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Assessing COVID-19 pandemic policies and behaviours and their economic and educational trade-offs across US states from Jan 1, 2020, to July 31, 2022: an observational analysis Lancet (IF 202.731) Pub Date : 2023-03-23 Thomas J Bollyky, Emma Castro, Aleksandr Y Aravkin, Kayleigh Bhangdia, Jeremy Dalos, Erin N Hulland, Samantha Kiernan, Amy Lastuka, Theresa A McHugh, Samuel M Ostroff, Peng Zheng, Hamza Tariq Chaudhry, Elle Ruggiero, Isabella Turilli, Christopher Adolph, Joanne O Amlag, Bree Bang-Jensen, Ryan M Barber, Austin Carter, Cassidy Chang, Joseph L Dieleman
Background The USA struggled in responding to the COVID-19 pandemic, but not all states struggled equally. Identifying the factors associated with cross-state variation in infection and mortality rates could help to improve responses to this and future pandemics. We sought to answer five key policy-relevant questions regarding the following: 1) what roles social, economic, and racial inequities had
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Evaluating the impact of alcohol minimum unit pricing on deaths and hospitalisations in Scotland: a controlled interrupted time series study Lancet (IF 202.731) Pub Date : 2023-03-20 Grant M A Wyper, Daniel F Mackay, Catriona Fraser, Jim Lewsey, Mark Robinson, Clare Beeston, Lucie Giles
Background Since May 1, 2018, every alcoholic drink sold in Scotland has had minimum unit pricing (MUP) of £0·50 per unit. Previous studies have indicated that the introduction of this policy reduced alcohol sales by 3%. We aimed to assess whether this has led to reductions in alcohol-attributable deaths and hospitalisations. Methods Study outcomes, wholly attributable to alcohol consumption, were
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Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial Lancet (IF 202.731) Pub Date : 2023-03-16 Roland Tschismarov, Pierre Van Damme, Clara Germain, Ilse De Coster, Mathieu Mateo, Stephanie Reynard, Alexandra Journeaux, Yvonne Tomberger, Kanchanamala Withanage, Denise Haslwanter, Katherine Terler, Sabrina Schrauf, Matthias Müllner, Erich Tauber, Katrin Ramsauer, Sylvain Baize
Background Lassa fever is a substantial health burden in west Africa. We evaluated the safety, tolerability, and immunogenicity of a recombinant, live-attenuated, measles-vectored Lassa fever vaccine candidate (MV-LASV). Methods This first-in-human phase 1 trial—consisting of an open-label dose-escalation stage and an observer-blinded, randomised, placebo-controlled treatment stage—was conducted at
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Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study Lancet (IF 202.731) Pub Date : 2023-03-13 Samuel Lederman, Faith D Ottery, Antonio Cano, Nanette Santoro, Marla Shapiro, Petra Stute, Rebecca C Thurston, Marci English, Catherine Franklin, Misun Lee, Genevieve Neal-Perry
Background Neurokinin 3 receptor antagonists are potential non-hormonal therapies for the treatment of vasomotor symptoms in menopausal women as options are scarce for those who cannot or do not want to take hormone therapy. Fezolinetant is one of the first non-hormonal neurokinin 3 receptor antagonists in development for the treatment of vasomotor symptoms due to menopause. This study investigated
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Early childhood lower respiratory tract infection and premature adult death from respiratory disease in Great Britain: a national birth cohort study Lancet (IF 202.731) Pub Date : 2023-03-07 James Peter Allinson, Nishi Chaturvedi, Andrew Wong, Imran Shah, Gavin Christopher Donaldson, Jadwiga Anna Wedzicha, Rebecca Hardy
Background Lower respiratory tract infections (LRTIs) in early childhood are known to influence lung development and lifelong lung health, but their link to premature adult death from respiratory disease is unclear. We aimed to estimate the association between early childhood LRTI and the risk and burden of premature adult mortality from respiratory disease. Methods This longitudinal observational
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Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus–diphtheria–acellular pertussis vaccine: a randomised, double-blind, phase 2b trial Lancet (IF 202.731) Pub Date : 2023-03-09 Cheryl Keech, Vicki E Miller, Barbara Rizzardi, Christopher Hoyle, Melinda J Pryor, Jonathan Ferrand, Ken Solovay, Marcel Thalen, Stephanie Noviello, Peter Goldstein, Andrew Gorringe, Breeze Cavell, Qiushui He, Alex-Mikael Barkoff, Keith Rubin, Camille Locht
Background Bordetella pertussis epidemics persist as transmission remains unabated despite high acellular pertussis vaccination rates. BPZE1, a live attenuated intranasal pertussis vaccine, was designed to prevent B pertussis infection and disease. We aimed to assess the immunogenicity and safety of BPZE1 compared with the tetanus–diphtheria–acellular pertussis vaccine (Tdap). Methods In this double-blind
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Effect of monthly intermittent preventive treatment with dihydroartemisinin–piperaquine with and without azithromycin versus monthly sulfadoxine–pyrimethamine on adverse pregnancy outcomes in Africa: a double-blind randomised, partly placebo-controlled trial Lancet (IF 202.731) Pub Date : 2023-03-10 Mwayiwawo Madanitsa, Hellen C Barsosio, Daniel T R Minja, George Mtove, Reginald A Kavishe, James Dodd, Queen Saidi, Eric D Onyango, Kephas Otieno, Duolao Wang, Ulla Ashorn, Jenny Hill, Crispin Mukerebe, Samwel Gesase, Omari A Msemo, Victor Mwapasa, Kamija S Phiri, Kenneth Maleta, Nigel Klein, Pascal Magnussen, Feiko O ter Kuile
Background Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin–piperaquine is more effective than IPTp with sulfadoxine–pyrimethamine at reducing malaria infection during pregnancy in areas with high-grade resistance to sulfadoxine–pyrimethamine by Plasmodium falciparum in east Africa. We aimed to assess whether IPTp with dihydroartemisinin–piperaquine, alone or combined with
