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Looking beyond COVID-19 vaccine phase 3 trials.

Jerome H Kim, Florian Marks, John D Clemens,

After the recent announcement of COVID-19 vaccine efficacy in clinical trials by several manufacturers for protection against severe disease, a comprehensive post-efficacy strategy for the next steps to ensure vaccination of the global population is now required. These considerations should include how to manufacture billions of doses of high-quality vaccines, ... Read more >>

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[2021, :]

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The limits of acceptable political influence over the FDA.

Holly Fernandez Lynch, Steven Joffe, Matthew S McCoy,

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[2021, :]

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High-frequency neuromodulation improves obsessive-compulsive behavior.

Shrey Grover, John A Nguyen, Vighnesh Viswanathan, Robert M G Reinhart,

Nearly one billion people worldwide suffer from obsessive-compulsive behaviors<sup>1,2</sup>, yet our mechanistic understanding of these behaviors is incomplete, and effective therapeutics are unavailable. An emerging perspective characterizes obsessive-compulsive behaviors as maladaptive habit learning<sup>3,4</sup>, which may be associated with abnormal beta-gamma neurophysiology of the orbitofrontal-striatal circuitry during reward processing<sup>5,6</sup>. We target ... Read more >>

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[2021, :]

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Antibiotic resistance: a call to action to prevent the next epidemic of inequality.

Maya L Nadimpalli, Courtney W Chan, Shira Doron,

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[2021, :]

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Impaired meningeal lymphatic drainage in patients with idiopathic Parkinson's disease.

Xue-Bing Ding, Xin-Xin Wang, Dan-Hao Xia, Han Liu, Hai-Yan Tian, Yu Fu, Yong-Kang Chen, Chi Qin, Jiu-Qi Wang, Zhi Xiang, Zhong-Xian Zhang, Qin-Chen Cao, Wei Wang, Jia-Yi Li, Erxi Wu, Bei-Sha Tang, Ming-Ming Ma, Jun-Fang Teng, Xue-Jing Wang,

Animal studies implicate meningeal lymphatic dysfunction in the pathogenesis of neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease (PD). However, there is no direct evidence in humans to support this role<sup>1-5</sup>. In this study, we used dynamic contrast-enhanced magnetic resonance imaging to assess meningeal lymphatic flow in cognitively normal ... Read more >>

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[2021, :]

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State-dependent responses to intracranial brain stimulation in a patient with depression.

Katherine W Scangos, Ghassan S Makhoul, Leo P Sugrue, Edward F Chang, Andrew D Krystal,

Deep brain stimulation is a promising treatment for severe depression, but lack of efficacy in randomized trials raises questions regarding anatomical targeting. We implanted multi-site intracranial electrodes in a severely depressed patient and systematically assessed the acute response to focal electrical neuromodulation. We found an elaborate repertoire of distinctive emotional ... Read more >>

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[2021, :]

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Cabozantinib for neurofibromatosis type 1-related plexiform neurofibromas: a phase 2 trial.

Michael J Fisher, Chie-Schin Shih, Steven D Rhodes, Amy E Armstrong, Pamela L Wolters, Eva Dombi, Chi Zhang, Steven P Angus, Gary L Johnson, Roger J Packer, Jeffrey C Allen, Nicole J Ullrich, Stewart Goldman, David H Gutmann, Scott R Plotkin, Tena Rosser, Kent A Robertson, Brigitte C Widemann, Abbi E Smith, Waylan K Bessler, Yongzheng He, Su-Jung Park, Julie A Mund, Li Jiang, Khadijeh Bijangi-Vishehsaraei, Coretta Thomas Robinson, Gary R Cutter, Bruce R Korf, , Jaishri O Blakeley, D Wade Clapp,

Neurofibromatosis type 1 (NF1) plexiform neurofibromas (PNs) are progressive, multicellular neoplasms that cause morbidity and may transform to sarcoma. Treatment of Nf1<sup>fl/fl</sup>;Postn-Cre mice with cabozantinib, an inhibitor of multiple tyrosine kinases, caused a reduction in PN size and number and differential modulation of kinases in cell lineages that drive PN ... Read more >>

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[2021, 27(1):165-173]

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Durvalumab compared to maintenance chemotherapy in metastatic breast cancer: the randomized phase II SAFIR02-BREAST IMMUNO trial.

