Idiopathic Pulmonary Fibrosis Registry China study (PORTRAY): protocol for a prospective, multicentre registry study by Ling Zhao, Min Liu, Huaping Dai, Chen Wang, Bingbing Xie, Yanhong Ren, Jing Geng, Xuan He, Chengjun Ban, Shiyao Wang, Dingyuan Jiang, Sa Luo, Qihang Chen, Ruie Feng

“…Biological specimens will also be collected from patients to develop a library of blood, bronchoalveolar lavage fluid and lung biopsy samples, to support future research. …”
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Anterior segment characteristics and spatial variations of different crystalline lens diseases by Jianxia Fang, Ce Shi, Xinyu Ma, Siting Sheng, Jingwei Xu, Sha Zhu, Yixuan Feng, Yu Zhang, Lirui Liu, Huiling Zhao, Zhe Xu, Wen Xu

“…Introduction: To evaluate anterior chamber and crystalline lens morphology in patients with cataracts, lens subluxation (LS), and microspherophakia (MSP) using three anterior segment (AS) imaging instruments, and to develop a novel method for assessing the spatial characteristics of crystalline lens position through anterior chamber morphology measurements. …”
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Mapping barriers, enablers and implementation determinants to shared models of care for physical health and sexual wellbeing among young people with mental health difficulties usin... by Allyson J Gallant, Karen O'Connor, John Paul Lyne, Donal O'Keeffe, Shaakya Anand-Vembar, Yulia Kartalova- O'Doherty, Caroline Wilson, Agnes Higgins, Mary Cannon, Greg Sheaf, Louise Doyle, Rebecca Murphy, David McEvoy, Leona Ryan, Olivia Longe, David Cotter, Sara Burke, Colm McDonald, Gary Donohoe, Catherine D Darker

“…The review will employ the Consolidated Framework for Implementation Research (CFIR) to organise and assess findings. A librarian developed the search strategy, which will be applied to Web of Science, Medline, Embase, CINAHL, and PsycINFO databases. …”
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Implementing a complex mental health intervention in occupational settings: process evaluation of the MENTUPP pilot study by Ulrich Hegerl, Paul Corcoran, eve griffin, Ella Arensman, Chantal Van Audenhove, Reiner Rugulies, Margaret Maxwell, Kahar Abula, Katherine Thompson, Kristian Wahlbeck, Asmae Doukani, Gentiana Qirjako, Jaap van Weeghel, Birgit Aust, Charlotte Paterson, Birgit Greiner, Grace Cully, Hans De Witte, Caleb Leduc, Hanna Reich, Sarita Sanches, Naim Fanaj, Fotini Tsantila, Victoria Ross, Sharna Mathieu, Arlinda Cerga Pashoja, György Purebl, Evelien Coppens, Lars De Winter, Arilda Dushaj, Bridget Hogg, Carolyn Holland, Mallorie Leduc, Doireann Ni Dhalaigh, Cliodhna O' Brien, Mónika Ditta Tóth, Benedikt Amann, Laura Cox, Johanna Creswell-Smith, Luigia D’Alessandro, Grace Davey, Kim Dooyoung, Stefan Hackel, Ana Moreno- Alcazar, Karen Mulcahy, Ainslie O’ Connor, Wendy Orchard, Saara Rapeli, Andras Szekely, Eva Zsak

“…Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19.Conclusions The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. …”
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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

“…Methods: The objective of the image navigator–based, automated CMRA prospective multi-center study is to evaluate the diagnostic accuracy of a newly developed, state-of-the-art, standardized, and automated CMRA framework compared to CCTA in 201 patients undergoing clinical investigation for CAD. …”
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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

“…Mobile health shows promise for cancer prevention, and a WeChat-based intelligent tool has been developed to support full-cycle CRC screening, including risk assessment, individualised screening recommendation, appointment management, result processing and health education. …”
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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

“…Introduction Selection of antiseizure medications (ASMs) for newly diagnosed epilepsy remains largely a trial-and-error process. We have developed a machine learning (ML) model using retrospective data collected from five international cohorts that predicts response to different ASMs as the initial treatment for individual adults with new-onset epilepsy. …”
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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

“…Endoscopic biliary drainage is the standard of care in most centers. Many patients develop drainage-related complications after endoscopic biliary drainage for malignant hilar biliary obstruction, in particular cholangitis, resulting in reinterventions, clinical deterioration and a high mortality rate. …”
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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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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

