Pharmacokinetics and predicted neutralisation coverage of VRC01 in HIV-uninfected participants of the Antibody Mediated Prevention (AMP) trials by Yunda Huang, Logashvari Naidoo, Lily Zhang, Lindsay N. Carpp, Erika Rudnicki, April Randhawa, Pedro Gonzales, Adrian McDermott, Julie Ledgerwood, Margarita M.Gomez Lorenzo, David Burns, Allan DeCamp, Michal Juraska, John Mascola, Srilatha Edupuganti, Nyaradzo Mgodi, Myron Cohen, Lawrence Corey, Philip Andrew, Shelly Karuna, Peter B. Gilbert, Kathryn Mngadi, Erica Lazarus

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Exposure to the antiretroviral drug dolutegravir impairs structure and neurogenesis in a forebrain organoid model of human embryonic cortical development by Emma LaNoce, Daniel Y. Zhang, Alan Garcia-Epelboim, Yijing Su, Yijing Su, Yusha Sun, Yusha Sun, Giana Alepa, Angelina R. Angelucci, Cagla Akay-Espinoza, Kelly L. Jordan-Sciutto, Hongjun Song, Hongjun Song, Hongjun Song, Hongjun Song, Hongjun Song, Guo-li Ming, Guo-li Ming, Guo-li Ming, Guo-li Ming, Kimberly M. Christian

“…IntroductionFor many therapeutic drugs, including antiretroviral drugs used to treat people living with HIV-1 (PLWH), we have little data on the potential effects on the developing human brain due to limited access to tissue and historical constraints on the inclusion of pregnant populations in clinical trials. Human induced pluripotent stem cells (iPSCs) offer a new avenue to gain insight on how drugs may impact human cell types representative of the developing central nervous system. …”
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Venetoclax resistance induced by activated T cells can be counteracted by sphingosine kinase inhibitors in chronic lymphocytic leukemia by Valeria J. Sarapura Martinez, Brenda Buonincontro, Chiara Cassarino, Juliana Bernatowiez, Ana Colado, Gregorio Cordini, Gregorio Cordini, Maria del Rosario Custidiano, Carolina Mahuad, Miguel A. Pavlovsky, Raimundo F. Bezares, Nicolás O. Favale, Nicolás O. Favale, Mónica Vermeulen, Mónica Vermeulen, Mercedes Borge, Mercedes Borge, Mirta Giordano, Mirta Giordano, Romina Gamberale, Romina Gamberale

“…To this aim we employed the dual SPHK1/2 inhibitor SKI-II and opaganib, a SPHK2 inhibitor that is being studied in clinical trials. We found that SPHK inhibitors reduce the activation of CLL cells and the generation of venetoclax resistance induced by activated T cells mainly due to a reduced upregulation of BCL-XL. …”
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Prepackaged formula low-residue diet vs. self-prepared low-residue diet before colonoscopy: A multicenter randomized controlled trial by Peng Pan, Lun Gu, Shengbing Zhao, Shuling Wang, Jiayi Ma, Hongyu Fu, Youxiang Chen, Shuixiang He, Zibin Tian, Le Xu, Zhijie Feng, Yanqing Li, Zhuo Yang, Lei Yang, Wen Wang, Qian Hou, Ting Liu, Chujun Li, Dean Tian, Xiaodi Wang, Yongmei Gao, Hanping Shi, Yu Bai, Zhaoshen Li

“…The trial was registered at ClinicalTrials.gov under the identifier NCT03943758.ResultsA total of 550 subjects were recruited. …”
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Identification of hub biomarkers of myocardial infarction by single-cell sequencing, bioinformatics, and machine learning by Qunhui Zhang, Qunhui Zhang, Yang Guo, Yang Guo, Benyin Zhang, Hairui Liu, Yanfeng Peng, Di Wang, Dejun Zhang, Dejun Zhang

“…Machine learning algorithms have a wide scope of utilization in biomedicine and have demonstrated superior efficiency in clinical trials. However, few studies integrate these three methods to investigate the role of mRNA in MI. …”
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Clinical advantage of targeted sequencing for unbiased tumor mutational burden estimation in samples with low tumor purity by Nayoung K D Kim, Woong-Yang Park, Sehhoon Park, Se-Hoon Lee, Jin Seok Ahn, Myung-Ju Ahn, Keunchil Park, Jong-Mu Sun, Boram Lee, Tae Hee Hong, Hongui Cha, Joon Ho Shim, Jongsuk Chung, Chung Lee, Yoon-La Choi, Soohyun Hwang, Yoomi Lee, Hyun Ae Jung, Ji-Yeon Kim, Yeon Hee Park

