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161. Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiNivo-2 Study.
作者: Toni K Choueiri.;Laurence Albiges.;Philippe Barthélémy.;Roberto Iacovelli.;Sheik Emambux.;Javier Molina-Cerrillo.;Benjamin Garmezy.;Pedro Barata.;Arnab Basu.;Maria T Bourlon.;Helen Moon.;Raffaele Ratta.;Rana R McKay.;Alexander Chehrazi-Raffle.;Hans Hammers.;Daniel Y C Heng.;Edgar Braendle.;Kathryn E Beckermann.;Bradley A McGregor.;Robert J Motzer.
来源: Lancet. 2024年404卷10460期1309-1320页
Immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor receptor tyrosine kinase inhibitors are cornerstones of first-line treatment for advanced renal cell carcinoma; however, optimal treatment sequencing after progression is unknown. This study aimed to assess clinical outcomes of tivozanib-nivolumab versus tivozanib monotherapy in patients with metastatic renal cell carcinoma who have progressed following one or two lines of therapy in the post-ICI setting.
162. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial.
作者: Richard M Bergenstal.;Ruth S Weinstock.;Chantal Mathieu.;Yukiko Onishi.;Vishali Vijayanagaram.;Michelle L Katz.;Molly C Carr.;Annette M Chang.
来源: Lancet. 2024年404卷10458期1132-1142页
Insulin efsitora alfa (efsitora) is a once-weekly basal insulin. This phase 3 study aimed to assess the efficacy and safety of efsitora compared with insulin degludec (degludec) in adults with type 1 diabetes.
163. Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea.
作者: Sung-Jin Hong.;Seung-Jun Lee.;Sang-Hyup Lee.;Jong-Young Lee.;Deok-Kyu Cho.;Jin Won Kim.;Sang Min Kim.;Seung-Ho Hur.;Jung Ho Heo.;Ji-Yong Jang.;Jin Sin Koh.;Hoyoun Won.;Jun-Won Lee.;Soon Jun Hong.;Dong-Kie Kim.;Jeong Cheon Choe.;Jin Bae Lee.;Soo-Joong Kim.;Tae-Hyun Yang.;Jung-Hee Lee.;Young Joon Hong.;Jong-Hwa Ahn.;Yong-Joon Lee.;Chul-Min Ahn.;Jung-Sun Kim.;Young-Guk Ko.;Donghoon Choi.;Myeong-Ki Hong.;Yangsoo Jang.;Byeong-Keuk Kim.; .
来源: Lancet. 2024年404卷10457期1029-1039页
Despite the detailed imaging information provided by optical coherence tomography (OCT) during percutaneous coronary intervention (PCI), clinical benefits of this imaging technique in this setting remain uncertain. The aim of the OCCUPI trial was to compare the clinical benefits of OCT-guided versus angiography-guided PCI for complex lesions, assessed as the rate of major adverse cardiac events at 1 year.
164. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial.
作者: Chao Gao.;Xingqiang He.;Fan Ouyang.;Zhihui Zhang.;Guidong Shen.;Mingxing Wu.;Ping Yang.;Likun Ma.;Feng Yang.;Zheng Ji.;Hua Wang.;Yanqing Wu.;Zhenfei Fang.;Hong Jiang.;Shangyu Wen.;Yi Liu.;Fei Li.;Jingyu Zhou.;Bin Zhu.;Yunpeng Liu.;Ruining Zhang.;Tingting Zhang.;Ping Wang.;Jianzheng Liu.;Zhiwei Jiang.;Jielai Xia.;Robert-Jan van Geuns.;Davide Capodanno.;Scot Garg.;Yoshinobu Onuma.;Duolao Wang.;Patrick W Serruys.;Ling Tao.; .
来源: Lancet. 2024年404卷10457期1040-1050页
The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions.
165. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials.
作者: Mikhail N Kosiborod.;John Deanfield.;Richard Pratley.;Barry A Borlaug.;Javed Butler.;Melanie J Davies.;Scott S Emerson.;Steven E Kahn.;Dalane W Kitzman.;Ildiko Lingvay.;Kenneth W Mahaffey.;Mark C Petrie.;Jorge Plutzky.;Søren Rasmussen.;Cecilia Rönnbäck.;Sanjiv J Shah.;Subodh Verma.;Peter E Weeke.;A Michael Lincoff.; .
