PREdiction and Diagnosis using Imaging and Clinical biomarkers Trial in Traumatic Brain Injury (PREDICT-TBI) study protocol: an observational, prospective, multicentre cohort study... by Siva Senthuran, Lewis Campbell, Jennifer Fleming, Virginia Newcombe, Michael Reade, Silvia Manzanero, James Walsham, Nathan Brown, Xuan Vinh To, Clifford Pollard, Fatima Nasrallah, Judith Bellapart, Esther Jacobson, Jason Meyer, Janine Stuart, Tracey Evans, Shekhar S Chandra, Jason Ross, James McCullough

“…The objective of this study is to develop a machine learning predictive model for neurological outcomes at 6 months in patients with a moderate-to-severe TBI, incorporating longitudinal clinical, multimodal neuroimaging and blood biomarker predictor variables.Methods and analysis A prospective, observational, cohort study will enrol 300 patients with moderate-to-severe TBI from seven Australian hospitals over 3 years. …”
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Acceptability of risk-based breast cancer screening among professionals and healthcare providers from 6 countries contributing to the MyPeBS study by Alexandra Roux, Lucile Hervouet, Francesca Di Stefano, David P. French, Livia Giordano, David Ritchie, Marie-Eve Rougé Bugat, Debbie Keatley, Rachel Cholerton, Lorna McWilliams, Paolo Giorgi Rossi, Corinne Balleyguier, Michal Guindy, Fiona J. Gilbert, Jean-Benoit Burrion, Marta Roman, Cécile Vissac-Sabatier, Daniel Couch, Suzette Delaloge, Sandrine de Montgolfier, On behalf of the MyPeBS Investigators and the MyPeBS Consortium

“…As professional acceptability is key for successful implementation, training for all professionals and tools to help them communicate risk to women will be necessary to develop risk assessment in BCS. Trial registration Study sponsor: Unicancer. …”
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Impact of allogeneic dental pulp stem cell injection on tissue regeneration in periodontitis: a multicenter randomized clinical trial by Yi Liu, Yitong Liu, Jingchao Hu, Jianhui Han, Lin Song, Xu Liu, Nannan Han, Xia Xia, Jia He, Hongfang Meng, Meng Wan, Haojie Wang, Xiaodan Liu, Zhanyi Gao, Xiao Wang, Chutse Wu, Songlin Wang

“…In this study, a human dental pulp stem cell (DPSC; hDP-MSC) injection was developed to promote periodontal regeneration through a non-invasive procedure. …”
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Mapping outcomes for recovery of consciousness in studies from 1986 to 2020: a scoping review protocol by Monica Steiner, Elizabeth Burns, Trudy Mallinson, Joshua Rosenow, Jennifer Weaver, Alison Cogan, Parie Bhandari, Erica Jacobs, Ariana Pape, Chantal Nguyen, Ann Guernon, Tom Harrod, Theresa Bender Pape, Marilyn Pacheco, Catherine Burress Kestner, Kelsey Watters, Elizabeth Yost, Henk Eilander, Berno Overbeek, Sophie Leeds, Kelly Krese, Haylee Winden, Mary Philbin, Stefani Cleaver, Vanessa Silva, Konner Nelson, André Lindsey, Angela Hartman, Kristen Maisano, Erika Cooley, Jessica Rudin Portnoff, Bailey Widener, Sarah Hollingsworth, Coty Wardwell, Julianne Angel, Ladan Hakima, Jennifer Nebel, Bint-e Zainab Awan

“…Results will be presented at national conferences and published in peer-reviewed journals.Trial registration number CRD42017058383.…”
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Derivation and internal–external validation of clinical prediction model for postoperative clinically important hypotension in patients undergoing noncardiac surgery: an internatio... by Stephen Su Yang, German Malaga, Maria Lazo-Porras, Patricia Busta-Flores, Aida del Carmen Rotta-Rotta, Pavel S. Roshanov, Daniel I. Sessler, Amal Bessissow, Thomas Schricker, Vicky Tagalakis, Diane Heels-Ansdell, Shirley Pettit, P.J. Devereaux

“…In 14 of the centres selected at random (derivation cohort), we evaluated 49 variables using logistic regression to develop a model to predict postoperative clinically important hypotension, defined as a systolic blood pressure ≤90 mm Hg, that resulted in clinical intervention. …”
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Synchronous metastases from colorectal cancer. Treatment and long-term survival compared to patients with metachronous metastases: a population-based study from Central Norway 2001... by Per Even Storli, Rachel Genne Dille- Amdam, Gaute Havik Skjerseth, Mads Vikhammer Gran, Tor Åge Myklebust, Jon Erik Grønbech, Erling A. Bringeland

