Effectiveness–implementation hybrid-2 randomised trial of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children (D... by Paula Lister, Kristen Gibbons, Zephanie Tyack, Luregn J Schlapbach, Samudragupta Bora, Maria Isabel Castillo, James Best, Debbie Long, Helen G Liley, Belinda Dow, Kerri-Lyn Webb, Christian Stocker, Debra Thoms, Carolyn Wharton, Lori Matuschka

“…Dissemination of the outcomes of the study is expected via publication in a peer-reviewed journal, presentation at relevant conferences, and via social media, podcast presentations and open-access medical education resources.Registration details The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry as ‘Pilot testing of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children’ (the DAISY Pilot Study).Trial registration number ACTRN12621000799853.…”
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Inpatient dialectical behavior therapy combined with trauma-focused therapy for PTSD and borderline personality disorder symptoms: study design of the naturalistic trauma therapy s... by Annemieke C. Kamstra, Annemieke C. Kamstra, Sybolt O. de Vries, Maarten F. Brilman, Petty Vasilev, Manna A. Alma, Antoinette D. I. van Asselt, Antoinette D. I. van Asselt, Mia De Wolf, Robert A. Schoevers, Frederike Jörg

“…Preregistration: Dutch registration database Centrale Commissie Mensgebonden Onderzoek and International Clinical Trials Registry Platform (NL-OMON46167/01.10.2018/https://trialsearch.who.int/Trial2.aspx?…”
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Survival after Locoregional Treatments for Hepatocellular Carcinoma: A Cohort Study in Real-World Patients by Simona Signoriello, Annalisa Annunziata, Nicola Lama, Giuseppe Signoriello, Paolo Chiodini, Ilario De Sio, Bruno Daniele, Giovanni G. Di Costanzo, Fulvio Calise, Graziano Olivieri, Vincenzo Castaldo, Rosario Lanzetta, Guido Piai, Giampiero Marone, Mario Visconti, Mario Fusco, Massimo Di Maio, Francesco Perrone, Ciro Gallo, Giovanni B. Gaeta

“…Adequately powered randomized clinical trials are still needed to definitely assess relative effectiveness of locoregional HCC treatment.…”
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Use of real-world data to study health services utilisation and comorbidities in long-term breast cancer survivors (the SURBCAN study): study protocol for a longitudinal population... by Xavier Castells, Beatriz Poblador-Plou, Alexandra Prados-Torres, Maria Sala, Javier Gorricho, Anna Jansana, Isabel Del Cura, Teresa Sanz Cuesta, A Gimeno Miguel, Manuela Lanzuela, Berta Ibañez, Ibai Tamayo, Conchi Moreno-Iribas, María Padilla-Ruiz, Maximino Redondo, Mercè Comas, Laia Domingo, Antonio Díaz-Holgado, Francisco Javier Salamanca, Mercè Abizanda, Talita Duarte, Javier Louro, María del Carmen Martínez, Cristóbal Molina, Guillermo Pérez, Ana María Muñoz, Óscar Toldos, Javier Baquedano, Rossana Burgui

“…The results of the study will be published in a peer-reviewed journal and will be presented at national and international scientific conferences and at patient associations.Trial registration number This protocol is registered in Clinical Trials.gov (identifier: NCT03846999).…”
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Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy (FADIGAS): a randomised, double-blinded, placebo-controlled trialResearch... by Katrine Lundby Høyer, Simon Mark Dahl Baunwall, Ditte Smed Kornum, Mette Winther Klinge, Asbjørn Mohr Drewes, Knud Bonnet Yderstræde, Louise Bruun Thingholm, Martin Steen Mortensen, Susan Mikkelsen, Christian Erikstrup, Christian Lodberg Hvas, Klaus Krogh