来源: Lancet. 2024年404卷10456期949-961页
Heart failure with mildly reduced or preserved ejection fraction (hereafter referred to as HFpEF) is the most common type of heart failure and is associated with a high risk of hospitalisation and death, especially in patients with overweight, obesity, or type 2 diabetes. In the STEP-HFpEF and STEP-HFpEF DM trials, semaglutide improved heart failure-related symptoms and physical limitations in participants with HFpEF. Whether semaglutide also reduces clinical heart failure events in this group remains to be established.
166. First dose of misoprostol administration at home or in hospital for medical abortion between 12-22 gestational weeks in Sweden (PRIMA): a multicentre, open-label, randomised controlled trial.
作者: Johanna Rydelius.;Helena Hognert.;Helena Kopp-Kallner.;Karin Brandell.;Joanna Romell.;Karin Zetterström.;Pia Teleman.;Kristina Gemzell-Danielsson.
来源: Lancet. 2024年404卷10455期864-873页
Medical abortion after 12 gestational weeks often requires a stay in hospital. We hypothesised that administering the first misoprostol dose at home could increase day-care procedures as compared with overnight care procedures, shorten inpatient stays, and improve patient satisfaction.
167. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial.
作者: John Deanfield.;Subodh Verma.;Benjamin M Scirica.;Steven E Kahn.;Scott S Emerson.;Donna Ryan.;Ildiko Lingvay.;Helen M Colhoun.;Jorge Plutzky.;Mikhail N Kosiborod.;G Kees Hovingh.;Søren Hardt-Lindberg.;Ofir Frenkel.;Peter E Weeke.;Søren Rasmussen.;Assen Goudev.;Chim C Lang.;Miguel Urina-Triana.;Mikko Pietilä.;A Michael Lincoff.; .
来源: Lancet. 2024年404卷10454期773-786页
Semaglutide, a GLP-1 receptor agonist, reduces the risk of major adverse cardiovascular events (MACE) in people with overweight or obesity, but the effects of this drug on outcomes in patients with atherosclerotic cardiovascular disease and heart failure are unknown. We report a prespecified analysis of the effect of once-weekly subcutaneous semaglutide 2·4 mg on ischaemic and heart failure cardiovascular outcomes. We aimed to investigate if semaglutide was beneficial in patients with atherosclerotic cardiovascular disease with a history of heart failure compared with placebo; if there was a difference in outcome in patients designated as having heart failure with preserved ejection fraction compared with heart failure with reduced ejection fraction; and if the efficacy and safety of semaglutide in patients with heart failure was related to baseline characteristics or subtype of heart failure.
168. Efficacy and safety of emodepside compared with albendazole in adolescents and adults with hookworm infection in Pemba Island, Tanzania: a double-blind, superiority, phase 2b, randomised controlled trial.
作者: Lyndsay Taylor.;Ahmada Ali Ahmada.;Msanif Said Ali.;Said Mohammed Ali.;Jan Hattendorf.;Ibrahim Said Mohammed.;Jennifer Keiser.
来源: Lancet. 2024年404卷10453期683-691页
Human hookworm is a cause of enormous global morbidity. Current treatments have insufficient efficacy and their extensive and indiscriminate distribution could also result in drug resistance. Therefore, we tested the efficacy and safety of emodepside, a strong anthelmintic candidate that is currently undergoing clinical development for onchocerciasis and soil-transmitted helminth infections.
169. Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial.
作者: Filip Rega.;Guillaume Lebreton.;Marylou Para.;Sebastian Michel.;René Schramm.;Emmanuelle Begot.;Katrien Vandendriessche.;Christine Kamla.;Gino Gerosa.;Marius Berman.;Udo Boeken.;Steven Clark.;Aaron Ranasinghe.;Fabio Ius.;Alberta Forteza.;Aldina Pivodic.;Felix Hennig.;Sabina Guenther.;Andreas Zuckermann.;Christoph Knosalla.;Göran Dellgren.;Andreas Wallinder.; .
