Image navigator–based, automated coronary magnetic resonance angiography for the detection of coronary artery stenosis by Gregory Wood, Reza Hajhosseiny, Alexandra Uglebjerg Pedersen, Simon Littlewood, Tina Juul Hansen, Radhouene Neji, Karl P. Kunze, Jens Wetzl, Bjarne Linde Nørgaard, Jesper Møller Jensen, Michael Maeng, Per Lav Madsen, Niels Vejlstrup, Claudia Prieto, René M. Botnar, Won Yong Kim

“…Discussion: If proven effective, CMRA could provide a non-invasive, needle-free, yet also clinically viable, alternative to CCTA. Trial Registration: This study is registered at ClinicalTrials.gov (NCT05473117).…”
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Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson’s symptoms against other clinical monitoring methods: study proto... by Juan Carlos Martinez-Castrillo, Maria Alvarez, Dolores Vilas, Ernest Balaguer, Ignacio Alvarez, Jon Infante, Silvia Jesús, Marina Mata, Pablo Mir, Pau Pastor, María Sierra, Lydia Vela, Isabel Gonzalez, Ana Rita Santos, Daniel Lopez, Antonio Hernández, Francisco Perez, Nuria Caballol, Antonio Salvador, Judith Jimenez, Alejandro Rodríguez-Molinero, Jorge Hernández-Vara, Antonio Miñarro, Carlos Pérez-López, Àngels Bayes-Rusiñol, David A Pérez-Martínez, Anna Planas-Ballvé, Mariateresa Buongiorno, Núria López, Mª Isabel Morales, Gema Sánchez, María Asunción Ávila, Anna Prats, Alexandre Gironell, Álvaro Sánchez-Ferro, Antonio Méndez, Elisabet Franquet, Sonia Escalante, Laura Muñoz-Delgado, Daniel Macías-García, Astrid Adarmes-Gómez, José Mª Salom, Silvia Martí, Carlos Leiva, Victor M. Puente, Irene Navalpotro, Sara Lucas, Antonio Koukoulis, Mª Gema Alonso, Mª Esther Cubo, Mª Victoria Sánchez, Carmen Borrúe, Mª Concepción Jimeno, Mª José Gómez, Lina Carazo, Alfredo López, Mª Pilar Solís, Rubén Alonso, Jessica González, Javier Ruiz, Ana Vinagre, Ioana Croitoru, Pilar Sánchez, Elisa Gamo, Sabela Novo, Esteban Peña, Esther Blanco, Rafael García, José López, Teresa Muñoz, Lucía Flores, Rocío García-Ramos, Eva López, Lourdes Ispierto, Ramiro Álvarez, Esther Catena, Berta Solano, Anna Cots, Lydia López Manzanares, Marta Recio-Bermejo

“…Introduction In recent years, multiple studies have aimed to develop and validate portable technological devices capable of monitoring the motor complications of Parkinson’s disease patients (Parkinson’s Holter). …”
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Evaluation of a novel approach for colorectal cancer screening using an intelligent tool (INTEL-PATH CRC): a protocol for a multicentre, real-world, cohort study by Hongda Chen, Min Dai, Yuelun Zhang, Dong Wu, Bin Lu, Na Li, Kai Song, Yuqing Chen, Chenyu Luo, Yueyang Zhou, Jiahui Luo, Yike Yan, Xinran Cheng, Zhiliang He

“…Expected outcomes will be disseminated through research reports, peer-reviewed papers, conference and patents.Trial registration number ChiCTR2400086754.…”
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Personalised selection of medication for newly diagnosed adult epilepsy: study protocol of a first-in-class, double-blind, randomised controlled trial by Mark Howard, Wendyl D’Souza, Emma Foster, Patrick Carney, Zanfina Ademi, Patrick Kwan, David N Vaughan, James Lee, Clare Stapleton, Zongyuan Ge, Zhibin Chen, Natasha A Lannin, Udaya Seneviratne, Robert Sparrow, Piero Perucca, Armin Nikpour, Chong Wong, John-Paul Nicolo, Michelle Kiley, Terence O’Brien, Jacqui-Lyn Saw, Dean Jones, David Reutens, Sandra Reeder, Richard Shek-kwan Chang, Ernest Somerville, Tania Farrar, Daniel Thom, Lata Vadlamudi