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Navigator programme for hospitalised adults experiencing homelessness: protocol for a pragmatic randomised controlled trial by Lucie Richard, Rosane Nisenbaum, Vicky Stergiopoulos, Kerry McBrien, Michael Liu, Rebecca Brown, Anita Palepu, Jesse Jenkinson, Gabriel Fabreau, Cheryl Pedersen, Katherine Francombe Pridham, Sareeha Virani, Fred Ellerington, Alyssa Ranieri, Oluwagbenga Dada, Matthew To, Stephen Hwang

“…The Navigator Programme is a Critical Time Intervention case management programme that was developed to help homeless patients with their postdischarge needs and to link them with community-based health and social services. …”
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Noninvasive imaging biomarker reveals invisible microscopic variation in acute ischaemic stroke (≤ 24 h): a multicentre retrospective study by Kui Sun, Rongchao Shi, Xinxin Yu, Ying Wang, Wei Zhang, Xiaoxia Yang, Mei Zhang, Jian Wang, Shu Jiang, Haiou Li, Bing Kang, Tong Li, Shuying Zhao, Yu Ai, Jianfeng Qiu, Haiyan Wang, Ximing Wang

“…Abstract To develop and validate non-contrast computed tomography (NCCT)-based radiomics method combines machine learning (ML) to investigate invisible microscopic acute ischaemic stroke (AIS) lesions. …”
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Reconstructed dose and geometric coverage for tight margins using intrafraction re-planning on an integrated magnetic resonance imaging and linear accelerator system for prostate c... by Ingeborg van den Berg, Cornel Zachiu, Eline N. de Groot-van Breugel, Thomas Willigenburg, Gijsbert H. Bol, Jan J.W. Lagendijk, Bas W. Raaymakers, Harm H.E. van Melick, Cornelis A.T. van den Berg, Jochem R.N. van der Voort van Zyp, Johannes C.J. de Boer

“…Intra- and inter-fraction dose accumulation was performed via an in-house developed deformable image registration algorithm. …”
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PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island by Cyril Ferdynus, Léa Bruneau, Antoine Bertolotti, Charline Dugast, Adrian Fianu, Karim Boussaid, Juliette Vuichard, Floreana Duloutre, Jessica Dumez, Nathalie Sultan-Bichat

“…This island has a multicultural and multiethnic population of 860 000 inhabitants, a quarter of whom are at high risk of developing skin cancer due to intense ultraviolet radiation. …”
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Omission of axillary lymph node dissection in patients with breast cancer with axillary pathological complete response confirmed by stained region lymph node biopsy after neoadjuva... by Yuanyuan Wang, Rui Chen, Xuan Li, Jue Wang, Jingjing Ding, Lexin Wang, Lingjun Ma, Ran Zheng, Yichun Gong, Hao Yao, Xiaoming Zha, Mingyu Wang, Xingye Sheng

“…SrLNB is a novel de-escalation axillary surgery, which was developed and tested in our preliminary study. The primary endpoint of this trial is the 3-year invasive disease-free survival (iDFS). …”
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Adaptive cohort design and LAT1 expression scale: study protocol for a Phase 2a trial of QBS72S in breast cancer brain metastases by Rukayat Taiwo, Paul M. Harary, Thy T. H. Trinh, Monica Granucci, Sophie Bertrand, Brandon Carlson-Clarke, Sophia B. Chernikova, Kate Therkelsen, Mili Arora, Michelle E. Melisko, Michael Iv, Hannes Vogel, Summer Han, Christine Xie, Susie Brain, Vivian Lee, Krishna L. Bharani, Seema Nagpal, Melanie Hayden Gephart

“…Up to 30% of patients with breast-to-brain metastases will develop leptomeningeal disease (LMD), with poor survival, rapid neurologic decline, and no durable treatment options. …”
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Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study prot... by Adam Slivka, Rohit Das, Asbjørn Mohr Drewes, Søren Schou Olesen, Mouen A Khashab, Vikesh K Singh, Dhiraj Yadav, Mahya Faghih, Anna Evans Phillips, Elham Afghani, Venkata Sandeep Akshintala, Panayiotis Y Benos, Jeffrey Easler, Charles Gabbert, Vivek Halappa, Jami L Saloman, Biatta Sholosh, Tianxiu Wang

“…Data and results will be reported and disseminated in conjunction with National Institutes of Health policies.Trial registration number NCT04996628.…”
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Holistic health and social care outreach for people experiencing homelessness with recent non-fatal overdose in Glasgow, Scotland: the Pharmacist and third sector Homeless charity... by Vibhu Paudyal, Nicola Greenlaw, Frances S Mair, Kate Stock, Andrew McPherson, Andrea E Williamson, Richard Lowrie, Donogh Maguire, Steven Ross, James Roy Robertson, Alison Boyle, Clare Duncan, Rebecca Blair, Cian Lombard, Fiona Hughes, Jane Moir, Ailsa Scott, Frank Reilly, Laura Sills, Jennifer Hislop, Stephen Wishart, David Brannan, Rebekah Ramage