Thomas Bachelot, Thomas Filleron, Ivan Bieche, Monica Arnedos, Mario Campone, Florence Dalenc, Florence Coussy, Marie-Paule Sablin, Marc Debled, Claudia Lefeuvre-Plesse, Anthony Goncalves, Marie-Ange Mouret Reynier, William Jacot, Benoit You, Philippe Barthelemy, Benjamin Verret, Nicolas Isambert, Xavier Tchiknavorian, Christelle Levy, Jean-Christophe Thery, Tifenn L'Haridon, Jean-Marc Ferrero, Alice Mege, Francesco Del Piano, Etienne Rouleau, Alicia Tran-Dien, Julien Adam, Amelie Lusque, Marta Jimenez, Alexandra Jacquet, Ingrid Garberis, Fabrice Andre,

The impact of single-agent antibodies against programmed death-ligand 1 (PD-L1) as maintenance therapy is unknown in patients with metastatic breast cancer. The SAFIR02-BREAST IMMUNO substudy included patients with human epidermal growth factor receptor type 2 (Her2)-negative metastatic breast cancer whose disease did not progress after six to eight cycles of ... Read more >>

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[2021, :]

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The androgen receptor is a tumor suppressor in estrogen receptor-positive breast cancer.

Theresa E Hickey, Luke A Selth, Kee Ming Chia, Geraldine Laven-Law, Heloisa H Milioli, Daniel Roden, Shalini Jindal, Mun Hui, Jessica Finlay-Schultz, Esmaeil Ebrahimie, Stephen N Birrell, Suzan Stelloo, Richard Iggo, Sarah Alexandrou, C Elizabeth Caldon, Tarek M Abdel-Fatah, Ian O Ellis, Wilbert Zwart, Carlo Palmieri, Carol A Sartorius, Alex Swarbrick, Elgene Lim, Jason S Carroll, Wayne D Tilley,

The role of the androgen receptor (AR) in estrogen receptor (ER)-α-positive breast cancer is controversial, constraining implementation of AR-directed therapies. Using a diverse, clinically relevant panel of cell-line and patient-derived models, we demonstrate that AR activation, not suppression, exerts potent antitumor activity in multiple disease contexts, including resistance to standard-of-care ... Read more >>

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[2021, :]

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An algorithmic approach to reducing unexplained pain disparities in underserved populations.

Emma Pierson, David M Cutler, Jure Leskovec, Sendhil Mullainathan, Ziad Obermeyer,

Underserved populations experience higher levels of pain. These disparities persist even after controlling for the objective severity of diseases like osteoarthritis, as graded by human physicians using medical images, raising the possibility that underserved patients' pain stems from factors external to the knee, such as stress. Here we use a ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):136-140]

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Author Correction: A global survey of potential acceptance of a COVID-19 vaccine.

Jeffrey V Lazarus, Scott C Ratzan, Adam Palayew, Lawrence O Gostin, Heidi J Larson, Kenneth Rabin, Spencer Kimball, Ayman El-Mohandes,

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[2021, :]

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Exome-wide evaluation of rare coding variants using electronic health records identifies new gene-phenotype associations.

Joseph Park, Anastasia M Lucas, Xinyuan Zhang, Kumardeep Chaudhary, Judy H Cho, Girish Nadkarni, Amanda Dobbyn, Geetha Chittoor, Navya S Josyula, Nathan Katz, Joseph H Breeyear, Shadi Ahmadmehrabi, Theodore G Drivas, Venkata R M Chavali, Maria Fasolino, Hisashi Sawada, Alan Daugherty, Yanming Li, Chen Zhang, Yuki Bradford, JoEllen Weaver, Anurag Verma, Renae L Judy, Rachel L Kember, John D Overton, Jeffrey G Reid, Manuel A R Ferreira, Alexander H Li, Aris Baras, Scott A LeMaire, Ying H Shen, Ali Naji, Klaus H Kaestner, Golnaz Vahedi, Todd L Edwards, Jinbo Chen, Scott M Damrauer, Anne E Justice, Ron Do, Marylyn D Ritchie, Daniel J Rader,

The clinical impact of rare loss-of-function variants has yet to be determined for most genes. Integration of DNA sequencing data with electronic health records (EHRs) could enhance our understanding of the contribution of rare genetic variation to human disease<sup>1</sup>. By leveraging 10,900 whole-exome sequences linked to EHR data in the ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):66-72]

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The distribution of cellular turnover in the human body.