“…Findings will be presented in academic conferences and submitted to peer-reviewed journals for publication.Trial registration number ACTRN12623000209695.…”
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What are the broader impacts and value from a randomised controlled trial conducted in six public hospital antenatal clinics in Australia? An impact assessment using the Framework... by Peter G Gibson, Kirsten McCaffery, John Attia, Joerg Mattes, Megan E Jensen, Andrew Searles, Paul B Colditz, Shanthi Ann Ramanathan, Vanessa E Murphy, Michael Hensley, Michael Peek, Andrew Bisits, Leonie Kaye Callaway, Helen Barrett, Sean Seeho, Melanie Rao, Elissa Elvidge, Karen McLaughlin, Annelies Robijn, Warwick Giles, Alistair Abbott

“…Of the 1200 mothers who were part of BLT, 508 now have written asthma plans, 268 had a clinically significant improvement in their asthma control score and the proportion who improved their asthma plan knowledge increased by 58 percentage points from 12 to 70%.Conclusion This case example in the developing field of impact assessment illustrates how researchers can use evidence to demonstrate and report more broadly on the impact of and returns on research investment in a clinical trial.Trial registration number ACTRN12613000202763; Post results.…”
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Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter random... by M. Rousian, V. van Verschuer, S. Franssen, D. Bijdevaate, R. P.H. Bokkers, A. E. Braat, J. de Bruijne, M. J. Bruno, M. C. Burgmans, O. M. van Delden, M. Dewulf, J. I. Erdmann, J. Hagendoorn, B. van der Holt, F. J.H. Hoogwater, A. Inderson, C. van der Leij, B. Mohseny, J. W. Poley, M. L.J. Smits, F. G.I. van Vilsteren, R. P. Voermans, I. A.J. Zijlstra, L. M.J.W. van Driel, B. Groot Koerkamp

“…First patient was randomized on August 9, 2023. Trial registration Netherlands Trial Register (NL-OMON53463), registered on May 12, 2023, and Clinicaltrials.gov (NCT06671418), registered on November 1, 2024.…”
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The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery by Kyeong Eui Kim, Sung Uk Bae, Seung Hyun Lee, Dae-Ro Lim, Heon-Kyun Ha, Jin Kim, Hyo Seon Ryu, Soo Yeon Park, Sung Il Kang, Gyung Mo Son, Soo Young Lee, Chang Hyun Kim, Kyung Ha Lee, Gi Won Ha, Hye Jin Kim, Woong Bae Ji, Woo Ram Kim, Sang Hee Kang, Nak Song Sung, Ji Hoon Kim, Taek-Gu Lee, Myung Jo Kim, Woon Kyung Jeong, Seong Kyu Baek

“…Recently, several articulating laparoscopic instruments have been developed and introduced as substitutes for multi-joint robotic system instruments. …”
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Evidence based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU): protocol for type III hybrid implementation-effectiveness study by Duncan Wagstaff, John Amuasi, Sumaiya Arfin, Diptesh Aryal, Mohd Basri Mat Nor, Joseph Bonney, Arjen Dondorp, David Dongelmans, Layoni Dullawe, Fathima Fazla, Aniruddha Ghose, Eva Hanciles, Rashan Haniffa, Madiha Hashmi, Adam Hewitt Smith, Bharath Kumar, Yen Lam Minh, Ramani Moonesinghe, Luigi Pisani, Cornelius Sendagire, Mohd Shahnaz Hasan, Maryam Shamal Ghalib, Moses Siaw Frimpong, Otavio Ranzani, Menbeu Sultan, David Thomson, Swagata Tripathy, Louise Thwaites, Rabiul Alam Md. Erfan Uddin, Mohd Zulfakar Mazlan, Wangari Waweru-Siika, Abigail Beane

“…Strategies to support stakeholder-led implementation include development of local protocols, registry-enabled audit and feedback, and education. …”
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Extracellular Vesicle Protein Panel Enables Early Lung Cancer Detection in a Large Clinical Cohort by Linxiao Han, Yuanlin Song, Lin Tong, Jiayuan Sun, Xiaoju Zhang, Shujing Chen, Ying Li, Ziqi Wang, Lei Gao, Qiaoliang Zhu, Yencheng Chao, Xiaocen Wang, Ge Zhang, Wensi Zhu, Ludan He, Jie Liu, Qin Wang, Zuoren Wu, Yuanyuan Ji, Chunxue Bai, Xiuzhen Lv, Jian Zhou