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Inflammation and cholesterol as predictors of cardiovascular events among patients receiving statin therapy: a collaborative analysis of three randomised trials Lancet (IF 202.731) Pub Date : 2023-03-06 Paul M Ridker, Deepak L Bhatt, Aruna D Pradhan, Robert J Glynn, Jean G MacFadyen, Steven E Nissen
Background Inflammation and hyperlipidaemia jointly contribute to atherothrombotic disease. However, when people are treated with intensive statin therapy, the relative contributions of inflammation and hyperlipidaemia to the risk of future cardiovascular events might change, which has implications for the choice of adjunctive cardiovascular therapeutics. We aimed to evaluate the relative importance
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Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial Lancet (IF 202.731) Pub Date : 2023-03-05 Niklas Dyrby Johansen, Muthiah Vaduganathan, Ankeet S Bhatt, Simin Gharib Lee, Daniel Modin, Brian L Claggett, Erica L Dueger, Sandrine I Samson, Matthew M Loiacono, Lars Køber, Scott D Solomon, Pradeesh Sivapalan, Jens Ulrik Stæhr Jensen, Cyril Jean-Marie Martel, Palle Valentiner-Branth, Tyra Grove Krause, Tor Biering-Sørensen
Background Influenza vaccination rates remain suboptimal despite effectiveness in preventing influenza infection and related complications. We investigated whether behavioural nudges, delivered via a governmental electronic letter system, would increase influenza vaccination uptake among older adults in Denmark. Methods We did a nationwide, pragmatic, registry-based, cluster-randomised implementation
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Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial Lancet (IF 202.731) Pub Date : 2023-03-05 Roberto Diletti, Wijnand K den Dekker, Johan Bennett, Carl E Schotborgh, Rene van der Schaaf, Manel Sabaté, Raúl Moreno, Koen Ameloot, Rutger van Bommel, Daniele Forlani, Bert van Reet, Giovanni Esposito, Maurits T Dirksen, Willem P T Ruifrok, Bert R C Everaert, Carlos Van Mieghem, Jacob J Elscot, Paul Cummins, Mattie Lenzen, Salvatore Brugaletta, Nicolas M Van Mieghem
Background In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged. Methods This prospective, open-label, non-inferiority, randomised trial was done
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Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies Lancet (IF 202.731) Pub Date : 2023-03-02 William J Sandborn, Séverine Vermeire, Laurent Peyrin-Biroulet, Marla C Dubinsky, Julian Panes, Andres Yarur, Timothy Ritter, Filip Baert, Stefan Schreiber, Sheldon Sloan, Fabio Cataldi, Kevin Shan, Christopher J Rabbat, Michael Chiorean, Douglas C Wolf, Bruce E Sands, Geert D'Haens, Silvio Danese, Martina Goetsch, Brian G Feagan
Background Etrasimod, a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, and 5, with no detectable activity on S1P2,3, is in development for the treatment of immune-mediated diseases, including ulcerative colitis. In these two phase 3 trials, we aimed to evaluate the safety and efficacy of etrasimod in adult patients with moderately
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Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial Lancet (IF 202.731) Pub Date : 2023-02-28 Timothy J Craig, Avner Reshef, H Henry Li, Joshua S Jacobs, Jonathan A Bernstein, Henriette Farkas, William H Yang, Erik S G Stroes, Isao Ohsawa, Raffi Tachdjian, Michael E Manning, William R Lumry, Inmaculada Martinez Saguer, Emel Aygören-Pürsün, Bruce Ritchie, Gordon L Sussman, John Anderson, Kimito Kawahata, Yusuke Suzuki, Petra Staubach, Markus Magerl
Background Hereditary angioedema is a rare and potentially life-threatening genetic disease that is associated with kallikrein–kinin system dysregulation. Garadacimab (CSL312), a novel, fully-human monoclonal antibody that inhibits activated factor XII (FXIIa), is being studied for the prevention of hereditary angioedema attacks. The aim of this study was to evaluate the efficacy and safety of once-monthly
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Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention versus usual care on cardiovascular disease (CRHCP): an open-label, blinded-endpoint, cluster-randomised trial Lancet (IF 202.731) Pub Date : 2023-03-02 Jiang He, Nanxiang Ouyang, Xiaofan Guo, Guozhe Sun, Zhao Li, Jianjun Mu, Dao Wen Wang, Lixia Qiao, Liying Xing, Guocheng Ren, Chunxia Zhao, Ruihai Yang, Zuyi Yuan, Chang Wang, Chuning Shi, Songyue Liu, Wei Miao, Guangxiao Li, Chung-Shiuan Chen, Yingxian Sun, Hua He
Background Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention on cardiovascular disease has not been established. We aimed to test the effectiveness of such an intervention compared with usual care on risk of cardiovascular disease and all-cause death among individuals with hypertension. Methods In this open-label, blinded-endpoint, cluster-randomised
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Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I) Lancet (IF 202.731) Pub Date : 2023-02-24 Eric F Morand, Edward M Vital, Michelle Petri, Ronald van Vollenhoven, Daniel J Wallace, Marta Mosca, Richard A Furie, Maria E Silk, Christina L Dickson, Gabriella Meszaros, Bochao Jia, Brenda Crowe, Inmaculada de la Torre, Thomas Dörner
Background Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. The objective of this trial was to evaluate the efficacy and safety
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Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II) Lancet (IF 202.731) Pub Date : 2023-02-24 Michelle Petri, Ian N Bruce, Thomas Dörner, Yoshiya Tanaka, Eric F Morand, Kenneth C Kalunian, Mario H Cardiel, Maria E Silk, Christina L Dickson, Gabriella Meszaros, Lu Zhang, Bochao Jia, Youna Zhao, Conor J McVeigh, Marta Mosca
Background Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. In this Article, we report the evaluation of efficacy and safety of
