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121. Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial.
作者: Michael J Foley.;Christopher A Rajkumar.;Fiyyaz Ahmed-Jushuf.;Florentina A Simader.;Shayna Chotai.;Rachel H Pathimagaraj.;Muhammad Mohsin.;Ahmed Salih.;Danqi Wang.;Prithvi Dixit.;John R Davies.;Tom R Keeble.;Claudia Cosgrove.;James C Spratt.;Peter D O'Kane.;Ranil De Silva.;Jonathan M Hill.;Sukhjinder S Nijjer.;Sayan Sen.;Ricardo Petraco.;Ghada W Mikhail.;Ramzi Khamis.;Tushar Kotecha.;Frank E Harrell.;Peter Kellman.;Darrel P Francis.;James P Howard.;Graham D Cole.;Matthew J Shun-Shin.;Rasha K Al-Lamee.
来源: Lancet. 2024年403卷10436期1543-1553页
The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement.
122. Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials.
作者: Javed Butler.;Sanjiv J Shah.;Mark C Petrie.;Barry A Borlaug.;Steen Z Abildstrøm.;Melanie J Davies.;G Kees Hovingh.;Dalane W Kitzman.;Daniél Vega Møller.;Subodh Verma.;Mette Nygaard Einfeldt.;Marie L Lindegaard.;Søren Rasmussen.;Walter Abhayaratna.;Fozia Z Ahmed.;Tuvia Ben-Gal.;Vijay Chopra.;Justin A Ezekowitz.;Michael Fu.;Hiroshi Ito.;Małgorzata Lelonek.;Vojtěch Melenovský.;Bela Merkely.;Julio Núñez.;Eduardo Perna.;Morten Schou.;Michele Senni.;Kavita Sharma.;Peter van der Meer.;Dirk Von Lewinski.;Dennis Wolf.;Mikhail N Kosiborod.; .
来源: Lancet. 2024年403卷10437期1635-1648页
In the STEP-HFpEF (NCT04788511) and STEP-HFpEF DM (NCT04916470) trials, the GLP-1 receptor agonist semaglutide improved symptoms, physical limitations, bodyweight, and exercise function in people with obesity-related heart failure with preserved ejection fraction. In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, we aimed to provide a more definitive assessment of the effects of semaglutide across a range of outcomes and to test whether these effects were consistent across key patient subgroups.
123. Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial.
作者: Zhen Ge.;Jing Kan.;Xiaofei Gao.;Afsar Raza.;Jun-Jie Zhang.;Bilal S Mohydin.;Fentang Gao.;Yibing Shao.;Yan Wang.;Hesong Zeng.;Feng Li.;Hamid Sharif Khan.;Naeem Mengal.;Hongliang Cong.;Mingliang Wang.;Lianglong Chen.;Yongyue Wei.;Feng Chen.;Gregg W Stone.;Shao-Liang Chen.; .
来源: Lancet. 2024年403卷10439期1866-1878页
Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE).
124. Feasibility, safety, and impact of the RTS,S/AS01E malaria vaccine when implemented through national immunisation programmes: evaluation of cluster-randomised introduction of the vaccine in Ghana, Kenya, and Malawi.
作者: Kwaku Poku Asante.;Don P Mathanga.;Paul Milligan.;Samuel Akech.;Abraham Oduro.;Victor Mwapasa.;Kerryn A Moore.;Titus K Kwambai.;Mary J Hamel.;Thomas Gyan.;Nelli Westercamp.;Atupele Kapito-Tembo.;Patricia Njuguna.;Daniel Ansong.;Simon Kariuki.;Tisungane Mvalo.;Paul Snell.;David Schellenberg.;Paul Welega.;Lucas Otieno.;Alfred Chimala.;Edwin A Afari.;Philip Bejon.;Kenneth Maleta.;Tsiri Agbenyega.;Robert W Snow.;Madaliso Zulu.;Jobiba Chinkhumba.;Aaron M Samuels.; .
来源: Lancet. 2024年403卷10437期1660-1670页
The RTS,S/AS01E malaria vaccine (RTS,S) was introduced by national immunisation programmes in Ghana, Kenya, and Malawi in 2019 in large-scale pilot schemes. We aimed to address questions about feasibility and impact, and to assess safety signals that had been observed in the phase 3 trial that included an excess of meningitis and cerebral malaria cases in RTS,S recipients, and the possibility of an excess of deaths among girls who received RTS,S than in controls, to inform decisions about wider use.
125. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): a randomised, open-label, phase 2 trial.
作者: José Manuel Pérez-García.;Javier Cortés.;Manuel Ruiz-Borrego.;Marco Colleoni.;Agostina Stradella.;Begoña Bermejo.;Florence Dalenc.;Santiago Escrivá-de-Romaní.;Lourdes Calvo Martínez.;Nuria Ribelles.;Frederik Marmé.;Alfonso Cortés.;Cinta Albacar.;Geraldine Gebhart.;Aleix Prat.;Khaldoun Kerrou.;Peter Schmid.;Sofia Braga.;Serena Di Cosimo.;Maria Gion.;Gabriele Antonarelli.;Crina Popa.;Emilia Szostak.;Daniel Alcalá-López.;Petra Gener.;Jose Rodríguez-Morató.;Leonardo Mina.;Miguel Sampayo-Cordero.;Antonio Llombart-Cussac.; .
来源: Lancet. 2024年403卷10437期1649-1659页
PHERGain was designed to assess the feasibility, safety, and efficacy of a chemotherapy-free treatment based on a dual human epidermal growth factor receptor 2 (HER2) blockade with trastuzumab and pertuzumab in patients with HER2-positive early breast cancer (EBC). It used an 18fluorine-fluorodeoxyglucose-PET-based, pathological complete response (pCR)-adapted strategy.
126. The safety and immunogenicity of a bivalent conjugate vaccine against Salmonella enterica Typhi and Paratyphi A in healthy Indian adults: a phase 1, randomised, active-controlled, double-blind trial.
作者: Prasad S Kulkarni.;Anirudha Vyankatesh Potey.;Sandesh Bharati.;Anil Kunhihitlu.;Bharath Narasimha.;Sindhu Yallapa.;Abhijeet Dharmadhikari.;Vinay Gavade.;Chandrashekhar D Kamat.;Asha Mallya.;Annamraju D Sarma.;Sunil Goel.;Sambhaji S Pisal.;Cyrus S Poonawalla.;Rajaram Venkatesan.;Elizabeth Jones.;Amy Flaxman.;Young Chan Kim.;Andrew J Pollard.; .
来源: Lancet. 2024年403卷10436期1554-1562页
Enteric fever caused by Salmonella enterica Typhi and Salmonella Paratyphi A is an important public health problem, especially in low-income and middle-income countries with limited access to safe water and sanitation. We present results from, to our knowledge, the first ever human study of a bivalent paratyphoid A-typhoid conjugate vaccine (Sii-PTCV).
127. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial.
作者: Domenica Lorusso.;Yang Xiang.;Kosei Hasegawa.;Giovanni Scambia.;Manuel Leiva.;Pier Ramos-Elias.;Alejandro Acevedo.;Vladyslav Sukhin.;Noelle Cloven.;Andrea J Pereira de Santana Gomes.;Fernando Contreras Mejía.;Ari Reiss.;Ali Ayhan.;Jung-Yun Lee.;Valeriya Saevets.;Flora Zagouri.;Lucy Gilbert.;Jalid Sehouli.;Ekkasit Tharavichitkul.;Kristina Lindemann.;Roberta Lazzari.;Chih-Long Chang.;Rudolf Lampé.;Hong Zhu.;Ana Oaknin.;Melissa Christiaens.;Stephan Polterauer.;Tomoka Usami.;Kan Li.;Karin Yamada.;Sarper Toker.;Stephen M Keefe.;Sandro Pignata.;Linda R Duska.; .
来源: Lancet. 2024年403卷10434期1341-1350页
Pembrolizumab has shown efficacy in persistent, recurrent, or metastatic cervical cancer. The effect of chemoradiotherapy might be enhanced by immunotherapy. In this phase 3 trial, we assessed the efficacy and safety of adding pembrolizumab to chemoradiotherapy in locally advanced cervical cancer.
128. Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES): a randomised, parallel, phase 3 trial.
作者: Jennifer L Steel.;Charles J George.;Lauren Terhorst.;Jonathan G Yabes.;Vincent Reyes.;Dan P Zandberg.;Marci Nilsen.;Gauri Kiefer.;Jonas Johnson.;Christopher Marsh.;Jason Bierenbaum.;Nishant Tageja.;Michal Krauze.;Robert VanderWeele.;Gaurav Goel.;Gopala Ramineni.;Michael Antoni.;Yoram Vodovotz.;Jon Walker.;Samer Tohme.;Timothy Billiar.;David A Geller.