“…Public trial registration, ClinicalTrials.gov NCT04749030. Findings: We randomised 20 patients to FMT or placebo. …”
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Incidence of self-reported tuberculosis treatment with community-wide universal testing and treatment for HIV and tuberculosis screening in Zambia and South Africa: A planned analy... by L Telisinghe, S Floyd, D MacLeod, A Schaap, R Dunbar, J Bwalya, N Bell-Mandla, E Piwowar-Manning, D Donnell, K Shaunaube, P Bock, S Fidler, R J Hayes, H M Ayles, HPTN 071 (PopART) study team

“…<h4>Trial registration</h4>ClinicalTrials.gov: NCT01900977.…”
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Pembrolizumab, radiotherapy, and an immunomodulatory five-drug cocktail in pretreated patients with persistent, recurrent, or metastatic cervical or endometrial carcinoma: Results... by Emiel A. De Jaeghere, Sandra Tuyaerts, An M. T. Van Nuffel, Ann Belmans, Kris Bogaerts, Regina Baiden-Amissah, Lien Lippens, Peter Vuylsteke, Stéphanie Henry, Xuan Bich Trinh, Peter A. van Dam, Sandrine Aspeslagh, Alex De Caluwé, Eline Naert, Diether Lambrechts, An Hendrix, Olivier De Wever, Koen K. Van de Vijver, Frédéric Amant, Katrien Vandecasteele, Hannelore G. Denys

“…Trial registration ClinicalTrials.gov (identifier NCT03192059) and EudraCT Registry (number 2016-001569-97).…”
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Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial by Andrea Tacchino, Michela Ponzio, Paolo Confalonieri, Letizia Leocani, Matilde Inglese, Diego Centonze, Eleonora Cocco, Paolo Gallo, Damiano Paolicelli, Marco Rovaris, Loredana Sabattini, Gioacchino Tedeschi, Luca Prosperini, Francesco Patti, Edoardo Sessa, Elisabetta Pedrazzoli, Mario Alberto Battaglia, Giampaolo Brichetto

“…Trial RegistrationClinicalTrials.gov NCT04011579; https://tinyurl.com/2p9n4d2t International Registered Report Identifier (IRRID)DERR1-10.2196/58026…”
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Effect of intravenous urokinase vs best medicine treatment on functional outcome for patients with acute minor stroke (TRUST): a randomized controlled trial by Yongli Tao, Yuan Gao, Lu Zhao, Yafang Xu, Chenyang Jiang, Kai Liu, Hui Fang, Lulu Pei, Xin Wang, Rui Zhang, Jun Wu, Jing Yang, Xinsheng Han, Hongling Guo, Baoguo Xue, Jinlou Li, Yuqian Liu, Hongqiu Gu, Kejin Du, Xin Cheng, Qiang Dong, Duolao Wang, Ferdinando S. Buonanno, MingMing Ning, Yuming Xu, Bo Song, the TRUST Trial Investigators

“…Trial registration ClinicalTrials.gov Identifier: NCT04420351.…”
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Improving the adoption of a school-based nutrition program: findings from a collaborative network of randomised trials by Courtney Barnes, Rachel Sutherland, Lisa Janssen, Jannah Jones, Katie Robertson, Justine Gowland-Ella, Nicola Kerr, Aimee Mitchell, Karen Gillham, Alison L. Brown, Luke Wolfenden

“…Trial registration The trials were prospectively registered with Australia New Zealand Clinical Trials Register: ANZCTR, ACTRN12622000257763, Registered 11/2/2022, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?…”
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Bibliometric analysis of laryngeal cancer treatment literature (2003–2023) by Yan Zhao, Jiancheng Xue

“…Current research hotspots include disease prognosis, models, clinical trials, tumor recurrence, and surveillance. Notably, targeted therapy and immunotherapy are rapidly advancing fields. …”
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Development of a core outcome set and core measurement set for kangaroo mother care: a study protocol by Yuan Li, Xia Li, Qiong Chen, Ying Xin Li, Han Mei Peng, Xue Mei Guo, Xiao Wen Li, Yan Ling Hu, Xing Li Wan

