Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial

Autor: Hugh Montgomery, F D Richard Hobbs, Francisco Padilla, Douglas Arbetter, Alison Templeton, Seth Seegobin, Kenneth Kim, Jesus Abraham Simón Campos, Rosalinda H Arends, Bryan H Brodek, Dennis Brooks, Pedro Garbes, Julieta Jimenez, Gavin C K W Koh, Kelly W Padilla, Katie Streicher, Rolando M Viani, Vijay Alagappan, Menelas N Pangalos, Mark T Esser, Wakana Abe, Tania Adan De Varona, Daria Adiatullina, Daniel Aguilar Zapata, Kevin Ahlers, Carolina Aimo, Ayoade Akere, Elena Akimova, Jorge Alatorre Alexander, Logan Aldrich, Ismael Ali Garcia, Karim Ali García, Lee Allison, Rosa Alonso Zuñiga, Ivan Aloysius, Javier Altclas, Andres Alvarisqueta, Martti Antila, Camila Anton, Elisabet Árboix Alamo, Samir Arora, Ramón Alejandro Avilés Felix, Natalya Bakhtina, Varenka Barbero-Becerra, Armando Barragan-Reyes, Alejandro Barreira, Mitchell Barrett, Jiri Beran, Nikolett Berki, Viktoria Berki, Richard Betten, Claudia Binelli, Lenka Brunzová, Cecilia Bussolari, Karianna Byargeon, Justyna Bytnar, Carlos Camberos, Pedro Campos Corzo, Grazia Cannon, Valentina Canovi, Simone Carla da Rosa, Ana Caroline Moser, Luis Carrera Rivas, Marcelo Martin Casas, Paulo Castañeda-Méndez, Ana Cavalcante, Eugenia Cherepova, Alexei Chermenskii, Lauren Clark, Mauro Codeluppi, Flavia Coelho, Belinda Contreras, Alex Cran, Taylor Dao, Chrisette Dharma, Cosimo Di Castri, Victoria Diaz Balocchi, Omar Durán, Kara Earl, Adam Ellery, Tomoko Endo, Andrea Everding, Rainald Fischer, Benedito Fonseca, Chelsea C. Franklin, Susan-Beatrice Franz, Anna Fumagalli, Mauricio Galindo-Amaya, Mariagiulia Galli, Laura Gerna, Karolly Gil Ureña, Henrikki Gomes Antila, Laura Ines Gomes Maricato, Gabriela Goncalvez, Martin Gonzalez, Jesús González-Lama, Stephen Granier, Jacob Granier, Stephan Grunwald, David Guardeño-Ropero, Monica Guberti, Sridhar Guduri, Carolina Guerrero García, Jehad Haggiagi, Kacie Hale, Toshimasa Hayashi, Maiara Hermes, Dante Hernandez Colin, Yuji Hirai, Masayuki Hojo, Tetsuya Homma, Billy Hour, Andreas Huber, Diego Iacovelli, Noriomi Ishibashi, Yutaro Iwabe, Shinyu Izumi, Arne Jessen, Heiko Jessen, Wilner Jeudy, Marta Jiménez Marcos, Rebecca Johnson, Eva Juárez-Hernández, Kiyomi Kabasawa, Katarzyna Kamińska, Megumi Kawabe, Angela Kemp, Oleg Khmelnitskiy, Carina Klassen, Olena Kobrynska, Pavel Koleckar, Stephanie Korn, Marc Kornmann, Viktor Kostenko, Evgenii Kovalchuk, Yana Kovalchuk, Tim Kümmerle, Ulrike