato, Raffaele Iorio, Tetsuya Kanai, Naoki Kawaguchi, Masahiro Mori, Yoko Kaneko, Akiko Kanzaki, Eri Kobayashi, Katsuhisa Masaki, Dai Matsuse, Takuya Matsushita, Taira Uehara, Misa Shimpo, Maki Jingu, Keiko Kikutake, Yumiko Nakamura, Yoshiko Sano, Yuriko Nagane, Ikuko Kamegamori, Tomoko Tsuda, Yuko Fujii, Kazumi Futono, Yukiko Ozawa, Aya Mizugami, Yuka Saito, Miyuki Morikawa, Makoto Samukawa, Sachiko Kamakura, Eriko Miyawaki, Teiichiro Mitazaki, Masakatsu Motomura, Akihiro Mukaino, Shunsuke Yoshimura, Shizuka Asada, Seiko Yoshida, Shoko Amamoto, Tomomi Kobashikawa, Megumi Koga, Yasuko Maeda, Kazumi Takada, Mihoko Takada, Masako Tsurumaru, Yumi Yamashita, Tetsuya Akiyama, Koichi Narikawa, Ohito Tano, Kenichi Tsukita, Rikako Kurihara, Fumie Meguro, Yusuke Fukuda, Miwako Sato, Soichiro Funaka, Tomohiro Kawamura, Masayuki Makamori, Masanori Takahashi, Namie Taichi, Tomoya Hasuike, Eriko Higuchi, Hisako Kobayashi, Kaori Osakada, Emiko Tsuda, Shun Shimohama, Takashi Hayashi, Shin Hisahara, Jun Kawamata, Takashi Murahara, Masaki Saitoh, Shuichiro Suzuki, Daisuke Yamamoto, Yoko Ishiyama, Naoko Ishiyama, Mayuko Noshiro, Rumi Takeyama, Kaori Uwasa, Ikuko Yasuda, Anneke van der Kooi, Marianne de Visser, Tamar Gibson, Carlos Casasnovas, Maria Antonia Alberti Aguilo, Christian Homedes-Pedret, Natalia Julia Palacios, Laura Diez Porras, Valentina Velez Santamaria, Ana Lazaro, Exuperio Diez Tejedor, Pilar Gomez Salcedo, Mireya Fernandez-Fournier, Pedro Lopez Ruiz, Francisco Javier Rodriguez de Rivera, Maria Sastre, Josep Gamez, Pilar Sune, Maria Salvado, Gisela Gili, Gonzalo Mazuela, Isabel Illa, Elena Cortes Vicente, Jordi Diaz-Manera, Luis Antonio Querol Gutierrez, Ricardo Rojas Garcia, Nuria Vidal, Elisabet Arribas-Ibar, Fredrik Piehl, Albert Hietala, Lena Bjarbo, Ihsan Sengun, Arzu Meherremova, Pinar Ozcelik, Bengu Balkan, Celal Tuga, Muzeyyen Ugur, Sevim Erdem-Ozdamar, Can Ebru Bekircan-Kurt, Nazire Pinar Acar, Ezgi Yilmaz, Yagmur Caliskan, Gulsah Orsel, Husnu Efendi, Seda Aydinlik, Hakan Cavus, Ayse Kutlu, Gulsah Becerikli, Cansu Semiz, Ozlem Tun, Murat Terzi, Baki Dogan, Musa Kazim Onar, Sedat Sen, Tugce Kirbas Cavdar, Adife Veske, Fiona Norwood, Aikaterini Dimitriou, Jakit Gollogly, Mohamed Mahdi-Rogers, Arshira Seddigh, Giannis Sokratous, Gal Maier, Faisal Sohail, Saiju Jacob, Girija Sadalage, Pravin Torane, Claire Brown, Amna Shah, Sivakumar Sathasivam, Heike Arndt, Debbie Davies, Dave Watling, Anthony Amato, Thomas Cochrane, Mohammed Salajegheh, Kristen Roe, Katherine Amato, Shirli Toska, Gil Wolfe, Nicholas Silvestri, Kara Patrick, Karen Zakalik, Jonathan Katz, Robert Miller, Marguerite Engel, Dallas Forshew, Elena Bravver, Benjamin Brooks, Sarah Plevka, Maryanne Burdette, Scott Cunningham, Mohammad Sanjak, Megan Kramer, Joanne Nemeth, Clara Schommer, Scott Tierney, Vern Juel, Jeffrey Guptill, Lisa Hobson-Webb, Janice Massey, Kate Beck, Donna Carnes, John Loor, Amanda Anderson, Robert Pascuzzi, Cynthia Bodkin, John Kincaid, Riley Snook, Sandra Guingrich, Angela Micheels, Vinay Chaudhry, Andrea Corse, Betsy Mosmiller, Andrea Kelley, Doreen Ho, Jayashri Srinivasan, Michal Vytopil, Jordan Jara, Nicholas Ventura, Stephanie Scala, Cynthia Carter, Craig Donahue, Carol Herbert, Elaine Weiner, Sharmeen Alam, Jonathan McKinnon, Laura Haar, Naya McKinnon, Karan Alcon, Kaitlyn McKenna, Nadia Sattar, Kevin Daniels, Dennis Jeffery, Miriam Freimer, Joseph Chad Hoyle, John Kissel, Julie Agriesti, Sharon Chelnick, Louisa Mezache, Colleen Pineda, Filiz Muharrem, Chafic Karam, Julie Khoury, Tessa Marburger, Harpreet Kaur, Diana Dimitrova, James Gilchrist, Brajesh Agrawal, Mona Elsayed, Stephanie Kohlrus, Angela Andoin, Taylor Darnell, Laura Golden, Barbara Lokaitis, Jenna Seelback, Srikanth Muppidi, Neelam Goyal, Sarada Sakamuri, Yuen T. So, Shirley Paulose, Sabrina Pol, Lesly Welsh, Ratna Bhavaraju-Sanka, Alejandro Tobon Gonzales, Lorraine Dishman, Floyd Jones, Anna Gonzalez, Patricia Padilla, Amy Saklad, Marcela Silva, Mohamed Kazamel, Mohammad Alsharabati, Liang Lu, Kenkichi Nozaki, Sandi Mumfrey-Thomas, Amy Woodall, Tahseen Mozaffar, Tiyonnoh Cash, Namita Goyal, Gulmohor Roy, Veena Mathew, Fatima Maqsood, Brian Minton, H. James Jones, Jeffrey Rosenfeld, Rebekah Garcia, Laura Echevarria, Sonia Garcia, Michael Pulley, Shachie Aranke, Alan Ross Berger, Jaimin Shah, Yasmeen Shabbir, Lisa Smith, Mary Varghese, Laurie Gutmann, Ludwig Gutmann, Nivedita Jerath, Christopher Nance, Andrea Swenson, Heena Olalde, Nicole Kressin, Jeri Sieren, Richard Barohn, Mazen Dimachkie, Melanie Glenn, April McVey, Mamatha Pasnoor, Jeffery Statland, Yunxia Wang, Tina Liu, Kelley Emmons, Nicole Jenci, Jerry Locheke, Alex Fondaw, Kathryn Johns, Gabrielle Rico, Maureen Walsh, Laura Herbelin, Charlene Hafer-Macko, Justin Kwan, Lindsay Zilliox, Karen Callison, Valerie Young, Beth DiSanzo, Kerry Naunton, Michael Benatar, Martin Bilsker, Khema Sharma, Anne Cooley, Eliana Reyes, Sara-Claude Michon, Danielle Sheldon, Julie Steele, James Howard Jr, Manisha Chopra, Rebecca Traub, Tuan Vu, Lara Katzin, Terry McClain, Brittany Harvey, Adam Hart, Kristin Huynh, Said Beydoun, Amaiak Chilingaryan, Victor Doan, Brian Droker, Hui Gong, Sanaz Karimi, Frank Lin, Krishna Pokala, Akshay Shah, Anh Tran, Salma Akhter, Ali Malekniazi, Rup Tandan, Michael Hehir, Waqar Waheed, Shannon Lucy, Michael Weiss, Jane Distad, Susan Strom, Sharon Downing, Bryan Kim, Richard Nowak, Daniel Dicapua, Benison Keung, Aditya Kumar, Huned Patwa, Kimberly Robeson, Irene Yang, Joan Nye, Hong Vu, H., Murai, A., Uzawa, Y., Suzuki, T., Imai, H., Shiraishi, H., Suzuki, M., Okumura, F., O'Brien, J. -J., Wang, K. P., Fujita, K., Utsugisawa, Gabriel Mazia 11, Claudio, Wilken 11, Miguel, Barroso 11, Fabio, Saba 11, Juliet, Rugiero 12, Marcelo, Bettini 12, Mariela, Chaves 12, Marcelo, Vidal 12, Gonzalo, Dalila Garcia 12, Alejandra, De Bleecker 13, Jan, Van den Abeele 13, Guy, de Koning 13, Kathy, De Mey 13, Katrien, Mercelis 14, Rudy, Mahieu 14, Délphine, Wagemaekers 14, Linda, Van Damme 15, Philip, Depreitere 16, Annelie, Schotte 16, Caroline, Smetcoren 16, Charlotte, Stevens 16, Olivier, Van Daele 16, Sien, Vandenbussche 16, Nicola, Vanhee 16, Annelie, Verjans 16, Sarah, Vynckier 16, Jan, D'Hondt 16, Ann, Tilkin 16, Petra, Alves de Siqueira Carvalho 17, Alzira, Dias Brockhausen 17, Igor, Feder 17, David, Ambrosio 17, Daniel, César 17, Pamela, Paula Melo 17, Ana, Martins Ribeiro 17, Renata, Rocha 17, Rosana, Bezerra Rosa 17, Bruno, Veiga 17, Thabata, Augusto da Silva 17, Luiz, Santos Engel 17, Murilo, Gonçalves Geraldo 17, Jordana, da Penha Ananias Morita 18, Maria, Nogueira Coelho 18, Erica, Paiva 18, Gabriel, Pozo 18, Marina, Prando 18, Natalia, Dada Martineli Torres 18, Debora, Fernanda Butinhao 18, Cristiani, Duran 18, Gustavo, Cristina Gomes da Silva 18, Tamire, Otavio Maia Gonçalves 18, Luiz, Eduardo Pazetto 18, Luca, Augusto Suriane Fialho 18, Tomá, Renata Cubas Volpe 18, Luciana, Souza Duca 18, Luciana, Souza Bulle Oliveira 19, Acary, Carolina Amaral Andrade 19, Ana, Annes 19, Marcelo, Duarte Silva 19, Liene, Cavalcante Lino 19, Valeria, Pinto 19, Wladimir, Assis 19, Natália, Carrara 19, Fernanda, Miranda 19, Carolina, Souza 19, Iandra, Fernandes 19, Patricia, Siddiqi 20, Zaeem, Phan 20, Cecile, Narayan 20, Jeffrey, Blackmore 20, Derrick, Mallon 20, Ashley, Roderus 20, Rikki, Watt 20, Elizabeth, Junkerova 21, Jana, Kurkova 21, Barbora, Reguliova 21, Katarina, Zapletalova 21, Olga, Pitha 22, Jiri, Novakova 22, Iveta, Tyblova 22, Michaela, Jurajdova 22, Ivana, Wolfova 22, Marcela, Andersen 23, Henning, Harbo 23, Thoma, Vinge 23, Lotte, Krogh 23, Susanne, Mogensen 23, Anita, Vissing 24, John, Højgaard 24, Joan, Witting 24, Nanna, Mette Ostergaard Autzen 24, Anne, Pedersen 24, Jane, Eralinna 25, Juha-Pekka, Laaksonen 25, Mikko, Oksaranta 25, Olli, Harrison 25, Tuula, Eriksson 25, Jaana, Rozsa 26, Csilla, Horvath 26, Melinda, Lovas 26, Gabor, Matolcsi 26, Judit, Szabo 26, Gyorgyi, Jakab 26, Gedeonne, Szabadosne 26, Brigitta, Antonini 27, Giovanni, Di Pasquale 27, Antonella, Garibaldi 27, Matteo, Morino 27, Stefania, Troili 27, Fernanda, Fionda 27, Laura, Filla, Allessandro, Costabile, Teresa, Marano, Enrico, Sacca', Francesco, Fasanaro, Angiola, Marsili, Angela, Puorro, Giorgia, Mantegazza 29, Renato, Antozzi 29, Carlo, Bonanno 29, Silvia, Camera 29, Giorgia, Locatelli 29, Alberta, Maggi 29, Lorenzo, Pasanisi 29, Maria, Campanella 29, Angela, Evoli 30, Amelia, Emilio Alboini 30, Paolo, D'Amato 30, Valentina, Iorio 30, Raffaele, Kanai 31, Tetsuya, Kawaguchi 31, Naoki, Mori 31, Masahiro, Kaneko 31, Yoko, Kanzaki 31, Akiko, Kobayashi 31, Eri, Masaki 32, Katsuhisa, Matsuse 32, Dai, Matsushita 32, Takuya, Uehara 32, Taira, Shimpo 32, Misa, Jingu 