“…This study aims to develop both a COS and a CMS for KMC to standardise outcome reporting, improve the quality assessments in clinical trials and facilitate data integration. This protocol outlines the methodology for developing a COS and CMS for KMC.Methods and analysis The development of the COS and CMS for KMC will follow six phases: (1) a systematic review, (2) semistructured interviews, (3) merging outcomes, (4) two/three rounds of international Delphi survey, (5) a consensus meeting and (6) development of the CMS. …”
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-Tyrosine Confers Residualizing Properties to a -Amino Acid-Rich Residualizing Peptide for Radioiodination of Internalizing Antibodies by Fook T. Lee PhD, Ingrid J. G. Burvenich PhD, Nancy Guo MBBS, MSc, Pece Kocovski BSc (Honors), Henri Tochon-Danguy PhD, Uwe Ackermann PhD, Graeme J. O’Keefe PhD, Sylvia Gong PhD, Angela Rigopoulos BSc, MSc, Zhanqi Liu MBBS, PhD, Hui K. Gan MBBS, FRACP, PhD, Andrew M. Scott MBBS, FRACP, MD

“…Conclusions: The mixed d / l -enantiomeric peptide, d Thr- d Pro- d Thr- dA sp -dA sp-Tyr -dA sp -dA sp- d Thr- d Pro- d Thr, is suitable for radiolabeling antibodies with radiohalogens such as 124 I for high-resolution immuno-PET imaging of tumors and for evaluation in early-phase clinical trials.…”
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The interaction between genetic predicted gut microbiome abundance and particulate matter on the risk of incident asthma in adults by Hehua Zhang, Yong Feng, Honghao Yang, Yuqian Li, Zheng Ma, Liuxin Li, Liangkai Chen, Yuhong Zhao, Lishen Shan, Yang Xia

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Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Stu... by Miao Liu, Yang Yang, Bin Hua, Rui Feng, Tianyu Xu, Mengyuan Wang, Xiaowei Qi, Yingming Cao, Bo Zhou, Fuzhong Tong, Peng Liu, Hongjun Liu, Lin Cheng, Houpu Yang, Fei Xie, Siyuan Wang, Chaobin Wang, Yuan Peng, Danhua Shen, Lei Chen, Jun Jiang, Shu Wang

“…Trial Registration ClinicalTrials.gov (https://www.clinicaltrials.gov/), NCT02869815…”
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Serum and urine eosinophil-derived neurotoxin (EDN) levels predict biologic response in severe asthma by Yu Ri Kang, MD, Hyunkyoung Kim, MS, MPH, Chae Eun Lee, BS, Jae-Woo Jung, MD, PhD, Ji-Yong Moon, MD, PhD, So Young Park, MD, MS, Sae-Hoon Kim, MD, PhD, Min-Suk Yang, MD, PhD, Byung Keun Kim, MD, PhD, Jae-Woo Kwon, MD, PhD, Hye-Kyung Park, MD, PhD, Young-Hee Nam, MD, PhD, Young-Joo Cho, MD, PhD, Taehoon Lee, MD, PhD, Ian M. Adcock, MD, PhD, Pank Bhavsar, MD, PhD, Kian Fan Chung, MD, PhD, Tae-Bum Kim, MD, PhD