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Hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy for patients with locally advanced recurrent nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial Lancet (IF 202.731) Pub Date : 2023-02-23 Rui You, You-Ping Liu, Yu-Long Xie, Chao Lin, Chong-Yang Duan, Dong-Ping Chen, Yi Pan, Bin Qi, Xiong Zou, Ling Guo, Jing-Yu Cao, Yi-Nuan Zhang, Zhi-Qiang Wang, Yong-Long Liu, Yan-Feng Ouyang, Kai Wen, Qi Yang, Ruo-Qi Xie, Hui-Feng Li, Xiao-Tong Duan, Ming-Yuan Chen
Background Reirradiation in standard fractionation for locally advanced recurrent nasopharyngeal carcinoma after a previous course of high-dose radiotherapy is often associated with substantial late toxicity, negating its overall benefit. We therefore aimed to investigate the efficacy and safety of hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy. Methods
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Mpox in people with advanced HIV infection: a global case series Lancet (IF 202.731) Pub Date : 2023-02-21 Oriol Mitjà, Andrea Alemany, Michael Marks, Jezer I Lezama Mora, Juan Carlos Rodríguez-Aldama, Mayara Secco Torres Silva, Ever Arturo Corral Herrera, Brenda Crabtree-Ramirez, José Luis Blanco, Nicolo Girometti, Valentina Mazzotta, Aniruddha Hazra, Macarena Silva, Juan José Montenegro-Idrogo, Kelly Gebo, Jade Ghosn, María Fernanda Peña Vázquez, Eduardo Matos Prado, Uche Unigwe, Judit Villar-García,
Background People living with HIV have accounted for 38–50% of those affected in the 2022 multicountry mpox outbreak. Most reported cases were in people who had high CD4 cell counts and similar outcomes to those without HIV. Emerging data suggest worse clinical outcomes and higher mortality in people with more advanced HIV. We describe the clinical characteristics and outcomes of mpox in a cohort of
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Past SARS-CoV-2 infection protection against re-infection: a systematic review and meta-analysis Lancet (IF 202.731) Pub Date : 2023-02-16
Background Understanding the level and characteristics of protection from past SARS-CoV-2 infection against subsequent re-infection, symptomatic COVID-19 disease, and severe disease is essential for predicting future potential disease burden, for designing policies that restrict travel or access to venues where there is a high risk of transmission, and for informing choices about when to receive vaccine
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Tenecteplase versus alteplase in acute ischaemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomised controlled, non-inferiority trial Lancet (IF 202.731) Pub Date : 2023-02-09 Yongjun Wang, Shuya Li, Yuesong Pan, Hao Li, Mark W Parsons, Bruce C V Campbell, Lee H Schwamm, Marc Fisher, Fengyuan Che, Hongguo Dai, Deyang Li, Runhui Li, Junhai Wang, Yilong Wang, Xingquan Zhao, Zixiao Li, Huaguang Zheng, Yunyun Xiong, Xia Meng, , Zhihua Long
Background There is increasing interest in replacing alteplase with tenecteplase as the preferred thrombolytic treatment for patients with acute ischaemic stroke. We aimed to establish the non-inferiority of tenecteplase to alteplase for these patients. Methods In this multicentre, prospective, open-label, blinded-endpoint, randomised controlled, non-inferiority trial, adults with an acute ischaemic
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Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial Lancet (IF 202.731) Pub Date : 2023-02-09 Robert J Motzer, Paul Russo, Viktor Grünwald, Yoshihiko Tomita, Bogdan Zurawski, Omi Parikh, Sebastiano Buti, Philippe Barthélémy, Jeffrey C Goh, Dingwei Ye, Alejo Lingua, Jean-Baptiste Lattouf, Laurence Albigès, Saby George, Brian Shuch, Jeffrey Sosman, Michael Staehler, Sergio Vázquez Estévez, Burcin Simsek, Julia Spiridigliozzi, Axel Bex
Background Effective adjuvant therapy for patients with resected localised renal cell carcinoma represents an unmet need, with surveillance being the standard of care. We report results from part A of a phase 3, randomised trial that aimed to assess the efficacy and safety of adjuvant nivolumab plus ipilimumab versus placebo. Methods The double-blind, randomised, phase 3 CheckMate 914 trial enrolled
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An investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled, crossover phase 2 trial Lancet (IF 202.731) Pub Date : 2023-02-09 Emel Aygören-Pürsün, Andrea Zanichelli, Danny M Cohn, Mauro Cancian, Roman Hakl, Tamar Kinaciyan, Markus Magerl, Inmaculada Martinez-Saguer, Marcin Stobiecki, Henriette Farkas, Sorena Kiani-Alikhan, Vesna Grivcheva-Panovska, Jonathan A Bernstein, H Henry Li, Hilary J Longhurst, Paul K Audhya, Michael D Smith, Christopher M Yea, Andreas Maetzel, Daniel K Lee, Marcus Maurer
Background Guidelines recommend effective on-demand therapy for all individuals with hereditary angioedema. We aimed to assess the novel oral plasma kallikrein inhibitor, sebetralstat, which is in development, for on-demand treatment of hereditary angioedema attacks. Methods In this two-part phase 2 trial, individuals with type 1 or 2 hereditary angioedema aged 18 years or older were recruited from
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Characterisation of SARS-CoV-2 variants in Beijing during 2022: an epidemiological and phylogenetic analysis Lancet (IF 202.731) Pub Date : 2023-02-08 Yang Pan, Liang Wang, Zhaomin Feng, Hui Xu, Fu Li, Ying Shen, Daitao Zhang, William J Liu, George F Gao, Quanyi Wang
Background Due to the national dynamic zero-COVID strategy in China, there were no persistent local transmissions of SARS-CoV-2 in Beijing before December, 2022. However, imported cases have been frequently detected over the past 3 years. With soaring growth in the number of COVID-19 cases in China recently, there are concerns that there might be an emergence of novel SARS-CoV-2 variants. Routine surveillance
