Categorising implementation determinants and strategies within the US HIV implementation literature: a systematic review protocol by Justin D Smith, Brian Mustanski, Virginia McKay, James Lorenz Merle, Dennis Li, Brennan Keiser, Alithia Zamantakis, Artur Queiroz, Carlos G Gallo, Juan A Villamar, Juan Pablo Zapata, Nanette Benbow

“…Implementation strategies and outcomes will be categorised in accordance with existing taxonomies and frameworks.Ethics and dissemination Ethics approval is not applicable. …”
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Does an increase in physiological indexes predict better cognitive performance: the PhyCog randomised cross-over protocol in type 2 diabetes by Frederic Dutheil, Guillaume T Vallet, Igor Tauveron, Julien S Baker, Valentin Magnon, Jordan Mille, Valentin Brusseau, Laetitia Silvert, Marie Izaute

“…To test the primary hypothesis, the relationship between improvement in physiological variables and improvement in cognitive variables (executive, memory and attention) will be collected.Ethics and dissemination This protocol was approved by the Est III French Ethics Committee (2020-A03228-31). …”
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The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vert... by Avril Drummond, Opinder Sahota, Simon Bishop, Dritan Pasku, Apostolos Fakis, Anastasios Bastounis, Chia Wei Tan, Maribel Cameron, Yuriy Arlachov, Michal Czernicki

“…Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data.Ethics and dissemination Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). …”
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Bearberry in the treatment of acute uncomplicated cystitis (BRUMI): protocol of a multicentre, randomised double-blind clinical trial by Péter Hegyi, Noémi Gede, Szilárd Váncsa, Barbara Tóth, András Jávorházy, Péter Nyirády, Boglárka Csupor-Löffler, Péter Birinyi, George Zhanel, Kurt Naber, Reinhard Länger, Nóra Vörhendi, Dezső Csupor

“…The number of recurrences and medications taken for treatment will be monitored for a follow-up period of 90 days (80–100 days).Ethics and dissemination This study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/4225-1/2021/EKU). …”
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Effect of photobiomodulation as preventive treatment of diabetic foot ulcer: randomised, controlled, double-blind, clinical trial protocol by Lara Jansiski Motta, Anna Carolina Ratto Tempestini Horliana, Kristianne Porta Santos Fernandes, Raquel Agnelli Mesquita-Ferrari, Sandra Kalil Bussadori, Roselene Lourenço, Silvana Torres Perez, Cinthya Cosme Gutierrez Duran, Alexandre Rocha Santos Padilha, Tainá Caroline dos Santos Malavazzi

“…Assessments will be performed at the beginning of the study, after 30 days (clinical examination) and after 60 days (clinical examination, assessment of peripheral neuropathy (PN) and peripheral artery disease (PAD), blood and urine examinations and quality of life).Ethics and dissemination This protocol received approval from the Human Research Ethics Committee of Nove de Julho University and the Mandaqui Hospital Complex (certificate number: 66098522.0.3001.5511; final approval date: 22 June 2023). …”
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Deriving and validating a risk prediction model for long COVID-19: protocol for an observational cohort study using linked Scottish data by Jennifer K Quint, Aziz Sheikh, Chris Robertson, Srinivasa Vittal Katikireddi, Emily Moore, Colin R Simpson, Luke Daines, Eleftheria Vasileiou, Syed Ahmar Shah, Rachel H Mulholland, Vicky Hammersley, Steven Kerr, Ting Shi, David Weatherill, Elisa Pesenti

“…We will then derive, internally and externally validate a prediction model to identify the epidemiological risk factors associated with long-COVID.Ethics and dissemination The EAVE II study has obtained approvals from the Research Ethics Committee (reference: 12/SS/0201), and the Public Benefit and Privacy Panel for Health and Social Care (reference: 1920-0279). …”
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Identifying biomarkers for epilepsy after cerebral malaria in Zambian children: rationale and design of a prospective observational study by Bo Zhang, Archana A Patel, Gretchen L Birbeck, Maitreyi Mazumdar, Suzanna Mwanza, Rosemary Nyirongo, Dixon Berejena, Joseph Kasolo, Tina Mwale, Violet Nambeye, Kafula Lisa Nkole, Nfwama Kawatu, Alexander Rotenberg