“…Therefore, pTMB could act as an invaluable biomarker in the setting of both clinical trials and practice outside of trials based on its reliable performance in mitigating the purity-related bias.…”
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Identification of a Serotonin 2A Receptor Subtype of Schizophrenia Spectrum Disorders With Pimavanserin: The Sub-Sero Proof-of-Concept Trial Protocol by Olga B. Baltzersen, Herbert Y. Meltzer, Vibe G. Frokjaer, Vibe G. Frokjaer, Jayachandra M. Raghava, Jayachandra M. Raghava, Lone Baandrup, Lone Baandrup, Birgitte Fagerlund, Henrik B.W. Larsson, H. Christian Fibiger, Birte Y. Glenthøj, Birte Y. Glenthøj, Gitte M. Knudsen, Gitte M. Knudsen, Bjørn H. Ebdrup, Bjørn H. Ebdrup

“…If successful, Sub-Sero will aid identification of a “serotonergic subtype” of schizophrenia spectrum patients, thereby promoting development of precision medicine in clinical psychiatry.Clinical Trial RegistrationClinicalTrials, identifier NCT03994965.…”
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Cardiac Fibrosis in the Pressure Overloaded Left and Right Ventricle as a Therapeutic Target by Katharina Schimmel, Katharina Schimmel, Katharina Schimmel, Kenzo Ichimura, Kenzo Ichimura, Kenzo Ichimura, Sushma Reddy, Sushma Reddy, Francois Haddad, Francois Haddad, Francois Haddad, Edda Spiekerkoetter, Edda Spiekerkoetter, Edda Spiekerkoetter

“…Finally, we discuss the mode of action, safety and efficacy of anti-fibrotic drugs currently tested for the treatment of left HF in clinical trials, which might guide development of new approaches to target right heart failure. …”
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Short-term effectiveness and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis: results from a 16-week real-world multicenter retrospective study – il AD (I... by Luigi Gargiulo, Luciano Ibba, Angela Alfano, Piergiorgio Malagoli, Fabrizio Amoruso, Anna Balato, Francesca Barei, Anna G. Burroni, Stefano Caccavale, Piergiacomo Calzavara-Pinton, Maria Esposito, Maria C. Fargnoli, Silvia M. Ferrucci, Caterina Foti, Giampiero Girolomoni, Massimo Gola, Mario B. Guanti, Carlotta Gurioli, Manfredi Magliulo, Martina Maurelli, Pietro Morrone, Maria L. Musumeci, Maddalena Napolitano, Michela Ortoncelli, Cataldo Patruno, Bianca M. Piraccini, Elena Pezzolo, Simone Ribero, Mariateresa Rossi, Paola Savoia, Claudio Sciarrone, Benedetta Tirone, Marco Vaccino, Federica Veronese, Antonio Costanzo, Alessandra Narcisi

“…Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab.Conclusion: Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib.…”
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Treat-to-target versus high-intensity statin treatment in patients with or without diabetes mellitus: a pre-specified analysis from the LODESTAR trialResearch in context by Seung-Jun Lee, Woong Chol Kang, Jong-Young Lee, Jin-Bae Lee, Tae-Hyun Yang, Junghan Yoon, Yong-Joon Lee, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Bum-Kee Hong, Yangsoo Jang, Myeong-Ki Hong, Myeong-Ki Hong, Donghoon Choi, Young-Guk Ko, Byeong-Keuk Kim, Jung-Sun Kim, Chul-Min Ahn, Sung-Jin Hong, Seung-Jun Lee, Yong-Joon Lee, Bum-Kee Hong, Hyuck Moon Kwon, Jong-Youn Kim, Pil Ki Min, Young Won Yoon, Byoung Kwon Lee, Se-Joong Rim, Eui-Young Choi, Woong CholKang, Pyung Chun Oh, Jong-Young Lee, Jin-Bae Lee, Kee Sik Kim, Ji Yong Choi, Jae Kean Ryu, Seung Pyo Hong, Chang Yeon Kim, Tae-Hyun Yang, Hyung-Jin Cho, Junghan Yoon, Min-Soo Ahn, Sung Gyun Ahn, Jun-Won Lee, Jung-Woo Son, Yangsoo Jang, Hyuck-Jun Yoon, Cheol Hyun Lee, Jongmin Hwang, Yun-Kyeong Cho, Seung-Ho Hur, Seongwook Han, Chang-Wook Nam, Hyoungseop Kim, Hyoung-Seob Park, In-Cheol Kim, Yun-Hyeong Cho, Hyeon-Ju Jeong, Jin-Ho Kim, Chewan Lim, Yongsung Suh, Eui Seok Hwang, Ji Hyun Lee, Sung Yun Lee, Sung Uk Kwon, Song-Yi Kim, Keun-Ho Park, Hyun Kuk Ki