“…Collectively, the findings highlight that EVELC‐M5 in conjunction with HNCIB is an effective diagnostic toolset for detecting early lung cancer and substantially promotes its diagnosis. Trial Registration: ClinicalTrials.gov identifier: ChiCTR2300072317…”
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Evaluating impacts of improved flooring on enteric and parasitic infections in rural households in Kenya: study protocol for a cluster-randomised controlled trial by Elizabeth Allen, Robert Dreibelbis, Katherine E Halliday, Rachel L Pullan, Charles S Mwandawiro, Carlos Mcharo, Doris Njomo, Stella Kepha, William E Oswald, Hugo Legge, Martin Rono, Lynne Elson, Beatrice K Kakoi, Sharon Muli, Jacinta Mwongeli, Margaret M Njoroge, Victoria Ochwal, Tuva K Safari, Ulrike Filinger, James Wambua Kaluli

“…Dissemination will also occur through publications and conference presentations.Trial registration number NCT05914363.…”
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Comparison of 6 cycles of isatuximab with lenalidomide, bortezomib and dexamethasone (I-VRd) versus 3 cycles of I-VRd followed by one cycle of high-dose melphalan in newly diagnose... by Theo Leitner, Evgenii Shumilov, Christina Schwitlick, Raphael Koch, Franziska Hamm, Marion Högner, Florian Bassermann, Katja Weisel, Hermann Einsele, Martin Kortüm, Leo Rasche, Martin Görner, Kai Wegehenkel, Stefan Knop, Jan Krönke, Axel Nogai, Inke R. König, Maren Vens, Kay Horn, Nikolas von Bubnoff, Cyrus Khandanpour

“…Registration Date: 21.07.2022.…”
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Efficacy of IsaPomDex triplet therapy in double refractory multiple myeloma patients in real clinical practice in Russia by M. V. Solovev, M. V. Solovevа, L. P. Mendeleeva, T. I. Pospelova, N. V. Skvortsova, S. V. Voloshin, A. D. Garifullin, A. S. Chuprakova, T. A. Mitina, I. S. Usankin, I. V. Vasileva, N. V. Medvedeva, V. V. Ryabchikova, M. Ya. Kiseleva, G. A. Dudina, Yu. S. Gammershmidt, O. S. Kuznetsova, Yu. V. Dolgushina, G. B. Kuchma, T. N. Tsyganok, E. N. Misyurina, E. I. Zhelnova, A. V. Kopylova, M. N. Zakharova, A. V. Korobkin, G. S. Tumyan, A. A. Semenova, E. G. Kirillova, E. M. Volodicheva, V. I. Bakhtina, T. I. Olkhovik, N. R. Solovkova, M. V. Demchenkova, O. E. Ochirova, O. L. Panteleeva, V. S. Abramova

“…Discontinuation of isatuximab due to the development of adverse event was recorded in 2 cases (2 %). …”
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Implementation and effectiveness of a nurse-enabled, shared-care follow-up model for early breast cancer survivors (The IBIS-Survivorship Study): protocol for a stepped-wedge clust... by Karla Hemming, Jane Turner, Meinir Krishnasamy, Nicolas H Hart, Patsy Yates, Helen Skerman, Elizabeth Eakin, Jon Emery, Jane Mahony, Kerry Patford, Bogda Koczwara, Fiona Crawford-Williams, Caroline Kristunas, Raymond J Chan, G Bruce Mann, Mary Azer, Louisa G Collins, Jasotha Sanmugarajah, Bethany Crowe, Gillian Blanchard, Laura Healey, Rhea Liang, Paul Craft, Amy Shorthouse, Ruth McCaffery

“…The IBIS-Survivorship intervention involves a nurse-led consultation, development of a Survivorship Care Plan and case-conferencing between a breast care nurse and the patient’s primary care provider. …”
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Acceptability of the live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) among young women at high risk of HIV acquisition in South Africa: data from the phase 2 placebo-... by A. Hemmerling, V. Govender, K. Dong, K. Dong, K. Dong, K. Dong, M. Dong, M. Dong, Sooseela Pillay, T. Ndung’u, T. Ndung’u, T. Ndung’u, T. Ndung’u, A. Bhoola, J. Moodley, G. Casillas, L. Lagenaur, C. M. Mitchell, C. M. Mitchell, D. S. Kwon, D. S. Kwon, D. S. Kwon, C. R. Cohen