Ron Sender, Ron Milo,

We integrated ubiquity, mass and lifespan of all major cell types to achieve a comprehensive quantitative description of cellular turnover. We found a total cellular mass turnover of 80 ± 20 grams per day, dominated by blood cells and gut epithelial cells. In terms of cell numbers, close to 90% of the (0.33 ± 0.02) × 10<sup>12</sup> ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):45-48]

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Immune determinants of COVID-19 disease presentation and severity.

Petter Brodin,

COVID-19, caused by SARS-CoV-2 infection, is mild to moderate in the majority of previously healthy individuals, but can cause life-threatening disease or persistent debilitating symptoms in some cases. The most important determinant of disease severity is age, with individuals over 65 years having the greatest risk of requiring intensive care, ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):28-33]

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Targeting metastatic cancer.

Karuna Ganesh, Joan Massagué,

Despite recent therapeutic advances in cancer treatment, metastasis remains the principal cause of cancer death. Recent work has uncovered the unique biology of metastasis-initiating cells that results in tumor growth in distant organs, evasion of immune surveillance and co-option of metastatic microenvironments. Here we review recent progress that is enabling ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):34-44]

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Microbiome connections with host metabolism and habitual diet from 1,098 deeply phenotyped individuals.

Francesco Asnicar, Sarah E Berry, Ana M Valdes, Long H Nguyen, Gianmarco Piccinno, David A Drew, Emily Leeming, Rachel Gibson, Caroline Le Roy, Haya Al Khatib, Lucy Francis, Mohsen Mazidi, Olatz Mompeo, Mireia Valles-Colomer, Adrian Tett, Francesco Beghini, Léonard Dubois, Davide Bazzani, Andrew Maltez Thomas, Chloe Mirzayi, Asya Khleborodova, Sehyun Oh, Rachel Hine, Christopher Bonnett, Joan Capdevila, Serge Danzanvilliers, Francesca Giordano, Ludwig Geistlinger, Levi Waldron, Richard Davies, George Hadjigeorgiou, Jonathan Wolf, José M Ordovás, Christopher Gardner, Paul W Franks, Andrew T Chan, Curtis Huttenhower, Tim D Spector, Nicola Segata,

The gut microbiome is shaped by diet and influences host metabolism; however, these links are complex and can be unique to each individual. We performed deep metagenomic sequencing of 1,203 gut microbiomes from 1,098 individuals enrolled in the Personalised Responses to Dietary Composition Trial (PREDICT 1) study, whose detailed long-term ... Read more >>

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[2021, :]

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Modeling human adaptive immune responses with tonsil organoids.

Lisa E Wagar, Ameen Salahudeen, Christian M Constantz, Ben S Wendel, Michael M Lyons, Vamsee Mallajosyula, Lauren P Jatt, Julia Z Adamska, Lisa K Blum, Neha Gupta, Katherine J L Jackson, Fan Yang, Katharina Röltgen, Krishna M Roskin, Kelly M Blaine, Kara D Meister, Iram N Ahmad, Mario Cortese, Emery G Dora, Sean N Tucker, Anne I Sperling, Aarti Jain, D Huw Davies, Philip L Felgner, Gregory B Hammer, Peter S Kim, William H Robinson, Scott D Boyd, Calvin J Kuo, Mark M Davis,

Most of what we know about adaptive immunity has come from inbred mouse studies, using methods that are often difficult or impossible to confirm in humans. In addition, vaccine responses in mice are often poorly predictive of responses to those same vaccines in humans. Here we use human tonsils, readily ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):125-135]

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Robust breast cancer detection in mammography and digital breast tomosynthesis using an annotation-efficient deep learning approach.

