Showing 661 - 680 results of 3,305 for search '"labelling"', query time: 0.06s Refine Results
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    Treat-to-target strategy with secukinumab as a first-line biological disease modifying anti-rheumatic drug compared to standard-of-care treatment in patients with active axial spondyloarthritis: protocol for a randomised open-label phase III study, AScalate by Xenofon Baraliakos, Denis Poddubnyy, Ludwig Hammel, Marvin Heyne, Justyna Veit, Claudia Jentzsch

    Published 2020-09-01
    “…This study aims to evaluate the efficacy of a T2T strategy in patients with axSpA, with secukinumab as a first-line bDMARD, compared with standard-of-care (SOC) treatment.Methods and analyses This is a randomised, parallel-group, open-label, multicentre ongoing study in patients with axSpA who are naïve to bDMARD and who have had an inadequate response to NSAIDs. …”
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  4. 664

    Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial by Ernest Choy, Kerenza Hood, Emma Thomas-Jones, Eleanor Barnes, Keith Wilson, Christian H Ottensmeier, Debbie Harris, Adrian Hill, Mark Tuthill, Richard Adams, Catherine Porter, Katie Ewer, Sian Griffin, Rebecca Tangney, Joanne Euden, Shirley Pringle, Lawrence Raisanen, Ruby Ray, Lisette Sheena Nixon, Melanie Varley, Craig Bodman, Paola Cicconi, Vivien Dagley, Steven Knapper

    Published 2025-01-01
    “…The RAPID-PROTECTION trial will determine the levels of immune protection that AZD7442 offers patients at the very highest risk of SARS-CoV-2 infection and whether this protection can be further enhanced by repeated vaccination against SARS-CoV-2 virus.Methods RAPID-PROTECTION is a multicentre, interventional and open-label adaptive platform trial that aims to recruit 350 immunocompromised participants across five UK centres. …”
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  5. 665

    Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial by Junya Furukawa, Yasumasa Kakei, Sae Murakami, Hiroshi Kita, Hideto Ueki, Takuto Hara, Jun Teishima, Nobuyuki Hinata, Hideaki Miyake, Masato Fujisawa, Toshiro Shirakawa

    Published 2025-02-01
    “…Abstract Background This is a multicenter, open-label, single-arm clinical trial to evaluate the safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer. …”
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    Protocol for a multicentre, prospective, open-label, randomised controlled trial to compare PROs and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction via a deep inferior epigastric perforator flap (CAPPELLA) in China by Li Zhang, Jiong Wu, Guangyu Liu, Shuang Hao, Jianjing Hou, Changming Zhou, Yifeng Hou, Keda Yu, Zhen Hu, Genhong Di, Zhi Min Shao, Xiaoli Yu

    Published 2025-01-01
    “…Further evaluation in a randomised trial comparing preoperative radiotherapy versus conventional PMRT in breast reconstruction is required to assess both oncological and patient-reported outcomes (PROs).Methods and analysis The CAPPELLA trial is a prospective, multicentre, open-label, randomised controlled trial across nine centres comparing PROs and safety outcomes between preoperative and postoperative radiotherapy in patients with locally advanced breast cancer requiring immediate DIEP flap reconstruction. …”
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    Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial by Ying Cheng, Panpan Zhang, Ming Lu, Zhendong Chen, Lijie Song, Si Shi, Feng Ye, Xing Zhang, Baorui Liu, Dongmei Ji, Yanqiao Zhang, Weiguo Su, Michael Shi, Songhua Fan, Panfeng Tan, Chen Zhong

    Published 2025-02-01
    “…Here, we report the efficacy and safety of this combination regimen in treatment-naive advanced or metastatic non-small-cell lung cancer (NSCLC) patients with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) of 1% or greater (PD-L1-positive) and patients with previously treated small-cell lung cancer (SCLC). Methods This open-label, single-arm phase II study included patients with treatment-naive advanced or metastatic PD-L1-positive NSCLC or previously treated SCLC in China. …”
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  18. 678

    Safety and tumour-specific immunological responses of combined dendritic cell vaccination and anti-CD40 agonistic antibody treatment for patients with metastatic pancreatic cancer: protocol for a phase I, open-label, single-arm, dose-escalation study (REACtiVe-2 trial) by Joachim G J V Aerts, Sjoerd H van der Burg, Martijn P Lolkema, Sai Ping Lau, Freek R van ’t Land, Marjolein Y V Homs, Casper H J van Eijck

    Published 2022-06-01
    “…This study will determine the safety of DC/anti-CD40 agonistic antibody combination treatment, and treatment-induced tumour-specific immunological responses.Methods and analysis In this open-label, single-centre (Erasmus Univsersity Medical Center, Rotterdam, Netherlands), single-arm, phase I dose finding study, adult patients with metastatic pancreatic cancer with progressive disease after FOLFIRINOX chemotherapy will receive monocyte-derived DCs loaded with an allogeneic tumour lysate in conjunction with a CD40 agonistic antibody. …”
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