32, Maki, Kikutake 32, Keiko, Nakamura 32, Yumiko, Sano 32, Yoshiko, Nagane 33, Yuriko, Kamegamori 33, Ikuko, Tsuda 33, Tomoko, Fujii 33, Yuko, Futono 33, Kazumi, Ozawa 33, Yukiko, Mizugami 33, Aya, Saito 33, Yuka, Morikawa 34, Miyuki, Samukawa 34, Makoto, Kamakura 34, Sachiko, Miyawaki 34, Eriko, Mitazaki 35, Teiichiro, Motomura 35, Masakatsu, Mukaino 35, Akihiro, Yoshimura 35, Shunsuke, Asada 35, Shizuka, Yoshida 35, Seiko, Amamoto 35, Shoko, Kobashikawa 35, Tomomi, Koga 35, Megumi, Maeda 35, Yasuko, Takada 35, Kazumi, Takada 35, Mihoko, Tsurumaru 35, Masako, Yamashita 35, Yumi, Akiyama 36, Tetsuya, Narikawa 36, Koichi, Tano 36, Ohito, Tsukita 36, Kenichi, Kurihara 36, Rikako, Meguro 36, Fumie, Fukuda 36, Yusuke, Sato 36, Miwako, Funaka 37, Soichiro, Kawamura 37, Tomohiro, Makamori 37, Masayuki, Takahashi 37, Masanori, Taichi 37, Namie, Hasuike 37, Tomoya, Higuchi 37, Eriko, Kobayashi 37, Hisako, Osakada 37, Kaori, Tsuda 38, Emiko, Shimohama 38, Shun, Hayashi 38, Takashi, Hisahara 38, Shin, Kawamata 38, Jun, Murahara 38, Takashi, Saitoh 38, Masaki, Suzuki 38, Shuichiro, Yamamoto 38, Daisuke, Ishiyama 38, Yoko, Ishiyama 38, Naoko, Noshiro 38, Mayuko, Takeyama 38, Rumi, Uwasa 38, Kaori, Yasuda 38, Ikuko, van der Kooi 39, Anneke, de Visser 39, Marianne, Gibson 39, Tamar, Casasnovas 40, Carlo, Antonia Alberti Aguilo 40, Maria, Homedes-Pedret 40, Christian, Julia Palacios 40, Natalia, Diez Porras 40, Laura, Velez Santamaria 40, Valentina, Lazaro 40, Ana, Diez Tejedor 41, Exuperio, Gomez Salcedo 41, Pilar, Fernandez-Fournier 41, Mireya, Lopez Ruiz 41, Pedro, Javier Rodriguez de Rivera 41, Francisco, Sastre 41, Maria, Gamez 42, Josep, Sune 42, Pilar, Salvado 42, Maria, Gili 42, Gisela, Mazuela 42, Gonzalo, Illa 43, Isabel, Cortes Vicente 43, Elena, Diaz-Manera 43, Jordi, Antonio Querol Gutierrez 43, Lui, Rojas Garcia 43, Ricardo, Vidal 43, Nuria, Arribas-Ibar 43, Elisabet, Piehl 44, Fredrik, Hietala 44, Albert, Bjarbo 44, Lena, Sengun 45, Ihsan, Meherremova 45, Arzu, Ozcelik 45, Pinar, Balkan 45, Bengu, Tuga 45, Celal, Ugur 45, Muzeyyen, Erdem-Ozdamar 46, Sevim, Ebru Bekircan-Kurt 46, Can, Pinar Acar 46, Nazire, Yilmaz 46, Ezgi, Caliskan 46, Yagmur, Orsel 46, Gulsah, Efendi 47, Husnu, Aydinlik 47, Seda, Cavus 47, Hakan, Kutlu 47, Ayse, Becerikli 47, Gulsah, Semiz 47, Cansu, Tun 47, Ozlem, Terzi 48, Murat, Dogan 48, Baki, Kazim Onar 48, Musa, Sen 48, Sedat, Kirbas Cavdar 48, Tugce, Veske 48, Adife, Norwood 49, Fiona, Dimitriou 49, Aikaterini, Gollogly 49, Jakit, Mahdi-Rogers 49, Mohamed, Seddigh 49, Arshira, Sokratous 49, Gianni, Maier 49, Gal, Sohail 49, Faisal, Jacob 50, Saiju, Sadalage 50, Girija, Torane 50, Pravin, Brown 50, Claire, Shah 50, Amna, Sathasivam 51, Sivakumar, Arndt 51, Heike, Davies 51, Debbie, Watling 51, Dave, Amato 52, Anthony, Cochrane 52, Thoma, Salajegheh 52, Mohammed, Roe 52, Kristen, Amato 52, Katherine, Toska 52, Shirli, Wolfe 53, Gil, Silvestri 53, Nichola, Patrick 53, Kara, Zakalik 53, Karen, Katz 54, Jonathan, Miller 54, Robert, Engel 54, Marguerite, Forshew 54, Dalla, Bravver 55, Elena, Brooks 55, Benjamin, Plevka 55, Sarah, Burdette 55, Maryanne, Cunningham 55, Scott, Sanjak 55, Mohammad, Kramer 55, Megan, Nemeth 55, Joanne, Schommer 55, Clara, Tierney 55, Scott, Juel 56, Vern, Guptill 56, Jeffrey, Hobson-Webb 56, Lisa, Massey 56, Janice, Beck 56, Kate, Carnes 56, Donna, Loor 56, John, Anderson 56, Amanda, Pascuzzi 57, Robert, Bodkin 57, Cynthia, Kincaid 57, John, Snook 57, Riley, Guingrich 57, Sandra, Micheels 57, Angela, Chaudhry 58, Vinay, Corse 58, Andrea, Mosmiller 58, Betsy, Kelley 58, Andrea, Ho 59, Doreen, Srinivasan 59, Jayashri, Vytopil 59, Michal, Jara 59, Jordan, Ventura 59, Nichola, Scala 59, Stephanie, Carter 59, Cynthia, Donahue 59, Craig, Herbert 59, Carol, Weiner 59, Elaine, Alam 59, Sharmeen, McKinnon 60, Jonathan, Haar 60, Laura, McKinnon 60, Naya, Alcon 60, Karan, McKenna 60, Kaitlyn, Sattar 60, Nadia, Daniels 60, Kevin, Jeffery 60, Denni, Freimer 61, Miriam, Chad Hoyle 61, Joseph, Kissel 61, John, Agriesti 61, Julie, Chelnick 61, Sharon, Mezache 61, Louisa, Pineda 61, Colleen, Muharrem 61, Filiz, Karam 62, Chafic, Khoury 62, Julie, Marburger 62, Tessa, Kaur 62, Harpreet, Dimitrova 62, Diana, Gilchrist 63, Jame, Agrawal 63, Brajesh, Elsayed 63, Mona, Kohlrus 63, Stephanie, Andoin 63, Angela, Darnell 63, Taylor, Golden 63, Laura, Lokaitis 63, Barbara, Seelback 63, Jenna, Muppidi 64, Srikanth, Goyal 64, Neelam, Sakamuri 64, Sarada, T So 64, Yuen, Paulose 64, Shirley, Pol 64, Sabrina, Welsh 64, Lesly, Bhavaraju-Sanka 65, Ratna, Tobon Gonzales 65, Alejandro, Dishman 65, Lorraine, Jones 65, Floyd, Gonzalez 65, Anna, Padilla 65, Patricia, Saklad 65, Amy, Silva 65, Marcela, Kazamel 66, Mohamed, Alsharabati 66, Mohammad, Lu 66, Liang, Nozaki 66, Kenkichi, Mumfrey-Thomas 66, Sandi, Woodall 66, Amy, Mozaffar 67, Tahseen, Cash 67, Tiyonnoh, Goyal 67, Namita, Roy 67, Gulmohor, Mathew 67, Veena, Maqsood 67, Fatima, Minton 67, Brian, James Jones 68, H, Rosenfeld 68, Jeffrey, Garcia 68, Rebekah, Echevarria 68, Laura, Garcia 68, Sonia, Pulley 69, Michael, Aranke 69, Shachie, Ross Berger 69, Alan, Shah 69, Jaimin, Shabbir 69, Yasmeen, Smith 69, Lisa, Varghese 69, Mary, Gutmann 70, Laurie, Gutmann 70, Ludwig, Jerath 70, Nivedita, Nance 70, Christopher, Swenson 70, Andrea, Olalde 70, Heena, Kressin 70, Nicole, Sieren 70, Jeri, Barohn 71, Richard, Dimachkie 71, Mazen, Glenn 71, Melanie, McVey 71, April, Pasnoor 71, Mamatha, Statland 71, Jeffery, Wang 71, Yunxia, Liu 71, Tina, Emmons 71, Kelley, Jenci 71, Nicole, Locheke 71, Jerry, Fondaw 71, Alex, Johns 71, Kathryn, Rico 71, Gabrielle, Walsh 71, Maureen, Herbelin 71, Laura, Hafer-Macko 72, Charlene, Kwan 72, Justin, Zilliox 72, Lindsay, Callison 72, Karen, Young 72, Valerie, DiSanzo 72, Beth, Naunton 72, Kerry, Benatar 73, Michael, Bilsker 73, Martin, Sharma 73, Khema, Cooley 73, Anne, Reyes 73, Eliana, Michon 73, Sara-Claude, Sheldon 73, Danielle, Steele 73, Julie, Howard Jr 74, Jame, Karam 74, Chafic, Chopra 74, Manisha, Traub 74, Rebecca, Vu 75, Tuan, Katzin 75, Lara, McClain 75, Terry, Harvey 75, Brittany, Hart 75, Adam, Huynh 75, Kristin, Beydoun 76, Said, Chilingaryan 76, Amaiak, Doan 76, Victor, Droker 76, Brian, Gong 76, Hui, Karimi 76, Sanaz, Lin 76, Frank, McClain 76, Terry, Pokala 76, Krishna, Shah 76, Akshay, Tran 76, Anh, Akhter 76, Salma, Malekniazi 76, Ali, Tandan 77, Rup, Hehir 77, Michael, Waheed 77, Waqar, Lucy 77, Shannon, Weiss 78, Michael, Distad 78, Jane, Strom 78, Susan, Downing 78, Sharon, Kim 78, Bryan, Nowak 79, Richard, Dicapua 79, Daniel, Keung 79, Benison, Kumar 79, Aditya, Patwa 79, Huned, Robeson 79, Kimberly, Yang 79, Irene, Nye 79, Joan, and Hong Vu
Subjects: Male, Pediatrics, Myasthenia gravi, Open-label extension study, Complement inhibitor, 0302 clinical medicine, Quality of life, Japan, Medicine and Health Sciences, Medicine, 030212 general & internal medicine, Myasthenia gravis, education.field_of_study, MG-ADL, Japanese patient, Eculizumab, Middle Aged, HLA, MG-QoL15, Treatment Outcome, Neurology, Female, Life Sciences & Biomedicine, COMPLEMENT INHIBITOR ECULIZUMAB, medicine.drug, Adult, medicine.medical_specialty, Population, Clinical Neurology, Subgroup analysis, Placebo, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Refractory, Asian People, Myasthenia Gravis, Humans, education, Aged, Science & Technology, business.industry, Neurosciences, medicine.disease, Complement Inactivating Agents, Japanese patients, ONSET, Neurology (clinical), Neurosciences & Neurology, business, 030217 neurology & neurosurgery
Abstract: The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52-week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAIN, treatment with open-label eculizumab resulted in generally similar outcomes in the Japanese and Caucasian populations. Rapid improvements were maintained for 52 weeks, assessed by change in score from open-label extension baseline to week 52 (mean [standard error]) using the following scales (in Japanese and Caucasian patients, respectively): Myasthenia Gravis Activities of Daily Living (-2.4 [1.34] and - 3.3 [0.65]); Quantitative Myasthenia Gravis (-2.9 [1.98] and - 4.3 [0.79]); Myasthenia Gravis Composite (-4.5 [2.63] and - 4.9 [1.19]); and Myasthenia Gravis Quality of Life 15-item questionnaire (-8.6 [5.68] and - 6.5 [1.93]). Overall, the safety of eculizumab was consistent with its known safety profile. In this interim sub-analysis, the efficacy and safety of eculizumab in Japanese and Caucasian patients were generally similar, and consistent with the overall REGAIN population. ispartof: JOURNAL OF THE NEUROLOGICAL SCIENCES vol:407 ispartof: location:Netherlands status: published
Published: 2019

11. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study

Author: Kazumi Takada, Vladislav Abramov, Seiko Yoshida, Pinar Ozcelik, Carolina Miranda, Jennifer Kane, Kaitlyn McKenna, Natasha Campbell, Sharon P. Nations, Shitiz Kumar Sriwastava, Yuko Fujii, Mayumi Murata, Linda Wagemaekers, Angela Andoin, Mollie Vanderhook, Yoshinori Okubo, Martin Bilsker, Taira Uehara, Vera Bril, Julia Wanschitz, Stanislava Toncrova, Mariela Bettini, Kazumi Futono, Shachie Aranke, Yool-hee Kim, Hiroyuki Murai, Anne Nyrhinen, Vinay Chaudhry, Raffaele Iorio, Takashi Kanda, Brittany Harvey, Francisco Javier Rodriguez de Rivera, Henning Andersen, Marianne de Visser, Miwako Sato, Yasuhiro Maeda, Fabienne Deruelle, Marina Pozo, Adam Hart, Masaki Saitoh, Wladimir Bocca Vieira de Rezende Pinto, Said R. Beydoun, Lindsay Zilliox, Akihiro Mukaino, Cinzia Caserta, Mahi Jasinarachchi, Andrea M. Corse, Nikoletta Papadopoulou, JuYoung Kwon, Fernanda Carrara, Juliet Saba, Masayuki Makamori, Vittorio Frasca, Luciana Souza Duca, Hoo Nam Kang, C. Trebst, Celile Phan, Muzeyyen Ugur, Eduardo Ng, Jonathan McKinnon, Hila Bali Kuperman, David Feder, Judit Matolcsi, Jiri Pitha, Martin Stangel, Kate Beck, Gabriel Paiva, Diego Lopergolo, Katrien De Mey, Hidenori Matsuo, Lucas Eduardo Pazetto, Eugene Lai, Amanda Anderson, Ann D'Hondt, Tetsuya Akiyama, Beverly Fyfe, Bella Gross, Elisabet Arribas-Ibar, Kathy de Koning, Gulmohor Roy, Dmitry Pokhabov, Maria Johanna Keijzers, Nicholas Ventura, Tessa Marburger, John Loor, Ji Eun Lee, Alessandro Filla, Celal Tuga, Stephanie Scala, Rudy Mercelis, Marc H. De Baets, Hisako Kobayashi, Stanislav Vohanka, Ana Paula Macagnan, Ana Carolina Amaral de Andrade, Heike Arndt, Giovanni Antonini, Yumi Yamashita, Gwendal Le Masson, Sonia Garcia, Sarah Verjans, James F. Howard, Zaeem A. Siddiqi, Yuen T. So, Megumi Koga, Exuperio Diez Tejedor, Teresa Costabile, Mihoko Takada Takada, Steve Hopkins, Jonathan S. Katz, Charlene Hafer-Macko, Erica Nogueira Coelho, Hung Youl Seok, Carol Herbert, Yuriko Nagane, Didem Altiparmak, Sachiko Kamakura, Mohammad Sanjak, Caroline Moreau, Jordi Díaz-Manera, Sivakumar Sathasivam, Michael Vytopil, Amelia Evoli, Masakatsu Motomura, Ester Reggio, Guy Van den Abeele, Hélène Zéphir, Asya Yarmoschuk, Jasmine Hewlett, Amy Wilson, Sachie Fukui, Cavit Boz, Iandra Souza, Morgane Gaboreau, Ivana Jurajdova, Sonia Decressac, Yong Seo Koo, Valentina Pegoraro, Seung Min Kim, Benison Keung, Rosana Rocha, Nanna Witting, John Vissing, Elaine Weiner, Ali Malekniazi, Larisa Babenko, Amanda C. Guidon, Gal Maier, Charlotte Smetcoren, Robert M. Pascuzzi, Domenico Marco Bonifati, Yumiko Nakamura, Tamires Cristina Gomes da Silva, Takashi Murahara, Sarah Plevka, Tomoko Tsuda, John C. Kincaid, Arnaud Lacour, Ibrez Bandukwala, Alan R. Berger, Chang Nyoung Lee, Jae-Sung Lim, Vern C. Juel, Tulio E. Bertorini, Valeria Cavalcante Lino, Namie Taichi, Ju-Hong Min, Josep Gamez, Nelly Greenbereg, William S. David, Srikanth Muppidi, Husnu Efendi, Pedro Lopez Ruiz, Baki Dogan, Cansu Semiz, Natalia Julia Palacios, Sharon Downing, Paola Cudia, Daniel Jacobs, Can Ebru Bekircan-Kurt, Takayasu Fukudome, Kristen Roe, Lena Bjarbo, Nicole Kassebaum, Makoto Samukawa, Shizuka Asada, Christina Dheel, Fatima Maqsood, Eun Bi Hwang, Kevin Daniels, Sevim Erdem-Ozdamar, Olivier Stevens, Claudio Mazia, Karan Alcon, Sibel Gazioglu, Keiko Kikutake, Luis Lay, Petra Tilkin, Corrado Angelini, Derrick Blackmore, Kimiaki Utsugisawa, Despoina Charalambous, Tuula Harrison, Kristin Huynh, Huned S. Patwa, Laura Echevarria, Henrique Mohr, Christian Homedes-Pedret, Richard J. Barohn, Byung Jo Kim, Daniel DiCapua, Terry McClain, Debora Dada Martineli Torres, Maria Salvado Figueras, Ana Paula Melo, Riley Snook, Miki Ogawa, Marcelo Annes, Yuka Saito, Isabel Illa, Evanthia Bernitsas, Nicole Smalley, Molly Lindsay, Robert G. Miller, Olga Azrilin, Silvia Bonanno, Evgeniya Kosykh, Marcela Wolfova, Olivier Outteryck, Shirli Toska, Anna Kostera-Pruszczyk, HyeJin Ra, Rup Tandan, Sotirios Papagiannopoulos, Natasha Willlems, Anne Mette Ostergaard Autzen, Meinoshin Okumura, Patrick Vermersch, Sarada Sakamuri, Maria Antonia Alberti Aguilo, Shigemi Shimose, Cynthia Carter, Ira Blount, Lisa Thompson, Maurer Pereira Martins, Richard Nowak, Hyung Seok Lee, Anna Kaminska, Joan Bratton, Nazire Pinar Acar, Junichi Ogasawara, Mohamed Mahdi-Rogers, Teiichiro Mitazaki, Marek Čierny, Craig Donahue, Jaya Trivedi, Neelam Goyal, Gonzalo Vidal, Brandy Quarles, Akiko Kanzaki, Yasuko Ikeda, Tomomi Kobashikawa, Morris Brown, Daisuke Yamamoto, Michel Deneve, Denis Korobko, Beth DiSanzo, Benedikt Schoser, Heidi Boterhoven, Eri Kobayashi, Maoko Shirane, Cristiani Fernanda Butinhao, Eriko Higuchi, Takashi Hayashi, Masanori Takahashi, Anne-Cécile Wielanek-Bachelet, Benjamin Rix Brooks, Emanuela Onesti, Tahseen Mozaffar, Liang Lu, Sevasti Bostantzopoulou, Christophe Vial, Shawn J. Bird, Sandi Mumfrey-Thomas, Julie Khoury, Kara Patrick, Kenichi Tsukita, Yoshiko Sano, Hiroshi Nakazora, David P. Richman, Gavin Brown, Yoon-Ho Hong, Tomohiro Kawamura, Igor Dias Brockhausen, Ye Liu, Acary Souza Bulle Oliveira, Soichiro Funaka, Tomoya Hasuike, Frank Lin, Luis Antonio Querol Gutierrez, Namita Goyal, Elena Pinzan, Michelle Mellion, Silvia Messina, Christopher Lindberg, Csilla Rozsa, J. Chad Hoyle, Yoko Kaneko, Gustavo Duran, Francesco Patti, Arshira Seddigh, Ele Kim Perez, Jayashri Srinivasan, Michael Benatar, Philip Van Damme, Salma Akhter, Daniel Ambrosio, Maria Salvado, Floyd Jones, Mark Sivak, Anneke J. van der Kooi, Karen Callison, Catherine Nigro, Rebekah Garcia, Thomas Arnold, Hideki Arima, Brigid Crabtree, Mary Varghese, Aditya Kumar, Miri Kim, Fanny O'Brien, Naya McKinnon, Lauren Wheeler, Hong Vu, Shunsuke Yoshimura, Masatoshi Omoto, Jeffrey T. Guptill, Maria Gabriele, Francoise Bouhour, Veena Mathew, Ritsu Nakayama, Rosa Hasan, Francesco Saccà, Mohammed Salajegheh, Diana Dimitrova, Alzira Alves de Siqueira Carvalho, Maurizio Inghilleri, George Sachs, Rekha Pillai, Enrico Marano, Monika Konyane, Anh Tran, Seda Aydinlik, Kendrick Henderson, Fumie Meguro, Alexandre Guerreiro, Amaiak Chilingaryan, Tiyonnoh Cash, Jun Kawamata, Julie Steele, Helene Gervais-Bernard, Thomas Harbo, Alejandra Dalila Garcia, Musa Kazim Onar, Sabrina Sacconi, Carlos Casasnovas Pons, Nadezhda Malkova, Denis Sazonov, Mireya Fernandez-Fournier, Karin Fricke, Laurie Gutmann, Amy Saklad, Clara Schommer, Sandra Taber, Fiona Norwood, Tugce Kirbas Cavdar, Monique Miesen, Fernanda Troili, Masanori Watanabe, Ratna Bhavaraju-Sanka, Ted M. Burns, Sari Atula, Faisal Sohail, Barbora Kurkova, Brigitta Szabadosne, Luciana Renata Cubas Volpe, Jane Pedersen, Jing Jing Wang, Masashi Inoue, Antonella Di Pasquale, Megan Kramer, Magda Chmelikova, Mehran Soltani, Tuan Vu, Laura Fionda, Eliz Agopian, Susan Shin, Anthony A. Amato, Lotte Vinge, Hakan Cavus, Gil I. Wolfe, Joan Nye, Delphine Mahieu, Miguel Wilken, Markus Färkkilä, Catherine Faber, Erin Manning, Emiko Tsuda, Rami Massie, Paolo Emilio Alboini, Yasmeen Shabbir, Angela Campanella, Aikaterini Dimitriou, Marcelo Rugiero, Cynthia Bodkin, Gyorgyi Szabo, Sharon Halton, Akshay Shah, Yasuko Maeda, Hans D. 