来源: Lancet. 2024年403卷10434期1351-1361页
The current standard of care of screening and referring patients for treatment for symptoms, such as depression, pain, and fatigue, is not effective. This trial aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care for patients with cancer and at least one of the following symptoms: depression, pain, or fatigue.
129. Optimised prevention of postnatal HIV transmission in Zambia and Burkina Faso (PROMISE-EPI): a phase 3, open-label, randomised controlled trial.
作者: Chipepo Kankasa.;Anaïs Mennecier.;Beninwendé L D Sakana.;Jean-Pierre Molès.;Mwiya Mwiya.;Catherine Chunda-Liyoka.;Morgana D'Ottavi.;Souleymane Tassembedo.;Maria M Wilfred-Tonga.;Paulin Fao.;David Rutagwera.;Beauty Matoka.;Dramane Kania.;Ousmane A Taofiki.;Thorkild Tylleskär.;Philippe Van de Perre.;Nicolas Nagot.; .
来源: Lancet. 2024年403卷10434期1362-1371页
Transmission through breastfeeding accounts for more than half of the unacceptably high number of new paediatric HIV infections worldwide. We hypothesised that, in addition to maternal antiretroviral therapy (ART), extended postnatal prophylaxis with lamivudine, guided by point-of-care assays for maternal viral load, could reduce postnatal transmission.
130. Telerehabilitation consultations with a physiotherapist for chronic knee pain versus in-person consultations in Australia: the PEAK non-inferiority randomised controlled trial.
作者: Rana S Hinman.;Penny K Campbell.;Alexander J Kimp.;Trevor Russell.;Nadine E Foster.;Jessica Kasza.;Anthony Harris.;Kim L Bennell.
来源: Lancet. 2024年403卷10433期1267-1278页
Telerehabilitation is perceived as less effective than in-person care for musculoskeletal problems. We aimed to determine if physiotherapy video conferencing consultations were non-inferior to in-person consultations for chronic knee pain.
131. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial.
作者: David M Brown.;David S Boyer.;Diana V Do.;Charles C Wykoff.;Taiji Sakamoto.;Peter Win.;Sunir Joshi.;Hani Salehi-Had.;András Seres.;Alyson J Berliner.;Sergio Leal.;Robert Vitti.;Karen W Chu.;Kimberly Reed.;Rohini Rao.;Yenchieh Cheng.;Wei Sun.;Delia Voronca.;Rafia Bhore.;Ursula Schmidt-Ott.;Thomas Schmelter.;Andrea Schulze.;Xin Zhang.;Boaz Hirshberg.;George D Yancopoulos.;Sobha Sivaprasad.; .
来源: Lancet. 2024年403卷10432期1153-1163页
A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO.
132. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial.
作者: Paolo Lanzetta.;Jean-François Korobelnik.;Jeffrey S Heier.;Sergio Leal.;Frank G Holz.;W Lloyd Clark.;David Eichenbaum.;Tomohiro Iida.;Sun Xiaodong.;Alyson J Berliner.;Andrea Schulze.;Thomas Schmelter.;Ursula Schmidt-Ott.;Xin Zhang.;Robert Vitti.;Karen W Chu.;Kimberly Reed.;Rohini Rao.;Rafia Bhore.;Yenchieh Cheng.;Wei Sun.;Boaz Hirshberg.;George D Yancopoulos.;Tien Y Wong.; .
来源: Lancet. 2024年403卷10432期1141-1152页
Intravitreal aflibercept 8 mg could improve treatment outcomes and provide sustained disease control in patients with neovascular age-related macular degeneration (nAMD), with extended dosing compared with aflibercept 2 mg.
133. Clinical effectiveness of the psychological therapy Mental Health Intervention for Children with Epilepsy in addition to usual care compared with assessment-enhanced usual care alone: a multicentre, randomised controlled clinical trial in the UK.
作者: Sophie D Bennett.;J Helen Cross.;Kashfia Chowdhury.;Tamsin Ford.;Isobel Heyman.;Anna E Coughtrey.;Emma Dalrymple.;Sarah Byford.;Bruce Chorpita.;Peter Fonagy.;Rona Moss-Morris.;Colin Reilly.;Jonathan A Smith.;Terence Stephenson.;Sophia Varadkar.;James Blackstone.;Harriet Quartly.;Tyler Hughes.;Amy Lewins.;Elana Moore.;Fahreen Walji.;Alice Welch.;Emily Whelan.;Alice Zacharia.;Anaïs D'Oelsnitz.;Mariam Shah.;Laila Xu.;Aikaterini Vezyroglou.;Kirsten Mitchell.;Isabella E Nizza.;Poushali Ganguli.;Roz Shafran.