“…A diagnostic panel (EV early lung cancer membrane protein 5, EVELC‐M5) consisting of five EV membrane proteins (CD81, PDL1, GLIPR1, LBR and SFTPA1) was developed using a High‐throughput Nano‐biochip Integrated System for Liquid Biopsy (HNCIB) to realize rapid analysis of a large cohort of patient samples at a single EV level. …”
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Clinical and cost-effectiveness of first contact physiotherapy for musculoskeletal disorders in primary care: the FRONTIER, mixed method realist evaluation by Nicola E Walsh, Alice Berry, Serena Halls, Rachel Thomas, Hannah Stott, Cathy Liddiard, Zoe Anchors, Fiona Cramp, Margaret E Cupples, Peter Williams, Heather Gage, Dan Jackson, Paula Kersten, Dave Foster, Justin Jagosh

“…These were then presented to a group of key stakeholders to validate, refine and develop as required. The areas identified for further exploration included Awareness of the FCPs; FCP team integration and communication; FCP approach to appointments; FCP levels of competency; practice workload; FCP professional development; impact of consultation modes; and employment models. …”
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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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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

“…To address relapse in MDD, we developed a moderated online social therapy platform (titled Rebound) that integrates: (i) peer-to-peer social networking; (ii) tailored third-wave therapeutic content targeting mindfulness, self-compassion and rumination; and (iii) three types of human support (clinicians, peer workers, career consultants), informed by self-determination theory. …”
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Telephone lifestyle intervention to prevent diabetes in women with recent gestational diabetes mellitus attending the national health system: the LINDA-Brasil clinical trial by Bruce B Duncan, Maria Inês Schmidt, Paula A Bracco, Maria A Nunes, Kadhija A Cherubini, Cristina D Castilhos, Jainara Z Spagiari, Leony M Galliano, Ruben Ladwig, Fabricio B Del Vecchio, Anelita H M Del Vecchio, Michele Drehmer, Adriana Costa Forti, Cristina Façanha, Lenita Zajdenverg, Bianca de Almeida-Pititto, Rosângela Roginski Réa, Patrícia Medici Dualib

“…The COVID-19 pandemic negatively impacted trial conduction.Trial registration number NCT02327286.…”
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HEV study protocol : design of a cluster-randomised, blinded trial to assess the safety, immunogenicity and effectiveness of the hepatitis E vaccine HEV 239 (Hecolin) in women of c... by Anisur Rahman, K Zaman, Susanne Dudman, Kathrine Stene-Johansen, Firdausi Qadri, Md Yunus, Synne Sandbu, Emily S Gurley, Joakim Overbo, Cathinka Halle Julin, Jennifer Lynn Dembinski, Quamrun Nahar, Taufiqur R Bhuiyan, Mustafizur Rahman, Warda Haque, Jahangir Khan, Asma Aziz, Mahbuba Khanam, Peter Kim Streatfield, John D Clemens

“…Introduction Hepatitis E virus (HEV) is a leading cause of acute viral hepatitis in the developing world and is a public health problem, in particular among pregnant women, where it may lead to severe or fatal complications. …”
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Optimizing treatment for depression in primary care using psychotherapy versus antidepressant medication in a low-resource setting: protocol for the OptimizeD randomized controlled... by Julia R. Pozuelo, Anuja Lahiri, Rahul S. P. Singh, Arvind Kushwah, Mimansa Khanduri, Akanksha Shukla, Azaz Khan, Sruthi G., Varun Shende, Yashika Parashar, Yashwant K. Mehra, Anant Bhan, Ronald C. Kessler, Daisy R. Singla, John A. Naslund, Karmel W. Choi, Pim Cuijpers, Robert DeRubeis, Mohammad M. Herzallah, Chunling Lu, Jordan W. Smoller, Tyler J. VanderWeele, Abhijit R. Rozatkar, Tamonud Modak, Michelle Melwyn Joel, Debasis Biswas, Shubham Atal, Umay Kulsum, Steven D. Hollon, Vikram Patel

“…Using machine learning, we will attempt to develop a precision treatment rule that leverages baseline clinical, psychological, cognitive, socioeconomic, and biological data to predict which treatment is most likely to achieve remission for each patient. …”
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