“…Determining acceptability of LBPs among African women at high risk of HIV is essential to guide product development.MethodsThe phase 2 double-blind randomized placebo-controlled trial recruited young sexually active cis-women with vaginal dysbiosis from a community-based research clinic. …”
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Predictors of treatment REsponse to inhaled corticosteroids (ICS) in Chronic Obstructive pulmonary disease: randomised controlled trials individual participant Data re-Evaluation–p... by Matthew Sperrin, John R Hurst, Michael Miligkos, Joergen Vestbo, Pradeesh Sivapalan, Mike Clarke, Lesley Stewart, Jørgen Vestbo, Dave Singh, Tim Felton, Alexander G Mathioudakis, Rebecca Fortescue, Jennifer Quint, Jonathan Marshall, Anurita Majumdar, Jan Hansel, Alice M Turner, Sinduja Manohar, Catherine Fullwood, Nawar Diar Bakerly, Mark Simmonds, Steven Barnes, Ashley Woodcock, Sebastian Bate, Jens-Ulrik Jensen, Markus Fally, Helen Ashdown, Ashley A Woodcock, Emily Howlett, John Linnell, Alan Preston, Glauco Cappellini, Dmitry Galkin, Olaf Joens

“…Our findings will be published in peer-reviewed journals and shared with the scientific and broader stakeholder communities.PROSPERO registration number CRD42024508286.…”
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The impact of preoperative immunonutritional status on postoperative complications in ovarian cancer by Xingyu Liu, Ming Li, Yingjun Zhao, Xiaofei Jiao, Yang Yu, Ruyuan Li, Shaoqing Zeng, Jianhua Chi, Guanchen Ma, Yabing Huo, Zikun Peng, Jiahao Liu, Qi Zhou, Dongling Zou, Li Wang, Qingshui Li, Jing Wang, Shuzhong Yao, Youguo Chen, Ding Ma, Ting Hu, Qinglei Gao

“…A predictive nomogram model was developed based on multivariate modeling. Results The study included a total of 922 patients diagnosed with epithelial ovarian cancer across seven medical centers with 565 (61.3%) patients experiencing postoperative complications. …”
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Universal, school-based, interventions to improve emotional outcomes in children and young people: a systematic review and meta-analysis by Daniel Hayes, Daniel Hayes, Emre Deniz, Kirsty Nisbet, Abigail Thompson, Anna March, Anna March, Carla Mason, Joao Santos, Rosie Mansfield, Emma Ashworth, Bettina Moltrect, Bettina Moltrect, Shaun Liverpool, Hannah Merrick, Jan Boehnke, Neil Humphrey, Paul Stallard, Praveetha Patalay, Praveetha Patalay, Jessica Deighton, Jessica Deighton

“…However, intervention developers and researchers should critically consider which theories/approaches are being applied, particularly when trying to improve anxiety outcomes.Systematic Review RegistrationPROSPERO CRD42020189845.…”
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Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial by Kirsten Howard, Anne Tiedemann, Catherine Sherrington, Tammy Hoffmann, Kim L Bennell, Colin Greaves, Rana S Hinman, Nicholas F Taylor, Andrew Milat, Marina Pinheiro, Leanne Hassett, Maria Crotty, Lisa Harvey, Daniel Treacy, Matthew Jennings, Maayken van den Berg, Siobhan Wong, Catherine Kirkham, Elizabeth Ramsay, Sandra O'Rourke

“…In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. …”
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CTN 328: immunogenicity outcomes in people living with HIV in Canada following vaccination for COVID-19 (HIV-COV): protocol for an observational cohort study by Cecilia T Costiniuk, Jean-Pierre Routy, Shari Margolese, Enrico Mandarino, Joel Singer, Mohammad-Ali Jenabian, Mario Ostrowski, Jonathan B Angel, Ann Burchell, Darrell Tan, Colin Kovacs, Mark Hull, Mark Brockman, Sharon Walmsley, Aslam H Anis, Marianne Harris, Curtis Cooper, Marc-André Langlois, Iva Kulic, Judy Needham, Zabrina Brumme

“…The findings will inform the design of future COVID-19 clinical trials, dosing strategies aimed to improve immune responses and guideline development for PLWH.Trial registration number NCT04894448.…”
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A mindfulness-based, cognitive, social, digital relapse-prevention intervention for youth with depression in Australia: study protocol for a randomised controlled trial of Rebound by Mario Alvarez-Jimenez, Sarah Bendall, Peter Koval, Simon Rice, Daniela Cagliarini, Lee Valentine, Penni Russon, Jess Phillips, Reeva Lederman, Cathrine Mihalopoulos, Helen Herrman, Cesar Gonzalez-Blanch, Alexandra Parker, Shaminka N Mangelsdorf, Richard M Ryan, Sarah Hetrick, Yong Yi Lee, Greg Murray, Christopher Davey, Virginia Liu, Simon D'Alfonso, Brendan Pawsey, John Gleeson

“…Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website.Trial registration number ANZCTR, ACTRN12619001412123.…”
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