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Jame, Rosenfeld, Jeffrey, Garcia, Rebekah, Garcia, Sonia, Echevarria, Laura, Pulley, Michael, Aranke, Shachie, Berger, Alan Ro, Shah, Jaimin, Shabbir, Yasmeen, Smith, Lisa, Varghese, Mary, Gutmann, Laurie, Gutmann, Ludwig, Swenson, Andrea, Olalde, Heena, Hafer-Macko, Charlene, Kwan, Justin, Zilliox, Lindsay, Callison, Karen, Disanzo, Beth, Naunton, Kerry, Bilsker, Martin, Sharma, Khema, Reyes, Eliana, Cooley, Anne, Michon, Sara-Claude, Steele, Julie, Karam, Chafic Karam, Chopra, Manisha, Bird, Shawn, Kaufman, Jacob, Gallatti, Nichole, Vu, Tuan, Katzin, Lara, Mcclain, Terry, Harvey, Brittany, Hart, Adam, Huynh, Kristin, Beydoun, Said, Chilingaryan, Amaiak, Droker, Brian, Lin, Frank, Shah, Akshay, Tran, Anh, Akhter, Salma, Malekniazi, Ali, Tandan, Rup, Hehir, Michael, Waheed, Waqar, Lucy, Shannon, Weiss, Michael, Distad, Jane, Downing, Sharon, Strom, Susan, Lisak, Robert, Bernitsas, Evanthia, Khan, Omar, Kumar Sriwastava, Shitiz, Tselis, Alexandro, Jia, Kelly, Bertorini, Tulio, Arnold, Thoma, Henderson, Kendrick, Pillai, Rekha, Liu, Ye, Wheeler, Lauren, Hewlett, Jasmine, Vanderhook, Mollie, Dicapua, Daniel, Keung, Benison, Kumar, Aditya, Patwa, Huned, Robeson, Kimberly, Nye, Joan, Vu, Hong, Howard, J, Utsugisawa, K, Benatar, M, Murai, H, Barohn, R, Illa, I, Jacob, S, Vissing, J, Burns, T, Kissel, J, Muppidi, S, Nowak, R, O'Brien, F, Wang, J, Mantegazza, R, and Bonanno, S
Subjects: Male, 0301 basic medicine, medicine.medical_treatment, Drug Resistance, Adult, Aged, Antibodies, Monoclonal, Humanized, Autoantibodies, Double-Blind Method, Female, Humans, Middle Aged, Myasthenia Gravis, Receptors, Cholinergic, Outcome Assessment (Health Care), Severity of Illness Index, Neurology (clinical), law.invention, Complement inhibitor, 0302 clinical medicine, Randomized controlled trial, law, Monoclonal, Receptors, Clinical endpoint, Humanized, Cholinergic, education.field_of_study, Eculizumab, Autoantibodie, Myasthenia Gravi, Settore MED/26 - NEUROLOGIA, Human, medicine.drug, Meningitides, medicine.medical_specialty, Population, Placebo, Antibodies, 03 medical and health sciences, Internal medicine, medicine, education, business.industry, Surgery, Thymectomy, 030104 developmental biology, business, 030217 neurology & neurosurgery
Abstract: Background Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial. Methods We did a phase 3, randomised, double-blind, placebo-controlled, multicentre study (REGAIN) in 76 hospitals and specialised clinics in 17 countries across North America, Latin America, Europe, and Asia. Eligible patients were aged at least 18 years, with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 6 or more, Myasthenia Gravis Foundation of America (MGFA) class II-IV disease, vaccination against Neisseria meningitides, and previous treatment with at least two immunosuppressive therapies or one immunosuppressive therapy and chronic intravenous immunoglobulin or plasma exchange for 12 months without symptom control. Patients with a history of thymoma or thymic neoplasms, thymectomy within 12 months before screening, or use of intravenous immunoglobulin or plasma exchange within 4 weeks before randomisation, or rituximab within 6 months before screening, were excluded. We randomly assigned participants (1:1) to either intravenous eculizumab or intravenous matched placebo for 26 weeks. Dosing for eculizumab was 900 mg on day 1 and at weeks 1, 2, and 3; 1200 mg at week 4; and 1200 mg given every second week thereafter as maintenance dosing. Randomisation was done centrally with an interactive voice or web-response system with patients stratified to one of four groups based on MGFA disease classification. Where possible, patients were maintained on existing myasthenia gravis therapies and rescue medication was allowed at the study physician's discretion. Patients, investigators, staff, and outcome assessors were masked to treatment assignment. The primary efficacy endpoint was the change from baseline to week 26 in MG-ADL total score measured by worst-rank ANCOVA. The efficacy population set was defined as all patients randomly assigned to treatment groups who received at least one dose of study drug, had a valid baseline MG-ADL assessment, and at least one post-baseline MG-ADL assessment. The safety analyses included all randomly assigned patients who received eculizumab or placebo. This trial is registered with ClinicalTrials.gov, number NCT01997229. Findings Between April 30, 2014, and Feb 19, 2016, we randomly assigned and treated 125 patients, 62 with eculizumab and 63 with placebo. The primary analysis showed no significant difference between eculizumab and placebo (least-squares mean rank 56·6 [SEM 4·5] vs 68·3 [4·5]; rank-based treatment difference -11·7, 95% CI -24·3 to 0·96; p=0·0698). No deaths or cases of meningococcal infection occurred during the study. The most common adverse events in both groups were headache and upper respiratory tract infection (ten [16%] for both events in the eculizumab group and 12 [19%] for both in the placebo group). Myasthenia gravis exacerbations were reported by six (10%) patients in the eculizumab group and 15 (24%) in the placebo group. Six (10%) patients in the eculizumab group and 12 (19%) in the placebo group required rescue therapy. Interpretation The change in the MG-ADL score was not statistically significant between eculizumab and placebo, as measured by the worst-rank analysis. Eculizumab was well tolerated. The use of a worst-rank analytical approach proved to be an important limitation of this study since the secondary and sensitivity analyses results were inconsistent with the primary endpoint result; further research into the role of complement is needed. Funding Alexion Pharmaceuticals.
Published: 2017