“…The study protocol is registered at ClinicalTrials.gov (NCT05164939). Results: The findings underscore strong correlations between serum EDN levels, blood eosinophil counts, and treatment responses, with EDN demonstrating comparable predictive capabilities to blood eosinophil counts to determine treatment responses. …”
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Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI) by Giorgio Walter Canonica, MD, Francesco Blasi, PhD, Pierluigi Paggiaro, MD, Enrico Heffler, PhD, Fulvio Braido, MD, Luisa Brussino, PhD, Giulia Scioscia, PhD, Cristina Cardini, MsC, Chiara Oriecuia, MsC, Isabella Sala, MsC, Vincenzo Bagnardi, PhD, Cecilia Calabrese, PhD, Gianna Camiciottoli, MD, Giovanna Elisiana Carpagnano, PhD, Stefano Centanni, PhD, Angelo Guido Corsico, PhD, Maria Teresa Costantino, MD, Claudia Crimi, PhD, Alice D'Adda, MD, Simona D’Alò, MD, Maria D'Amato, PhD, Corrado D'Andria, MD, Stefano Del Giacco, MD, Fabiano Di Marco, PhD, Nicola Cosimo Facciolongo, MD, Alessandro Farsi, MD, Manuela Latorre, PhD, Manlio Milanese, PhD, Eustachio Nettis, MD, Eleonora Nucera, MD, Giovanni Passalacqua, MD, Girolamo Pelaia, MD, Laura Pini, MD, Luisa Ricciardi, PhD, Fabio Luigi Massimo Ricciardolo, PhD, Luca Richeldi, PhD, Erminia Ridolo, PhD, Pierachille Santus, PhD, Nicola Scichilone, PhD, Gianenrico Senna, MD, Giuseppe Spadaro, MD, Antonio Spanevello, MD, Paolo Tarsia, MD

“…Trial registration: ClinicalTrials.gov ID: NCT06625216; Central Ethics Committee: Comitato Etico Area Vasta Nord-Ovest Toscana (study number 1245/2016, protocol number:73714).…”
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Non-Immersive Virtual Reality Exercise Can Increase Exercise in Older Adults Living in the Community and in Long-Term Care: A Randomized Controlled Trial by Sheehy L, Bharadwaj L, Nissen KA, Estey JL

“…Most were interested to continue beyond the study.Conclusion: Non-immersive virtual reality for home-based and facility-based older adults is safe, enjoyable and feasible and may increase users’ weekly levels of physical activity leading to clinical benefits for functional walking in facility-based users.Trial Registration: ClinicalTrials.gov (NCT04083885; registered 2019– 09-06).Plain language summary: Regular exercise is so important for older adults. …”
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Durvalumab and tremelimumab in patients with advanced rare cancer: a multi-centre, non-blinded, open-label phase II basket trialResearch in context by Abha A. Gupta, Anna Tinker, Derek Jonker, Rahma Jamal, Hal Hirte, Eric W. Winquist, Quincy Chu, Christian Kollmannsberger, Ralph Wong, Thierry Alcindor, Torsten O. Nielsen, Ming Tsao, Tricia R. Cottrell, Diane Provencher, John Hilton, Monika K. Krzyżanowska, Christine Elser, Sebastien Hotte, Joana Sederias, Siwei Zhang, Wei Tu, Janet Dancey

“…This trial is registered with ClinicalTrials.gov, NCT02879162. Findings: From December 14th, 2016, to August 14, 2019, 140 patients enrolled into seven cohorts. …”
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Multicentre Harmonisation of a Six-Colour Flow Cytometry Panel for Naïve/Memory T Cell Immunomonitoring by Iole Macchia, Valentina La Sorsa, Irene Ruspantini, Massimo Sanchez, Valentina Tirelli, Maria Carollo, Giorgio Fedele, Pasqualina Leone, Giovanna Schiavoni, Carla Buccione, Paola Rizza, Paola Nisticò, Belinda Palermo, Stefania Morrone, Helena Stabile, Aurelia Rughetti, Marianna Nuti, Ilaria Grazia Zizzari, Cinzia Fionda, Roberta Maggio, Cristina Capuano, Concetta Quintarelli, Matilde Sinibaldi, Chiara Agrati, Rita Casetti, Andrea Rozo Gonzalez, Floriana Iacobone, Angela Gismondi, Filippo Belardelli, Mauro Biffoni, Francesca Urbani

“…Flow cytometry (FCM) methods represent an essential tool for immunomonitoring, and their harmonisation is crucial to obtain comparable data in multicentre clinical trials. The objective of this study was to design a harmonisation workflow able to address the most effective issues contributing to intra- and interoperator variabilities in a multicentre project. …”
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