来源: Lancet. 2024年404卷10453期670-682页
Static cold storage (SCS) remains the gold standard for preserving donor hearts before transplantation but is associated with ischaemia, anaerobic metabolism, and organ injuries, leading to patient morbidity and mortality. We aimed to evaluate whether continuous, hypothermic oxygenated machine perfusion (HOPE) of the donor heart is safe and superior compared with SCS.
170. Effect of high versus standard protein provision on functional recovery in people with critical illness (PRECISe): an investigator-initiated, double-blinded, multicentre, parallel-group, randomised controlled trial in Belgium and the Netherlands.
作者: Julia L M Bels.;Steven Thiessen.;Rob J J van Gassel.;Albertus Beishuizen.;Ashley De Bie Dekker.;Vincent Fraipont.;Stoffel Lamote.;Didier Ledoux.;Clarissa Scheeren.;Elisabeth De Waele.;Arthur R H van Zanten.;Laura Bormans-Russell.;Bas C T van Bussel.;Marlies M J Dictus.;Tom Fivez.;Ingeborg Harks.;Iwan C C van der Horst.;Joop Jonckheer.;Hugues Marechal.;Paul B Massion.;Ingrid Meex.;Michelle C Paulus.;Martin Rinket.;Susanne van Santen.;Katrien Tartaglia.;Adam M Deane.;Frieda Demuydt.;Zudin Puthucheary.;Lilian C M Vloet.;Peter J M Weijs.;Sander M J van Kuijk.;Marcel C G van de Poll.;Dieter Mesotten.; .
来源: Lancet. 2024年404卷10453期659-669页
Increased protein provision might ameliorate muscle wasting and improve long-term outcomes in critically ill patients. The aim of the PRECISe trial was to assess whether higher enteral protein provision (ie, 2·0 g/kg per day) would improve health-related quality of life and functional outcomes in critically ill patients who were mechanically ventilated compared with standard enteral protein provision (ie, 1·3 g/kg per day).
171. Safety and efficacy of subcutaneous iscalimab (CFZ533) in two distinct populations of patients with Sjögren's disease (TWINSS): week 24 results of a randomised, double-blind, placebo-controlled, phase 2b dose-ranging study.
作者: Benjamin A Fisher.;Xavier Mariette.;Athena Papas.;Thomas Grader-Beck.;Hendrika Bootsma.;Wan-Fai Ng.;P L A van Daele.;Stephanie Finzel.;Ghaith Noaiseh.;Sergio Elgueta.;Josef Hermann.;Sara S McCoy.;Esen Akpek.;Arthur Bookman.;Monika Sopala.;Michela Montecchi-Palmer.;Wen-Lin Luo.;Cornelia Scheurer.;Wolfgang Hueber.; .
来源: Lancet. 2024年404卷10452期540-553页
Sjögren's disease is a chronic autoimmune disease with an unmet need for targeted therapies. The aim of the TWINSS study is to evaluate the safety and efficacy of iscalimab, a monoclonal antibody against CD40, in patients with active Sjögren's disease.
172. Molecularly guided therapy versus chemotherapy after disease control in unfavourable cancer of unknown primary (CUPISCO): an open-label, randomised, phase 2 study.
作者: Alwin Krämer.;Tilmann Bochtler.;Chantal Pauli.;Kai-Keen Shiu.;Natalie Cook.;Juliana Janoski de Menezes.;Roberto A Pazo-Cid.;Ferran Losa.;Debbie Gj Robbrecht.;Jiří Tomášek.;Cagatay Arslan.;Mustafa Özgüroğlu.;Michael Stahl.;Frédéric Bigot.;Sun Young Kim.;Yoichi Naito.;Antoine Italiano.;Nasséra Chalabi.;Gonzalo Durán-Pacheco.;Chantal Michaud.;Jeremy Scarato.;Marlene Thomas.;Jeffrey S Ross.;Holger Moch.;Linda Mileshkin.