来源: Lancet. 2024年403卷10433期1254-1266页
Mental health difficulties are common in children and young people with chronic health conditions, but many of those in need do not access evidence-based psychological treatments. The study aim was to evaluate the clinical effectiveness of integrated mental health treatment for children and young people with epilepsy, a common chronic health condition known to be associated with a particularly high rate of co-occurring mental health difficulties.
134. Safety of the novel oral poliovirus vaccine type 2 (nOPV2) in infants and young children aged 1 to <5 years and lot-to-lot consistency of the immune response to nOPV2 in infants in The Gambia: a phase 3, double-blind, randomised controlled trial.
作者: Magnus Ochoge.;Ahmed Cherno Futa.;Ama Umesi.;Lucy Affleck.;Larry Kotei.;Baboucarr Daffeh.;Ebrima Saidy-Jah.;Anna Njie.;Oluwafemi Oyadiran.;Bassey Edem.;Musa Jallow.;Edrissa Jallow.;Simon A Donkor.;Erman Tritama.;Talha Abid.;Kathryn A V Jones.;Bernardo A Mainou.;John O Konz.;Alan Fix.;Chris Gast.;Ed Clarke.
来源: Lancet. 2024年403卷10432期1164-1175页
Novel oral poliovirus vaccine type 2 (nOPV2) has been engineered to improve the genetic stability of Sabin oral poliovirus vaccine (OPV) and reduce the emergence of circulating vaccine-derived polioviruses. This trial aimed to provide key safety and immunogenicity data required for nOPV2 licensure and WHO prequalification.
135. Sunitinib for metastatic progressive phaeochromocytomas and paragangliomas: results from FIRSTMAPPP, an academic, multicentre, international, randomised, placebo-controlled, double-blind, phase 2 trial.
作者: Eric Baudin.;Bernard Goichot.;Alfredo Berruti.;Julien Hadoux.;Salma Moalla.;Sandrine Laboureau.;Svenja Nölting.;Christelle de la Fouchardière.;Tina Kienitz.;Timo Deutschbein.;Stefania Zovato.;Laurence Amar.;Magalie Haissaguerre.;Henri Timmers.;Patricia Niccoli.;Antongiulio Faggiano.;Moussa Angokai.;Livia Lamartina.;Florina Luca.;Deborah Cosentini.;Stefanie Hahner.;Felix Beuschlein.;Marie Attard.;Matthieu Texier.;Martin Fassnacht.; .; .
来源: Lancet. 2024年403卷10431期1061-1070页
No randomised controlled trial has ever been done in patients with metastatic phaeochromocytomas and paragangliomas. Preclinical and first clinical evidence suggested beneficial effects of sunitinib. We aimed to evaluate the safety and efficacy of sunitinib in patients with metastatic phaeochromocytomas and paragangliomas.
136. Long-term efficacy of a recombinant hepatitis E vaccine in adults: 10-year results from a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Shoujie Huang.;Xuefeng Zhang.;Yingying Su.;Chunlan Zhuang.;Zimin Tang.;Xingcheng Huang.;Qi Chen.;Kongxin Zhu.;Xiaowen Hu.;Dong Ying.;Xiaohui Liu.;Hanmin Jiang.;Xia Zang.;Zhongze Wang.;Changlin Yang.;Donglin Liu.;Yijun Wang.;Quan Tang.;Wentong Shen.;Huanhuan Cao.;Huirong Pan.;Shengxiang Ge.;Yue Huang.;Ting Wu.;Zizheng Zheng.;Fengcai Zhu.;Jun Zhang.;Ningshao Xia.
来源: Lancet. 2024年403卷10429期813-823页
Hepatitis E virus (HEV) is a frequently overlooked causative agent of acute hepatitis. Evaluating the long-term durability of hepatitis E vaccine efficacy holds crucial importance.
137. Targeted prophylactic anticoagulation based on the TRiP(cast) score in patients with lower limb immobilisation: a multicentre, stepped wedge, randomised implementation trial.