12. How good is quality-of-life for children receiving home parenteral nutrition? – A pilot study

Author: Veena Zamvar, Natalia Iglesias, Dominique Pham, Gill Lazonby, Rakesh Vora, Donna Ellis, Léa Chantal Tran, Remy Morello, Jenny Goldthorpe, Julie Steele, John W L Puntis, Leeds General Infirmary (LGI), Leeds Teaching Hospitals NHS Trust, CHU Amiens-Picardie, Unité de Biostatistique et de Recherche Clinique (UBRC), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, and Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)
Subjects: Male, Short Bowel Syndrome, 0301 basic medicine, medicine.medical_specialty, Activities of daily living, Adolescent, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], Population, Nutritional Status, Pilot Projects, 030209 endocrinology & metabolism, 03 medical and health sciences, 0302 clinical medicine, Rating scale, Surveys and Questionnaires, Intestinal failure, Activities of Daily Living, Intestine, Small, Humans, Medicine, Child, Grading (education), education, Social functioning, education.field_of_study, 030109 nutrition & dietetics, Nutrition and Dietetics, business.industry, 4. Education, Enterostomy, Infant, Hospitals, humanities, Intestinal Diseases, Cross-Sectional Studies, Parenteral nutrition, Child, Preschool, Family medicine, Quality of Life, Etiology, Female, Parenteral Nutrition, Home, business
Abstract: Summary Background & aims Children on home parenteral nutrition and their parents not only engage with complex nutritional issues but also have to manage difficult social and financial problems with social and clinical support that may not always meet their needs. Baxter's HPN-QOL questionnaire, assesses the QOL of adult patients treated with HPN, and has been developed rigorously using standard guidelines, measuring various dimensions of QOL. Our aim was to use this tool to explore how HPN influences the QOL of paediatric patients. Methods The HPN-QOL questionnaire was modified to suit a paediatric HPN population. Data on demographics, aetiology of intestinal failure and duration of HPN were collected from a departmental database. Quality-of-Life grading of functional and symptom scales, HPN specific items and overall QOL Numerical Rating Scales were determined. Results Fourteen out of 17 families returned the completed questionnaires. QOL was significantly impaired by increased dependency regarding items of daily living such as eating, dressing, washing, and mobility, but was not affected in the domains of school attendance, general fatigue, pain and body image. There were no significant differences in QOL when patients with and without enterostomy were compared. Patients felt well supported by the hospital nutrition team in managing logistics related to HPN. Conclusions QOL in HPN patients was not significantly affected by the medical aspects of care. This descriptive study highlights the need for further integration of medical and social care in order to support families of children receiving HPN as QOL was impaired in relation to activities of daily living and social functioning.
Published: 2019

13. Seven-Year Experience From the National Institute of Neurological Disorders and Stroke–Supported Network for Excellence in Neuroscience Clinical Trials

Author: Jean Baptiste Le Pichon, Stephanie Lowenhaupt, Jessica Lamb, Eric D. Foster, Patricia K. Coyle, Mariam Andersen, Christine Annis, Alexander J. Stein, Angela Molloy, Tracy A. Glauser, Laurie Gutmann, Steven M. Greenberg, Mengesha Teshome, A. Gordon Smith, Richard J. Barohn, Paula R. Clemens, Susan T. Iannaccone, Robert G. Holloway, Carole Seeley, Luis J. Mejico, Audrey Ellis, Bjorn Oskarsson, Jeremy M. Shefner, Emine O. Bayman, R. Peters, Anthony A. Amato, Louis B. Nabors, Beth A. Malow, Blagovest Nikolov, Mark Quigg, Claudia A. Chiriboga, Peggy Clark, Christine L. Amity, Mark P. Goldberg, Joseph F. Quinn, Trevis Huff, E. Clarke Haley, Codrin Lungu, Kellie Keith, David B. Clifford, Julie Steele, Stephen J. Kolb, Michael Benatar, Muhammad Maaz Iqbal, Shlomo Shinnar, Lawrence R. Wechsler, Basil T. Darras, Melanie Benge, Robin Conwit, Tanya Simuni, Catherine P. Canamar, Timothy Vollmer, Roger J. Packer, Michael Bosch, Khurram Bashir, Sara DeGregorio, Karen W. Adkins, James Bowen, Tina Ward, Dixie Ecklund, Marianne Chase, Bruce H. Dobkin, Stewart A. Factor, Gil I. Wolfe, Katy Mahoney, James C. Torner, Donna Patch, Mariana Doudova, Amy Bartlett, Nadege Gilles, Jeffrey D. Long, Caryl Tongco, Karen Marder, Claire Henchcliffe, Joyce Ann Moran, Mazen M. Dimachkie, Jon W. Yankey, Merit Cudkowicz, J. Robinson Singleton, Craig M. McDonald, Christopher S. Coffey, Annemarie Crumlish, Noreen L. Connolly, Brenda Thornell, John T. Kissel, Steven R. Levine, Kevin J. Staley, Erik K Henricson, and Daniel Woo
Subjects: media_common.quotation_subject, MEDLINE, Patient advocacy, Article, 03 medical and health sciences, 0302 clinical medicine, Mentorship, Excellence, Humans, Medicine, National Institute of Neurological Disorders and Stroke (U.S.), 030212 general & internal medicine, media_common, Receipt, Clinical Trials as Topic, business.industry, Neurosciences, Institutional review board, United States, Clinical trial, Clinical research, Neurology, Neurology (clinical), Nervous System Diseases, business, Neuroscience, 030217 neurology & neurosurgery
Abstract: Importance One major advantage of developing large, federally funded networks for clinical research in neurology is the ability to have a trial-ready network that can efficiently conduct scientifically rigorous projects to improve the health of people with neurologic disorders. Observations National Institute of Neurological Disorders and Stroke Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) was established in 2011 and renewed in 2018 with the goal of being an efficient network to test between 5 and 7 promising new agents in phase II clinical trials. A clinical coordinating center, data coordinating center, and 25 sites were competitively chosen. Common infrastructure was developed to accelerate timelines for clinical trials, including central institutional review board (a first for the National Institute of Neurological Disorders and Stroke), master clinical trial agreements, the use of common data elements, and experienced research sites and coordination centers. During the first 7 years, the network exceeded the goal of conducting 5 to 7 studies, with 9 funded. High interest was evident by receipt of 148 initial applications for potential studies in various neurologic disorders. Across the first 8 studies (the ninth study was funded at end of initial funding period), the central institutional review board approved the initial protocol in a mean (SD) of 59 (21) days, and additional sites were added a mean (SD) of 22 (18) days after submission. The median time from central institutional review board approval to first site activation was 47.5 days (mean, 102.1; range, 1-282) and from first site activation to first participant consent was 27 days (mean, 37.5; range, 0-96). The median time for database readiness was 3.5 months (mean, 4.0; range, 0-8) from funding receipt. In the 4 completed studies, enrollment met or exceeded expectations with 96% overall data accuracy across all sites. Nine peer-reviewed manuscripts were published, and 22 oral presentations or posters and 9 invited presentations were given at regional, national, and international meetings. Conclusions and Relevance NeuroNEXT initiated 8 studies, successfully enrolled participants at or ahead of schedule, collected high-quality data, published primary results in high-impact journals, and provided mentorship, expert statistical, and trial management support to several new investigators. Partnerships were successfully created between government, academia, industry, foundations, and patient advocacy groups. Clinical trial consortia can efficiently and successfully address a range of important neurologic research and therapeutic questions.
Published: 2020

14. NOx emissions from a Central California dairy

Author: Shawn Ashkan, Julie Steele, Austen Scruggs, Srikar Middala, Catalina Olea, Lucien Nana, Alam S. Hasson, Kenwood Scoggin, Kennedy Vu, Segun Ogunjemiyo, Steven Trabue, and Laxmi R. Addala
Subjects: Atmospheric Science, Silage, Animal feed, Environmental engineering, Gaussian plume, Atmospheric sciences, symbols.namesake, Flux (metallurgy), Chamber method, symbols, Environmental science, AERMOD, Lagrangian, NOx, General Environmental Science
Abstract: Concentrations of NO x (NO + NO 2 ) were monitored downwind from a Central California dairy facility during 2011 and 2012. NO x concentrations at the dairy were significantly higher than the background levels during August 2011 primarily due to the presence of elevated NO, but were indistinguishable from background concentrations during January and April 2012. A Gaussian plume model (AERMOD) and a Lagrangian back trajectory model (Wind Trax) were used to estimate the flux of NO from the dairy during August 2011 with the assumption that emissions were primarily from animal feed. NO emissions from silage were also directly measured from feed to provide additional insight into the sources. Isolation flux chamber measurements imply an NO flux from the feed of about 1.3 × 10 −3 g m −2 h −1 , but these relatively low fluxes are inconsistent with the elevated NO concentrations observed during August 2011. This implies that either the flux chamber method grossly underestimates the true NO emissions from feed, or that most of the ambient NO measured at the dairy is from other sources. Emissions from farm machinery may account for the NO concentrations observed. Animal feed thus appears to be a small contributor to NO x emissions within Central California.
Published: 2013

15. Motor neuron involvement in multisystem proteinopathy: Implications for ALS

Author: Michael Benatar, Heather Katzen, Bjorn Oskarsson, Joanne Wuu, J. Paul Taylor, Catalina Fernandez, Conrad C. Weihl, and Julie Steele
Subjects: Adult, Male, Weakness, Valosin-containing protein, Cell Cycle Proteins, Disease, medicine.disease_cause, Article, Myositis, Inclusion Body, Valosin Containing Protein, Heterogeneous-Nuclear Ribonucleoprotein Group A-B, medicine, Humans, Amyotrophic lateral sclerosis, Adenosine Triphosphatases, Motor Neurons, Mutation, biology, Amyotrophic Lateral Sclerosis, Middle Aged, Motor neuron, Osteitis Deformans, medicine.disease, Multisystem proteinopathy, medicine.anatomical_structure, Muscular Dystrophies, Limb-Girdle, Frontotemporal Dementia, biology.protein, Female, Neurology (clinical), medicine.symptom, Neuroscience, Frontotemporal dementia
Abstract: Objective: To explore the putative connection between inclusion body myopathy, Paget disease, frontotemporal dementia (IBMPFD) and motor neuron disease (MND). Methods: Clinical, genetic, and EMG characterization of 17 patients from 8 IBMPFD families. Results: Limb weakness was the most common clinical manifestation (present in 15 patients, median onset age 38 years, range 25–52), with unequivocal evidence of upper motor neuron dysfunction in 3. EMG, abnormal in all 17, was purely neurogenic in 4, purely myopathic in 6, and mixed neurogenic/myopathic in 7. Cognitive/behavioral impairment was detected in at least 8. Mutations in VCP (R155H, R159G, R155C) were identified in 6 families, and in hnRNPA2B1 (D290V) in another family. The genetic cause in the eighth family has not yet been identified. Conclusion: Mutations in at least 4 genes may cause IBMPFD, and its phenotypic spectrum extends beyond IBM, Paget disease, and frontotemporal dementia (FTD). Weakness, the most common and disabling manifestation, may be caused by muscle disease or MND. The acronym IBMPFD is, therefore, insufficient to describe disorders due to VCP mutations or other recently identified IBMPFD-associated genes. Instead, we favor the descriptor multisystem proteinopathy (MSP), which encompasses both the extended clinical phenotype and the previously described prominent pathologic feature of protein aggregation in affected tissues. The nomenclature MSP1, MSP2, and MSP3 may be used for VCP -, HNRNPA2B1 -, and HNRNPA1 -associated disease, respectively. Genetic defects in MSP implicate a range of biological mechanisms including RNA processing and protein homeostasis, both with potential relevance to the pathobiology of more common MNDs such as amyotrophic lateral sclerosis (ALS) and providing an additional link between ALS and FTD.
Published: 2013