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Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial Lancet (IF 202.731) Pub Date : 2023-02-07 Adrianus Johannes de Langen, Melissa L Johnson, Julien Mazieres, Anne-Marie C Dingemans, Giannis Mountzios, Miklos Pless, Jürgen Wolf, Martin Schuler, Hervé Lena, Ferdinandos Skoulidis, Yasuto Yoneshima, Sang-We Kim, Helena Linardou, Silvia Novello, Anthonie J van der Wekken, Yuanbin Chen, Solange Peters, Enriqueta Felip, Benjamin J Solomon, Suresh S. Ramalingam, Luis Paz-Ares
Background Sotorasib is a specific, irreversible inhibitor of the GTPase protein, KRASG12C. We compared the efficacy and safety of sotorasib with a standard-of-care treatment in patients with non-small-cell lung cancer (NSCLC) with the KRASG12C mutation who had been previously treated with other anticancer drugs. Methods We conducted a randomised, open-label phase 3 trial at 148 centres in 22 countries
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Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials Lancet (IF 202.731) Pub Date : 2023-02-03 Alexa B Kimball, Gregor B E Jemec, Afsaneh Alavi, Ziad Reguiai, Alice B Gottlieb, Falk G Bechara, Carle Paul, Evangelos J Giamarellos Bourboulis, Axel P Villani, Andreas Schwinn, Franziska Ruëff, Larisha Pillay Ramaya, Adam Reich, Ines Lobo, Rodney Sinclair, Thierry Passeron, Antonio Martorell, Pedro Mendes-Bastos, Georgios Kokolakis, Pierre-Andre Becherel, Elisa Muscianisi
Background Few therapeutic options are available for patients with moderate-to-severe hidradenitis suppurativa. We aimed to assess the efficacy of secukinumab in patients with moderate-to-severe hidradenitis suppurativa in two randomised trials. Methods SUNSHINE and SUNRISE were identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials done in 219 primary sites in 40 countries
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Cell-free fetal DNA for genetic evaluation in Copenhagen Pregnancy Loss Study (COPL): a prospective cohort study Lancet (IF 202.731) Pub Date : 2023-02-02
Background One in four pregnancies end in a pregnancy loss. Although the effect on couples is well documented, evidence-based treatments and prediction models are absent. Fetal aneuploidy is associated with a higher chance of a next successful pregnancy compared with euploid pregnancy loss in which underlying maternal conditions might be causal. Ploidy diagnostics are therefore advantageous but challenging
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A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study Lancet (IF 202.731) Pub Date : 2023-02-02 Jesse J Swen, Cathelijne H van der Wouden, Lisanne EN Manson, Heshu Abdullah-Koolmees, Kathrin Blagec, Tanja Blagus, Stefan Böhringer, Anne Cambon-Thomsen, Erika Cecchin, Ka-Chun Cheung, Vera HM Deneer, Mathilde Dupui, Magnus Ingelman-Sundberg, Siv Jonsson, Candace Joefield-Roka, Katja S Just, Mats O Karlsson, Lidija Konta, Rudolf Koopmann, Marjolein Kriek, Arjunan Rajasingam
Background The benefit of pharmacogenetic testing before starting drug therapy has been well documented for several single gene–drug combinations. However, the clinical utility of a pre-emptive genotyping strategy using a pharmacogenetic panel has not been rigorously assessed. Methods We conducted an open-label, multicentre, controlled, cluster-randomised, crossover implementation study of a 12-gene
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Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial Lancet (IF 202.731) Pub Date : 2023-02-01 Andrew W Horne, Stephen Tong, Catherine A Moakes, Lee J Middleton, W Colin Duncan, Ben W Mol, Lucy H R Whitaker, Davor Jurkovic, Arri Coomarasamy, Natalie Nunes, Tom Holland, Fiona Clarke, Ann M Doust, Jane P Daniels
Background Tubal ectopic pregnancies can cause substantial morbidity or even death. Current treatment is with methotrexate or surgery. Methotrexate treatment fails in approximately 30% of women who subsequently require rescue surgery. Gefitinib, an epidermal growth factor receptor inhibitor, might improve the effects of methotrexate. We assessed the efficacy of oral gefitinib with methotrexate, versus
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Cooling cities through urban green infrastructure: a health impact assessment of European cities Lancet (IF 202.731) Pub Date : 2023-01-31 Tamara Iungman, Marta Cirach, Federica Marando, Evelise Pereira Barboza, Sasha Khomenko, Pierre Masselot, Marcos Quijal-Zamorano, Natalie Mueller, Antonio Gasparrini, José Urquiza, Mehdi Heris, Meelan Thondoo, Mark Nieuwenhuijsen
Background High ambient temperatures are associated with many health effects, including premature mortality. The combination of global warming due to climate change and the expansion of the global built environment mean that the intensification of urban heat islands (UHIs) is expected, accompanied by adverse effects on population health. Urban green infrastructure can reduce local temperatures. We
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Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study Lancet (IF 202.731) Pub Date : 2023-01-26
Background Janus kinase (JAK) inhibitors approved for myelofibrosis provide spleen and symptom improvements but do not meaningfully improve anaemia. Momelotinib, a first-in-class inhibitor of activin A receptor type 1 as well as JAK1 and JAK2, has shown symptom, spleen, and anaemia benefits in myelofibrosis. We aimed to confirm the differentiated clinical benefits of momelotinib versus the active comparator
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Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial Lancet (IF 202.731) Pub Date : 2023-01-26
Background WHO has identified Marburg virus as an emerging virus requiring urgent vaccine research and development, particularly due to its recent emergence in Ghana. We report results from a first-in-human clinical trial evaluating a replication-deficient recombinant chimpanzee adenovirus type 3 (cAd3)-vectored vaccine encoding a wild-type Marburg virus Angola glycoprotein (cAd3-Marburg) in healthy
