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Steven Fishbane, Aamir Jamal, Catherine Munera, Warren Wen, Frédérique Menzaghi
BACKGROUND: Difelikefalin is a peripherally restricted and selective agonist of kappa opioid receptors that are considered to be important in modulating pruritus in conditions such as chronic kidney disease. METHODS: In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks...
November 8, 2019: New England Journal of Medicine
#2
Shibadas Biswal, Humberto Reynales, Xavier Saez-Llorens, Pio Lopez, Charissa Borja-Tabora, Pope Kosalaraksa, Chukiat Sirivichayakul, Veerachai Watanaveeradej, Luis Rivera, Felix Espinoza, LakKumar Fernando, Reynaldo Dietze, Kleber Luz, Rivaldo Venâncio da Cunha, José Jimeno, Eduardo López-Medina, Astrid Borkowski, Manja Brose, Martina Rauscher, Inge LeFevre, Svetlana Bizjajeva, Lulu Bravo, Derek Wallace
BACKGROUND: Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019. METHODS: We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart...
November 6, 2019: New England Journal of Medicine
#3
EDITORIAL
Francis S Collins
No abstract text is available yet for this article.
October 31, 2019: New England Journal of Medicine
#4
Zachariah DeFilipp, Patricia P Bloom, Mariam Torres Soto, Michael K Mansour, Mohamad R A Sater, Miriam H Huntley, Sarah Turbett, Raymond T Chung, Yi-Bin Chen, Elizabeth L Hohmann
Fecal microbiota transplantation (FMT) is an emerging therapy for recurrent or refractory Clostridioides difficile infection and is being actively investigated for other conditions. We describe two patients in whom extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli bacteremia occurred after they had undergone FMT in two independent clinical trials; both cases were linked to the same stool donor by means of genomic sequencing. One of the patients died. Enhanced donor screening to limit the transmission of microorganisms that could lead to adverse infectious events and continued vigilance to define the benefits and risks of FMT across different patient populations are warranted...
October 30, 2019: New England Journal of Medicine
#5
Robert H Goldstein, Rochelle P Walensky
No abstract text is available yet for this article.
October 30, 2019: New England Journal of Medicine
#6
EDITORIAL
Martin J Blaser
No abstract text is available yet for this article.
October 30, 2019: New England Journal of Medicine
#7
LETTER
Zain Kassam, Nancy Dubois, Bharat Ramakrishna, Kelly Ling, Taha Qazi, Mark Smith, Colleen R Kelly, Monika Fischer, Jessica R Allegretti, Shrish Budree, Pratik Panchal, Ciarán P Kelly, Majdi Osman
No abstract text is available yet for this article.
October 30, 2019: New England Journal of Medicine
#8
Dereck R Tait, Mark Hatherill, Olivier Van Der Meeren, Ann M Ginsberg, Elana Van Brakel, Bruno Salaun, Thomas J Scriba, Elaine J Akite, Helen M Ayles, Anne Bollaerts, Marie-Ange Demoitié, Andreas Diacon, Thomas G Evans, Paul Gillard, Elizabeth Hellström, James C Innes, Maria Lempicki, Mookho Malahleha, Neil Martinson, Doris Mesia Vela, Monde Muyoyeta, Videlis Nduba, Thierry G Pascal, Michele Tameris, Friedrich Thienemann, Robert J Wilkinson, François Roman
BACKGROUND: Results of an earlier analysis of a trial of the M72/AS01E candidate vaccine against Mycobacterium tuberculosis showed that in infected adults, the vaccine provided 54.0% protection against active pulmonary tuberculosis disease, without evident safety concerns. We now report the results of the 3-year final analysis of efficacy, safety, and immunogenicity. METHODS: From August 2014 through November 2015, we enrolled adults 18 to 50 years of age with M...
October 29, 2019: New England Journal of Medicine
#9
Yue-Yung Hu, Ryan J Ellis, D Brock Hewitt, Anthony D Yang, Elaine Ooi Cheung, Judith T Moskowitz, John R Potts, Jo Buyske, David B Hoyt, Thomas R Nasca, Karl Y Bilimoria
BACKGROUND: Physicians, particularly trainees and those in surgical subspecialties, are at risk for burnout. Mistreatment (i.e., discrimination, verbal or physical abuse, and sexual harassment) may contribute to burnout and suicidal thoughts. METHODS: A cross-sectional national survey of general surgery residents administered with the 2018 American Board of Surgery In-Training Examination assessed mistreatment, burnout (evaluated with the use of the modified Maslach Burnout Inventory), and suicidal thoughts during the past year...
October 28, 2019: New England Journal of Medicine
#10
Vinay K Rathi, Joseph S Ross
No abstract text is available yet for this article.
October 23, 2019: New England Journal of Medicine
#11
Victor J Dzau, Sharon K Inouye, John W Rowe, Elizabeth Finkelman, Tadataka Yamada
No abstract text is available yet for this article.
October 21, 2019: New England Journal of Medicine
#12
Daniel F Mackay, Emma R Russell, Katy Stewart, John A MacLean, Jill P Pell, William Stewart
BACKGROUND: Neurodegenerative disorders have been reported in elite athletes who participated in contact sports. The incidence of neurodegenerative disease among former professional soccer players has not been well characterized. METHODS: We conducted a retrospective cohort study to compare mortality from neurodegenerative disease among 7676 former professional soccer players (identified from databases of Scottish players) with that among 23,028 controls from the general population who were matched to the players on the basis of sex, age, and degree of social deprivation...