16. ESMO/ASCO recommendations for a Global Curriculum (GC) in medical oncology-edition 2016

Author: C. Dittrich, M. Kosty, S. Jezdic, D. Pyle, R. Berardi, J. Bergh, N. El Saghir, J.-P. Lotz, P. Österlund, N. Pavlidis, G. Purkalne, Hetty Carraway, Julia Lee Close, Jill Gilbert, Carsten Bokemeyer, Andrés Cervantes, Yuichiro Ohe, Miklos Pless, Keith McGregor, Katharine Fumassoli, Roberta Candiani, Gracemarie Bricalli, Tanya Kenny, Nicola Latino, Marina Cogo, Vanessa Pavinato, Vanessa Marchesi, Ahmad Awada, Susana Banerjee, Smita Bhatia, Jan Bogaerts, Jan Buckner, Fatima Cardoso, Paolo Casali, Edward Chu, Bertrand Coiffier, Roisin Connolly, Sarah Coupland, Luigi De Petris, Maria De Santis, Elisabeth G.E. de Vries, Don S. Dizon, Jennifer Duff, Linda R. Duska, Alexandru Eniu, Marc Ernstoff, Enriqueta Felip, Martin F. Fey, Nicolas Girard, Andor W.J.M. Glaudemans, Priya K. Gopalan, Axel Grothey, Stephen M. Hahn, Diana Hanna, Christian Herold, Jørn Herrstedt, Krisztian Homicsko, Dennie V. Jones, Lorenz Jost, Ulrich Keilholz, Saad Khan, Alexander Kiss, Claus-Henning Köhne, Rainer Kunstfeld, Heinz-Josef Lenz, Stuart Lichtman, Lisa Licitra, Thomas Lion, Saskia Litière, Lifang Liu, Patrick J. Loehrer, Merry Jennifer Markham, Ben Markman, Marius Mayerhoefer, Johannes G. Meran, Olivier Michielin, Elizabeth Charlotte Moser, Giannis Mountzios, Timothy Moynihan, Torsten Nielsen, Kjell Öberg, Antonio Palumbo, Fedro Alessandro Peccatori, Michael Pfeilstöcker, Chandrajit Raut, Scot C. Remick, Mark Robson, Piotr Rutkowski, Roberto Salgado, Lidia Schapira, Eva Schernhammer, Martin Schlumberger, Hans-Joachim Schmoll, Lowell Schnipper, Cristiana Sessa, Charles L. Shapiro, Julie Steele, Cora N. Sternberg, Friedrich Stiefel, Florian Strasser, Roger Stupp, Richard Sullivan, Josep Tabernero, Luzia Travado, Marcel Verheij, Emile Voest, Everett Vokes, Jamie Von Roenn, Jeffrey S. Weber, Hans Wildiers, Yosef Yarden, Pavlidis, Nicholas [0000-0002-2195-9961], Berardi, Rossana [0000-0002-9529-2960], Bergh, Jonas [0000-0001-5526-1847], Saghir, Nagi El [0000-0001-9612-4224], Österlund, Pia [0000-0002-7124-3515], Clinicum, Department of Oncology, ESMO/ASCO Global Curriculum Working Group, Carraway, H., Lee Close, J., Gilbert, J., Bokemeyer, C., Cervantes, A., Ohe, Y., Pless, M., McGregor, K., Fumassoli, K., Candiani, R., Bricalli, G., Kenny, T., Latino, N., Cogo, M., Pavinato, V., Marchesi, V., Awada, A., Banerjee, S., Bhatia, S., Bogaerts, J., Buckner, J., Cardoso, F., Casali, P., Chu, E., Coiffier, B., Connolly, R., Coupland, S., De Petris, L., De Santis, M., de Vries, E.G., Dizon, D.S., Duff, J., Duska, L.R., Eniu, A., Ernstoff, M., Felip, E., Fey, M.F., Girard, N., Glaudemans, A.W., Gopalan, P.K., Grothey, A., Hahn, S.M., Hanna, D., Herold, C., Herrstedt, J., Homicsko, K., Jones, D.V., Jost, L., Keilholz, U., Khan, S., Kiss, A., Köhne, C.H., Kunstfeld, R., Lenz, H.J., Lichtman, S., Licitra, L., Lion, T., Litière, S., Liu, L., Loehrer, P.J., Jennifer Markham, M., Markman, B., Mayerhoefer, M., Meran, J.G., Michielin, O., Charlotte Moser, E., Mountzios, G., Moynihan, T., Nielsen, T., Öberg, K., Palumbo, A., Alessandro Peccatori, F., Pfeilstöcker, M., Raut, C., Remick, S.C., Robson, M., Rutkowski, P., Salgado, R., Schapira, L., Schernhammer, E., Schlumberger, M., Schmoll, H.J., Schnipper, L., Sessa, C., Shapiro, C.L., Steele, J., Sternberg, C.N., Stiefel, F., Strasser, F., Stupp, R., Sullivan, R., Tabernero, J., Travado, L., Verheij, M., Voest, E., Vokes, E., Von Roenn, J., Weber, J.S., Wildiers, H., Yarden, Y., University of Zurich, Dittrich, C, and Guided Treatment in Optimal Selected Cancer Patients (GUTS)
Subjects: 0301 basic medicine, Medical education, Professional competence, 2720 Hematology, education, 3122 Cancers, Health care system, Molecular imaging, 610 Medicine & health, Patient care, Clinical practice, Global Health, Medical Oncology, 03 medical and health sciences, 0302 clinical medicine, Terminal care, Humans, Curriculum/standards, Europe, Global Health/education, Global Health/standards, Medical Oncology/education, Medical Oncology/standards, Societies, Medical/standards, United States, Medical specialist, Curriculum development, Societies, Medical, Priority journal, Editorials, Hematology, Awareness, Medical society, 030104 developmental biology, Editorial, Oncology, Health education, 030220 oncology & carcinogenesis, 10032 Clinic for Oncology and Hematology, 2730 Oncology, Curriculum, Internalization
Abstract: Non
Published: 2016

17. Racecadotril May Reduce Diarrhoea in Microvillous Inclusion Disease

Author: Veena Zamvar, Jenny Goldthorpe, Julie Steele, Natalia Iglesias, Lea C. Tran, Rakesh Vora, John W L Puntis, Donna Ellis, and Gill Lazonby
Subjects: medicine.medical_specialty, business.industry, Gastroenterology, MEDLINE, Microvillous inclusion disease, medicine.disease, Racecadotril, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, Internal medicine, Pediatrics, Perinatology and Child Health, medicine, 030211 gastroenterology & hepatology, business, medicine.drug
Published: 2017

18. PD03-07: Breast Cancer Heterogeneity and Treatment Resistance: Clues from Metaplastic Tumors

Author: Sarah S. Murray, Deirdre O'Sullivan, Ali Torkamani, Mihaela Lorger, ML Telli, A Fernandez-Santidrian, SV Vaughn, H Cunliffe, Julie Steele, Dhara MacDermed, Brunhilde Felding-Habermann, and SS Jeffrey
Subjects: CA15-3, Cancer Research, Pathology, medicine.medical_specialty, Bevacizumab, business.industry, Cancer, medicine.disease, Inflammatory breast cancer, Primary tumor, Metastasis, Breast cancer, Oncology, medicine, Cancer research, Malignant pleural effusion, business, medicine.drug
Abstract: At late stage, nearly all breast cancers are heterogeneous and refractory to treatment, like metaplastic breast cancer is at an early stage. These rare carcinomas are highly aggressive and de-differentiated. They are enriched for mesenchymal and stem cell features and essentially fail current therapies. As metaplastic tumors provide a time-compressed picture of breast cancer progression early on, understanding these tumors will yield insight into mechanisms that drive breast cancer into advanced stages and treatment resistance. To investigate a genetic basis for heterogeneity in metaplastic breast cancer, we established a progression model comprising three cell lines. The cell lines were derived from a primary tumor, a local recurrence and a pleural effusion of a 40-year old patient. The primary tumor was a stage III invasive metaplastic, triple negative, inflammatory breast cancer, resected after neoadjuvant chemotherapy (capecitabine and taxotere, then adriamycin and one cycle of bevacizumab). The local recurrence, biopsied seven months post mastectomy, developed after the patient received adjuvant carboplatin and gemcitabine for 3 cycles and then radiation to the chest wall. At this time, the patient had lung metastases and was treated with taxol and bevacizumab yielding a mixed response. Local invasive growth continued and a malignant pleural effusion developed four months later. Analyzing the genetic and molecular characteristics of this progression model in vitro, its tumorigenicity and metastasis in vivo, and interrogating lead findings in a growing collection of metaplastic tumors helps us to dissect the genetic heterogeneity in breast cancer, and potentially to identify the cell types that drive disease progression and treatment resistance. Our gene expression analyses and genomic evaluations identified epithelial to mesenchymal transition (EMT) as a key characteristic in the progression and treatment resistance of this cancer. Major changes in cytoskeletal genes, chemokines and their receptors, amplification of drug transporter proteins, metalloproteinases and matrix proteins seen with increasing motility and invasiveness along with recruitment of host inflammatory responses in the in vivo model, loss of chromosomal regions harboring known and putative tumor suppressors, and deletions of genes encoding proteins for metabolic inactivation of sex hormones in the breast tissue, along with specific loss of clusters of desmosomal genes are guiding our understanding of metaplastic breast cancer progression. The results provide insight into the development, the extremely invasive nature, and treatment resistance of these tumors. Our collaborative network of clinicians, pathologists, translational genomic researchers and bioinformatics specialists will enable us to identify and prioritize genetic events as disease drivers, prognostic biomarkers of disease progression, and determinants of treatment resistance. Our goal is to identify molecular and functional targets for effective therapy and evaluate them in the clinic. Lessons learned from metaplastic breast cancer will improve our understanding of breast cancer progression in general, and could translate into effective treatments for advanced breast cancer where current standard of care is failing. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD03-07.
Published: 2011