“…We will test the performance of these EEG and clinical metrics in predicting development of epilepsy through multivariate logistic regression analyses.Ethics and dissemination This study has been approved by the Boston Children’s Hospital Institutional Review Board, University of Zambia Biomedical Research Ethics Committee, and National Health Research Authority of Zambia. …”
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Exploring SLEEPINESS through home monitoring with ultra-long-term subcutaneous EEG and ecological momentary assessment in sleepy treatment naïve obstructive sleep apnea patients st... by Mathias Sarkez-Knudsen, Martin Ballegaard, Martin Ballegaard, Henning Piilgaard, Esben Ahrens, Martin Christian Hemmsen, Tobias Søren Andersen, Jakob Eyvind Bradram, Preben Homøe, Preben Homøe

“…Ethical approval from the Region Zealand Ethics Committee on 13/09/2021 (SJ939, EMN-2021-06803). …”
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An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol f... by Ana Paula Taboada Sobral, Elaine Marcilio Santos, Marcela Leticia Leal Gonçalves, Lara Jansiski Motta, Anna Carolina Ratto Tempestini Horliana, Sandra Kalil Bussadori, Elza Padilha Ferri, Juliana Maria Altavista Sagretti Gallo, Thais Gimenez, José Carlos Pettorossi Imparato

“…Secondary outcomes will include tooth survival, longevity of restoration, quality of life, perception and satisfaction of the participants’ parents/guardians.Ethics and dissemination This protocol has been approved by the Human Research Ethics Committee of Universidade Metropolitana de Santos (protocol number: 6.019.297. …”
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Effect of environmental enrichment on relapse rates in patients with severe alcohol use disorder: protocol for a randomised controlled trial by Lila Barillot, Claudia Chauvet, Marc Besnier, Nematollah Jaafari, Marcello Solinas, Armand Chatard

“…This study is approved by the Ethics Committee Nord Ouest IV of Lille (reference number 2022-A01156-37). …”
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Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial by Lara Jansiski Motta, Anna Carolina Ratto Tempestini Horliana, Sandra Kalil Bussadori, Maria Fernanda Setúbal Destro Rodrigues, Ana Eliza Castanho Garrini dos Santos, Marcelo Mendes Pinto, Dácio Antonio Pantano Junior, Aldo Brugnera Jr, Fátima Antonia Aparecida Zanin

“…Multivariate analysis of variance (MANOVA) and the Wilcoxon test will be used for comparing data from the PIDAQ.Ethics and dissemination This protocol has been approved by the Human Research Ethics Committee of UniversidadeNove de Julho (certificate: 2.034.518). …”
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A surveillance study to determine the accuracy of mild traumatic brain injury diagnosis in an emergency department: protocol for a retrospective cohort study by Ian D Cameron, Ilaria Pozzato, Ashley Craig, Bamini Gopinath, Mark Gillett, Annette Kifley, Kim Van Vu, Susanne Meares, Anthony Liang

“…We estimate that 30 000 ED attendances will be screened and that a sample size of 500 cases with mTBI will be identified during this 1-year period, which will provide reliable estimates of mTBI occurrence in the ED setting.Ethics and dissemination The study was approved by the Northern Sydney Local Health District Ethics Committee. …”
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Efficacy of the Foodbot Factory digital curriculum-based nutrition education intervention in improving children’s nutrition knowledge, attitudes and behaviours in elementary school... by Wendy Lou, Michael Farkouh, JoAnne Arcand, Jacqueline Marie Brown, Saman Tahir, Beatriz Franco-Arellano, Ann LeSage, Janette Hughes, Bill Kapralos, Ellen Vogel, Claire Tugault-Lafleur