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The effect of higher protein dosing in critically ill patients with high nutritional risk (EFFORT Protein): an international, multicentre, pragmatic, registry-based randomised trial Lancet (IF 202.731) Pub Date : 2023-01-25 Daren K Heyland, Jayshil Patel, Charlene Compher, Todd W Rice, Danielle E Bear, Zheng-Yii Lee, Victoria C González, Kevin O'Reilly, Racquel Regala, Courtney Wedemire, Miguel Ibarra-Estrada, Christian Stoppe, Luis Ortiz-Reyes, Xuran Jiang, Andrew G Day
Background On the basis of low-quality evidence, international critical care nutrition guidelines recommend a wide range of protein doses. The effect of delivering high-dose protein during critical illness is unknown. We aimed to test the hypothesis that a higher dose of protein provided to critically ill patients would improve their clinical outcomes. Methods This international, investigator-initiated
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Sodium bicarbonate for kidney transplant recipients with metabolic acidosis in Switzerland: a multicentre, randomised, single-blind, placebo-controlled, phase 3 trial Lancet (IF 202.731) Pub Date : 2023-01-25 Nilufar Mohebbi, Alexander Ritter, Anna Wiegand, Nicole Graf, Suzan Dahdal, Daniel Sidler, Spyridon Arampatzis, Karine Hadaya, Thomas F Mueller, Carsten A Wagner, Rudolf P Wüthrich
Background Metabolic acidosis is common in kidney transplant recipients and is associated with declining graft function. Sodium bicarbonate treatment effectively corrects metabolic acidosis, but no prospective studies have examined its effect on graft function. Therefore, we aimed to test whether sodium bicarbonate treatment would preserve graft function and slow the progression of estimated glomerular
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Efficacy of pyriproxyfen-pyrethroid long-lasting insecticidal nets (LLINs) and chlorfenapyr-pyrethroid LLINs compared with pyrethroid-only LLINs for malaria control in Benin: a cluster-randomised, superiority trial Lancet (IF 202.731) Pub Date : 2023-01-24
Background New classes of long-lasting insecticidal nets (LLINs) combining mixtures of insecticides with different modes of action could put malaria control back on track after rebounds in transmission across sub-Saharan Africa. We evaluated the relative efficacy of pyriproxyfen-pyrethroid LLINs and chlorfenapyr-pyrethroid LLINs compared with standard LLINs against malaria transmission in an area of
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Performance of cardiovascular disease risk prediction equations in more than 14 000 survivors of cancer in New Zealand primary care: a validation study Lancet (IF 202.731) Pub Date : 2023-01-23
Background People with cancer have an increased risk of cardiovascular disease. Risk prediction equations developed in New Zealand accurately predict 5-year cardiovascular disease risk in a general primary care population in the country. We assessed the performance of these equations for survivors of cancer in New Zealand. Methods For this validation study, patients aged 30–74 years from the PREDICT
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Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study Lancet (IF 202.731) Pub Date : 2023-01-17 Jose Villar, Constanza P Soto Conti, Robert B Gunier, Shabina Ariff, Rachel Craik, Paolo I Cavoretto, Stephen Rauch, Serena Gandino, Ricardo Nieto, Adele Winsey, Camilla Menis, Gabriel B Rodriguez, Valeria Savasi, Niyazi Tug, Sonia Deantoni, Marta Fabre, Begoña Martinez de Tejada, Maria Jose Rodriguez-Sibaja, Stefania Livio, Raffaele Napolitano, Aris T Papageorghiou
Background In 2021, we showed an increased risk associated with COVID-19 in pregnancy. Since then, the SARS-CoV-2 virus has undergone genetic mutations. We aimed to examine the effects on maternal and perinatal outcomes of COVID-19 during pregnancy, and evaluate vaccine effectiveness, when omicron (B.1.1.529) was the variant of concern. Methods INTERCOVID-2022 is a large, prospective, observational
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2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial Lancet (IF 202.731) Pub Date : 2023-01-17 Elisabeth M L de Wijkerslooth, Evert-Jan G Boerma, Charles C van Rossem, Joost van Rosmalen, Coen I M Baeten, Frédérique H Beverdam, Johanna W A M Bosmans, Esther C J Consten, Jan Willem T Dekker, Marloes Emous, Anna A W van Geloven, Anton F Gijsen, Luc A Heijnen, An P Jairam, Damian C Melles, Augustinus P T van der Ploeg, Pascal Steenvoorde, Boudewijn R Toorenvliet, Maarten Vermaas, Bas Wiering, B
Background The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs. Methods In this pragmatic, open-label, non-inferiority trial in 15 hospitals in the Netherlands, patients with complex appendicitis
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Machine learning-based marker for coronary artery disease: derivation and validation in two longitudinal cohorts Lancet (IF 202.731) Pub Date : 2022-12-20 Iain S Forrest, Ben O Petrazzini, Áine Duffy, Joshua K Park, Carla Marquez-Luna, Daniel M Jordan, Ghislain Rocheleau, Judy H Cho, Robert S Rosenson, Jagat Narula, Girish N Nadkarni, Ron Do
Background Binary diagnosis of coronary artery disease does not preserve the complexity of disease or quantify its severity or its associated risk with death; hence, a quantitative marker of coronary artery disease is warranted. We evaluated a quantitative marker of coronary artery disease derived from probabilities of a machine learning model. Methods In this cohort study, we developed and validated
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Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial Lancet (IF 202.731) Pub Date : 2022-12-22 Christopher C Butler, F D Richard Hobbs, Oghenekome A Gbinigie, Najib M Rahman, Gail Hayward, Duncan B Richards, Jienchi Dorward, David M Lowe, Joseph F Standing, Judith Breuer, Saye Khoo, Stavros Petrou, Kerenza Hood, Jonathan S Nguyen-Van-Tam, Mahendra G Patel, Benjamin R Saville, Joe Marion, Emma Ogburn, Julie Allen, Heather Rutter, Azhar Zafar