19. Advocating for Optimal Listening in the Classroom

Author: Julie Steele, Deborah Edwards, and Kathleen Salathiel
Subjects: Medical education, Hearing loss, business.industry, Best practice, Audiologist, Mainstreaming, Speech and Hearing, Documentation, Assistive technology, Student achievement, Pedagogy, ComputingMilieux_COMPUTERSANDEDUCATION, medicine, Active listening, medicine.symptom, business
Abstract: Hearing professionals need to be prepared for today's students as the ultimate arbiters regarding acceptable hearing assistive technology (HAT). Current educational laws and acts along with best practice standards are in place for assistive technology teams to implement collaborative goals and objectives to improve student achievement and close the achievement gap for students with hearing loss. Although the benefits of HAT are documented, historically its use declines for older students and those mainstreaming to their home school with normally hearing peers. Not wanting to be different and/or not receiving acceptable benefit are issues of the past. Now, being different is the norm, and students can be more like their peers through the use of technology. HAT allows student access and connectivity to home, school, and community. In this article, guidelines are discussed as they pertain to the role of the audiologist on the school assistive technology team. It is the responsibility of the audiologist to bring new HAT developments to the assistive technology team and advocate for optimal listening in the classroom. Audiologists need to step up and embrace new technology trends and keep options attractive to students. Professionals can arm themselves for this challenge with the supportive documentation presented in this article.
Published: 2010

20. Motivational Interviewing

Author: Jennifer, Hettema, Julie, Steele, and William R, Miller
Subjects: Psychotherapy, Motivation, Psychiatry and Mental health, Clinical Psychology, Treatment Outcome, Substance-Related Disorders, Interview, Psychological, Humans, Regression Analysis, General Medicine
Abstract: Motivational interviewing (MI) is a client-centered, directive therapeutic style to enhance readiness for change by helping clients explore and resolve ambivalence. An evolution of Rogers's person-centered counseling approach, MI elicits the client's own motivations for change. The rapidly growing evidence base for MI is summarized in a new meta-analysis of 72 clinical trials spanning a range of target problems. The average short-term between-group effect size of MI was 0.77, decreasing to 0.30 at follow-ups to one year. Observed effect sizes of MI were larger with ethnic minority populations, and when the practice of MI was not manual-guided. The highly variable effectiveness of MI across providers, populations, target problems, and settings suggests a need to understand and specify how MI exerts its effects. Progress toward a theory of MI is described, as is research on how clinicians develop proficiency in this method.
Published: 2005

21. Botulinum toxin improves sialorrhea and quality of living in bulbar amyotrophic lateral sclerosis

Author: Julie Steele and Ashok Verma
Subjects: Male, medicine.medical_specialty, Botulinum Toxins, Physiology, Drooling, Injections, Central nervous system disease, Cellular and Molecular Neuroscience, stomatognathic system, Quality of life, Physiology (medical), medicine, Humans, Parotid Gland, Prospective Studies, Amyotrophic lateral sclerosis, Adverse effect, Aged, Sialorrhea, Anti-Dyskinesia Agents, business.industry, Amyotrophic Lateral Sclerosis, medicine.disease, Botulinum toxin, Surgery, Parotid gland, Treatment Outcome, medicine.anatomical_structure, Anesthesia, Quality of Life, Female, Neurology (clinical), medicine.symptom, business, medicine.drug
Abstract: Sialorrhea is frequently a socially disabling symptom in patients with bulbar amyotrophic lateral sclerosis (ALS). In this open-label prospective study, we report the effect of botulinum toxin A (Botox) injection into the parotid glands in 10 patients with bulbar ALS and socially disabling sialorrhea. We applied three different outcome measures to determine the effect of Botox therapy on sialorrhea. Botox significantly improved the degree of sialorrhea and a drooling impact score and, by inference, the quality of living, in over half of the patients with bulbar ALS and severe sialorrhea. The beneficial effect of Botox lasted for at least 2 months in those who responded. No major adverse effects were noted. Local injection of a small dose of Botox into the parotid glands can control sialorrhea and potentially improve living quality in some patients with bulbar ALS.
Published: 2006

22. Designing Data Visualizations : Representing Informational Relationships

Author: Noah Iliinsky, Julie Steele, Noah Iliinsky, and Julie Steele
Subjects: Information visualization
Abstract: Data visualization is an efficient and effective medium for communicating large amounts of information, but the design process can often seem like an unexplainable creative endeavor. This concise book aims to demystify the design process by showing you how to use a linear decision-making process to encode your information visually.Delve into different kinds of visualization, including infographics and visual art, and explore the influences at work in each one. Then learn how to apply these concepts to your design process.Learn data visualization classifications, including explanatory, exploratory, and hybridDiscover how three fundamental influences—the designer, the reader, and the data—shape what you createLearn how to describe the specific goal of your visualization and identify the supporting dataDecide the spatial position of your visual entities with axesEncode the various dimensions of your data with appropriate visual properties, such as shape and colorSee visualization best practices and suggestions for encoding various specific data types
Published: 2011

23. Interviews

Author: Barbara S. McCrady, Benjamin O. Ladd, Julie Steele, and Leah Vermont and
Subjects: Psychology
Published: 2010

24. Placental mesenchymal dysplasia is associated with high rates of intrauterine growth restriction and fetal demise: A report of 11 new cases and a review of the literature

Author: Julie Steele, Carla Stayboldt, Kurt Benirschke, Truc T. Pham, and Linda Chan
Subjects: Adult, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, Beckwith-Wiedemann Syndrome, Placenta Diseases, Placenta, Intrauterine growth restriction, Gestational Age, Abnormal chorionic villi, Placental Mesenchymal Dysplasia, Ultrasonography, Prenatal, Pathogenesis, Mesoderm, Pregnancy, medicine, Humans, Fetal Death, reproductive and urinary physiology, Partial Hydatidiform Mole, Gynecology, High rate, Fetal Growth Retardation, Obstetrics, business.industry, General Medicine, medicine.disease, embryonic structures, Fetal Demise, Female, Neonatal death, Chorionic Villi, business
Abstract: Placental mesenchymal dysplasia (PMD) is a rare condition of placentomegaly and abnormal chorionic villi often clinically mistakenly as partial hydatidiform mole. However, it is clinicopathologically distinct with high incidence of intrauterine growth restriction (IUGR) and fetal death. This study presents 11 new PMD cases and provides a meta-analysis of the associated IUGR and fetal death rates. The cases were identified between 1971 and 2005, mostly from consultation files. To our knowledge, 71 PMD cases have previously been reported; 15 of these were associated with Beckwith-Wiedemann syndrome (BWS). With the addition of our new results, among all cases without BWS, 50% had IUGR and 43% had intrauterine fetal demise (IUFD) or neonatal death. Females represented 82% of cases. Thus, PMD is associated with high IUGR and IUFD/neonatal death rates and disproportionally affects females. The cause and pathogenesis are yet unknown. The current understanding and hypotheses involving PMD are discussed.
Published: 2006

25. A Phase I safety study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis

Author: Ricardo Prado, Julie Steele, Miguel A. Perez-Pinzon, Kristopher L E Arheart, Luis A. Matos, Raul Busto, Walter G. Bradley, and Eustorgio A. Lopez
Subjects: Male, medicine.medical_specialty, Weakness, Isometric exercise, chemistry.chemical_compound, Hyperbaric oxygen, medicine, Humans, Increased fatigue, In patient, Amyotrophic lateral sclerosis, Aged, Hyperbaric Oxygenation, business.industry, Amyotrophic Lateral Sclerosis, Middle Aged, medicine.disease, Surgery, Vascular endothelial growth factor, chemistry, Mitochondrial abnormalities, Anesthesia, Linear Models, Female, Neurology (clinical), medicine.symptom, business
Abstract: Vascular endothelial growth factor and mitochondrial abnormalities have been described in ALS and its animal models. We have reported that hyperbaric oxygen (HBO) treatment delayed the onset of weakness in the wobbler mouse.To perform a Phase I safety study of HBO in patients with ALS.Five patients with ALS were treated for 60min with 100% oxygen at 2 atmospheres pressure daily for five days a week for four weeks. The patients reported any deterioration in their condition after each treatment, and their neurological condition was measured serially during the four weeks of the treatment, and for four further weeks.Four patients reported decreased fatigue, while one patient dropped out at three weeks because of increased fatigue. Maximum isometric voluntary contraction (MVIC) of all muscle groups except right hand grip improved significantly by up to 97%. Most improvement occurred during the four weeks after treatment. It is possible that the improvement in muscle strength was a placebo or a learning effect, though no such effects have been detected in prior therapeutic trials in ALS using MVIC. No change was detected in other measures of neuromuscular function.A longer duration, placebo controlled trial in a larger number of patients is needed to determine the safety and efficacy of HBO. Until that is completed, it is not recommended that ALS patients should be treated with HBO.
Published: 2005

26. Analysis and design of developable surfaces for shipbuilding

Author: Chalfant, Julie Steele and Chalfant, Julie Steele
Abstract: Developable surfaces are widely used in manufacturing with materials that are not amenable to stretching. Applications include the formation of ship hulls, ducts, shoes, clothing and automobile parts such as upholstery and body panels. In shipbuilding, developable surfaces are shaped using only rollers or presses. Heat treatment is then used only to remove distortion induced by welding or other means. Doubly curved surfaces, on the other hand, must be heat treated after rolling to induce the additional curvature. The heat treatment is normally done by hand, by a skilled artisan with years of training to achieve the correct amount of bending. This is an extremely time consuming, labor intensive and thus expensive process. According to Avondale/IHI Shipbuilding Technology Transfer data for a tanker, only 15.1% of the curved plates in a ship hull are singly curved, while 65.8% of the plates are doubly curved, requiring roller and heat treatment processes. An intensive effort to increase the amount of developable surfaces in the hulls of merchant ships at Burmeister & Wain Shipyard has resulted in a reported 20% reduction in manhours required to produce a hull. Designing a ship entirely of singly curved, or developable, surfaces would reduce construction costs even more. The main goal of this research is to develop a user-friendly method of designing developable surfaces with a B-spline representation. The effort is then extended to address some common differential geometry properties that will be useful in the design and manufacturing process. The ultimate goal is to provide a method to design a complete ship hull from developable surfaces and to generate cutting and bending information in a format that is user friendly for both the engineer and the worker. Although this thesis does not go that far, it takes a major step toward this goal, http://archive.org/details/analysisnddesign109457877
Published: 2012