October 21, 2019: New England Journal of Medicine
#13
EDITORIAL
Robert A Stern
No abstract text is available yet for this article.
October 21, 2019: New England Journal of Medicine
#14
Mark T Dransfield, Helen Voelker, Surya P Bhatt, Keith Brenner, Richard Casaburi, Carolyn E Come, J Allen D Cooper, Gerard J Criner, Jeffrey L Curtis, MeiLan K Han, Umur Hatipoğlu, Erika S Helgeson, Vipul V Jain, Ravi Kalhan, David Kaminsky, Robert Kaner, Ken M Kunisaki, Allison A Lambert, Matthew R Lammi, Sarah Lindberg, Barry J Make, Fernando J Martinez, Charlene McEvoy, Ralph J Panos, Robert M Reed, Paul D Scanlon, Frank C Sciurba, Anthony Smith, Peruvemba S Sriram, William W Stringer, Jeremy A Weingarten, J Michael Wells, Elizabeth Westfall, Stephen C Lazarus, John E Connett
BACKGROUND: Observational studies suggest that beta-blockers may reduce the risk of exacerbations and death in patients with moderate or severe chronic obstructive pulmonary disease (COPD), but these findings have not been confirmed in randomized trials. METHODS: In this prospective, randomized trial, we assigned patients between the ages of 40 and 85 years who had COPD to receive either a beta-blocker (extended-release metoprolol) or placebo. All the patients had a clinical history of COPD, along with moderate airflow limitation and an increased risk of exacerbations, as evidenced by a history of exacerbations during the previous year or the prescribed use of supplemental oxygen...
October 20, 2019: New England Journal of Medicine
#15
EDITORIAL
William MacNee
No abstract text is available yet for this article.
October 20, 2019: New England Journal of Medicine
#16
Sue A Brown, Boris P Kovatchev, Dan Raghinaru, John W Lum, Bruce A Buckingham, Yogish C Kudva, Lori M Laffel, Carol J Levy, Jordan E Pinsker, R Paul Wadwa, Eyal Dassau, Francis J Doyle, Stacey M Anderson, Mei Mei Church, Vikash Dadlani, Laya Ekhlaspour, Gregory P Forlenza, Elvira Isganaitis, David W Lam, Craig Kollman, Roy W Beck
BACKGROUND: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. METHODS: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3...
October 16, 2019: New England Journal of Medicine
#17
Elizabeth A Samuels, Otis U Warren, Corey S Davis, Paul P Christopher
New England Journal of Medicine, Volume 381, Issue 19, Page 1795-1797, November 2019.
October 16, 2019: New England Journal of Medicine
#18
EDITORIAL
Daniela Bruttomesso
New England Journal of Medicine, Volume 381, Issue 18, Page 1774-1775, October 2019.
October 16, 2019: New England Journal of Medicine
#19
Diane Mackle, Rinaldo Bellomo, Michael Bailey, Richard Beasley, Adam Deane, Glenn Eastwood, Simon Finfer, Ross Freebairn, Victoria King, Natalie Linke, Edward Litton, Colin McArthur, Shay McGuinness, Rakshit Panwar, Paul Young
BACKGROUND: Patients who are undergoing mechanical ventilation in the intensive care unit (ICU) often receive a high fraction of inspired oxygen (Fio2 ) and have a high arterial oxygen tension. The conservative use of oxygen may reduce oxygen exposure, diminish lung and systemic oxidative injury, and thereby increase the number of ventilator-free days (days alive and free from mechanical ventilation). METHODS: We randomly assigned 1000 adult patients who were anticipated to require mechanical ventilation beyond the day after recruitment in the ICU to receive conservative or usual oxygen therapy...
October 14, 2019: New England Journal of Medicine
#20
Jinkuk Kim, Chunguang Hu, Christelle Moufawad El Achkar, Lauren E Black, Julie Douville, Austin Larson, Mary K Pendergast, Sara F Goldkind, Eunjung A Lee, Ashley Kuniholm, Aubrie Soucy, Jai Vaze, Nandkishore R Belur, Kristina Fredriksen, Iva Stojkovska, Alla Tsytsykova, Myriam Armant, Renata L DiDonato, Jaejoon Choi, Laura Cornelissen, Luis M Pereira, Erika F Augustine, Casie A Genetti, Kira Dies, Brenda Barton, Lucinda Williams, Benjamin D Goodlett, Bobbie L Riley, Amy Pasternak, Emily R Berry, Kelly A Pflock, Stephen Chu, Chantal Reed, Kimberly Tyndall, Pankaj B Agrawal, Alan H Beggs, P Ellen Grant, David K Urion, Richard O Snyder, Susan E Waisbren, Annapurna Poduri, Peter J Park, Al Patterson, Alessandra Biffi, Joseph R Mazzulli, Olaf Bodamer, Charles B Berde, Timothy W Yu
Genome sequencing is often pivotal in the diagnosis of rare diseases, but many of these conditions lack specific treatments. We describe how molecular diagnosis of a rare, fatal neurodegenerative condition led to the rational design, testing, and manufacture of milasen, a splice-modulating antisense oligonucleotide drug tailored to a particular patient. Proof-of-concept experiments in cell lines from the patient served as the basis for launching an "N-of-1" study of milasen within 1 year after first contact with the patient...
October 9, 2019: New England Journal of Medicine
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