Lachmund, Kerstin Lammersmann, Flávio Lastebasse, Ivana Lattuada, Felicitas Lauer, Kyrylo Lebed, Olga Lebed, Diego Lecona-Garcia, Maria Christina Leoni, Marina Lima, Raymond Little, Holly Little, Andrea Lizardi-Díaz, Michele Lobo-Becker, Francesco Luppi, Veronica Macias, Shigefumi Maesaki, Cristiano Magnaghi, Annalisa Mancini, Stanisław Mazur, Tatiana Melnikova, Sergio Menchaca, Ibrahim Menendez-Perez, Ewa Międlar, Shuuichi Mizunuma, Anastasiya Mochalova, Mihad Mohamed, Theresa Moll, Camila Montalvo, Amber Mottola, Birgit Mück, Rebeca Mussi Brugnolli, Akanksha Nanda, Dörthe Neuner, Agatha Ngwueke, Sebastian Noe, Martin Novacek, Laura Nuzzolo-Shihadeh, Emeka Obiekwe, Isaias G. Ocampo Gaytán, Norio Ohmagari, Shin Ohta, Ptuonye Onyewuchi, Iurii Pankov, Maurício Pedrosa, Yael Peré, Alejandro Pereyra, Eliana Perez, Eduardo Perez-Alba, Paloma Perpiña Lozano, Tanya Perrei, Dena Peterson, Ligia Pierroti, Felipe Pineda-Cárdenas, Teresa Plascencia Sanchez, Camila Poletti, Chiara Pomaranzi, Lisette Portes, Nils Postel, Monica Ramirez, Isabel Ramírez, Miguel Ramirez-Baena, Mahadev Ramjee, Giovanna Ratti, Jackie Reeve, Petr Reichert, Petra Reichertová, Edgar Alejandro Reyes Garcia, Celso Ricardo, Nicomedes Rodríguez Rodríguez, Jaun Roldán Sánchez, Matilde Romero-Lopez, Tyrone Rosales, Harvey Rosales, Mohamed Roshan, Simran Roshan, Patrizia Rovere Querini, Heather Rutter, Sadaf Sachwani, Hironori Sagara, Jun Sakai, Nina Samson, José Héctor Sánchez Mijangos, Liliana Sánchez, Ana Sánchez-González, Micko Sandford, Laura Santana, Felipe Santos de Carvalho, Reiko Sasao, Lubna Sato, Elizabeth Scheuermann, Olaf Schmidt, Masafumi Seki, Safia Shaikh, Daishi Shimada, Masaharu Shinkai, Masahiro Shinoda, Jackie Smith, Fernando Solorzano, Silvia Soncini, Katalin Soregine, Erica Sosa, Olalekan Sowade, Veronika Špinková, Ruth Staniford, Iska Steigemann, Vivien Steiner, Vladimir Strelkov, Cintya R. Suárez Pineda, Hiroki Suenaga, Shintaro Suzaki, Hannah Swayze, Yuji Tada, Yuichiro Takeshita, Yasuo Takiguchi, Akihiko Tanaka, Norihito Tarumoto, Albina Tatarintseva, Michelle Taubert, Elizaveta Terenya, César Tinoco, Tomohiro Tomiyasu, Gladys Torres-Vidal, Gabriela Trejo-Aguiar, Kenji Tsushima, Emma Tunstall, Caterina Turrà, Yoandy Valdes, Nelly Valencia Castro, Guilherme Visconti, Giordano Vitali, Apinya Vutikullird, Jezdancher Watti, Doreen Werth, Cheyanne Wilson, Philippe Wilson, Amy Workman, Pamela Wörle, Christoph Wyen, Yoshiko Yamaguchi, Kei Yamamoto

