CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trialsResearch in context by Jan Rekowski, Christina Guo, Olga Solovyeva, Munyaradzi Dimairo, Mahtab Rouhifard, Dhrusti Patel, Emily Alger, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Johann de Bono, Thomas R. Jeffry Evans, Elizabeth Garrett–Mayer, Robert M. Golub, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Israel Maia, Adrian Mander, Lynley V. Marshall, James Matcham, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Lesley Seymour, Yoshiya Tanaka, Moreno Ursino, Christopher J. Weir, Christina Yap

“…The international consensus-based CONSORT-DEFINE (Consolidated Standards for Reporting Trials Dose-finding Extension) statement, an extension of the CONSORT statement for randomised trials, was developed to improve the reporting of EPDF trials. …”
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Trends in tuberculosis mortality among older adults in China, 2004–2021: a Joinpoint regression and age–period–cohort analysis by Mengdi Zhang, Xin Wang, Yiran Xiao, Qiqi Wang, Fei Huang, Xiang Ren, Xiaomin Guo, Wenshan Sun, Jinqi Deng, Qi Jiang, Jianjun Liu, Wenjing Zheng, Hongyan Yao

“…An age–period–cohort (APC) analysis using the intrinsic estimator (IE) method was conducted to estimate the independent effects of age, period, and cohort.ResultsThe age-standardized TB mortality rate was 5.68 per 100,000, with higher rates observed in men, rural areas, and western regions. …”
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Comparative CT with stress manoeuvres for diagnosing distal isolated tibiofibular syndesmotic injury in acute ankle sprain: a protocol for an accuracy- test prospective study by João Carlos Rodrigues, Mario Lenza, Laercio Alberto Rosemberg, Durval do Carmo Santos Barros, Mario Ferretti, Alexandre Leme Godoy Santos, Marcelo Pires Prado, José Felipe Marion Alloza, Renato Amaral Masagão, Adham do Amaral e Castro, Marco Kawamura Demange

“…Three strategies of the CT index test (one in the neutral position and two with stress) will examine the accuracy using MRI as the reference standard. The external rotation and dorsiflexion of the ankle will guide the stress manoeuvres. …”
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Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Bip... by Madison T. Baxter, Christopher C. Conlin, Aditya Bagrodia, Tristan Barrett, Hauke Bartsch, Anja Brau, Matthew Cooperberg, Anders M. Dale, Arnaud Guidon, Michael E. Hahn, Mukesh G. Harisinghani, Juan F. Javier-DesLoges, Sophia C. Kamran, Christopher J. Kane, Joshua M. Kuperman, Daniel J.A. Margolis, Paul M. Murphy, Nabih Nakrour, Michael A. Ohliger, Rebecca Rakow-Penner, Ahmed Shabaik, Jeffry P. Simko, Clare M. Tempany, Natasha Wehrli, Sean A. Woolen, Jingjing Zou, Tyler M. Seibert

“…Advanced Restriction imaging and reconstruction Technology for Prostate MRI (ART-Pro) is a multisite, multinational trial that aims to evaluate whether IV contrast can be avoided in the setting of standardized, state-of-the-art image acquisition, with or without addition of RSIrs. …”
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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

“…Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. …”
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Noninvasive Brain Stimulations for Unilateral Spatial Neglect after Stroke: A Systematic Review and Meta-Analysis of Randomized and Nonrandomized Controlled Trials by Flávio Taira Kashiwagi, Regina El Dib, Huda Gomaa, Nermeen Gawish, Erica Aranha Suzumura, Taís Regina da Silva, Fernanda Cristina Winckler, Juli Thomaz de Souza, Adriana Bastos Conforto, Gustavo José Luvizutto, Rodrigo Bazan

“…Studies were selected if they were controlled and noncontrolled trials examining transcranial direct current stimulation (tDCS), repetitive transcranial magnetic stimulation (rTMS), and theta burst stimulation (TBS) in USN after stroke, with outcomes measured by standardized USN and functional tests. Results. Twelve RCTs (273 participants) and 4 non-RCTs (94 participants) proved eligible. …”
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Dietary Micronutrient Intake and the Prevalence of Metabolic Conditions among Children from the United States–Affiliated Pacific Region in the Children’s Healthy Living Program by Lucia A Seale, Ashley B Yamanaka, Kristi Hammond, Eunjung Lim, Lynne R Wilkens, Pauline McFall, Tanisha F Aflague, Patricia Coleman, Travis Fleming, Leslie Shallcross, Jonathan Deenik, Rachel Novotny