来源: Lancet. 2024年404卷10452期527-539页
Patients with unfavourable subset cancer of unknown primary (CUP) have a poor prognosis when treated with standard platinum-based chemotherapy. Whether first-line treatment guided by comprehensive genomic profiling (CGP) can improve outcomes is unknown. The CUPISCO trial was designed to inform a molecularly guided treatment strategy to improve outcomes over standard platinum-based chemotherapy in patients with newly diagnosed, unfavourable, non-squamous CUP. The aim of the trial was to compare the efficacy and safety of molecularly guided therapy (MGT) versus standard platinum-based chemotherapy in these patients. This was to determine whether the inclusion of CGP in the initial diagnostic work-up leads to improved outcomes over the current standard of care. We herein report the primary analysis.
173. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials.
作者: Jonathan I Silverberg.;Andreas Wollenberg.;Adam Reich.;Diamant Thaçi.;Franz J Legat.;Kim A Papp.;Linda Stein Gold.;Jean-David Bouaziz.;Andrew E Pink.;José Manuel Carrascosa.;Barbara Rewerska.;Jacek C Szepietowski.;Dorota Krasowska.;Blanka Havlíčková.;Monika Kalowska.;Nina Magnolo.;Sylvia Pauser.;Navid Nami.;Maxwell B Sauder.;Vipul Jain.;Kamila Padlewska.;Soo Yeon Cheong.;Patricia Fleuranceau Morel.;Liliana Ulianov.;Christophe Piketty.; .
来源: Lancet. 2024年404卷10451期445-460页
Nemolizumab, an interleukin (IL)-31 receptor subunit α antagonist, inhibits the IL-31 pathway of itch and skin inflammation in atopic dermatitis. Two international phase 3 studies were done to assess the efficacy and safety of nemolizumab in atopic dermatitis. In this Article we report results for the 16-week initial treatment period of both trials.
174. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials.
作者: Robert Bissonnette.;Richard B Warren.;Andreas Pinter.;Tove Agner.;Melinda Gooderham.;Marie L A Schuttelaar.;Marie-Noëlle Crépy.;Luca Stingeni.;Esther Serra-Baldrich.;Keith Baranowski.;Sofie Korn.;Merle Kurvits.;Ursula Plohberger.;Natacha Strange Vest.;Sibylle Schliemann.; .
来源: Lancet. 2024年404卷10451期461-473页
Chronic hand eczema is a fluctuating, inflammatory, pruritic, often painful disease of hands and wrists that strongly impacts quality of life and occupational capabilities of patients. The aim of phase 3 DELTA 1 and DELTA 2 was to assess the efficacy and safety of twice-daily applications of the topical pan-Janus kinase inhibitor delgocitinib cream 20 mg/g versus cream vehicle in adults with moderate to severe chronic hand eczema.
175. Clinical effectiveness and safety of time-lapse imaging systems for embryo incubation and selection in in-vitro fertilisation treatment (TILT): a multicentre, three-parallel-group, double-blind, randomised controlled trial.
作者: Priya Bhide.;David Y L Chan.;Doris Lanz.;Odai Alqawasmeh.;Eleanor Barry.;Dominic Baxter.;Francisco Gonzalez Carreras.;Yasmin Choudhury.;Ying Cheong.;Jacqueline Pui Wah Chung.;Bonnie Collins.;Luping Cong.;Sally Doidge.;James Heighway.;Deepali Patel.;M Carmen Pardo.;Annabel Rattos.;Annie Wright.;Julie Dodds.;Teresa Perez.;Khalid S Khan.;Shakila Thangaratinam.
来源: Lancet. 2024年404卷10449期256-265页
Time-lapse imaging systems for embryo incubation and selection might improve outcomes of in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) treatment due to undisturbed embryo culture conditions, improved embryo selection, or both. However, the benefit remains uncertain. We aimed to evaluate the effectiveness of time-lapse imaging systems providing undisturbed culture and embryo selection, and time-lapse imaging systems providing only undisturbed culture, and compared each with standard care without time-lapse imaging.
176. Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial.