Background: Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody combination, tixagevimab–cilgavimab, to non-hospitalised adults with mild to moderate COVID-19 has potential to prevent disease progression. We aimed to e

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d94fa5ffbc73770cc232f4cba4d22465
https://ora.ox.ac.uk/objects/uuid:a692f8eb-aeed-49a1-a1a8-3275e433517b

Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial

Autor: Markus P Schlaich, Marc Bellet, Michael A Weber, Parisa Danaietash, George L Bakris, John M Flack, Roland F Dreier, Mouna Sassi-Sayadi, Lloyd P Haskell, Krzysztof Narkiewicz, Ji-Guang Wang, Christopher Reid, Markus Schlaich, Ivor Katz, Andrew Ajani, Sinjini Biswas, Murray Esler, Grahame Elder, Simon Roger, David Colquhoun, John Mooney, Tine De Backer, Alexandre Persu, Martin Chaumont, Jean-Marie Krzesinski, Thomas Vanassche, Ginette Girard, Lew Pliamm, Ernesto Schiffrin, Fatima Merali, George Dresser, Michel Vallee, Shivinder Jolly, Stephen Chow, Jiguang Wang, Jianjun Mu, Jing Yu, Hong Yuan, Yingqing Feng, Xin Zhang, Jianhong Xie, Ling Lin, Miroslav Soucek, Jiri Widimsky, Renata Cifkova, Jan Vaclavik, Martin Ullrych, Martin Lukac, Ivan Rychlik, Thomas Guldager Lauridsen, Ilkka Kantola, Jyrki Taurio, Olavi Ukkola, Olivier Ormezzano, Philippe Gosse, Michel Azizi, Pierre-Yves Courand, Pascal Delsart, Jean Michel Tartiere, Felix Mahfoud, Roland Schmieder, Johannes Stegbauer, Philipp Lurz, Michael Koziolek, Christian Ott, Nicole Toursarkissian, Konstantinos Tsioufis, Konstantinos Kyfnidis, Athanasios Manolis, Sotirios Patsilinakos, Pantelis Zebekakis, Apostolos Karavidas, Pall Denes, Katalin Bezzegh, Marianna Zsom, Laszlo Kovacs, Yehonatan Sharabi, Mazen Elias, Ivetta Sukholutsky, Chaim Yosefy, Irina Kenis, Shaul Atar, Massimo Volpe, Muiesan Maria Lorenza, Stefano Taddei, Guido Grassi, Franco Veglio, Jung Woo Son, Jang-Young Kim, Joong-Il Park, Chang Hoon Lee, Hae-Young Lee, Rasa Raugaliene, Jolanta Elena Marcinkeviciene, Roma Kavaliauskiene, Jaap Deinum, Abraham Kroon, Bert-Jan van den Born, Andrzej Januszewicz, Andrzej Tykarski, Jolanta Walczewska, Zbigniew Gaciong, Andrzej Wiecek, Marzena Chrostowska, Andrzej Kleinrok, Jan Krekora, Grzegorz Kania, Anna Podrazka-Szczepaniak, Cezary Golawski, Maciej Podziewski, Barbara Kaczmarek, Grzegorz Skoczylas, Andrzej Wilkolaski, Iwona Wozniak, Marzena Janik-Palazzolo, Barbara Rewerska, Aleksandra Konradi, Yuriy Shvarts, Tamara Pecherina, Konstantin Nikolaev, Gapon Liudmila, Olga Orlikova, Viktor Mordovin, Natalia Petrochenkova, Gadel Kamalov, Elena Kosmacheva, Vadim Tyrenko, Vladimir Gorbunov, Andrey Obrezan, Tatiana Supryadkina, Irina Ler, Oleg Kotenko, Anatoly Kuzin, Fernando Martínez García, Josep Redon, Anna Oliveras, Luis Beltran Romero, Valerii Shatylo, Leonid Rudenko, Andriy Bazylevych, Yurii Rudyk, Oleksandr Karpenko, Mykola Stanislavchuk, Vira Tseluyko, Mykola Kushnir, Ervin Asanov, Yuriy Sirenko, Andriy Yagensky, David Collier, Pankaj Gupta, David Webb, Mary MacLeod, James McLay, Aaron Peace, Samir Arora, Patricia Buchanan, Robert Harris, Ronald Degarmo, Mario Guillen, Adam Karns, Joel Neutel, Yogesh Paliwal, Karlton Pettis, Phillip D. Toth, Jeffrey M. Wayne, Michael Bain Butcher, Phillip M. Diller, Suzanne Oparil, David Calhoun, Donald Brautigam, John Flack, Jesse M. Goldman, Arash Rashidi, Nabeel Aslam, William Haley, Nabil Andrawis, Brian Lang, Randy Miller, James Powell, Robert Dewhurst, James Pritchard, Dinesh Khanna, Dennis Tang, Nashwa Gabra, Jean Park, Conigliaro Jones, Cranford Scott, Blanca Luna, Murtaza Mussaji, Ravi Bhagwat, Michael Bauer, John McGinty, Rajesh Nambiar, Renee Sangrigoli, William Ross Davis, William Eaves, Frank McGrew, Ahmed Awad, Eric Bolster, David Scott, Paramjit Kalirao, Pascal Dabel, Wesley Calhoun, Steven Gouge, Mark Warren, Mary Katherine Lawrence, Aamir Jamal, Mohamed El-Shahawy, Carlos Mercado, Jayant Kumar, Pedro Velasquez-Mieyer, Robert Busch, Todd Lewis, Lisa Rich