“…Obesity and AN were measured by standardized staff. Results: Most USAP children did not meet daily intake recommendations for micronutrients, with low intake of calcium, potassium, vitamin D, vitamin E, excess sodium, vitamin A, folate, and niacin. …”
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Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial by Robert Clarke, Emma J Crosbie, Basil G Issa, John Belcher, Helen Clarke, Anthony Howell, Michelle Harvie, Hannah Harrison, Cheryl Lombardelli, Suzanne Krizak, Katharine Sellers, Yit Y Lim, Caroline Parkin, Shruthi Patel, Anthony J Maxwell, Julie Wisely, Sacha J Howell

“…Results will be published in peer-reviewed journals, presented at conferences and shared with trial participants.Trial registration number International Standard Randomised Controlled Trial Number Registry (ISRCTN15358157).…”
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Comparing the efficacy of different methods in assessing cervical stromal invasion in endometrial carcinoma: a retrospective study of 2,020 patients by Ying Yang, Ying Yang, Zhijun Ye, Zhijun Ye, Yifei Zhao, Yifei Zhao, Zhengyu Li, Zhengyu Li

“…Using the postoperative pathological diagnosis as the gold standard, the diagnostic efficacies of different preoperative methods were analyzed. …”
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Monitoring of Circulating Tumor DNA and Indication of De-Escalation Adjuvant Targeted Therapy for EGFR-Mutated NSCLC After Complete Resection by Song Dong, PhD, Bingfa Yan, PhD, Si-Yang Liu, PhD, Xuan Gao, PhD, Hui-Zhao Hong, MD, Hong-Ji Li, MD, Wei Gao, PhD, Hong-Hong Yan, PhD, Si-Yang Maggie Liu, PhD, Hai-Yan Tu, PhD, Yi Pan, PhD, Qing Zhou, PhD, Xue-Ning Yang, PhD, Xue-Feng Xia, PhD, Xin Yi, PhD, Wen-Zhao Zhong, PhD, Yi-Long Wu, MD, Jia-Tao Zhang, PhD

“…Introduction: EGFR tyrosine kinase inhibitor (TKI) is the standard adjuvant treatment for patients with stages IB to IIIA EGFR-mutated NSCLC. …”
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Biomechanical enhancement in rotator cuff repairs: the impact of innovative nanofiber technology by James Johnson, PhD, Ben Gadomski, PhD, Daniel Regan, DVM, PhD, DACVP, Jed Johnson, PhD, Brad Nelson, MS, PhD, DVM, DACVS, Kirk McGilvray, PhD, Kevin Labus, PhD, Anthony Romeo, MD, Jeremiah Easley, DVM, Dipl, ACVS

“…All repairs were performed using the standard double-row configuration with suture tape; half of the repairs were augmented with the bioresorbable nanofiber scaffold. …”
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Intra-mesenteric steroids for steroid-refractory graft-versus-host disease in pediatric patients: A safe option by Ana M. Aristizábal, Lina P. Montaña, Jaiber Gutiérrez, Diego Medina, Alexis A. Franco, Eliana Manzi, Ángela Devia Zapata, Walter Mosquera

“…Reports in the adult population have shown an approximately 50% response rate with few complications, making it a second-line management standard. As far as we know, this is the largest pediatric cohort reported in Latin America. …”
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Rapid and specific on-site H5Nx avian influenza diagnosis via RPA and PAM-independent CRISPR-Cas12a assay combined with anti-NP antibody-based viral RNA purification by Jin-Ha Song, Seung-Eun Son, Ho-Won Kim, Seung-Ji Kim, Se-Hee An, Chung-Young Lee, Hyuk-Joon Kwon, Hyuk-Joon Kwon, Hyuk-Joon Kwon, Hyuk-Joon Kwon, Kang-Seuk Choi, Kang-Seuk Choi

