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241. Clinical outcomes of uninterrupted embryo culture with or without time-lapse-based embryo selection versus interrupted standard culture (SelecTIMO): a three-armed, multicentre, double-blind, randomised controlled trial.
作者: D C Kieslinger.;C G Vergouw.;L Ramos.;B Arends.;M H J M Curfs.;E Slappendel.;E H Kostelijk.;M H E C Pieters.;D Consten.;M O Verhoeven.;D E Besselink.;F Broekmans.;B J Cohlen.;J M J Smeenk.;S Mastenbroek.;C H de Koning.;Y M van Kasteren.;E Moll.;J van Disseldorp.;E A Brinkhuis.;E A M Kuijper.;W M van Baal.;H G I van Weering.;P J Q van der Linden.;M H Gerards.;P M Bossuyt.;M van Wely.;C B Lambalk.
来源: Lancet. 2023年401卷10386期1438-1446页
Time-lapse monitoring is increasingly used in fertility laboratories to culture and select embryos for transfer. This method is offered to couples with the promise of improving pregnancy chances, even though there is currently insufficient evidence for superior clinical results. We aimed to evaluate whether a potential improvement by time-lapse monitoring is caused by the time-lapse-based embryo selection method itself or the uninterrupted culture environment that is part of the system.
242. Endovascular treatment versus no endovascular treatment after 6-24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands: a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial.
作者: Susanne G H Olthuis.;F Anne V Pirson.;Florentina M E Pinckaers.;Wouter H Hinsenveld.;Daan Nieboer.;Angelique Ceulemans.;Robrecht R M M Knapen.;M M Quirien Robbe.;Olvert A Berkhemer.;Marianne A A van Walderveen.;Geert J Lycklama À Nijeholt.;Maarten Uyttenboogaart.;Wouter J Schonewille.;P Matthijs van der Sluijs.;Lennard Wolff.;Henk van Voorst.;Alida A Postma.;Stefan D Roosendaal.;Anouk van der Hoorn.;Bart J Emmer.;Menno G M Krietemeijer.;Pieter-Jan van Doormaal.;Bob Roozenbeek.;Robert-Jan B Goldhoorn.;Julie Staals.;Inger R de Ridder.;Christiaan van der Leij.;Jonathan M Coutinho.;H Bart van der Worp.;Rob T H Lo.;Reinoud P H Bokkers.;Ewoud I van Dijk.;Hieronymus D Boogaarts.;Marieke J H Wermer.;Adriaan C G M van Es.;Julia H van Tuijl.;Hans G J Kortman.;Rob A R Gons.;Lonneke S F Yo.;Jan-Albert Vos.;Karlijn F de Laat.;Lukas C van Dijk.;Ido R van den Wijngaard.;Jeannette Hofmeijer.;Jasper M Martens.;Paul J A M Brouwers.;Tomas Bulut.;Michel J M Remmers.;Thijs E A M de Jong.;Heleen M den Hertog.;Boudewijn A A M van Hasselt.;Anouk D Rozeman.;Otto E H Elgersma.;Bas van der Veen.;Davy R Sudiono.;Hester F Lingsma.;Yvo B W E M Roos.;Charles B L M Majoie.;Aad van der Lugt.;Diederik W J Dippel.;Wim H van Zwam.;Robert J van Oostenbrugge.; .
来源: Lancet. 2023年401卷10385期1371-1380页
Endovascular treatment for anterior circulation ischaemic stroke is effective and safe within a 6 h window. MR CLEAN-LATE aimed to assess efficacy and safety of endovascular treatment for patients treated in the late window (6-24 h from symptom onset or last seen well) selected on the basis of the presence of collateral flow on CT angiography (CTA).
243. Efficacy and safety of fitusiran prophylaxis in people with haemophilia A or haemophilia B with inhibitors (ATLAS-INH): a multicentre, open-label, randomised phase 3 trial.
作者: Guy Young.;Alok Srivastava.;Kaan Kavakli.;Cecil Ross.;Jameela Sathar.;Chur-Woo You.;Huyen Tran.;Jing Sun.;Runhui Wu.;Stacey Poloskey.;Zhiying Qiu.;Salim Kichou.;Shauna Andersson.;Baisong Mei.;Savita Rangarajan.
来源: Lancet. 2023年401卷10386期1427-1437页
Fitusiran, a subcutaneous investigational small interfering RNA therapeutic, targets antithrombin to rebalance haemostasis in people with haemophilia A or haemophilia B, irrespective of inhibitor status. We evaluated the efficacy and safety of fitusiran prophylaxis in people with haemophilia A or haemophilia B with inhibitors.
244. Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial.
作者: 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.
来源: Lancet. 2023年401卷10384期1267-1276页
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).