William Lotter, Abdul Rahman Diab, Bryan Haslam, Jiye G Kim, Giorgia Grisot, Eric Wu, Kevin Wu, Jorge Onieva Onieva, Yun Boyer, Jerrold L Boxerman, Meiyun Wang, Mack Bandler, Gopal R Vijayaraghavan, A Gregory Sorensen,

Breast cancer remains a global challenge, causing over 600,000 deaths in 2018 (ref. <sup>1</sup>). To achieve earlier cancer detection, health organizations worldwide recommend screening mammography, which is estimated to decrease breast cancer mortality by 20-40% (refs. <sup>2,3</sup>). Despite the clear value of screening mammography, significant false positive and false negative ... Read more >>

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[2021, :]

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Pathophysiology-based subphenotyping of individuals at elevated risk for type 2 diabetes.

Robert Wagner, Martin Heni, Adam G Tabák, Jürgen Machann, Fritz Schick, Elko Randrianarisoa, Martin Hrabě de Angelis, Andreas L Birkenfeld, Norbert Stefan, Andreas Peter, Hans-Ulrich Häring, Andreas Fritsche,

The state of intermediate hyperglycemia is indicative of elevated risk of developing type 2 diabetes<sup>1</sup>. However, the current definition of prediabetes neither reflects subphenotypes of pathophysiology of type 2 diabetes nor is predictive of future metabolic trajectories. We used partitioning on variables derived from oral glucose tolerance tests, MRI-measured body ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):49-57]

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Brown adipose tissue is associated with cardiometabolic health.

Tobias Becher, Srikanth Palanisamy, Daniel J Kramer, Mahmoud Eljalby, Sarah J Marx, Andreas G Wibmer, Scott D Butler, Caroline S Jiang, Roger Vaughan, Heiko Schöder, Allyn Mark, Paul Cohen,

White fat stores excess energy, whereas brown and beige fat are thermogenic and dissipate energy as heat. Thermogenic adipose tissues markedly improve glucose and lipid homeostasis in mouse models, although the extent to which brown adipose tissue (BAT) influences metabolic and cardiovascular disease in humans is unclear<sup>1,2</sup>. Here we retrospectively ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):58-65]

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Treatment of one eye affects both.

Hannah Stower,

Nat Med (Nature medicine)
[2021, 27(1):21]

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Women and children last? Shaking up exclusion criteria for vaccine trials.

Beate Kampmann,

Nat Med (Nature medicine)
[2021, 27(1):8]

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Eight ways machine learning is assisting medicine.

Mike May,

Nat Med (Nature medicine)
[2021, 27(1):2-3]

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Liver metastasis restrains immunotherapy efficacy via macrophage-mediated T cell elimination.

Jiali Yu, Michael D Green, Shasha Li, Yilun Sun, Sara N Journey, Jae Eun Choi, Syed Monem Rizvi, Angel Qin, Jessica J Waninger, Xueting Lang, Zoey Chopra, Issam El Naqa, Jiajia Zhou, Yingjie Bian, Long Jiang, Alangoya Tezel, Jeremy Skvarce, Rohan K Achar, Merna Sitto, Benjamin S Rosen, Fengyun Su, Sathiya P Narayanan, Xuhong Cao, Shuang Wei, Wojciech Szeliga, Linda Vatan, Charles Mayo, Meredith A Morgan, Caitlin A Schonewolf, Kyle Cuneo, Ilona Kryczek, Vincent T Ma, Christopher D Lao, Theodore S Lawrence, Nithya Ramnath, Fei Wen, Arul M Chinnaiyan, Marcin Cieslik, Ajjai Alva, Weiping Zou,

Metastasis is the primary cause of cancer mortality, and cancer frequently metastasizes to the liver. It is not clear whether liver immune tolerance mechanisms contribute to cancer outcomes. We report that liver metastases diminish immunotherapy efficacy systemically in patients and preclinical models. Patients with liver metastases derive limited benefit from ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):152-164]

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A neuroimaging biomarker for sustained experimental and clinical pain.

Jae-Joong Lee, Hong Ji Kim, Marta Čeko, Bo-Yong Park, Soo Ahn Lee, Hyunjin Park, Mathieu Roy, Seong-Gi Kim, Tor D Wager, Choong-Wan Woo,

Sustained pain is a major characteristic of clinical pain disorders, but it is difficult to assess in isolation from co-occurring cognitive and emotional features in patients. In this study, we developed a functional magnetic resonance imaging signature based on whole-brain functional connectivity that tracks experimentally induced tonic pain intensity and ... Read more >>

Nat Med (Nature medicine)
[2021, 27(1):174-182]

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