Hypofractionated radiotherapy combined with a PD-1 inhibitor, granulocyte macrophage-colony stimulating factor, and thymosin-α1 in advanced metastatic solid tumors: a multicenter Phase II clinical trial by Jiamin Yu, Li Yin, Wenjie Guo, Qiang Wang, Juying Liu, Lansheng Zhang, Hongxun Ye, Jianhong Xia, Youyou Xia, Jianfeng Wu, Wanwei Wang, Yanguang Yang, Dan Zong, Xia He, Lijun Wang, Hong Jiang

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The Antimicrobial Effect of Pomegranate Peel Extract versus Chlorhexidine in High Caries Risk Individuals Using Quantitative Real-Time Polymerase Chain Reaction: A Randomized Triple-Blind Controlled Clinical Trial by Benoy Jacob, Nivedhitha Malli Sureshbabu, Manish Ranjan, Aishwarya Ranganath, Riluwan Siddique

“…This triple-blind randomized clinical trial involved 60 high caries risk adult patients, 19–59 years of age, randomly allocated into two groups of 30 subjects each. …”
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Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China by Yang Zhang, Shiyuan Wang, Guifan Li, Jinhui Shi, Xianyun Chang, Hao Zhang, Fengcai Zhu, Jingxin Li, Hongxing Pan, Jinfang Sun

“…Additionally, the incidence rates of swelling and fatigue were lower in the test group compared to the control group after vaccination.Conclusions The test freeze-dried live attenuated VarV demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 13-55 years.Clinical trials registration www.clinicaltrials.gov identifier: NCT06592456.…”
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Effect of a multimodal analgesia strategy on remifentanil daily consumption in mechanically ventilated adult ICU patients: study protocol for a randomised, placebo-controlled, double-blind, parallel-group clinical trial by Thibault Mura, Jean-Yves Lefrant, Remy Widehem, Camille Nicolet, Violaine Delannoy, Laurie Barthelemi, Ian Soulairol, Claire Roger

“…Secondary outcomes will include drug tolerance, mechanical ventilation duration, ICU and hospital length of stay, 28-day and 90-day mortalities and 90-day opioid consumption.Ethics and dissemination The study protocol was accepted by the Nîmes University Hospital’s research committee, the French ethics committee (Institutional Review Board OUEST IV) and the French National Agency for the Safety of Medicines and Health Products (ANSM).Trial registration number ClinicalTrials.gov: NCT05825560…”
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Patients’ acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualitative secondary analysis of a mixed-method randomised clinical trial by Tempei Miyaji, Yosuke Uchitomi, Hiroyuki Okada, Masatoshi Inagaki, Maiko Fujimori, Taichi Shimazu, Masaki Fujiwara, Masafumi Kodama, Ryuhei So, Takanori Matsushita, Yusaku Yoshimura, Shigeo Horii, Hirokazu Takahashi, Naoki Nakaya, Shiro Hinotsu, Keita Harada, Norihito Yamada, Yuto Yamada, Tsuyoshi Etoh

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Outcomes of a pilot randomized clinical trial testing brief interventions to increase HIV pre-exposure prophylaxis uptake among rural people who inject drugs attending syringe services programs by Hilary L. Surratt, Sarah Brown, Abby L. Burton, Will Cranford, Laura C. Fanucchi, Christie Green, Stephanie M. Mersch, Rebecca Rains, Philip M. Westgate

“…Trial registration: Prospective registration with ClinicalTrials.gov, NCT05037513 (registered August 5, 2021).…”
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TARGET Protein: the effect of augmented administration of enteral protein to critically ill adults on clinical outcomes—statistical analysis plan for a cluster randomized, cross-sectional, double cross-over, clinical trial by Sophie Zaloumis, Matthew J. Summers, Jeffrey J. Presneill, Rinaldo Bellomo, Lee-anne S. Chapple, Marianne J. Chapman, Adam M. Deane, Suzie Ferrie, Craig French, Sally Hurford, Nima Kakho, Matthew J. Maiden, Stephanie N. O’Connor, Sandra L. Peake, Emma J. Ridley, An Tran-Duy, Patricia J. Williams, Paul J. Young, Amalia Karahalios, on behalf of the TARGET Protein Investigators, the Australian, New Zealand Intensive Care Society Clinical Trials Group

“…Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12621001484831). Registered on November 1, 2021.…”
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Efficacy and safety of an algorithm using C-reactive protein to guide antibiotic therapy applied through a digital clinical decision support system: a study protocol for a randomised controlled clinical trial by Vandack Nobre, Pedro R Povoa, Vitoria Moura Leite Rabelo Rezende, Isabela Nascimento Borges, Cecilia Gomez Ravetti, Renan Pedra De Souza, Paula Frizera Vassalo, Ana Clara de Paula Caldas, Felipe Rodrigues Gatto, Getulio Hideyoshi Okamura, Raquel Lopes de Brito Lacerda