Publikováno v: The Lancet (London), 400, 1927-1937
The Lancet, 400(10367), 1927-1937. Elsevier Limited
The Lancet (London), 400, 10367, pp. 1927-1937

Contains fulltext : 286841.pdf (Publisher’s version ) (Closed access) BACKGROUND: Resistant hypertension is associated with increased cardiovascular risk. The endothelin pathway has been implicated in the pathogenesis of hypertension, but it is cur

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a8661784163094e06b4019a9c7edb043
http://hdl.handle.net/2066/286841

Immunogenicity and safety of a 3-antigen hepatitis B vaccine vs a single-antigen hepatitis B vaccine : a phase 3 randomized clinical trial

Autor: Johanna Spaans, Bebi Yassin-Rajkumar, Peter Ruane, Timo Vesikari, Saul N. Faust, Amina Z Haggag, Bruce Rankin, Benita Ukkonen, Michael Levin, Michael Manns, Satu Kokko, Gerald Vallieres, Carl Griffin, David E. Anderson, Vlad Popovic, Francisco Diaz-Mitoma, Mary B Manning, Azhar Toma, Hamilton Sah, Clancy L. Cone, Nathalie Machluf, Nathan Segall, Williams Hayes, Mark A. Turner, Aino Forsten, Outi Laajalahti, Maija Rössi, Anitta Ahonen, Mark E Kutner, Naveen Garg, M N Ramasamy, Adam Finn, Isabel Leroux-Roels, Olli Henriksson, Dennis Reich, Geert Leroux-Roels, Pierre Van Damme, Pauliina Paavola, Catherine Cosgrove, Barbara E. Rizzardi, Ilkka Seppä, Ronnie Aronson, Samir Arora

Publikováno v: JAMA NETWORK OPEN
JAMA Network Open
Vesikari, T, Finn, A, van Damme, P, Leroux-Roels, I, Leroux-Roels, G, Segall, N, Toma, A, Vallieres, G, Aronson, R, Reich, D, Arora, S, Ruane, P J, Cone, C L, Manns, M, Cosgrove, C, Faust, S N, Ramasamy, M N, Machluf, N, Spaans, J N, Yassin-Rajkumar, B, Anderson, D, Popovic, V, Diaz-Mitoma, F 2021, ' Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine : A Phase 3 Randomized Clinical Trial ', JAMA Network Open, vol. 4, no. 10, e2128652, pp. e2128652 . https://doi.org/10.1001/jamanetworkopen.2021.28652
JAMA Netw Open

Importance There is a need for improved immunogenicity of hepatitis B virus (HBV) vaccines among young adults with risk of infection. Objectives To demonstrate manufacturing equivalence of a 3-antigen (3A) HBV vaccine, evaluate noninferiority of sero

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6fb4f067c6f9010c585085536e06f1af
https://hdl.handle.net/1854/LU-8759301

579: SAFETY, TOLERABILITY AND PHARMACODYNAMIC ASSESSMENT OF KAN-101, A NOVEL LIVER-TARGETED THERAPY TO INDUCE IMMUNOLOGICAL TOLERANCE TO GLIADIN IN CELIAC DISEASE

Autor: Joseph A. Murray, Karen Dunn, Samir Arora, Peter Winkle, Kaela E. Goldstein, Simon Cooper, Rajesh Manchanda, Stephan Kontos, Kristie M. Grebe

Publikováno v: Gastroenterology. 162:S-141

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::07a46795fb7d4999eae99e0af5bbf8e7
https://doi.org/10.1016/s0016-5085(22)60341-x

Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA

Autor: Rongchang Chen, Yasuhiro Gon, Ubaldo J. Martin, David Collier, Nanshan Zhong, Brian Lipworth, Colin Reisner, Koichi Nishi, Samir Arora, Andrea Maes, Shahid Siddiqui

Publikováno v: International Journal of Chronic Obstructive Pulmonary Disease

Brian J Lipworth,1 David J Collier,2 Yasuhiro Gon,3 Nanshan Zhong,4 Koichi Nishi,5 Rongchang Chen,4 Samir Arora,6 Andrea Maes,7 Shahid Siddiqui,8 Colin Reisner,7,8 Ubaldo J Martin8 1Scottish Centre for Respiratory Research, Ninewells Hospital, Univer

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9c2caaa8eb8d728130893c266aab3c96
http://europepmc.org/articles/PMC6167125