“…This trial is registered with ClinicalTrials.gov, NCT02579499. Findings: Between September 9, 2016 and November 27, 2019, 4400 patients with CAD were enrolled in the LODESTAR trial. …”
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Prospective comparison of [18F]AlF-NOTA-octreotide PET/MRI to [68Ga]Ga-DOTATATE PET/CT in neuroendocrine tumor patients by Lennert Boeckxstaens, Elin Pauwels, Vincent Vandecaveye, Wies Deckers, Frederik Cleeren, Jeroen Dekervel, Timon Vandamme, Kim Serdons, Michel Koole, Guy Bormans, Annouschka Laenen, Paul M. Clement, Karen Geboes, Eric Van Cutsem, Kristiaan Nackaerts, Sigrid Stroobants, Chris Verslype, Koen Van Laere, Christophe M. Deroose

“…Trial registration ClinicalTrials.gov: NCT04552847. Registered 17 September 2020, https://beta.clinicaltrials.gov/study/NCT04552847…”
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Implementation of serological and molecular tools to inform COVID-19 patient management: protocol for the GENCOV prospective cohort study by David Richardson, Tony Mazzulli, Marc Clausen, Chloe Mighton, Jordan Lerner-Ellis, Yvonne Bombard, Allison McGeer, Hanna Faghfoury, Trevor J Pugh, Shelley L McLeod, Ahmed Taher, Steven Marc Friedman, Bjug Borgundvaag, Selina Casalino, Anne-Claude Gingras, Jennifer Taher, Sunakshi Chowdhary, Erika Frangione, Saranya Arnoldo, Erin Bearss, Alexandra Binnie, Howard Chertkow, Luke Devine, Zeeshan Khan, Jared Simpson, Seth Stern, Lisa Strug

“…Participants can learn their genome sequencing, antibody and viral sequencing results; patient-reported outcomes of receiving this information will be assessed through surveys and qualitative interviews.Ethics and dissemination This study was approved by Clinical Trials Ontario Streamlined Ethics Review System (CTO Project ID: 3302) and the research ethics boards at participating hospitals. …”
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CASCADIA: a prospective community-based study protocol for assessing SARS-CoV-2 vaccine effectiveness in children and adults using a remote nasal swab collection and web-based surv... by Jeremy Stone, Richard A Mularski, Sarah N Cox, Mark A Schmidt, Helen Y Chu, Janet A Englund, Peter D Han, Caitlin R Wolf, Stephen P Fortmann, Sharon Saydah, Ning Smith, Marco Carone, Claire M Midgley, Allison L Naleway, Melissa Briggs-Hagen, Jennifer L Kuntz, Tara M Babu, Leora R Feldstein, Zachary Acker, Cassandra L Boisvert, Amanda Casto, Brenna Ehmen, Collrane J Frivold, Holly Groom, Tina Lockwood, Tara Ogilvie, Sacha L Reich, Lea Starita, Meredith Vandermeer, Ana A Weil

“…These authorisations were based on clinical trials, understanding real-world vaccine effectiveness (VE) in the setting of emerging variants is critical. …”
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What Do We Have to Know about PD-L1 Expression in Prostate Cancer? A Systematic Literature Review. Part 2: Clinic–Pathologic Correlations by Andrea Palicelli, Martina Bonacini, Stefania Croci, Cristina Magi-Galluzzi, Sofia Cañete-Portillo, Alcides Chaux, Alessandra Bisagni, Eleonora Zanetti, Dario De Biase, Beatrice Melli, Francesca Sanguedolce, Magda Zanelli, Maria Paola Bonasoni, Loredana De Marco, Alessandra Soriano, Stefano Ascani, Maurizio Zizzo, Carolina Castro Ruiz, Antonio De Leo, Guido Giordano, Matteo Landriscina, Giuseppe Carrieri, Luigi Cormio, Daniel M. Berney, Jatin Gandhi, Giacomo Santandrea, Maria Carolina Gelli, Alessandro Tafuni, Moira Ragazzi

“…We performed a systematic literature review (PRISMA guidelines) to critically evaluate human tissue-based studies (immunohistochemistry, molecular analysis, etc.), experimental research (cell lines, mouse models), and clinical trials. Despite some controversial results and study limitations, PD-L1 expression by tumor cells may be related to clinic–pathologic features of adverse outcome, including advanced tumor stage (high pT, presence of lymph node, and distant metastases), positivity of surgical margins, high Grade Group, and castration resistance. …”
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The metformin in tuberous sclerosis (MiTS) study: A randomised double-blind placebo-controlled trial by Sam Amin, Andrew A Mallick, Hannah Edwards, Mario Cortina-Borja, Matthew Laugharne, Marcus Likeman, Finbar J.K. O'Callaghan