“…While CRP is less studied, it offers advantages such as lower cost and broader availability compared with PCT.Methods and analysis This randomised clinical trial aims to evaluate a novel algorithm for non-critically ill adult patients. …”
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Efficacy and safety of SHEN26, a novel oral small molecular RdRp inhibitor for COVID-19 treatment: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial by Jiangtao Bai, Tetsuya Asakawa, Wenfang Yuan, Yuanlong Lin, Hao Ju, Dandan Xu, Mingming Yang, Shuo Li, Guanguan Li, Deyin Guo, Hongzhou Lu, Xumu Zhang

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Effectiveness of a family customised online FOCUS programme aimed on building resiliency in dyad relationship to support dyadic illness management in persons with heart failure and their informal caregiver: a randomised clinical trial protocol by Xin Zhang, Xiaonan Zhang, Yongjun Cao, Weiling Yang, Yanting Li, Xuedong Li, Sixuan Jiang, Qingyun LV, Mei Cheng, Xiaoying Zang

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A phase 1b clinical trial to determine the safety, tolerability and immunogenicity of simian adenovirus and poxvirus vectored vaccines against Mycobacterium avium complex subspecies in patients with active Crohn’s diseaseResearch in context by Jeremy Sanderson, Jeremy Aboagye, Rebecca Makinson, Katerina Rapi, Samuel Provstgaard-Morys, Lisa Stockdale, Alison Lawrie, Isabelle Lanigan, Nishat Halim, Abdel Douiri, Emily Greenlay, Rayka Malek, Emma Gray, Lindsey West, Fatima El Oulidi, Paul Ian Cross, Michael Stallibrass, Sarah C. Gilbert, Adrian V.S. Hill, Katie J. Ewer

“…The Sponsor was involved in protocol development, trial conduct, including data monitoring and analysis, and the preparation of this manuscript in line with the Medicines for Human Use (Clinical Trials) Regulations 2004 and amendments.…”
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A core set of risk factors in individuals at risk of rheumatoid arthritis: a systematic literature review informing the EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis by Daniel Aletaha, Kulveer Mankia, Paul Emery, Deshire Alpizar-Rodriguez, Andreas Kerschbaumer, Andrea Di Matteo, Heidi Siddle, Joel Kerry

“…This SLR informed the EULAR taskforce for points to consider on conducting clinical trials and studies in individuals at risk of RA.…”
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Anaesthetic Efficacy of 4% Articaine in Comparison with 2% Lidocaine as Intraligamentary Injections after an Ineffective Inferior Alveolar Nerve Block in Mandibular Molars with Irreversible Pulpitis: A Prospective Randomised Triple-Blind Clinical Trial by Nazanin Zargar, Elnaz Shooshtari, Leila Pourmusavi, Alireza Akbarzadeh Baghban, Hengameh Ashraf, Ardavan Parhizkar

“…The objective of the current study was to compare the anaesthetic efficacy of supplemental intraligamentary (IL) injection of 4% articaine with that of 2% lidocaine in the mandibular first and second molars with irreversible pulpitis after an ineffective inferior alveolar nerve block injection (IANB) using the same anaesthetic in a randomised triple-blind clinical trial. Seventy-six adult patients, who were diagnosed with irreversible pulpitis in the mandibular first or second molars, were divided into 2 groups and received IANB randomly. …”
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Post Hoc Analyses of Data from a 90-Day Clinical Trial Evaluating the Tolerability and Efficacy of Tapentadol Immediate Release and Oxycodone Immediate Release for the Relief of Moderate to Severe Pain in Elderly and Nonelderly Patients by Gary Vorsanger, Jim Xiang, David Biondi, David Upmalis, Jacqueline Delfgaauw, René Allard, Bruce Moskovitz