“…Currently, RT-qPCR with spin column RNA extraction is the gold standard for HPAIV surveillance, but its long reaction time and need for specialized equipment limit its effectiveness for rapid response. …”
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Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic... by Michael Schmoeckel, Matthias Thielmann, Keti Vitanova, Thomas Eberle, Nandor Marczin, Kambiz Hassan, Andreas Liebold, Sandra Lindstedt, Georg Mächler, Marijana Matejic-Spasic, Daniel Wendt, Efthymios N. Deliargyris, Robert F. Storey

“…Outcome measurements included bleeding events according to standardized definitions and 24-hour chest-tube-drainage (CTD). …”
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Comprehensive assessment of physicochemical quality, heavy metals, and ecological risks in the Someshwari river water, Netrokona, Bangladesh by Rima Sarker, Md. Sirajul Islam, Md. Humayun Kabir, Shahrina Sultana, Nowara Tamanna Meghla, Mir Md. Mozammal Hoque, Tanmoy Roy Tusher

“…The findings of the study revealed that temperature, pH, DO, BOD, TDS, EC, and total alkalinity were within established standard limits. The pH values across all water samples exhibited variation within the range of 7.60 to 7.80. …”
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Prognostic Factors for Clinical Response in Systemic Lupus Erythematosus Patients Treated by Allogeneic Mesenchymal Stem Cells by Lihui Wen, Myriam Labopin, Manuela Badoglio, Dandan Wang, Lingyun Sun, Dominique Farge-Bancel

“…There is no cure for SLE, but current standard pharmacotherapies can improve disease prognosis in most patients. …”
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Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol by Andrew Xanthopoulos, Eleni Kapreli, Garyfallia Pepera, Konstantinos I Gourgoulianis, Varsamo Antoniou, Gregory Giamouzis, Constantinos Davos, Ladislav Batalik, Vasileios Stavrou, John Skoularigis

“…Participants will receive a 12-week exercise-based rehabilitation programme, remotely monitored for the TELE-CR group and standard supervised for the CB-CR group. All participants will perform aerobic training at 70% of their maximal heart rate, as obtained from cardiopulmonary exercise testing (CPET) for 20 min plus 20 min for strengthening and balance training, three times per week. …”
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Access to healthcare: waiting time until the surgical procedure by Cassiane de Santana Lemos, Ana Maria Muller Magalhães, Danielle Saraiva Tuma dos Reis, Alessandra Yuri Takehana de Andrade, Karla Cristina de Almeida, Fabiana Zerbieri Martins, Nancy Reynolds, Vanessa de Brito Poveda

“…There was a difference in the perception of quality of life between the immediate and late postoperative periods (p = 0.007) and in the physical domain, with an increase in scores among older patients (p = 0.004) and previous clinical history (p = 0.03).Conclusion Access to the health system varies by region and does not meet the standards proposed by the Brazilian health system. …”
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Normative and limit values of speed, endurance and power tests results of young football players by Michał Nowak, Michał Nowak, Marta Szymanek-Pilarczyk, Marta Szymanek-Pilarczyk, Artur Stolarczyk, Łukasz Oleksy, Łukasz Oleksy, Jarosław Muracki, Jacek Wąsik

“…IntroductionThis study aimed to assess the development of speed, endurance and power in young football players and to create percentile charts and tables for standardized assessment.MethodsCross-sectional data were collected from 495 male players aged 12–16 years at RKS Raków Częstochowa Academy in 2018–2022. …”
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The modern options of chronic hepatitis C antiviral therapy with daclatasvir: results of named patient program by V. T. Ivashkin, M. V. Mayevskaya, D. T. Abdurakhmanov, I. G. Bakulin, N. I. Geyvandova, M. L. Zubkin, S. N. Kizhlo, A. V. Kuznetsova, I. B. Latysheva, N. A. Mamonova, V. G. Morozov, O. I. Sagalova, Ye. V. Esaulenko, Ye. O. Lyusina

“…The options of antiviral therapy (AVT) in the stages of severe liver fibrosis and cirrhosis (LC) as well as in the patients with comorbidities for the long time were limited to the standard therapy by pegilated interferon (peg-IFN) in combination to ribavirin (RBV). …”
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