作者: Delphine Douillet.;Andrea Penaloza.;Damien Viglino.;Jean-Jacques Banihachemi.;Anmar Abboodi.;Mathilde Helderlé.;Emmanuel Montassier.;Fréderic Balen.;Christian Brice.;Saïd Laribi.;Thibault Duchenoy.;Philippe Vives.;Louis Soulat.;Nicolas Marjanovic.;Thomas Moumneh.;Dominique Savary.;Jérémie Riou.;Pierre-Marie Roy.
来源: Lancet. 2024年403卷10431期1051-1060页
Prophylactic anticoagulation in emergency department patients with lower limb trauma requiring immobilisation is controversial. The Thrombosis Risk Prediction for Patients with Cast Immobilisation-TRiP(cast)-score could identify a large subgroup of patients at low risk of venous thromboembolism for whom prophylactic anticoagulation can be safely withheld. We aimed to prospectively assess the safety of withholding anticoagulation for patients with lower limb trauma at low risk of venous thromboembolism, defined by a TRiP(cast) score of less than 7.
138. Solar-powered O2 delivery for the treatment of children with hypoxaemia in Uganda: a stepped-wedge, cluster randomised controlled trial.
作者: Nicholas Conradi.;Robert O Opoka.;Qaasim Mian.;Andrea L Conroy.;Laura L Hermann.;Olaro Charles.;Jackson Amone.;Juliet Nabwire.;Bonita E Lee.;Abdullah Saleh.;Piush Mandhane.;Sophie Namasopo.;Michael T Hawkes.
来源: Lancet. 2024年403卷10428期756-765页
Supplemental O2 is not always available at health facilities in low-income and middle-income countries (LMICs). Solar-powered O2 delivery can overcome gaps in O2 access, generating O2 independent of grid electricity. We hypothesized that installation of solar-powered O2 systems on the paediatrics ward of rural Ugandan hospitals would lead to a reduction in mortality among hypoxaemic children.
139. Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): a randomised, international, multicentre, double-blind, placebo-controlled trial.
作者: Juergen Rech.;Koray Tascilar.;Melanie Hagen.;Arnd Kleyer.;Bernhard Manger.;Verena Schoenau.;Axel J Hueber.;Stefan Kleinert.;Xenofon Baraliakos.;Jürgen Braun.;Uta Kiltz.;Martin Fleck.;Andrea Rubbert-Roth.;David M Kofler.;Frank Behrens.;Martin Feuchtenberger.;Michael Zaenker.;Reinhard Voll.;Nils Venhoff.;Jens Thiel.;Cornelia Glaser.;Eugen Feist.;Gerd R Burmester.;Kirsten Karberg.;Johannes Strunk.;Juan D Cañete.;Ladislav Senolt.;Maria Filkova.;Esperanza Naredo.;Raquel Largo.;Gerhard Krönke.;Maria-Antonietta D'Agostino.;Mikkel Østergaard.;Georg Schett.
来源: Lancet. 2024年403卷10429期850-859页
Individuals with anti-citrullinated protein antibodies (ACPAs) and subclinical inflammatory changes in joints are at high risk of developing rheumatoid arthritis. Treatment strategies to intercept this pre-stage clinical disease remain to be developed. We aimed to assess whether 6-month treatment with abatacept improves inflammation in preclinical rheumatoid arthritis.
140. Abatacept in individuals at high risk of rheumatoid arthritis (APIPPRA): a randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2b clinical trial.
作者: Andrew P Cope.;Marianna Jasenecova.;Joana C Vasconcelos.;Andrew Filer.;Karim Raza.;Sumera Qureshi.;Maria Antonietta D'Agostino.;Iain B McInnes.;John D Isaacs.;Arthur G Pratt.;Benjamin A Fisher.;Christopher D Buckley.;Paul Emery.;Pauline Ho.;Maya H Buch.;Coziana Ciurtin.;Dirkjan van Schaardenburg.;Thomas Huizinga.;René Toes.;Evangelos Georgiou.;Joanna Kelly.;Caroline Murphy.;A Toby Prevost.; .
来源: Lancet. 2024年403卷10429期838-849页
Individuals with serum antibodies to citrullinated protein antigens (ACPA), rheumatoid factor, and symptoms, such as inflammatory joint pain, are at high risk of developing rheumatoid arthritis. In the arthritis prevention in the pre-clinical phase of rheumatoid arthritis with abatacept (APIPPRA) trial, we aimed to evaluate the feasibility, efficacy, and acceptability of treating high risk individuals with the T-cell co-stimulation modulator abatacept.
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