作者: R Michael Gendreau.;Lance M McCracken.;David A Williams.;Juan V Luciano.;Yifei Dai.;Nicolette Vega.;Zunera Ghalib.;Kristen Guthrie.;Allison C Kraus.;Michael J Rosenbluth.;Ben Vaughn.;Jennifer M Zomnir.;Dana Reddy.;Andrea L Chadwick.;Daniel J Clauw.;Lesley M Arnold.
来源: Lancet. 2024年404卷10450期364-374页
International guidelines have recommended cognitive behavioural therapy, including acceptance and commitment therapy (ACT), as it offers validated benefits for managing fibromyalgia; however, it is inaccessible to most patients. We aimed to evaluate the effect of a 12-week, self-guided, smartphone-delivered digital ACT programme on fibromyalgia management.
177. Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial.
作者: Peter Borchmann.;Justin Ferdinandus.;Gundolf Schneider.;Alden Moccia.;Richard Greil.;Mark Hertzberg.;Valdete Schaub.;Andreas Hüttmann.;Felix Keil.;Judith Dierlamm.;Mathias Hänel.;Urban Novak.;Julia Meissner.;Andreas Zimmermann.;Stephan Mathas.;Josée M Zijlstra.;Alexander Fosså.;Andreas Viardot.;Bernd Hertenstein.;Sonja Martin.;Pratyush Giri.;Sebastian Scholl.;Max S Topp.;Wolfram Jung.;Vladan Vucinic.;Hans-Joachim Beck.;Andrea Kerkhoff.;Benjamin Unger.;Andreas Rank.;Roland Schroers.;Christian Meyer Zum Büschenfelde.;Maike de Wit.;Karolin Trautmann-Grill.;Peter Kamper.;Daniel Molin.;Stefanie Kreissl.;Helen Kaul.;Bastian von Tresckow.;Sven Borchmann.;Karolin Behringer.;Michael Fuchs.;Andreas Rosenwald.;Wolfram Klapper.;Hans-Theodor Eich.;Christian Baues.;Athanasios Zomas.;Michael Hallek.;Markus Dietlein.;Carsten Kobe.;Volker Diehl.; .; .; .; .; .
来源: Lancet. 2024年404卷10450期341-352页
Intensified systemic chemotherapy has the highest primary cure rate for advanced-stage, classical Hodgkin lymphoma but this comes with a cost of severe and potentially life long, persisting toxicities. With the new regimen of brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (BrECADD), we aimed to improve the risk-to-benefit ratio of treatment of advanced-stage, classical Hodgkin lymphoma guided by PET after two cycles.
178. Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial.
作者: Jiamin Liu.;Yan Li.;Jinzhuo Ge.;Xiaofang Yan.;Haibo Zhang.;Xin Zheng.;Jiapeng Lu.;Xi Li.;Yan Gao.;Lubi Lei.;Jing Liu.;Jing Li.; .
来源: Lancet. 2024年404卷10449期245-255页
Uncertainty exists about whether lowering systolic blood pressure to less than 120 mm Hg is superior to that of less than 140 mm Hg, particularly in patients with diabetes and patients with previous stroke.
179. Livebirth rate after one frozen embryo transfer in ovulatory women starting with natural, modified natural, or artificial endometrial preparation in Viet Nam: an open-label randomised controlled trial.
作者: Vu N A Ho.;Toan D Pham.;Nam T Nguyen.;Rui Wang.;Robert J Norman.;Ben W Mol.;Tuong M Ho.;Lan N Vuong.
来源: Lancet. 2024年404卷10449期266-275页
Use of frozen embryo transfer (FET) in in-vitro fertilisation (IVF) has increased. However, the best endometrial preparation protocol for FET cycles is unclear. We compared natural and modified natural cycle strategies with an artificial cycle strategy for endometrial preparation before FET.
180. Effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention for the prevention of low back pain recurrence in Australia (WalkBack): a randomised controlled trial.
作者: Natasha C Pocovi.;Chung-Wei Christine Lin.;Simon D French.;Petra L Graham.;Johanna M van Dongen.;Jane Latimer.;Dafna Merom.;Anne Tiedemann.;Christopher G Maher.;Ornella Clavisi.;Shuk Yin Kate Tong.;Mark J Hancock.
来源: Lancet. 2024年404卷10448期134-144页
Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain.
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