“…QoL and treatment uptake appeared to be higher in PHOENIx versus UC at 6 and 9 months.Conclusions A definitive RCT is merited, to assess the impact of PHOENIx on people with multiple, severe disadvantages.Trial registration number ISRCTN10585019.…”
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Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol by Nicolas Penel, Dominique Vaur, Juliette Thariat, Alexandre Escande, Jennifer le Guevelou, Colin Debaigt, Esma Saada-Bouzid, Julien Viotti, Nazim Khalladi, David Thibouw, Marie Pierre Sunyach, Laurence Moureau-Zabotto, Mohamed Benchalal, Ovidiu Veresezan, Anne Ducassou, Cecile le Pechoux, Maria Jolnerovski, Celine Bazille, Raphael Serre, Christine Lovera

“…Introduction Up to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. …”
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Rapid diagnosis of adult-type diffuse glioma using a layered scheme by Jinsong Wu, Shuai Wu, Dandan Cao, Zhang Xiong, Jianhua Zhang, Yourui Zou, Zanyi Wu, Yanli Nie, Chen Luo, Ye Yao, Yanyan Song, Yuchen Jiao, Hong Chen, Hui Ma, Dezhi Kang, Ying Mao, Hai Yan

“…Methods We propose a novel layered diagnostic scheme for adult-type diffuse gliomas, with IDH and TERTp mutation detection as the initial layer. We also developed a rapid intraoperative testing technology capable of detecting TERTp and IDH mutations within 35 min. …”
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CMOEP regimen in the treatment of untreated peripheral T-cell lymphoma: a multicenter, single-arm, phase I study by Jingwei Yu, Xiuhua Sun, Guangxun Gao, Li Yu, Jiesong Wang, Lihua Qiu, Zhengzi Qian, Wei Li, Huilai Zhang

“…The current first-line treatment for peripheral T-cell lymphoma (PTCL) has a typically poor prognosis. Developing a new regimen is urgently needed. This phase I study evaluated the maximum tolerated dose (MTD), safety, and efficacy of mitoxantrone hydrochloride liposome (Lipo-MIT) plus cyclophosphamide, vincristine, etoposide, and prednisone (COEP) in untreated PTCL. …”
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Inhaled Nitric Oxide ReDuce postoperatIve pulmoNAry complicaTions in patiEnts with recent COVID-19 infection (INORDINATE): protocol for a randomised controlled trial by Hui Zhang, Xiaomei Wang, Xue Yang, Ziyu Zheng, Gang Luo, Qianqian Fan, Huang Nie, Baobao Gao, Lini Wang, Chong Lei, Shuxiu Wang, Bingqing Zhao, Hailong Dong

“…Consequently, it is crucial to develop perioperative management strategies that can mitigate these increased risks in surgical patients who have recently been infected with SARS-CoV-2. …”
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Artificial Intelligence‐Based Detection of Central Retinal Artery Occlusion Within 4.5 Hours on Standard Fundus Photographs by Ayse Gungor, Ilias Sarbout, Aubrey L. Gilbert, Steffen Hamann, Pierre Lebranchu, Cristina Hobeanu, Philippe Gohier, Catherine Vignal‐Clermont, Oana M. Dumitrascu, Salomon‐Yves Cohen, Wolf A. Lagrèze, Nicolas Feltgen, Frank van der Heide, Cédric Lamirel, Jost B. Jonas, Michael Obadia, Daniel Racoceanu, Dan Milea

“…However, most stroke centers lack onsite ophthalmic expertise before considering fibrinolytic treatment. This study aimed to develop, train, and test a deep learning system to detect hyperacute CRAO on retinal fundus photographs within the critical 4.5‐hour treatment window and up to 24 hours after visual loss to aid in secondary stroke prevention. …”
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Within-laboratory SARS-CoV-2 real time PCR testing operations in Nepal: a simulation-based analysisResearch in context by Fannie L. Côté, Nadia Lahrichi, Erica Gralla, Hannah Bakker, Parvathy Krishnan Krishnakumari, Joaquim Gromicho, Arunkumar Govindakarnavar, Runa Jha, Lilee Shrestha, Nirajan Bhusal, Saugat Shrestha, Rashmi Mulmi, Priya Jha, Reuben Samuel, Dhamari Naidoo, Victor J. del Rio Vilas

“…In this study, we used a simulated laboratory environment, based on a model of operating laboratories in Nepal, to identify opportunities for improvement. Methods: We developed a discrete event simulation (DES) model, based on data from and in collaboration with Nepali health authorities, to analyse laboratory operations in Nepal. …”
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