Efficacy of Antibiotic Versus Probiotics as Adjuncts to Mechanical Debridement for the Treatment of Peri-Implant Mucositis by Sindhu Sudhakar Kumararama, Manali Patil, Bhavna Jha Kukreja, Manjiri Salkar, Shikha Verma, Naina Pattnaik, Lalit Patil

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A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers by Alevtina A. Lidzhieva, Alisa Yu. Medkova, Sergey V. Kulikov, Ludmila N. Sinyashina, Rezida A. Sioundioukova, Andrey P. Markov, Aleksey B. Verveda, Natalia E. Abaeva, Irina N. Chernyshova, Marina V. Gavrilova, Kristina K. Bushkova, Ilya N. Dyakov, Gennady I. Karataev

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Healing potentiality of blood clot, S-PRF and A-PRF as scaffold in treatment of non-vital mature single rooted teeth with chronic peri-apical periodontitis following regenerative endodontic therapy: randomized clinical trial by Omnia Badawy Darwish, Said Mohamed Abdel Aziz, Hany Samy Sadek

“…There is a need for future randomized clinical studies to consolidate procedures in this field with more prolonged evaluation periods. Clinical trial registration The study was retrospectively registered with ClinicalTrials.gov (ID: NCT04606719 ) in 28/10/2020.…”
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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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Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [vers... by Sammy Ainsworth, Cherry-Ann Waldron, Sarah Jones, Julie Carman, Martina Svobodova, Graham Prestwich, Margaret Ogden, Melanie Gager, Liza Keating

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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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Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands by John W Devlin, Zoran Trogrlic, Mathieu van der Jagt, Lisa Smit, Robert-Jan Osse, Huibert H Ponssen, Arjen J C Slooter, Nicole G M Hunfeld, Wim J R Rietdijk, Diederik Gommers, M. van den Boogaard, A.J.B.W. Brouwers, J.A. Lens, B.J.M. van der Meer, H. Ponssen, F.J. Schoonderbeek, K.S. Simons, E. Berger, A. Bouman, M. Campo, D. van Duijn, H. Embden – van Donk, D. van de Graaf, E. Hoogendoorn, P. Ormskerk, N. Roovers, E. Toscano, A. Vileito, T. van Zuylen, C. Exler, E. van den Berg, J. van Meeteren, M. Koopmanschap, I. Nutma, E. Kuijper

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Effects of self-monitoring physical activity with wearable activity trackers on perceived joint function and health-related quality of life in people with hip and knee osteoarthritis: a secondary analysis of a cluster-randomised clinical trial by Elin Östlind, Frida Eek, Kjerstin Stigmar, Eva Ekvall Hansson

“…Trial registration ClinicalTrials.gov, NCT03354091. Registered 15/11/2017.…”
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Comparison of Chest-to-Back Skin-to-Skin Contact and Chest-to-Chest Skin-to-Skin Contact on the Risk of Oxygen Desaturation and Change in Heart Rate in Low Birth Weight and/or Premature Babies: A Randomized Controlled Clinical Trial by Sisay Gere, Yemane Berhane, Alemayehu Worku

“…We used a parallel-group randomized controlled clinical trial. Peripheral arterial blood oxygen saturation (SpO2) and heart rate (HR) were measured using an OxiMaxN-600X Pulse Oximeter. …”
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