Background The safety, effectiveness, and cost-effectiveness of molnupiravir, an oral antiviral medication for SARS-CoV-2, has not been established in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. We aimed to establish whether the addition of molnupiravir to usual care reduced hospital admissions and deaths associated with COVID-19 in this population
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An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study Lancet (IF 202.731) Pub Date : 2022-12-09 Emma Guttman-Yassky, Eric L Simpson, Kristian Reich, Kenji Kabashima, Ken Igawa, Tetsuya Suzuki, Hirotaka Mano, Takeshi Matsui, Ehsanollah Esfandiari, Masutaka Furue
Background OX40 is crucial for T-cell differentiation and memory induction. The anti-OX40 antibody, rocatinlimab inhibits the OX40 pathway. We evaluated the efficacy and safety of rocatinlimab in adults with moderate-to-severe atopic dermatitis. Methods This multicentre, double-blind, placebo-controlled phase 2b study was done at 65 secondary and tertiary sites in the USA, Canada, Japan, and Germany
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Effects of race and ethnicity on perinatal outcomes in high-income and upper-middle-income countries: an individual participant data meta-analysis of 2 198 655 pregnancies Lancet (IF 202.731) Pub Date : 2022-12-08 Jameela Sheikh, John Allotey, Tania Kew, Borja M Fernández-Félix, Javier Zamora, Asma Khalil, Shakila Thangaratinam
Background Existing evidence on the effects of race and ethnicity on pregnancy outcomes is restricted to individual studies done within specific countries and health systems. We aimed to assess the impact of race and ethnicity on perinatal outcomes in high-income and upper-middle-income countries, and to ascertain whether the magnitude of disparities, if any, varied across geographical regions. Methods
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The impact of urbanisation on the cardiometabolic health of Indigenous Brazilian peoples: a systematic review and meta-analysis, and data from the Brazilian Health registry Lancet (IF 202.731) Pub Date : 2022-12-08 Caroline K Kramer, Cristiane B Leitão, Luciana V Viana
Background Indigenous Brazilian peoples have faced an unparalleled increase in the rate of cardiovascular diseases following rapid nutritional transition to more urban diets. We aimed to conduct a systematic review and meta-analysis to evaluate the association between urbanisation (including data from Amazon rainforest deforestation) and cardiometabolic risk factors and outcomes. Methods In this systematic
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Population-level contribution of interpersonal discrimination to psychological distress among Australian Aboriginal and Torres Strait Islander adults, and to Indigenous–non-Indigenous inequities: cross-sectional analysis of a community-controlled First Nations cohort study Lancet (IF 202.731) Pub Date : 2022-12-08 Katherine A Thurber, Makayla-May Brinckley, Roxanne Jones, Olivia Evans, Kirsty Nichols, Naomi Priest, Shuaijun Guo, David R Williams, Gilbert C Gee, Grace Joshy, Emily Banks, Joanne Thandrayen, Bernard Baffour, Janine Mohamed, Tom Calma, Raymond Lovett
Background International and population-specific evidence identifies elevated psychological distress prevalence among those experiencing interpersonal discrimination. We aim to quantify the potential whole-of-population contribution of interpersonal discrimination to psychological distress prevalence and Indigenous–non-Indigenous gaps in Australia. Methods We did a cross-sectional analysis of data
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Evaluation of the safety, immunogenicity, and faecal shedding of novel oral polio vaccine type 2 in healthy newborn infants in Bangladesh: a randomised, controlled, phase 2 clinical trial Lancet (IF 202.731) Pub Date : 2022-12-07 Khaelqu Zaman, Ananda S Bandyopadhyay, Masuma Hoque, Christopher Gast, Mohammad Yunus, Khondoker M Jamil, Bernardo A Mainou, Jennifer L Konopka-Anstadt, William S Hendley, Annelet Vincent, Ralf Clemens, Sue Ann Costa Clemens, Allen G Ross, John D Clemens, Erman Tritama
Background Type 2 circulating vaccine-derived polioviruses (cVDPV2) from Sabin oral poliovirus vaccines (OPVs) are the leading cause of poliomyelitis. A novel type 2 OPV (nOPV2) has been developed to be more genetically stable with similar tolerability and immunogenicity to that of Sabin type 2 vaccines to mitigate the risk of cVDPV2. We aimed to assess these aspects of nOPV2 in poliovirus vaccine-naive
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Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial Lancet (IF 202.731) Pub Date : 2022-12-07 Sara A Hurvitz, Roberto Hegg, Wei-Pang Chung, Seock-Ah Im, William Jacot, Vinod Ganju, Joanne Wing Yan Chiu, Binghe Xu, Erika Hamilton, Srinivasan Madhusudan, Hiroji Iwata, Sevilay Altintas, Jan-Willem Henning, Giuseppe Curigliano, José Manuel Perez-Garcia, Sung-Bae Kim, Vanessa Petry, Chiun-Sheng Huang, Wei Li, Jean-Sebastien Frenel, Javier Cortés
Background An improvement in progression-free survival was shown with trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer in the progression-free survival interim analysis of the DESTINY-Breast03 trial. The aim of DESTINY-Breast03 was to compare the efficacy and safety of trastuzumab deruxtecan versus trastuzumab emtansine. Methods This open-label
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Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE) Lancet (IF 202.731) Pub Date : 2022-12-06 Joseph F Merola, Robert Landewé, Iain B McInnes, Philip J Mease, Christopher T Ritchlin, Yoshiya Tanaka, Akihiko Asahina, Frank Behrens, Dafna D Gladman, Laure Gossec, Alice B Gottlieb, Diamant Thaçi, Richard B Warren, Barbara Ink, Deepak Assudani, Rajan Bajracharya, Vishvesh Shende, Jason Coarse, Laura C Coates