27. Negative results of a phase II study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis

Author: Deepti Zutshi, Julie Steele, and Walter G. Bradley
Subjects: business.industry, Treatment outcome, Follow up studies, Phases of clinical research, General Medicine, medicine.disease, humanities, law.invention, Phase i study, Clinical trial, Hyperbaric oxygen, Neurology, Randomized controlled trial, law, Anesthesia, Medicine, Neurology (clinical), Amyotrophic lateral sclerosis, business
Abstract: Dear Sir,We reported the results of a phase I study of hyperbaric oxygen therapy (HBOT) in amyotrophic lateral sclerosis (ALS) in this journal in 2004 [1]. Although that report described a pilot st...
Published: 2007

28. Three-dimensional object registration using wavelet features

Author: Nicholas M. Patrikalakis., Massachusetts Institute of Technology. Dept. of Mechanical Engineering., Chalfant, Julie Steele, Nicholas M. Patrikalakis., Massachusetts Institute of Technology. Dept. of Mechanical Engineering., and Chalfant, Julie Steele
Abstract: Thesis (Ph. D.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2008., Includes bibliographical references (p. 97-109)., Recent developments in shape-based modeling and data acquisition have brought three-dimensional models to the forefront of computer graphics and visualization research. New data acquisition methods are producing large numbers of models in a variety of fields. Three-dimensional shape-based matching and registration (alignment) are key to the useful application of such models in areas from automated surface inspection to cancer detection and surgery. The three-dimensional models in these applications are typically huge. State-of-the-art simulations in computational fluid dynamics produce upward of four terabytes of data per second of flow. Research-level magnetic resonance imaging (MRI) resolutions can reach 1 cubic micro-meter. As a result, object registration and matching algorithms must handle very large amounts of data. The algorithms developed in this thesis accomplish automatic registration and matching of three-dimensional voxelized models. We employ features in a wavelet transform domain to accomplish registration. The features are extracted in a multiresolutional format, thus delineating features at various scales for robust and rapid matching. Registration is achieved through seeking peaks in sets of rotation quaternions using a voting scheme, then separately identifying translation. The method is robust to occlusion, clutter and noise. The efficacy of the algorithm is demonstrated through examples from solid modeling and medical imaging applications., by Julie S. Chalfant., Ph.D.
Published: 2008

29. Abstract 5251: CXCL14 as a functional determinant in a novel model of inflammatory, triple negative breast cancer progression

Author: Sarah S. Murray, Jane Forsyth, Joan Kroener, Vaughn V. Smider, Julie Steele, Melissa Ritland, Brunhilde Felding-Habermann, Dhara MacDermed, Deirdre O'Sullivan, Mihaela Lorger, and Ali Torkamani
Subjects: Oncology, Cancer Research, medicine.medical_specialty, business.industry, medicine.medical_treatment, Cancer, medicine.disease, Primary tumor, Cytokine, Breast cancer, Internal medicine, Cancer cell, medicine, Cancer research, Bioluminescence imaging, business, CXCL14, Triple-negative breast cancer
Abstract: CXCL14 (BRAK) is a cytokine implicated in inflammatory responses, but its contribution to cancer is largely unknown. Recent studies in clinical breast cancer indicate an association between CXCL14 expression and shortened time to metastatic progression, as well as the presence of CXCL14 in a subset of breast epithelial cells with a stem-like phenotype. Using global gene expression profiling, we identified CXCL14 as the most prominently upregulated cytokine in a novel progression model of triple-negative inflammatory and metaplastic breast cancer that we generated. The model comprises tumor cells established from a locally aggressive primary tumor obtained from a patient at the time of initial surgery (TES-1), and tumor cells from the same site at the time of local failure in the chest wall after chemo and radiation therapy (TES-2b). In contrast to TES-1, TES-2b cells are tumorigenic in immuno deficient mice and can be followed and quantified by non-invasive bioluminescence imaging after injecting the F-luc tagged cancer cells into the 4th mammary fat pad. Illumina microarray analysis revealed a 66-fold increase in CXCL14 expression in TES-2b cells over TES-1 cells, ranking it as one of the top 25 genes most differentially expressed among over 25,000 identified gene transcripts. We validated CXCL14 overexpression in TES-2b cells by real time PCR (TaqMan) (64 fold), and found a significant increase in CXCL14 protein secretion in cultured TES-2b cells (3.8 fold) by immuno-capture ELISA. To address a functional role in CXCL14 in the progression of these aggressive breast cancer cells, we stably reduced CXCL14 expression in TES-2b cells by lentiviral transduction with small interfering RNA and confirmed an 80% reduction in gene expression. CXCL14 protein production was concomitantly reduced 2.7 fold. Importantly, xenograft studies revealed a critical role of CXCL14 in the in vivo growth behavior of these breast cancer cells, as the tumor growth rate in the mammary fat pad of CXCL14 knock-down cells was significantly reduced compared to scrambled control vector treated cells. After injecting 5×105 F-luc tagged tumor cells, 4/6 mice had tumors measuring 10 mm in diameter after 11 weeks (requiring sacrifice of the animals) compared with 1/6 in the CXCL14 knock-down group. These initial results indicate a critical role of tumor cell derived CXCL14 in the in vivo survival and proliferation of these breast cancer cells. Our findings provide a basis for further analyses of CXCL14 in breast cancer progression in vivo and for detailed studies of the mechanisms through which CXCL14 may promote disease progression of highly aggressive triple-negative breast cancer. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr 5251. doi:10.1158/1538-7445.AM2011-5251
Published: 2011

30. Analysis and design of developable surfaces for shipbuilding

Author: Chalfant, Julie Steele and Chalfant, Julie Steele
Abstract: Developable surfaces are widely used in manufacturing with materials that are not amenable to stretching. Applications include the formation of ship hulls, ducts, shoes, clothing and automobile parts such as upholstery and body panels. In shipbuilding, developable surfaces are shaped using only rollers or presses. Heat treatment is then used only to remove distortion induced by welding or other means. Doubly curved surfaces, on the other hand, must be heat treated after rolling to induce the additional curvature. The heat treatment is normally done by hand, by a skilled artisan with years of training to achieve the correct amount of bending. This is an extremely time consuming, labor intensive and thus expensive process. According to Avondale/IHI Shipbuilding Technology Transfer data for a tanker, only 15.1% of the curved plates in a ship hull are singly curved, while 65.8% of the plates are doubly curved, requiring roller and heat treatment processes. An intensive effort to increase the amount of developable surfaces in the hulls of merchant ships at Burmeister & Wain Shipyard has resulted in a reported 20% reduction in manhours required to produce a hull. Designing a ship entirely of singly curved, or developable, surfaces would reduce construction costs even more. The main goal of this research is to develop a user-friendly method of designing developable surfaces with a B-spline representation. The effort is then extended to address some common differential geometry properties that will be useful in the design and manufacturing process. The ultimate goal is to provide a method to design a complete ship hull from developable surfaces and to generate cutting and bending information in a format that is user friendly for both the engineer and the worker. Although this thesis does not go that far, it takes a major step toward this goal
Published: 1997

31. I.V. CATHETERS

Author: Julie Steele
Subjects: Advanced and Specialized Nursing, Physics, Assessment and Diagnosis, Emergency Nursing, LPN and LVN, Critical Care Nursing, Biomedical engineering
Published: 1990

32. Wearable textile biofeedback systems: Are they too intelligent for the wearer?

Author: Munro, B. J., Julie Steele, Toni Campbell, and Gordon Wallace

33. The occurrence, causes and perceived performance effects of breast injuries in elite female athletes

Author: Brisbine, B. R., Julie Steele, Phillips, E. J., and Deirdre McGhee

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33 results on '"Julie Steele"'

1. Patient Perceptions Of Physical Rehabilitation And Its Method Of Delivery For A Variety Of Adverse Physical Effects Following Breast Cancer Surgery

2. ESMO / ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2016

3. How much error is associated with calculating breast volume from three-dimensional breast scans obtained when women are standing? Implications for bra design and bra fit

4. Long-term lessons learned in biomechanics: 2021 Geoffrey Dyson Lecture

5. Short bowel syndrome in infancy: recent advances and practical management

6. Evaluation of an Opioid-Free Anesthesia Protocol for Elective Abdominal Surgery in a Community Hospital

7. Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

8. Moves for Launching a New Year of Student-Centered Coaching

9. Expanding the Design Space Explored by S3D

10. Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study

11. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study

12. How good is quality-of-life for children receiving home parenteral nutrition? – A pilot study

13. Seven-Year Experience From the National Institute of Neurological Disorders and Stroke–Supported Network for Excellence in Neuroscience Clinical Trials

14. NOx emissions from a Central California dairy

15. Motor neuron involvement in multisystem proteinopathy: Implications for ALS

16. ESMO/ASCO recommendations for a Global Curriculum (GC) in medical oncology-edition 2016

17. Racecadotril May Reduce Diarrhoea in Microvillous Inclusion Disease

18. PD03-07: Breast Cancer Heterogeneity and Treatment Resistance: Clues from Metaplastic Tumors

19. Advocating for Optimal Listening in the Classroom

20. Motivational Interviewing

21. Botulinum toxin improves sialorrhea and quality of living in bulbar amyotrophic lateral sclerosis

22. Designing Data Visualizations : Representing Informational Relationships

23. Interviews

24. Placental mesenchymal dysplasia is associated with high rates of intrauterine growth restriction and fetal demise: A report of 11 new cases and a review of the literature

25. A Phase I safety study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis

26. Analysis and design of developable surfaces for shipbuilding

27. Negative results of a phase II study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis

28. Three-dimensional object registration using wavelet features

29. Abstract 5251: CXCL14 as a functional determinant in a novel model of inflammatory, triple negative breast cancer progression

30. Analysis and design of developable surfaces for shipbuilding

31. I.V. CATHETERS

32. Wearable textile biofeedback systems: Are they too intelligent for the wearer?

33. The occurrence, causes and perceived performance effects of breast injuries in elite female athletes

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33 results on '"Julie Steele"'

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