“…The trial is registered with The International Standard Randomised Controlled Trial Number (ISRCTN), number 92545532, and the European Union Drug Regulating Authorities Clinical Trials (EUDRACT), number 2011-001319-30. Findings: Between 1 November 2012 and 30 September 2015 72 patients were screened and 55 were randomly assigned to metformin (28) or placebo (27). …”
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Identifying MAGE-A4-positive tumors for TCR T cell therapies in HLA-A∗02-eligible patients by Tianjiao Wang, Jean-Marc Navenot, Stavros Rafail, Cynthia Kurtis, Mark Carroll, Marian Van Kerckhoven, Sofie Van Rossom, Kelly Schats, Konstantinos Avraam, Robyn Broad, Karen Howe, Ashley Liddle, Amber Clayton, Ruoxi Wang, Laura Quinn, Joseph P. Sanderson, Cheryl McAlpine, Carly Carozza, Eric Pimpinella, Susan Hsu, Francine Brophy, Erica Elefant, Paige Bayer, Dennis Williams, Marcus O. Butler, Jeffrey M. Clarke, Justin F. Gainor, Ramaswamy Govindan, Victor Moreno, Melissa Johnson, Janet Tu, David S. Hong, George R. Blumenschein, Jr.

“…Overall, MAGE-A4 prevalence based on clinical trial enrollment was 26% (447/1,750) across 10 solid tumor types, and was highest in synovial sarcoma (70%) and lowest in gastric cancer (9%). …”
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Exploring the Relationship Between the Acceptability of an Internet-Based Intervention for Depression in Primary Care and Clinical Outcomes: Secondary Analysis of a Randomized Cont... by Adriana Mira, Adriana Mira, Carla Soler, Marta Alda, Marta Alda, Marta Alda, Rosa Baños, Rosa Baños, Diana Castilla, Diana Castilla, Diana Castilla, Adoración Castro, Adoración Castro, Javier García-Campayo, Javier García-Campayo, Javier García-Campayo, Azucena García-Palacios, Azucena García-Palacios, Margalida Gili, Margalida Gili, Mariena Hurtado, Fermín Mayoral, Fermín Mayoral, Jesús Montero-Marín, Jesús Montero-Marín, Jesús Montero-Marín, Crisitina Botella, Crisitina Botella

“…Research on IBI acceptability could help to implement the treatment offered.Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01611818.…”
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Harnessing the power within: engineering the microbiome for enhanced gynecologic health by Caitriona Brennan, Kristina Chan, Tanya Kumar, Erica Maissy, Linda Brubaker, Marisol I Dothard, Jack A Gilbert, Katharine E Gilbert, Amanda L Lewis, Varykina G Thackray, Amir Zarrinpar, Rob Knight

“…In light of this, we present a selected review of clinical trials and preclinical studies targeting both the vaginal and gut microbiomes for the prevention or treatment of various gynecologic conditions. …”
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Case Report: Clinical Management of a Patient With Metastatic Non-Small Cell Lung Cancer Newly Receiving Immune Checkpoint Inhibition During Symptomatic COVID-19 by Sibylle C. Mellinghoff, Sibylle C. Mellinghoff, Sibylle C. Mellinghoff, Sibylle C. Mellinghoff, Kanika Vanshylla, Christine Dahlke, Christine Dahlke, Christine Dahlke, Marylyn M. Addo, Marylyn M. Addo, Marylyn M. Addo, Oliver A. Cornely, Oliver A. Cornely, Oliver A. Cornely, Oliver A. Cornely, Florian Klein, Florian Klein, Florian Klein, Thorsten Persigehl, Jan Rybniker, Henning Gruell, Paul J. Bröckelmann, Paul J. Bröckelmann, Paul J. Bröckelmann

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A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Th... by Jonathan W. Goldman, Julien Mazieres, Fabrice Barlesi, Konstantin H. Dragnev, Marianna Koczywas, Tuncay Göskel, Alexis B. Cortot, Nicolas Girard, Claas Wesseler, Helge Bischoff, Ernest Nadal, Keunchil Park, Shun Lu, Alvaro Taus, Manuel Cobo, Shawn T. Estrem, Sameera R. Wijayawardana, Kellie Turner, Gerard Joseph Oakley, Karla C. Hurt, Alan Y. Chiang, Anwar M. Hossain, William J. John, Luis Paz-Ares

“…The increases in response rates and PFS support further investigation of abemaciclib in other NSCLC subpopulations or in combination with other agents.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier: NCT02152631…”
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