“…Generalised linear mixed models will assess changes in outcomes between groups.Ethics and dissemination The study protocol is approved by research ethics boards at Ontario Tech University and participating school boards. …”
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Study protocol: an observational study of distress, immune function and persistent pain in HIV by John A Joska, Mark R Hutchinson, Maia Lesosky, Victoria J Madden, Ncumisa Msolo, Luyanduthando Mqadi, Gillian J Bedwell, Jonathan Grant Peter, Romy Parker, Andrew Schrepf, Robert R Edwards

“…The study has been approved by the Human Research Ethics Committee of the University of Cape Town (approval number: 764/2019) and the City of Cape Town (ref: 24699).Trial registration number NCT04757987.…”
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Multicentre, 26-week, open-label phase 2 trial of the JAK inhibitor filgotinib in Behçet’s disease, idiopathic inflammatory myopathies and IgG4-related disease: DRIMID study protoc... by Sander W Tas, Joost Raaphorst, Paco M J Welsing, Jacob M van Laar, Rogier M Thurlings, Robbert J Goekoop, César Magro Checa, Jan A M van Laar, Bettina C Geertsema-Hoeve, Nicolle H Rekers, Erik Present

“…The coprimary endpoints are disease activity and quality of life across and within each disease.Ethics and dissemination The study received approval from the Medical Research Ethics Committee in Utrecht, Netherlands. …”
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Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being by Harald Baumeister, Ann-Marie Küchler, David Ebert, Natalie Bauereiss, Eileen Bendig, Benjamin Erb, Lena Weger, Echo Meißner

“…SISU guides participants through a 3-day intervention.Ethics and dissemination This trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). …”
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RadBone: bone toxicity following pelvic radiotherapy – a prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecologica... by Janelle Yorke, Sarah O’Connell, Sally Taylor, Karen Johnson, Robert G Bristow, Martin Eden, Kate Haslett, John Moore, Rohit Kochhar, Victoria Chatzimavridou Grigoriadou, Lisa H Barraclough, Ivona Baricevic-Jones, Zoe Merchant, Thomas Westwood, Anthony David Whetton, Claire E Higham

“…Clinical effectiveness and bone turnover markers will be evaluated as secondary outcomes.Ethics and dissemination This study has been approved by the Greater Manchester East Research Ethics Committee (Reference: 20/NW/0410, November 2020). …”
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Prevalence and determinants of persistent symptoms after infection with SARS-CoV-2: protocol for an observational cohort study (LongCOVID-study) by Lotte Haverman, Eelco Franz, Ka Yin Leung, Albert Jan Van Hoek, Hans Knoop, Cees C van den Wijngaard, Elizabeth N Mutubuki, Tessa van der Maaden, Albert Wong, Anna D Tulen, Siméon de Bruijn

“…Secondary outcomes include effect of vaccination prior to infection on persistent symptoms, loss of health-related quality of life (HRQoL) and risk factors for persisting symptoms following infection with SARS-CoV-2.Ethics and dissemination The Utrecht Medical Ethics Committee (METC) declared in February 2021 that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study (METC protocol number 21-124/C). …”
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Protocol on establishing a prospective enhanced surveillance of vaccine preventable diseases in residential aged care facilities in Central Queensland, Australia: an observational... by Mohammad Rashidul Hashan, Robert Booy, Michael Kirk, Gulam Khandaker, Gwenda Chapman, Jacina Walker, Sonya Jayne Davidson, Jill Auriac, Nicolas Smoll, Delwar Akbar

“…Descriptive statistics, univariate and multivariate regression analysis will be conducted to identify the predictors of morbidity and clinical outcomes following infection.Ethics and dissemination The study has been approved by the CQHHS Human Research Ethics Committee (HREC) (reference number HREC/2021/QCQ/74305). …”
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RECIST 1.1 versus mRECIST for assessment of tumour response to molecular targeted therapies and disease outcomes in patients with hepatocellular carcinoma: a systematic review and... by Yao Yang, Yuping Bai, Hongli Yu, Qiang Zhu, Xiaoyu Xie, Yuemin Feng

“…However, the performance of both criteria in assessing disease progression is identical.PROSPERO registration number CRD42020200895.Ethics approval Ethics approval is not required in this meta-analysis.…”
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