Background Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A. This study compared the efficacy and safety of bimekizumab with placebo over 16 weeks in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α (TNFα) inhibitors. Methods BE COMPLETE was a phase 3, multicentre, randomised, double-blind
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Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL) Lancet (IF 202.731) Pub Date : 2022-12-06 Iain B McInnes, Akihiko Asahina, Laura C Coates, Robert Landewé, Joseph F Merola, Christopher T Ritchlin, Yoshiya Tanaka, Laure Gossec, Alice B Gottlieb, Richard B Warren, Barbara Ink, Deepak Assudani, Rajan Bajracharya, Vishvesh Shende, Jason Coarse, Philip J Mease
Background Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F. We assessed the efficacy and safety of bimekizumab in patients with active psoriatic arthritis who were naive to biologic disease-modifying antirheumatic drugs (DMARDs). Methods BE OPTIMAL was a 52-week, phase 3, multicentre, randomised, double-blind, placebo-controlled, active reference
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Pregnancy outcomes after first-trimester treatment with artemisinin derivatives versus non-artemisinin antimalarials: a systematic review and individual patient data meta-analysis Lancet (IF 202.731) Pub Date : 2022-11-25 Makoto Saito, Rose McGready, Halidou Tinto, Toussaint Rouamba, Dominic Mosha, Stephen Rulisa, Simon Kariuki, Meghna Desai, Christine Manyando, Eric M Njunju, Esperanca Sevene, Anifa Vala, Orvalho Augusto, Christine Clerk, Edwin Were, Sigilbert Mrema, William Kisinza, Josaphat Byamugisha, Mike Kagawa, Jan Singlovic, Stephanie Dellicour
Background Malaria in the first trimester of pregnancy is associated with adverse pregnancy outcomes. Artemisinin-based combination therapies (ACTs) are a highly effective, first-line treatment for uncomplicated Plasmodium falciparum malaria, except in the first trimester of pregnancy, when quinine with clindamycin is recommended due to concerns about the potential embryotoxicity of artemisinins. We
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Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial Lancet (IF 202.731) Pub Date : 2022-11-25 George R Thompson, Alex Soriano, Oliver A Cornely, Bart Jan Kullberg, Marin Kollef, Jose Vazquez, Patrick M Honore, Matteo Bassetti, John Pullman, Methee Chayakulkeeree, Ivan Poromanski, Cecilia Dignani, Anita F Das, Taylor Sandison, Peter G Pappas
Background Rezafungin is a next-generation, once-a-week echinocandin in development for the treatment of candidaemia and invasive candidiasis and for the prevention of invasive fungal disease caused by Candida, Aspergillus, and Pneumocystis spp after blood and marrow transplantation. We aimed to compare the efficacy and safety of intravenous rezafungin versus intravenous caspofungin in patients with
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Global mortality associated with 33 bacterial pathogens in 2019: a systematic analysis for the Global Burden of Disease Study 2019 Lancet (IF 202.731) Pub Date : 2022-11-21
Background Reducing the burden of death due to infection is an urgent global public health priority. Previous studies have estimated the number of deaths associated with drug-resistant infections and sepsis and found that infections remain a leading cause of death globally. Understanding the global burden of common bacterial pathogens (both susceptible and resistant to antimicrobials) is essential
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Human monkeypox virus infection in women and non-binary individuals during the 2022 outbreaks: a global case series Lancet (IF 202.731) Pub Date : 2022-11-17 John P Thornhill, Romain Palich, Jade Ghosn, Sharon Walmsley, Davide Moschese, Claudia P Cortes, Rafael Mello Galliez, Amy B Garlin, Silvia Nozza, Oriol Mitja, Asa E Radix, Jose Luis Blanco, Brenda Crabtree-Ramirez, Melanie Thompson, Lothar Wiese, Hubert Schulbin, Ariela Levcovich, Marco Falcone, Anna Lucchini, Elena Sendagorta, Chloe M Orkin
Background Between May and November, 2022, global outbreaks of human monkeypox virus infection have been reported in more than 78 000 people worldwide, predominantly in men who have sex with men. We describe the epidemiological and clinical characteristics of monkeypox virus infection in cisgender (cis) and transgender (trans) women and non-binary individuals assigned female sex at birth to improve
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Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials Lancet (IF 202.731) Pub Date : 2022-11-10 Madeleine N Jones, Kirsten R Palmer, Maleesa M Pathirana, Jose Guilherme Cecatti, Olimpio B Moraes Filho, Lena Marions, Måns Edlund, Martina Prager, Craig Pennell, Jan E Dickinson, Nelson Sass, Marta Jozwiak, Mieke Ten Eikelder, Katrien Oude Rengerink, Kitty W M Bloemenkamp, Amanda Henry, Ellen C L Løkkegaard, Ib Jarle Christensen, Wentao Li
Background Induction of labour is one of the most common obstetric interventions globally. Balloon catheters and vaginal prostaglandins are widely used to ripen the cervix in labour induction. We aimed to compare the effectiveness and safety profiles of these two induction methods. Methods We did an individual participant data meta-analysis comparing balloon catheters and vaginal prostaglandins for
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Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: a phase 2, randomised, double-blind, placebo-controlled trial Lancet (IF 202.731) Pub Date : 2022-11-10 Amanda Vrselja, Ardian Latifi, Rodney J Baber, Bronwyn G A Stuckey, Michael G Walker, Vered Stearns, Martha Hickey, Susan R Davis
Background Vasomotor symptoms (hot flushes and night sweats) are experienced by more than two-thirds of women with breast cancer taking oral adjuvant endocrine therapy. Safe and effective treatments are lacking. Q-122 is a novel, non-hormonal compound that has shown promise for reducing vasomotor symptoms by modulation of oestrogen-responsive neurons in the hypothalamus. We aimed to assess the efficacy