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Determinants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials: results from the Pembro-real 5Y global registry by Mieke Van Hemelrijck, Salvatore Grisanti, Avinash Aujayeb, Martin Forster, Giannis Mountzios, Andrea Napolitano, Bruno Vincenzi, Joachim G J V Aerts, Marina Garassino, Valter Torri, Solange Peters, Alex Friedlaender, Alfredo Addeo, Giuseppe Lo Russo, Roberto Ferrara, Diego Signorelli, Alessandro Russo, So Yeon Kim, Jarushka Naidoo, Scott Gettinger, Heather Wakelee, Martin Sebastian, Mark Awad, Abdul Rafeh Naqash, Alessio Cortellini, Raffaele Giusti, Michele De Tursi, Federica Zoratto, Marco Russano, Rita Chiari, Biagio Ricciuti, Andrea De Giglio, Alain Gelibter, Giuseppe Tonini, Amin H Nassar, Alessandra Curioni-Fontecedro, Eleni Karapanagiotou, Emilio Bria, Jack Bell, Paolo Bironzo, Joao V Alessi, Alessandro Morabito, David J Pinato, Francesco Passiglia, Carlo Genova, Francesca Mazzoni, Alessandro Inno, Francesco Grossi, Luca Cantini, Lorenza Landi, Luigi Della Gravara, Margarita Majem, Uma Mukherjee, Federica Biello, Alessandro Leonetti, Annalisa Guida, Marianna Macerelli, Gabriele Minuti, Giulio Metro, Thomas Newsom-Davis, Eleni Josephides, Andrea Camerini, Elisa Roca, David O’Reilly, Mingjia Li, Laura Mezquita, Teresa Gorría, Claudia A M Fulgenzi, Lauren Young, Joel W Neal, Javier Baena, Francesco Pantano, Jacobo Rogado, Mary Jo Fidler, Teresa Beninato, Federica Pecci, Alessandro Di Federico, Kazuki Takada, Leonardo Brunetti, Talal El Zarif, Laura Moliner, Alberto Servetto, Sukumar Kalvapudi, Sai Yendamuri, Edoardo Garbo, Giuseppina Rita Di Fazio, Monica Loza, Ritujith Jayakrishnan, Michele Montrone, Nichola O Awosika, Bartlomiej Tomasik, Maximilian Rost, Isabelle Monnet, Francesco Agustoni, Artur Katz, Dwight Hall Owen, Michele Ghidini, Armida D’Incecco, Gianpaolo Spinelli, Monica Verrico, Manuel Dupont, Rafael Di Marco Barros, Diego Luigi Cortinovis, Chiara Bennati, Frank Aboubakar Nana, Anne-Marie Dingemans, Taher Abu Hejleh

“…To further assess the reproducibility of clinical trial results, we reconstructed the “KN024 look-alike” cohort by excluding patients with an Eastern Cooperative Oncology Group-performance status (ECOG-PS)≥2, those requiring corticosteroids with doses ≥10 mg of prednisolone/equivalent, patients with positive/unknown epidermal growth factor receptor/anaplastic lymphoma kinase genotype, and those with pre-existing autoimmune disease. …”
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Implementation of Virtual and Face-to-Face Childbirth Preparation Training for the Spouses of the Primiparous Women to Reduce the Fear of Childbirth, Improve the Pregnancy Experience, and Enhance Mother- and Father-Infant Attachment: Protocol for a Quasiexperimental Clinical Trial by Zari Doaltabadi, Leila Amiri-Farahani, Seyedeh Batool Hasanpoor-Azghady

“…This research has been funded by the Iran University of Medical Sciences, approved by the Thailand Registry of Clinical Trials, and will commence in May 2020. Results will be disseminated through peer-reviewed journals and shared with the academic and medical community to pregnancy and childbirth outcomes. …”
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The potential of stem cell therapy in Multiple Sclerosis treatment: a review by Sorina Amarculesei, Ava O'Meara Cushen, Cathy Brougham

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Comparison of surgical wound infection and dehiscence following the use of two methods of nylon sutures and skin staples in staples in diabetic mellitus patients undergoing total knee arthroplasty surgery: a randomized clinical trial study by Haadiyeh Rahbari, Mohammadamin Ahmadi, Mina Amiri Doreh, Samira Mahmoudi, Parvin Ghaemmaghami, Armin Fereidouni

“…Methods This is a single-blind randomized clinical trial including 70 diabetic mellitus patients undergoing TKA. …”
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Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial by Fengcai Zhu, Ting Huang, Pengfei Jin, Linglin Zhang, Zhongqiang Jin, Wenli Zhang, Dongya Yuan, Zhong Wang, Yusong Deng, Jiaxin Li, Xiao Shen, Yongpan Fu, Jian Li, Xinjie Yang, Jing Li, Liangzhi Xie

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Post-kala-azar dermal leishmaniasis (PKDL) drug efficacy study landscape: A systematic scoping review of clinical trials and observational studies to assess the feasibility of establishing an individual participant-level data (IPD) platform. by Sauman Singh-Phulgenda, Rishikesh Kumar, Prabin Dahal, Abdalla Munir, Sumayyah Rashan, Rutuja Chhajed, Caitlin Naylor, Brittany J Maguire, Niyamat Ali Siddiqui, Eli Harriss, Manju Rahi, Fabiana Alves, Shyam Sundar, Kasia Stepniewska, Ahmed Musa, Philippe J Guerin, Krishna Pandey

“…Eight (14.3%) were randomised clinical trials, and 48 (85.7%) were non-randomised studies. …”
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