245. The Peer Education Project to improve mental health literacy in secondary school students in England: a qualitative realist evaluation.
作者: Esther Louise Curtin.;Emily Widnall.;Steve Dodd.;Mark Limmer.;Ruth Simmonds.;Abigail Emma Russell.;Judi Kidger.
来源: Lancet. 2022年400 Suppl 1卷S34页
Worsening of adolescent mental health and exacerbated health inequalities after the COVID-19 pandemic calls for universal preventative strategies. The Mental Health Foundation's school-based Peer Education Project seeks to improve students' mental health literacy through peer educators (aged 14-18 years) teaching peer learners (aged 11-13 years) to recognise good and bad mental health, identify risk and protective factors, and seek help accordingly. Although previous before and after quantitative assessments have found the intervention to be effective, this realist evaluation aimed to qualitatively develop the theory of change, exploring how the mechanisms played out in different contexts to achieve the desired outcomes.
246. Evaluating the Change4Life Food Scanner app in reducing children's sugar intake: a randomised pilot and feasibility study.
The Change4Life Food Scanner app displays nutritional information using visual images alongside traffic light labels. The app's effectiveness for improving dietary choices is unknown. This study investigated the feasibility and acceptability of evaluating the effectiveness of the Food Scanner app in reducing children's sugar intake in the UK.
247. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study.
作者: 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.
来源: Lancet. 2023年401卷10382期1091-1102页
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 the safety and efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
248. 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.
作者: 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.;John P A Lusingu.;Simon Kariuki.;Jacklin F Mosha.;Michael Alifrangis.;Helle Hansson.;Christentze Schmiegelow.;Julie R Gutman.;R Matthew Chico.;Feiko O Ter Kuile.
来源: Lancet. 2023年401卷10381期1020-1036页
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 azithromycin, can reduce adverse pregnancy outcomes compared with IPTp with sulfadoxine-pyrimethamine.
249. Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus-diphtheria-acellular pertussis vaccine: a randomised, double-blind, phase 2b trial.
作者: 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.
来源: Lancet. 2023年401卷10379期843-855页
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).
250. Inflammation and cholesterol as predictors of cardiovascular events among patients receiving statin therapy: a collaborative analysis of three randomised trials.
作者: Paul M Ridker.;Deepak L Bhatt.;Aruna D Pradhan.;Robert J Glynn.;Jean G MacFadyen.;Steven E Nissen.; .
来源: Lancet. 2023年401卷10384期1293-1301页
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 of high-sensitivity C-reactive protein (CRP) and low-density lipoprotein cholesterol (LDLC) as determinants of risk for major adverse cardiovascular events, cardiovascular death, and all-cause-death among patients receiving statins.
251. 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.
作者: 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.;Eric Boersma.;Nicolas M Van Mieghem.; .
来源: Lancet. 2023年401卷10383期1172-1182页
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.
252. Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial.
作者: 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.
来源: Lancet. 2023年401卷10382期1103-1114页
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.
253. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies.
作者: 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.
来源: Lancet. 2023年401卷10383期1159-1171页
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 to severely active ulcerative colitis.
254. 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.
作者: 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.; .
来源: Lancet. 2023年401卷10380期928-938页
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.
255. 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.
作者: 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.;Regina Treudler.;Henrike Feuersenger.;Fiona Glassman.;Iris Jacobs.;Markus Magerl.
来源: Lancet. 2023年401卷10382期1079-1090页
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 subcutaneous administrations of garadacimab as prophylaxis for hereditary angioedema.
256. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II).
作者: 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.
来源: Lancet. 2023年401卷10381期1011-1019页
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 baricitinib in patients with SLE in a 52-week phase 3 study.
257. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I).
作者: 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.
来源: Lancet. 2023年401卷10381期1001-1010页
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 of baricitinib in patients with active SLE in a 52-week phase 3 study.
258. 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.
作者: 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.;Xi Ding.;Lan Peng.;Si-Yuan Chen.;Jiong-Lin Liang.;Zheng-Kai Feng.;Tian-Liang Xia.;Rui-Ling Xie.;Rou Jiang.;Chen-Mei Gu.;Rong-Zeng Liu.;Rui Sun.;Xin Yang.;Li-Zhi Liu.;Li Ling.;Qing Liu.;Wai Tong Ng.;Yi-Jun Hua.;Pei-Yu Huang.;Ming-Yuan Chen.
来源: Lancet. 2023年401卷10380期917-927页
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.
259. Tenecteplase versus alteplase in acute ischaemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomised controlled, non-inferiority trial.
作者: 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.; .
来源: Lancet. 2023年401卷10377期645-654页
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.
260. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial.
作者: 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.;Aleksander Chudnovsky.;Axel Bex.
来源: Lancet. 2023年401卷10379期821-832页
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.
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