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Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial Lancet (IF 202.731) Pub Date : 2022-11-08 Ruth L Goodall, Sarah K Meredith, Andrew J Nunn, Adamu Bayissa, Anuj K Bhatnagar, Gay Bronson, Chen-Yuan Chiang, Francesca Conradie, Meera Gurumurthy, Bruce Kirenga, Nana Kiria, Daniel Meressa, Ronelle Moodliar, Gopalan Narendran, Nosipho Ngubane, Mohammed Rassool, Karen Sanders, Rajesh Solanki, S Bertel Squire, Gabriela Torrea, Chuluunbaatar Zagd
Background The STREAM stage 1 trial showed that a 9-month regimen for the treatment of rifampicin-resistant tuberculosis was non-inferior to the 20-month 2011 WHO-recommended regimen. In STREAM stage 2, we aimed to compare two bedaquiline-containing regimens with the 9-month STREAM stage 1 regimen. Methods We did a randomised, phase 3, non-inferiority trial in 13 hospital clinics in seven countries
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Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial Lancet (IF 202.731) Pub Date : 2022-11-07 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
Background Resistant hypertension is associated with increased cardiovascular risk. The endothelin pathway has been implicated in the pathogenesis of hypertension, but it is currently not targeted therapeutically, thereby leaving this relevant pathophysiological pathway unopposed with currently available drugs. The aim of the study was to assess the blood pressure lowering efficacy of the dual endothelin
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Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial Lancet (IF 202.731) Pub Date : 2022-11-07 Alexandre Mebazaa, Beth Davison, Ovidiu Chioncel, Alain Cohen-Solal, Rafael Diaz, Gerasimos Filippatos, Marco Metra, Piotr Ponikowski, Karen Sliwa, Adriaan A Voors, Christopher Edwards, Maria Novosadova, Koji Takagi, Albertino Damasceno, Hadiza Saidu, Etienne Gayat, Peter S Pang, Jelena Celutkiene, Gad Cotter
Background There is a paucity of evidence for dose and pace of up-titration of guideline-directed medical therapies after admission to hospital for acute heart failure. Methods In this multinational, open-label, randomised, parallel-group trial (STRONG-HF), patients aged 18–85 years admitted to hospital with acute heart failure, not treated with full doses of guideline-directed drug treatment, were
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Impact of diabetes on the effects of sodium glucose co-transporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials Lancet (IF 202.731) Pub Date : 2022-11-06
Background Large trials have shown that sodium glucose co-transporter-2 (SGLT2) inhibitors reduce the risk of adverse kidney and cardiovascular outcomes in patients with heart failure or chronic kidney disease, or with type 2 diabetes and high risk of atherosclerotic cardiovascular disease. None of the trials recruiting patients with and without diabetes were designed to assess outcomes separately
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Bivalirudin plus a high-dose infusion versus heparin monotherapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomised trial Lancet (IF 202.731) Pub Date : 2022-11-06 Yi Li, Zhenyang Liang, Lei Qin, Mian Wang, Xianzhao Wang, Huanyi Zhang, Yin Liu, Yan Li, Zhisheng Jia, Limin Liu, Hongyan Zhang, Jun Luo, Songwu Dong, Jincheng Guo, Hengqing Zhu, Shengli Li, Haijun Zheng, Lijun Liu, Yanqing Wu, Yiming Zhong, Gregg W Stone
Background Previous randomised trials of bivalirudin versus heparin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) have reported conflicting results, in part because of treatment with different pharmacological regimens. We designed a large-scale trial examining bivalirudin with a post-PCI high-dose infusion compared with
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Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial Lancet (IF 202.731) Pub Date : 2022-11-05 Paul R Kalra, John G F Cleland, Mark C Petrie, Elizabeth A Thomson, Philip A Kalra, Iain B Squire, Fozia Z Ahmed, Abdallah Al-Mohammad, Peter J Cowburn, Paul W X Foley, Fraser J Graham, Alan G Japp, Rebecca E Lane, Ninian N Lang, Andrew J Ludman, Iain C Macdougall, Pierpaolo Pellicori, Robin Ray, Michele Robertson, Alison Seed, Debra Stuart
Background For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the short-term and reduces hospital admissions for heart failure up to 1 year. We aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients
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Helicobacter pylori eradication for primary prevention of peptic ulcer bleeding in older patients prescribed aspirin in primary care (HEAT): a randomised, double-blind, placebo-controlled trial Lancet (IF 202.731) Pub Date : 2022-11-03 Chris Hawkey, Anthony Avery, Carol A C Coupland, Colin Crooks, Jennifer Dumbleton, F D Richard Hobbs, Denise Kendrick, Michael Moore, Clive Morris, Gregory Rubin, Murray Smith, Diane Stevenson
Background Peptic ulcers in patients receiving aspirin are associated with Helicobacter pylori infection. We aimed to investigate whether H pylori eradication would protect against aspirin-associated ulcer bleeding. Methods We conducted a randomised, double-blind, placebo-controlled trial (Helicobacter Eradication Aspirin Trial [HEAT]) at 1208 primary care centres in the UK, using routinely collected
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Elective surgery system strengthening: development, measurement, and validation of the surgical preparedness index across 1632 hospitals in 119 countries Lancet (IF 202.731) Pub Date : 2022-10-31
Background The 2015 Lancet Commission on global surgery identified surgery and anaesthesia as indispensable parts of holistic health-care systems. However, COVID-19 exposed the fragility of planned surgical services around the world, which have also been neglected in pandemic recovery planning. This study aimed to develop and validate a novel index to support local elective surgical system strengthening